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Sample records for drug-loaded implantable devices

  1. Biological in situ Dose Painting for Image-Guided Radiation Therapy Using Drug-Loaded Implantable Devices

    SciTech Connect

    Cormack, Robert A.; Sridhar, Srinivas; Suh, W. Warren; D'Amico, Anthony V.; Makrigiorgos, G. Mike

    2010-02-01

    Purpose: Implantable devices routinely used for increasing spatial accuracy in modern image-guided radiation treatments (IGRT), such as fiducials or brachytherapy spacers, encompass the potential for in situ release of biologically active drugs, providing an opportunity to enhance the therapeutic ratio. We model this new approach for two types of treatment. Methods and Materials: Radiopaque fiducials used in IGRT, or prostate brachytherapy spacers ('eluters'), were assumed to be loaded with radiosensitizer for in situ drug slow release. An analytic function describing the concentration of radiosensitizer versus distance from eluters, depending on diffusion-elimination properties of the drug in tissue, was developed. Tumor coverage by the drug was modeled for tumors typical of lung stereotactic body radiation therapy treatments for various eluter dimensions and drug properties. Six prostate {sup 125}I brachytherapy cases were analyzed by assuming implantation of drug-loaded spacers. Radiosensitizer-induced subvolume boost was simulated from which biologically effective doses for typical radiosensitizers were calculated in one example. Results: Drug distributions from three-dimensional arrangements of drug eluters versus eluter size and drug properties were tabulated. Four radiosensitizer-loaded fiducials provide adequate radiosensitization for {approx}4-cm-diameter lung tumors, thus potentially boosting biologically equivalent doses in centrally located stereotactic body treated lesions. Similarly, multiple drug-loaded spacers provide prostate brachytherapy with flexible shaping of 'biologically equivalent doses' to fit requirements difficult to meet by using radiation alone, e.g., boosting a high-risk region juxtaposed to the urethra while respecting normal tissue tolerance of both the urethra and the rectum. Conclusions: Drug loading of implantable devices routinely used in IGRT provides new opportunities for therapy modulation via biological in situ dose painting.

  2. Assessment of different polymers and drug loads for fused deposition modeling of drug loaded implants.

    PubMed

    Kempin, Wiebke; Franz, Christian; Koster, Lynn-Christine; Schneider, Felix; Bogdahn, Malte; Weitschies, Werner; Seidlitz, Anne

    2017-06-01

    The 3D printing technique of fused deposition modeling® (FDM) has lately come into focus as a potential fabrication technique for pharmaceutical dosage forms and medical devices that allows the preparation of delivery systems with nearly any shape. This is particular promising for implants administered at application sites with a high anatomical variability where an individual shape adaption appears reasonable. In this work different polymers (Eudragit®RS, polycaprolactone (PCL), poly(l-lactide) (PLLA) and ethyl cellulose (EC)) were evaluated with respect to their suitability for FDM of drug loaded implants and their drug release behaviour was evaluated. The fluorescent dye quinine was used as a model drug to visualize drug distribution in filaments and implants. Quinine loaded filaments were produced by solvent casting and subsequent hot melt extrusion (HME) and model implants were printed as hollow cylinders using a standard FDM printer. Parameters were found at which model implants (hollow cylinders, outer diameter 4-5mm, height 3mm) could be produced from all tested polymers. The drug release which was examined by incubation of the printed implants in phosphate buffered saline solution (PBS) pH 7.4 was highly dependent on the used polymer. The fastest relative drug release of approximately 76% in 51days was observed for PCL and the lowest for Eudragit®RS and EC with less than 5% of quinine release in 78 and 100days, respectively. For PCL further filaments were prepared with different quinine loads ranging from 2.5% to 25% and thermal analysis proved the presence of a solid dispersion of quinine in the polymer for all tested concentrations. Increasing the drug load also increased the overall percentage of drug released to the medium since nearly the same absolute amount of quinine remained trapped in PCL at the end of drug release studies. This knowledge is valuable for future developments of printed implants with a desired drug release profile that might be

  3. Effects of implant diameter, drug loading and end-capping on praziquantel release from PCL implants.

    PubMed

    Li, Changyan; Cheng, Liang; Zhang, Yaqiong; Guo, Shengrong; Wu, Weiping

    2010-02-15

    Praziquantel (PZQ)-loaded poly(epsilon-caprolactone) (PCL) cylindrical implants were fabricated and characterized. Implant diameter (3, 4 and 8mm), drug loading (25% and 50%), and the end-capping were investigated to evaluate their effects on drug release. The evolution of implants with release time was conducted in terms of implant microstructure, crystallinity, drug content and molecular weight of PCL. The results showed that drug release was fastest for the implant with a diameter of 3mm and slowest for the implant with a diameter of 8mm; drug release from the implant with a drug content of 50% was faster than that from the implant with a drug content of 25%; the release of PZQ from the end-capped implants was slightly slower than that from the corresponding end-uncapped implants. The effect of drug loadings on PZQ release was related with diameter of the implants and the effect was weakened as diameter of the implants increased. The drug release data for all the implants were best fitted with Ritger-Peppas model, therefore Fickian diffusion was the predominant release mechanism. The evolution of implants with release time verified that PZQ was gradually released from the exterior to the interior of the implants.

  4. Near-infrared fluorescence imaging platform for quantifying in vivo nanoparticle diffusion from drug loaded implants

    PubMed Central

    Markovic, Stacey; Belz, Jodi; Kumar, Rajiv; Cormack, Robert A; Sridhar, Srinivas; Niedre, Mark

    2016-01-01

    Drug loaded implants are a new, versatile technology platform to deliver a localized payload of drugs for various disease models. One example is the implantable nanoplatform for chemo-radiation therapy where inert brachytherapy spacers are replaced by spacers doped with nanoparticles (NPs) loaded with chemotherapeutics and placed directly at the disease site for long-term localized drug delivery. However, it is difficult to directly validate and optimize the diffusion of these doped NPs in in vivo systems. To better study this drug release and diffusion, we developed a custom macroscopic fluorescence imaging system to visualize and quantify fluorescent NP diffusion from spacers in vivo. To validate the platform, we studied the release of free fluorophores, and 30 nm and 200 nm NPs conjugated with the same fluorophores as a model drug, in agar gel phantoms in vitro and in mice in vivo. Our data verified that the diffusion volume was NP size-dependent in all cases. Our near-infrared imaging system provides a method by which NP diffusion from implantable nanoplatform for chemo-radiation therapy spacers can be systematically optimized (eg, particle size or charge) thereby improving treatment efficacy of the platform. PMID:27069363

  5. Efficient antitumor effect of co-drug-loaded nanoparticles with gelatin hydrogel by local implantation

    PubMed Central

    Zhang, Hao; Tian, Yong; Zhu, Zhenshu; Xu, Huae; Li, Xiaolin; Zheng, Donghui; Sun, Weihao

    2016-01-01

    Tetrandrine (Tet) could enhance the antitumor effect of Paclitaxel (Ptx) by increasing intracellular Reactive Oxygen Species (ROS) levels, which leads to the possibility of co-delivery of both drugs for synergistic antitumor effect. In the current study, we reported an efficient, local therapeutic strategy employing effective Tet and Ptx delivery with a nanoparticle-loaded gelatin system. Tet- and Ptx co-loaded mPEG-PCL nanoparticles (P/T-NPs) were encapsulated into the physically cross-linked gelatin hydrogel and then implanted on the tumor site for continuous drug release. The drug-loaded gelatin hydrogel underwent a phase change when the temperature slowly increased. In vitro study showed that Tet/Ptx-loaded PEG-b-PCL nanoparticles encapsulated within a gelatin hydrogel (P/T-NPs-Gelatin) inhibited the growth and invasive ability of BGC-823 cells more effectively than the combination of free drugs or P/T-NPs. In vivo study validated the therapeutic potential of P/T-NPs-Gelatin. P/T-NPs-Gelatin significantly inhibited the activation of p-Akt and the downstream anti-apoptotic Bcl-2 protein and also inducing the activation of pro-apoptotic Bax protein. Moreover, the molecular-modulating effect of P/T-NPs-Gelatin on related proteins varied slightly under the influence of NAC, which was supported by the observations of the tumor volumes and weights. Based on these findings, local implantation of P/T-NPs-Gelatin may be a promising therapeutic strategy for the treatment of gastric cancer. PMID:27226240

  6. Implantable CMOS Biomedical Devices

    PubMed Central

    Ohta, Jun; Tokuda, Takashi; Sasagawa, Kiyotaka; Noda, Toshihiko

    2009-01-01

    The results of recent research on our implantable CMOS biomedical devices are reviewed. Topics include retinal prosthesis devices and deep-brain implantation devices for small animals. Fundamental device structures and characteristics as well as in vivo experiments are presented. PMID:22291554

  7. Implantable Medical Devices

    MedlinePlus

    ... a Heart Attack Treatment of a Heart Attack Life After a Heart Attack Heart Failure About Heart Failure ... Attack Introduction Medications Surgical Procedures Implantable Medical Devices • Life After a Heart Attack • Heart Attack Tools & Resources • Support ...

  8. Implantable ultrasound devices

    NASA Astrophysics Data System (ADS)

    Vilkomerson, David; Chilipka, Thomas; Bogan, John; Blebea, John; Choudry, Rashad; Wang, John; Salvatore, Michael; Rotella, Vittorio; Soundararajan, Krishnan

    2008-03-01

    Using medical implants to wirelessly report physiological data is a technique that is rapidly growing. Ultrasound is well-suited for implants -- it requires little power and this form of radiated energy has no ill effects on the body. We report here on techniques we have developed in our experience gained in implanting over a dozen Doppler ultrasound flow-measuring implants in dogs. The goal of our implantable device is to measure flow in an arterial graft. To accomplish this, we place a Doppler transducer in the wall of a graft and an implant unit under the skin that energizes the 20 MHz Doppler transducer system, either when started by external command or by internal timetable. The implant records the digitized Doppler real and imaginary channels and transmits the data to a nearby portable computer for storage and evaluation. After outlining the overall operation of the system, we will concentrate on three areas of implant design where special techniques are required: ensuring safety, including biocompatibility to prevent the body from reacting to its invasion; powering the device, including minimizing energy used so that a small battery can provide long-life; and transmitting the data obtained.

  9. Silicon microfluidic flow focusing devices for the production of size-controlled PLGA based drug loaded microparticles.

    PubMed

    Keohane, Kieran; Brennan, Des; Galvin, Paul; Griffin, Brendan T

    2014-06-05

    The increasing realisation of the impact of size and surface properties on the bio-distribution of drug loaded colloidal particles has driven the application of micro fabrication technologies for the precise engineering of drug loaded microparticles. This paper demonstrates an alternative approach for producing size controlled drug loaded PLGA based microparticles using silicon Microfluidic Flow Focusing Devices (MFFDs). Based on the precise geometry and dimensions of the flow focusing channel, microparticle size was successfully optimised by modifying the polymer type, disperse phase (Qd) flow rate, and continuous phase (Qc) flow rate. The microparticles produced ranged in sizes from 5 to 50 μm and were highly monodisperse (coefficient of variation <5%). A comparison of Ciclosporin (CsA) loaded PLGA microparticles produced by MFFDs vs conventional production techniques was also performed. MFFDs produced microparticles with a narrower size distribution profile, relative to the conventional approaches. In-vitro release kinetics of CsA was found to be influenced by the production technique, with the MFFD approach demonstrating the slowest rate of release over 7 days (4.99 ± 0.26%). Finally, MFFDs were utilised to produce pegylated microparticles using the block co-polymer, PEG-PLGA. In contrast to the smooth microparticles produced using PLGA, PEG-PLGA microparticles displayed a highly porous surface morphology and rapid CsA release, with 85 ± 6.68% CsA released after 24h. The findings from this study demonstrate the utility of silicon MFFDs for the precise control of size and surface morphology of PLGA based microparticles with potential drug delivery applications.

  10. Implantable electrical device

    NASA Technical Reports Server (NTRS)

    Jhabvala, M. D. (Inventor)

    1982-01-01

    A fully implantable and self contained device is disclosed composed of a flexible electrode array for surrounding damaged nerves and a signal generator for driving the electrode array with periodic electrical impulses of nanoampere magnitude to induce regeneration of the damaged nerves.

  11. Implantable biomedical devices on bioresorbable substrates

    DOEpatents

    Rogers, John A; Kim, Dae-Hyeong; Omenetto, Fiorenzo; Kaplan, David L; Litt, Brian; Viventi, Jonathan; Huang, Yonggang; Amsden, Jason

    2014-03-04

    Provided herein are implantable biomedical devices, methods of administering implantable biomedical devices, methods of making implantable biomedical devices, and methods of using implantable biomedical devices to actuate a target tissue or sense a parameter associated with the target tissue in a biological environment. Each implantable biomedical device comprises a bioresorbable substrate, an electronic device having a plurality of inorganic semiconductor components supported by the bioresorbable substrate, and a barrier layer encapsulating at least a portion of the inorganic semiconductor components. Upon contact with a biological environment the bioresorbable substrate is at least partially resorbed, thereby establishing conformal contact between the implantable biomedical device and the target tissue in the biological environment.

  12. Sustained Zero-Order Release of Intact Ultra-Stable Drug-Loaded Liposomes from an Implantable Nanochannel Delivery System

    PubMed Central

    Celia, Christian; Ferrati, Silvia; Bansal, Shyam; van de Ven, Anne L.; Ruozi, Barbara; Zabre, Erika; Hosali, Sharath; Paolino, Donatella; Sarpietro, Maria Grazia; Fine, Daniel; Fresta, Massimo; Ferrari, Mauro

    2014-01-01

    Metronomic chemotherapy supports the idea that long-term, sustained, constant administration of chemotherapeutics, currently not achievable, could be effective against numerous cancers. Particularly appealing are liposomal formulations, used to solubilize hydrophobic therapeutics and minimize side effects, while extending drug circulation time and enabling passive targeting. As liposome alone cannot survive in circulation beyond 48 hrs, sustaining their constant plasma level for many days is a challenge. To address this, we developed, as a proof of concept, an implantable nanochannel delivery system and ultra-stable PEGylated lapatinib loaded-liposomes, and we demonstrate the release of intact vesicles for over 18 days. Further, we investigate intravasation kinetics of subcutaneously delivered liposomes and verify their biological activity post nanochannel release on BT474 breast cancer cells. The key innovation of this work is the combination of two nanotechnologies to exploit the synergistic effect of liposomes, demonstrated as passive-targeting vectors and nanofluidics to maintain therapeutic constant plasma levels. In principle, this approach could maximize efficacy of metronomic treatments. PMID:23881575

  13. Biocompatibility of implantable biomedical devices

    NASA Astrophysics Data System (ADS)

    Lyu, Suping

    2008-03-01

    Biomedical devices have been broadly used to treat human disease, especially chronic diseases where pharmaceuticals are less effective. Heart valve and artificial joint are examples. Biomedical devices perform by delivering therapies such as electric stimulations, mechanical supports and biological actions. While the uses of biomedical devices are highly successful they can trigger adverse biological reactions as well. The property that medical devices perform with intended functions but not causing unacceptable adverse effects was called biocompatibility in the early time. As our understanding of biomaterial-biological interactions getting broader, biocompatibility has more meanings. In this talk, I will present some adverse biological reactions observed with implantable biomedical devices. Among them are surface fouling of implantable sensors, calcification with vascular devices, restenosis with stents, foreign particle migration and mechanical fractures of devices due to inflammation reactions. While these effects are repeatable, there are very few quantitative data and theories to define them. The purpose of this presentation is to introduce this biocompatibility concept to biophysicists to stimulate research interests at different angles. An open question is how to quantitatively understand the biocompatibility that, like many other biological processes, has not been quantified experimentally.

  14. Batteries used to Power Implantable Biomedical Devices

    PubMed Central

    Bock, David C.; Marschilok, Amy C.; Takeuchi, Kenneth J.; Takeuchi, Esther S.

    2012-01-01

    Battery systems have been developed that provide years of service for implantable medical devices. The primary systems utilize lithium metal anodes with cathode systems including iodine, manganese oxide, carbon monofluoride, silver vanadium oxide and hybrid cathodes. Secondary lithium ion batteries have also been developed for medical applications where the batteries are charged while remaining implanted. While the specific performance requirements of the devices vary, some general requirements are common. These include high safety, reliability and volumetric energy density, long service life, and state of discharge indication. Successful development and implementation of these battery types has helped enable implanted biomedical devices and their treatment of human disease. PMID:24179249

  15. Batteries used to Power Implantable Biomedical Devices.

    PubMed

    Bock, David C; Marschilok, Amy C; Takeuchi, Kenneth J; Takeuchi, Esther S

    2012-12-01

    Battery systems have been developed that provide years of service for implantable medical devices. The primary systems utilize lithium metal anodes with cathode systems including iodine, manganese oxide, carbon monofluoride, silver vanadium oxide and hybrid cathodes. Secondary lithium ion batteries have also been developed for medical applications where the batteries are charged while remaining implanted. While the specific performance requirements of the devices vary, some general requirements are common. These include high safety, reliability and volumetric energy density, long service life, and state of discharge indication. Successful development and implementation of these battery types has helped enable implanted biomedical devices and their treatment of human disease.

  16. Middle Ear Implantable Hearing Devices: An Overview

    PubMed Central

    Haynes, David S.; Young, Jadrien A.; Wanna, George B.; Glasscock, Michael E.

    2009-01-01

    Hearing loss affects approximately 30 million people in the United States. It has been estimated that only approximately 20% of people with hearing loss significant enough to warrant amplification actually seek assistance for amplification. A significant interest in middle ear implants has emerged over the years to facilitate patients who are noncompliant with conventional hearing aides, do not receive significant benefit from conventional aides, or are not candidates for cochlear implants. From the initial studies in the 1930s, the technology has greatly evolved over the years with a wide array of devices and mechanisms employed in the development of implantable middle ear hearing devices. Currently, these devices are generally available in two broad categories: partially or totally implantable using either piezoelectric or electromagnetic systems. The authors present an up-to-date overview of the major implantable middle ear devices. Although the current devices are largely in their infancy, indications for middle ear implants are ever evolving as promising studies show good results. The totally implantable devices provide the user freedom from the social and practical difficulties of using conventional amplification. PMID:19762429

  17. Implantable drug therapy device: A concept

    NASA Technical Reports Server (NTRS)

    Feldstein, C.

    1972-01-01

    Design is described of small, rechargeable, implantable infusor which contains fluid medicament stored under pressure and which dispenses fluid continuously through catheter. Body of infusor is covered by pliable silicone rubber sheath attached to suture pad for securing device.

  18. Single atom devices by ion implantation.

    PubMed

    van Donkelaar, Jessica; Yang, C; Alves, A D C; McCallum, J C; Hougaard, C; Johnson, B C; Hudson, F E; Dzurak, A S; Morello, A; Spemann, D; Jamieson, D N

    2015-04-22

    To expand the capabilities of semiconductor devices for new functions exploiting the quantum states of single donors or other impurity atoms requires a deterministic fabrication method. Ion implantation is a standard tool of the semiconductor industry and we have developed pathways to deterministic ion implantation to address this challenge. Although ion straggling limits the precision with which atoms can be positioned, for single atom devices it is possible to use post-implantation techniques to locate favourably placed atoms in devices for control and readout. However, large-scale devices will require improved precision. We examine here how the method of ion beam induced charge, already demonstrated for the deterministic ion implantation of 14 keV P donor atoms in silicon, can be used to implant a non-Poisson distribution of ions in silicon. Further, we demonstrate the method can be developed to higher precision by the incorporation of new deterministic ion implantation strategies that employ on-chip detectors with internal charge gain. In a silicon device we show a pulse height spectrum for 14 keV P ion impact that shows an internal gain of 3 that has the potential of allowing deterministic implantation of sub-14 keV P ions with reduced straggling.

  19. Biofeedback With Implanted Blood-Pressure Device

    NASA Technical Reports Server (NTRS)

    Rischell, Robert E.

    1988-01-01

    Additional uses found for equipment described in "Implanted Blood-Pressure-Measuring Device" (GSC-13042). Implanted with device electronic circuitry that measures, interprets, and transmits data via inductive link through patient's skin to external receiver. Receiver includes audible alarm generator activated when patient's blood pressure exceeds predetermined threshold. Also included in receiver a blood-pressure display, recorder, or both, for use by patient or physician.

  20. Microbattery technologies for miniaturized implantable medical devices.

    PubMed

    Nathan, Menachem

    2010-06-01

    Implanted medical devices (IMDs), in particular neuro-stimulators, drug delivery chips and cochlear implants are undergoing miniaturization. Some of these miniaturized IMDs are "active" in the sense that they require a power source for operation. In most cases, the ideal power source needs to be an implanted battery of dimensions similar to that of the device. The state-of-the-art of battery miniaturization is reviewed with emphasis on novel Li and Li-ion two- and three-dimensional thin-film microbatteries. It is shown that three-dimensional thin-film batteries may provide a solution to the power requirements of miniaturized IMDs.

  1. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted electrical urinary continence device... Implanted electrical urinary continence device. (a) Identification. An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in...

  2. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted electrical urinary continence device... Implanted electrical urinary continence device. (a) Identification. An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in...

  3. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted electrical urinary continence device... Implanted electrical urinary continence device. (a) Identification. An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in...

  4. Toward biomaterial-based implantable photonic devices

    NASA Astrophysics Data System (ADS)

    Humar, Matjaž; Kwok, Sheldon J. J.; Choi, Myunghwan; Yetisen, Ali K.; Cho, Sangyeon; Yun, Seok-Hyun

    2017-03-01

    Optical technologies are essential for the rapid and efficient delivery of health care to patients. Efforts have begun to implement these technologies in miniature devices that are implantable in patients for continuous or chronic uses. In this review, we discuss guidelines for biomaterials suitable for use in vivo. Basic optical functions such as focusing, reflection, and diffraction have been realized with biopolymers. Biocompatible optical fibers can deliver sensing or therapeutic-inducing light into tissues and enable optical communications with implanted photonic devices. Wirelessly powered, light-emitting diodes (LEDs) and miniature lasers made of biocompatible materials may offer new approaches in optical sensing and therapy. Advances in biotechnologies, such as optogenetics, enable more sophisticated photonic devices with a high level of integration with neurological or physiological circuits. With further innovations and translational development, implantable photonic devices offer a pathway to improve health monitoring, diagnostics, and light-activated therapies.

  5. Implantable diagnostic and therapeutic devices in children

    PubMed Central

    Le, T-N.; Gouw, S.C.; Hoorntje, T.M.; Sreeram, N.

    2002-01-01

    Many advances have been made in the use of implantable diagnostic and therapeutic devices in adults. In children the indications for and diagnostic and therapeutic value of these devices still have to be determined. Our aim is to provide an overview of the clinical use of diagnostic and therapeutic devices in children. The role of implantable loop recorders (ILR), the feasibility and safety of transvenous pacing in neonates, the value of permanent pacing in children with recurrent syncope or reflex anoxic seizures and the role of implantable cardioverter defibrillator devices are highlighted with relevant case histories. ImagesFigure 1a and bFigure 2aFigure 2b and 2c PMID:25696046

  6. [Batteries Used in Active Implantable Medical Devices].

    PubMed

    Ma, Bozhi; Hao, Hongwei; Li, Luming

    2015-03-01

    In recent years active implantable medical devices(AIMD) are being developed rapidly. Many battery systems have been developed for different AIMD applications. These batteries have the same requirements which include high safety, reliability, energy density and long service life, discharge indication. History, present and future of batteries used in AIMD are introduced in the article.

  7. Implantable Devices for Sustained, Intravesical Drug Delivery

    PubMed Central

    2016-01-01

    In clinical settings, intravesical instillation of a drug bolus is often performed for the treatment of bladder diseases. However, it requires repeated instillations to extend drug efficacy, which may result in poor patient compliance. To alleviate this challenge, implantable devices have been developed for the purpose of sustained, intravesical drug delivery. In this review, we briefly summarize the current trend in the development of intravesical drug-delivery devices. We also introduce the most recently developed devices with strong potential for intravesical drug-delivery applications. PMID:27377941

  8. [Design and application of implantable medical device information management system].

    PubMed

    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.

  9. COMMUNICATION: Drug loading of nanoporous TiO2 films

    NASA Astrophysics Data System (ADS)

    Ayon, Arturo A.; Cantu, Michael; Chava, Kalpana; Mauli Agrawal, C.; Feldman, Marc D.; Johnson, Dave; Patel, Devang; Marton, Denes; Shi, Emily

    2006-12-01

    The loading of therapeutic amounts of drug on a nanoporous TiO2 surface is described. This novel drug-loading scheme on a biocompatible surface, when employed on medical implants, will benefit patients who require the deployment of drug-eluting implants. Anticoagulants, analgesics and antibiotics can be considered on the associated implants for drug delivery during the time of maximal pain or risk for patients undergoing orthopedic procedures. Therefore, this scheme will maximize the chances of patient recovery.

  10. Power Approaches for Implantable Medical Devices

    PubMed Central

    Ben Amar, Achraf; Kouki, Ammar B.; Cao, Hung

    2015-01-01

    Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health). In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources. PMID:26580626

  11. Power Approaches for Implantable Medical Devices.

    PubMed

    Ben Amar, Achraf; Kouki, Ammar B; Cao, Hung

    2015-11-13

    Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health). In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources.

  12. Implantable photonic devices for improved medical treatments.

    PubMed

    Sheinman, Victor; Rudnitsky, Arkady; Toichuev, Rakhmanbek; Eshiev, Abdyrakhman; Abdullaeva, Svetlana; Egemkulov, Talantbek; Zalevsky, Zeev

    2014-01-01

    An evolving area of biomedical research is related to the creation of implantable units that provide various possibilities for imaging, measurement, and the monitoring of a wide range of diseases and intrabody phototherapy. The units can be autonomic or built-in in some kind of clinically applicable implants. Because of specific working conditions in the live body, such implants must have a number of features requiring further development. This topic can cause wide interest among developers of optical, mechanical, and electronic solutions in biomedicine. We introduce preliminary clinical trials obtained with an implantable pill and devices that we have developed. The pill and devices are capable of applying in-body phototherapy, low-level laser therapy, blue light (450 nm) for sterilization, and controlled injection of chemicals. The pill is also capable of communicating with an external control box, including the transmission of images from inside the patient’s body. In this work, our pill was utilized for illumination of the sinus-carotid zone in dog and red light influence on arterial pressure and heart rate was demonstrated. Intrabody liver tissue laser ablation and nanoparticle-assisted laser ablation was investigated. Sterilization effect of intrabody blue light illumination was applied during a maxillofacial phlegmon treatment.

  13. Implantable photonic devices for improved medical treatments

    NASA Astrophysics Data System (ADS)

    Sheinman, Victor; Rudnitsky, Arkady; Toichuev, Rakhmanbek; Eshiev, Abdyrakhman; Abdullaeva, Svetlana; Egemkulov, Talantbek; Zalevsky, Zeev

    2014-10-01

    An evolving area of biomedical research is related to the creation of implantable units that provide various possibilities for imaging, measurement, and the monitoring of a wide range of diseases and intrabody phototherapy. The units can be autonomic or built-in in some kind of clinically applicable implants. Because of specific working conditions in the live body, such implants must have a number of features requiring further development. This topic can cause wide interest among developers of optical, mechanical, and electronic solutions in biomedicine. We introduce preliminary clinical trials obtained with an implantable pill and devices that we have developed. The pill and devices are capable of applying in-body phototherapy, low-level laser therapy, blue light (450 nm) for sterilization, and controlled injection of chemicals. The pill is also capable of communicating with an external control box, including the transmission of images from inside the patient's body. In this work, our pill was utilized for illumination of the sinus-carotid zone in dog and red light influence on arterial pressure and heart rate was demonstrated. Intrabody liver tissue laser ablation and nanoparticle-assisted laser ablation was investigated. Sterilization effect of intrabody blue light illumination was applied during a maxillofacial phlegmon treatment.

  14. Left Ventricular Assist Device Implantation After Intracardiac Parachute Device Removal.

    PubMed

    Abu Saleh, Walid K; Al Jabbari, Odeaa; Bruckner, Brian A; Suarez, Erik E; Estep, Jerry D; Loebe, Matthias

    2015-08-01

    Left ventricular assist device implantation is a proven and efficient modality for the treatment of end-stage heart failure. Left ventricular assist device versatility as a bridge to heart transplantation or destination therapy has led to improved patient outcomes with a concomitant rise in its overall use. Other less invasive treatment modalities are being developed to improve heart function and morbidity and mortality for the heart failure population. Percutaneous ventricular restoration is a new investigational therapy that deploys an intracardiac parachute to wall off damaged myocardium in patients with dilated left ventricles and ischemic heart failure. Clinical trials are under way to test the efficacy of percutaneous ventricular restoration using the parachute device. This review describes our encounter with the parachute device, its explantation due to refractory heart failure, and surgical replacement with a left ventricular assist device. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  15. Delivering optical power to subcutaneous implanted devices.

    PubMed

    Ayazian, Sahar; Hassibi, Arjang

    2011-01-01

    In this paper, a new, easy-to-implement, and MRI-compatible approach for delivering power to implantable devices is presented. The idea is to harvest the energy of light within the therapeutic window wavelengths, where the optical absorption is small, by using subcutaneous photovoltaic (PV) cells. Depending on the application, this energy can then be used to directly drive the embedded electronics of an implanted device or recharge its battery. To show the feasibility of this system, a CMOS chip based on this concept has been implemented and tested. The experimental results demonstrate that μW's of power in ambient light conditions can be harvested using mm(2)-size PV cells. This amount of power is sufficient to address the needs of many low-power applications.

  16. Regenerative implantable medical devices: an overview.

    PubMed

    Yu, Shu-Yang; Li, Fu-Yao; Wang, Hong-Man

    2016-06-01

    To conduct a bibliometric evaluation and trend prediction of English literature on animal-derived regenerative implantable medical devices based on tissue engineering technology. Data identified by a search strategy with eleven combinations of keywords before 1 January, 2014 were downloaded from eight databases on 25 November, 2014. The study analysed publication year, journal preference, authors' geographic location and research topics. Research on animal-derived regenerative implantable medical devices is gradually increasing. The majority of the first authors are from colleges or universities. Approximately one-third of the papers were the result of cooperation of different institutions. The top five productive countries are the United States, China, UK, Germany and Italy. Biomaterials are the main literature source. Bradford's law analysis shows that a core journal area has formed. The active areas of research and future research directions are 'scaffold materials', 'biocompatibility', 'growth factors' and 'extracellular matrix'. Research of animal-derived regenerative implantable medical devices has attracted more and more attention from the academia. But most of the research achievements are generated by a few developed countries. Researchers around the world need to complement each other in knowledge and academic resources by communication and cooperation. © 2016 Health Libraries Group.

  17. 78 FR 38867 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

    ...; Reclassification of Implanted Blood Access Devices AGENCY: Food and Drug Administration, HHS. ACTION: Proposed... reclassify the implanted blood access device preamendments class III device into class II (special controls... section 513(e) proposing the reclassification of implanted blood access devices for hemodialysis (77...

  18. Cardiac device implantation in Fabry disease

    PubMed Central

    Sené, Thomas; Lidove, Olivier; Sebbah, Joel; Darondel, Jean-Marc; Picard, Hervé; Aaron, Laurent; Fain, Olivier; Zenone, Thierry; Joly, Dominique; Charron, Philippe; Ziza, Jean-Marc

    2016-01-01

    Abstract The incidence and predictive factors of arrhythmias and/or conduction abnormalities (ACAs) requiring cardiac device (CD) implantation are poorly characterized in Fabry disease (FD). The aim of our retrospective study was to determine the prevalence, incidence, and factors associated with ACA requiring CD implantation in a monocentric cohort of patients with confirmed FD who were followed up in a department of internal medicine and reference center for FD. Forty-nine patients (20M, 29F) were included. Nine patients (4M, 5F; 18%) had at least one episode of ACA leading to device therapy. Six patients (4M/2F) required a pacemaker (PM) for sinus node dysfunction (n = 4) or atrioventricular disease (n = 2). One female patient required an internal cardioverter-defibrillator (ICD) to prevent sudden cardiac death because of nonsustained ventricular tachycardia (nSVT). One female patient required PM-ICD for sinus node dysfunction and nSVT. One patient underwent CD implantation before the diagnosis of FD. The annual rate of CD implantation was estimated at 1.90 per 100 person years. On univariate analysis at the end of the follow-up period, the factors associated with ACAs requiring CD implantation were as follows: delayed diagnosis of FD, delayed initiation of enzyme replacement therapy, age at the last follow-up visit, and severe multiorgan phenotype (hypertrophic cardiomyopathy, chronic kidney disease, and/or sensorineural hearing loss). On multivariate analysis, age at diagnosis of FD and age at the last follow-up visit were independently associated with an increased risk of ACAs requiring CD (P < 0.05). Considering the high frequency of ACAs requiring CD implantation and the risk of sudden death in patients with FD, regular monitoring is mandatory, especially in patients with a late diagnosis of FD and/or with a severe phenotype. Regular Holter ECGs, therapeutic education of patients, and deliverance of an emergency card including a phenotype

  19. Integrated Microbatteries for Implantable Medical Devices

    NASA Technical Reports Server (NTRS)

    Whitacre, Jay; West, William

    2008-01-01

    Integrated microbatteries have been proposed to satisfy an anticipated need for long-life, low-rate primary batteries, having volumes less than 1 mm3, to power electronic circuitry in implantable medical devices. In one contemplated application, such a battery would be incorporated into a tubular hearing-aid device to be installed against an eardrum. This device is based on existing tube structures that have already been approved by the FDA for use in human ears. As shown in the figure, the battery would comprise a single cell at one end of the implantable tube. A small volume of Li-based primary battery cathode material would be compacted and inserted in the tube near one end, followed by a thin porous separator, followed by a pressed powder of a Li-containing alloy. Current-collecting wires would be inserted, with suitably positioned insulators to prevent a short circuit. The battery would contain a liquid electrolyte consisting of a Li-based salt in an appropriate solvent. Hermetic seals would be created by plugging both ends with a waterproof polymer followed by deposition of parylene.

  20. Arrhythmias in Patients with Cardiac Implantable Electrical Devices after Implantation of a Left Ventricular Assist Device.

    PubMed

    Rosenbaum, Andrew N; Kremers, Walter K; Duval, Sue; Sakaguchi, Scott; John, Ranjit; Eckman, Peter M

    2016-01-01

    Utilization of continuous-flow left ventricular assist devices (CF-LVADs) for advanced heart failure is increasing, and the role of cardiac implantable electrical devices (CIED) is unclear. Prior studies of the incidence of arrhythmias and shocks are frequently limited by ascertainment. One hundred and seventy-eight patients were examined with a previous CIED who were implanted with a CF-LVAD. Medical history, medications, and CIED data from device interrogations were gathered. A cardiac surgery control group (n = 38) was obtained to control for surgical factors. Several clinically significant events increased after LVAD implantation: treated-zone ventricular arrhythmias (VA; p < 0.01), monitored-zone VA (p < 0.01), antitachycardia pacing (ATP)-terminated episodes (p < 0.01), and shocks (p = 0.01), although administered shocks later decreased (p < 0.01). Presence of a preimplant VA was associated with postoperative VA (odds ratio [OR]: 4.31; confidence interval [CI]: 1.5-12.3, p < 0.01). Relative to cardiac surgery, LVAD patients experienced more perioperative events (i.e., monitored VAs and shocks, p < 0.01 and p = 0.04). Neither implantable cardioverter defibrillator (ICD) shocks before implant nor early or late postimplant arrhythmias or shocks predicted survival (p = 0.07, p = 0.55, and p = 0.55). Our experience demonstrates time-dependent effects on clinically significant arrhythmias after LVAD implantation, including evidence that early LVAD-related arrhythmias may be caused by the unique arrhythmogenic effects of VAD implant.

  1. Temporary anchorage devices – Mini-implants

    PubMed Central

    Singh, Kamlesh; Kumar, Deepak; Jaiswal, Raj Kumar; Bansal, Amol

    2010-01-01

    Orthodontists are accustomed to using teeth and auxiliary appliances, both intraoral and extraoral, to control anchorage. These methods are limited in that it is often difficult to achieve results commensurate with our idealistic goals. Recently, a number of case reports have appeared in the orthodontic literature documenting the possibility of overcoming anchorage limitations via the use of temporary anchorage devices—biocompatible devices fixed to bone for the purpose of moving teeth, with the devices being subsequently removed after treatment. Although skeletal anchorage is here to stay in orthodontics, there are still many unanswered questions. This article describes the development of skeletal anchorage and provides an overview of the use of implants for orthodontic anchorage. PMID:22442547

  2. Modulation Techniques for Biomedical Implanted Devices and Their Challenges

    PubMed Central

    Hannan, Mahammad A.; Abbas, Saad M.; Samad, Salina A.; Hussain, Aini

    2012-01-01

    Implanted medical devices are very important electronic devices because of their usefulness in monitoring and diagnosis, safety and comfort for patients. Since 1950s, remarkable efforts have been undertaken for the development of bio-medical implanted and wireless telemetry bio-devices. Issues such as design of suitable modulation methods, use of power and monitoring devices, transfer energy from external to internal parts with high efficiency and high data rates and low power consumption all play an important role in the development of implantable devices. This paper provides a comprehensive survey on various modulation and demodulation techniques such as amplitude shift keying (ASK), frequency shift keying (FSK) and phase shift keying (PSK) of the existing wireless implanted devices. The details of specifications, including carrier frequency, CMOS size, data rate, power consumption and supply, chip area and application of the various modulation schemes of the implanted devices are investigated and summarized in the tables along with the corresponding key references. Current challenges and problems of the typical modulation applications of these technologies are illustrated with a brief suggestions and discussion for the progress of implanted device research in the future. It is observed that the prime requisites for the good quality of the implanted devices and their reliability are the energy transformation, data rate, CMOS size, power consumption and operation frequency. This review will hopefully lead to increasing efforts towards the development of low powered, high efficient, high data rate and reliable implanted devices. PMID:22368470

  3. Modulation techniques for biomedical implanted devices and their challenges.

    PubMed

    Hannan, Mahammad A; Abbas, Saad M; Samad, Salina A; Hussain, Aini

    2012-01-01

    Implanted medical devices are very important electronic devices because of their usefulness in monitoring and diagnosis, safety and comfort for patients. Since 1950s, remarkable efforts have been undertaken for the development of bio-medical implanted and wireless telemetry bio-devices. Issues such as design of suitable modulation methods, use of power and monitoring devices, transfer energy from external to internal parts with high efficiency and high data rates and low power consumption all play an important role in the development of implantable devices. This paper provides a comprehensive survey on various modulation and demodulation techniques such as amplitude shift keying (ASK), frequency shift keying (FSK) and phase shift keying (PSK) of the existing wireless implanted devices. The details of specifications, including carrier frequency, CMOS size, data rate, power consumption and supply, chip area and application of the various modulation schemes of the implanted devices are investigated and summarized in the tables along with the corresponding key references. Current challenges and problems of the typical modulation applications of these technologies are illustrated with a brief suggestions and discussion for the progress of implanted device research in the future. It is observed that the prime requisites for the good quality of the implanted devices and their reliability are the energy transformation, data rate, CMOS size, power consumption and operation frequency. This review will hopefully lead to increasing efforts towards the development of low powered, high efficient, high data rate and reliable implanted devices.

  4. Degradability of Polymers for Implantable Biomedical Devices

    PubMed Central

    Lyu, SuPing; Untereker, Darrel

    2009-01-01

    Many key components of implantable medical devices are made from polymeric materials. The functions of these materials include structural support, electrical insulation, protection of other materials from the environment of the body, and biocompatibility, as well as other things such as delivery of a therapeutic drug. In such roles, the stability and integrity of the polymer, over what can be a very long period of time, is very important. For most of these functions, stability over time is desired, but in other cases, the opposite–the degradation and disappearance of the polymer over time is required. In either case, it is important to understand both the chemistry that can lead to the degradation of polymers as well as the kinetics that controls these reactions. Hydrolysis and oxidation are the two classes of reactions that lead to the breaking down of polymers. Both are discussed in detail in the context of the environmental factors that impact the utility of various polymers for medical device applications. Understanding the chemistry and kinetics allows prediction of stability as well as explanations for observations such as porosity and the unexpected behavior of polymeric composite materials in some situations. In the last part, physical degradation such interfacial delamination in composites is discussed. PMID:19865531

  5. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted electrical urinary continence device. 876.5270 Section 876.5270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Therapeutic Devices § 876.5270...

  6. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted electrical urinary continence device. 876.5270 Section 876.5270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Therapeutic Devices § 876.5270...

  7. Dealing with a left ventricular pseudoaneurysm during assist device implant.

    PubMed

    Ha, Richard V; Chiu, Peter; Banerjee, Dipanjan; Sheikh, Ahmad Y

    2016-06-01

    Despite increasing use of left ventricular devices for the surgical treatment of heart failure, there is limited experience with implantation of devices in the setting of challenging left apical anatomy. We report the case of a 68-year-old man with a chronic post-infarction calcified apical pseudoaneurysm, who underwent pseudoaneurysmectomy, ventricular myoplasty, and left ventricular assist device implantation. A review of the literature and operative strategies are presented. © The Author(s) 2015.

  8. Implantation of a second glaucoma drainage device.

    PubMed

    Francis, Brian A; Fernandes, Rodrigo A B; Akil, Handan; Chopra, Vikas; Diniz, Bruno; Tan, James; Huang, Alex

    2017-05-01

    To evaluate success rates in controlling intraocular pressure (IOP) after implantation of a second glaucoma drainage device (GDD) with a Baerveldt glaucoma implant in patients with refractory glaucoma, with a secondary aim of reducing the need for postoperative glaucoma medications. This retrospective, noncomparative, interventional study included patients undergoing a second GDD for uncontrolled glaucoma from a tertiary care glaucoma service. Data were obtained from the medical records for the preoperative period and after the 1st, 15th, and 30th day, 3, 6, and 12 months, and then yearly until the last postoperative visit. Visual acuity, IOP, and number of glaucoma medications (NGM) from the follow-up visits were compared to baseline. Success and failure criteria were analyzed based on IOP level or need of glaucoma medications. Forty-nine patients were studied, with a mean follow-up time of 25 ± 21 months. The mean preoperative IOP was 23.7 ± 8.2 mmHg, and decreased to 14.8 ± 4.0 mmHg after 1 year, 14.4 ± 3.9 mmHg after 2 years, and 16.6 ± 8.5 mmHg after 3 years. The mean preoperative NGM was 3.4 ± 1.3, and decreased to 2.0 ± 1.8 after 1 year, 2.5 ± 1.6 after 2 years, and 2.8 ± 2.0 after 3 years. Absolute success was 9% after 1 year for a postoperative IOP between 5 and 18 mmHg, and 76% for a postoperative IOP between 5 and 21 mmHg. The qualified success was 88% at the first and second years and 83% at the third year. With up to 3 years of follow-up, a second glaucoma drainage device was successful in reducing IOP to below 21 mmHg, but not as successful below 18 mmHg. The success rate is improved with the use of glaucoma medications with up to 3 years of follow-up.

