Real World Experience With Ion Implant Fault Detection at Freescale Semiconductor
NASA Astrophysics Data System (ADS)
Sing, David C.; Breeden, Terry; Fakhreddine, Hassan; Gladwin, Steven; Locke, Jason; McHugh, Jim; Rendon, Michael
2006-11-01
The Freescale automatic fault detection and classification (FDC) system has logged data from over 3.5 million implants in the past two years. The Freescale FDC system is a low cost system which collects summary implant statistics at the conclusion of each implant run. The data is collected by either downloading implant data log files from the implant tool workstation, or by exporting summary implant statistics through the tool's automation interface. Compared to the traditional FDC systems which gather trace data from sensors on the tool as the implant proceeds, the Freescale FDC system cannot prevent scrap when a fault initially occurs, since the data is collected after the implant concludes. However, the system can prevent catastrophic scrap events due to faults which are not detected for days or weeks, leading to the loss of hundreds or thousands of wafers. At the Freescale ATMC facility, the practical applications of the FD system fall into two categories: PM trigger rules which monitor tool signals such as ion gauges and charge control signals, and scrap prevention rules which are designed to detect specific failure modes that have been correlated to yield loss and scrap. PM trigger rules are designed to detect shifts in tool signals which indicate normal aging of tool systems. For example, charging parameters gradually shift as flood gun assemblies age, and when charge control rules start to fail a flood gun PM is performed. Scrap prevention rules are deployed to detect events such as particle bursts and excessive beam noise, events which have been correlated to yield loss. The FDC system does have tool log-down capability, and scrap prevention rules often use this capability to automatically log the tool into a maintenance state while simultaneously paging the sustaining technician for data review and disposition of the affected product.
An implantable blood pressure and flow transmitter.
NASA Technical Reports Server (NTRS)
Rader, R. D.; Meehan, J. P.; Henriksen, J. K. C.
1973-01-01
A miniature totally implantable FM/FM telemetry system has been developed to simultaneously measure blood pressure and blood flow, thus providing an appreciation of the hemodynamics of the circulation to the entire body or to a particular organ. Developed for work with animal subjects, the telemetry system's transmission time is controlled by an RF signal that permits an operating life of several months. Pressure is detected by a miniature intravascular transducer and flow is detected by an extravascular interferometric ultrasonic technique. Both pressure and flow are calibrated prior to implanting. The pressure calibration can be checked after the implanting by cannulation; flow calibration can be verified only at the end of the experiment by determining the voltage output from the implanted sensing system as a function of several measured flow rates. The utility of this device has been established by its use in investigating canine renal circulation during exercise, emotional encounters, administration of drugs, and application of accelerative forces.
The bacterial sealing capacity of morse taper implant-abutment systems in vitro.
Ranieri, Rogerio; Ferreira, Andreia; Souza, Emmanuel; Arcoverde, Joao; Dametto, Fabio; Gade-Neto, Cicero; Seabra, Flavio; Sarmento, Carlos
2015-05-01
The use of Morse taper systems in dental implantology has been associated widely with a more precise adaptation between implants and their respective abutments. This may lead to an increase in the stability of the implant system and may also prevent microbial invasion through the implant-abutment interface. The aim of this study was to investigate in vitro the ability of four commercially available Morse taper system units to impede bacterial penetration through their implant-abutment interfaces. Abutments were screwed onto the implants, and the units were subsequently immersed in Streptococcus sanguinis bacterial broth (1 × 10(8) colony forming units/mL) for 48 hours. The units were examined by scanning electron microscopy (SEM) under three conditions: 1) with the implant-abutment components assembled as units to investigate for both the existence of microgaps and the presence of bacteria; 2) with the implants and abutments separated for examination of internal surfaces; and 3) with the implant-abutment components again assembled as units to measure any microgaps detected. The mean size of the microgaps in each unit was determined by measuring, under SEM, their width in four equidistant points. Microgaps were detected in all units with no significant differences in dimension (Kruskal-Wallis test, P >0.05). Within all units, the presence of bacteria was also observed. The seals provided by the interfaces of the commercially available Morse taper implant-abutment units tested were not sufficiently small to shield the implant from bacterial penetration.
A new system of implant abutment connection: how to improve a two piece implant system sealing.
Grecchi, F; DI Girolamo, M; Cura, F; Candotto, V; Carinci, F
2017-01-01
Implant dentistry has become one of the most successful dentistry techniques for replacing missing teeth. The success rate of implant dentistry is above 80%. However, peri-implantitis is a later complication of implant dentistry that if untreated, can lead to implant loss. One of the hypotized causes of peri-implantis is the bacterial leakage at the level of implant-abutment connection. Bacterial leakage is favored to the presence of a micro gap at the implant-abutment interface, allowing microorganisms to penetrate and colonize the inner part of the implant leading to biofilm accumulation and consequently to peri-implantitis development. To identify the capability of the implant to protect the internal space from the external environment, the passage of genetically modified Escherichia coli across implant-abutment interface was evaluated. Implants were immerged in a bacterial culture for twenty-four hours and then bacteria amount was measured inside implant-abutment interface with Real-time PCR. Bacteria were detected inside all studied implants, with a median percentage of 9%. The reported results are better to those of previous studies carried out on different implant systems. Until now, none implant-abutment system has been proven to seal the gap between implant and abutment.
Josephs, S F; Loudovaris, T; Dixit, A; Young, S K; Johnson, R C
1999-01-01
Continuous delivery of therapeutic peptide to the systemic circulation would be the optimal treatment for a variety of diseases. The Baxter TheraCyte system is a membrane encapsulation system developed for implantation of tissues, cells such as endocrine cells or cell lines genetically engineered for therapeutic peptide delivery in vivo. To demonstrate the utility of this system, cell lines were developed which expressed human growth hormone (hGH) at levels exceeding 1 microgram per million cells per day. These were loaded into devices which were then implanted into juvenile nude rats. Significant levels of hGH of up to 2.5 ng/ml were detected in plasma throughout the six month duration of the study. In contrast, animals implanted with free cells showed peak plasma levels of 0.5 to 1.2 ng four days after implantation with no detectable hGH beyond 10 days. Histological examination of explanted devices showed they were vascularized and contained cells that were viable and morphologically healthy. After removal of the implants, no hGH could be detected which confirmed that the source of hGH was from cells contained within the device. The long term expression of human growth hormone as a model peptide has implications for the peptide therapies for a variety of human diseases using membrane encapsulated cells.
Subcutaneous chronic implantable defibrillation systems in humans.
Cappato, Riccardo; Smith, Warren M; Hood, Margaret A; Crozier, Ian G; Jordaens, Luc; Spitzer, Stefan G; Ardashev, Andrey V; Boersma, Lucas; Lupo, Pierpaolo; Grace, Andrew A; Bardy, Gust H
2012-09-01
The recent introduction of subcutaneous implantable cardioverter defibrillator (S-ICD) has raised attention about the potential of this technology for clinical use in daily clinical practice. We review the methods and results of the four studies conducted in humans for approval of this innovative technology for daily practice. Two studies using a temporary S-ICD system (acute human studies) were conducted to search for an appropriate lead configuration and energy requirements. For this purpose, 4 S-ICD configurations were tested in 78 patients at the time of transvenous (TV)-ICD implantation. The optimal configuration was tested in 49 more patients to comparatively assess the subcutaneous defibrillation threshold (S-DFT) versus the standard TV-ICD. Long-term implants were evaluated in 55 patients using an implanted system (chronic human study). The acute humans studies led to an optimal S-ICD configuration comprising a parasternal electrode and left anterolateral thoracic pulse generator. Both configurations successfully terminated 98% of induced ventricular fibrillation (VF), but significantly higher energy levels were required with S-ICD than with TV-ICD systems (36.6 ± 19.8 J vs. 11.1 ± 8.5 J). In the chronic study, all 137 VF episodes induced at time of implant were detected with a 98% conversion rate. Two pocket infections and four lead revisions were required during 10 ± 1 months of follow-up. During this period, survival was 98%, and 12 spontaneous ventricular tachyarrhythmias were detected and treated by the device. These data show that the S-ICD systems here consistently detected and converted VF induced at time of implant as well as sustained ventricular tachyarrhythmias occurring during follow-up (248).
Metallic orthopaedic implants and airport metal detectors.
Kamineni, S; Legge, S; Ware, H
2002-01-01
Airport security can detect in vivo metallic implants. We hypothesized that a soft tissue shield and fast transit through archway detectors would decrease implant detectability, whereas greater implant mass would increase detectability. Twelve patients with 8 orthopaedic implants in vivo and 60 trauma and arthroplasty implants in vitro were subjected to standard airport security measures at Stanstead Airport (British Airports Authority), including arch and standard and nonstandard hand-held detectors. Archway detectors failed to detect some implants; hand-held detectors detected almost all implants except an ankle arthroplasty. Positive archway detection was related to implant transit speed through the detection field. The implant mass consistently affected detection in stainless steel and titanium implants, and a 1-inch wax shield had no effect. Patients with metallic implants should prepare routinely with documentation of their implant before traveling through security ports.
The Effect of Breast Implants on Mammogram Outcomes.
Kam, Kelli; Lee, Esther; Pairawan, Seyed; Anderson, Kendra; Cora, Cherie; Bae, Won; Senthil, Maheswari; Solomon, Naveenraj; Lum, Sharon
2015-10-01
Breast cancer detection in women with implants has been questioned. We sought to evaluate the impact of breast implants on mammographic outcomes. A retrospective review of women undergoing mammography between March 1 and October 30, 2013 was performed. Demographic characteristics and mammogram results were compared between women with and without breast implants. Overall, 4.8 per cent of 1863 women identified during the study period had breast implants. Median age was 59 years (26-93). Women with implants were younger (53.9 vs 59.2 years, P < 0.0001), had lower body mass index (25.4 vs 28.9, P < 0.0001), and were more likely to have dense breast tissue (72.1% vs 56.4%, P = 0.004) than those without. There were no statistically significant differences with regards to Breast Imaging Recording and Data System 0 score (13.3% with implants vs 21.4% without), call back exam (18.9% with vs 24.1% without), time to resolution of abnormal imaging (58.6 days with vs 43.3 without), or cancer detection rate (0% with implants vs 1.0% without). Because implants did not significantly affect mammogram results, women with implants should be reassured that mammography remains useful in detecting cancer. However, future research is required to determine whether lower call back rates and longer time to resolution of imaging findings contribute to delays in diagnosis in patients with implants.
Yip, Marcus; Jin, Rui; Nakajima, Hideko Heidi; Stankovic, Konstantina M; Chandrakasan, Anantha P
2015-01-01
A system-on-chip for an invisible, fully-implantable cochlear implant is presented. Implantable acoustic sensing is achieved by interfacing the SoC to a piezoelectric sensor that detects the sound-induced motion of the middle ear. Measurements from human cadaveric ears demonstrate that the sensor can detect sounds between 40 and 90 dB SPL over the speech bandwidth. A highly-reconfigurable digital sound processor enables system power scalability by reconfiguring the number of channels, and provides programmable features to enable a patient-specific fit. A mixed-signal arbitrary waveform neural stimulator enables energy-optimal stimulation pulses to be delivered to the auditory nerve. The energy-optimal waveform is validated with in-vivo measurements from four human subjects which show a 15% to 35% energy saving over the conventional rectangular waveform. Prototyped in a 0.18 μ m high-voltage CMOS technology, the SoC in 8-channel mode consumes 572 μ W of power including stimulation. The SoC integrates implantable acoustic sensing, sound processing, and neural stimulation on one chip to minimize the implant size, and proof-of-concept is demonstrated with measurements from a human cadaver ear.
Imaging of common breast implants and implant-related complications: A pictorial essay
Shah, Amisha T; Jankharia, Bijal B
2016-01-01
The number of women undergoing breast implant procedures is increasing exponentially. It is, therefore, imperative for a radiologist to be familiar with the normal and abnormal imaging appearances of common breast implants. Diagnostic imaging studies such as mammography, ultrasonography, and magnetic resonance imaging are used to evaluate implant integrity, detect abnormalities of the implant and its surrounding capsule, and detect breast conditions unrelated to implants. Magnetic resonance imaging of silicone breast implants, with its high sensitivity and specificity for detecting implant rupture, is the most reliable modality to asses implant integrity. Whichever imaging modality is used, the overall aim of imaging breast implants is to provide the pertinent information about implant integrity, detect implant failures, and to detect breast conditions unrelated to the implants, such as cancer. PMID:27413269
Imaging of common breast implants and implant-related complications: A pictorial essay.
Shah, Amisha T; Jankharia, Bijal B
2016-01-01
The number of women undergoing breast implant procedures is increasing exponentially. It is, therefore, imperative for a radiologist to be familiar with the normal and abnormal imaging appearances of common breast implants. Diagnostic imaging studies such as mammography, ultrasonography, and magnetic resonance imaging are used to evaluate implant integrity, detect abnormalities of the implant and its surrounding capsule, and detect breast conditions unrelated to implants. Magnetic resonance imaging of silicone breast implants, with its high sensitivity and specificity for detecting implant rupture, is the most reliable modality to asses implant integrity. Whichever imaging modality is used, the overall aim of imaging breast implants is to provide the pertinent information about implant integrity, detect implant failures, and to detect breast conditions unrelated to the implants, such as cancer.
Automatic patient respiration failure detection system with wireless transmission
NASA Technical Reports Server (NTRS)
Dimeff, J.; Pope, J. M.
1968-01-01
Automatic respiration failure detection system detects respiration failure in patients with a surgically implanted tracheostomy tube, and actuates an audible and/or visual alarm. The system incorporates a miniature radio transmitter so that the patient is unencumbered by wires yet can be monitored from a remote location.
Hybrid Donor-Dot Devices made using Top-down Ion Implantation for Quantum Computing
NASA Astrophysics Data System (ADS)
Bielejec, Edward; Bishop, Nathan; Carroll, Malcolm
2012-02-01
We present progress towards fabricating hybrid donor -- quantum dots (QD) for quantum computing. These devices will exploit the long coherence time of the donor system and the surface state manipulation associated with a QD. Fabrication requires detection of single ions implanted with 10's of nanometer precision. We show in this talk, 100% detection efficiency for single ions using a single ion Geiger mode avalanche (SIGMA) detector integrated into a Si MOS QD process flow. The NanoImplanter (nI) a focused ion beam system is used for precision top-down placement of the implanted ion. This machine has a 10 nm resolution combined with a mass velocity filter, allowing for the use of multi-species liquid metal ion sources (LMIS) to implant P and Sb ions, and a fast blanking and chopping system for single ion implants. The combination of the nI and integration of the SIGMA with the MOS QD process flow establishes a path to fabricate hybrid single donor-dot devices. Sandia National Laboratories is a multi-program laboratory managed and operated by Sandia Corporation, a wholly owned subsidiary of Lockheed Martin Corporation, for the U.S. Department of Energy's National Nuclear Security Administration under contract DE-AC04-94AL85000.
Baj, A; Bolzoni, A; Russillo, A; Lauritano, D; Palmieri, A; Cura, F; Silvestre, F J; Giannì, A B
2017-01-01
Osseointegrated implants are very popular dental treatments today in the world. In osseointegrated implants, the occlusal forces are transmitted from prosthesis through an abutment to a dental implant. The abutment is connected to the implant by mean of a screw. A screw is the most used mean for connecting an implant to an abutment. Frequently the screws break and are lost. There is an alternative to screw retained abutment systems: the cone-morse connection (CMC). The CMC, thanks to the absence of the abutment screw, guarantees no micro-gaps, no micro-movements, and a reduction of bacterial leakage between implant and abutment. As P. gingivalis and T. forsythia penetration might have clinical relevance, it was the purpose of this investigation to evaluate molecular leakage of these two bacteria in a new CMC implants systems (Leone Spa®, Florence, Italy). To identify the capability of the implant to protect the internal space from the external environment, the passage of genetically modified Escherichia coli across implant-abutment interface was evaluated. Four cone-morse Leone implants (Leone® Spa, Florence, Italy) were immerged in a bacterial culture for 24 h and bacteria amount was then measured inside implant-abutment interface with Real-time PCR. Bacteria were detected inside all studied implants, with a median percentage of 3% for P. gingivalis and 4% for T. forsythia. Cone-morse connection implant system has very low bacterial leakage percentage and is similar to one-piece implants.
[The subcutaneous cardioverter-defibrillator: When less is more].
Kuschyk, J; Rudic, B; Akin, I; Borggrefe, M; Röger, S
2015-06-01
In the last few decades, defibrillator therapy has revolutionized treatment of patients at risk for sudden cardiac death. Multiple clinical trials have shown the benefit of implantable cardioverter-defibrillators (ICD) for primary and secondary prevention of sudden cardiac death. Being an entirely subcutaneous system, the S-ICD® avoids important periprocedural and long-term complications associated with transvenous implantable cardioverter-defibrillator (TV-ICD) systems as well as the need for fluoroscopy during implant surgery. In patients with challenging anatomic conditions or after infection, the S-ICD® might be reasonable. In multicenter studies and registries efficacy and safety of the S-ICD® was equal or better to transvenous implantable defibrillators. The cardiac rhythm is detected by the use of 1 of the 3 potential vectors. The S-ICD® automatically selects the most suitable vector for rhythm detection. If ventricular tachyarrhythmia is detected, the device is able to deliver up to five shocks of 80 J, while postshock pacing is available at 50 bpm for 30 s. The implantation technique is different from that of conventional ICDs, but easily learnable by experienced cardiologists. Initially observed hurdles (e.g., inappropriate shocks or infections) have been overcome by standardized implantation techniques, operator learning curves, and modification of algorithms. The S-ICD® predominately might be suitable in all patients with ICD indication except patients with pacing or cardiac resynchronization therapy (CRT) indication, ventricular tachycardia < 170 bpm, negative screening, or in the occasional patient whose arrhythmia might be suppressed by overdrive pacing. The system received CE certification in 2009 and was approved by the FDA in 2012. Currently, in Germany the S-ICD® has been integrated into the DRG system and can be reimbursed as a single chamber ICD.
Probability of detection of internal voids in structural ceramics using microfocus radiography
NASA Technical Reports Server (NTRS)
Baaklini, G. Y.; Roth, D. J.
1986-01-01
The reliability of microfocous X-radiography for detecting subsurface voids in structural ceramic test specimens was statistically evaluated. The microfocus system was operated in the projection mode using low X-ray photon energies (20 keV) and a 10 micro m focal spot. The statistics were developed for implanted subsurface voids in green and sintered silicon carbide and silicon nitride test specimens. These statistics were compared with previously-obtained statistics for implanted surface voids in similar specimens. Problems associated with void implantation are discussed. Statistical results are given as probability-of-detection curves at a 95 precent confidence level for voids ranging in size from 20 to 528 micro m in diameter.
Probability of detection of internal voids in structural ceramics using microfocus radiography
NASA Technical Reports Server (NTRS)
Baaklini, G. Y.; Roth, D. J.
1985-01-01
The reliability of microfocus x-radiography for detecting subsurface voids in structural ceramic test specimens was statistically evaluated. The microfocus system was operated in the projection mode using low X-ray photon energies (20 keV) and a 10 micro m focal spot. The statistics were developed for implanted subsurface voids in green and sintered silicon carbide and silicon nitride test specimens. These statistics were compared with previously-obtained statistics for implanted surface voids in similar specimens. Problems associated with void implantation are discussed. Statistical results are given as probability-of-detection curves at a 95 percent confidence level for voids ranging in size from 20 to 528 micro m in diameter.
Maglia, Giampiero; Curnis, Antonio; Brieda, Marco; Anaclerio, Matteo; Caccavo, Vincenzo; Bonfanti, Paolo; Melissano, Donato; Caravati, Fabrizio; Giovene, Lisa; Gargaro, Alessio
2015-10-01
Despite the fact that magnetic resonance (MR)-conditional pacemaker and lead systems have been introduced more than 5 years ago, it is still not clear whether they have actually facilitated the access of pacemaker patients to this important diagnostic tool. Factors limiting MR scans in daily practice in patients with MR-conditional cardiac implantable electronic device (CIED) systems may be related to organizational, cultural and sometimes legal aspects. The Really ProMRI registry is an ongoing survey designed to assess the annual rate of MR examinations in patients with MR-conditional implants, with either pacemakers or implantable cardioverter defibrillators, and to detect the main factors limiting MRI. The primary endpoint of the Really ProMRI registry is to assess the current access to MRI of patients with MR-conditional pacemaker or implantable cardioverter defibrillator systems during normal practice. Data in the literature reported a 17% annual incidence of medical conditions requiring MRI in CIED patients. The Really ProMRI registry has been designed to detect 4.5% absolute difference with an 80% statistical power, by recruiting 600 patients already implanted with MR-conditional CIED implant. Patients will be followed up for 1 year, during which they will be asked to refer any prescription, execution or denial of an MR examination by patient questionnaires and original source documents. The ongoing Really ProMRI registry will assess the actual rate of and factors limiting the access to MRI for patients with MR-conditional CIEDs.
A physiological and behavioral system for hearing restoration with cochlear implants
King, Julia; Shehu, Ina; Roland, J. Thomas; Svirsky, Mario A.
2016-01-01
Cochlear implants are neuroprosthetic devices that provide hearing to deaf patients, although outcomes are highly variable even with prolonged training and use. The central auditory system must process cochlear implant signals, but it is unclear how neural circuits adapt—or fail to adapt—to such inputs. The knowledge of these mechanisms is required for development of next-generation neuroprosthetics that interface with existing neural circuits and enable synaptic plasticity to improve perceptual outcomes. Here, we describe a new system for cochlear implant insertion, stimulation, and behavioral training in rats. Animals were first ensured to have significant hearing loss via physiological and behavioral criteria. We developed a surgical approach for multichannel (2- or 8-channel) array insertion, comparable with implantation procedures and depth in humans. Peripheral and cortical responses to stimulation were used to program the implant objectively. Animals fitted with implants learned to use them for an auditory-dependent task that assesses frequency detection and recognition in a background of environmentally and self-generated noise and ceased responding appropriately to sounds when the implant was temporarily inactivated. This physiologically calibrated and behaviorally validated system provides a powerful opportunity to study the neural basis of neuroprosthetic device use and plasticity. PMID:27281743
Optimization of single keV ion implantation for the construction of single P-donor devices
NASA Astrophysics Data System (ADS)
Yang, Changyi; Jamieson, David N.; Hopf, Toby; Andresen, Soren E.; Hearne, Sean M.; Hudson, Fay E.; Pakes, Christopher I.; Mitic, Mladen; Gauja, Eric; Tamanyan, Grigori; Dzurak, Andrew S.; Prawer, Steven; Clark, Robert G.
2005-02-01
We report recent progress in single keV ion implantation and online detection for the controlled implantation of single donors in silicon. When integrated with silicon nanofabrication technology this forms the "top down" strategy for the construction of prototype solid state quantum computer devices based on phosphorus donors in silicon. We have developed a method of single ion implantation and online registration that employs detector electrodes adjacent to the area into which the donors are to be implanted. The implantation sites are positioned with nanometer accuracy using an electron beam lithography patterned PMMA mask. Control of the implantation depth of 20 nm is achieved by tuning the phosphorus ion energy to 14 keV. The counting of single ion implantation in each site is achieved by the detection of e-/h+ pairs produced by the implanted phosphorus ion in the substrate. The system is calibrated by use of Mn K-line x-rays (5.9 and 6.4 keV) and we find the ionization energy of the 14 keV phosphorus ions in silicon to be about 3.5-4.0 keV for implants through a 5 nm SiO2 surface layer. This paper describes the development of an improved PIN detector structure that provides more reliable performance of the earlier MOS structure. With the new structure, the energy noise threshold has been minimized to 1 keV or less. Unambiguous detection/counting of single keV ion implantation events were achieved with a confidence level greater than 98% with a reliable and reproducible fabrication process.
Baj, A; Beltramini, G A; Bolzoni, A; Cura, F; Palmieri, A; Scarano, A; Ottria, L; Giannì, A B
2017-01-01
Bacterial leakage at the implant-abutment connection of a two-piece implant system is considered the main cause of peri-implantitis. Prevention of bacterial leakage at the implant-abutment connection is mandatory for reducing inflammation process around implant neck and achieving bone stability. Micro-cavities at implant-abutment connection level can favour bacterial leakage, even in modern two-piece implant systems. The conical connection with an internal octagon (CCIO) is considered to be more stable mechanically and allows a more tight link between implant and abutment. As P. gingivalis and T. forsythia penetration might have clinical relevance, it was the purpose of this investigation to evaluate molecular leakage of these two bacteria in a new two-implant system with an internal conical implant-abutment connection with internal octagon (Shiner XT, FMD Falappa Medical Devices S.p.A. Rome, Italy). To verify the ability of the implant in protecting the internal space from the external environment, the passage of genetically modified Escherichia c oli across implant-abutment interface was evaluated. Four Shiner XT implants (FMD, Falappa Medical Devices®, Rome, Italy) were immerged in a bacterial culture for 24 h and bacteria amount was measured inside implant-abutment interface with Real-time PCR. Bacteria were detected inside all studied implants, with a median percentage of 6% for P. gingivalis and 5% for T. forsythia. Other comparable studies about the tightness of the tested implant system reported similar results. The gap size at the implant-abutment connection of CCIOs was measured by other authors discovering a gap size of 1–2μm of the AstraTech system and of 4μm for the Ankylos system. Bacterial leakage along implant-abutment connection of cylindrical and tapered implants, Shiner XT, (FMD Falappa Medical Devices S.p.A. Rome, Italy) showed better results compared to other implants. Additional studies are needed to explore the relationship in terms of microbiota of the CCIO. In addition, the dynamics of internal colonization needs to be thoroughly documented in longitudinal in vivo studies.
Zipprich, Holger; Miatke, Sven; Hmaidouch, Rim; Lauer, Hans-Christoph
2016-01-01
This study aimed to test bacterial microleakage at the implant-abutment interface (IAI) before and after dynamic loading using a new chewing simulation. Fourteen implant systems (n = 5 samples of each) were divided into two groups: (1) systems with conical implant-abutment connections (IACs), and (2) systems with flat IACs. For collecting samples without abutment disconnection, channels (Ø = 0.3 mm) were drilled into implants perpendicularly to their axes, and stainless-steel cannulas were adhesively glued inside these channels to allow a sterilized rinsing solution to enter the implant interior and to exit with potential contaminants for testing. Implants were embedded in epoxy resin matrices, which were supported by titanium cylinders with lateral openings for inward and outward cannulas. Abutments were tightened and then provided with vertically adjustable, threaded titanium balls, which were cemented using composite cement. Specimens were immersed in a bacterial liquid and after a contact time of 15 minutes, the implant interior was rinsed prior to chewing simulation (0 N ≘ static seal testing). Specimens were exposed to a Frankfurt chewing simulator. Two hundred twenty force cycles per power level (110 in ± X-axis) were applied to simulate a daily masticatory load of 660 chewing cycles (equivalent to 1,200,000 cycles/5 years). The applied load was gradually increased from 0 N to a maximum load of 200 N in 25-N increments. The implant interior was rinsed to obtain samples before each new power level. All samples were tested using fluorescence microscopy; invading microorganisms could be counted and evaluated. No bacterial contamination was detected under static loading conditions in both groups. After loading, bacterial contamination was detected in one sample from one specimen in group 1 and in two samples from two specimens in group 2. Controlled dynamic loading applied in this study simulated a clinical situation and enabled time-dependent analysis regarding the bacterial seal of different implant systems. Conical IACs offer a better bacterial seal compared with flat IACs, which showed increased microleakage after dynamic loading. IAC design plays a crucial role in terms of bacterial colonization. Taking samples of the implant interior without abutment disconnection eliminates an error source.
Jilek, Clemens; Tzeis, Stylianos; Reents, Tilko; Estner, Heidi-Luise; Fichtner, Stephanie; Ammar, Sonia; Wu, Jinjin; Hessling, Gabriele; Deisenhofer, Isabel; Kolb, Christof
2010-10-01
Electromagnetic interference with pacemaker and implantable cardioverter defibrillator (ICD) systems may cause temporary or permanent system malfunction of implanted devices. The aim of this study was to evaluate potential interference of a novel magnetic navigation system with implantable rhythm devices. A total of 121 devices (77 pacemakers, 44 ICDs) were exposed to an activated NIOBE II® Magnetic Navigation System (Stereotaxis, St. Louis, MO, USA) at the maximal magnetic field strength of 0.1 Tesla and evaluated in vitro with respect to changes in parameter settings of the device, changes of the battery status/detection of elective replacement indication, or alterations of data stored in the device. A total of 115 out of 121 (95%) devices were free of changes in parameter settings, battery status, and internally stored data after repeated exposition to the electromagnetic field of the remote magnetic navigation system. Interference with the magnetic navigation field was observed in 6 pacemakers, resulting in reprogramming to a power-on-reset mode with or without detection of the elective replacement indication in 5 devices and abnormal variance of battery status in one device. All pacemakers could be reprogrammed to the initial modes and the battery status proved to be normal some minutes after the pacemakers had been removed from the magnetic field. Interference of a remote magnetic navigation system (at maximal field strength) with pacemakers and ICDs not connected to leads with antitachycardic detection and therapies turned off is rare. Occurring functional abnormalities could be reprogrammed in our sample. An in vitro study will give information about interference of devices connected to leads. © 2010 Wiley Periodicals, Inc.
Li, Yu-Jung; Lu, Chih-Cheng
2015-01-01
A miniature intra-oral dental implant system including a built-in biosensor device is proposed in this article. The dental implant system, or platform, is replaced over maxilla and allows relatively non-invasive procedures for a novel biosensing scheme for human blood analysis. Due to placement of the implant fixture, periodontal ligaments and the pulp structure, which are regarded as the main origin of pain, are thus removed, and long-term, continuous blood analysis and management through maxillary bone marrow becomes achievable through the dental implant platform. The new pathway of biological sensing is for the first time presented to realize an accurate and painless approach without injections. The dental implant system mainly consists of an implant fixture and a prosthetic abutment, a biosensor module, a bluetooth 4.0 wireless module and a dc button cell battery. The electrochemical biosensor possesses three electrodes, including working, reference and counter ones, which are arranged to pass through the titanium implant fixture below the biosensor module. The electrodes are exposed to the blood pool inside the maxillary bone marrow and perform oxidation/reduction reactions with the coating of biosensing enzyme. To prove the proposed platform, the immobilization process of glucose oxidase (GOD) enzyme and in vitro detections of glucose levels are successfully carried out, and proven sensitivity, linearity and repeatability of the glucose biosensor system are obtained. Moreover, a preliminary canine animal model adopting the new pathway shows significant consistency with the traditional method through dermal pricks for blood sugar detection. Despite the prospective results, further challenges in engineering implementation and clinical practices are addressed and discussed. In brief, the novel biosensing pathway and intra-oral biosensor platform may increasingly reveal their promising value and feasibilities in current bio-medical analysis, diagnosis, drug release and even healthcare technologies. PMID:26404283
Li, Yu-Jung; Lu, Chih-Cheng
2015-09-25
A miniature intra-oral dental implant system including a built-in biosensor device is proposed in this article. The dental implant system, or platform, is replaced over maxilla and allows relatively non-invasive procedures for a novel biosensing scheme for human blood analysis. Due to placement of the implant fixture, periodontal ligaments and the pulp structure, which are regarded as the main origin of pain, are thus removed, and long-term, continuous blood analysis and management through maxillary bone marrow becomes achievable through the dental implant platform. The new pathway of biological sensing is for the first time presented to realize an accurate and painless approach without injections. The dental implant system mainly consists of an implant fixture and a prosthetic abutment, a biosensor module, a bluetooth 4.0 wireless module and a dc button cell battery. The electrochemical biosensor possesses three electrodes, including working, reference and counter ones, which are arranged to pass through the titanium implant fixture below the biosensor module. The electrodes are exposed to the blood pool inside the maxillary bone marrow and perform oxidation/reduction reactions with the coating of biosensing enzyme. To prove the proposed platform, the immobilization process of glucose oxidase (GOD) enzyme and in vitro detections of glucose levels are successfully carried out, and proven sensitivity, linearity and repeatability of the glucose biosensor system are obtained. Moreover, a preliminary canine animal model adopting the new pathway shows significant consistency with the traditional method through dermal pricks for blood sugar detection. Despite the prospective results, further challenges in engineering implementation and clinical practices are addressed and discussed. In brief, the novel biosensing pathway and intra-oral biosensor platform may increasingly reveal their promising value and feasibilities in current bio-medical analysis, diagnosis, drug release and even healthcare technologies.
Thermo-Acoustic Ultrasound for Detection of RF-Induced Device Lead Heating in MRI.
Dixit, Neerav; Stang, Pascal P; Pauly, John M; Scott, Greig C
2018-02-01
Patients who have implanted medical devices with long conductive leads are often restricted from receiving MRI scans due to the danger of RF-induced heating near the lead tips. Phantom studies have shown that this heating varies significantly on a case-by-case basis, indicating that many patients with implanted devices can receive clinically useful MRI scans without harm. However, the difficulty of predicting RF-induced lead tip heating prior to scanning prevents numerous implant recipients from being scanned. Here, we demonstrate that thermo-acoustic ultrasound (TAUS) has the potential to be utilized for a pre-scan procedure assessing the risk of RF-induced lead tip heating in MRI. A system was developed to detect TAUS signals by four different TAUS acquisition methods. We then integrated this system with an MRI scanner and detected a peak in RF power absorption near the tip of a model lead when transmitting from the scanner's body coil. We also developed and experimentally validated simulations to characterize the thermo-acoustic signal generated near lead tips. These results indicate that TAUS is a promising method for assessing RF implant safety, and with further development, a TAUS pre-scan could allow many more patients to have access to MRI scans of significant clinical value.
Overdentures on implants placed in bone augmented with fresh frozen bone.
Rigo, L; Viscioni, A; Franco, M; Lucchese, A; Zollino, I; Brunelli, G; Carinci, F
2011-01-01
In the last decade several studies have been performed to evaluate the clinical outcome of one or two stage loaded implants supporting overdentures. Since fresh frozen bone (FFB) has an ever-increasing number of clinical applications and few reports are available on implants inserted into FFB, we performed a retrospective study on fixtures inserted in FFB and bearing overdentures. In the period between December 2003 and December 2006, 17 patients (14 females and 3 males with a median age of about 56 years) were grafted and 60 implants inserted thereafter. A total of 17 overdentures were delivered: 8 in the mandible and 9 in the maxilla. Multiple implant systems were used: 22 Double etched, 7 SLA, 9 Anodic oxidized, and 22 CaPo4 ceramic-blasted. Implant diameter ranged from 3.25 to 4.3 mm and length from 11.5 to 16.0 mm. Implants were inserted to replace 23 incisors, 9 cuspids, 20 premolars and 8 molars. No implants were lost (i.e., survival rate=100%) and no differences were detected among the studied variables. Kaplan Meier algorithm and Cox regression did not reveal any statistical differences among the studied variables also as regards the success rate. Implants inserted FFB and bearing overdentures have a high survival rate and success rates, which are comparable to those of implants inserted in non-grafted bone. FFB bone is a reliable material for alveolar ridge augmentation. No difference was detected among removable prostheses supported by two or more implants.
Microbial Profiles and Detection Techniques in Peri-Implant Diseases: a Systematic Review
Padial-Molina, Miguel; López-Martínez, Jesús; O’Valle, Francisco
2016-01-01
ABSTRACT Objectives To describe the microbial profiles of peri-implant diseases and the main detection methods. Material and Methods A literature search was performed in MEDLINE via PubMed database to identify studies on microbial composition of peri-implant surfaces in humans published in the last 5 years. Studies had to have clear implant status definition for health, peri-implant mucositis and/or peri-implantitis and specifically study microbial composition of the peri-implant sulcus. Results A total of 194 studies were screened and 47 included. Peri-implant sites are reported to be different microbial ecosystems compared to periodontal sites. However, differences between periodontal and peri-implant health and disease are not consistent across all studies, possibly due to the bias introduced by the microbial detection technique. New methods non species-oriented are being used to find ‘unexpected’ microbiota not previously described in these scenarios. Conclusions Microbial profile of peri-implant diseases usually includes classic periodontopathogens. However, correlation between studies is difficult, particularly because of the use of different detection methods. New metagenomic techniques should be promoted for future studies to avoid detection bias. PMID:27833735
Szmukler-Moncler, S; Bischof, M; Nedir, R; Ermrich, M
2010-09-01
Acid etching is a popular method to texture the surface of dental implants. During etching, the titanium oxide protective layer is dissolved and small native hydrogen ions diffuse into the unprotected implant surface. They enrich the implant surface with hydrogen and precipitate into titanium hydride (TiH). The aim of this study was to measure the concentration of TiH at the implant surface and the total concentration of Hydrogen at five commercially available implant systems, made of either commercially pure (cp) titanium or titanium alloy. X-Ray diffraction (XRD) was conducted on each implant system to determine the compounds present at the implant surface. Following a TiH(2)/Ti calibration curve, the concentration of TiH was determined. Concentration of hydrogen in the implants was measured by the inert gas fusion thermal conductivity/infrared detection method. XRD data showed that TiH was present on all cp titanium implants but not on the alloyed implants. TiH concentration varied between 5% and 37%. Hydrogen concentration varied between 43 and 108 ppm, no difference in uptake was found between the cp titanium and alloyed implants. Low solubility of hydrogen in alpha-titanium is responsible for precipitation into TiH. Stronger etching conditions led to higher concentration of TiH2-x. High solubility of hydrogen in the beta-phase of the alloy is preventing hydrogen from precipitating into TiH. All implants, even those lacking TiH at the surface, were enriched with hydrogen. In all implants, hydrogen concentration was within the normative limit of 130 ppm.
Performance of conical abutment (Morse Taper) connection implants: a systematic review.
Schmitt, Christian M; Nogueira-Filho, Getulio; Tenenbaum, Howard C; Lai, Jim Yuan; Brito, Carlos; Döring, Hendrik; Nonhoff, Jörg
2014-02-01
In this systematic review, we aimed to compare conical versus nonconical implant-abutment connection systems in terms of their in vitro and in vivo performances. An electronic search was performed using PubMed, Embase, and Medline databases with the logical operators: "dental implant" AND "dental abutment" AND ("conical" OR "taper" OR "cone"). Names of the most common conical implant-abutment connection systems were used as additional key words to detect further data. The search was limited to articles published up to November 2012. Recent publications were also searched manually in order to find any relevant studies that might have been missed using the search criteria noted above. Fifty-two studies met the inclusion criteria and were included in this systematic review. As the data and methods, as well as types of implants used was so heterogeneous, this mitigated against the performance of meta-analysis. In vitro studies indicated that conical and nonconical abutments showed sufficient resistance to maximal bending forces and fatigue loading. However, conical abutments showed superiority in terms of seal performance, microgap formation, torque maintenance, and abutment stability. In vivo studies (human and animal) indicated that conical and nonconical systems are comparable in terms of implant success and survival rates with less marginal bone loss around conical connection implants in most cases. This review indicates that implant systems using a conical implant-abutment connection, provides better results in terms of abutment fit, stability, and seal performance. These design features could lead to improvements over time versus nonconical connection systems. © 2013 Wiley Periodicals, Inc.
Function of an Implanted Tissue Glucose Sensor for More than One Year in Animals
Gough, David A.; Kumosa, Lucas S.; Routh, Timothy L.; Lin, Joe T.; Lucisano, Joseph Y.
2015-01-01
An implantable sensor capable of long-term monitoring of tissue glucose concentrations by wireless telemetry has been developed for eventual application in people with diabetes. In a recent trial, the sensor-telemetry system functioned continuously while implanted in subcutaneous tissues of two pigs for a total of 222 days and 520 days respectively, with each animal in both non-diabetic and diabetic states. The sensor detects glucose via an enzyme electrode principle that is based on differential electrochemical oxygen detection, which reduces the sensitivity of the sensor to encapsulation by the body, variations in local microvascular perfusion, limited availability of tissue oxygen, and inactivation of the enzymes. After an initial two-week stabilization period, the implanted sensors maintained stability of calibration for extended periods. The lag between blood and tissue glucose concentrations was 11.8 ± 5.7 minutes and 6.5 ± 13.3 minutes respectively, for rising and falling blood glucose challenges (mean ± SD). The lag was determined mainly by glucose mass transfer in the tissues, rather than the intrinsic response of the sensor, and showed no systematic change over implant test periods. These results represent a milestone in the translation of the sensor system to human applications. PMID:20668297
A Wireless, Fully-Passive Recorder for Medical Applications (2016 Version)
NASA Astrophysics Data System (ADS)
Lee, Cedric W.
This dissertation presents a fully-passive wireless neurorecording system for moni- toring very low level neuropotential. The subject new recording device has no battery, power harvester or regulator. As a result, it addresses concerns related to: (1) exter- nal wired connection (causing lack of mobility and risk of infection in patients), and (2) heat generation that may impact neural functioning. The developed sensor also exhibits large bandwidth and extremely high sensitivity down to 20 muVpp. Specifi- cally, this minimum detectable voltage is 25 times lower than previous fully-passive wireless neurorecorder. Further, for the first time, it allows detection of signals up to 5000 Hz. As a result, it can detect all neural signals of interest. A key aspect of the proposed sensors increased sensitivity is the introduction of an anti-parallel diode pair (APDP) to greatly reduce the second harmonic mixing conversion loss in the implant. Also, a smaller size antenna allows for a less intrusive implant. The implant is excited by an external interrogator possibly integrated within a baseball cap, to power the implanted recorder and reading the neurosignal.
Towards a disposable in vivo miniature implantable fluorescence detector
NASA Astrophysics Data System (ADS)
Bellis, Stephen; Jackson, J. Carlton; Mathewson, Alan
2006-02-01
In the field of fluorescent microscopy, neuronal activity, diabetes and drug treatment are a few of the wide ranging biomedical applications that can be monitored with the use of dye markers. Historically, in-vivo fluorescent detectors consist of implantable probes coupled by optical fibre to sophisticated bench-top instrumentation. These systems typically use laser light to excite the fluorescent marker dies and using sensors, such as the photo-multiplier tube (PMT) or charge coupled devices (CCD), detect the fluorescent light that is filtered from the total excitation. Such systems are large and expensive. In this paper we highlight the first steps toward a fully implantable in-vivo fluorescence detection system. The aim is to make the detector system small, low cost and disposable. The current prototype is a hybrid platform consisting of a vertical cavity surface emitting laser (VCSEL) to provide the excitation and a filtered solid state Geiger mode avalanche photo-diode (APD) to detect the emitted fluorescence. Fluorescence detection requires measurement of extremely low levels of light so the proposed APD detectors combine the ability to count individual photons with the added advantage of being small in size. At present the exciter and sensor are mounted on a hybrid PCB inside a 3mm diameter glass tube.This is wired to external electronics, which provide quenching, photon counting and a PC interface. In this configuration, the set-up can be used for in-vitro experimentation and in-vivo analysis conducted on animals such as mice.
Mau, Jochen; Behneke, Alexandra; Behneke, Nikolaus; Fritzemeier, Claus Udo; Gomez-Roman, German; d'Hoedt, Bernd; Spiekermann, Hubertus; Strunz, Volker; Yong, Mei
2003-01-01
Two treatment concepts for implant-supported bar retention of mandibular overdentures-2 intramobile cylinder (IMZ) implants and a Dolder bar and 4 titanium plasma-sprayed (TPS) screw implants and an angulated bar-were compared in a randomized controlled clinical trial with respect to postprosthetic efficacy and safety. Four hundred twenty-five patients with edentulous mandibles were enrolled; 212 were randomized to TPS implants (control group) and 213 to IMZ implants (test group). Endpoints were occurrences of postprosthetic integration deficiency (ID), functional deficiency (FD), and complications. The trial was sized to detect a 10% difference in 5-year ID-free postprosthetic system lifetime with a power of 80%. With 340 protocol-completed cases, the trial achieved its predetermined power. The 2 systems did not show statistically significant differences in occurrences of postprosthetic ID and FD; 5-year occurrence-free postprosthetic system lifetime probabilities were estimated as 42.5% with IMZ and 42.8% with TPS, for ID; and as 82.6% with IMZ and 87.2% with TPS, for FD. However, at 3 to 6 months after surgery, mean Periotest values were significantly higher (P = .0001 without adjustment) with IMZ implants (5.6, SD 4.2) than with TPS implants (0.8, SD 4.3). TPS implants showed a higher incidence of inflammation and recession, while IMZ implants had a higher incidence of implant fracture after functional loading. The system-wise approach overcomes potential bias with implant-wise analyses. A combination of radiographic and clinical criteria distinguishes between desirable integration and functional anchorage. The in situ survival rates at 5 years in this study (95% for IMZ, 92% for TPS) match rates reported in the literature. This study demonstrated equivalent efficacy of 2 IMZ cylinders and 4 TPS screws in implant-supported, bar-retained mandibular overdentures and indicated a higher rate of complications with the TPS screw implants.
Systemic levels of metallic ions released from orthodontic mini-implants.
de Morais, Liliane Siqueira; Serra, Glaucio Guimarães; Albuquerque Palermo, Elisabete Fernandes; Andrade, Leonardo Rodrigues; Müller, Carlos Alberto; Meyers, Marc André; Elias, Carlos Nelson
2009-04-01
Orthodontic mini-implants are a potential source of metallic ions to the human body because of the corrosion of titanium (Ti) alloy in body fluids. The purpose of this study was to gauge the concentration of Ti, aluminum (Al), and vanadium (V), as a function of time, in the kidneys, livers, and lungs of rabbits that had Ti-6Al-4V alloy orthodontic mini-implants placed in their tibia. Twenty-three New Zealand rabbits were randomly divided into 4 groups: control, 1 week, 4 weeks, and 12 weeks. Four orthodontic mini-implants were placed in the left proximal tibia of 18 rabbits. Five control rabbits had no orthodontic mini-implants. After 1, 4, and 12 weeks, the rabbits were killed, and the selected tissues were extracted and prepared for analysis by graphite furnace atomic absorption spectrophotometry. Low amounts of Ti, Al, and V were detectable in the 1-week, 4-weeks, and 12-weeks groups, confirming that release of these metals from the mini-implants occurs, with diffusion and accumulation in remote organs. Despite the tendency of ion release when using the Ti alloy as orthodontic mini-implants, the amounts of metals detected were significantly below the average intake of these elements through food and drink and did not reach toxic concentrations.
A Novel Percutaneous Electrode Implant for Improving Robustness in Advanced Myoelectric Control
Hahne, Janne M.; Farina, Dario; Jiang, Ning; Liebetanz, David
2016-01-01
Despite several decades of research, electrically powered hand and arm prostheses are still controlled with very simple algorithms that process the surface electromyogram (EMG) of remnant muscles to achieve control of one prosthetic function at a time. More advanced machine learning methods have shown promising results under laboratory conditions. However, limited robustness has largely prevented the transfer of these laboratory advances to clinical applications. In this paper, we introduce a novel percutaneous EMG electrode to be implanted chronically with the aim of improving the reliability of EMG detection in myoelectric control. The proposed electrode requires a minimally invasive procedure for its implantation, similar to a cosmetic micro-dermal implant. Moreover, being percutaneous, it does not require power and data telemetry modules. Four of these electrodes were chronically implanted in the forearm of an able-bodied human volunteer for testing their characteristics. The implants showed significantly lower impedance and greater robustness against mechanical interference than traditional surface EMG electrodes used for myoelectric control. Moreover, the EMG signals detected by the proposed systems allowed more stable control performance across sessions in different days than that achieved with classic EMG electrodes. In conclusion, the proposed implants may be a promising interface for clinically available prostheses. PMID:27065783
Chatzinoff, Yonatan; Szczepanski, Debby; Bing, Chenchen; Shaikh, Sumbul; Wyman, Omar; Perry, Cameron E.; Richardson, James A.; Burns, Dennis K.; Evers, Bret M.; Greenberg, David E.; Chopra, Rajiv
2018-01-01
Treatment of prosthetic joint infections often involves multiple surgeries and prolonged antibiotic administration, resulting in a significant burden to patients and the healthcare system. We are exploring a non-invasive method to eradicate biofilm on metal implants utilizing high-frequency alternating magnetic fields (AMF) which can achieve surface induction heating. Although proof-of-concept studies demonstrate the ability of AMF to eradicate biofilm in vitro, there is a legitimate safety concern related to the potential for thermal damage to surrounding tissues when considering heating implanted metal objects. The goal of this study was to explore the feasibility of detecting acoustic emissions associated with boiling at the interface between a metal implant and surrounding soft tissue as a wireless safety sensing mechanism. Acoustic emissions generated during in vitro and in vivo AMF exposures were captured with a hydrophone, and the relationship with surface temperature analyzed. The effect of AMF exposure power, surrounding media composition, implant location within the AMF transmitter, and implant geometry on acoustic detection during AMF therapy was also evaluated. Acoustic emissions were reliably identified in both tissue-mimicking phantom and mouse studies, and their onset coincided with the implant temperature reaching the boiling threshold. The viscosity of the surrounding medium did not impact the production of acoustic emissions; however, emissions were not present when the medium was oil due to the higher boiling point. Results of simulations and in vivo studies suggest that short-duration, high-power AMF exposures combined with acoustic sensing can be used to minimize the amount of thermal damage in surrounding tissues. These studies support the hypothesis that detection of boiling associated acoustic emissions at a metal/tissue interface could serve as a real-time, wireless safety indicator during AMF treatment of biofilm on metallic implants. PMID:29746579
Cheng, Bingbing; Chatzinoff, Yonatan; Szczepanski, Debby; Bing, Chenchen; Shaikh, Sumbul; Wyman, Omar; Perry, Cameron E; Richardson, James A; Burns, Dennis K; Evers, Bret M; Greenberg, David E; Chopra, Rajiv
2018-01-01
Treatment of prosthetic joint infections often involves multiple surgeries and prolonged antibiotic administration, resulting in a significant burden to patients and the healthcare system. We are exploring a non-invasive method to eradicate biofilm on metal implants utilizing high-frequency alternating magnetic fields (AMF) which can achieve surface induction heating. Although proof-of-concept studies demonstrate the ability of AMF to eradicate biofilm in vitro, there is a legitimate safety concern related to the potential for thermal damage to surrounding tissues when considering heating implanted metal objects. The goal of this study was to explore the feasibility of detecting acoustic emissions associated with boiling at the interface between a metal implant and surrounding soft tissue as a wireless safety sensing mechanism. Acoustic emissions generated during in vitro and in vivo AMF exposures were captured with a hydrophone, and the relationship with surface temperature analyzed. The effect of AMF exposure power, surrounding media composition, implant location within the AMF transmitter, and implant geometry on acoustic detection during AMF therapy was also evaluated. Acoustic emissions were reliably identified in both tissue-mimicking phantom and mouse studies, and their onset coincided with the implant temperature reaching the boiling threshold. The viscosity of the surrounding medium did not impact the production of acoustic emissions; however, emissions were not present when the medium was oil due to the higher boiling point. Results of simulations and in vivo studies suggest that short-duration, high-power AMF exposures combined with acoustic sensing can be used to minimize the amount of thermal damage in surrounding tissues. These studies support the hypothesis that detection of boiling associated acoustic emissions at a metal/tissue interface could serve as a real-time, wireless safety indicator during AMF treatment of biofilm on metallic implants.
Dijkman, B; Wellens, H J
2001-09-01
Dual chamber implantable cardioverter defibrillator (ICD) combines the possibility to detect and treat ventricular and atrial arrhythmias with the possibility of modern heart stimulation techniques. Advanced pacing algorithms together with extended arrhythmia detection capabilities can give rise to new types of device-device interactions. Some of the possible interactions are illustrated by four cases documented in four models of dual chamber ICDs. Functioning of new features in dual chamber devices is influenced by the fact that the pacemaker is not a separate device but a part of the ICD system and that both are being used in a patient with arrhythmia. Programming measures are suggested to optimize use of new pacing algorithms while maintaining correct arrhythmia detection.
Telemedicine and cardiac implants: what is the benefit?
Varma, Niraj; Ricci, Renato Pietro
2013-01-01
Cardiac implantable electronic devices are increasing in prevalence. The post-implant follow-up is important for monitoring both device function and patient condition. However, practice is inconsistent. For example, ICD follow-up schedules vary from 3 monthly to yearly according to facility and physician preference and availability of resources. Recommended follow-up schedules impose significant burden. Importantly, no surveillance occurs between follow-up visits. In contrast, implantable devices with automatic remote monitoring capability provide a means for performing constant surveillance, with the ability to identify salient problems rapidly. Remote home monitoring reduces the volume of device clinic visits and provides early detection of patient and/or system problems. PMID:23211231
NASA Technical Reports Server (NTRS)
Lovelady, R. W.; Ferguson, R. L.
1975-01-01
Self-powered sonar device may be implanted in body of fish. It transmits signal that can be detected with portable tracking gear or by automatic detection-and-tracking system. Operating life of over 4000 hours may be expected. Device itself may be used almost indefinitely.
Engineering Approaches for the Detection and Control of Orthopaedic Biofilm Infections
Ehrlich, Garth D.; Stoodley, Paul; Kathju, Sandeep; Zhao, Yongjun; McLeod, Bruce R.; Balaban, Naomi; Hu, Fen Ze; Sotereanos, Nicholas G.; Costerton, J. William; Stewart, Philip S.; Post, J. Christopher; Lin, Qiao
2005-01-01
Artificial joints are subject to chronic infections associated with bacterial biofilms, which only can be eradicated by the traumatic removal of the implant followed by sustained intravenous antibiotic therapy. We have adopted an engineering approach to develop electrical–current-based approaches to bacterial eradication and microelectromechanical systems that could be embedded within the implanted joint to detect the presence of bacteria and to provide in situ treatment of the infection before a biofilm can form. In the former case we will examine the combined bactericidal effects of direct and indirect electrical fields in combination with antibiotic therapy. In the latter case, bacterial detection will occur by developing a microelectromechanical–systems-based biosensor that can “eavesdrop” on bacterial quorum–sensing-based communication systems. Treatment will be effected by the release of a cocktail of pharmaceutical reagents contained within integral reservoirs associated with the implant, including a molecular jamming signal that competitively binds to the bacteria’s quorum sensing receptors (which will “blind” the bacteria, preventing the production of toxins) and multiple high dose antibiotics to eradicate the planktonic bacteria. This approach is designed to take advantage of the relatively high susceptibility to antibiotics that planktonic bacteria display compared with biofilm envirovars. Here we report the development of a generic microelectromechanical systems biosensor that measures changes in internal viscosity in a base fluid triggered by a change in the external environment. PMID:16056027
In Vivo Ultrasonic Detection of Polyurea Crosslinked Silica Aerogel Implants
Sabri, Firouzeh; Sebelik, Merry E.; Meacham, Ryan; Boughter, John D.; Challis, Mitchell J.; Leventis, Nicholas
2013-01-01
Background Polyurea crosslinked silica aerogels are highly porous, lightweight, and mechanically strong materials with great potential for in vivo applications. Recent in vivo and in vitro studies have demonstrated the biocompatibility of this type of aerogel. The highly porous nature of aerogels allows for exceptional thermal, electric, and acoustic insulating capabilities that can be taken advantage of for non-invasive external imaging techniques. Sound-based detection of implants is a low cost, non-invasive, portable, and rapid technique that is routinely used and readily available in major clinics and hospitals. Methodology In this study the first in vivo ultrasound response of polyurea crosslinked silica aerogel implants was investigated by means of a GE Medical Systems LogiQe diagnostic ultrasound machine with a linear array probe. Aerogel samples were inserted subcutaneously and sub-muscularly in a) fresh animal model and b) cadaveric human model for analysis. For comparison, samples of polydimethylsiloxane (PDMS) were also imaged under similar conditions as the aerogel samples. Conclusion/significance Polyurea crosslinked silica aerogel (X-Si aerogel) implants were easily identified when inserted in either of the regions in both fresh animal model and cadaveric model. The implant dimensions inferred from the images matched the actual size of the implants and no apparent damage was sustained by the X-Si aerogel implants as a result of the ultrasonic imaging process. The aerogel implants demonstrated hyperechoic behavior and significant posterior shadowing. Results obtained were compared with images acquired from the PDMS implants inserted at the same location. PMID:23799093
In vivo ultrasonic detection of polyurea crosslinked silica aerogel implants.
Sabri, Firouzeh; Sebelik, Merry E; Meacham, Ryan; Boughter, John D; Challis, Mitchell J; Leventis, Nicholas
2013-01-01
Polyurea crosslinked silica aerogels are highly porous, lightweight, and mechanically strong materials with great potential for in vivo applications. Recent in vivo and in vitro studies have demonstrated the biocompatibility of this type of aerogel. The highly porous nature of aerogels allows for exceptional thermal, electric, and acoustic insulating capabilities that can be taken advantage of for non-invasive external imaging techniques. Sound-based detection of implants is a low cost, non-invasive, portable, and rapid technique that is routinely used and readily available in major clinics and hospitals. In this study the first in vivo ultrasound response of polyurea crosslinked silica aerogel implants was investigated by means of a GE Medical Systems LogiQe diagnostic ultrasound machine with a linear array probe. Aerogel samples were inserted subcutaneously and sub-muscularly in a) fresh animal model and b) cadaveric human model for analysis. For comparison, samples of polydimethylsiloxane (PDMS) were also imaged under similar conditions as the aerogel samples. Polyurea crosslinked silica aerogel (X-Si aerogel) implants were easily identified when inserted in either of the regions in both fresh animal model and cadaveric model. The implant dimensions inferred from the images matched the actual size of the implants and no apparent damage was sustained by the X-Si aerogel implants as a result of the ultrasonic imaging process. The aerogel implants demonstrated hyperechoic behavior and significant posterior shadowing. Results obtained were compared with images acquired from the PDMS implants inserted at the same location.
Ahn, C Y; DeBruhl, N D; Gorczyca, D P; Shaw, W W; Bassett, L W
1994-10-01
With the current controversy regarding the safety of silicone implants, the detection and evaluation of implant rupture are causing concern for both plastic surgeons and patients. Our study obtained comparative value analysis of mammography, sonography, and magnetic resonance imaging (MRI) in the detection of silicone implant rupture. Twenty-nine symptomatic patients (total of 59 silicone implants) were entered into the study. Intraoperative findings revealed 21 ruptured implants (36 percent). During physical examination, a positive "squeeze test" was highly suggestive of implant rupture. Mammograms were obtained of 51 implants (sensitivity 11 percent, specificity 89 percent). Sonography was performed on 57 implants (sensitivity 70 percent, specificity 92 percent). MRI was performed on 55 implants (sensitivity 81 percent, specificity 92 percent). Sonographically, implant rupture is demonstrated by the "stepladder sign." Double-lumen implants may appear as false-positive results for rupture on sonography. On MRI, the "linguine sign" represents disrupted fragments of a ruptured implant. The most reliable imaging modality for implant rupture detection is MRI, followed by sonogram. Mammogram is the least reliable. Our study supports the clinical indication and diagnostic value of sonogram and MRI in the evaluation of symptomatic breast implant patients.
Detection of orthopaedic foot and ankle implants by security screening devices.
Bluman, Eric M; Tankson, Cedric; Myerson, Mark S; Jeng, Clifford L
2006-12-01
A common question asked by patients contemplating foot and ankle surgery is whether the implants used will set off security screening devices in airports and elsewhere. Detectability of specific implants may require the orthopaedic surgeon to provide attestation regarding their presence in patients undergoing implantation of these devices. Only two studies have been published since security measures became more stringent in the post-9/11 era. None of these studies specifically focused on the large numbers of orthopaedic foot and ankle implants in use today. This study establishes empiric data on the detectability by security screening devices of some currently used foot and ankle implants. A list of foot and ankle procedures was compiled, including procedures frequently used by general orthopaedists as well as those usually performed only by foot and ankle specialists. Implants tested included those used for open reduction and internal fixation, joint fusion, joint arthroplasty, osteotomies, arthroreisis, and internal bone stimulation. A test subject walked through a gate-type security device and was subsequently screened using a wand-type detection device while wearing each construct grouping. The screening was repeated with the implants placed within uncooked steak to simulate subcutaneous and submuscular implantation. None of the implants were detected by the gate-type security device. Specific implants that triggered the wand-type detection device regardless of coverage with the meat were total ankle prostheses, implantable bone stimulators, large metatarsophalangeal hemiarthroplasty, large arthroreisis plugs, medial distal tibial locking construct, supramalleolar osteotomy fixation, stainless steel bimalleolar ankle fracture fixation, calcaneal fracture plate and screw constructs, large fragment blade plate constructs, intramedullary tibiotalocalcaneal fusion constructs, and screw fixation for calcaneal osteotomies, ankle arthrodeses, triple arthrodeses, and stainless steel first metatarsophalangeal joint arthrodeses. The placement of implants in meat prevented the detectability of only the stainless steel Jones fracture implant (stainless steel 6.5-mm cannulated screw) and the stainless steel midfoot fusion construct (four stainless steel 4.0-mm cannulated screws). These data may help the orthopaedic surgeon in counseling patients as to the detectability of some orthopaedic foot and ankle implants in use today. Specific constructs for which documentation may need to be provided to the patient are identified. As security standards evolve and the environments in which they are practiced change, empiric testing of many of these devices may need to be repeated.
Airport detection of implanted orthopedic devices.
Ostrum, Robert F
2006-10-01
Since the attacks of September 11, 2001, the United States and other countries have increased airport security. Metal detectors (archway and handheld wand) are used to detect potentially dangerous instruments during airport screening. One consequence is that orthopedic implants are sometimes detected, and patients are detained and searched. The orthopedic literature is inconsistent in its reports on airport screening of patients with orthopedic implants. In this article, I review that literature and examine the factors that make detection of orthopedic implants a less than consistent science.
A Wireless 32-Channel Implantable Bidirectional Brain Machine Interface
Su, Yi; Routhu, Sudhamayee; Moon, Kee S.; Lee, Sung Q.; Youm, WooSub; Ozturk, Yusuf
2016-01-01
All neural information systems (NIS) rely on sensing neural activity to supply commands and control signals for computers, machines and a variety of prosthetic devices. Invasive systems achieve a high signal-to-noise ratio (SNR) by eliminating the volume conduction problems caused by tissue and bone. An implantable brain machine interface (BMI) using intracortical electrodes provides excellent detection of a broad range of frequency oscillatory activities through the placement of a sensor in direct contact with cortex. This paper introduces a compact-sized implantable wireless 32-channel bidirectional brain machine interface (BBMI) to be used with freely-moving primates. The system is designed to monitor brain sensorimotor rhythms and present current stimuli with a configurable duration, frequency and amplitude in real time to the brain based on the brain activity report. The battery is charged via a novel ultrasonic wireless power delivery module developed for efficient delivery of power into a deeply-implanted system. The system was successfully tested through bench tests and in vivo tests on a behaving primate to record the local field potential (LFP) oscillation and stimulate the target area at the same time. PMID:27669264
Technical aids for the flexible use of the Leksell stereotactic system.
Salcman, M; Bellis, E H; Sewchand, W; Amin, P
1989-06-01
As part of a multimodality therapy program for intracranial tumours, 105 stereotactic and implant procedures have been carried out utilizing the CT-compatible Leksell stereotactic system. In the iridium implant series, 86 catheters have been implanted for an average of 3.6 targets per patient. There have been no deaths or missed targets and only two incidential haemorrhages detected. In order to facilitate the reliability, safety and speed of multiple catheter insertion, several techniques have been developed including: (a) a standardized single-length catheter and flange system; (b) a ceramic catheter for microwave hyperthermia; (c) a mnemonic card for ease of calculation; (d) a radiation shield for nursing; (e) a stereotactic drill and surgical approaches to far lateral and posterior fossa targets. Principles for the use of these technical aids are discussed.
Detection of orthopaedic implants by airport metal detectors.
Obremskey, William T; Austin, Tom; Crosby, Colin; Driver, Robin; Kurtz, Will; Shuler, Franklin; Kregor, Philip
2007-02-01
To report the effect of patient's body mass index (BMI), implant type, size, location, number, and material on detection by certified Transportation Security Administration (TSA) and Federal Aviation Administration (FAA) airport metal detectors set to today's standard sensitivity. Retrospective clinical study. Level 1 university trauma center. Ninety-six regularly scheduled trauma clinic patients with a wide variety of orthopaedic implants were enrolled in the study from August 2004 through December 2004. Patients walked through an airport arch metal detector and were also wanded with a handheld metal detector. Detection of implants by arch detector or wand was recorded. We also gathered information regarding BMI, location of implants, type, metal composition, and size. All unilateral prostheses (8/8) and bilateral prostheses (1/1) were detected. Subjects with 4 or fewer screws and no other implants were never detected by the arch metal detector (0/7). For the remaining 78 subjects, the 2 best predictors of detection by the arch were having plates of length >10 holes and having titanium nails (P < 0.001 for each predictor, Wald's test for effects in a logistic model). Prostheses, plates of length >10 holes, and titanium nails were the best predictors of detection by the arch. These 3 factors accounted for 42 of the 43 detections by the arch. Body mass index was not shown to affect detectability of orthopaedic implants.
Schmalz, Gerhard; Tsigaras, Sandra; Rinke, Sven; Kottmann, Tanja; Haak, Rainer; Ziebolz, Dirk
2016-07-01
The aim of this study was to compare the microbial analysis methods of polymerase chain reaction (PCR) and real-time PCR (RT-PCR) in terms of detection of five selected potentially periodontal pathogenic bacteria in peri-implant disease. Therefore 45 samples of healthy, mucositis and peri-implantitis (n = 15 each) were assessed according to presence of the following bacteria using PCR (DNA-strip technology) and RT-PCR (fluorescent dye SYBR green-system): Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Treponema denticola (Td), Tanerella forsythia (Tf), and Fusobacterium nucleatum (Fn). There were no significant correlations between the bacterial and disease patterns, so the benefit of using microbiological tests for the diagnosis of peri-implant diseases is questionable. Correlations between the methods were highest for Tf (Kendall's Tau: 0.65, Spearman: 0.78), Fn (0.49, 0.61) and Td (0.49, 0.59). For Aa (0.38, 0.42) and Pg (0.04, 0.04), lower correlation values were detected. Accordingly, conventional semi-quantitative PCR seems to be sufficient for analyzing potentially periodontal pathogenic bacterial species. Copyright © 2016 Elsevier Inc. All rights reserved.
Ngamsom, Supak; Arayasantiparb, Raweewan; Pornprasertsuk-Damrongsri, Suchaya; Sureephong, Boonchoo
2015-11-01
The aim of the present study was to evaluate the correlation between calcified carotid atheromas (CCA) detected on digital panoramic radiographs and underlying systemic diseases. Panoramic radiographs and underlying systemic diseases of retained mandibular denture implants in 265 patients (56 males, 209 females) aged over 50 years were retrospectively evaluated at the Dental Unit of Prasat Neurological Institute, Bangkok, Thailand. The mean age of the patients was 71 ± 7.1 years. The prevalence of CCA was 38.49%. The major underlying systemic diseases were hypertension, hyperlipidemia, diabetes mellitus, and cardiovascular diseases (CVD), respectively. No relationship was found among these four systemic diseases in detecting CCA on panoramic radiographs. Similar findings were also observed in patients with only one systemic disease versus in combination with other diseases. The presence of CCA on dental panoramic radiographs was not found to be related to the presence of underlying systemic diseases, including hypertension, hyperlipidemia, diabetes mellitus, and CVD. © 2014 Wiley Publishing Asia Pty Ltd.
Detection of crestal radiolucencies around dental implants: an in vitro experimental study.
Sirin, Yigit; Horasan, Sinan; Yaman, Duygu; Basegmez, Cansu; Tanyel, Cem; Aral, Ali; Guven, Koray
2012-07-01
The aim of this study was to compare the diagnostic potentials and practical advantages of different imaging modalities in detecting bone defects around dental implants. Crestal bone defects with sequentially larger diameters were randomly prepared around 100 implants that were inserted in bovine bone blocks. Conventional periapical radiography (PR), direct digital radiography (DDR), panoramic radiography (PANO), cone-beam computed tomography (CBCT), and multislice computed tomography (MSCT) were performed for all specimens. The diagnostic accuracies of the devices, confidence of the answers, subjective image quality, defect visibility in planar orientations, and duration of diagnosis were analyzed based on the interpretations of 7 calibrated observers. The agreement levels of intra- and interobserver scores were rated good. PR, DDR, and CBCT were mostly more accurate than PANO and MSCT (P < .05). Confidence levels were positively correlated with the defect size (ρ = 0.20, P < .01), and that of DDR was the highest (P < .05). The subjective image quality of PR and DDR was higher than that of CBCT, PANO, and MSCT (P < .05 for all comparisons). Axial-coronal-sagittal visibilities of the defects were higher for CBCT compared with MSCT (P < .05). The diagnostic time was shorter for DDR (P < .05) and longer for the tomographic systems (P < .05) than for the other devices. DDR may provide a faster and more confident diagnostic option that is as accurate as PR in detecting peri-implant radiolucencies. CBCT has a comparable potential to these intraoral systems but with slower decision making and lower image quality, whereas PANO and MSCT become more reliable when bone defects have a diameter that is at least 1.5 mm larger than that of the implant. Copyright © 2012 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.
Ear epistheses as an alternative to autogenous reconstruction.
Federspil, Philipp A
2009-08-01
An ear episthesis is an artificial substitute for the auricle. The term EAR PROSTHESIS is used synonymously. The breakthrough came with the introduction of the modern silicones and their colorings. Although there are still indications for noninvasive methods of retention such as medical adhesives, the best and most reliable method of fixation is by bone anchorage. Long-lasting osseointegration with reaction-free skin penetration can be achieved with titanium implants. The first system used extraorally was the Brånemark flange fixture. Later, different solitary titanium implants were introduced, such as the ITI system. A different strategy used the titanium grids (Epitec) or plates (Epiplating) derived from osteosynthesis systems. These systems are fixed subperiosteally with several bone screws and are therefore also labeled as grouped implants. With these modern developments, secure retention can be achieved also in unfavorable anatomic situations. The grouped systems are resistant to torque with abutment insertion. The latest development is the subcutaneously implanted double magnet without skin penetration. The advantages of implant retained ear epistheses include optimal camouflage, predictable cosmetic results, fast rehabilitation, no donor site morbidity, and early detection of tumor recurrence. Depending on the clinical setting, prosthetic rehabilitation may be more than just an alternative to plastic reconstructive surgery. Copyright Thieme Medical Publishers.
Costa, Paulo Dias; Reis, A Hipólito; Rodrigues, Pedro P
2013-02-01
Traditional follow-up of patients with cardiovascular devices is still an activity that, in addition to serving an increasing population, requires a considerable amount of time and specialized human and technical resources. Our aim was to evaluate the applicability of the CareLink(®) (Medtronic, Minneapolis, MN) remote monitoring system as a complementary option to the follow-up of patients with implanted devices, between in-office visits. Evaluated outcomes included both clinical (event detection and time to diagnosis) and nonclinical (patient's satisfaction and economic costs) aspects. An observational, longitudinal, prospective study was conducted with patients from a Portuguese central hospital sampled by convenience during 1 week (43 patients). Data were collected in four moments: two in-office visits and two remote evaluations, reproducing 1 year of clinical follow-up. Data sources included health records, implant reports, initial demographic data collection, follow-up printouts, and a questionnaire. After selection criteria were verified, 15 patients (11 men [73%]) were included, 63.4±10.8 years old, representing 14.0±6.3 implant months. Clinically, 15 events were detected (9 by remote monitoring and 6 by patient-initiated activation), of which only 9 were symptomatic. We verified that remote monitoring could detect both symptomatic and asymptomatic events, whereas patient-initiated activation only detected symptomatic ones (p=0.028). Moreover, the mean diagnosis anticipation in patients with events was approximately 58 days (p<0.001). In nonclinical terms, we observed high or very high satisfaction (67% and 33%, respectively) with using remote monitoring technology, but still 8 patients (53%) stated they preferred in-office visits. Finally, the introduction of remote monitoring technology has the ability to reduce total follow-up costs for patients by 25%. We conclude that the use of this system constitutes a viable complementary option to the follow-up of patients with implantable devices, between in-office visits.
Mortellaro, Mark; DeHennis, Andrew
2014-11-15
A continuous glucose monitoring (CGM) system consisting of a wireless, subcutaneously implantable glucose sensor and a body-worn transmitter is described and clinical performance over a 28 day implant period in 12 type 1 diabetic patients is reported. The implantable sensor is constructed of a fluorescent, boronic-acid based glucose indicating polymer coated onto a miniaturized, polymer-encased optical detection system. The external transmitter wirelessly communicates with and powers the sensor and contains Bluetooth capability for interfacing with a Smartphone application. The accuracy of 19 implanted sensors were evaluated over 28 days during 6 in-clinic sessions by comparing the CGM glucose values to venous blood glucose measurements taken every 15 min. Mean absolute relative difference (MARD) for all sensors was 11.6 ± 0.7%, and Clarke error grid analysis showed that 99% of paired data points were in the combined A and B zones. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.
Persistence of bacterial DNA in orthopedic infections.
Kaplan, Heidi B; Miranda, Justin A; Gogola, Gloria R; Gomez, Karen; Ambrose, Catherine G
2018-06-01
Polymerase chain reaction (PCR) has been proposed as a method to identify bacteria in clinical samples because it is more sensitive than culture techniques and can produce results rapidly. However, PCR can detect DNA from dead cells and thus cannot distinguish between live and dead cells in a tissue sample. Killed Staphylococcus aureus cells were implanted into the femurs and knee joints of rats to determine the length of time that DNA from dead cells is detectable in a living animal under conditions similar to common orthopedic infections. In the joint infection model studied here, the DNA from the dead planktonic bacteria was detected using PCR immediately after injection or 24 h later, but was undetectable 48 and 72 h after injection. In the biofilm implanted-device model studied, the DNA from these dead biofilm cells was detected by PCR immediately after implantation and at 24 h, but not at 48 or 72 h. Thus, our results indicate that DNA from dead cells does not persist in these animal model systems for more than 2 days, which should reduce concerns about possible false positive results using molecular DNA-based techniques for the detection of pathogens. Copyright © 2018. Published by Elsevier Inc.
Jespersen, Bente; Møldrup, Ulla; Keller, Anna K.
2017-01-01
Background Vascular occlusion is a rare, but serious complication after kidney transplantation often resulting in graft loss. We therefore aimed to develop an experimental porcine model for stepwise reduction of the renal venous blood flow and to compare an implantable Doppler probe and microdialysis for fast detection of vascular occlusion. Methods In 20 pigs, implantable Doppler probes were placed on the renal artery and vein and a microdialysis catheter was placed in the renal cortex. An arterial flowprobe served as gold standard. Following two-hour baseline measurements, the pigs were randomised to stepwise venous occlusion, complete venous occlusion, complete arterial occlusion or controls. Results All parameters were stable through baseline measurements. Glutamate and lactate measured by microdialysis increased significantly (p = 0.02 and p = 0.03 respectively) 30 minutes after a 2/3 (66%) reduction in renal blood flow. The implantable Doppler probe was not able to detect flow changes until there was total venous occlusion. Microdialysis detected changes in local metabolism after both arterial and venous occlusion; the implantable Doppler probe could only detect vascular occlusions on the vessel it was placed. Conclusions We developed a new model for stepwise renal venous blood flow occlusion. Furthermore, the first comparison of the implantable Doppler probe and microdialysis for detection of renal vascular occlusions was made. The implantable Doppler probe could only detect flow changes after a complete occlusion, whereas microdialysis detected changes earlier, and could detect both arterial and venous occlusion. Based on these results, the implantable Doppler probe for early detection of vascular occlusions cannot be recommended. PMID:28542429
Breast augmentation and reconstructive surgery: MR imaging of implant rupture and malignancy.
Herborn, Christoph U; Marincek, Borut; Erfmann, Daniel; Meuli-Simmen, Claudia; Wedler, Volker; Bode-Lesniewska, Beate; Kubik-Huch, Rahel A
2002-09-01
The purpose of this study was to assess the diagnostic accuracy of MRI in detecting prosthesis integrity and malignancy after breast augmentation and reconstruction. Forty-one implants in 25 patients were analyzed by MRI before surgical removal. Imaging results were compared with ex vivo findings. Magnetic resonance imaging of the breast was performed on a 1.5-T system using a dedicated surface breast coil. Axial and sagittal T2-weighted fast spin-echo as well as dynamic contrast-enhanced T1-weighted gradient-recalled-echo sequences were acquired. The linguine sign indicating collapse of the silicone shell or siliconomas indicating free silicone proved implant rupture, whereas early focal contrast enhancement of a lesion was suspicious for malignancy. The sensitivity for detection of implant rupture was 86.7% with a specificity of 88.5%. The positive and negative predictive values were 81.3 and 92.0%, respectively. The linguine sign as a predictor of intracapsular implant rupture had a sensitivity of 80% with a specificity of 96.2%. Magnetic resonance imaging revealed two lesions with suspicious contrast enhancement (one carcinoma, one extra-abdominal fibromatosis). Magnetic resonance imaging is a reliable and reproducible technique for diagnosing both implant rupture and malignant lesions in women after breast augmentation and reconstruction.
[Management of surgery patients with implanted cardiac pacemakers].
Ugljen, R; Dadić, D; Ferek-Petrić, B; Jelić, I; Letica, D; Anić, D; Husar, J
1995-01-01
Patients having cardiac pacemaker implanted may be subjected to various general surgery procedures. Application of electrosurgery for the purpose of resection and coagulation, provides a high frequency electric field which produces electric voltage on the electrodes of the pacing system. This voltage may be detected within the pacing system, and various arrhythmias can be provoked in correlation with underlying rhythm and mode of pacing. Preoperative patient control and proper pacemaker programming can prevent the pacing malfunctions due to the electrosurgery application. Appropriate positioning of the neutral electrode in relation to the pacing system avoids the electric fields intersection and decreases their interference.
Detection of In Vivo Foot and Ankle Implants by Walkthrough Metal Detectors.
Chan, Jeremy Y; Mani, Sriniwasan B; Williams, Phillip N; O'Malley, Martin J; Levine, David S; Roberts, Matthew M; Ellis, Scott J
2014-08-01
Heightened security concerns have made metal detectors a standard security measure in many locations. While prior studies have investigated the detection rates of various hip and knee implants, none have looked specifically at the detection of foot and ankle implants in an in vivo model. Our goals were to identify which commonly used foot and ankle implants would be detected by walkthrough metal detectors both in vivo and ex vivo. Over a 7-month period, 153 weightbearing patients with foot and ankle hardware were recruited to walk through a standard airport metal detector at 3 different program settings (buildings, airports, and airports enhanced) with a base sensitivity of 165 (arbitrary units), as currently used by the Transportation Security Administration. The number of implants, location and type, as well as the presence of concomitant hardware outside of the foot and ankle were recorded. To determine the detection rate of common foot and ankle implants ex vivo, different hardware sets were walked through the detector at all 3 program settings. Seventeen patients were found to have detectable hardware at the buildings, airports, and airports enhanced settings. An additional 3 patients had hardware only detected at the airports enhanced setting. All 20 of these patients had concomitant metal implants outside of the foot and ankle from other orthopaedic procedures. All patients with foot and ankle implants alone passed through undetected. Seven hardware sets were detected ex vivo at the airports enhanced setting. Our results indicate that patients with foot and ankle implants alone are unlikely to be detected by walkthrough metal detectors at standard airport settings. When additional hardware is present from orthopaedic procedures outside of the foot and ankle, metal detection rates were higher. We believe that these results are important for surgeons in order to educate patients on how they might be affected when walking through a metal detector such as while traveling. Level II, prospective comparative study. © The Author(s) 2014.
Wireless microsensor network solutions for neurological implantable devices
NASA Astrophysics Data System (ADS)
Abraham, Jose K.; Whitchurch, Ashwin; Varadan, Vijay K.
2005-05-01
The design and development of wireless mocrosensor network systems for the treatment of many degenerative as well as traumatic neurological disorders is presented in this paper. Due to the advances in micro and nano sensors and wireless systems, the biomedical sensors have the potential to revolutionize many areas in healthcare systems. The integration of nanodevices with neurons that are in communication with smart microsensor systems has great potential in the treatment of many neurodegenerative brain disorders. It is well established that patients suffering from either Parkinson"s disease (PD) or Epilepsy have benefited from the advantages of implantable devices in the neural pathways of the brain to alter the undesired signals thus restoring proper function. In addition, implantable devices have successfully blocked pain signals and controlled various pelvic muscles in patients with urinary and fecal incontinence. Even though the existing technology has made a tremendous impact on controlling the deleterious effects of disease, it is still in its infancy. This paper presents solutions of many problems of today's implantable and neural-electronic interface devices by combining nanowires and microelectronics with BioMEMS and applying them at cellular level for the development of a total wireless feedback control system. The only device that will actually be implanted in this research is the electrodes. All necessary controllers will be housed in accessories that are outside the body that communicate with the implanted electrodes through tiny inductively-coupled antennas. A Parkinson disease patient can just wear a hat-system close to the implantable neural probe so that the patient is free to move around, while the sensors continually monitor, record, transmit all vital information to health care specialist. In the event of a problem, the system provides an early warning to the patient while they are still mobile thus providing them the opportunity to react and trigger the feed back system or contact a point-of-care office that can remotely control the implantable system. The remote monitoring technology can be adaptable to EEG monitoring of children with epilepsy, implantable cardioverters/defibrillators, pacemakers, chronic pain management systems, treatment for sleep disorders, patients with implantable devices for diabetes. In addition, the development of a wireless neural electronics interface to detect, transmit and analyze neural signals could help patients with spinal injuries to regain some semblance of mobile activity.
Detection of biological molecules using chemical amplification and optical sensors
Van Antwerp, William Peter; Mastrototaro, John Joseph
2000-01-01
Methods are provided for the determination of the concentration of biological levels of polyhydroxylated compounds, particularly glucose. The methods utilize an amplification system that is an analyte transducer immobilized in a polymeric matrix, where the system is implantable and biocompatible. Upon interrogation by an optical system, the amplification system produces a signal capable of detection external to the skin of the patient. Quantitation of the analyte of interest is achieved by measurement of the emitted signal.
Detection of biological molecules using chemical amplification and optical sensors
Van Antwerp, William Peter; Mastrototaro, John Joseph
2004-10-12
Methods are provided for the determination of the concentration of biological levels of polyhydroxylated compounds, particularly glucose. The methods utilize an amplification system that is an analyte transducer immobilized in a polymeric matrix, where the system is implantable and biocompatible. Upon interrogation by an optical system, the amplification system produces a signal capable of detection external to the skin of the patient. Quantitation of the analyte of interest is achieved by measurement of the emitted signal.
Early diagnosis of orthopedic implant failure using macromolecular imaging agents.
Ren, Ke; Dusad, Anand; Zhang, Yijia; Purdue, P Edward; Fehringer, Edward V; Garvin, Kevin L; Goldring, Steven R; Wang, Dong
2014-08-01
To develop and evaluate diagnostic tools for early detection of wear particle-induced orthopaedic implant loosening. N-(2-Hydroxypropyl)methacrylamide (HPMA) copolymer was tagged with a near infrared dye and used to detect the inflammation induced by polymethylmethacrylate (PMMA) particles in a murine peri-implant osteolysis model. It was established by inserting an implant into the distal femur and challenging with routine PMMA particles infusion. The osteolysis was evaluated by micro-CT and histological analysis at different time points. Significant peri-implant osteolysis was found 3-month post PMMA particle challenge by micro-CT and histological analysis. At 1-month post challenge, when there was no significant peri-implant bone loss, the HPMA copolymer-near infrared dye conjugate was found to specifically target the femur with PMMA particles deposition, but not the contralateral control femur with phosphate buffered saline (PBS) infusion. The results from this study demonstrate the feasibility of utilizing the macromolecular diagnostic agent to detect particle-induced peri-implant inflammation prior to the development of detectable osteolysis. Recognition of this early pathological event would provide the window of opportunity for prevention of peri-implant osteolysis and subsequent orthopaedic implant failure.
Nickenig, Hans-Joachim; Eitner, Stephan
2007-01-01
We assessed the reliability of implant placement after virtual planning of implant positions using cone-beam CT data and surgical guide templates. A total of 102 patients (250 implants, 55.4% mandibular; mean patient age, 40.4 years) who had undergone implant treatment therapy in an armed forces dental clinic (Cologne, Germany) between July 1, 2005 and December 1, 2005. They were treated with a system that allows transfer of virtual planning to surgical guide templates. Only in eight cases the surgical guides were not used because a delayed implant placement was necessary. In four posterior mandibular cases, handling was limited because of reduced interocclusal distance, requiring 50% shortening of the drill guides. The predictability of implant size was high: only one implant was changed to a smaller diameter (because of insufficient bone). In all cases, critical anatomical structures were protected and no complications were detected in postoperative panoramic radiographs. In 58.1% (147) of the 250 implants, a flapless surgery plan was realized. Implant placement after virtual planning of implant positions using cone beam CT data and surgical templates can be reliable for preoperative assessment of implant size, position, and anatomical complications. It is also indicative of cases amenable to flapless surgery.
Further In-vitro Characterization of an Implantable Biosensor for Ethanol Monitoring in the Brain
Secchi, Ottavio; Zinellu, Manuel; Spissu, Ylenia; Pirisinu, Marco; Bazzu, Gianfranco; Migheli, Rossana; Desole, Maria Speranza; O′Neill, Robert D.; Serra, Pier Andrea; Rocchitta, Gaia
2013-01-01
Ethyl alcohol may be considered one of the most widespread central nervous system (CNS) depressants in Western countries. Because of its toxicological and neurobiological implications, the detection of ethanol in brain extracellular fluid (ECF) is of great importance. In a previous study, we described the development and characterization of an implantable biosensor successfully used for the real-time detection of ethanol in the brain of freely-moving rats. The implanted biosensor, integrated in a low-cost telemetry system, was demonstrated to be a reliable device for the short-time monitoring of exogenous ethanol in brain ECF. In this paper we describe a further in-vitro characterization of the above-mentioned biosensor in terms of oxygen, pH and temperature dependence in order to complete its validation. With the aim of enhancing ethanol biosensor performance, different enzyme loadings were investigated in terms of apparent ethanol Michaelis-Menten kinetic parameters, viz. IMAX, KM and linear region slope, as well as ascorbic acid interference shielding. The responses of biosensors were studied over a period of 28 days. The overall findings of the present study confirm the original biosensor configuration to be the best of those investigated for in-vivo applications up to one week after implantation. PMID:23881145
Dundar, Serkan; Yaman, Ferhan; Gecor, Orhan; Cakmak, Omer; Kirtay, Mustafa; Yildirim, Tuba Talo; Karaman, Tahir; Benlidayi, Mehmet Emre
2017-06-01
The aim of this study was to evaluate the effects of local and systemic zoledronic acid (ZA) applications on titaniumoksit ceramic blasted (TiO-CB)- and sandblasted large acid-grit (SLA)-surfaced titanium implant osseointegration. Twelve New Zealand White rabbits were used in the study, divided into 6 groups: the TiO-CB (TiO-CB-CNT) (n = 2) and SLA (SLA-CNT) (n = 2) control groups in which TiO-CB- and SLA-surfaced titanium implants were surgically inserted into rabbit tibias but no treatment was applied; the TiO-CB (TiO-CB-LZA) (n = 2) and SLA (SLA-LZA) (n = 2) local ZA groups in which 1 mL of normal saline solution containing 2 mg of ZA was injected into sockets and after this the implants were integrated; and the TiO-CB (TiO-CB-SZA) (n = 2) and SLA (SLA-SZA) (n = 2) systemic ZA groups in which a single infusion of 0.1 mg/kg of ZA was administered during surgical implant insertion. Following a period of osseointegration, bone implant contact (BIC) was recorded as a proportion of the total implant surface length in direct contact with the bone. Results of this study indicate that BIC was greater in the systemic ZA application groups than in the local ZA application groups, and BIC was greater in the local ZA groups than in the controls. Statistically significant differences in BIC were not detected between the TiO-CB- and SLA-surfaced implants in all the groups. Furthermore, this study did not reveal significant differences between the 2 types of surfaces due to similar average roughness values. Overall, systemic ZA application was found to be more effective in increasing BIC than local ZA application based on the results obtained by testing 2 implant surfaces.
Moore, Brian C J
2003-03-01
To review how the properties of sounds are "coded" in the normal auditory system and to discuss the extent to which cochlear implants can and do represent these codes. Data are taken from published studies of the response of the cochlea and auditory nerve to simple and complex stimuli, in both the normal and the electrically stimulated ear. REVIEW CONTENT: The review describes: 1) the coding in the normal auditory system of overall level (which partly determines perceived loudness), spectral shape (which partly determines perceived timbre and the identity of speech sounds), periodicity (which partly determines pitch), and sound location; 2) the role of the active mechanism in the cochlea, and particularly the fast-acting compression associated with that mechanism; 3) the neural response patterns evoked by cochlear implants; and 4) how the response patterns evoked by implants differ from those observed in the normal auditory system in response to sound. A series of specific issues is then discussed, including: 1) how to compensate for the loss of cochlear compression; 2) the effective number of independent channels in a normal ear and in cochlear implantees; 3) the importance of independence of responses across neurons; 4) the stochastic nature of normal neural responses; 5) the possible role of across-channel coincidence detection; and 6) potential benefits of binaural implantation. Current cochlear implants do not adequately reproduce several aspects of the neural coding of sound in the normal auditory system. Improved electrode arrays and coding systems may lead to improved coding and, it is hoped, to better performance.
Airport detectors and orthopaedic implants.
van der Wal, Bart C H; Grimm, Bernd; Heyligers, Ide C
2005-08-01
As a result of the rising threats of terrorism, airport security has become a major issue. Patients with orthopaedic implants are concerned that they may activate alarms at airport security gates. A literature overview showed that the activation rate of the alarm by hand-held detectors is higher than for arch detectors (100% versus 56%). Arch detection rate has significantly increased from 0% before 1995 up to 83.3% after 1994. Reported factors which influence detection rates are implant mass, implant combinations, implant volume, transfer speed, side of implant, detector model, sensitivity settings, material and tissue masking. Detection rate has been improved by more sensitive devices and improved filter software. Doctors should be able to objectively inform patients. A form is presented which will easily inform the airport security staff.
Osseointegration of zirconia implants: an SEM observation of the bone-implant interface.
Depprich, Rita; Zipprich, Holger; Ommerborn, Michelle; Mahn, Eduardo; Lammers, Lydia; Handschel, Jörg; Naujoks, Christian; Wiesmann, Hans-Peter; Kübler, Norbert R; Meyer, Ulrich
2008-11-06
The successful use of zirconia ceramics in orthopedic surgery led to a demand for dental zirconium-based implant systems. Because of its excellent biomechanical characteristics, biocompatibility, and bright tooth-like color, zirconia (zirconium dioxide, ZrO2) has the potential to become a substitute for titanium as dental implant material. The present study aimed at investigating the osseointegration of zirconia implants with modified ablative surface at an ultrastructural level. A total of 24 zirconia implants with modified ablative surfaces and 24 titanium implants all of similar shape and surface structure were inserted into the tibia of 12 Göttinger minipigs. Block biopsies were harvested 1 week, 4 weeks or 12 weeks (four animals each) after surgery. Scanning electron microscopy (SEM) analysis was performed at the bone implant interface. Remarkable bone attachment was already seen after 1 week which increased further to intimate bone contact after 4 weeks, observed on both zirconia and titanium implant surfaces. After 12 weeks, osseointegration without interposition of an interfacial layer was detected. At the ultrastructural level, there was no obvious difference between the osseointegration of zirconia implants with modified ablative surfaces and titanium implants with a similar surface topography. The results of this study indicate similar osseointegration of zirconia and titanium implants at the ultrastructural level.
Detection of biological molecules using boronate-based chemical amplification and optical sensors
Van Antwerp, William Peter; Mastrototaro, John Joseph; Lane, Stephen M.; Satcher, Jr., Joe H.; Darrow, Christopher B.; Peyser, Thomas A.; Harder, Jennifer
1999-01-01
Methods are provided for the determination of the concentration of biological levels of polyhydroxylated compounds, particularly glucose. The methods utilize an amplification system that is an analyte transducer immobilized in a polymeric matrix, where the system is implantable and biocompatible. Upon interrogation by an optical system, the amplification system produces a signal capable of detection external to the skin of the patient. Quantitation of the analyte of interest is achieved by measurement of the emitted signal.
Detection of biological molecules using boronate-based chemical amplification and optical sensors
Van Antwerp, William Peter; Mastrototaro, John Joseph; Lane, Stephen M.; Satcher, Jr., Joe H.; Darrow, Christopher B.; Peyser, Thomas A.; Harder, Jennifer
2004-06-15
Methods are provided for the determination of the concentration of biological levels of polyhydroxylated compounds, particularly glucose. The methods utilize an amplification system that is an analyte transducer immobilized in a polymeric matrix, where the system is implantable and biocompatible. Upon interrogation by an optical system, the amplification system produces a signal capable of detection external to the skin of the patient. Quantitation of the analyte of interest is achieved by measurement of the emitted signal.
Sircoglou, Julie; Gehrke, Maria; Tardivel, Meryem; Siepmann, Florence; Siepmann, Juergen; Vincent, Christophe
2015-09-01
The purpose of this study was to develop a new strategy to deliver drugs to the inner ear from dexamethasone (DXM)-loaded silicone implants and to evaluate the distribution of the drug in the cochlea with confocal microscopy. Systemic drug administration for the treatment of inner ear disorders is tricky because of the blood-cochlear barrier, a difficult anatomical access, the small size of the cochlea, and can cause significant adverse effects. An effective way to overcome these obstacles is to administer drugs locally. In vitro, the drug release from DXM-loaded silicone-based thin films and tiny implants into artificial perilymph was thoroughly analyzed by high-performance liquid chromatography. In vivo, a silicone implant loaded with 10% DXM and 5% polyethylene glycol 400 was implanted next to the stapes's footplate of gerbils. Delivery of DXM into the inner ear was proved by confocal microscopy imaging of the whole cochlea and the organ of Corti. The study showed a continuous and prolonged release during 90 days in vitro. This was confirmed by confocal microscopy that allowed detection of DXM by fluorescence labeling in the cell body of the hair cells for at least 30 days. Interestingly, fluorescence was already observed after 20 minutes of implantation, reached a climax at day 7, and could still be detected 30 days after implantation. Thus, we developed a new device for local corticosteroids delivery into the oval window with an extended drug release of DXM to the inner ear.
Gherlone, Enrico F.; Rapanelli, Andrea; Crespi, Roberto; Gastaldi, Giorgio
2018-01-01
Objectives The aim of this clinical study was to evaluate a new type of prefabricated bar system, supported by axial and tilted implants at 5-year follow-up. Materials and Methods Twenty-nine consecutive participants (19 females, 10 males) (mean age 61.4 years), edentulous in one or both jaws, with severe atrophy of the posterior regions, were treated according to the All-on-four® protocol with immediately loaded axial (64) and tilted (64) implants supporting complete-arch screw-retained prostheses (12 maxillary, 20 mandibular) featuring a prefabricated bar as framework. Follow-up visits were performed at 3, 6, 12, 24, 48, and 60 months after implant insertion. Radiographic assessments were made using panoramic radiographs obtained immediately after surgery and at each follow-up visit. Bone level measurements around the axial and tilted implants were compared by means of the Student's t-test. Results One axial implant failed in the lower jaw and did not compromise prosthetic function. The 60-month overall implant survival rate was 100% for axially positioned implants and 98.44% for tilted implants. The implant survival rates were 100% in the maxilla and 98.75% in the mandible. None of the 32 fixed prostheses were lost during the observation period, representing a prosthetic survival rate of 100%. No statistically significant differences (P > 0.05) in marginal bone loss between tilted and axial implants were detected in either jaw over time. Conclusions The use of the evaluated prefabricated bar for immediately loaded implants placed according to the All-on-four concept may significantly reduce implant failures; however, more long-term prospective clinical trials are needed to affirm the effectiveness of the surgical-prosthetic protocol. PMID:29682552
NASA Astrophysics Data System (ADS)
Pena, A. E.; Kuntaegowdanahalli, S. S.; Abbas, J. J.; Patrick, J.; Horch, K. W.; Jung, R.
2017-12-01
Objective. A neural interface system has been developed that consists of an implantable stimulator/recorder can with a 15-electrode lead that trifurcates into three bundles of five individual wire longitudinal intrafascicular electrodes. This work evaluated the mechanical fatigue resistance of the branched lead and distributed electrode system under conditions designed to mimic anticipated strain profiles that would be observed after implantation in the human upper arm. Approach. Custom test setups and procedures were developed to apply linear or angular strain at four critical stress riser points on the lead and electrode system. Each test was performed to evaluate fatigue under a high repetition/low amplitude paradigm designed to test the effects of arm movement on the leads during activities such as walking, or under a low repetition/high amplitude paradigm designed to test the effects of more strenuous upper arm activities. The tests were performed on representative samples of the implantable lead system for human use. The specimens were fabricated using procedures equivalent to those that will be used during production of human-use implants. Electrical and visual inspections of all test specimens were performed before and after the testing procedures to assess lead integrity. Main results. Measurements obtained before and after applying repetitive strain indicated that all test specimens retained electrical continuity and that electrical impedance remained well below pre-specified thresholds for detection of breakage. Visual inspection under a microscope at 10× magnification did not reveal any signs of damage to the wires or silicone sheathing at the stress riser points. Significance. These results demonstrate that the branched lead of this implantable neural interface system has sufficient mechanical fatigue resistance to withstand strain profiles anticipated when the system is implanted in an arm. The novel test setups and paradigms may be useful in testing other lead systems.
In vivo Electrochemical Biosensor for Brain Glutamate Detection: A Mini Review
HAMDAN, Siti Kartika; MOHD ZAIN, ainiharyati
2014-01-01
Glutamate is one of the most prominent neurotransmitters in mammalian brains, which plays an important role in neuronal excitation. High levels of neurotransmitter cause numerous alterations, such as calcium overload and the dysfunction of mitochondrial and oxidative stress. These alterations may lead to excitotoxicity and may trigger multiple neuronal diseases, such as Alzheimer’s disease, stroke, and epilepsy. Excitotoxicity is a pathological process that damages nerve cells and kills cells via excessive stimulation by neurotransmitters. Monitoring the concentration level of brain glutamate via an implantable microbiosensor is a promising alternative approach to closely investigate in the function of glutamate as a neurotransmitter. This review outlines glutamate microbiosensor designs to enhance the sensitivity of glutamate detection with less biofouling occurrence and minimal detection of interference species. There are many challenges in the development of a reproducible and stable implantable microbiosensor because many factors and limitations may affect the detection performance. However, the incorporation of multiple scales is needed to address the basic issues and combinations across the various disciplines needed to achieve the success of the system to overcome the challenges in the development of an implantable glutamate biosensor. PMID:25941459
Accelerometer-based step initiation control for gait-assist neuroprostheses.
Foglyano, Kevin M; Schnellenberger, John R; Kobetic, Rudi; Lombardo, Lisa; Pinault, Gilles; Selkirk, Stephen; Makowski, Nathaniel S; Triolo, Ronald J
2016-01-01
Electrical activation of paralyzed musculature can generate or augment joint movements required for walking after central nervous system trauma. Proper timing of stimulation relative to residual volitional control is critical to usefully affecting ambulation. This study evaluates three-dimensional accelerometers and customized algorithms to detect the intent to step from voluntary movements to trigger stimulation during walking in individuals with significantly different etiologies, mobility limitations, manual dexterities, and walking aids. Three individuals with poststroke hemiplegia or partial spinal cord injury exhibiting varying gait deficits were implanted with multichannel pulse generators to provide joint motions at the hip, knee, and ankle. An accelerometer integrated into the external control unit was used to detect heel strike or walker movement, and wireless accelerometers were used to detect crutch strike. Algorithms were developed for each sensor location to detect intent to step to progress through individualized stimulation patterns. Testing these algorithms produced detection accuracies of at least 90% on both level ground and uneven terrain. All participants use their accelerometer-triggered implanted gait systems in the community; the validation/system testing was completed in the hospital. The results demonstrated that safe, reliable, and convenient accelerometer-based step initiation can be achieved regardless of specific gait deficits, manual dexterities, and walking aids.
Kempen, John H.; Altaweel, Michael M.; Holbrook, Janet T.; Jabs, Douglas A.; Louis, Thomas A.; Sugar, Elizabeth A.; Thorne, Jennifer E.
2011-01-01
Objective To compare the relative effectiveness of systemic corticosteroids plus immunosuppression when indicated (systemic therapy) versus fluocinolone acetonide implant (implant therapy) for non-infectious intermediate, posterior or panuveitis (uveitis). Design Randomized controlled parallel superiority trial. Participants Patients with active/recently active uveitis. Methods Participants were randomized (allocation ratio 1:1) to systemic or implant therapy at 23 centers (three countries). Implant-assigned participants with bilateral uveitis were assigned to have each eye that warranted study treatment implanted. Treatment-outcome associations were analyzed by assigned treatment for all eyes with uveitis. Main Outcome Measures Masked examiners measured the primary outcome: change in best-corrected visual acuity from baseline. Secondary outcomes included patient-reported quality of life (QoL), ophthalmologist-graded uveitis activity, and local and systemic complications of uveitis or therapy. Reading Center graders and glaucoma specialists assessing ocular complications were masked. Participants, ophthalmologists, and coordinators were unmasked. Results Among 255 patients randomized to implant and systemic therapy (479 eyes with uveitis), evaluating changes from baseline to 24 months, the implant and systemic therapy groups respectively had +6.0 vs. +3.2 letters' improvement in visual acuity (p=0.16, 95% confidence interval on difference in improvement between groups: −1.2 to +6.7 letters, positive values favoring implant), +11.4 vs. +6.8 units' vision-related QoL improvement (p=0.043), +0.02 vs. −0.02 change in EuroQol-EQ5D health utility (p=0.060), and 12% vs. 29% had active uveitis (p=0.001). Over 24 months, implant-assigned eyes had a higher risk of cataract surgery (80%, hazard ratio (HR) = 3.3, p<0.0001), treatment for elevated intraocular pressure (61%, HR=4.2, p<0.0001), and glaucoma (17%, HR = 4.2, p=0.0008). Systemic-assigned patients had more prescription-requiring infections (0.60 vs. 0.36/person-year, p=0.034), without notable long-term consequences; systemic adverse outcomes otherwise were unusual in both groups, with minimal differences between groups. Conclusion In each treatment group, mean visual acuity improved over 24 months, with neither approach superior to a degree detectable with the study's power. Therefore, the specific advantages and disadvantages identified should dictate selection between the alternative treatments in consideration of individual patients' particular circumstances. Systemic therapy with aggressive use of corticosteroid-sparing immunosuppression was well-tolerated, suggesting that this approach is reasonably safe for local and systemic inflammatory disorders. PMID:21840602
Kotiadis, D; Hermens, H J; Veltink, P H
2010-05-01
An Inertial Gait Phase Detection system was developed to replace heel switches and footswitches currently being used for the triggering of drop foot stimulators. A series of four algorithms utilising accelerometers and gyroscopes individually and in combination were tested and initial results are shown. Sensors were positioned on the outside of the upper shank. Tests were performed on data gathered from a subject, sufferer of stroke, implanted with a drop foot stimulator and triggered with the current trigger, the heel switch. Data tested includes a variety of activities representing everyday life. Flat surface walking, rough terrain and carpet walking show 100% detection and the ability of the algorithms to ignore non-gait events such as weight shifts. Timing analysis is performed against the current triggering method, the heel switch. After evaluating the heel switch timing against a reference system, namely the Vicon 370 marker and force plates system. Initial results show a close correlation between the current trigger detection and the inertial sensor based triggering algorithms. Algorithms were tested for stairs up and stairs down. Best results are observed for algorithms using gyroscope data. Algorithms were designed using threshold techniques for lowest possible computational load and with least possible sensor components to minimize power requirements and to allow for potential future implantation of sensor system.
Varma, Niraj; Epstein, Andrew E; Schweikert, Robert; Michalski, Justin; Love, Charles J
2016-03-01
The incidence of unscheduled encounters and problem occurrence between ICD implant and first in-person evaluation (IPE) recommended at 12 weeks is unknown. Automatic remote home monitoring (HM) may be useful in this potentially unstable period. ICD patients were randomized 2:1 to HM enabled post-implant (n = 908) or to conventional monitoring (CM; n = 431). Groups were compared between implant and prior to first scheduled IPE for IPE incidence, causes, and actionability (reprogramming, system revision, medication changes) and event detection time. HM and CM patients were similar (mean age 63 years, 72% male, LVEF 29%, primary prevention 73%, DDD 57%). In the post-implant interval assessed (HM 100 ± 21.3 days vs. CM 101 ± 20.8 days, P = 0.54), 85.4% (776/908) HM patients and 87.7% CM (378/431) patients had no cause for IPE (P = 0.31). When IPE occurred, actionability in HM (64/177 [36.2%]) was greater versus CM (15/62 [24.2%], P = 0.12). Actionable items were discovered sooner with HM (P = 0.025). Device reprogramming or lead revision was triggered following 53/177 (29.9%) IPEs in HM versus 9/62 (14.5%) in CM (P = 0.018). Arrhythmia detection was enhanced by HM: 276 atrial and ventricular episodes were detected in 135 follow-ups in contrast to CM (65 episodes at 17 IPEs). More silent arrhythmic episodes were discovered by HM (7.2% vs. 1.5% [P = 0.15]). Since 27/42 (64.3%) IPEs driven by HM alerts were actionable, event notification was a valuable method for problem detection. Importantly, HM did not increase incidence of non-actionable IPEs (P = 0.72). Activation of automatic remote monitoring should be encouraged soon post-ICD implant. © 2015 Wiley Periodicals, Inc.
Susceptibility of metallic magnesium implants to bacterial biofilm infections.
Rahim, Muhammad Imran; Rohde, Manfred; Rais, Bushra; Seitz, Jan-Marten; Mueller, Peter P
2016-06-01
Magnesium alloys have promising mechanical and biological properties as biodegradable medical implant materials for temporary applications during bone healing or as vascular stents. Whereas conventional implants are prone to colonization by treatment resistant microbial biofilms in which bacteria are embedded in a protective matrix, magnesium alloys have been reported to act antibacterial in vitro. To permit a basic assessment of antibacterial properties of implant materials in vivo an economic but robust animal model was established. Subcutaneous magnesium implants were inoculated with bacteria in a mouse model. Contrary to the expectations, bacterial activity was enhanced and prolonged in the presence of magnesium implants. Systemic antibiotic treatments were remarkably ineffective, which is a typical property of bacterial biofilms. Biofilm formation was further supported by electron microscopic analyses that revealed highly dense bacterial populations and evidence for the presence of extracellular matrix material. Bacterial agglomerates could be detected not only on the implant surface but also at a limited distance in the peri-implant tissue. Therefore, precautions may be necessary to minimize risks of metallic magnesium-containing implants in prospective clinical applications. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 104A: 1489-1499, 2016. © 2016 Wiley Periodicals, Inc.
De Andres, Jose; Villanueva, Vicente; Palmisani, Stefano; Cerda-Olmedo, German; Lopez-Alarcon, Maria Dolores; Monsalve, Vicente; Minguez, Ana; Martinez-Sanjuan, Vicente
2011-05-01
It is common clinical practice to perform magnetic resonance imaging (MRI) in patients with indwelling programmable intrathecal drug delivery (IDD) systems, although the safety of the procedure has never been documented. We performed a single-center, 3-year, prospective evaluation in patients with a programmable implanted IDD to assess patient discomfort, IDD technical failures, and adverse effects during and after exposure to MRI. Forty-three consecutive patients with an implanted programmable IDD system (SynchroMed® EL Implantable Infusion Pump, Model 8626L-18, and SynchroMed® II Model 8637-20, 8637-40; Medtronic, Inc., Minneapolis, MN) requiring a scheduled MRI evaluation were studied during a 3-year period. All MRI scans were performed with a 1.5-tesla clinical use magnet and a specific absorption rate of no more than 0.9 W/kg. Radiograph control was used to confirm postexposure pump rotor movement and detect system dislocations. IDD system failures, patient satisfaction, and discomfort were recorded. None of the patients experienced signs of drug overinfusion that could lead to hemodynamic, respiratory, or neurologic alterations. Radiologic evaluation after MRI revealed no spatial displacements of the intrathecal catheter tip or body pump, and programmer telemetry confirmed the infusion recovery. Patients' satisfaction after the procedure was high. Performing an MRI scan with the proposed protocol in patients with an implanted Medtronic programmable IDD system resulted in virtually no technical or medical complications. © 2011 International Anesthesia Research Society
Tehini, Georges; Rifai, Khaldoun; Bou Nasser Eddine, Farah; El Zein, Nabil; Badran, Bassam
2014-01-01
Objectives. Hollow space between implant and abutment may act as reservoir for commensal and/or pathogenic bacteria representing a potential source of tissue inflammation. Microbial colonization of the interfacial gap may ultimately lead to infection and bone resorption. Using Rhodamine B, a sensitive fluorescent tracer dye, we aim in this study to investigate leakage at implant-abutment connection of three implant systems having the same prosthetic interface. Materials and Methods. Twenty-one implants (seven Astra Tech, seven Euroteknika, and seven Dentium) with the same prosthetic interface were connected to their original abutments, according to the manufacturers' recommendation. After determination of the inner volume of each implant systems, the kinetic quantification of leakage was evaluated for each group using Rhodamine B (10−2 M). For each group, spectrophotometric analysis was performed to detect leakage with a fluorescence spectrophotometer at 1 h (T0) and 48 h (T1) of incubation time at room temperature. Results. Astra Tech had the highest inner volume (6.8 μL), compared to Dentium (4 μL) and Euroteknika (2.9 μL). At T0 and T1, respectively, the leakage volume and percentage of each system were as follows: Astra Tech 0.043 μL or 1.48% (SD 0.0022), 0.08 μL or 5.56% (SD 0.0074), Euroteknika 0.09 μL or 6.93% (SD 0.0913), 0.21 μL or 20.55% (SD 0.0035), and Dentium 0.07 μL or 4.6% (SD 0.0029), 0.12 μL or 10.47% (SD 0.0072). Conclusion. The tested internal conical implant-abutment connections appear to be unable to prevent leakage. In average, Astra Tech implants showed the highest inner volume and the least leakage. PMID:24899896
Fast internal marker tracking algorithm for onboard MV and kV imaging systems
Mao, W.; Wiersma, R. D.; Xing, L.
2008-01-01
Intrafraction organ motion can limit the advantage of highly conformal dose techniques such as intensity modulated radiation therapy (IMRT) due to target position uncertainty. To ensure high accuracy in beam targeting, real-time knowledge of the target location is highly desired throughout the beam delivery process. This knowledge can be gained through imaging of internally implanted radio-opaque markers with fluoroscopic or electronic portal imaging devices (EPID). In the case of MV based images, marker detection can be problematic due to the significantly lower contrast between different materials in comparison to their kV-based counterparts. This work presents a fully automated algorithm capable of detecting implanted metallic markers in both kV and MV images with high consistency. Using prior CT information, the algorithm predefines the volumetric search space without manual region-of-interest (ROI) selection by the user. Depending on the template selected, both spherical and cylindrical markers can be detected. Multiple markers can be simultaneously tracked without indexing confusion. Phantom studies show detection success rates of 100% for both kV and MV image data. In addition, application of the algorithm to real patient image data results in successful detection of all implanted markers for MV images. Near real-time operational speeds of ∼10 frames∕sec for the detection of five markers in a 1024×768 image are accomplished using an ordinary PC workstation. PMID:18561670
Release of low molecular weight silicones and platinum from silicone breast implants.
Lykissa, E D; Kala, S V; Hurley, J B; Lebovitz, R M
1997-12-01
We have conducted a series of studies addressing the chemical composition of silicone gels from breast implants as well as the diffusion of low molecular weight silicones (LM-silicones) and heavy metals from intact implants into various surrounding media, namely, lipid-rich medium (soy oil), aqueous tissue culture medium (modified Dulbecco's medium, DMEM), or an emulsion consisting of DMEM plus 10% soy oil. LM-silicones in both implants and surrounding media were detected and quantitated using gas chromatography (GC) coupled with atomic emission (GC-AED) as well as mass spectrometric (GC/MS) detectors, which can detect silicones in the nanogram range. Platinum, a catalyst used in the preparation of silicone gels, was detected and quantitated using inductive argon-coupled plasma/mass spectrometry (ICP-MS), which can detect platinum in the parts per trillion range. Our results indicate that GC-detectable low molecular weight silicones contribute approximately 1-2% to the total gel mass and consist predominantly of cyclic and linear poly-(dimethylsiloxanes) ranging from 3 to 20 siloxane [(CH3)2-Si-O] units (molecular weight 200-1500). Platinum can be detected in implant gels at levels of approximately 700 micrograms/kg by ICP-MS. The major component of implant gels appears to be high molecular weight silicone polymers (HM-silicones) too large to be detected by GC. However, these HM-silicones can be converted almost quantitatively (80% by mass) to LM-silicones by heating implant gels at 150-180 degrees C for several hours. We also studied the rates at which LM-silicones and platinum leak through the intact implant outer shell into the surrounding media under a variety of conditions. Leakage of silicones was greatest when the surrounding medium was lipid-rich, and up to 10 mg/day LM-silicones was observed to diffuse into a lipid-rich medium per 250 g of implant at 37 degrees C. This rate of leakage was maintained over a 7-day experimental period. Similarly, platinum was also observed to leak through intact implants into lipid-containing media at rates of approximately 20-25 micrograms/day/250 g of implant at 37 degrees C. The rates at which both LM-silicones and platinum have been observed to leak from intact implants could lead to significant accumulation within lipid-rich tissues and should be investigated more fully in vivo.
Milekovic, Tomislav; Ball, Tonio; Schulze-Bonhage, Andreas; Aertsen, Ad; Mehring, Carsten
2013-01-01
Background Brain-machine interfaces (BMIs) can translate the neuronal activity underlying a user’s movement intention into movements of an artificial effector. In spite of continuous improvements, errors in movement decoding are still a major problem of current BMI systems. If the difference between the decoded and intended movements becomes noticeable, it may lead to an execution error. Outcome errors, where subjects fail to reach a certain movement goal, are also present during online BMI operation. Detecting such errors can be beneficial for BMI operation: (i) errors can be corrected online after being detected and (ii) adaptive BMI decoding algorithm can be updated to make fewer errors in the future. Methodology/Principal Findings Here, we show that error events can be detected from human electrocorticography (ECoG) during a continuous task with high precision, given a temporal tolerance of 300–400 milliseconds. We quantified the error detection accuracy and showed that, using only a small subset of 2×2 ECoG electrodes, 82% of detection information for outcome error and 74% of detection information for execution error available from all ECoG electrodes could be retained. Conclusions/Significance The error detection method presented here could be used to correct errors made during BMI operation or to adapt a BMI algorithm to make fewer errors in the future. Furthermore, our results indicate that smaller ECoG implant could be used for error detection. Reducing the size of an ECoG electrode implant used for BMI decoding and error detection could significantly reduce the medical risk of implantation. PMID:23383315
Cehreli, Secil; Yilmaz, Alev; Arman-Ozcirpici, Ayca
2013-04-01
To measure strains around orthodontic implants upon torque tightening and loading and to assess correlations between factors influencing primary stability. Self-drilling implants were placed into bovine iliac crest blocks after CT assessments. Upon bonding of strain gauges on bone adjacent to the implants, strain measurements were performed using a data acquisition system during torque tightening and 250 g orthodontic force application by elastic chains. The torque required to place straight implants (12.16 N.cm) was higher than 30- to 40-degree angulated implants (9.31 N.cm) (P < 0.05). Cortical bone strain amplitudes of both implant placements were comparable (P > 0.05). Strains during torque tightening of straight (196 με) and tilted (114 με) implants were higher than those obtained during orthodontic loading (20-30 με). Despite the positive and direct relationship found between torque and torque strain output, strong correlations between other parameters could not be detected. Vertically aligned and 30- to 40-degree angulated immediate orthodontic microimplants are associated with low amplitude strains upon torque tightening and orthodontic loading.
Kolb, Christof; Ocklenburg, Rolf
2016-09-01
For physicians involved in the treatment of patients with implantable cardioverter-defibrillators (ICDs) the knowledge of tachycardia detection algorithms is of paramount importance. This knowledge is essential for adequate device selection during de-novo implantation, ICD replacement, and for troubleshooting during follow-up. This review describes tachycardia detection algorithms incorporated in ICDs by Sorin/LivaNova and analyses their strengths and weaknesses.
Detection of trace cobalt ions in in vivo plant cells using a voltammetric interlocking system.
Ly, Suw Young; Shin, Myoung Ho; Lee, Chang Hyun; Lee, Jin Hui; Kim, Mi Sook; Ji, Sang Woo; Park, Dong Won
2013-01-01
This experiment was conducted to establish a system for detecting trace cobalt ions in water and plant tissues using a voltammetric in vivo sensor. Cyclic and stripping voltammetry was devised from hand-made, macro-type implantable three-electrode systems. The results reached micro and nano working ranges at 100 sec accumulation time. The statistical detection limit (S/N) was attained at 6.0 ng L(-1). For the in vivo application, direct assay of cobalt ions was carried out in Eichhornia crassipes (EC) deep tissue in real time with a preconcentration time of 100 s. Interfaced techniques can be interlocked with other control systems.
Detection of Orthopaedic Implants by Airport Metal Detectors
Abbassian, Ali; Datla, Balarama; Brooks, RA
2007-01-01
INTRODUCTION We performed a questionnaire study to establish the frequency and consequences of the detection of orthopaedic implants by airport security and to help us advise patients correctly. All published literature on this subject is based on experimental studies and no ‘real-life’ data are available. PATIENTS AND METHODS A total of 200 patients with a variety of implants were identified. All patients were sent a postal questionnaire enquiring about their experience with airport security since their surgery. RESULTS Of the cohort, 154 (77%) patients responded. About half of the implants (47%) were detected, but the majority of patients (72%) were not significantly inconvenienced. When detected, only 9% of patients were asked for documentary evidence of their implant. We also found that patients with a total knee replacement (TKR) had a greater chance of detection as compared to those with a total hip replacement (THR; 71% versus 31%; P = 0.03). CONCLUSIONS All patients, and in particular those with a TKR, can be re-assured that, although they have a fair chance of detection by airport security, a major disruption to their journey is unlikely. We advise that documentation to prove the presence of an orthopaedic implant should be offered to those who are concerned about the potential for inconvenience, but such documentation is not required routinely. PMID:17394716
Detection of orthopaedic implants by airport metal detectors.
Abbassian, Ali; Datla, Balarama; Brooks, R A
2007-04-01
We performed a questionnaire study to establish the frequency and consequences of the detection of orthopaedic implants by airport security and to help us advise patients correctly. All published literature on this subject is based on experimental studies and no 'real-life' data are available. A total of 200 patients with a variety of implants were identified. All patients were sent a postal questionnaire enquiring about their experience with airport security since their surgery. Of the cohort, 154 (77%) patients responded. About half of the implants (47%) were detected, but the majority of patients (72%) were not significantly inconvenienced. When detected, only 9% of patients were asked for documentary evidence of their implant. We also found that patients with a total knee replacement (TKR) had a greater chance of detection as compared to those with a total hip replacement (THR; 71% versus 31%; P = 0.03). All patients, and in particular those with a TKR, can be re-assured that, although they have a fair chance of detection by airport security, a major disruption to their journey is unlikely. We advise that documentation to prove the presence of an orthopaedic implant should be offered to those who are concerned about the potential for inconvenience, but such documentation is not required routinely.
Dursun, Erhan; Tulunoglu, Ibrahim; Canpınar, Pınar; Uysal, Serdar; Akalın, Ferda Alev; Tözüm, Tolga F
2012-10-01
The aim of this study was to evaluate short-term bone level and stability/mobility measurement alterations at platform switched (PS) and standard platform (SP) implants placed in mandibular premolar/molar regions using a single-stage protocol. Sixteen PS and 16 SP implants restorated with fixed prosthesis were included. Standard implant dimensions were used for both implant systems. After 3 months of osseointegration, implants were connected to abutments and final restorations were performed. Marginal bone loss was measured by standardized periapical radiographs. Implant stability/mobility was determined by resonance frequency analysis (RFA) and mobility measuring (MM) device values. Peri-implant parameters were evaluated with clinical periodontal indices and all parameters were assessed at baseline, 1, 3, and 6 months after the surgery. After 6 months, all implants showed uneventful healing. Radiographic evaluation showed a mean bone loss of 0.72 mm for PS and 0.56 mm for SP implants, and there were no significant differences between implant types. At 6 months, mean implant stability quotient (ISQ) values were 73.38 and 77 for PS and SP implants, respectively. Mean MM values were -4.75 for PS and -6.38 for SP implants. Mean MM values were lower for SP implants compared to PS implants at all time points. No significant differences were detected between implant types according to clinical peri-implant parameters. The micro-gap at crestal level which immediately exposed to the oral cavity in non-submerged two part implants seems to have adverse influence on the marginal bone level. © 2011 John Wiley & Sons A/S.
Lee, Mi-Young; Heo, Seong-Joo; Park, Eun-Jin; Park, Ji-Man
2013-08-01
The aim of this study was to compare the passivity of implant superstructures by assessing the strain development around the internal tapered connection implants with strain gauges. A polyurethane resin block in which two implants were embedded served as a measurement model. Two groups of implant restorations utilized cement-retained design and internal surface of the first group was adjusted until premature contact between the restoration and the abutment completely disappeared. In the second group, only nodules detectable to the naked eye were removed. The third group employed screw-retained design and specimens were generated by computer-aided design/computer-aided manufacturing system (n=10). Four strain gauges were fixed on the measurement model mesially and distally to the implants. The strains developed in each strain gauge were recorded during fixation of specimens. To compare the difference among groups, repeated measures 2-factor analysis was performed at a level of significance of α=.05. The absolute strain values were measured to analyze the magnitude of strain. The mean absolute strain value ranged from 29.53 to 412.94 µm/m at the different strain gauge locations. According to the result of overall comparison, the cement-retained prosthesis groups exhibited significant difference. No significant difference was detected between milled screw-retained prostheses group and cement-retained prosthesis groups. Within the limitations of the study, it was concluded that the cement-retained designs do not always exhibit lower levels of stress than screw-retained designs. The internal adjustment of a cement-retained implant restoration is essential to achieve passive fit.
Detection of biological molecules using chemical amplification and optical sensors
Van Antwerp, William Peter; Mastrototaro, John Joseph
2001-01-01
Methods are provided for the determination of the concentration of biological levels of polyhydroxylated compounds, particularly glucose. The methods utilize an amplification system that is an analyte transducer immobilized in a polymeric matrix, where the system is implantable and biocompatible. Upon interrogation by an optical system, the amplification system produces a signal capable of detection external to the skin of the patient. Quantitation of the analyte of interest is achieved by measurement of the emitted signal. Specifically, the analyte transducer immobilized in a polymeric matrix can be a boronic acid moiety.
Parahuleva, Mariana S; Soydan, Nedim; Divchev, Dimitar; Lüsebrink, Ulrich; Schieffer, Bernhard; Erdogan, Ali
2017-11-01
The Home Monitoring (HM) system of cardiac implantable electronic devices (CIEDs) permits early detection of arrhythmias or device system failures. The aim of this pilot study was to examine how the safety and efficacy of the HM system in patients after ambulatory implanted primary CIEDs compare to patients with a standard procedure and hospitalization. We hypothesized that HM and their modifications would be a useful extension of the present concepts for ambulatory implanted CIEDs. This retrospective analysis evaluates telemetric data obtained from 364 patients in an ambulatory single center over 6 years. Patients were assigned to an active group (n = 217), consisting of those who were discharged early on the day of implantation of the primary CIED, or to a control group (n = 147), consisting of those discharged and followed up with the HM system according to usual medical practices. The mean duration of hospitalization was 73.2% shorter in the active group than in the control group, corresponding to 20.5 ± 13 fewer hours (95% confidence interval [CI]: 6.3-29.5; P < 0.01) spent in the hospital (7.5 ± 1.5 vs 28 ± 4.5 h). This shorter mean hospital stay was attributable to a 78.8% shorter postoperative period in the active group. The proportion of patients with treatment-related adverse events was 11% (n = 23) in the active group and 17% (n = 25) in the control group (95% CI: 5.5-8.3; P = 0.061). This 6% absolute risk reduction (95% CI: 3.3-9.1; P = 0.789) confirmed the noninferiority of the ambulatory implanted CIED when compared with standard management of these patients. Early discharge with the HM system after ambulatory CIED implantation was safe and not inferior to the classic medical procedure. Thus, together with lower costs, HM and its modifications would be a useful extension of the present concepts for ambulatory implanted CIEDs. © 2017 Wiley Periodicals, Inc.
Yousif, Aziz; Kelly, Shawn K
2016-08-01
There has been a push for a greater number of channels in implantable neuroprosthetic devices; but, that number has largely been limited by current hermetic packaging technology. Microfabricated packaging is becoming reality, but a standard testing system is needed to prepare these devices for clinical trials. Impedance measurements of electrodes built into the packaging layers may give an early warning of device failure and predict device lifetime. Because the impedance magnitudes of such devices can be on the order of gigaohms, a versatile system was designed to accommodate ultra-high impedances and allow future integrated circuit implementation in current neural prosthetic technologies. Here we present the circuitry, control software, and preliminary testing results of our designed system.
Alkan, Eylem Ayhan; Mau, Lian Ping; Schoolfield, John; Guest, Gary F; Cochran, David L
To evaluate the number of patients with dental implants who present to a dental school clinic for screening and to report the prevalence of peri-implant bone level change detected on digital panoramic radiographs of those subjects. Patient screening files for 9,422 patients over a 2-year period were examined to see how many patients presented with dental implants. Those patients with at least one implant were further evaluated by measuring the bone level on the mesial and distal sides of the implant using the screening radiograph. A total of 187 patients (2%) had at least one implant. In regard to implants, 423 were examined and 146 (33%) had no detectable bone loss defined as bone level below the top of the implant. When thresholds of bone loss were evaluated, 109 implants (25%) had ≥ 2 mm of bone loss on either the mesial or distal sides or both. The median bone loss was 1.74 mm for the 277 implants with detectable bone loss and 2.97 mm for the 109 implants that had ≥ 2 mm bone loss. Interestingly, patients who were ≥ 70 years of age had significantly (P = .03) more bone loss in the mandible compared with the maxilla, while patients who were 60 to 69 years of age had significantly greater loss in the maxilla. These data reveal that for patients presenting to the dental school for a screening over a 2-year period, 1.98% had one or more dental implants. Furthermore, those patients with implants had a minimum amount of bone loss as measured from the top of the implant.
Park, Steve; Guan, Xiying; Kim, Youngwan; Creighton, Francis Pete X; Wei, Eric; Kymissis, Ioannis John; Nakajima, Hideko Heidi; Olson, Elizabeth S
2018-01-01
We report the fabrication and characterization of a prototype polyvinylidene fluoride polymer-based implantable microphone for detecting sound inside gerbil and human cochleae. With the current configuration and amplification, the signal-to-noise ratios were sufficiently high for normally occurring sound pressures and frequencies (ear canal pressures >50-60 dB SPL and 0.1-10 kHz), though 10 to 20 dB poorer than for some hearing aid microphones. These results demonstrate the feasibility of the prototype devices as implantable microphones for the development of totally implantable cochlear implants. For patients, this will improve sound reception by utilizing the outer ear and will improve the use of cochlear implants.
Guan, Xiying; Kim, Youngwan; Creighton, Francis (Pete) X.; Wei, Eric; Kymissis, Ioannis(John); Nakajima, Hideko Heidi; Olson, Elizabeth S.
2018-01-01
We report the fabrication and characterization of a prototype polyvinylidene fluoride polymer-based implantable microphone for detecting sound inside gerbil and human cochleae. With the current configuration and amplification, the signal-to-noise ratios were sufficiently high for normally occurring sound pressures and frequencies (ear canal pressures >50–60 dB SPL and 0.1–10 kHz), though 10 to 20 dB poorer than for some hearing aid microphones. These results demonstrate the feasibility of the prototype devices as implantable microphones for the development of totally implantable cochlear implants. For patients, this will improve sound reception by utilizing the outer ear and will improve the use of cochlear implants. PMID:29732950
Stoecklin, S; Volk, T; Yousaf, A; Reindl, L
2015-01-01
In this paper, an enhanced approach of a class E amplifier being insensitive to coil impedance variations is presented. While state of the art class E amplifiers widely being used to supply implanted systems show a strong degradation of efficiency when powering distance, coil orientation or the implant current consumption deviate from the nominal design, the presented concept is able to detect these deviations on-line and to reconfigure the amplifier automatically. The concept is facilitated by a new approach of sensing the load impedance without interruption of the power supply to the implant, while the main components of the class E amplifier are programmable by software. Therefore, the device is able to perform dynamic impedance matching. Besides presenting the operational principle and the design equations, we show an adaptive prototype reader system which achieves a drain efficiency of up to 92% for a wide range of reflected coil impedances from 1 to 40 Ω. The integrated communication concept allows downlink data rates of up to 500 kBit/s, while the load modulation based uplink from implant to reader was verified of providing up to 1.35 MBit/s.
Wireless ultrasound-powered biotelemetry for implants.
Towe, Bruce C; Larson, Patrick J; Gulick, Daniel W
2009-01-01
A miniature piezoelectric receiver coupled to a diode is evaluated as a simple device for wireless transmission of bioelectric events to the body surface. The device converts the energy of a surface-applied ultrasound beam to a high frequency carrier current in solution. Bioelectrical currents near the implant modulate the carrier amplitude, and this signal is remotely detected and demodulated to recover the biopotential waveform. This technique achieves millivolt sensitivity in saline tank tests, and further attention to system design is expected to improve sensitivity.
Delayed Propionibacterium acnes surgical site infections occur only in the presence of an implant
Shiono, Yuta; Ishii, Ken; Nagai, Shigenori; Kakinuma, Hiroaki; Sasaki, Aya; Funao, Haruki; Kuramoto, Tetsuya; Yoshioka, Kenji; Ishihama, Hiroko; Isogai, Norihiro; Takeshima, Kenichiro; Tsuji, Takashi; Okada, Yasunori; Koyasu, Shigeo; Nakamura, Masaya; Toyama, Yoshiaki; Aizawa, Mamoru; Matsumoto, Morio
2016-01-01
Whether Propionibacterium acnes (P. acnes) causes surgical-site infections (SSI) after orthopedic surgery is controversial. We previously reported that we frequently find P. acnes in intraoperative specimens, yet none of the patients have clinically apparent infections. Here, we tracked P. acnes for 6 months in a mouse osteomyelitis model. We inoculated P. acnes with an implant into the mouse femur in the implant group; the control group was treated with the bacteria but no implant. We then observed over a 6-month period using optical imaging system. During the first 2 weeks, bacterial signals were detected in the femur in the both groups. The bacterial signal completely disappeared in the control group within 28 days. Interestingly, in the implant group, bacterial signals were still present 6 months after inoculation. Histological and scanning electron-microscope analyses confirmed that P. acnes was absent from the control group 6 months after inoculation, but in the implant group, the bacteria had survived in a biofilm around the implant. PCR analysis also identified P. acnes in the purulent effusion from the infected femurs in the implant group. To our knowledge, this is the first report showing that P. acnes causes SSI only in the presence of an implant. PMID:27615686
Robotic cadaver testing of a new total ankle prosthesis model (German Ankle System).
Richter, Martinus; Zech, Stefan; Westphal, Ralf; Klimesch, Yvone; Gosling, Thomas
2007-12-01
An investigation was carried out into possible increased forces, torques, and altered motions during load-bearing ankle motion after implantation of two different total ankle prostheses. We hypothesized that the parameters investigated would not differ in relation to the two implants compared. We included two different ankle prostheses (Hintegra, Newdeal, Vienne, France; German Ankle System, R-Innovation, Coburg, Germany). The prostheses were implanted in seven paired cadaver specimens. The specimens were mounted on an industrial robot that enables complex motion under predefined conditions (RX 90, Stäubli, Bayreuth, Germany). The robot detected the load-bearing (30 kg) motion of the 100(th) cycle of the specimens without prostheses as the baseline for the later testing, and mimicked that exact motion during 100 cycles after the prostheses were implanted. The resulting forces, torques, and bone motions were recorded and the differences between the prostheses compared. The Hintegra and German Ankle System, significantly increased the forces and torques in relation to the specimen without a prosthesis with one exception (one-sample-t-test, each p < or = 0.01; exception, parameter lateral force measured with the German Ankle System, p = 0.34). The force, torque, and motion differences between the specimens before and after implantation of the prostheses were lower with the German Ankle System than with the Hintegra (unpaired t-test, each p < or = 0.05). The German Ankle System prosthesis had less of an effect on resulting forces and torques during partial weightbearing passive ankle motion than the Hintegra prosthesis. This might improve function and minimize loosening during the clinical use.
[Classification of prosthetic loosening and determination of wear particles].
Otto, M
2008-11-01
Nowaday, loosening of orthopaedic implants implies important medical and socioeconomic problems. Implant loosening is caused by implant infections as well as aseptic loosening, due to particle disease and mechanical alterations. Clinically we divide the implant infection into early and late infections. Morphologically it is possible to reliably detect the infection by quantification of neutrophil granulocytes. Additionally molecular methods are suitable to detect micro-organisms which are responsible for the prosthetic joint infection including their resistance to antibiotics. Particle disease may be reproducibly classified by the detection of different types of wear particles, particularly polyethylene, metal, ceramic and cement. The aetiology of the indeterminate type of the periprosthetic membrane is obscure, but may be associated with osteopathies. This classification of the periprosthetic membrane morphology provides clinically significant information concerning clinical management of implant loosening.
Siebert, Frank-André; Hirt, Markus; Niehoff, Peter; Kovács, György
2009-08-01
Ultrasound imaging is becoming increasingly important in prostate brachytherapy. In high-dose-rate (HDR) real-time planning procedures the definition of the implant needles is often performed by transrectal ultrasound. This article describes absolute measurements of the visibility and accuracy of manual detection of implant needle tips and compares measurement results of different biplane ultrasound systems in transversal and longitudinal (i.e., sagittal) ultrasound modes. To obtain a fixed coordinate system and stable conditions the measurements were carried out in a water tank using a dedicated marker system. Needles were manually placed in the phantom until the observer decided by the real-time ultrasound image that the zero position was reached. A comparison of three different ultrasound systems yielded an offset between 0.8 and 3.1 mm for manual detection of the needle tip in ultrasound images by one observer. The direction of the offset was discovered to be in the proximal direction, i.e., the actual needle position was located more distally compared to the ultrasound-based definition. In the second part of the study, the ultrasound anisotropy of trocar implant needles is reported. It was shown that the integrated optical density in a region of interest around the needle tip changes with needle rotation. Three peaks were observed with a phase angle of 120 degrees. Peaks appear not only in transversal but also in longitudinal ultrasound images, with a phase shift of 60 degrees. The third section of this study shows results of observer dependent influences on needle tip detection in sagittal ultrasound images considering needle rotation. These experiments were carried out using the marker system in a water tank. The needle tip was placed exactly at the position z=0 mm. It was found that different users tend to differently interpret the same ultrasound images. The needle tip was manually detected five times in the ultrasound images by three experienced observers at positions (+/- standard deviation) -0.53 +/- 0.16, -0.16 +/- 0.14, and -0.30 +/- 0.16 mm using a gain of 15 dB. The minus sign indicates that the needle tips were detected more proximally than the actual position of the needle tip. When using a gain of -15 dB the mean values of two observers resulted in -0.62 +/- 0.08 and -0.51 +/- 0.12 mm. Additionally an alternative approach to the direct needle tip definition was investigated. Two observers detected the solid part of the needle tip in sagittal images. This solid part, often named as "dead space end," is the distance between the needle tip and the beginning of the hollow part of the implant needle. The dead space end is 6.2 mm for the investigated needle type. Two users found mean values of -6.70 +/- 0.16 and -7.00 +/- 0.06 mm, respectively, for 15 dB gain and -6.90 +/- 0.09 and -7.02 +/- 0.06 mm using the -15 dB gain setting. The results show that ultrasound-based needle tip definition in sagittal viewing mode is accurate. The inter- and intraobserver errors should, however, be taken into account. A lower gain setting of the ultrasound system reduces the intraobserver error.
Multimodality Imaging-based Evaluation of Single-Lumen Silicone Breast Implants for Rupture.
Seiler, Stephen J; Sharma, Pooja B; Hayes, Jody C; Ganti, Ramapriya; Mootz, Ann R; Eads, Emily D; Teotia, Sumeet S; Evans, W Phil
2017-01-01
Breast implants are frequently encountered on breast imaging studies, and it is essential for any radiologist interpreting these studies to be able to correctly assess implant integrity. Ruptures of silicone gel-filled implants often occur without becoming clinically obvious and are incidentally detected at imaging. Early diagnosis of implant rupture is important because surgical removal of extracapsular silicone in the breast parenchyma and lymphatics is difficult. Conversely, misdiagnosis of rupture may prompt a patient to undergo unnecessary additional surgery to remove the implant. Mammography is the most common breast imaging examination performed and can readily depict extracapsular free silicone, although it is insensitive for detection of intracapsular implant rupture. Ultrasonography (US) can be used to assess the internal structure of the implant and may provide an economical method for initial implant assessment. Common US signs of intracapsular rupture include the "keyhole" or "noose" sign, subcapsular line sign, and "stepladder" sign; extracapsular silicone has a distinctive "snowstorm" or echogenic noise appearance. Magnetic resonance (MR) imaging is the most accurate and reliable means for assessment of implant rupture and is highly sensitive for detection of both intracapsular and extracapsular rupture. MR imaging findings of intracapsular rupture include the keyhole or noose sign, subcapsular line sign, and "linguine" sign, and silicone-selective MR imaging sequences are highly sensitive to small amounts of extracapsular silicone. © RSNA, 2017.
Remote Left Ventricular Hemodynamic Monitoring Using a Novel Intracardiac Sensor.
Mondritzki, Thomas; Boehme, Philip; White, Jason; Park, Jin Woo; Hoffmann, Jessica; Vogel, Julia; Kolkhof, Peter; Walsh, Stuart; Sandner, Peter; Bischoff, Erwin; Dinh, Wilfried; Hüser, Jörg; Truebel, Hubert
2018-05-01
Heart failure (HF) remains the most common reason for hospital admission in patients aged >65 years. Despite modern drug therapy, mortality and readmission rates for patients hospitalized with HF remain high. This necessitates further research to identify early patients at risk for readmission to limit hospitalization by timely adjustment of medical therapy. Implantable devices can monitor left ventricular (LV) hemodynamics and remotely and continuously detect the early signs of decompensation to trigger interventions and reduce the risk of hospitalization for HF. Here, we report the first preclinical study validating a new batteryless and easy to implant LV-microelectromechanical system to assess LV performance. A miniaturized implantable wireless pressure sensor was adapted for implantation in the LV apex. The LV-microelectromechanical system sensor was tested in a canine model of HF. The wireless pressure sensor measurements were compared with invasive left heart catheter-derived measurements at several time points. During different pharmacological challenge studies with dobutamine or vasopressin, the device was equally sensitive compared with invasive standard procedures. No adverse events or any observable reaction related to the implantation and application of the device for a period of 35 days was observed. Our miniaturized wireless pressure sensor placed in the LV (LV-microelectromechanical system) has the potential to become a new telemetric tool to earlier identify patients at risk for HF decompensation and to guide the treatment of patients with HF. © 2018 American Heart Association, Inc.
A system for gathering small mammal data
Robert D. Neely; Robert W. Campbell
1973-01-01
As an aid to studying vertebrate predators of the gypsy moth, a radio telemetry system was designed to detect the death of small mammals and facilitate recovery of the remains. An intraperitoneally implanted radio transmitter is triggered by the drop in body temperature when the animal dies. The device was tested in white-footed mice.
NASA Astrophysics Data System (ADS)
Oancea, C.; Shipulin, K.; Mytsin, G.; Molokanov, A.; Niculae, D.; Ambrožová, I.; Davídková, M.
2017-03-01
A dosimetric experiment was performed at the Medico-Technical Complex in the Joint Institute for Nuclear Research, Dubna, to investigate the effects of metallic dental implants in the treatment of head and neck tumours with proton therapy. The goal of the study was to evaluate the 2D dose distributions of different clinical treatment plans measured in an anthropomorphic phantom, and compare them to predictions from a treatment planning system. The anthropomorphic phantom was sliced into horizontal segments. Two grade 4 Titanium implants were inserted between 2 slices, corresponding to a maxillary area. GafChromic EBT2 films were placed between the segments containing the implants to measure the 2D delivered dose. Two different targets were designed: the first target includes the dental implants in the isocentre, and in the second target, the proton beam is delivered through the implants, which are located at the entrance region of the Bragg curve. The experimental results were compared to the treatment plans made using our custom 3D Treatment Planning System, named RayTreat. To quantitatively determine differences in the isodose distributions (measured and calculated), the gamma index (3 mm, 3%) was calculated for each target for the matrix value in the region of high isodose (> 90%): for the experimental setup, which includes the implants in the SOBP region, the result obtained was 84.3%. When the implants were localised in the entrance region of the Bragg curve, the result obtained was 86.4%. In conclusion, the uncertainties introduced by the clinically planned dose distribution are beyond reasonable limits. The linear energy transfer spectra in close proximity to the implants were investigated using solid state nuclear track detectors (TED). Scattered particles outside the target were detected.
Hollow fiber: a biophotonic implant for live cells
NASA Astrophysics Data System (ADS)
Silvestre, Oscar F.; Holton, Mark D.; Summers, Huw D.; Smith, Paul J.; Errington, Rachel J.
2009-02-01
The technical objective of this study has been to design, build and validate biocompatible hollow fiber implants based on fluorescence with integrated biophotonics components to enable in fiber kinetic cell based assays. A human osteosarcoma in vitro cell model fiber system has been established with validation studies to determine in fiber cell growth, cell cycle analysis and organization in normal and drug treated conditions. The rationale for implant development have focused on developing benchmark concepts in standard monolayer tissue culture followed by the development of in vitro hollow fiber designs; encompassing imaging with and without integrated biophotonics. Furthermore the effect of introducing targetable biosensors into the encapsulated tumor implant such as quantum dots for informing new detection readouts and possible implant designs have been evaluated. A preliminary micro/macro imaging approach has been undertaken, that could provide a mean to track distinct morphological changes in cells growing in a 3D matrix within the fiber which affect the light scattering properties of the implant. Parallel engineering studies have showed the influence of the optical properties of the fiber polymer wall in all imaging modes. Taken all together, we show the basic foundation and the opportunities for multi-modal imaging within an in vitro implant format.
Physicochemical and microscopic characterization of implant-abutment joints.
Lopes, Patricia A; Carreiro, Adriana F P; Nascimento, Rubens M; Vahey, Brendan R; Henriques, Bruno; Souza, Júlio C M
2018-01-01
The purpose of this study was to investigate Morse taper implant-abutment joints by chemical, mechanical, and microscopic analysis. Surfaces of 10 Morse taper implants and the correlated abutments were inspected by field emission gun-scanning electron microscopy (FEG-SEM) before connection. The implant-abutment connections were tightened at 32 Ncm. For microgap evaluation by FEG-SEM, the systems were embedded in epoxy resin and cross-sectioned at a perpendicular plane of the implant-abutment joint. Furthermore, nanoindentation tests and chemical analysis were performed at the implant-abutment joints. Results were statistically analyzed via one-way analysis of variance, with a significance level of P < 0.05. Defects were noticed on different areas of the abutment surfaces. The minimum and maximum size of microgaps ranged from 0.5 μm up to 5.6 μm. Furthermore, defects were detected throughout the implant-abutment joint that can, ultimately, affect the microgap size after connection. Nanoindentation tests revealed a higher hardness (4.2 ± 0.4 GPa) for abutment composed of Ti6Al4V alloy when compared to implant composed of commercially pure Grade 4 titanium (3.2 ± 0.4 GPa). Surface defects produced during the machining of both implants and abutments can increase the size of microgaps and promote a misfit of implant-abutment joints. In addition, the mismatch in mechanical properties between abutment and implant can promote the wear of surfaces, affecting the size of microgaps and consequently the performance of the joints during mastication.
Rühling, A; Kocher, T; Kreusch, J; Plagmann, H C
1994-03-01
Removal of plaque and calculus by means of sonic and ultrasonic scalers causes considerable damage to implants. With a view to avoiding the aggressive effects of these instruments, an experimental study was carried out for which conventional sonic and ultrasonic scalers were coated with Teflon. The effects of these instruments on implant surfaces was then compared with that of plastic and metal implant curettes. Stereo-microscopy, scanning electron microscopy and surface profilometry were used to detect and record damage to implant surfaces and changes in surface roughness. Generation and propagation of heat in subgingival simulation of use of sonic and ultrasonic scalers were also recorded by means of temperature measurements at the implant surface. The results revealed that no discernible damage was caused by Teflon-coated sonic and ultrasonic scalers or implant curettes made of plastic on smooth titanium surfaces. Instrument material residues were found on rough implant surfaces. It was not the intention of this study to provide an analysis of the prerequisites for the cleaning of rough implant surfaces, but rather to determine what type of damage is to be expected when contact is made with smooth and rough surfaces unintentionally. Temperature measurements during the subgingival use of sonic and ultrasonic scalers indicated satisfactory functioning of the cooling system. Coating of sonic and ultrasonic scaler tips with Teflon thus facilitates the use of high-frequency instruments to achieve professional cleaning of implants.
Subclinical atrial fibrillation and the risk of stroke.
Healey, Jeff S; Connolly, Stuart J; Gold, Michael R; Israel, Carsten W; Van Gelder, Isabelle C; Capucci, Alessandro; Lau, C P; Fain, Eric; Yang, Sean; Bailleul, Christophe; Morillo, Carlos A; Carlson, Mark; Themeles, Ellison; Kaufman, Elizabeth S; Hohnloser, Stefan H
2012-01-12
One quarter of strokes are of unknown cause, and subclinical atrial fibrillation may be a common etiologic factor. Pacemakers can detect subclinical episodes of rapid atrial rate, which correlate with electrocardiographically documented atrial fibrillation. We evaluated whether subclinical episodes of rapid atrial rate detected by implanted devices were associated with an increased risk of ischemic stroke in patients who did not have other evidence of atrial fibrillation. We enrolled 2580 patients, 65 years of age or older, with hypertension and no history of atrial fibrillation, in whom a pacemaker or defibrillator had recently been implanted. We monitored the patients for 3 months to detect subclinical atrial tachyarrhythmias (episodes of atrial rate >190 beats per minute for more than 6 minutes) and followed them for a mean of 2.5 years for the primary outcome of ischemic stroke or systemic embolism. Patients with pacemakers were randomly assigned to receive or not to receive continuous atrial overdrive pacing. By 3 months, subclinical atrial tachyarrhythmias detected by implanted devices had occurred in 261 patients (10.1%). Subclinical atrial tachyarrhythmias were associated with an increased risk of clinical atrial fibrillation (hazard ratio, 5.56; 95% confidence interval [CI], 3.78 to 8.17; P<0.001) and of ischemic stroke or systemic embolism (hazard ratio, 2.49; 95% CI, 1.28 to 4.85; P=0.007). Of 51 patients who had a primary outcome event, 11 had had subclinical atrial tachyarrhythmias detected by 3 months, and none had had clinical atrial fibrillation by 3 months. The population attributable risk of stroke or systemic embolism associated with subclinical atrial tachyarrhythmias was 13%. Subclinical atrial tachyarrhythmias remained predictive of the primary outcome after adjustment for predictors of stroke (hazard ratio, 2.50; 95% CI, 1.28 to 4.89; P=0.008). Continuous atrial overdrive pacing did not prevent atrial fibrillation. Subclinical atrial tachyarrhythmias, without clinical atrial fibrillation, occurred frequently in patients with pacemakers and were associated with a significantly increased risk of ischemic stroke or systemic embolism. (Funded by St. Jude Medical; ASSERT ClinicalTrials.gov number, NCT00256152.).
Self-Powered Implantable Skin-Like Glucometer for Real-Time Detection of Blood Glucose Level In Vivo
NASA Astrophysics Data System (ADS)
Zhang, Wanglinhan; Zhang, Linlin; Gao, Huiling; Yang, Wenyan; Wang, Shuai; Xing, Lili; Xue, Xinyu
2018-06-01
Implantable bioelectronics for analyzing physiological biomarkers has recently been recognized as a promising technique in medical treatment or diagnostics. In this study, we developed a self-powered implantable skin-like glucometer for real-time detection of blood glucose level in vivo. Based on the piezo-enzymatic-reaction coupling effect of GOx@ZnO nanowire, the device under an applied deformation can actively output piezoelectric signal containing the glucose-detecting information. No external electricity power source or battery is needed for this device, and the outputting piezoelectric voltage acts as both the biosensing signal and electricity power. A practical application of the skin-like glucometer implanted in mouse body for detecting blood glucose level has been simply demonstrated. These results provide a new technique path for diabetes prophylaxis and treatment.
NASA Astrophysics Data System (ADS)
Yamaguchi, Takahiro; Takehara, Hiroaki; Sunaga, Yoshinori; Haruta, Makito; Motoyama, Mayumi; Ohta, Yasumi; Noda, Toshihiko; Sasagawa, Kiyotaka; Tokuda, Takashi; Ohta, Jun
2016-04-01
A self-reset pixel of 15 × 15 µm2 with high signal-to-noise ratio (effective peak SNR ≃64 dB) for an implantable image sensor has been developed for intrinsic signal detection arising from hemodynamic responses in a living mouse brain. For detecting local conversion between oxyhemoglobin (HbO) and deoxyhemoglobin (HbR) in brain tissues, an implantable imaging device was fabricated with our newly designed self-reset image sensor and orange light-emitting diodes (LEDs; λ = 605 nm). We demonstrated imaging of hemodynamic responses in the sensory cortical area accompanied by forelimb stimulation of a living mouse. The implantable imaging device for intrinsic signal detection is expected to be a powerful tool to measure brain activities in living animals used in behavioral analysis.
Gibson, C Michael; Krucoff, Mitchell; Kirtane, Ajay J; Rao, Sunil V; Mackall, Judith A; Matthews, Ray; Saba, Samir; Waksman, Ron; Holmes, David
2014-10-01
In the setting of ST-segment elevation myocardial infarction, timely restoration of normal blood flow is associated with improved myocardial salvage and survival. Despite improvements in door-to-needle and door-to-balloon times, there remains an unmet need with respect to improved symptom-to-door times. A prior report of an implanted device to monitor ST-segment deviation demonstrated very short times to reperfusion among patients with an acute coronary syndrome (ACS) with documented thrombotic occlusion. The goal of the ANALYZE ST study is to evaluate the safety and effectiveness of a novel ST-segment monitoring feature using an existing implantable cardioverter-defibrillator (ICD) among patients with known coronary artery disease. The ANALYZE ST study is a prospective, nonrandomized, multicenter, pivotal Investigational Device Exemption study enrolling 5,228 patients with newly implanted ICD systems for standard clinical indications who also have a documented history of coronary artery disease. Patients will be monitored for 48 months, during which effectiveness of the device for the purpose of early detection of cardiac injury will be evaluated by analyzing the sensitivity of the ST monitoring feature to identify clinical ACS events. In addition, the safety of the ST monitoring feature will be evaluated through the assessment of the percentage of patients for which monitoring produces a false-positive event over the course of 12 months. The ANALYZE ST trial is testing the hypothesis that the ST monitoring feature in the Fortify ST ICD system (St. Jude Medical, Inc., St. Paul, MN) (or other ICD systems with the ST monitoring feature) will accurately identify patients with clinical ACS events. Copyright © 2014 Mosby, Inc. All rights reserved.
de Souza, Raphael F; Bedos, Christophe; Esfandiari, Shahrokh; Makhoul, Nicholas M; Dagdeviren, Didem; Abi Nader, Samer; Jabbar, Areej A; Feine, Jocelyne S
2018-04-23
Overdentures retained by a single implant in the midline have arisen as a minimal implant treatment for edentulous mandibles. The success of this treatment depends on the performance of a single stud attachment that is susceptible to wear-related retention loss. Recently developed biomaterials used in attachments may result in better performance of the overdentures, offering minimal retention loss and greater patient satisfaction. These biomaterials include resistant polymeric matrixes and amorphous diamond-like carbon applied on metallic components. The objective of this explanatory mixed-methods study is to compare Novaloc, a novel attachment system with such characteristics, to a traditional alternative for single implants in the mandible of edentate elderly patients. We will carry out a randomized cross-over clinical trial comparing Novaloc attachments to Locators for single-implant mandibular overdentures in edentate elderly individuals. Participants will be followed for three months with each attachment type; patient-based, clinical, and economic outcomes will be gathered. A sample of 26 participants is estimated to be required to detect clinically relevant differences in terms of the primary outcome (patient ratings of general satisfaction). Participants will choose which attachment they wish to keep, then be interviewed about their experiences and preferences with a single implant prosthesis and with the two attachments. Data from the quantitative and qualitative assessments will be integrated through a mixed-methods explanatory strategy. A last quantitative assessment will take place after 12 months with the preferred attachment; this latter assessment will enable measurement of the attachments' long-term wear and maintenance requirements. Our results will lead to evidence-based recommendations regarding these systems, guiding providers and patients when making decisions on which attachment systems and implant numbers will be most appropriate for individual cases. The recommendation of a specific attachment for elderly edentulous patients may combine positive outcomes from patient perspectives with low cost, good maintenance, and minimal invasiveness. ClinicalTrials.gov, NCT03126942 . Registered on 13 April 2017.
Xie, Yufen; Wang, Yingchun; Sun, Tong; Wang, Fangfei; Trostinskaia, Anna; Puscheck, Elizabeth; Rappolee, Daniel A
2005-05-01
Mitogen-activated protein kinase (MAPK) signaling pathways play an important role in controlling embryonic proliferation and differentiation. It has been demonstrated that sequential lipophilic signal transduction mediators that participate in the MAPK pathway are null post-implantation lethal. It is not clear why the lethality of these null mutants arises after implantation and not before. One hypothesis is that the gene product of these post-implantation lethal null mutants are not present before implantation in normal embryos and do not have function until after implantation. To test this hypothesis, we selected a set of lipophilic genes mediating MAPK signal transduction pathways whose null mutants result in early peri-implantation or placental lethality. These included FRS2alpha, GAB1, GRB2, SOS1, Raf-B, and Raf1. Products of these selected genes were detected and their locations and functions indicated by indirect immunocytochemistry and Western blotting for proteins and RT-polymerase chain reaction (PCR) for mRNA transcription. We report here that all six signal mediators are detected at the protein level in preimplantation mouse embryo, placental trophoblasts, and in cultured trophoblast stem cells (TSC). Proteins are all detected in E3.5 embryos at a time when the first known mitogenic intercellular communication has been documented. mRNA transcripts of two post-implantation null mutant genes are expressed in mouse preimplantation embryos and unfertilized eggs. These mRNA transcripts were detected as maternal mRNA in unfertilized eggs that could delay the lethality of null mutants. All of the proteins were detected in the cytoplasm or in the cell membrane. This study of spatial and temporal expression revealed that all of these six null mutants post-implantation genes in MAPK pathway are expressed and, where tested, phosphorylated/activated proteins are detected in the blastocyst. Studies on RNA expression using RT-PCR suggest that maternal RNA could play an important role in delaying the presence of the lethal phenotype of null mutations. Copyright (c) 2005 Wiley-Liss, Inc.
Raghunathan, Shriram; Gupta, Sumeet K; Markandeya, Himanshu S; Roy, Kaushik; Irazoqui, Pedro P
2010-10-30
Implantable neural prostheses that deliver focal electrical stimulation upon demand are rapidly emerging as an alternate therapy for roughly a third of the epileptic patient population that is medically refractory. Seizure detection algorithms enable feedback mechanisms to provide focally and temporally specific intervention. Real-time feasibility and computational complexity often limit most reported detection algorithms to implementations using computers for bedside monitoring or external devices communicating with the implanted electrodes. A comparison of algorithms based on detection efficacy does not present a complete picture of the feasibility of the algorithm with limited computational power, as is the case with most battery-powered applications. We present a two-dimensional design optimization approach that takes into account both detection efficacy and hardware cost in evaluating algorithms for their feasibility in an implantable application. Detection features are first compared for their ability to detect electrographic seizures from micro-electrode data recorded from kainate-treated rats. Circuit models are then used to estimate the dynamic and leakage power consumption of the compared features. A score is assigned based on detection efficacy and the hardware cost for each of the features, then plotted on a two-dimensional design space. An optimal combination of compared features is used to construct an algorithm that provides maximal detection efficacy per unit hardware cost. The methods presented in this paper would facilitate the development of a common platform to benchmark seizure detection algorithms for comparison and feasibility analysis in the next generation of implantable neuroprosthetic devices to treat epilepsy. Copyright © 2010 Elsevier B.V. All rights reserved.
Growth of melanoma brain tumors monitored by photoacoustic microscopy
NASA Astrophysics Data System (ADS)
Staley, Jacob; Grogan, Patrick; Samadi, Abbas K.; Cui, Huizhong; Cohen, Mark S.; Yang, Xinmai
2010-07-01
Melanoma is a primary malignancy that is known to metastasize to the brain and often causes death. The ability to image the growth of brain melanoma in vivo can provide new insights into its evolution and response to therapies. In our study, we use a reflection mode photoacoustic microscopy (PAM) system to detect the growth of melanoma brain tumor in a small animal model. The melanoma tumor cells are implanted in the brain of a mouse at the beginning of the test. Then, PAM is used to scan the region of implantation in the mouse brain, and the growth of the melanoma is monitored until the death of the animal. It is demonstrated that PAM is capable of detecting and monitoring the brain melanoma growth noninvasively in vivo.
Design of a Tool Integrating Force Sensing With Automated Insertion in Cochlear Implantation
Schurzig, Daniel; Labadie, Robert F.; Hussong, Andreas; Rau, Thomas S.; Webster, Robert J.
2012-01-01
The quality of hearing restored to a deaf patient by a cochlear implant in hearing preservation cochlear implant surgery (and possibly also in routine cochlear implant surgery) is believed to depend on preserving delicate cochlear membranes while accurately inserting an electrode array deep into the spiral cochlea. Membrane rupture forces, and possibly, other indicators of suboptimal placement, are below the threshold detectable by human hands, motivating a force sensing insertion tool. Furthermore, recent studies have shown significant variability in manual insertion forces and velocities that may explain some instances of imperfect placement. Toward addressing this, an automated insertion tool was recently developed by Hussong et al. By following the same insertion tool concept, in this paper, we present mechanical enhancements that improve the surgeon’s interface with the device and make it smaller and lighter. We also present electomechanical design of new components enabling integrated force sensing. The tool is designed to be sufficiently compact and light that it can be mounted to a microstereotactic frame for accurate image-guided preinsertion positioning. The new integrated force sensing system is capable of resolving forces as small as 0.005 N, and we provide experimental illustration of using forces to detect errors in electrode insertion. PMID:23482414
Ahmed, Gazi Jased; Tatsukawa, Eri; Morishita, Kota; Shibata, Yasuaki; Suehiro, Fumio; Kamitakahara, Masanobu; Yokoi, Taishi; Koji, Takehiko; Umeda, Masahiro; Nishimura, Masahiro; Ikeda, Tohru
2016-01-01
The implantation of biomaterials induces a granulomatous reaction accompanied by foreign body giant cells (FBGCs). The characterization of multinucleated giant cells (MNGCs) around bone substitutes implanted in bone defects is more complicated because of healing with bone admixed with residual bone substitutes and their hybrid, and the appearance of two kinds of MNGCs, osteoclasts and FBGCs. Furthermore, the clinical significance of osteoclasts and FBGCs in the healing of implanted regions remains unclear. The aim of the present study was to characterize MNGCs around bone substitutes using an extraskeletal implantation model and evaluate the clinical significance of osteoclasts and FBGCs. Beta-tricalcium phosphate (β-TCP) granules were implanted into rat subcutaneous tissue with or without bone marrow mesenchymal cells (BMMCs), which include osteogenic progenitor cells. We also compared the biological significance of plasma and purified fibrin, which were used as binders for implants. Twelve weeks after implantation, osteogenesis was only detected in specimens implanted with BMMCs. The expression of two typical osteoclast markers, tartrate-resistant acid phosphatase (TRAP) and cathepsin-K (CTSK), was analyzed, and TRAP-positive and CTSK-positive osteoclasts were only detected beside bone. In contrast, most of the MNGCs in specimens without the implantation of BMMCs were FBGCs that were negative for TRAP, whereas the degradation of β-TCP was detected. In the region implanted with β-TCP granules with plasma, FBGCs tested positive for CTSK, and when β-TCP granules were implanted with purified fibrin, FBGCs tested negative for CTSK. These results showed that osteogenesis was essential to osteoclastogenesis, two kinds of FBGCs, CTSK-positive and CTSK-negative, were induced, and the expression of CTSK was plasma-dependent. In addition, the implantation of BMMCs was suggested to contribute to osteogenesis and the replacement of implanted β-TCP granules to bone. PMID:27462135
DOE Office of Scientific and Technical Information (OSTI.GOV)
Racine, E; Hautvast, G; Binnekamp, D
Purpose: To report on the results of a complete permanent implant brachytherapy procedure assisted by an electromagnetic (EM) hollow needle possessing both 3D tracking and seed drop detection abilities. Methods: End-to-end in-phantom EM-assisted LDR procedures were conducted. The novel system consisted of an EM tracking apparatus (NDI Aurora V2, Planar Field Generator), a 3D US scanner (Philips CX50), a hollow needle prototype allowing 3D tracking and seed drop detection and a specially designed treatment planning software (Philips Healthcare). A tungsten-doped 30 cc spherical agarose prostate immersed in gelatin was used for the treatment. A cylindrical shape of 0.8 cc wasmore » carved along its diameter to mimic the urethra. An initial plan of 26 needles and 47 seeds was established with the system. The plan was delivered with the EM-tracked hollow needle, and individual seed drop locations were recorded on the fly. The phantom was subsequently imaged with a CT scanner from which seed positions and contour definitions were obtained. The DVHs were then independently recomputed and compared with those produced by the planning system, both before and after the treatment. Results: Of the 47 seeds, 45 (96%) were detected by the EM technology embedded in the hollow needle design. The executed plan (from CT analysis) differed from the initial plan by 2%, 14% and 8% respectively in terms of V100, D90 and V150 for the prostate, and by 8%, 7% and 10% respectively in terms of D5, V100 and V120 for the urethra. Conclusion: The average DVH deviations between initial and executed plans were within a 5% tolerance imposed for this proof-of-concept assessment. This relatively good concordance demonstrates the feasibility and potential benefits of combining EM tracking and seed drop detection for real-time dosimetry validation and assistance in permanent implant brachytherapy procedures. This project has been entirely funded by Philips Healthcare.« less
[Study on Microbial Diversity of Peri-implantitis Subgingival by High-throughput Sequencing].
Li, Zhi-jie; Wang, Shao-guo; Li, Yue-hong; Tu, Dong-xiang; Liu, Shi-yun; Nie, Hong-bing; Li, Zhi-qiang; Zhang, Ju-mei
2015-07-01
To study microbial diversity of peri-implantitis subgingival with high-throughput sequencing, and investigate microbiological etiology of peri-implantitis. Subgingival plaques were sampled from the patients with peri-implantitis (D group) and non-peri-implantitis subjects (N group). The microbiological diversity of the subgingival plaques was detected by sequencing V4 region of 16S rRNA with Illumina Miseq platform. The diversity of the community structure was analyzed using Mothur software. A total of 156 507 gene sequences were detected in nine samples and 4 402 operational taxonomic units (OTUs) were found. Selenomonas, Pseudomonas, and Fusobacterium were dominant bacteria in D group, while Fusobacterium, Veillonella and Streptococcus were dominant bacteria in N group. Differences between peri-implantitis and non-peri-implantitis bacterial communities were observed at all phylogenetic levels by LEfSe, which was also found in PcoA test. The occurrence of peri-implantitis is not only related to periodontitis pathogenic microbe, but also related with the changes of oral microbial community structure. Treponema, Herbaspirillum, Butyricimonas and Phaeobacte may be closely related to the occurrence and development of peri-implantitis.
Malavasi, N V; Rodrigues, D B; Chammas, R; Chura-Chambi, R M; Barbuto, J A M; Balduino, K; Nonogaki, S; Morganti, L
2010-01-01
Endostatin (ES) is a potent inhibitor of angiogenesis and tumor growth. Continuous ES delivery of ES improves the efficacy and potency of the antitumoral therapy. The TheraCyte system is a polytetrafluoroethylene (PTFE) semipermeable membrane macroencapsulation system for implantation of genetically engineered cells specially designed for the in vivo delivery of therapeutic proteins, such as ES, which circumvents the problem of limited half-life and variation in circulating levels. In order to enable neovascularization at the tissues adjacent to the devices prior to ES secretion by the cells inside them, we designed a scheme in which empty TheraCyte devices were preimplanted SC into immunodeficient mice. Only after healing (17 days later) were Chinese hamster ovary cells expressing ES injected into the preimplanted devices. In another model for device implantation, the cells expressing ES where loaded into the immunoisolation devices prior to implantation into the animals, and the TheraCyte were then immediately implanted SC into the mice. Throughout the 2-month study, constant high ES levels of up to 3.7 microg/ml were detected in the plasma of the mice preimplanted with the devices, while lower but also constant levels of ES (up to 2.1 microg/ml plasma) were detected in the mice that had received devices preloaded with the ES-expressing cells. Immunohistochemistry using anti-ES antibody showed reaction within the device and outside it, demonstrating that ES, secreted by the confined recombinant cells, permeated through the membrane and reached the surrounding tissues.