  9. Energy harvesting for the implantable biomedical devices: issues and challenges.

    PubMed

    Hannan, Mahammad A; Mutashar, Saad; Samad, Salina A; Hussain, Aini

    2014-06-20

    The development of implanted devices is essential because of their direct effect on the lives and safety of humanity. This paper presents the current issues and challenges related to all methods used to harvest energy for implantable biomedical devices. The advantages, disadvantages, and future trends of each method are discussed. The concept of harvesting energy from environmental sources and human body motion for implantable devices has gained a new relevance. In this review, the harvesting kinetic, electromagnetic, thermal and infrared radiant energies are discussed. Current issues and challenges related to the typical applications of these methods for energy harvesting are illustrated. Suggestions and discussion of the progress of research on implantable devices are also provided. This review is expected to increase research efforts to develop the battery-less implantable devices with reduced over hole size, low power, high efficiency, high data rate, and improved reliability and feasibility. Based on current literature, we believe that the inductive coupling link is the suitable method to be used to power the battery-less devices. Therefore, in this study, the power efficiency of the inductive coupling method is validated by MATLAB based on suggested values. By further researching and improvements, in the future the implantable and portable medical devices are expected to be free of batteries.

  10. Energy harvesting for the implantable biomedical devices: issues and challenges

    PubMed Central

    2014-01-01

    The development of implanted devices is essential because of their direct effect on the lives and safety of humanity. This paper presents the current issues and challenges related to all methods used to harvest energy for implantable biomedical devices. The advantages, disadvantages, and future trends of each method are discussed. The concept of harvesting energy from environmental sources and human body motion for implantable devices has gained a new relevance. In this review, the harvesting kinetic, electromagnetic, thermal and infrared radiant energies are discussed. Current issues and challenges related to the typical applications of these methods for energy harvesting are illustrated. Suggestions and discussion of the progress of research on implantable devices are also provided. This review is expected to increase research efforts to develop the battery-less implantable devices with reduced over hole size, low power, high efficiency, high data rate, and improved reliability and feasibility. Based on current literature, we believe that the inductive coupling link is the suitable method to be used to power the battery-less devices. Therefore, in this study, the power efficiency of the inductive coupling method is validated by MATLAB based on suggested values. By further researching and improvements, in the future the implantable and portable medical devices are expected to be free of batteries. PMID:24950601

  11. Perioperative Management of Multiple Noncardiac Implantable Electronic Devices.

    PubMed

    Ramos, Juan A; Brull, Sorin J

    2015-12-01

    The number of patients with noncardiac implantable electronic devices is increasing, and the absence of perioperative management standards, guidelines, practice parameters, or expert consensus statements presents clinical challenges. A 69-year-old woman presented for latissimus dorsi breast reconstruction. The patient had previously undergone implantation of a spinal cord stimulator, a gastric pacemaker, a sacral nerve stimulator, and an intrathecal morphine pump. After consultation with device manufacturers, the devices with patient programmability were switched off. Bipolar cautery was used intraoperatively. Postoperatively, all devices were interrogated to ensure appropriate functioning before home discharge. Perioperative goals include complete preoperative radiologic documentation of device component location, minimizing electromagnetic interference, and avoiding mechanical damage to implanted device components.

  12. [Radiotherapy and implantable medical device: example of infusion pumps].

    PubMed

    Abrous-Anane, S; Benhassine, S; Lopez, S; Cristina, K; Mazeron, J-J

    2013-12-01

    Indication for radiotherapy is often questioned for patients equipped with implantable medical devices like infusion pumps as the radiation tolerance is poor or not known. We report here on the case of a patient who we treated with pelvic radiotherapy for cervical cancer and who had an infusion pump in iliac fossa. We conducted a series of tests on five identical pumps that insured that the treatment protocol is harmless to the implanted device.

  13. Development of Implantable Medical Devices: From an Engineering Perspective

    PubMed Central

    2013-01-01

    From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medical device development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medical devices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medical devices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medical devices will be presented from the viewpoint of an engineering mind. PMID:24143287

  14. 77 FR 36951 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ...-36955] [FR Doc No: 2012-15024] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21... Implanted Blood Access Devices AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to reclassify the implanted blood access device...

  15. 78 FR 17940 - Certain Computerized Orthopedic Surgical Devices, Software, Implants, and Components Thereof...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

    ... COMMISSION Certain Computerized Orthopedic Surgical Devices, Software, Implants, and Components Thereof..., Software, Implants, and Components Thereof, DN 2945; the Commission is soliciting comments on any public... devices, software, implants, and components thereof. The complaint names as respondents Stanmore...

  16. Complete removal of infected devices and simultaneous implantation of new devices for infective endocarditis after pacemaker implantation.

    PubMed

    Miura, Takuya; Inoue, Kazushige; Yokota, Takenori; Iwata, Takashi; Yoshitatsu, Masao

    2017-02-01

    Two cases of infective endocarditis after pacemaker implantation were reported. Complete removal of infected devices was performed under cardiopulmonary bypass, and simultaneous implantation of new devices was performed using epicardial leads and generator on the abdominal wall. The postoperative course was uneventful and recurrence was not recognized. These procedures may be suitable for the patients who depend on the pacemaker or who have repeat bacteremia with other infectious disease or conditions.

  17. Implantation of left ventricular assist device complicated by undiagnosed thrombophilia.

    PubMed

    Szarszoi, Ondrej; Maly, Jiri; Turek, Daniel; Urban, Marian; Skalsky, Ivo; Riha, Hynek; Maluskova, Jana; Pirk, Jan; Netuka, Ivan

    2012-01-01

    A patient with dilated cardiomyopathy and no history of thromboembolic events received a surgically implanted axial-flow left ventricular assist device. After implantation, transesophageal echocardiography revealed a giant thrombus on the lateral and anterior aspects of the left ventricle. The inflow cannula inserted through the apex of the left ventricle was not obstructed, and the device generated satisfactory blood flow. Laboratory screening for thrombophilia showed protein S deficiency, heterozygous factor V Leiden mutation, and heterozygous MTHFR C667T mutation. During the entire duration of circulatory support, no significant suction events were detected, and the patient was listed for heart transplantation. Ventricular assist device implantation can unmask previously undiagnosed thrombophilia; therefore, it should be necessary to identify thrombophilic patients before cardiac support implantation.

  18. Surgical and medical complications in different cochlear implant devices.

    PubMed

    Migirov, Lela; Dagan, Elad; Kronenberg, Jona

    2009-07-01

    There were no surgery-related complications among the patients in the current study. Positioner and removable magnets have been associated with postoperative problems, and the silicone devices were the only ones found by us to cause foreign body and allergic reactions. To evaluate the complication rate in patients who were implanted with cochlear devices manufactured by different companies. This retrospective study included all the patients who underwent cochlear implantation (138 Nucleus, 105 Med-El and 14 Clarion devices) via the suprameatal approach in our department during 2001-2007 and followed up for at least 18 months. Complications such as magnet displacement, foreign body reaction and protrusion of the positioner were considered as being implant-related. Allergy to implant, cholesteatoma, perforated tympanic membrane, intraoperative cerebrospinal fluid (CSF) leakage, wound breakdown, haematoma or seroma, and vestibular disturbances were considered to be patient-related. Vestibular and wound problems emerged as the most common complications, but there were no significant differences in their rate of occurrence among the various devices. Explantation of the device was required in one case of foreign body reaction, one case of allergy to implant and one case of extrusion of the positioner followed by device failure.

  19. Recharging the battery of implantable biomedical devices by light.

    PubMed

    Algora, Carlos; Peña, Rafael

    2009-10-01

    This article describes a new powering system for implantable medical devices that could significantly increase their lifetime. The idea is based on the substitution of the usual implantable device battery for an electric accumulator (rechargeable battery), which is fed by the electric power generated by a photovoltaic converter inside the implantable device. Light impinges on the photovoltaic device through an optical fiber going from the photovoltaic device to just beneath the patient's epidermis. Light can enter the optical fiber by passing through the skin. A complete power-by-light system has been developed and tested with a real implantable pulse generator for spinal cord stimulation. The feasibility of the proposed system has been evaluated theoretically. For example, after 13 h/week of laser exposure, the lifetime of the implantable device would increase by 50%. Other combinations resulting in lifetime increases of more than 100% are also possible. So, the proposed system is now ready to take a further step forward: in vivo animal testing.

  20. Left ventricular assist device implantation strategies and outcomes

    PubMed Central

    Smith, LaVone A.; Yarboro, Leora T.

    2015-01-01

    Over the past 15 years, the field of mechanical circulatory support has developed significantly. Currently, there are a multitude of options for both short and long term cardiac support. Choosing the appropriate device for each patient depends on the amount of support needed and the goals of care. This article focuses on long term, implantable devices for both bridge to transplantation and destination therapy indications. Implantation strategies, including the appropriate concomitant surgeries are discussed as well as expected long term outcomes. As device technology continues to improve, long term mechanical circulatory support may become a viable alternative to transplantation. PMID:26793328

  1. Implantable ventricular assist device exchange with focused intravascular deairing techniques.

    PubMed

    Woo, Y Joseph; Acker, Michael A

    2011-01-01

    As ventricular assist devices are increasingly adopted and widely implemented as a highly effective therapy for end-stage heart disease, extended utilization periods for destination therapy or bridge-to-transplantation have created the possibility of device failure, infection, or thrombosis, requiring challenging implant exchanges. A major problem in these operations is the risk of air embolization, particularly in a nonsternotomy approach that precludes access to the outflow aortic graft and to the ascending aorta. We report a minimally invasive, nonsternotomy HeartMate II implantable left ventricular assist device (LVAD) exchange, using peripheral cardiopulmonary support and a novel approach to continuous intravascular ascending aortic air removal.

  2. Tracking and surveillance of patients with medical devices and implants.

    PubMed

    Morgan, R W

    1993-01-01

    The United States Congress and FDA recently proposed modifications to the regulation for the tracking of certain medical devices and implants that will place significant demands on the manufacturers and importers of those products. The regulation, which comes into effect in August this year, will require the industry to carry out not only tracking of those devices or implants to the end user, but also continued observation of the device user or implant recipient throughout the life of the patient or the device. In this article, the author outlines FDA requirements and advises how best to meet those demands. The important elements for setting up a patient-tracking programme are discussed; these include the use of a Patient Registry as a basis for tracking and the importance of confidentiality throughout the tracking process.

  3. Totally implantable vascular access devices for cystic fibrosis.

    PubMed

    A-Rahman, A; Spencer, D

    2003-01-01

    Totally implantable vascular access devices are widely used in people with cystic fibrosis to provide intermittent venous access for therapeutic infusions. Their use is associated with some complications such as thrombosis, embolism and infection. To assess if totally implantable venous access devices are a safe and effective route for providing venous access for intermittent administration of intravenous antibiotics in people with cystic fibrosis, also to assess strategies to reduce possible complications of totally implantable venous access devices (e.g. anticoagulants to reduce the risk of thrombosis). We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and abstract books of conference proceedings. Date of the most recent search: May 2003. Randomised and quasi-randomised controlled trials which compared the use of totally implantable venous access devices in people with cystic fibrosis to other means of vascular access, trials which compared the different types of these devices against each other and trials which assessed strategies to reduce complications of these devices. No relevant trials were identified. No trials were included in this review. Totally implantable vascular access devices are widely used in people with cystic fibrosis to provide intermittent venous access for therapeutic infusions. Reports of their use in people with cystic fibrosis suggest that they are safe and effective. These reports also suggest that certain interventions might reduce the risk of complications; however, it is disappointing that these reports have not been assessed by randomised controlled trials. This systematic review identifies the need for a multicentre randomised controlled trial assessing both efficacy and possible adverse effects of totally implantable venous access devices in cystic fibrosis.

  4. Totally implantable vascular access devices for cystic fibrosis.

    PubMed

    A-Rahman, Amel K M; Spencer, David

    2012-05-16

    Totally implantable vascular access devices are widely used in people with cystic fibrosis to provide intermittent venous access for therapeutic infusions. Their use is associated with some complications such as thrombosis, embolism and infection. To assess if totally implantable venous access devices provide a safe and effective route for venous access for intermittent administration of intravenous antibiotics in people with cystic fibrosis. Also to assess strategies to reduce possible complications of totally implantable venous access devices (e.g. anticoagulants to reduce the risk of thrombosis). We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings.Date of the most recent search: 05 April 2012. Randomised and quasi-randomised controlled trials which compared the use of totally implantable venous access devices in people with cystic fibrosis to other means of vascular access, trials which compared the different types of these devices against each other and trials which assessed strategies to reduce complications of these devices. No relevant trials were identified. No trials were included in this review. Totally implantable vascular access devices are widely used in people with cystic fibrosis to provide intermittent venous access for therapeutic infusions. Reports of their use in people with cystic fibrosis suggest that they are safe and effective. These reports also suggest that certain interventions might reduce the risk of complications; however, it is disappointing that these reports have not been assessed by randomised controlled trials. This systematic review identifies the need for a multicentre randomised controlled trial assessing both efficacy and possible adverse effects of totally implantable venous access devices in cystic fibrosis.

  5. Implanted Blood-Pressure-Measuring Device

    NASA Technical Reports Server (NTRS)

    Fischell, Robert E.

    1988-01-01

    Arterial pressure compared with ambient bodily-fluid pressure. Implanted apparatus, capable of measuring blood pressure of patient, includes differential-pressure transducer connected to pressure sensor positioned in major artery. Electrical signal is function of differential pressure between blood-pressure sensor and reference-pressure sensor transmitted through skin of patient to recorder or indicator.

  6. Cardiac Implantable Electronic Device Safety during Magnetic Resonance Imaging

    PubMed Central

    Hwang, You Mi; Lee, Ji Hyun; Kim, Minsu; Nam, Gi-Byoung; Choi, Kee-Joon; Kim, You-Ho

    2016-01-01

    Background and Objectives Although magnetic resonance imaging (MRI) conditional cardiac implantable electronic devices (CIEDs) have become recently available, non-MRI conditional devices and the presence of epicardial and abandoned leads remain a contraindication for MRIs. Subjects and Methods This was a single center retrospective study, evaluating the clinical outcomes and device parameter changes in patients with CIEDs who underwent an MRI from June 1992 to March 2015. Clinical and device related information was acquired by a thorough chart review. Results A total of 40 patients, 38 with a pacemaker (including epicardially located pacemaker leads) and 2 with implantable cardioverter defibrillators, underwent 50 MRI examinations. Among the patients, 11 had MRI conditional CIEDs, while the remaining had non-MRI conditional devices. Among these patients, 23 patients had traditional contraindications for an MRI: (1) nonfunctional leads (n=1, 2.5%), (2) epicardially located leads (n=9, 22.5%), (3) scanning area in proximity to a device (n=9, 22.5%), (4) devices implanted within 6 weeks (n=2, 5%), and (5) MRI field strength at 3.0 Tesla (n=6, 15%). All patients underwent a satisfactory MRI examination with no adverse events during or after the procedure. There were no significant changes in parameters or malfunctioning devices in any patients with CIEDs. Conclusion Under careful monitoring, MRI is safe to perform on patients with non-MRI conditional CIEDs, remnant leads, and epicardially located leads, as well as MRI-conditional devices. PMID:27826339

  7. Single Glucose Biofuel Cells Implanted in Rats Power Electronic Devices

    PubMed Central

    Zebda, A.; Cosnier, S.; Alcaraz, J.-P.; Holzinger, M.; Le Goff, A.; Gondran, C.; Boucher, F.; Giroud, F.; Gorgy, K.; Lamraoui, H.; Cinquin, P.

    2013-01-01

    We describe the first implanted glucose biofuel cell (GBFC) that is capable of generating sufficient power from a mammal's body fluids to act as the sole power source for electronic devices. This GBFC is based on carbon nanotube/enzyme electrodes, which utilize glucose oxidase for glucose oxidation and laccase for dioxygen reduction. The GBFC, implanted in the abdominal cavity of a rat, produces an average open-circuit voltage of 0.57 V. This implanted GBFC delivered a power output of 38.7 μW, which corresponded to a power density of 193.5 μW cm−2 and a volumetric power of 161 μW mL−1. We demonstrate that one single implanted enzymatic GBFC can power a light-emitting diode (LED), or a digital thermometer. In addition, no signs of rejection or inflammation were observed after 110 days implantation in the rat. PMID:23519113

  8. Improved device performance by multistep or carbon Co-implants

    SciTech Connect

    Liefting, R. . MESA Research Inst. FOM Inst. for Atomic and Molecular Physics, Amsterdam ); Wijburg, R.C.M.; Wallinga, H. . MESA Research Inst.); Custer, J.S.; Saris, F.W. )

    1994-01-01

    High-energy ion implantation is used for forming the collector in vertical bipolar transistors in a BiCMOS process. Secondary defects, remaining after annealing the implant damage, give rise to an increased leakage current and to collector-emitter shorts. These shorts reduce the transistor yield. The use of multiple step implants or the introduction of a C gettering layer are demonstrated to avoid dislocation formation. Experimental results show that these schemes subsequently lower the leakage current and dramatically increase device yield. The presence of C can cause increased collector/substrate leakage, indicating that the C profile needs to be optimized with respect to the doping profiles.

  9. Tritium implantation in the accelerator production of tritium device

    SciTech Connect

    Kidman, R.B.

    1997-11-01

    We briefly describe the methods we have developed to compute the magnitude and spatial distribution of born and implanted tritons and protons in the Accelerator Production of Tritium (AFT) device. The methods are verified against experimental measurements and then used to predict that 16% of the tritium is implanted in the walls of the APT distribution tubes. The methods are also used to estimate the spatial distribution of implanted tritium, which will be required for determining the possible diffusion of tritium out of the walls and back into the gas stream.

  10. Implantable rhythm devices and electromagnetic interference: myth or reality?

    PubMed

    Dyrda, Katia; Khairy, Paul

    2008-07-01

    Current medical guidelines have prompted implementation of increasing numbers of implantable rhythm devices, be they pacemakers, internal cardioverter-defibrillators or loop recorders. These devices rely on complex microcircuitry and use electromagnetic waves for communication. They are, therefore, susceptible to interference from surrounding electromagnetic radiation and magnetic energy. Hermetic shielding in metallic cases, filters, interference rejection circuits and bipolar sensing have contributed to their relative resistance to electromagnetic interference (EMI) in household and workplace environments. Device interactions have occurred in hospitals where EMI sources are ubiquitous, including radiation, electrocautery and MRI exposures. However, with rapidly evolving technology, devices and potential sources of EMI continue to change. This review provides a contemporary overview of the current state of knowledge regarding risks attributable to EMI; highlights current limitations of implantable rhythm devices; and attempts to distinguish myths from realities.

  11. Implanted contacts for diamond semiconductor devices

    NASA Astrophysics Data System (ADS)

    Tan, Soo-Hee; Beetz, C. P., Jr.

    1992-01-01

    The key to future diamond semiconductor development are ohmic and Schottky contacts that are stable at high temperatures. Wide bandgap materials, such as diamond (5.5 eV), pose special problems and demand ingenious solutions. Prior to our work, recent research into stable ohmic and Schottky contacts had been primarily limited to e-beam evaporation of carbide forming metals such as Ti, Ta, and Mo. These approaches have been relatively successful at decreasing the specific contact resistivity to as low as 10(exp -5) ohm sq cm on natural semiconducting diamond with about 10(exp 16) boron atoms/cubic cm. In our Phase 1 SBIR program we investigated metal systems coupled with a shallow Si implant that would form low resistivity, high temperature stable metal silicides. We showed in our Phase 1 results that the barrier height of metals such as Pt, Ti and Mo were reduced when deposited on shallow Si implants and given a heat treatment at 500 C. The barrier height of Pt on diamond was reduced from 1.89 to 0.97 eV by annealing of a sputtered Pt contact on a Si implanted dose of 10(exp 15) cm(exp -2) sq A into the diamond surface. Using the same approach, the barrier height of Ti on diamond was reduced from 2.00 to 1.29 eV.

  12. MRI interactions of a fully implantable pressure monitoring device.

    PubMed

    Stehlin, Ellyce F; McCormick, Daniel; Malpas, Simon C; Pontré, Beau P; Heppner, Peter A; Budgett, David M

    2015-11-01

    To investigate the potential patient risk and interactions between a prototype implantable pressure monitoring device and a 3T clinical magnetic resonance imaging (MRI) machine to guide device design towards MR Conditional safety approval. The pressure monitor device contained a catheter-mounted piezo-resistive pressure sensor, rechargeable battery, wireless communication system, and inductive pickup coil. Standard testing methods were used to guide experiments to investigate static field induced force and torque, radiofrequency (RF)-induced heating, image artifacts, and the MR's effect on device function. The specific clinical application of intracranial pressure monitoring was considered. RF-induced heating experiments were supported by numerical modeling of the RF body coil, the device, and experimental phantom. Sensing catheter lead length and configuration was an important component of the device design. A short 150 mm length catheter produced a heating effect of less than 2°C and a long 420 mm length catheter caused heating of 7.2°C. Static magnetic field interactions were below standard safety risk levels and the MR did not interfere with device function; however, artifacts have the potential to interfere with image quality. Investigation of MR interactions at the prototype stage provides useful implantable device design guidance and confidence that an implantable pressure monitor may be able to achieve MR Conditional safety approval. © 2015 Wiley Periodicals, Inc.

  13. Implantable optical-electrode device for stimulation of spinal motoneurons

    NASA Astrophysics Data System (ADS)

    Matveev, M. V.; Erofeev, A. I.; Zakharova, O. A.; Pyatyshev, E. N.; Kazakin, A. N.; Vlasova, O. L.

    2016-08-01

    Recent years, optogenetic method of scientific research has proved its effectiveness in the nerve cell stimulation tasks. In our article we demonstrate an implanted device for the spinal optogenetic motoneurons activation. This work is carried out in the Laboratory of Molecular Neurodegeneration of the Peter the Great St. Petersburg Polytechnic University, together with Nano and Microsystem Technology Laboratory. The work of the developed device is based on the principle of combining fiber optic light stimulation of genetically modified cells with the microelectrode multichannel recording of neurons biopotentials. The paper presents a part of the electrode implant manufacturing technique, combined with the optical waveguide of ThorLabs (USA).

  14. Optimal operating frequency in wireless power transmission for implantable devices.

    PubMed

    Poon, Ada S Y; O'Driscoll, Stephen; Meng, Teresa H

    2007-01-01

    This paper examines short-range wireless powering for implantable devices and shows that existing analysis techniques are not adequate to conclude the characteristics of power transfer efficiency over a wide frequency range. It shows, theoretically and experimentally, that the optimal frequency for power transmission in biological media can be in the GHz-range while existing solutions exclusively focus on the MHz-range. This implies that the size of the receive coil can be reduced by 10(4) times which enables the realization of fully integrated implantable devices.

  15. 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

  16. Development of an auditory implant manipulator for minimally invasive surgical insertion of implantable hearing devices.

    PubMed

    Stieger, C; Caversaccio, M; Arnold, A; Zheng, G; Salzmann, J; Widmer, D; Gerber, N; Thurner, M; Nauer, C; Mussard, Y; Kompis, M; Nolte, L P; Häusler, R; Weber, S

    2011-03-01

    To present the auditory implant manipulator, a navigation-controlled mechanical and electronic system which enables minimally invasive ('keyhole') transmastoid access to the tympanic cavity. The auditory implant manipulator is a miniaturised robotic system with five axes of movement and an integrated drill. It can be mounted on the operating table. We evaluated the surgical work field provided by the system, and the work sequence involved, using an anatomical whole head specimen. The work field provided by the auditory implant manipulator is considerably greater than required for conventional mastoidectomy. The work sequence for a keyhole procedure included pre-operative planning, arrangement of equipment, the procedure itself and post-operative analysis. Although system improvements are necessary, our preliminary results indicate that the auditory implant manipulator has the potential to perform keyhole insertion of implantable hearing devices.

  17. Hypersensitivity Reactions to Implanted Metal Devices: Facts and Fictions.

    PubMed

    Teo Wendy, Z W; Schalock, P C

    The use of metals in the medical field has become increasingly prevalent over the past few decades. Patients find themselves being exposed to metals in a variety of ways, ranging from external exposure to instruments such as the stainless steel in surgical blades to internal exposure via medical devices being implanted in their bodies. There has been growing interest in the possibility of developing hypersensitivity reactions to constituent metals in medical implant devices, both in cutaneous and systemic forms. Hypersensitivity reactions to metals are uncommon, but they are reported and require appropriate evaluation and management, particularly if they are symptomatic. In view of the lack of consensus in the field on the appropriate steps to evaluate and manage patients with suspected metal hypersensitivity reactions, this review aims to analyze current evidence on hypersensitivity reactions to metallic implants in orthopedic surgery, endovascular surgery, obstetrics and gynecology, and dental surgery.

  18. Right heart failure post left ventricular assist device implantation

    PubMed Central

    Argiriou, Mihalis; Kolokotron, Styliani-Maria; Sakellaridis, Timothy; Argiriou, Orestis; Charitos, Christos; Katsikogiannis, Nikolaos; Kougioumtzi, Ioanna; Machairiotis, Nikolaos; Tsiouda, Theodora; Tsakiridis, Kosmas; Zarogoulidis, Konstantinos

    2014-01-01

    Right heart failure (RHF) is a frequent complication following left ventricular assist device (LVAD) implantation. The incidence of RHF complicates 20-50% (range, 9-44%) of cases and is a major factor of postoperative morbidity and mortality. Unfortunately, despite the fact that many risk factors contributing to the development of RHF after LVAD implantation have been identified, it seems to be extremely difficult to avoid them. Prevention of RHF consists of the management of the preload and the afterload of the right ventricle with optimum inotropic support. The administration of vasodilators designed to reduce pulmonary vascular resistance is standard practice in most centers. The surgical attempt of implantation of a right ventricular assist device does not always resolve the problem and is not available in all cardiac surgery centers. PMID:24672699

  19. Right heart failure post left ventricular assist device implantation.

    PubMed

    Argiriou, Mihalis; Kolokotron, Styliani-Maria; Sakellaridis, Timothy; Argiriou, Orestis; Charitos, Christos; Zarogoulidis, Paul; Katsikogiannis, Nikolaos; Kougioumtzi, Ioanna; Machairiotis, Nikolaos; Tsiouda, Theodora; Tsakiridis, Kosmas; Zarogoulidis, Konstantinos

    2014-03-01

    Right heart failure (RHF) is a frequent complication following left ventricular assist device (LVAD) implantation. The incidence of RHF complicates 20-50% (range, 9-44%) of cases and is a major factor of postoperative morbidity and mortality. Unfortunately, despite the fact that many risk factors contributing to the development of RHF after LVAD implantation have been identified, it seems to be extremely difficult to avoid them. Prevention of RHF consists of the management of the preload and the afterload of the right ventricle with optimum inotropic support. The administration of vasodilators designed to reduce pulmonary vascular resistance is standard practice in most centers. The surgical attempt of implantation of a right ventricular assist device does not always resolve the problem and is not available in all cardiac surgery centers.

  20. Ultrasound appearances of Implanon implanted contraceptive devices.

    PubMed

    McNeill, G; Ward, E; Halpenny, D; Snow, A; Torreggiani, W

    2009-01-01

    Subdermal contraceptive devices represent a popular choice of contraception. Whilst often removed without the use of imaging, circumstances exist where imaging is required. Ultrasound is the modality of choice. The optimal technique and typical sonographic appearances are detailed in this article.

  1. Adhesive bonding of medical and implantable devices.

    PubMed

    Tavakoli, S M

    2002-09-01

    Although there are many commercially available medical-grade adhesives, their use for new applications requires detailed investigation. It is also important that as well as the initial joint strength, durability of the bonded components during intended use, including exposure to low and high temperatures, stress, fluids and sterilisation, are investigated. Design of accelerated ageing tests, which can simulate the service environments, is critical in providing realistic durability data. Interpretation of ageing data and lifetime prediction of the joint is essential in assessing the performance of medical devices. Emergence of new types of adhesives as well as further development of precision dispensing and rapid-curing technologies offer many exciting and commercially attractive opportunities for joining medical devices.

  2. [Implanted medical device-related infections: pathophysiology and prevention].

    PubMed

    Lebeaux, David; Ghigo, Jean-Marc; Lucet, Jean-Christophe

    2014-05-01

    Medical progress led to an increase in the number of indications for indwelling devices. However, colonization of implanted devices by pathogenic microorganisms also increases risks of formation of microbial communities surrounded by an extracellular matrix called biofilms. Biofilms are able to survive in the presence of high concentrations of antimicrobials, therefore leading to treatment difficulties and exposing patients to the risk of infection recurrence. Because of these features, preventive measures reducing the risk of microbial contamination are cornerstone for the management of any patient carrying an indwelling device.

  3. Subcutaneous implantable cardioverter-defibrillator: First single-center experience with other cardiac implantable electronic devices.

    PubMed

    Kuschyk, Jürgen; Stach, Ksenija; Tülümen, Erol; Rudic, Boris; Liebe, Volker; Schimpf, Rainer; Borggrefe, Martin; Röger, Susanne

    2015-11-01

    The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an implantable device for antiarrhythmic therapy with no intravascular leads. The purpose of this study was to describe the technical feasibility of combining the S-ICD with other cardiac implantable electronic devices (CIEDs), including pacemakers with transvenous or epicardial electrodes. We also provide the first experience of combining an S-ICD with catheter-based therapies, including cardiac contractility modulation (CCM) and vagus nerve stimulation. Between July 2011 and November 2014, 6 patients received a CCM device and S-ICD, 3 patients with a single-chamber pacemaker using either transvenous or epicardial pacing electrodes received and S-ICD, and 1 patient with an implanted S-ICD received vagus nerve stimulation. In all patients, intraoperative S-ICD testing, crosstalk tests, and postoperative ergometric testing were performed. In all 10 patients, device implantations were successfully performed without complications. S-ICD therapy was shown to be technically feasible with concomitant CIED. Mean follow-up was nearly 17 months. S-ICD testing and crosstalk testing before and during exercise enabled device programming across a broad range of test conditions and was associated with no subsequent evidence of adverse device interaction. None of the devices required permanent inactivation or removal, and no patient received an inappropriate shock. In suitable patients, combining an S-ICD with CCM or pacemaker may provide an acceptable means to reduce the number of transvascular leads. S-ICD appeared safe with CCM over an intermediate follow-up period. Additional prospective randomized controlled trials examining S-ICD in conjunction with CIEDs are warranted. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  4. Perioperative management of patients with cardiac implantable electronic devices.

    PubMed

    Poveda-Jaramillo, R; Castro-Arias, H D; Vallejo-Zarate, C; Ramos-Hurtado, L F

    2017-05-01

    The use of implantable cardiac devices in people of all ages is increasing, especially in the elderly population: patients with pacemakers, cardioverter-defibrillators or cardiac resynchronization therapy devices regularly present for surgery for non-cardiac causes. This review was made in order to collect and analyze the latest evidence for the proper management of implantable cardiac devices in the perioperative period. Through a detailed exploration of PubMed, Academic Search Complete (EBSCO), ClinicalKey, Cochrane (Ovid), the search software UpToDate, textbooks and patents freely available to the public on Google, we selected 33 monographs, which matched the objectives of this publication. Copyright © 2016 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

  5. Infection after implantation of pulsatile mechanical circulatory support devices.

    PubMed

    Holman, William L; Kirklin, James K; Naftel, David C; Kormos, Robert L; Desvign-Nickens, Patricia; Camacho, Margarita T; Ascheim, Deborah D

    2010-06-01

    INTERMACS is a registry of mechanical circulatory support devices sponsored by the National Institutes of Health. This analysis uses INTERMACS data to define the time course, incidence, and outcome of infection adverse events focusing on the first 3 months after implant. Patients entered into INTERMACS from June 23, 2006, to September 30, 2008, were analyzed. Preimplant data (demographics, hemodynamics, and laboratory values), infection adverse events, and other outcomes were recorded. Infection adverse events were analyzed to compare infection rates in subgroups of patients and define risk factors for death. The analysis was confined to pulsatile mechanical circulatory support devices. A total of 593 patients from 88 institutions were entered. Infection was a relatively common event within the first 3 months of implant and was significantly (P = .005) more common in patients with biventricular assist devices than in patients with left ventricular assist devices, although the prevalence of infection equalized in months 4 to 12. Infection had a significant adverse effect on survival. Independent risk factors for death included support with a biventricular assist device, older age, severity of patient illness implantation of the device (INTERMACS level 1), and higher blood urea nitrogen. Infection remains a relatively frequent adverse event and is associated with decreased survival. Interventions to prevent infection that focus on the preoperative and immediate postoperative periods are the ones most likely to achieve success by diminishing the incidence of infection during the initial 3 months after implantation. Rotary (continuous-flow) pumps are expected to have lower infection rates, but this remains to be seen. Published by Mosby, Inc.

  6. Potential for Personal Digital Assistant interference with implantable cardiac devices.

    PubMed

    Tri, Jeffrey L; Trusty, Jane M; Hayes, David L

    2004-12-01

    To determine whether the wireless local area network (WLAN) technology, specifically the Personal Digital Assistant (PDA), interferes with implantable cardiac pacemakers and defibrillators. Various pacemakers and defibrillators were tested in vitro at the Mayo Clinic in Rochester, Minn, between March 6 and July 30, 2003. These cardiac devices were exposed to an HP Compaq IPAQ PDA fitted with a Cisco Aironet WLAN card. Initial testing was designed to show whether the Aironet card radiated energy in a consistent pattern from the antenna of the PDA to ensure that subsequent cardiac device testing would not be affected by the orientation of the PDA to the cardiac device. Testing involved placing individual cardiac devices in a simulator and uniformly exposing each device at its most sensitive programmable value to the WLAN card set to maximum power. During testing with the Cisco WLAN Aironet card, all devices programmed to the unipolar or bipolar configuration single- or dual-chamber mode had normal pacing and sensing functions and exhibited no effects of electromagnetic interference except for 1 implantable cardioverter-defibrillator (ICD). This aberration was determined to relate to the design of the investigators' testing apparatus and not to the output of the PDA. The ICD device appropriately identified and labeled the electromagnetic aberration as "noise." We documented no electromagnetic interference caused by the WLAN technology by using in vitro testing of pacemakers and ICDs; however, testing ideally should be completed in vivo to confirm the lack of any clinically important interactions.

  7. 21 CFR 876.5280 - Implanted mechanical/hydraulic urinary continence device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted mechanical/hydraulic urinary continence....5280 Implanted mechanical/hydraulic urinary continence device. (a) Identification. An implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incontinence by...

  8. 21 CFR 876.5280 - Implanted mechanical/hydraulic urinary continence device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted mechanical/hydraulic urinary continence....5280 Implanted mechanical/hydraulic urinary continence device. (a) Identification. An implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incontinence by...

  9. 21 CFR 876.5280 - Implanted mechanical/hydraulic urinary continence device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted mechanical/hydraulic urinary continence....5280 Implanted mechanical/hydraulic urinary continence device. (a) Identification. An implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incontinence by...

  10. Accuracy of mechanical torque-limiting devices for dental implants.

    PubMed

    L'Homme-Langlois, Emilie; Yilmaz, Burak; Chien, Hua-Hong; McGlumphy, Edwin

    2015-10-01

    A common complication in implant dentistry is unintentional implant screw loosening. The critical factor in the prevention of screw loosening is the delivery of the appropriate target torque value. Mechanical torque-limiting devices (MTLDs) are the most frequently recommended devices by the implant manufacturers to deliver the target torque value to the screw. Two types of MTLDs are available: friction-style and spring-style. Limited information is available regarding the influence of device type on the accuracy of MTLDs. The purpose of this study was to determine and compare the accuracy of spring-style and friction-style MTLDs. Five MTLDs from 6 different dental implant manufacturers (Astra Tech/Dentsply, Zimmer Dental, Biohorizons, Biomet 3i, Straumann [ITI], and Nobel Biocare) (n=5 per manufacturer) were selected to determine their accuracy in delivering target torque values preset by their manufacturers. All torque-limiting devices were new and there were 3 manufacturers for the friction-style and 3 manufacturers for the spring-style. The procedure of target torque measurement was performed 10 times for each device and a digital torque gauge (Chatillon Model DFS2-R-ND; Ametek) was used to record the measurements. Statistical analysis used nonparametric tests to determine the accuracy of the MTLDs in delivering target torque values and Bonferroni post hoc tests were used to assess pairwise comparisons. Median absolute difference between delivered torque values and target torque values of friction-style and spring-style MTLDs were not significantly different (P>.05). Accuracy of Astra Tech and Zimmer Dental friction-style torque-limiting devices were significantly different than Biohorizons torque-limiting devices (P<.05). There is no difference between the accuracy of new friction-style MTLDs and new spring-style MTLDs. All MTLDs fell within ±10% of the target torque value. Astra Tech and Zimmer Dental friction-style torque-limiting devices were significantly

  11. Forensic identification using multiple lot numbers of an implanted device.

    PubMed

    Takeshita, H; Nagai, T; Sagi, M; Chiba, S; Kanno, S; Takada, M; Mukai, T

    2014-01-01

    We report a case in which identification of a deceased individual was established using multiple lot numbers printed on a body implantable device. Autopsy of an unknown woman revealed an intramedullary nail inserted within her right femur. The device manufacturer was identified from the configuration of the intramedullary nail, and the "use history" was traced from lot numbers printed on the device's multiple parts. The deceased individual was thus identified as a woman who had attempted suicide by jumping from a height about a year previously and had been transported to a hospital and undergone surgery that included implantation of the intramedullary nail. The main factor contributing to the rapid identification was the manufacturer's and distributor's record of the use history (traceability) of the product, because of their accountability for purposes of quality control. A second contributing factor was multiple lot numbers, resulting in extremely low probability of the same combination of lot numbers being present in multiple individuals. This case confirmed the utility of multiple lot numbers of body implantable devices in forensic identification.

  12. Improved survival in patients enrolled promptly into remote monitoring following cardiac implantable electronic device implantation.

    PubMed

    Mittal, Suneet; Piccini, Jonathan P; Snell, Jeff; Prillinger, Julie B; Dalal, Nirav; Varma, Niraj

    2016-08-01

    Guidelines advocate remote monitoring (RM) in patients with a cardiac implantable electronic device (CIED). However, it is not known when RM should be initiated. We hypothesized that prompt initiation of RM (within 91 days of implant) is associated with improved survival compared to delayed initiation. This retrospective, national, observational cohort study evaluated patients receiving new implants of market-released St. Jude Medical™ pacemakers (PM), implantable cardioverter defibrillators (ICD), and cardiac resynchronization therapy (CRT) devices. Patients were assigned to one of two groups: an "RM Prompt" group, in which RM was initiated within 91 days of implant; and an "RM Delayed" group, in which RM was initiated >91 days but ≤365 days of implant. The primary endpoint was all-cause mortality. The cohort included 106,027 patients followed for a mean of 2.6 ± 0.9 years. Overall, 47,014 (44 %) patients had a PM, 31,889 (30 %) patients had an ICD, 24,005 (23 %) patients had a CRT-D, and 3119 (3 %) patients had a CRT-P. Remote monitoring was initiated promptly (median 4 weeks [IQR 2, 8 weeks]) in 66,070 (62 %) patients; in the other 39,957 (38 %) patients, RM initiation was delayed (median 24 weeks [IQR 18, 34 weeks]). In comparison to delayed initiation, prompt initiation of RM was associated with a lower mortality rate (4023 vs. 4679 per 100,000 patient-years, p < 0.001) and greater adjusted survival (HR 1.18 [95 % CI 1.13-1.22], p < 0.001). Our data, for the first time, show improved survival in patients enrolled promptly into RM following CIED implantation. This advantage was observed across all CIED device types.

  13. Cardiovascular implantable electronic devices: patient education, information and ethical issues.

    PubMed

    Manaouil, Cécile; Gignon, Maxime; Traulle, Sarah

    2012-09-01

    Cardiovascular implantable electronic devices (CIED) are implanted increasingly frequently. CIEDs are indicated for the treatment of bradycardia, tachycardia and heart failure and therefore improve quality of life and life expectancy. CIED can treat ventricular arrhythmias that would be fatal without immediate care. However, CIEDs raise several patient education, medico-legal, and ethical questions that will be addressed in this article. Information is a patient's right, and necessary for informed consent. When implanting a CIED, the patient must be educated about the need for the device, the function of the device, any restrictions that apply postimplant, and postimplant follow-up methods and schedules. This transfer of information to the patient makes the patient responsible. The occupational physician can determine whether a patient wearing a CIED is able to work. Under current French law, patients are not prohibited from working while wearing a CIED. However, access to certain job categories remains limited, such as jobs involving mechanical stress to the chest, exposure to electromagnetic fields, or jobs requiring permanent vigilance. Pacemakers and defibrillators are medical treatments and are subject to the same ethical and clinical considerations as any other treatment. However, stopping a pacemaker or a defibrillator raises different ethical issues. Implantable Cardioverter Defibrillator shocks can be considered to be equivalent to resuscitation efforts and can be interpreted as being unreasonable in an end-of-life patient. Pacing is painless and it is unlikely to unnecessarily prolong the life of a patient with a terminal disease. Patients with a CIED should live as normally as possible, but must also be informed about the constraints related to the device and must inform each caregiver about the presence of the device. The forensic and ethical implications must be assessed in relation to current legislation.

  14. A Review of the Biocompatibility of Implantable Devices: Current Challenges to Overcome Foreign Body Response

    PubMed Central

    Onuki, Yoshinori; Bhardwaj, Upkar; Papadimitrakopoulos, Fotios; Burgess, Diane J.

    2008-01-01

    In recent years, a variety of devices (drug-eluting stents, artificial organs, biosensors, catheters, scaffolds for tissue engineering, heart valves, etc.) have been developed for implantation into patients. However, when such devices are implanted into the body, the body can react to these in a number of different ways. These reactions can result in an unexpected risk for patients. Therefore, it is important to assess and optimize the biocompatibility of implantable devices. To date, numerous strategies have been investigated to overcome body reactions induced by the implantation of devices. This review focuses on the foreign body response and the approaches that have been taken to overcome this. The biological response following device implantation and the methods for biocompatibility evaluation are summarized. Then the risks of implantable devices and the challenges to overcome these problems are introduced. Specifically, the challenges used to overcome the functional loss of glucose sensors, restenosis after stent implantation, and calcification induced by implantable devices are discussed. PMID:19885290

  15. Remote monitoring of cardiovascular implantable electronic devices: prerequisite or luxury?

    PubMed

    Sticherling, Christian; Kühne, Michael; Schaer, Beat; Altmann, David; Osswald, Stefan

    2009-10-17

    The number of patients implanted with cardiovascular electronic devices (CIED) like implantable defibrillators (ICD), cardiac resynchronisation (CRT) devices, and pacemakers continues to grow. These devices require regular follow-up interrogation in dedicated device clinics. Contemporary CIED are capable of wireless remote interrogation and monitoring. This technology has been proven to be technically reliable and helpful in certain conditions. It is of particular benefit in monitoring devices that are under a safety alert since it allows early identification of device malfunction and minimises the risk of under-reporting. There is also strong evidence that it helps to reduce heart failure hospitalisations in CRT and ICD patients. Furthermore, this technology proves to be very helpful in the early detection of arrhythmias like atrial fibrillation or ventricular tachyarrhythmias. Remote monitoring significantly reduces the number of follow-up visits, patients' and physicians' time spent per visit, and increases patients' adherence to follow-up visits. Future studies are needed to determine how to best allocate this new technology in a cost-effective manner.