Takase, Mai; Murata, Masataka; Hibi, Kyoko; Huifeng, Ren; Endo, Hideaki
2014-04-01
We developed a wireless monitoring system to monitor fish condition by tracking the change in whole cholesterol concentration. The whole cholesterol concentration of fish is a source of steroid hormones or indicator of immunity level, which makes its detection important for tracking physiological condition of fish. Wireless monitoring system comprises of mediator-type biosensor and wireless transmission device. Biosensor is implantable to fish body, and transmission device is so light, in that fish is allowed to swim freely during monitoring. Cholesterol esterase and oxidase were fixated on to the detection site of biosensor and used to detect the whole cholesterol concentration. However, cholesterol oxidase incorporates oxidation-reduction reaction of oxygen for detection, which concentration fluctuates easily due to change in environmental condition. Meanwhile, mediator-type biosensor enables monitoring of whole cholesterol concentration by using mediator to substitute that oxidation-reduction reaction of oxygen. Characteristic of fabricated mediator-type biosensor was tested. The sensor output current of mediator-type biosensor remained stable compared to output current of non-mediator-type biosensor under fluctuating oxygen concentration of 0-8 ppm, which implied that this sensor is less affected by change in dissolved oxygen concentration. That biosensor was then implanted into fish for wireless monitoring. As a result, approximately 48 h of real-time monitoring was successful.
Chadha, Neil K; Papsin, Blake C; Jiwani, Salima; Gordon, Karen A
2011-09-01
To measure speech detection in noise performance for children with bilateral cochlear implants (BiCI), to compare performance in children with simultaneous implant versus those with sequential implant, and to compare performance to normal-hearing children. Prospective cohort study. Tertiary academic pediatric center. Children with early-onset bilateral deafness and 2-year BiCI experience, comprising the "sequential" group (>2 yr interimplantation delay, n = 12) and "simultaneous group" (no interimplantation delay, n = 10) and normal-hearing controls (n = 8). Thresholds to speech detection (at 0-degree azimuth) were measured with noise at 0-degree azimuth or ± 90-degree azimuth. Spatial unmasking (SU) as the noise condition changed from 0-degree azimuth to ± 90-degree azimuth and binaural summation advantage (BSA) of 2 over 1 CI. Speech detection in noise was significantly poorer than controls for both BiCI groups (p < 0.0001). However, the SU in the simultaneous group approached levels found in normal controls (7.2 ± 0.6 versus 8.6 ± 0.6 dB, p > 0.05) and was significantly better than that in the sequential group (3.9 ± 0.4 dB, p < 0.05). Spatial unmasking was unaffected by the side of noise presentation in the simultaneous group but, in the sequential group, was significantly better when noise was moved to the second rather than the first implanted ear (4.8 ± 0.5 versus 3.0 ± 0.4 dB, p < 0.05). This was consistent with a larger BSA from the sequential group's second rather than first CI. Children with simultaneously implanted BiCI demonstrated an advantage over children with sequential implant by using spatial cues to improve speech detection in noise.
Development of an Implantable Myoelectric Sensor for Advanced Prosthesis Control
Merrill, Daniel R.; Lockhart, Joseph; Troyk, Phil R.; Weir, Richard F.; Hankin, David L.
2013-01-01
Modern hand and wrist prostheses afford a high level of mechanical sophistication, but the ability to control them in an intuitive and repeatable manner lags. Commercially available systems using surface electromyographic (EMG) or myoelectric control can supply at best two degrees of freedom (DOF), most often sequentially controlled. This limitation is partially due to the nature of surface-recorded EMG, for which the signal contains components from multiple muscle sources. We report here on the development of an implantable myoelectric sensor using EMG sensors that can be chronically implanted into an amputee’s residual muscles. Because sensing occurs at the source of muscle contraction, a single principal component of EMG is detected by each sensor, corresponding to intent to move a particular effector. This system can potentially provide independent signal sources for control of individual effectors within a limb prosthesis. The use of implanted devices supports inter-day signal repeatability. We report on efforts in preparation for human clinical trials, including animal testing, and a first-in-human proof of principle demonstration where the subject was able to intuitively and simultaneously control two DOF in a hand and wrist prosthesis. PMID:21371058
Botros, Andrew; van Dijk, Bas; Killian, Matthijs
2007-05-01
AutoNRT is an automated system that measures electrically evoked compound action potential (ECAP) thresholds from the auditory nerve with the Nucleus Freedom cochlear implant. ECAP thresholds along the electrode array are useful in objectively fitting cochlear implant systems for individual use. This paper provides the first detailed description of the AutoNRT algorithm and its expert systems, and reports the clinical success of AutoNRT to date. AutoNRT determines thresholds by visual detection, using two decision tree expert systems that automatically recognise ECAPs. The expert systems are guided by a dataset of 5393 neural response measurements. The algorithm approaches threshold from lower stimulus levels, ensuring recipient safety during postoperative measurements. Intraoperative measurements use the same algorithm but proceed faster by beginning at stimulus levels much closer to threshold. When searching for ECAPs, AutoNRT uses a highly specific expert system (specificity of 99% during training, 96% during testing; sensitivity of 91% during training, 89% during testing). Once ECAPs are established, AutoNRT uses an unbiased expert system to determine an accurate threshold. Throughout the execution of the algorithm, recording parameters (such as implant amplifier gain) are automatically optimised when needed. In a study that included 29 intraoperative and 29 postoperative subjects (a total of 418 electrodes), AutoNRT determined a threshold in 93% of cases where a human expert also determined a threshold. When compared to the median threshold of multiple human observers on 77 randomly selected electrodes, AutoNRT performed as accurately as the 'average' clinician. AutoNRT has demonstrated a high success rate and a level of performance that is comparable with human experts. It has been used in many clinics worldwide throughout the clinical trial and commercial launch of Nucleus Custom Sound Suite, significantly streamlining the clinical procedures associated with cochlear implant use.
Demonstration of bacterial biofilms in culture-negative silicone stent and jones tube.
Parsa, Kami; Schaudinn, Christoph; Gorur, Amita; Sedghizadeh, Parish P; Johnson, Thomas; Tse, David T; Costerton, John W
2010-01-01
To demonstrate the presence of bacterial biofilms on a dacryocystorhinostomy silicone stent and a Jones tube. One dacryocystorhinostomy silicone stent and one Jones tube were removed from 2 patients who presented with an infection of their respective nasolacrimal system. Cultures were obtained, and the implants were processed for scanning electron microscopy and confocal laser scanning microscopy, advanced microscopic methods that are applicable for detection of uncultivable biofilm organisms. Routine bacterial cultures revealed no growth, but bacterial biofilms on outer and inner surfaces of both implants were confirmed by advanced microscopic techniques. To the authors' knowledge, this is the first article that documents the presence of biofilms on a Crawford stent or a Jones tube on patients who presented with infections involving the nasolacrimal system. Although initial cultures revealed absence of any bacterial growth, confocal laser scanning microscopy and scanning electron microscopy documented bacterial colonization. Clinicians should consider the role of biofilms and the limitation of our standard culturing techniques while treating patients with device- or implant-related infections.
Polymorphisms of Il-10 (-1082) and RANKL (-438) Genes and the Failure of Dental Implants
Ribeiro, Rodrigo; Melo, Rayanne; Tortamano Neto, Pedro; Vajgel, André
2017-01-01
Background. Genetic polymorphisms in certain cytokines and chemokines have been investigated to understand why some individuals display implant flaws despite having few risk factors at the time of implant. Purpose. To investigate the association of genetic polymorphisms in interleukin- (IL-) 10 [-1082 region (A/G)] and RANKL [-438 region (A/G)] with the failure of dental implants. Materials and Methods. This study included 90 partially edentulous male and female patients who were rehabilitated with a total of 245 Straumann dental implants. An implant was considered a failure if any of the following occurred: mobility, persistent subjective complaint, recurrent peri-implant infection with suppuration, continuous radiolucency around the implant, probing depth ≥ 5 mm, and bleeding on probing. Buccal mucosal cells were collected for analysis of RANKL438 and IL-10. Results. The implant success rate in this population was 34.4%. The mutant allele (G) in RANKL had an incidence of 52.3% and mutant allele (A) in IL-10 was observed in 37.8%. No statistically significant difference was detected between the failure of the implant and the genotypes and allelic frequencies. Conclusion. No association was detected between the genetic polymorphisms of RANKL (-438) and IL-10 (-1082) and the failure of dental implants in the population studied. PMID:28348592
Polymorphisms of Il-10 (-1082) and RANKL (-438) Genes and the Failure of Dental Implants.
Ribeiro, Rodrigo; Melo, Rayanne; Tortamano Neto, Pedro; Vajgel, André; Souza, Paulo Roberto Eleutério; Cimões, Renata
2017-01-01
Background . Genetic polymorphisms in certain cytokines and chemokines have been investigated to understand why some individuals display implant flaws despite having few risk factors at the time of implant. Purpose . To investigate the association of genetic polymorphisms in interleukin- (IL-) 10 [-1082 region (A/G)] and RANKL [-438 region (A/G)] with the failure of dental implants. Materials and Methods . This study included 90 partially edentulous male and female patients who were rehabilitated with a total of 245 Straumann dental implants. An implant was considered a failure if any of the following occurred: mobility, persistent subjective complaint, recurrent peri-implant infection with suppuration, continuous radiolucency around the implant, probing depth ≥ 5 mm, and bleeding on probing. Buccal mucosal cells were collected for analysis of RANKL438 and IL-10 . Results . The implant success rate in this population was 34.4%. The mutant allele (G) in RANKL had an incidence of 52.3% and mutant allele (A) in IL-10 was observed in 37.8%. No statistically significant difference was detected between the failure of the implant and the genotypes and allelic frequencies. Conclusion . No association was detected between the genetic polymorphisms of RANKL (-438) and IL-10 (-1082) and the failure of dental implants in the population studied.
Prihandana, Gunawan Setia; Ito, Hikaru; Tanimura, Kohei; Yagi, Hiroshi; Hori, Yuki; Soykan, Orhan; Sudo, Ryo; Miki, Norihisa
2015-08-01
This article presents the concept of an implantable cage system that can house and protect implanted biomedical sensing and therapeutic devices in the body. Cylinder-shaped cages made of porous polyvinyl alcohol (PVA) sheets with an 80-µm pore size and/or stainless steel meshes with 0.54-mm openings were implanted subcutaneously in the dorsal region of rats for 5 weeks. Analysis of the explanted cages showed the formation of fibrosis tissue around the cages. PVA cages had fibrotic tissue growing mostly along the outer surface of cages, while stainless steel cages had fibrotic tissue growing into the inside surface of the cage structure, due to the larger porosity of the stainless steel meshes. As the detection of target molecules with short time lags for biosensors and mass transport with low diffusion resistance into and out of certain therapeutic devices are critical for the success of such devices, we examined whether the fibrous tissue formed around the cages were permeable to molecules of our interest. For that purpose, bath diffusion and microfluidic chamber diffusion experiments using solutions containing the target molecules were performed. Diffusion of sodium, potassium and urea through the fibrosis tissue was confirmed, thus suggesting the potential of these cylindrical cages surrounded by fibrosis tissue to successfully encase implantable sensors and therapeutic apparatus. © 2014 Wiley Periodicals, Inc.
NASA Astrophysics Data System (ADS)
Amrute, Junedh M.; Athanasiou, Lambros S.; Rikhtegar, Farhad; de la Torre Hernández, José M.; Camarero, Tamara García; Edelman, Elazer R.
2018-03-01
Polymeric endovascular implants are the next step in minimally invasive vascular interventions. As an alternative to traditional metallic drug-eluting stents, these often-erodible scaffolds present opportunities and challenges for patients and clinicians. Theoretically, as they resorb and are absorbed over time, they obviate the long-term complications of permanent implants, but in the short-term visualization and therefore positioning is problematic. Polymeric scaffolds can only be fully imaged using optical coherence tomography (OCT) imaging-they are relatively invisible via angiography-and segmentation of polymeric struts in OCT images is performed manually, a laborious and intractable procedure for large datasets. Traditional lumen detection methods using implant struts as boundary limits fail in images with polymeric implants. Therefore, it is necessary to develop an automated method to detect polymeric struts and luminal borders in OCT images; we present such a fully automated algorithm. Accuracy was validated using expert annotations on 1140 OCT images with a positive predictive value of 0.93 for strut detection and an R2 correlation coefficient of 0.94 between detected and expert-annotated lumen areas. The proposed algorithm allows for rapid, accurate, and automated detection of polymeric struts and the luminal border in OCT images.
Remote monitoring of patients with implanted devices: data exchange and integration.
Van der Velde, Enno T; Atsma, Douwe E; Foeken, Hylke; Witteman, Tom A; Hoekstra, Wybo H G J
2013-06-01
Remote follow-up of implanted implantable cardioverter defibrillators (ICDs) may offer a solution to the problem of overcrowded outpatient clinics, and may also be effective in detecting clinical events early. Data obtained from remote follow up systems, as developed by all major device companies, are stored in a central database system, operated and owned by the device company. A problem now arises that the patient's clinical information is partly stored in the local electronic health record (EHR) system in the hospital, and partly in the remote monitoring database, which may potentially result in patient safety issues. To address the requirement of integrating remote monitoring data in the local EHR, the Integrating the Healthcare Enterprise (IHE) Implantable Device Cardiac Observation (IDCO) profile has been developed. This IHE IDCO profile has been adapted by all major device companies. In our hospital, we have implemented the IHE IDCO profile to import data from the remote databases from two device vendors into the departmental Cardiology Information System (EPD-Vision). Data is exchanged via a HL7/XML communication protocol, as defined in the IHE IDCO profile. By implementing the IHE IDCO profile, we have been able to integrate the data from the remote monitoring databases in our local EHRs. It can be expected that remote monitoring systems will develop into dedicated monitoring and therapy platforms. Data retrieved from these systems should form an integral part of the electronic patient record as more and more out-patient clinic care will shift to personalized care provided at a distance, in other words at the patient's home.
Wang, Xiaolin; Ioacara, Sorin; DeHennis, Andrew
2015-11-01
This study analyzed the overall nocturnal performance during home use of a long-term subcutaneous implantable continuous glucose monitoring (CGM) sensor. In this study, 12 subjects with type 1 diabetes mellitus (T1DM) (mean±SD age, 37±8 years; mean±SD disease duration, 11±6 years) were implanted with an investigational continuous glucose sensor in the upper arm for up to 90 days. All subjects received full access to real-time glucose display and user programmable hypo- and hyperglycemic alarms. Subjects calibrated the sensors with a self-monitoring of blood glucose (SMBG) meter and continued to rely on their regular SMBG measurements for their diabetes management. Accuracy of the sensors during the home-use study was calculated using SMBG as the reference. The nocturnal sensor attenuation (NSA) concept was tested. Sensitivity and specificity of the nocturnal hypoglycemic alarm were calculated. Mean±SD glucose sensor life span was 87±7 days. The mean±SE absolute relative difference over the range of 40-400 mg/dL for the sensors in this home-use study was 12.3±0.7% using SMBG as the reference. The hypoglycemia alarms were set to be triggered when the glucose level went below 70 mg/dL. Percentage of nights with hypoglycemic alarms triggered for at least 10 min was 13.6%. Recovery into euglycemia within 30 min from the timestamp of the immediate confirmatory SMBG testing was obtained in 74% of all episodes (n=20). The implanted continuous glucose sensor showed a hypoglycemia detection sensitivity and specificity of 77% and 96%, respectively. The NSA-associated high negative rate of change of at least -4 mg/dL/min was not encountered during night use of the system. This home-use study of a fully implantable, long-term continuous glucose sensor shows excellent performance in nocturnal hypoglycemia detection in T1DM patients. The apparent lack of NSA affecting the implanted sensor and the high specificity of the hypoglycemic alarm expedite the recovery from nighttime hypoglycemia.
Optimization of programming parameters in children with the advanced bionics cochlear implant.
Baudhuin, Jacquelyn; Cadieux, Jamie; Firszt, Jill B; Reeder, Ruth M; Maxson, Jerrica L
2012-05-01
Cochlear implants provide access to soft intensity sounds and therefore improved audibility for children with severe-to-profound hearing loss. Speech processor programming parameters, such as threshold (or T-level), input dynamic range (IDR), and microphone sensitivity, contribute to the recipient's program and influence audibility. When soundfield thresholds obtained through the speech processor are elevated, programming parameters can be modified to improve soft sound detection. Adult recipients show improved detection for low-level sounds when T-levels are set at raised levels and show better speech understanding in quiet when wider IDRs are used. Little is known about the effects of parameter settings on detection and speech recognition in children using today's cochlear implant technology. The overall study aim was to assess optimal T-level, IDR, and sensitivity settings in pediatric recipients of the Advanced Bionics cochlear implant. Two experiments were conducted. Experiment 1 examined the effects of two T-level settings on soundfield thresholds and detection of the Ling 6 sounds. One program set T-levels at 10% of most comfortable levels (M-levels) and another at 10 current units (CUs) below the level judged as "soft." Experiment 2 examined the effects of IDR and sensitivity settings on speech recognition in quiet and noise. Participants were 11 children 7-17 yr of age (mean 11.3) implanted with the Advanced Bionics High Resolution 90K or CII cochlear implant system who had speech recognition scores of 20% or greater on a monosyllabic word test. Two T-level programs were compared for detection of the Ling sounds and frequency modulated (FM) tones. Differing IDR/sensitivity programs (50/0, 50/10, 70/0, 70/10) were compared using Ling and FM tone detection thresholds, CNC (consonant-vowel nucleus-consonant) words at 50 dB SPL, and Hearing in Noise Test for Children (HINT-C) sentences at 65 dB SPL in the presence of four-talker babble (+8 signal-to-noise ratio). Outcomes were analyzed using a paired t-test and a mixed-model repeated measures analysis of variance (ANOVA). T-levels set 10 CUs below "soft" resulted in significantly lower detection thresholds for all six Ling sounds and FM tones at 250, 1000, 3000, 4000, and 6000 Hz. When comparing programs differing by IDR and sensitivity, a 50 dB IDR with a 0 sensitivity setting showed significantly poorer thresholds for low frequency FM tones and voiced Ling sounds. Analysis of group mean scores for CNC words in quiet or HINT-C sentences in noise indicated no significant differences across IDR/sensitivity settings. Individual data, however, showed significant differences between IDR/sensitivity programs in noise; the optimal program differed across participants. In pediatric recipients of the Advanced Bionics cochlear implant device, manually setting T-levels with ascending loudness judgments should be considered when possible or when low-level sounds are inaudible. Study findings confirm the need to determine program settings on an individual basis as well as the importance of speech recognition verification measures in both quiet and noise. Clinical guidelines are suggested for selection of programming parameters in both young and older children. American Academy of Audiology.
Yang, Hua-Wei; Tang, Xiao-Shan; Tian, Zhuo-Wei; Wang, Yang; Yang, Wen-Yi; Hu, Jing-Zhou
2017-09-25
BACKGROUND This study explored the effects of nano-hydroxyapatite/polyetheretherketone (n-HA/PEEK)- coated sandblasted, large-grit, and acid-etched (SLA) implants on inflammatory cytokines and osseointegration in peri-implantitis model beagle dogs. MATERIAL AND METHODS Peri-implantitis models were established. Eight beagle dogs were randomly and evenly assigned into SLA tied, SLA + n-HA/PEEK tied, SLA untied, or SLA + n-HA/PEEK untied groups. A special periodontal probe was used to detect the plaque index (PLI), probing depth (PD), and modified Sulcus Bleeding Index (mSBI). Gingival crevicular fluid was collected and an ELISA kit was utilized to detect IL-1, IL-6, and IL-17 levels. The colony-forming units were counted and the maximum shear strength of implants was tested using the axial pullout test. HE staining was used to detect the inflammation of peri-implant bone tissues. Osseointegration was observed through toluidine blue staining. Bone-to-implant contact (BIC) was obtained through histological observation and the mineral apposition rate (MAR) was calculated after immune fluorescent double staining. RESULTS The SLA tied group demonstrated higher levels of PLI, PD, mSBI, IL-1, IL-6, and IL-17 and a higher degree of inflammation than the SLA + n-HA/PEEK tied group. The tied groups also displayed similar results over the untied groups at the same time point. The maximum shear strength, BIC, and MAR in the SLA tied group were significantly lower than in the SLA + n-HA/PEEK tied group. CONCLUSIONS Our findings demonstrate that SLA + n-HA/PEEK implants can promote osseointegration and relieve the inflammation response of peri-implantitis in beagle dogs.
Popova, Anfisa; Tsvirkun, Darya; Dolgov, Oleg; Anokhin, Konstantin; Alberts, Jeffrey; Lagereva, Evgeniia; Custaud, Marc-Antoine; Gauquelin-Koch, Guillemette; Vinogradova, Olga; Andreev-Andrievskiy, Alexander
Implantable telemetry enables continuous monitoring of physiological functions in freely moving animals and can greatly complement pharmacological research. Despite its miniaturization, a sensor/transmitter constitutes 5% or more of a mouse's bodyweight. The aim of the present study was to evaluate whether factors related to the presence of a probe/transmitter influence the ambulatory activity, strength, agility, or operant, motivated behaviors of this small rodent. Adult male mice (C57BL/6N, 22-25g, 9-10weeks; implanted n=26, intact n=45) were evaluated during week-long tests, conducted three and eight weeks after surgical implantation of the PA-C10 blood pressure probe. An open field test, grip force measurement, Rotarod test were performed, followed by 7-day continuous monitoring of spontaneous wheel running activity and positively reinforced operant conditioning in an automated data collection system. An implanted blood pressure transmitter did not affect behavior of mice in the open field test, on the Rotarod or their grip force, compared to unoperated controls. Voluntary wheel running distance was reduced three, but not eight weeks after implantation. Three weeks after the surgery, performance in the positively reinforced operant conditioning in operated mice was slightly decreased compared to intact animals, while retention and acquisition of a 2nd, reversal-learning task eight weeks after the surgery were unaffected. We conclude that an implantable transmitter may have detectable effects in the first few weeks following implantation on some elements of mouse behavior. With sufficient recovery, mice perform comparably to unoperated controls in tests of strength, endurance, agility and learned operant behavior. Copyright © 2017 Elsevier Inc. All rights reserved.
Real-time Seizure Detection System Using Multiple Single-Neuron Recordings
2001-10-25
electrodes were implanted bilaterally into the temporal lobe of each rat. The rats were anesthetized with nebutal (50mg/kg). Small craniotomies were...1997. [9] Fanselow, E.E., Reid, A.P., Nicolelis, M.A.L., Reduction of pentylenetetrazole-induced seizure activity in awake rats by seizure-triggered
Söth-Hansen, Malene; Witt, Christoffer Tobias; Rasmussen, Mathis; Kristensen, Jens; Gerdes, Christian; Nielsen, Jens Cosedis
2018-05-24
Remote monitoring (RM) is an established technology integrated into routine follow-up of patients with implantable cardioverter-defibrillator (ICD). Current RM systems differ according to transmission frequency and alert definition. We aimed to compare time difference between detection and acknowledgement of clinically relevant events between four RM systems. We analyzed time delay between detection of ventricular arrhythmic and technical events by the ICD and acknowledgement by hospital staff in 1.802 consecutive patients followed with RM during September 2014 - August 2016. Devices from Biotronik (BIO, n=374), Boston Scientific (BSC, n=196), Medtronic (MDT, n=468) and St Jude Medical (SJM, n=764) were included. We identified all events from RM webpages and their acknowledgement with RM or at in-clinic follow-up. Events occurring during weekends were excluded. We included 3.472 events. Proportion of events acknowledged within 24 hours was 72%, 23%, 18% and 65% with BIO, BSC, MDT and SJM, respectively, with median times of 13, 222, 163 and 18 hours from detection to acknowledgement (p<0.001 for both comparisons between manufacturers). Including only events transmitted as alerts by RM, 72%, 68%, 61% and 65% for BIO, BSC, MDT and SJM, respectively were acknowledged within 24 hours. Variation in time to acknowledgement of ventricular tachyarrhythmia episodes not treated with shock therapy was the primary cause for the difference between manufacturers. Significant and clinically relevant differences in time delay from event detection to acknowledgement exist between RM systems. Varying definitions of which events RM transmits as alerts are important for the differences observed. Copyright © 2018. Published by Elsevier Inc.
Optoelectronic system and apparatus for connection to biological systems
DOE Office of Scientific and Technical Information (OSTI.GOV)
Okandan, Murat; Nielson, Gregory N.
The present invention relates to a biological probe structure, as well as apparatuses, systems, and methods employing this structure. In particular embodiments, the structure includes a hermetically sealed unit configured to receive and transmit one or more optical signals. Furthermore, the structure can be implanted subcutaneously and interrogated externally. In this manner, a minimally invasive method can be employed to detect, treat, and/or assess the biological target. Additional methods and systems are also provided.
Stingl, Katarina; Schippert, Ruth; Bartz-Schmidt, Karl U.; Besch, Dorothea; Cottriall, Charles L.; Edwards, Thomas L.; Gekeler, Florian; Greppmaier, Udo; Kiel, Katja; Koitschev, Assen; Kühlewein, Laura; MacLaren, Robert E.; Ramsden, James D.; Roider, Johann; Rothermel, Albrecht; Sachs, Helmut; Schröder, Greta S.; Tode, Jan; Troelenberg, Nicole; Zrenner, Eberhart
2017-01-01
Purpose: We assessed the safety and efficacy of a technically advanced subretinal electronic implant, RETINA IMPLANT Alpha AMS, in end stage retinal degeneration in an interim analysis of two ongoing prospective clinical trials. The purpose of this article is to describe the interim functional results (efficacy). Methods: The subretinal visual prosthesis RETINA IMPLANT Alpha AMS (Retina Implant AG, Reutlingen, Germany) was implanted in 15 blind patients with hereditary retinal degenerations at four study sites with a follow-up period of 12 months (www.clinicaltrials.gov NCT01024803 and NCT02720640). Functional outcome measures included (1) screen-based standardized 2- or 4-alternative forced-choice (AFC) tests of light perception, light localization, grating detection (basic grating acuity (BaGA) test), and Landolt C-rings; (2) gray level discrimination; (3) performance during activities of daily living (ADL-table tasks). Results: Implant-mediated light perception was observed in 13/15 patients. During the observation period implant mediated localization of visual targets was possible in 13/15 patients. Correct grating detection was achieved for spatial frequencies of 0.1 cpd (cycles per degree) in 4/15; 0.33 cpd in 3/15; 0.66 cpd in 2/15; 1.0 cpd in 2/15 and 3.3 cpd in 1/15 patients. In two patients visual acuity (VA) assessed with Landolt C- rings was 20/546 and 20/1111. Of 6 possible gray levels on average 4.6 ± 0.8 (mean ± SD, n = 10) were discerned. Improvements (power ON vs. OFF) of ADL table tasks were measured in 13/15 patients. Overall, results were stable during the observation period. Serious adverse events (SAEs) were reported in 4 patients: 2 movements of the implant, readjusted in a second surgery; 4 conjunctival erosion/dehiscence, successfully treated; 1 pain event around the coil, successfully treated; 1 partial reduction of silicone oil tamponade leading to distorted vision (silicon oil successfully refilled). The majority of adverse events (AEs) were transient and mostly of mild to moderate intensity. Conclusions: Psychophysical and subjective data show that RETINA IMPLANT Alpha AMS is reliable, well tolerated and can restore limited visual functions in blind patients with degenerations of the outer retina. Compared with the previous implant Alpha IMS, longevity of the new implant Alpha AMS has been considerably improved. Alpha AMS has meanwhile been certified as a commercially available medical device, reimbursed in Germany by the public health system. PMID:28878616
Molecular Identification of Bacteria from Aseptically Loose Implants
Kobayashi, Naomi; Procop, Gary W.; Krebs, Viktor; Kobayashi, Hideo
2008-01-01
Polymerase chain reaction (PCR) assays have been used to detect bacteria adherent to failed orthopaedic implants, but some PCR assays have had problems with probable false-positive results. We used a combination of a Staphylococcus species-specific PCR and a universal PCR followed by DNA sequencing to identify bacteria on implants retrieved from 52 patients (92 implants) at revision arthroplasty. We addressed two questions in this study: (1) Is this method able to show the existence of bacterial DNA on presumed aseptic loosed implants?; and (2) What proportion of presumed aseptic or culture-negative implants was positive for bacterial DNA by PCR? Fourteen implants (15%) were believed infected, whereas 74 implants (85%) were believed aseptic. Each implant was sonicated and the resulting solution was submitted for dual real-time PCR assay and culture. All implants believed aseptically loose were culture-negative, but nine of the 74 (12%) had bacterial DNA by PCR; two (2.7%) were PCR-positive and also showed histologic findings suggestive of infection. Uniquely developed PCR and bacterial sequencing assays showed bacterial DNA on 12% of implants removed for presumed aseptic loosening. Additional studies are needed to determine the clinical importance of bacterial DNA detected by PCR but not by conventional culture. Level of Evidence: Level III, diagnostic study. See the Guidelines for Authors for a complete description of levels of evidence. PMID:18438724
Kim, Jeong Tae; Ho, Samuel Y M; Kim, Youn Hwan
2014-02-01
Postoperative flap monitoring is a vital aspect of free tissue transfer in order to detect early vascular compromise and to enable early flap salvage. The implantable Doppler monitoring system is one of many monitoring devices used to ensure accuracy and reduce unnecessary flap explorations. However, there are a number of concerns with its use, namely tension on the anastomosis, possible vessel constriction and false-negative detection. This study aimed to alleviate these concerns, by introducing a new method of placing the implantable Doppler probe on the adjacent vessel limb of a chimaeric flap. This is illustrated by a case series of chimaeric free tissue flaps that allow this surrogate placement of the Doppler probe. The flap is raised in a chimaeric fashion, with a main perforator pedicle to the skin or muscle paddle for the main reconstructive purpose and a side branch from the main pedicle going to a smaller adipofascial or muscle flap for monitoring. This branch vascular pedicle leading to the chimaeric tissue is kept sufficiently long to enable placement of the Doppler cuff and prevent turbulence. The probe of a Cook-Swartz implantable Doppler system is placed around the branch pedicle, approximately 5 mm from the branching point, and secured with a vessel clip. This is then secured away from the major vessels of the main free flap. Removal of the probe's crystal and wire is easily done with a single gentle traction on postoperative day 7. Five cases of chimaeric free flaps were performed with this manoeuvre: three thoracodorsal perforator chimaeric flaps for head-and-neck or extremity reconstruction, one latissimus dorsi neuromuscular chimaeric flap for facial reanimation and one digastric lymph node transfer for the treatment of lower limb lymphoedema. The Doppler system showed a low but sustained oscillating flow in all cases indicating vascular patency, with minimal flow interference from other large-calibre vessels. There was no discernible kinking on the anastomosis. There were no complications encountered during probe removal. This postoperative monitoring manoeuvre was done successfully with good results. The monitoring equipment is very sensitive to any flow disturbance due to positional changes in the head-and-neck region or the extremities and is able to detect flow changes in buried flaps postoperatively. Chimaeric flap composition is easier now than before because of perforator-oriented pedicle dissection, and surrogate Doppler monitoring is one more application of the chimaeric flap. This novel chimaeric fashion of implantable Doppler probe placement is a good surrogate measure of flow in the main pedicle. Copyright © 2013. Published by Elsevier Ltd.
Bischof, F; Langer, J; Begall, K
2008-11-01
Every day life is detectably affected by manifold natural sources of electromagnetic fields (EMF), e. g. infrared radiation, light and the terrestrial magnetic field. However, there is still uncertainty about the consequences or hazards of artificial EMF, which emerge from mobile phone or wireless network (wireless local area network [WLAN]) services, for instance. Following recommendations of the International Commission on Non-Ionizing Radiation Protection (ICNIRP) the German Commission on Radiation Protection (SSK) defined corresponding thresholds for high frequency electromagnetic fields (HF-EMF) in 2003. By observing those thresholds HF-EMF is thought to be innocent so far. However, there is still controversial discussion about induction of cancer or neurovegetative symptoms due to inconsistent study results. Patients with cochlea implants are of particular interest within the speciality of otorhinolaryngology due to specific hazards, which arise during mobile telephone use from the distance between brain and inductive metal implants (electrode) on the one hand and the electronic system of the cochlear implant and the source of HF-EMF on the other hand. Besides many studies about the impact of HF-EMF on common welfare, there are only very few surveys (n = 6) covering the effects on patients with cochlear implants. The purpose of this paper is to overview sources, thresholds and subsequently harmful or harmless effects of HFEMF. Due to the current state of knowledge about the impact of mobile phone use on health, we assume, that HF-EMF are harmless both for healthy people and patients with cochlea implants, provided that legal thresholds are observed.
Yang, Jianjun; Wang, Ke; Liu, Guangyuan; Wang, Dashan
2013-11-01
Zirconia powder in nanometers can be fabricated into inter-joined abutment of dental implant system with the injection shaping technique. This study was to detect the resistance of inter-joined zirconia abutment with different angle loading for clinical applications. The inter-joined abutments were shaped with the technique of injection of zirconia powder in nanometers. Sixty Osstem GSII 5 × 10 mm implants were used with 30 zirconia abutments and 30 Osstem GSII titanium abutments for fixation using 40 N torque force. The loading applications included 90°, 30°, and 0° formed by the long axis of abutments and pressure head of universal test machine. The fracture resistances of zirconia and titanium abutments were documented and analyzed. The inter-joined zirconia abutments were assembled to the Osstem GSII implants successfully. In the 90° loading mode, the fracture resistance of zirconia abutment group and titanium abutment group were 301.5 ± 15.4 N and 736.4 ± 120.1 N, respectively. And those in the 30° groups were 434.7 ± 36.1 N and 1073.1 ± 74 N, correspondingly. Significant difference in the two groups was found using t-test and Wilcoxon test. No damage on the abutments of the two groups but S-shaped bending on the implants was found when the 0° loading was 1300-2000 N. Through the assembly of Zirconia abutments and implants, all the components presented sufficient resistance acquired for the clinical application under loadings with different angle. © 2012 John Wiley & Sons A/S.
Online gamma-camera imaging of 103Pd seeds (OGIPS) for permanent breast seed implantation
NASA Astrophysics Data System (ADS)
Ravi, Ananth; Caldwell, Curtis B.; Keller, Brian M.; Reznik, Alla; Pignol, Jean-Philippe
2007-09-01
Permanent brachytherapy seed implantation is being investigated as a mode of accelerated partial breast irradiation for early stage breast cancer patients. Currently, the seeds are poorly visualized during the procedure making it difficult to perform a real-time correction of the implantation if required. The objective was to determine if a customized gamma-camera can accurately localize the seeds during implantation. Monte Carlo simulations of a CZT based gamma-camera were used to assess whether images of suitable quality could be derived by detecting the 21 keV photons emitted from 74 MBq 103Pd brachytherapy seeds. A hexagonal parallel hole collimator with a hole length of 38 mm, hole diameter of 1.2 mm and 0.2 mm septa, was modeled. The design of the gamma-camera was evaluated on a realistic model of the breast and three layers of the seed distribution (55 seeds) based on a pre-implantation CT treatment plan. The Monte Carlo simulations showed that the gamma-camera was able to localize the seeds with a maximum error of 2.0 mm, using only two views and 20 s of imaging. A gamma-camera can potentially be used as an intra-procedural image guidance system for quality assurance for permanent breast seed implantation.
Teijink, J A W; van Herwaarden, J A; van den Berg, J C; Overtoom, T C; Moll, F L
2004-06-01
In the treatment of coronary artery disease, peripheral loss of a coronary stent is an unusual complication. We present the case of a patient who suggested that his right leg claudication was caused by a slipped coronary stent 2 years previously. The patient was convinced about this unusual finding based on an airport security check. Examination proved him to be right. However, the ability to detect an object using eddy currents is dependent on the object's permeability and its conductivity. Ferrous (iron) content is not the critical factor. Modern implant materials and processing techniques result in implants that are difficult to magnetize i.e. their permeability is very low. In addition their conductivity is very low. This enables modern implants to escape detection at airports. For this reason the event at the airport, as described by our patient, is considered coincidental.
Sagbo, S; Blochaou, F; Langlotz, F; Vangenot, C; Nolte, L-P; Zheng, G
2005-01-01
Computer-Assisted Orthopaedic Surgery (CAOS) has made much progress over the last 10 years. Navigation systems have been recognized as important tools that help surgeons, and various such systems have been developed. A disadvantage of these systems is that they use non-standard formalisms and techniques. As a result, there are no standard concepts for implant and tool management or data formats to store information for use in 3D planning and navigation. We addressed these limitations and developed a practical and generic solution that offers benefits for surgeons, implant manufacturers, and CAS application developers. We developed a virtual implant database containing geometrical as well as calibration information for orthopedic implants and instruments, with a focus on trauma. This database has been successfully tested for various applications in the client/server mode. The implant information is not static, however, because manufacturers periodically revise their implants, resulting in the deletion of some implants and the introduction of new ones. Tracking these continuous changes and keeping CAS systems up to date is a tedious task if done manually. This leads to additional costs for system development, and some errors are inevitably generated due to the huge amount of information that has to be processed. To ease management with respect to implant life cycle, we developed a tool to assist end-users (surgeons, hospitals, CAS system providers, and implant manufacturers) in managing their implants. Our system can be used for pre-operative planning and intra-operative navigation, and also for any surgical simulation involving orthopedic implants. Currently, this tool allows addition of new implants, modification of existing ones, deletion of obsolete implants, export of a given implant, and also creation of backups. Our implant management system has been successfully tested in the laboratory with very promising results. It makes it possible to fill the current gap that exists between the CAS system and implant manufacturers, hospitals, and surgeons.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Korolev, D. S.; Mikhaylov, A. N.; Belov, A. I.
The composition and structure of silicon surface layers subjected to combined gallium and nitrogen ion implantation with subsequent annealing have been studied by the X-ray photoelectron spectroscopy, Rutherford backscattering, electron spin resonance, Raman spectroscopy, and transmission electron microscopy techniques. A slight redistribution of the implanted atoms before annealing and their substantial migration towards the surface during annealing depending on the sequence of implantations are observed. It is found that about 2% of atoms of the implanted layer are replaced with gallium bonded to nitrogen; however, it is impossible to detect the gallium-nitride phase. At the same time, gallium-enriched inclusions containingmore » ∼25 at % of gallium are detected as candidates for the further synthesis of gallium-nitride inclusions.« less
Wegner, Kerstin; Weskott, Katharina; Zenginel, Martha; Rehmann, Peter; Wöstmann, Bernd
2013-01-01
This in vitro study aimed to identify the effects of the implant system, impression technique, and impression material on the transfer accuracy of implant impressions. The null hypothesis tested was that, in vitro and within the parameters of the experiment, the spatial relationship of a working cast to the placement of implants is not related to (1) the implant system, (2) the impression technique, or (3) the impression material. A steel maxilla was used as a reference model. Six implants of two different implant systems (Standard Plus, Straumann; Semados, Bego) were fixed in the reference model. The target variables were: three-dimensional (3D) shift in all directions, implant axis direction, and rotation. The target variables were assessed using a 3D coordinate measuring machine, and the respective deviations of the plaster models from the nominal values of the reference model were calculated. Two different impression techniques (reposition/pickup) and four impression materials (Aquasil Ultra, Flexitime, Impregum Penta, P2 Magnum 360) were investigated. In all, 80 implant impressions for each implant system were taken. Statistical analysis was performed using multivariate analysis of variance. The implant system significantly influenced the transfer accuracy for most spatial dimensions, including the overall 3D shift and implant axis direction. There was no significant difference between the two implant systems with regard to rotation. Multivariate analysis of variance showed a significant effect on transfer accuracy only for the implant system. Within the limits of the present study, it can be concluded that the transfer accuracy of the intraoral implant position on the working cast is far more dependent on the implant system than on the selection of a specific impression technique or material.
Breast implants and breast cancer: a review of incidence, detection, mortality, and survival.
Deapen, Dennis
2007-12-01
Soon after breast implants were commercially introduced over 30 years ago, questions about potential carcinogenicity were raised. Animal experiments dating back to the mid-twentieth century demonstrated that foreign body implantation of many materials, including silicone, can induce sarcomas. Indeed, female breast cancer incidence rates in the United States have increased substantially over that period. Of the several published studies from various countries that have formally investigated the risk of breast cancer among augmentation mammaplasty patients, none show any evidence of increased risk. In fact, most find lower than expected risk, some with statistically significant reductions. Similarly, breast cancer mortality among these patients is generally found to be below that expected of other similar women. Delayed detection of breast cancer is a concern for these patients because implants can interfere with mammography. However, using indicators such as stage at diagnosis and tumor size, current research shows that augmentation patients do not experience delayed detection. Furthermore, several comparisons of post-breast cancer survival of augmented versus nonaugmented patients have found no significant differences. In summary, breast implants are not associated with an increased risk of breast cancer incidence or death, and these patients do not experience delayed detection or poorer post-breast cancer survival.
Deng, Zhiqun D.; Martinez, J. J.; Li, H.; ...
2017-02-21
Acoustic telemetry is one of the primary technologies for studying the behavior and survival of fishes throughout the world. The size and performance of the transmitters is still the key limiting factor despite that considerable effort has been expended to understand the biological effects of implantation of acoustic transmitters in yearling and subyearling Chinook salmon. The newly developed injectable transmitter is the first active acoustic tag that can be implanted via injection instead of surgery. It also lasts more than four times longer than the commercially-available transmitters. A two-part field study was conducted to evaluate the performance of the injectablemore » transmitter and its effect on the survival of implanted fish. The injectable transmitter performed well and similarly to the other commercially-available transmitters tested. Snake River subyearling Chinook salmon smolts implanted with the injectable tag had a higher survival probability from release to each of 11 downstream detection arrays than concurrent releases of fish surgically implanted with commercially-available tags. In addition, reach-specific survival estimates were significantly higher for the injectable group in three of the eleven reaches examined. Overall, the injectable group had a 0.263 (SE = 0.017) survival probability over the entire 500 km study area compared to 0.199 (0.012) for the surgically implanted group. The differences in survival may have been caused by warm water temperatures and higher rates of infection experienced by the surgically implanted group due to the presence of sutures acting as an attachment site for pathogens. The reduction in size and ability to implant the new transmitter via injection has further reduced the tag or tagging effect bias associated with studying small fishes. As a result, the information gathered with this new technology is helping minimize the impact of dams on fish, leading to more environmentally sustainable energy systems.« less
DOE Office of Scientific and Technical Information (OSTI.GOV)
Deng, Zhiqun D.; Martinez, J. J.; Li, H.
Acoustic telemetry is one of the primary technologies for studying the behavior and survival of fishes throughout the world. The size and performance of the transmitters is still the key limiting factor despite that considerable effort has been expended to understand the biological effects of implantation of acoustic transmitters in yearling and subyearling Chinook salmon. The newly developed injectable transmitter is the first active acoustic tag that can be implanted via injection instead of surgery. It also lasts more than four times longer than the commercially-available transmitters. A two-part field study was conducted to evaluate the performance of the injectablemore » transmitter and its effect on the survival of implanted fish. The injectable transmitter performed well and similarly to the other commercially-available transmitters tested. Snake River subyearling Chinook salmon smolts implanted with the injectable tag had a higher survival probability from release to each of 11 downstream detection arrays than concurrent releases of fish surgically implanted with commercially-available tags. In addition, reach-specific survival estimates were significantly higher for the injectable group in three of the eleven reaches examined. Overall, the injectable group had a 0.263 (SE = 0.017) survival probability over the entire 500 km study area compared to 0.199 (0.012) for the surgically implanted group. The differences in survival may have been caused by warm water temperatures and higher rates of infection experienced by the surgically implanted group due to the presence of sutures acting as an attachment site for pathogens. The reduction in size and ability to implant the new transmitter via injection has further reduced the tag or tagging effect bias associated with studying small fishes. As a result, the information gathered with this new technology is helping minimize the impact of dams on fish, leading to more environmentally sustainable energy systems.« less
Jin, Tao; Nicholls, Francesca J; Crum, William R; Ghuman, Harmanvir; Badylak, Stephen F; Modo, Michel
2017-01-01
Extracellular matrix (ECM) is widely used as an inductive biological scaffold to repair soft tissue after injury by promoting functional site-appropriate remodeling of the implanted material. However, there is a lack of non-invasive analysis methods to monitor the remodeling characteristics of the ECM material after implantation and its biodegradation over time. We describe the use of diamagnetic chemical exchange saturation transfer (CEST) magnetic resonance imaging to monitor the distribution of an ECM hydrogel after intracerebral implantation into a stroke cavity. In vitro imaging indicated a robust concentration-dependent detection of the ECM precursor and hydrogel at 1.8 and 3.6 ppm, which broadly corresponded to chondroitin sulfate and fibronectin. This detection was robust to changes in pH and improved at 37 °C. In vivo implantation of ECM hydrogel into the stroke cavity in a rat model corresponded macroscopically to the distribution of biomaterial as indicated by histology, but mismatches were also evident. Indeed, CEST imaging detected an endogenous "increased deposition". To account for this endogenous activity, pre-implantation images were subtracted from post-implantation images to yield a selective visualization of hydrogel distribution in the stroke cavity and its evolution over 7 days. The CEST detection of ECM returned to baseline within 3 days due to a decrease in fibronectin and chondroitin sulfate in the hydrogel. The distribution of ECM hydrogel within the stroke cavity is hence feasible in vivo, but further advances are required to warrant a selective long-term monitoring in the context of biodegradation. Copyright © 2016 Elsevier Ltd. All rights reserved.
Electronic design of a multichannel programmable implant for neuromuscular electrical stimulation.
Arabi, K; Sawan, M A
1999-06-01
An advanced stimulator for neuromuscular stimulation of spinal cord injured patients has been developed. The stimulator is externally controlled and powered by a single encoded radio frequency carrier and has four independently controlled bipolar stimulation channels. It offers a wide range of reprogrammability and flexibility, and can be used in many neuromuscular electrical stimulation applications. The implant system is adaptable to patient's needs and to future developments in stimulation algorithms by reprogramming the stimulator. The stimulator is capable of generating a wide range of stimulation waveforms and stimulation patterns and therefore is very suitable for selective nerve stimulation techniques. The reliability of the implant has been increased by using a forward error detection and correction communication protocol and by designing the chip for structural testability based on scan test approach. Implemented testability scheme makes it possible to verify the complete functionality of the implant before and after implantation. The stimulators architecture is designed to be modular and therefore its different blocks can be reused as standard building blocks in the design and implementation of other neuromuscular prostheses. Design for low-power techniques have also been employed to reduce power consumption of the electronic circuitry.
Arndt, Susan; Aschendorff, Antje; Laszig, Roland; Wesarg, Thomas
2016-01-01
The ability to detect a target signal masked by noise is improved in normal-hearing listeners when interaural phase differences (IPDs) between the ear signals exist either in the masker or in the signal. To improve binaural hearing in bilaterally implanted cochlear implant (BiCI) users, a coding strategy providing the best possible access to IPD is highly desirable. In this study, we compared two coding strategies in BiCI users provided with CI systems from MED-EL (Innsbruck, Austria). The CI systems were bilaterally programmed either with the fine structure processing strategy FS4 or with the constant rate strategy high definition continuous interleaved sampling (HDCIS). Familiarization periods between 6 and 12 weeks were considered. The effect of IPD was measured in two types of experiments: (a) IPD detection thresholds with tonal signals addressing mainly one apical interaural electrode pair and (b) with speech in noise in terms of binaural speech intelligibility level differences (BILD) addressing multiple electrodes bilaterally. The results in (a) showed improved IPD detection thresholds with FS4 compared with HDCIS in four out of the seven BiCI users. In contrast, 12 BiCI users in (b) showed similar BILD with FS4 (0.6 ± 1.9 dB) and HDCIS (0.5 ± 2.0 dB). However, no correlation between results in (a) and (b) both obtained with FS4 was found. In conclusion, the degree of IPD sensitivity determined on an apical interaural electrode pair was not an indicator for BILD based on bilateral multielectrode stimulation. PMID:27659487
Zirn, Stefan; Arndt, Susan; Aschendorff, Antje; Laszig, Roland; Wesarg, Thomas
2016-09-22
The ability to detect a target signal masked by noise is improved in normal-hearing listeners when interaural phase differences (IPDs) between the ear signals exist either in the masker or in the signal. To improve binaural hearing in bilaterally implanted cochlear implant (BiCI) users, a coding strategy providing the best possible access to IPD is highly desirable. In this study, we compared two coding strategies in BiCI users provided with CI systems from MED-EL (Innsbruck, Austria). The CI systems were bilaterally programmed either with the fine structure processing strategy FS4 or with the constant rate strategy high definition continuous interleaved sampling (HDCIS). Familiarization periods between 6 and 12 weeks were considered. The effect of IPD was measured in two types of experiments: (a) IPD detection thresholds with tonal signals addressing mainly one apical interaural electrode pair and (b) with speech in noise in terms of binaural speech intelligibility level differences (BILD) addressing multiple electrodes bilaterally. The results in (a) showed improved IPD detection thresholds with FS4 compared with HDCIS in four out of the seven BiCI users. In contrast, 12 BiCI users in (b) showed similar BILD with FS4 (0.6 ± 1.9 dB) and HDCIS (0.5 ± 2.0 dB). However, no correlation between results in (a) and (b) both obtained with FS4 was found. In conclusion, the degree of IPD sensitivity determined on an apical interaural electrode pair was not an indicator for BILD based on bilateral multielectrode stimulation. © The Author(s) 2016.
Hammoud, Abbas; Chamseddine, Ahmad; Nguyen, Dang K; Sawan, Mohamad
2016-08-01
The need of continuous real-time monitoring device for in-vivo drug level detection has been widely articulated lately. Such monitoring could guide drug posology and timing of intake, detect low or high drug levels, in order to take adequate measures, and give clinicians a valuable window into patients' health and their response to therapeutics. This paper presents a novel implantable bio-sensor based on impedance measurement capable of continuously monitoring various antiepileptic drug levels. This portable point-of-care microsystem replaces large and stationary conventional macrosystems, and is a one of a kind system designed with an array of electrodes to monitor various anti-epileptic drugs rather than one drug. The micro-system consists of (i) the front-end circuit including an inductive coil to receive energy from an external base station, and to exchange data with the latter; (ii) the power management block; (iii) the readout and control block; and (iv) the biosensor array. The electrical circuitry was designed using the 0.18-um CMOS process technology intended to be miniature and consume ultra-low power.
Jacobs, R; van Steenberghe, D
1991-01-01
To clarify more of the tactile function of oral implants, both an interocclusal thickness detection and discrimination task were carried out in 4 different test conditions on 37 patients: t (tooth)/t, i (implant)/t, i/i and d (denture)/o (overdenture supported by implants). For the interocclusal detection of steel foils, the 50% detection threshold level (RL) in the 4 conditions was 20, 48, 64 and 108 microns, respectively, which indicates significant differences. The ability to discriminate interdental thickness differences was tested with a 0.2 and 1.0 mm standard. It was evaluated as the 75% discrimination level (DL). In the 0.2 mm discrimination task, corresponding DL-values for the t/t, i/t, i/i and d/o condition were 25, 55, 66 and 134 microns, whereas the 1.0 mm standard gave values of 193, 293, 336 and 348 microns, respectively. All results differed significantly from each other (p less than 0.05) except for the i/i-d/o comparison of the 1.0 mm discrimination task where the difference was negligible. The present findings indicate that the tactile sensibility of implants is reduced with regard to natural teeth. Remaining receptors of the peri-implant tissues might play a compensatory role in the decreased exteroceptive function.
Definitive diagnosis of breast implant rupture using magnetic resonance imaging.
Ahn, C Y; Shaw, W W; Narayanan, K; Gorczyca, D P; Sinha, S; Debruhl, N D; Bassett, L W
1993-09-01
Breast implant rupture is an important complication of augmented and reconstructed breasts. Although several techniques such as mammography, xeromammography, ultrasound, thermography, and computed tomographic (CT) scanning have been proven to be useful to detect implant rupture, they have several disadvantages and lack specificity. In the current study, we have established magnetic resonance imaging (MRI) as a definitive, reliable, and reproducible technique to diagnose both intracapsular and extracapsular ruptures. The study was conducted in 100 symptomatic patients. Our imaging parameters were able to identify ruptures in implants with silicone shells. All the ruptures showed the presence of wavy lines, free-floating silicone shell within the gel ("free-floating loose-thread sign" or "linguine sign"). We had a 3.75 percent incidence of false-positive and false-negative results. The sensitivity for detection of silicone implant rupture was 76 percent, with a specificity of 97 percent. In addition, we also were able to identify the artifacts that may interfere with the definitive diagnosis of implant rupture.
Bitter, Thomas; Gutleben, Klaus-Jürgen; Horstkotte, Dieter; Oldenburg, Olaf
2014-01-01
Sleep-disordered breathing (SDB) is of growing interest in cardiology because SDB is a highly prevalent comorbidity in patients with a variety of cardiovascular diseases. The prevalence of SDB is particularly high in patients with cardiac dysrhythmias and/or heart failure. In this setting, many patients now have implantable cardiac devices, such as pacemakers, implantable cardioverter-defibrillators or implanted cardiac resynchronisation therapy devices (CRT). Treatment of SDB using implantable cardiac devices has been studied previously, with atrial pacing and CRT being shown not to bring about satisfactory results in SDB care. The latest generations of these devices have the capacity to determine transthoracic impedance, to detect and quantify breathing efforts and to identify SDB. The capability of implantable cardiac devices to detect SDB is of potential importance for patients with cardiovascular disease, allowing screening for SDB, monitoring of the course of SDB in relation to cardiac status, and documenting of the effects of treatment. PMID:26835077
Fox, Henrik; Bitter, Thomas; Gutleben, Klaus-Jürgen; Horstkotte, Dieter; Oldenburg, Olaf
2014-08-01
Sleep-disordered breathing (SDB) is of growing interest in cardiology because SDB is a highly prevalent comorbidity in patients with a variety of cardiovascular diseases. The prevalence of SDB is particularly high in patients with cardiac dysrhythmias and/or heart failure. In this setting, many patients now have implantable cardiac devices, such as pacemakers, implantable cardioverter-defibrillators or implanted cardiac resynchronisation therapy devices (CRT). Treatment of SDB using implantable cardiac devices has been studied previously, with atrial pacing and CRT being shown not to bring about satisfactory results in SDB care. The latest generations of these devices have the capacity to determine transthoracic impedance, to detect and quantify breathing efforts and to identify SDB. The capability of implantable cardiac devices to detect SDB is of potential importance for patients with cardiovascular disease, allowing screening for SDB, monitoring of the course of SDB in relation to cardiac status, and documenting of the effects of treatment.
Gordon, Karen A.; Deighton, Michael R.; Abbasalipour, Parvaneh; Papsin, Blake C.
2014-01-01
There are significant challenges to restoring binaural hearing to children who have been deaf from an early age. The uncoordinated and poor temporal information available from cochlear implants distorts perception of interaural timing differences normally important for sound localization and listening in noise. Moreover, binaural development can be compromised by bilateral and unilateral auditory deprivation. Here, we studied perception of both interaural level and timing differences in 79 children/adolescents using bilateral cochlear implants and 16 peers with normal hearing. They were asked on which side of their head they heard unilaterally or bilaterally presented click- or electrical pulse- trains. Interaural level cues were identified by most participants including adolescents with long periods of unilateral cochlear implant use and little bilateral implant experience. Interaural timing cues were not detected by new bilateral adolescent users, consistent with previous evidence. Evidence of binaural timing detection was, for the first time, found in children who had much longer implant experience but it was marked by poorer than normal sensitivity and abnormally strong dependence on current level differences between implants. In addition, children with prior unilateral implant use showed a higher proportion of responses to their first implanted sides than children implanted simultaneously. These data indicate that there are functional repercussions of developing binaural hearing through bilateral cochlear implants, particularly when provided sequentially; nonetheless, children have an opportunity to use these devices to hear better in noise and gain spatial hearing. PMID:25531107
Escorihuela García, Vicente; Pitarch Ribas, María Ignacia; Llópez Carratalá, Ignacio; Latorre Monteagudo, Emilia; Morant Ventura, Antonio; Marco Algarra, Jaime
2016-01-01
The studies that have evaluated the effectiveness of bilateral cochlear implantation in children suggest an improvement in hearing about sound localization and speech discrimination. In this paper we show the differences in audio-linguistic achievements with early bilateral cochlear implantation versus unilateral, and differences between simultaneous and sequential bilateral implantation. We present 88 children with bilateral profound sensorineural hearing loss, treated with bilateral cochlear implantation in 32 cases and unilateral in 56 cases, during the first 12 months (27 children) of life and between 12 and 24 months (61 children). We conducted a statistical comparison of both groups in the audiometry, IT-Mais, Nottingham, LittlEars scales and verbal tests. No significant differences in hearing thresholds and questionnaires between unilateral and bilateral implantation were detected in either the first or second year. Verbal tests do show statistically significant differences: children with bilateral cochlear implant obtain 100% recognition of disyllabic and phrases within 2-3 years after implantation whilst children with one implant do not obtain those results at 5 years after surgery. No differences between simultaneous and sequential bilateral implantation were detected. We emphasize the importance of ensuring good early audiological screening, to carry out an early and bilateral cochlear implantation with the consequent development of audio-language skills similar to normal hearing children. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. All rights reserved.
Endo, Takao; Fujikado, Takashi; Hirota, Masakazu; Kanda, Hiroyuki; Morimoto, Takeshi; Nishida, Kohji
2018-04-20
To evaluate the improvement in targeted reaching movements toward targets of various contrasts in a patient implanted with a suprachoroidal-transretinal stimulation (STS) retinal prosthesis. An STS retinal prosthesis was implanted in the right eye of a 42-year-old man with advanced Stargardt disease (visual acuity: right eye, light perception; left eye, hand motion). In localization tests during the 1-year follow-up period, the patient attempted to touch the center of a white square target (visual angle, 10°; contrast, 96, 85, or 74%) displayed at a random position on a monitor. The distance between the touched point and the center of the target (the absolute deviation) was averaged over 20 trials with the STS system on or off. With the left eye occluded, the absolute deviation was not consistently lower with the system on than off for high-contrast (96%) targets, but was consistently lower with the system on for low-contrast (74%) targets. With both eyes open, the absolute deviation was consistently lower with the system on than off for 85%-contrast targets. With the system on and 96%-contrast targets, we detected a shorter response time while covering the right eye, which was being implanted with the STS, compared to covering the left eye (2.41 ± 2.52 vs 8.45 ± 3.78 s, p < 0.01). Performance of a reaching movement improved in a patient with an STS retinal prosthesis implanted in an eye with residual natural vision. Patients with a retinal prosthesis may be able to improve their visual performance by using both artificial vision and their residual natural vision. Beginning date of the trial: Feb. 20, 2014 Date of registration: Jan. 4, 2014 Trial registration number: UMIN000012754 Registration site: UMIN Clinical Trials Registry (UMIN-CTR) http://www.umin.ac.jp/ctr/index.htm.
NASA Astrophysics Data System (ADS)
Tarifeño-Saldivia, A.; Tain, J. L.; Domingo-Pardo, C.; Calviño, F.; Cortés, G.; Phong, V. H.; Riego, A.; Agramunt, J.; Algora, A.; Brewer, N.; Caballero-Folch, R.; Coleman-Smith, P. J.; Davinson, T.; Dillmann, I.; Estradé, A.; Griffin, C. J.; Grzywacz, R.; Harkness-Brennan, L. J.; Kiss, G. G.; Kogimtzis, M.; Labiche, M.; Lazarus, I. H.; Lorusso, G.; Matsui, K.; Miernik, K.; Montes, F.; Morales, A. I.; Nishimura, S.; Page, R. D.; Podolyák, Z. S.; Pucknell, V. F. E.; Rasco, B. C.; Regan, P.; Rubio, B.; Rykaczewski, K. P.; Saito, Y.; Sakurai, H.; Simpson, J.; Sokol, E.; Surman, R.; Svirkhin, A.; Thomas, S. L.; Tolosa, A.; Woods, P.
2017-04-01
The conceptual design of the BRIKEN neutron detector at the radioactive ion beam factory (RIBF) of the RIKEN Nishina Center is reported. The BRIKEN setup is a complex system aimed at detecting heavy-ion implants, β particles, γ rays and β-delayed neutrons. The whole setup includes the Advanced Implantation Detection Array (AIDA), two HPGe Clover detectors and up to 166 3He-filled counters embedded in a high-density polyethylene moderator. The design is quite complex due to the large number and different types of 3He-tubes involved and the additional constraints introduced by the ancillary detectors for charged particles and γ rays. This article reports on a novel methodology developed for the conceptual design and optimisation of the 3He-counter array, aiming for the best possible performance in terms of neutron detection. The algorithm is based on a geometric representation of two selected detector parameters of merit, namely, the average neutron detection efficiency and the efficiency flatness as a function of a reduced number of geometric variables. The response of the neutron detector is obtained from a systematic Monte Carlo simulation implemented in GEANT4. The robustness of the algorithm allowed us to design a versatile detection system, which operated in hybrid mode includes the full neutron counter and two clover detectors for high-precision gamma spectroscopy. In addition, the system can be reconfigured into a compact mode by removing the clover detectors and re-arranging the 3He tubes in order to maximize the neutron detection performance. Both operation modes shows a rather flat and high average efficiency. In summary, we have designed a system which shows an average efficiency for hybrid mode (3He tubes + clovers) of 68.6% and 64% for neutron energies up to 1 and 5 MeV, respectively. For compact mode (only 3He tubes), the average efficiency is 75.7% and 71% for neutron energies up to 1 and 5 MeV, respectively. The performance of the BRIKEN detection system has been also quantified by means of Monte Carlo simulations with different neutron energy distributions.
Application of TXRF for ion implanter dose matching experiments
NASA Astrophysics Data System (ADS)
Frost, M. R.; French, M.; Harris, W.
2004-06-01
Secondary ion mass spectrometry (SIMS) has been utilized for many years to measure the dose of ion implants in silicon for the purpose of verifying the ability of ion implantation equipment to accurately and reproducibly implant the desired species at the target dose. The development of statistically and instrumentally rigorous protocols has lead to high confidence levels, particularly with regard to accuracy and short-term repeatability. For example, high-dose, high-energy B implant dosimetry can be targeted to within ±1%. However, performing dose determination experiments using SIMS does have undesirable aspects, such as being highly labor intensive and sample destructive. Modern total reflection X-ray fluorescence (TXRF) instruments are equipped with capabilities for full 300 mm wafer handling, automated data acquisition software and intense X-ray sources. These attributes enable the technique to overcome the SIMS disadvantages listed above, as well as provide unique strengths that make it potentially highly amenable to implanter dose matching. In this paper, we report on data collected to date that provides confidence that TXRF is an effective and economical method to perform these measurements within certain limitations. We have investigated a number of ion implanted species that are within the "envelope" of TXRF application. This envelope is defined by a few important parameters. Species: For the anode materials used in the more common X-ray sources on the market, each has its own set of elements that can be detected. We have investigated W and Mo X-ray sources, which are the most common in use in commercial instrumentation. Implant energy: In general, if the energy of the implanted species is too high (or more specifically, the distribution of the implanted species is too deep), the amount of dopant not detected by TXRF may be significant, increasing the error of the measurement. Therefore, for each species investigated, the implant energy cannot exceed a certain level. Dose: Logically, as the implanted dose falls below a certain point, the concentration will be below the TXRF detection limit. In addition to the improved precision of TXRF over SIMS for dose matching, a number of other advantages will be discussed.
Garrido, L; Young, V L
1999-09-01
The amount of silicone (polydimethylsiloxane [PDMS]) in capsular tissue surgically removed from women with breast implants was measured by using (29)Si and (1)H magic-angle spinning solid-state NMR spectroscopy. Twelve women having smooth surface silicone gel-filled implants, including a subject with "low-bleed" double-lumen implants, had detectable levels of PDMS ranging from 0. 05 to 9.8% silicon in wet tissue (w/w). No silicon-containing compounds other than PDMS were detected. No correlation was found between the amount of PDMS measured in the capsular tissue and the length of implantation time (Pearson correlation coefficient, r = 0. 22). The results showed no relationship between higher amounts of PDMS and capsular contracture (p = 0.74) or other symptoms (p = 0. 53). Magn Reson Med 42:436-441, 1999. Copyright 1999 Wiley-Liss, Inc.
Ono, Maki; Varma, Niraj
2017-05-01
Strong evidence exists for the utility of remote monitoring in cardiac implantable electronic devices for early detection of arrhythmias and evaluation of system performance. The application of remote monitoring for the management of chronic disease such as heart failure has been an active area of research. Areas covered: This review aims to cover the latest evidence of remote monitoring of implantable cardiac defibrillators in terms of heart failure prognosis. This article also updates the current technology relating to the method and discusses key factors to be addressed in order to better use the approach. PubMed and internet searches were conducted to acquire most recent data and technology information. Expert commentary: Multiparameter monitoring with automatic transmission is useful for heart failure management. Improved adherence to remote monitoring and an optimal algorithm for transmitted alerts and their management are warranted in the management of heart failure.
Hontanilla, Bernardo; Marre, Diego
2013-04-01
This study aims to analyse the efficacy of static techniques, namely gold weight implant and tendon sling, in the reanimation of the paralytic eyelid. Upper eyelid rehabilitation in terms of excursion and blinking velocity is performed using the automatic motion capture system, FACIAL CLIMA. Seventy-four patients underwent a total of 101 procedures including 58 upper eyelid gold weight implants and 43 lower eyelid tendon suspension with 27 patients undergoing both procedures. The presence of lagophtalmos, eye dryness, corneal ulcer, epiphora and lower lid ptosis/ectropion was assessed preoperatively. The Wilcoxon signed-rank test was used to compare preoperative versus postoperative measurements of upper eyelid excursion and blinking velocity determined with FACIAL CLIMA. Significance was set at p <0.05. FACIAL CLIMA revealed significant improvement of eyelid excursion and velocity of blinking (p < 0.001). Eye dryness improved in 49 patients (90.7%) and corneal ulcer resolved without any further treatment in 12 (85.7%) of those with a gold weight inserted. Implant extrusion was observed in 8.6% of the cases. Of the patients with lower lid tendon suspension, correction of ptosis/ectropion and epiphora was achieved in 93.9% and 91.9% of cases, respectively. In eight patients (18.6%), further surgery was needed to adjust tendon tension. The paralytic upper and lower eyelid can be successfully managed with gold weight implant and tendon suspension. The FACIAL CLIMA system is a reliable method to quantify upper eyelid excursion and blinking velocity and to detect the exact position of the lower eyelid. Copyright © 2012 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Comparison of the compressive strength of 3 different implant design systems.
Pedroza, Jose E; Torrealba, Ysidora; Elias, Augusto; Psoter, Walter
2007-01-01
The aims of this study were twofold: to compare the static compressive strength at the implant-abutment interface of 3 design systems and to describe the implant abutment connection failure mode. A stainless steel holding device was designed to align the implants at 30 degrees with respect to the y-axis. Sixty-nine specimens were used, 23 for each system. A computer-controlled universal testing machine (MTS 810) applied static compression loading by a unidirectional vertical piston until failure. Specimens were evaluated macroscopically for longitudinal displacement, abutment looseness, and screw and implant fracture. Data were analyzed by analysis of variance (ANOVA). The mean compressive strength for the Unipost system was 392.5 psi (SD +/-40.9), for the Spline system 342.8 psi (SD+/-25.8), and for the Screw-Vent system 269.1 psi (SD+/-30.7). The Unipost implant-abutment connection demonstrated a statistically significant superior mechanical stability (P < or = .009) compared with the Spline implant system. The Spline implant system showed a statistically significant higher compressive strength than the Screw-Vent implant system (P < or =.009). Regarding failure mode, the Unipost system consistently broke at the same site, while the other systems failed at different points of the connection. The Unipost system demonstrated excellent fracture resistance to compressive forces; this resistance may be attributed primarily to the diameter of the abutment screw and the 2.5 mm counter bore, representing the same and a unique piece of the implant. The Unipost implant system demonstrated a statistically significant superior compressive strength value compared with the Spline and Screw-Vent systems, at a 30 degrees angulation.
In Vitro Investigation of the Effect of Oral Bacteria in the Surface Oxidation of Dental Implants.
Sridhar, Sathyanarayanan; Wilson, Thomas G; Palmer, Kelli L; Valderrama, Pilar; Mathew, Mathew T; Prasad, Shalini; Jacobs, Michael; Gindri, Izabelle M; Rodrigues, Danieli C
2015-10-01
Bacteria are major contributors to the rising number of dental implant failures. Inflammation secondary to bacterial colonization and bacterial biofilm is a major etiological factor associated with early and late implant failure (peri-implantitis). Even though there is a strong association between bacteria and bacterial biofilm and failure of dental implants, their effect on the surface of implants is yet not clear. To develop and establish an in vitro testing methodology to investigate the effect of early planktonic bacterial colonization on the surface of dental implants for a period of 60 days. Commercial dental implants were immersed in bacterial (Streptococcus mutans in brain-heart infusion broth) and control (broth only) media. Immersion testing was performed for a period of 60 days. During testing, optical density and pH of immersion media were monitored. The implant surface was surveyed with different microscopy techniques post-immersion. Metal ion release in solution was detected with an electrochemical impedance spectroscopy sensor platform called metal ion electrochemical biosensor (MIEB). Bacteria grew in the implant-containing medium and provided a sustained acidic environment. Implants immersed in bacterial culture displayed various corrosion features, including surface discoloration, deformation of rough and smooth interfaces, pitting attack, and severe surface rusting. The surface features were confirmed by microscopic techniques, and metal particle generation was detected by the MIEB. Implant surface oxidation occurred in bacteria-containing medium even at early stages of immersion (2 days). The incremental corrosion resulted in dissolution of metal ions and debris into the testing solution. Dissolution of metal ions and particles in the oral environment can trigger or contribute to the development of peri-implantitis at later stages. © 2015 Wiley Periodicals, Inc.
Kempe, Sabine; Metz, Hendrik; Pereira, Priscila G C; Mäder, Karsten
2010-01-01
In the present study, we used benchtop magnetic resonance imaging (BT-MRI) for non-invasive and continuous in vivo studies of in situ forming poly(lactide-co-glycolide) (PLGA) implants without the use of contrast agents. Polyethylene glycol (PEG) 400 was used as an alternative solvent to the clinically used NMP. In addition to BT-MRI, we applied electron paramagnetic resonance (EPR) spectroscopy to characterize implant formation and drug delivery processes in vitro and in vivo. We were able to follow key processes of implant formation by EPR and MRI. Because EPR spectra are sensitive to polarity and mobility, we were able to follow the kinetics of the solvent/non-solvent exchange and the PLGA precipitation. Due to the high water affinity of PEG 400, we observed a transient accumulation of water in the implant neighbourhood. Furthermore, we detected the encapsulation by BT-MRI of the implant as a response of the biological system to the polymer, followed by degradation over a period of two months. We could show that MRI in general has the potential to get new insights in the in vivo fate of in situ forming implants. The study also clearly shows that BT-MRI is a new viable and much less expensive alternative for superconducting MRI machines to monitor drug delivery processes in vivo in small mammals. Copyright 2009 Elsevier B.V. All rights reserved.
Lazzeri, Davide; Agostini, Tommaso; Bocci, Guido; Giannotti, Giordano; Fanelli, Giovanni; Naccarato, Antonio Giuseppe; Danesi, Romano; Tuccori, Marco; Pantaloni, Marcello; D'Aniello, Carlo
2011-10-01
Concerns have been raised recently regarding the increasing number of reports of non-Hodgkin lymphoma (NHL) that developed in close proximity to silicone or saline breast implants. In particular, an increased risk of anaplastic large cell lymphoma (ALCL) in patients with breast prostheses has been proposed. We reviewed clinical and pathologic findings in 40 women who received a diagnosis of breast NHL arising in association with breast implants and of 27 patients who had a diagnosis of ALCL with breast involvement reported in the published literature. Among the 40 reported cases of prosthesis-associated breast lymphomas, 28 were anaplastic lymphoma kinase-1-negative (ALK-1(-)) ALCLs, whereas of 27 ALCLs in patients without implants found in the literature, only 10 were ALK-1(-). The finding of 28 cases of breast ALK-1(-) ALCL occurring in patients with implants compared with 10 cases in women without implants is in favor of an association between silicone breast prostheses and ALK-1(-) ALCL. Although the incidence of this type of lymphoma remains remarkably low given that breast prostheses have been widely used for decades, clinical and pathologic evidence for a causative role is becoming dramatically strong. The histologic, phenomenologic, and clinical similarities of the majority of implant-related ALK-1(-) ALCLs suggest a common mechanism, especially when compared with the counterpart of patients without implants in which very few and highly dishomogeneous cases of the same malignancy were detected. There is convincing evidence that primary implant-related ALK-1(-) ALCL represents a distinct clinicopathologic entity that has been inappropriately fitted into the category of systemic ALK-1(-) ALCL. Thus it should be recognized as a separate category and classified on its own. Copyright © 2011 Elsevier Inc. All rights reserved.
Design of a multi-axis implantable MEMS sensor for intraosseous bone stress monitoring
NASA Astrophysics Data System (ADS)
Alfaro, Fernando; Weiss, Lee; Campbell, Phil; Miller, Mark; Fedder, Gary K.
2009-08-01
The capability to assess the biomechanical properties of living bone is important for basic research as well as the clinical management of skeletal trauma and disease. Even though radiodensitometric imaging is commonly used to infer bone quality, bone strength does not necessarily correlate well with these non-invasive measurements. This paper reports on the design, fabrication and initial testing of an implantable ultra-miniature multi-axis sensor for directly measuring bone stresses at a micro-scale. The device, which is fabricated with CMOS-MEMS processes, is intended to be permanently implanted within open fractures, or embedded in bone grafts, or placed on implants at the interfaces between bone and prosthetics. The stress sensor comprises an array of piezoresistive pixels to detect a stress tensor at the interfacial area between the MEMS chip and bone, with a resolution to 100 Pa, in 1 s averaging. The sensor system design and manufacture is also compatible with the integration of wireless RF telemetry, for power and data retrieval, all within a 3 mm × 3 mm × 0.3 mm footprint. The piezoresistive elements are integrated within a textured surface to enhance sensor integration with bone. Finite element analysis led to a sensor design for normal and shear stress detection. A wired sensor was fabricated in the Jazz 0.35 µm BiCMOS process and then embedded in mock bone material to characterize its response to tensile and bending loads up to 250 kPa.
Optical tomograph optimized for tumor detection inside highly absorbent organs
NASA Astrophysics Data System (ADS)
Boutet, Jérôme; Koenig, Anne; Hervé, Lionel; Berger, Michel; Dinten, Jean-Marc; Josserand, Véronique; Coll, Jean-Luc
2011-05-01
This paper presents a tomograph for small animal fluorescence imaging. The compact and cost-effective system described in this article was designed to address the problem of tumor detection inside highly absorbent heterogeneous organs, such as lungs. To validate the tomograph's ability to detect cancerous nodules inside lungs, in vivo tumor growth was studied on seven cancerous mice bearing murine mammary tumors marked with Alexa Fluor 700. They were successively imaged 10, 12, and 14 days after the primary tumor implantation. The fluorescence maps were compared over this time period. As expected, the reconstructed fluorescence increases with the tumor growth stage.
Visual BOLD Response in Late Blind Subjects with Argus II Retinal Prosthesis
Castaldi, E.; Cicchini, G. M.; Cinelli, L.; Rizzo, S.; Morrone, M. C.
2016-01-01
Retinal prosthesis technologies require that the visual system downstream of the retinal circuitry be capable of transmitting and elaborating visual signals. We studied the capability of plastic remodeling in late blind subjects implanted with the Argus II Retinal Prosthesis with psychophysics and functional MRI (fMRI). After surgery, six out of seven retinitis pigmentosa (RP) blind subjects were able to detect high-contrast stimuli using the prosthetic implant. However, direction discrimination to contrast modulated stimuli remained at chance level in all of them. No subject showed any improvement of contrast sensitivity in either eye when not using the Argus II. Before the implant, the Blood Oxygenation Level Dependent (BOLD) activity in V1 and the lateral geniculate nucleus (LGN) was very weak or absent. Surprisingly, after prolonged use of Argus II, BOLD responses to visual input were enhanced. This is, to our knowledge, the first study tracking the neural changes of visual areas in patients after retinal implant, revealing a capacity to respond to restored visual input even after years of deprivation. PMID:27780207
Time Course of Peri-Implant Bone Regeneration around Loaded and Unloaded Implants in a Rat Model
Jariwala, Shailly H.; Wee, Hwabok; Roush, Evan P.; Whitcomb, Tiffany L.; Murter, Christopher; Kozlansky, Gery; Lakhtakia, Akhlesh; Kunselman, Allen R.; Donahue, Henry J.; Armstrong, April D.; Lewis, Gregory S.
2018-01-01
The time-course of cancellous bone regeneration surrounding mechanically loaded implants affects implant fixation, and is relevant to determining optimal rehabilitation protocols following orthopaedic surgeries. We investigated the influence of controlled mechanical loading of titanium-coated polyether-ether ketone (PEEK) implants on osseointegration using time-lapsed, non-invasive, in vivo micro-computed tomography (micro-CT) scans. Implants were inserted into proximal tibial metaphyses of both limbs of eight female Sprague-Dawley rats. External cyclic loading (60 μm or 100 μm displacement, 1 Hz, 60 seconds) was applied every other day for 14 days to one implant in each rat, while implants in contralateral limbs served as the unloaded controls. Hind limbs were imaged with high-resolution micro-CT (12.5 μm voxel size) at 2, 5, 9, and 12 days post-surgery. Trabecular changes over time were detected by 3D image registration allowing for measurements of bone-formation rate (BFR) and bone-resorption rate (BRR). At day 9, mean %BV/TV for loaded and unloaded limbs were 35.5 ± 10.0 % and 37.2 ± 10.0 %, respectively, and demonstrated significant increases in bone volume compared to day 2. BRR increased significantly after day 9. No significant differences between bone volumes, BFR, and BRR were detected due to implant loading. Although not reaching significance (p = 0.16), an average 119 % increase in pull-out strength was measured in the loaded implants. PMID:27381807
Embedded electronics for a 64-channel wireless brain implant
NASA Astrophysics Data System (ADS)
Burgert, Johann D.; Malasek, Jan; Martel, Sylvain M.; Wiseman, Colette; Fofonoff, Timothy; Dyer, Robert; Hunter, Ian W.; Hatsopoulos, Nicholas; Donoghue, John
2001-10-01
The Telemetric Electrode Array System (TEAS) is a surgically implantable device for the study of neural activity in the brain. An 8x8 array of electrodes collects intra-cortical neural signals and connects them to an analog front end. The front end amplifies and digitizes these microvolt-level signals with 12 bits of resolution and at 31KHz per channel. Peak detection is used to extract the information carrying features of these signals, which are transmitted over a Bluetooth-based radio link at 725 Kbit/sec. The electrode array is made up of 1mm tall, 60-micron square electrodes spaced 500 microns tip-to-tip. A flex circuit connector provides mechanical isolation between the brain and the electronics, which are mounted to the cranium. Power consumption and management is a critical aspect of the design. The entire system must operate off a surgically implantable battery. With this power source, the system must provide the functionality of a wireless, 64-channel oscilloscope for several hours. The system also provides a low-power sleep mode during which the battery can be inductively charged. Power dissipation and biocompatibility issues also affect the design of the electronics for the probe. The electronics system must fit between the skull and the skin of the test subject. Thus, circuit miniaturization and microassembly techniques are essential to construct the probe's electronics.
Mueller, Cornelia Katharina; Solcher, Philipp; Peisker, Andrè; Mtsariashvilli, Maia; Schlegel, Karl Andreas; Hildebrand, Gerhard; Rost, Juergen; Liefeith, Klaus; Chen, Jiang; Schultze-Mosgau, Stefan
2013-07-01
It was the aim of this study to analyze the influence of implant design and surface topography on the osseointegration of dental zirconium implants. Six different implant designs were tested in the study. Nine or 10 test implants were inserted in the frontal skull in each of 10 miniature pigs. Biopsies were harvested after 2 and 4 months and subjected to microradiography. No significant differences between titanium and zirconium were found regarding the microradiographically detected bone-implant contact (BIC). Cylindric zirconium implants showed a higher BIC at the 2-month follow-up than conic zirconium implants. Among zirconium implants, those with an intermediate Ra value showed a significantly higher BIC compared with low and high Ra implants 4 months after surgery. Regarding osseointegration, titanium and zirconium showed equal properties. Cylindric implant design and intermediate surface roughness seemed to enhance osseointegration. Copyright © 2013 Elsevier Inc. All rights reserved.
Dose Control System in the Optima XE Single Wafer High Energy Ion Implanter
DOE Office of Scientific and Technical Information (OSTI.GOV)
Satoh, Shu; Yoon, Jongyoon; David, Jonathan
2011-01-07
Photoresist outgassing can significantly compromise accurate dosimetry of high energy implants. High energy implant even at a modest beam current produces high beam powers which create significantly worse outgassing than low and medium energy implants and the outgassing continues throughout the implant due to the low dose in typical high energy implant recipes. In the previous generation of high energy implanters, dose correction by monitoring of process chamber pressure during photoresist outgassing has been used. However, as applications diversify and requirements change, the need arises for a more versatile photoresist correction system to match the versatility of a single wafermore » high energy ion implanter. We have successfully developed a new dosimetry system for the Optima XE single wafer high energy ion implanter which does not require any form of compensation due to the implant conditions. This paper describes the principles and performance of this new dose system.« less
Yamazaki, Hiroshi; O'Leary, Stephen; Moran, Michelle; Briggs, Robert
2014-04-01
Accurate diagnosis of cochlear implant failures is important for management; however, appropriate strategies to assess possible device failures are not always clear. The purpose of this study is to understand correlation between causes of device failure and the presenting clinical symptoms as well as results of in situ integrity testing and to propose effective strategies for diagnosis of device failure. Retrospective case review. Cochlear implant center at a tertiary referral hospital. Twenty-seven cases with suspected device failure of Cochlear Nucleus systems (excluding CI512 failures) on the basis of deterioration in auditory perception from January 2000 to September 2012 in the Melbourne cochlear implant clinic. Clinical presentations and types of abnormalities on in situ integrity testing were compared with modes of device failure detected by returned device analysis. Sudden deterioration in auditory perception was always observed in cases with "critical damage": either fracture of the integrated circuit or most or all of the electrode wires. Subacute or gradually progressive deterioration in auditory perception was significantly associated with a more limited number of broken electrode wires. Cochlear implant mediated auditory and nonauditory symptoms were significantly associated with an insulation problem. An algorithm based on the time course of deterioration in auditory perception and cochlear implant-mediated auditory and nonauditory symptoms was developed on the basis of these retrospective analyses, to help predict the mode of device failure. In situ integrity testing, which included close monitoring of device function in routine programming sessions as well as repeating the manufacturer's integrity test battery, was sensitive enough to detect malfunction in all suspected device failures, and each mode of device failure showed a characteristic abnormality on in situ integrity testing. Our clinical manifestation-based algorithm combined with in situ integrity testing may be useful for accurate diagnosis and appropriate management of device failure. Close monitoring of device function in routine programming sessions as well as repeating the manufacturer's integrity test battery is important if the initial in situ integrity testing is inconclusive because objective evidence of failure in the implanted device is essential to recommend explantation/reimplantation.
Quek, H C; Tan, Keson B; Nicholls, Jack I
2008-01-01
Biomechanical load-fatigue performance data on single-tooth implant systems with different implant-abutment interface designs is lacking in the literature. This study evaluated the load fatigue performance of 4 implant-abutment interface designs (Brånemark-CeraOne; 3i Osseotite-STA abutment; Replace Select-Easy abutment; and Lifecore Stage-1-COC abutment system). The number of load cycles to fatigue failure of 4 implant-abutment designs was tested with a custom rotational load fatigue machine. The effect of increasing and decreasing the tightening torque by 20% respectively on the load fatigue performance was also investigated. Three different tightening torque levels (recommended torque, -20% recommended torque, +20% recommended torque) were applied to the 4 implant systems. There were 12 test groups with 5 samples in each group. The rotational load fatigue machine subjected specimens to a sinusoidally applied 35 Ncm bending moment at a test frequency of 14 Hz. The number of cycles to failure was recorded. A cutoff of 5 x 10(6) cycles was applied as an upper limit. There were 2 implant failures and 1 abutment screw failure in the Brånemark group. Five abutment screw failures and 4 implant failures was recorded for the 3i system. The Replace Select system had 1 implant failure. Five cone screw failures were noted for the Lifecore system. Analysis of variance revealed no statistically significant difference in load cycles to failure for the 4 different implant-abutment systems torqued at recommended torque level. A statistically significant difference was found between the -20% torque group and the +20% torque group (P < .05) for the 3i system. Load fatigue performance and failure location is system specific and related to the design characteristics of the implant-abutment combination. It appeared that if the implant-abutment interface was maintained, load fatigue failure would occur at the weakest point of the implant. It is important to use the torque level recommended by the manufacturer.
Brief ultrasonication improves detection of biofilm-formative bacteria around a metal implant.
Kobayashi, Naomi; Bauer, Thomas W; Tuohy, Marion J; Fujishiro, Takaaki; Procop, Gary W
2007-04-01
Biofilms are complex microenvironments produced by microorganisms on surfaces. Ultrasonication disrupts biofilms and may make the microorganism or its DNA available for detection. We determined whether ultrasonication could affect our ability to detect bacteria adherent to a metal substrate. A biofilm-formative Staphylococcus aureus strain was used for an in vitro implant infection model (biofilm-formative condition). We used quantitative culture and real time-polymerase chain reaction to determine the influence of different durations of ultrasound on bacterial adherence and viability. Sonication for 1 minute increased the yield of bacteria. Sonication longer than 5 minutes led to fewer bacterial colonies by conventional culture but not by polymerase chain reaction. This suggests short periods of sonication help release bacteria from the metal substrate by disrupting the biofilm, but longer periods of sonication lyse bacteria prohibiting their detection in microbiologic cultures. A relatively short duration of sonication may be desirable for maximizing detection of biofilm-formative bacteria around implants by culture or polymerase chain reaction.
Manna, Soumyarwit; Banerjee, Rupak K; Augsburger, James J; Al-Rjoub, Marwan F; Donnell, Anna; Correa, Zelia M
2015-08-01
The purpose of this study was to evaluate the pharmacokinetics and toxicity of a chitosan (CS) and polylactic acid (PLA) based methotrexate (MTX) intravitreal micro-implant in an animal model using rabbit eyes. CS- and PLA-based micro-implants containing 400 μg of MTX were fabricated using lyophilization and dip-coating techniques. The micro-implants were surgically implanted in the vitreous of eight New Zealand rabbits employing minimally invasive technique. The PLA-coated CS-MTX micro-implant was inserted in the right eye and the placebo micro-implant in the left eye of each rabbit. Two rabbits were euthanized at each pre-determined time point post-implantation (days 5, 12, 19, and 33) for pharmacokinetics and histopathology evaluation. A therapeutic concentration of MTX (0.1-1.0 μM) in the vitreous was detected in the rabbit eyes studied for 33 days. The MTX release from the coated micro-implants followed a first order kinetics (R (2) ~ 0.88), implying that MTX release depends on the concentration of MTX in the micro-implant. Histopathological analysis of the enucleated eyes failed to show any signs of infection or tissue toxicity in any of the specimens. The PLA-coated CS-MTX micro-implants were able to deliver therapeutic release of MTX for a period of more than 1 month without detectable toxicity in a rabbit model. The micro-implants can be further investigated as a prospective alternative to current treatment protocols of repeated intravitreal MTX injections in intraocular disorders such as primary intraocular lymphoma, and selected cases of non-microbial intraocular inflammation.
Suppression of estrus in cats with melatonin implants.
Gimenez, F; Stornelli, M C; Tittarelli, C M; Savignone, C A; Dorna, I V; de la Sota, R L; Stornelli, M A
2009-09-01
The objective of this study was to assess the efficacy of a subcutaneous melatonin implant to suppress estrus in queens (felis catus). The hypothesis was that this implant would temporarily and reversibly suppress estrus in queens without producing any clinically detectable side effects. Fourteen adult queens were maintained in cages under artificial illumination (14h light:10h dark) for 45 d and then randomly assigned to one of two treatments. At interestrus, queens received a single subcutaneous melatonin implant (18mg; Melovine [CEVA Sante Animal, Libourne, France]; MEL: n=9), or a single subcutaneous placebo implant without melatonin (0mg; PLA; n=5). At the next estrus, all queens received a second MEL (n=9) or PLA (n=5) implant. Blood samples were taken when queens displayed estrous signs and during interestrus to measure estradiol (E(2)) and progesterone (P(4)), respectively, by radioimmunoassay. There were no significant differences in duration of the interestrus interval in PLA cats, regardless of whether the implants were placed during interestrus or estrus (6.0+/-9.7 d vs. 6.0+/-9.7 d, respectively; least square means [LSM]+/-SEM). However, when MEL implants were placed during interestrus, the duration of interestrus was approximately twice as long as that occurring when MEL implants were placed during estrus (113.3+/-6.1 d vs. 61.1+/-6.8 d, respectively; P<0.01). Serum E(2) and P(4) concentrations were similar in queens with PLA and MEL implants and in queens that received implants in estrus and interestrus. In conclusion, a subcutaneous MEL implant effectively and reversibly suppressed estrus in queens for approximately 2 to 4 mo with no clinically detectable side effects.
[Comparative evaluation of two kinds of micro-implant system with different size].
Wang, Zhen-Dong; Li, Qing-Yi; Wang, Lin; Gu, Yong-Jia
2009-04-01
To offer some reference for micro-implant's development and population by analyzing clinical application of two kinds of micro-implant systems. 38 patients treated with MIA (micro-implant anchorage) and 28 patients treated with SDIA (self-driven titanium implant for orthodontic anchorage) were included. Analyzing the rate of lost implants, the gum's reactivity and the efficiency of moving teeth summarized the excellences and shortcomings of two systems. 1) Six of MIA implants fell off after being inserted. Seven of SDIA implants lost when they had been implanted for a month. But they were stable after being inserted again. 2) The gum around 12 SDIA implants got inflammation symptom, but the gum around MIA implants was normal. 3) Both MIA implants and SDIA implants could move teeth effectively and persistently when they were stable. When we apply micro-implant in clinic, we should prevent it from closing roots of teeth and choose the small tip micro-implant. The embedded position should be in area of attachment gum. At the same time, the areas around the tip of micro-implant should be keeping clean.
Unique presentation of Twiddler’s syndrome
Parikh, Valay; Barsoum, Emad A; Morcus, Rewais; Azab, Basem; Lafferty, James; Kohn, Jeffrey
2013-01-01
We present a rare case of Twiddler’s syndrome diagnosed in an asymptomatic patient on a routine follow up. This case reiterates the need for frequent monitoring of the implanted device. In addition, it was detected 4 years after implantation of an automatic implantable cardioverter defibrillator. This late representation is extremely uncommon. PMID:23802049
Ding, Qian; Zhang, Lei; Geraets, Wil; Wu, Wuqing; Zhou, Yongsheng; Wismeijer, Daniel; Xie, Qiufei
The present study aimed to explore the association between marginal bone loss and type of peri-implant bony defect determined using a new peri-implant bony defect classification system. A total of 110 patients with implant-supported mandibular overdentures were involved. Clinical information was collected, including gender, age, smoking habit, and the overdenture attachment system used. Peri-implant bony defect types and marginal distances (ie, distance between the marginal bone level and the top of the implant shoulder) of all sites were identified on panoramic radiographs by a single experienced observer. The associations between marginal distance and peri-implant bony defect type, gender, age, smoking habit, attachment system, and time after implantation were investigated using marginal generalized linear models and regression analysis. A total of 83 participants were included in the final sample with a total of 224 implants involving 3,124 implant sites. The mean observation time was 10.7 years. All peri-implant bony defect types except Type 5 (slit-like) were significantly related to marginal distance in all models (P < .01). Smoking and time after implantation were significantly related to marginal distance while gender, age, and the overdenture attachment system used were not. The peri-implant bony defect type, determined using the new classification system, is associated with the extent of marginal bone loss.
Deng, Z. D.; Martinez, J. J.; Li, H.; Harnish, R. A.; Woodley, C. M.; Hughes, J. A.; Li, X.; Fu, T.; Lu, J.; McMichael, G. A.; Weiland, M. A.; Eppard, M. B.; Skalski, J. R.; Townsend, R. L.
2017-01-01
Acoustic telemetry is one of the primary technologies for studying the behavior and survival of fishes throughout the world. The size and performance of the transmitter are key limiting factors. The newly developed injectable transmitter is the first acoustic transmitter that can be implanted via injection instead of surgery. A two-part field study was conducted to evaluate the performance of the injectable transmitter and its effect on the survival of implanted fish. The injectable transmitter performed well and similarly to the proceeding generation of commercially-available JSATS transmitters tested concurrently. Snake River subyearling Chinook salmon smolts implanted with the injectable transmitter had a higher survival probability from release to each of eleven downstream detection arrays, because reach-specific survival estimates were significantly higher for the injectable group in three of the eleven reaches examined. Overall, the injectable group had a 0.263 (SE = 0.017) survival probability over the entire 500 km study area compared to 0.199 (0.012) for the surgically implanted group. The reduction in size and ability to implant the new transmitter via injection has reduced the tag or tagging effect bias associated with studying small fishes. The information gathered with this new technology is helping to evaluate the impacts of dams on fishes. PMID:28220850
Deng, Z D; Martinez, J J; Li, H; Harnish, R A; Woodley, C M; Hughes, J A; Li, X; Fu, T; Lu, J; McMichael, G A; Weiland, M A; Eppard, M B; Skalski, J R; Townsend, R L
2017-02-21
Acoustic telemetry is one of the primary technologies for studying the behavior and survival of fishes throughout the world. The size and performance of the transmitter are key limiting factors. The newly developed injectable transmitter is the first acoustic transmitter that can be implanted via injection instead of surgery. A two-part field study was conducted to evaluate the performance of the injectable transmitter and its effect on the survival of implanted fish. The injectable transmitter performed well and similarly to the proceeding generation of commercially-available JSATS transmitters tested concurrently. Snake River subyearling Chinook salmon smolts implanted with the injectable transmitter had a higher survival probability from release to each of eleven downstream detection arrays, because reach-specific survival estimates were significantly higher for the injectable group in three of the eleven reaches examined. Overall, the injectable group had a 0.263 (SE = 0.017) survival probability over the entire 500 km study area compared to 0.199 (0.012) for the surgically implanted group. The reduction in size and ability to implant the new transmitter via injection has reduced the tag or tagging effect bias associated with studying small fishes. The information gathered with this new technology is helping to evaluate the impacts of dams on fishes.
NASA Astrophysics Data System (ADS)
Deng, Z. D.; Martinez, J. J.; Li, H.; Harnish, R. A.; Woodley, C. M.; Hughes, J. A.; Li, X.; Fu, T.; Lu, J.; McMichael, G. A.; Weiland, M. A.; Eppard, M. B.; Skalski, J. R.; Townsend, R. L.
2017-02-01
Acoustic telemetry is one of the primary technologies for studying the behavior and survival of fishes throughout the world. The size and performance of the transmitter are key limiting factors. The newly developed injectable transmitter is the first acoustic transmitter that can be implanted via injection instead of surgery. A two-part field study was conducted to evaluate the performance of the injectable transmitter and its effect on the survival of implanted fish. The injectable transmitter performed well and similarly to the proceeding generation of commercially-available JSATS transmitters tested concurrently. Snake River subyearling Chinook salmon smolts implanted with the injectable transmitter had a higher survival probability from release to each of eleven downstream detection arrays, because reach-specific survival estimates were significantly higher for the injectable group in three of the eleven reaches examined. Overall, the injectable group had a 0.263 (SE = 0.017) survival probability over the entire 500 km study area compared to 0.199 (0.012) for the surgically implanted group. The reduction in size and ability to implant the new transmitter via injection has reduced the tag or tagging effect bias associated with studying small fishes. The information gathered with this new technology is helping to evaluate the impacts of dams on fishes.
Role of Pancreatic Cancer-derived Exosomes in Salivary Biomarker Development*
Lau, Chang; Kim, Yong; Chia, David; Spielmann, Nadine; Eibl, Guido; Elashoff, David; Wei, Fang; Lin, Yi-Ling; Moro, Aune; Grogan, Tristan; Chiang, Samantha; Feinstein, Eric; Schafer, Christopher; Farrell, James; Wong, David T. W.
2013-01-01
Recent studies have demonstrated that discriminatory salivary biomarkers can be readily detected upon the development of systemic diseases such as pancreatic cancer, breast cancer, lung cancer, and ovarian cancer. However, the utility of salivary biomarkers for the detection of systemic diseases has been undermined due to the absence of the biological and mechanistic rationale as to why distal diseases from the oral cavity would lead to the development of discriminatory biomarkers in saliva. Here, we examine the hypothesis that pancreatic tumor-derived exosomes are mechanistically involved in the development of pancreatic cancer-discriminatory salivary transcriptomic biomarkers. We first developed a pancreatic cancer mouse model that yielded discriminatory salivary biomarkers by implanting the mouse pancreatic cancer cell line Panc02 into the pancreas of the syngeneic host C57BL/6. The role of pancreatic cancer-derived exosomes in the development of discriminatory salivary biomarkers was then tested by engineering a Panc02 cell line that is suppressed for exosome biogenesis, implanting into the C56BL/6 mouse, and examining whether the discriminatory salivary biomarker profile was ablated or disrupted. Suppression of exosome biogenesis results in the ablation of discriminatory salivary biomarker development. This study supports that tumor-derived exosomes provide a mechanism in the development of discriminatory biomarkers in saliva and distal systemic diseases. PMID:23880764
In vivo evaluation of a magnesium-based degradable intramedullary nailing system in a sheep model.
Rössig, Christina; Angrisani, Nina; Helmecke, Patrick; Besdo, Silke; Seitz, Jan-Marten; Welke, Bastian; Fedchenko, Nickolay; Kock, Heiko; Reifenrath, Janin
2015-10-01
The biocompatibility and the degradation behavior of the LAE442 magnesium-based intramedullary interlocked nailing system (IM-NS) was assessed in vivo in a comparative study (stainless austenitic steel 1.4441LA) for the first time. IM-NS was implanted into the right tibia (24-week investigation period; nails/screws diameter: 9 mm/3.5 mm, length: 130 mm/15-40 mm) of 10 adult sheep (LAE442, stainless steel, n=5 each group). Clinical and radiographic examinations, in vivo computed tomography (CT), ex vivo micro-computed tomography (μCT), mechanical and histological examinations and element analyses of alloying elements in inner organs were performed. The mechanical examinations (four-point bending) revealed a significant decrease of LAE442 implant stiffness, force at 0.2% offset yield point and maximum force. Periosteal (new bone formation) and endosteal (bone decline) located bone alterations occurred in both groups (LAE442 alloy more pronounced). Moderate gas formation was observed within the LAE442 alloy group. The CT-measured implant volume decreased slightly (not significant). Histologically a predominantly direct bone-to-implant interface existed within the LAE442 alloy group. Formation of a fibrous tissue capsule around the nail occurred in the steel group. Minor inflammatory infiltration was observed in the LAE442 alloy group. Significantly increased quantities of rare earth elements were detected in the LAE442 alloy group. μCT examination showed the beginning of corrosion in dependence of the surrounding tissue. After 24 weeks the local biocompatibility of LAE442 can be considered as suitable for a degradable implant material. An application oriented interlocked intramedullary nailing system in a comparative study (degradable magnesium-based LAE442 alloy vs. steel alloy) was examined in a sheep model for the first time. We focused in particular on the examination of implant degradation by means of (μ-)CT, mechanical properties (four-point bending), clinical compatibility, local bone reactions (X-ray and histology) and possible systemic toxicity (histology and element analyses of inner organs). A significant decrease of magnesium (LAE442 alloy) implant stiffness and maximum force occurred. Moderate not clinically relevant gas accumulation was determined. A predominantly direct bone-to-implant contact existed within the magnesium (LAE442 alloy) group compared to an indirect contact in the steel group. Rare earth element accumulation could be observed in inner organs but H&E staining was inconspicuous. Copyright © 2015 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.
Evaluation of ion-implanted-silicon detectors for use in intraoperative positron-sensitive probes.
Raylman, R R; Wahl, R L
1996-11-01
The continuing development of probes for use with beta (positron and electron) emitting radionuclides may result in more complete excision of tracer-avid tumors. Perhaps one of the most promising radiopharmaceuticals for this task is 18F-labeled-Fluoro-2-Deoxy-D-Glucose (FDG). This positron-emitting agent has been demonstrated to be avidly and rapidly absorbed by many human cancers. We have investigated the use of ion-implanted-silicon detectors in intraoperative positron-sensitive surgical probes for use with FDG. These detectors possess very high positron detection efficiency, while the efficiency for 511 keV photon detection is low. The spatial resolution, as well as positron and annihilation photon detection sensitivity, of an ion-implanted-silicon detector used with 18F was measured at several energy thresholds. In addition, the ability of the device to detect the presence of relatively small amounts of FDG during surgery was evaluated by simulating a surgical field in which some tumor was left intact following lesion excision. The performance of the ion-implanted-silicon detector was compared to the operating characteristics of a positron-sensitive surgical probe which utilizes plastic scintillator. In all areas of performance the ion-implanted-silicon detector proved superior to the plastic scintillator-based probe. At an energy threshold of 14 keV positron sensitivity measured for the ion-implanted-silicon detector was 101.3 cps/kBq, photon sensitivity was 7.4 cps/kBq. In addition, spatial resolution was found to be relatively unaffected by the presence of distant sources of annihilation photon flux. Finally, the detector was demonstrated to be able to localize small amounts of FDG in a simulated tumor bed; indicating that this device has promise as a probe to aid in FDG-guided surgery.
Song, Jae W.; Kim, Hyungjin Myra; Bellfi, Lillian T.; Chung, Kevin C.
2010-01-01
Background All silicone breast implant recipients are recommended by the US Food and Drug Administration to undergo serial screening to detect implant rupture with magnetic resonance imaging (MRI). We performed a systematic review of the literature to assess the quality of diagnostic accuracy studies utilizing MRI or ultrasound to detect silicone breast implant rupture and conducted a meta-analysis to examine the effect of study design biases on the estimation of MRI diagnostic accuracy measures. Method Studies investigating the diagnostic accuracy of MRI and ultrasound in evaluating ruptured silicone breast implants were identified using MEDLINE, EMBASE, ISI Web of Science, and Cochrane library databases. Two reviewers independently screened potential studies for inclusion and extracted data. Study design biases were assessed using the QUADAS tool and the STARDS checklist. Meta-analyses estimated the influence of biases on diagnostic odds ratios. Results Among 1175 identified articles, 21 met the inclusion criteria. Most studies using MRI (n= 10 of 16) and ultrasound (n=10 of 13) examined symptomatic subjects. Meta-analyses revealed that MRI studies evaluating symptomatic subjects had 14-fold higher diagnostic accuracy estimates compared to studies using an asymptomatic sample (RDOR 13.8; 95% CI 1.83–104.6) and 2-fold higher diagnostic accuracy estimates compared to studies using a screening sample (RDOR 1.89; 95% CI 0.05–75.7). Conclusion Many of the published studies utilizing MRI or ultrasound to detect silicone breast implant rupture are flawed with methodological biases. These methodological shortcomings may result in overestimated MRI diagnostic accuracy measures and should be interpreted with caution when applying the data to a screening population. PMID:21364405
Periprosthetic Joint Infection of Shoulder Arthroplasties: Diagnostic and Treatment Options
Sevelda, Florian
2017-01-01
Periprosthetic joint infection (PJI) is one of the most frequent reasons for painful shoulder arthroplasties and revision surgery of shoulder arthroplasties. Cutibacterium acnes (Propionibacterium acnes) is one of the microorganisms that most often causes the infection. However, this slow growing microorganism is difficult to detect. This paper presents an overview of different diagnostic test to detect a periprosthetic shoulder infection. This includes nonspecific diagnostic tests and specific tests (with identifying the responsible microorganism). The aspiration can combine different specific and nonspecific tests. In dry aspiration and suspected joint infection, we recommend a biopsy. Several therapeutic options exist for the treatment of PJI of shoulder arthroplasties. In acute infections, the options include leaving the implant in place with open debridement, septic irrigation with antibacterial fluids like octenidine or polyhexanide solution, and exchange of all removable components. In late infections (more than four weeks after implantation) the therapeutic options are a permanent spacer, single-stage revision, and two-stage revision with a temporary spacer. The functional results are best after single-stage revisions with a success rate similar to two-stage revisions. For single-stage revisions, the microorganism should be known preoperatively so that specific antibiotics can be mixed into the cement for implantation of the new prosthesis and specific systemic antibiotic therapy can be applied to support the surgery. PMID:29423407
Ryan, Aideen E; Lohan, Paul; O'Flynn, Lisa; Treacy, Oliver; Chen, Xizhe; Coleman, Cynthia; Shaw, Georgina; Murphy, Mary; Barry, Frank; Griffin, Matthew D; Ritter, Thomas
2014-01-01
Allogeneic mesenchymal stem cells (allo-MSCs) have potent regenerative and immunosuppressive potential and are being investigated as a therapy for osteoarthritis; however, little is known about the immunological changes that occur in allo-MSCs after ex vivo induced or in vivo differentiation. Three-dimensional chondrogenic differentiation was induced in an alginate matrix, which served to immobilize and potentially protect MSCs at the site of implantation. We show that allogeneic differentiated MSCs lost the ability to inhibit T-cell proliferation in vitro, in association with reduced nitric oxide and prostaglandin E2 secretion. Differentiation altered immunogenicity as evidenced by induced proliferation of allogeneic T cells and increased susceptibility to cytotoxic lysis by allo-specific T cells. Undifferentiated or differentiated allo-MSCs were implanted subcutaneously, with and without alginate encapsulation. Increased CD3+ and CD68+ infiltration was evident in differentiated and splenocyte encapsulated implants only. Without encapsulation, increased local memory T-cell responses were detectable in recipients of undifferentiated and differentiated MSCs; however, only differentiated MSCs induced systemic memory T-cell responses. In recipients of encapsulated allogeneic cells, only differentiated allo-MSCs induced memory T-cell responses locally and systemically. Systemic alloimmune responses to differentiated MSCs indicate immunogenicity regardless of alginate encapsulation and may require immunosuppressive therapy for therapeutic use. PMID:24184966
Metal elements in tissue with dental peri-implantitis: a pilot study.
Fretwurst, Tobias; Buzanich, Guenter; Nahles, Susanne; Woelber, Johan Peter; Riesemeier, Heinrich; Nelson, Katja
2016-09-01
Dental peri-implantitis is characterized by a multifactorial etiology. The role of metal elements as an etiological factor for peri-implantitis is still unclear. The aim of this study was to investigate the incidence of metal elements in bone and mucosal tissues around dental Grade 4 CP titanium implants with signs of peri-implantitis in human patients. In this prospective pilot study, all patients were enrolled consecutively in two study centers. Bone and soft tissue samples of patients with peri-implantitis with indication for explantation were analyzed for the incidence of different elements (Ca, P, Ti, Fe) by means of synchrotron radiation X-ray fluorescence spectroscopy (SRXRF) and polarized light microscopy (PLM). The existence of macrophages and lymphocytes in the histologic specimens was analyzed. Biopsies of 12 patients (seven bone samples, five mucosal samples) were included and analyzed. In nine of the 12 samples (75%), the SRXRF examination revealed the existence of titanium (Ti) and an associated occurrence with Iron (Fe). Metal particles were detected in peri-implant soft tissue using PLM. In samples with increased titanium concentration, lymphocytes were detected, whereas M1 macrophages were predominantly seen in samples with metal particles. Titanium and Iron elements were found in soft and hard tissue biopsies retrieved from peri-implantitis sites. Further histologic and immunohistochemical studies need to clarify which specific immune reaction metal elements/particles induce in dental peri-implant tissue. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
A novel bioerodible deep scleral lamellar cyclosporine implant for uveitis.
Gilger, Brian C; Salmon, Jacklyn H; Wilkie, David A; Cruysberg, Lars P J; Kim, Jonghyeon; Hayat, Matt; Kim, Hyuncheol; Kim, Stephanie; Yuan, Peng; Lee, Susan S; Harrington, Susan M; Murray, Patrick R; Edelhauser, Henry F; Csaky, Karl G; Robinson, Michael R
2006-06-01
To determine the feasibility, safety, and effectiveness of an episcleral or deep scleral lamellar sustained release cyclosporine (CsA) device in a naturally occurring animal model of uveitis. A two-compartment perfusion chamber was used to assess in vitro human and equine scleral permeability of fluorescein, dexamethasone-fluorescein, or CsA. A biodegradable, matrix-reservoir CsA implant was designed, and release rates of CsA were determined in vitro. Tissue CsA levels were measured in eyes with the implant. Horses with equine recurrent uveitis (ERU) received episcleral or deep scleral lamellar CsA implants and were monitored for up to 3 years. Dexamethasone-fluorescein and CsA penetrated the in vitro equine sclera poorly; however, low but detectable levels of CsA were detected intraocularly in vivo. The implant placed episclerally failed to control inflammatory episodes in ERU. CsA implants placed in the deep sclera adjacent to the suprachoroidal space resulted in high levels of CsA in most ocular tissues. In clinical equine patients with ERU, frequency of uveitic flare-ups was significantly decreased after implantation of a deep scleral lamellar CsA implant. Diffusion of CsA across the sclera from the episcleral space was not a feasible method of drug delivery to the equine eye. However, placing a deep scleral lamellar CsA implant adjacent to the suprachoroidal space was effective in achieving therapeutic ocular drug concentrations and controlling uveitis in horses with ERU.
Luminescent Tension-Indicating Orthopedic Strain Gauges for Non-Invasive Measurements Through Tissue
NASA Technical Reports Server (NTRS)
Anker, Jeffrey (Inventor); Anderson, Dakota (Inventor); Heath, Jonathon (Inventor); Rogalski, Melissa (Inventor)
2015-01-01
Strain gauges that can provide information with regard to the state of implantable devices are described. The strain gauges can exhibit luminescence that is detectable through living tissue, and the detectable luminescent emission can vary according to the strain applied to the gauge. A change in residual strain of the device can signify a loss of mechanical integrity and/or loosening of the implant, and this can be non-invasively detected either by simple visual detection of the luminescent emission or through examination of the emission with a detector such as a spectrometer or a camera.
3D analysis of bone formation around titanium implants using micro-computed tomography (μCT)
NASA Astrophysics Data System (ADS)
Bernhardt, Ricardo; Scharnweber, Dieter; Müller, Bert; Beckmann, Felix; Goebbels, Jürgen; Jansen, John; Schliephake, Henning; Worch, Hartmut
2006-08-01
The quantitative analysis of bone formation around biofunctionalised metallic implants is an important tool for the further development of implants with higher success rates. This is, nowadays, especially important in cases of additional diseases like diabetes or osteoporosis. Micro computed tomography (μCT), as non-destructive technique, offers the possibility for quantitative three-dimensional recording of bone close to the implant's surface with micrometer resolution, which is the range of the relevant bony structures. Within different animal models using cylindrical and screw-shaped Ti6Al4V implants we have compared visualization and quantitative analysis of newly formed bone by the use of synchrotron-radiation-based CT-systems in comparison with histological findings. The SRμCT experiments were performed at the beamline BW 5 (HASYLAB at DESY, Hamburg, Germany; at the BAMline (BESSY, Berlin, Germany). For the experiments, PMMA-embedded samples were prepared with diameters of about 8 mm, which contain in the center the implant surrounded by the bony tissue. To (locally) quantify the bone formation, models were developed and optimized. The comparison of the results obtained by SRμCT and histology demonstrates the advantages and disadvantages of both approaches, although the bone formation values for the different biofunctionalized implants are identical within the error bars. SRμCT allows the clear identification of fully mineralized bone around the different titanium implants. As hundreds of virtual slices were easily generated for the individual samples, the quantification and interactive bone detection led to conclusions of high precision and statistical relevance. In this way, SRμCT in combination with interactive data analysis is proven to be more significant with respect to classical histology.
Moschetta, Marco; Telegrafo, Michele; Capuano, Giulia; Rella, Leonarda; Scardapane, Arnaldo; Angelelli, Giuseppe; Stabile Ianora, Amato Antonio
2013-10-01
To assess the contribute of intra-prosthetic MRI virtual navigation for evaluating breast implants and detecting implant ruptures. Forty-five breast implants were evaluated by MR examination. Only patients with a clinical indication were assessed. A 1.5-T device equipped with a 4-channel breast coil was used by performing axial TSE-T2, axial silicone-only, axial silicone suppression and sagittal STIR images. The obtained dicom files were also analyzed by using virtual navigation software. Two blinded radiologists evaluated all MR and virtual images. Eight patients for a total of 13 implants underwent surgical replacement. Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) were calculated for both imaging strategies. Intra-capsular rupture was diagnosed in 13 out of 45 (29%) implants by using MRI. Basing on virtual navigation, 9 (20%) cases of intra-capsular rupture were diagnosed. Sensitivity, specificity, accuracy, PPV and NPV values of 100%, 86%, 89%, 62% and 100%, respectively, were found for MRI. Virtual navigation increased the previous values up to 100%, 97%, 98%, 89% and 100%. Intra-prosthetic breast MR virtual navigation can represent an additional promising tool for the evaluation of breast implants being able to reduce false positives and to provide a more accurate detection of intra-capsular implant rupture signs. Copyright © 2013 Elsevier Inc. All rights reserved.
Effects of non-equilibrium plasma in the treatment of ligature-induced peri-implantitis.
Shi, Qi; Song, Ke; Zhou, Xincai; Xiong, Zilan; Du, Tianfeng; Lu, Xinpei; Cao, Yingguang
2015-05-01
To evaluate the effects of non-equilibrium plasma in the treatment of ligature-induced peri-implantitis in beagle dogs. Six beagles received 12 implants installed in the position of the fourth mandibular premolars. Ligature-induced peri-implantitis was initiated at 3 months post-implantation. When approximately 40% of the supporting bone was lost, the ligatures were removed. The implants were subjected to the muco-periosteal scaling and chlorhexidine irrigation with or without plasma irrigation. Three months later, clinical, radiographic and microbiological analyses were performed. Block biopsies were prepared for micro-CT and histomorphometric analysis. The primary outcome was the difference in bone healing of peri-implant sites, and the secondary outcomes included changes in clinical parameters (SBI, PD) and bacterial detection. At baseline, no significant differences were observed between the two groups. At 3 months post-treatment, the plasma group showed a significantly higher bone level than the control group (p < 0.05), a significantly decreased detection of bacteria (Porphyromonas gingivalis and Tannerella forsythia) (p < 0.05), and a significant improvement in clinical examination (p < 0.05). Within the limits of this study, non-equilibrium plasma treatment as an adjunct to the conventional therapy is a feasible approach for the treatment of peri-implantitis. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Rella, L; Telegrafo, M; Nardone, A; Milella, A; Stabile Ianora, A A; Lioce, M; Angelelli, G; Moschetta, M
2015-09-01
To evaluate the effect of post-mastectomy radiation therapy (RT) on breast implants as detected by magnetic resonance imaging (MRI) searching for short-term complications. One hundred and forty patients (total of 144 implants) were evaluated by MRI; 80 (group 1) had undergone RT, whereas the remaining 60 patients (group 2) underwent mastectomy with implant reconstruction without RT. Two radiologists evaluated MRI images searching for implant rupture signs, sub-capsular seromas, capsular contracture, soft-tissue oedema, peri-implant fluid collections. Implant ruptures were classified as severe complications; seromas and capsular contractures as moderate complications; oedema and fluid collections as mild complications. The prevalence of MRI findings in the two groups was calculated and compared by unpaired t-test. Cohen's kappa statistics was used to assess interobserver agreement. Sixty-nine out of 144 (48%) implants presented pathological findings at MRI with complication rates of 47.5 and 48.4 for groups 1 and 2, respectively. Two (5%) severe complications, 10 (26%) moderate complications, and 26 (69%) mild complications occurred in group 1 and surgical treatment was performed in 10 cases. Two (6%) severe complications, seven (23%) moderate complications, and 22 (71%) mild complications occurred in group 2 and surgical treatment was performed in eight cases. No significant difference between the two groups was found (p>0.1). Almost perfect agreement between the two radiologists was found for MRI image detection (k=0.86). RT does not seem to cause a significant effect on breast implants in terms of complication rate in patients undergoing implant-based breast reconstruction. One-stage immediate implant-based breast reconstruction performed at the same time as mastectomy could be proposed. Copyright © 2015 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.
Holländer, Jens; Lorenz, Jonas; Stübinger, Stefan; Hölscher, Werner; Heidemann, Detlef; Ghanaati, Shahram; Sader, Robert
2016-01-01
In recent years, dental implants made from zirconia have been further developed and are considered a reliable treatment method for replacing missing teeth. The aim of this study was to analyze dental implants made from zirconia regarding their clinical performance compared with natural teeth (control). One hundred six zirconia implants in 38 adults were analyzed in a clinical study after 1 year of loading. The plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD), probing attachment level (PAL), and creeping or recession (CR/REC) of the gingiva were detected and compared with natural control teeth (CT). Furthermore, the papilla index (PAP), Periotest values (PTV), microbial colonization of the implant/dental sulcus fluid, and patient satisfaction were assessed. The survival rate was 100%. No statistical significance was observed between implants and teeth regarding BOP, PPD, and PAL. A statistical significance was detected regarding PI and CR/REC with significantly less plaque accumulation and recession in the study group. Mean PAP was 1.76 ± 0.55, whereas the mean PTV was -1.31 ± 2.24 (range from -5 to +6). A non-statistically significant higher colonization of periodontitis/peri-implantitis bacteria was observed in the implant group. The questionnaire showed that the majority of the patients were satisfied with the overall treatment. One-piece zirconia dental implants exhibited similar clinical results (BOP, PPD, and PAL) compared with natural teeth in regard to adhesion of plaque (PI) and creeping attachment (CR/REC); zirconia implants performed even better. The favorable results for PAL and CR/REC reflect the comparable low affinity of zirconia for plaque adhesion. Patient satisfaction indicated a high level of acceptance for zirconia implants. However, a long-term follow-up is needed to support these findings.
NASA Astrophysics Data System (ADS)
Märk, J.; Benoit, D.; Balasse, L.; Benoit, M.; Clémens, J. C.; Fieux, S.; Fougeron, D.; Graber-Bolis, J.; Janvier, B.; Jevaud, M.; Genoux, A.; Gisquet-Verrier, P.; Menouni, M.; Pain, F.; Pinot, L.; Tourvielle, C.; Zimmer, L.; Morel, C.; Laniece, P.
2013-07-01
The investigation of neurophysiological mechanisms underlying the functional specificity of brain regions requires the development of technologies that are well adjusted to in vivo studies in small animals. An exciting challenge remains the combination of brain imaging and behavioural studies, which associates molecular processes of neuronal communications to their related actions. A pixelated intracerebral probe (PIXSIC) presents a novel strategy using a submillimetric probe for beta+ radiotracer detection based on a pixelated silicon diode that can be stereotaxically implanted in the brain region of interest. This fully autonomous detection system permits time-resolved high sensitivity measurements of radiotracers with additional imaging features in freely moving rats. An application-specific integrated circuit (ASIC) allows for parallel signal processing of each pixel and enables the wireless operation. All components of the detector were tested and characterized. The beta+ sensitivity of the system was determined with the probe dipped into radiotracer solutions. Monte Carlo simulations served to validate the experimental values and assess the contribution of gamma noise. Preliminary implantation tests on anaesthetized rats proved PIXSIC's functionality in brain tissue. High spatial resolution allows for the visualization of radiotracer concentration in different brain regions with high temporal resolution.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Shin, Chang Seouk; School of Mechanical Engineering, Pusan National University, Pusan 609-735; Lee, Byoung-Seob
2016-02-15
The installation of the 28 GHz electron cyclotron resonance ion source (ECRIS) ion implantation beamline was recently completed at the Korea Basic Science Institute. The apparatus contains a beam monitoring system and a sample holder for the ion implantation process. The new implantation system can function as a multipurpose tool since it can implant a variety of ions, ranging hydrogen to uranium, into different materials with precise control and with implantation areas as large as 1–10 mm{sup 2}. The implantation chamber was designed to measure the beam properties with a diagnostic system as well as to perform ion implantation withmore » an in situ system including a mass spectrometer. This advanced implantation system can be employed in novel applications, including the production of a variety of new materials such as metals, polymers, and ceramics and the irradiation testing and fabrication of structural and functional materials to be used in future nuclear fusion reactors. In this investigation, the first nitrogen ion implantation experiments were conducted using the new system. The 28 GHz ECRIS implanted low-energy, multi-charged nitrogen ions into copper, zinc, and cobalt substrates, and the ion implantation depth profiles were obtained. SRIM 2013 code was used to calculate the profiles under identical conditions, and the experimental and simulation results are presented and compared in this report. The depths and ranges of the ion distributions in the experimental and simulation results agree closely and demonstrate that the new system will enable the treatment of various substrates for advanced materials research.« less
[The VB system: a new modular osteosynthesis material involving both screws and wires].
Dubert, T; Valenti, P; Dinh, A; Osman, N
2002-01-01
VB is an osteosynthesis system for the stabilisation of small fragments, which combines the benefits of both wires and screws. It is a modular system comprising a threaded pin and a ring. The threaded pin is first positioned. Then a ring is grasped and opened by the progressive angulation of a screwdriver. Still anchored on the screwdriver, the ring slides easily on the pin. It is clamped on the pin by simply removing the screwdriver and the pin is then cut. This modular system includes 1.8 and 1.1 mm pins and different types of rings (threaded or non threaded, with or without collars). The system is easy to handle and can be introduced using an open or percutaneous technique, allowing compression or distraction. Our preliminary series, performed in accordance with National clinical trial protocol (Huriet) consisted of 50 cases in 24 patients (five women and 19 men) with an average age of 48 years, and a follow-up of more than six months. Fourteen cases of fractures (28 implants) were treated as emergencies (two radial heads, one capitellum, one trochlea of the humerus, seven distal radius fractures, one trapezium, two metacarpals) and 12 cases (22 implants) were elective cases: arthrodesis (one trapezo-metacarpal, one intermetacarpal, two interphalangeal, two carpal), non-union (six scaphoids, one phalangeal) and one phalangeal malunion. Hardware removal was performed in 16 cases. No implant failure has been detected. One case, a DIP arthrodesis, had a suspicion of sepsis which led to the removal of the implants at six weeks. The results of this study have convinced us of the merits of the system, which combines the advantages of both wires and screws. The system allows the user to perform either distraction or compression, and to adjust the force by hand. Compared to the fixed amount of compression produced by lag screws, this feature seems to be a real step forward.
Fritz, M E
1999-06-01
Since the advent of osseointegration approximately 20 years ago, there has been a great deal of scientific data developed on two-stage integrated implant systems. Although these implants were originally designed primarily for fixed prostheses in the mandibular arch, they have been used in partially dentate patients, in patients needing overdentures, and in single-tooth restorations. In addition, this implant system has been placed in extraction sites, in bone-grafted areas, and in maxillary sinus elevations. Often, the documentation of these procedures has lagged. In addition, most of the reports use survival criteria to describe results, often providing overly optimistic data. It can be said that the literature describes a true adhesion of the epithelium to the implant similar to adhesion to teeth, that two-stage implants appear to have direct contact somewhere between 50% and 70% of the implant surface, that the microbial flora of the two-stage implant system closely resembles that of the natural tooth, and that the microbiology of periodontitis appears to be closely related to peri-implantitis. In evaluations of the data from implant placement in all of the above-noted situations by means of meta-analysis, it appears that there is a strong case that two-stage dental implants are successful, usually showing a confidence interval of over 90%. It also appears that the mandibular implants are more successful than maxillary implants. Studies also show that overdenture therapy is valid, and that single-tooth implants and implants placed in partially dentate mouths have a success rate that is quite good, although not quite as high as in the fully edentulous dentition. It would also appear that the potential causes of failure in the two-stage dental implant systems are peri-implantitis, placement of implants in poor-quality bone, and improper loading of implants. There are now data addressing modifications of the implant surface to alter the percentage of osseointegration. New types of reinforcements for dental implants and the use of growth factors to augment bone regeneration so that implants can be placed more easily are now being actively investigated.
Quaba, Omar; Quaba, Awf
2013-09-01
To determine the true rupture rates of PIP implants from a large single surgeon cohort and to assess whether rupture rates varied depending on time of implant insertion. In addition, the efficacy of ultra sound scanning (USS) in determining rupture is examined. Predominantly prospectively based analysis of patient records, investigations and surgical findings. 338 patients (676 implants) were included in the study and they all had removal of their implants. The senior author operated on all patients at some stage of their treatment. 160 patients were imaged pre-operatively with USS. Patients had implants inserted between 1999 and 2007 for cosmetic breast augmentation. A total of 144 ruptured implants were removed from 119 patients, giving a rupture rate of 35.2% per patient and 21.3% per implant over a mean implantation period of 7.8 years. A statistical difference (P < 0.001) in rupture rates between implants inserted prior to 2003 and those inserted from 2003 was demonstrated, with higher failure rates in the latter group. There was a significant difference in rupture rates depending on pocket placement of the implants. The sensitivity and specificity of USS at detecting rupture was 90.6% and 98.3% respectively. A proportion of patients (29.4%) demonstrated loco-regional spread of silicone to the axilla on scanning. Our paper has confirmed high rates of PIP implant failure in the largest published series to date. The significant difference in rupture rates between implants inserted prior to 2003 and those after this time supports the view that industrial silicone was used in the devices after 2003. Implants are more likely to rupture if inserted in the sub muscular plane compared to the sub glandular plane. USS is highly effective at detecting rupture in PIP implants and loco-regional spread is high compared to other devices. We believe this paper provides hard data enabling more informed decision making for patients, clinicians and providers in what remains an active issue affecting thousands of women. Copyright © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Chen, Pei; Cai, Xiaoxiao; Xu, Lijun; Zhang, Jing; Yang, Ying; Gao, Qianying; Ge, Jian; Yu, Keming; Zhuang, Jing
2017-09-01
To determine whether posterior chamber phakic implantable collamer lens (ICL) surgery in high myopia patients impedes oxygen saturation of retinal vessels. Mean oxygen saturation and diameter in retinal blood vessels were measured before and after ICL implantation surgery to correct high myopia refractive errors (i.e. -6.00 to -20.25 dioptres [D]), using an Oxymap T1 retinal oximeter. In 17 eyes of 17 patients, the Oxymap T1 retinal oximeter detected a small but significant decrease in oxygen saturation of retinal venules, 1-week postoperatively (compared to preoperative measurements). Moreover, at 1 week after ICL implantation, the diameter of patient retinal vessels had consistently contracted, compared to preoperative measurements. By 1 month after ICL surgery, however, both the oxygen saturation and retinal vessel diameter had returned to preoperative levels. Otherwise, no statistically significant difference in oxygen saturation and diameter of retinal arterioles was found when comparing their measurements before and 1 week after implantation. Stable levels of oxygen saturation in retinal vessels, as detected by the Oxymap T1 oximeter, show ICL implantation would not leave lasting impact or adverse effects to retina oxygen saturation in high myopia patients. © 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.
NMR detection of short-lived β-emitter 12N implanted in water
NASA Astrophysics Data System (ADS)
Sugihara, T.; Mihara, M.; Shimaya, J.; Matsuta, K.; Fukuda, M.; Ohno, J.; Tanaka, M.; Yamaoka, S.; Watanabe, K.; Iwakiri, S.; Yanagihara, R.; Tanaka, Y.; Du, H.; Onishi, K.; Kambayashi, S.; Minamisono, T.; Nishimura, D.; Izumikawa, T.; Ozawa, A.; Ishibashi, Y.; Kitagawa, A.; Sato, S.; Torikoshi, M.; Momota, S.
2017-11-01
The beta-detected nuclear magnetic resonance ( β-NMR) in liquid H2O has been observed for the first time using a short-lived β-ray emitter 12N ( I π = 1+, T 1/2=11 ms). A nuclear spin polarized 12N beam with an energy of about 20 MeV/nucleon was implanted into an enclosed water sample. About 50 % of implanted 12N ions maintained nuclear polarization and exhibited a β-NMR spectrum. The chemical shift of 12N in H2O relative to 12N in Pt was deduced to be -(3.6±0.5) × 102 ppm.
Atomic layer deposition to prevent metal transfer from implants: An X-ray fluorescence study
NASA Astrophysics Data System (ADS)
Bilo, Fabjola; Borgese, Laura; Prost, Josef; Rauwolf, Mirjam; Turyanskaya, Anna; Wobrauschek, Peter; Kregsamer, Peter; Streli, Christina; Pazzaglia, Ugo; Depero, Laura E.
2015-12-01
We show that Atomic Layer Deposition is a suitable coating technique to prevent metal diffusion from medical implants. The metal distribution in animal bone tissue with inserted bare and coated Co-Cr alloys was evaluated by means of micro X-ray fluorescence mapping. In the uncoated implant, the migration of Co and Cr particles from the bare alloy in the biological tissues is observed just after one month and the number of particles significantly increases after two months. In contrast, no metal diffusion was detected in the implant coated with TiO2. Instead, a gradient distribution of the metals was found, from the alloy surface going into the tissue. No significant change was detected after two months of aging. As expected, the thicker is the TiO2 layer, the lower is the metal migration.
Long-range effect in nitrogen ion-implanted AISI 316L stainless steel
NASA Astrophysics Data System (ADS)
Budzynski, P.
2015-01-01
The effect of nitrogen ion implantation on AISI 316L stainless steel was investigated. The microstructure and composition of an N implanted layer were studied by RBS, GIXRD, SEM, and EDX measurements. Friction and wear tests were also performed. The discrepancy between the measured and calculated stopped ion maximum range does not exceed 0.03 μm. After nitrogen implantation with a fluence of 5 × 1017 ion/cm2, additional phases of expanded austenite were detected. At a 5-fold larger depth than the maximum ion range, improvement in the coefficient of friction and wear was detected. We have shown, for the first time, the long-range effect in tribological investigations. The long-range effect is caused by movement of not only defects along the depth of the sample, as assumed so far, but also nitrogen atoms.
Cho, Sung-Yong; Huh, Yun-Hyuk; Park, Chan-Jin; Cho, Lee-Ra
To investigate the stress distribution in an implant-abutment complex with a preloaded abutment screw by comparing implant-abutment engagement features using three-dimensional finite element analysis (FEA). For FEA modeling, two implants-one with a single (S) engagement system and the other with a double (D) engagement system-were placed in the human mandibular molar region. Two types of abutments (hexagonal, conical) were connected to the implants. Different implant models (a single implant, two parallel implants, and mesial and tilted distal implants with 1-mm bone loss) were assumed. A static axial force and a 45-degree oblique force of 200 N were applied as the sum of vectors to the top of the prosthetic occlusal surface with a preload of 30 Ncm in the abutment screw. The von Mises stresses at the implant-abutment and abutment-screw interfaces were measured. In the single implant model, the S-conical abutment type exhibited broader stress distribution than the S-hexagonal abutment. In the double engagement system, the stress concentration was high in the lower contact area of the implant-abutment engagement. In the tilted implant model, the stress concentration point was different from that in the parallel implant model because of the difference in the bone level. The double engagement system demonstrated a high stress concentration at the lower contact area of the implant-abutment interface. To decrease the stress concentration, the type of engagement features of the implant-abutment connection should be carefully considered.
Nicoll, Roxanna J; Sun, Albert; Haney, Stephan; Turkyilmaz, Ilser
2013-01-01
The fabrication of an accurately fitting implant-supported fixed prosthesis requires multiple steps, the first of which is assembling the impression coping on the implant. An imprecise fit of the impression coping on the implant will cause errors that will be magnified in subsequent steps of prosthesis fabrication. The purpose of this study was to characterize the 3-dimensional (3D) precision of fit between impression coping and implant replica pairs for 3 implant systems. The selected implant systems represent the 3 main joint types used in implant dentistry: external hexagonal, internal trilobe, and internal conical. Ten impression copings and 10 implant replicas from each of the 3 systems, B (Brånemark System), R (NobelReplace Select), and A (NobelActive) were paired. A standardized aluminum test body was luted to each impression coping, and the corresponding implant replica was embedded in a stone base. A coordinate measuring machine was used to quantify the maximum range of displacement in a vertical direction as a function of the tightening force applied to the guide pin. Maximum angular displacement in a horizontal plane was measured as a function of manual clockwise or counterclockwise rotation. Vertical and rotational positioning was analyzed by using 1-way analysis of variance (ANOVA). The Fisher protected least significant difference (PLSD) multiple comparisons test of the means was applied when the F-test in the ANOVA was significant (α=.05). The mean and standard deviation for change in the vertical positioning of impression copings was 4.3 ±2.1 μm for implant system B, 2.8 ±4.2 μm for implant system R, and 20.6 ±8.8 μm for implant system A. The mean and standard deviation for rotational positioning was 3.21 ±0.98 degrees for system B, 2.58 ±1.03 degrees for system R, and 5.30 ±0.79 degrees for system A. The P-value for vertical positioning between groups A and B and between groups A and R was <.001. No significant differences were found for vertical positioning between groups B and R. The P-value for rotational positioning between groups A and B and between groups A and R was <.001. No significant differences were found for rotational positioning between groups B and R. The results of the study confirmed that implant systems differ in precision of fit. Vertical precision between paired implant components is a function of joint type and the tightening force applied to the guide pin. The magnitude of vertical displacement with applied torque is greater for conical connections than for butt joint connections. The rotational freedom between paired components is unique to the implant system and is presumably related to the machining tolerances specified by the manufacturer. Copyright © 2013 The Editorial Council of the Journal of Prosthetic Dentistry. Published by Mosby, Inc. All rights reserved.
Accuracy of a laboratory-based computer implant guiding system.
Barnea, Eitan; Alt, Ido; Kolerman, Roni; Nissan, Joseph
2010-05-01
Computer-guided implant placement is a growing treatment modality in partially and totally edentulous patients, though data about the accuracy of some systems for computer-guided surgery is limited. The purpose of this study was to evaluate the accuracy of a laboratory computer-guided system. A laboratory-based computer guiding system (M Guide; MIS technologies, Shlomi, Israel) was used to place implants in a fresh sheep mandible. A second computerized tomography (CT) scan was taken after placing the implants . The drill plan figures of the planned implants were positioned using assigned software (Med3D, Heidelberg, Germany) on the second CT scan to compare the implant position with the initial planning. Values representing the implant locations of the original drill plan were compared with that of the placed implants using SPSS software. Six measurements (3 vertical, 3 horizontal) were made on each implant to assess the deviation from the initial implant planning. A repeated-measurement analysis of variance was performed comparing the location of measurement (center, abutment, apex) and type of deviation (vertical vs. horizontal). The vertical deviation (mean -0.168) was significantly smaller than the horizontal deviation (mean 1.148). The laboratory computer-based guiding system may be a viable treatment concept for placing implants. Copyright (c) 2010 Mosby, Inc. All rights reserved.
Development of Clinically Relevant Implantable Pressure Sensors: Perspectives and Challenges
Clausen, Ingelin; Glott, Thomas
2014-01-01
This review describes different aspects to consider when developing implantable pressure sensor systems. Measurement of pressure is in general highly important in clinical practice and medical research. Due to the small size, light weight and low energy consumption Micro Electro Mechanical Systems (MEMS) technology represents new possibilities for monitoring of physiological parameters inside the human body. Development of clinical relevant sensors requires close collaboration between technological experts and medical clinicians. Site of operation, size restrictions, patient safety, and required measurement range and resolution, are only some conditions that must be taken into account. An implantable device has to operate under very hostile conditions. Long-term in vivo pressure measurements are particularly demanding because the pressure sensitive part of the sensor must be in direct or indirect physical contact with the medium for which we want to detect the pressure. New sensor packaging concepts are demanded and must be developed through combined effort between scientists in MEMS technology, material science, and biology. Before launching a new medical device on the market, clinical studies must be performed. Regulatory documents and international standards set the premises for how such studies shall be conducted and reported. PMID:25248071
Development of clinically relevant implantable pressure sensors: perspectives and challenges.
Clausen, Ingelin; Glott, Thomas
2014-09-22
This review describes different aspects to consider when developing implantable pressure sensor systems. Measurement of pressure is in general highly important in clinical practice and medical research. Due to the small size, light weight and low energy consumption Micro Electro Mechanical Systems (MEMS) technology represents new possibilities for monitoring of physiological parameters inside the human body. Development of clinical relevant sensors requires close collaboration between technological experts and medical clinicians. Site of operation, size restrictions, patient safety, and required measurement range and resolution, are only some conditions that must be taken into account. An implantable device has to operate under very hostile conditions. Long-term in vivo pressure measurements are particularly demanding because the pressure sensitive part of the sensor must be in direct or indirect physical contact with the medium for which we want to detect the pressure. New sensor packaging concepts are demanded and must be developed through combined effort between scientists in MEMS technology, material science, and biology. Before launching a new medical device on the market, clinical studies must be performed. Regulatory documents and international standards set the premises for how such studies shall be conducted and reported.
Yu, Ki Jun; Kuzum, Duygu; Hwang, Suk-Won; Kim, Bong Hoon; Juul, Halvor; Kim, Nam Heon; Won, Sang Min; Chiang, Ken; Trumpis, Michael; Richardson, Andrew G; Cheng, Huanyu; Fang, Hui; Thomson, Marissa; Bink, Hank; Talos, Delia; Seo, Kyung Jin; Lee, Hee Nam; Kang, Seung-Kyun; Kim, Jae-Hwan; Lee, Jung Yup; Huang, Younggang; Jensen, Frances E; Dichter, Marc A; Lucas, Timothy H; Viventi, Jonathan; Litt, Brian; Rogers, John A
2016-07-01
Bioresorbable silicon electronics technology offers unprecedented opportunities to deploy advanced implantable monitoring systems that eliminate risks, cost and discomfort associated with surgical extraction. Applications include postoperative monitoring and transient physiologic recording after percutaneous or minimally invasive placement of vascular, cardiac, orthopaedic, neural or other devices. We present an embodiment of these materials in both passive and actively addressed arrays of bioresorbable silicon electrodes with multiplexing capabilities, which record in vivo electrophysiological signals from the cortical surface and the subgaleal space. The devices detect normal physiologic and epileptiform activity, both in acute and chronic recordings. Comparative studies show sensor performance comparable to standard clinical systems and reduced tissue reactivity relative to conventional clinical electrocorticography (ECoG) electrodes. This technology offers general applicability in neural interfaces, with additional potential utility in treatment of disorders where transient monitoring and modulation of physiologic function, implant integrity and tissue recovery or regeneration are required.
Hasan, I; Röger, B; Heinemann, F; Keilig, L; Bourauel, C
2012-09-01
The aim of the present study was to investigate experimentally and numerically the influence of a fine threaded- against a roughened-cervical region of immediately loaded dental implants in combination with straight and 20°-angled abutments on the implant primary stability. A total of 30 implants were inserted in bovine rib-segments, 14 cervically roughened implants and 16 implants with fine cervical threads. Each implant system received two abutments, straight and 20°-angled. Implant displacements and rotations were measured using a biomechanical measurement system. Subsequently, eight samples were selected for geometrical reconstruction and numerical investigation of stress and strain distributions in the bone by means of the finite element method. Experimentally, both implant systems showed similar behaviour with the straight abutments concerning displacements and rotations. However, fine threaded implants showed much less displacement and rotation against roughened implants when angled abutments were considered. Numerically, stresses were within 35-45 MPa in the cortical bone for both implant systems. The strains showed highest values within the spongious bone with the roughened implants connected to angled abutments. The results indicate that implants with fine cervical threads could be recommended in particular with angled abutments. The outcomes of this study are currently confirmed by long-term clinical investigations. Copyright © 2011 IPEM. Published by Elsevier Ltd. All rights reserved.
Electro-optical detection of THz radiation in Fe implanted LiNbO3
NASA Astrophysics Data System (ADS)
Wang, Yuhua; Ni, Hongwei; Zhan, Weiting; Yuan, Jie; Wang, Ruwu
2013-01-01
In this letter, the authors present first observation of terahertz generation from Fe implantation of LiNbO3 crystal substrate. LiNbO3 single crystal is grown by Czochralski method. Metal nanoparticles synthesized by Fe ion implantation were implanted into LiNbO3 single crystal using metal vapor vacuum arc (MEVVA) ion source. 1 kHz, 35 fs laser pulsed centered at 800 nm were focused onto the samples. Terahertz was generated via optical rectification. The findings suggest that under the investigated implantation parameter, a spectral component in excess of 0.44 THz emission were found from Fe ion implantation of LiNbO3.
Warreth, Abdulhadi; Alkadhimi, Aslam Fadel; Sultan, Ahmed; Byrne, Caroline; Woods, Edel
2015-01-01
The use of dental implants in replacing missing teeth is an integral part of restorative dental treatment. Use of conventional complete dentures is associated with several problems such as lack of denture stability, support and retention. However, when mandibular complete dentures were used with two or more implants, an improvement in the patients' psychological and social well-being could be seen. There is general consensus that removable implant-supported overdentures (RISOs) with two implants should be considered as the first-choice standard of care for an edentulous mandible. This treatment option necessitates the use of attachment systems that connect the complete denture to the implant. Nevertheless, each attachment system has its inherent advantages and disadvantages, which should be considered when choosing a system. The first part of this article provides an overview on options available to restore the mandibular edentulous arch with dental implants. Different types of attachment systems, their features and drawbacks are also reviewed.
NASA Astrophysics Data System (ADS)
Mehrmohammadi, Mohammad; Alizad, Azra; Kinnick, Randall R.; Davis, Brian J.; Fatemi, Mostafa
2013-03-01
Effective brachytherapy procedures require precise placement of radioactive seeds in the prostate. Currently, transrectal ultrasound (TRUS) imaging is one of the main intraoperative imaging modalities to assist physicians in placement of brachytherapy seeds. However, the seed detection rate with TRUS is poor mainly because ultrasound imaging is highly sensitive to variations in seed orientation. The purpose of this study is to investigate the abilities of a new acoustic radiation force imaging modality, vibro-acoustography (VA), equipped with a 1.75D array transducer and implemented on a customized clinical ultrasound scanner, to image and localize brachytherapy seeds in prostatic tissue. To perform experiments, excised cadaver prostate specimens were implanted with dummy brachytherapy seeds, and embedded in tissue mimicking gel to simulate the properties of the surrounding soft tissues. The samples were scanned using the VA system and the resulting VA signals were used to reconstruct VA images at several depths inside the tissue. To further evaluate the performance of VA in detecting seeds, X-ray computed tomography (CT) images of the same tissue sample, were obtained and used as a gold-standard to compare the number of seeds detected by the two methods. Our results indicate that VA is capable of imaging of brachytherapy seeds with accuracy and high contrast, and can detect a large percentage of the seeds implanted within the tissue samples.
Suzuki, N; Nadano, D; Paria, B C; Kupriyanov, S; Sugihara, K; Fukuda, M N
2000-11-01
Trophinin mediates apical cell adhesion between two human cell lines, trophoblastic teratocarcinoma and endometrial adenocarcinoma. In humans, trophinin is specifically expressed in cells involved in implantation and early placentation. The present study was undertaken to establish trophinin expression by the mouse uterus. In the pregnant mouse uterus, trophinin transcripts are expressed during the time which coincides with the timing of blastocyst implantation. Trophinin is also expressed in the nonpregnant mouse uterus at estrus stage. Uteri from ovariectomized mice did not express trophinin, whereas strong expression was induced by estrogen but not by progesterone. Trophinin transcripts and protein were found in the pseudopregnant mouse uterus. No differences were detected in trophinin expression by the uteri in the pregnant, pseudopregnant, and pseudopregnant received blastocysts. In delayed implantation model, trophinin proteins were found in both luminal and glandular epithelium, whereas dormant blastocysts were negative for trophinin. Upon activation with estrogen, however, no significant changes were detected either in the blastocyst or in the uterus. These results indicate that ovarian hormones regulate trophinin expression by the mouse uterus, and that an implanting blastocyst has no effect on trophinin expression in the surrounding endometrial luminal epithelial cells.
Monitoring osseointegration and developing intelligent systems (Conference Presentation)
NASA Astrophysics Data System (ADS)
Salvino, Liming W.
2017-05-01
Effective monitoring of structural and biological systems is an extremely important research area that enables technology development for future intelligent devices, platforms, and systems. This presentation provides an overview of research efforts funded by the Office of Naval Research (ONR) to establish structural health monitoring (SHM) methodologies in the human domain. Basic science efforts are needed to utilize SHM sensing, data analysis, modeling, and algorithms to obtain the relevant physiological and biological information for human-specific health and performance conditions. This overview of current research efforts is based on the Monitoring Osseointegrated Prosthesis (MOIP) program. MOIP develops implantable and intelligent prosthetics that are directly anchored to the bone of residual limbs. Through real-time monitoring, sensing, and responding to osseointegration of bones and implants as well as interface conditions and environment, our research program aims to obtain individualized actionable information for implant failure identification, load estimation, infection mitigation and treatment, as well as healing assessment. Looking ahead to achieve ultimate goals of SHM, we seek to expand our research areas to cover monitoring human, biological and engineered systems, as well as human-machine interfaces. Examples of such include 1) brainwave monitoring and neurological control, 2) detecting and evaluating brain injuries, 3) monitoring and maximizing human-technological object teaming, and 4) closed-loop setups in which actions can be triggered automatically based on sensors, actuators, and data signatures. Finally, some ongoing and future collaborations across different disciplines for the development of knowledge automation and intelligent systems will be discussed.
A power-efficient analog integrated circuit for amplification and detection of neural signals.
Borghi, T; Bonfanti, A; Gusmeroli, R; Zambra, G; Spinelli, A S
2008-01-01
We present a neural amplifier that optimizes the trade-off between power consumption and noise performance down to the best so far reported. In the perspective of realizing a fully autonomous implantable system we also address the problem of spike detection by using a new simple algorithm and we discuss the implementation with analog integrated circuits. Implemented in 0.35-microm CMOS technology and with total current consumption of about 20 microA, the whole circuit occupies an area of 0.18 mm(2). Reduced power consumption and small area make it suited to be used in chronic multichannel recording systems for neural prosthetics and neuroscience experiments.
Design and fabrication of prototype system for early warning of impending bearing failure
NASA Technical Reports Server (NTRS)
Meacher, J.; Chen, H. M.
1974-01-01
A test program was conducted with the objective of developing a method and equipment for on-line monitoring of installed ball bearings to detect deterioration or impending failure of the bearings. The program was directed at the spin-axis bearings of a control moment gyro. The bearings were tested at speeds of 6000 and 8000 rpm, thrust loads from 50 to 1000 pounds, with a wide range of lubrication conditions, with and without a simulated fatigue spall implanted in the inner race ball track. It was concluded that a bearing monitor system based on detection and analysis of modulations of a fault indicating bearing resonance frequency can provide a low threshold of sensitivity.
Artificial heart development program. Volume I. System development. Phase III summary report
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
1977-01-01
The report documents efforts and results in the development of the power system portions of a calf implantable model of nuclear-powered artificial heart. The primary objective in developing the implantable model was to solve the packaging problems for total system implantation. The power systems portion is physically that portion of the implantable model between the Pu-238 heat sources and the blood pump ventricles. The work performed had two parallel themes. The first of these was the development of an integrated implantable model for bench and animal experiments plus design effort on a more advanced model. The second was research andmore » development on components of the system done in conjunction with the development of the implantable model and to provide technology for incorporation into advanced models plus support to implantations, at the University of Utah, of the systems blood pumping elements when driven by electric motor. The efforts and results of implantable model development are covered, mainly, in the text of the report. The research and development efforts and results are reported, primarily, in the appendices (Vol. 2).« less
Sancho-Puchades, Manuel; Hämmerle, Christoph H F; Benic, Goran I
2015-10-01
The aim of this study was to test whether or not the intensity of artifacts around implants in cone-beam computed tomography (CBCT) differs between titanium, titanium-zirconium and zirconium dioxide implants. Twenty models of a human mandible, each containing one implant in the single-tooth gap position 45, were cast in dental stone. Five test models were produced for each of the following implant types: titanium 4.1 mm diameter (Ti4.1 ), titanium 3.3 mm diameter (Ti3.3 ), titanium-zirconium 3.3 mm diameter (TiZr3.3 ) and zirconium dioxide 3.5-4.5 mm diameter (ZrO3.5-4.5 ) implants. For control purposes, three models without implants were produced. Each model was scanned using a CBCT device. Gray values (GV) were recorded at eight circumferential positions around the implants at 0.5 mm, 1 mm and 2 mm from the implant surface (GVT est ). GV were assessed in the corresponding volumes of interest (VOI) in the control models without implants (GVC ontrol ). Differences of gray values (ΔGV) between GVT est and GVC ontrol were calculated as percentages. One-way ANOVA and post hoc tests were applied to detect differences between implant types. Mean ΔGV for ZrO3.5-4.5 presented the highest absolute values, generally followed by TiZr3.3 , Ti4.1 and Ti3.3 implants. The differences of ΔGV between ZrO3.5-4.5 and the remaining groups were statistically significant in the majority of the VOI (P ≤ 0.0167). ΔGV for TiZr3.3 , Ti4.1 and Ti3.3 implants did not differ significantly in the most VOI. For all implant types, ΔGV showed positive values buccally, mesio-buccally, lingually and disto-lingually, whereas negative values were detected mesially and distally. Zirconium dioxide implants generate significantly more artifacts as compared to titanium and titanium-zirconium implants. The intensity of artifacts around zirconium dioxide implants exhibited in average the threefold in comparison with titanium implants. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
A Hermetic Wireless Subretinal Neurostimulator for Vision Prostheses
Shire, Douglas B.; Chen, Jinghua; Doyle, Patrick; Gingerich, Marcus D.; Cogan, Stuart F.; Drohan, William A.; Behan, Sonny; Theogarajan, Luke; Wyatt, John L.; Rizzo, Joseph F.
2016-01-01
A miniaturized, hermetically encased, wirelessly operated retinal prosthesis has been developed for preclinical studies in the Yucatan minipig, and includes several design improvements over our previously reported device. The prosthesis attaches conformally to the outside of the eye and electrically drives a microfabricated thin-film polyimide array of sputtered iridium oxide film electrodes. This array is implanted into the subretinal space using a customized ab externo surgical technique. The implanted device includes a hermetic titanium case containing a 15-channel stimulator chip and discrete circuit components. Feedthroughs in the case connect the stimulator chip to secondary power and data receiving coils on the eye and to the electrode array under the retina. Long-term in vitro pulse testing of the electrodes projected a lifetime consistent with typical devices in industry. The final assembly was tested in vitro to verify wireless operation of the system in physiological saline using a custom RF transmitter and primary coils. Stimulation pulse strength, duration, and frequency were programmed wirelessly from a Peripheral Component Interconnect eXtensions for Instrumentation (PXI) computer. Operation of the retinal implant has been verified in two pigs for up to five and a half months by detecting stimulus artifacts generated by the implanted device. PMID:21859595
Zhang, Dongqing; Zhao, Yiyuan; Noble, Jack H; Dawant, Benoit M
2018-04-01
Cochlear implants (CIs) are neural prostheses that restore hearing using an electrode array implanted in the cochlea. After implantation, the CI processor is programmed by an audiologist. One factor that negatively impacts outcomes and can be addressed by programming is cross-electrode neural stimulation overlap (NSO). We have proposed a system to assist the audiologist in programming the CI that we call image-guided CI programming (IGCIP). IGCIP permits using CT images to detect NSO and recommend deactivation of a subset of electrodes to avoid NSO. We have shown that IGCIP significantly improves hearing outcomes. Most of the IGCIP steps are robustly automated but electrode configuration selection still sometimes requires manual intervention. With expertise, distance-versus-frequency curves, which are a way to visualize the spatial relationship learned from CT between the electrodes and the nerves they stimulate, can be used to select the electrode configuration. We propose an automated technique for electrode configuration selection. A comparison between this approach and one we have previously proposed shows that our method produces results that are as good as those obtained with our previous method while being generic and requiring fewer parameters.
Ellenor, Christopher W; Stang, Pascal P; Etezadi-Amoli, Maryam; Pauly, John M; Scott, Greig C
2015-03-01
The concept of a "radiofrequency safety prescreen" is investigated, wherein dangerous interactions between radiofrequency fields used in MRI, and conductive implants in patients are detected through impedance changes in the radiofrequency coil. The behavior of coupled oscillators is reviewed, and the resulting, observable impedance changes are discussed. A birdcage coil is loaded with a static head phantom and a wire phantom with a wire close to its resonant length, the shape, position, and orientation of which can be changed. Interactions are probed with a current sensor and network analyzer. Impedance spectra show dramatic, unmistakable splitting in cases of strong coupling, and strong correlation is observed between induced current and scattering parameters. The feasibility of a new, low-power prescreening technique has been demonstrated in a simple phantom experiment, which can unambiguously detect resonant interactions between an implanted wire and an imaging coil. A new technique has also been presented which can detect parallel transmit null modes for the wire. © 2014 Wiley Periodicals, Inc.
Controlled atmosphere annealing of ion implanted gallium arsenide. Final report 1 Jul 76-30 Nov 79
DOE Office of Scientific and Technical Information (OSTI.GOV)
Anderson, C.L.; Eu, V.; Feng, M.
1980-08-01
Controlled atmosphere techniques were developed as an alternative to dielectric encapsulation for the high temperature anneal of ion implanted layers in GaAs. Two approaches: (1) the controlled atmosphere technique (CAT), and (2) the melt controlled ambient technique (MCAT) have been investigated. Using the CAT procedure, which involves annealing in flowing hydrogen with an arsenic overpressure, annealing without detectable surface erosion, has been performed at temperatures as high as 950 C, with or without encapsulants. Impurity diffusion, damage recovery, and electrical activity were investigated as a function of anneal parameters. Range studies of technologically important impurities such as S, Si, Se,more » Be and Mg were carried out. For the first time the role of the encapsulant on implanted profile degradation and the importance of Cr redistribution during the anneal cycle were determined. An improved CAT anneal system capable of production quantity throughput was developed and is in current use for device processing.« less
Annamaria, Martino; Andrea, Scapigliati; Michela, Casella; Tommaso, Sanna; Gemma, Pelargonio; Antonio, Dello Russo; Roberto, Zamparelli; Stefano, De Paulis; Fulvio, Bellocci; Rocco, Schiavello
2008-08-01
External electrical cardioversion or defibrillation may be necessary in patients with implanted cardiac pacemaker (PM) or implantable cardioverter defibrillator (ICD). Sudden discharge of high electrical energy employed in direct current (DC) transthoracic countershock may damage the PM/ICD system resulting in a series of possible device malfunctions. For this reason, when defibrillation or cardioversion must be attempted in a patient with a PM or ICD, some precautions should be taken, particularly in PM dependent patients, in order to prevent damage to the device. We report the case of a 76-year-old woman with a dual chamber PM implanted in the right subclavicular region, who received two consecutive transthoracic DC shocks to treat haemodynamically unstable broad QRS complex tachycardia after cardiac surgery performed with a standard sternotomic approach. Because of the sternal wound and thoracic drainage tubes together with the severe clinical compromise, the anterior paddle was positioned near the pulse generator. At the following PM test, a complete battery discharge was detected.
Implant technology and usability.
Meadows, Paul M
2008-08-01
Implanted electrical stimulation technology has changed greatly in the roughly five decades of its existence. Many factors determine the viability of the technology and whether the systems and products developed ultimately go on to help the target patient population. This article describes the successful introduction of an implanted system and the challenges to implanted system development, acceptance, and usability of these systems by the patient and clinical communities.
Ryan, Kevin J.; Zydlewski, Joseph D.; Calhoun, Aram J.K.
2014-01-01
Pure-diploid Blue-spotted Salamanders (Ambystoma laterale) are the smallest members of the family Ambystomatidae which makes tracking with radio-transmitters difficult because of small battery capacity. Passive integrated transponder (PIT) tags provide another tracking approach for small fossorial animals such as salamanders. We evaluated the use of portable PIT tag readers (PIT packs) to detect PIT tag-implanted pure-diploid Blue-spotted Salamanders in situ. We also examined the detection probability of salamanders with PIT tags held in enclosures in wetland and terrestrial habitats, as well as the underground detection range of PIT packs by scanning for buried tags not implanted into salamanders. Of the 532 PIT tagged salamanders, we detected 6.84% at least once during scanning surveys. We scanned systematically within a 13.37 ha area surrounding a salamander breeding pool on 34 occasions (~119 hours of survey time) and detected PIT tags 74 times. We detected 55% of PITs in tagged salamanders and 45%were expelled tags. We were able to reliably detect buried PIT tags from 1–22cm below the ground surface. Because nearly half the locations represented expelled tags, our data suggest this technique is inappropriate for future studies of pure-diploid Blue-spotted Salamanders, although it may be suitable for polyploid Blue-spotted Salamanders and other ambystomatid species, which are larger in size and may exhibit higher tag retention rates. It may also be prudent to conduct long-term tag retention studies in captivity before tagging and releasing salamanders for in situ study, and to double-mark individuals.
Sensor to detect endothelialization on an active coronary stent
2010-01-01
Background A serious complication with drug-eluting coronary stents is late thrombosis, caused by exposed stent struts not covered by endothelial cells in the healing process. Real-time detection of this healing process could guide physicians for more individualized anti-platelet therapy. Here we present work towards developing a sensor to detect this healing process. Sensors on several stent struts could give information about the heterogeneity of healing across the stent. Methods A piezoelectric microcantilever was insulated with parylene and demonstrated as an endothelialization detector for incorporation within an active coronary stent. After initial characterization, endothelial cells were plated onto the cantilever surface. After they attached to the surface, they caused an increase in mass, and thus a decrease in the resonant frequencies of the cantilever. This shift was then detected electrically with an LCR meter. The self-sensing, self-actuating cantilever does not require an external, optical detection system, thus allowing for implanted applications. Results A cell density of 1300 cells/mm2 on the cantilever surface is detected. Conclusions We have developed a self-actuating, self-sensing device for detecting the presence of endothelial cells on a surface. The device is biocompatible and functions reliably in ionic liquids, making it appropriate for implantable applications. This sensor can be placed along the struts of a coronary stent to detect when the struts have been covered with a layer of endothelial cells and are no longer available surfaces for clot formation. Anti-platelet therapy can be adjusted in real-time with respect to a patient's level of healing and hemorrhaging risks. PMID:21050471
Peavey, Mary C; Reynolds, Corey L; Szwarc, Maria M; Gibbons, William E; Valdes, Cecilia T; DeMayo, Francesco J; Lydon, John P
2017-10-24
High-frequency ultrasonography (HFUS) is a common method to non-invasively monitor the real-time development of the human fetus in utero. The mouse is routinely used as an in vivo model to study embryo implantation and pregnancy progression. Unfortunately, such murine studies require pregnancy interruption to enable follow-up phenotypic analysis. To address this issue, we used three-dimensional (3-D) reconstruction of HFUS imaging data for early detection and characterization of murine embryo implantation sites and their individual developmental progression in utero. Combining HFUS imaging with 3-D reconstruction and modeling, we were able to accurately quantify embryo implantation site number as well as monitor developmental progression in pregnant C57BL6J/129S mice from 5.5 days post coitus (d.p.c.) through to 9.5 d.p.c. with the use of a transducer. Measurements included: number, location, and volume of implantation sites as well as inter-implantation site spacing; embryo viability was assessed by cardiac activity monitoring. In the immediate post-implantation period (5.5 to 8.5 d.p.c.), 3-D reconstruction of the gravid uterus in both mesh and solid overlay format enabled visual representation of the developing pregnancies within each uterine horn. As genetically engineered mice continue to be used to characterize female reproductive phenotypes derived from uterine dysfunction, this method offers a new approach to detect, quantify, and characterize early implantation events in vivo. This novel use of 3-D HFUS imaging demonstrates the ability to successfully detect, visualize, and characterize embryo-implantation sites during early murine pregnancy in a non-invasive manner. The technology offers a significant improvement over current methods, which rely on the interruption of pregnancies for gross tissue and histopathologic characterization. Here we use a video and text format to describe how to successfully perform ultrasounds of early murine pregnancy to generate reliable and reproducible data with reconstruction of the uterine form in mesh and solid 3-D images.
Implantable Myoelectric Sensors (IMESs) for Intramuscular Electromyogram Recording
Weir, Richard F. ff.; Troyk, Phil R.; DeMichele, Glen A.; Kerns, Douglas A.; Schorsch, Jack F.; Maas, Huub
2011-01-01
We have developed a multichannel electrogmyography sensor system capable of receiving and processing signals from up to 32 implanted myoelectric sensors (IMES). The appeal of implanted sensors for myoelectric control is that electromyography (EMG) signals can be measured at their source providing relatively cross-talk-free signals that can be treated as independent control sites. An external telemetry controller receives telemetry sent over a transcutaneous magnetic link by the implanted electrodes. The same link provides power and commands to the implanted electrodes. Wireless telemetry of EMG signals from sensors implanted in the residual musculature eliminates the problems associated with percutaneous wires, such as infection, breakage, and marsupialization. Each implantable sensor consists of a custom-designed application-specified integrated circuit that is packaged into a bio-compatible RF BION capsule from the Alfred E. Mann Foundation. Implants are designed for permanent long-term implantation with no servicing requirements. We have a fully operational system. The system has been tested in animals. Implants have been chronically implanted in the legs of three cats and are still completely operational four months after implantation. PMID:19224729
The development of the Nucleus Freedom Cochlear implant system.
Patrick, James F; Busby, Peter A; Gibson, Peter J
2006-12-01
Cochlear Limited (Cochlear) released the fourth-generation cochlear implant system, Nucleus Freedom, in 2005. Freedom is based on 25 years of experience in cochlear implant research and development and incorporates advances in medicine, implantable materials, electronic technology, and sound coding. This article presents the development of Cochlear's implant systems, with an overview of the first 3 generations, and details of the Freedom system: the CI24RE receiver-stimulator, the Contour Advance electrode, the modular Freedom processor, the available speech coding strategies, the input processing options of Smart Sound to improve the signal before coding as electrical signals, and the programming software. Preliminary results from multicenter studies with the Freedom system are reported, demonstrating better levels of performance compared with the previous systems. The final section presents the most recent implant reliability data, with the early findings at 18 months showing improved reliability of the Freedom implant compared with the earlier Nucleus 3 System. Also reported are some of the findings of Cochlear's collaborative research programs to improve recipient outcomes. Included are studies showing the benefits from bilateral implants, electroacoustic stimulation using an ipsilateral and/or contralateral hearing aid, advanced speech coding, and streamlined speech processor programming.
Acidification of uterine epithelium during embryo implantation in mice†
Xiao, Shuo; Li, Rong; El Zowalaty, Ahmed E.; Diao, Honglu; Zhao, Fei; Choi, Yongwon; Ye, Xiaoqin
2017-01-01
Abstract Uterine luminal epithelium (LE) is essential for establishing uterine receptivity. Previous microarray analysis revealed upregulation of Atp6v0d2 in gestation day 4.5 (D4.5) LE in mice. Realtime PCR showed upregulation of uterine Atp6v0d2 starting right before embryo attachment ∼D4.0. In situ hybridization demonstrated specific uterine localization of Atp6v0d2 in LE upon embryo implantation. Atp6v0d2 encodes one subunit for vacuolar-type H+-ATPase (V-ATPase), which regulates acidity of intracellular organelles and extracellular environment. LysoSensor Green DND-189 detected acidic signals in LE and glandular epithelium upon embryo implantation, correlating with Atp6v0d2 upregulation in early pregnant uterus. Atp6v0d2−/− females had significantly reduced implantation rate and marginally reduced delivery rate from first mating only, but comparable number of implantation sites and litter size compared to control and comparable fertility to control from subsequent matings, suggesting a nonessential role of Atp6v0d2 subunit in embryo implantation. Successful implantation in both control and Atp6v0d2−/− females was associated with uterine epithelial acidification. No significant compensatory upregulation of Atp6v0d1 mRNA was detected in D4.5 Atp6v0d2−/− uteri. To determine the role of V-ATPase instead of a single subunit in embryo implantation, a specific V-ATPase inhibitor bafilomycin A1 (2.5 μg/kg) was injected via uterine fat pad on D3 18:00 h. This treatment resulted in reduced uterine epithelial acidification, delayed implantation, and reduced number of implantation sites. It also suppressed oil-induced artificial decidualization. These data demonstrate uterine epithelial acidification as a novel phenomenon during embryo implantation and V-ATPase is involved in uterine epithelial acidification and uterine preparation for embryo implantation. PMID:28395338
"Bionic Man" Showcases Medical Research | NIH MedlinePlus the Magazine
... Wisconsin Implantable Sensors for Prosthesis Control Implantable myoelectric (electrical properties of muscle) sensors detect nerve signals above ... treatments reach the brain. Spinal Stimulation for Paralysis Electrical stimulation of the spinal cord is being used ...
Cochlear implants: system design, integration, and evaluation.