  16. Objective Comparison of Commercially Available Breast Implant Devices.

    PubMed

    Henderson, Peter W; Nash, David; Laskowski, Marta; Grant, Robert T

    2015-10-01

    Breast implants are frequently used for both cosmetic breast augmentation and breast reconstruction after mastectomy. Three companies currently offer FDA-approved breast implants (Allergan, Mentor, and Sientra), but their product offerings-including permanent breast implants, breast tissue expanders, sizers, and post-operative warranty-can be difficult to compare because of brand names and company-specific jargon. The ability to have a brand-agnostic understanding of all available options is important for both the surgical trainee as well as the surgeon in clinical practice. After a brief review of the history of breast implant devices, this review utilizes a unique conceptual framework based on variables such as fill material, shape, relative dimensions, and surface coating to facilitate a better understanding of the similarities and differences between the different company's offerings. Specifically, we identify which types of devices are offered by all three companies, those that are offered by only one company, those that have very limited product offerings, and those combinations that are not available at all. Finally, clinical implications are drawn from this framework that can be used by both cosmetic and reconstructive surgeons to counsel patients about all available options. Importantly, this project is entirely independent of any company's funding, support, or input. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

  17. Catheter embolization from implanted venous access devices: case reports.

    PubMed

    Carr, M E

    1989-04-01

    Two cases of catheter embolization from implanted venous access devices are reported and the available literature is reviewed. The catheter from an implanted venous access device migrated into the right heart after slippage of the O-ring, which attaches the catheter to the infusion port. The distal 6 cm of an infusion port catheter embolized to the right heart after spontaneous fracture of the catheter at the point where it passed between the clavicle and first rib. Both catheters were removed percutaneously without complication. Risk factors for embolization were apparent on x-ray films with evidence of O-ring slippage in 1 case an obvious kinking of the catheter in the other. Symptoms of embolization included chest discomfort, right upper quadrant pain, and nausea. In 1 case, an extra heart sound, initially thought to be an S3, disappeared when the catheter was removed.

  18. An Implantable Neuroprosthetic Device to Normalize Bladder Function after SCI

    DTIC Science & Technology

    2012-10-01

    design the novel neuroprosthetic device. Based on our previous studies, we propose in this project to use pudendal nerve stimulation and blockade to...injured animals. These results indicated that an implantable stimulator for pudendal nerve stimulation/ blockade could be developed for human subjects...stimulation and blockade to restore both continence and micturition after SCI. Our strategy does not require sacral posterior root rhizotomy, preserves the

  19. Integration of High Dose Boron Implants--Modification of Device Parametrics through Implant Temperature Control

    SciTech Connect

    Schmeide, Matthias; Ameen, M. S.; Kondratenko, Serguei; Krimbacher, Bernhard; Reece, Ronald N.

    2011-01-07

    In the present study, we have extended a previously reported 250 nm logic p-S/D implant (7 keV B 4.5x10{sup 15} cm{sup -2}) process matching exercise [5] to include wafer temperature, and demonstrate that matching can be obtained by increasing the temperature of the wafer during implant. We found that the high dose rate delivered by the single wafer implanter caused the formation of a clear amorphous layer, which upon subsequent annealing altered the diffusion, activation, and clustering properties of the boron. Furthermore, increasing the temperature of the wafer during the implant was sufficient to suppress amorphization, allowing profiles and device parameters to become matched. Figure 5 shows a representative set of curves indicating the cluster phenomena observed for the lower temperature, high flux single wafer implanter, and the influence of wafer temperature on the profiles. The results indicate the strong primary effect of dose rate in determining final electrical properties of devices, and successful implementation of damage engineering using wafer temperature control.

  20. Tunable Ultrasonic Energy Harvesting for Implantable Biosensors and Medical Devices

    NASA Astrophysics Data System (ADS)

    Pellegrino, M.; Eovino, B. E.; Beker, L.; Bourouina, T.; Lin, L.

    2016-11-01

    This work reports a tunable ultrasonic energy harvesting (UEH) device capable of high power output and/or large bandwidth based on concentric piezoelectric ring-shaped structures. Two different designs are presented: (1) the single ring-shaped UEH (r-UEH), and (2) concentric r-UEHs. Concentric r-UEHs can save space and therefore can provide benefits in powering low-power implantable biosensors and medical devices. This paper presents results of simulation studies and initial experiments of a single r-UEH.

  1. Ultra-thin layer packaging for implantable electronic devices

    NASA Astrophysics Data System (ADS)

    Hogg, A.; Aellen, T.; Uhl, S.; Graf, B.; Keppner, H.; Tardy, Y.; Burger, J.

    2013-07-01

    State of the art packaging for long-term implantable electronic devices generally uses reliable metal and glass housings; however, these are limited in the miniaturization potential and cost reduction. This paper focuses on the development of biocompatible hermetic thin-film packaging based on poly-para-xylylene (Parylene-C) and silicon oxide (SiOx) multilayers for smart implantable microelectromechanical systems (MEMS) devices. For the fabrication, a combined Parylene/SiOx single-chamber deposition system was developed. Topological aspects of multilayers were characterized by atomic force microscopy and scanning electron microscopy. Material compositions and layer interfaces were analyzed by Fourier transform infrared spectrometry and x-ray photoelectron spectroscopy. To evaluate the multilayer corrosion protection, water vapor permeation was investigated using a calcium mirror test. The calcium mirror test shows very low water permeation rates of 2 × 10-3 g m-2 day-1 (23 °C, 45% RH) for a 4.7 µm multilayer, which is equivalent to a 1.9 mm pure Parylene-C coating. According to the packaging standard MIL-STD-883, the helium gas tightness was investigated. These helium permeation measurements predict that a multilayer of 10 µm achieves the hermeticity acceptance criterion required for long-term implantable medical devices.

  2. In-vivo orthopedic implant diagnostic device for sensing load, wear, and infection

    DOEpatents

    Evans, III, Boyd McCutchen; Thundat, Thomas G.; Komistek, Richard D.; Dennis, Douglas A.; Mahfouz, Mohamed

    2006-08-29

    A device for providing in vivo diagnostics of loads, wear, and infection in orthopedic implants having at least one load sensor associated with the implant, at least one temperature sensor associated with the implant, at least one vibration sensor associated with the implant, and at least one signal processing device operatively coupled with the sensors. The signal processing device is operable to receive the output signal from the sensors and transmit a signal corresponding with the output signal.

  3. Current use of implantable electrical devices in Sweden: data from the Swedish pacemaker and implantable cardioverter-defibrillator registry.

    PubMed

    Gadler, Fredrik; Valzania, Cinzia; Linde, Cecilia

    2015-01-01

    The National Swedish Pacemaker and Implantable Cardioverter-Defibrillator (ICD) Registry collects prospective data on all pacemaker and ICD implants in Sweden. We aimed to report the 2012 findings of the Registry concerning electrical devices implantation rates and changes over time, 1 year complications, long-term device longevity and patient survival. Forty-four Swedish implanting centres continuously contribute implantation of pacemakers and ICDs to the Registry by direct data entry on a specific website. Clinical and technical information on 2012 first implants and postoperative complications were analysed and compared with previous years. Patient survival data were obtained from the Swedish population register database. In 2012, the mean pacemaker and ICD first implantation rates were 697 and 136 per million inhabitants, respectively. The number of cardiac resynchronization therapy (CRT) first implantations/million capita was 41 (CRT pacemakers) and 55 (CRT defibrillators), with only a slight increase in CRT-ICD rate compared with 2011. Most device implantations were performed in men. Complication rates for pacemaker and ICD procedures were 5.3 and 10.1% at 1 year, respectively. Device and lead longevity differed among manufacturers. Pacemaker patients were older at the time of first implant and had generally worse survival rate than ICD patients (63 vs. 82% after 5 years). Pacemaker and ICD implantation rates seem to have reached a level phase in Sweden. Implantable cardioverter-defibrillator and CRT implantation rates are very low and do not reflect guideline indications. Gender differences in CRT and ICD implantations are pronounced. Device and patient survival rates are variable, and should be considered when deciding device type. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  4. Technologies for Prolonging Cardiac Implantable Electronic Device Longevity.

    PubMed

    Lau, Ernest W

    2017-01-01

    Prolonged longevity of cardiac implantable electronic devices (CIEDs) is needed not only as a passive response to match the prolonging life expectancy of patient recipients, but will also actively prolong their life expectancy by avoiding/deferring the risks (and costs) associated with device replacement. CIEDs are still exclusively powered by nonrechargeable primary batteries, and energy exhaustion is the dominant and an inevitable cause of device replacement. The longevity of a CIED is thus determined by the attrition rate of its finite energy reserve. The energy available from a battery depends on its capacity (total amount of electric charge), chemistry (anode, cathode, and electrolyte), and internal architecture (stacked plate, folded plate, and spiral wound). The energy uses of a CIED vary and include a background current for running electronic circuitry, periodic radiofrequency telemetry, high-voltage capacitor reformation, constant ventricular pacing, and sporadic shocks for the cardiac resynchronization therapy defibrillators. The energy use by a CIED is primarily determined by the patient recipient's clinical needs, but the energy stored in the device battery is entirely under the manufacturer's control. A larger battery capacity generally results in a longer-lasting device, but improved battery chemistry and architecture may allow more space-efficient designs. Armed with the necessary technical knowledge, healthcare professionals and purchasers will be empowered to make judicious selection on device models and maximize the utilization of all their energy-saving features, to prolong device longevity for the benefits of their patients and healthcare systems.

  5. Cardiac device implantation in Fabry disease: A retrospective monocentric study.

    PubMed

    Sené, Thomas; Lidove, Olivier; Sebbah, Joel; Darondel, Jean-Marc; Picard, Hervé; Aaron, Laurent; Fain, Olivier; Zenone, Thierry; Joly, Dominique; Charron, Philippe; Ziza, Jean-Marc

    2016-10-01

    The incidence and predictive factors of arrhythmias and/or conduction abnormalities (ACAs) requiring cardiac device (CD) implantation are poorly characterized in Fabry disease (FD). The aim of our retrospective study was to determine the prevalence, incidence, and factors associated with ACA requiring CD implantation in a monocentric cohort of patients with confirmed FD who were followed up in a department of internal medicine and reference center for FD.Forty-nine patients (20M, 29F) were included. Nine patients (4M, 5F; 18%) had at least one episode of ACA leading to device therapy. Six patients (4M/2F) required a pacemaker (PM) for sinus node dysfunction (n = 4) or atrioventricular disease (n = 2). One female patient required an internal cardioverter-defibrillator (ICD) to prevent sudden cardiac death because of nonsustained ventricular tachycardia (nSVT). One female patient required PM-ICD for sinus node dysfunction and nSVT. One patient underwent CD implantation before the diagnosis of FD. The annual rate of CD implantation was estimated at 1.90 per 100 person years. On univariate analysis at the end of the follow-up period, the factors associated with ACAs requiring CD implantation were as follows: delayed diagnosis of FD, delayed initiation of enzyme replacement therapy, age at the last follow-up visit, and severe multiorgan phenotype (hypertrophic cardiomyopathy, chronic kidney disease, and/or sensorineural hearing loss). On multivariate analysis, age at diagnosis of FD and age at the last follow-up visit were independently associated with an increased risk of ACAs requiring CD (P < 0.05).Considering the high frequency of ACAs requiring CD implantation and the risk of sudden death in patients with FD, regular monitoring is mandatory, especially in patients with a late diagnosis of FD and/or with a severe phenotype. Regular Holter ECGs, therapeutic education of patients, and deliverance of an emergency card including a phenotype summary are

  6. Ultrasonic transcutaneous energy transfer for powering implanted devices.

    PubMed

    Ozeri, Shaul; Shmilovitz, Doron

    2010-05-01

    This paper investigates ultrasonic transcutaneous energy transfer (UTET) as a method for energizing implanted devices at power level up to a few 100 mW. We propose a continuous wave 673 kHz single frequency operation to power devices implanted up to 40 mm deep subcutaneously. The proposed UTET demonstrated an overall peak power transfer efficiency of 27% at 70 mW output power (rectified DC power at the load). The transducers consisted of PZT plane discs of 15 mm diameter and 1.3mm thick acoustic matching layer made of graphite. The power rectifier on the implant side attained 88.5% power transfer efficiency. The proposed approach is analyzed in detail, with design considerations provided to address issues such as recommended operating frequency range, acoustic link matching, receiver's rectifying electronics, and tissue bio-safety concerns. Global optimization and design considerations for maximum power transfer are presented and verified by means of finite element simulations and experimental results. Copyright 2009 Elsevier B.V. All rights reserved.

  7. Feasibility study for future implantable neural-silicon interface devices.

    PubMed

    Al-Armaghany, Allann; Yu, Bo; Mak, Terrence; Tong, Kin-Fai; Sun, Yihe

    2011-01-01

    The emerging neural-silicon interface devices bridge nerve systems with artificial systems and play a key role in neuro-prostheses and neuro-rehabilitation applications. Integrating neural signal collection, processing and transmission on a single device will make clinical applications more practical and feasible. This paper focuses on the wireless antenna part and real-time neural signal analysis part of implantable brain-machine interface (BMI) devices. We propose to use millimeter-wave for wireless connections between different areas of a brain. Various antenna, including microstrip patch, monopole antenna and substrate integrated waveguide antenna are considered for the intra-cortical proximity communication. A Hebbian eigenfilter based method is proposed for multi-channel neuronal spike sorting. Folding and parallel design techniques are employed to explore various structures and make a trade-off between area and power consumption. Field programmable logic arrays (FPGAs) are used to evaluate various structures.

  8. Remotely powered multichannel microprocessor-based telemetry systems for smart implantable devices and smart structures

    NASA Astrophysics Data System (ADS)

    Townsend, Christopher P.; Arms, Steven W.; Hamel, Michael J.

    1999-07-01

    The development of improved implantable devices and materials require knowledge of their in vivo behavior. However, little is known about the actual loads borne by implanted devices in vivo. Direct load measurement would provide extremely valuable information, for the improvement of device designs, and for the rapid rehabilitation of individuals in which devices have been implanted. Multichannel telemetry systems, combined with strain gauges, can provide this information.

  9. [The management of implantable medical device and the application of the internet of things in hospitals].

    PubMed

    Zhou, Li; Xu, Liang

    2011-11-01

    Implantable medical device is a special product which belongs to medical devices. It not only possesses product characteristics in common, but also has specificity for safety and effectiveness. Implantable medical device must be managed by the relevant laws and regulations of the State Food and Drug Administration. In this paper, we have used cardiac pacemakers as an example to describe the significance of the management of implantable medical device products and the application of the internet of things in hospitals.

  10. Middle ear implantable hearing device: ongoing animal and human evaluation.

    PubMed

    Hough, J; Dormer, K J; Baker, R S; Meikle, M; Himelick, T

    1988-01-01

    The first five patients have been permanently implanted with an electromagnetic middle ear implantable hearing device. Hearing tests were performed at the time of operation and at 8 weeks postoperatively with a coil held at the isthmus of the ear canal. All patients reported clear, high fidelity sound, as proven by speech discrimination scores. Improvements were seen in all frequencies, including 4,000 Hz. Improvement in pure tones as tested with an audiometer monitoring sounds amplified by a 3-V sound processor was as high as 50 dB sound pressure level. That which remains to be done is the final design of a compact, wearable sound processor with filtering and signal-processing capabilities to meet the needs of the sensorineural hearing-impaired population.

  11. The cardiac implantable electronic device power source: evolution and revolution.

    PubMed

    Mond, Harry G; Freitag, Gary

    2014-12-01

    Although the first power source for an implantable pacemaker was a rechargeable nickel-cadmium battery, it was rapidly replaced by an unreliable short-life zinc-mercury cell. This sustained the small pacemaker industry until the early 1970s, when the lithium-iodine cell became the dominant power source for low voltage, microampere current, single- and dual-chamber pacemakers. By the early 2000s, a number of significant advances were occurring with pacemaker technology which necessitated that the power source should now provide milliampere current for data logging, telemetric communication, and programming, as well as powering more complicated pacing devices such as biventricular pacemakers, treatment or prevention of atrial tachyarrhythmias, and the integration of innovative physiologic sensors. Because the current delivery of the lithium-iodine battery was inadequate for these functions, other lithium anode chemistries that can provide medium power were introduced. These include lithium-carbon monofluoride, lithium-manganese dioxide, and lithium-silver vanadium oxide/carbon mono-fluoride hybrids. In the early 1980s, the first implantable defibrillators for high voltage therapy used a lithium-vanadium pentoxide battery. With the introduction of the implantable cardioverter defibrillator, the reliable lithium-silver vanadium oxide became the power source. More recently, because of the demands of biventricular pacing, data logging, and telemetry, lithium-manganese dioxide and the hybrid lithium-silver vanadium oxide/carbon mono-fluoride laminate have also been used. Today all cardiac implantable electronic devices are powered by lithium anode batteries. ©2014 Wiley Periodicals, Inc.

  12. Challenges in patient selection for the parachute device implantation.

    PubMed

    Bozdag-Turan, Ilkay; Bermaoui, Benjamin; Paranskaya, Liliya; GökmenTuran, R; D'Ancona, Giuseppe; Kische, Stephan; Birkemeyer, Ralph; Jovanovic, Bojan; Schuetz, Jan; Akin, Ibrahim; Turan, Cem Hakan; Ortak, Jasmin; Hauenstein, K; Nienaber, Cristoph Anton; Ince, Hueseyin

    2013-11-01

    A novel percutaneous ventricular restoration therapy (PVRT) has been recently proposed to treat patients with ischemic heart failure (IHF) and antero-apical regional wall motion abnormalities after myocardial infarction (MI). In this prospective, single center, non-randomized study, we herein propose safety and feasibility evaluation of the device, in which a different patient selection strategy was used. A three-stage evaluation was adopted in a series of patients referred for a Parachute Ventricular Partitioning Device (Parachute™). After an initial clinical evaluation, a secondary screening step was performed according to echocardiographic functional (LVEF<40%, apical/anterior akinesia/dyskinesia) and anatomical criteria [diameter of LV-apex (LVAD) = 4.0 × 5.0 cm, left ventricular end diastolic diameter (LVEDD)>56 mm, left ventricular end systolic diameter (LVESD)>38 mm]. Patients encountering the echocardiographic criteria were selected for 3D cardiac CT (architecture, geometry, and trabeculation of the left ventricle) and eventually treated with the Parachute™. Fifty patients were screened according to the echocardiographic criteria. Twenty-seven of those that met the echo inclusion criteria underwent further cardiac CT imaging. After CT imaging, eight patients were scheduled for Parachute™ implantation. The device was successfully implanted in all eight patients with no in-hospital mortality. A 3-month follow-up echocardiography showed LV-volume reduction [95% CI; LVEDV: -76.5 (-116; -36.8), P = 0.002 and LVESV: -47.4 (-63.8; -30.9), P = 0.003] and improvement of global EF [95% CI; global EF: 6.87 (5.36; 8.39), P = 0.008]. Selection criteria for Parachute™ placement should include left ventricular functional and anatomical parameters. When preprocedural echocardiography and cardiac CT are adequately implemented, satisfactory periprocedural and short term follow-up results may be achieved after Parachute™ implantation. Copyright © 2013 Wiley

  13. Study of device malfunctions in patients with implantable ventricular assist devices living at home.

    PubMed

    Kashiwa, Koichi; Nishimura, Takashi; Kubo, Hitoshi; Tamai, Hisayoshi; Baba, Atsushi; Ono, Minoru; Takamoto, Shinichi; Kyo, Shunei

    2010-09-01

    Clinical introduction of implantable ventricular assist devices (VADs) is expected to encourage VAD therapy for severe heart failure patients in Japan. Since even minor device malfunctions can lead to serious outcomes in these patients, it is very important to collect and analyze data on device malfunctions occurring during their use at home. This study was undertaken to collect and analyze such data from 9 patients with implanted VADs (EVAHEART™, 4 patients; Jarvik2000, 3 patients; Duraheart™, 2 patients) living at home, within the framework of a clinical trial carried out at our hospital. During the home stay period of 449 ± 253 days (range 12-801 days, total 4044 days), the total number of device malfunctions was 31 (0.31 events/patient/year). Those with EVAHEART™ were Cool-seal system-related (9 events) and battery-related (6 events) malfunctions. Those with Jarvik2000 were battery-related (7 events), alarm (1 event) and uncertain cause (1 event) malfunctions. Those with Duraheart™ were battery-related (3 events), alarm (3 events) and other component (1 event) malfunctions. Although the incidence was not very high and none of these device malfunctions led to cessation of blood pump operation in this study, it is necessary to establish a communication system for properly obtaining detailed information in the event of serious device malfunctions. Furthermore, establishment of a home-living-patient support system covering extensive areas is urgently needed, since this can facilitate rapid action to deal with serious device malfunctions.

  14. Management of Patients With Cardiovascular Implantable Electronic Devices in Dental, Oral, and Maxillofacial Surgery.

    PubMed

    Tom, James

    2016-01-01

    The prevalence of cardiovascular implantable electronic devices as life-prolonging and life-saving devices has evolved from a treatment of last resort to a first-line therapy for an increasing number of patients. As these devices become more and more popular in the general population, dental providers utilizing instruments and medications should be aware of dental equipment and medications that may affect these devices and understand the management of patients with these devices. This review article will discuss the various types and indications for pacemakers and implantable cardioverter-defibrillators, common drugs and instruments affecting these devices, and management of patients with these devices implanted for cardiac dysrhythmias.

  15. Management of Patients With Cardiovascular Implantable Electronic Devices in Dental, Oral, and Maxillofacial Surgery

    PubMed Central

    Tom, James

    2016-01-01

    The prevalence of cardiovascular implantable electronic devices as life-prolonging and life-saving devices has evolved from a treatment of last resort to a first-line therapy for an increasing number of patients. As these devices become more and more popular in the general population, dental providers utilizing instruments and medications should be aware of dental equipment and medications that may affect these devices and understand the management of patients with these devices. This review article will discuss the various types and indications for pacemakers and implantable cardioverter-defibrillators, common drugs and instruments affecting these devices, and management of patients with these devices implanted for cardiac dysrhythmias. PMID:27269668

  16. From hemodynamic towards cardiomechanic sensors in implantable devices

    NASA Astrophysics Data System (ADS)

    Ferek-Petric, Bozidar

    2013-06-01

    Sensor could significantly improve the cardiac electrotherapy. It has to provide long-term stabile signal not impeding the device longevity and lead reliability. It may not introduce special implantation and adjustment procedures. Hemodynamic sensors based on the blood flow velocity and cardiomechanic sensors based on the lead bending measurement are disclosed. These sensors have a broad clinical utility. Triboelectric and high-frequency lead bending sensors yield accurate and stable signals whereby functioning with every cardiac lead. Moreover, high frequency measurement avoids use of any kind of special hardware mounted on the cardiac lead.

  17. Silicon based materials for drug delivery devices and implants.

    PubMed

    Bernik, Delia L

    2007-01-01

    This patent review focuses on silicon based materials for drug delivery systems and implant devices devoted to medical applications. The article describes some representative examples of the most depictive silicon based compounds associated with drug release formulations and tissue engineering biomaterials. Ranging from inorganic to organic and hybrid inorganic-organic silicon compounds, the paper referrers to patents describing inventions which make use of the best properties of silicon dioxide, silica aerogel and xerogel, silicon bioactive materials, silicones and ormosils, pointing out the usefulness of each kind of compound within the invention embodiment.

  18. Galvanic disruption of vestibulospinal postural control by cochlear implant devices.

    PubMed

    Black, F O; Wall, C; O'Leary, D P; Bilger, R C; Wolf, R V

    1978-12-01

    All subjects with implanted cochlear stimulators demonstrated evidence of abnormal postural stability without their stimulators activated. Instability increased when they were tested with cochlear stimulation units turned on, and additional instability was demonstrated in four of these subjects when tested in noise. These findings suggest that the electrical stimulation delivered by the cochlear prosthesis is not limited to the auditory system. The precise characteristics of electrical stimulation devices designed for stimulations limited to the cochlea and their spurious effects upon motor performance should be investigated. The design of future intralabyrinthine auditory electrical prostheses must include hardware designs and stimulus paradigms that avoid undesirable vestibular system stimulation.

  19. New molecular strategies for reducing implantable medical devices associated infections.

    PubMed

    Holban, Alina Maria; Gestal, Monica Cartelle; Grumezescu, Alexandru Mihai

    2014-01-01

    Due to the great prevalence of persistent and recurrent implanted device associated-infections novel and alternative therapeutic approaches are intensely investigated. For reducing complications and antibiotic resistance development, one major strategy is using natural or synthetic modulators for targeting microbial molecular pathways which are not related with cell multiplication and death, as Quorum Sensing, virulence and biofilm formation. The purpose of this review paper is to discuss the most recent in vitro approaches, investigating the efficiency of some novel antimicrobial products and the nano-technologic progress performed in order to increase their effect and stability.

  20. An implantable thermoresponsive drug delivery system based on Peltier device.

    PubMed

    Yang, Rongbing; Gorelov, Alexander V; Aldabbagh, Fawaz; Carroll, William M; Rochev, Yury

    2013-04-15

    Locally dropping the temperature in vivo is the main obstacle to the clinical use of a thermoresponsive drug delivery system. In this paper, a Peltier electronic element is incorporated with a thermoresponsive thin film based drug delivery system to form a new drug delivery device which can regulate the release of rhodamine B in a water environment at 37 °C. Various current signals are used to control the temperature of the cold side of the Peltier device and the volume of water on top of the Peltier device affects the change in temperature. The pulsatile on-demand release profile of the model drug is obtained by turning the current signal on and off. The work has shown that the 2600 mAh power source is enough to power this device for 1.3 h. Furthermore, the excessive heat will not cause thermal damage in the body as it will be dissipated by the thermoregulation of the human body. Therefore, this simple novel device can be implanted and should work well in vivo.

  1. Cardiac Implantable Electronic Device Infection: From an Infection Prevention Perspective

    PubMed Central

    Sastry, Sangeeta; Rahman, Riaz; Yassin, Mohamed H.

    2015-01-01

    A cardiac implantable electronic device (CIED) is indicated for patients with severely reduced ejection fraction or with life-threatening cardiac arrhythmias. Infection related to a CIED is one of the most feared complications of this life-saving device. The rate of CIED infection has been estimated to be between 2 and 25; though evidence shows that this rate continues to rise with increasing expenditure to the patient as well as healthcare systems. Multiple risk factors have been attributed to the increased rates of CIED infection and host comorbidities as well as procedure related risks. Infection prevention efforts are being developed as defined bundles in numerous hospitals around the country given the increased morbidity and mortality from CIED related infections. This paper aims at reviewing the various infection prevention measures employed at hospitals and also highlights the areas that have relatively less established evidence for efficacy. PMID:26550494

  2. Wireless energy transfer platform for medical sensors and implantable devices.

    PubMed

    Zhang, Fei; Hackworth, Steven A; Liu, Xiaoyu; Chen, Haiyan; Sclabassi, Robert J; Sun, Mingui

    2009-01-01

    Witricity is a newly developed technique for wireless energy transfer. This paper presents a frequency adjustable witricity system to power medical sensors and implantable devices. New witricity resonators are designed for both energy transmission and reception. A prototype platform is described, including an RF power source, two resonators with new structures, and inductively coupled input and output stages. In vitro experiments, both in open air and using a human head phantom consisting of simulated tissues, are employed to verify the feasibility of this platform. An animal model is utilized to evaluate in vivo energy transfer within the body of a laboratory pig. Our experiments indicate that witricity is an effective new tool for providing a variety of medical sensors and devices with power.

  3. Safety of active implantable devices during MRI examinations: a finite element analysis of an implantable pump.

    PubMed

    Büchler, Philippe; Simon, Anne; Burger, Jürgen; Ginggen, Alec; Crivelli, Rocco; Tardy, Yanik; Luechinger, Roger; Olsen, Sigbjørn

    2007-04-01

    The goal of this study was to propose a general numerical analysis methodology to evaluate the magnetic resonance imaging (MRI)-safety of active implants. Numerical models based on the finite element (FE) technique were used to estimate if the normal operation of an active device was altered during MRI imaging. An active implanted pump was chosen to illustrate the method. A set of controlled experiments were proposed and performed to validate the numerical model. The calculated induced voltages in the important electronic components of the device showed dependence with the MRI field strength. For the MRI radiofrequency fields, significant induced voltages of up to 20 V were calculated for a 0.3T field-strength MRI. For the 1.5 and 3.0OT MRIs, the calculated voltages were insignificant. On the other hand, induced voltages up to 11 V were calculated in the critical electronic components for the 3.0T MRI due to the gradient fields. Values obtained in this work reflect to the worst case situation which is virtually impossible to achieve in normal scanning situations. Since the calculated voltages may be removed by appropriate protection circuits, no critical problems affecting the normal operation of the pump were identified. This study showed that the proposed methodology helps the identification of the possible incompatibilities between active implants and MR imaging, and can be used to aid the design of critical electronic systems to ensure MRI-safety.

  4. Oxygen supply by photosynthesis to an implantable islet cell device.

    PubMed

    Evron, Y; Zimermann, B; Ludwig, B; Barkai, U; Colton, C K; Weir, G C; Arieli, B; Maimon, S; Shalev, N; Yavriyants, K; Goldman, T; Gendler, Z; Eizen, L; Vardi, P; Bloch, K; Barthel, A; Bornstein, S R; Rotem, A

    2015-01-01

    Transplantation of islet cells is an effective treatment for type 1 diabetes with critically labile metabolic control. However, during islet isolation, blood supply is disrupted, and the transport of nutrients/metabolites to and from the islet cells occurs entirely by diffusion. Adequate oxygen supply is essential for function/survival of islet cells and is the limiting factor for graft integrity. Recently, we developed an immunoisolated chamber system for transplantation of human islets without immunosuppression. This system depended on daily oxygen supply. To provide independence from this external source, we incorporated a novel approach based on photosynthetically-generated oxygen. The chamber system was packed sandwich-like with a slab of immobilized photosynthetically active microorganisms (Synechococcus lividus) on top of a flat light source (LEDs, red light at 660 nm, intensity of 8 μE/m(2)/s). Islet cells immobilized in an alginate slab (500-1,000 islet equivalents/cm(2)) were mounted on the photosynthetic slab separated by a gas permeable silicone rubber-Teflon membrane, and the complete module was sealed with a microporous polytetrafluorethylene (Teflon) membrane (pore size: 0.4 μm) to protect the contents from the host immune cells. Upon illumination, oxygen produced by photosynthesis diffused via the silicone Teflon membrane into the islet compartment. Oxygen production from implanted encapsulated microorganisms was stable for 1 month. After implantation of the device into diabetic rats, normoglycemia was achieved for 1 week. Upon retrieval of the device, blood glucose levels returned to the diabetic state. Our results demonstrate that an implanted photosynthetic bioreactor can supply oxygen to transplanted islets and thus maintain islet viability/functionality. © Georg Thieme Verlag KG Stuttgart · New York.

  5. Implanted medical devices in the radiation environment of commercial spaceflight.

    PubMed

    Reyes, David P; McClure, Steven S; Chancellor, Jeffery C; Blue, Rebecca S; Castleberry, Tarah L; Vanderploeg, James M

    2014-11-01

    Some commercial spaceflight participants (SFPs) may have medical conditions that require implanted medical devices (IMDs), such as cardiac pacemakers, defibrillators, insulin pumps, or similar electronic devices. The effect of space radiation on the function of IMDs is unknown. This review will identify known effects of terrestrial and aviation electromagnetic interference (EMI) and radiation on IMDs in order to provide insight into the potential effects of radiation exposures in the space environment. A systematic literature review was conducted on available literature on human studies involving the effects of EMI as well as diagnostic and therapeutic radiation on IMDs. The literature review identified potential transient effects from EMI and diagnostic radiation levels as low as 10 mGy on IMDs. High-energy, therapeutic, ionizing radiation can cause more permanent device malfunctions at doses as low as 40 mGy. Radiation doses from suborbital flight altitudes and durations are anticipated to be less than those experienced during an average round-trip, cross-country airline flight and are unlikely to result in significant detriment, though longer, orbital flights may expose SFPs to doses potentially harmful to IMD function. Individuals with IMDs should experience few, if any, radiation-related device malfunctions during suborbital flight, but could have problems with radiation exposures associated with longer, orbital flights.

  6. Investigations with an implantable, electrically actuated ventricular assist device.

    PubMed

    Bernhard, W F; Gernes, D G; Clay, W C; Schoen, F J; Burgeson, R; Valeri, R C; Melaragno, A J; Poirier, V L

    1984-07-01

    A permanent, implantable, circulatory support system for patients with irreversible cardiomyopathy is gradually becoming a reality. Progress has been achieved toward formation of a stable, nonthrombogenic, blood-prosthesis interface, and an electrically actuated ventricular assist device has reached an advanced stage of fabrication. The two most important components of the system, an electromechanical energy converter and a contiguous, pusher-plate, blood pump (stroke volume 85 ml) were employed in these studies. The energy converter consisted of a 50 volt, low-speed, brushless, torque motor and a mechanism to convert rotary motion into a pulsatile output. An electronic controller and variable-volume compliance chamber were not evaluated. Left ventricular bypass experiments were conducted in 13 calves for periods of 30 to 149 days. Preoperatively, four devices were inoculated with bovine, fetal fibroblasts to accelerate formation of a collagenous lining, and nine nonseeded pumps served as controls. The collagen-lined devices functioned for longer periods of time with unrestricted blood flow and no thromboembolic complications when compared to the control devices. Additional studies are contemplated employing a complete VAD system prior to undertaking preclinical trials.

  7. Little Black Boxes: Noncardiac Implantable Electronic Medical Devices and Their Anesthetic and Surgical Implications.

    PubMed

    Srejic, Una; Larson, Paul; Bickler, Philip E

    2017-07-01

    Implanted electronic medical devices. or stimulators such as pacemakers and nerve stimulators have grown enormously in diversity and complexity over recent decades. The function and potential interaction of these devices with the perioperative environment is of increasing concern for anesthesiologists and surgeons. Because of the innate electromagnetic environment of the hospital (operating room, gastrointestinal procedure suite, and imaging suite), implanted device malfunction, reprogramming, or destruction may occur and cause physical harm (including nerve injury, blindness, deafness, burn, stroke, paralysis, or coma) to the patient. It is critical for the anesthesiologist and surgeon to be aware of the function and interaction of implanted devices, both with other implanted devices and procedures (such as magnetic resonance imaging and cardioversion) in the hospital environment. Because of these interactions, it is imperative that proper device function is assessed when the surgical procedure is complete. This review article will discuss these important issues for 12 different types of "little black boxes," or noncardiac implantable electronic medical devices.

  8. Cardiac Device Implant Skin Closure with a Novel Adjustable, Coaptive Tape-Based Device.

    PubMed

    Lalani, Gautam G; Schricker, Amir A; Salcedo, Jonathan; Hebsur, Shrinivas; Hsu, Jonathan; Feld, Gregory; Birgersdotter-Green, Ulrika

    2016-10-01

    The purpose of this study was to compare a unique zip-type adjustable coaptive tape-based skin closure device to traditional subcuticular sutures in three domains: time, cosmesis, and wound closure-related outcomes in cardiac implantable electronic device (CIED) procedures. A total of 40 patients were enrolled in a prospective randomized controlled trial to assess time to wound closure, as well as cosmesis and wound closure-related outcomes. The adjustable coaptive tape-based skin closure device had shorter overall closure time (78 ± 6.6 seconds vs 216 ± 21.5 seconds; P < 0.001) and mean closure time per centimeter (18.0 ± 2.0 s/cm vs 50.1 ± 6.7 s/cm; P < 0.001) versus sutures, with less intersurgeon and interpatient variability with the use of adjustable coaptive device versus sutures (P < 0.001). There was no difference between groups in postoperative pain or scar cosmesis during the follow-up period. Neither group had any closure-related adverse events. The adjustable coaptive tape-based skin closure device demonstrated shorter closure times with less variability when compared to sutures. It is a safe and acceptable alternative to sutures for skin closure following CIED implantation. © 2016 Wiley Periodicals, Inc.

  9. Pore structures in an implantable sol gel titania ceramic device used in controlled drug release applications: A modeling study

    NASA Astrophysics Data System (ADS)

    Peterson, Aaron; Lopez, Tessy; Islas, Emma Ortiz; Gonzalez, Richard D.

    2007-04-01

    Several process variables, which may be helpful in optimizing the rate at which drugs are released from implantable, sol-gel titania devices have been identified in this study. The controlled rate of drug release is compared for two different anticonvulsant drugs, valproic acid and sodic phenytoin. Contrary to what one might expect, when the concentration is increased in the titania reservoir the rate of initial drug delivery decreases. This is a desirable result, because it may reduce the danger of a high initial discharge, which may harm the epileptic rat. The structure of the porous structure within the titania network has been studied using a generalized form of the BET equation which considers only n layers. In general, following an initial discharge, the rate at which the drug is released will increase with the increasing concentration. Pore mouth blocking can present a problem. However, this problem tends to disappear following the initial discharge. The extent of drug loading is a useful variable parameter, which can be adjusted in order to deliver the amount of drug required in a given application.

  10. Perioperative management of antithrombotic treatment during implantation or revision of cardiac implantable electronic devices: the European Snapshot Survey on Procedural Routines for Electronic Device Implantation (ESS-PREDI).

    PubMed

    Deharo, Jean-Claude; Sciaraffia, Elena; Leclercq, Christophe; Amara, Walid; Doering, Michael; Bongiorni, Maria G; Chen, Jian; Dagres, Nicolaus; Estner, Heidi; Larsen, Torben B; Johansen, Jens B; Potpara, Tatjana S; Proclemer, Alessandro; Pison, Laurent; Brunet, Caroline; Blomström-Lundqvist, Carina

    2016-05-01

    The European Snapshot Survey on Procedural Routines for Electronic Device Implantation (ESS-PREDI) was a prospective European survey of consecutive adults who had undergone implantation/surgical revision of a cardiac implantable electronic device (CIED) on chronic antithrombotic therapy (enrolment March-June 2015). The aim of the survey was to investigate perioperative treatment with oral anticoagulants and antiplatelets in CIED implantation or surgical revision and to determine the incidence of complications, including clinically significant pocket haematomas. Information on antithrombotic therapy before and after surgery and bleeding and thromboembolic complications occurring after the intervention was collected at first follow-up. The study population comprised 723 patients (66.7% men, 76.9% aged ≥66 years). Antithrombotic treatment was continued during surgery in 489 (67.6%) patients; 6 (0.8%) had their treatment definitively stopped; 46 (6.4%) were switched to another antithrombotic therapy. Heparin bridging was used in 55 out of 154 (35.8%) patients when interrupting vitamin K antagonist (VKA) treatment. Non-vitamin K oral anticoagulant (NOAC) treatment was interrupted in 88.7% of patients, with heparin bridging in 25.6%, but accounted for only 25.3% of the oral anticoagulants used. A total of 108 complications were observed in 98 patients. No intracranial haemorrhage or embolic events were observed. Chronic NOAC treatment before surgery was associated with lower rates of minor pocket haematoma (1.4%; P= 0.042) vs. dual antiplatelet therapy (13.0%), VKA (11.4%), VKA + antiplatelet (9.2%), or NOAC + antiplatelet (7.7%). Similar results were observed for bleeding complications (P= 0.028). Perioperative management of patients undergoing CIED implantation/surgical revision while on chronic antithrombotic therapy varies, with evidence of a disparity between guideline recommendations and practice patterns in Europe. Haemorrhagic complications were significantly

  11. Simulation study of a high power density rectenna array for biomedical implantable devices

    NASA Astrophysics Data System (ADS)

    Day, John; Yoon, Hargsoon; Kim, Jaehwan; Choi, Sang H.; Song, Kyo D.

    2016-04-01

    The integration of wireless power transmission devices using microwaves into the biomedical field is close to a practical reality. Implanted biomedical devices need a long lasting power source or continuous power supply. Recent development of high efficiency rectenna technology enables continuous power supply to these implanted devices. Due to the size limit of most of medical devices, it is imperative to minimize the rectenna as well. The research reported in this paper reviews the effects of close packing the rectenna elements which show the potential of directly empowering the implanted devices, especially within a confined area. The rectenna array is tested in the X band frequency range.

  12. Endoscopic Electrosurgery in Patients with Cardiac Implantable Electronic Devices

    PubMed Central

    Baeg, Myong Ki; Kim, Sang-Woo; Ko, Sun-Hye; Lee, Yoon Bum; Hwang, Seawon; Lee, Bong-Woo; Choi, Hye Jin; Park, Jae Myung; Lee, In-Seok; Oh, Yong-Seog; Choi, Myung-Gyu

    2016-01-01

    Background/Aims: Patients with cardiac implantable electronic devices (CIEDs) undergoing endoscopic electrosurgery (EE) are at a risk of electromagnetic interference (EMI). We aimed to analyze the effects of EE in CIED patients. Methods: Patients with CIED who underwent EE procedures such as snare polypectomy, endoscopic submucosal dissection (ESD), and endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (EST) were retrospectively analyzed. Postprocedural symptoms as well as demographic and outpatient follow-up data were reviewed through medical records. Electrical data, including preprocedural and postprocedural arrhythmia records, were reviewed through pacemaker interrogation, 24-hour Holter monitoring, or electrocardiogram. Results: Fifty-nine procedures in 49 patients were analyzed. Fifty procedures were performed in 43 patients with a pacemaker, and nine were performed in six patients with an implantable cardioverter-defibrillator. There were one gastric and 44 colon snare polypectomies, five gastric and one colon ESDs, and eight ERCPs with EST. Fifty-five cases of electrical follow-up were noted, with two postprocedural changes not caused by EE. Thirty-one pacemaker interrogations had procedure recordings, with two cases of asymptomatic tachycardia. All patients were asymptomatic with no adverse events. Conclusions: Our study reports no adverse events from EE in patients with CIED, suggesting that this procedure is safe. However, because of the possibility of EMI, recommendations on EE should be followed. PMID:26867552

  13. Thrombotic complications of implanted central venous access devices: prospective evaluation.

    PubMed

    Labourey, Jean-Luc; Lacroix, Philippe; Genet, Dominique; Gobeaux, François; Martin, Jean; Venat-Bouvet, Laurence; Lavau-Denes, Sandrine; Maubon, Antoine; Tubiana-Mathieu, Nicole

    2004-05-01

    Implanted venous access devices (IVAD) are routinely used in oncologic patients. Thrombotic complication is a source of morbidity. During one year 246 patients with different solid neoplastic diseases received IVAD for chemotherapy administration. Two hundred forty-nine IVAD were placed percutaneously or by surgical cutdown. IVAD were flushed immediately after implantation with 3-5 mL of heparinized saline (100 U/mL). No monthly flush was required. A prospective evaluation of thrombotic complications was realised. in event of catheter dysfunction and/or clinical symptoms of phlebitis, a catheter opacification and/or a Doppler ultrasonography were performed. Twenty-three catheter dysfunctions were noted, corresponding to 13 catheter occlusions. Twelve patients presented clinical symptoms of phlebitis. Eleven venous thrombosis were diagnosed in this group; 10 by echo-Doppler and one by scanography. A unvaried statistic analysis using Fisher's test was performed to detect risk factors. Two factors were identified: the position of catheter tip above T4 (p < 0.001) and mediastinal or cervical lymph nodes larger than 6 cm (p < 0.001). The first increased the risk of catheter occlusion and the second increased the risk of phlebitis.