Zeng, Fan-Gang; Rebscher, Stephen; Harrison, William; Sun, Xiaoan; Feng, Haihong
2008-01-01
As the most successful neural prosthesis, cochlear implants have provided partial hearing to more than 120000 persons worldwide; half of which being pediatric users who are able to develop nearly normal language. Biomedical engineers have played a central role in the design, integration and evaluation of the cochlear implant system, but the overall success is a result of collaborative work with physiologists, psychologists, physicians, educators, and entrepreneurs. This review presents broad yet in-depth academic and industrial perspectives on the underlying research and ongoing development of cochlear implants. The introduction accounts for major events and advances in cochlear implants, including dynamic interplays among engineers, scientists, physicians, and policy makers. The review takes a system approach to address critical issues in cochlear implant research and development. First, the cochlear implant system design and specifications are laid out. Second, the design goals, principles, and methods of the subsystem components are identified from the external speech processor and radio frequency transmission link to the internal receiver, stimulator and electrode arrays. Third, system integration and functional evaluation are presented with respect to safety, reliability, and challenges facing the present and future cochlear implant designers and users. Finally, issues beyond cochlear implants are discussed to address treatment options for the entire spectrum of hearing impairment as well as to use the cochlear implant as a model to design and evaluate other similar neural prostheses such as vestibular and retinal implants.
Kang, Sarah; Niak, Ali; Gada, Neha; Brinker, Allen; Jones, S Christopher
2017-12-01
To describe clinical outcomes of etonogestrel implant patients with migration to the vasculature, chest wall and other distant body sites spontaneously reported to the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. We performed a standardized Medical Dictionary for Regulatory Activities (MedDRA) query in the FAERS database (through November 15, 2015), with reports coded with one or more MedDRA preferred terms that indicate complications with device placement or migration of the device from the original site of insertion to the vasculature, chest wall and other distant body sites. We excluded any cases previously described in the medical literature. We identified 38 cases of pronounced etonogestrel implant migration. Migration locations included the lung/pulmonary artery (n=9), chest wall (n=1), vasculature at locations other than the lung/pulmonary artery (n=14) and extravascular migrations (n=14) to other body sites (e.g., the axilla and clavicle/neck line/shoulder). The majority of cases were asymptomatic and detected when the patient desired implant removal; however, seven cases reported symptoms such as pain, discomfort and dyspnea in association with implant migration. Three cases also describe pulmonary fibrosis and skin reactions as a result of implant migration to the vasculature, chest wall and other distant body sites. Sixteen cases reported surgical removal in an operating room setting. Our FAERS case series demonstrates etonogestrel implant migration to the vasculature, chest wall and other body sites distant from the site of original insertion. As noted by the sponsor in current prescribing information, a key determinant in the risk for etonogestrel contraceptive implant migration appears to be improper insertion technique. Although migration of etonogestrel implants to the vasculature is rare, awareness of migration and education on proper insertion technique may reduce the risk. Published by Elsevier Inc.
Moraes, A P; Silva, E J; Lamas, C C; Portugal, P H; Neves, A A
2016-06-01
To evaluate the potential for electromagnetic interference (EMI) of electronic apex locators (EALs) and a gutta-percha heating device (HD) in patients with implantable cardiac pacemakers (ICPs) or cardioverter-defibrillators (ICDs). Two types of EALs (Romiapex A-15 and Novapex) and a HD (Touch'n Heat) were tested in patients followed in an outpatient clinic for cardiac arrhythmias. The heart rhythm was monitored on a computer screen during all experimental phases. After baseline data collection, the patient held each appliance (turned on) for 30 s, simulating their clinical use. If background noise was detected on the cardiac monitor, the sensitivity of the ICP/ICD was lowered by the cardiologist to evaluate the intensity of the detected EMI. Twelve patients were evaluated (5 female and 7 male), and in nine instances, background noise in their cardiac devices related to the use of the endodontic devices was detected (6 patients). After lowering the sensitivity of the cardiac implants, three patients had more severe EMI in six instances, including pauses in ICP function. The presence of a symptomatic or asymptomatic pause was related to the patient's underlying heart rhythm. The HD device produced background noise more often compared to EALs. These were associated with more severe types of EMI. The EALs and gutta-percha HD were capable of causing background noise detection or pauses in cardiac implants in vivo. The use of electronic dental devices nearby patients with cardiac implants should be carefully considered in clinical practice. © 2015 International Endodontic Journal. Published by John Wiley & Sons Ltd.
Cho, Eugenia H; Shammas, Ronnie L; Phillips, Brett T; Greenup, Rachel A; Hwang, E Shelley; Hollenbeck, Scott T
2017-06-01
Breast augmentation with subglandular versus subpectoral implants may differentially impact the early detection of breast cancer and treatment recommendations. The authors assessed the impact of prior augmentation on the diagnosis and management of breast cancer in women undergoing mastectomy. Breast cancer diagnosis and management were retrospectively analyzed in all women with prior augmentation undergoing therapeutic mastectomy at the authors' institution from 1993 to 2014. Comparison was made to all women with no prior augmentation undergoing mastectomy in 2010. Subanalyses were performed according to prior implant placement. A total of 260 women with (n = 89) and without (n = 171) prior augmentation underwent mastectomy for 95 and 179 breast cancers, respectively. Prior implant placement was subglandular (n = 27) or subpectoral (n = 63) (For five breasts, the placement was unknown). Breast cancer stage at diagnosis (p = 0.19) and detection method (p = 0.48) did not differ for women with and without prior augmentation. Compared to subpectoral augmentation, subglandular augmentation was associated with the diagnosis of invasive breast cancer rather than ductal carcinoma in situ (p = 0.01) and detection by self-palpation rather than screening mammography (p = 0.03). Immediate two-stage implant reconstruction was the preferred reconstructive method in women with augmentation (p < 0.01). Breast cancer stage at diagnosis was similar for women with and without prior augmentation. Among women with augmentation, however, subglandular implants were associated with more advanced breast tumors commonly detected on palpation rather than mammography. Increased vigilance in breast cancer screening is recommended among women with subglandular augmentation. Therapeutic, III.
Joint angle sensors for closed-loop control
NASA Astrophysics Data System (ADS)
Ko, Wen H.; Miao, Chih-Lei
In order to substitute braces that have built-in goniometers and to provide feedback signals for closed loop control of lower extremity Functional Neuromuscular System in paraplegics, a stretchable capacitive sensor was developed to accurately detect angular movement in joints. Promising clinical evaluations on the knee joints of a paraplegic and a volunteer were done. The evaluations show great promise for the possibility of implantation applications.
Hartmann, Albrecht; Hannemann, Franziska; Lützner, Jörg; Seidler, Andreas; Drexler, Hans; Günther, Klaus-Peter; Schmitt, Jochen
2013-01-01
Introduction The use of metal-on-metal (MoM) total hip arthroplasty (THA) increased in the last decades. A release of metal products (i.e. particles, ions, metallo-organic compounds) in these implants may cause local and/or systemic adverse reactions. Metal ion concentrations in body fluids are surrogate measures of metal exposure. Objective To systematically summarize and critically appraise published studies concerning metal ion concentrations after MoM THA. Methods Systematic review of clinical trials (RCTs) and epidemiological studies with assessment of metal ion levels (cobalt, chromium, titanium, nickel, molybdenum) in body fluids after implantation of metalliferous hip replacements. Systematic search in PubMed and Embase in January 2012 supplemented by hand search. Standardized abstraction of pre- and postoperative metal ion concentrations stratified by type of bearing (primary explanatory factor), patient characteristics as well as study quality characteristics (secondary explanatory factors). Results Overall, 104 studies (11 RCTs, 93 epidemiological studies) totaling 9.957 patients with measurement of metal ions in body fluids were identified and analyzed. Consistently, median metal ion concentrations were persistently elevated after implantation of MoM-bearings in all investigated mediums (whole blood, serum, plasma, erythrocytes, urine) irrespective of patient characteristics and study characteristics. In several studies very high serum cobalt concentrations above 50 µg/L were measured (detection limit typically 0.3 µg/L). Highest metal ion concentrations were observed after treatment with stemmed large-head MoM-implants and hip resurfacing arthroplasty. Discussion Due to the risk of local and systemic accumulation of metallic products after treatment with MoM-bearing, risk and benefits should be carefully balanced preoperatively. The authors support a proposed „time out“ for stemmed large-head MoM-THA and recommend a restricted indication for hip resurfacing arthroplasty. Patients with implanted MoM-bearing should receive regular and standardized monitoring of metal ion concentrations. Further research is indicated especially with regard to potential systemic reactions due to accumulation of metal products. PMID:23950923
Cardiovascular ultrasonography detection of embolic sources in trauma.
Saranteas, Theodosios; Mavrogenis, Andreas F; Poularas, John; Kostroglou, Andreas; Mandila, Christina; Panou, Fotios
2018-06-01
Venous thromboembolism (deep vein thrombosis and pulmonary embolism) and bone cement implantation syndrome are major sources of embolic events in trauma patients. In these patients, embolic events due to venous thromboembolism and bone cement implantation syndrome have been detected with cardiac and vascular ultrasonography in the emergency setting, during the perioperative period, and in the intensive care unit. This article discusses the ultrasonography modalities and imaging findings of embolic events related to venous thromboembolism and bone cement implantation syndrome. The aim is to present a short review with exceptional illustrations that can enable physicians to identify sources of emboli in trauma patients with cardiovascular ultrasonography. Copyright © 2018 Elsevier Inc. All rights reserved.
Safety of the Wearable Cardioverter Defibrillator (WCD) in Patients with Implanted Pacemakers.
Schmitt, Joern; Abaci, Guezine; Johnson, Victoria; Erkapic, Damir; Gemein, Christopher; Chasan, Ritvan; Weipert, Kay; Hamm, Christian W; Klein, Helmut U
2017-03-01
The wearable cardioverter defibrillator (WCD) is an important approach for better risk stratification, applied to patients considered to be at high risk of sudden arrhythmic death. Patients with implanted pacemakers may also become candidates for use of the WCD. However, there is a potential risk that pacemaker signals may mislead the WCD detection algorithm and cause inappropriate WCD shock delivery. The aim of the study was to test the impact of different types of pacing, various right ventricular (RV) lead positions, and pacing modes for potential misleading of the WCD detection algorithm. Sixty patients with implanted pacemakers received the WCD for a short time and each pacing mode (AAI, VVI, and DDD) was tested for at least 30 seconds in unipolar and bipolar pacing configuration. In case of triggering the WCD detection algorithm and starting the sequence of arrhythmia alarms, shock delivery was prevented by pushing of the response buttons. In six of 60 patients (10%), continuous unipolar pacing in DDD mode triggered the WCD detection algorithm. In no patient, triggering occurred with bipolar DDD pacing, unipolar and bipolar AAI, and VVI pacing. Triggering was independent of pacing amplitude, RV pacing lead position, and pulse generator implantation site. Unipolar DDD pacing bears a high risk of false triggering of the WCD detection algorithm. Other types of unipolar pacing and all bipolar pacing modes do not seem to mislead the WCD detection algorithm. Therefore, patients with no reprogrammable unipolar DDD pacing should not become candidates for the WCD. © 2016 Wiley Periodicals, Inc.
Al-Munajjed, Amir A; Hammer, Joachim; Mayr, Edgar; Nerlich, Michael; Lenich, Andreas
2008-01-01
Proximal femur fractures are of main concern for elderly and especially osteoporotic patients. Despite advanced implant modifications and surgical techniques, serious mechanical complication rates between 4-18% are found in conventional osteosyntheses of proximal femur fractures. Clinical complications such as the rotation of the femoral head and the cut-out phenomenon of the fracture fixation bolt are often diagnosed during post-operative treatments. Therefore, efforts in new intramedulary techniques focus on the load bearing characteristics of the implant by developing new geometries to improve the implant-tissue interface. The objective of this investigation was to analyse the osteosynthesis/femur head interaction of two commonly used osteosyntheses, one with a helical blade and the other one with a screw design under different loading conditions. For the comparative investigation the helical blade of the Proximal Femur Nail Antirotation was investigated versus the screw system of the Dynamic Hip Screw. After implantation in a femoral head the loads for rotational overwinding of the implants were analysed. Pull-out forces with suppressed rotation were investigated with analysis of the influence of the previous overwinding. All investigations were performed on human femoral heads taken of patients with average age of 70.3+/-11.8. The bone mineral densities of the human specimens were detected by QCT-scans (average BMD: 338.9+/- 61.3$\\frac[\\mathit[mg
Cochlear implant in Hong Kong Cantonese.
Tang, S O; Luk, W S; Lau, C C; So, K W; Wong, C M; Yiu, M L; Kwok, C L
1990-11-01
Cochlear implant surgery was performed in four Cantonese-speaking postlingually deaf Chinese adults, using the House/3M single channel device. This article outlines the methodology, including preoperative assessment and postoperative rehabilitation; and explains the necessary modifications in speech and audiologic work-up in Cantonese-speaking patients. Salient features of Cantonese phonetics, especially its tonal characteristics, are described. The findings of the study are presented. The results of the cochlear implant would suggest a performance superior to that of the hearing aid. Furthermore, the cochlear implant is able to detect tonal cues. This quality of the cochlear implant may prove to be a valuable asset to a tonal language-speaking cochlear implantee.
Emmert, Maximilian Y; Weber, Benedikt; Behr, Luc; Sammut, Sebastien; Frauenfelder, Thomas; Wolint, Petra; Scherman, Jacques; Bettex, Dominique; Grünenfelder, Jürg; Falk, Volkmar; Hoerstrup, Simon P
2014-01-01
While transcatheter aortic valve implantation (TAVI) has rapidly evolved for the treatment of aortic valve disease, the currently used bioprostheses are prone to continuous calcific degeneration. Thus, autologous, cell-based, living, tissue-engineered heart valves (TEHVs) with regeneration potential have been suggested to overcome these limitations. We investigate the technical feasibility of combining the concept of TEHV with transapical implantation technology using a state-of-the-art transcatheter delivery system facilitating the exact anatomical position in the systemic circulation. Trileaflet TEHVs fabricated from biodegradable synthetic scaffolds were sewn onto self-expanding Nitinol stents seeded with autologous marrow stromal cells, crimped and transapically delivered into the orthotopic aortic valve position of adult sheep (n = 4) using the JenaValve transapical TAVI System (JenaValve, Munich, Germany). Delivery, positioning and functionality were assessed by angiography and echocardiography before the TEHV underwent post-mortem gross examination. For three-dimensional reconstruction of the stent position of the anatomically oriented system, a computed tomography analysis was performed post-mortem. Anatomically oriented, transapical delivery of marrow stromal cell-based TEHV into the orthotopic aortic valve position was successful in all animals (n = 4), with a duration from cell harvest to TEHV implantation of 101 ± 6 min. Fluoroscopy and echocardiography displayed sufficient positioning, thereby entirely excluding the native leaflets. There were no signs of coronary obstruction. All TEHV tolerated the loading pressure of the systemic circulation and no acute ruptures occurred. Animals displayed intact and mobile leaflets with an adequate functionality. The mean transvalvular gradient was 7.8 ± 0.9 mmHg, and the mean effective orifice area was 1.73 ± 0.02 cm(2). Paravalvular leakage was present in two animals, and central aortic regurgitation due to a single-leaflet prolapse was detected in two, which was primarily related to the leaflet design. No stent dislocation, migration or affection of the mitral valve was observed. For the first time, we demonstrate the technical feasibility of a transapical TEHV delivery into the aortic valve position using a commercially available and clinically applied transapical implantation system that allows for exact anatomical positioning. Our data indicate that the combination of TEHV and a state-of-the-art transapical delivery system is feasible, representing an important step towards translational, transcatheter-based TEHV concepts.
Kamke, Marc R; Van Luyn, Jeanette; Constantinescu, Gabriella; Harris, Jill
2014-01-01
Evidence suggests that deafness-induced changes in visual perception, cognition and attention may compensate for a hearing loss. Such alterations, however, may also negatively influence adaptation to a cochlear implant. This study investigated whether involuntary attentional capture by salient visual stimuli is altered in children who use a cochlear implant. Thirteen experienced implant users (aged 8-16 years) and age-matched normally hearing children were presented with a rapid sequence of simultaneous visual and auditory events. Participants were tasked with detecting numbers presented in a specified color and identifying a change in the tonal frequency whilst ignoring irrelevant visual distractors. Compared to visual distractors that did not possess the target-defining characteristic, target-colored distractors were associated with a decrement in visual performance (response time and accuracy), demonstrating a contingent capture of involuntary attention. Visual distractors did not, however, impair auditory task performance. Importantly, detection performance for the visual and auditory targets did not differ between the groups. These results suggest that proficient cochlear implant users demonstrate normal capture of visuospatial attention by stimuli that match top-down control settings.
Alsabeeha, Nabeel H M; Payne, Alan G T; De Silva, Rohana K; Thomson, W Murray
2011-03-01
To determine surgical and prosthodontic outcomes of mandibular single-implant overdentures, opposing complete maxillary dentures, using a wide diameter implant and large ball attachment system compared with different regular diameter implants with standard attachment systems. Thirty-six edentulous participants (mean age 68 years, SD 9.2) were randomly assigned into three treatment groups (n=12). A single implant was placed in the mandibular midline of participants to support an overdenture using a 6-week loading protocol. The control group received Southern regular implants and standard ball attachments. One group received Southern 8-mm-wide implants and large ball attachments. Another group received Neoss regular implants and Locator attachments. Parametric and non-parametric tests of a statistical software package (SPSS) were used to determine between groups differences in marginal bone loss, implant stability, implant, and prosthodontic success (P<0.05). Implant success after 1 year was 75% for Southern regular implant (control) group; and 100% for the Southern wide and Neoss regular implant groups (P=0.038). Mean marginal bone loss at 1 year was 0.19 mm (SD 0.39) without significant differences observed. Implant stability quotient (ISQ) at baseline was significantly lower for the Southern regular (control) group than the other two groups (P=0.001; P=0.009). At 1 year, no significant difference in implant stability was observed (mean ISQ 74.6, SD 6.1). The change in implant stability from baseline to 1 year was significant for the control group (P=0.025). Prosthodontic success was comparable between the groups but the maintenance (41 events overall, mean 1.2) was greater for the Locator and the standard ball attachments. Mandibular single-implant overdentures are a successful treatment option for older edentulous adults with early loading protocol using implants of different diameters and with different attachment systems. © 2010 John Wiley & Sons A/S.
Cao, Hung; Landge, Vaibhav; Tata, Uday; Seo, Young-Sik; Rao, Smitha; Tang, Shou-Jiang; Tibbals, H F; Spechler, Stuart; Chiao, J-C
2012-11-01
In this study, a device for gastroesophageal reflux disease (GERD) monitoring has been prototyped. The system consists of an implantable, batteryless and wireless transponder with integrated impedance and pH sensors; and a wearable, external reader that wirelessly powers up the transponder and interprets the transponded radio-frequency signals. The transponder implant with the total size of 0.4 cm × 0.8 cm × 3.8 cm harvests radio frequency energy to operate dual-sensor and load-modulation circuitry. The external reader can store the data in a memory card and/or send it to a base station wirelessly, which is optional in the case of multiple-patient monitoring in a hospital or conducting large-scale freely behaving animal experiments. Tests were carried out to verify the signal transduction reliability in different situations for antenna locations and orientation. In vitro, experiments were conducted in a mannequin model by positioning the sensor capsule inside the wall of a tube mimicking the esophagus. Different liquids with known pH values were flushed through the tube creating reflux episodes and wireless signals were recorded. Live pigs under anesthesia were used for the animal models with the transponder implant attached on the esophageal wall. The reflux episodes were created while the sensor data were recorded wirelessly. The data were compared with those recorded independently by a clinically used wireless pH sensor capsule placed next to our implant transponder. The results showed that our transponder detected every episode in both acid and nonacid nature, while the commercial pH sensor missed events that had similar, repeated pH values, and failed to detect pH values higher than 10. Our batteryless transponder does not require a battery thus allowing longer diagnosis and prognosis periods to monitor drug efficacy, as well as providing accurate assessment of GERD symptoms.
Bloemen-van Gurp, Esther J; Murrer, Lars H P; Haanstra, Björk K C; van Gils, Francis C J M; Dekker, Andre L A J; Mijnheer, Ben J; Lambin, Philippe
2009-01-01
In vivo dosimetry during brachytherapy of the prostate with (125)I seeds is challenging because of the high dose gradients and low photon energies involved. We present the results of a study using metal-oxide-semiconductor field-effect transistor (MOSFET) dosimeters to evaluate the dose in the urethra after a permanent prostate implantation procedure. Phantom measurements were made to validate the measurement technique, determine the measurement accuracy, and define action levels for clinical measurements. Patient measurements were performed with a MOSFET array in the urinary catheter immediately after the implantation procedure. A CT scan was performed, and dose values, calculated by the treatment planning system, were compared to in vivo dose values measured with MOSFET dosimeters. Corrections for temperature dependence of the MOSFET array response and photon attenuation in the catheter on the in vivo dose values are necessary. The overall uncertainty in the measurement procedure, determined in a simulation experiment, is 8.0% (1 SD). In vivo dose values were obtained for 17 patients. In the high-dose region (> 100 Gy), calculated and measured dose values agreed within 1.7% +/- 10.7% (1 SD). In the low-dose region outside the prostate (< 100 Gy), larger deviations occurred. MOSFET detectors are suitable for in vivo dosimetry during (125)I brachytherapy of prostate cancer. An action level of +/- 16% (2 SD) for detection of errors in the implantation procedure is achievable after validation of the detector system and measurement conditions.
Scarano, Antonio; Valbonetti, Luca; Degidi, Marco; Pecci, Raffaella; Piattelli, Adriano; de Oliveira, P S; Perrotti, Vittoria
2016-10-01
The presence of a microgap between implant and abutment could produce a bacterial reservoir which could interfere with the long-term health of the periimplant tissues. The aim of this article was to evaluate, by x-ray 3-dimensional microtomography, implant-abutment contact surfaces and microgaps at the implant-abutment interface in different types of implant-abutment connections. A total of 40 implants were used in this in vitro study. Ten implants presented a screw-retained internal hexagon abutment (group I), 10 had a Morse Cone taper internal connection (group II), 10 another type of Morse Cone taper internal connection (group III), and 10 had a screwed trilobed connection (group IV). In both types of Morse Cone internal connections, there was no detectable separation at the implant-abutment in the area of the conical connection, and there was an absolute congruity without any microgaps between abutment and implant. No line was visible separating the implant and the abutment. On the contrary, in the screwed abutment implants, numerous gaps and voids were present. The results of this study support the hypothesis that different types of implant-abutment joints are responsible for the observed differences in bacterial penetration.
Distribution of peri-implant stresses with a countertorque device.
Sendyk, Claudio Luiz; Lopez, Thais Torralbo; de Araujo, Cleudmar Amaral; Sendyk, Wilson Roberto; Goncalvez, Valdir Ferreira
2013-01-01
To verify the effectiveness of a countertorque device in dental implants in redistributing stress to the bone-implant interface during tightening of the abutment screw. Two prismatic photoelastic samples containing implants were made, one with a 3.75-mm-diameter implant and the other with a 5.0-mm-diameter implant (both implants had an external-hexagon interface) and the respective abutments were attached (CeraOne). The samples were placed in a support and submitted to torques of 10, 20, 32, and 45 Ncm with an electronic torque meter. The torque application was repeated 10 times on each sample (n = 10) with and without a countertorque device. Photoelastic patterns were detected; thus, a photographic register of each test was selected. The fringe patterns were analyzed at discrete points near the implants' external arch. In both implants analyzed, a stress gradient reduction was observed through the implant with the countertorque device. The countertorque device used in this study proved to be effective in reducing the stresses generated in the peri-implant bone tissue during torque application.
RAPID MANUFACTURING SYSTEM OF ORTHOPEDIC IMPLANTS
Relvas, Carlos; Reis, Joana; Potes, José Alberto Caeiro; Fonseca, Fernando Manuel Ferreira; Simões, José Antonio Oliveira
2015-01-01
This study, aimed the development of a methodology for rapid manufacture of orthopedic implants simultaneously with the surgical intervention, considering two potential applications in the fields of orthopedics: the manufacture of anatomically adapted implants and implants for bone loss replacement. This work innovation consists on the capitation of the in situ geometry of the implant by direct capture of the shape using an elastomeric material (polyvinylsiloxane) which allows fine detail and great accuracy of the geometry. After scanning the elastomeric specimen, the implant is obtained by machining using a CNC milling machine programmed with a dedicated CAD/CAM system. After sterilization, the implant is able to be placed on the patient. The concept was developed using low cost technology and commercially available. The system has been tested in an in vivo hip arthroplasty performed on a sheep. The time increase of surgery was 80 minutes being 40 minutes the time of implant manufacturing. The system developed has been tested and the goals defined of the study achieved enabling the rapid manufacture of an implant in a time period compatible with the surgery time. PMID:27004181
Metal levels in corrosion of spinal implants
Beguiristain, Jose; Duart, Julio
2007-01-01
Corrosion affects spinal instrumentations and may cause local and systemic complications. Diagnosis of corrosion is difficult, and nowadays it is performed almost exclusively by the examination of retrieved instrumentations. We conducted this study to determine whether it is possible to detect corrosion by measuring metal levels on patients with posterior instrumented spinal fusion. Eleven asymptomatic patients, with radiological signs of corrosion of their stainless steel spinal instrumentations, were studied by performing determinations of nickel and chromium in serum and urine. Those levels were compared with the levels of 22 patients with the same kind of instrumentation but without evidence of corrosion and to a control group of 22 volunteers without any metallic implants. Statistical analysis of our results revealed that the patients with spinal implants without radiological signs of corrosion have increased levels of chromium in serum and urine (P < 0.001) compared to volunteers without implants. Corrosion significantly raised metal levels, including nickel and chromium in serum and urine when compared to patients with no radiological signs of corrosion and to volunteers without metallic implants (P < 0.001). Metal levels measured in serum have high sensibility and specificity (area under the ROC curve of 0.981). By combining the levels of nickel and chromium in serum we were able to identify all the cases of corrosion in our series of patients. The results of our study confirm that metal levels in serum and urine are useful in the diagnosis of corrosion of spinal implants and may be helpful in defining the role of corrosion in recently described clinical entities such as late operative site pain or late infection of spinal implants. PMID:17256156
Badar, Muhammad; Lünsdorf, Heinrich; Evertz, Florian; Rahim, Muhammad Imran; Glasmacher, Birgit; Hauser, Hansjörg; Mueller, Peter P
2013-07-01
Magnesium alloys have been proposed as prospective degradable implant materials. To elucidate the complex interactions between the corroding implants and the tissue, magnesium implants were analyzed in a mouse model and the response was compared to that induced by Ti and by the resorbable polymer polyglactin, respectively. One month after implantation, distinct traces of corrosion were apparent but the magnesium implants were still intact, whereas resorbable polymeric wound suture implants were already fragmented. Analysis of magnesium implants 2weeks after implantation by energy-dispersive X-ray spectroscopy indicated that magnesium, oxygen, calcium and phosphate were present at the implant surface. One month after implantation, the element composition of the outermost layer of the implant was indicative of tissue without detectable levels of magnesium, indicating a protective barrier function of this organic layer. In agreement with this notion, gene expression patterns in the surrounding tissue were highly similar for all implant materials investigated. However, high-resolution imaging using energy-filtered transmission electron microscopy revealed magnesium-containing microparticles in the tissue in the proximity of the implant. The release of such corrosion particles may contribute to the accumulation of calcium phosphate in the nearby tissue and to bone conductive activities of magnesium implants. Copyright © 2013 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.
Intracapsular implant rupture: MR findings of incomplete shell collapse.
Soo, M S; Kornguth, P J; Walsh, R; Elenberger, C; Georgiade, G S; DeLong, D; Spritzer, C E
1997-01-01
The objective of this study was to determine the frequency and significance of the MR findings of incomplete shell collapse for detecting implant rupture in a series of surgically removed breast prostheses. MR images of 86 breast implants in 44 patients were studied retrospectively and correlated with surgical findings at explantation. MR findings included (a) complete shell collapse (linguine sign), 21 implants; (b) incomplete shell collapse (subcapsular line sign, teardrop sign, and keyhole sign), 33 implants; (c) radial folds, 31 implants; and (d) normal, 1 implant. The subcapsular line sign was seen in 26 implants, the teardrop sign was seen in 27 implants, and the keyhole sign was seen in 23 implants. At surgery, 48 implants were found to be ruptured and 38 were intact. The MR findings of ruptured implants showed signs of incomplete collapse in 52% (n = 25), linguine sign in 44% (n = 21), and radial folds in 4% (n = 2). The linguine sign perfectly predicted implant rupture, but sensitivity was low. Findings of incomplete shell collapse improved sensitivity and negative predictive values, and the subcapsular line sign produced a significant incremental increase in predictive ability. MRI signs of incomplete shell collapse were more common than the linguine sign in ruptured implants and are significant contributors to the high sensitivity and negative predictive values of MRI for evaluating implant integrity.
Kurita, Hiroshi; Sakai, Hironori; Uehara, Shinobu; Kurashina, Kenji
2008-01-01
This clinical article describes a case of dental rehabilitation using an implant-carrying plate system (EPITEC) for a patient with severely resorbed edentulous maxilla and microstomia. In this case, the presence of microstomia prevented bone augmentation procedures through an intraoral approach. Treatment using 2 endosseous implants inserted in the canine regions and an implant-supported overdenture was planned. However, endosseous implants were not feasible on the right side because of insufficient available bone volume. An implant-carrying plate system was then utilized on the right side. Four months later, an implant-supported ball-attachment overdenture was fabricated. At the 2-year follow-up, the clinical course remained uneventful, and the patient remained satisfied with the treatment.
Cranial implant design using augmented reality immersive system.
Ai, Zhuming; Evenhouse, Ray; Leigh, Jason; Charbel, Fady; Rasmussen, Mary
2007-01-01
Software tools that utilize haptics for sculpting precise fitting cranial implants are utilized in an augmented reality immersive system to create a virtual working environment for the modelers. The virtual environment is designed to mimic the traditional working environment as closely as possible, providing more functionality for the users. The implant design process uses patient CT data of a defective area. This volumetric data is displayed in an implant modeling tele-immersive augmented reality system where the modeler can build a patient specific implant that precisely fits the defect. To mimic the traditional sculpting workspace, the implant modeling augmented reality system includes stereo vision, viewer centered perspective, sense of touch, and collaboration. To achieve optimized performance, this system includes a dual-processor PC, fast volume rendering with three-dimensional texture mapping, the fast haptic rendering algorithm, and a multi-threading architecture. The system replaces the expensive and time consuming traditional sculpting steps such as physical sculpting, mold making, and defect stereolithography. This augmented reality system is part of a comprehensive tele-immersive system that includes a conference-room-sized system for tele-immersive small group consultation and an inexpensive, easily deployable networked desktop virtual reality system for surgical consultation, evaluation and collaboration. This system has been used to design patient-specific cranial implants with precise fit.
[Design on tester of pull-out force for orthodontic micro implant].
Su, He; Wu, Pei; Wang, Huiyuan; Chen, Yan; Bao, Xuemei
2013-09-01
A special device for measuring the pull-out force of orthodontic micro implant was designed, which has the characteristics of simple construction and easy operation, and can be used to detect the pull-out-force of orthodontic micro implant. The tested data was stored and analyzed by a computer, and as the results, the pull-out-force curve, maximum pull-out force as well as average pull-out force were outputted, which was applied in analyzing or investigating the initial stability and immediate loading property of orthodontic micro implant.
Barão, Valentim Adelino Ricardo; Assunção, Wirley Gonçalves; Tabata, Lucas Fernando; Delben, Juliana Aparecida; Gomes, Erica Alves; de Sousa, Edson Antonio Capello; Rocha, Eduardo Passos
2009-07-01
This finite element analysis compared stress distribution on complete dentures and implant-retained overdentures with different attachment systems. Four models of edentulous mandible were constructed: group A (control), complete denture; group B, overdenture retained by 2 splinted implants with bar-clip system; group C, overdenture retained by 2 unsplinted implants with o'ring system; and group D, overdenture retained by 2 splinted implants with bar-clip and 2 distally placed o'ring system. Evaluation was performed on Ansys software, with 100-N vertical load applied on central incisive teeth. The lowest maximum general stress value (in megapascal) was observed in group A (64.305) followed by groups C (119.006), D (258.650), and B (349.873). The same trend occurred in supporting tissues with the highest stress value for cortical bone. Unsplinted implants associated with the o'ring attachment system showed the lowest maximum stress values among all overdenture groups. Furthermore, o'ring system also improved stress distribution when associated with bar-clip system.
Optimization of an acoustic telemetry array for detecting transmitter-implanted fish
Clements, S.; Jepsen, D.; Karnowski, M.; Schreck, C.B.
2005-01-01
The development of miniature acoustic transmitters and economical, robust automated receivers has enabled researchers to study the movement patterns and survival of teleosts in estuarine and ocean environments, including many species and age-classes that were previously considered too small for implantation. During 2001-2003, we optimized a receiver mooring system to minimize gear and data loss in areas where current action or wave action and acoustic noise are high. In addition, we conducted extensive tests to determine (1) the performance of a transmitter and receiver (Vemco, Ltd.) that are widely used, particularly in North America and Europe and (2) the optimal placement of receivers for recording the passage of fish past a point in a linear-flow environment. Our results suggest that in most locations the mooring system performs well with little loss of data; however, boat traffic remains a concern due to entanglement with the mooring system. We also found that the reception efficiency of the receivers depends largely on the method and location of deployment. In many cases, we observed a range of 0-100% reception efficiency (the percentage of known transmissions that are detected while the receiver is within range of the transmitter) when using a conventional method of mooring. The efficiency was improved by removal of the mounting bar and obstructions from the mooring line. ?? Copyright by the American Fisheries Society 2005.
Sebők, Béla; Kiss, Gábor; Szabó, Péter J; Rigler, Dániel; Molnár, Milán L; Dobos, Gábor; Réti, Ferenc; Szőcs, Hajnal; Joób, Arpád F; Bogdán, Sándor; Szabó, György
2013-03-01
The long term effect of the human body on a pyrolytic carbon covered C/C composite maxillofacial implant (CarBulat(Tm)) was investigated by comparing the structure, the surface morphology and composition of an implant retrieved after 8 years to a sterilized, but not implanted one. Although the thickness of the carbon fibres constituting the implants did not change during the 8 year period, the surface of the implant retrieved was covered with a thin surface layer not present on the unimplanted implant. The composition of this layer is identical to the composition of the underlying carbon fibres. Calcium can only be detected on the surface as a trace element implying that the new layer is not formed by bone tissue. Residual soft tissue penetrating the bulk material between the carbon fibre bunches was found on the retrieved implant indicating the importance of the surface morphology in tissue growth and adhering to implants.
Application of uniform design to improve dental implant system.
Cheng, Yung-Chang; Lin, Deng-Huei; Jiang, Cho-Pei
2015-01-01
This paper introduces the application of uniform experimental design to improve dental implant systems subjected to dynamic loads. The dynamic micromotion of the Zimmer dental implant system is calculated and illustrated by explicit dynamic finite element analysis. Endogenous and exogenous factors influence the success rate of dental implant systems. Endogenous factors include: bone density, cortical bone thickness and osseointegration. Exogenous factors include: thread pitch, thread depth, diameter of implant neck and body size. A dental implant system with a crest module was selected to simulate micromotion distribution and stress behavior under dynamic loads using conventional and proposed methods. Finally, the design which caused minimum micromotion was chosen as the optimal design model. The micromotion of the improved model is 36.42 μm, with an improvement is 15.34% as compared to the original model.
Esposito, Marco; Trullenque-Eriksson, Anna; Blasone, Rodolfo; Malaguti, Giuliano; Gaffuri, Cristiano; Caneva, Marco; Minciarelli, Armando; Luongo, Giuseppe
To evaluate the safety and clinical effectiveness of a novel dental implant system (GENESIS Implant System, Keystone Dental, Massachusetts, USA) using another dental implant system by the same manufacturer as a control (PRIMA Implant System, Keystone Dental). A total of 53 patients requiring at least two single crowns had their sites randomised according to a split-mouth design to receive both implant systems at six centres. If implants could be placed with a torque superior to 40 Ncm they were to be loaded immediately with provisional crowns, otherwise after 3 months of submerged healing. Provisional crowns were replaced by definitive crowns 4 months after initial loading, when the follow-up period for the initial part of this study was completed. Outcome measures were crown/implant failures, complications, pink esthetic score (PES), peri-implant marginal bone level changes, plaque score, marginal bleeding, patients and preference of the clinician. In total 53 PRIMA and 53 GENESIS implants were placed. Three patients dropped out but all of the remaining patients were followed up to 4-months post-loading. No PRIMA implant failed whereas four GENESIS implants failed. Only two complications were reported for PRIMA implants. There were no statistically significant differences for crown/implant failures (difference in proportions = 0.080; P (McNemar test) = 0.125) and complications (difference in proportions = -0.04; P (McNemar test) = 0.500) between the implant systems. There were no differences at 4-months post-loading for plaque (difference = -0.54, 95% CI: -3.01 to 1.93; P (Paired t-test) = 0.660), marginal bleeding (difference = -3.8, 95% CI: -7.63 to 0.019; P (Paired t-test) = 0.051), PES (difference = 0.47, 95% CI: -0.56 to 1.50; P (Paired t-test) = 0.365) and marginal bone level changes (difference in mm = -0.04, 95% CI: -0.33 to 0.26; P (Paired t-test) = 0.795). The majority of the patients (46) had no preference regarding the two implant systems evaluated. Three operators preferred GENESIS implants, two had no preference and one preferred GENESIS in medium and soft bone and PRIMA in hard bone. No statistically significant differences were observed between the systems' implant types, although four GENESIS implants failed versus none of the PRIMA type. Longer follow-ups of wider patient populations are needed to better understand whether there is an effective advantage with one of the two implant designs. Conflict-of-interest statement: This research project was originally funded by Keystone Italia, Dental spa (Verona, Italy), the manufacturer of the implants evaluated in this investigation. However, when Keystone Italia received the data of the present manuscript, they refused to honour the financial agreement for the present publication. Therefore, no further follow-ups of this trial will be considered. A legal action was initiated against Keystone Italia. The data belonged to the authors and by no means was the manufacturer allowed to interfere with the conduct of the trial or the publication of the results.
Implantable power generation system utilizing muscle contractions excited by electrical stimulation.
Sahara, Genta; Hijikata, Wataru; Tomioka, Kota; Shinshi, Tadahiko
2016-06-01
An implantable power generation system driven by muscle contractions for supplying power to active implantable medical devices, such as pacemakers and neurostimulators, is proposed. In this system, a muscle is intentionally contracted by an electrical stimulation in accordance with the demands of the active implantable medical device for electrical power. The proposed system, which comprises a small electromagnetic induction generator, electrodes with an electrical circuit for stimulation and a transmission device to convert the linear motion of the muscle contractions into rotational motion for the magneto rotor, generates electrical energy. In an ex vivo demonstration using the gastrocnemius muscle of a toad, which was 28 mm in length and weighed 1.3 g, the electrical energy generated by the prototype exceeded the energy consumed for electrical stimulation, with the net power being 111 µW. It was demonstrated that the proposed implantable power generation system has the potential to replace implantable batteries for active implantable medical devices. © IMechE 2016.
2011-01-01
Background Magnesium alloys as biodegradable implant materials received much interest in recent years. It is known that products of implant degradation can induce several types of immune response. Hence, the aim of this study was to examine the morphological changes of efferent lymph nodes after implantation of different resorbable magnesium alloys (MgCa0.8, LAE442) in comparison to commercially available resorbable (PLA) and non-resorbable (titanium) implant materials as well as control groups without implant material. Methods The different implant materials were inserted intramedullary into the rabbit tibia. After postoperative observation periods of three and six months, popliteal lymph nodes were examined histologically and immunhistologically and compared to lymph nodes of sham operated animals and animals without surgery. Haematoxylin and eosin staining was performed for cell differentiation. Mouse anti-CD79α and rat anti-CD3 monoclonal primary antibodies were used for B- and T-lymphocyte detection, mouse anti-CD68 primary antibodies for macrophage detection. Evaluation of all sections was performed applying a semi quantitative score. Results The histological evaluation demonstrated low and moderate levels of morphological changes for both magnesium alloys (LAE442 and MgCa0.8). Higher than moderate values were reached for titanium in sinus histiocytosis and histiocytic apoptosis (3 months) and for PLA in histiocytic apoptosis (3 and 6 months). The immune response to all investigated implants had a non-specific character and predominantly was a foreign-body reaction. LAE442 provoked the lowest changes which might be due to a lower degradation rate in comparison to MgCa0.8. Therewith it is a promising candidate for implants with low immunogenic potential. Conclusion Both examined magnesium alloys did not cause significantly increased morphological changes in efferent lymph nodes in comparison to the widely used implant materials titanium and PLA. LAE442 induced even lower immunological reactions. Therewith MgCa0.8 and especially LAE442 are appropriate candidates for biomedical use. PMID:21521497
PIP breast implants: rupture rate and correlation with breast cancer
MOSCHETTA, M.; TELEGRAFO, M.; CORNACCHIA, I.; VINCENTI, L.; RANIERI, V.; CIRILLI, A.; RELLA, L.; IANORA, A.A. STABILE; ANGELELLI, G.
2014-01-01
Aim To evaluate the incidence of Poly Implant Prosthése (PIP) rupture as assessed by magnetic resonance imaging (MRI), the prevalence of the detected signs and the potential correlation with breast carcinoma. Patients and methods 67 patients with silicone breast implants and clinical indications for breast MRI were evaluated for a total of 125 implants: 40 (32%) PIP in 21 patients and 85 non-PIP in 46 patients (68%), the latest considered as control group. A 1.5-T MR imaging device was used in order to assess implant integrity with dedicated sequences and in 6 cases a dynamic study was performed for characterizing breast lesions. Two radiologists with more than 5 years’ experience in the field of MRI evaluated in consensus all MR images searching for the presence of clear signs of intra or extra-capsular implant rupture. Results 20/40 (50%) PIP implants presented signs of intra-capsular rupture: linguine sign in 20 cases (100%), tear-drop sign in 6 (30%). In 12/20 cases (60%), MRI signs of extra-capsular rupture were detected. In the control group, an intra-capsular rupture was diagnosed in 12/85 cases (14%) associated with extra-capsular one in 5/12 cases (42%). Among the six cases with suspected breast lesions, in 2/21 patients with PIP implants (10%) a breast carcinoma was diagnosed (mucinous carcinoma, n=1; invasive ductal carcinoma, n=1). In 4/46 patients (9%) with non-PIP implants, an invasive ductal carcinoma was diagnosed. Conclusion The rupture rate of PIP breast implants is significantly higher than non-PIP (50% vs 14%). MRI represents the most accurate imaging tool for evaluating breast prostheses and the linguine sign is the most common MRI sign to be searched. The incidence of breast carcinoma does not significantly differ between the PIP and non-PIP implants and a direct correlation with breast cancer can not been demonstrated. PMID:25644728
PIP breast implants: rupture rate and correlation with breast cancer.
Moschetta, M; Telegrafo, M; Cornacchia, I; Vincenti, L; Ranieri, V; Cirili, A; Rella, L; Stabile Ianora, A A; Angelelli, G
2014-01-01
To evaluate the incidence of Poly Implant Prosthése (PIP) rupture as assessed by magnetic resonance imaging (MRI), the prevalence of the detected signs and the potential correlation with breast carcinoma. 67 patients with silicone breast implants and clinical indications for breast MRI were evaluated for a total of 125 implants: 40 (32%) PIP in 21 patients and 85 non-PIP in 46 patients (68%), the latest considered as control group. A 1.5-T MR imaging device was used in order to assess implant integrity with dedicated sequences and in 6 cases a dynamic study was performed for characterizing breast lesions. Two radiologists with more than 5 years' experience in the field of MRI evaluated in consensus all MR images searching for the presence of clear signs of intra or extra-capsular implant rupture. 20/40 (50%) PIP implants presented signs of intra-capsular rupture: linguine sign in 20 cases (100%), tear-drop sign in 6 (30%). In 12/20 cases (60%), MRI signs of extra-capsular rupture were detected. In the control group, an intra-capsular rupture was diagnosed in 12/85 cases (14%) associated with extra-capsular one in 5/12 cases (42%). Among the six cases with suspected breast lesions, in 2/21 patients with PIP implants (10%) a breast carcinoma was diagnosed (mucinous carcinoma, n=1; invasive ductal carcinoma, n=1). In 4/46 patients (9%) with non-PIP implants, an invasive ductal carcinoma was diagnosed. The rupture rate of PIP breast implants is significantly higher than non-PIP (50% vs 14%). MRI represents the most accurate imaging tool for evaluating breast prostheses and the linguine sign is the most common MRI sign to be searched. The incidence of breast carcinoma does not significantly differ between the PIP and non-PIP implants and a direct correlation with breast cancer can not been demonstrated.
Beeman, John W.; Hayes, Brian; Wright, Katrina
2012-01-01
A series of in-stream passive integrated transponder (PIT) detection antennas installed across the Klamath River in August 2010 were tested using tagged fish in the summer of 2011. Six pass-by antennas were constructed and anchored to the bottom of the Klamath River at a site between the Shasta and Scott Rivers. Two of the six antennas malfunctioned during the spring of 2011 and two pass-through antennas were installed near the opposite shoreline prior to system testing. The detection probability of the PIT tag detection system was evaluated using yearling coho salmon implanted with a PIT tag and a radio transmitter and then released into the Klamath River slightly downstream of Iron Gate Dam. Cormack-Jolly-Seber capture-recapture methods were used to estimate the detection probability of the PIT tag detection system based on detections of PIT tags there and detections of radio transmitters at radio-telemetry detection systems downstream. One of the 43 PIT- and radio-tagged fish released was detected by the PIT tag detection system and 23 were detected by the radio-telemetry detection systems. The estimated detection probability of the PIT tag detection system was 0.043 (standard error 0.042). Eight PIT-tagged fish from other studies also were detected. Detections at the PIT tag detection system were at the two pass-through antennas and the pass-by antenna adjacent to them. Above average river discharge likely was a factor in the low detection probability of the PIT tag detection system. High discharges dislodged two power cables leaving 12 meters of the river width unsampled for PIT detections and resulted in water depths greater than the read distance of the antennas, which allowed fish to pass over much of the system with little chance of being detected. Improvements in detection probability may be expected under river discharge conditions where water depth over the antennas is within maximum read distance of the antennas. Improvements also may be expected if additional arrays of antennas are used.
Hämmerle, C H; Brägger, U; Bürgin, W; Lang, N P
1996-06-01
In order to achieve esthetically more satisfying results, it has been proposed to place ITI implants with their border between the rough and smooth surfaces below the level of the alveolar crest, thereby obtaining a submucosally located implant shoulder following healing. The aim of the present experimental study was to clinically and radiographically evaluate the tissue response to the placement of one-stage transmucosal implants with the border between the rough and the smooth surfaces sunk by 1 mm into a subcrestal location. 11 patients underwent comprehensive dental care including the placement of 2 implants of the ITI Dental Implant System in the same quadrant (test and control). Randomly assigned control implants were placed according to the manufacturer's instructions, i.e. the border between the rough titanium plasma-sprayed and the smooth polished surfaces precisely at the alveolar crest. At the test implant the apical border of the polished surface was placed approximately 1 mm below the alveolar crest. Probing bone levels were assessed at implant placement (baseline), 4 and 12 months later. Modified plaque and modified gingival indices were recorded at 1, 2, 3, 4 and 12 months. Clinical probing depth and "attachment" levels were measured at 4 and 12 months. All parameters were assessed at 6 sites around each implant. The mean for each implant was calculated and used for analysis. The Wilcoxon matched pairs signed rank test and the Student t-test were applied to detect differences over time and between the test and control implants. At baseline, a mean difference in probing bone level of -0.86 mm (SD 0.43 mm, p < 0.05) was found between test and control implants with the test implants being placed more deeply. Both test and control implants lost a significant amount of clinical bone height during the first 4 months (test 1.16 mm, p < 0.05; control 0.58 mm, p < 0.05). However, only the test implants significantly lost clinical bone height from 4-12 months (test 1.04 mm, p < 0.05; control 0.45 mm, p = 0.08). Overall, the test implants lost 2.26 mm and the control implants 1.02 mm of bone height during the first year of service. On the average, the test implants demonstrated a bone level of 0.38 mm lower than the controls at 12 months. Except for the modified gingival index at 4 months (mean difference 0.21, SD 0.19, p < 0.05), no clinical parameters yielded significant differences between test and control implants at any time. It is concluded that in addition to the crestal bone resorption occurring at implants placed under standard conditions, the bone adjacent to the polished surface of more deeply placed ITI implants is also lost over time. From a biological point of view, the placement of the border between the rough and the smooth surfaces into a subcrestal location should not be recommended.
Cochlear Implants:System Design, Integration and Evaluation
Rebscher, Stephen; Harrison, William V.; Sun, Xiaoan; Feng, Haihong
2009-01-01
As the most successful neural prosthesis, cochlear implants have provided partial hearing to more than 120,000 persons worldwide; half of which being pediatric users who are able to develop nearly normal language. Biomedical engineers have played a central role in the design, integration and evaluation of the cochlear implant system, but the overall success is a result of collaborative work with physiologists, psychologists, physicians, educators, and entrepreneurs. This review presents broad yet in-depth academic and industrial perspectives on the underlying research and ongoing development of cochlear implants. The introduction accounts for major events and advances in cochlear implants, including dynamic interplays among engineers, scientists, physicians, and policy makers. The review takes a system approach to address critical issues from design and specifications to integration and evaluation. First, the cochlear implant system design and specifications are laid out. Second, the design goals, principles, and methods of the subsystem components are identified from the external speech processor and radio frequency transmission link to the internal receiver, stimulator and electrode arrays. Third, system integration and functional evaluation are presented with respect to safety, reliability, and challenges facing the present and future cochlear implant designers and users. Finally, issues beyond cochlear implants are discussed to address treatment options for the entire spectrum of hearing impairment as well as to use the cochlear implant as a model to design and evaluate other similar neural prostheses such as vestibular and retinal implants. PMID:19946565
Prostate Brachytherapy Seed Reconstruction with Gaussian Blurring and Optimal Coverage Cost
Lee, Junghoon; Liu, Xiaofeng; Jain, Ameet K.; Song, Danny Y.; Burdette, E. Clif; Prince, Jerry L.; Fichtinger, Gabor
2009-01-01
Intraoperative dosimetry in prostate brachytherapy requires localization of the implanted radioactive seeds. A tomosynthesis-based seed reconstruction method is proposed. A three-dimensional volume is reconstructed from Gaussian-blurred projection images and candidate seed locations are computed from the reconstructed volume. A false positive seed removal process, formulated as an optimal coverage problem, iteratively removes “ghost” seeds that are created by tomosynthesis reconstruction. In an effort to minimize pose errors that are common in conventional C-arms, initial pose parameter estimates are iteratively corrected by using the detected candidate seeds as fiducials, which automatically “focuses” the collected images and improves successive reconstructed volumes. Simulation results imply that the implanted seed locations can be estimated with a detection rate of ≥ 97.9% and ≥ 99.3% from three and four images, respectively, when the C-arm is calibrated and the pose of the C-arm is known. The algorithm was also validated on phantom data sets successfully localizing the implanted seeds from four or five images. In a Phase-1 clinical trial, we were able to localize the implanted seeds from five intraoperative fluoroscopy images with 98.8% (STD=1.6) overall detection rate. PMID:19605321
Spectral-Temporal Modulated Ripple Discrimination by Children With Cochlear Implants.
Landsberger, David M; Padilla, Monica; Martinez, Amy S; Eisenberg, Laurie S
A postlingually implanted adult typically develops hearing with an intact auditory system, followed by periods of deafness (or near deafness) and adaptation to the implant. For an early implanted child whose brain is highly plastic, the auditory system matures with consistent input from a cochlear implant. It is likely that the auditory system of early implanted cochlear implant users is fundamentally different than postlingually implanted adults. The purpose of this study is to compare the basic psychophysical capabilities and limitations of these two populations on a spectral resolution task to determine potential effects of early deprivation and plasticity. Performance on a spectral resolution task (Spectral-temporally Modulated Ripple Test [SMRT]) was measured for 20 bilaterally implanted, prelingually deafened children (between 5 and 13 years of age) and 20 hearing children within the same age range. Additionally, 15 bilaterally implanted, postlingually deafened adults, and 10 hearing adults were tested on the same task. Cochlear implant users (adults and children) were tested bilaterally, and with each ear alone. Hearing listeners (adults and children) were tested with the unprocessed SMRT and with a vocoded version that simulates an 8-channel cochlear implant. For children with normal hearing, a positive correlation was found between age and SMRT score for both the unprocessed and vocoded versions. Older hearing children performed similarly to hearing adults in both the unprocessed and vocoded test conditions. However, for children with cochlear implants, no significant relationship was found between SMRT score and chronological age, age at implantation, or years of implant experience. Performance by children with cochlear implants was poorer than performance by cochlear implanted adults. It was also found that children implanted sequentially tended to have better scores with the first implant compared with the second implant. This difference was not observed for adults. An additional finding was that SMRT score was negatively correlated with age for adults with implants. Results from this study suggest that basic psychophysical capabilities of early implanted children and postlingually implanted adults differ when assessed in the sound field using their personal implant processors. Because spectral resolution does not improve with age for early implanted children, it seems likely that the sparse representation of the signal provided by a cochlear implant limits spectral resolution development. These results are supported by the finding that postlingually implanted adults, whose auditory systems matured before the onset of hearing loss, perform significantly better than early implanted children on the spectral resolution test.
Hasan, Istabrak; Heinemann, Friedhelm; Schwegmann, Monika; Keilig, Ludger; Stark, Helmut; Bourauel, Christoph
2017-02-01
Small diameter (mini) dental implants have become more popular in recent years as alternatives to classical implant treatment in clinical cases with critical bony situations. However, an in-depth scientific analysis of the mechanical and biomechanical effects of small diameter implants has not yet been published. The aim of the present study was to investigate experimentally different commercial mini implants by measuring their displacements under immediate loading. Twelve commercially available mini implants were measured. Implants were inserted into porcine mandibular segments and loaded by means of a predefined displacement of 0.5 mm of the loading system. The implants were loaded at an angle of 30° to the implant long axis using the self-developed biomechanical hexapod measurement system. Implant displacements were registered. The experimental results were compared to the numerical ones from a previous study. Measured implant displacements were within the range of 39-194 μm. A large variation in the displacements was obtained among the different implant systems due to the different designs and thread profiles. Comparing experimental and numerical results, the displacements that were obtained numerically were within the range of 79-347 μm. The different commercial mini implants showed acceptable primary stability and could be loaded immediately after their insertion.
Spectrophotometric and visual evaluation of peri-implant soft tissue color.
Benic, Goran I; Scherrer, Daniela; Sancho-Puchades, Manuel; Thoma, Daniel S; Hämmerle, Christoph H F
2017-02-01
To spectrophotometrically and visually test whether the peri-implant mucosal color differs from the color of the natural gingiva. Forty single implants in the incisor and premolar region of 40 patients were assessed 3-7 years after implant placement. The differences of the color components lightness, chroma along red-green axis, chroma along yellow-blue axis, and the total color difference ΔE between peri-implant mucosa and natural gingiva were measured with a spectrophotometer. The color difference between peri-implant mucosa and natural gingiva was visually evaluated by clinicians and rated as "clinically visible" or "clinically invisible" from speaking distance. The dimensions of peri-implant mucosa and gingiva at the mid-buccal aspect were evaluated by using cone-beam CT. Spearman analysis was performed to detect correlations between different variables. Two-sided t-test, ANOVA, Mann-Whitney, and Kruskal-Wallis tests were applied to detect differences between the groups. The spectrophotometrically assessed color difference ΔE between peri-implant mucosa and natural gingiva amounted to 7.0 ± 3.9. The peri-implant mucosa presented a significant dark, greenish and bluish discoloration in comparison with gingiva at control teeth. Clinical investigation revealed that in 60% of sites the color difference between peri-implant mucosa and natural gingiva was clinically visible from speaking distance. The threshold value ΔE for the extraoral clinical distinction of mucosal color differences measured 7.5. When comparing the groups with visible and invisible color differences with respect to the three color components, a significant difference was found only for chroma along yellow-blue axis. In the group with visible color difference, mucosa presented a bluish discoloration. Correlation analysis indicated that with an increase in mucosal thickness, a trend for smaller ΔE was found. The spectrophotometrically assessed color of the peri-implant mucosa revealed more dark, green and blue components compared to the natural gingiva. At 60% of the implants, peri-implant mucosal discoloration was visible from speaking distance. The sites with visible and those with invisible mucosal discolorations differed significantly only regarding the chroma along yellow-blue axis. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
* Murine Model of Progressive Orthopedic Wear Particle-Induced Chronic Inflammation and Osteolysis.
Pajarinen, Jukka; Nabeshima, Akira; Lin, Tzu-Hua; Sato, Taishi; Gibon, Emmanuel; Jämsen, Eemeli; Lu, Laura; Nathan, Karthik; Yao, Zhenyu; Goodman, Stuart B
2017-12-01
Periprosthetic osteolysis and subsequent aseptic loosening of total joint replacements are driven by byproducts of wear released from the implant. Wear particles cause macrophage-mediated inflammation that culminates with periprosthetic bone loss. Most current animal models of particle-induced osteolysis are based on the acute inflammatory reaction induced by wear debris, which is distinct from the slowly progressive clinical scenario. To address this limitation, we previously developed a murine model of periprosthetic osteolysis that is based on slow continuous delivery of wear particles into the murine distal femur over a period of 4 weeks. The particle delivery was accomplished by using subcutaneously implanted osmotic pumps and tubing, and a hollow titanium rod press-fit into the distal femur. In this study, we report a modification of our prior model in which particle delivery is extended to 8 weeks to better mimic the progressive development of periprosthetic osteolysis and allow the assessment of interventions in a setting where the chronic particle-induced osteolysis is already present at the initiation of the treatment. Compared to 4-week samples, extending the particle delivery to 8 weeks significantly exacerbated the local bone loss observed with μCT and the amount of both peri-implant F4/80 + macrophages and tartrate-resistant acid phosphatase-positive osteoclasts detected with immunohistochemical and histochemical staining. Furthermore, systemic recruitment of reporter macrophages to peri-implant tissues observed with bioluminescence imaging continued even at the later stages of particle-induced inflammation. This modified model system could provide new insights into the mechanisms of chronic inflammatory bone loss and be particularly useful in assessing the efficacy of treatments in a setting that resembles the clinical scenario of developing periprosthetic osteolysis more closely than currently existing model systems.
Implant retention systems for implant-retained overdentures.
Laverty, D P; Green, D; Marrison, D; Addy, L; Thomas, M B M
2017-03-10
Implant retained overdentures are being increasingly utilised in both general and specialist practice to rehabilitate patients with missing teeth, particularly those that are edentate. This article aims to inform the reader of a variety of retention systems that are available to retain an implant overdenture and to understand how these systems work, their advantages and disadvantages and to outline some of the clinical and treatment planning considerations involved in selecting the most appropriate retention system for patients.
Chronic In Vivo Stability Assessment of Carbon Fiber Microelectrode Arrays
Patel, Paras R.; Zhang, Huanan; Robbins, Matthew T.; Nofar, Justin B.; Marshall, Shaun P.; Kobylarek, Michael J.; Kozai, Takashi D. Y.; Kotov, Nicholas A.; Chestek, Cynthia A.
2016-01-01
Objective Individual carbon fiber microelectrodes can record unit activity in both acute and semi-chronic (∼1 month) implants. Additionally, new methods have been developed to insert a 16 channel array of carbon fiber microelectrodes. Before assessing the in vivo long-term viability of these arrays, accelerated soak tests were carried out to determine the most stable site coating material. Next, a multi-animal, multi-month, chronic implantation study was carried out with carbon fiber microelectrode arrays and silicon electrodes. Approach Carbon fibers were first functionalized with one of two different formulations of PEDOT and subjected to accelerated aging in a heated water bath. After determining the best PEDOT formula to use, carbon fiber arrays were chronically implanted in rat motor cortex. Some rodents were also implanted with a single silicon electrode, while others received both. At the end of the study a subset of animals were perfused and the brain tissue sliced. Tissue sections were stained for astrocytes, microglia, and neurons. The local reactive responses were assessed using qualitative and quantitative methods. Main results Electrophysiology recordings showed the carbon fibers detecting unit activity for at least 3 months with average amplitudes of ∼200 μV. Histology analysis showed the carbon fiber arrays with a minimal to non-existent glial scarring response with no adverse effects on neuronal density. Silicon electrodes showed large glial scarring that impacted neuronal counts. Significance This study has validated the use of carbon fiber microelectrode arrays as a chronic neural recording technology. These electrodes have demonstrated the ability to detect single units with high amplitude over 3 months, and show the potential to record for even longer periods. In addition, the minimal reactive response should hold stable indefinitely, as any response by the immune system may reach a steady state after 12 weeks. PMID:27705958
Chronic in vivo stability assessment of carbon fiber microelectrode arrays
NASA Astrophysics Data System (ADS)
Patel, Paras R.; Zhang, Huanan; Robbins, Matthew T.; Nofar, Justin B.; Marshall, Shaun P.; Kobylarek, Michael J.; Kozai, Takashi D. Y.; Kotov, Nicholas A.; Chestek, Cynthia A.
2016-12-01
Objective. Individual carbon fiber microelectrodes can record unit activity in both acute and semi-chronic (∼1 month) implants. Additionally, new methods have been developed to insert a 16 channel array of carbon fiber microelectrodes. Before assessing the in vivo long-term viability of these arrays, accelerated soak tests were carried out to determine the most stable site coating material. Next, a multi-animal, multi-month, chronic implantation study was carried out with carbon fiber microelectrode arrays and silicon electrodes. Approach. Carbon fibers were first functionalized with one of two different formulations of PEDOT and subjected to accelerated aging in a heated water bath. After determining the best PEDOT formula to use, carbon fiber arrays were chronically implanted in rat motor cortex. Some rodents were also implanted with a single silicon electrode, while others received both. At the end of the study a subset of animals were perfused and the brain tissue sliced. Tissue sections were stained for astrocytes, microglia, and neurons. The local reactive responses were assessed using qualitative and quantitative methods. Main results. Electrophysiology recordings showed the carbon fibers detecting unit activity for at least 3 months with average amplitudes of ∼200 μV. Histology analysis showed the carbon fiber arrays with a minimal to non-existent glial scarring response with no adverse effects on neuronal density. Silicon electrodes showed large glial scarring that impacted neuronal counts. Significance. This study has validated the use of carbon fiber microelectrode arrays as a chronic neural recording technology. These electrodes have demonstrated the ability to detect single units with high amplitude over 3 months, and show the potential to record for even longer periods. In addition, the minimal reactive response should hold stable indefinitely, as any response by the immune system may reach a steady state after 12 weeks.
Shon, Ahnsei; Chu, Jun-Uk; Jung, Jiuk; Kim, Hyungmin; Youn, Inchan
2017-12-21
Recently, implantable devices have become widely used in neural prostheses because they eliminate endemic drawbacks of conventional percutaneous neural interface systems. However, there are still several issues to be considered: low-efficiency wireless power transmission; wireless data communication over restricted operating distance with high power consumption; and limited functionality, working either as a neural signal recorder or as a stimulator. To overcome these issues, we suggest a novel implantable wireless neural interface system for simultaneous neural signal recording and stimulation using a single cuff electrode. By using widely available commercial off-the-shelf (COTS) components, an easily reconfigurable implantable wireless neural interface system was implemented into one compact module. The implantable device includes a wireless power consortium (WPC)-compliant power transmission circuit, a medical implant communication service (MICS)-band-based radio link and a cuff-electrode path controller for simultaneous neural signal recording and stimulation. During in vivo experiments with rabbit models, the implantable device successfully recorded and stimulated the tibial and peroneal nerves while communicating with the external device. The proposed system can be modified for various implantable medical devices, especially such as closed-loop control based implantable neural prostheses requiring neural signal recording and stimulation at the same time.
Shon, Ahnsei; Chu, Jun-Uk; Jung, Jiuk; Youn, Inchan
2017-01-01
Recently, implantable devices have become widely used in neural prostheses because they eliminate endemic drawbacks of conventional percutaneous neural interface systems. However, there are still several issues to be considered: low-efficiency wireless power transmission; wireless data communication over restricted operating distance with high power consumption; and limited functionality, working either as a neural signal recorder or as a stimulator. To overcome these issues, we suggest a novel implantable wireless neural interface system for simultaneous neural signal recording and stimulation using a single cuff electrode. By using widely available commercial off-the-shelf (COTS) components, an easily reconfigurable implantable wireless neural interface system was implemented into one compact module. The implantable device includes a wireless power consortium (WPC)-compliant power transmission circuit, a medical implant communication service (MICS)-band-based radio link and a cuff-electrode path controller for simultaneous neural signal recording and stimulation. During in vivo experiments with rabbit models, the implantable device successfully recorded and stimulated the tibial and peroneal nerves while communicating with the external device. The proposed system can be modified for various implantable medical devices, especially such as closed-loop control based implantable neural prostheses requiring neural signal recording and stimulation at the same time. PMID:29267230
An implantable myoelectric sensor based prosthesis control system.
DeMichele, Glenn A; Troyk, Philip R; Kerns, Douglas A; Weir, Richard
2006-01-01
We present progress on the design and testing of an upper-extremity prosthesis control system based on implantable myoelectric sensors. The implant consists of a single silicon chip packaged with transmit and receive coils. Forward control telemetry to, and reverse EMG data telemetry from multiple implants has been demonstrated.
Brain Tissue Responses to Neural Implants Impact Signal Sensitivity and Intervention Strategies
2015-01-01
Implantable biosensors are valuable scientific tools for basic neuroscience research and clinical applications. Neurotechnologies provide direct readouts of neurological signal and neurochemical processes. These tools are generally most valuable when performance capacities extend over months and years to facilitate the study of memory, plasticity, and behavior or to monitor patients’ conditions. These needs have generated a variety of device designs from microelectrodes for fast scan cyclic voltammetry (FSCV) and electrophysiology to microdialysis probes for sampling and detecting various neurochemicals. Regardless of the technology used, the breaching of the blood–brain barrier (BBB) to insert devices triggers a cascade of biochemical pathways resulting in complex molecular and cellular responses to implanted devices. Molecular and cellular changes in the microenvironment surrounding an implant include the introduction of mechanical strain, activation of glial cells, loss of perfusion, secondary metabolic injury, and neuronal degeneration. Changes to the tissue microenvironment surrounding the device can dramatically impact electrochemical and electrophysiological signal sensitivity and stability over time. This review summarizes the magnitude, variability, and time course of the dynamic molecular and cellular level neural tissue responses induced by state-of-the-art implantable devices. Studies show that insertion injuries and foreign body response can impact signal quality across all implanted central nervous system (CNS) sensors to varying degrees over both acute (seconds to minutes) and chronic periods (weeks to months). Understanding the underlying biological processes behind the brain tissue response to the devices at the cellular and molecular level leads to a variety of intervention strategies for improving signal sensitivity and longevity. PMID:25546652
Oliveira, J T; Santos, T C; Martins, L; Silva, M A; Marques, A P; Castro, A G; Neves, N M; Reis, R L
2009-10-01
Gellan gum is a polysaccharide that has been recently proposed by our group for cartilage tissue-engineering applications. It is commonly used in the food and pharmaceutical industry and has the ability to form stable gels without the use of harsh reagents. Gellan gum can function as a minimally invasive injectable system, gelling inside the body in situ under physiological conditions and efficiently adapting to the defect site. In this work, gellan gum hydrogels were combined with human articular chondrocytes (hACs) and were subcutaneously implanted in nude mice for 4 weeks. The implants were collected for histological (haematoxylin and eosin and Alcian blue staining), biochemical [dimethylmethylene blue (GAG) assay], molecular (real-time PCR analyses for collagen types I, II and X, aggrecan) and immunological analyses (immunolocalization of collagen types I and II). The results showed a homogeneous cell distribution and the typical round-shaped morphology of the chondrocytes within the matrix upon implantation. Proteoglycans synthesis was detected by Alcian blue staining and a statistically significant increase of proteoglycans content was measured with the GAG assay quantified from 1 to 4 weeks of implantation. Real-time PCR analyses showed a statistically significant upregulation of collagen type II and aggrecan levels in the same periods. The immunological assays suggest deposition of collagen type II along with some collagen type I. The overall data shows that gellan gum hydrogels adequately support the growth and ECM deposition of human articular chondrocytes when implanted subcutaneously in nude mice. Copyright (c) 2009 John Wiley & Sons, Ltd.
Brooks, R; Garan, H; Torchiana, D; Vlahakes, G J; Dziuban, S; Newell, J; McGovern, B A; Ruskin, J N
1994-11-15
To date, no long-term clinical data have been published in patients undergoing a nonthoracotomy approach to cardioverter-defibrillator system implantation. In the present report, 189 consecutive patients prospectively underwent a standardized approach to cardioverter-defibrillator system implantation in which the nonthoracotomy configurations were tested first. If satisfactory defibrillation thresholds were not obtained, thoracotomy was performed during the same intraoperative session. A nonthoracotomy system was successfully implanted in 149 of 189 patients (79%), with a higher success rate (90%) observed in patients who had more recent implantations. The overall rate of complications associated with these systems was low (11%). Over a mean follow-up of 12.5 +/- 9.3 months, 17 patients (9%) died. Three-year total, cardiac, and sudden death-free actuarial survival for all patients was 83 +/- 11%, 88 +/- 7%, and 94 +/- 2%, respectively. Three-year sudden death-free actuarial survival was higher in the nonthoracotomy than in the thoracotomy patients (97 +/- 2% vs 87 +/- 6%, p = 0.047), although total survival was similar (77 +/- 11% vs 83 +/- 7%, p = 0.77). These data suggest that a majority of patients (> 80%) requiring a cardioverter-defibrillator system can undergo implantation using a nonthoracotomy approach. Patients receiving nonthoracotomy systems have 3-year outcomes comparable to those implanted via thoracotomy. If these results are maintained, a nonthoracotomy approach will supplant thoracotomy-implanted systems as the preferred method because of the simpler implant procedure and lower overall cost involved.
Hogg, Wiebke Semper; Zulauf, Kris; Mehrhof, Jürgen; Nelson, Katja
2015-01-01
The influence of repeated system-specific torque tightening on the position stability of the abutment after de- and reassembly of the implant components was evaluated in six dental implant systems with a conical implant-abutment connection. An established experimental setup was used in this study. Rotation, vertical displacement, and canting moments of the abutment were observed; they depended on the implant system (P = .001, P < .001, P = .006, respectively). Repeated torque tightening of the abutment screw does not eliminate changes in position of the abutment.
Biocompatibility and tissue interactions of a new filler material for medical use.
Zarini, Elena; Supino, Rosanna; Pratesi, Graziella; Laccabue, Diletta; Tortoreto, Monica; Scanziani, Eugenio; Ghisleni, Gabriele; Paltrinieri, Saverio; Tunesi, Gianfranco; Nava, Maurizio
2004-09-15
Filler materials for medical use present limits, such as the induction of chronic inflammation and fibrosis. In the search for synthetic materials with improved biocompatible properties, a new polyacrylamide hydrogel, Aquamid (Contura SA, Montreux, Switzerland), has been investigated in preclinical systems. In cell cultures (endothelial cells and fibroblast), no or only transient biological effects were associated with 10% Aquamid exposure. The Aquamid-host interactions were examined in mice (10 mice per group) implanted subcutaneously or in the mammary fat pad with a very large volume (1.5 ml) of the material. Blood analysis, performed after 15 and 94 days (five mice per time for each group) to detect acute or late manifestations of toxicity, did not reveal relevant abnormalities in either group of Aquamid-bearing mice compared with control mice, except for a transient thrombocytopenia and a mild leukocytosis. Histological analysis of the pellet showed the presence of a thin, poorly vascularized cyst wall in implants. Only mild mesenchymal reparative and inflammatory processes were observed, even at longer observation times (more than 400 days). No alterations in any organ were detected. Despite the large volume implanted (approximately 5 percent of mouse body weight), the Aquamid pellet maintained its original size and shape without spreading or sticking to surrounding tissues. In conclusion, the study indicated a good tolerability of the new biopolymer in preclinical systems. The clinical utility of this new compound, if confirmed by clinical randomized trials showing its atoxic properties, could be in the field of aesthetic plastic surgery as a filler material for body contouring and in reconstructive surgery and above all in cancer patients to restore surgical defects.
Method to improve passive fit of frameworks on implant-supported prostheses: An in vitro study.
Manzella, Carlo; Bignardi, Cristina; Burello, Valerio; Carossa, Stefano; Schierano, Gianmario
2016-07-01
The passivity of the superstructure to the abutments of implant-supported prostheses is necessary for implant-prosthesis success. Improvements are needed in the methods of verifying passivity. The purpose of this in vitro study was to evaluate an inexpensive, easy to make, and user-friendly device to verify the position of the implant abutment replicas of the definitive cast and to avoid framework misfit before fabrication. Eighty stone devices were constructed on a metal base for the in vitro tests. The horizontal, vertical, and angled positions of the implant replicas were created to simulate misfits. The devices were fitted on the abutment replicas, and their ability to identify misfits was evaluated. A statistical analysis was not indicated, because the probability of fracture of the stone devices was 0 or 1. Two mathematical models were built using computer-aided design software (SolidWorks Premium; Dassault Systèmes SolidWorks Corp), and the finite element method was used (Ansys; ANSYS Inc) to simulate the structural behavior of 2 implant configurations (4 and 6 implants). Horizontal misfits of 150 μm, vertical misfits of 50 μm, and angled misfits of 1 degree were detected during the in vitro tests. Different loads and bone quality in the mathematical models did not change stress in the prosthesis configurations on 4 or 6 implants in a relevant way. The fabricated device was easily able to detect the misfits in accordance with the defined parameters. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
Wang, R; Pillai, K; Jones, P K
1998-01-01
The purpose of this study was to examine the dose enhancement at bone-implant interfaces from scattered radiation during simulated head and neck radiotherapy. Three cylindric implant systems with different compositions (pure titanium, titanium-aluminum-vanadium alloy, titanium coated with hydroxyapatite) and a high gold content transmandibular implant system (gold-copper-silver alloy) were studied. Extruded lithium fluoride single crystal chips were used as thermoluminescent material to measure radiation dose enhancement at 0, 1, and 2 mm from the bone-implant interface. The relative doses in buccal, lingual, mesial, and distal directions were also recorded and compared. The results indicated that the highest dose enhancement occurred at a distance of 0 mm from the bone-implant interface for all the implant systems studied. The transmandibular implants had higher scattered radiation than other groups at 0 mm and at 1 mm from the bone-implant interface. There was no significant difference of dose enhancement between buccal, lingual, mesial, and distal directions. Titanium implants coated with hydroxyapatite demonstrated the best results under the simulated irradiation.
Sub-micron surface plasmon resonance sensor systems
NASA Technical Reports Server (NTRS)
Glazier, James A. (Inventor); Amarie, Dragos (Inventor)
2013-01-01
Wearable or implantable devices combining microfluidic control of sample and reagent flow and micro-cavity surface plasmon resonance sensors functionalized with surface treatments or coatings capable of specifically binding to target analytes, ligands, or molecules in a bodily fluid are provided. The devices can be used to determine the presence and concentration of target analytes in the bodily fluids and thereby help diagnose, monitor or detect changes in disease conditions.
Pulp Cell Tracking by Radionuclide Imaging for Dental Tissue Engineering
Souron, Jean-Baptiste; Petiet, Anne; Decup, Franck; Tran, Xuan Vinh; Lesieur, Julie; Poliard, Anne; Le Guludec, Dominique; Letourneur, Didier; Chaussain, Catherine; Rouzet, Francois
2014-01-01
Pulp engineering with dental mesenchymal stem cells is a promising therapy for injured teeth. An important point is to determine the fate of implanted cells in the pulp over time and particularly during the early phase following implantation. Indeed, the potential engraftment of the implanted cells in other organs has to be assessed, in particular, to evaluate the risk of inducing ectopic mineralization. In this study, our aim was to follow by nuclear imaging the radiolabeled pulp cells after implantation in the rat emptied pulp chamber. For that purpose, indium-111-oxine (111In-oxine)-labeled rat pulp cells were added to polymerizing type I collagen hydrogel to obtain a pulp equivalent. This scaffold was implanted in the emptied pulp chamber space in the upper first rat molar. Labeled cells were then tracked during 3 weeks by helical single-photon emission computed tomography (SPECT)/computed tomography performed on a dual modality dedicated small animal camera. Negative controls were performed using lysed radiolabeled cells obtained in a hypotonic solution. In vitro data indicated that 111In-oxine labeling did not affect cell viability and proliferation. In vivo experiments allowed a noninvasive longitudinal follow-up of implanted living cells for at least 3 weeks and indicated that SPECT signal intensity was related to implanted cell integrity. Notably, there was no detectable systemic release of implanted cells from the tooth. In addition, histological analysis of the samples showed mitotically active fibroblastic cells as well as neoangiogenesis and nervous fibers in pulp equivalents seeded with entire cells, whereas pulp equivalents prepared from lysed cells were devoid of cell colonization. In conclusion, our study demonstrates that efficient labeling of pulp cells can be achieved and, for the first time, that these cells can be followed up after implantation in the tooth by nuclear imaging. Furthermore, it appears that grafted cells retained the label and are viable to follow the repair process. This technique is expected to be of major interest for monitoring implanted cells in innovative therapies for injured teeth. PMID:23789732
Automated dental implantation using image-guided robotics: registration results.
Sun, Xiaoyan; McKenzie, Frederic D; Bawab, Sebastian; Li, Jiang; Yoon, Yongki; Huang, Jen-K
2011-09-01
One of the most important factors affecting the outcome of dental implantation is the accurate insertion of the implant into the patient's jaw bone, which requires a high degree of anatomical accuracy. With the accuracy and stability of robots, image-guided robotics is expected to provide more reliable and successful outcomes for dental implantation. Here, we proposed the use of a robot for drilling the implant site in preparation for the insertion of the implant. An image-guided robotic system for automated dental implantation is described in this paper. Patient-specific 3D models are reconstructed from preoperative Cone-beam CT images, and implantation planning is performed with these virtual models. A two-step registration procedure is applied to transform the preoperative plan of the implant insertion into intra-operative operations of the robot with the help of a Coordinate Measurement Machine (CMM). Experiments are carried out with a phantom that is generated from the patient-specific 3D model. Fiducial Registration Error (FRE) and Target Registration Error (TRE) values are calculated to evaluate the accuracy of the registration procedure. FRE values are less than 0.30 mm. Final TRE values after the two-step registration are 1.42 ± 0.70 mm (N = 5). The registration results of an automated dental implantation system using image-guided robotics are reported in this paper. Phantom experiments show that the practice of robot in the dental implantation is feasible and the system accuracy is comparable to other similar systems for dental implantation.
2012-01-01
Background Hydroxyapatite (HA) coatings composed with bisphosphonates (BPs) which have high mineral-binding affinities have been confirmed to successfully enhance implant stability. However, few previous studies focused on HA coatings composed with low-affinity BPs or on systemic effects of locally released BPs. Methods In this long-term study, we developed two kinds of BP-HA composite coatings using either high-affinity BP (alendronate, ALN) or low-affinity BP (risedronate, RIS). Thirty-six rabbits were divided into three groups according to different coating applications (group I: HA, group II: ALN-HA, and group III: RIS-HA). Implants were inserted into the proximal region of the medullary cavity of the left tibiay. At insertion, 2 × 108 wear particles were injected around implants to induce a peri-implant high bone turnover environment. Both local (left tibias) and systemic (right tibias and lumbar vertebrae) inhibitory effect on bone resorption were compared, including bone-implant integration, bone architecture, bone mineral density (BMD), implant stability, and serum levels of bone turnover markers. Results The results indicated that ALN-HA composite coating, which could induce higher bone-implant contact (BIC) ratio, bone mass augmentation, BMD, and implant stability in the peri-implant region, was more potent on peri-implant bone, while RIS-HA composite coating, which had significant systemic effect, was more potent on non-peri-implant bone, especially lumbar vertebrae. Conclusions It is instructive and meaningful to further clinical studies that we could choose different BP-HA composite coatings according to the patient’s condition. PMID:22686414
Ansó, Juan; Dür, Cilgia; Gavaghan, Kate; Rohrbach, Helene; Gerber, Nicolas; Williamson, Tom; Calvo, Enric M; Balmer, Thomas Wyss; Precht, Christina; Ferrario, Damien; Dettmer, Matthias S; Rösler, Kai M; Caversaccio, Marco D; Bell, Brett; Weber, Stefan
2016-01-01
A multielectrode probe in combination with an optimized stimulation protocol could provide sufficient sensitivity and specificity to act as an effective safety mechanism for preservation of the facial nerve in case of an unsafe drill distance during image-guided cochlear implantation. A minimally invasive cochlear implantation is enabled by image-guided and robotic-assisted drilling of an access tunnel to the middle ear cavity. The approach requires the drill to pass at distances below 1 mm from the facial nerve and thus safety mechanisms for protecting this critical structure are required. Neuromonitoring is currently used to determine facial nerve proximity in mastoidectomy but lacks sensitivity and specificity necessaries to effectively distinguish the close distance ranges experienced in the minimally invasive approach, possibly because of current shunting of uninsulated stimulating drilling tools in the drill tunnel and because of nonoptimized stimulation parameters. To this end, we propose an advanced neuromonitoring approach using varying levels of stimulation parameters together with an integrated bipolar and monopolar stimulating probe. An in vivo study (sheep model) was conducted in which measurements at specifically planned and navigated lateral distances from the facial nerve were performed to determine if specific sets of stimulation parameters in combination with the proposed neuromonitoring system could reliably detect an imminent collision with the facial nerve. For the accurate positioning of the neuromonitoring probe, a dedicated robotic system for image-guided cochlear implantation was used and drilling accuracy was corrected on postoperative microcomputed tomographic images. From 29 trajectories analyzed in five different subjects, a correlation between stimulus threshold and drill-to-facial nerve distance was found in trajectories colliding with the facial nerve (distance <0.1 mm). The shortest pulse duration that provided the highest linear correlation between stimulation intensity and drill-to-facial nerve distance was 250 μs. Only at low stimulus intensity values (≤0.3 mA) and with the bipolar configurations of the probe did the neuromonitoring system enable sufficient lateral specificity (>95%) at distances to the facial nerve below 0.5 mm. However, reduction in stimulus threshold to 0.3 mA or lower resulted in a decrease of facial nerve distance detection range below 0.1 mm (>95% sensitivity). Subsequent histopathology follow-up of three representative cases where the neuromonitoring system could reliably detect a collision with the facial nerve (distance <0.1 mm) revealed either mild or inexistent damage to the nerve fascicles. Our findings suggest that although no general correlation between facial nerve distance and stimulation threshold existed, possibly because of variances in patient-specific anatomy, correlations at very close distances to the facial nerve and high levels of specificity would enable a binary response warning system to be developed using the proposed probe at low stimulation currents.
Color Analysis of Periimplant Soft Tissues Focusing on Implant System: A Case Series.
Varoni, Elena M; Moltrasio, Giuseppe; Gargano, Marco; Ludwig, Nicola; Lodi, Giovanni; Scaringi, Riccardo
2017-04-01
To assess the impact of implant system on color harmonization of periimplant mucosa. In this case series, color of periimplant mucosa was compared with color of natural tooth gingiva. Seventeen intercanine implants were analyzed (11 bone level [BL], 6 tissue level [TL] implants). Colorimetric data, at 2, 4, and 6 mm from gingival margin, were collected through fiber optics reflectance spectroscopy, and color differences calculated as ΔE. Dentists, dental students, and lay people, in blind, performed an additional visual color analysis on clinical images. Independently from implant system, the color of periimplant mucosa was significantly different from gingiva (ΔE = 8.2 ± 0.7), resulting darker at L* comparison (P ≤ 0.05). TL periimplant mucosa showed higher ΔE than BL (9.0 ± 1.0 vs 6.6 ± 0.8, respectively; P ≤ 0.05). Observers correctly identified where the implant was placed in about half of the cases, with no significant difference between implant systems. Within the limitations of this study, the color of periimplant soft tissues appears different from gingiva, at spectroscopic analysis. Color discrepancy results higher in the presence of TL implants than in BL implants, although the difference may not be clinically significant.
Biomedical Imaging in Implantable Drug Delivery Systems
Zhou, Haoyan; Hernandez, Christopher; Goss, Monika; Gawlik, Anna; Exner, Agata A.
2015-01-01
Implantable drug delivery systems (DDS) provide a platform for sustained release of therapeutic agents over a period of weeks to months and sometimes years. Such strategies are typically used clinically to increase patient compliance by replacing frequent administration of drugs such as contraceptives and hormones to maintain plasma concentration within the therapeutic window. Implantable or injectable systems have also been investigated as a means of local drug administration which favors high drug concentration at a site of interest, such as a tumor, while reducing systemic drug exposure to minimize unwanted side effects. Significant advances in the field of local DDS have led to increasingly sophisticated technology with new challenges including quantification of local and systemic pharmacokinetics and implant-body interactions. Because many of these sought-after parameters are highly dependent on the tissue properties at the implantation site, and rarely represented adequately with in vitro models, new nondestructive techniques that can be used to study implants in situ are highly desirable. Versatile imaging tools can meet this need and provide quantitative data on morphological and functional aspects of implantable systems. The focus of this review article is an overview of current biomedical imaging techniques, including magnetic resonance imaging (MRI), ultrasound imaging, optical imaging, X-ray and computed tomography (CT), and their application in evaluation of implantable DDS. PMID:25418857
21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.
Code of Federal Regulations, 2012 CFR
2012-04-01
... System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable intra...
21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.
Code of Federal Regulations, 2013 CFR
2013-04-01
... System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable intra...
21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.
Code of Federal Regulations, 2014 CFR
2014-04-01
... System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable intra...
1980-12-01
AFIT/GEO/EE/80D-1 I -’ SYSTEM OPTIMIZATION OF THE GLOW DISCHARGE OPTICAL SPECTROSCOPY TECHNIQUE USED FOR IMPURITY PROFILING OF ION IMPLANTED GALLIUM ...EE/80D-1 (\\) SYSTEM OPTIMIZATION OF THE GLOW DISCHARGE OPTICAL SPECTROSCOPY TECHNIQUE USED FOR IMPURITY PROFILING OF ION IMPLANTED GALLIUM ARSENIDE...semiconductors, specifically annealed and unan- nealed ion implanted gallium arsenide (GaAs). Methods to improve the sensitivity of the GDOS system have
Al-Zubeidi, Mohammed I; Alsabeeha, Nabeel H M; Thomson, W Murray; Payne, Alan G T
2012-05-01
Patient-based outcomes with maxillary overdentures on a minimum number of implants, opposing mandibular 2-implant overdentures are not evident in the literature. To evaluate patient's satisfaction with maxillary 3-implant overdentures, opposing mandibular 2-implant overdentures, using two different attachment systems over the first 2 years of service. Forty participants wearing mandibular 2-implant overdentures for 3 years were randomly allocated to one of two similar implant system groups to receive maxillary 3-implant overdentures. Twenty participants were allocated to splinted and unsplinted attachment system treatment groups for each system. Patient satisfaction with pre-treatment complete maxillary dentures, with maxillary 3-implant overdentures at baseline and annually for 2 years, was measured using visual analogue scale questionnaires and the oral health impact profiles. Palatal coverage of the maxillary overdentures was reduced at the first annual recall. Data showed significant improvement in pain reduction, comfort, stability, and function variables of the visual analogue scale after treatment. Analysis by prosthodontic design using visual analogue scale showed no significant difference. The total oral health impact profile-14 scores after treatment for all participants, regardless of prosthodontic design, were significantly lower (more satisfied). The overall oral health impact profile-20E score at baseline was significantly higher (more satisfied) compared with pre-treatment conventional maxillary dentures. No significant changes were observed in the first or second years compared with baseline results. Twenty-two participants (84.6%) preferred reduced palatal coverage, regardless of prosthodontic design, after 1 year. Twenty participants (76.9%) still preferred reduced palatal coverage at the end of the second year. The provision of maxillary 3-implant overdentures to oppose mandibular 2-implant overdentures significantly improve levels of patient satisfaction compared with conventional maxillary dentures. © 2011 Wiley Periodicals, Inc.
Significantly enhanced visible light response in single TiO2 nanowire by nitrogen ion implantation
NASA Astrophysics Data System (ADS)
Wu, Pengcheng; Song, Xianyin; Si, Shuyao; Ke, Zunjian; Cheng, Li; Li, Wenqing; Xiao, Xiangheng; Jiang, Changzhong
2018-05-01
The metal-oxide semiconductor TiO2 shows enormous potential in the field of photoelectric detection; however, UV-light absorption only restricts its widespread application. It is considered that nitrogen doping can improve the visible light absorption of TiO2, but the effect of traditional chemical doping is far from being used for visible light detection. Herein, we dramatically broadened the absorption spectrum of the TiO2 nanowire (NW) by nitrogen ion implantation and apply the N-doped single TiO2 NW to visible light detection for the first time. Moreover, this novel strategy effectively modifies the surface states and thus regulates the height of Schottky barriers at the metal/semiconductor interface, which is crucial to realizing high responsivity and a fast response rate. Under the illumination of a laser with a wavelength of 457 nm, our fabricated photodetector exhibits favorable responsivity (8 A W-1) and a short response time (0.5 s). These results indicate that ion implantation is a promising method in exploring the visible light detection of TiO2.
Significantly enhanced visible light response in single TiO2 nanowire by nitrogen ion implantation.
Wu, Pengcheng; Song, Xianyin; Si, Shuyao; Ke, Zunjian; Cheng, Li; Li, Wenqing; Xiao, Xiangheng; Jiang, Changzhong
2018-05-04
The metal-oxide semiconductor TiO 2 shows enormous potential in the field of photoelectric detection; however, UV-light absorption only restricts its widespread application. It is considered that nitrogen doping can improve the visible light absorption of TiO 2 , but the effect of traditional chemical doping is far from being used for visible light detection. Herein, we dramatically broadened the absorption spectrum of the TiO 2 nanowire (NW) by nitrogen ion implantation and apply the N-doped single TiO 2 NW to visible light detection for the first time. Moreover, this novel strategy effectively modifies the surface states and thus regulates the height of Schottky barriers at the metal/semiconductor interface, which is crucial to realizing high responsivity and a fast response rate. Under the illumination of a laser with a wavelength of 457 nm, our fabricated photodetector exhibits favorable responsivity (8 A W -1 ) and a short response time (0.5 s). These results indicate that ion implantation is a promising method in exploring the visible light detection of TiO 2 .
Ellenor, Christopher W; Stang, Pascal P; Etezadi-Amoli, Maryam; Pauly, John M; Scott, Greig C
2015-01-01
Purpose The concept of a “radiofrequency safety prescreen” is investigated, wherein dangerous interactions between radiofrequency fields used in MRI, and conductive implants in patients are detected through impedance changes in the radiofrequency coil. Theory The behavior of coupled oscillators is reviewed, and the resulting, observable impedance changes are discussed. Methods A birdcage coil is loaded with a static head phantom and a wire phantom with a wire close to its resonant length, the shape, position, and orientation of which can be changed. Interactions are probed with a current sensor and network analyzer. Results Impedance spectra show dramatic, unmistakable splitting in cases of strong coupling, and strong correlation is observed between induced current and scattering parameters. Conclusions The feasibility of a new, low-power prescreening technique has been demonstrated in a simple phantom experiment, which can unambiguously detect resonant interactions between an implanted wire and an imaging coil. A new technique has also been presented which can detect parallel transmit null modes for the wire. Magn Reson Med 73:1328–1339, 2015. © 2014 Wiley Periodicals, Inc. PMID:24623586
Stress analysis in oral obturator prostheses, part II: photoelastic imaging
NASA Astrophysics Data System (ADS)
Pesqueira, Aldiéris Alves; Goiato, Marcelo Coelho; da Silva, Emily Vivianne Freitas; Haddad, Marcela Filié; Moreno, Amália; Zahoui, Abbas; dos Santos, Daniela Micheline
2014-06-01
In part I of the study, two attachment systems [O-ring; bar-clip (BC)] were used, and the system with three individualized O-rings provided the lowest stress on the implants and the support tissues. Therefore, the aim of this study was to assess the stress distribution, through the photoelastic method, on implant-retained palatal obturator prostheses associated with different attachment systems: BOC-splinted implants with a bar connected to two centrally placed O-rings, and BOD-splinted implants with a BC connected to two distally placed O-rings (cantilever). One photoelastic model of the maxilla with oral-sinus-nasal communication with three parallel implants was fabricated. Afterward, two implant-retained palatal obturator prostheses with the two attachment systems described above were constructed. Each assembly was positioned in a circular polariscope and a 100-N axial load was applied in three different regions with implants by using a universal testing machine. The results were obtained through photograph record analysis of stress. The BOD system exhibited the highest stress concentration, followed by the BOC system. The O-ring, centrally placed on the bar, allows higher mobility of the prostheses and homogeneously distributes the stress to the region of the alveolar ridge and implants. It can be concluded that the use of implants with O-rings, isolated or connected with a bar, to rehabilitate maxillectomized patients allows higher prosthesis mobility and homogeneously distributes the stress to the alveolar ridge region, which may result in greater chewing stress distribution to implants and bone tissue. The clinical implication of the augmented bone support loss after maxillectomy is the increase of stress in the attachment systems and, consequently, a higher tendency for displacement of the prosthesis.
Insights from imaging the implanting embryo and the uterine environment in three dimensions
Arora, Ripla; Fries, Adam; Oelerich, Karina; Marchuk, Kyle; Sabeur, Khalida; Giudice, Linda C.
2016-01-01
Although much is known about the embryo during implantation, the architecture of the uterine environment in which the early embryo develops is not well understood. We employed confocal imaging in combination with 3D analysis to identify and quantify dynamic changes to the luminal structure of murine uterus in preparation for implantation. When applied to mouse mutants with known implantation defects, this method detected striking peri-implantation abnormalities in uterine morphology that cannot be visualized by histology. We revealed 3D organization of uterine glands and found that they undergo a stereotypical reorientation concurrent with implantation. Furthermore, we extended this technique to generate a 3D rendering of the cycling human endometrium. Analyzing the uterine and embryo structure in 3D for different genetic mutants and pathological conditions will help uncover novel molecular pathways and global structural changes that contribute to successful implantation of an embryo. PMID:27836961
NASA Astrophysics Data System (ADS)
Zhao, Z. Y.; Ostapenko, S.; Anundson, R.; Tvinnereim, M.; Belyaev, A.; Anthony, M.
2001-07-01
The semiconductor industry does not have effective metrology for well implants. The ability to measure such deep level implants will become increasingly important as we progress along the technology road map. This work explores the possibility of using the acoustic whistle effect on ion implanted silicon wafers. The technique detects the elastic stress and defects in silicon wafers by measuring the sub-harmonic f/2 resonant vibrations on a wafer induced via backside contact to create standing waves, which are measured by a non-contact ultrasonic probe. Preliminary data demonstrates that it is sensitive to implant damage, and there is a direct correlation between this sub-harmonic acoustic mode and some of the implant and anneal conditions. This work presents the results of a feasibility study to assess and quantify the correspondent whistle effect to implant damage, residual damage after annealing and intrinsic defects.
NASA Astrophysics Data System (ADS)
Vlachynska, Alzbeta; Oplatkova, Zuzana Kominkova; Sramka, Martin
2017-07-01
The aim of the work is to determine the coordinate system of an eye and insert a polar-axis system into images captured by a slip lamp. The image of the eye with the polar axis helps a surgeon accurately implant toric intraocular lens in the required position/rotation during the cataract surgery. In this paper, two common algorithms for pupil detection are compared: the circle Hough transform and Daugman's algorithm. The procedures were tested and analysed on the anonymous data set of 128 eyes captured at Gemini eye clinic in 2015.
Encoding and decoding amplitude-modulated cochlear implant stimuli—a point process analysis
Shea-Brown, Eric; Rubinstein, Jay T.
2010-01-01
Cochlear implant speech processors stimulate the auditory nerve by delivering amplitude-modulated electrical pulse trains to intracochlear electrodes. Studying how auditory nerve cells encode modulation information is of fundamental importance, therefore, to understanding cochlear implant function and improving speech perception in cochlear implant users. In this paper, we analyze simulated responses of the auditory nerve to amplitude-modulated cochlear implant stimuli using a point process model. First, we quantify the information encoded in the spike trains by testing an ideal observer’s ability to detect amplitude modulation in a two-alternative forced-choice task. We vary the amount of information available to the observer to probe how spike timing and averaged firing rate encode modulation. Second, we construct a neural decoding method that predicts several qualitative trends observed in psychophysical tests of amplitude modulation detection in cochlear implant listeners. We find that modulation information is primarily available in the sequence of spike times. The performance of an ideal observer, however, is inconsistent with observed trends in psychophysical data. Using a neural decoding method that jitters spike times to degrade its temporal resolution and then computes a common measure of phase locking from spike trains of a heterogeneous population of model nerve cells, we predict the correct qualitative dependence of modulation detection thresholds on modulation frequency and stimulus level. The decoder does not predict the observed loss of modulation sensitivity at high carrier pulse rates, but this framework can be applied to future models that better represent auditory nerve responses to high carrier pulse rate stimuli. The supplemental material of this article contains the article’s data in an active, re-usable format. PMID:20177761
Hasturk, Hatice; Nguyen, Daniel Huy; Sherzai, Homa; Song, Xiaoping; Soukos, Nikos; Bidlack, Felicitas B; Van Dyke, Thomas E
2013-08-01
The purpose of this study was to compare the impact of the removal of biofilm with hand scalers of different material composition on the surface of implant abutments by assessing the surface topography and residual plaque after scaling using scanning electron microscopy (SEM). Titanium implant analogs from 3 manufacturers (Straumann USA LLC, Andover, Maine, Nobel BioCare USA LLC, Yorba Linda, Cali, Astra Tech Implant Systems, Dentsply, Mölndal, Sweden) were mounted in stone in plastic vials individually with authentic prosthetic abutments. Plaque samples were collected from a healthy volunteer, inoculated into growth medium and incubated with the abutments anaerobically for 1 week. A blinded, calibrated hygienist performed scaling to remove the biofilm using 6 implant scalers (in triplicate), 1 scaler for 1 abutment. The abutments were mounted on an imaging stand and processed for SEM. Images were captured in 3 randomly designated areas of interest on each abutment. Analysis of the implant polished abutment surface and plaque area measurements were performed using ImageJ image analysis software. Surface alterations were characterized by the number, length, depth and the width of the scratches observed. Glass filled resin scalers resulted in significantly more and longer scratches on all 3 abutment types compared to other scalers, while unfilled resin scalers resulted in the least surface change (p < 0.05). Filled resin-graphite reinforced scalers, carbon fiber reinforced resin scalers and titanium scalers resulted in more superficial scratches compared to glass filled resin, as well as more scratches than unfilled resin. No statistically significant differences were found between scalers and abutments with regard to plaque removal. The impact of scalers on implant abutment surfaces varies between abutment types presumably due to different surface characteristics with no apparent advantage of one abutment type over the other with regard to resistance to surface damage. Unfilled resin was found consistently to be the least damaging to abutment surfaces, although all scalers of all compositions caused detectable surface changes to polished surfaces of implant abutments.
Qualitative and quantitative observations of bone tissue reactions to anodised implants.
Sul, Young-Taeg; Johansson, Carina B; Röser, Kerstin; Albrektsson, Tomas
2002-04-01
Research projects focusing on biomaterials related factors; the bulk implant material, the macro-design of the implant and the microsurface roughness are routinely being conducted at our laboratories. In this study, we have investigated the bone tissue reactions to turned commercially pure (c.p.) titanium implants with various thicknesses of the oxide films after 6 weeks of insertion in rabbit bone. The control c.p. titanium implants had an oxide thickness of 17-200 nm while the test implants revealed an oxide thickness between 600 and 1000 nm. Routine histological investigations of the tissue reactions around the implants and enzyme histochemical detections of alkaline and acid phosphatase activities demonstrated similar findings around both the control and test implants. In general, the histomorphometrical parameters (bone to implant contact and newly formed bone) revealed significant quantitative differences between the control and test implants. The test implants demonstrated a greater bone response histomorphometrically than control implants and the osteoconductivity was more pronounced around the test implant surfaces. The parameters that differed between the implant surfaces, i.e. the oxide thickness, the pore size distribution, the porosity and the crystallinity of the surface oxides may represent factors that have an influence on the histomorphometrical results indicated by a stronger bone tissue response to the test implant surfaces, with an oxide thickness of more than 600 nm.
Gaydos, Joseph K.; Massey, J. Gregory; Mulcahy, Daniel M.; Gaskins, Lori A.; Nysewander, David; Evenson, Joseph; Siegel, Paul B.; Ziccardi, Michael H.
2011-01-01
Two pilot trials and one study in a closely related grebe species suggest that Western grebes (Aechmophorus occidentalis) will not tolerate intracoelomic transmitter implantation with percutaneous antennae and often die within days of surgery. Wild Western grebes (n = 21) were captured to evaluate a modified surgical technique. Seven birds were surgically implanted with intracoelomic transmitters with percutaneous antennae by using the modified technique (transmitter group), 7 received the same surgery without transmitter implantation (celiotomy group), and 7 served as controls (only undergoing anesthesia). Modifications included laterally offsetting the body wall incision from the skin incision, application of absorbable cyanoacrylate tissue glue to the subcutaneous space between the body wall and skin incisions, application of a waterproof sealant to the skin incision after suture closure, and application of a piece of porcine small intestine submucosa to the antenna egress. Survival did not differ among the 3 groups with 7 of 7 control, 6 of 7 celiotomy, and 6 of 7 transmitter birds surviving the 9-day study. Experimental birds were euthanized at the end of the study, and postmortem findings indicated normal healing. Significant differences in plasma chemistry or immune function were not detected among the 3 groups, and only minor differences were detected in red blood cell indices and plasma proteins. After surgery, the birds in the transmitter group spent more time preening tail feathers than those in the control and celiotomy groups. These results demonstrate that, in a captive situation, celiotomy and intracoelomic transmitter implantation caused minimal detectable homeostatic disturbance in this species and that Western grebes can survive implantation of intracoelomic transmitters with percutaneous antennae. It remains to be determined what potential this modified surgical procedure has to improve postoperative survival of Western grebes that are intracelomically implanted with transmitters with percutaneous antennae and released into the wild.
Morgan, Simeon J; Paolini, Antonio G
2012-06-06
Acute animal preparations have been used in research prospectively investigating electrode designs and stimulation techniques for integration into neural auditory prostheses, such as auditory brainstem implants and auditory midbrain implants. While acute experiments can give initial insight to the effectiveness of the implant, testing the chronically implanted and awake animals provides the advantage of examining the psychophysical properties of the sensations induced using implanted devices. Several techniques such as reward-based operant conditioning, conditioned avoidance, or classical fear conditioning have been used to provide behavioral confirmation of detection of a relevant stimulus attribute. Selection of a technique involves balancing aspects including time efficiency (often poor in reward-based approaches), the ability to test a plurality of stimulus attributes simultaneously (limited in conditioned avoidance), and measure reliability of repeated stimuli (a potential constraint when physiological measures are employed). Here, a classical fear conditioning behavioral method is presented which may be used to simultaneously test both detection of a stimulus, and discrimination between two stimuli. Heart-rate is used as a measure of fear response, which reduces or eliminates the requirement for time-consuming video coding for freeze behaviour or other such measures (although such measures could be included to provide convergent evidence). Animals were conditioned using these techniques in three 2-hour conditioning sessions, each providing 48 stimulus trials. Subsequent 48-trial testing sessions were then used to test for detection of each stimulus in presented pairs, and test discrimination between the member stimuli of each pair. This behavioral method is presented in the context of its utilisation in auditory prosthetic research. The implantation of electrocardiogram telemetry devices is shown. Subsequent implantation of brain electrodes into the Cochlear Nucleus, guided by the monitoring of neural responses to acoustic stimuli, and the fixation of the electrode into place for chronic use is likewise shown.
Kose, Nusret; Çaylak, Remzi; Pekşen, Ceren; Kiremitçi, Abdurrahman; Burukoglu, Dilek; Koparal, Savaş; Doğan, Aydın
2016-02-01
Despite improvement in operative techniques and antibiotic therapy, septic complications still occur in open fractures. We developed silver ion containing ceramic nano powder for implant coating to provide not only biocompatibility but also antibacterial activity to the orthopaedic implants. We hypothesised silver ion doped calcium phosphate based ceramic nano-powder coated titanium nails may prevents bacterial colonisation and infection in open fractures as compared with uncoated nails. 33 rabbits divided into three groups. In the first group uncoated, in the second group hydroxyapatite coated, and in the third group silver doped hydroxyapatite coated titanium nails were inserted left femurs of animals from knee regions with retrograde fashion. Before implantation of nails 50 μl solution containing 10(6)CFU/ml methicillin resistance Staphylococcus aureus (MRSA) injected intramedullary canal. Rabbits were monitored for 10 weeks. Blood was taken from rabbits before surgery and on 2nd, 6th and 10th weeks. Blood was analysed for biochemical parameters, blood count, C-reactive protein and silver levels. At the end of the 10 weeks animals were sacrificed and rods were extracted in a sterile fashion. Swab cultures were taken from intramedullary canal. Bacteria on titanium rods were counted. Liver, heart, spleen, kidney and central nervous tissues samples were taken for determining silver levels. Histopathological evaluation of bone surrounding implants was also performed. No significant difference was detected between the groups from hematologic, biochemical, and toxicological aspect. Microbiological results showed that less bacterial growth was detected with the use of silver doped ceramic coated implants compared to the other two groups (p=0.003). Accumulation of silver was not detected. No cellular inflammation was observed around the silver coated prostheses. No toxic effect of silver on bone cells was seen. Silver ion doped calcium phosphate based ceramic nano powder coating to orthopaedic implants may prevents bacterial colonisation and infection in open fractures compared with those for implants without any coating. Copyright © 2015 Elsevier Ltd. All rights reserved.
Implanted near-infrared spectroscopy for cardiac monitoring
NASA Astrophysics Data System (ADS)
Bhunia, Sourav K.; Cinbis, Can
2011-02-01
Implanted Cardioverter Defibrillator (ICD) provides one of the most effective therapies for the prevention of sudden cardiac death, but also delivers some high voltage shocks inappropriately, causing morbidity and mortality. Implanted near-infrared spectroscopy (NIRS) may augment ICD arrhythmia detection by monitoring skeletal muscle perfusion. A two-wavelength, single-distance, continuous-wave implanted NIRS has been evaluated in-vivo. A weighted difference of the changes in attenuation at two wavelengths, across the isobestic point of the hemoglobin spectra, was taken to be the microvascular oxygenation trend indicator (O2 Index). Although the exact weight depends on the local vascular distribution and their oxygen levels, the hypothesis that a constant weight may be adequate for hemodynamic trending during short arrhythmic episodes, was tested. The sensor was implanted subcutaneously both on fresh tissue and inside scar tissue that formed around a pre-existing implant, in 3 animals each. Attenuations were recorded at 660 and 890 nm during normal sinus rhythm (NSR) and induced ventricular fibrillation (VF). The slope of the O2 Index over 10 seconds was computed for 7 NSR and 8 VF episodes in fresh and 13 NSR and 15 VF episodes in scar tissue pockets. The mean O2 Index slope was significantly different (p<0.0001) between NSR and VF rhythms for both the fresh and scar tissue pockets. Therefore implanted NIRS may be useful for preventing inappropriate detection of VF during electromagnetic interference, double counting of ECG T-wave as an R-wave, ICD lead failure, electrocardiographic aberrancy etc.
Hung, Kuo-Feng; Wang, Feng; Wang, Hao-Wei; Zhou, Wen-Jie; Huang, Wei; Wu, Yi-Qun
2017-06-01
A real-time surgical navigation system potentially increases the accuracy when used for quad-zygomatic implant placement. To evaluate the accuracy of a real-time surgical navigation system when used for quad zygomatic implant placement. Patients with severely atrophic maxillae were prospectively recruited. Four trajectories for implants were planned, and zygomatic implants were placed using a real-time surgical navigation system. The planned-placed distance deviations at entry (entry deviation)points, exit (exit deviation) points, and angle deviation of axes (angle deviation) were measured on fused operation images. The differences of all the deviations between different groups, classified based on the lengths and locations of implants, were analysed. A P value of < 0.05 indicated statistical significance. Forty zygomatic implants were placed as planned in 10 patients. The entry deviation, exit deviation and angle deviation were 1.35 ± 0.75 mm, 2.15 mm ± 0.95 mm, and 2.05 ± 1.02 degrees, respectively. The differences of all deviations were not significant, irrespective of the lengths (P = .259, .158, and .914, respectively) or locations of the placed implants (P = .698, .072, and .602, respectively). A real-time surgical navigation system used for the placement of quad zygomatic implants demonstrated a high level of accuracy with only minimal planned-placed deviations, irrespective of the lengths or locations of the implants. © 2017 Wiley Periodicals, Inc.
Guarnieri, Michael; Tyler, Betty M; Detolla, Louis; Zhao, Ming; Kobrin, Barry
2014-01-01
Long-acting therapy in laboratory animals offers advantages over the current practice of 2-3 daily drug injections. Yet little is known about the disintegration of biodegradable drug implants in rodents. Compare bioavailability of buprenorphine with the biodegradation of lipid-encapsulated subcutaneous drug pellets. Pharmacokinetic and histopathology studies were conducted in BALB/c female mice implanted with cholesterol-buprenorphine drug pellets. Drug levels are below the level of detection (0.5 ng/mL plasma) within 4-5 days of implant. However, necroscopy revealed that interstitial tissues begin to seal implants within a week. Visual inspection of the implant site revealed no evidence of inflammation or edema associated with the cholesterol-drug residue. Chemical analyses demonstrated that the residues contained 10-13% of the initial opiate dose for at least two weeks post implant. The results demonstrate that biodegradable scaffolds can become sequestered in the subcutaneous space. Drug implants can retain significant and unintended reservoirs of drugs.
Guarnieri, Michael; Tyler, Betty M.; DeTolla, Louis; Zhao, Ming; Kobrin, Barry
2014-01-01
Background: Long-acting therapy in laboratory animals offers advantages over the current practice of 2-3 daily drug injections. Yet little is known about the disintegration of biodegradable drug implants in rodents. Objective: Compare bioavailability of buprenorphine with the biodegradation of lipid-encapsulated subcutaneous drug pellets. Methods: Pharmacokinetic and histopathology studies were conducted in BALB/c female mice implanted with cholesterol-buprenorphine drug pellets. Results: Drug levels are below the level of detection (0.5 ng/mL plasma) within 4-5 days of implant. However, necroscopy revealed that interstitial tissues begin to seal implants within a week. Visual inspection of the implant site revealed no evidence of inflammation or edema associated with the cholesterol-drug residue. Chemical analyses demonstrated that the residues contained 10-13% of the initial opiate dose for at least two weeks post implant. Discussion: The results demonstrate that biodegradable scaffolds can become sequestered in the subcutaneous space. Conclusion: Drug implants can retain significant and unintended reservoirs of drugs. PMID:24459402
Saito, Nao; Taru, Chiemi; Miyawaki, Ikuko
2016-12-02
This prospective study clarified changes in the mood states of Japanese patients with implantable cardioverter defibrillators as well as factors related to the mood states. Using a longitudinal repeated-measure design, 29 patients with implantable cardioverter defibrillators completed the Profile of Mood States-Short Form Japanese Version questionnaire before discharge and 1, 4, 7, and 13 months after implantation. One month after discharge, the mood states of the patients with implantable cardioverter defibrillators improved. From 7 to 13 months after discharge, moods deteriorated; 13 months after discharge, moods were equivalent to those at the time of discharge. No relationship with defibrillation experience was detected in this study, but employment, age, sex, and lack of experience of syncopal attack were factors related to poor mood states for patients with implantable cardioverter defibrillators. Therefore, Japanese patients with implantable cardioverter defibrillators with any factor deteriorating their mood state should be monitored so that their mood state does not deteriorate again between six months and one year after implantation.
Mengel, Reiner; Kruse, Björn; Flores-de-Jacoby, Lavin
2006-07-01
The aim of this study of native pig mandibles was to investigate the accuracy and quality of the representation of peri-implant defects by intraoral radiography (IR), panoramic radiography (PR), computer tomography (CT), and digital volume tomography (DVT). The examination was carried out on 19 native pig mandibles. In the toothless sections of the mandibles, one or two implants were inserted. Following the standardized preparation of peri-implant defects (11 each of dehiscences, fenestrations, and 2- to 3-walled intrabony defects), IR, PR, CT, and DVT were performed. The peri-implant defects were measured using appropriate software on the digitized IR and PR image programs. As a control method, the peri-implant bone defects were measured directly using a reflecting stereomicroscope with measuring ocular. The statistical comparison between the measurements of the radiographic scans and those of the direct readings of the peri-implant defects was performed with Pearson's correlation coefficient. The quality of the radiographic scans was determined through the subjective perception and detectability of the peri-implant defects by five independent observers. In the DVT and CT scans, it was possible to measure all the bone defects in three planes. Comparison with the direct peri-implant defect measurements yielded a mean deviation of 0.17+/-0.11 mm for the DVT scans and 0.18+/-0.12 mm for the CT scans. On the IR and PR images, the defects could be detected only in the mesio-distal and cranio-caudal planes. In comparison with the direct measurements of the peri-implant defects, the IR images revealed a mean deviation of 0.34+/-0.30 mm, and the PR images revealed a mean deviation of 0.41+/-0.35 mm. The quality rating of the radiographic images was highest for the DVT scans. Overall, the CT and DVT scans displayed only a slight deviation in the extent of the peri-implant defects. Both radiographic imaging techniques permitted imaging of peri-implant defects in three planes, true to scale, and without overlay or distortion. The DVT scans showed the best imaging quality.
Wein, Wolfgang; Karamalis, Athanasios; Baumgartner, Adrian; Navab, Nassir
2015-06-01
The transfer of preoperative CT data into the tracking system coordinates within an operating room is of high interest for computer-aided orthopedic surgery. In this work, we introduce a solution for intra-operative ultrasound-CT registration of bones. We have developed methods for fully automatic real-time bone detection in ultrasound images and global automatic registration to CT. The bone detection algorithm uses a novel bone-specific feature descriptor and was thoroughly evaluated on both in-vivo and ex-vivo data. A global optimization strategy aligns the bone surface, followed by a soft tissue aware intensity-based registration to provide higher local registration accuracy. We evaluated the system on femur, tibia and fibula anatomy in a cadaver study with human legs, where magnetically tracked bone markers were implanted to yield ground truth information. An overall median system error of 3.7 mm was achieved on 11 datasets. Global and fully automatic registration of bones aquired with ultrasound to CT is feasible, with bone detection and tracking operating in real time for immediate feedback to the surgeon.
[Fusion implants of carbon fiber reinforced plastic].
Früh, H J; Liebetrau, A; Bertagnoli, R
2002-05-01
Carbon fiber reinforced plastics (CFRP) are used in the medical field when high mechanical strength, innovative design, and radiolucency (see spinal fusion implants) are needed. During the manufacturing process of the material CFRP carbon fibers are embedded into a resin matrix. This resin material could be thermoset (e.g., epoxy resin EPN/DDS) or thermoplastic (e.g., PEAK). CFRP is biocompatible, radiolucent, and has higher mechanical capabilities compared to other implant materials. This publication demonstrates the manufacturing process of fusion implants made of a thermoset matrix system using a fiber winding process. The material has been used clinically since 1994 for fusion implants of the cervical and lumbar spine. The results of the fusion systems CORNERSTONE-SR C (cervical) and UNION (lumbar) showed no implant-related complications. New implant systems made of this CFRP material are under investigation and are presented.
Tal, Haim; Weinreb, Miron; Shely, Asaf; Nemcovsky, Carlos E; Moses, Ofer
2016-07-01
The present study evaluated the degradation of collagen matrix (CM) immersed in tetracycline (TTC) or phosphate-buffered saline (PBS) in diabetic and normoglycemic rats. Diabetes was induced in 15 rats by systemic streptozotocin (STZ) (experimental); 15 healthy rats served as controls. One day before implantation 60 CM disks, 5 mm in diameter, were labeled with biotin: 30 were immersed in tetracycline (TTC) and 30 in PBS. One disk of each type was implanted subdermally in each rat. Animals were euthanized after 3 weeks, and tissue specimens containing the disks were prepared for histologic analysis. Horseradish peroxidase (HRP)-conjugated streptavidin was used to detect the remaining biotinylated collagen. Residual collagen area within the CM disks was analyzed and compared to baseline. Diabetes significantly increased the CM degradation. Immersion of the CM disks in a 50-mg/mL TTC solution before implantation decreased its degradation both in diabetic and normoglycemic rats. Diabetes significantly increases collagen matrix degradation; immersion of collagen matrix in TTC before implantation decreases its degradation in both diabetic and normoglycemic conditions. Immersion of medical collagen devices in TTC may be an effective means to decrease their resorption rate and increase their effectiveness, especially in situations with increased degradation such as diabetes.
NASA Astrophysics Data System (ADS)
Wiwanto, Siska; Sulistyani, Lilies Dwi; Latief, Fourier Dzar Eljabbar; Supriadi, Sugeng; Priosoeryanto, Bambang Pontjo; Latief, Benny Syariefsyah
2018-02-01
Study of biodegradations of Magnesium ECAP (Equal Channel Angular Pressing) miniplate in the osteosynthesis system has been used as a new material for plate and screw in oral and maxillofacial surgery. This miniplate and screw that were made of Magnesium ECAP were implanted in the femurs of New Zealand rabbits. The degradation process was detected through pocket gas that appeared in hard and soft tissues surrounding in the implanted miniplates and screws. From the changes on the tissues, we can assess the biodegradation process by measuring the gas pocket through micro-CT Scan. Upon the first month of study we euthanized the rabbits and made a micro-CT Scan to see how far the effect of the gas pocket was. Histological analyses were performed to investigate the local tissue response adjacent to the Magnesium ECAP miniplates. We analyzed the femur of a rabbit a month, three months, and five months after implantation. The result showed a degradation rate in the implanted Magnesium ECAP miniplate of 0.61±0.39 mm/year. Unlike the screws, miniplates have higher water content and blood flow than bone, therefore they degrade faster. This study shows promising results for further development of Magnesium ECAP and in the production of osteosynthesis material for rigid fixation in Oral and Maxillofacial skeleton.
Urgast, Dagmar S; Ellingsen, Dag G; Berlinger, Balázs; Eilertsen, Einar; Friisk, Grete; Skaug, Vidar; Thomassen, Yngvar; Beattie, John H; Kwun, In-Sook; Feldmann, Jörg
2012-07-01
In recent years, bismuth has been promoted as a "green element" and is used as a substitute for the toxic lead in ammunition and other applications. However, the bioavailability and toxicity of bismuth is still not very well described. Following a hunting accident with bismuth-containing shots, a bioavailability study of bismuth from metal pellets inoculated into rat limb muscles was carried out. Bismuth could be found in urine and blood of the animals. Bio-imaging using laser ablation ICP-MS of thin sections of the tissue around the metal implant was carried out to find out more about the distribution of the metal diffusing into the tissue. Two laser ablation systems with different ablation cell designs were compared regarding their analytical performance. Low concentrations of bismuth showing a non-symmetrical pattern were detected in the tissue surrounding the metal implant. This was partly an artefact from cutting the thin sections but also bio-mobilisation of the metals of the implant could be seen. An accumulation of zinc around the implant was interpreted as a marker of inflammation. Challenges regarding sample preparation for laser ablation and bio-imaging of samples of diverse composition became apparent during the analysis.
(68)Ga-DOTA-Siglec-9 PET/CT imaging of peri-implant tissue responses and staphylococcal infections.
Ahtinen, Helena; Kulkova, Julia; Lindholm, Laura; Eerola, Erkki; Hakanen, Antti J; Moritz, Niko; Söderström, Mirva; Saanijoki, Tiina; Jalkanen, Sirpa; Roivainen, Anne; Aro, Hannu T
2014-01-01
Staphylococcus epidermidis (S. epidermidis) has emerged as one of the leading pathogens of biomaterial-related infections. Vascular adhesion protein-1 (VAP-1) is an inflammation-inducible endothelial molecule controlling extravasation of leukocytes. Sialic acid-binding immunoglobulin-like lectin 9 (Siglec-9) is a leukocyte ligand of VAP-1. We hypothesized that (68)Ga-labeled 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid-conjugated Siglec-9 motif containing peptide ((68)Ga-DOTA-Siglec-9) could detect inflammatory response due to S. epidermidis peri-implant infection by positron emission tomography (PET). Thirty Sprague-Dawley rats were randomized into three groups. A sterile catheter was implanted into the medullary canal of the left tibia. In groups 1 and 2, the implantation was followed by peri-implant injection of S. epidermidis or Staphylococcus aureus (S. aureus) with adjunct injections of aqueous sodium morrhuate. In group 3, sterile saline was injected instead of bacteria and no aqueous sodium morrhuate was used. At 2 weeks after operation, (68)Ga-DOTA-Siglec-9 PET coupled with computed tomography (CT) was performed with the measurement of the standardized uptake value (SUV). The presence of the implant-related infection was verified by microbiological analysis, imaging with fluorescence microscope, and histology. The in vivo PET results were verified by ex vivo measurements by gamma counter. In group 3, the tibias with implanted sterile catheters showed an increased local uptake of (68)Ga-DOTA-Siglec-9 compared with the intact contralateral bones (SUVratio +29.5%). (68)Ga-DOTA-Siglec-9 PET detected inflammation induced by S. epidermidis and S. aureus catheter-related bone infections (SUVratio +58.1% and +41.7%, respectively). The tracer uptake was significantly higher in the S. epidermidis group than in group 3 without bacterial inoculation, but the difference between S. epidermidis and S. aureus groups was not statistically significant. The difference between the S. aureus group and group 3 was neither statistically significant. PET/CT imaging with novel (68)Ga-DOTA-Siglec-9 tracer was able to detect inflammatory tissue response induced by catheter implantation and staphylococcal infections.
68Ga-DOTA-Siglec-9 PET/CT imaging of peri-implant tissue responses and staphylococcal infections
2014-01-01
Background Staphylococcus epidermidis (S. epidermidis) has emerged as one of the leading pathogens of biomaterial-related infections. Vascular adhesion protein-1 (VAP-1) is an inflammation-inducible endothelial molecule controlling extravasation of leukocytes. Sialic acid-binding immunoglobulin-like lectin 9 (Siglec-9) is a leukocyte ligand of VAP-1. We hypothesized that 68Ga-labeled 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid-conjugated Siglec-9 motif containing peptide (68Ga-DOTA-Siglec-9) could detect inflammatory response due to S. epidermidis peri-implant infection by positron emission tomography (PET). Methods Thirty Sprague-Dawley rats were randomized into three groups. A sterile catheter was implanted into the medullary canal of the left tibia. In groups 1 and 2, the implantation was followed by peri-implant injection of S. epidermidis or Staphylococcus aureus (S. aureus) with adjunct injections of aqueous sodium morrhuate. In group 3, sterile saline was injected instead of bacteria and no aqueous sodium morrhuate was used. At 2 weeks after operation, 68Ga-DOTA-Siglec-9 PET coupled with computed tomography (CT) was performed with the measurement of the standardized uptake value (SUV). The presence of the implant-related infection was verified by microbiological analysis, imaging with fluorescence microscope, and histology. The in vivo PET results were verified by ex vivo measurements by gamma counter. Results In group 3, the tibias with implanted sterile catheters showed an increased local uptake of 68Ga-DOTA-Siglec-9 compared with the intact contralateral bones (SUVratio +29.5%). 68Ga-DOTA-Siglec-9 PET detected inflammation induced by S. epidermidis and S. aureus catheter-related bone infections (SUVratio +58.1% and +41.7%, respectively). The tracer uptake was significantly higher in the S. epidermidis group than in group 3 without bacterial inoculation, but the difference between S. epidermidis and S. aureus groups was not statistically significant. The difference between the S. aureus group and group 3 was neither statistically significant. Conclusion PET/CT imaging with novel 68Ga-DOTA-Siglec-9 tracer was able to detect inflammatory tissue response induced by catheter implantation and staphylococcal infections. PMID:25520903
Influence of red wine fermentation oenological additives on inoculated strain implantation.
Duarte, Filomena L; Alves, Ana Claudia; Alemão, Maria Filomena; Baleiras-Couto, M Margarida
2013-06-01
Pure selected cultures of Saccharomyces cerevisiae starters are regularly used in the wine industry. A survey of S. cerevisiae populations during red wine fermentations was performed in order to evaluate the influence of oenological additives on the implantation of the inoculated strain. Pilot scale fermentations (500 L) were conducted with active dry yeast (ADY) and other commercial oenological additives, namely two commercial fermentation activators and two commercial tannins. Six microsatellite markers were used to type S. cerevisiae strains. The methodology proved to be very discriminating as a great diversity of wild strains (48 genotypes) was detected. Statistical analysis confirmed a high detection of the inoculated commercial strain, and for half the samples an effective implantation of ADY (over 80 %) was achieved. At late fermentation time, ADY strain implantation in fermentations conducted with commercial additives was lower than in the control. These results question the efficacy of ADY addition in the presence of other additives, indicating that further studies are needed to improve knowledge on oenological additives' use.
Baldassano, Steven N; Brinkmann, Benjamin H; Ung, Hoameng; Blevins, Tyler; Conrad, Erin C; Leyde, Kent; Cook, Mark J; Khambhati, Ankit N; Wagenaar, Joost B; Worrell, Gregory A; Litt, Brian
2017-06-01
There exist significant clinical and basic research needs for accurate, automated seizure detection algorithms. These algorithms have translational potential in responsive neurostimulation devices and in automatic parsing of continuous intracranial electroencephalography data. An important barrier to developing accurate, validated algorithms for seizure detection is limited access to high-quality, expertly annotated seizure data from prolonged recordings. To overcome this, we hosted a kaggle.com competition to crowdsource the development of seizure detection algorithms using intracranial electroencephalography from canines and humans with epilepsy. The top three performing algorithms from the contest were then validated on out-of-sample patient data including standard clinical data and continuous ambulatory human data obtained over several years using the implantable NeuroVista seizure advisory system. Two hundred teams of data scientists from all over the world participated in the kaggle.com competition. The top performing teams submitted highly accurate algorithms with consistent performance in the out-of-sample validation study. The performance of these seizure detection algorithms, achieved using freely available code and data, sets a new reproducible benchmark for personalized seizure detection. We have also shared a 'plug and play' pipeline to allow other researchers to easily use these algorithms on their own datasets. The success of this competition demonstrates how sharing code and high quality data results in the creation of powerful translational tools with significant potential to impact patient care. © The Author (2017). Published by Oxford University Press on behalf of the Guarantors of Brain. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
Li, Meiyan; Li, Meng; Sun, Ling; Han, Tian; Ding, Lan; Xiang, Jun; Zhou, Xingtao
2018-01-01
To investigate re-innervation in the implanted lenticule, as well as changes to the cornea, after correcting hyperopia with an autologous implantation of a lenticule obtained through small incision lenticule extraction (SMILE). This study retrospectively analysed re-innervation in the implanted lenticule, as well as microscopic morphological changes in the corneal architecture of the recipient cornea in five patients (with myopia in one eye and hyperopia in the contralateral eye) who received SMILE in the myopic eye and femtosecond laser in situ keratomileusis (FS-LASIK) combined with lenticule implantation in the contralateral hyperopic eye. Re-innervation in the implanted lenticule, as well as microscopic morphological changes in corneal architecture, were evaluated by in vivo confocal microscopy. One patient was examined at postoperative week six, two were examined at postoperative month two, one was examined at postoperative month nine, and one was examined at postoperative month 12. Partial subbasal nerve fibre regeneration was detected in two patients (Case 4 who was examined at postoperative month nine and Case 5 who was examined at postoperative month 12). Regenerated and branched nerve fibres were detected in the implanted lenticule in Case 5 who was examined at postoperative month 12. Both the anterior and posterior interfaces showed an absence or decrease of keratocytes and the presence of small particles of various brightnesses. Keratocytes in the implanted lenticule presented abnormal morphology in size and shape after surgery in all treated eyes, but showed partial morphological recovery in two patients (Case 4 who was examined at postoperative month nine and Case 5 who was examined at postoperative month 12). These preliminary findings suggest that nerve fibres will regenerate into the implanted lenticule after autologous lenticule implantation. Keratocytes in lenticules demonstrated a gradual return to a normal morphology. © 2017 Optometry Australia.
Junaid, Sarah; Gregory, Thomas; Fetherston, Shirley; Emery, Roger; Amis, Andrew A; Hansen, Ulrich
2018-03-23
Definite glenoid implant loosening is identifiable on radiographs, however, identifying early loosening still eludes clinicians. Methods to monitor glenoid loosening in vitro have not been validated to clinical imaging. This study investigates the correlation between in vitro measures and CT images. Ten cadaveric scapulae were implanted with a pegged glenoid implant and fatigue tested to failure. Each scapulae were cyclically loaded superiorly and CT scanned every 20,000 cycles until failure to monitor progressive radiolucent lines. Superior and inferior rim displacements were also measured. A finite element (FE) model of one scapula was used to analyze the interfacial stresses at the implant/cement and cement/bone interfaces. All ten implants failed inferiorly at the implant-cement interface, two also failed at the cement-bone interface inferiorly, and three showed superior failure. Failure occurred at of 80,966 ± 53,729 (mean ± SD) cycles. CT scans confirmed failure of the fixation, and in most cases, was observed either before or with visual failure. Significant correlations were found between inferior rim displacement, vertical head displacement and failure of the glenoid implant. The FE model showed peak tensile stresses inferiorly and high compressive stresses superiorly, corroborating experimental findings. In vitro monitoring methods correlated to failure progression in clinical CT images possibly indicating its capacity to detect loosening earlier for earlier clinical intervention if needed. Its use in detecting failure non-destructively for implant development and testing is also valuable. The study highlights failure at the implant-cement interface and early signs of failure are identifiable in CT images. © 2018 The Authors. Journal of Orthopaedic Research ® Published by Wiley Periodicals, Inc. on behalf of the Orthopaedic Research Society. J Orthop Res 9999:XX-XX, 2018. © 2018 The Authors. Journal of Orthopaedic Research® Published by Wiley Periodicals, Inc. on behalf of the Orthopaedic Research Society.
Ion implantation for deterministic single atom devices
NASA Astrophysics Data System (ADS)
Pacheco, J. L.; Singh, M.; Perry, D. L.; Wendt, J. R.; Ten Eyck, G.; Manginell, R. P.; Pluym, T.; Luhman, D. R.; Lilly, M. P.; Carroll, M. S.; Bielejec, E.
2017-12-01
We demonstrate a capability of deterministic doping at the single atom level using a combination of direct write focused ion beam and solid-state ion detectors. The focused ion beam system can position a single ion to within 35 nm of a targeted location and the detection system is sensitive to single low energy heavy ions. This platform can be used to deterministically fabricate single atom devices in materials where the nanostructure and ion detectors can be integrated, including donor-based qubits in Si and color centers in diamond.
Ion implantation for deterministic single atom devices
Pacheco, J. L.; Singh, M.; Perry, D. L.; ...
2017-12-04
Here, we demonstrate a capability of deterministic doping at the single atom level using a combination of direct write focused ion beam and solid-state ion detectors. The focused ion beam system can position a single ion to within 35 nm of a targeted location and the detection system is sensitive to single low energy heavy ions. This platform can be used to deterministically fabricate single atom devices in materials where the nanostructure and ion detectors can be integrated, including donor-based qubits in Si and color centers in diamond.
Kon, Elizaveta; Robinson, Dror; Verdonk, Peter; Drobnic, Matej; Patrascu, Jenel Mariano; Dulic, Oliver; Gavrilovic, Gordon; Filardo, Giuseppe
2016-12-01
Chondral and osteochondral lesions represent a debilitating disease. Untreated lesions remain a risk factor for more extensive joint damage. The objective of this clinical study is to evaluate safety and early results of an aragonite-based scaffold used for osteochondral unit repair, by analysing both clinical outcome and MRI results, as well as the benefits of the procedure optimization through novel tapered shaped implants. A crystalline aragonite bi-phasic scaffold was implanted in patients affected by focal chondral-osteochondral knee lesions of the condyle and trochlea. Twenty-one patients (17 men, 4 women with a mean age of 31.0 ± 8.6 years) without severe OA received tapered shaped implants for the treatment of 2.5 ±1.7 cm 2 sized defects. The control group consisted of 76 patients selected according to the same criteria from a database of patients who previously underwent implantation of cylindrical-shaped implants. The clinical outcome of all patients was evaluated with the IKDC subjective score, the Lysholm score, and all 5 KOOS subscales administered preoperatively and at 6 and 12 months after surgery, while MRI evaluation was performed at the 12 month follow-up. A statistically significant improvement in all clinical scores was documented both in the tapered implants and the cylindrical group. No difference could be detected in the comparison between the improvement obtained with the two implant types, neither in the clinical nor in imaging evaluations. A difference could be detected instead in terms of revision rate, which was lower in the tapered implant group with no implant removal - 0% vs 8/76-10.5% failures in the cylindrical implants. This study highlighted both safety and potential of a novel aragonite-based scaffold for the treatment of chondral and osteochondral lesions in humans. A tapered shape relative to the cylindrical shaped implant design, improved the scaffold's safety profile. Tapered scaffolds maintain the clinical improvement observed in cylindrical implants while reducing the postoperative risk of revision surgery. This aragonite-based implant was associated with a significant clinical improvement at the 12 month follow-up. Moreover, MRI findings revealed graft integration with good bone and cartilage formation. Copyright © 2016 Elsevier Ltd. All rights reserved.
Real-time in vivo detection of biomaterial-induced reactive oxygen species.
Liu, Wendy F; Ma, Minglin; Bratlie, Kaitlin M; Dang, Tram T; Langer, Robert; Anderson, Daniel G
2011-03-01
The non-specific host response to implanted biomaterials is often a key challenge of medical device design. To evaluate biocompatibility, measuring the release of reactive oxygen species (ROS) produced by inflammatory cells in response to biomaterial surfaces is a well-established method. However, the detection of ROS in response to materials implanted in vivo has not yet been demonstrated. Here, we develop a bioluminescence whole animal imaging approach to observe ROS released in response to subcutaneously-implanted materials in live animals. We compared the real-time generation of ROS in response to two representative materials, polystyrene and alginate, over the course of 28 days. High levels of ROS were observed near polystyrene, but not alginate implants, and persisted throughout the course of 28 days. Histological analysis revealed that high levels of ROS correlated not only with the presence of phagocytic cells at early timepoints, but also fibrosis at later timepoints, suggesting that ROS may be involved in both the acute and chronic phase of the foreign body response. These data are the first in vivo demonstration of ROS generation in response to implanted materials, and describe a novel technique to evaluate the host response. Copyright © 2010 Elsevier Ltd. All rights reserved.
Feldman, David S; Moazami, Nader; Adamson, Philip B; Vierecke, Juliane; Raval, Nir; Shreenivas, Satya; Cabuay, Barry M; Jimenez, Javier; Abraham, William T; O'Connell, John B; Naka, Yoshifumi
Proper timing of left ventricular assist device (LVAD) implantation in advanced heart failure patients is not well established and is an area of intense interest. In addition, optimizing LVAD performance after implantation remains difficult and represents a significant clinical need. Implantable hemodynamic monitoring systems may provide physicians with the physiologic information necessary to improve the timing of LVAD implantation as well as LVAD performance when compared with current methods. The CardioMEMS Heart sensor Allows for Monitoirng of Pressures to Improve Outcomes in NYHA Class III heart failure patients (CHAMPION) Trial enrolled 550 previously hospitalized patients with New York Heart Association (NYHA) class III heart failure. All patients were implanted with a pulmonary artery (PA) pressure monitoring system and randomized to a treatment and control groups. In the treatment group, physicians used the hemodynamic information to make heart failure management decisions. This information was not available to physicians for the control group. During an average of 18 month randomized follow-up, 27 patients required LVAD implantation. At the time of PA pressure sensor implantation, patients ultimately requiring advanced therapy had higher PA pressures, lower systemic pressure, and similar cardiac output measurements. Treatment and control patients in the LVAD subgroup had similar clinical profiles at the time of enrollment. There was a trend toward a shorter length of time to LVAD implantation in the treatment group when hemodynamic information was available. After LVAD implantation, most treatment group patients continued to provide physicians with physiologic information from the hemodynamic monitoring system. As expected PA pressures declined significantly post LVAD implant in all patients, but the magnitude of decline was higher in patients with PA pressure monitoring. Implantable hemodynamic monitoring appeared to improve the timing of LVAD implantation as well as optimize LVAD performance when compared with current methods. Further studies are necessary to evaluate these findings in a prospective manner.
MRI information for commonly used otologic implants: review and update.
Azadarmaki, Roya; Tubbs, Rhonda; Chen, Douglas A; Shellock, Frank G
2014-04-01
To review information on magnetic resonance imaging (MRI) issues for commonly used otologic implants. Manufacturing companies, National Library of Medicine's online database, and an additional online database (www.MRIsafety.com). A literature review of the National Library of Medicine's online database with focus on MRI issues for otologic implants was performed. The MRI information on implants provided by manufacturers was reviewed. Baha and Ponto Pro osseointegrated implants' abutment and fixture and the implanted magnet of the Sophono Alpha 1 and 2 abutment-free systems are approved for 3-Tesla magnetic resonance (MR) systems. The external processors of these devices are MR Unsafe. Of the implants tested, middle ear ossicular prostheses, including stapes prostheses, except for the 1987 McGee prosthesis, are MR Conditional for 1.5-Tesla (and many are approved for 3-Tesla) MR systems. Cochlear implants with removable magnets are approved for patients undergoing MRI at 1.5 Tesla after magnet removal. The MED-EL PULSAR, SONATA, CONCERT, and CONCERT PIN cochlear implants can be used in patients undergoing MRI at 1.5 Tesla with application of a protective bandage. The MED-EL COMBI 40+ can be used in 0.2-Tesla MR systems. Implants made from nonmagnetic and nonconducting materials are MR Safe. Knowledge of MRI guidelines for commonly used otologic implants is important. Guidelines on MRI issues approved by the US Food and Drug Administration are not always the same compared with other parts of the world. This monograph provides a current reference for physicians on MRI issues for commonly used otologic implants.
Terrier, Alexandre; Latypova, Adeliya; Guillemin, Maika; Parvex, Valérie; Guyen, Olivier
2017-03-01
Constrained devices, standard implants with large heads, and dual mobility systems have become popular options to manage instability after total hip arthroplasty (THA). Clinical results with these options have shown variable success rates and significant higher rates of aseptic loosening and mechanical failures with constrained implants. Literature suggests potential advantages of dual mobility, however little is known about its biomechanics. We present a comparative biomechanical study of a standard implant, a constrained implant, and a dual mobility system. A finite element analysis was developed to assess and compare these acetabular options with regard to the range of motion (ROM) to impingement, the angle of dislocation, the resistive torque, the volume of polyethylene (PE) with a stress above 80% of the elastic limit, and the interfacial cup/bone stress. Dual mobility implants provided the greatest ROM to impingement and allowed delaying subluxation and dislocation when compared to standard and constrained implants. Dual mobility also demonstrated the lowest resistive torque at subluxation while the constrained implant provided the greatest one. The lowest critical PE volume was observed with the dual mobility implant, and the highest stress at the interfaces was observed with the constrained implant. This study highlights the biomechanical advantages of dual mobility systems over constrained and standard implants, and is supported by the clinical results reported. Therefore, the use of dual mobility systems in situations at risk for instability should be advocated and constrained implants should be restricted to salvage situations.
Acoustic emission studies of posterior stabilized and cruciate retaining knee arthroplasties.
Schwarzkopf, Ran; Kummer, Frederick J; Jaffe, William L
2011-09-01
Different acoustic frequencies have been used to diagnose progression of osteoarthritis, gross pathology, and wear in knee prostheses. It is possible that detailed analysis of higher frequencies could detect and quantify the smaller geometric changes (asperities) that develop in articular prosthetic wear. In this study we evaluated the feasibility of using ultrasonic emission to determine total knee arthroplasty (TKA) type and time from implantation using a simple, handheld measurement system. We examined the ultrasound emission generated by similar designs of posterior stabilized (PS) and cruciate retaining (CR) total knee prostheses and native knees of 58 patients and 10 controls. The subjects were asked to sit, rise, sit again, and take five steps while recording the acoustic data from both knees. Acoustic emission analysis examined frequency distributions and power spectrums of the recorded signals, and their relations to prosthesis type and time from implantation. We screened 44 CR and 48 PS TKAs, as well as 24 native knees. Analysis of this data suggested a possibility of differentiating between type of implants, and a relation to time since implantation. Our data suggest that we might be able to assess the status and time from implantation of a TKA by acoustic emission signals. Further in vitro analysis of the relationship of wear to ultrasonic emission data are needed for accurate quantification of arthroplasty wear. A simple, in-office screening tool for TKA patients could indicate which patients require closer follow-up and monitoring due to risk of potential problems.
Magnet-Retained Two-Mini-Implant Overdenture: Clinical and Mechanical Consideration.
Ishida, Yuichi; Kumar, H S Kiran; Goto, Takaharu; Watanabe, Megumi; Wigianto, Rudi; Ichikawa, Tetsuo
2016-10-10
Two-implant overdentures have become the accepted treatment for restoring mandibular edentulism. The dimensions of regular implants sometimes limit their use, such as in the case of narrow ridges. Mini-implants with reduced diameters (less than 3.0 mm) enable insertion into narrow ridges. A magnet-retained two-mini-implant overdenture system was developed and is described in this paper. Additionally, we describe a clinical mandibular procedure using the system and evaluate its biomechanical performance.
Magnet-Retained Two-Mini-Implant Overdenture: Clinical and Mechanical Consideration
Ishida, Yuichi; Kumar, H. S. Kiran; Goto, Takaharu; Watanabe, Megumi; Wigianto, Rudi; Ichikawa, Tetsuo
2016-01-01
Two-implant overdentures have become the accepted treatment for restoring mandibular edentulism. The dimensions of regular implants sometimes limit their use, such as in the case of narrow ridges. Mini-implants with reduced diameters (less than 3.0 mm) enable insertion into narrow ridges. A magnet-retained two-mini-implant overdenture system was developed and is described in this paper. Additionally, we describe a clinical mandibular procedure using the system and evaluate its biomechanical performance. PMID:29563477
Petsinis, Vassilis; Kamperos, Georgios; Alexandridi, Foteini; Alexandridis, Konstantinos
2017-08-01
To evaluate the impact of glucocorticosteroids, administered for the treatment of systemic diseases, on the osseointegration and survival of dental implants placed without bone grafting. A retrospective study was conducted in search of patients treated with dental implants while receiving glucocorticosteroid therapy for various systemic diseases. In these cases, a conventional two-stage surgical protocol was used, without bone regeneration procedures. The osseointegration was clinically and radiographically tested at the uncovering of the implants. The follow-up after loading was set at a minimum of 3 years. A total of 31 patients were included in the study. Of the 105 dental implants placed, 104 were osseointegrated (99%). No bone absorption was radiographically noted at the uncovering of the osseointegrated implants. All of the osseointegrated implants were successfully loaded for the prosthetic restoration. The mean follow-up period after loading was 71 months, with an implant survival rate of 99%. Glucocorticosteroid intake for systemic diseases does not have a significant impact on the osseointegration and the 3-year survival of dental implants placed with a conventional two-stage surgical protocol and without bone grafting. Therefore, it should not be considered a contraindication for dental implant placement. Copyright © 2017 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.
Parsley, Michael J.
2009-01-01
Acoustic transmitters implanted in green sturgeon (Acipenser medirostris) captured in rivers in California were detected by acoustic receivers deployed within and around Baker Bay. The receivers were deployed at eight locations in the Bay and adjacent navigation channels of the Lower Columbia River during a period of anticipated channel dredging. Three of the transmitters detected were confirmed to have been implanted into green sturgeon in previous years; two were from the Sacramento River and one was from the Klamath River. The transmitters (fish) were within detection range of the receivers for only a short period, which is consistent with findings of earlier studies that green sturgeon make rapid and extensive intra-estuary movements.
A macro- and nanostructure evaluation of a novel dental implant.
Tetè, Stefano; Mastrangelo, Filiberto; Traini, Tonino; Vinci, Raffaele; Sammartino, Gilberto; Marenzi, Gaetano; Gherlone, Enrico
2008-09-01
Success in implant dentistry also comes from the implant macrodesign and nanostructure of its surface. Titanium implant surface treatments have been shown to enhance osseointegration, maximize bone healing, and bone-to-implant contact for predictable clinical results. The aim of the study, was to evaluate the geometric macrodesign and the surface nanostructure of a novel dental implant full contact covering (FCC) obtained by electrochemical procedures. FCC implants were analyzed by scanning electronic microscope, profilometer, and x-ray photoelectron spectroscopy and compared with commercial sandblasted and sandblasted, large-grit acid-etched dental implants. Sample analysis allowed to distinguish the different implant macrodesigns, the step and the profile of the coils that cover the fixture, and the surface characteristics. FCC implant showed novel macro-characteristic of crestal module, coils, and apical zone compared with sandblasted and sandblasted and acid-etched dental implants. Moreover, the FCC nanostructure surface showed roughness values statistically higher than the 2 other surfaces, with a more homogeneity in a peaks and valleys arrangement. Finally, the x-ray photoelectron spectroscopy analysis detected differences between the examined surfaces, with the presence of several contaminants according to the different treatment procedures. Research on new macrostructures and nano morphology should result in a better qualitative and quantitative osseointegration response, with a predictability of the clinical results and long-term success of the implants.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Mehrmohammadi, Mohammad; Kinnick, Randall R.; Fatemi, Mostafa, E-mail: fatemi.mostafa@mayo.edu
2014-09-15
Purpose: Effective permanent prostate brachytherapy (PPB) requires precise placement of radioactive seeds in and around the prostate. The impetus for this research is to examine a new ultrasound-based imaging modality, vibro-acoustography (VA), which may serve to provide a high rate of PPB seed detection while also effecting enhanced prostate imaging. The authors investigate the ability of VA, implemented on a clinical ultrasound (US) scanner and equipped with a quasi-2D (Q2D) array US transducer, to detect and localize PPB seeds in excised prostate specimens. Methods: Nonradioactive brachytherapy seeds were implanted into four excised cadaver prostates. A clinical US scanner equipped withmore » a Q2D array US transducer was customized to acquire both US and C-scan VA images at various depths. The VA images were then used to detect and localize the implanted seeds in prostate tissue. To validate the VA results, computed tomography (CT) images of the same tissue samples were obtained to serve as the reference by which to evaluate the performance of VA in PPB seed detection. Results: The results indicate that VA is capable of accurately identifying the presence and distribution of PPB seeds with a high imaging contrast. Moreover, a large ratio of the PPB seeds implanted into prostate tissue samples could be detected through acquired VA images. Using CT-based seed identification as the standard, VA was capable of detecting 74%–92% of the implanted seeds. Additionally, the angular independency of VA in detecting PPB seeds was demonstrated through a well-controlled phantom experiment. Conclusions: Q2DVA detected a substantial portion of the seeds by using a 2D array US transducer in excised prostate tissue specimens. While VA has inherent advantages associated with conventional US imaging, it has the additional advantage of permitting detection of PPB seeds independent of their orientation. These results suggest the potential of VA as a method for PPB imaging that ultimately may allow US-based real-time intraoperative dosimetry.« less
Mehrmohammadi, Mohammad; Alizad, Azra; Kinnick, Randall R.; Davis, Brian J.; Fatemi, Mostafa
2014-01-01
Purpose: Effective permanent prostate brachytherapy (PPB) requires precise placement of radioactive seeds in and around the prostate. The impetus for this research is to examine a new ultrasound-based imaging modality, vibro-acoustography (VA), which may serve to provide a high rate of PPB seed detection while also effecting enhanced prostate imaging. The authors investigate the ability of VA, implemented on a clinical ultrasound (US) scanner and equipped with a quasi-2D (Q2D) array US transducer, to detect and localize PPB seeds in excised prostate specimens. Methods: Nonradioactive brachytherapy seeds were implanted into four excised cadaver prostates. A clinical US scanner equipped with a Q2D array US transducer was customized to acquire both US and C-scan VA images at various depths. The VA images were then used to detect and localize the implanted seeds in prostate tissue. To validate the VA results, computed tomography (CT) images of the same tissue samples were obtained to serve as the reference by which to evaluate the performance of VA in PPB seed detection. Results: The results indicate that VA is capable of accurately identifying the presence and distribution of PPB seeds with a high imaging contrast. Moreover, a large ratio of the PPB seeds implanted into prostate tissue samples could be detected through acquired VA images. Using CT-based seed identification as the standard, VA was capable of detecting 74%–92% of the implanted seeds. Additionally, the angular independency of VA in detecting PPB seeds was demonstrated through a well-controlled phantom experiment. Conclusions: Q2DVA detected a substantial portion of the seeds by using a 2D array US transducer in excised prostate tissue specimens. While VA has inherent advantages associated with conventional US imaging, it has the additional advantage of permitting detection of PPB seeds independent of their orientation. These results suggest the potential of VA as a method for PPB imaging that ultimately may allow US-based real-time intraoperative dosimetry. PMID:25186418
Pantchenko, Oxana S; Seidman, Seth J; Guag, Joshua W
2011-10-21
Over the last decade, the number of neurostimulator systems implanted in patients has been rapidly growing. Nearly 50, 000 neurostimulators are implanted worldwide annually. The most common type of implantable neurostimulators is indicated for pain relief. At the same time, commercial use of other electromagnetic technologies is expanding, making electromagnetic interference (EMI) of neurostimulator function an issue of concern. Typically reported sources of neurostimulator EMI include security systems, metal detectors and wireless equipment. When near such sources, patients with implanted neurostimulators have reported adverse events such as shock, pain, and increased stimulation. In recent in vitro studies, radio frequency identification (RFID) technology has been shown to inhibit the stimulation pulse of an implantable neurostimulator system during low frequency exposure at close distances. This could potentially be due to induced electrical currents inside the implantable neurostimulator leads that are caused by magnetic field coupling from the low frequency identification system. To systematically address the concerns posed by EMI, we developed a test platform to assess the interference from coupled magnetic fields on implantable neurostimulator systems. To measure interference, we recorded the output of one implantable neurostimulator, programmed for best therapy threshold settings, when in close proximity to an operating low frequency RFID emitter. The output contained electrical potentials from the neurostimulator system and those induced by EMI from the RFID emitter. We also recorded the output of the same neurostimulator system programmed for best therapy threshold settings without RFID interference. Using the Spatially Extended Nonlinear Node (SENN) model, we compared threshold factors of spinal cord fiber excitation for both recorded outputs. The electric current induced by low frequency RFID emitter was not significant to have a noticeable effect on electrical stimulation. We demonstrated a method for analyzing effects of coupled magnetic field interference on implantable neurostimulator system and its electrodes which could be used by device manufacturers during the design and testing phases of the development process.
2011-01-01
Background Over the last decade, the number of neurostimulator systems implanted in patients has been rapidly growing. Nearly 50, 000 neurostimulators are implanted worldwide annually. The most common type of implantable neurostimulators is indicated for pain relief. At the same time, commercial use of other electromagnetic technologies is expanding, making electromagnetic interference (EMI) of neurostimulator function an issue of concern. Typically reported sources of neurostimulator EMI include security systems, metal detectors and wireless equipment. When near such sources, patients with implanted neurostimulators have reported adverse events such as shock, pain, and increased stimulation. In recent in vitro studies, radio frequency identification (RFID) technology has been shown to inhibit the stimulation pulse of an implantable neurostimulator system during low frequency exposure at close distances. This could potentially be due to induced electrical currents inside the implantable neurostimulator leads that are caused by magnetic field coupling from the low frequency identification system. Methods To systematically address the concerns posed by EMI, we developed a test platform to assess the interference from coupled magnetic fields on implantable neurostimulator systems. To measure interference, we recorded the output of one implantable neurostimulator, programmed for best therapy threshold settings, when in close proximity to an operating low frequency RFID emitter. The output contained electrical potentials from the neurostimulator system and those induced by EMI from the RFID emitter. We also recorded the output of the same neurostimulator system programmed for best therapy threshold settings without RFID interference. Using the Spatially Extended Nonlinear Node (SENN) model, we compared threshold factors of spinal cord fiber excitation for both recorded outputs. Results The electric current induced by low frequency RFID emitter was not significant to have a noticeable effect on electrical stimulation. Conclusions We demonstrated a method for analyzing effects of coupled magnetic field interference on implantable neurostimulator system and its electrodes which could be used by device manufacturers during the design and testing phases of the development process. PMID:22014169
The potential of the second sight system bionic eye implant for partial sight restoration.
Luo, Yvonne Hsu-Lin; Fukushige, Eka; Da Cruz, Lyndon
2016-07-01
Second Sight System bionic eye implant, a commercially available visual prosthesis developed by Second Sight Medical Products, has been implanted in over 125 patients with outer retinal dystrophies such as retinitis pigmentosa. The system has gained regulatory approval in both the USA and Europe, and aims to restore vision by electrical stimulation of the nerve cells of the inner retina. In this review, we present the safety profile of this implant from the international clinical trial and discuss the nature and levels of improvement in visual function achieved by patients implanted with the system. Expert commentary: Future developments for the system will be explored following the discussion of the current usefulness of the device, its limitation as and the areas in which further development is necessary.
Micro-nano-biosystems: An overview of European research.
Lymberis, Andreas
2010-06-01
New developments in science, technologies and applications are blurring the boundaries between information and communications technology (ICT), micro-nano systems and life sciences, e.g. through miniaturisation and the ability to manipulate matter at the atomic scale and to interface live and man-made systems. Interdisciplinary research towards integrated systems and their applications based on emerging convergence of information & communication technologies, micro-nano and bio technologies is expected to have a direct influence on healthcare, ageing population and well being. Micro-Nano-Bio Systems (MNBS) research and development activities under the European Union's R&D Programs, Information & Communication Technologies priority address miniaturised, smart and integrated systems for in-vitro testing e.g. lab-on-chips and systems interacting with the human e.g. autonomous implants, endoscopic capsules and robotics for minimally invasive surgery. The MNBS group involves hundreds of key public and private international organisations working on system development and validation in diverse applications such as cancer detection and therapy follow-up, minimally invasive surgery, capsular endocsopy, wearable biochemical monitoring and repairing of vital functions with active implant devices. The paper presents MNBS rationale and activities, discusses key research and innovation challenges and proposes R&D directions to achieve the expected impact on healthcare and quality of life.
Ernstberger, Thorsten; Heidrich, Gabert; Schultz, Wolfgang; Grabbe, Eckhardt
2007-02-01
Intervertebral spacers for anterior spine fusion are made of different materials, such as titanium and cobalt chromium alloys and carbon fiber-reinforced polymers. Implant-related susceptibility artifacts can decrease the quality of MRI scans. The aim of this cadaveric study was to demonstrate the extent that implant-related MRI artifacting affects the postfusion differentiation of determined regions of interest (ROIs). In six cadaveric porcine spines, we evaluated the postimplantation MRI scans of a titanium, cobalt-chromium and carbon spacer that differed in shape and surface qualities. A spacer made of human cortical bone was used as a control. A defined evaluation unit was divided into ROIs to characterize the spinal canal as well as the intervertebral disc space. Considering 15 different MRI sequences read independently by an interobserver-validated team of specialists the artifact-affected image quality of the median MRI slice was rated on a score of 0-3. A maximum score of 18 points (100%) for the determined ROIs was possible. Turbo spin echo sequences produced the best scores for all spacers and the control. Only the control achieved a score of 100%. For the determined ROI maximum scores for the cobalt-chromium, titanium and carbon spacers were 24%, 32% and 84%, respectively. By using favored T1 TSE sequences the carbon spacer showed a clear advantage in postfusion spinal imaging. Independent of artifact dimensions, the scoring system used allowed us to create an implant-related ranking of MRI scan quality in reference to the bone control.
Chongtham, Dhanaraj Singh; Bahl, Ajay; Kumar, Rohit Manoj; Talwar, K K
2007-05-31
We report a patient with hypertrophic cardiomyopathy who received an inappropriate implantable cardioverter defibrillator shock due to electrical interference from a washing machine. This electrical interference was detected as an episode of ventricular fibrillation with delivery of shock without warning symptoms.
Shock whilst gardening--implantable defibrillators & lawn mowers.
Von Olshausen, G; Lennerz, C; Grebmer, C; Pavaci, H; Kolb, C
2014-02-01
Electromagnetic interference with implantable cardioverter defibrillators (ICDs) can cause inappropriate shock delivery or temporary inhibition of ICD functions. We present a case of electromagnetic interference between a lawn mower and an ICD resulting in an inappropriate discharge of the device due to erroneous detection of ventricular fibrillation.
Oshida, Yoshiki; Tuna, Elif B.; Aktören, Oya; Gençay, Koray
2010-01-01
Among various dental materials and their successful applications, a dental implant is a good example of the integrated system of science and technology involved in multiple disciplines including surface chemistry and physics, biomechanics, from macro-scale to nano-scale manufacturing technologies and surface engineering. As many other dental materials and devices, there are crucial requirements taken upon on dental implants systems, since surface of dental implants is directly in contact with vital hard/soft tissue and is subjected to chemical as well as mechanical bio-environments. Such requirements should, at least, include biological compatibility, mechanical compatibility, and morphological compatibility to surrounding vital tissues. In this review, based on carefully selected about 500 published articles, these requirements plus MRI compatibility are firstly reviewed, followed by surface texturing methods in details. Normally dental implants are placed to lost tooth/teeth location(s) in adult patients whose skeleton and bony growth have already completed. However, there are some controversial issues for placing dental implants in growing patients. This point has been, in most of dental articles, overlooked. This review, therefore, throws a deliberate sight on this point. Concluding this review, we are proposing a novel implant system that integrates materials science and up-dated surface technology to improve dental implant systems exhibiting bio- and mechano-functionalities. PMID:20480036
Scherer, Michael D; McGlumphy, Edwin A; Seghi, Robert R; Campagni, Wayne V
2013-01-01
The purpose of this investigation was to evaluate the effects of number and distribution of implants upon in vitro dislodging forces to a simulated implant-supported overdenture and to examine differences between several different attachment systems. An experiment was undertaken utilizing a model simulating a mandibular edentulous ridge with dental implants in positions on the model approximating tooth positions in the natural dentition. A cobalt-chromium-cast testing framework was used to measure the peak load required to disconnect an attachment. Four different types of commercially available attachments were used in various positions on the model in sequence to evaluate the effects of retention and stability of overdentures based on implant number and distribution: (1) ERA, (2) O-Ring, (3) Locator, and (4) Ball. For each group, 10 measurements were made of peak dislodging forces. Means were calculated and differences among the systems, directions, and groups were identified using a repeated measured analysis of variance (α = .05). The interactions between the attachment system, direction of force, and implant number and distribution were statistically significant. Vertical dislodging forces of the simulated overdenture prosthesis increased with additional widely spaced implants. Oblique dislodging forces of the simulated prosthesis increased with additional widely spaced implants except in the two-implant model with all attachments, and in the four-implant groups with Locator attachments. Anteroposterior dislodging forces of a simulated overdenture prosthesis increased with additional widely spaced implants except in the four-implant groups with Ball and Locator attachments. Ball attachments reported the highest levels of retention and stability followed by Locator, O-Ring, and ERA. Within the limitations of this study, retention and stability of an implant overdenture prosthesis are significantly affected by implant number, implant distribution, and abutment type.
Soo, M S; Kornguth, P J; Walsh, R; Elenberger, C D; Georgiade, G S
1996-06-01
Detection of intracapsular rupture of silicone breast prostheses using MR imaging is often performed by identifying the "linguine sign" [1]. The linguine sign is easily differentiated from simple radial folds that are seen in intact implants. However, more subtle signs of intracapsular rupture, including undulating subcapsular lines and the "teardrop sign," are less often recognized [2-5] and may prove difficult for the less experienced radiologist to differentiate from complex radial folds of intact implants. In this essay, we illustrate the MR imaging findings of complex radial folds in intact implants and compare them with findings of incomplete shell collapse in ruptured implants in a surgically confirmed series of explanted silicone breast prostheses.
Hakki, Sema S; Tatar, Gulsah; Dundar, Niyazi; Demiralp, Burak
2017-04-01
The aims of this in vitro study are to compare the efficacy of different cleaning methods in removing debris of failed implants and to detect thermal changes of the implants treated by various scaling instruments. Twenty-seven failed implants and two unused implants as control were included to this study-group 1: plastic curette (P), group 2: titanium curette (T), group 3: carbon curette (C), group 4: titanium brush (TB), group 5: Er:YAG laser (laser 1 (L1) 100 mJ/pulse at 10 Hz), group 6: Er:YAG laser (laser 2 (L2) 150 mJ/pulse at 10 Hz), group 7: Er:YAG laser (laser 3 (L3) 200 mJ/pulse at 10 Hz), group 8: ultrasonic scaler appropriate for titanium (US), group 9: air abrasive method (AA) + citric acid, and group 10: implantoplasty (I). The changes on the treated/untreated titanium surfaces and remnant debris were observed by scanning electron microscopy (SEM). Temperature of the implants before and after treatment was detected using a thermocouple. The use of air abrasive and citric acid combination and Er:YAG laser groups was found as the best methods for the decontamination of titanium surfaces of failed implant. When the hand instruments were compared, titanium curette was found better than both the plastic and the carbon curettes which leave plastics and carbon remnants on the titanium surface. The temperature was higher after hand instrumentation when compared to other experimental groups (p < 0.05). Within the limitations of the present in vitro model, it can be concluded that the best method for decontamination of the implant surface is the use of air abrasives and Er:YAG laser.
Duan, Yourong; Wu, Yao; Wang, Chaoyuan; Chen, Jiyong; Zhang, Xingdong
2003-03-01
Bone-like apatite formation on the surface of calcium phosphate ceramics has been believed to be necessary for new bone to grow on the ceramics and to be related to the osteoinductivity of the material. The research of bone-like apatite formation is a great help to understanding the mechanism of osteoinduction. Synthetic porous calcium phosphate ceramics (HA/TCP = 70/30) were implanted intramuscularly in pigs, dogs, rabbits and rats to make a comparative study of the bone-like apatite formation onto the porous HA/TCP ceramics in different animals. Specimens were harvested at 14 days after implantation. Samples were detected for the surface morphology with SEM. The chemical composition of the sample surface after implantation was analyzed with reflection infrared (R-IR). Obvious bone-like apatite formation could be detected in the sections of porous specimens harvested from all animals after 14 days intramuscular implantation. Crystal deposition could be only observed on the surface of the concave regions of the samples collected from dogs, rabbits and rat. On the contrary, evenly distributed flake-shaped crystal could be found on the pore surface and also on the outer surface of the materials implanted in pigs. The morphology of bone-like apatite in pigs was different from that in the others animals. Bone-like apatite was not observed in dense specimen implanted intramuscularly. Bone-like apatite formed faster on specimens implanted in rabbit than that in other animals. This formation sequence is different from the sequence of osteoinductivity of biphasic calcium phosphate ceramics implanted in these animals. The results demonstrated that the formation of bone-like apatite on materials is a prerequisite condition to their osteoinduction but other factors also play important roles in osteoinduction.
Lavigne, Eric; Holowaty, Eric J; Pan, Sai Yi; Villeneuve, Paul J; Johnson, Kenneth C; Fergusson, Dean A; Morrison, Howard; Brisson, Jacques
2013-04-29
To evaluate whether the stage distribution among women diagnosed as having breast cancer differs between those who have received breast implants for cosmetic purposes and those with no implants and to evaluate whether cosmetic breast augmentation before the detection of breast cancer is a predictor of post-diagnosis survival. Systematic review of observational studies with two meta-analyses. Systematic search of the literature published before September 2012 conducted in Medline, Embase, Global health, CINAHL, IPAB, and PsycINFO. Eligible publications were those that included women diagnosed as having breast cancer and who had had augmentation mammaplasty for cosmetic purposes. The overall odds ratio of the first meta-analysis based on 12 studies was 1.26 (95% confidence interval 0.99 to 1.60; P=0.058; I(2)=35.6%) for a non-localized stage of breast cancer at diagnosis comparing women with implants who had breast cancer and women without implants who had breast cancer. The second meta-analysis, based on five studies, evaluated the relation between cosmetic breast implantation and survival. This meta-analysis showed reduced survival after breast cancer among women who had implants compared with those who did not (overall hazard ratio for breast cancer specific mortality 1.38, 95% confidence interval 1.08 to 1.75). The research published to date suggests that cosmetic breast augmentation adversely affects the survival of women who are subsequently diagnosed as having breast cancer. These findings should be interpreted with caution, as some studies included in the meta-analysis on survival did not adjust for potential confounders. Further investigations are warranted regarding diagnosis and prognosis of breast cancer among women with breast implants.
Modified titanium implant as a gateway to the human body: the implant mediated drug delivery system.