  14. Central nervous system MRI and cardiac implantable electronic devices.

    PubMed

    Cadieu, Romain; Peron, Marilyne; Le Ven, Florent; Kerdraon, Sébastien; Boutet, Claire; Mansourati, Jacques; Ben Salem, Douraied

    2017-02-01

    As the population ages and indications for MRI increase, it is estimated that 50 to 75% of patients with a cardiac implantable electronic device (CIED) - pacemaker (PM) or implanted cardiac defibrillator (ICD) - will need an MRI during their CIED's lifetime. Three categories of materials are defined: MRI compatible, MRI non-compatible, and MRI conditional. MRI compatible CIEDs without electrodes have been developed, but do not allow battery changes, so that they are exclusively indicated for patients whose life expectancy is less than that of the battery (6-7years). For MRI conditional CIEDs, all manufacturers publish restrictions. These restrictions can relate to the patient (size, position in the MRI, body temperature), the MRI parameters (magnetic field), or the examination in itself (gradients, specific absorption rate, duration, isocenter). The neuroradiologist can expect to be confronted with the issue of MRI in patients with a CIED. The purpose of this review is to provide them with updated information on MRI and CIEDs.

  15. Thin-film Rechargeable Lithium Batteries for Implantable Devices

    DOE R&D Accomplishments Database

    Bates, J. B.; Dudney, N. J.

    1997-05-01

    Thin films of LiCoO{sub 2} have been synthesized in which the strongest x ray reflection is either weak or missing, indicating a high degree of preferred orientation. Thin film solid state batteries with these textured cathode films can deliver practical capacities at high current densities. For example, for one of the cells 70% of the maximum capacity between 4.2 V and 3 V ({approximately}0.2 mAh/cm{sup 2}) was delivered at a current of 2 mA/cm{sup 2}. When cycled at rates of 0.1 mA/cm{sup 2}, the capacity loss was 0.001%/cycle or less. The reliability and performance of Li LiCoO{sub 2} thin film batteries make them attractive for application in implantable devices such as neural stimulators, pacemakers, and defibrillators.

  16. Thin-film rechargeable lithium batteries for implantable devices

    SciTech Connect

    Bates, J.b.; Dudney, N.J.

    1997-05-01

    Thin films of LiCoO{sub 2} have been synthesized in which the strongest x-ray reflection is either weak or missing, indicating a high degree of preferred orientation. Thin-film solid state batteries with these textured cathode films can deliver practical capacities at high current densities. For example, for one of the cells 70% of the maximum capacity between 4.2 V and 3 V ({approximately}0.2 mAh/cm{sup 2}) was delivered at a current of 2 mA/cm{sup 2}. When cycled at rates of 0.1 mA/cm{sup 2}, the capacity loss was 0.001 %/cycle or less. The reliability and performance of Li-LiCoO{sub 2} thin-film batteries make them attractive for application in implantable devices such as neural stimulators, pacemakers, and defibrillators.

  17. Thin film rechargeable lithium batteries for implantable devices.

    PubMed

    Bates, J B; Dudney, N J

    1997-01-01

    Thin films of LiCoO2 have been synthesized in which the strongest x-ray reflection is either weak or missing, indicating a high degree of preferred orientation. Thin film solid state batteries with these textured cathode films can deliver practical capacities at high current densities. For example, for one of the cells, 70% of the maximum capacity between 4.2 and 3 V (approximately 0.2 mAh/cm2) was delivered at a current of 2 mA/cm2. When cycled at rates of 0.1 mA/cm2, the capacity loss was < or = 0.001%/cycle. The reliability and performance of Li-LiCoO2 thin film batteries make them attractive for application in implantable devices such as neural stimulators, pacemakers, and defibrillators.

  18. Experimenting with microbial fuel cells for powering implanted biomedical devices.

    PubMed

    Roxby, Daniel N; Nham Tran; Pak-Lam Yu; Nguyen, Hung T

    2015-08-01

    Microbial Fuel Cell (MFC) technology has the ability to directly convert sugar into electricity by using bacteria. Such a technology could be useful for powering implanted biomedical devices that require a surgery to replace their batteries every couple of years. In steps towards this, parameters such as electrode configuration, inoculation size, stirring of the MFC and single versus dual chamber reactor configuration were tested for their effect on MFC power output. Results indicate that a Top-Bottom electrode configuration, stirring and larger amounts of bacteria in single chamber MFCs, and smaller amounts of bacteria in dual chamber MFCs give increased power outputs. Finally, overall dual chamber MFCs give several fold larger MFC power outputs.

  19. Risk Factors Influencing Complications of Cardiac Implantable Electronic Device Implantation: Infection, Pneumothorax and Heart Perforation

    PubMed Central

    Lin, Yu-Sheng; Hung, Sheng-Ping; Chen, Pei-Rung; Yang, Chia-Hung; Wo, Hung-Ta; Chang, Po-Cheng; Wang, Chun-Chieh; Chou, Chung-Chuan; Wen, Ming-Shien; Chung, Chang-Ming; Chen, Tien-Hsing

    2014-01-01

    Abstract As the number of cardiac implantable electronic devices (CIEDs) is increasing annually, CIED-related complications are becoming increasingly important. The aim of the study was to assess the risks associated with CIEDs by a nationwide database. Patients were selected from the Taiwan National Health Insurance Database. Admissions for CIED implantation, replacement, and revision were evaluated and the evaluation period was 14 years. Endpoints included CIED-related infection, pneumothorax, and heart perforation. The study included 40,608 patients with a mean age of 71.8 ± 13.3 years. Regarding infection, the incidence rate was 2.45 per 1000 CIED-years. Male gender, younger age, device replacement, and previous infection were risks for infection while old age and high-volume centers (>200 per year) were protectors. The incidence of pneumothorax was 0.6%, with an increased risk in individuals who had chronic obstructive lung disease (COPD) and cardiac resynchronized therapy (CRT). The incidence of heart perforation was 0.09%, with an increased risk in individuals who had pre-operation temporal pacing and steroid use. High-volume center was found to decrease infection rate while male gender, young people, and individuals who underwent replacements were associated with an increased risk of infection. Additionally, pre-operation temporal pacing and steroid use should be avoided if possible. Furthermore, COPD patients or those who accept CRTs should be monitored closely. PMID:25501080

  20. Sequential bilateral cochlear implantation in children: parents' perspective and device use.

    PubMed

    Sparreboom, Marloes; Leeuw, A Rens; Snik, Ad F M; Mylanus, Emmanuel A M

    2012-03-01

    The purpose of this study was (1) to measure parental expectations before surgery of a sequentially placed second cochlear implant and compare these results with parental observations postoperatively and (2) to measure device use of the second cochlear implant and compare to unilateral implant use. Thirty prelingually deaf children with a unilateral cochlear implant (mean age at first implant 1.8 years) received a second implant at a mean age of 5.3 years. To measure parental expectations and observations, parents completed the Parents' Perspective before surgery of the second implant and after 12 and 24 months. The questionnaire included 1 additional question on sound localization. Device use of both the first and second implants was assessed retrospectively after 6, 12 and 24 months of implant use. Device use of the study group was also compared to a reference group of 30 unilateral implant users matched for age at second implantation. Parental expectations with regard to sound localization were significantly higher than the observed changes within the first year of bilateral implant use. The observed changes in communication, listening to speech without lipreading, and speech and language skills met or surpassed parental expectations. Irrespective of age at second implantation, the second implant was significantly less worn than the first implant. No significant difference was observed between the use of the second implant of the study group and device use of the reference group. Second implant use was significantly correlated with the difference in speech recognition between the 2 implants alone. Preoperative parental expectations were too high with regard to the observed localization skills within the first year of bilateral implant use. The study showed that several of these sequentially implanted children had more difficulties in wearing the second implant than in wearing the first implant during the rehabilitation period. The present results suggest that

  1. From micro- to nanostructured implantable device for local anesthetic delivery.

    PubMed

    Zorzetto, Laura; Brambilla, Paola; Marcello, Elena; Bloise, Nora; De Gregori, Manuela; Cobianchi, Lorenzo; Peloso, Andrea; Allegri, Massimo; Visai, Livia; Petrini, Paola

    2016-01-01

    Local anesthetics block the transmission of painful stimuli to the brain by acting on ion channels of nociceptor fibers, and find application in the management of acute and chronic pain. Despite the key role they play in modern medicine, their cardio and neurotoxicity (together with their short half-life) stress the need for developing implantable devices for tailored local drug release, with the aim of counterbalancing their side effects and prolonging their pharmacological activity. This review discusses the evolution of the physical forms of local anesthetic delivery systems during the past decades. Depending on the use of different biocompatible materials (degradable polyesters, thermosensitive hydrogels, and liposomes and hydrogels from natural polymers) and manufacturing processes, these systems can be classified as films or micro- or nanostructured devices. We analyze and summarize the production techniques according to this classification, focusing on their relative advantages and disadvantages. The most relevant trend reported in this work highlights the effort of moving from microstructured to nanostructured systems, with the aim of reaching a scale comparable to the biological environment. Improved intracellular penetration compared to microstructured systems, indeed, provides specific drug absorption into the targeted tissue and can lead to an enhancement of its bioavailability and retention time. Nanostructured systems are realized by the modification of existing manufacturing processes (interfacial deposition and nanoprecipitation for degradable polyester particles and high- or low-temperature homogenization for liposomes) or development of novel strategies (electrospun matrices and nanogels). The high surface-to-volume ratio that characterizes nanostructured devices often leads to a burst drug release. This drawback needs to be addressed to fully exploit the advantage of the interaction between the target tissues and the drug: possible strategies

  2. Electromagnetic interference of endodontic equipments with cardiovascular implantable electronic device.

    PubMed

    Dadalti, Manoela Teixeira de Sant'Anna; da Cunha, Antônio José Ledo Alves; de Araújo, Marcos César Pimenta; de Moraes, Luis Gustavo Belo; Risso, Patrícia de Andrade

    2016-03-01

    Assess the electromagnetic interference (EMI) of endodontic equipment with cardiovascular implantable electronic devices (CIEDs) and related factors. The laser device, electronic apex locators (EAL), optical microscope, endodontic rotary motors, gutta-percha heat carrier (GH), gutta-percha gun and ultrasonic device were tested next to CIEDs (Medtronic and Biotronik) with varied sensitivity settings and distances. CIEDs were immersed in a saline solution to simulate the electrical resistence of the human body. The endodontic equipment was tested in both horizontal and vertical positions in relation to the components of the CIED. The tests were performed on a dental chair in order to assess the cumulative effect of electromagnetic fields. It was found no EMI with the Biotronik pacemaker. EALs caused EMI with Medtronic PM at a 2 cm distance, with the NSK(®) EAL also affecting the Medtronic defibrillator. GH caused EMI at 2 cm and 5 cm from the Medtronic defibrillator. EMI occurred when devices were horizontally positioned to the CIED. In the majority of the cases, EMI occurred when the pacemaker was set to maximum sensitivity. There was cumulative effect of electromagnetic fields between GH and dental chair. EALs and GH caused EMI which ranged according to type and sensitivity setting of the CIEDs and the distance. However, no endodontic equipment caused permanent damage to the CIED. The use of GH caused a cumulative effect of electromagnetic fields. It suggests that during the treatment of patients with CIEDs, only the necessary equipments should be kept turned on. Patients with CIEDs may be subject to EMI from electronic equipment used in dental offices, as they remain turned on throughout the treatment. This is the first article assessing the cumulative effect of electromagnetic fields. Copyright © 2016. Published by Elsevier Ltd.

  3. From micro- to nanostructured implantable device for local anesthetic delivery

    PubMed Central

    Zorzetto, Laura; Brambilla, Paola; Marcello, Elena; Bloise, Nora; De Gregori, Manuela; Cobianchi, Lorenzo; Peloso, Andrea; Allegri, Massimo; Visai, Livia; Petrini, Paola

    2016-01-01

    Local anesthetics block the transmission of painful stimuli to the brain by acting on ion channels of nociceptor fibers, and find application in the management of acute and chronic pain. Despite the key role they play in modern medicine, their cardio and neurotoxicity (together with their short half-life) stress the need for developing implantable devices for tailored local drug release, with the aim of counterbalancing their side effects and prolonging their pharmacological activity. This review discusses the evolution of the physical forms of local anesthetic delivery systems during the past decades. Depending on the use of different biocompatible materials (degradable polyesters, thermosensitive hydrogels, and liposomes and hydrogels from natural polymers) and manufacturing processes, these systems can be classified as films or micro- or nanostructured devices. We analyze and summarize the production techniques according to this classification, focusing on their relative advantages and disadvantages. The most relevant trend reported in this work highlights the effort of moving from microstructured to nanostructured systems, with the aim of reaching a scale comparable to the biological environment. Improved intracellular penetration compared to microstructured systems, indeed, provides specific drug absorption into the targeted tissue and can lead to an enhancement of its bioavailability and retention time. Nanostructured systems are realized by the modification of existing manufacturing processes (interfacial deposition and nanoprecipitation for degradable polyester particles and high- or low-temperature homogenization for liposomes) or development of novel strategies (electrospun matrices and nanogels). The high surface-to-volume ratio that characterizes nanostructured devices often leads to a burst drug release. This drawback needs to be addressed to fully exploit the advantage of the interaction between the target tissues and the drug: possible strategies

  4. Implantation technique of the CentriMag biventricular assist device allowing ambulatory rehabilitation.

    PubMed

    Takayama, Hiroo; Chen, Jonathan M; Jorde, Ulrich P; Naka, Yoshifumi

    2011-02-01

    Non-implantable ventricular assist device plays a major role in emergent or urgent situation where a patient has acutely decompensating hemodynamics. One of its major disadvantages is that the patient needs to be bed-bound after insertion. We have developed a surgical technique that allows ambulatory management of the patients who received non-implantable device with CentriMag.

  5. 21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Classification of implants, life-supporting or life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a)...

  6. 21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Classification of implants, life-supporting or life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a)...

  7. 21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Classification of implants, life-supporting or life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a)...

  8. 21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Classification of implants, life-supporting or life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a)...

  9. Ion implantation in compound semiconductors for high-performance electronic devices

    SciTech Connect

    Zolper, J.C.; Baca, A.G.; Sherwin, M.E.; Klem, J.F.

    1996-05-01

    Advanced electronic devices based on compound semiconductors often make use of selective area ion implantation doping or isolation. The implantation processing becomes more complex as the device dimensions are reduced and more complex material systems are employed. The authors review several applications of ion implantation to high performance junction field effect transistors (JFETs) and heterostructure field effect transistors (HFETs) that are based on compound semiconductors, including: GaAs, AlGaAs, InGaP, and AlGaSb.

  10. Implantation reduces the negative effects of bio-logging devices on birds.

    PubMed

    White, Craig R; Cassey, Phillip; Schimpf, Natalie G; Halsey, Lewis G; Green, Jonathan A; Portugal, Steven J

    2013-02-15

    Animal-borne logging or telemetry devices are widely used for measurements of physiological and movement data from free-living animals. For such measurements to be relevant, however, it is essential that the devices themselves do not affect the data of interest. A recent meta-analysis reported an overall negative effect of these devices on the birds that bear them, i.e. on nesting productivity, clutch size, nest initiation date, offspring quality, body condition, flying ability, foraging behaviours, energy expenditure and survival rate. Method of attachment (harness, collar, glue, anchor, implant, breast-mounted or tailmount) had no influence on the strength of these effects but anchored and implanted transmitters had the highest reported rates of device-induced mortality. Furthermore, external devices, but not internal devices, caused an increase in 'device-induced behaviour' (comfort behaviours such as preening, fluffing and stretching, and unrest activities including unquantifiable 'active' behaviours). These findings suggest that, with the exception of device-induced behaviour, external attachment is preferable to implantation. In the present study we undertake a meta-analysis of 183 estimates of device impact from 39 studies of 36 species of bird designed to explicitly compare the effects of externally attached and surgically implanted devices on a range of traits, including condition, energy expenditure and reproduction. In contrast to a previous study, we demonstrate that externally attached devices have a consistent detrimental effect (i.e. negative influences on body condition, reproduction, metabolism and survival), whereas implanted devices have no consistent effect. We also show that the magnitude of the negative effect of externally attached devices decreases with time. We therefore conclude that device implantation is preferable to external attachment, providing that the risk of mortality associated with the anaesthesia and surgery required for

  11. Electronic security systems and active implantable medical devices.

    PubMed

    Irnich, Werner

    2002-08-01

    How do active implantable medical devices react in the presence of strong magnetic fields in the frequency range between extremely low frequency (ELF) to radiofrequency (RF) as they are emitted by electronic security systems (ESS)? There are three different sorts of ESSs: electronic article surveillance (EAS) devices, metal detector (MDS) devices, and radiofrequency identification (RFID) systems. Common to all is the production of magnetic fields. There is an abundance of literature concerning interference by ESS gates with respect to if there is an influence possible and if such an influence can bear a risk for the AIMD wearers. However, there has been no attempt to study the physical mechanism nor to develop a model of how and under which conditions magnetic fields can influence pacemakers and defibrillators and how they could be disarmed by technological means. It is too often assumed that interference of AIMD with ESS is inevitable. Exogenous signals of similar intensity and rhythm to heart signals can be misinterpreted and, thus, confuse the implant. Important for the interference coupling mechanism is the differentiation between a "unipolar" and a "bipolar" system. With respect to magnetic fields, the left side implanted pacemaker is the most unfavorable case as the lead forms approximately a semicircular area of maximum 225 cm2 into which a voltage can be induced. This assumption yields an interference coupling model that can be expressed by simple mathematics. The worst-case conditions for induced interference voltages are a coupling area of 225 cm2 that is representative for a large human, a homogeneous magnetic field perpendicular to the area formed by the lead, and a unipolar ventricular pacemaker system that is implanted on the left side of the thorax and has the highest interference sensitivity. In bipolar systems the fields must be 17 times larger when compared to a unipolar system to have the same effect. The magnetic field for interfering with ICDs

  12. Changes in Spirometry After Left Ventricular Assist Device Implantation.

    PubMed

    Mohamedali, Burhan; Bhat, Geetha; Yost, Gardner; Tatooles, Antone

    2015-12-01

    Left ventricular assist devices (LVADs) are increasingly being used as life-saving therapy in patients with end-stage heart failure. The changes in spirometry following LVAD implantation and subsequent unloading of the left ventricle and pulmonary circulation are unknown. In this study, we explored long-term changes in spirometry after LVAD placement. In this retrospective study, we compared baseline preoperative pulmonary function test (PFT) results to post-LVAD spirometric measurements. Our results indicated that pulmonary function tests were significantly reduced after LVAD placement (forced expiratory volume in one second [FEV1 ]: 1.9 vs.1.7, P = 0.016; forced vital capacity [FVC]: 2.61 vs. 2.38, P = 0.03; diffusing capacity of the lungs for carbon monoxide [DLCO]: 14.75 vs. 11.01, P = 0.01). Subgroup analysis revealed greater impairment in lung function in patients receiving HeartMate II (Thoratec, Pleasanton, CA, USA) LVADs compared with those receiving HeartWare (HeartWare, Framingham, MA, USA) devices. These unexpected findings may result from restriction of left anterior hemi-diaphragm; however, further prospective studies to validate our findings are warranted.

  13. 21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE CLASSIFICATION PROCEDURES Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a)...

  14. 21 CFR 876.5280 - Implanted mechanical/hydraulic urinary continence device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted mechanical/hydraulic urinary continence device. 876.5280 Section 876.5280 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Therapeutic Devices § 876...

  15. 21 CFR 876.5280 - Implanted mechanical/hydraulic urinary continence device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted mechanical/hydraulic urinary continence device. 876.5280 Section 876.5280 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Therapeutic Devices § 876...

  16. An analysis of implantable cardiac device reliability. The case for improved postmarketing risk assessment and surveillance.

    PubMed

    Laskey, Warren; Awad, Khaled; Lum, Jeremy; Skodacek, Ken; Zimmerman, Barbara; Selzman, Kimberly; Zuckerman, Bram

    2012-07-01

    Implantable cardiac devices have become the mainstay of the treatment of patients with heart disease. However, data regarding their reliability and, inferentially, safety have been called into question. We reviewed annual reports submitted to the Food and Drug Administration Office of Device Evaluation by device manufacturers from 2003 to 2007. The annual number of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillator (CRT-D) implants, explants, and returned devices were tabulated along with the cumulative (Cum) number of implants for each device. We derived an annual explantation rate (AER) defined as the ratio of the annual number of explants less the number of normal battery depletions/Cum (×1000). From 2003 to 2007, 256,392 CRT-D and 459,300 ICD devices were implanted in the United States. The overall mean (±SD) AERs for ICD and CRT-D devices were, respectively, 49.5 (15.6) per 1000 ICD devices and 82.6 (35.5) per 1000 CRT-D devices. The AER for each device type significantly decreased over the study period (P for trend <0.001) although the AER for CRT-D devices was 38% higher than that for ICD devices (P < 0.001). On average, 20.3% of CRT-D devices and 22.6% of ICD devices were returned to the manufacturer for analysis after explantation. The rates of explanted CRT-D and ICD devices decreased from 2003 to 2007. Notwithstanding this favorable trend, the AER for CRT-D devices was higher than that for ICD devices. Improved methods for tracking individual device histories are needed for more precise estimates of the risk of device explantation for suspected malfunction. The proportion of devices returned to the manufacturer is suboptimal and needs to be improved to better understand the mechanisms of device malfunction.

  17. Percutaneous Endovascular Salvage Techniques for Implanted Venous Access Device Dysfunction

    SciTech Connect

    Breault, Stéphane; Glauser, Frédéric; Babaker, Malik Doenz, Francesco Qanadli, Salah Dine

    2015-06-15

    PurposeImplanted venous access devices (IVADs) are often used in patients who require long-term intravenous drug administration. The most common causes of device dysfunction include occlusion by fibrin sheath and/or catheter adherence to the vessel wall. We present percutaneous endovascular salvage techniques to restore function in occluded catheters. The aim of this study was to evaluate the feasibility, safety, and efficacy of these techniques.Methods and MaterialsThrough a femoral or brachial venous access, a snare is used to remove fibrin sheath around the IVAD catheter tip. If device dysfunction is caused by catheter adherences to the vessel wall, a new “mechanical adhesiolysis” maneuver was performed. IVAD salvage procedures performed between 2005 and 2013 were analyzed. Data included clinical background, catheter tip position, success rate, recurrence, and rate of complication.ResultsEighty-eight salvage procedures were performed in 80 patients, mostly women (52.5 %), with a mean age of 54 years. Only a minority (17.5 %) of evaluated catheters were located at an optimal position (i.e., cavoatrial junction ±1 cm). Mechanical adhesiolysis or other additional maneuvers were used in 21 cases (24 %). Overall technical success rate was 93.2 %. Malposition and/or vessel wall adherences were the main cause of technical failure. No complications were noted.ConclusionThese IVAD salvage techniques are safe and efficient. When a catheter is adherent to the vessel wall, mechanical adhesiolysis maneuvers allow catheter mobilization and a greater success rate with no additional risk. In patients who still require long-term use of their IVAD, these procedures can be performed safely to avoid catheter replacement.

  18. Surgical outcomes of superior versus inferior glaucoma drainage device implantation

    PubMed Central

    Martino, Amy Z.; Iverson, Shawn; Feuer, William J.; Greenfield, David S.

    2013-01-01

    Purpose To compare the safety and intraocular pressure (IOP) lowering efficacy of initial glaucoma drainage device (GDD) implantation performed at the superior versus inferior limbus. Methods A retrospective chart review was conducted to identify glaucoma patients that had undergone initial Baerveldt GDD surgery at the inferior limbus for uncontrolled IOP. All eyes had a minimum of 6 months of postoperative follow-up. These eyes were frequency matched to eyes with initial Baerveldt GDD implantation performed at the superior limbus to within 5 years of age and 6 months of follow-up. Baseline demographic and clinical information, as well as preoperative and postoperative IOP, visual acuity, and number of anti-glaucoma medications were extracted. Failure was defined as IOP > 21 mmHg or not reduced by 20% below baseline on two consecutive follow-up visits after 3 months, IOP ≤ 5 mmHg on two consecutive follow-up visits after 3 months, reoperation for glaucoma, or loss of light perception vision. Statistical methods consisted of Student's t-tests, chi-squared test, and Kaplan-Meier time to failure analysis. Results Fifty eyes (17 inferior, 33 superior) of 43 patients were enrolled. Mean postoperative follow-up in both groups were similar (mean 26.2 ± 15.2 for inferior and 23.9 ± 10.43 months for superior, p=0.54). Prior trabeculectomy had been performed in 8/17 (47%) and 11/33 (33%) eyes (p=0.34) with inferior and superior implants, respectively. Mean preoperative IOP (mmHg) in the superior group (26 ± 11) was significantly higher (p=0.02) than in the inferior group (21 ± 7). Success rates were similar (p>0.05) between the inferior and superior GDD groups during the study period, with 64.7% and 75.8% classified as successful at 1-year of follow-up and 43.1% and 65.7% at 2-years of follow-up, respectively. There was no difference in cumulative proportions of eyes failing between the groups (p=0.20, log-rank test). Mean postoperative IOP and number of anti

  19. Assessment of more than 1,000 implanted percutaneous bone conduction devices: skin reactions and implant survival.

    PubMed

    Dun, Catharina A J; Faber, Hubert T; de Wolf, Maarten J F; Mylanus, Emmanuel A M; Cremers, Cor W R J; Hol, Myrthe K S

    2012-02-01

    This study assesses soft tissue reactions and implant stability of 1,132 percutaneous titanium implants (970 patients) for bone conduction devices (BCDs). In addition, it examines BCD usage and comparisons between different patient groups. Retrospective survey. Mean follow-up time of 4.6 years. Tertiary care referral center. The surveyed cohort was divided into 3 different age groups (children, adults, and the elderly). In addition, 4 groups with variable loading times (i.e., the time between placement of the implant and loading the BCD sound processor) were identified as well as a subgroup of patients with mental retardation. Soft tissue reactions around the percutaneous implants as classified by the Holgers grading system, implant failure, and revision surgery rates. In 95.5% of the 7,415 observations of 1,132 implants, there were no adverse soft tissue reactions. Implant loss was 8.3%. Significantly more soft tissue reactions and implant failures were observed in children compared with adults and the elderly (p < 0.05). Implant survival was lower in patients with mental retardation compared with patients without mental retardation (p = 0.001). The loading time did not influence the occurrence of soft tissue reactions and implant survival rates. Children and patients with mental retardation are the most vulnerable to soft tissue reactions and implant losses. Additional and more frequent care needs to be given during outpatient consultations. Because loading as early as 3 to 5 weeks did not negatively affect skin reactions or implant survival, full BCD installation can occur earlier without risk.

  20. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark

    PubMed Central

    Kirkfeldt, Rikke Esberg; Johansen, Jens Brock; Nohr, Ellen Aagaard; Jørgensen, Ole Dan; Nielsen, Jens Cosedis

    2014-01-01

    Aims Complications after cardiac implantable electronic device (CIED) treatment, including permanent pacemakers (PMs), cardiac resynchronization therapy devices with defibrillators (CRT-Ds) or without (CRT-Ps), and implantable cardioverter defibrillators (ICDs), are associated with increased patient morbidity, healthcare costs, and possibly increased mortality. Methods and results Population-based cohort study in all Danish patients who underwent a CIED procedure from May 2010 to April 2011. Data on complications were gathered on review of all patient charts while baseline data were obtained from the Danish Pacemaker and ICD Register. Adjusted risk ratios (aRRs) with 95% confidence intervals were estimated using binary regression. The study population consisted of 5918 consecutive patients. A total of 562 patients (9.5%) experienced at least one complication. The risk of any complication was higher if the patient was a female (aRR 1.3; 1.1–1.6), underweight (aRR 1.5; 1.1–2.3), implanted in a centre with an annual volume <750 procedures (0–249 procedures: aRR 1.6; 1.1–2.2, 250–499: aRR 2.0; 1.6–2.7, 500–749: aRR 1.5; 1.2–1.8), received a dual-chamber ICD (aRR 2.0; 1.4–2.7) or CRT-D (aRR 2.6; 1.9–3.4), underwent system upgrade or lead revision (aRR 1.3; 1.0–1.7), had an operator with an annual volume <50 procedures (aRR 1.9; 1.4–2.6), or underwent an emergency, out-of-hours procedure (aRR 1.5; 1.0–2.3). Conclusion CIED complications are more frequent than generally acknowledged. Both patient- and procedure-related predictors may identify patients with a particularly high risk of complications. This information should be taken into account both in individual patient treatment and in the planning of future organization of CIED treatment. PMID:24347317

  1. Smartphone-Based Electrocardiographic and Cardiac Implantable Electronic Device Monitoring.

    PubMed

    Mittal, Suneet

    The field of arrhythmia monitoring is changing rapidly. The rapid advent of technology in combination with marked improvements in cellular communication and an increased desire by patients to be actively engaged in their care has ushered in a new era of clinical care. Today, physicians need to think about their patients outside the traditional in-office setting. Two technologies that embody this changing landscape are smartphone-based electrocardiographic (ECG) monitors and remote monitoring of cardiac implantable electronic devices (CIEDs). Smartphone-based ECG monitors allow the patient to assume a greater stake in their own care. They purchase the monitor, couple it to their smartphone, own it forever, and can capture a representative ECG whenever they want to assess symptoms. The physician needs to accept that this approach is vastly different from the use of standard ambulatory external ECG monitors that have been used for years in clinical practice. A similar paradigm shift is underway with respect to the care of the CIED patient. Remote follow-up was once considered an acceptable alternative to in-office calendar-based follow-up of CIEDs. Today, guidelines recommend remote monitoring to be the preferred method for device follow-up. Remote monitoring is tailor-made for the current evolution to a value-based healthcare system, having been demonstrated to reduce scheduled office visits, hospital admissions, and mortality. It is now time to educate patients and physicians on the value of remote monitoring and to ensure that clinical practices develop the infrastructure needed to enroll, monitor, and manage their patients.

  2. Characterization of piezoelectric device for implanted pacemaker energy harvesting

    NASA Astrophysics Data System (ADS)

    Jay, Sunny; Caballero, Manuel; Quinn, William; Barrett, John; Hill, Martin

    2016-10-01

    Novel implanted cardiac pacemakers that are powered by energy harvesters driven by the cardiac motion and have a 40 year lifetime are currently under development. To satisfy space constraints and energy requirements of the device, silicon-based MEMS energy harvesters are being developed in the EU project (MANpower1). Such MEMS harvesters for vibration frequencies below 50 Hz have not been widely reported. In this paper, an analytical model and a 3D finite element model (FEM) to predict displacement and open circuit voltage, validated through experimental analysis using an off-the-shelf low frequency energy harvester, are presented. The harvester was excited through constant amplitude sinusoidal base displacement over a range of 20 to 70 Hz passing through its first mode natural frequency at 47 Hz. At resonance both models predict displacements with an error of less than 2% when compared to the experimental result. Comparing the two models, the application of the experimentally measured damping ratio differs for accurate displacement prediction and the differences in symmetry in the measured and modelled displacement and voltage data around the resonance frequency indicate the two piezoelectric voltage models use different fundamental equations.

  3. A device for vacuum drying, inert gas backfilling and solder sealing of hermetic implant packages.

    PubMed

    Schuettler, Martin; Huegle, Matthias; Ordonez, Juan S; Wilde, Juergen; Stieglitz, Thomas

    2010-01-01

    Modern implanted devices utilize microelectronics that have to be protected from the body fluids in order to maintain their functionality over decades. Moisture protection of implants is addressed by enclosing the electronic circuits into gas-tight packages. In this paper we describe a device that allows custom-built hermetic implant packages to be vacuum-dried (removing residual moisture from inside the package), backfilled with an inert gas at adjustable pressure and hermetically sealed employing a solder seal. A typical operation procedure of the device is presented.

  4. Comparative ex vivo evaluation of two electronic percussive testing devices measuring the stability of dental implants.

    PubMed

    Geckili, Onur; Bilhan, Hakan; Cilingir, Altug; Bilmenoglu, Caglar; Ates, Gokcen; Urgun, Aliye Ceren; Bural, Canan

    2014-12-01

    A comparative ex vivo study was performed to determine electronic percussive test values (PTVs) measured by cabled and wireless electronic percussive testing (EPT) devices and to evaluate the intra- and interobserver reliability of the wireless EPT device. Forty implants were inserted into the vertebrae and forty into the pelvis of a steer, a safe distance apart. The implants were all 4.3 mm wide and 13 mm long, from the same manufacturer. PTV of each implant was measured by four different examiners, using both EPT devices, and compared. Additionally, the intra- and interobserver reliability of the wireless EPT device was evaluated. Statistically significant differences (P <0.05) were observed between PTVs made by the two EPT devices. PTVs measured by the wireless EPT device were significantly higher than the cabled EPT device (P <0.05), indicating lower implant stability. The intraobserver reliability of the wireless EPT device was evaluated as excellent for the measurements in type II bone and good-to-excellent in type IV bone; interobserver reliability was evaluated as fair-to-good in both bone types. The wireless EPT device gives PTVs higher than the cabled EPT device, indicating lower implant stability, and its inter- and intraobserver reliability is good and acceptable.

  5. High drug-loading nanomedicines: progress, current status, and prospects

    PubMed Central

    Shen, Shihong; Wu, Youshen; Liu, Yongchun; Wu, Daocheng

    2017-01-01

    Drug molecules transformed into nanoparticles or endowed with nanostructures with or without the aid of carrier materials are referred to as “nanomedicines” and can overcome some inherent drawbacks of free drugs, such as poor water solubility, high drug dosage, and short drug half-life in vivo. However, most of the existing nanomedicines possess the drawback of low drug-loading (generally less than 10%) associated with more carrier materials. For intravenous administration, the extensive use of carrier materials might cause systemic toxicity and impose an extra burden of degradation, metabolism, and excretion of the materials for patients. Therefore, on the premise of guaranteeing therapeutic effect and function, reducing or avoiding the use of carrier materials is a promising alternative approach to solve these problems. Recently, high drug-loading nanomedicines, which have a drug-loading content higher than 10%, are attracting increasing interest. According to the fabrication strategies of nanomedicines, high drug-loading nanomedicines are divided into four main classes: nanomedicines with inert porous material as carrier, nanomedicines with drug as part of carrier, carrier-free nanomedicines, and nanomedicines following niche and complex strategies. To date, most of the existing high drug-loading nanomedicines belong to the first class, and few research studies have focused on other classes. In this review, we investigate the research status of high drug-loading nanomedicines and discuss the features of their fabrication strategies and optimum proposal in detail. We also point out deficiencies and developing direction of high drug-loading nanomedicines. We envision that high drug-loading nanomedicines will occupy an important position in the field of drug-delivery systems, and hope that novel perspectives will be proposed for the development of high drug-loading nanomedicines. PMID:28615938

  6. Electromagnetic interference caused by common surgical energy-based devices on an implanted cardiac defibrillator.

    PubMed

    Paniccia, Alessandro; Rozner, Marc; Jones, Edward L; Townsend, Nicole T; Varosy, Paul D; Dunning, James E; Girard, Guillaume; Weyer, Christopher; Stiegmann, Gregory V; Robinson, Thomas N

    2014-12-01

    Surgical energy-based devices emit energy, which can interfere with other electronic devices (eg, implanted cardiac pacemakers and/or defibrillators). The purpose of this study was to quantify the amount of unintentional energy (electromagnetic interference [EMI]) transferred to an implanted cardiac defibrillator by common surgical energy-based devices. A transvenous cardiac defibrillator was implanted in an anesthetized pig. The primary outcome measure was the average maximum EMI occurring on the implanted cardiac device during activations of multiple different surgical energy-based devices. The EMI transferred to the implanted cardiac device is as follows: traditional bipolar 30 W .01 ± .004 mV, advanced bipolar .004 ± .003 mV, ultrasonic shears .01 ± .004 mV, monopolar Bovie 30 W coagulation .50 ± .20 mV, monopolar Bovie 30 W blend .92 ± .63 mV, monopolar instrument without dispersive electrode .21 ± .07 mV, plasma energy 3.48 ± .78 mV, and argon beam coagulator 2.58 ± .34 mV. Surgeons can minimize EMI on implanted cardiac defibrillators by preferentially utilizing bipolar and ultrasonic devices. Copyright © 2014 Elsevier Inc. All rights reserved.

  7. Immediate postpartum intrauterine device and implant program outcomes: a prospective analysis.

    PubMed

    Eggebroten, Jennifer L; Sanders, Jessica N; Turok, David K

    2017-07-01

    In-hospital placement of intrauterine devices and contraceptive implants following vaginal and cesarean delivery is increasingly popular and responds to maternal motivation for highly effective postpartum contraception. Immediate postpartum intrauterine device insertion is associated with higher expulsion than interval placement, but emerging evidence suggests that the levonorgestrel intrauterine device may have a higher expulsion rate than the copper intrauterine device. This study evaluated in-hospital provision, expulsion, and 6-month continuation of immediate postpartum copper T380 intrauterine devices, levonorgestrel intrauterine devices, and contraceptive implants. We offered enrollment in this prospective observational trial to women presenting to the University of Utah labor and delivery unit from October 2013 through February 2016 who requested an intrauterine device or implant for postpartum contraception during prenatal care or hospitalization at the time of delivery. Following informed consent, participants completed questionnaires prior to hospital discharge and at 3 and 6 months postpartum. Data on expulsions at 6 months were validated by chart abstraction. During the study period, 639 patients requested a postpartum intrauterine device or implant and 350 patients enrolled in prospective follow-up prior to discharge from the hospital. Among enrollees, 325 (93%) received their preferred contraceptive device prior to hospital discharge: 88 (27%) copper intrauterine device users, 123 (38%) levonorgestrel intrauterine device users, and 114 (35%) implant users. Participants predominantly were Hispanic (90%), were multiparous (87%), reported a household income <$24,000 per year (87%), and underwent a vaginal delivery (77%). At 6 months postpartum, 289 of 325 device recipients (89%) completed follow-up. Among levonorgestrel intrauterine device users 17% reported expulsions relative to 4% of copper intrauterine device users. The adjusted hazard ratio for

  8. Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices.

    PubMed

    Zuckerman, Diana; Brown, Paul; Das, Aditi

    2014-11-01

    Under the 510(k) process, the US Food and Drug Administration (FDA) clears about 400 implanted medical devices that are considered moderate to high risk for market each year without requiring clinical testing. Instead, the FDA requires the applicant to provide scientific evidence that the new device is "substantially equivalent" to a device or devices already on the market (predicate devices). Companies are legally required to submit the evidence to the FDA and to make publicly available at least a summary of the evidence. To assess the types of scientific evidence used to determine substantial equivalence, safety, or effectiveness for a representative sample of implanted medical devices; the number of predicates for each implant; and whether this evidence was publicly available. Using FDA databases, we determined the device categories of the first 5 implanted medical devices cleared through the 510(k) process in 2008: cardiovascular, dental, general and plastic surgery, neurological, and orthopedic. We then identified the first 2 implanted medical devices approved in each of the 5 categories for each year from 2008 through 2012. The sample of 50 devices included, for example, total hip implants, vascular embolization devices, and surgical mesh. We also identified the 1105 predicates the manufacturers listed for these devices. For each implanted medical device and its predicates, we determined whether clinical or nonclinical scientific evidence was provided to the FDA to support the claim of substantial equivalence and whether this evidence was publicly available. We also determined if safety or effectiveness data were provided. Scientific data to support the claim of substantial equivalence were publicly available for 8 of the 50 newly cleared implants (16%) and 31 of their 1105 listed predicates (3%). Most of the evidence was nonclinical data; some of the data also evaluated safety or effectiveness. Despite the legal requirement that scientific evidence of

  9. Identification of causative organism in cardiac implantable electronic device infections.

    PubMed

    Fukunaga, Masato; Goya, Masahiko; Nagashima, Michio; Hiroshima, Kenichi; Yamada, Takashi; An, Yoshimori; Hayashi, Kentaro; Makihara, Yu; Ohe, Masatsugu; Ichihashi, Kei; Ohtsuka, Morimasa; Miyazaki, Hiroaki; Ando, Kenji

    2017-11-01

    The causative organism in cardiovascular implantable electronic device (CIED) infection is usually diagnosed with the cultures from blood, removed leads, and/or infected pocket material. The cultured organism, however, is sometimes different among these samples. Two hundred sixty patients with CIED infection, who underwent lead extraction between April 2005 and December 2014, were analyzed. More than two blood culture sets, all the extracted leads, and swab culture of the pocket were sent to the laboratory for culture. Among the patients all of whose microbiological examinations were available, we analyzed the causative organism defined as the species detected in at least two different sites. All the culture results were available in the 208 patients, showing 69 systemic infections (including 30 cases of infectious endocarditis) and 139 local infections. Blood culture, lead culture, and swab culture were positive in 57 (27%), 169 (81%), and 152 (73%), respectively. Staphylococcus aureus [37% including methicillin-resistant S. aureus (MRSA) (12%)] and coagulase-negative staphylococci (CoNS, 36%) were the most common causative organism, followed by non-staphylococci (23%), and poly-microbial infection (4%). The detection of S. aureus from pocket or removed leads rendered higher predictive value of a causative organism than that of CoNS. The detection of Gram-negative bacteria, fungi, and mycobacteria indicated that it was most likely a causative organism. Gram-positive bacteria excluding Staphylococcus, such as Corynebacterium spp., tended to coexist as a benign organism. The causative organism is mostly S. aureus and CoNS. Detection of S. aureus or Gram-negative bacteria means that it is more likely a causative organism. Copyright © 2017 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  10. Ethnic differences in atrial fibrillation identified using implanted cardiac devices.