Park, Young-Seok; Cho, Joo-Youn; Lee, Shin-Jae; Hwang, Chee Il
2014-01-01
The aim of this study was to investigate the efficacy of a proposed new implant mediated drug delivery system (IMDDS) in rabbits. The drug delivery system is applied through a modified titanium implant that is configured to be implanted into bone. The implant is hollow and has multiple microholes that can continuously deliver therapeutic agents into the systematic body. To examine the efficacy and feasibility of the IMDDS, we investigated the pharmacokinetic behavior of dexamethasone in plasma after a single dose was delivered via the modified implant placed in the rabbit tibia. After measuring the plasma concentration, the areas under the curve showed that the IMDDS provided a sustained release for a relatively long period. The result suggests that the IMDDS can deliver a sustained release of certain drug components with a high bioavailability. Accordingly, the IMDDS may provide the basis for a novel approach to treating patients with chronic diseases.
Hao, Shiying; Gorjon, Jose; Taylor, Stephen
2014-03-01
This work describes the functions of the external, portable part of a telemetry system for powering and interrogating implantable electrical devices built within orthopaedic implants for real-time data acquisition of strain, load, temperature, humidity and other relevant data (e.g. from inertial sensors). The system contains a battery powered inductive energiser and demodulator to remotely power the implant electronics and demodulate the signals transmitted from the implanted device. Due to the housing of the internal coil, sufficient inductive coupling is obtained between the external and internal tuned circuits to enable simultaneous power and data transmission over the same inductive link. The actual performance of this system when used with one specific implant was studied, and some correspondence made to the relevant theory. Performance factors relating to both power efficiency and data reconstruction were identified. Copyright © 2013 IPEM. Published by Elsevier Ltd. All rights reserved.
Implant-retained craniofacial prostheses for facial defects
Federspil, Philipp A.
2012-01-01
Craniofacial prostheses, also known as epistheses, are artificial substitutes for facial defects. The breakthrough for rehabilitation of facial defects with implant-retained prostheses came with the development of the modern silicones and bone anchorage. Following the discovery of the osseointegration of titanium in the 1950s, dental implants have been made of titanium in the 1960s. In 1977, the first extraoral titanium implant was inserted in a patient. Later, various solitary extraoral implant systems were developed. Grouped implant systems have also been developed which may be placed more reliably in areas with low bone presentation, as in the nasal and orbital region, or the ideally pneumatised mastoid process. Today, even large facial prostheses may be securely retained. The classical atraumatic surgical technique has remained an unchanged prerequisite for successful implantation of any system. This review outlines the basic principles of osseointegration as well as the main features of extraoral implantology. PMID:22073096
Exotic encounters with dental implants: managing complications with unidentified systems.
Mattheos, N; Janda, M Schittek
2012-06-01
As the application of dental implants increases worldwide, so is the number of technical and biological complications that general dental practitioners will be called to manage, while maintaining implant patients. In addition, the greater patient mobility encountered today combined with a growing trend of 'dental implant tourism' will very often result in situations where the dentist is requested to deal with complications in implants placed elsewhere and which sometimes might be of an 'exotic' system one cannot directly recognize. Such a situation can pose significant challenges to even experienced clinicians. The challenges are not only in the scientific field, but often include professional and ethical implications. This case report will discuss strategies for the management of implant complications in cases of unidentified implant systems. Critical factors in such situations would be the clinician's experience and special training, the correct radiographic technique, as well as access to the appropriate tools and devices. © 2012 Australian Dental Association.
NASA Astrophysics Data System (ADS)
Hoskin, HLD; Furie, E.; Collins, W.; Ganey, TM; Schlatterer, DR
2017-05-01
Since Sir John Charnley began his monumental hip arthroplasty work in 1958, clinical researchers have been incrementally improving longevity and functionality of total joint systems, although implant failure occurs on occasion. The purpose of this study is to report the fracture of the humeral tray Morse taper of a reverse total shoulder system (RTSS), which to date has not been reported with metallurgic analysis for any RTSS. There was no reported antecedent fall, motor vehicle collision, or other traumatic event prior to implant fracture in this case. Analysis was performed on the retrieved failed implant by Scanning Electron Microscopy (SEM) and Electron Dispersion Spectroscopy (EDS) in an attempt to determine the failure method, as well as to offer improvements for future implants. At the time of revision surgery all explants were retained from the left shoulder of a 61-year old male who underwent a non-complicated RTSS 4 years prior. The explants, particularly the cracked humeral tray, were processed as required for SEM and EDS. Analysis was performed on the failure sites in order to determine the chemical composition of the different parts of the implant, discover the chemical composition of the filler metal used during the electron beam welding process, and to detect any foreign elements that could suggest corrosion or other evidence of failure etiology. Gross visual inspection of all explants revealed that implant failure was a result of dissociation of the taper from the humeral tray at the weld, leaving the Morse taper embedded in the humeral stem while the tray floated freely in the patient’s shoulder. SEM further confirmed the jagged edges noted grossly at the weld fracture site, both suggesting failure due to torsional forces. EDS detected elevated levels of carbon and oxygen at the fracture site on the taper only and not on the humeral tray. In order to determine the origin of the high levels of C and O, it was considered that in titanium alloys, C and O are used as stabilizers that help raise the temperature at which titanium can be cast. Since the presence of stabilizers reduces ductility and fatigue strength, all interstitial elements are removed after casting. Considering this, the presence of C and O suggests that not all of the interstitials were removed during the manufacturing process, resulting in decreased fatigue strength. Further destructive analytical testing would verify weld quality and failure mode. RTSSs are quite successful in select patients not amenable to traditional shoulder arthroplasty options. This case report highlights how an implant may function well for several years and then suddenly fail without warning. SEM and EDS analysis suggest that residual C and O in the taper lowered the metal implant’s integrity, leading to torsional cracking at the weld junction of the humeral tray and the taper. The elevated levels of C and O measured at fracture sites on both the tray and the taper suggest poor quality filler metal or failure to remove all interstitial elements after casting. In both cases, the results would be decreased fatigue strength and overall toughness, leading to mechanical failure. A manufacturer’s recall of all implants soon followed the reporting of this implant failure; subsequently, the metal materials were changed from Ti6Al4V to both titanium alloy and cobalt-chrome alloy (Co-Cr-Mo). Time will tell if the alterations were sufficient.
Monahan, Torin; Fisher, Jill A
2010-10-01
The aim of this study was to assess empirically the social and ethical risks associated with implantable radio-frequency identification (RFID) devices. Qualitative research included observational studies in twenty-three U.S. hospitals that have implemented new patient identification systems and eighty semi-structured interviews about the social and ethical implications of new patient identification systems, including RFID implants. The study identified three primary social and ethical risks associated with RFID implants: (i) unfair prioritization of patients based on their participation in the system, (ii) diminished trust of patients by care providers, and (iii) endangerment of patients who misunderstand the capabilities of the systems. RFID implants may aggravate inequalities in access to care without any clear health benefits. This research underscores the importance of critically evaluating new healthcare technologies from the perspective of both normative ethics and empirical ethics.
Huang, Xuechen; Denprasert, Petcharat May; Zhou, Li; Vest, Adriana Nicholson; Kohan, Sam; Loeb, Gerald E
2017-09-01
We have developed and applied new methods to estimate the functional life of miniature, implantable, wireless electronic devices that rely on non-hermetic, adhesive encapsulants such as epoxy. A comb pattern board with a high density of interdigitated electrodes (IDE) could be used to detect incipient failure from water vapor condensation. Inductive coupling of an RF magnetic field was used to provide DC bias and to detect deterioration of an encapsulated comb pattern. Diodes in the implant converted part of the received energy into DC bias on the comb pattern. The capacitance of the comb pattern forms a resonant circuit with the inductor by which the implant receives power. Any moisture affects both the resonant frequency and the Q-factor of the resonance of the circuitry, which was detected wirelessly by its effects on the coupling between two orthogonal RF coils placed around the device. Various defects were introduced into the comb pattern devices to demonstrate sensitivity to failures and to correlate these signals with visual inspection of failures. Optimized encapsulation procedures were validated in accelerated life tests of both comb patterns and a functional neuromuscular stimulator under development. Strong adhesive bonding between epoxy and electronic circuitry proved to be necessary and sufficient to predict 1 year packaging reliability of 99.97% for the neuromuscular stimulator.
Development of luminescent pH sensor films for monitoring bacterial growth through tissue.
Wang, Fenglin; Raval, Yash; Chen, Hongyu; Tzeng, Tzuen-Rong J; DesJardins, John D; Anker, Jeffrey N
2014-02-01
Although implanted medical devices (IMDs) offer many benefits, they are susceptible to bacterial colonization and infections. Such infections are difficult to treat because bacteria could form biofilms on the implant surface, which reduce antibiotics penetration and generate local dormant regions with low pH and low oxygen. In addition, these infections are hard to detect early because biofilms are often localized on the surface. Herein, an optical sensor film is developed to detect local acidosis on an implanted surface. The film contains both upconverting particles (UCPs) that serve as a light source and a pH indicator that alters the luminescence spectrum. When irradiated with 980 nm light, the UCPs produce deeply penetrating red light emission, while generating negligible autofluorescence in the tissue. The basic form of the pH indicator absorbs more of upconversion luminescence at 661 nm than at 671 nm and consequently the spectral ratio indicates pH. Implanting this pH sensor film beneath 6-7 mm of porcine tissue does not substantially affect the calibration curve because the peaks are closely spaced. Furthermore, growth of Staphylococcus epidermidis on the sensor surface causes a local pH decrease that can be detected non-invasively through the tissue. Copyright © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
Chrzanowski, Wojciech; Armitage, David Andrew; Knowles, Jonathan Campbell; Szade, Jacek; Korlacki, Wojciech; Marciniak, Jan
2008-07-01
The aim of this work is to examine the corrosion properties, chemical composition, and material-implant interaction after different periods of implantation of plates used to correct funnel chest. The implants are made of 316L stainless steel. Examinations are carried out on three implants: new (nonimplanted) and two implanted for 29 and 35 months. The corrosion study reveals that in the potential range that could occur in the physiological condition the new bar has the lowest current density and the highest corrosion potential. This indicates that the new plate has the highest corrosion resistance and the corrosion resistance could be reduced during implantation by the instruments used during the operation. XPS analysis reveals changes in the surface chemistry. The longer the implantation time the more carbon and oxygen are observed and only trace of elements such as Cr, Mo are detected indicating that surface is covered by an organic layer. On some parts of the implants whitish tissue is observed: the thickness of which increased with the time of implantation. This tissue was identified as an organic layer; mainly attached to the surface on the areas close to where the implant was bent to attain anatomical fit and thus where the implant has higher surface roughness. The study indicates that the chest plates are impaired by the implantation procedure and contact with biological environment. The organic layer on the surface shows that the implant did not stay passive but some reactions at the tissue-implant interface occurred. These reactions should be seen as positive, as it indicates that the implants were accepted by the tissues. Nevertheless, if the implants react, they may continue to release chromium, nickel, and other harmful ions long term as indicated by lower corrosion resistance of the implants following implantation.
Rubio, Juan Carlos; Garcia-Alonso, Maria Cristina; Alonso, Concepcion; Alobera, Miguel Angel; Clemente, Celia; Munuera, Luis; Escudero, Maria Lorenza
2008-01-01
Metallic transfer from implants does not stop at surrounding tissues, and metallic elements may be transferred by proteins to become lodged in organs far from the implant. This work presents an in vivo study of metallic implant corrosion to measure metallic element accumulation in organs located far from the implant, such as kidneys, livers, lungs and spleens. The studied metallic implant materials were CoCr alloy, Ti, and the experimental alloy MA956 coated with alpha-alumina. The implants were inserted in the hind legs of Wistar rats. Analysis for Co, Cr, Ti and Al metallic traces was performed after a long exposure time of 12 months by Inductively Coupled Plasma (ICP) with Mass Spectrometry (MS). According to the results, the highest Cr and Ti concentrations were detected in spleens. Co is mainly found in kidneys, since this element is eliminated via urine. Cr and Ti traces increased significantly in rat organs after the long implantation time. The organs of rats implanted with the alpha-alumina coated experimental MA956 did not present any variation in Al content after 12 months, which means there was no degradation of the alumina layer surface.
NASA Astrophysics Data System (ADS)
Yoshida, Y.; Matsumura, A.; Higeta, K.; Inoue, T.; Shimizu, S.; Motonami, Y.; Sato, M.; Sadahiro, T.; Fujii, K.
1991-07-01
The hardness depth profiles of cemented carbides which were implanted with high-energy B + ions have been estimated using a dynamic microhardness tester. The B + implantations into (16% Co)-cemented WC alloys were carried out under conditions where the implantation energies were 1-3 MeV and the fluences 1 × 10 17-1 × 10 18ions/cm 2. The profiles show that the implanted layer becomes harder as fluences are chosen at higher values and there is a peak at a certain depth which depends on the implantation energy. In X-ray diffraction (XRD) studies of the implanted surface the broadened refraction peaks of only WC and Co are detected and the increments of lattice strain and of residual stress in the near-surface region are observed. It is supposed that the hardening effect should be induced by an increase in residual stress produced by lattice strain. The hardness depth profile in successive implantation of ions with different energies agrees with the compounded profile of each one of the implantations. It is concluded that the hardness depth profile can be controlled under adequate conditions of implantation.
International classification of reliability for implanted cochlear implant receiver stimulators.
Battmer, Rolf-Dieter; Backous, Douglas D; Balkany, Thomas J; Briggs, Robert J S; Gantz, Bruce J; van Hasselt, Andrew; Kim, Chong Sun; Kubo, Takeshi; Lenarz, Thomas; Pillsbury, Harold C; O'Donoghue, Gerard M
2010-10-01
To design an international standard to be used when reporting reliability of the implanted components of cochlear implant systems to appropriate governmental authorities, cochlear implant (CI) centers, and for journal editors in evaluating manuscripts involving cochlear implant reliability. The International Consensus Group for Cochlear Implant Reliability Reporting was assembled to unify ongoing efforts in the United States, Europe, Asia, and Australia to create a consistent and comprehensive classification system for the implanted components of CI systems across manufacturers. All members of the consensus group are from tertiary referral cochlear implant centers. None. A clinically relevant classification scheme adapted from principles of ISO standard 5841-2:2000 originally designed for reporting reliability of cardiac pacemakers, pulse generators, or leads. Standard definitions for device failure, survival time, clinical benefit, reduced clinical benefit, and specification were generated. Time intervals for reporting back to implant centers for devices tested to be "out of specification," categorization of explanted devices, the method of cumulative survival reporting, and content of reliability reports to be issued by manufacturers was agreed upon by all members. The methodology for calculating Cumulative survival was adapted from ISO standard 5841-2:2000. The International Consensus Group on Cochlear Implant Device Reliability Reporting recommends compliance to this new standard in reporting reliability of implanted CI components by all manufacturers of CIs and the adoption of this standard as a minimal reporting guideline for editors of journals publishing cochlear implant research results.
A classification of growth friendly spine implants.
Skaggs, David L; Akbarnia, Behrooz A; Flynn, John M; Myung, Karen S; Sponseller, Paul D; Vitale, Michael G
2014-01-01
Various types of spinal implants have been used with the objective of minimizing spinal deformities while maximizing the spine and thoracic growth in a growing child with a spinal deformity. The aim of this study was to describe a classification system of growth friendly spinal implants to allow researchers and clinicians to have a common language and facilitate comparative studies. Growth friendly spinal implant systems fall into 3 categories based upon the forces of correction the implants exert on the spine, which are as follows: Distraction-based systems correct spinal deformities by mechanically applying a distractive force across a deformed segment with anchors at the top and bottom of the implants, which commonly attach to the spine, rib, and/or the pelvis. The present examples of distraction-based implants are spine-based or rib-based growing rods, vertical expandable titanium rib prosthesis, and remotely expandable devices. Compression-based systems correct spinal deformities with a compressive force applied to the convexity of the curve causing convex growth inhibition. This compressive force may be generated both mechanically at the time of implantation, as well as over time resulting from longitudinal growth of vertebral endplates hindered by the spinal implants. Examples of compression-based systems are vertebral staples and tethers. Guided growth systems correct spinal deformity by anchoring multiple vertebrae (usually including the apical vertebrae) to rods with mechanical forces including translation at the time of the initial implant. The majority of the anchors are not rigidly attached to the rods, thus permitting longitudinal growth over time as the anchors slide over the rods. Examples of guided growth systems include the Luque trolley and Shilla. Each system has its benefits and shortcomings. Knowledge of the fundamental principles upon which these systems are based may aid the clinician to choose an appropriate treatment for patients. Having a common language for these systems may aid in comparative research. Vertical expandable titanium rib prosthesis is used with humanitarian exemption. The other devices mentioned in this manuscript are not approved for growing constructs by the Food and Drug Administration and are used off-label.
Pellegrino, Gerardo; Taraschi, Valerio; Vercellotti, Tomaso; Ben-Nissan, Besim; Marchetti, Claudio
This case report describes new implant site preparation techniques joining the benefits of using an intraoral navigation system to optimize three-dimensional implant site positioning in combination with an ultrasonic osteotomy. A report of five patients is presented, and the implant positions as planned in the navigation software with the postoperative scan image were compared. The preliminary results are useful, although further clinical studies with larger populations are needed to confirm these findings.
Lindenblatt, Nicole; El-Rabadi, Karem; Helbich, Thomas H; Czembirek, Heinrich; Deutinger, Maria; Benditte-Klepetko, Heike
2014-01-01
Silicone gel breast implants may silently rupture without detection. This has been the main reason for magnetic resonance imaging (MRI) of the augmented or reconstructed breast. The aim of the present study was to investigate the accuracy of MRI for implant rupture. Fifty consecutive patients with 85 silicone gel implants were included in the study. The mean age of the patients was 51 (range 21-72) years, with a mean duration of implantation of 3.8 (range 1-28) years. All patients underwent clinical examination and breast MRI. Intraoperative implant rupture was diagnosed by the operating surgeon. Nineteen of the 50 patients suffered from clinical symptoms. An implant rupture was diagnosed by MRI in 22 of 85 implants (26%). In seven of 17 removed implants (41%), the intraoperative diagnosis corresponded with the positive MRI result. However, only 57% of these patients were symptomatic. Ultrasound imaging of the harvested implants showed signs of interrupted inner layers of the implant despite integrity of the outer shell. By microsurgical separation of the different layers of the implant shell, we were able to reproduce this phenomenon and to produce signs of implant rupture on MRI. Our results show that rupture of only the inner layers of the implant shell with integrity of the outer shell leads to a misdiagnosis on MRI. Correlation with clinical symptoms and the specific wishes of the patient should guide the indication for implant removal.
Lindenblatt, Nicole; El-Rabadi, Karem; Helbich, Thomas H; Czembirek, Heinrich; Deutinger, Maria; Benditte-Klepetko, Heike
2014-01-01
Background Silicone gel breast implants may silently rupture without detection. This has been the main reason for magnetic resonance imaging (MRI) of the augmented or reconstructed breast. The aim of the present study was to investigate the accuracy of MRI for implant rupture. Methods Fifty consecutive patients with 85 silicone gel implants were included in the study. The mean age of the patients was 51 (range 21–72) years, with a mean duration of implantation of 3.8 (range 1–28) years. All patients underwent clinical examination and breast MRI. Intraoperative implant rupture was diagnosed by the operating surgeon. Results Nineteen of the 50 patients suffered from clinical symptoms. An implant rupture was diagnosed by MRI in 22 of 85 implants (26%). In seven of 17 removed implants (41%), the intraoperative diagnosis corresponded with the positive MRI result. However, only 57% of these patients were symptomatic. Ultrasound imaging of the harvested implants showed signs of interrupted inner layers of the implant despite integrity of the outer shell. By microsurgical separation of the different layers of the implant shell, we were able to reproduce this phenomenon and to produce signs of implant rupture on MRI. Conclusion Our results show that rupture of only the inner layers of the implant shell with integrity of the outer shell leads to a misdiagnosis on MRI. Correlation with clinical symptoms and the specific wishes of the patient should guide the indication for implant removal. PMID:25114595
Evaluation of bone loss in antibacterial coated dental implants: An experimental study in dogs.
Godoy-Gallardo, Maria; Manzanares-Céspedes, Maria Cristina; Sevilla, Pablo; Nart, José; Manzanares, Norberto; Manero, José M; Gil, Francisco Javier; Boyd, Steven K; Rodríguez, Daniel
2016-12-01
The aim of this study was to evaluate the in vivo effect of antibacterial modified dental implants in the first stages of peri-implantitis. Thirty dental implants were inserted in the mandibular premolar sites of 5 beagle dogs. Sites were randomly assigned to Ti (untreated implants, 10units), Ti_Ag (silver electrodeposition treatment, 10units), and Ti_TSP (silanization treatment, 10units). Coated implants were characterized by scanning electron microscopy, interferometry and X-ray photoelectron spectroscopy. Two months after implant insertion, experimental peri-implantitis was initiated by ligature placement. Ligatures were removed 2months later, and plaque formation was allowed for 2 additional months. Clinical and radiographic analyses were performed during the study. Implant-tissue samples were prepared for micro computed tomography, backscattered scanning electron microscopy, histomorphometric and histological analyses and ion release measurements. X-ray, SEM and histology images showed that vertical bone resorption in treated implants was lower than in the control group (P<0.05). This effect is likely due to the capacity of the treatments to reduce bacteria colonization on the implant surface. Histological analysis suggested an increase of peri-implant bone formation on silanized implants. However, the short post-ligature period was not enough to detect differences in clinical parameters among implant groups. Within the limits of this study, antibacterial surface treatments have a positive effect against bone resorption induced by peri-implantitis. Copyright © 2016 Elsevier B.V. All rights reserved.
Neuro-Prosthetic Implants With Adjustable Electrode Arrays
NASA Technical Reports Server (NTRS)
Whitacre, Jay; DelCastillo, Linda Y.; Mojarradi, Mohammad; Johnson, Travis; West, William; Andersen, Richard
2006-01-01
Brushlike arrays of electrodes packaged with application-specific integrated circuits (ASICs) are undergoing development for use as electronic implants especially as neuro-prosthetic devices that might be implanted in brains to detect weak electrical signals generated by neurons. These implants partly resemble the ones reported in Integrated Electrode Arrays for Neuro-Prosthetic Implants (NPO-21198), NASA Tech Briefs, Vol. 27, No. 2 (February 2003), page 48. The basic idea underlying both the present and previously reported implants is that the electrodes would pick up signals from neurons and the ASICs would amplify and otherwise preprocess the signals for monitoring by external equipment. The figure presents a simplified and partly schematic view of an implant according to the present concept. Whereas the electrodes in an implant according to the previously reported concept would be microscopic wires, the electrodes according to the present concept are in the form of microscopic needles. An even more important difference would be that, unlike the previously reported concept, the present concept calls for the inclusion of microelectromechanical actuators for adjusting the depth of penetration of the electrodes into brain tissue. The prototype implant now under construction includes an array of 100 electrodes and corresponding array of electrode contact pads formed on opposite faces of a plate fabricated by techniques that are established in the art of microelectromechanical systems (MEMS). A mixed-signal ASIC under construction at the time of reporting the information for this article will include 100 analog amplifier channels (one amplifier per electrode). On one face of the mixed-signal ASIC there will be a solder-bump/micro-pad array that will have the same pitch as that of the electrode array, and that will be used to make the electrical and mechanical connections between the electrode array and the ASIC. Once the electrode array and the ASIC are soldered together, the remaining empty space between them will be filled with a biocompatible epoxy, the remaining exposed portions of the ASIC will be covered with micromachined plates for protection against corrosive bodily fluids, and then the ASIC and its covering micromachined plates will be coated with parylene
Sherwood, Leslie C; Aqil, Farrukh; Vadhanam, Manicka V; Jeyabalan, Jeyaprakash; Munagala, Radha; Hoetker, David; Srivastava, Sanjay; Singh, Inder P; Cambron, Scott; O'Toole, Martin; Spencer, Wendy; Parker, Lynn P; Gupta, Ramesh C
2017-12-01
Cervical cancer is caused by human papillomavirus (HPV). The disease develops over many years through a series of precancerous lesions. Cervical cancer can be prevented by HPV-vaccination, screening and treatment of precancer before development of cervical cancer. The treatment of high-grade cervical dysplasia (CIN 2+ ) has traditionally been by cervical conization. Surgical procedures are associated with increased risk of undesirable side effects including bleeding, infection, scarring (stenosis), infertility and complications in later pregnancies. An inexpensive, non-invasive method of delivering therapeutics locally will be favorable to treat precancerous cervical lesions without damaging healthy tissue. The feasibility and safety of a sustained, continuous drug-releasing cervical polymeric implant for use in clinical trials was studied using a large animal model. The goat (Capra hircus), non-pregnant adult female Boer goats, was chosen due to similarities in cervical dimensions to the human. Estrus was induced with progesterone CIDR® vaginal implants for 14days followed by the administration of chorionic gonadotropins 48h prior to removal of the progesterone implants to relax the cervix to allow for the placement of the cervical implant. Cervical implants, containing 2% and 4% withaferin A (WFA), with 8 coats of blank polymer, provided sustained release for a long duration and were used for the animal study. The 'mushroom'-shaped cervical polymeric implant, originally designed for women required redesigning to be accommodated within the goat cervix. The cervical implants were well tolerated by the animals with no obvious evidence of discomfort, systemic or local inflammation or toxicity. In addition, we developed a new method to analyze tissue WFA levels by solvent extractions and LS/MS-MS. WFA was found to be localized to the target and adjacent tissues with 12-16ng WFA/g tissue, with essentially no detectable WFA in distant tissues. This study suggests that the goat is a good large animal model for the future development and evaluation of therapeutic efficacy of continuous local drug delivery by cervical polymeric implants to treat precancerous cervical lesions. Copyright © 2017. Published by Elsevier Inc.
Gandolfi, M G; Taddei, P; Siboni, F; Perrotti, V; Iezzi, G; Piattelli, A; Prati, C
2015-02-01
The creation of micro-textured dental implant surfaces possessing a stimulating activity represents a challenge in implant dentistry; particularly, the formation of a thin, biologically active, calcium-phosphate layer on their surface could help to strengthen the bond to the surrounding bone. The aim of the present study was to characterize in terms of macrostructure, micro-topography and reactivity in simulated body fluid (SBF), the surface of titanium (Ti) implants blasted with TiO2 particles, acid etched with hydrofluoric acid, and activated with Ca and Mg-containing nanoparticles. Sandblasted and acid-etched implants were analyzed by ESEM-EDX (environmental scanning electron microscope with energy dispersive X-ray system) to study the micromorphology of the surface and to perform elemental X-ray microanalysis (microchemical analyses) and element mapping. ESEM-EDX analyses were performed at time 0 and after a 28-day soaking period in SBF Hank's balanced salt solution (HBSS) following ISO 23317 (implants for surgery—in vitro evaluation for apatite-forming ability of implant materials). Microchemical analyses (weight % and atomic %) and element mapping were carried out to evaluate the relative element content, element distribution, and calcium/phosphorus (Ca/P) atomic ratio. Raman spectroscopy was used to assess the possible presence of impurities due to manufacturing and to investigate the phases formed upon HBSS soaking. Micro-morphological analyses showed a micro-textured, highly rough surface with microgrooves. Microchemical analyses showed compositional differences among the apical, middle, and distal thirds. The micro-Raman analyses of the as-received implant showed the presence of amorphous Ti oxide and traces of anatase, calcite, and a carbonaceous material derived from the decomposition of an organic component of lipidic nature (presumably used as lubricant). A uniform layer of Ca-poor calcium phosphates (CaPs) (Ca/P ratio <1.47) was observed after soaking in HBSS; the detection of the 961 cm⁻¹ Raman band confirms this finding. These implants showed a micro-textured surface supporting the formation of CaPs when immersed in SBF. These properties may likely favor bone anchorage and healing by stimulation of mineralizing cells.
Attachment systems for mandibular implant overdentures: a systematic review
Kim, Ha-Young; Lee, Jeong-Yol; Bryant, S. Ross
2012-01-01
PURPOSE The aim of this systematic review was to address treatment outcome according to attachment systems for mandibular implant overdentures in terms of implant survival rate, prosthetic maintenance and complications, and patient satisfaction. MATERIALS AND METHODS A systematic literature search was conducted using PubMed and hand searching of relevant journals considering inclusion and exclusion criteria. Clinical trial studies on mandibular implant overdentures until August, 2010 were selected if more than one type of overdenture attachment was reported. Twenty four studies from 1098 studies were finally included and the data on implant survival rate, prosthetic maintenance and complications, patient satisfaction were analyzed relative to attachment systems. RESULTS Four studies presented implant survival rates (95.8 - 97.5% for bar, 96.2 - 100% for ball, 91.7% for magnet) according to attachment system. Ten other studies presented an implant survival rate ranging from 93.3% to 100% without respect to the attachment groups. Common prosthetic maintenance and complications were replacement of an assay for magnet attachments, and activation of a matrix or clip for ball or bar attachments. Prosthetic maintenance and complications most commonly occurred in the magnet groups. Conflicting findings were found on the rate of prosthetic maintenance and complications comparing ball and bar attachments. Most studies showed no significant differences in patient satisfaction depending upon attachment systems. CONCLUSION The implant survival rate of mandibular overdentures seemed to be high regardless attachment systems. The prosthetic maintenance and complications may be influenced by attachment systems. However patient satisfaction may be independent of the attachment system. PMID:23236571
van Hengel, Ingmar A J; Riool, Martijn; Fratila-Apachitei, Lidy E; Witte-Bouma, Janneke; Farrell, Eric; Zadpoor, Amir A; Zaat, Sebastian A J; Apachitei, Iulian
2017-09-01
Implant-associated infection and limited longevity are two major challenges that orthopedic devices need to simultaneously address. Additively manufactured porous implants have recently shown tremendous promise in improving bone regeneration and osseointegration, but, as any conventional implant, are threatened by infection. In this study, we therefore used rational design and additive manufacturing in the form of selective laser melting (SLM) to fabricate porous titanium implants with interconnected pores, resulting in a 3.75 times larger surface area than corresponding solid implants. The SLM implants were biofunctionalized by embedding silver nanoparticles in an oxide surface layer grown using plasma electrolytic oxidation (PEO) in Ca/P-based electrolytes. The PEO layer of the SLM implants released silver ions for at least 28 days. X-ray diffraction analysis detected hydroxyapatite on the SLM PEO implants but not on the corresponding solid implants. In vitro and ex vivo assays showed strong antimicrobial activity of these novel SLM PEO silver-releasing implants, without any signs of cytotoxicity. The rationally designed SLM porous implants outperformed solid implants with similar dimensions undergoing the same biofunctionalization treatment. This included four times larger amount of released silver ions, two times larger zone of inhibition, and one additional order of magnitude of reduction in numbers of CFU in an ex vivo mouse infection model. Copyright © 2017 Elsevier Ltd. All rights reserved.
Khoshhal, Masoumeh; Vafaei, Fariborz; Najafi, Mahsa; Nikkhah, Masoumeh
2018-01-01
Background. In successful replacement of a tooth with a dental implant, soft tissue esthetic is as important as stability and function of the implant. Quality and quantity of the peri-implant mucosa can influence esthetic outcomes. This study assessed implant esthetic success of two different implant systems. In this regard the interdental papilla was evaluated and the relation-ship between implant type and crestal bone loss adjacent to implant was assessed. Methods. Eighteen patients (11 males, 7 females) with a total of 18 implants participated in this historical cohort study. Patients were divided into two groups based on the type of implants: Implantium group and SPI group; 36 interproximal papillae were evaluated photographically, using Jemt’s papillary presence index (PPI). Radiographic analysis was carried out to find out the relation between bone loss and type of implant. Analysis of data was performed with SPSS 18, using Fisher's exact test, independent t-test, Spearman's correlation coefficient and ANOVA. Results. Comparison of photographs did not show a statistically significant difference in PPI between the two groups (P=0.94). Radiographic evaluation of crestal bone loss adjacent to implant shoulder did not reveal significant differences between the two groups (P=0.30). Conclusion. Implant therapy in the anterior maxilla, using Implantium or SPI system, did not result in significant differences in esthetics. In this study, there was an inverse relationship between the distance of contact point to bone crest and papilla index (P=0.002 in the SPI group) (P=0.02 in the Implantium group). PMID:29732019
Duarte, Antônio R C; Neto, João P Silva; Souza, Júlio C M; Bonachela, Wellington C
2013-06-01
Implant-abutment connections still present failures in the oral cavity due to the loosening of mechanical integrity by detorque and corrosion of the abutment screws. The objective of this study was to evaluate the detorque of dental abutment screws before and after immersion in fluoridated solutions. Five commercial implant-abutment assemblies were assessed in this investigation: (C) Conexão®, (E) Emfils®, (I) INP®, (S) SIN®, and (T) Titanium Fix®. The implants were embedded in an acrylic resin and then placed in a holding device. The abutments were first connected to the implants and torqued to 20 Ncm using a handheld torque meter. The detorque values of the abutments were evaluated after 10 minutes. After applying a second torque of 20 Ncm, implant-abutment assemblies were withdrawn every 3 hours for 12 hours in a fluoridated solution over a period of 90 days. After that period, detorque of the abutments was examined. Scanning electronic microscopy (SEM) associated to energy dispersive spectroscopy (EDS) was applied to inspect the surfaces of abutments. Detorque values of systems C, E, and I immersed in the fluoridated solution were significantly higher than those of the initial detorque. ANOVA demonstrated no significant differences in detorque values between designs S and T. Signs of localized corrosion could not be detected by SEM although chemical analysis by EDS showed the presence of elements involved in corrosive processes. An increase of detorque values recorded on abutments after immersion in fluoridated artificial saliva solutions was noticed in this study. Regarding chemical analysis, such an increase of detorque can result from a corrosion layer formed between metallic surfaces at static contact in the implant-abutment joint during immersion in the fluoridated solutions. © 2012 by the American College of Prosthodontists.
Hahn, Michael; Busse, Björn; Procop, Mathias; Zustin, Jozef; Amling, Michael; Katzer, Alexander
2017-10-01
Most resurfacing systems are manufactured from cobalt-chromium alloys with metal-on-metal (MoM) bearing couples. Because the quantity of particulate metal and corrosion products which can be released into the periprosthetic milieu is greater in MoM bearings than in metal-on-polyethylene (MoP) bearings, it is hypothesized that the quantity and distribution of debris released by the MoM components induce a compositional change in the periprosthetic bone. To determine the validity of this claim, nondestructive µ-X-ray fluorescence analysis was carried out on undecalcified histological samples from 13 femoral heads which had undergone surface replacement. These samples were extracted from the patients after gradient time points due to required revision surgery. Samples from nonintervened femoral heads as well as from a MoP resurfaced implant served as controls. Light microscopy and µ-X-ray fluorescence analyses revealed that cobalt debris was found not only in the soft tissue around the prosthesis and the bone marrow, but also in the mineralized bone tissue. Mineralized bone exposed to surface replacements showed significant increases in cobalt concentrations in comparison with control specimens without an implant. A maximum cobalt concentration in mineralized hard tissue of up to 380 ppm was detected as early as 2 years after implantation. Values of this magnitude are not found in implants with a MoP surface bearing until a lifetime of more than 20 years. This study demonstrates that hip resurfacing implants with MoM bearings present a potential long-term health risk due to rapid cobalt ion accumulation in periprosthetic hard tissue. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 1855-1862, 2017. © 2016 Wiley Periodicals, Inc.
[Design and application of implantable medical device information management system].
Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying
2013-03-01
Through the establishment of implantable medical device information management system, with the aid of the regional joint sharing of resources, we further enhance the implantable medical device traceability management level, strengthen quality management, control of medical risk.
Prospects of using titanium nickelide implants with modified surface in dental implantology.
Razdorsky, V V
2008-06-01
Corrosion resistance and biocompatibility of 60 specimens of titanium nickelide with modified surfaces implanted into spongy bone were studied in rabbit experiments. Specimens modified by molybdenum ions exhibited high inertness and favorable tissue reaction. No accumulation of nickel and titanium ions in animal organs was detected.
Long-term venous access using a subcutaneous implantable drug delivery system.
Soo, K. C.; Davidson, T. I.; Selby, P.; Westbury, G.
1985-01-01
To facilitate long-term venous access in patients receiving chemotherapy, a subcutaneous totally implantable system (Port-a-Cath, Phamacia) has been used in 14 patients. The method of implantation and the advantages over conventional central venous catheters are discussed. The expense of the system necessitates careful patient selection. PMID:4037644
Weiland, Mark A.; Deng, Z. Daniel; Seim, Tom A.; LaMarche, Brian L.; Choi, Eric Y.; Fu, Tao; Carlson, Thomas J.; Thronas, Aaron I.; Eppard, M. Brad
2011-01-01
In 2001 the U.S. Army Corps of Engineers, Portland District (OR, USA), started developing the Juvenile Salmon Acoustic Telemetry System, a nonproprietary sensing technology, to meet the needs for monitoring the survival of juvenile salmonids through eight large hydroelectric facilities within the Federal Columbia River Power System (FCRPS). Initial development focused on coded acoustic microtransmitters and autonomous receivers that could be deployed in open reaches of the river for detection of the juvenile salmonids implanted with microtransmitters as they passed the autonomous receiver arrays. In 2006, the Pacific Northwest National Laboratory began the development of an acoustic receiver system for deployment at hydropower facilities (cabled receiver) for detecting fish tagged with microtransmitters as well as tracking them in two or three dimensions for determining route of passage and behavior as the fish passed at the facility. The additional information on route of passage, combined with survival estimates, is used by the dam operators and managers to make structural and operational changes at the hydropower facilities to improve survival of fish as they pass the facilities through the FCRPS. PMID:22163918
DOE Office of Scientific and Technical Information (OSTI.GOV)
Krempien, Robert; Hoppe, Harald; Kahrs, Lueder
Purpose: The aim of this study is to implement augmented reality in real-time image-guided interstitial brachytherapy to allow an intuitive real-time intraoperative orientation. Methods and Materials: The developed system consists of a common video projector, two high-resolution charge coupled device cameras, and an off-the-shelf notebook. The projector was used as a scanning device by projecting coded-light patterns to register the patient and superimpose the operating field with planning data and additional information in arbitrary colors. Subsequent movements of the nonfixed patient were detected by means of stereoscopically tracking passive markers attached to the patient. Results: In a first clinical study,more » we evaluated the whole process chain from image acquisition to data projection and determined overall accuracy with 10 patients undergoing implantation. The described method enabled the surgeon to visualize planning data on top of any preoperatively segmented and triangulated surface (skin) with direct line of sight during the operation. Furthermore, the tracking system allowed dynamic adjustment of the data to the patient's current position and therefore eliminated the need for rigid fixation. Because of soft-part displacement, we obtained an average deviation of 1.1 mm by moving the patient, whereas changing the projector's position resulted in an average deviation of 0.9 mm. Mean deviation of all needles of an implant was 1.4 mm (range, 0.3-2.7 mm). Conclusions: The developed low-cost augmented-reality system proved to be accurate and feasible in interstitial brachytherapy. The system meets clinical demands and enables intuitive real-time intraoperative orientation and monitoring of needle implantation.« less
Krempien, Robert; Hoppe, Harald; Kahrs, Lüder; Daeuber, Sascha; Schorr, Oliver; Eggers, Georg; Bischof, Marc; Munter, Marc W; Debus, Juergen; Harms, Wolfgang
2008-03-01
The aim of this study is to implement augmented reality in real-time image-guided interstitial brachytherapy to allow an intuitive real-time intraoperative orientation. The developed system consists of a common video projector, two high-resolution charge coupled device cameras, and an off-the-shelf notebook. The projector was used as a scanning device by projecting coded-light patterns to register the patient and superimpose the operating field with planning data and additional information in arbitrary colors. Subsequent movements of the nonfixed patient were detected by means of stereoscopically tracking passive markers attached to the patient. In a first clinical study, we evaluated the whole process chain from image acquisition to data projection and determined overall accuracy with 10 patients undergoing implantation. The described method enabled the surgeon to visualize planning data on top of any preoperatively segmented and triangulated surface (skin) with direct line of sight during the operation. Furthermore, the tracking system allowed dynamic adjustment of the data to the patient's current position and therefore eliminated the need for rigid fixation. Because of soft-part displacement, we obtained an average deviation of 1.1 mm by moving the patient, whereas changing the projector's position resulted in an average deviation of 0.9 mm. Mean deviation of all needles of an implant was 1.4 mm (range, 0.3-2.7 mm). The developed low-cost augmented-reality system proved to be accurate and feasible in interstitial brachytherapy. The system meets clinical demands and enables intuitive real-time intraoperative orientation and monitoring of needle implantation.
Comparison of load distribution for implant overdenture attachments.
Porter, Joseph A; Petropoulos, Vicki C; Brunski, John B
2002-01-01
The aim of this study was to compare the force and moment distributions that develop on different implant overdenture attachments when vertical compressive forces are applied to an implant-retained overdenture. The following attachments were examined: Nobel Biocare bar and clip (NBC), Nobel Biocare standard ball (NSB), Nobel Biocare 2.25-mm-diameter ball (NB2), Zest Anchor Advanced Generation (ZAAG), Sterngold ERA white (SEW), Sterngold ERA orange (SEO), Compliant Keeper System with titanium shims (CK-Ti), Compliant Keeper System with black nitrile 2SR90 sleeve rings (CK-70), and Compliant Keeper System with clear silicone 2SR90 sleeve rings (CK-90). The attachments were tested using custom strain-gauged abutments and 2 Brånemark System implants placed in a test model. Each attachment type had one part embedded in a denture-like housing and the other part (the abutment) screwed into the implants. Compressive static loads of 100 N were applied (1) bilaterally, over the distal midline (DM); (2) unilaterally, over the right implant (RI); (3) unilaterally, over the left implant (LI); and (4) between implants in the mid-anterior region (MA). Both the force and bending moment on each implant were recorded for each loading location and attachment type. Results were analyzed using 2-way analysis of variance and the Duncan multiple-range test. Both loading location and attachment type were statistically significant factors (P < .05). In general, the force and moment on an implant were greater when the load was applied directly over the implant or at MA. While not significant at every loading location, the largest implant forces tended to occur with ZAAG attachments; the smallest were found with the SEW, the SEO, the NSB, the CK-70, and the CK-90. Typically, higher moments existed for NBC and ZAAG, while lower moments existed for SEW, SEO, NSB, CK-90, and CK-70. For different loading locations, significant differences were found among the different overdenture attachment systems.
Adaptive Transcutaneous Power Transfer to Implantable Devices: A State of the Art Review
Bocan, Kara N.; Sejdić, Ervin
2016-01-01
Wireless energy transfer is a broad research area that has recently become applicable to implantable medical devices. Wireless powering of and communication with implanted devices is possible through wireless transcutaneous energy transfer. However, designing wireless transcutaneous systems is complicated due to the variability of the environment. The focus of this review is on strategies to sense and adapt to environmental variations in wireless transcutaneous systems. Adaptive systems provide the ability to maintain performance in the face of both unpredictability (variation from expected parameters) and variability (changes over time). Current strategies in adaptive (or tunable) systems include sensing relevant metrics to evaluate the function of the system in its environment and adjusting control parameters according to sensed values through the use of tunable components. Some challenges of applying adaptive designs to implantable devices are challenges common to all implantable devices, including size and power reduction on the implant, efficiency of power transfer and safety related to energy absorption in tissue. Challenges specifically associated with adaptation include choosing relevant and accessible parameters to sense and adjust, minimizing the tuning time and complexity of control, utilizing feedback from the implanted device and coordinating adaptation at the transmitter and receiver. PMID:26999154
Adaptive Transcutaneous Power Transfer to Implantable Devices: A State of the Art Review.
Bocan, Kara N; Sejdić, Ervin
2016-03-18
Wireless energy transfer is a broad research area that has recently become applicable to implantable medical devices. Wireless powering of and communication with implanted devices is possible through wireless transcutaneous energy transfer. However, designing wireless transcutaneous systems is complicated due to the variability of the environment. The focus of this review is on strategies to sense and adapt to environmental variations in wireless transcutaneous systems. Adaptive systems provide the ability to maintain performance in the face of both unpredictability (variation from expected parameters) and variability (changes over time). Current strategies in adaptive (or tunable) systems include sensing relevant metrics to evaluate the function of the system in its environment and adjusting control parameters according to sensed values through the use of tunable components. Some challenges of applying adaptive designs to implantable devices are challenges common to all implantable devices, including size and power reduction on the implant, efficiency of power transfer and safety related to energy absorption in tissue. Challenges specifically associated with adaptation include choosing relevant and accessible parameters to sense and adjust, minimizing the tuning time and complexity of control, utilizing feedback from the implanted device and coordinating adaptation at the transmitter and receiver.
Durability of implanted electrodes and leads in an upper-limb neuroprosthesis.
Kilgore, Kevin L; Peckham, P Hunter; Keith, Michael W; Montague, Fred W; Hart, Ronald L; Gazdik, Martha M; Bryden, Anne M; Snyder, Scott A; Stage, Thomas G
2003-01-01
Implanted neuroprosthetic systems have been successfully used to provide upper-limb function for over 16 years. A critical aspect of these implanted systems is the safety, stability, and-reliability of the stimulating electrodes and leads. These components are (1) the stimulating electrode itself, (2) the electrode lead, and (3) the lead-to-device connector. A failure in any of these components causes the direct loss of the capability to activate a muscle consistently, usually resulting in a decrement in the function provided by the neuroprosthesis. Our results indicate that the electrode, lead, and connector system are extremely durable. We analyzed 238 electrodes that have been implanted as part of an upper-limb neuroprosthesis. Each electrode had been implanted at least 3 years, with a maximum implantation time of over 16 years. Only three electrode-lead failures and one electrode infection occurred, for a survival rate of almost 99 percent. Electrode threshold measurements indicate that the electrode response is stable over time, with no evidence of electrode migration or continual encapsulation in any of the electrodes studied. These results have an impact on the design of implantable neuroprosthetic systems. The electrode-lead component of these systems should no longer be considered a weak technological link.
A wireless monitoring system for Hydrocephalus shunts.
Narayanaswamy, A; Nourani, M; Tamil, L; Bianco, S
2015-08-01
Patients with Hydrocephalus are usually treated by diverting the excess Cerebrospinal Fluid (CSF) to other parts of the body using shunts. More than 40 percentage of shunts implanted fail within the first two years. Obstruction in the shunts is one of the major causes of failure (45 percent) and the detection of obstruction reduces the complexity of the revision surgery. This paper describes a proposed wireless monitoring system for clog detection and flow measurement in shunts. A prototype was built using multiple pressure sensors along the shunt catheters for sensing the location of clog and flow rate. Regular monitoring of flow rates can be used to adjust the valve in the shunt to prevent over drainage or under drainage of CSF. The accuracy of the flow measurement is more than 90 percent.
Dissolution behavior and early bone apposition of calcium phosphate-coated machined implants
Hwang, Ji-Wan; Lee, Eun-Ung; Lee, Jung-Seok; Jung, Ui-Won; Lee, In-Seop
2013-01-01
Purpose Calcium phosphate (CaP)-coated implants promote osseointegration and survival rate. The aim of this study was to (1) analyze the dissolution behavior of the residual CaP particles of removed implants and (2) evaluate bone apposition of CaP-coated machined surface implants at the early healing phase. Methods Mandibular premolars were extracted from five dogs. After eight weeks, the implants were placed according to drilling protocols: a nonmobile implant (NI) group and rotational implant (RI) group. For CaP dissolution behavior analysis, 8 implants were removed after 0, 1, 2, and 4 weeks. The surface morphology and deposition of the coatings were observed. For bone apposition analysis, block sections were obtained after 1-, 2-, and 4-week healing periods and the specimens were analyzed. Results Calcium and phosphorus were detected in the implants that were removed immediately after insertion, and the other implants were composed mainly of titanium. There were no notable differences between the NI and RI groups in terms of the healing process. The bone-to-implant contact and bone density in the RI group showed a remarkable increase after 2 weeks of healing. Conclusions It can be speculated that the CaP coating dissolves early in the healing phase and chemically induces early bone formation regardless of the primary stability. PMID:24455442
Automated location detection of injection site for preclinical stereotactic neurosurgery procedure
NASA Astrophysics Data System (ADS)
Abbaszadeh, Shiva; Wu, Hemmings C. H.
2017-03-01
Currently, during stereotactic neurosurgery procedures, the manual task of locating the proper area for needle insertion or implantation of electrode/cannula/optic fiber can be time consuming. The requirement of the task is to quickly and accurately find the location for insertion. In this study we investigate an automated method to locate the entry point of region of interest. This method leverages a digital image capture system, pattern recognition, and motorized stages. Template matching of known anatomical identifiable regions is used to find regions of interest (e.g. Bregma) in rodents. For our initial study, we tackle the problem of automatically detecting the entry point.
Noble, Jack H.; Camarata, Stephen M.; Sunderhaus, Linsey W.; Dwyer, Robert T.; Dawant, Benoit M.; Dietrich, Mary S.; Labadie, Robert F.
2018-01-01
Adult cochlear implant (CI) recipients demonstrate a reliable relationship between spectral modulation detection and speech understanding. Prior studies documenting this relationship have focused on postlingually deafened adult CI recipients—leaving an open question regarding the relationship between spectral resolution and speech understanding for adults and children with prelingual onset of deafness. Here, we report CI performance on the measures of speech recognition and spectral modulation detection for 578 CI recipients including 477 postlingual adults, 65 prelingual adults, and 36 prelingual pediatric CI users. The results demonstrated a significant correlation between spectral modulation detection and various measures of speech understanding for 542 adult CI recipients. For 36 pediatric CI recipients, however, there was no significant correlation between spectral modulation detection and speech understanding in quiet or in noise nor was spectral modulation detection significantly correlated with listener age or age at implantation. These findings suggest that pediatric CI recipients might not depend upon spectral resolution for speech understanding in the same manner as adult CI recipients. It is possible that pediatric CI users are making use of different cues, such as those contained within the temporal envelope, to achieve high levels of speech understanding. Further investigation is warranted to investigate the relationship between spectral and temporal resolution and speech recognition to describe the underlying mechanisms driving peripheral auditory processing in pediatric CI users. PMID:29716437
NASA Astrophysics Data System (ADS)
Yang, Jinkyu; Silvestro, Claudio; Sangiorgio, Sophia N.; Borkowski, Sean L.; Ebramzadeh, Edward; De Nardo, Luigi; Daraio, Chiara
2012-01-01
We propose a new biomedical sensing technique based on highly nonlinear solitary waves to assess orthopaedic implant stability in a nondestructive and efficient manner. We assemble a granular crystal actuator consisting of a one-dimensional tightly packed array of spherical particles, to generate acoustic solitary waves. Via direct contact with the specimen, we inject acoustic solitary waves into a biomedical prosthesis, and we nondestructively evaluate the mechanical integrity of the bone-prosthesis interface, studying the properties of the waves reflected from the contact zone between the granular crystal and the implant. The granular crystal contains a piezoelectric sensor to measure the travelling solitary waves, which allows it to function also as a sensor. We perform a feasibility study using total hip arthroplasty (THA) samples made of metallic stems implanted in artificial composite femurs using polymethylmethacrylate for fixation. We first evaluate the sensitivity of the proposed granular crystal sensor to various levels of prosthesis insertion into the composite femur. Then, we impose a sequence of harsh mechanical loading on the THA samples to degrade the mechanical integrity at the stem-cement interfaces, using a femoral load simulator that simulates aggressive, accelerated physiological loading. We investigate the implant stability via the granular crystal sensor-actuator during testing. Preliminary results suggest that the reflected waves respond sensitively to the degree of implant fixation. In particular, the granular crystal sensor-actuator successfully detects implant loosening at the stem-cement interface following violent cyclic loading. This study suggests that the granular crystal sensor and actuator has the potential to detect metal-cement defects in a nondestructive manner for orthopaedic applications.
Localization and Tracking of Implantable Biomedical Sensors
Umay, Ilknur; Fidan, Barış; Barshan, Billur
2017-01-01
Implantable sensor systems are effective tools for biomedical diagnosis, visualization and treatment of various health conditions, attracting the interest of researchers, as well as healthcare practitioners. These systems efficiently and conveniently provide essential data of the body part being diagnosed, such as gastrointestinal (temperature, pH, pressure) parameter values, blood glucose and pressure levels and electrocardiogram data. Such data are first transmitted from the implantable sensor units to an external receiver node or network and then to a central monitoring and control (computer) unit for analysis, diagnosis and/or treatment. Implantable sensor units are typically in the form of mobile microrobotic capsules or implanted stationary (body-fixed) units. In particular, capsule-based systems have attracted significant research interest recently, with a variety of applications, including endoscopy, microsurgery, drug delivery and biopsy. In such implantable sensor systems, one of the most challenging problems is the accurate localization and tracking of the microrobotic sensor unit (e.g., robotic capsule) inside the human body. This article presents a literature review of the existing localization and tracking techniques for robotic implantable sensor systems with their merits and limitations and possible solutions of the proposed localization methods. The article also provides a brief discussion on the connection and cooperation of such techniques with wearable biomedical sensor systems. PMID:28335384
Dual- versus single-coil implantable defibrillator leads: review of the literature.
Neuzner, Jörg; Carlsson, Jörg
2012-04-01
The preferred use of dual-coil implantable defibrillator lead systems in current implantable defibrillator therapy is likely based on data showing statistically lower defibrillation thresholds with dual-coil defibrillator lead systems. The following review will summarize the clinical data for dual- versus single-coil defibrillator leads in the left and right pectoral implant locations, and will then discuss the clinical implications of single- versus dual-coil usage for atrial defibrillation, venous complications, and the risks associated with lead extraction. It will be noted that there are no comparative clinical studies on the use and outcomes of single- versus dual-coil lead systems in implantable defibrillator therapy over a long-term follow-up. The limited long-term reliability of defibrillator leads is a major concern in implantable defibrillator and cardiac resynchronization therapy. A simpler single-coil defibrillator lead system may improve the long-term performance of implanted leads. Furthermore, the superior vena cava coil is suspected to increase interventional risk in transvenous lead extraction. Therefore, the need for objective data on extractions and complications will be emphasized.
Elders with implant overdentures: a 22-year clinical report.
Alsabeeha, Nabeel H M
2012-09-01
To report on the long-term survival and prosthodontic maintenance of two edentulous adults with mandibular overdentures supported by hydroxyapatite (HA)-coated implants. Mandibular implant overdentures are a successful treatment option with positive impact on the quality of life of elderly edentulous adults. Long-term survival of the implants requires continued rigorous prosthodontic maintenance. Two elderly edentulous adults with mandibular overdentures supported by 2 HA-coated implants were presented for prosthodontic rehabilitation after 22 years of placement. The implants were osseo-integrated and surviving at presentation based on accepted criteria. The mandibular implant overdentures suffered recurrent loss of retention and stability. Prosthodontic treatment involving the replacement of defective attachment systems and construction of new sets of mandibular implant overdentures opposing complete maxillary dentures is presented. The long-term survival of mandibular 2-implant overdentures requires continued prosthodontic maintenance. A conservative approach in the rehabilitation of two older edentulous adults with mandibular 2-implant overdentures was described including proper selection of attachment systems. © 2012 The Gerodontology Society and John Wiley & Sons A/S.
Fluorinated polyurethane scaffolds for 19F magnetic resonance imaging
Rahimi, Khosrow; Shi, Yang; Schulz, Volkmar; Kuehne, Alexander J. C.; Jockenhoevel, Stefan; Kiessling, Fabian
2017-01-01
Polymers are increasingly employed in implant materials. To reduce the incidence of complications, which in the case of vascular grafts include incorrect placement and restenosis, materials are needed which allow for image-guided implantation, as well as for accurate and efficient postoperative implant imaging. We here describe amorphous fluorinated polymers based on thermoplastic polyurethane (19F-TPU), and show that are useful starting materials for developing tissue-engineered vascular grafts which can be detected using 19F MRI. PMID:28413258
Monitoring Ion Implantation Energy Using Non-contact Characterization Methods
NASA Astrophysics Data System (ADS)
Tallian, M.; Pap, A.; Mocsar, K.; Somogyi, A.; Nadudvari, Gy.; Kosztka, D.; Pavelka, T.
2011-01-01
State-of-the-art ultra-shallow junctions are produced using extremely low ion implant energies, down to the range of 1-3 keV. This can be achieved by a variety of production techniques; however there is a significant risk that the actual implantation energy differs from the desired value. To detect this, sensitive measurement methods need to be utilized. Experiments show that both Photomodulated Reflection measurements before anneal and Junction Photovoltage-based sheet resistance measurements after anneal are suitable for this purpose.
Thirty-fifth anniversary of the optical affinity sensor for glucose: a personal retrospective.
Schultz, Jerome S
2015-01-01
Since 1962 when Clark introduced the enzyme electrode, research has been intense for a robust implantable glucose sensor. An alternative "optical affinity sensor" was introduced by Jerome Schultz in 1979. The evolution of this sensor technology into a new methodology is reviewed. The approach integrates a variety of disparate concepts: the selectivity of immunoassays-selectivity for glucose was obtained with concanavalin A, detection sensitivity was obtained with fluorescence (FITC-Dextran), and miniaturization was achieved by the use of an optical fiber readout system. Refinements of Schultz's optical affinity sensor approach over the past 35 years have led to a number of configurations that show great promise to meet the needs of a successful implantable continuous monitoring device for diabetics, some of which are currently being tested clinically. © 2014 Diabetes Technology Society.
Implantable Wireless MEMS Sensors for Medical Uses
NASA Technical Reports Server (NTRS)
Chimbayo, Alexander
2006-01-01
Sensors designed and fabricated according to the principles of microelectromechanical systems (MEMS) are being developed for several medical applications in outer space and on Earth. The designs of these sensors are based on a core design family of pressure sensors, small enough to fit into the eye of a needle, that are fabricated by a "dissolved wafer" process. The sensors are expected to be implantable, batteryless, and wireless. They would be both powered and interrogated by hand-held radio transceivers from distances up to about 6 in. (about 15 cm). One type of sensor would be used to measure blood pressure, particularly for congestive heart failure. Another type would be used to monitor fluids in patients who have hydrocephalus (high brain pressure). Still other types would be used to detect errors in delivery of drugs and to help patients having congestive heart failure.
NASA Astrophysics Data System (ADS)
Morgan, I.; Benjamin, J. D.
1985-08-01
Methods of powering devices to which only ac contact can be made and receiving data transmitted back from them are described. Such devices include medical implants which communicate with the external environment via ultrasound or rf links. Two breadboard systems were built to demonstrate the techniques. In both the device is powered by picking up an ac input and rectifying it. A signal voltage detected by the device is encoded as a frequency, transmitted and decoded. In one case this is performed on a separate channel from that used to power the device. In the other only one channel is used for both signals, and data is transmitted by modulating the impedance presented by the device. The resulting modulation of the input signal is picked up by the external circuit and decoded.
Electromagnetic Interference in Implantable Defibrillators in Single-Engine Fixed-Wing Aircraft.
de Rotte, Alexandra A J; van der Kemp, Peter; Mundy, Peter A; Rienks, Rienk; de Rotte, August A
2017-01-01
Little is known about the possible electromagnetic interferences (EMI) in the single-engine fixed-wing aircraft environment with implantable cardio-defibrillators (ICDs). Our hypothesis is that EMI in the cockpit of a single-engine fixed-wing aircraft does not result in erroneous detection of arrhythmias and the subsequent delivery of an inappropriate device therapy. ICD devices of four different manufacturers, incorporated in a thorax phantom, were transported in a Piper Dakota Aircraft with ICAO type designator P28B during several flights. The devices under test were programmed to the most sensitive settings for detection of electromagnetic signals from their environment. After the final flight the devices under test were interrogated with the dedicated programmers in order to analyze the number of tachycardias detected. Cumulative registration time of the devices under test was 11,392 min, with a mean of 2848 min per device. The registration from each one of the devices did not show any detectable "tachycardia" or subsequent inappropriate device therapy. This indicates that no external signals, which could be originating from electromagnetic fields from the aircraft's avionics, were detected by the devices under test. During transport in the cockpit of a single-engine fixed-wing aircraft, the tested ICDs did not show any signs of being affected by electromagnetic fields originating from the avionics of the aircraft. This current study indicates that EMI is not a potential safety issue for transportation of passengers with an ICD implanted in a single-engine fixed-wing aircraft.de Rotte AAJ, van der Kemp P, Mundy PA, Rienks R, de Rotte AA. Electromagnetic interference in implantable defibrillators in single-engine fixed-wing aircraft. Aerosp Med Hum Perform. 2017; 88(1):52-55.
A Suggested Model for Building Robust Biomedical Implants Registries.
Aloufi, Bader; Alshagathrah, Fahad; Househ, Mowafa
2017-01-01
Registries are an essential source of information for clinical and non-clinical decision-makers; because they provide evidence for post-market clinical follow-up and early detection of safety signals for biomedical implants. Yet, many of todays biomedical implants registries are facing a variety of challenges relating to a poorly designed dataset, the reliability of inputted data and low clinician and patient participation. The purpose of this paper is to present a best practice model for the implementation and use of biomedical implants registries to monitor the safety and effectiveness of implantable medical devices. Based on a literature review and an analysis of multiple national relevant registries, we identified six factors that address contemporary challenges and are believed to be the keys for building a successful biomedical implants registry, which include: sustainable development, international comparability, data reliability, purposeful design, ease of patient participation, and collaborative development at the national level.
Early human bone response to laser metal sintering surface topography: a histologic report.
Mangano, Carlo; Piattelli, Adriano; d'Avila, Susana; Iezzi, Giovanna; Mangano, Francesco; Onuma, Tatiana; Shibli, Jamil Awad
2010-01-01
This histologic report evaluated the early human bone response to a direct laser metal sintering implant surface retrieved after a short period of healing. A selective laser sintering procedure using a Ti-6Al-4V alloy powder with a particle size of 25-45 microm prepared this surface topography. One experimental microimplant was inserted into the anterior mandible of a patient during conventional implant surgery of the jaw. The microimplant and surrounding tissues were removed after 2 months of unloaded healing and were prepared for histomorphometric analysis. Histologically, the peri-implant bone appeared in close contact with the implant surface, whereas marrow spaces could be detected in other areas along with prominently stained cement lines. The mean of bone-to-implant contact was 69.51%. The results of this histologic report suggest that the laser metal sintering surface could be a promising alternative to conventional implant surface topographies.
Oral Rehabilitation with Implant-Retained Overdenture in a Patient with Down Syndrome.
Altintas, Nuray Yilmaz; Kilic, Serdar; Altintas, Subutay Han
2017-01-24
Down syndrome, known as trisomy 21, is the most common chromosomal disorder. The disorder affects mental and systemic development as well as oral structure, including dental anomalies, high susceptibility of periodontal disease, and poor quality of alveolar bone. This report presents a case of dental rehabilitation by means of dental implants of a patient with Down syndrome. Two titanium dental implants were placed in the maxilla, and three titanium dental implants were installed in the mandible. One implant was lost during the osseointegration period. The prosthetic rehabilitation was performed with implant-retained maxillary and mandibular overdentures with the Locator attachment system. After a 2-year follow-up period, the patient was doing well, and all implants were clinically stable with no signs of bone loss or inflammation. The present study emphasizes that implant-retained overdentures with Locator attachment system could be a therapeutic option even for patients with Down syndrome. This therapy prevents crestal bone loss around the implants, improves functional and esthetic outcomes, and provides optimum oral hygiene for patients with mild mental impairment. Careful patient selection and education of patients and caregivers are essential considerations for a successful and safe treatment with dental implants in Down syndrome patients. © 2017 by the American College of Prosthodontists.
Mohammadi, Abdolreza Rashidi; Chen, Keqin; Ali, Mohamed Sultan Mohamed; Takahata, Kenichi
2011-12-15
The rupture of a cerebral aneurysm is the most common cause of subarachnoid hemorrhage. Endovascular embolization of the aneurysms by implantation of Guglielmi detachable coils (GDC) has become a major treatment approach in the prevention of a rupture. Implantation of the coils induces formation of tissues over the coils, embolizing the aneurysm. However, blood entry into the coiled aneurysm often occurs due to failures in the embolization process. Current diagnostic methods used for aneurysms, such as X-ray angiography and computer tomography, are ineffective for continuous monitoring of the disease and require extremely expensive equipment. Here we present a novel technique for wireless monitoring of cerebral aneurysms using implanted embolization coils as radiofrequency resonant sensors that detect the blood entry. The experiments show that commonly used embolization coils could be utilized as electrical inductors or antennas. As the blood flows into a coil-implanted aneurysm, parasitic capacitance of the coil is modified because of the difference in permittivity between the blood and the tissues grown around the coil, resulting in a change in the coil's resonant frequency. The resonances of platinum GDC-like coils embedded in aneurysm models are detected to show average responses of 224-819 MHz/ml to saline injected into the models. This preliminary demonstration indicates a new possibility in the use of implanted GDC as a wireless sensor for embolization failures, the first step toward realizing long-term, noninvasive, and cost-effective remote monitoring of cerebral aneurysms treated with coil embolization. Copyright © 2011 Elsevier B.V. All rights reserved.
Displacement of dental implants in trabecular bone under a static lateral load in fresh bovine bone.
Engelke, Wilfried; Müller, Alois; Decco, Oscar A; Rau, María J; Cura, Andrea C; Ruscio, Mara L; Knösel, Michael
2013-04-01
The study aims to provide objective data for the displacement of titanium screw implants in trabecular bone specimens. One hundred Semados implants (Bego, Bremen, Germany) were inserted in bovine type IV bone specimens. All implants had a diameter of 3.75 mm; 50 implants had a length of 8.5 mm and 50 implants had a length of 15 mm. Insertion torque was determined at intervals of 10, 20, and 30 Ncm. Implants were loaded horizontally with 10, 20, and 30 N for 2 seconds. An indicator strip was attached to the implant abutment to allow direct observation of implant movement relative to the bone surface. Horizontal displacement was assessed with an accuracy of measurement of 10 µm. Seven implants got lost by visible loosening. Degree of displacement was subject to evaluation with all others. Those implants showed a mean displacement of 59 µm for 10 N (n = 100), 173 µm for 20 N (n = 99), and 211 µm for 30 N (n = 93). The mean displacement of 15-mm implants (16, 37, 51 µm) was significantly lower compared with 8.5-mm implants (103, 311, 396 µm) corresponding to 10, 20, and 30 N as lateral loads. Displacement of screw implants in trabecular bone can be detected and visualized using commercially available endoscopes with a high magnification. A lateral load of 20 N indicates a mean displacement of over 100 µm and therefore results in a critical displacement. © 2011 Wiley Periodicals, Inc.
Becker, Stephan T; Beck-Broichsitter, Benedicta E; Rossmann, Christian M; Behrens, Eleonore; Jochens, Arne; Wiltfang, Jörg
2016-06-01
The aim of this study was to evaluate the long-term dental implant survival rates of Straumann dental implants in a university hospital environment over 12 to 23 years. A total of 388 Straumann dental implants with titanium-sprayed surfaces (TPS) were inserted in 92 patients between 1988 and 1999 in the Department of Oral and Maxillofacial Surgery of the University Hospital Schleswig-Holstein in Kiel, and they were reevaluated with standardized clinical and radiological exams. Kaplan-Meier analyses were performed for individual factors. Cox proportional hazard regression analysis was used to detect the factors influencing long-term implant failure. The long-term implant survival rate was 88.03% after an observation time of 12.2 to 23.5 years. Cox regression revealed statistically significant influences of the International Team for Implantology (ITI) implantation type (p = .00354) and tobacco smoking (p = .01264) on implant failure. A proportion 82.8% of the patients with implant losses had a medical history of periodontitis. Peri-implantitis was diagnosed in 9.7% of the remaining implants in the long-term survey. This study emphasized the long-term rehabilitation capabilities of Straumann dental implants in complex cases. The survival rates after several years constitute important information for patients, as well as for clinicians, in deciding about different concepts of tooth replacement. Patient-related and technical factors - determined before implant placement - could help to predict the risk of implant loss. © 2015 Wiley Periodicals, Inc.
Rosier, Arnaud; Mabo, Philippe; Chauvin, Michel; Burgun, Anita
2015-05-01
The patient population benefitting from cardiac implantable electronic devices (CIEDs) is increasing. This study introduces a device annotation method that supports the consistent description of the functional attributes of cardiac devices and evaluates how this method can detect device changes from a CIED registry. We designed the Cardiac Device Ontology, an ontology of CIEDs and device functions. We annotated 146 cardiac devices with this ontology and used it to detect therapy changes with respect to atrioventricular pacing, cardiac resynchronization therapy, and defibrillation capability in a French national registry of patients with implants (STIDEFIX). We then analyzed a set of 6905 device replacements from the STIDEFIX registry. Ontology-based identification of therapy changes (upgraded, downgraded, or similar) was accurate (6905 cases) and performed better than straightforward analysis of the registry codes (F-measure 1.00 versus 0.75 to 0.97). This study demonstrates the feasibility and effectiveness of ontology-based functional annotation of devices in the cardiac domain. Such annotation allowed a better description and in-depth analysis of STIDEFIX. This method was useful for the automatic detection of therapy changes and may be reused for analyzing data from other device registries.
Al-Sabbagh, Mohanad; Jenkins, Diane W; de Leeuw, Reny; Nihill, Patricia; Robinson, Fonda G; Thomas, Mark V
2014-11-01
The University of Kentucky College of Dentistry (UKCD) established an implant training program that provides training in the use of a single implant system, evidence-based diagnostic and treatment protocols (standardized work practices), and a total quality management system (Implant Quality Assurance Program). The aim of this study was to assess the programmatic effectiveness of the UKCD implant training program by reporting the success and survival of implants placed, using patient-reported outcomes and comparing them to previously established benchmarks. A total of 415 patients (963 implants) were interviewed, approximately 50 percent of all qualified patients. The implant survival rate was 97 percent, and 88 percent of the implants were considered successful (as determined by patient-centric criteria). These outcomes were consistent with the program's previously established benchmarks of 90 percent. These results suggest that work standardization (in the form of specific treatment protocols) and the use of a formal, incremental learning system can result in positive patient outcomes. Clinical outcomes should be monitored in academic dental settings as part of clinical process improvement, and these outcomes can provide a means of assessing the effectiveness of the training program.
Comparison and characterization of Android-based fall detection systems.
Luque, Rafael; Casilari, Eduardo; Morón, María-José; Redondo, Gema
2014-10-08
Falls are a foremost source of injuries and hospitalization for seniors. The adoption of automatic fall detection mechanisms can noticeably reduce the response time of the medical staff or caregivers when a fall takes place. Smartphones are being increasingly proposed as wearable, cost-effective and not-intrusive systems for fall detection. The exploitation of smartphones' potential (and in particular, the Android Operating System) can benefit from the wide implantation, the growing computational capabilities and the diversity of communication interfaces and embedded sensors of these personal devices. After revising the state-of-the-art on this matter, this study develops an experimental testbed to assess the performance of different fall detection algorithms that ground their decisions on the analysis of the inertial data registered by the accelerometer of the smartphone. Results obtained in a real testbed with diverse individuals indicate that the accuracy of the accelerometry-based techniques to identify the falls depends strongly on the fall pattern. The performed tests also show the difficulty to set detection acceleration thresholds that allow achieving a good trade-off between false negatives (falls that remain unnoticed) and false positives (conventional movements that are erroneously classified as falls). In any case, the study of the evolution of the battery drain reveals that the extra power consumption introduced by the Android monitoring applications cannot be neglected when evaluating the autonomy and even the viability of fall detection systems.
Comparison and Characterization of Android-Based Fall Detection Systems
Luque, Rafael; Casilari, Eduardo; Morón, María-José; Redondo, Gema
2014-01-01
Falls are a foremost source of injuries and hospitalization for seniors. The adoption of automatic fall detection mechanisms can noticeably reduce the response time of the medical staff or caregivers when a fall takes place. Smartphones are being increasingly proposed as wearable, cost-effective and not-intrusive systems for fall detection. The exploitation of smartphones' potential (and in particular, the Android Operating System) can benefit from the wide implantation, the growing computational capabilities and the diversity of communication interfaces and embedded sensors of these personal devices. After revising the state-of-the-art on this matter, this study develops an experimental testbed to assess the performance of different fall detection algorithms that ground their decisions on the analysis of the inertial data registered by the accelerometer of the smartphone. Results obtained in a real testbed with diverse individuals indicate that the accuracy of the accelerometry-based techniques to identify the falls depends strongly on the fall pattern. The performed tests also show the difficulty to set detection acceleration thresholds that allow achieving a good trade-off between false negatives (falls that remain unnoticed) and false positives (conventional movements that are erroneously classified as falls). In any case, the study of the evolution of the battery drain reveals that the extra power consumption introduced by the Android monitoring applications cannot be neglected when evaluating the autonomy and even the viability of fall detection systems. PMID:25299953
Systemic immunity influences hearing preservation in cochlear implantation.
Souter, Melanie; Eastwood, Hayden; Marovic, Paul; Kel, Gordana; Wongprasartsuk, Sarin; Ryan, Allen F; O'Leary, Stephen John
2012-06-01
To determine whether a systemic immune response influences hearing thresholds and tissue response after cochlear implantation of hearing guinea pigs. Guinea pigs were inoculated with sterile antigen (Keyhole limpet hemocyanin) 3 weeks before cochlear implantation. Pure-tone auditory brainstem response thresholds were performed before implantation and 1 and 4 weeks later. Dexamethasone phosphate 20% was adsorbed onto a hyaluronic acid carboxymethylcellulose sponge and was applied to the round window for 30 minutes before electrode insertion. Normal saline was used for controls. Cochlear histology was performed at 4 weeks after implantation to assess the tissue response to implantation. To control for the effect of keyhole limpet hemocyanin priming, a group of unprimed animals underwent cochlear implantation with a saline-soaked pledget applied to the round window. Keyhole limpet hemocyanin priming had no significant detrimental effect on thresholds without implantation. Thresholds were elevated after implantation across all frequencies tested (2-32 kHz) in primed animals but only at higher frequencies (4-32 kHz) in unprimed controls. In primed animals, dexamethasone treatment significantly reduced threshold shifts at 2 and 8 kHz. Keyhole limpet hemocyanin led to the more frequent observation of lymphocytes in the tissue response to the implant. Systemic immune activation at the time of cochlear implantation broadened the range of frequencies experiencing elevated thresholds after implantation. Local dexamethasone provides partial protection against this hearing loss, but the degree and extent of protection are less compared to previous studies with unprimed animals.
Oginosawa, Yasushi; Kohno, Ritsuko; Honda, Toshihiro; Kikuchi, Kan; Nozoe, Masatsugu; Uchida, Takayuki; Minamiguchi, Hitoshi; Sonoda, Koichiro; Ogawa, Masahiro; Ideguchi, Takeshi; Kizaki, Yoshihisa; Nakamura, Toshihiro; Oba, Kageyuki; Higa, Satoshi; Yoshida, Keiki; Tsunoda, Soichi; Fujino, Yoshihisa; Abe, Haruhiko
2017-08-25
Shocks delivered by implanted anti-tachyarrhythmia devices, even when appropriate, lower the quality of life and survival. The new SmartShock Technology ® (SST) discrimination algorithm was developed to prevent the delivery of inappropriate shock. This prospective, multicenter, observational study compared the rate of inaccurate detection of ventricular tachyarrhythmia using the SST vs. a conventional discrimination algorithm.Methods and Results:Recipients of implantable cardioverter defibrillators (ICD) or cardiac resynchronization therapy defibrillators (CRT-D) equipped with the SST algorithm were enrolled and followed up every 6 months. The tachycardia detection rate was set at ≥150 beats/min with the SST algorithm. The primary endpoint was the time to first inaccurate detection of ventricular tachycardia (VT) with conventional vs. the SST discrimination algorithm, up to 2 years of follow-up. Between March 2012 and September 2013, 185 patients (mean age, 64.0±14.9 years; men, 74%; secondary prevention indication, 49.5%) were enrolled at 14 Japanese medical centers. Inaccurate detection was observed in 32 patients (17.6%) with the conventional, vs. in 19 patients (10.4%) with the SST algorithm. SST significantly lowered the rate of inaccurate detection by dual chamber devices (HR, 0.50; 95% CI: 0.263-0.950; P=0.034). Compared with previous algorithms, the SST discrimination algorithm significantly lowered the rate of inaccurate detection of VT in recipients of dual-chamber ICD or CRT-D.
Intrinsic point-defect balance in self-ion-implanted ZnO.
Neuvonen, Pekka T; Vines, Lasse; Svensson, Bengt G; Kuznetsov, Andrej Yu
2013-01-04
The role of excess intrinsic atoms for residual point defect balance has been discriminated by implanting Zn or O ions into Li-containing ZnO and monitoring Li redistribution and electrical resistivity after postimplant anneals. Strongly Li-depleted regions were detected in the Zn-implanted samples at depths beyond the projected range (R(p)) upon annealing ≥ 600 °C, correlating with a resistivity decrease. In contrast, similar anneals of the O-implanted samples resulted in Li accumulation at R(p) and an increased resistivity. Control samples implanted with Ar or Ne ions, yielding similar defect production as for the Zn or O implants but with no surplus of intrinsic atoms, revealed no Li depletion. Thus, the depletion of Li shows evidence of excess Zn interstitials (Zn(I)) being released during annealing of the Zn-implanted samples. These Zn(I)'s convert substitutional Li atoms (Li(Zn)) into highly mobile interstitial ones leading to the strongly Li-depleted regions. In the O-implanted samples, the high resistivity provides evidence of stable O(I)-related acceptors.
Real-time automatic fiducial marker tracking in low contrast cine-MV images
DOE Office of Scientific and Technical Information (OSTI.GOV)
Lin, Wei-Yang; Lin, Shu-Fang; Yang, Sheng-Chang
2013-01-15
Purpose: To develop a real-time automatic method for tracking implanted radiographic markers in low-contrast cine-MV patient images used in image-guided radiation therapy (IGRT). Methods: Intrafraction motion tracking using radiotherapy beam-line MV images have gained some attention recently in IGRT because no additional imaging dose is introduced. However, MV images have much lower contrast than kV images, therefore a robust and automatic algorithm for marker detection in MV images is a prerequisite. Previous marker detection methods are all based on template matching or its derivatives. Template matching needs to match object shape that changes significantly for different implantation and projection angle.more » While these methods require a large number of templates to cover various situations, they are often forced to use a smaller number of templates to reduce the computation load because their methods all require exhaustive search in the region of interest. The authors solve this problem by synergetic use of modern but well-tested computer vision and artificial intelligence techniques; specifically the authors detect implanted markers utilizing discriminant analysis for initialization and use mean-shift feature space analysis for sequential tracking. This novel approach avoids exhaustive search by exploiting the temporal correlation between consecutive frames and makes it possible to perform more sophisticated detection at the beginning to improve the accuracy, followed by ultrafast sequential tracking after the initialization. The method was evaluated and validated using 1149 cine-MV images from two prostate IGRT patients and compared with manual marker detection results from six researchers. The average of the manual detection results is considered as the ground truth for comparisons. Results: The average root-mean-square errors of our real-time automatic tracking method from the ground truth are 1.9 and 2.1 pixels for the two patients (0.26 mm/pixel). The standard deviations of the results from the 6 researchers are 2.3 and 2.6 pixels. The proposed framework takes about 128 ms to detect four markers in the first MV images and about 23 ms to track these markers in each of the subsequent images. Conclusions: The unified framework for tracking of multiple markers presented here can achieve marker detection accuracy similar to manual detection even in low-contrast cine-MV images. It can cope with shape deformations of fiducial markers at different gantry angles. The fast processing speed reduces the image processing portion of the system latency, therefore can improve the performance of real-time motion compensation.« less
Jimbo, Ryo; Anchieta, Rodolfo; Baldassarri, Marta; Granato, Rodrigo; Marin, Charles; Teixeira, Hellen S; Tovar, Nick; Vandeweghe, Stefan; Janal, Malvin N; Coelho, Paulo G
2013-12-01
Commercial implants differ at macro-, micro-, and nanolevels, which makes it difficult to distinguish their effect on osseointegration. The aim of this study was to evaluate the early integration of 5 commercially available implants (Astra OsseoSpeed, Straumann SLA, Intra-Lock Blossom Ossean, Nobel Active, and OsseoFix) by histomorphometry and nanoindentation. Implants were installed in the tibiae of 18 beagle dogs. Samples were retrieved at 1, 3, and 6 weeks (n = 6 for each time point) and were histologically and nanomechanically evaluated. The results presented that both time (P < 0.01) and implant system and time interaction (P < 0.02) significantly affected the bone-to-implant contact (BIC). At 1 week, the different groups presented statistically different outcomes. No significant changes in BIC were noted thereafter. There were no significant differences in rank elastic modulus (E) or in rank hardness (H) for time (E: P > 0.80; H: P > 0.75) or implant system (E: P > 0.90; H: P > 0.85). The effect of different implant designs on osseointegration was evident especially at early stages of bone healing.
Chronically implanted pressure sensors: challenges and state of the field.
Yu, Lawrence; Kim, Brian J; Meng, Ellis
2014-10-31
Several conditions and diseases are linked to the elevation or depression of internal pressures from a healthy, normal range, motivating the need for chronic implantable pressure sensors. A simple implantable pressure transduction system consists of a pressure-sensing element with a method to transmit the data to an external unit. The biological environment presents a host of engineering issues that must be considered for long term monitoring. Therefore, the design of such systems must carefully consider interactions between the implanted system and the body, including biocompatibility, surgical placement, and patient comfort. Here we review research developments on implantable sensors for chronic pressure monitoring within the body, focusing on general design requirements for implantable pressure sensors as well as specifications for different medical applications. We also discuss recent efforts to address biocompatibility, efficient telemetry, and drift management, and explore emerging trends.
Perioperative management of calves undergoing implantation of a left ventricular assist device.
Wilson, D V; Kantrowitz, A; Pacholewicz, J; Salat, O; Paules, B R; Zhou, Y; Dawe, E J
2000-01-01
To describe perioperative management of calves that underwent left lateral thoracotomy, aortic cross-clamping, partial left heart bypass and implantation of a left ventricular assist device. A total of 43 healthy castrated male calves, weighing 121 +/- 24 kg. Diazepam (mean +/- SD, 0.26 +/- 0.07 mg/kg), ketamine (5.9 +/- 2.17 mg/kg) and isoflurane were used in the anesthetic management of calves undergoing implantation of a left ventricular assist device in the descending thoracic aorta. Other adjunctive agents administered were fentanyl (11 +/- 5.4 microg/kg), lidocaine (4.9 +/- 3.19 mg/kg), bupivacaine (0.75%) and butorphanol (0.49 +/- 0.13 mg/kg). None of the calves regurgitated at induction or during intubation. A tube was used to drain the rumen and prevent bloat during the procedure. Partial left heart bypass was used to perfuse the caudal half of the body during the period of aortic cross clamp and device implantation. Initial mean systemic blood pressure was 96 +/- 25 mm Hg, and pressures measured in the auricular artery increased during aortic cross-clamping and bypass. Vasoconstrictor therapy was required to treat caudal arterial hypotension during the procedure in 9 calves. Mean systemic arterial pressures returned to baseline values by the end of the anesthetic period. Initial mean pulmonary arterial pressures (PAP) were 22 +/- 3 mm Hg. A significant but transient increase in pulmonary arterial pressure occurred after both heparin and protamine administration. The described anesthetic protocol was effective for thoracotomy and implantation of an intra-aortic left ventricular assist device in normal calves. Partial left ventricular bypass was a useful adjunct during the period of aortic cross clamp. The doses of heparin and protamine administered were effective. Responsibility to monitor oxygenation of the cranial half of the animal continues during the bypass period as hypoxemia due to pulmonary dysfunction will not be detected by the perfusionist.