    PubMed

    Lau, Chu-Pak; Gbadebo, T David; Connolly, Stuart J; Van Gelder, Isabelle C; Capucci, Alessandro; Gold, Michael R; Israel, Carsten W; Morillo, Carlos A; Siu, Chung-Wah; Abe, Haruhiko; Carlson, Mark; Tse, Hung-Fat; Hohnloser, Stefan H; Healey, Jeff S

    2013-04-01

    Atrial fibrillation (AF) is suggested to be less common among black and Asian individuals, which could reflect bias in symptom reporting and access to care. In the Asymptomatic AF and Stroke Evaluation in Pacemaker Patients and the AF Reduction Atrial Pacing Trial (ASSERT), patients with hypertension but no history of AF had AF recorded via an implanted pacemaker or defibrillator, thus allowing both symptomatic and asymptomatic AF incidence to be determined without ascertainment bias. The ASSERT enrolled 2,580 patients in 23 countries in North America, Europe, and Asia. AF was defined as device-recorded AF episodes >190/min, lasting either for >6 minutes or >6 hours in duration. All ethnic groups with >50 patients were enrolled. Ethnic groups studied include Europeans (n = 1900), black Africans (n = 73), Chinese (n = 89), and Japanese (n = 105) patients. Compared to Europeans, black Africans had more risk factors for AF such as heart failure (27.8 vs 14.6%) and diabetes (41.7 vs 26.3%). At 2.5 years follow-up, all 3 non-European races had a lower incidence of AF (8.3%, 10.1%, and 9.5% vs 18.0%, respectively, for AF>6 minutes, P < 0.006). When adjusted for baseline difference, Chinese had a lower incidence of AF > 6 minutes (P < 0.007), and Japanese and black Africans had a lower incidence of AF > 6 hours (P < 0.04 and P = 0.057, respectively). Black Africans, Chinese, and Japanese had lower incidence of AF compared to Europeans. In the case of black Africans, this is despite an increased prevalence of AF risk factors. © 2013 Wiley Periodicals, Inc.

  11. Implantable cardioverter defibrillator knowledge and end-of-life device deactivation: A cross-sectional survey.

    PubMed

    McEvedy, Samantha M; Cameron, Jan; Lugg, Eugene; Miller, Jennifer; Haedtke, Chris; Hammash, Muna; Biddle, Martha J; Lee, Kyoung Suk; Mariani, Justin A; Ski, Chantal F; Thompson, David R; Chung, Misook Lee; Moser, Debra K

    2017-06-01

    End-of-life implantable cardioverter defibrillator deactivation discussions should commence before device implantation and be ongoing, yet many implantable cardioverter defibrillators remain active in patients' last days. To examine associations among implantable cardioverter defibrillator knowledge, patient characteristics and attitudes to implantable cardioverter defibrillator deactivation. Cross-sectional survey using the Experiences, Attitudes and Knowledge of End-of-Life Issues in Implantable Cardioverter Defibrillator Patients Questionnaire. Participants were classified as insufficient or sufficient implantable cardioverter defibrillator knowledge and the two groups were compared. Implantable cardioverter defibrillator recipients ( n = 270, mean age 61 ± 14 years; 73% male) were recruited from cardiology and implantable cardioverter defibrillator clinics attached to two tertiary hospitals in Melbourne, Australia, and two in Kentucky, the United States. Participants with insufficient implantable cardioverter defibrillator knowledge ( n = 77, 29%) were significantly older (mean age 66 vs 60 years, p = 0.001), less likely to be Caucasian (77% vs 87%, p  = 0.047), less likely to have received implantable cardioverter defibrillator shocks (26% vs 40%, p = 0.031), and more likely to have indications of mild cognitive impairment (Montreal Cognitive Assessment score <24: 44% vs 16%, p < 0.001). Insufficient implantable cardioverter defibrillator knowledge was associated with attitudes suggesting unwillingness to discuss implantable cardioverter defibrillator deactivation, even during the last days towards end of life ( p < 0.05). Implantable cardioverter defibrillator recipients, especially those who are older or have mild cognitive impairment, often have limited knowledge about implantable cardioverter defibrillator deactivation. This study identified several potential teachable moments throughout the patients' treatment trajectory

  12. Implanting inequality: empirical evidence of social and ethical risks of implantable radio-frequency identification (RFID) devices.

    PubMed

    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.

  13. Kinetic and thermal energy harvesters for implantable medical devices and biomedical autonomous sensors

    NASA Astrophysics Data System (ADS)

    Cadei, Andrea; Dionisi, Alessandro; Sardini, Emilio; Serpelloni, Mauro

    2014-01-01

    Implantable medical devices usually require a battery to operate and this can represent a severe restriction. In most cases, the implantable medical devices must be surgically replaced because of the dead batteries; therefore, the longevity of the whole implantable medical device is determined by the battery lifespan. For this reason, researchers have been studying energy harvesting techniques from the human body in order to obtain batteryless implantable medical devices. The human body is a rich source of energy and this energy can be harvested from body heat, breathing, arm motion, leg motion or the motion of other body parts produced during walking or any other activity. In particular, the main human-body energy sources are kinetic energy and thermal energy. This paper reviews the state-of-art in kinetic and thermoelectric energy harvesters for powering implantable medical devices. Kinetic energy harvesters are based on electromagnetic, electrostatic and piezoelectric conversion. The different energy harvesters are analyzed highlighting their sizes, energy or power they produce and their relative applications. As they must be implanted, energy harvesting devices must be limited in size, typically about 1 cm3. The available energy depends on human-body positions; therefore, some positions are more advantageous than others. For example, favorable positions for piezoelectric harvesters are hip, knee and ankle where forces are significant. The energy harvesters here reported produce a power between 6 nW and 7.2 mW; these values are comparable with the supply requirements of the most common implantable medical devices; this demonstrates that energy harvesting techniques is a valid solution to design batteryless implantable medical devices.

  14. Nanotechnology and Long-Term Implantable Devices. Army Research Office Overview

    DTIC Science & Technology

    2007-10-24

    Nanotechnology and Long-Term Implantable Devices Army Research Office Overview 2007 TATRC IRT Dr. David M. Stepp Materials Science Division US Army...to comply with a collection of information if it does not display a currently valid OMB control number. 1. REPORT DATE 24 OCT 2007 2. REPORT TYPE 3...DATES COVERED 00-00-2007 to 00-00-2007 4 . TITLE AND SUBTITLE Nanotechnology and Long-Term Implantable Devices. Army Research Office Overview

  15. Internet-Based Device-Assisted Remote Monitoring of Cardiovascular Implantable Electronic Devices

    PubMed Central

    Pron, G; Ieraci, L; Kaulback, K

    2012-01-01

    Executive Summary Objective The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions. Clinical Need: Condition and Target Population Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD. Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities. Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs. Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however

  16. Improvement of device isolation using field implantation for GaN MOSFETs

    NASA Astrophysics Data System (ADS)

    Jiang, Ying; Wang, Qingpeng; Zhang, Fuzhe; Li, Liuan; Shinkai, Satoko; Wang, Dejun; Ao, Jin-Ping

    2016-03-01

    Gallium nitride (GaN) metal-oxide-semiconductor field-effect transistors (MOSFETs) with boron field implantation isolation and mesa isolation were fabricated and characterized. The process of boron field implantation was altered and subsequently conducted after performing high-temperature ohmic annealing and gate oxide thermal treatment. Implanted regions with high resistivity were achieved. The circular MOSFET fabricated in the implanted region showed an extremely low current of 6.5 × 10-12 A under a gate voltage value up to 10 V, thus demonstrating that the parasitic MOSFET in the isolation region was eliminated by boron field implantation. The off-state drain current of the rectangular MOSFET with boron field implantation was 5.5 × 10-11 A, which was only one order of magnitude higher than the 6.6 × 10-12 A of the circular device. By contrast, the rectangular MOSFET with mesa isolation presented an off-state drain current of 3.2 × 10-9 A. The field isolation for GaN MOSFETs was achieved by using boron field implantation. The implantation did not reduce the field-effect mobility. The isolation structure of both mesa and implantation did not influence the subthreshold swing, whereas the isolation structure of only the implantation increased the subthreshold swing. The breakdown voltage of the implanted region with 5 μm spacing was up to 901.5 V.

  17. Science and technology of biocompatible thin films for implantable biomedical devices.

    SciTech Connect

    Li, W.; Kabius, B.; Auciello, O.; Materials Science Division

    2010-01-01

    This presentation focuses on reviewing research to develop two critical biocompatible film technologies to enable implantable biomedical devices, namely: (1) development of bioinert/biocompatible coatings for encapsulation of Si chips implantable in the human body (e.g., retinal prosthesis implantable in the human eye) - the coating involves a novel ultrananocrystalline diamond (UNCD) film or hybrid biocompatible oxide/UNCD layered films; and (2) development of biocompatible films with high-dielectric constant and microfabrication process to produce energy storage super-capacitors embedded in the microchip to achieve full miniaturization for implantation into the human body.

  18. National projections of time, cost and failure in implantable device identification: Consideration of unique device identification use.

    PubMed

    Wilson, Natalia; Broatch, Jennifer; Jehn, Megan; Davis, Charles

    2015-12-01

    U.S. health care is responding to significant regulation and meaningful incentives for higher quality care, patient safety, electronic documentation and data exchange. FDA's Unique Device Identification (UDI) Rule, a relatively new regulation aligned with these goals, requires standard labeling of medical devices by manufacturers. This lays the foundation for UDI scanning and documentation in the electronic health record, expected to change the landscape of medical device identification and postmarket surveillance. We developed national projections for time, cost and failure in implant identification prior to revision total hip and knee arthroplasty (THA/TKA) using American Association of Hip and Knee Surgeons 2012 membership survey data, Nationwide Inpatient Sample 2011 data and THA/TKA demand projection data. Our projections suggest that cumulative surgeon time spent identifying failed implants could reach 133,000 h in 2030, representing opportunity to perform over 500,000 15 min established patient office visits. Staff time could reach 220,000 h with a cost of $3.3m. Failed implants that cannot be identified may be greater than 50,000 preoperatively and 25,000 intraoperatively in 2030. Study projections indicate significant time, cost and inability to identify failed implants, supporting need for improvement of implant documentation. FDA's UDI Rule sets the foundation for UDI scanning and documentation in the electronic health record, a process poised to serve as the standard system for device documentation. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. Implantable device for in-vivo intracranial and cerebrospinal fluid pressure monitoring

    DOEpatents

    Ericson, Milton N.; McKnight, Timothy E.; Smith, Stephen F.; Hylton, James O.

    2003-01-01

    The present invention relates to a completely implantable intracranial pressure monitor, which can couple to existing fluid shunting systems as well as other internal monitoring probes. The implant sensor produces an analog data signal which is then converted electronically to a digital pulse by generation of a spreading code signal and then transmitted to a location outside the patient by a radio-frequency transmitter to an external receiver. The implanted device can receive power from an internal source as well as an inductive external source. Remote control of the implant is also provided by a control receiver which passes commands from an external source to the implant system logic. Alarm parameters can be programmed into the device which are capable of producing an audible or visual alarm signal. The utility of the monitor can be greatly expanded by using multiple pressure sensors simultaneously or by combining sensors of various physiological types.

  20. Critical problems of ion implantation in processing small geometry integrated devices

    NASA Astrophysics Data System (ADS)

    Tokuyama, Takashi

    1989-02-01

    A brief review is described on the critical problems of ion implantation in processing small geometry integrated devices. The commonly recognized critical paths of the technology, i.e. formation of shallow junctions, impurity doping of vertical side walls, shadowing and the scattering effect of the incident beam are discussed based on recent data. Discussion is also given of the annealing behavior and residual defects of small and isolated implanted regions, and the considerable difference from those of the continuous implanted layers is shown. These problems are more or less related to the fundamental principles of implantation that impurities are doped by the incidence of energetic ions. Based on these facts, attempts are made to estimate the final size of the future devices to which implantation can be applied.

  1. Nanomaterials and synergistic low intensity direct current (LIDC) stimulation technology for orthopaedic implantable medical devices

    PubMed Central

    Samberg, Meghan E.; Cohen, Paul H.; Wysk, Richard A.; Monteiro-Riviere, Nancy A.

    2012-01-01

    Nanomaterials play a significant role in biomedical research and applications due to their unique biological, mechanical, and electrical properties. In recent years, they have been utilised to improve the functionality and reliability of a wide range of implantable medical devices ranging from well-established orthopaedic residual hardware devices (e.g. hip implants) that can repair defects in skeletal systems to emerging tissue engineering scaffolds that can repair or replace organ functions. This review summarizes the applications and efficacies of these nanomaterials that include synthetic or naturally occurring metals, polymers, ceramics, and composites in orthopaedic implants, the largest market segment of implantable medical devices. The importance of synergistic engineering techniques that can augment or enhance the performance of nanomaterial applications in orthopaedic implants is also discussed,, the focus being on a low intensity direct electric current (LIDC) stimulation technology to promote the long-term antibacterial efficacy of oligodynamic metal-based surfaces by ionization, while potentially accelerating tissue growth and osseointegration. While many nanomaterials have clearly demonstrated their ability to provide more effective implantable medical surfaces, further decisive investigations are necessary before they can translate into medically safe and commercially viable clinical applications. The paper concludes with a discussion about some of the critical impending issues with the application of nanomaterials-based technologies in implantable medical devices, and potential directions to address these. PMID:23335493

  2. Nanomaterials and synergistic low-intensity direct current (LIDC) stimulation technology for orthopedic implantable medical devices.

    PubMed

    Shirwaiker, Rohan A; Samberg, Meghan E; Cohen, Paul H; Wysk, Richard A; Monteiro-Riviere, Nancy A

    2013-01-01

    Nanomaterials play a significant role in biomedical research and applications because of their unique biological, mechanical, and electrical properties. In recent years, they have been utilized to improve the functionality and reliability of a wide range of implantable medical devices ranging from well-established orthopedic residual hardware devices (e.g., hip implants) that can repair defects in skeletal systems to emerging tissue engineering scaffolds that can repair or replace organ functions. This review summarizes the applications and efficacies of these nanomaterials that include synthetic or naturally occurring metals, polymers, ceramics, and composites in orthopedic implants, the largest market segment of implantable medical devices. The importance of synergistic engineering techniques that can augment or enhance the performance of nanomaterial applications in orthopedic implants is also discussed, the focus being on a low-intensity direct electric current (LIDC) stimulation technology to promote the long-term antibacterial efficacy of oligodynamic metal-based surfaces by ionization, while potentially accelerating tissue growth and osseointegration. While many nanomaterials have clearly demonstrated their ability to provide more effective implantable medical surfaces, further decisive investigations are necessary before they can translate into medically safe and commercially viable clinical applications. The article concludes with a discussion about some of the critical impending issues with the application of nanomaterials-based technologies in implantable medical devices, and potential directions to address these. Copyright © 2013 Wiley Periodicals, Inc.

  3. Implantation of a newly developed direct optic nerve electrode device for artificial vision in rabbits.

    PubMed

    Sakaguchi, Hirokazu; Kamei, Motohiro; Nishida, Kentaro; Terasawa, Yasuo; Fujikado, Takashi; Ozawa, Motoki; Nishida, Kohji

    2012-09-01

    The purpose of this study was to investigate the surgical procedures involved in the implantation of a newly developed direct optic nerve electrode device for inducing artificial vision. The electrode device comprised seven wire stimulation electrodes and a return electrode (diameter 50 μm), one manipulation rod (diameter 100 μm), and a cylindrical silicone board (diameter 2.0 mm). The stimulation electrodes and the manipulation rod protruded through the board to allow implantation of the electrode tips into the optic disc of the rabbit eye. The surgical procedures required to insert the device into the vitreous cavity and implant the device into the optic disc were evaluated. When the electrodes were stimulated, electrically evoked potentials (EEPs) were recorded at the visual cortex. The electrode device was inserted into the vitreous cavity with no damage using a trocar through a scleral incision. The device was easily manipulated using vitreoretinal forceps in the vitreous cavity, and the electrode tips were implanted into the optic disc in a single insertion after vitrectomy. When electrical stimulation was applied, EEPs were recorded from all electrode pairs. The newly developed electrode device was inserted into the eye and implanted into the optic nerve disc smoothly and safely, suggesting that these surgical procedures are useful for our artificial vision system.

  4. Implantable Smart Technologies (IST): Defining the 'Sting' in Data and Device.

    PubMed

    Haddow, Gill; Harmon, Shawn H E; Gilman, Leah

    2016-09-01

    In a world surrounded by smart objects from sensors to automated medical devices, the ubiquity of 'smart' seems matched only by its lack of clarity. In this article, we use our discussions with expert stakeholders working in areas of implantable medical devices such as cochlear implants, implantable cardiac defibrillators, deep brain stimulators and in vivo biosensors to interrogate the difference facets of smart in 'implantable smart technologies', considering also whether regulation needs to respond to the autonomy that such artefacts carry within them. We discover that when smart technology is deconstructed it is a slippery and multi-layered concept. A device's ability to sense and transmit data and automate medicine can be associated with the 'sting' of autonomy being disassociated from human control as well as affecting individual, group, and social environments.

  5. Animal Models for Evaluation of Bone Implants and Devices: Comparative Bone Structure and Common Model Uses.

    PubMed

    Wancket, L M

    2015-09-01

    Bone implants and devices are a rapidly growing field within biomedical research, and implants have the potential to significantly improve human and animal health. Animal models play a key role in initial product development and are important components of nonclinical data included in applications for regulatory approval. Pathologists are increasingly being asked to evaluate these models at the initial developmental and nonclinical biocompatibility testing stages, and it is important to understand the relative merits and deficiencies of various species when evaluating a new material or device. This article summarizes characteristics of the most commonly used species in studies of bone implant materials, including detailed information about the relevance of a particular model to human bone physiology and pathology. Species reviewed include mice, rats, rabbits, guinea pigs, dogs, sheep, goats, and nonhuman primates. Ultimately, a comprehensive understanding of the benefits and limitations of different model species will aid in rigorously evaluating a novel bone implant material or device.

  6. Patient Report and Review of Rapidly Growing Mycobacterial Infection after Cardiac Device Implantation.

    PubMed

    Phadke, Varun K; Hirsh, David S; Goswami, Neela D

    2016-03-01

    Mycobacterial infections resulting from cardiac implantable electronic devices are rare, but as more devices are implanted, these organisms are increasingly emerging as causes of early-onset infections. We report a patient with an implantable cardioverter-defibrillator pocket and associated bloodstream infection caused by an organism of the Mycobacterium fortuitum group, and we review the literature regarding mycobacterial infections resulting from cardiac device implantations. Thirty-two such infections have been previously described; most (70%) were caused by rapidly growing species, of which M. fortuitum group species were predominant.When managing such infections, clinicians should consider the potential need for extended incubation of routine cultures or dedicated mycobacterial cultures for accurate diagnosis; combination antimicrobial drug therapy, even for isolates that appear to be macrolide susceptible, because of the potential for inducible resistance to this drug class; and the arrhythmogenicity of the antimicrobial drugs traditionally recommended for infections caused by these organisms.

  7. Technical Note: minimal access surgery for cochlear implantation with MED-EL devices.

    PubMed

    Mann, Wolf J; Gosepath, Jan

    2006-01-01

    Minimally invasive techniques have been described for cochlear implant surgery, but so far this had not been the case for Med-EL devices. To describe a newly developed minimal access approach for the implantation of Med-EL devices and report our results after up to 1 year of follow-up in 52 patients. The use of a minimally invasive approach without raising a flap or extensive drilling of a bony well was feasible in all 52 patients of this series. It shortened the surgical time to an average of 45 min and there were no specific postoperative complications. The average follow-up of 8.4 months was uneventful with the implants well covered and fixed in their position. The described approach therefore appears to be a safe, time- and cost-effective alternative to the standard procedure in cochlear implant surgery using Med-EL devices.

  8. Adaptive Transcutaneous Power Transfer to Implantable Devices: A State of the Art Review

    PubMed Central

    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

  9. Adaptive Transcutaneous Power Transfer to Implantable Devices: A State of the Art Review.

    PubMed

    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.

  10. High-Frequency Spinal Cord Stimulation in a Patient with an Implanted Cardiac Device.

    PubMed

    Kissoon, Narayan R; Hoelzer, Bryan C; Martin, David P; Lamer, Tim J

    2017-04-01

    New advances in spinal cord stimulation have led to improved treatment of patients suffering from chronic pain. While the overall safety of newer stimulation devices has been established, no published reports exist regarding safety considerations when these devices are implanted in patients with a preexisting cardiac device. An 83-year-old man with a history of out-of-hospital cardiac arrest secondary to an episode of ventricular fibrillation underwent automated implantable cardiac defibrillator placement. Concomitantly, he suffered from intractable chronic low axial back pain and was deemed a candidate for high-frequency (10 kHz) spinal cord stimulation (SCS). Cardiac monitoring during SCS trial and implantation was performed with no interference noted. Following high-frequency SCS implantation, the patient was observed to have significant pain relief with functional improvement. While others have reported safety during traditional SCS in patients with implanted cardiac devices, this is the first case report to describe safe and effective use of high-frequency SCS in a patient with an implanted cardiac device. © 2016 World Institute of Pain.

  11. High Curie temperature drive layer materials for ion-implanted magnetic bubble devices

    NASA Technical Reports Server (NTRS)

    Fratello, V. J.; Wolfe, R.; Blank, S. L.; Nelson, T. J.

    1984-01-01

    Ion implantation of bubble garnets can lower the Curie temperature by 70 C or more, thus limiting high temperature operation of devices with ion-implanted propagation patterns. Therefore, double-layer materials were made with a conventional 2-micron bubble storage layer capped by an ion-implantable drive layer of high Curie temperature, high magnetostriction material. Contiguous disk test patterns were implanted with varying doses of a typical triple implant. Quality of propagation was judged by quasistatic tests on 8-micron period major and minor loops. Variations of magnetization, uniaxial anisotropy, implant dose, and magnetostriction were investigated to ensure optimum flux matching, good charged wall coupling, and wide operating margins. The most successful drive layer compositions were in the systems (SmDyLuCa)3(FeSi)5O12 and (BiGdTmCa)3(FeSi)5O12 and had Curie temperatures 25-44 C higher than the storage layers.

  12. Capsule endoscopy in patients with cardiac pacemakers, implantable cardioverter defibrillators and left heart assist devices

    PubMed Central

    Bandorski, Dirk; Höltgen, Reinhard; Stunder, Dominik; Keuchel, Martin

    2014-01-01

    According to the recommendations of the US Food and Drug Administration and manufacturers, capsule endoscopy should not be used in patients carrying implanted cardiac devices. For this review we considered studies indexed (until 30.06.2013) in Medline [keywords: capsule endoscopy, small bowel endoscopy, cardiac pacemaker, implantable cardioverter defibrillator, interference, left heart assist device], technical information from Given Imaging and one own publication (not listed in Medline). Several in vitro and in vivo studies included patients with implanted cardiac devices who underwent capsule endoscopy. No clinically relevant interference was noticed. Initial reports on interference with a simulating device were not reproduced. Furthermore technical data of PillCam (Given Imaging) demonstrate that the maximum transmission power is below the permitted limits for cardiac devices. Hence, impairment of cardiac pacemaker, defibrillator or left ventricular heart assist device function by capsule endoscopy is not expected. However, wireless telemetry can cause dysfunction of capsule endoscopy recording. Application of capsule endoscopy is feasible and safe in patients with implanted cardiac devices such as pacemakers, cardioverter defibrillators, and left heart assist devices. Development of new technologies warrants future re-evaluation. PMID:24714370

  13. 78 FR 2647 - Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... reclassify this preamendments class III device into class II. FDA believes that this new information is... dental implant, a preamendments class III device, into class II (special controls). On its own initiative, based on new information, FDA is proposing to revise the classification of blade-form endosseous...

  14. [Anaesthetic management in left ventricular assist device implantation as destination therapy: Our first experience].

    PubMed

    del Barrio Gómez, E; Rodríguez, J M; Martínez, S; García, E; Vargas, M C; Sastre, J A

    2016-03-01

    Left ventricular assist devices have emerged as one of the main therapies of advanced cardiac failure due the increase of this disease and lack of organ supply for cardiac transplantation. The anaesthetic management is described on a patient without cardiac transplantation criteria. The device was successfully implanted as a destination therapy.

  15. A Review of the Design Process for Implantable Orthopedic Medical Devices

    PubMed Central

    Aitchison, G.A; Hukins, D.W.L; Parry, J.J; Shepherd, D.E.T; Trotman, S.G

    2009-01-01

    The design process for medical devices is highly regulated to ensure the safety of patients. This paper will present a review of the design process for implantable orthopedic medical devices. It will cover the main stages of feasibility, design reviews, design, design verification, manufacture, design validation, design transfer and design changes. PMID:19662153

  16. An unusual etiological agent of implantable cardioverter device endocarditis: Corynebacterium mucifaciens

    PubMed Central

    Kaya, Adnan; Tekkesin, Ahmet Ilker; Kalenderoglu, Koray; Alper, Ahmet Taha

    2016-01-01

    Cardiac pacing devices and implantable cardioverter defibrillator (ICD) are becoming the mainstay of therapy in cardiology and infective endocarditis (IE) and pocket infection; however, these devices require careful monitoring. Here, we describe a case of a 68-year-old female with an ICD presenting with a previously unknown etiological agent of IE, Corynebacterium mucifaciens. PMID:27133333

  17. Implantable mechanical circulatory support: demystifying patients with ventricular assist devices and artificial hearts.

    PubMed

    Shah, Keyur B; Tang, Daniel G; Cooke, Richard H; Harton, Suzanne; Flattery, Maureen; Katlaps, Gundars J; Kasirajan, Vigneshwar; Hess, Michael L

    2011-03-01

    Engineering advancements have expanded the role for mechanical circulatory support devices in the patient with heart failure. More patients with mechanical circulatory support are being discharged from the implanting institution and will be seen by clinicians outside the immediate surgical or heart-failure team. This review provides a practical understanding of device design and physiology, general troubleshooting, and limitations and complications for implantable left ventricular assist devices (pulsatile-flow and continuous-flow pumps) and the total artificial heart. © 2011 Wiley Periodicals, Inc.

  18. Percutaneous implantation of a parachute device for treatment of ischemic heart failure.

    PubMed

    Cilingiroglu, Mehmet; Rollefson, William A; Mego, David

    2013-01-01

    Congestive heart failure (CHF) secondary to ischemic cardiomyopathy is associated with significant morbidity and mortality despite currently available medical therapy. The Parachute(TM) device is a novel left ventricular partitioning device that is delivered percutaneously in the left ventricle (LV) in patients with anteroapical regional wall motion abnormalities, dilated LV and systolic dysfunction after anterior myocardial infarction with favorable clinical and LV hemodynamic improvements post-implantation. Here, we do review the current literature and present a case of the Parachute device implantation. Copyright © 2013 Elsevier Inc. All rights reserved.

  19. Assisted retention of a hearing device in an implant-retained auricular prosthesis.

    PubMed

    Taft, R M; von Gonten, A S; Wheeler, S T

    2001-10-01

    The use of bone-anchored hearing aids is not possible for all patients who wear an implant-retained auricular prosthesis. For some patients, the external ear canal cannot be occluded with a conventional hearing device. Currently manufactured hearing aids may not readily fit the contours of an implant-retained auricular prosthesis. This article describes a technique that allows a modular hearing aid device to be inserted into a custom "sleeve." With this device, the patient can take advantage of binaural cues.

  20. Drug loading into porous calcium carbonate microparticles by solvent evaporation.

    PubMed

    Preisig, Daniel; Haid, David; Varum, Felipe J O; Bravo, Roberto; Alles, Rainer; Huwyler, Jörg; Puchkov, Maxim

    2014-08-01

    Drug loading into porous carriers may improve drug release of poorly water-soluble drugs. However, the widely used impregnation method based on adsorption lacks reproducibility and efficiency for certain compounds. The aim of this study was to evaluate a drug-loading method based on solvent evaporation and crystallization, and to investigate the underlying drug-loading mechanisms. Functionalized calcium carbonate (FCC) microparticles and four drugs with different solubility and permeability properties were selected as model substances to investigate drug loading. Ibuprofen, nifedipine, losartan potassium, and metronidazole benzoate were dissolved in acetone or methanol. After dispersion of FCC, the solvent was removed under reduced pressure. For each model drug, a series of drug loads were produced ranging from 25% to 50% (w/w) in steps of 5% (w/w). Loading efficiency was qualitatively analyzed by scanning electron microscopy (SEM) using the presence of agglomerates and drug crystals as indicators of poor loading efficiency. The particles were further characterized by mercury porosimetry, specific surface area measurements, differential scanning calorimetry, and USP2 dissolution. Drug concentration was determined by HPLC. FCC-drug mixtures containing equivalent drug fractions but without specific loading strategy served as reference samples. SEM analysis revealed high efficiency of pore filling up to a drug load of 40% (w/w). Above this, agglomerates and separate crystals were significantly increased, indicating that the maximum capacity of drug loading was reached. Intraparticle porosity and specific surface area were decreased after drug loading because of pore filling and crystallization on the pore surface. HPLC quantification of drugs taken up by FCC showed only minor drug loss. Dissolution rate of FCC loaded with metronidazole benzoate and nifedipine was faster than the corresponding FCC-drug mixtures, mainly due to surface enlargement, because only small

  1. Wireless communication with implanted medical devices using the conductive properties of the body

    PubMed Central

    Ferguson, John E; Redish, A David

    2013-01-01

    Many medical devices that are implanted in the body use wires or wireless radiofrequency telemetry to communicate with circuitry outside the body. However, the wires are a common source of surgical complications, including breakage, infection and electrical noise. In addition, radiofrequency telemetry requires large amounts of power and results in low-efficiency transmission through biological tissue. As an alternative, the conductive properties of the body can be used to enable wireless communication with implanted devices. In this article, several methods of intrabody communication are described and compared. In addition to reducing the complications that occur with current implantable medical devices, intrabody communication can enable novel types of miniature devices for research and clinical applications. PMID:21728728

  2. Current State and Future Perspectives of Energy Sources for Totally Implantable Cardiac Devices.

    PubMed

    Bleszynski, Peter A; Luc, Jessica G Y; Schade, Peter; PhilLips, Steven J; Tchantchaleishvili, Vakhtang

    There is a large population of patients with end-stage congestive heart failure who cannot be treated by means of conventional cardiac surgery, cardiac transplantation, or chronic catecholamine infusions. Implantable cardiac devices, many designated as destination therapy, have revolutionized patient care and outcomes, although infection and complications related to external power sources or routine battery exchange remain a substantial risk. Complications from repeat battery replacement, power failure, and infections ultimately endanger the original objectives of implantable biomedical device therapy - eliminating the intended patient autonomy, affecting patient quality of life and survival. We sought to review the limitations of current cardiac biomedical device energy sources and discuss the current state and trends of future potential energy sources in pursuit of a lifelong fully implantable biomedical device.

  3. Identification of Bodies by Unique Serial Numbers on Implanted Medical Devices.

    PubMed

    Blessing, Melissa M; Lin, Peter T

    2017-07-18

    Visual identification is the most common identification method used by medical examiners but is not always possible. Alternative methods include X-ray, fingerprint, or DNA comparison, but these methods require additional resources. Comparison of serial numbers on implanted medical devices is a rapid and definitive method of identification. To assess the practicality of using this method, we reviewed 608 consecutive forensic autopsies performed at a regional medical examiner office. Of these, 56 cases required an alternative method of identification due to decomposition (n = 35), gunshot wound (n = 9), blunt trauma (n = 6), or charring (n = 6). Of these 56 cases, eight (14.3%) were known to have an implanted medical device. Of these eight cases, five (63%) could be positively identified by comparing serial numbers. If an implanted medical device is known to be present, and medical records are available, identification by medical device serial number should be a first-line method. © 2017 American Academy of Forensic Sciences.

  4. Wireless communication with implanted medical devices using the conductive properties of the body.

    PubMed

    Ferguson, John E; Redish, A David

    2011-07-01

    Many medical devices that are implanted in the body use wires or wireless radiofrequency telemetry to communicate with circuitry outside the body. However, the wires are a common source of surgical complications, including breakage, infection and electrical noise. In addition, radiofrequency telemetry requires large amounts of power and results in low-efficiency transmission through biological tissue. As an alternative, the conductive properties of the body can be used to enable wireless communication with implanted devices. In this article, several methods of intrabody communication are described and compared. In addition to reducing the complications that occur with current implantable medical devices, intrabody communication can enable novel types of miniature devices for research and clinical applications.

  5. Multifunctional High Drug Loading Nanocarriers for Cancer Drug Delivery

    NASA Astrophysics Data System (ADS)

    Jin, Erlei

    2011-12-01

    Most anticancer drugs have poor water-solubility, rapid blood clearance, low tumor-selectivity and severe systemic toxicity to healthy tissues. Thus, polymeric nanocarriers have been widely explored for anticancer drugs to solve these problems. However, polymer nanocarriers developed to date still suffer drawbacks including low drug loading contents, premature drug release, slow cellular internalization, slow intracellular drug release and thereby low therapeutic efficiency in cancer thermotherapy. Accordingly, in this dissertation, functional nanocapsules and nanoparticles including high drug loading liposome-like nanocapsules, high drug loading phospholipid-mimic nanocapsules with fast intracellular drug release, high drug loading charge-reversal nanocapsules, TAT based long blood circulation nanoparticles and charge-reversal nuclear targeted nanoparticles are designed and synthesized. These functional carriers have advantages such as high drug loading contents without premature drug release, fast cellular internalization and intracellular drug release, nuclear targeted delivery and long blood circulation. As a result, all these drug carriers show much higher in vitro and in vivo anti-cancer activities.

  6. Development of braided drug-loaded nanofiber sutures

    NASA Astrophysics Data System (ADS)

    Hu, Wen; Huang, Zheng-Ming; Liu, Xiang-Yang

    2010-08-01

    The objectives of this work are twofold. Firstly, while most work on electrospinning is limited to the development of only functional materials, a structural application of electrospun nanofibers is explored. Secondly, a drug-loaded tissue suture is fabricated and its various properties are characterized. Braided drug-loaded nanofiber sutures are obtained by combining an electrospinning process with a braiding technique followed by a coating procedure. Two different electrospinning techniques, i.e. blend and coaxial electrospinning, to incorporate a model drug cefotaxime sodium (CFX-Na) into poly(L-lactic acid) (PLLA) nanofibers have been applied and compared with each other. Properties of the braided drug-loaded sutures are characterized through a variety of methods including SEM, TEM and tensile testing. The results show that the nanofibers had a preferable micromorphology. The drug was incorporated into the polymer nanofibers homogeneously, with no cross-linking. The nanofibers maintained their fibrous structures. An in vitro release study indicates that the drug-loaded nanofibers fabricated by blend electrospinning and coaxial electrospinning had a different drug release behavior. An inhibition zone experiment shows that both sutures obtained from the nanofibers of the different electrospinning techniques had favorable antibacterial properties. The drug-loaded sutures had preferable histological compatibility performance compared with commercial silk sutures in an in vivo comparative study.

  7. Biomedical Impact in Implantable Devices-The Transcatheter Aortic Valve as an example

    NASA Astrophysics Data System (ADS)

    Anastasiou, Alexandros; Saatsakis, George

    2015-09-01

    Objective: To update of the scientific community about the biomedical engineering involvement in the implantable devices chain. Moreover the transcatheter Aortic Valve (TAV) replacement, in the field of cardiac surgery, will be analyzed as an example of contemporary implantable technology. Methods: A detailed literature review regarding biomedical engineers participating in the implantable medical product chain, starting from the design of the product till the final implantation technique. Results: The scientific role of biomedical engineers has clearly been established. Certain parts of the product chain are implemented almost exclusively by experienced biomedical engineers such as the transcatheter aortic valve device. The successful professional should have a multidisciplinary knowledge, including medicine, in order to pursue the challenges for such intuitive technology. This clearly indicates that biomedical engineers are among the most appropriate scientists to accomplish such tasks. Conclusions: The biomedical engineering involvement in medical implantable devices has been widely accepted by the scientific community, worldwide. Its important contribution, starting from the design and extended to the development, clinical trials, scientific support, education of other scientists (surgeons, cardiologists, technicians etc.), and even to sales, makes biomedical engineers a valuable player in the scientific arena. Notably, the sector of implantable devices is constantly raising, as emerging technologies continuously set up new targets.

  8. New implantable therapeutic device for the control of an atrial fibrillation attack using the Peltier element.

    PubMed

    Yambe, Tomoyuki; Sumiyoshi, Taketada; Koga, Chihiro; Shiraishi, Yasuyuki; Miura, Hidekazu; Sugita, Norihiro; Tanaka, Akira; Yoshizawa, Makoto

    2012-01-01

    For the development of the new therapeutic device for the atrial fibrillation, implantable cooling device using Peltier element was developed in this study. An implantable cooling device had been consisted from Peltier element with transcutaneous energy transmission system (TETS). 1st coil can be contacted from outside of the body, when the patients will feel palpitation. Electrical current will be induced to the implanted 2nd coil. Peltier element will able to cool the surface of the atrium. For the confirmation of the effect of the cooling device, trial manufacture model was developed. Animal experiments using six healthy adult goats after animal ethical committee allowance was carried out. Fourth intercostals space had been opened after anesthesia inhalation, and various sensors had been inserted. AF was induced by the electrical current with battery. As the results, AF had been recovered to the normal sinus rhythm after cooling in all six goats. So, this cooling system for the control of AF showed evident effect in these experiments. Smaller size cooling device has been under development aiming at totally implantable type. Catheter type cooling device for the insertion by the use of fiber-scope type is now under planning for the clinical application. This new type device may be able to become good news for the patients with uncontrollable AF.

  9. PLA/F68/dexamethasone implants prepared by hot-melt extrusion for controlled release of anti-inflammatory drug to implantable medical devices: I. Preparation, characterization and hydrolytic degradation study.

    PubMed

    Li, DeXia; Guo, Gang; Fan, RangRang; Liang, Jian; Deng, Xin; Luo, Feng; Qian, ZhiYong

    2013-01-30

    Dexamethasone (Dex)-loaded implants were prepared by poly(d,l-lactic acid) (PLA) and poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) copolymer (PEG-PPG-PEG, Pluronic F68) using hot-melt extrusion method. The purpose of this research was to develop a hot-melt extruded implant PLA/F68/Dex for controlling release of Dex at the implant site. Drug loading and encapsulation efficiency were determined by UV spectrophotometer analysis. The maximum value of the drug loading and encapsulation efficiency for the implants was up to 48.9% and 97.9%, respectively. Differential scanning calorimetry was used to evaluate stability and interaction between the implant and drug. We had studied the water uptake of PLA/F68 implants kept constant at about 12% due to the water was absorbed to a large extent. Dex release profile in vitro was studied, and the results showed that the maximum value of the release rate was approximately 20%. The degradation behavior was confirmed by mass loss and scanning electron microscopy. In addition, the in vivo biocompatibility study indicated that the implants had no negative influence as a foreign material in the body response.

  10. MEMS Based Broadband Piezoelectric Ultrasonic Energy Harvester (PUEH) for Enabling Self-Powered Implantable Biomedical Devices

    PubMed Central

    Shi, Qiongfeng; Wang, Tao; Lee, Chengkuo

    2016-01-01

    Acoustic energy transfer is a promising energy harvesting technology candidate for implantable biomedical devices. However, it does not show competitive strength for enabling self-powered implantable biomedical devices due to two issues – large size of bulk piezoelectric ultrasound transducers and output power fluctuation with transferred distance due to standing wave. Here we report a microelectromechanical systems (MEMS) based broadband piezoelectric ultrasonic energy harvester (PUEH) to enable self-powered implantable biomedical devices. The PUEH is a microfabricated lead zirconate titanate (PZT) diaphragm array and has wide operation bandwidth. By adjusting frequency of the input ultrasound wave within the operation bandwidth, standing wave effect can be minimized for any given distances. For example, at 1 cm distance, power density can be increased from 0.59 μW/cm2 to 3.75 μW/cm2 at input ultrasound intensity of 1 mW/cm2 when frequency changes from 250 to 240 kHz. Due to the difference of human body and manual surgical process, distance fluctuation for implantable biomedical devices is unavoidable and it strongly affects the coupling efficiency. This issue can be overcome by performing frequency adjustment of the PUEH. The proposed PUEH shows great potential to be integrated on an implanted biomedical device chip as power source for various applications. PMID:27112530

  11. MEMS Based Broadband Piezoelectric Ultrasonic Energy Harvester (PUEH) for Enabling Self-Powered Implantable Biomedical Devices

    NASA Astrophysics Data System (ADS)

    Shi, Qiongfeng; Wang, Tao; Lee, Chengkuo

    2016-04-01

    Acoustic energy transfer is a promising energy harvesting technology candidate for implantable biomedical devices. However, it does not show competitive strength for enabling self-powered implantable biomedical devices due to two issues - large size of bulk piezoelectric ultrasound transducers and output power fluctuation with transferred distance due to standing wave. Here we report a microelectromechanical systems (MEMS) based broadband piezoelectric ultrasonic energy harvester (PUEH) to enable self-powered implantable biomedical devices. The PUEH is a microfabricated lead zirconate titanate (PZT) diaphragm array and has wide operation bandwidth. By adjusting frequency of the input ultrasound wave within the operation bandwidth, standing wave effect can be minimized for any given distances. For example, at 1 cm distance, power density can be increased from 0.59 μW/cm2 to 3.75 μW/cm2 at input ultrasound intensity of 1 mW/cm2 when frequency changes from 250 to 240 kHz. Due to the difference of human body and manual surgical process, distance fluctuation for implantable biomedical devices is unavoidable and it strongly affects the coupling efficiency. This issue can be overcome by performing frequency adjustment of the PUEH. The proposed PUEH shows great potential to be integrated on an implanted biomedical device chip as power source for various applications.

  12. MEMS Based Broadband Piezoelectric Ultrasonic Energy Harvester (PUEH) for Enabling Self-Powered Implantable Biomedical Devices.

    PubMed

    Shi, Qiongfeng; Wang, Tao; Lee, Chengkuo

    2016-04-26

    Acoustic energy transfer is a promising energy harvesting technology candidate for implantable biomedical devices. However, it does not show competitive strength for enabling self-powered implantable biomedical devices due to two issues - large size of bulk piezoelectric ultrasound transducers and output power fluctuation with transferred distance due to standing wave. Here we report a microelectromechanical systems (MEMS) based broadband piezoelectric ultrasonic energy harvester (PUEH) to enable self-powered implantable biomedical devices. The PUEH is a microfabricated lead zirconate titanate (PZT) diaphragm array and has wide operation bandwidth. By adjusting frequency of the input ultrasound wave within the operation bandwidth, standing wave effect can be minimized for any given distances. For example, at 1 cm distance, power density can be increased from 0.59 μW/cm(2) to 3.75 μW/cm(2) at input ultrasound intensity of 1 mW/cm(2) when frequency changes from 250 to 240 kHz. Due to the difference of human body and manual surgical process, distance fluctuation for implantable biomedical devices is unavoidable and it strongly affects the coupling efficiency. This issue can be overcome by performing frequency adjustment of the PUEH. The proposed PUEH shows great potential to be integrated on an implanted biomedical device chip as power source for various applications.

  13. Holter monitoring for syncope: diagnostic yield in different patient groups and impact on device implantation.

    PubMed

    Kühne, M; Schaer, B; Moulay, N; Sticherling, C; Osswald, S

    2007-12-01

    Holter monitoring is routinely used in patients referred for the evaluation of syncope, but its diagnostic value in different patient groups is unclear, as is its impact on device implantation (pacemaker or cardioverter-defibrillator). To determine the diagnostic yield of Holter monitoring in the routine evaluation of syncope, and its impact on subsequent device implantation. Retrospective record review. We reviewed all Holter studies in patients referred with syncope between 2000 and 2005. Strict criteria were applied to determine whether a study was diagnostic. The diagnostic value of Holter monitoring (overall and in five subgroups: age, gender, structural heart disease, ejection fraction, medication) and its impact on the implantation of devices, were determined. Of 4877 Holter studies, 826 were performed in patients with syncope (age 72 +/- 15 years): 71 (8.6%) were considered to explain the syncope. Structural heart disease, ejection fraction and age were significant predictors of a diagnostic study (all p < 0.01), whereas gender and cardiac medication were not. A device was implanted in 33 patients (4.4%) whose initial Holter did not explain their syncope, after mean 7 months, whereas 45 patients (5.4%) received a pacemaker based on the Holter results (p = 0.32). The overall diagnostic yield of Holter monitoring in the evaluation of syncope was 8.6%, with dramatic differences between subgroups. Our data suggest that the impact of Holter monitoring on device implantation is generally overestimated.

  14. Biofunctionalization of surfaces by energetic ion implantation: Review of progress on applications in implantable biomedical devices and antibody microarrays

    NASA Astrophysics Data System (ADS)

    Bilek, Marcela M. M.

    2014-08-01

    Despite major research efforts in the field of biomaterials, rejection, severe immune responses, scar tissue and poor integration continue to seriously limit the performance of today's implantable biomedical devices. Implantable biomaterials that interact with their host via an interfacial layer of active biomolecules to direct a desired cellular response to the implant would represent a major and much sought after improvement. Another, perhaps equally revolutionary, development that is on the biomedical horizon is the introduction of cost-effective microarrays for fast, highly multiplexed screening for biomarkers on cell membranes and in a variety of analyte solutions. Both of these advances will rely on effective methods of functionalizing surfaces with bioactive molecules. After a brief introduction to other methods currently available, this review will describe recently developed approaches that use energetic ions extracted from plasma to facilitate simple, one-step covalent surface immobilization of bioactive molecules. A kinetic theory model of the immobilization process by reactions with long-lived, mobile, surface-embedded radicals will be presented. The roles of surface chemistry and microstructure of the ion treated layer will be discussed. Early progress on applications of this technology to create diagnostic microarrays and to engineer bioactive surfaces for implantable biomedical devices will be reviewed.

  15. Accuracy and Reproducibility of Radiographic Images for Assessing Crestal Bone Height of Implants Using the Precision Implant X-ray Locator (PIXRL) Device.

    PubMed

    Malloy, Kyle A; Wadhwani, Chandur; McAllister, Bradley; Wang, Mansen; Katancik, James A

    Assessment of crestal bone levels around implants is essential to monitor success and health. This is best accomplished with intraoral radiographs exposed at 90 degrees to the long axis of the implant, but this can be challenging to achieve clinically. Radiographic paralleling devices produce orthogonal radiographs but traditionally have required access to the implant body for each exposure. This study was conducted to determine if use of the Precision Implant X-ray Locator (PIXRL), a radiographic paralleling device that indexes the implant at the time of surgical placement, can produce orthogonal radiographs of dental implants more accurately than traditional radiologic techniques for assessing crestal bone levels. Three dental implants were inserted in dry human skulls in supracrestal positions to simulate crestal bone loss (maxillary right first premolar [site 14], maxillary right central incisor [site 11], and mandibular left second premolar [site 35]). The implants were masked with a soft tissue moulage and restored with provisional restorations. Four dental assistants exposed six radiographs using their usual and customary technique and six using the PIXRL device for each implant. A single examiner measured crestal bone levels on the radiographs relative to the implant platform shoulder on the mesial and distal of each implant. Recorded measurements were compared to the known values. Statistical analysis was completed using a generalized linear regression model to analyze the differences, and post-hoc comparisons with pairwise adjustment were applied. The images produced using the PIXRL device were more accurate overall compared to traditional techniques and were also more consistent. The greater degree of accuracy was statistically significant for all sites with the exception of the mesial measurements of the implant at site 11. This study demonstrates that the use of the PIXRL device can assist clinicians in obtaining more accurate orthogonal radiographs

  16. Perceptions of healthcare professionals' support, shock anxiety and device acceptance among implantable cardioverter defibrillator recipients.

    PubMed

    Morken, Ingvild M; Norekvål, Tone M; Bru, Edvin; Larsen, Alf I; Karlsen, Bjørg

    2014-09-01

    To investigate the extent to which perceived support from healthcare professionals and shock anxiety is related to device acceptance among implantable cardioverter defibrillator recipients. Device acceptance can be influenced by several factors, one of which is shock anxiety associated with poor device acceptance. Reduced shock anxiety, as well as increased device acceptance, has been reported after psycho-educational programmes. As healthcare professionals appear to play a significant role in providing support and education during regular follow-up visits, they may constitute an important social support system that could be another factor influencing device acceptance. However, little is known about the relationship between perceived support from healthcare professionals and device acceptance among recipients. A cross-sectional survey design. A sample comprising implantable cardioverter defibrillator recipients completed questionnaires assessing perceived support from healthcare professionals, shock anxiety and device acceptance. Demographic and clinical data were collected by self-report and from medical records in September-October 2010. The descriptive results indicated that approximately 85% of the recipients experienced high device acceptance. Regression analysis demonstrated that constructive support from healthcare professionals was positively associated with device acceptance and moderated the negative relationship between shock anxiety and device acceptance. Non-constructive support and shock anxiety had a negative statistical association with device acceptance. Healthcare professionals may represent a valuable constructive support system that can enhance device acceptance among implantable cardioverter defibrillator recipients, partly by preventing shock anxiety from leading to poor device acceptance. Non-constructive communication on the part of healthcare professionals could hinder device acceptance. © 2014 John Wiley & Sons Ltd.

  17. Predictors and management of right heart failure after left ventricular assist device implantation.

    PubMed

    Fida, Nadia; Loebe, Matthias; Estep, Jerry D; Guha, Ashrith

    2015-01-01

    Newer generation continuous-flow left ventricular assist devices (LVADs) have overall improved outcomes with lower incidences of right ventricular failure (RVF) than their pulsatile predecessors, yet RVF still occurs in 9% to 40% of LVAD recipients. Post-implant, RVF is associated with poor outcomes, end-organ dysfunction, high mortality, and reduced survival to transplant. Therefore, preoperative risk stratification, appropriate patient selection, and optimal timing of implant are of paramount importance. In this article, we review the definition, incidence, pathophysiology, and current risk prediction models for RVF and touch on the contemporary management of RVF perioperatively and post-LVAD implant.

  18. An analytical model for inductively coupled implantable biomedical devices with ferrite rods.

    PubMed

    Theilmann, P T; Asbeck, P M

    2009-02-01

    Using approximations applicable to near field coupled implants simplified expressions for the complex mutual inductance of coaxial aligned coils with and without a cylindrical ferrite rod are derived. Experimental results for ferrite rods of various sizes and permeabilities are presented to verify the accuracy of this expression. An equivalent circuit model for the inductive link between an implant and power coil is then presented and used to investigate how ferrite size, permeability and loss affect the power available to the implant device. Enhancements in coupling provided by high frequency, low permeability nickel zinc rods are compared with low frequency high permeability manganese zinc rods.

  19. Ion Implantation Defects in Silicon and the Performance of Micron and Submicron Devices.

    DTIC Science & Technology

    1983-01-31

    AD-R124 497 ION IMPLANTATION DEFECTS IN SILICON AND THE PERFORMANC / OF MICRON AND SUB..(U) ILLINOIS UNIV AT URBANA COOMRNTED SCIENCE LAB B G...TEST CHART -NATINAC. BURMA OF STANWM-1*3-A ION IMPLANTATION DEFECTS IN SILICON AND THE PERFORMANCE OF MICRON AND SUBMICRON DEVICES FINAL REPORT B. G...NUMUER FINAL £7 /7_ _ _ _ _ _ _ 4. TITLE (an Swe) IL TYPE OF REPORT & PERIOD COVERED ION IMPLANTATION DEFECTS IN SILICON AND THE Final 6/80-1/16/83

  20. Prosthetic devices: challenges and implications of robotic implants and biological interfaces.

    PubMed

    Lai, J C K; Schoen, M P; Perez Gracia, A; Naidu, D S; Leung, S W

    2007-02-01

    Although among designs of prosthetics there have been some successes in the design of functional robotic implants, there remain many issues and challenges concerned with the failure to meet the 'ideal' requirements of a satisfactory prosthetic. These 'ideals' require the device to be easy to control, comfortable to wear, and cosmetically pleasing. Because the literature on prosthetics and robotic implants are voluminous, this review focuses on four topics to determine key challenges and opportunities underlying these interdisciplinary research areas: firstly, an artificial hand as a biomimetic; secondly, prosthetic implants (electromyography signals and control); thirdly, prosthetic implants and tissue reactions to the material(s) of implants; fourthly, how inflammatory responses of cells and tissues surrounding implanted sensors interfere with the signal transmission of such sensors. This review also notes the importance of the biological interfaces that robotic implants and other prosthetic devices are in contact with and how an improved knowledge of pathophysiological changes at such biological interfaces will lead to improved and more biocompatible designs of prosthetics. This review concludes with the vision that, to develop a design that satisfies the above 'ideals', an interdisciplinary team of biomedical and tissue engineers, and biomaterial and biomedical scientists is needed to work together holistically and synergistically.

  1. Successful Implantation of a Left Ventricular Assist Device After Treatment With the Paracor HeartNet.

    PubMed

    Schweiger, Martin; Stepanenko, Alexander; Potapov, Evgenji; Drews, Thorsten; Hetzer, Roland; Krabatsch, Thomas

    2010-01-01

    The Paracor HeartNet, a ventricular constraint device for the treatment of heart failure (HF), is implanted through a left lateral thoracotomy. It envelopes the heart like a mesh "bag." This method of application raises the question of whether adhesions with the pericardium allow the safe implantation of a left ventricular assist device (LVAD) if HF worsens. A male patient who had undergone implantation of the Paracor HeartNet 42 months earlier presented with advanced HF for cardiac transplantation. The patient's condition deteriorated, and because no suitable organ for transplantation was available, implantation of an LVAD became necessary. Surgery was performed via a median sternotomy without complications. No severe adhesions were found. This is the first report on "how to do" LVAD implantation after Paracor HeartNet implantation with images and information about cutting the constraint. Because the Paracor HeartNet is "wrapped" around the heart, concerns persist that severe adhesions with the pericardium might occur. In this case, LVAD implantation after therapy with the Paracor HeartNet was without complications, and the expected massive adhesions were absent.

  2. Gentamicin-loaded calcium carbonate materials: comparison of two drug-loading modes.

    PubMed

    Lucas-Girot, Anita; Verdier, Marie-Clémence; Tribut, Olivier; Sangleboeuf, Jean-Christophe; Allain, Hervé; Oudadesse, Hassane

    2005-04-01

    Synthetic aragonite-based porous materials were drug loaded with gentamicin sulphate, an antibiotic active on Staphylococcus aureus responsible for osteomyelitis. Drug loading was accomplished by two different ways: by integration of gentamicin in material during processing or by soaking material into gentamicin solutions. We first investigated the influence of drug loading on compressive strength of materials. Results indicate that soaked materials presented the same compressive strength than unloaded materials with the same porosity. By contrast, the integration of gentamicin during processing increased significantly the compressive strength of materials. The materials drug content before elution was a least 10 times higher when gentamicin was integrated during processing comparatively to soaked materials. The study of in vitro gentamicin release showed that for materials with gentamicin integrated during material processing, high concentrations of gentamicin were released up to 8 or 12 days, against 4 days for soaked materials. The transport coefficients calculation, for the first step of release, indicated that the rate of release was higher for materials with integrated gentamicin because of the higher gentamicin content. The porosity rate influenced the rate of release for materials positively with gentamicin integrated during processing contrary to soaked materials for which a higher porosity rate allowed a deeper penetration of gentamicin during drug loading and then a slightly slower release. Results indicate that aragonite-based material with gentamicin integrated during material processing may be used either as resorbable device for release of high concentrations of gentamicin or as biomaterial for combined therapy: bone substitution and prevention or treatment of osteomyelitis.

  3. [Biodegradable synthetic polymers for the design of implantable medical devices: the ligamentoplasty case].

    PubMed

    Garric, Xavier; Nottelet, Benjamin; Pinese, Coline; Leroy, Adrien; Coudane, Jean

    2017-01-01

    The sector of implantable medical devices is a growing sector of health products especially dynamic in the field of research. To improve the management of patients and to meet clinical requirements, researchers are developing new types of medical devices. They use different families of biomaterials presenting various chemical and physical characteristics in order for providing clinicians with health products optimized for biomedical applications. In this article, we aim to show how, starting from a family of biomaterials (degradable polymers), it is possible to design an implantable medical device for the therapeutic management of the failure of anterior cruciate ligament. The main steps leading to the design of a total ligament reinforcement are detailed. They range from the synthesis and characterization of degradable polymer to the shaping of the knitted implant, through the assessment of the study of the impact of sterilization on mechanical properties and checking cytocompatibility.

  4. Security and privacy issues in implantable medical devices: A comprehensive survey.

    PubMed

    Camara, Carmen; Peris-Lopez, Pedro; Tapiador, Juan E

    2015-06-01

    Bioengineering is a field in expansion. New technologies are appearing to provide a more efficient treatment of diseases or human deficiencies. Implantable Medical Devices (IMDs) constitute one example, these being devices with more computing, decision making and communication capabilities. Several research works in the computer security field have identified serious security and privacy risks in IMDs that could compromise the implant and even the health of the patient who carries it. This article surveys the main security goals for the next generation of IMDs and analyzes the most relevant protection mechanisms proposed so far. On the one hand, the security proposals must have into consideration the inherent constraints of these small and implanted devices: energy, storage and computing power. On the other hand, proposed solutions must achieve an adequate balance between the safety of the patient and the security level offered, with the battery lifetime being another critical parameter in the design phase. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. Implantable imaging device for brain functional imaging system using flavoprotein fluorescence

    NASA Astrophysics Data System (ADS)

    Sunaga, Yoshinori; Yamaura, Hiroshi; Haruta, Makito; Yamaguchi, Takahiro; Motoyama, Mayumi; Ohta, Yasumi; Takehara, Hiroaki; Noda, Toshihiko; Sasagawa, Kiyotaka; Tokuda, Takashi; Yoshimura, Yumiko; Ohta, Jun

    2016-03-01

    The autofluorescence of mitochondrial flavoprotein is very useful for functional brain imaging because the fluorescence intensity of flavoprotein changes as per neural activities. In this study, we developed an implantable imaging device for green fluorescence imaging and detected fluorescence changes of flavoprotein associated with visual stimulation using the device. We examined the device performance using anesthetized mice. We set the device on the visual cortex and measured fluorescence changes of flavoprotein in response to visual stimulation. A full-field sinusoidal grating with a vertical orientation was used for applying to activate the visual cortex. We successfully observed visually evoked fluorescence changes in the mouse visual cortex using our implantable device. This result suggests that we can observe the fluorescence changes of flavoprotein associated with visual stimulation in a freely moving mouse by using this technology.

  6. Intelligent implantable medical devices: the epilepsy problem (Keynote Paper)

    NASA Astrophysics Data System (ADS)

    Tetzlaff, Ronald; Niederhofer, Christian; Fischer, Philipp

    2005-06-01

    In this paper we present our work analysing electroencephalographic (EEG) signals for the detection of seizure precursors in epilepsy. Volterra-systems and Cellular Nonlinear Networks are considered for a multidimensional signal analysis which is called the feature extraction problem throughout this contribution. Recent results obtained by applying a pattern detection algorithm and a nonlinear prediction of brain electrical activity will be discussed in detail. The aim of this interdisciplinary project is the realization of an implantable seizure warning and preventing system.

  7. Traditional Postextractive Implant Site Preparation Compared with Pre-extractive Interradicular Implant Bed Preparation in the Mandibular Molar Region, Using an Ultrasonic Device: A Randomized Pilot Study.

    PubMed

    Scarano, Antonio

    The immediate placement of single postextractive implants is increasing in the everyday clinical practice. Due to insufficient bone tissue volume, proper primary stability, essential for subsequent osseointegration, is sometimes not reached. The aim of this work was to compare two different approaches: implant bed preparation before and after root extraction. Twenty-two patients of both sexes were selected who needed an implant-prosthetic rehabilitation of the fractured first mandibular molar or presented an untreatable endodontic pathology. The sites were randomly assigned to the test group (treated with implant bed preparation before molar extractions) or control group (treated with implant bed preparation after molar extractions) by a computer-generated table. All implants were placed by the same operator, who was experienced in both traditional and ultrasonic techniques. The implant stability quotient (ISQ) and the position of the implant were evaluated. Statistical analysis was carried out. In the control group, three implants were placed in the central portion of the bone septum, while eight implants were placed with a tilted axis in relation to the septum; in the test group, all implants were placed in ideal positions within the root extraction sockets. The different position of the implants between the two procedures was statistically significant. This work presented an innovative approach for implant placement at the time of mandibular molar extraction. Preparing the implant bed with an ultrasonic device before root extraction is a simple technique and also allows greater stability to be reached in a selective case.

  8. Shape-memory alloy overload protection device for osseointegrated transfemoral implant prosthetic limb attachment system

    NASA Astrophysics Data System (ADS)

    Xu, Wei; Shao, Fei; Hughes, Steven

    2002-11-01

    The osseointegrated trans-femoral implant system provides a direct anchoring technique to attach prosthetic limb. This technique was first introduced PI Brenmark in Sweden. The UK had the first clinical trial in 1997 and currently has 6 active limb wearers. The success of this procedure has the potential for improved gait function and mobility, increased employability and significant long-term improvements in the quality of life for above knee amputees. However, the significant load involved in the trans-femoral implant system has caused permanent deformation and/or fractures of the implant abutment in several occasions. To protect the implant system, the implant abutment in particularly, an overloading protection device was introduced. The device uses mechanical mechanism to release torsion overload on the abutment. However, the bending overload protection remains unsolved. To solve the problem, a new overload protection device was developed. This device uses SMA component for bending overload protection. In this paper, the results of non-linear finite element modelling of the SMA and steel (AISI 1040) components were presented. Experiments were also carried out using steel components to assess the design which is based on the non-linear property of the materials.

  9. Clinical use of antibacterial mesh envelopes in cardiovascular electronic device implantations

    PubMed Central

    Hirsh, David S; Bloom, Heather L

    2015-01-01

    Cardiovascular implantable electronic device system infection is a serious complication of cardiac device implantation and carries with it a risk of significant morbidity and mortality. In the last 15 years, expansions of indications for cardiac devices have resulted in much higher volumes of much sicker patients being implanted, carrying significant risk of infection. Coagulase (−) Staphylococcus and Staphylococcus aureus are responsible for the majority of these infections, and these organisms are increasingly resistant to methicillin. The Aigis™ envelop is a Food and Drug Administration–approved implantable mesh that is impregnated with antibiotics that can be placed in the surgical incision prior to closure. The antibiotics elute off the mesh for 7–10 days, providing in vivo surgical site coverage with rifampin and minocyclin. This paper reviews the three retrospective clinical trials published in peer-reviewed journals and the interim analysis of the two ongoing prospective trials that have been presented at international conferences. Overall consensus is that the Aigis™ offers significant risk reduction for cardiovascular implantable electronic device infection. We then give a comprehensive discussion of how to use the Aigis™ envelop in the clinical setting, comparing the manufacturer’s recommendations with our extensive clinical experience. PMID:25624774

  10. Utilization of YouTube as a Tool to Assess Patient Perception Regarding Implanted Cardiac Devices.

    PubMed

    Hayes, Kevin; Mainali, Prajeena; Deshmukh, Abhishek; Pant, Sadip; Badheka, Apurva O; Paydak, Hakan

    2014-07-01

    The outreach of YouTube may have a dramatic role in the widespread dissemination of knowledge on implantable cardioverter devices (ICD). This study was designed to review and analyze the information available on YouTube pertaining to implantable cardiac devices such as implantable cardioverter defibrillators (ICDs) and pacemakers. YouTube was queried for the terms "ICD", "Implantable Cardioverter Defibrillator", and "Pacemaker". The videos were reviewed and categorized as according to content; number of views and "likes" or "dislikes" was recorded by two separate observers. Of the 55 videos reviewed, 18 of the videos were categorized as patient education, 12 were advertisements, 8 were intraoperative videos documenting the device implantation procedures, 7 of the videos were produced to document personal patient experiences, and 4 were categorized as documentation of a public event. 3 were intended to educate health care workers. The remaining 3 were intended to raise public awareness about sudden cardiac death. The videos portraying intraoperative procedures generated the most "likes" or "dislikes" per view. While YouTube provides a logical platform for delivery of health information, the information on this platform is not regulated. Initiative by reputed authorities and posting accurate information in such platform can be a great aid in public education regarding device therapy.

  11. Stab injury and device implantation within the brain results in inversely multiphasic neuroinflammatory and neurodegenerative responses

    NASA Astrophysics Data System (ADS)

    Potter, Kelsey A.; Buck, Amy C.; Self, Wade K.; Capadona, Jeffrey R.

    2012-08-01

    An estimated 25 million people in the US alone rely on implanted medical devices, ˜2.5 million implanted within the nervous system. Even though many devices perform adequately for years, the host response to medical devices often severely limits tissue integration and long-term performance. This host response is believed to be particularly limiting in the case of intracortical microelectrodes, where it has been shown that glial cell encapsulation and localized neuronal cell loss accompany intracortical microelectrode implantation. Since neuronal ensembles must be within ˜50 µm of the electrode to obtain neuronal spikes and local field potentials, developing a better understanding of the molecular and cellular environment at the device-tissue interface has been the subject of significant research. Unfortunately, immunohistochemical studies of scar maturation in correlation to device function have been inconclusive. Therefore, here we present a detailed quantitative study of the cellular events and the stability of the blood-brain barrier (BBB) following intracortical microelectrode implantation and cortical stab injury in a chronic survival model. We found two distinctly inverse multiphasic profiles for neuronal survival in device-implanted tissue compared to stab-injured animals. For chronically implanted animals, we observed a biphasic paradigm between blood-derived/trauma-induced and CNS-derived inflammatory markers driving neurodegeneration at the interface. In contrast, stab injured animals demonstrated a CNS-mediated neurodegenerative environment. Collectively these data provide valuable insight to the possibility of multiple roles of chronic neuroinflammatory events on BBB disruption and localized neurodegeneration, while also suggesting the importance to consider multiphasic neuroinflammatory kinetics in the design of therapeutic strategies for stabilizing neural interfaces.

  12. Recovery of Serum Cholesterol Predicts Survival After Left Ventricular Assist Device Implantation

    PubMed Central

    Vest, Amanda R.; Kennel, Peter J.; Maldonado, Dawn; Young, James B.; Mountis, Maria M.; Naka, Yoshifumi; Colombo, Paolo C.; Mancini, Donna M.; Starling, Randall C.; Schulze, P. Christian

    2017-01-01

    Background Advanced systolic heart failure is associated with myocardial and systemic metabolic abnormalities, including low levels of total cholesterol and low-density lipoprotein. Low cholesterol and low-density lipoprotein have been associated with greater mortality in heart failure. Implantation of a left ventricular assist device (LVAD) reverses some of the metabolic derangements of advanced heart failure. Methods and Results A cohort was retrospectively assembled from 2 high-volume implantation centers, totaling 295 continuous-flow LVAD recipients with ≥2 cholesterol values available. The cohort was predominantly bridge-to-transplantation (67%), with median age of 59 years and 49% ischemic heart failure cause. Total cholesterol, low-density lipoprotein, high-density lipoprotein, and triglyceride levels all significantly increased after LVAD implantation (median values from implantation to 3 months post implantation 125–150 mg/dL, 67–85 mg/dL, 32–42 mg/dL, and 97–126 mg/dL, respectively). On Cox proportional hazards modeling, patients achieving recovery of total cholesterol levels, defined as a median or greater change from pre implantation to 3 months post-LVAD implantation, had significantly better unadjusted survival (hazard ratio, 0.445; 95% confidence interval, 0.212–0.932) and adjusted survival (hazard ratio, 0.241; 95% confidence interval, 0.092–0.628) than those without cholesterol recovery after LVAD implantation. The continuous variable of total cholesterol at 3 months post implantation and the cholesterol increase from pre implantation to 3 months were also both significantly associated with survival during LVAD support. Conclusions Initiation of continuous-flow LVAD support was associated with significant recovery of all 4 lipid variables. Patients with a greater increase in total cholesterol by 3 months post implantation had superior survival during LVAD support. PMID:27623768

  13. Committee Opinion No. 642: Increasing Access to Contraceptive Implants and Intrauterine Devices to Reduce Unintended Pregnancy.

    PubMed

    2015-10-01

    Unintended pregnancy persists as a major public health problem in the United States. Although lowering unintended pregnancy rates requires multiple approaches, individual obstetrician-gynecologists may contribute by increasing access to contraceptive implants and intrauterine devices. Obstetrician-gynecologists should encourage consideration of implants and intrauterine devices for all appropriate candidates, including nulliparous women and adolescents. Obstetrician-gynecologists should adopt best practices for long-acting reversible contraception insertion. Obstetrician-gynecologists are encouraged to advocate for coverage and appropriate payment and reimbursement for every contraceptive method by all payers in all clinically appropriate circumstances.

  14. Risk factors predictive of right ventricular failure after left ventricular assist device implantation.

    PubMed

    Drakos, Stavros G; Janicki, Lindsay; Horne, Benjamin D; Kfoury, Abdallah G; Reid, Bruce B; Clayson, Stephen; Horton, Kenneth; Haddad, Francois; Li, Dean Y; Renlund, Dale G; Fisher, Patrick W

    2010-04-01

    Right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation appears to be associated with increased mortality. However, the determination of which patients are at greater risk of developing postoperative RVF remains controversial and relatively unknown. We sought to determine the preoperative risk factors for the development of RVF after LVAD implantation. The data were obtained for 175 consecutive patients who had received an LVAD. RVF was defined by the need for inhaled nitric oxide for >/=48 hours or intravenous inotropes for >14 days and/or right ventricular assist device implantation. An RVF risk score was developed from the beta coefficients of the independent variables from a multivariate logistic regression model predicting RVF. Destination therapy (DT) was identified as the indication for LVAD implantation in 42% of our patients. RVF after LVAD occurred in 44% of patients (n = 77). The mortality rates for patients with RVF were significantly greater at 30, 180, and 365 days after implantation compared to patients with no RVF. By multivariate logistic regression analysis, 3 preoperative factors were significantly associated with RVF after LVAD implantation: (1) a preoperative need for intra-aortic balloon counterpulsation, (2) increased pulmonary vascular resistance, and (3) DT. The developed RVF risk score effectively stratified the risk of RV failure and death after LVAD implantation. In conclusion, given the progressively growing need for DT, the developed RVF risk score, derived from a population with a large percentage of DT patients, might lead to improved patient selection and help stratify patients who could potentially benefit from early right ventricular assist device implantation. Copyright 2010 Elsevier Inc. All rights reserved.

  15. Safety, efficacy, and performance of implanted recycled cardiac rhythm management (CRM) devices in underprivileged patients.

    PubMed

    Hasan, Reema; Ghanbari, Hamid; Feldman, Dustin; Menesses, Daniel; Rivas, Daniel; Zakhem, Nicole C; Duarte, Carlos; Machado, Christian

    2011-06-01

    Patients in underdeveloped nations have limited access to life-saving medical technology including cardiac rhythm management (CRM) devices. We evaluated alternative means to provide such technology to this patient population while assessing the safety and efficacy of such a practice. Patients in the United States with clinical indications for extraction of CRM devices were consented. Antemortem CRM devices were cleaned and sterilized following a protocol established at our institution. Surveillance in vitro cultures were performed for quality assurance. The functional status of pulse generators was tested with a pacing system analyzer to confirm at least 70% battery life. Most generators were transported, in person, to an implanting institution in Nicaragua. Recipients with a Class I indication for CRM implantation, and meeting economical criteria set forth, were consented for implantation of a recycled device. Between 2003 and 2009, implantation was performed in 17 patients with an average age of 42.1 ± 20.3 years. Of the 17 patients, nine were male and eight were female. Mean follow-up was 68 ± 38 months. Device evaluation occurred prior to discharge, 4 weeks post implantation, and every 6 months thereafter. There were three deaths during the follow-up period secondary to myocardial infarction, stroke, and heart failure. Hematoma formation occurred in one patient. No infections, early battery depletion, or device malfunction were identified during follow-up. Our case series is the longest follow-up of recipients of recycled antemortem CRM devices. Our findings support the feasibility and safety of this alternative acquisition of life-saving technology. ©2011, The Authors. Journal compilation ©2011 Wiley Periodicals, Inc.

  16. Endophthalmitis With Corneal Infiltrate After EX-PRESS Glaucoma Drainage Device Implantation.

    PubMed

    Cherof, Amy M; SooHoo, Jeffery R; Kahook, Malik Y; Seibold, Leonard K

    2016-03-01

    To report a case of endophthalmitis occurring shortly after EX-PRESS implantation with the formation of a corneal infiltrate overlying the EX-PRESS, requiring device removal for adequate treatment. This is a case report of a 56-year-old male with uncontrolled open-angle glaucoma who underwent right eye EX-PRESS implantation under a partial-thickness scleral flap with intraoperative application of mitomycin C. On postoperative day 16, the patient was found to have bleb-associated endophthalmitis with a corneal infiltrate adjacent to the bleb and overlying the EX-PRESS. Two days after pars plana vitrectomy with injection of intravitreal antibiotics, the corneal infiltrate was enlarging and centered on the distal end of the EX-PRESS, while the back plate of the device became partially exposed. Clinical improvement was not achieved until the device was removed and the original surgical site was reinforced with a patch graft. By week 10 after device removal, intraocular pressure was 8 mm Hg and the corneal infiltrate had resolved into an opaque, partially vascularized scar. Endophthalmitis after EX-PRESS implantation may be complicated by corneal infiltrate formation and persistent infection. Clinicians should monitor for these complications in the management of infection after EX-PRESS implantation and consider early device removal to achieve resolution.

  17. Six-month and 1-year continuation rates following postpartum insertion of implants and intrauterine devices.

    PubMed

    Woo, Irene; Seifert, Sara; Hendricks, Dacia; Jamshidi, Roxanne M; Burke, Anne E; Fox, Michelle C

    2015-12-01

    Studies show immediate postpartum (PP) insertion increases use of contraceptive implants and intrauterine devices (IUDs). Our objective was to compare the satisfaction and continuation rates of the two types of devices at 6 months and 1 year following PP insertion. We enrolled 133 women in a prospective cohort study following immediate PP insertion of an implant or IUD at two academic hospitals during 8 months of 2011. Subjects completed an enrollment survey during hospital admission and a follow-up phone survey 6 months and 1 year PP. At 6 months PP, 72% of subjects provided follow-up information. Implant users were more likely to be using the originally-placed device (40/41, 98% vs. 45/55, 82%, p=0.02); nine women reported IUD expulsions. When accounting for replacement of expelled IUDs, IUD continuation at 6 months was 89% yielding similar continuation rates between groups (p=0.12). At 1 year PP, 51% provided follow-up. Of those, 82% still had a LARC method in place with similar continuation by device type (84% for implants, 81% for IUDs, p=0.96). Overall, satisfaction was similarly high in both groups. Due to IUD expulsion, implants had a higher continuation rate than IUDs six months following immediate PP insertion. After replacement of expelled IUDs, continuation and satisfaction were similar for both devices at 6 months and 1 year. Placement of implants and IUDs immediately PP can lead to high satisfaction. Despite early IUD expulsions, continuation rates were similar to those placed outside of the immediate PP period. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. Single-center experience with percutaneous extraction of cardiac implantable electric devices.

    PubMed

    Okada, Ayako; Shoda, Morio; Tabata, Hiroaki; Shoin, Wataru; Kobayashi, Hideki; Okano, Takahiro; Yoshie, Koji; Oguchi, Yasutaka; Takeuchi, Takahiro; Kato, Ken; Kuwahara, Koichiro

    2017-09-13

    The estimated incidence of infected cardiac implantable electric devices (CIED) has recently increased to 1-2% in Japan. Extraction of long-term implanted devices is generally difficult. There are few reports about lead extraction in Japan. We describe our experience with and outcomes of lead extraction using excimer lasers, mechanical sheaths, and manual extraction. We retrospectively analyzed the characteristics, types of devices, and indications for extraction in 29 patients with 67 leads who required CIED lead extraction at Shinshu University Hospital between April 2014 and October 2016. Mean patient age was 71 years and 25 patients were male. The indications for device extraction were infections (n=25) and non-functioning leads (n=4). A total of 67 leads (active fixation lead, n=28; passive fixation lead, n=39) had been implanted for a median duration of 6.3±5.6 years. Extractions were performed using an excimer laser sheath (n=26), laser with mechanical sheath (n=7), only mechanical sheath (Cook Vascular Inc., Leechburg, PA, USA) (n=1), and manually (n=1). The procedure was successful in all patients. There were no major or minor complications during extraction. There was no recurrence of infection after infected device extraction. Two patients were implanted with subcutaneous implantable defibrillators after extraction of the implantable cardioverter defibrillator (ICD). CIED lead extraction, especially of those that are adherent to the subclavian vein, can be successfully performed in Japanese subjects using an excimer laser and mechanical sheath, without complications. Copyright © 2017 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  19. Right ventricular assist device with membrane oxygenator support for right ventricular failure following implantable left ventricular assist device placement.

    PubMed

    Leidenfrost, Jeremy; Prasad, Sunil; Itoh, Akinobu; Lawrance, Christopher P; Bell, Jennifer M; Silvestry, Scott C

    2016-01-01

    Cardiogenic shock from refractory right ventricular (RV) failure during left ventricular assist device placement is associated with high morbidity and mortality. The addition of extracorporeal membrane oxygenation to RV mechanical assistance may help RV recovery and lead to improved outcomes. We retrospectively reviewed all implanted continuous-flow left ventricular assist devices from April 2009 to June 2013. RV mechanical support was utilized for RV failure defined as haemodynamic instability despite vasopressors, pulmonary vascular dilators and inotropic therapy. RV assist devices were utilized with and without in-line membrane oxygenation. During the study period, 267 continuous-flow left ventricular assist devices were implanted. RV mechanical support was utilized in 27 (10%) patients; 12 (46%) had the addition of in-line extracorporeal membrane oxygenation. The mean age of patients with a right ventricular assist device with membrane oxygenation was lower than that in patients with a right ventricular assist device alone (45.6 ± 15.9 vs 64.6 ± 6.5, P = 0.001). Support was weaned in 66% (10 of 15) of patients with right ventricular assist device (RVAD) alone vs 83% (10 of 12) of those with RVAD with membrane oxygenation (P = 0.42). The RVAD was removed after 10.4 ± 9.4 vs 5 ± 2.99 days for patients with a RVAD with membrane oxygenation (P = 0.1). Patients with RVAD with membrane oxygenation had a 30-day mortality rate of 8 vs 47% for those with RVAD alone (P = 0.04). The survival rate after discharge was 86, 63 and 54% at 3, 6 and 12 months for both groups combined. Patients with a RVAD with membrane oxygenation support for acute RV failure after continuous-flow left ventricular assist device implantation had a lower 30-day mortality than those with a RVAD alone. Patients who survive to discharge have a reasonable 1-year survival. Combining membrane oxygenation with RVAD support appears to offer a short-term survival benefit in patients with RV failure

  20. Auditory midbrain implant: a combined approach for vestibular schwannoma surgery and device implantation.

    PubMed

    Samii, Amir; Lenarz, Minoo; Majdani, Omid; Lim, Hubert H; Samii, Madjid; Lenarz, Thomas

    2007-01-01

    The lateral suboccipital approach is a well-established route for safe removal of vestibular schwannomas in neurofibromatosis Type 2 (NF2) patients. The goal of this study was to assess if this approach can be extended to a lateral supracerebellar infratentorial approach to enable insertion of an auditory midbrain implant (AMI) penetrating array along the tonotopic gradient of the inferior colliculus central nucleus (ICC). The AMI is a new auditory prosthesis designed for penetrating stimulation of the ICC in patients with neural deafness. The initial candidates are NF2 patients who, because of the growth and/or surgical removal of bilateral acoustic neuromas, develop neural deafness and are unable to benefit from cochlear implants. The ideal surgical approach in NF2 patients must first enable safe removal of vestibular schwannomas and then provide sufficient exposure of the midbrain for AMI implantation. This study was performed on formalin-fixed and fresh cadaver specimens. Computed tomography scan and magnetic resonance imaging were used to study the heads of the specimens and for surgical navigation. The lateral suboccipital craniotomy enabled sufficient exposure of the cerebellopontine angle and internal auditory canal for tumor removal. It could then be extended to a lateral supracerebellar infratentorial approach that provided good exposure of the dorsolateral aspect of the tentorial hiatus and mesencephalon for implantation of the AMI along the tonotopic gradient of the ICC. This approach did not endanger the trochlear nerve or any major midline venous structures in the quadrigeminal cistern. This modified lateral suboccipital approach ensures safe removal of large vestibular schwannomas and provides sufficient exposure of the inferior colliculus for ideal AMI implantation.

  1. New cosurface capacitive stimulators for the development of active osseointegrative implantable devices

    NASA Astrophysics Data System (ADS)

    Soares Dos Santos, Marco P.; Marote, Ana; Santos, T.; Torrão, João; Ramos, A.; Simões, José A. O.; da Cruz E Silva, Odete A. B.; Furlani, Edward P.; Vieira, Sandra I.; Ferreira, Jorge A. F.

    2016-07-01

    Non-drug strategies based on biophysical stimulation have been emphasized for the treatment and prevention of musculoskeletal conditions. However, to date, an effective stimulation system for intracorporeal therapies has not been proposed. This is particularly true for active intramedullary implants that aim to optimize osseointegration. The increasing demand for these implants, particularly for hip and knee replacements, has driven the design of innovative stimulation systems that are effective in bone-implant integration. In this paper, a new cosurface-based capacitive system concept is proposed for the design of implantable devices that deliver controllable and personalized electric field stimuli to target tissues. A prototype architecture of this system was constructed for in vitro tests, and its ability to deliver controllable stimuli was numerically analyzed. Successful results were obtained for osteoblastic proliferation and differentiation in the in vitro tests. This work provides, for the first time, a design of a stimulation system that can be embedded in active implantable devices for controllable bone-implant integration and regeneration. The proposed cosurface design holds potential for the implementation of novel and innovative personalized stimulatory therapies based on the delivery of electric fields to bone cells.

  2. Electromagnetic interference of implantable cardiac devices from a shoulder massage machine.

    PubMed

    Yoshida, Saeko; Fujiwara, Kousaku; Kohira, Satoshi; Hirose, Minoru

    2014-09-01

    Shoulder massage machines have two pads that are driven by solenoid coils to perform a per cussive massage on the shoulders. There have been concerns that such machines might create electromagnetic interference (EMI) in implantable cardiac devices because of the time-varying magnetic fields produced by the alternating current in the solenoid coils. The objective of this study was to investigate the potential EMI from one such shoulder massage machine on implantable cardiac devices. We measured the distribution profile of the magnetic field intensity around the massage machine. Furthermore, we performed an inhibition test and an asynchronous test on an implantable cardiac pacemaker using the standardized Irnich human body model. We examined the events on an implantable cardioverter-defibrillator (ICD) using a pacemaker programmer while the massage machine was in operation. The magnetic field distribution profile exhibited a peak intensity of 212 (A/m) in one of the solenoid coils. The maximal interference distance between the massage machine and the implantable cardiac pacemaker was 28 cm. Ventricular fibrillation was induced when the massage machine was brought near the electrode of the ICD and touched the Irnich human body model. It is necessary to provide a "don't use" warning on the box or the exterior of the massage machines or in the user manuals and to caution patients with implanted pacemakers about the dangers and appropriate usage of massage machines.

  3. Infection related to implantable central venous access devices in cancer patients: epidemiology and risk factors.

    PubMed

    Freire, Maristela P; Pierrotti, Ligia C; Zerati, Antônio E; Araújo, Pedro H X N; Motta-Leal-Filho, J M; Duarte, Laiane P G; Ibrahim, Karim Y; Souza, Antonia A L; Diz, Maria P E; Pereira, Juliana; Hoff, Paulo M; Abdala, Edson

    2013-07-01

    To describe the epidemiology of infections related to the use of implantable central venous access devices (CVADs) in cancer patients and to evaluate measures aimed at reducing the rates of such infections. Prospective cohort study. Referral hospital for cancer in São Paulo, Brazil. We prospectively evaluated all implantable CVADs employed between January 2009 and December 2011. Inpatients and outpatients were followed until catheter removal, transfer to another facility, or death. Outcome measures were bloodstream infection and pocket infection. We also evaluated the effects that the creation of a multidisciplinary team for CVAD care, avoiding in-hospital implantation of CVADs, and limiting CVAD insertion in neutropenic patients have on the rates of such infections. During the study period, 966 CVADs (mostly venous ports) were implanted in 933 patients, for a combined total of 243,792 catheter-days. We identified 184 episodes of infection: 154 (84%) were bloodstream infections, 21 (11%) were pocket infections, and 9 (5%) were surgical site infections. During the study period, the rate of CVAD-related infection dropped from 2.2 to 0.24 per 1,000 catheter-days ([Formula: see text]). Multivariate analysis revealed that relevant risk factors for such infection include surgical reintervention, implantation in a neutropenic patient, in-hospital implantation, use of a cuffed catheter, and nonchemotherapy indication for catheter use. Establishing a multidisciplinary team specifically focused on CVAD care, together with systematic reporting of infections, appears to reduce the rates of infection related to the use of these devices.

  4. New cosurface capacitive stimulators for the development of active osseointegrative implantable devices

    PubMed Central

    Soares dos Santos, Marco P.; Marote, Ana; Santos, T.; Torrão, João; Ramos, A.; Simões, José A. O.; da Cruz e Silva, Odete A. B.; Furlani, Edward P.; Vieira, Sandra I.; Ferreira, Jorge A. F.