Atzori, F; Sabatini, L; Deledda, D; Schirò, M; Lo Baido, R; Baido, R L; Massè, A
2015-04-01
Total knee arthroplasty gives excellent objective results. Nevertheless, the subjective findings do not match the normal knee perception: Often, it depends on patellar pain onset. In this study, we analyzed clinical and radiological items that can affect resurfaced patellar tracking, and role of a patella-friendly femoral component and patellar size on patellar pain onset. Thirty consecutive patients were implanted using the same-cemented posterior-stabilized TKA associated with patella resurfacing. Fifteen patients were implanted using a classical femoral component, while another 15 patients were implanted using a patella-friendly femoral component. The statistical analysis was set to detect a significant difference (p < 0.05) in clinical and radiological outcomes related to several surgical parameters. Clinical and functional outcomes were recorded using the Knee Society Scoring System (KSS) and patellar pain with the Burnett questionnaire. Mean follow-up was 25 months. KSS results were excellent in both groups. Group 2 (patella-friendly femoral model) reached a higher percentage of 100 points in the clinical and functional KSS, but there was no statistical difference. Also, no statistical differences for Burnett Questionnaire results were recorded. We had one case of patellar clunk syndrome in the standard femoral component group and one poor result in the second group. Postoperative radiographic measurements evidenced no statistical differences in both groups. In group 1 (classical femoral component), better significant result (p < 0.05) war recorded at clinical evaluation according to the Knee Society Scoring System (KSS) in case of wider patellar component resurfaced. The present study reveals no statistically significant difference in the incidence of anterior knee pain between classical and "patella-friendly" femoral components. With the particular type of implant design utilized in this study, when the classical femoral component is used, bigger patellar implant sizes (38 and 41 mm) showed superior clinical outcome.
Lee, Du-Hyeong
Implant guide systems can be classified by their supporting structure as tooth-, mucosa-, or bone-supported. Mucosa-supported guides for fully edentulous arches show lower accuracy in implant placement because of errors in image registration and guide positioning. This article introduces the application of a novel microscrew system for computer-aided implant surgery. This technique can markedly improve the accuracy of computer-guided implant surgery in fully edentulous arches by eliminating errors from image fusion and guide positioning.
Accuracy of various impression materials and methods for two implant systems: An effect size study.
Schmidt, Alexander; Häussling, Teresa; Rehmann, Peter; Schaaf, Heidrun; Wöstmann, Bernd
2018-04-01
An accurate impression is required for implant treatment. The aim of this in-vitro study was to determine the effect size of the impression material/method, implant system and implant angulation on impression transfer precision. An upper jaw model with three BEGO and three Straumann implants (angulations 0°, 15°, 20°) in the left and right maxilla was used as a reference model. One polyether (Impregum Penta) and two polyvinyl siloxanes (Flexitime Monophase/Aquasil Ultra Monophase) were examined with two impression techniques (open and closed tray). A total of 60 impressions were made. A coordinate measurement machine was used to measure the target variables for 3D-shift, implant axis inclination and implant axis rotation. All the data were subjected to a four-way ANOVA. The effect size (partial eta-squared [η 2 P ]) was reported. The impression material had a significant influence on the 3D shift and the implant axis inclination deviation (p-values=.000), and both factors had very large effect sizes (3D-shift [η 2 P ]=.599; implant axis inclination [η 2 P ]=.298). Impressions made with polyvinyl siloxane exhibited the highest transfer precision. When the angulation of the implants was larger, more deviations occurred for the implant axis rotational deviation. The implant systems and impression methods showed partially significant variations (p-values=.001-.639) but only very small effect sizes (η 2 P =.001-.031). The impression material had the greatest effect size on accuracy in terms of the 3D shift and the implant axis inclination. For multiunit restorations with disparallel implants, polyvinyl siloxane materials should be considered. In addition, the effect size of a multivariate investigation should be reported. Copyright © 2017 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.
Tomaszewski, P K; Verdonschot, N; Bulstra, S K; Rietman, J S; Verkerke, G J
2012-11-01
Direct attachment of an upper leg prosthesis to the skeletal system by a percutaneous implant is an alternative solution to the traditional socket fixation. In this study, we investigated long-term periprosthetic bone changes around two types of fixation implants using two different initial conditions, namely immediate post-amputation implantation and the conventional implantation after considerable time of socket prosthesis use. We questioned the difference in bone modeling response the implants provoked and if it could lead to premature bone fracture. Generic CT-based finite element models of an intact femoral bone and amputated bone implanted with models of two existing direct-fixation implants, the OPRA system (Integrum AB) and the ISP Endo/Exo prosthesis (ESKA Implants AG) were created for this study. Adaptive bone-remodeling simulations used the heel-strike and toe-off loads from a normal walking cycle. The bone loss caused by prolonged use of socket prosthesis had more severe effects on the ultimate bone quality than adaptation induced by the direct-fixation implants. Both implants showed considerable bone remodeling; the titanium screw implant (OPRA system) provoked more bone loss than the porous coated CoCrMo stem (ISP implant). The chance of the peri-prosthetic bone fracture remained higher for the post-socket case as compared to the direct amputation cases. In conclusion, both direct-fixation implants lead to considerable bone loss and bone loss is more severe after a prolonged period of post-socket use. Hence, from a biomechanical perspective it is better to limit the post-socket time and to re-design direct fixation devices to reduce bone loss and the probability of peri-prosthetic bone fractures. Copyright © 2012 Elsevier Ltd. All rights reserved.
Three-dimensional accuracy of plastic transfer impression copings for three implant systems.
Teo, Juin Wei; Tan, Keson B; Nicholls, Jack I; Wong, Keng Mun; Uy, Joanne
2014-01-01
The purpose of this study was to compare the three-dimensional accuracy of indirect plastic impression copings and direct implant-level impression copings from three implant systems (Nobel Biocare [NB], Biomet 3i [3i], and Straumann [STR]) at three interimplant buccolingual angulations (0, 8, and 15 degrees). Two-implant master models were used to simulate a three-unit implant fixed partial denture. Test models were made from Impregum impressions using direct implant-level impression copings (DR). Abutments were then connected to the master models for impressions using the plastic impression copings (INDR) at three different angulations for a total of 18 test groups (n = 5 in each group). A coordinate measuring machine was used to measure linear distortions, three-dimensional (3D) distortions, angular distortions, and absolute angular distortions between the master and test models. Three-way analysis of variance showed that the implant system had a significant effect on 3D distortions and absolute angular distortions in the x- and y-axes. Interimplant angulation had a significant effect on 3D distortions and absolute angular distortions in the y-axis. Impression technique had a significant effect on absolute angular distortions in the y-axis. With DR, the NB and 3i systems were not significantly different. With INDR, 3i appeared to have less distortion than the other systems. Interimplant angulations did not significantly affect the accuracy of NBDR, 3iINDR, and STRINDR. The accuracy of INDR and DR was comparable at all interimplant angulations for 3i and STR. For NB, INDR was comparable to DR at 0 and 8 degrees but was less accurate at 15 degrees. Three-dimensional accuracy of implant impressions varied with implant system, interimplant angulation, and impression technique.
Al-Zubeidi, Mohammed I; Alsabeeha, Nabeel H M; Thomson, W Murray; Payne, Alan G T
2012-10-01
Different attachment systems for mandibular two-implant overdentures could influence levels of patient satisfaction. Positive consensus of the majority of patients being satisfied does not preclude the possibility of dissatisfaction for some. To evaluate patient satisfaction and dissatisfaction before and after 5 years of wearing mandibular two implant overdentures using different attachment systems ; to determine the prognostic relevance of pretreatment complete denture complaints to treatment outcomes. A total of 106 edentulous participants enrolled in a clinical trial completed a preliminary self-report inventory of their original complete denture complaints.New complete maxillary dentures and mandibular two-implant overdentures were provided to each participant using one of six different attachment systems. Patient satisfaction was determined at pretreatment; at baseline with mandibular two-implant overdenture insertion; and then annually for 5 years, using visual analogue and Likert-type scales. Patient satisfaction with mandibular two-implant overdentures showed significant changes pre- to posttreatment(baseline) in all domains, but these were significant immediately and maintained without further significance for 5 years, other than pain with the overdenture. After 5 years, no significant differences were observed with all the attachment systems. Highly significant differences were found with some social and psychological aspects by the fifth year compared to baseline. Diagnostic and prognostic indicators from a pretreatment inventory identified 12 participants (13.5%) who were dissatisfied. These indicators revealed a maladaptive predisposition to mandibular two-implant overdentures. The provision of mandibular two-implant overdentures will, in the majority of patients, significantly enhance levels of patient satisfaction for 5 years, as compared to complete mandibular dentures, regardless of the attachment system. Careful evaluation of pretreatment complaints with conventional dentures can possibly identify patient dissatisfaction with mandibular two-implant overdentures [corrected]. © 2010 Wiley Periodicals, Inc.
Ogawa, Munehiro; Tohma, Yasuaki; Ohgushi, Hajime; Takakura, Yoshinori; Tanaka, Yasuhito
2012-01-01
To establish the methods of demonstrating early fixation of metal implants to bone, one side of a Cobalt-Chromium (CoCr) based alloy implant surface was seeded with rabbit marrow mesenchymal cells and the other side was left unseeded. The mesenchymal cells were further cultured in the presence of ascorbic acid, β-glycerophosphate and dexamethasone, resulting in the appearance of osteoblasts and bone matrix on the implant surface. Thus, we succeeded in generating tissue-engineered bone on one side of the CoCr implant. The CoCr implants were then implanted in rabbit bone defects. Three weeks after the implantation, evaluations of mechanical test, undecalcified histological section and electron microscope analysis were performed. Histological and electron microscope images of the tissue engineered surface exhibited abundant new bone formation. However, newly formed bone tissue was difficult to detect on the side without cell seeding. In the mechanical test, the mean values of pull-out forces were 77.15 N and 44.94 N for the tissue-engineered and non-cell-seeded surfaces, respectively. These findings indicate early bone fixation of the tissue-engineered CoCr surface just three weeks after implantation.
Ogawa, Munehiro; Tohma, Yasuaki; Ohgushi, Hajime; Takakura, Yoshinori; Tanaka, Yasuhito
2012-01-01
To establish the methods of demonstrating early fixation of metal implants to bone, one side of a Cobalt-Chromium (CoCr) based alloy implant surface was seeded with rabbit marrow mesenchymal cells and the other side was left unseeded. The mesenchymal cells were further cultured in the presence of ascorbic acid, β-glycerophosphate and dexamethasone, resulting in the appearance of osteoblasts and bone matrix on the implant surface. Thus, we succeeded in generating tissue-engineered bone on one side of the CoCr implant. The CoCr implants were then implanted in rabbit bone defects. Three weeks after the implantation, evaluations of mechanical test, undecalcified histological section and electron microscope analysis were performed. Histological and electron microscope images of the tissue engineered surface exhibited abundant new bone formation. However, newly formed bone tissue was difficult to detect on the side without cell seeding. In the mechanical test, the mean values of pull-out forces were 77.15 N and 44.94 N for the tissue-engineered and non-cell-seeded surfaces, respectively. These findings indicate early bone fixation of the tissue-engineered CoCr surface just three weeks after implantation. PMID:22754313
Plinkert, P K; Federspil, P A; Plinkert, B; Henrich, D
2002-03-01
Excellent precision, miss of retiring, reproducibility are main characteristics of robots in the operating theatre. Because of these facts their use for surgery in the lateral scull base is of great interest. In recent experiments we determined process parameters for robot assisted reaming of a cochlea implant bed and for a mastoidectomy. These results suggested that optimizing parameters for thrilling with the robot is needed. Therefore we implemented a suitable reaming curve from the geometrical data of the implant and a force controlled process control for robot assisted reaming at the lateral scull base. Experiments were performed with an industrial robot on animal and human scull base specimen. Because of online force detection and feedback of sensory data the reaming with the robot was controlled. With increasing force values above a defined limit feed rates were automatically regulated. Furthermore we were able to detect contact of the thrill to dura mater by analyzing the force values. With the new computer program the desired implant bed was exactly prepared. Our examinations showed a successful reaming of an implant bed in the lateral scull base with a robot. Because of a force controlled reaming process locale navigation is possible and enables careful thrilling with a robot.
Urinary hCG patterns during the week following implantation
Nepomnaschy, PA; Weinberg, CR; Wilcox, AJ; Baird, DD
2013-01-01
BACKGROUND Human chorionic gonadotropin (hCG) is used to monitor pregnancy status. Yet the pattern of hCG excretion in the first week following implantation has not been adequately described. OBJECTIVE To describe hCG's average profile and its variability during the 7 days following estimated implantation in a population of naturally-conceived pregnancies. METHODS We measured daily hCG concentrations in first-morning urine for 142 clinical pregnancies from women with no known fertility problems. Mixed-effects regression models were used to estimate the hCG trajectory and its variability in relation to pregnancy outcomes. RESULTS HCG rose three-fold between the day of detection and the next day (95% CI = 2.7–3.4). The relative rate of rise decreased thereafter, reaching 1.6-fold (95% CI = 1.5–1.8) between days 6 and 7. HCG levels followed a log-quadratic trajectory, and the patterns of rise were unrelated to number of fetuses, risk of miscarriage, or sex of the baby. Later implantations (after 10 luteal days) produced slower rates of increase. CONCLUSIONS While mean hCG follows a log-quadratic trajectory during the first week of detectability, there is high variability across pregnancies. Later implantation may reflect characteristics of the uterus or conceptus that slow hCG production. PMID:18083748
Rupture rate and patterns of shell failure with the McGhan Style 153 double-lumen breast implant.
Neaman, Keith C; Albert, Mark; Hammond, Dennis C
2011-01-01
In 2005, the McGhan Style 153 double-lumen breast implant was removed from the market secondary to a higher rupture rate when contrasted with other implants in the Core Study group. The high rupture rate was attributed to the development of a posterior tear in the shell where the inner implant is bonded to the posterior wall of the device. The purpose of this study was to report the existing rupture rate and describe the apparent mechanism of failure in the Style 153 double-lumen breast implant. Ninety-seven patients (157 implants) who received the McGhan Style 153 double-lumen breast implant by the senior author were reviewed. Intraoperative observations and photographic images of ruptured implants were reviewed and characterized based on severity and location of implant rupture. With a mean length of follow-up of greater than 6 years (82 months), the rupture rate was 19.1 percent per implant. Physical examination (60 percent) was the most common method of rupture detection. Ruptures tended to occur in the marginal aspect (63 percent) of the implant. Only three ruptures occurred secondary to a disruption of the inner bladder from the posterior portion of the implant. The rupture rate of the Style 153 double-lumen breast implant is higher than previously thought, with a rate of 19.1 percent. A majority of ruptures occurred in the peripheral aspects of the implant. It is postulated that these ruptures were likely secondary to fold flaws that led to failure of the implant shell.
Percutaneous Implants with Porous Titanium Dermal Barriers: An In Vivo Evaluation of Infection Risk
Isackson, Dorthyann; McGill, Lawrence D.; Bachus, Kent N.
2010-01-01
Osseointegrated percutaneous implants are a promising prosthetic alternative for a subset of amputees. However, as with all percutaneous implants, they have an increased risk of infection since they breach the skin barrier. Theoretically, host tissues could attach to the metal implant creating a barrier to infection. When compared with smooth surfaces, it is hypothesized that porous surfaces improve the attachment of the host tissues to the implant, and decrease the infection risk. In this study, 4 titanium implants, manufactured with a percutaneous post and a subcutaneous disk, were placed subcutaneously on the dorsum of eight New Zealand White rabbits. Beginning at four weeks post-op, the implants were inoculated weekly with 108 CFU Staphylococcus aureus until signs of clinical infection presented. While we were unable to detect a difference in the incidence of infection of the porous metal implants, smooth surface (no porous coating) percutaneous and subcutaneous components had a 7-fold increased risk of infection compared to the implants with a porous coating on one or both components. The porous coated implants displayed excellent tissue ingrowth into the porous structures; whereas, the smooth implants were surrounded with a thick, organized fibrotic capsule that was separated from the implant surface. This study suggests that porous coated metal percutaneous implants are at a significantly lower risk of infection when compared to smooth metal implants. The smooth surface percutaneous implants were inadequate in allowing a long-term seal to develop with the soft tissue, thus increasing vulnerability to the migration of infecting microorganisms. PMID:21145778
Scotti, Roberto; Pellegrino, Gerardo; Marchetti, Claudio; Corinaldesi, Guiseppe; Ciocca, Leonardo
2010-01-01
To test if using a CAD/CAM system might reduce the necessity of bone augmentation in patients with atrophic maxillary arches before implant therapy. Twenty male and female patients consecutively scheduled for bone augmentation of the jaw before implant surgery were included in this study, with a total of 29 jaws (maxillary and mandibular) to analyze for the implant-supported fixed prosthesis group and 19 maxillary arches for the implant-supported removable prosthesis group. NobelGuide System (Nobel Biocare), Autocad System (Autodesk), and routine manual CT measurements of available bone were used in this study. The total results of the mean values of the fixed prosthesis group plus the mean values of the removable prosthesis group showed a statistically significant difference between the NobelGuide intervention score and both manual (P = .004) and Autocad (P = .001) measurements. The NobelGuide System represents a viable diagnostic device to reduce the entity or avoid bone reconstructive surgery before implant placements in the atrophic maxilla and mandible.
NASA Astrophysics Data System (ADS)
Akazawa, Masamichi; Yokota, Naoshige; Uetake, Kei
2018-02-01
We report experimental results for the detection of deep-level defects in GaN after Mg ion implantation before high-temperature annealing. The n-type GaN samples were grown on GaN free-standing substrates by metalorganic vapor phase epitaxy. Mg ions were implanted at 50 keV with a small dosage of 1.5×1011 cm-2, which did not change the conduction type of the n-GaN. By depositing Al2O3 and a Ni/Au electrode onto the implanted n-GaN, metal-oxide-semiconductor (MOS) diodes were fabricated and tested. The measured capacitance-voltage (C-V) characteristics showed a particular behavior with a plateau region and a region with an anomalously steep slope. Fitting to the experimental C-V curves by simulation showed the existence of deep-level defects and a reduction of the carrier concentration near the GaN surface. By annealing at 800oC, the density of the deep-level defects was reduced and the carrier concentration partially recovered.
Ronchi, A; Montella, M; Argenzio, V; Lucia, A; De Renzo, A; Alfano, R; Franco, R; Cozzolino, I
2018-04-06
Peri-implant breast seroma is a late clinical presentation of reconstructive surgery or augmentation mammoplasty with breast implants. Pre-operative cytological evaluation of the peri-implant breast seroma is a common clinical approach, showing mainly an inflammatory reaction or more rarely a breast implant-associated anaplastic large cell lymphoma. Herein, we reported the role of cytology in the evaluation of peri-implant breast seroma and its critical pre-operative implications. Eight cases of peri-implant breast seroma from files at Luigi Vanvitelli University were identified between January and December 2017. In all cases, seroma was aspirated; cytospins were performed and stained by Papanicolaou stain; finally, in all cases, a cell block was obtained for immunocytochemical evaluation and, in one case, for FISH to detect ALK1-gene translocation. The median age of patients was 48 years and the mean time between the implant placement and the occurrence of peri-implant breast seroma was 18 months. Microscopic examination showed breast implant-associated anaplastic large cell lymphoma in one case, aspecific inflammatory reaction in six cases and silicon-associated reaction in one case. Peri-implant breast seroma may be caused by several pathological conditions with different clinical behaviour. A proper cytological approach to peri-implant breast seroma allows a correct differential diagnosis between inflammatory conditions and breast implant-associated anaplastic large cell lymphoma and an appropriate management of the patient. © 2018 John Wiley & Sons Ltd.
The effect of silicone implants on the diagnosis, prognosis, and treatment of breast cancer.
Handel, Neal
2007-12-01
Because of the prevalence of breast cancer, many augmented women eventually will develop the disease. This article reviews what is known about the effect of implants on the detection, prognosis, and treatment of carcinoma of the breast. Observations were made on 4082 breast cancer patients (3953 nonaugmented and 129 augmented) treated over a 23-year time span. Findings in the two groups were compared and differences analyzed statistically. Mammograms of all women with palpable lesions were reviewed to assess mammographic sensitivity in patients with and without implants. Cosmetic outcomes in augmented patients treated with breast conservation therapy were reviewed. Augmented patients presented more frequently with palpable lesions, invasive tumors, axillary nodal metastases, and false-negative mammograms. However, there was no significant difference in stage of disease, tumor size, recurrence rates, or survival between the two groups. Augmented patients treated with breast conservation therapy often experienced poor cosmetic results and frequently required reoperation. Despite the diminished sensitivity of mammography in women with implants, augmented and nonaugmented patients are diagnosed at a similar stage of disease and have a comparable prognosis. Implants may impair mammography but appear to facilitate tumor detection on physical examination. Magnetic resonance imaging and breast ultrasound may be useful adjuncts, but conventional mammography remains the most reliable tool for diagnosing early breast cancer in augmented patients. Breast implants do not interfere with mastectomy or breast reconstruction but may compromise the outcome of breast conservation therapy.
Baier, Martin; Staudt, Patric; Klein, Roman; Sommer, Ulrike; Wenz, Robert; Grafe, Ingo; Meeder, Peter Jürgen; Nawroth, Peter P; Kasperk, Christian
2013-06-07
Calcium phosphate cements are used frequently in orthopedic and dental surgeries. Strontium-containing drugs serve as systemic osteoblast-activating medication in various clinical settings promoting mechanical stability of the osteoporotic bone. Strontium-containing calcium phosphate cement (SPC) and calcium phosphate cement (CPC) were compared regarding their local and systemic effects on bone tissue in a standard animal model for osteoporotic bone. A bone defect was created in the distal femoral metaphysis of 60 ovariectomized Sprague-Dawley rats. CPC and SPC were used to fill the defects in 30 rats in each group. Local effects were assessed by histomorphometry at the implant site. Systemic effects were assessed by bone mineral density (BMD) measurements at the contralateral femur and the spine. Faster osseointegration and more new bone formation were found for SPC as compared to CPC implant sites. SPC implants exhibited more cracks than CPC implants, allowing more bone formation within the implant. Contralateral femur BMD and spine BMD did not differ significantly between the groups. The addition of strontium to calcium phosphate stimulates bone formation in and around the implant. Systemic release of strontium from the SPC implants did not lead to sufficiently high serum strontium levels to induce significant systemic effects on bone mass in this rat model.
Dubner, Sergio; Auricchio, Angelo; Steinberg, Jonathan S; Vardas, Panos; Stone, Peter; Brugada, Josep; Piotrowicz, Ryszard; Hayes, David L; Kirchhof, Paulus; Breithardt, Günter; Zareba, Wojciech; Schuger, Claudio; Aktas, Mehmet K; Chudzik, Michal; Mittal, Suneet; Varma, Niraj
2012-02-01
We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable devices (CIEDs) with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, device function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers (IPGs), implantable cardioverter-defibrillators (ICDs), devices for cardiac resynchronization therapy (CRT) (both, with and without defibrillation properties), loop recorders, and haemodynamic monitoring devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology (ISHNE) and the European Heart Rhythm Association (EHRA) combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.
Pollonini, Luca; Olds, Cristen; Abaya, Homer; Bortfeld, Heather; Beauchamp, Michael S; Oghalai, John S
2014-03-01
The primary goal of most cochlear implant procedures is to improve a patient's ability to discriminate speech. To accomplish this, cochlear implants are programmed so as to maximize speech understanding. However, programming a cochlear implant can be an iterative, labor-intensive process that takes place over months. In this study, we sought to determine whether functional near-infrared spectroscopy (fNIRS), a non-invasive neuroimaging method which is safe to use repeatedly and for extended periods of time, can provide an objective measure of whether a subject is hearing normal speech or distorted speech. We used a 140 channel fNIRS system to measure activation within the auditory cortex in 19 normal hearing subjects while they listed to speech with different levels of intelligibility. Custom software was developed to analyze the data and compute topographic maps from the measured changes in oxyhemoglobin and deoxyhemoglobin concentration. Normal speech reliably evoked the strongest responses within the auditory cortex. Distorted speech produced less region-specific cortical activation. Environmental sounds were used as a control, and they produced the least cortical activation. These data collected using fNIRS are consistent with the fMRI literature and thus demonstrate the feasibility of using this technique to objectively detect differences in cortical responses to speech of different intelligibility. Copyright © 2013 Elsevier B.V. All rights reserved.
Ozelo, Margareth C; Vidal, Barbara; Brown, Christine; Notley, Colleen; Hegadorn, Carol; Webster, Sandra; Harpell, Lori; Ahlin, James; Winterborn, Andrew; Handforth, Janine; Arruda, Valder R; Hough, Christine; Lillicrap, David
2014-06-26
Ex vivo gene therapy strategies avoid systemic delivery of viruses thereby mitigating the risk of vector-associated immunogenicity. Previously, we delivered autologous factor VIII (FVIII)-expressing blood outgrowth endothelial cells (BOECs) to hemophilia A mice and showed that these cells remained sequestered within the implanted matrix and provided therapeutic levels of FVIII. Prior to translating this strategy into the canine (c) model of hemophilia A, we increased cFVIII transgene expression by at least 100-fold with the use of the elongation factor 1 alpha (EF1α) promoter and a strong endothelial enhancer element. BOECs isolated from hemophilia A dogs transduced with this lentiviral vector express levels of cFVIII ranging between 1.0 and 1.5 U/mL per 10(6) cells over 24 hours. Autologous BOECs have been implanted into the omentum of 2 normal and 3 hemophilia A dogs. These implanted cells formed new vessels in the omentum. All 3 hemophilia A dogs treated with FVIII-expressing autologous BOECs developed anti-FVIII immunoglobulin G2 antibodies, but in only 2 of the dogs were these antibodies inhibitory. FVIII antigen levels >40% in the absence of FVIII coagulant function were detected in the circulation for up to a year after a single gene therapy treatment, indicating prolonged cellular viability and synthesis of FVIII. © 2014 by The American Society of Hematology.
Enhancing the Performance of Medical Implant Communication Systems through Cooperative Diversity
Hegyi, Barnabás; Levendovszky, János
2010-01-01
Battery-operated medical implants—such as pacemakers or cardioverter-defibrillators—have already been widely used in practical telemedicine and telecare applications. However, no solution has yet been found to mitigate the effect of the fading that the in-body to off-body communication channel is subject to. In this paper, we reveal and assess the potential of cooperative diversity to combat fading—hence to improve system performance—in medical implant communication systems. In the particular cooperative communication scenario we consider, multiple cooperating receiver units are installed across the room accommodating the patient with a medical implant inside his/her body. Our investigations have shown that the application of cooperative diversity is a promising approach to enhance the performance of medical implant communication systems in various aspects such as implant lifetime and communication link reliability. PMID:20379346
Comparative study of design and PCL-substituting systems of total knee prosthesis.
Adam, R; Orban, C; Orban, H
2014-01-01
The aim of this study is to assess postoperative results obtained by different knee implants. The main implant types differences are given by generally implant design and by PCL substituting systems that are used. Between 04.2004 - 02.2012 we have performed 506 total knee arthroplasties (TKA), on a group of 460 patients. Our choice, was for cemented total knee prostheses, using PCL-substituting systems. Regarding general design and PCL-substituting systems of the implant we had divided the main group in three lots. In order to assess post operative result we had used the American Knee Society Score(AKSS). All prostheses types that we had implanted, had registered satisfactory values of AKSS. Our study showed that one group scored higher values of AKSS, compared the other two, but there are not statistical semnificative differences (p=0,09). Celsius.
Fetter, J G; Benditt, D G; Stanton, M S
1996-08-01
This study was designed to determine the susceptibility of an implanted cardioverter-defibrillator to electromagnetic interference in an electrically hostile work site environment, with the ultimate goal of allowing the patient to return to work. Normal operation of an implanted cardioverter-defibrillator depends on reliable sensing of the heart's electrical activity. Consequently, there is concern that external electromagnetic interference from external sources in the work place, especially welding equipment or motor-generator systems, may be sensed and produce inappropriate shocks or abnormal reed switch operation, temporarily suspending detection of ventricular tachycardia or ventricular fibrillation. The effects of electromagnetic interference on the operation of one type of implantable cardioverter-defibrillator (Medtronic models 7217 and 7219) was measured by using internal event counter monitoring in 10 patients operating arc welders at up to 900 A or working near 200-hp motors and 1 patient close to a locomotive starter drawing up to 400 A. The electromagnetic interference produced two sources of potential interference on the sensing circuit or reed switch operation, respectively: 1) electrical fields with measured frequencies up to 50 MHz produced by the high currents during welding electrode activation, and 2) magnetic fields produced by the current in the welding electrode and cable. The defibrillator sensitivity was programmed to the highest (most sensitive) value: 0.15 mV (model 7219) or 0.3 mV (model 7217). The ventricular tachycardia and ventricular fibrillation therapies were temporarily turned off but the detection circuits left on. None of the implanted defibrillators tested were affected by oversensing of the electric field as verified by telemetry from the detection circuits. The magnetic field from 225-A welding current produced a flux density of 1.2 G; this density was not adequate to close the reed switch, which requires approximately 10 G. Our testing at the work site revealed no electrical interference with this type of defibrillator. Patients were allowed to return to work. The following precautions should be observed by the patient: 1) maintain a minimal distance of 2 ft (61 cm) from the welding arc and cables or large motors, 2) do not exceed tested currents with the welding equipment, 3) wear insulated gloves while operating electrical equipment, 4) verify that electrical equipment is properly grounded, and 5) stop welding and leave the work area immediately if a therapy is delivered or a feeling of lightheadedness is experienced.
Wireless energizing system for an automated implantable sensor.
Swain, Biswaranjan; Nayak, Praveen P; Kar, Durga P; Bhuyan, Satyanarayan; Mishra, Laxmi P
2016-07-01
The wireless drive of an automated implantable electronic sensor has been explored for health monitoring applications. The proposed system comprises of an automated biomedical sensing system which is energized through resonant inductive coupling. The implantable sensor unit is able to monitor the body temperature parameter and sends back the corresponding telemetry data wirelessly to the data recoding unit. It has been observed that the wireless power delivery system is capable of energizing the automated biomedical implantable electronic sensor placed over a distance of 3 cm from the power transmitter with an energy transfer efficiency of 26% at the operating resonant frequency of 562 kHz. This proposed method ensures real-time monitoring of different human body temperatures around the clock. The monitored temperature data have been compared with a calibrated temperature measurement system to ascertain the accuracy of the proposed system. The investigated technique can also be useful for monitoring other body parameters such as blood pressure, bladder pressure, and physiological signals of the patient in vivo using various implantable sensors.
Borba, Marcelo; Deluiz, Daniel; Lourenço, Eduardo José Veras; Oliveira, Luciano; Tannure, Patrícia Nivoloni
2017-08-21
This study aimed to evaluate dental implant outcomes and to identify risk factors associated with implant failure over 12 years via dental records of patients attending an educational institution. Dental records of 202 patients receiving 774 dental implants from 2002 to 2014 were analyzed by adopting a more reliable statistical method to evaluate risk factors with patients as the unit [generalized estimating equation (GEE)]. Information regarding patient age at implantation, sex, use of tobacco, and history of systemic diseases was collected. Information about implant location in the arch region and implant length, diameter, and placement in a grafted area was evaluated after 2 years under load. Systemic and local risk factors for early and late implant failure were studied. A total of 18 patients experienced 25 implant failures, resulting in an overall survival rate of 96.8% (2.84% and 0.38% early and late implant failures, respectively). The patient-based survival rate was 91.8%. GEE univariate and multivariate analyses revealed that a significant risk factor for implant failure was the maxillary implant (p = 0.006 and p = 0.014, respectively). Bone grafting appeared to be a risk factor for implant failure (p = 0.054). According to GEE analyses, maxillary implants had significantly worse outcomes in this population and were considered to be a risk factor for implant failure. Our results suggested that implants placed in a bone augmentation area had a tendency to fail.
The potential of isotopically enriched magnesium to study bone implant degradation in vivo.
Draxler, Johannes; Martinelli, Elisabeth; Weinberg, Annelie M; Zitek, Andreas; Irrgeher, Johanna; Meischel, Martin; Stanzl-Tschegg, Stefanie E; Mingler, Bernhard; Prohaska, Thomas
2017-03-15
This pilot study highlights the substantial potential of using isotopically enriched (non-radioactive) metals to study the fate of biodegradable metal implants. It was possible to show that magnesium (Mg) release can be observed by combining isotopic mass spectrometry and isotopic pattern deconvolution for data reduction, even at low amounts of Mg released a from slowly degrading 26 Mg enriched (>99%) Mg metal. Following implantation into rats, structural in vivo changes were monitored by μCT. Results showed that the applied Mg had an average degradation rate of 16±5μmyear -1 , which corresponds with the degradation rate of pure Mg. Bone and tissue extraction was performed 4, 24, and 52weeks after implantation. Bone cross sections were analyzed by laser ablation inductively coupled plasma mass spectrometry (ICP-MS) to determine the lateral 26 Mg distribution. The 26 Mg/ 24 Mg ratios in digested tissue and excretion samples were analyzed by multi collector ICP-MS. Isotope pattern deconvolution in combination with ICP-MS enabled detection of Mg pin material in amounts as low as 200ppm in bone tissues and 20ppm in tissues up to two fold increased Mg levels with a contribution of pin-derived Mg of up to 75% (4weeks) and 30% (24weeks) were found adjacent to the implant. After complete degradation, no visual bone disturbance or residual pin-Mg could be detected in cortical bone. In organs, increased Δ 26 Mg/ 24 Mg values up to 16‰ were determined compared to control samples. Increased Δ 26 Mg/ 24 Mg values were detected in serum samples at a constant total Mg level. In contrast to urine, feces did not show a shift in the 26 Mg/ 24 Mg ratios. This investigation showed that the organism is capable of handling excess Mg well and that bones fully recover after degradation. Magnesium alloys as bone implants have faced increasing attention over the past years. In vivo degradation and metabolism studies of these implant materials have shown the promising application in orthopaedic trauma surgery. With advance in Mg research it has become increasingly important to monitor the fate of the implant material in the organism. For the first time, the indispensible potential of isotopically enriched materials is documented by applying 26 Mg enriched Mg implants in an animal model. Therefore, the spatial distribution of pin-Mg in bone and the pin-Mg migration and excretion in the organism could be monitored to better understand metal degradation as well as Mg turn over and excretion. Copyright © 2017. Published by Elsevier Ltd.
2010-01-01
Background Recent studies have shown the potential suitability of magnesium alloys as biodegradable implants. The aim of the present study was to compare the soft tissue biocompatibility of MgCa0.8 and commonly used surgical steel in vivo. Methods A biodegradable magnesium calcium alloy (MgCa0.8) and surgical steel (S316L), as a control, were investigated. Screws of identical geometrical conformation were implanted into the tibiae of 40 rabbits for a postoperative follow up of two, four, six and eight weeks. The tibialis cranialis muscle was in direct vicinity of the screw head and thus embedded in paraffin and histologically and immunohistochemically assessed. Haematoxylin and eosin staining was performed to identify macrophages, giant cells and heterophil granulocytes as well as the extent of tissue fibrosis and necrosis. Mouse anti-CD79α and rat anti-CD3 monoclonal primary antibodies were used for B- and T-lymphocyte detection. Evaluation of all sections was performed by applying a semi-quantitative score. Results Clinically, both implant materials were tolerated well. Histology revealed that a layer of fibrous tissue had formed between implant and overlying muscle in MgCa0.8 and S316L, which was demarcated by a layer of synoviocyte-like cells at its interface to the implant. In MgCa0.8 implants cavities were detected within the fibrous tissue, which were surrounded by the same kind of cell type. The thickness of the fibrous layer and the amount of tissue necrosis and cellular infiltrations gradually decreased in S316L. In contrast, a decrease could only be noted in the first weeks of implantation in MgCa0.8, whereas parameters were increasing again at the end of the observation period. B-lymphocytes were found more often in MgCa0.8 indicating humoral immunity and the presence of soluble antigens. Conversely, S316L displayed a higher quantity of T-lymphocytes. Conclusions Moderate inflammation was detected in both implant materials and resolved to a minimum during the first weeks indicating comparable biocompatibility for MgCa0.8 and S316L. Thus, the application of MgCa0.8 as biodegradable implant material seems conceivable. Since the inflammatory parameters were re-increasing at the end of the observation period in MgCa0.8 it is important to observe the development of inflammation over a longer time period in addition to the present study. PMID:20974008
Earfold Implantable Clip System for Correction of Prominent Ears: Analysis of Safety in 403 Patients
Sojitra, Nilesh; Glumicic, Sinisa; Vlok, Jacobus A.; O’Toole, Greg; Hannan, S. Alam; Sabbagh, Walid
2018-01-01
Background: The Earfold system, a new treatment for the correction of prominent ears, consists of 3 components: the Earfold implant, the Earfold introducer, and the Prefold positioner. Methods: This is an interim report based on an ongoing analysis of safety in a series of patients treated for prominent ears with the Earfold implant between February 2013 and September 2014. Safety was assessed based on adverse event reports and the need for implant revision; follow-up is ongoing. Results: Seven surgeons used 1,200 Earfold implants to treat 403 patients (ages, 7–70 years; 63% male); the time since the initial implant procedure now ranges from 30 to 48 months. To date, 145 patients (36%) have returned for a follow-up visit (mean, 7.7 months [range, 1–34 months]). Adverse events requiring intervention have affected 39 of 403 (9.7%) patients; these include implant revisions (n = 17 [4.2%], most often due to implant visibility), skin erosion over the implant (n = 15 [3.7%]), and infection (n = 7 [1.7%]). Bleeding, recurrence of prominence, hematoma, deformity, or adverse scarring did not occur. Conclusions: This interim analysis has shown that Earfold prominent ear correction system is associated with relatively few adverse events that require intervention; a small number of patients experienced infection, implant extrusion, or implant visibility that required revision. Most adverse events were related to either patient selection or technical errors at implantation. It is expected that with continued use of Earfold by surgeons experienced in otoplasty, the adverse event incidence will decrease. PMID:29464160
Di Stefano, Danilo Alessio; Giacometti, Edoardo; Greco, Gian Battista; Gastaldi, Giorgio; Gherlone, Enrico
2016-01-01
The aim of this retrospective study was to evaluate medium-term marginal peri-implant bone loss following placement of root-form implants featuring a micro-threaded rough-surfaced neck and a platform-switched implant-abutment connection. Records were identified of patients treated with such implants over a 3-year period at three Italian dental centers. Patient radiographs were digitized and subjected to computerized analysis of peri-implant bone resorption. Records of 112 patients who received 257 implants were analyzed. Although implant diameters and lengths varied, all had a 0.3-mm platform-switching width and a 2.5-mm high micro-threaded neck. All patients healed uneventfully, and no peri-implant infection, implant mobility, or radiolucency around the implant were detected at any follow-up control. At the 72-month control (average 71 ± 5 months) all implants were successful according to Albrektsson and Zarb's criteria. At implant level, average peri-implant bone resorption was 0.18 ± 0.12 mm at 6 months, 0.22 ± 0.15 mm at 12 months, 0.23 ± 0.16 mm at 24 months, 0.25 ± 0.17 mm at 36 months, 0.26 ± 0.15 mm at 48 months, and stable at subsequent controls, regardless of the implant diameter and length. At patient level, a similar trend was observed, with crestal bone loss stabilizing from 48 months onward. The surface, geometry, and platform-switching features of the implant under investigation allowed effective bone preservation on a medium-term basis.
Kim, Hae-Young; Yang, Jin-Yong; Chung, Bo-Yoon; Kim, Jeong Chan; Yeo, In-Sung
2013-04-01
The aim of this study was to measure the peri-implant bone length surrounding implants that penetrate the sinus membrane at the posterior maxilla and to evaluate the survival rate of these implants. Treatment records and orthopantomographs of 39 patients were reviewed and analyzed. The patients had partial edentulism at the posterior maxilla and limited vertical bone height below the maxillary sinus. Implants were inserted into the posterior maxilla, penetrating the sinus membrane. Four months after implant insertion, provisional resin restorations were temporarily cemented to the abutments and used for one month. Then, a final impression was taken at the abutment level, and final cement-retained restorations were delivered with mutually protected occlusion. The complications from the implant surgery were examined, the number of failed implants was counted, and the survival rate was calculated. The peri-implant bone lengths were measured using radiographs. The changes in initial and final peri-implant bone lengths were statistically analyzed. Nasal bleeding occurred after implant surgery in three patients. No other complications were found. There were no failures of the investigated implants, resulting in a survival rate of 100%. Significantly more bone gain around the implants (estimated difference=-0.6 mm, P=0.025) occurred when the initial residual bone height was less than 5 mm compared to the >5 mm groups. No significant change in peri-implant bone length was detected when the initial residual bone height was 5 mm or larger. This study suggests that implants penetrating the sinus membrane at the posterior maxilla in patients with limited vertical bone height may be safe and functional.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Leung, S.
1990-09-01
Since 1984, perineal template/needle techniques for interstitial implantation of gynecologic cancer-cervix, vagina, vulva-have been developed at the Peter MacCallum Cancer Institute. The Paris System of dosimetry has been used resulting in greater dose homogeneity, fewer needles and radioactive sources and considerable simplification and ease of implantation compared with comparable techniques developed in the United States. Principles and techniques of implantation are described in detail.
Chronically Implanted Pressure Sensors: Challenges and State of the Field
Yu, Lawrence; Kim, Brian J.; Meng, Ellis
2014-01-01
Several conditions and diseases are linked to the elevation or depression of internal pressures from a healthy, normal range, motivating the need for chronic implantable pressure sensors. A simple implantable pressure transduction system consists of a pressure-sensing element with a method to transmit the data to an external unit. The biological environment presents a host of engineering issues that must be considered for long term monitoring. Therefore, the design of such systems must carefully consider interactions between the implanted system and the body, including biocompatibility, surgical placement, and patient comfort. Here we review research developments on implantable sensors for chronic pressure monitoring within the body, focusing on general design requirements for implantable pressure sensors as well as specifications for different medical applications. We also discuss recent efforts to address biocompatibility, efficient telemetry, and drift management, and explore emerging trends. PMID:25365461
Alsabeeha, Nabeel; Payne, Alan G T; De Silva, Rohana K; Swain, Michael V
2009-04-01
To review the literature on mandibular single-implant overdentures (opposing complete maxillary dentures), and present surgical and prosthodontic perspectives of a novel approach for this treatment option. An electronic search through the databases of Pubmed, Embase and Medline using the linked key words 'mandibular single implant overdentures' was performed. The search was limited to English language articles published up to August 2008. Hand searches through articles retrieved from the electronic search, peer-reviewed journals and recent conference proceedings were also conducted. A limited number of reports were identified on mandibular single-implant overdentures (opposing maxillary complete dentures). They comprised of case-series reports, short-term prospective trials and current randomized-controlled clinical trials. Different loading protocols with different implant systems have been used, but always with regular diameter implants. Specific anatomical and vascular dangers of the mandibular midline symphysis are identified including a novel surgical approach using a currently available short, wide diameter tapered implant. In addition, the prosthodontic rationale for using a larger attachment system (incorporating a platform switch) for mandibular single-implant overdentures is described. The review reveals that there is a lack of published randomized clinical trials using mandibular single-implant overdentures, opposing maxillary complete dentures. Without the evidence from randomized clinical trials, routine use of this novel approach cannot be recommended, compared with using regular diameter implants and matching attachment systems.
Maló, Paulo; Friberg, Bertil; Polizzi, Giovanni; Gualini, Federico; Vighagen, Torbjörn; Rangert, Bo
2003-01-01
Immediate/early implant function means great benefits for patients and therapists because treatment time and cost can be substantially reduced. This concept has become an accepted alternative for complete arch fixed restorations in the mandible, and clinical documentation is emerging for other indications. The purpose of this prospective clinical multicenter study was to evaluate the outcome of implants placed in incisor, canine, and premolar regions in maxillas or mandibles. Implants were loaded with provisional crowns and bridges on the same day or within a few days and were followed up for 1 year during function. Four centers treated 76 patients each in need of an implant-retained prosthesis in the anterior and premolar regions in the maxilla or mandible. A total of 116 titanium implants with machined surfaces (Brånemark System , Nobel Biocare AB, Gothenburg, Sweden) were placed: 74 in maxillas and 42 in mandibles. Eighty-seven prostheses were made, of which 63 were single crowns and 24 were bridges (supported by 53 splinted implants). Twenty-two implants in 14 patients were placed in fresh extraction sites. The goal with the preparation and insertion technique was to achieve good primary implant stability and a minimum implant insertion torque of 30 Ncm before the implant was completely seated. The occlusion was adjusted to eliminate direct contact with the provisional prostheses. After 6 months, the patients received their permanent prostheses. Sixty-seven patients were followed for 1 year. Five implants were lost in five patients, three in the maxilla and two in the mandible. Four of the lost implants were single-tooth replacements and one was splinted. The cumulative survival rate (CSR) was 95.7% for all implants after 1 year and 93.7% and 98.1% for single-tooth and splinted implants, respectively. There were no implant losses in the extraction sites. The CSR of 96% at 1 year indicates that immediate function of Brånemark System implants placed in incisor to premolar regions in both jaws is a viable concept. More failures occurred with single-tooth replacements (6.3%) than with splinted implants (1.9%).
In-vitro and in-vivo characterization of a buprenorphine delivery system.
Kleppner, Sofie R; Patel, Raj; McDonough, Joseph; Costantini, Lauren C
2006-03-01
Buprenorphine is a mu-opioid receptor partial agonist with enhanced safety and comparable efficacy to methadone for treatment of opioid dependence. The sublingual formulation of buprenorphine, approved for treatment of opioid dependence, produces variable buprenorphine blood levels and requires frequent dosing that limits patient compliance. To achieve stable buprenorphine levels that may improve patient outcome, an implantable sustained buprenorphine delivery system was developed. Each implant consists of ethylene vinyl acetate copolymer and 90 mg buprenorphine HCl, and measures 26 mm in length and 2.4 mm in diameter. Steady-state release in-vitro was 0.5 mg/implant/day. In-vivo pharmacokinetics and safety were examined for up to 52 weeks in beagle dogs receiving 8, 16 or 24 subcutaneous implants. Plasma buprenorphine concentrations correlated with the number of implants administered. Peak buprenorphine concentrations were generally reached within 24 h after implantation. Steady-state plasma levels were attained between 3 and 8 weeks, and were maintained for study duration, with a calculated mean release rate of 0.14+/-0.04 mg/implant/day. There were no test-article-related adverse effects. This delivery system can provide long-term stable systemic buprenorphine levels, and may increase patient compliance, thereby improving outcome for opioid-dependent patients.
Cochlear implantation in children and adults in Switzerland.
Brand, Yves; Senn, Pascal; Kompis, Martin; Dillier, Norbert; Allum, John H J
2014-02-04
The cochlear implant (CI) is one of the most successful neural prostheses developed to date. It offers artificial hearing to individuals with profound sensorineural hearing loss and with insufficient benefit from conventional hearing aids. The first implants available some 30 years ago provided a limited sensation of sound. The benefit for users of these early systems was mostly a facilitation of lip-reading based communication rather than an understanding of speech. Considerable progress has been made since then. Modern, multichannel implant systems feature complex speech processing strategies, high stimulation rates and multiple sites of stimulation in the cochlea. Equipped with such a state-of-the-art system, the majority of recipients today can communicate orally without visual cues and can even use the telephone. The impact of CIs on deaf individuals and on the deaf community has thus been exceptional. To date, more than 300,000 patients worldwide have received CIs. In Switzerland, the first implantation was performed in 1977 and, as of 2012, over 2,000 systems have been implanted with a current rate of around 150 CIs per year. The primary purpose of this article is to provide a contemporary overview of cochlear implantation, emphasising the situation in Switzerland.
Metzler, Philipp; von Wilmowsky, Cornelius; Stadlinger, Bernd; Zemann, Wolfgang; Schlegel, Karl Andreas; Rosiwal, Stephan; Rupprecht, Stephan
2013-09-01
Promising biomaterial characteristics of diamond-coatings in biomedicine have been described in the literature. However, there is a lack of knowledge about implant osseointegration of this surface modification compared to the currently used sandblasted acid-etched Ti-Al6-V4 implants. The aim of this study was to investigate the osseointegration of microwave plasma-chemical-vapour deposition (MWP-CVD) diamond-coated Ti-Al6-V4 dental implants after healing periods of 2 and 5 months. Twenty-four MWP-CVD diamond-coated and 24 un-coated dental titanium-alloy implants (Ankylos(®)) were placed in the frontal skull of eight adult domestic pigs. To evaluate the effects of the nano-structured surfaces on bone formation, a histomorphometric analysis was performed after 2 and 5 months of implant healing. Histomorphometry analysed the bone-to-implant contact (BIC). No significant difference in BIC for the diamond-coated implants in comparison to reference implants could be observed for both healing periods. Scanning electron microscopy revealed an adequate interface between the bone and the diamond surface. No delamination or particle-dissociation due to shearing forces could be detected. In this study, diamond-coated dental titanium-alloy implants and sandblasted acid-etched implants showed a comparable degree of osseointegration. Copyright © 2012 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.
Wireless implantable passive strain sensor: design, fabrication and characterization
NASA Astrophysics Data System (ADS)
Umbrecht, F.; Wägli, P.; Dechand, S.; Gattiker, F.; Neuenschwander, J.; Sennhauser, U.; Hierold, Ch
2010-08-01
This work presents a new passive sensor concept for monitoring the deformation of orthopedic implants. The novel sensing principle of the WIPSS (wireless implantable passive strain sensor) is based on a hydro-mechanical amplification effect. The WIPSS is entirely made from biocompatible PMMA and consists of a microchannel attached to a reservoir, which is filled with an incompressible fluid. As the reservoir is exposed to strain, its volume changes and consequently the fill level inside the microchannel varies. The wireless detection of the microchannel's strain-dependent fill level is based on ultrasound. The WIPSS' sensing principle is proved by finite-element simulations and the reservoir's design is optimized toward maximum volume change, in order to achieve high sensitivity. A fabrication process for WIPSS sensor devices entirely made from PMMA is presented. The obtained measurement results confirmed the sensor's functionality and showed very good agreement with the obtained results of the conducted FE simulations regarding the sensor's sensitivity. A strain resolution of 1.7 ± 0.2 × 10-5 was achieved. Further, the determination of the cross-sensitivity to temperature and strains applied out of the sensing direction is presented. The response to dynamic inputs (0.1-5 Hz) has been measured and showed decreasing sensor output with increasing frequency. Test structures of the sensor device allow the application of a signal bandwidth up to 1 Hz. Therefore, the proposed sensor concept of the WIPSS presents a promising new sensor system for static in vivo strain monitoring of orthopedic implants. In combination with the developed ultrasound-based read-out method, this new sensor system offers the potential of wireless sensor read-out with medical ultrasound scanners, which are commercially available.
Wellmer, Jörg; Parpaley, Yaroslav; von Lehe, Marec; Huppertz, Hans-Jürgen
2010-01-01
Focal cortical dysplasias (FCDs) are highly epileptogenic lesions. Surgical removal is frequently the best treatment option for pharmacoresistant epilepsy. However, subtle FCDs may remain undetected even after high-resolution magnetic resonance imaging (MRI). Morphometric MRI analysis, which compares the individual brain with a normal database, can facilitate the detection of FCDs. We describe how the results of normal database-based MRI postprocessing can be used to guide stereotactic electrode implantation and subsequent resection of lesions that are suspected to be FCDs. A presurgical evaluation was conducted on a 19-year-old woman with pharmacoresistant hypermotor seizures. Conventional high-resolution MRI was classified as negative for epileptogenic lesions. However, morphometric analysis of the spatially normalized MRI revealed abnormal gyration and blurring of the gray-white matter junction, which was suggestive of a small and deeply seated FCD in the left frontal lobe. The brain region highlighted by morphometric analysis was marked as a region of interest, transferred back to the original dimension of the individual MRI, and imported into a neuronavigation system. This allowed the region of interest-targeted stereotactic implantation of 2 depth electrodes, by which seizure onset was confirmed in the lesion. The electrodes also guided the final resection, which rendered the patient seizure-free. The lesion was histologically classified as FCD Palmini and Lüders IIB. Transferring normal database-based MRI postprocessing results into a neuronavigation system is a new and worthwhile extension of multimodal neuronavigation. The combination of resulting regions of interest with functional and anatomic data may facilitate planning of electrode implantation for invasive electroencephalographic recordings and the final resection of small or deeply seated FCDs.
MR imaging of breast implants.
Gorczyca, D P
1994-11-01
MR imaging has proved to be an excellent imaging modality in locating free silicone and evaluating an implant for rupture, with a sensitivity of approximately 94% and specificity of 97%. Silicone has a unique MR resonance frequency and long T1 and T2 relaxation times, which allows several MR sequences to provide excellent diagnostic images. The most commonly used sequences include T2-weighted, STIR, and chemical shift imaging (Figs. 3, 13, and 14). The T2-weighted and STIR sequences are often used in conjunction with chemical water suppression. The most reliable findings on MR images for detection of implant rupture include identification of the collapsed implant shell (linguine sign) and free silicone within the breast parenchyma.
Emerging Synergy between Nanotechnology and Implantable Biosensors: A Review
Vaddiraju, Santhisagar; Tomazos, Ioannis; Burgess, Diane J; Jain, Faquir C; Papadimitrakopoulos, Fotios
2010-01-01
The development of implantable biosensors for continuous monitoring of metabolites is an area of sustained scientific and technological interest. On the other hand, nanotechnology, a discipline which deals with the properties of materials at the nanoscale, is developing as a potent tool to enhance the performance of these biosensors. This article reviews the current state of implantable biosensors, highlighting the synergy between nanotechnology and sensor performance. Emphasis is placed on the electrochemical method of detection in light of its widespread usage and substantial nanotechnology-based improvements in various aspects of electrochemical biosensor performance. Finally, issues regarding toxicity and biocompatibility of nanomaterials, along with future prospects for the application of nanotechnology in implantable biosensors, are discussed. PMID:20042326
Petrovičová, Andrea; Kurča, Egon; Brozman, Miroslav; Hasilla, Jozef; Vahala, Pavel; Blaško, Peter; Andrášová, Andrea; Hatala, Robert; Urban, Luboš; Sivák, Štefan
2015-12-03
Cardio-embolic etiology is the most frequently predicted cause of cryptogenic stroke/TIA. Detection of occult paroxysmal atrial fibrillation is crucial for selection of appropriate medication. Enrolment of eligible cryptogenic stroke and TIA patients began in 2014 and will continue until 2018. The patients undergo long-term (12 months) ECG monitoring (implantable loop recorder) and testing for PITX2 (chromosome 4q25) and ZFHX3 (chromosome 16q22) gene mutations. There will be an appropriate control group of age- and sex-matched healthy volunteers. To analyse the results descriptive statistics, statistical tests for group differences, and correlation analyses will be used. In our study we are focusing on a possible correlation between detection of atrial fibrillation by an implantable ECG recorder, and PITX2 and/or ZFHX3 gene mutations in cryptogenic stroke/TIA patients. A correlation could lead to implementation of this genomic approach to cryptogenic stroke/TIA diagnostics and management. The results will be published in 2018. ClinicalTrials.gov: NCT02216370 .
Microbiology and cytokine levels around healthy dental implants and teeth.
Nowzari, Hessam; Botero, Javier Enrique; DeGiacomo, Marina; Villacres, Maria C; Rich, Sandra K
2008-09-01
Elicitation of the relationship of periodontopathogens and pro-inflammatory cytokines to bone resorption and formation is significant to a growing body of research known as osteoimmunology. It is essential that clinically healthy peri-implant and periodontal sites are studied to contribute comparison data for investigations that are addressing diseased sites. The purpose of this study was to describe levels of selected pro-inflammatory cytokines in clinically healthy peri-implant and periodontal sites, and to examine whether cytokine levels may be related to specific bacterial/viral pathogens. Eleven subjects (mean age 56.2 +/- 10) participated in the study. Subgingival microbial samples were cultured for periodontopathic bacteria. Gingival crevicular fluid samples were analyzed by nested polymerase chain reaction for Cytomegalovirus (HCMV) and were tested for the quantification of Interleukin (IL)-8, IL-1beta, IL-6, IL-10, Tumor Necrosis Factor (TNF)-alpha, and IL-12p70 using flow cytometry (FACS). Findings for microbiota composition and cytokine levels were compared between implants and teeth (chi square, Kruskall-Wallis, Mann-Whitney; p < or = .05). Both the frequency (%) and levels (%) of periodontopathic bacteria were higher around teeth than implants. The concentration (picogram per milliliter) of cytokines was more prominent around implants than teeth, reaching nearly twofold differences in some instances. Cytokine levels were higher when the sites analyzed were positive for any bacteria tested. HCMV was not detected. Pro-inflammatory cytokine production was unrelated to heavy bacterial challenge. Nevertheless, when periodontopathic bacteria were detected by culture, cytokine levels were increased around both implants and teeth. Studies are needed to investigate the pro-inflammatory cytokines (especially IL-1beta and TNF-alpha) produced in spite of minimal bacterial accumulation.
Wieners, G; Pech, M; Streitparth, F; Jansson, V; Plitz, W
2007-01-01
The aim of this study was the detection of areas at risk at the proximal femur after implantation of different femur neck prostheses using the photoelastic stress analysis. Twelve pairs of human femurs were used as examination material. The analysis of the stress pattern was done with a stepwise increasing load up to the quadruple of body weight before and after implantation of three models of femur neck prostheses which were implanted cementless. The "CUT" and "Cigar" models are coated with a tripod structure. The "Cigar" model has a lateral thrust plate. The lateral end of the "CUT" model is curved and this end is attached to the lateral corticalis. The third model, the "rip prosthesis" has two layers for rotational stability. Subsequently, the micromotions of the implanted prosthesis in the femural neck were examined with alternating weight loads (1000 +/- 700 N). The Cigar prosthesis showed the most changes of stress distribution because of the lateral thrust plate with concentration of isochromatic lines to the lateral boring. In the region of the oseotomy an increase of strain up 1440 microm/m could be detected for the Cigar and up to 1000 microm/m for the rib prosthesis. The stress pattern after implantation of the CUT prosthesis remained very similar apart from a slight increase of stress values (720 microm/m). Only for the Cigar prostheses were the measured micromotions below the critical value for a possible osteointegration with a mean value of 134 microm/m. The stress pattern after implantation of the CUT prosthesis remained most similar to the preinterventional stress distribution. Because of this, it is to be expected that the osseous modification would stay at a low level. The question of osteointegration can only be answered in long-term in-vivo studies.
NASA Astrophysics Data System (ADS)
Pillaca, E. J. D. M.; Ueda, M.; Oliveira, R. M.; Pichon, L.
2014-08-01
Effects of E × B fields as mechanism to carbon-nitrogen plasma immersion ion implantation (PIII) have been investigated. This magnetic configuration when used in PIII allows obtaining high nitrogen plasma density close to the ion implantation region. Consequently, high ions dose on the target is possible to be achieved compared with standard PIII. In this scenario, nitrogen and carbon ions were implanted simultaneously on stainless steel, as measured by GDOES and detected by X-ray diffraction. Carbon-tape disposed on the sample-holder was sputtered by intense bombardment of nitrogen ions, being the source of carbon atoms in this experiment. The implantation of both N and C caused changes on sample morphology and improvement of the tribological properties of the stainless steel.
Cheng, Yicheng; Gao, Bo; Liu, Xianghui; Zhao, Xianghui; Sun, Weige; Ren, Huifang; Wu, Jiang
2016-01-01
To prevent peri-implant infection, a new antibacterial coating containing a halogenated furanone compound, (Z-)-4-bromo-5-(bromomethylene)-2(5H)-furanone-loaded poly(l-lactic acid) nanoparticles, has been fabricated. The current study was designed to evaluate the preventive effect of the antibacterial coating under a simulated environment of peri-implant infection in vivo. Microarc-oxidized titanium implants treated with minocycline hydrochloride ointment were used as positive control group, and microarc-oxidized titanium implants without any treatment were used as blank control group. Three kinds of implants were implanted in dogs' mandibles, and the peri-implant infection was simulated by silk ligation and feeding high sugar diet. After 2-month implantation, the results showed that no significant differences were detected between the experimental and positive control groups (P>0.05), but the data of clinical measurements of the blank control group were significantly higher than those of the other two groups (P<0.05), and the bone-implant contact rate and ultimate interfacial strength were significantly lower than those of the other two groups (P<0.05). Scanning electron microscope observation and histological examination showed that more new bone was formed on the surface of the experimental and positive control groups. It can be concluded that the antibacterial coating fabricated on implants has remarkable preventive effect on peri-implant infection at the early stage.
Integrated Avalanche Photodiode arrays
DOE Office of Scientific and Technical Information (OSTI.GOV)
Harmon, Eric S.
2017-04-18
The present disclosure includes devices for detecting photons, including avalanche photon detectors, arrays of such detectors, and circuits including such arrays. In some aspects, the detectors and arrays include a virtual beveled edge mesa structure surrounded by resistive material damaged by ion implantation and having side wall profiles that taper inwardly towards the top of the mesa structures, or towards the direction from which the ion implantation occurred. Other aspects are directed to masking and multiple implantation and/or annealing steps. Furthermore, methods for fabricating and using such devices, circuits and arrays are disclosed.
Integrated avalanche photodiode arrays
Harmon, Eric S.
2015-07-07
The present disclosure includes devices for detecting photons, including avalanche photon detectors, arrays of such detectors, and circuits including such arrays. In some aspects, the detectors and arrays include a virtual beveled edge mesa structure surrounded by resistive material damaged by ion implantation and having side wall profiles that taper inwardly towards the top of the mesa structures, or towards the direction from which the ion implantation occurred. Other aspects are directed to masking and multiple implantation and/or annealing steps. Furthermore, methods for fabricating and using such devices, circuits and arrays are disclosed.
“In vitro” Implantation Technique Based on 3D Printed Prosthetic Prototypes
NASA Astrophysics Data System (ADS)
Tarnita, D.; Boborelu, C.; Geonea, I.; Malciu, R.; Grigorie, L.; Tarnita, D. N.
2018-06-01
In this paper, Rapid Prototyping ZCorp 310 system, based on high-performance composite powder and on resin-high strength infiltration system and three-dimensional printing as a manufacturing method are used to obtain physical prototypes of orthopaedic implants and prototypes of complex functional prosthetic systems directly from the 3D CAD data. These prototypes are useful for in vitro experimental tests and measurements to optimize and obtain final physical prototypes. Using a new elbow prosthesis model prototype obtained by 3D printing, the surgical technique of implantation is established. Surgical implantation was performed on male corpse elbow joint.
A, Lan; Xu, Wenzhou; Zhao, Jinghui; Li, Chunyan; Qi, Manlin; Li, Xue; Wang, Lin; Zhou, Yanmin
2018-06-20
Minocycline has been widely used in central nervous system disease. However, the effect of minocycline on the repairing of nerve fibers around dental implants had not been previously investigated. The aim of the present study was to evaluate the possibility of using minocycline for the repairing of nerve fibers around dental implants by investigating the effect of minocycline on the proliferation of Schwann cells and secretion of neurotrophic factors nerve growth factor and glial cell line-derived neurotrophic factor in vitro. TiO 2 nanotubes were fabricated on the surface of pure titanium via anodization at the voltage of 20, 30, 40 and 50 V. The nanotubes structure were characterized by scanning electron microscopy and examined with an optical contact angle. Then drug loading capability and release behavior were detected in vitro. The TiO 2 nanotubes loaded with different concentration of minocycline were used to produce conditioned media with which to treat the Schwann cells. A cell counting kit-8 assay and cell viability were both selected to study the proliferative effect of the specimens on Schwann cell. Reverse transcription-quantitative PCR and western blot analyses were used to detect the related gene/protein expression of Schwann cells. The results showed that the diameter of TiO 2 nanotubes at different voltage varied from 100 to 200 nm. The results of optical contact angle and releasing profile showed the nanotubes fabricated at the voltage of 30 V met the needs of the carrier of minocycline. In addition, the TiO 2 nanotubes loaded with the concentration of 20 μg/mL minocycline increased Schwann cells proliferation and secretion of neurotrophic factors in vitro. The results suggested that the surface functionalization of TiO 2 nanotubes with minocycline was a promising candidate biomaterial for the peripheral nerve regeneration around dental implants and has potential to be applied in improving the osseoperception of dental implant.
Glotzer, Taya V; Daoud, Emile G; Wyse, D George; Singer, Daniel E; Holbrook, Reece; Pruett, Khadeeja; Smith, Kenneth; Hilker, Christopher E
2006-01-01
Sustained atrial fibrillation (AF) is a common risk factor for stroke. While intermittent AF also appears to pose a substantial stroke risk, the quantitative relationship between the percentage of time spent in AF and stroke risk is poorly specified and "intermittent" AF is not the same as paroxysmal AF. Improved assessment of the impact of AF burden on stroke risk will allow more targeted and safer use of antithrombotic therapy. The primary objective of this study is to determine if AT/AF (all device detected atrial tachyarrhythmias, including atrial flutter, atrial fibrillation, and atrial tachycardia) burden over a 30 day period is an independent predictor of the occurrence of ischemic stroke, transient ischemic attack (TIA) and/or systemic embolism in subjects not receiving anticoagulation therapy. TRENDS is a prospective, post-market, non-randomized, multicenter study designed to enroll 3100 subjects who have an independent Class I/II indication for cardiac rhythm device implantation and who have demographic features suggestive of an increased risk for thromboembolic complications related to AT/AF. All implanted devices will have the ability to collect long-term AT/AF burden trending data and will be equivalently programmed to ensure consistent data collection. All subjects will be followed with device interrogations every 3 months and clinic visits every 6 months for 1 year. Subjects with a documented history of AT/AF prior to enrollment and those who develop AT/AF during the 12-month follow-up will be followed until the last subject enrolled in the study has completed their 24-month follow-up. The results of the TRENDS study should help clarify the implications of data retrieved from an implantable device with regard to the risk for thromboembolic complications from atrial arrhythmias, even in the absence of symptoms.
Mastenbroek, Mirjam H; Pedersen, Susanne S; van der Tweel, Ingeborg; Doevendans, Pieter A; Meine, Mathias
2016-02-15
Novel implantable cardioverter defibrillator (ICD) discrimination algorithms and programming strategies have significantly reduced the incidence of inappropriate shocks, but there are still gains to be made with respect to reducing appropriate but unnecessary antitachycardia pacing (ATP) and shocks. We examined whether programming a number of intervals to detect (NID) of 60/80 for ventricular tachyarrhythmia (VT)/ventricular fibrillation (VF) detection was safe and the impact of this strategy on (1) adverse events related to ICD shocks and syncopal events; (2) ATPs/shocks; and (3) patient-reported outcomes. The "ENHANCED Implantable Cardioverter Defibrillator programming to reduce therapies and improve quality of life" study (ENHANCED-ICD study) was a prospective, safety-monitoring study enrolling 60 primary and secondary prevention patients at the University Medical Center Utrecht. Patients implanted with any type of ICD with SmartShock technology and aged 18 to 80 years were eligible to participate. In all patients, a prolonged NID 60/80 was programmed. The cycle length for VT/fast VT/VF was 360/330/240 ms, respectively. Programming a NID 60/80 proved safe for ICD patients. Because of the new programming strategy, unnecessary ICD therapy was prevented in 10% of ENHANCED-ICD patients during a median follow-up period of 1.3 years. With respect to patient-reported outcomes, levels of distress were highest and perceived health status lowest at the time of implantation, which both gradually improved during follow-up. In conclusion, the ENHANCED-ICD study demonstrates that programming a NID 60/80 for VT/VF detection is safe for ICD patients and does not negatively impact their quality of life. Copyright © 2016 Elsevier Inc. All rights reserved.
NASA Astrophysics Data System (ADS)
Barker, Beau; Meyer, Edmund; Schacht, Mike; Collins, Lee; Wilkerson, Marianne; Zhao, Xinxin
2016-05-01
The low-lying (7.8 eV) isomeric state in 229 Th has the potential to become a nuclear frequency standard. 229 Th recoils from 233 U decays have been collected in MgF2 for use in the direct search of the transition. Of interest is the oxidation state of the implanted 229 Th atoms as this can have an influence on the decay mechanisms and photon emission rate. Too determine the oxidation state of the implanted 229 Th recoils we have employed laser induced florescence (LIF), and plan-wave pseudopotential DFT calculations to search for emission from thorium ions in oxidation states less than + 4. Our search focused on detecting emission from Th3+ ions. The DFT calculations predicted the Th3+ state to be the most likely to be present in the crystal after Th4+. We also calculated the band structure for the Th3+ doped MgF2 crystal. For LIF spectra a number of excitation wavelengths were employed, emission spectra in the visible to near-IR were recorded along with time-resolved emission spectra. We have found no evidence for Th3+ in the MgF2 plates. We also analyzed the detection limit of our apprentice and found that the minimum number of Th3+ atoms that we could detect is quite small compared to the number of implanted 229 Th recoils. The number of implanted 229 Th recoils was derived from a γ-ray spectrum by monitoring emission from the daughters of 228 Th. These were present in the MgF2 plates due to a 232 U impurity, which decays to 228 Th, in the source. LA-UR-16-20442.
Scherer, Michael D; McGlumphy, Edwin A; Seghi, Robert R; Campagni, Wayne V
2014-09-01
The location of dental implants and the choice of retentive attachments for implant-retained overdentures are selected based on clinician preference, expert opinion, or empirical information. Limited information is available regarding implant position and the effect on the retention and stability of 2-implant mandibular implant overdentures. The purpose of this investigation was to evaluate the effect of implant location on the in vitro retention and stability of a simulated 2-implant-supported overdenture and to examine the differences among different attachment systems. A model that simulates a mandibular edentulous ridge with dental implants in positions that approximate tooth positions, and a cobalt-chromium cast framework attached to a universal testing machine was used to measure the peak load (N) required to disconnect the attachments. Four different types of attachments (Ball/Cap, ERA, Locator, and O-Ring) were used in sequence in various positions on the model to evaluate the effect of implant location on the retention and stability of a simulated 2-implant-retained overdenture. Means were calculated, and differences among the systems, directions, and groups were identified by using a repeated measured ANOVA (α=.05). For differences observed between measurements, the Bonferroni post hoc method at the 5% level of significance was used to determine the location and magnitude of difference. The interactions between the attachment system, direction of force, and implant location were statistically significant (P=.01). The vertical retention and horizontal stability of a simulated overdenture prosthesis increased with the distal implant location up to the second premolar, and the anteroposterior stability increased with distal implant location. The attachment type affected retention and stability differently by location. Ball attachments produced the highest levels of retention and stability, followed by Locator (pink), O-Ring, and ERA (orange). The retention and stability of a 2-implant simulated overdenture prosthesis is significantly affected by implant location (P=.01) and abutment type (P=.01). Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
Ion implantation system and process for ultrasensitive determination of target isotopes
DOE Office of Scientific and Technical Information (OSTI.GOV)
Farmer, III, Orville T.; Liezers, Martin
2016-09-13
A system and process are disclosed for ultrasensitive determination of target isotopes of analytical interest in a sample. Target isotopes may be implanted in an implant area on a high-purity substrate to pre-concentrate the target isotopes free of contaminants. A known quantity of a tracer isotope may also be implanted. Target isotopes and tracer isotopes may be determined in a mass spectrometer. The present invention provides ultrasensitive determination of target isotopes in the sample.
Choi, Jae-Won; Choi, Kyung-Hee; Chae, Hee-Jin; Chae, Sung-Ki; Bae, Eun-Bin; Lee, Jin-Ju; Lee, So-Hyoun; Jeong, Chang-Mo; Huh, Jung-Bo
2018-04-06
The aim of this study was to introduce the newly developed micro-locking implant prosthetic system and to evaluate the resulting its characteristics. To evaluate load-bearing capacity, 25 implants were divided into five groups: external-hexagon connection (EH), internal-octagon connection (IO), internal-hexagon connection (IH), one-body implant (OB), micro-locking implant system (ML). The maximum compressive load was measured using a universal testing machine (UTM) according to the ISO 14801. Retention was evaluated in two experiments: (1) a tensile test of the structure modifications of the components (attachment and implant) and (2) a tensile test after cyclic loading (total 5,000,000 cycles, 100 N, 2 Hz). The load-bearing capacity of the ML group was not significantly different from the other groups ( p > 0.05). The number of balls in the attachment and the presence of a hexagonal receptacle did not show a significant correlation with retention ( p > 0.05), but the shape of the retentive groove in the implant post had a statistically significant effect on retention ( p < 0.05). On the other hand, the retention loss was observed during the initial 1,000,000 cycles, but an overall constant retention was maintained afterward. Various preclinical studies on this novel micro-locking implant prosthetic system should continue so that it can be applied in clinical practice.
Choi, Kyung-Hee; Chae, Hee-Jin; Chae, Sung-Ki; Bae, Eun-Bin; Lee, Jin-Ju; Lee, So-Hyoun; Jeong, Chang-Mo; Huh, Jung-Bo
2018-01-01
The aim of this study was to introduce the newly developed micro-locking implant prosthetic system and to evaluate the resulting its characteristics. To evaluate load-bearing capacity, 25 implants were divided into five groups: external-hexagon connection (EH), internal-octagon connection (IO), internal-hexagon connection (IH), one-body implant (OB), micro-locking implant system (ML). The maximum compressive load was measured using a universal testing machine (UTM) according to the ISO 14801. Retention was evaluated in two experiments: (1) a tensile test of the structure modifications of the components (attachment and implant) and (2) a tensile test after cyclic loading (total 5,000,000 cycles, 100 N, 2 Hz). The load-bearing capacity of the ML group was not significantly different from the other groups (p > 0.05). The number of balls in the attachment and the presence of a hexagonal receptacle did not show a significant correlation with retention (p > 0.05), but the shape of the retentive groove in the implant post had a statistically significant effect on retention (p < 0.05). On the other hand, the retention loss was observed during the initial 1,000,000 cycles, but an overall constant retention was maintained afterward. Various preclinical studies on this novel micro-locking implant prosthetic system should continue so that it can be applied in clinical practice. PMID:29642407
Mencucci, Rita; Favuzza, Eleonora; Salvatici, Maria Cristina; Spadea, Leopoldo; Allen, David
2018-02-01
To evaluate by Environmental Scanning Electron Microscopy (ESEM) the corneal incision architecture after intraocular lens (IOL) implantation in pig eyes, using manual, automated injectors or preloaded delivery systems. Twenty-four pig eyes underwent IOL implantation in the anterior chamber using three different injectors: manual (Monarch III) (n = 8), automated (AutoSert) (n = 8), or a preloaded system (UltraSert) (n = 8). Acrysof IQ IOLs, 21 Dioptres (D) (n = 12) and 27D (n = 12), were implanted through 2.2 mm clear corneal incisions. Incision width was measured using corneal calipers. The endothelial side of the incision was analyzed with ESEM. In each group, the final size of the corneal wound after IOL implantation, measured by calipers, was 2.3-2.4 mm. The incision architecture resulted more irregular in the Monarch group compared with the other injectors. In every group the 27D IOL-implanted specimens showed more alterations than in 21D IOL-implanted samples, and this was less evident in the UltraSert group. The Descemet tear length was higher in the Monarch group than AutoSert and UltraSert group. The automated and preloaded delivery systems provided a good corneal incision architecture; after high-power IOL implantation the incisions were more regular and less damaged with the preloaded system than with the other devices.
Visual servoing of a laser ablation based cochleostomy
NASA Astrophysics Data System (ADS)
Kahrs, Lüder A.; Raczkowsky, Jörg; Werner, Martin; Knapp, Felix B.; Mehrwald, Markus; Hering, Peter; Schipper, Jörg; Klenzner, Thomas; Wörn, Heinz
2008-03-01
The aim of this study is a defined, visually based and camera controlled bone removal by a navigated CO II laser on the promontory of the inner ear. A precise and minimally traumatic opening procedure of the cochlea for the implantation of a cochlear implant electrode (so-called cochleostomy) is intended. Harming the membrane linings of the inner ear can result in damage of remaining organ functions (e.g. complete deafness or vertigo). A precise tissue removal by a laser-based bone ablation system is investigated. Inside the borehole the pulsed laser beam is guided automatically over the bone by using a two mirror galvanometric scanner. The ablation process is controlled by visual servoing. For the detection of the boundary layers of the inner ear the ablation area is monitored by a color camera. The acquired pictures are analyzed by image processing. The results of this analysis are used to control the process of laser ablation. This publication describes the complete system including image processing algorithms and the concept for the resulting distribution of single laser pulses. The system has been tested on human cochleae in ex-vivo studies. Further developments could lead to safe intraoperative openings of the cochlea by a robot based surgical laser instrument.
A Multimodal, SU-8 - Platinum - Polyimide Microelectrode Array for Chronic In Vivo Neurophysiology
Márton, Gergely; Orbán, Gábor; Kiss, Marcell; Fiáth, Richárd; Pongrácz, Anita; Ulbert, István
2015-01-01
Utilization of polymers as insulator and bulk materials of microelectrode arrays (MEAs) makes the realization of flexible, biocompatible sensors possible, which are suitable for various neurophysiological experiments such as in vivo detection of local field potential changes on the surface of the neocortex or unit activities within the brain tissue. In this paper the microfabrication of a novel, all-flexible, polymer-based MEA is presented. The device consists of a three dimensional sensor configuration with an implantable depth electrode array and brain surface electrodes, allowing the recording of electrocorticographic (ECoG) signals with laminar ones, simultaneously. In vivo recordings were performed in anesthetized rat brain to test the functionality of the device under both acute and chronic conditions. The ECoG electrodes recorded slow-wave thalamocortical oscillations, while the implanted component provided high quality depth recordings. The implants remained viable for detecting action potentials of individual neurons for at least 15 weeks. PMID:26683306
A Multimodal, SU-8 - Platinum - Polyimide Microelectrode Array for Chronic In Vivo Neurophysiology.
Márton, Gergely; Orbán, Gábor; Kiss, Marcell; Fiáth, Richárd; Pongrácz, Anita; Ulbert, István
2015-01-01
Utilization of polymers as insulator and bulk materials of microelectrode arrays (MEAs) makes the realization of flexible, biocompatible sensors possible, which are suitable for various neurophysiological experiments such as in vivo detection of local field potential changes on the surface of the neocortex or unit activities within the brain tissue. In this paper the microfabrication of a novel, all-flexible, polymer-based MEA is presented. The device consists of a three dimensional sensor configuration with an implantable depth electrode array and brain surface electrodes, allowing the recording of electrocorticographic (ECoG) signals with laminar ones, simultaneously. In vivo recordings were performed in anesthetized rat brain to test the functionality of the device under both acute and chronic conditions. The ECoG electrodes recorded slow-wave thalamocortical oscillations, while the implanted component provided high quality depth recordings. The implants remained viable for detecting action potentials of individual neurons for at least 15 weeks.
Patient ECG recording control for an automatic implantable defibrillator
NASA Technical Reports Server (NTRS)
Fountain, Glen H. (Inventor); Lee, Jr., David G. (Inventor); Kitchin, David A. (Inventor)
1986-01-01
An implantable automatic defibrillator includes sensors which are placed on or near the patient's heart to detect electrical signals indicative of the physiology of the heart. The signals are digitally converted and stored into a FIFO region of a RAM by operation of a direct memory access (DMA) controller. The DMA controller operates transparently with respect to the microprocessor which is part of the defibrillator. The implantable defibrillator includes a telemetry communications circuit for sending data outbound from the defibrillator to an external device (either a patient controller or a physician's console or other) and a receiver for sensing at least an externally generated patient ECG recording command signal. The patient recording command signal is generated by the hand held patient controller. Upon detection of the patient ECG recording command, DMA copies the contents of the FIFO into a specific region of the RAM.
Svirydenka, Hanna; Delso, Gaspar; De Galiza Barbosa, Felipe; Huellner, Martin; Davison, Helen; Fanti, Stefano; Veit-Haibach, Patrick; Ter Voert, Edwin E G W
2017-07-01
Metalic implants may affect attenuation correction (AC) in PET/MR imaging. The purpose of this study was to evaluate the effect of susceptibility artifacts related to metallic implants on adjacent metabolically active lesions in clinical simultaneous PET/MR scanning for both time-of-flight (TOF) and non-TOF reconstructed PET images. Methods: We included 27 patients without implants but with confirmed 18 F-FDG-avid lesions adjacent to common implant locations. In all patients, a clinically indicated whole-body 18 F-FDG PET/MR scan was acquired. Baseline non-TOF and TOF PET images were reconstructed. Reconstruction was repeated after the introduction of artificial signal voids in the AC map to simulate metallic implants in standard anatomic areas. All reconstructed images were qualitatively and quantitatively assessed and compared with the baseline images. Results: In total, 51 lesions were assessed. In 40 and 50 of these cases (non-TOF and TOF, respectively), the detectability of the lesions did not change; in 9 and 1 cases, the detectability changed; and in 2 non-TOF cases, the lesions were no longer visible after the introduction of metallic artifacts. The inclusion of TOF information significantly reduced artifacts due to simulated implants in the femoral head, sternum, and spine ( P = 0.01, 0.01, and 0.03, respectively). It also improved image quality in these locations ( P = 0.02, 0.01, and 0.01, respectively). The mean percentage error was -3.5% for TOF and -4.8% for non-TOF reconstructions, meaning that the inclusion of TOF information reduced the percentage error in SUV max by 28.5% ( P < 0.01). Conclusion: Qualitatively, there was a significant reduction of artifacts in the femoral head, sternum, and spine. There was also a significant qualitative improvement in image quality in these locations. Furthermore, our study indicated that simulated susceptibility artifacts related to metallic implants have a significant effect on small, moderately 18 F-FDG-avid lesions near the implant site that possibly may go unnoticed without TOF information. On larger, highly 18 F-FDG-avid lesions, the metallic implants had only a limited effect. The largest significant quantitative difference was found in artifacts of the sternum. There was only a weak inverse correlation between lesions affected by artifacts and distance from the implant. © 2017 by the Society of Nuclear Medicine and Molecular Imaging.