    2016-01-01

    Non-drug strategies based on biophysical stimulation have been emphasized for the treatment and prevention of musculoskeletal conditions. However, to date, an effective stimulation system for intracorporeal therapies has not been proposed. This is particularly true for active intramedullary implants that aim to optimize osseointegration. The increasing demand for these implants, particularly for hip and knee replacements, has driven the design of innovative stimulation systems that are effective in bone-implant integration. In this paper, a new cosurface-based capacitive system concept is proposed for the design of implantable devices that deliver controllable and personalized electric field stimuli to target tissues. A prototype architecture of this system was constructed for in vitro tests, and its ability to deliver controllable stimuli was numerically analyzed. Successful results were obtained for osteoblastic proliferation and differentiation in the in vitro tests. This work provides, for the first time, a design of a stimulation system that can be embedded in active implantable devices for controllable bone-implant integration and regeneration. The proposed cosurface design holds potential for the implementation of novel and innovative personalized stimulatory therapies based on the delivery of electric fields to bone cells. PMID:27456818

  5. Implantable optogenetic device with CMOS IC technology for simultaneous optical measurement and stimulation

    NASA Astrophysics Data System (ADS)

    Haruta, Makito; Kamiyama, Naoya; Nakajima, Shun; Motoyama, Mayumi; Kawahara, Mamiko; Ohta, Yasumi; Yamasaki, Atsushi; Takehara, Hiroaki; Noda, Toshihiko; Sasagawa, Kiyotaka; Ishikawa, Yasuyuki; Tokuda, Takashi; Hashimoto, Hitoshi; Ohta, Jun

    2017-05-01

    In this study, we have developed an implantable optogenetic device that can measure and stimulate neurons by an optical method based on CMOS IC technology. The device consist of a blue LED array for optically patterned stimulation, a CMOS image sensor for acquiring brain surface image, and eight green LEDs surrounding the CMOS image sensor for illumination. The blue LED array is placed on the CMOS image sensor. We implanted the device in the brain of a genetically modified mouse and successfully demonstrated the stimulation of neurons optically and simultaneously acquire intrinsic optical images of the brain surface using the image sensor. The integrated device can be used for simultaneously measuring and controlling neuronal activities in a living animal, which is important for the artificial control of brain functions.

  6. Preventing bacterial growth on implanted device with an interfacial metallic film and penetrating X-rays.

    PubMed

    An, Jincui; Sun, An; Qiao, Yong; Zhang, Peipei; Su, Ming

    2015-02-01

    Device-related infections have been a big problem for a long time. This paper describes a new method to inhibit bacterial growth on implanted device with tissue-penetrating X-ray radiation, where a thin metallic film deposited on the device is used as a radio-sensitizing film for bacterial inhibition. At a given dose of X-ray, the bacterial viability decreases as the thickness of metal film (bismuth) increases. The bacterial viability decreases with X-ray dose increases. At X-ray dose of 2.5 Gy, 98% of bacteria on 10 nm thick bismuth film are killed; while it is only 25% of bacteria are killed on the bare petri dish. The same dose of X-ray kills 8% fibroblast cells that are within a short distance from bismuth film (4 mm). These results suggest that penetrating X-rays can kill bacteria on bismuth thin film deposited on surface of implant device efficiently.

  7. Additive manufacturing of polymer melts for implantable medical devices and scaffolds.

    PubMed

    Youssef, Almoatazbellah; Hollister, Scott J; Dalton, Paul D

    2017-02-28

    Melt processing is routinely used to fabricate medical polymeric devices/implants for clinical reconstruction and can be incorporated into quality systems procedures for medical device manufacture. As additive manufacturing (AM) becomes increasingly used for biomaterials and biofabrication, the translation of new, customizable, medical devices to the clinic becomes paramount. Melt processing is therefore a distinguishable group within AM that provides an avenue to manufacture scaffolds/implants with a clinical end-point. Three key melt processing AM technologies are highlighted in this review: melt micro-extrusion, selective laser sintering and melt electrospinning writing. The in vivo (including clinical) outcomes of medical devices and scaffolds made with these processes are reviewed. Together, they encompass the melt AM of scaffold architectures with feature sizes and resolutions ranging from 800 nm up to 700 μm.

  8. Prospective clinical study of a new implantable peripheral nerve stimulation device to treat chronic pain.

    PubMed

    Deer, Timothy R; Levy, Robert M; Rosenfeld, Evan L

    2010-06-01

    To evaluate clinical use of the StimRouter, an investigational implanted peripheral nerve stimulator for treating chronic neuropathic pain, using the median nerve as a model for that general application. Eight patients with carpal tunnel syndrome and chronic pain despite both carpal tunnel release and treatment with oral pain medications were enrolled in a single-center, open-label trial after institutional review board approval. Primary endpoints were successful implantation near the target peripheral nerve and safety. All 8 patients were implanted temporarily at the median nerve in at least one arm and 2 patients were implanted bilaterally, with 10 implants total. Each implant was considered a separate "patient." For 5 days, all patients received 6 hours of daily transdermal electrical stimulation targeting the median nerve. Pain was measured at baseline, during implant, and after explant. Two patients experienced clinically meaningful (>or=30%) pain reduction throughout the entire 5-day treatment period. Apparent carryover effect in pain reduction also was observed after daily stimulation. After explant, pain returned to baseline, increasing 36.8% to 45.6% relative to average reduced pain with daily stimulation. No significant or unexpected adverse events occurred. Mean patient study satisfaction was 96%, and 100% of patients indicated a preference for permanent implant. Temporary implant of the StimRouter device resulted in both pain reduction and reduced use of oral opioid pain medication during the 5-day stimulation period. The results suggest that permanent implant of the StimRouter System may be safe and effective for treating chronic peripheral neuropathic pain.

  9. An Implantable MEMS Drug Delivery Device for Rapid Delivery in Ambulatory Emergency Care

    DTIC Science & Technology

    2009-06-01

    Rabideau for his assistance during the fabrication process. 10. References W. S. Aronow, “Review Article: Treatment of Unstable Angina Pectoris /Non...delivery. Potential pathologies that the device can address with patients at high risk include: cardiac arrest, vasovagal syncope, angina , strokes...pacemaker in this case. Another potential use of this device is for treating angina . The IRD 3 could be implanted in high-risk patients to deliver

  10. The role of intravenous catheters in cardiovascular implantable electronic device infections: identifying potential targets for prevention.

    PubMed

    Othman, Hussein; Fishbain, Joel T; Khatib, Riad

    2013-04-01

    Infections related to cardiac implantable electronic devices (CIEDs) are increasing in prevalence and carry substantial morbidity and mortality. Complications involving peripheral intravenous catheters resulting in CIED infections have not yet been investigated and may pose an important risk factor. We report 5 cases of CIED infection related to documented complications of peripheral vascular devices. Copyright © 2013 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

  11. Factors constraining patient engagement in implantable medical device discussions and decisions: interviews with physicians.

    PubMed

    Gagliardi, Anna R; Lehoux, Pascale; Ducey, Ariel; Easty, Anthony; Ross, Sue; Bell, Chaim M; Trbovich, Patricia; Takata, Julie; Urbach, David R

    2017-04-01

    Patient engagement (PE) is warranted when treatment risks and outcomes are uncertain, as is the case for higher risk medical devices. Previous research found that patients were not engaged in discussions or decisions about implantable medical devices. This study explored physician views about engaging patients in such discussions. Qualitative interviews using a basic descriptive approach. Canada. Practicing cardiovascular and orthopaedic physicians. Level, processes and determinants of PE in medical device discussions and decisions. Views were largely similar among 10 cardiovascular and 12 orthopaedic physicians interviewed. Most said that it was feasible to inform and sometimes involve patients in discussions, but not to partner with them in medical device decision-making. PE was constrained by patient (comfort with PE, technical understanding, physiologic/demographic characteristics, prognosis), physician (device preferences, time), health system (purchasing contracts) and device factors (number of devices on market, comparative advantage). A framework was generated to help physicians engage patients in discussions about medical devices, even when decisions may not be preference sensitive due to multiple constraints on choice. This study identified that patients are not engaged in discussions or decisions about implantable medical devices. This may be due to multiple constraints. Further research should establish the legitimacy, prevalence and impact of constraining factors, and examine whether and how different levels and forms of PE are needed and feasible.

  12. Clinical Characteristics and Outcome of Cardiovascular Implantable Electronic Device Infections in Turkey.

    PubMed

    Aydin, Mesut; Yildiz, Abdulkadir; Kaya, Zeynettin; Kaya, Zekeriya; Basarir, Ahmet Ozgur; Cakmak, Nazmiye; Donmez, Ibrahim; Morrad, Baktash; Avci, Ahmet; Demir, Kenan; Cagliyan, Emre Caglar; Yuksel, Murat; Elbey, Mehmet Ali; Kayan, Fethullah; Ozaydogdu, Necdet; Islamoglu, Yahya; Cayli, Murat; Alan, Said; Ulgen, Mehmet Siddik; Ozhan, Hakan

    2016-07-01

    Infection is one of the most devastating outcomes of cardiovascular implantable electronic device (CIED) implantation and is related to significant morbidity and mortality. In our country, there is no evaluation about CIED infection. Therefore, our aim was to investigate clinical characteristics and outcome of patients who had infection related to CIED implantation or replacement. The study included 144 consecutive patients with CIED infection treated at 11 major hospitals in Turkey from 2005 to 2014 retrospectively. We analyzed the medical files of all patients hospitalized with the diagnosis of CIED infection. Inclusion criteria were definite infection related to CIED implantation, replacement, or revision. Generator pocket infection, with or without bacteremia, was the most common clinical presentation, followed by CIED-related endocarditis. Coagulase-negative staphylococci and Staphylococcus aureus were the leading causative agents of CIED infection. Multivariate analysis showed that infective endocarditis and ejection fraction were the strongest predictors of in-hospital mortality.

  13. Science and technology of biocompatible thin films for implantable biomedical devices.

    PubMed

    Li, Wei; Kabius, Bernd; Auciello, Orlando

    2010-01-01

    This presentation focuses on reviewing research to develop two critical biocompatible film technologies to enable implantable biomedical devices, namely: 1) development of bioinert/biocompatible coatings for encapsulation of Si chips implantable in the human body (e.g., retinal prosthesis implantable in the human eye)-the coating involves a novel ultrananocrystalline diamond (UNCD) film or hybrid biocompatible oxide/UNCD layered films; and 2) development of biocompatible films with high-dielectric constant and microfabrication process to produce energy storage super-capacitors embedded in the microchip to achieve full miniaturization for implantation into the human bodynovel Al2O3/TiO2 nanolaminates exhibit abnormally high dielectric constant to enable super-capacitors with very high-capacitance.

  14. A phone-assistive device based on Bluetooth technology for cochlear implant users.

    PubMed

    Qian, Haifeng; Loizou, Philipos C; Dorman, Michael F

    2003-09-01

    Hearing-impaired people, and particularly hearing-aid and cochlear-implant users, often have difficulty communicating over the telephone. The intelligibility of telephone speech is considerably lower than the intelligibility of face-to-face speech. This is partly because of lack of visual cues, limited telephone bandwidth, and background noise. In addition, cellphones may cause interference with the hearing aid or cochlear implant. To address these problems that hearing-impaired people experience with telephones, this paper proposes a wireless phone adapter that can be used to route the audio signal directly to the hearing aid or cochlear implant processor. This adapter is based on Bluetooth technology. The favorable features of this new wireless technology make the adapter superior to traditional assistive listening devices. A hardware prototype was built and software programs were written to implement the headset profile in the Bluetooth specification. Three cochlear implant users were tested with the proposed phone-adapter and reported good speech quality.

  15. Security Risks, Low-tech User Interfaces, and Implantable Medical Devices: A Case Study with Insulin Pump Infusion Systems

    SciTech Connect

    Paul, Nathanael R; Kohno, Tadayoshi

    2012-01-01

    Portable implantable medical device systems are playing a larger role in modern health care. Increasing attention is now being given to the wireless control interface of these systems. Our position is that wireless security in portable implantable medical device systems is just a part of the overall system security, and increased attention is needed to address low-tech security issues.

  16. B-Type Natriuretic Peptide Levels Predict Ventricular Arrhythmia Post Left Ventricular Assist Device Implantation.

    PubMed

    Hellman, Yaron; Malik, Adnan S; Lin, Hongbo; Shen, Changyu; Wang, I-Wen; Wozniak, Thomas C; Hashmi, Zubair A; Pickrell, Jeanette; Jani, Milena; Caccamo, Marco A; Gradus-Pizlo, Irmina; Hadi, Azam

    2015-12-01

    B-type natriuretic peptide (BNP) levels have been shown to predict ventricular arrhythmia (VA) and sudden death in patients with heart failure. We sought to determine whether BNP levels before left ventricular assist device (LVAD) implantation can predict VA post LVAD implantation in advanced heart failure patients. We conducted a retrospective study consisting of patients who underwent LVAD implantation in our institution during the period of May 2009-March 2013. The study was limited to patients receiving a HeartMate II or HeartWare LVAD. Acute myocardial infarction patients were excluded. We compared between the patients who developed VA within 15 days post LVAD implantation to the patients without VA. A total of 85 patients underwent LVAD implantation during the study period. Eleven patients were excluded (five acute MI, four without BNP measurements, and two discharged earlier than 13 days post LVAD implantation). The incidence of VA was 31%, with 91% ventricular tachycardia (VT) and 9% ventricular fibrillation. BNP remained the single most powerful predictor of VA even after adjustment for other borderline significant factors in a multivariate logistic regression model (P < 0.05). BNP levels are a strong predictor of VA post LVAD implantation, surpassing previously described risk factors such as age and VT in the past.

  17. A Study of Success Rate of Miniscrew Implants as Temporary Anchorage Devices in Singapore

    PubMed Central

    Yi Lin, Song; Mimi, Yow; Ming Tak, Chew; Kelvin Weng Chiong, Foong; Hung Chew, Wong

    2015-01-01

    Objective. To find out the success rate of miniscrew implants in the National Dental Centre of Singapore (NDCS) and the impact of patient-related, location-related, and miniscrew implant-related factors. Materials and Methods. Two hundred and eighty-five orthodontic miniscrew implants were examined from NDCS patient records. Eleven variables were analysed to see if there is any association with success. Outcome was measured twice, immediately after surgery prior to orthodontic loading (T1) and 12 months after surgery (T2). The outcome at T2 was assessed 12 months after the miniscrew's insertion date or after its use as a temporary anchorage device has ceased. Results. Overall success rate was 94.7% at T1 and 83.3% at T2. Multivariate analysis revealed only the length of miniscrew implant to be significantly associated with success at both T1 (P = 0.002) and T2 (P = 0.030). Miniscrew implants with lengths of 10–12 mm had the highest success rate (98.0%) compared to other lengths, and this is statistically significant (P = 0.035). At T2, lengths of 10–12 mm had significantly (P = 0.013) higher success rates (93.5%) compared to 6-7 mm (76.7%) and 8 mm (82.1%) miniscrew implants. Conclusion. Multivariate statistical analyses of 11 variables demonstrate that length of miniscrew implant is significant in determining success. PMID:25861272

  18. A new device for impression transfer for non-parallel endosseus implants

    PubMed Central

    Danza, Matteo; Zollino, Ilaria; Guidi, Riccardo; Carinci, Francesco

    2009-01-01

    The three-dimensional orientation of dental implant is transferred to a model by means of transfer device and impression material. If more than one implant is inserted and fixtures are not perfectly parallel, the impression may become distorted when removed from the mouth. In this case, a transfer that can be disengaged from the internal implant-abutment connection and removed together with the tray could be useful. An impression transfer device composed of a proper transfer, an inner hexagon and a central screw is described. When the central screw and the hexagon are removed, the proper transfer is free to move horizontally and the tray can be removed from the mouth without distortion of the impression material. PMID:23960464

  19. A new device for impression transfer for non-parallel endosseus implants.

    PubMed

    Danza, Matteo; Zollino, Ilaria; Guidi, Riccardo; Carinci, Francesco

    2009-07-01

    The three-dimensional orientation of dental implant is transferred to a model by means of transfer device and impression material. If more than one implant is inserted and fixtures are not perfectly parallel, the impression may become distorted when removed from the mouth. In this case, a transfer that can be disengaged from the internal implant-abutment connection and removed together with the tray could be useful. An impression transfer device composed of a proper transfer, an inner hexagon and a central screw is described. When the central screw and the hexagon are removed, the proper transfer is free to move horizontally and the tray can be removed from the mouth without distortion of the impression material.

  20. Simulative and experimental research on wireless power transmission technique in implantable medical device.

    PubMed

    Yu, Yue; Hao, Hongwei; Wang, Weiming; Li, Luming

    2009-01-01

    As the development of implantable biomedical devices, the rechargeable battery is applied to improve the life of implantable devices. Inductive transcutaneous power transfer, as a suitable way of charging the implantable rechargeable batteries, is widely used. During charging period, there are several stages based on the charging rule and the load resistance is varying simultaneously. In this paper, a model of inductive transcutaneous power transfer is set up with a compensative capacitor for primary coil in series and another compensative capacitor for secondary coil in parallel to descript the relationship in coupling coefficient, load resistance and conversion efficiency. Simulations were done and experiments were carried out to verify the model, and some suggestions on wireless power transfer design are given.

  1. Ensuring Safety of Implanted Devices under MRI using Reversed RF Polarization

    PubMed Central

    Overall, William R.; Pauly, John M.; Stang, Pascal P.; Scott, Greig C.

    2011-01-01

    Patients with long-wire medical implants are currently prevented from undergoing MRI scans due to the risk of RF heating. We have developed a simple technique for determining the heating potential for these implants using reversed RF polarization. This technique could be used on a patient-to-patient basis as a part of the standard pre-scan procedure to ensure that the subject’s device does not pose a heating risk. By using reversed quadrature polarization, the MR scan can be sensitized exclusively to the potentially dangerous currents in the device. Here, we derive the physical principles governing the technique and explore the primary sources of inaccuracy. These principles are verified through finite-difference simulations and through phantom scans of implant leads. These studies demonstrate the potential of the technique for sensitively detecting potentially dangerous coupling conditions before they can do harm. PMID:20593374

  2. Transdermal power transfer for recharging implanted drug delivery devices via the refill port.

    PubMed

    Evans, Allan T; Chiravuri, Srinivas; Gianchandani, Yogesh B

    2010-04-01

    This paper describes a system for transferring power across a transdermal needle into a smart refill port for recharging implantable drug delivery systems. The device uses a modified 26 gauge (0.46 mm outer diameter) Huber needle with multiple conductive elements designed to couple with mechanical springs in the septum of the refill port of a drug delivery device to form an electrical connection that can sustain the current required to recharge a battery during a reservoir refill session. The needle is fabricated from stainless steel coated with Parylene, and the refill port septum is made from micromachined stainless steel contact springs and polydimethylsiloxane. The device properties were characterized with dry and wet ambient conditions. The needle and port pair had an average contact resistance of less than 2 Omega when mated in either environment. Electrical isolation between the system, the liquid in the needle lumen, and surrounding material has been demonstrated. The device was used to recharge a NiMH battery with currents up to 500 mA with less than 15 degrees C of resistive heating. The system was punctured 100 times to provide preliminary information with regard to device longevity, and exhibited about 1 Omega variation in contact resistance. The results suggest that this needle and refill port system can be used in an implant to enable battery recharging. This allows for smaller batteries to be used and ultimately increases the volume efficiency of an implantable drug delivery device.

  3. Incidence of Pocket Infection Postcardiac Device Implantation Using Antibiotic versus Saline Solution for Pocket Irrigation.

    PubMed

    Lakshmanadoss, Umashankar; Nuanez, Bonita; Kutinsky, Ilana; Khalid, Rizwan; Haines, David E; Wong, Wai Shun

    2016-09-01

    Preprocedure systemic antibiotic prophylaxis reduces infections in patients undergoing cardiac implantable electronic devices (CIEDs) implantations. Whether pocket irrigation with antibiotic solution offers any advantage over saline solution in CIED implantation is unknown. Records from 327 consecutive patients who underwent CIED implantation by three operators from February 2011 to January 2014 were reviewed. From February 2011 to January 2012, the antibiotic solution was used for pocket irrigation; from February 2012 to January 2014, saline solution was used. All patients received preprocedural IV antibiotics. Baseline demographics, comorbidities, lab data, and occurrence of any pocket infection postimplant were collected. There were 118 and 209 patients in the antibiotic solution and saline solution group, respectively. A total of four (1.2%) patients had CIED infection: two in the antibiotic solution group and two in the saline solution group. Median time to infection from implant date was 81.5 ± 35 days. Two patients (50%) had infection after first device implantation. Of the four patients, one had positive blood culture, three had positive pocket cultures, one had lead vegetation, one underwent pocket exploration, and all of them had devices/leads extracted, with reimplantation on the contralateral side. No mortality was observed due to infectious complications. When compared to pocket irrigation in the antibiotic solution group, the saline solution group was not associated with increased incidence of infectious complications after CIED implantation. The use of saline solution pocket irrigation alone may be used in CIED pocket irrigation periprocedurally.  Further evaluation in larger randomized trials is needed. © 2016 Wiley Periodicals, Inc.

  4. Caudal fluoroscopy to guide venous access for pacemaker device implantation: should this now be standard practice?

    PubMed Central

    Patel, Hitesh C; Hayward, Carl; Nanayakkara, Shane; Broughton, Archer; Mariani, Justin A

    2017-01-01

    We describe a technique that uses both posterior-anterior and caudal fluoroscopy to achieve venous access for pacemaker device implantation. A significant advantage of this technique is the ability to clearly demarcate both the anatomy of venous drainage and the lung border. We would encourage all centres to adopt this technique as a safe approach to venous access. PMID:28321268

  5. Method to pattern <10 micrometer conducting and passivating features on 3D substrates for implantable devices

    DOEpatents

    Tolosa, Vanessa; Pannu, Satinderpall S.; Sheth, Heeral; Tooker, Angela C.; Shah, Kedar G.

    2017-07-04

    An implantable device has a cylindrical base, at least one electrode on the cylindrical base, at least one electrically conducting lead on the cylindrical base connected to the electrode wherein the electrically conducting lead has a feature size of <10 micrometers. A protective coating on the cylindrical base covers the at least one electrically conducting lead.

  6. Risk of electromagnetic interference induced by dental equipment on cardiac implantable electrical devices.

    PubMed

    Miranda-Rius, Jaume; Lahor-Soler, Eduard; Brunet-Llobet, Lluís; Sabaté de la Cruz, Xavier

    2016-12-01

    Patients with cardiac implantable electrical devices should take special precautions when exposed to electromagnetic fields. Proximity to equipment used in clinical dentistry may cause interference. This study evaluated in vitro the risks associated with different types/makes of cardiac devices and types of dental equipment. Six electronic dental tools were tested on three implantable cardioverter defibrillators and three pacemakers made by different manufacturers. Overall, the risk of interference with the pacemakers was 37% lower than with the implantable cardioverter defibrillators. Regarding the types/makes of cardiac devices analysed, that from Boston Scientific had a five-fold greater risk of interference than did that from Biotronik [prevalence ratio (PR) = 5.58]; there was no difference between that from Biotronik and that from Medtronic. Among the dental equipment, the electric pulp tester had the greatest risk of inducing interference and therefore this device was used as the benchmark. The electronic apex locator (PR = 0.29), Periotest M (PR = 0.47), and the ultrasonic dental scaler (PR = 0.59) were less likely to induce interference than the electric pulp tester. The risk was lowest with the electronic apex locator. Pacemakers presented a lower risk of light to moderate interference (PR = 0.63). However, the risk of severe electromagnetic interference was 3.5 times higher with pacemakers than with implantable cardioverter defibrillators (PR = 3.47).

  7. Infections in Cardiac Implantable Electronic Devices: Diagnosis and Management in a Referral Center.

    PubMed

    Gutiérrez Carretero, Encarnación; Arana Rueda, Eduardo; Lomas Cabezas, José Manuel; Laviana Martínez, Fernando; Villa Gil-Ortega, Manuel; Acosta Martínez, Jesús; Pedrote Martínez, Alonso; de Alarcón González, Arístides

    2017-05-01

    Infections in cardiac implantable electronic devices are increasing due to the expansion of the indications of these devices. The management of some aspects is controversial. Here, we report our broad experience. Between 1985 and 2015, 325 infections (196 local and 129 systemic) were registered; 28.5% of them were referred from other centers: 229 pacemakers, 69 implantable cardioverter-defibrillators, and 27 patients with cardiac resynchronization therapy. The follow-up was at least 1 year after hospital discharge. Percutaneous traction (PCT) was the most frequent procedure (n=280) in local (n=166) and systemic infections (n=114), with complete extraction of the system in 82.5% of the patients, clinical success in 89%, and few complications (2 deaths attributable to the technique). Overall mortality was 1% in local infections and 8% in systemic infections. After 212 complete PCT, a new device was placed in 209: of these, a contralateral system was implanted in the same procedure in 152 (73%) and in a second procedure in 57, with no differences in relapses (2 in the 1-stage procedure, and 1 in the 2-stage procedure). Percutaneous traction in experienced hands has good results with very few complications. It is possible to perform contralateral implantation of the new device on the same day without increasing the risk of relapse. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  8. The Challenges of Balancing Safety and Security in Implantable Medical Devices.

    PubMed

    Katzis, Konstantinos; Jones, Richard W; Despotou, George

    2016-01-01

    Modern Implantable Medical Devices (IMDs), implement capabilities that have contributed significantly to patient outcomes, as well as quality of life. The ever increasing connectivity of IMD's does raise security concerns though there are instances where implemented security measures might impact on patient safety. The paper discusses challenges of addressing both of these attributes in parallel.

  9. Wireless blood pressure monitoring with a novel implantable device: long-term in vivo results.

    PubMed

    Cleven, Nina J; Isfort, Peter; Penzkofer, Tobias; Woitok, Anna; Hermanns-Sachweh, Benita; Steinseifer, Ulrich; Schmitz-Rode, Thomas

    2014-12-01

    Devices constantly tracking the blood pressure (BP) of hypertensive patients are highly desired to facilitate effective patient management and to reduce hospitalization. We report on experiences gathered in a pilot study that was designed to evaluate the prototype of a newly developed, minimally invasive implantable sensor system for long-term BP monitoring. The device was implanted in the femoral artery (FA) of 12 sheep via standard FA catheterization under fluoroscopic control. Accuracy of the recorded blood pressure was determined by comparison with a reference catheter, which was positioned in the contralateral FA immediately after implantation. Regular follow-up included angiography, computed tomography (CT), and control of functionality and position of the BP sensor. Animals were euthanized after 6 months. FA segments with in situ pressure sensor underwent macroscopic and histopathologic examinations. All implantations of the novel sensor device in the FA were successful and uneventful. High-quality BP recordings were documented. Bland-Altman plots indicate very good agreement. Comparison with measurements taken from the reference sensor revealed mean differences and standard deviations of -0.56 ± 0.85, 0.29 ± 1.44, and 0.85 ± 2.27 mmHg (diastolic, systolic, and pulse pressure, respectively) after exclusion of one outlier. CT uncovered deficiencies in cable stability that were addressed in a redesign. No thrombus formation, necrosis, or apoptosis were detected. The pilot study proved the technical feasibility of wireless BP measurement in the FA via a novel miniature sensor device.

  10. Constant pressure fluid infusion into rat neocortex from implantable microfluidic devices

    NASA Astrophysics Data System (ADS)

    Retterer, S. T.; Smith, K. L.; Bjornsson, C. S.; Turner, J. N.; Isaacson, M. S.; Shain, W.

    2008-12-01

    Implantable electrode arrays capable of recording and stimulating neural activity with high spatial and temporal resolution will provide a foundation for future brain computer interface technology. Currently, their clinical impact has been curtailed by a general lack of functional stability, which can be attributed to the acute and chronic reactive tissue responses to devices implanted in the brain. Control of the tissue environment surrounding implanted devices through local drug delivery could significantly alter both the acute and chronic reactive responses, and thus enhance device stability. Here, we characterize pressure-mediated release of test compounds into rat cortex using an implantable microfluidic platform. A fixed volume of fluorescent cell marker cocktail was delivered using constant pressure infusion at reservoir backpressures of 0, 5 and 10 psi. Affected tissue volumes were imaged and analyzed using epifluorescence and confocal microscropies and quantitative image analysis techniques. The addressable tissue volume for the 5 and 10 psi infusions, defined by fluorescent staining with Hoescht 33342 dye, was significantly larger than the tissue volume addressed by simple diffusion (0 psi) and the tissue volume exhibiting insertion-related cell damage (stained by propidium iodide). The results demonstrate the potential for using constant pressure infusion to address relevant tissue volumes with appropriate pharmacologies to alleviate reactive biological responses around inserted neuroprosthetic devices.

  11. Short-term canine implantation of a glucose monitoring-telemetry device.

    PubMed

    Atanasov, P; Yang, S; Salehi, C; Ghindilis, A L; Wilkins, E

    1996-12-01

    In this study we report the development and short-term in vivo evaluation of an integrated implantable device consisting of an amperometric glucose biosensor, a miniature potentiostat, a FM signal transmitter, and power supply. The device (dimensions: 5.0 x 7.0 x 1.5 cm) was implanted under the skin of medium-size anaesthetized dog. The experimental set-up included several methods for data collection: analog recording via wired X-T chart recorders; data collection by wearable microprocessor--data logger, and remote data collection via antenna and receiver linked to a computer-based data acquisition system. The device (sensor) performance was evaluated in vitro prior to implantation, using different model solutions simulating the physiological environment. A linear response to glucose concentration was obtained up to 25 mM glucose, with a sensitivity of 0.5 microA/mM. The results of short-term subcutaneous implantation of the integrated device reveal adequate monitoring of an artificially-induced glycaemia. The delay-time was 3-7 minutes. These tests demonstrate the feasibility of data transmission by the telemetry system through the skin of a medium-sized dog and allow the commencement of chronic in vivo experimentation.

  12. [The establishment of three methods to improve the management of implantable medical device].

    PubMed

    Zhong, Jianping; Ge, Yi

    2011-01-01

    Based on the managerial deficiencies of Implantable medical device, using the RFID technology, the automatically comparison of data, Intelligent logistics, this article has established three conceptional methods of the original system of increment and iterative development. And details are included in aspect of principle, framework and etc. Meanwhile, advices have been given in the scientific and effective management of the medical instrument.

  13. Quantifying the effect of cardiorenal syndrome on mortality after left ventricular assist device implant.

    PubMed

    Kirklin, James K; Naftel, David C; Kormos, Robert L; Pagani, Francis D; Myers, Susan L; Stevenson, Lynne W; Givertz, Michael M; Young, James B

    2013-12-01

    Comorbidities complicate recovery and contribute to mortality after implant of a left ventricular assist device (LVAD). Coexistent cardiac and renal dysfunction (so-called cardiorenal syndrome) increases the risk of death, both with advanced heart failure and after LVAD implantation. We analyzed patients from the Interagency Registry for Mechanically Assist Circulatory Support to better estimate postimplant mortality according to the severity of renal dysfunction. Patients with a continuous-flow LVAD were grouped according to their pre-implant level of renal dysfunction: severe was defined as dialysis and/or estimated glomerular filtration rate (eGFR) < 30 ml/min; moderate if eGFR was 30 to 59 ml/min or blood urea nitrogen (BUN) was > 60 mg/dl; and mild or no renal dysfunction if eGFR was ≥ 60 ml/min and BUN was < 60 mg/dl. Of the 4,917 patients with a continuous-flow LVAD implanted between June 2006 and March 2012, 3,160 (64%) were identified with mild or no renal dysfunction, 1,475 (30%) with moderate dysfunction, and 282 (6%) with severe dysfunction. Worsening renal dysfunction correlated with decreased survival, with nearly a 20% reduction in the 2-year survival going from low to severe dysfunction. The major negative survival effect occurred during the first 3 months. Combination of severe renal dysfunction and cardiogenic shock predicted the highest early mortality. Pre-implant renal dysfunction predicts higher mortality after LVAD implant. The progressive reduction in survival with higher grades of renal dysfunction supports consideration of LVAD implant before cardiorenal syndrome is advanced. For patients with severe renal dysfunction and other major comorbidities, initial support with a temporary device while awaiting organ recovery before implanting a durable pump could be considered. © 2013 International Society for Heart and Lung Transplantation Published by International Society for the Heart and Lung Transplantation All rights reserved.

  14. Legal, ethical, and procedural bases for the use of aseptic techniques to implant electronic devices

    USGS Publications Warehouse

    Mulcahy, Daniel M.

    2013-01-01

    The popularity of implanting electronic devices such as transmitters and data loggers into captive and free-ranging animals has increased greatly in the past two decades. The devices have become smaller, more reliable, and more capable (Printz 2004; Wilson and Gifford 2005; Metcalfe et al. 2012). Compared with externally mounted devices, implanted devices are largely invisible to external viewers such as tourists and predators; exist in a physically protected, thermally stable environment in mammals and birds; and greatly reduce drag and risk of entanglement. An implanted animal does not outgrow its device or attachment method as can happen with collars and harnesses, which allows young animals to be more safely equipped. However, compared with mounting external devices, implantation requires greater technical ability to perform the necessary anesthesia, analgesia, and surgery. More than 83% of publications in the 1990s that used radiotelemetry on animals assumed that there were no adverse effects on the animal (Godfrey and Bryant 2003). It is likely that some studies using implanted electronic devices have not been published due to a high level of unexpected mortality or to aberrant behavior or disappearance of the implanted animals, a phenomenon known as the “file drawer” problem (Rosenthal 1979; Scargle 2000). The near absence of such studies from the published record may be providing a false sense of security that procedures being used are more innocuous than they actually are. Similarly, authors sometimes state that it was unlikely that device implantation was problematic because study animals appeared to behave normally, or authors state that previous investigators used the same technique and saw no problems. Such statements are suppositions if no supporting data are provided or if the animals were equipped because there was no other way to follow their activity. Moreover, such suppositions ignore other adverse effects that affect behavior indirectly, and

  15. Optimal timing of same-admission orthotopic heart transplantation after left ventricular assist device implantation

    PubMed Central

    Gulati, Gunsagar; Ouyang, David; Ha, Richard; Banerjee, Dipanjan

    2017-01-01

    AIM To investigate the impact of timing of same-admission orthotopic heart transplant (OHT) after left ventricular assist device (LVAD) implantation on in-hospital mortality and post-transplant length of stay. METHODS Using data from the Nationwide Inpatient Sample from 1998 to 2011, we identified patients 18 years of age or older who underwent implantation of a LVAD and for whom the procedure date was available. We calculated in-hospital mortality for those patients who underwent OHT during the same admission as a function of time from LVAD to OHT, adjusting for age, sex, race, household income, and number of comorbid diagnoses. Finally, we analyzed the effect of time to OHT after LVAD implantation on the length of hospital stay post-transplant. RESULTS Two thousand and two hundred patients underwent implantation of a LVAD in this cohort. One hundred and sixty-four (7.5%) patients also underwent OHT during the same admission, which occurred on average 32 d (IQR 7.75-66 d) after LVAD implantation. Of patients who underwent OHT, patients who underwent transplantation within 7 d of LVAD implantation (“early”) experienced increased in-hospital mortality (26.8% vs 12.2%, P = 0.0483) compared to patients who underwent transplant after 8 d (“late”). There was no statistically significant difference in age, sex, race, household income, or number of comorbid diagnoses between the early and late groups. Post-transplant length of stay after LVAD implantation was also not significantly different between patients who underwent early vs late OHT. CONCLUSION In this cohort of patients who received LVADs, the rate of in-hospital mortality after OHT was lower for patients who underwent late OHT (at least 8 d after LVAD implantation) compared to patients who underwent early OHT. Delayed timing of OHT after LVAD implantation did not correlate with longer hospital stays post-transplant. PMID:28289529

  16. The Analog Blanking Period of Implantable Cardiac Rhythm Devices.

    PubMed

    Barold, S Serge; Kucher, Andreas

    2017-02-01

    Analog blanking periods (BPs) that hold down the display of electrograms (EGMs) in cardiac rhythm devices have received much less attention than the well-known digital BPs which do not influence the EGM display. In Biotronik devices (Biotronik GmbH, Berlin, Germany), when a paced event initiates an analog BP in one chamber (right atrium, right ventricle [RV], or left ventricle [LV]), an identical cross-chamber analog BP starts in the other two chambers. All clinical observations were recorded from patients with Biotronik devices. The effect of the atrial cross-chamber analog BP initiated by a ventricular paced event on the atrial EGM was studied in the records of seven patients with frequent paroxysmal atrial flutter to determine the effect of critically timed RV paced event (RVp) or LV paced event (LVp) upon the atrial EGM. The effect of atrial pacing triggering cross-chamber analog BPs in the RV and LV channels on the RV and LV EGMs was also investigated in cases of conducted supraventricular beats and ventricular premature complexes. The effect of a triggered LVp initiating a cross-chamber analog BP in the RV channel on the EGM of a sensed RV sensed event was evaluated in 10 cases. Simulation studies were also performed to verify the clinical observations. Patients with atrial flutter showed intermittent truncation or deformity and even disappearance of the atrial signals due to an atrial cross-chamber analog BP initiated by RVp and/or LVp. Three patients demonstrated deformity of the signal shape of ventricular premature beats falling within a ventricular cross-chamber analog BP initiated by right atrial paced event (RAp). We found only one case of a supraventricular QRS complex trapped in a ventricular cross-chamber analog BP initiated by RAp. All the recordings of LVp triggering upon RVs revealed a variety of RV signal deformities occasionally with preservation of the terminal part of the RV signal. Simulation studies confirmed the effect of the analog BP on

  17. [Progress of researches on drug-loaded nanoparticles].

    PubMed

    Zhao, Jian; Sheng, Yan; Shan, Xiaoqian; Zhang, Xiaolan; Yuan, Yuan; Liu, Changsheng

    2008-02-01

    The progress of researches on drug-loaded nanoparticles was summarized in this review. The major emphasis was laid on the selection of wall polymers, technology of preparation, surface modification, investigation of release in vitro and biocompatibility evaluation. Additionally, we envisioned a perspective regarding the development in this field. With the development of synthesis of biodegradable polymer, with the appearance of novel equipment, and with the deep-going studies on modification of nanoparticles surface method, on fabrication of nanoparticles art as well as on evaluation of drug release and reaction between drug and organ, further researches in this field will open up the way to applications of drug-loaded nanoparticles in larger field.

  18. Cerebrospinal fluid-compensated medication reservoir for an implantable infusion device: concept and preliminary evaluation.

    PubMed

    Nam, Kyoung Won; Choi, Seong Wook; Kim, In Young; Kim, Kwang Gi; Jo, Yung Ho; Kim, Dae Hyun

    2013-05-17

    Conventional gas-compensated medication reservoirs used for implantable infusion devices require perfect sealing of the gas chamber, because the gases used are generally toxic. In addition, the physical properties of selected gas critically affect the performance of infusion devices and hydraulic performance of the infusion device can be affected by the amount of medication discharged.
In this study, we suggest a new medication reservoir that adopts a cerebrospinal fluid (CSF)-compensating mechanism, such that when a medication is released from the reservoir by a mechanical actuator, native CSF enters into the reservoir to minimize the build-up of pressure drop. We evaluated in vitro performance and conducted in vivo feasibility tests by using an intrathecal infusion device developed at the Korean National Cancer Center. Experimental results showed that the proposed CSF-compensated infusion pump was essentially less affected by ambient temperature or pressure conditions compared to the gas-compensated infusion pump. Moreover, it showed moderate implant feasibility and operating stability during an animal experiment performed for 12 days. We believe that the proposed volume-compensating mechanism could be applied in various medical fields that use implantable devices.

  19. Anaesthetic management of pregnant patients with cardiac implantable electronic devices: case reports and review.

    PubMed

    Salman, M M; Kemp, H I; Cauldwell, M R; Dob, D P; Sutton, R

    2017-08-04

    Heart disease is a leading cause of maternal mortality and morbidity. Pregnant women with structural, conduction or degenerative cardiac disease who require rhythm control or who are at high risk of sudden cardiac death may carry a cardiac implantable electronic device or may occasionally require the insertion of one during their pregnancy. These women are now encountered more frequently in clinical practice, and it is essential that a multidisciplinary approach, beginning from the early antenatal phase, be adopted in their counselling and management. Contemporary cardiac rhythm control devices are a constantly evolving technology with increasingly sophisticated features; anaesthetists should therefore have an adequate understanding of the principles of their operation and the special considerations for their use, in order to enable their safe management in the peripartum period. Of particular importance is the potential adverse effect of electromagnetic interference, which may cause device malfunction or damage, and the precautions required to reduce this risk. The ultimate goal in the management of this patient subgroup is to minimise the disruption to cardiovascular physiology that may occur near the time of labour and delivery and to control the factors that impact on device integrity and function. We present the ante- and peripartum management of two pregnant women with an implantable cardioverter-defibrillator, followed by a review and update of the anaesthetic management of parturients with cardiac implantable electronic devices. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. Osseointegration of metallic devices: current trends based on implant hardware design.

    PubMed

    Coelho, Paulo G; Jimbo, Ryo

    2014-11-01

    Osseointegration of metallic devices has been one of the most successful treatments in rehabilitative dentistry and medicine over the past five decades. While highly successful, the quest for designing surgical instrumentation and associated implantable devices that hastens osseointegration has been perpetual and has often been approached as single variable preclinical investigations. The present manuscript presents how the interplay between surgical instrumentation and device macrogeometry not only plays a key role on both early and delayed stages of osseointegration, but may also be key in how efficient smaller length scale designing (at the micrometer and nanometer scale levels) may be in hastening early stages of osseointegration. Copyright © 2014 Elsevier Inc. All rights reserved.

  1. Biodegradable click capsules with engineered drug-loaded multilayers.

    PubMed

    Ochs, Christopher J; Such, Georgina K; Yan, Yan; van Koeverden, Martin P; Caruso, Frank

    2010-03-23

    We report the modular assembly of a polymer-drug conjugate into covalently stabilized, responsive, biodegradable, and drug-loaded capsules with control over drug dose and position in the multilayer film. The cancer therapeutic, doxorubicin hydrochloride (DOX), was conjugated to alkyne-functionalized poly(l-glutamic acid) (PGA(Alk)) via amide bond formation. PGA(Alk) and PGA(Alk+DOX) were assembled via hydrogen bonding with poly(N-vinyl pyrrolidone) (PVPON) on planar and colloidal silica templates. The films were subsequently covalently stabilized using diazide cross-linkers, and PVPON was released from the multilayers by altering the solution pH to disrupt hydrogen bonding. After removal of the sacrificial template, single-component PGA(Alk) capsules were obtained and analyzed by optical microscopy, transmission electron microscopy, and atomic force microscopy. The PGA(Alk) capsules were stable in the pH range between 2 and 11 and exhibited reversible swelling/shrinking behavior. PGA(Alk+DOX) was assembled to form drug-loaded polymer capsules with control over drug dose and position in the multilayer system (e.g., DOX in every layer or exclusively in layer 3). The drug-loaded capsules could be degraded enzymatically, resulting in the sustained release of active DOX over approximately 2 h. Cellular uptake studies demonstrate that the viability of cells incubated with DOX-loaded PGA(Alk) capsules significantly decreased. The general applicability of this modular approach, in terms of incorporation of polymer-drug conjugates in other click multilayer systems, was also demonstrated. Biodegradable click capsules with drug-loaded multilayers are promising candidates as carrier systems for biomedical applications.

  2. Cardiac implantable electronic device infections: facts, current practice, and the unanswered questions.

    PubMed

    Tarakji, Khaldoun G; Wilkoff, Bruce L

    2014-09-01

    Over the last 2 decades, there has been a surge in newly implanted cardiac implantable electronic devices (CIEDs). This is largely due to the increasing indications for these devices and their role in improving both survival and quality of life among certain groups of patients with heart disease. However, the net benefit of these devices is affected by adverse events and complications. CIED infection is one of these complications that increase morbidity and mortality. Patients with CIED infection can present with pocket infection or endovascular infection. Management usually involves CIED removal and antibiotic therapy. Despite its importance, many questions remain unanswered. Longitudinal studies and randomized clinical trials are needed to better define risk factors for CIED infections and outcomes and to help assess best practices to prevent this complication.

  3. Molecular-beam epitaxial regrowth on oxygen-implanted GaAs substrates for device integration

    NASA Astrophysics Data System (ADS)

    Chen, C. L.; Mahoney, L. J.; Calawa, S. D.; Molvar, K. M.; Maki, P. A.; Mathews, R. H.; Sage, J. P.; Sollner, T. C. L. G.

    1999-06-01

    Device-quality layers were regrown on GaAs wafers by molecular-beam epitaxy over conductive pregrown areas and on selectively patterned high-resistivity areas formed by oxygen implantation. The regrowth over both areas resulted in comparable device-quality GaAs. The high resistivity of the oxygen-implanted area was maintained after the regrowth and no oxygen incorporation was observed in the regrown layer. The cutoff frequency of a 1.5-μm-gate metal-semiconductor field-effect transistor fabricated on the regrown layer over the high-resistivity areas is 7 GHz. This demonstration shows that planar technology can be used in epitaxial regrowth, simplifying the integration of vastly different devices into monolithic circuits.

  4. An implantable sensor device measuring suture tension dynamics: results of developmental and experimental work.

    PubMed

    Schachtrupp, A; Wetter, O; Höer, J

    2016-08-01

    Knowledge about suture tension dynamics after laparotomy closure is limited due to the lack of adequate measurement tools. As a consequence, a miniaturized implantable sensor and data logger were developed and applied experimentally in a porcine model to measure suture tension dynamics after laparotomy closure. We developed an implantable device (6 × 3 × 1 mm) fitted with silicon strain gauges and an implantable data logger allowing long-term registration. In nine domestic pigs, sensors and loggers were implanted along the suture closing a median laparotomy registering suture tension over a period of 23 h. Fascial closure was achieved by a mean suture tension of 1.07 N. After 30 minutes, suture tension was reduced to 0.81N (-24.3 %, p = 0.0003). After 12 h, tension showed a further decrease to 0.69 N (-35.5 %, n.s.), after 23 h mean suture tension reached 0.56 N, (-47.7 %, p = 0.014). The aim to develop an implantable miniaturized sensor device registering long-term suture tension dynamics was achieved. The use in the animal experiment was feasible and safe. We observed a loss of almost 50 % of suture tension 23 h after fascial closure. This could mean that up to 50 % of initial suture tension may be an unnecessary surplus not contributing to tissue stability but to the risk of suture failure.

  5. Compensating for Tissue Changes in an Ultrasonic Power Link for Implanted Medical Devices.

    PubMed

    Vihvelin, Hugo; Leadbetter, Jeff; Bance, Manohar; Brown, Jeremy A; Adamson, Robert B A

    2016-04-01

    Ultrasonic power transfer using piezoelectric devices is a promising wireless power transfer technology for biomedical implants. However, for sub-dermal implants where the separation between the transmitter and receiver is on the order of several acoustic wavelengths, the ultrasonic power transfer efficiency (PTE) is highly sensitive to the distance between the transmitter and receiver. This sensitivity can cause large swings in efficiency and presents a serious limitation on battery life and overall performance. A practical ultrasonic transcutaneous energy transfer (UTET) system design must accommodate different implant depths and unpredictable acoustic changes caused by tissue growth, hydration, ambient temperature, and movement. This paper describes a method used to compensate for acoustic separation distance by varying the transmit (Tx) frequency in a UTET system. In a benchtop UTET system we experimentally show that without compensation, power transfer efficiency can range from 9% to 25% as a 5 mm porcine tissue sample is manipulated to simulate in situ implant conditions. Using an active frequency compensation method, we show that the power transfer efficiency can be kept uniformly high, ranging from 20% to 27%. The frequency compensation strategy we propose is low-power, non-invasive, and uses only transmit-side measurements, making it suitable for active implanted medical device applications.

  6. Safety of magnetic resonance imaging in patients with implanted cardiac prostheses and metallic cardiovascular electronic devices.

    PubMed

    Baikoussis, Nikolaos G; Apostolakis, Efstratios; Papakonstantinou, Nikolaos A; Sarantitis, Ioannis; Dougenis, Dimitrios

    2011-06-01

    Magnetic resonance imaging (MRI) in patients with implanted cardiac prostheses and metallic cardiovascular electronic devices is sometimes a risky procedure. Thus MRI in these patients should be performed when it is the only examination able to help with the diagnosis. Moreover the diagnostic benefit must outweigh the risks. Coronary artery stents, prosthetic cardiac valves, metal sternal sutures, mediastinal vascular clips, and epicardial pacing wires are not contraindications for MRI, in contrast to pacemakers and implantable cardioverter-defibrillators. Appropriate patient selection and precautions ensure MRI safety. However it is commonly accepted that although hundreds of patients with pacemakers or implantable cardioverter-defibrillators have undergone safe MRI scanning, it is not a safe procedure. Currently, heating of the pacemaker lead is the major problem undermining MRI safety. According to the US Food and Drug Administration (FDA), there are currently neither "MRI-safe" nor "MRI-compatible" pacemakers and implantable cardioverter-defibrillators. In this article we review the international literature in regard to safety during MRI of patients with implanted cardiac prostheses and metallic cardiovascular electronic devices. Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  7. Integration of High Dose Boron Implants—Modification of Device Parametrics through Implant Temperature Control

    NASA Astrophysics Data System (ADS)

    Schmeide, Matthias; Ameen, M. S.; Kondratenko, Serguei; Krimbacher, Bernhard; Reece, Ronald N.

    2011-01-01

    In the present study, we have extended a previously reported 250 nm logic p-S/D implant (7 keV B 4.5×1015 cm-2) process matching exercise [5] to include wafer temperature, and demonstrate that matching can be obtained by increasing the temperature of the wafer during implant. We found that the high dose rate delivered by the single wafer implanter caused the formation of a clear amorphous layer, which upon subsequent annealing altered the diffusion, activation, and clustering properties of the boron. Furthermore, increasing the temperature of the wafer during the implant was sufficient to suppress amorphization, allowing profiles and device parameters to become matched. Figure 5 shows a representative set of curves indicating the cluster phenomena observed for the lower temperature, high flux single wafer implanter, and the influence of wafer temperature on the profiles. The results indicate the strong primary effect of dose rate in determining final electrical properties of devices, and successful implementation of damage engineering using wafer temperature control.

  8. Predictors of right ventricular failure after left ventricular assist device implantation.

    PubMed

    Koprivanac, Marijan; Kelava, Marta; Sirić, Franjo; Cruz, Vincent B; Moazami, Nader; Mihaljević, Tomislav

    2014-12-01

    Number of left ventricular assist device (LVAD) implantations increases every year, particularly LVADs for destination therapy (DT). Right ventricular failure (RVF) has been recognized as a serious complication of LVAD implantation. Reported incidence of RVF after LVAD ranges from 6% to 44%, varying mostly due to differences in RVF definition, different types of LVADs, and differences in patient populations included in studies. RVF complicating LVAD implantation is associated with worse postoperative mortality and morbidity including worse end-organ function, longer hospital length of stay, and lower success of bridge to transplant (BTT) therapy. Importance of RVF and its predictors in a setting of LVAD implantation has been recognized early, as evidenced by abundant number of attempts to identify independent risk factors and develop RVF predictor scores with a common purpose to improve patient selection and outcomes by recognizing potential need for biventricular assist device (BiVAD) at the time of LVAD implantation. The aim of this article is to review and summarize current body of knowledge on risk factors and prediction scores of RVF after LVAD implantation. Despite abundance of studies and proposed risk scores for RVF following LVAD, certain common limitations make their implementation and clinical usefulness questionable. Regardless, value of these studies lies in providing information on potential key predictors for RVF that can be taken into account in clinical decision making. Further investigation of current predictors and existing scores as well as new studies involving larger patient populations and more sophisticated statistical prediction models are necessary. Additionally, a short description of our empirical institutional approach to management of RVF following LVAD implantation is provided.

  9. Predictors of right ventricular failure after left ventricular assist device implantation

    PubMed Central

    Koprivanac, Marijan; Kelava, Marta; Sirić, Franjo; Cruz, Vincent B.; Moazami, Nader; Mihaljević, Tomislav

    2014-01-01

    Number of left ventricular assist device (LVAD) implantations increases every year, particularly LVADs for destination therapy (DT). Right ventricular failure (RVF) has been recognized as a serious complication of LVAD implantation. Reported incidence of RVF after LVAD ranges from 6% to 44%, varying mostly due to differences in RVF definition, different types of LVADs, and differences in patient populations included in studies. RVF complicating LVAD implantation is associated with worse postoperative mortality and morbidity including worse end-organ function, longer hospital length of stay, and lower success of bridge to transplant (BTT) therapy. Importance of RVF and its predictors in a setting of LVAD implantation has been recognized early, as evidenced by abundant number of attempts to identify independent risk factors and develop RVF predictor scores with a common purpose to improve patient selection and outcomes by recognizing potential need for biventricular assist device (BiVAD) at the time of LVAD implantation. The aim of this article is to review and summarize current body of knowledge on risk factors and prediction scores of RVF after LVAD implantation. Despite abundance of studies and proposed risk scores for RVF following LVAD, certain common limitations make their implementation and clinical usefulness questionable. Regardless, value of these studies lies in providing information on potential key predictors for RVF that can be taken into account in clinical decision making. Further investigation of current predictors and existing scores as well as new studies involving larger patient populations and more sophisticated statistical prediction models are necessary. Additionally, a short description of our empirical institutional approach to management of RVF following LVAD implantation is provided. PMID:25559829

  10. A modified oxidation procedure for ion-implanted silicon carbide devices annealed at low temperatures

    NASA Astrophysics Data System (ADS)

    Capano, M. A.

    2001-12-01

    There is recent evidence that the temperature at which implants in SiC are activated plays a determining role in the performance of some devices. One example is the dependence of the channel mobility of SiC metal-oxide-semiconductor field-effect transistors (MOSFETs) on the annealing temperature needed to activate source and drain implants. Another example is the dependence of surface roughness on anneal temperature. In both cases, there are definite advantages in using low processing temperatures for implant activation anneals. This paper considers low-temperature ion implantation processing of SiC electronic materials, and modifications to the gate oxidation step for SiC MOSFETs that may be required by the use of low-temperature activation annealing. The term 'low-temperature' is used to indicate annealing temperatures well below 1500 °C which are typically used for donor implant activation in SiC. The substitution of phosphorus for nitrogen in the fabrication of MOSFETs, while enabling low-temperature activation annealing, leads to excessive gate leakage currents. The cause of oxide leakage is discussed speculatively in terms of excess carbon on the SiC prior to gate oxidation. These assumptions form the premise for SiC MOSFET experiments fabricated with phosphorus-implanted source and drain regions, and a modified oxidation procedure. MOSFETs built using phosphorus implants annealed at 1200 °C and the modified oxidation procedure exhibit ID/ IG current ratios greater than 10 4, and channel mobilities in excess of 10 cm 2/V s. The device yield is greater than 90%.

  11. Inhibition of Staphylococcus aureus Biofilms by a Novel Antibacterial Envelope for Use with Implantable Cardiac Devices

    PubMed Central

    Agostinho, Alessandra; James, Garth; Wazni, Oussama; Citron, Mark; Wilkoff, Bruce D.

    2009-01-01

    Abstract Biofilm formation on representative implantable medical devices using a known human pathogen (Staphylococcus aureus) was significantly reduced (p < 0.01) at all time points measured (24,48, and 72 hours) by employing a novel antibacterial envelope (AIGIS Rx™). The result was demonstrated using a standard US Centers for Disease Control (CDC) bioreactor model and the results were confirmed by Scanning Electron Microscopy (SEM). The antibacterial envelope used in the study is coated with a proprietary combination broad spectrum antibiotics (rifampin and minocycline) embedded in a resorbable polymeric coating. The antibiotics are designed to elute out of the coating over a multi‐day period for controlled, site‐specific drug delivery. The infection rate for patients receiving pacemakers and defibrillators is increasing faster than the rate of new implants and the growing resistance of S. aureus strains suggests that conventional, systemic antibiotic prophylaxis may have limited future utility. Moreover, emerging evidence suggests that bacterial biofilms result in infections of implantable medical devices. These findings demonstrate the in vitro efficacy of a new means to address potential biofilm‐derived Hospital Acquired Infections (HAIs) related to implantable medical devices composed of titanium inclusive of pacemakers and defibrillators by means of a locally delivered, low dose, combination antibacterial treatment. PMID:20443892

  12. A wireless power transmission system for implantable devices in freely moving rodents.

    PubMed

    Eom, Kyungsik; Jeong, Joonsoo; Lee, Tae Hyung; Kim, Jinhyung; Kim, Junghoon; Lee, Sung Eun; Kim, Sung June

    2014-08-01

    Reliable wireless power delivery for implantable devices in animals is highly desired for safe and effective experimental use. Batteries require frequent replacement; wired connections are inconvenient and unsafe, and short-distance inductive coupling requires the attachment of an exterior transmitter to the animal's body. In this article, we propose a solution by which animals with implantable devices can move freely without attachments. Power is transmitted using coils attached to the animal's cage and is received by a receiver coil implanted in the animal. For a three-dimensionally uniform delivery of power, we designed a columnar dual-transmitter coil configuration. A resonator-based inductive link was adopted for efficient long-range power delivery, and we used a novel biocompatible liquid crystal polymer substrate as the implantable receiver device. Using this wireless power delivery system, we obtain an average power transfer efficiency of 15.2% (minimum efficiency of 10% and a standard deviation of 2.6) within a cage of 15×20×15 cm3.

  13. Remote monitoring of cardiac implantable devices in the Asia-Pacific.

    PubMed

    Lau, Chu-Pak; Zhang, Shu

    2013-06-01

    Remote monitoring of pacemakers and implantable cardioverter defibrillators (ICDs) has emerged as a tool to replace regular follow-up of such devices, and to detect hardware failure, arrhythmias, and heart failure decompensation. The Asia-Pacific region is a geographically diverse area, with widely different cardiac device implant rates and expertise. However, common to all countries, distance and logistic for patients to reach an expert monitoring centre for routine follow up are significant, and in some countries, this will likely be replaced by remote monitoring. Unscheduled visits such as for the treatment of atrial fibrillation and ICD shocks will be expedited. There has been an increase in both pacemaker and ICD implant rates in Asia-Pacific, due to an ageing population and improvement in economic condition. Among the countries, Australia and Japan are the major users of remote monitoring. According to the statistics of the suppliers, in Australia, up to 15% of pacemakers, 40% ICD, and 30% cardiac resynchronization therapy (CRT)/cardiac resynchronization therapy defibrillator (CTRD) are remotely monitored. The corresponding numbers for Japan are 5, 50, and 50% respectively. The monitoring personnel include nurses, technicians, and doctors, either from local centre or from device companies. Cost, lack of reimbursement, and logistic support are major issues in widespread application of remote monitoring technology. In conclusion, remote monitoring is increasing in Asia-Pacific region despite the increase in cost. Implantable cardioverter defibrillators and CRT/CRTDs are more likely than pacemakers to be enabled with remote monitoring.

  14. Solute diffusion through fibrotic tissue formed around protective cage system for implantable devices.

    PubMed

    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.

  15. Nanobionics: the impact of nanotechnology on implantable medical bionic devices.

    PubMed

    Wallace, G G; Higgins, M J; Moulton, S E; Wang, C

    2012-08-07

    The nexus of any bionic device can be found at the electrode-cellular interface. Overall efficiency is determined by our ability to transfer electronic information across that interface. The nanostructure imparted to electrodes plays a critical role in controlling the cascade of events that determines the composition and structure of that interface. With commonly used conductors: metals, carbon and organic conducting polymers, a number of approaches that promote control over structure in the nanodomain have emerged in recent years with subsequent studies revealing a critical dependency between nanostructure and cellular behaviour. As we continue to develop our understanding of how to create and characterise electromaterials in the nanodomain, this is expected to have a profound effect on the development of next generation bionic devices. In this review, we focus on advances in fabricating nanostructured electrodes that present new opportunities in the field of medical bionics. We also briefly evaluate the interactions of living cells with the nanostructured electromaterials, in addition to highlighting emerging tools used for nanofabrication and nanocharacterisation of the electrode-cellular interface.

  16. Fabrication and Characterization of Thin Film Ion Implanted Composite Materials for Integrated Nonlinear Optical Devices

    NASA Technical Reports Server (NTRS)

    Sarkisov, S.; Curley, M.; Williams, E. K.; Wilkosz, A.; Ila, D.; Poker, D. B.; Hensley, D. K.; Smith, C.; Banks, C.; Penn, B.; Clark, R.

    1998-01-01

    Ion implantation has been shown to produce a high density of metal colloids within the layer regions of glasses and crystalline materials. The high-precipitate volume fraction and small size of metal nanoclusters formed leads to values for the third-order susceptibility much greater than those for metal doped solids. This has stimulated interest in use of ion implantation to make nonlinear optical materials. On the other side, LiNbO3 has proved to be a good material for optical waveguides produced by MeV ion implantation. Light confinement in these waveguides is produced by refractive index step difference between the implanted region and the bulk material. Implantation of LiNbO3 with MeV metal ions can therefore result into nonlinear optical waveguide structures with great potential in a variety of device applications. We describe linear and nonlinear optical properties of a waveguide structure in LiNbO3-based composite material produced by silver ion implantation in connection with mechanisms of its formation.

  17. RF communication with implantable wireless device: effects of beating heart on performance of miniature antenna.

    PubMed

    Murphy, Olive H; Borghi, Alessandro; Bahmanyar, Mohammad Reza; McLeod, Christopher N; Navaratnarajah, Manoraj; Yacoub, Magdi; Toumazou, Christofer

    2014-06-01

    The frequency response of an implantable antenna is key to the performance of a wireless implantable sensor. If the antenna detunes significantly, there are substantial power losses resulting in loss of accuracy. One reason for detuning is because of a change in the surrounding environment of an antenna. The pulsating anatomy of the human heart constitutes such a changing environment, so detuning is expected but this has not been quantified dynamically before. Four miniature implantable antennas are presented (two different geometries) along with which are placed within the heart of living swine the dynamic reflection coefficients. These antennas are designed to operate in the short range devices frequency band (863-870 MHz) and are compatible with a deeply implanted cardiovascular pressure sensor. The measurements recorded over 27 seconds capture the effects of the beating heart on the frequency tuning of the implantable antennas. When looked at in the time domain, these effects are clearly physiological and a combination of numerical study and posthumous autopsy proves this to be the case, while retrospective simulation confirms this hypothesis. The impact of pulsating anatomy on antenna design and the need for wideband implantable antennas is highlighted.

  18. Minimally invasive sinus lift implant device: a multicenter safety and efficacy trial preliminary results.

    PubMed

    Better, Hadar; Slavescu, Dragos; Barbu, Horia; Cochran, David L; Chaushu, Gabi

    2014-08-01

    In cases of advanced maxillary sinus atrophy of the bone (pneumatization), the sinus floor has to be augmented in order to obtain acceptable bone volume for implantation. The objective of the present study is to evaluate a new procedure and device, designed as a closed sinus lift using a dedicated dental implant that allows for Schneiderian membrane elevation and the placement of a flowable bone replacement graft. Eighteen patients (8 males, 10 females) underwent 23 procedures. All procedures were completed successfully, with elevation of the sinus membrane and insertion of bone graft and the dental implant at the planned site. No membrane tears were noted. No intraoperative or postoperative adverse events were observed in any of the cases. There were no postprocedural emergency or distress calls. The patients' average age was 52 (range 38-72). The mean residual alveolar ridge height was 5.5 mm (range 4.0-7.0). The average bone gain was 11.2 mm (range 9-13) after an average healing period of 8.7 months (range 6.7-13.1). All implants achieved clinical stability and prosthetic rehabilitation was uneventful. A closed sinus floor elevation procedure can be accomplished using a dedicated dental implant that allows for hydraulic elevation of the Schneiderian membrane and placement of a flowable bone replacement graft and dental implant placement all at the same time with minimal patient discomfort. © 2012 Wiley Periodicals, Inc.

  19. The Application of Virtual Planning and Navigation Devices for Mandible Reconstruction and Immediate Dental Implantation

    PubMed Central

    Rahimov, Chingiz R.; Farzaliyev, Ismayil M.; Fathi, Hamid Reza; Davudov, Mahammad M.; Aliyev, Anar; Hasanov, Emin

    2015-01-01

    Routine reconstruction of subtotal defects of the mandible and orthopedic rehabilitation supported by dental implants is achieved by means of detailed planning and lasts over a year. This article shows the outcomes of single-stage surgical treatment and immediate orthopedic rehabilitation performed with the help of preoperative virtual computer simulation. 3D investigation of pathological and donor sites, virtual simulation of tumor resection, positioning of the dental implants into fibula, virtual flap bending and transfer, virtual bending of fixing reconstruction plates, and fabrication of navigation templates and bridge prosthesis supported by dental implants were done preoperatively. The surgery included tumor resection, insertion of dental implants into fibula, elevation of fibula osteocutaneous free flap, rigid fixation within recipient site, and immediate loading by bridge orthopedic device. On 10-month follow-up, functional and esthetic results were asses as reasonable. Radiography showed dental implants to be integrated and positioned appropriately. We found that successful rehabilitation of the patients with extensive defects of the jaws could be achieved by ablative tumor resection, dental implants insertion prior to flap elevation guided by navigation templates, further osteotomy, modeling of the flap based on navigation template, flap transfer, and rigid fixation within recipient site by prebended plates, with application of prefabricated prosthesis. PMID:27162568

  20. Fabrication and Characterization of Thin Film Ion Implanted Composite Materials for Integrated Nonlinear Optical Devices

    NASA Technical Reports Server (NTRS)

    Sarkisov, S.; Curley, M.; Williams, E. K.; Wilkosz, A.; Ila, D.; Poker, D. B.; Hensley, D. K.; Smith, C.; Banks, C.; Penn, B.; hide

    1998-01-01

    Ion implantation has been shown to produce a high density of metal colloids within the layer regions of glasses and crystalline materials. The high-precipitate volume fraction and small size of metal nanoclusters formed leads to values for the third-order susceptibility much greater than those for metal doped solids. This has stimulated interest in use of ion implantation to make nonlinear optical materials. On the other side, LiNbO3 has proved to be a good material for optical waveguides produced by MeV ion implantation. Light confinement in these waveguides is produced by refractive index step difference between the implanted region and the bulk material. Implantation of LiNbO3 with MeV metal ions can therefore result into nonlinear optical waveguide structures with great potential in a variety of device applications. We describe linear and nonlinear optical properties of a waveguide structure in LiNbO3-based composite material produced by silver ion implantation in connection with mechanisms of its formation.

  1. Amplification options in unilateral aural atresia: an active middle ear implant or a bone conduction device?

    PubMed

    Agterberg, Martijn J H; Frenzel, Henning; Wollenberg, Barbara; Somers, Thomas; Cremers, Cor W R J; Snik, Ad F M

    2014-01-01

    There is no consensus on treatment of patients with congenital unilateral aural atresia. Currently, 3 intervention options are available, namely, surgical reconstruction, application of a bone-conduction device (BCD), or application of a middle ear implant. The present study aims to compare the BCD with the application of a middle ear implant. We hypothesized that cross-hearing (stimulating the cochlea by means of bone conduction contralateral to the implanted side) would cause BCD users to have difficulty performing localization tasks. Audiologic data of 4 adult patients with a middle ear implant coupled directly to the cochlea were compared with data of 4 adult patients fitted with an osseointegrated BCD. All patients were fitted during adulthood. The emphasis of this study is on directional hearing. The middle ear implant and the BCD improved sound localization of patients with congenital unilateral aural atresia. Unaided scores demonstrate a large variation. Our results demonstrate that there was no advantage of the middle ear implant over the BCD for directional hearing in patients who had no amplification in childhood. The BCD users had the best bandwidth.

  2. A 10.5 cm ultrasound link for deep implanted medical devices.

    PubMed

    Mazzilli, Francesco; Lafon, Cyril; Dehollain, Catherine

    2014-10-01

    A study on ultrasound link for wireless energy transmission dedicated to deeply implanted medical devices is presented. The selection of the frequency to avoid biological side effects (e.g., cavitations), the choice of the power amplifier to drive the external transducers and the design of the rectifier to maximize the energy extraction from the implanted transducer are described in details. The link efficiency is characterized in water using a phantom material for a transmitter-receiver distance of 105 mm, transducers active area of 30 mm × 96 mm and 5 mm × 10 mm, respectively, and a system efficiency of 1.6% is measured.

  3. An implantable device for neuropsychiatric rehabilitation by chronic deep brain stimulation in freely moving rats

    PubMed Central

    Wang, Chenguang; Zhang, Fuqiang; Jia, Hong

    2017-01-01

    Successful practice of clinical deep brain stimulation (DBS) calls for basic research on the mechanisms and explorations of new indications in animals. In the article, a new implantable, single-channel, low-power miniature device is proposed, which may transmit pulses chronically into the brain nucleus of freely moving rats. The DBS system consists of an implantable pulse generator (IPG), a bipolar electrode, and an external programmer. The IPG circuit module is assembled as a 20-mm diameter circular board and fixed on a rat’s skull together with an electrode and battery. The rigid electrode may make its fabrication and implantation more easy. The external programmer is designed for bidirectional communication with the IPG by a telecontrol transceiver and adjusts stimulation parameters. A biological validation was performed in which the effects of electrical stimulation in brain nucleus accumbens were detected. The programmed parameters were accurate, implant steady, and power sufficient to allow stimulation for more than 3 months. The larger area of the electrode tip provided a moderate current or charge density and minimized the damage from electrochemistry and pyroelectricity. The rats implanted with the device showed a reduction in morphine-induced conditioned place preference after high-frequency stimulation. In conclusion, the DBS device is based on the criteria of simple technology, minimal invasion, low cost, small in size, light-weight, and wireless controlled. This shows that our DBS device is appropriate and can be used for preclinical studies, indicating its potential utility in the therapy and rehabilitation of neuropsychiatric disorders. PMID:28121810

  4. To ventricular assist devices or not: When is implantation of a ventricular assist device appropriate in advanced ambulatory heart failure?

    PubMed Central

    Cerier, Emily; Lampert, Brent C; Kilic, Arman; McDavid, Asia; Deo, Salil V; Kilic, Ahmet

    2016-01-01

    Advanced heart failure has been traditionally treated via either heart transplantation, continuous inotropes, consideration for hospice and more recently via left ventricular assist devices (LVAD). Heart transplantation has been limited by organ availability and the futility of other options has thrust LVAD therapy into the mainstream of therapy for end stage heart failure. Improvements in technology and survival combined with improvements in the quality of life have made LVADs a viable option for many patients suffering from heart failure. The question of when to implant these devices in those patients with advanced, yet still ambulatory heart failure remains a controversial topic. We discuss the current state of LVAD therapy and the risk vs benefit of these devices in the treatment of heart failure. PMID:28070237

  5. Current Trends in Implantable Left Ventricular Assist Devices

    PubMed Central

    Garbade, Jens; Bittner, Hartmuth B.; Barten, Markus J.; Mohr, Friedrich-Wilhelm

    2011-01-01

    The shortage of appropriate donor organs and the expanding pool of patients waiting for heart transplantation have led to growing interest in alternative strategies, particularly in mechanical circulatory support. Improved results and the increased applicability and durability with left ventricular assist devices (LVADs) have enhanced this treatment option available for end-stage heart failure patients. Moreover, outcome with newer pumps have evolved to destination therapy for such patients. Currently, results using nonpulsatile continuous flow pumps document the evolution in outcomes following destination therapy achieved subsequent to the landmark Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure Trial (REMATCH), as well as the outcome of pulsatile designed second-generation LVADs. This review describes the currently available types of LVADs, their clinical use and outcomes, and focuses on the patient selection process. PMID:21822483

  6. Preferred tools and techniques for implantation of cardiac electronic devices in Europe: results of the European Heart Rhythm Association survey.

    PubMed

    Bongiorni, Maria Grazia; Proclemer, Alessandro; Dobreanu, Dan; Marinskis, Germanas; Pison, Laurent; Blomstrom-Lundqvist, Carina

    2013-11-01

    The aim of this European Heart Rhythm Association (EHRA) survey was to assess clinical practice in relation to the tools and techniques used for cardiac implantable electronic devices procedures in the European countries. Responses to the questionnaire were received from 62 members of the EHRA research network. The survey involved high-, medium-, and low-volume implanting centres, performing, respectively, more than 200, 100-199 and under 100 implants per year. The following topics were explored: the side approach for implantation, surgical techniques for pocket incision, first venous access for lead implantation, preference of lead fixation, preferred coil number for implantable cardioverter-defibrillator (ICD) leads, right ventricular pacing site, generator placement site, subcutaneous ICD implantation, specific tools and techniques for cardiac resynchronization therapy (CRT), lead implantation sequence in CRT, coronary sinus cannulation technique, target site for left ventricular lead placement, strategy in left ventricular lead implant failure, mean CRT implantation time, optimization of the atrioventricular (AV) and ventriculo-ventricular intervals, CRT implants in patients with permanent atrial fibrillation, AV node ablation in patients with permanent AF. This panoramic view allows us to find out the operator preferences regarding the techniques and tools for device implantation in Europe. The results showed different practices in all the fields we investigated, nevertheless the survey also outlines a good adherence to the common standards and recommendations.

  7. Nellix EndoVascular Aneurysm Sealing System: Device description, technique of implantation, and literature review.

    PubMed

    Batagini, Nayara Cioffi; Hardy, David; Clair, Daniel G; Kirksey, Lee

    2016-03-01

    Clinical outcome reports document that from 30% to 60% of endovascular aneurysm repair procedures are performed outside of US Food and Drug Administration-approved Instruction for Use, or "off label." Endovascular aneurysm repair performed outside of Instruction for Use has a significantly higher rate of device failure, potentially requiring device reintervention and even planned or emergent explant. The Nellix device has the potential to reduce the rate of aneurysm device failure through its novel design. The objective of this article was to introduce the Nellix EndoVascular Aneurysm Sealing System and indications for use and describe the technique of implantation. We describe various modes of endovascular aneurysm repair failure and how the Nellix system can reduce these unplanned adverse outcomes. Additional clinical applications and theoretical shortcomings of endovascular aneurysm sealing devices are detailed. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Intrinsic signal imaging of brain function using a small implantable CMOS imaging device

    NASA Astrophysics Data System (ADS)

    Haruta, Makito; Sunaga, Yoshinori; Yamaguchi, Takahiro; Takehara, Hironari; Noda, Toshihiko; Sasagawa, Kiyotaka; Tokuda, Takashi; Ohta, Jun

    2015-04-01

    A brain functional imaging technique over a long period is important to understand brain functions related to animal behavior. We have developed a small implantable CMOS imaging device for measuring brain activity in freely moving animals. This device is composed of a CMOS image sensor chip and LEDs for illumination. In this study, we demonstrated intrinsic signal imaging of blood flow using the device with a green LED light source at a peak wavelength of 535 nm, which corresponds to one of the absorption spectral peaks of blood cells. Brain activity increases regional blood flow. The device light weight of about 0.02 g makes it possible to stably measure brain activity through blood flow over a long period. The device has successfully measured the intrinsic signal related to sensory stimulation on the primary somatosensory cortex.

  9. Development of high impedance measurement system for water leakage detection in implantable neuroprosthetic devices.

    PubMed

    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.

  10. Development of drug-loaded polymer microcapsules for treatment of epilepsy.

    PubMed

    Chen, Yu; Gu, Qi; Yue, Zhilian; Crook, Jeremy M; Moulton, Simon E; Cook, Mark J; Wallace, Gordon G

    2017-09-26

    Despite significant progress in developing new drugs for seizure control, epilepsy still affects 1% of the global population and is drug-resistant in more than 30% of cases. To improve the therapeutic efficacy of epilepsy medication, a promising approach is to deliver anti-epilepsy drugs directly to affected brain areas using local drug delivery systems. The drug delivery systems must meet a number of criteria, including high drug loading efficiency, biodegradability, neuro-cytocompatibility and predictable drug release profiles. Here we report the development of fibre- and sphere-based microcapsules that exhibit controllable uniform morphologies and drug release profiles as predicted by mathematical modelling. Importantly, both forms of fabricated microcapsules are compatible with human brain derived neural stem cells and differentiated neurons and neuroglia, indicating clinical compliance for neural implantation and therapeutic drug delivery.

  11. Percutaneously implanted left ventricular assist device: establishing a program from implant to intensive care unit.

    PubMed

    Speiser, Bernadette S

    2011-01-01

    Cardiogenic shock is a critical disease process that claims lives every year. A new device on the market allows 2.5 L of cardiac output through the heart to assist in patient stabilization while attempting treatment options such as percutaneous coronary intervention to open closed coronary arteries.

  12. Adhoc electromagnetic compatibility testing of non-implantable medical devices and radio frequency identification.

    PubMed

    Seidman, Seth J; Guag, Joshua W

    2013-07-11

    The use of radiofrequency identification (RFID) in healthcare is increasing and concerns for electromagnetic compatibility (EMC) pose one of the biggest obstacles for widespread adoption. Numerous studies have documented that RFID can interfere with medical devices. The majority of past studies have concentrated on implantable medical devices such as implantable pacemakers and implantable cardioverter defibrillators (ICDs). This study examined EMC between RFID systems and non-implantable medical devices. Medical devices were exposed to 19 different RFID readers and one RFID active tag. The RFID systems used covered 5 different frequency bands: 125-134 kHz (low frequency (LF)); 13.56 MHz (high frequency (HF)); 433 MHz; 915 MHz (ultra high frequency (UHF])) and 2.4 GHz. We tested three syringe pumps, three infusion pumps, four automatic external defibrillators (AEDs), and one ventilator. The testing procedure is modified from American National Standards Institute (ANSI) C63.18, Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters. For syringe pumps, we observed electromagnetic interference (EMI) during 13 of 60 experiments (22%) at a maximum distance of 59 cm. For infusion pumps, we observed EMI during 10 of 60 experiments (17%) at a maximum distance of 136 cm. For AEDs, we observed EMI during 18 of 75 experiments (24%) at a maximum distance of 51 cm. The majority of the EMI observed was classified as probably clinically significant or left the device inoperable. No EMI was observed for all medical devices tested during exposure to 433 MHz (two readers, one active tag) or 2.4 GHz RFID (two readers). Testing confirms that RFID has the ability to interfere with critical medical equipment. Hospital staff should be aware of the potential for medical device EMI caused by RFID systems and should be encouraged to perform on-site RF immunity tests prior

  13. Adhoc electromagnetic compatibility testing of non-implantable medical devices and radio frequency identification

    PubMed Central

    2013-01-01

    Background The use of radiofrequency identification (RFID) in healthcare is increasing and concerns for electromagnetic compatibility (EMC) pose one of the biggest obstacles for widespread adoption. Numerous studies have documented that RFID can interfere with medical devices. The majority of past studies have concentrated on implantable medical devices such as implantable pacemakers and implantable cardioverter defibrillators (ICDs). This study examined EMC between RFID systems and non-implantable medical devices. Methods Medical devices were exposed to 19 different RFID readers and one RFID active tag. The RFID systems used covered 5 different frequency bands: 125–134 kHz (low frequency (LF)); 13.56 MHz (high frequency (HF)); 433 MHz; 915 MHz (ultra high frequency (UHF])) and 2.4 GHz. We tested three syringe pumps, three infusion pumps, four automatic external defibrillators (AEDs), and one ventilator. The testing procedure is modified from American National Standards Institute (ANSI) C63.18, Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters. Results For syringe pumps, we observed electromagnetic interference (EMI) during 13 of 60 experiments (22%) at a maximum distance of 59 cm. For infusion pumps, we observed EMI during 10 of 60 experiments (17%) at a maximum distance of 136 cm. For AEDs, we observed EMI during 18 of 75 experiments (24%) at a maximum distance of 51 cm. The majority of the EMI observed was classified as probably clinically significant or left the device inoperable. No EMI was observed for all medical devices tested during exposure to 433 MHz (two readers, one active tag) or 2.4 GHz RFID (two readers). Conclusion Testing confirms that RFID has the ability to interfere with critical medical equipment. Hospital staff should be aware of the potential for medical device EMI caused by RFID systems and should be encouraged to

  14. Electromagnetic immunity of implantable pacemakers exposed to wi-fi devices.

    PubMed

    Mattei, Eugenio; Censi, Federica; Triventi, Michele; Calcagnini, Giovanni

    2014-10-01

    The purpose of this study is to evaluate the potential for electromagnetic interference (EMI) and to assess the immunity level of implantable pacemakers (PM) when exposed to the radiofrequency (RF) field generated by Wi-Fi devices. Ten PM from five manufacturers, representative of what today is implanted in patients, have been tested in vitro and exposed to the signal generated by a Wi-Fi transmitter. An exposure setup that reproduces the actual IEEE 802.11b/g protocol has been designed and used during the tests. The system is able to amplify the Wi-Fi signal and transmits at power levels higher than those allowed by current international regulation. Such approach allows one to obtain, in case of no EMI, a safety margin for PM exposed to Wi-Fi signals, which otherwise cannot be derived if using commercial Wi-Fi equipment. The results of this study mitigate concerns about using Wi-Fi devices close to PM: none of the PM tested exhibit any degradation of their performance, even when exposed to RF field levels five times higher than those allowed by current international regulation (20 W EIRP). In conclusion, Wi-Fi devices do not pose risks of EMI to implantable PM. The immunity level of modern PM is much higher than the transmitting power of RF devices operating at 2.4 GHz.

  15. In-situ photopolymerization and monitoring device for controlled shaping of tissue fillers, replacements, or implants

    NASA Astrophysics Data System (ADS)

    Schmocker, Andreas M.; Khoushabi, Azadeh; Bourban, Pierre-Etienne; Schizas, Constantin; Pioletti, Dominique; Moser, Christophe

    2015-03-01

    Photopolymerization is a common tool to harden materials initially in a liquid state. A surgeon can directly trigger the solidification of a dental implant or a bone or tissue filler simply by illumination. Traditionally, photopolymerization has been used mainly in dentistry. Over the last decade advances in material development including a wide range of biocompatible gel- and cement-systems open up a new avenue for in-situ photopolymerization. However, at the device level, surgical endoscopic probes are required. We present a miniaturized light probe where a photoactive material can be 1) mixed, pressurized and injected 2) photopolymerized or photoactivated and 3) monitored during the chemical reaction. The device enables surgeries to be conducted through a hole smaller than 1 mm in diameter. Beside basic injection mechanics, the tool consists of an optical fiber guiding the light required for photopolymerization and for chemical analysis. Combining photorheology and fluorescence spectroscopy, the current state of the photopolymerization is inferred and monitored in real time. Biocompatible and highly tuneable Poly-Ethylene-Glycol (PEG) hydrogels were used as the injection material. The device was tested on a model for intervertebral disc replacement. Gels were successfully implanted into a bovine caudal model and mechanically tested in-vitro during two weeks. The photopolymerized gel was evaluated at the tissue level (adherence and mechanical properties of the implant), at the cellular level (biocompatibility and cytotoxicity) and ergonomic level (sterilization procedure and feasibility study). This paper covers the monitoring aspect of the device.

  16. Compatibility of Radiofrequency Surgical Sponge Detection Technology with Cardiac Implantable Electronic Devices and Temporary Pacemakers.

    PubMed

    Salcedo, Jonathan D; Pretorius, Victor G; Hsu, Jonathan C; Lalani, Gautam G; Schricker, Amir A; Hebsur, Shrinivas M; McGARRY, Thomas J; Hunter, Jessica A; Lewis, Kathryn E; Krummen, David E; Feld, Gregory K; Birgersdotter-Green, Ulrika

    2016-11-01

    Radiofrequency (RF) technology has improved detection of retained surgical sponges with a reported 100% sensitivity and specificity. However, the potential for interactions of the RF signals emitted by the detection system with cardiac implantable electronic devices (CIEDs) or temporary pacemakers may limit its use in those patients with these devices. This study investigated whether RF detection technology causes interference or clinically significant changes in the programmed settings of implanted pacemakers and defibrillators or temporary epicardial pacemakers. Fifty patients who were scheduled either for CIED removal or placement of a temporary epicardial pacemaker (at the time of open heart surgery) were recruited for this study. Device settings and measurements from separate interrogations before and after scanning with the RF detection system were compared. For the temporary pacemakers, we observed for any changes in hemodynamics or signs of pacing interference. Twenty (40%) pacemakers, 20 (40%) implantable cardioverter defibrillators, and 10 (20%) temporary pacemakers were analyzed in this study. During scanning, no signal interference was detected in any permanent device, and there were no significant changes in programmed settings after scanning with the RF detection system. However, pacing inhibition was detected with temporary pacing systems when programmed to a synchronous mode (DDD). RF detection technology can be safely used to scan for retained surgical sponges in patients with permanent CIEDs and temporary pacemakers set to asynchronous mode. © 2016 Wiley Periodicals, Inc.

  17. Evaluation of biofouling in stainless microfluidic channels for implantable multilayered dialysis device

    NASA Astrophysics Data System (ADS)

    Ota, Takashi; To, Naoya; Kanno, Yoshihiko; Miki, Norihisa

    2017-06-01

    An implantable artificial kidney can markedly improve the quality of life of renal disease patients. Our group has developed an implantable multilayered dialysis system consisting of microfluidic channels and dialysis membranes. Long-term evaluation is necessary for implant devices where biofouling is a critical factor, culminating in the deterioration of dialysis performance. Our previous work revealed that surface conditions, which depend on the manufacturing process, determine the amount of biofouling, and that electrolytic etching is the most suitable technique for forming a channel wall free of biofouling. In this study, we investigated the electrolytic etching conditions in detail. We conducted in vitro experiments for 7 d and evaluated the adhesion of biomaterials by scanning electron microscopy. The experiments revealed that a surface mirror-finished by electrolytic etching effectively prevents biofouling.

  18. Robotic Left Ventricular Assist Device Implantation Using Left Thoracotomy Approach in Patients with Previous Sternotomies.

    PubMed

    Khalpey, Zain; Bin Riaz, Irbaz; Marsh, Katherine M; Ansari, Muhammad Zubair Ahmad; Bilal, Jawad; Cooper, Anthony; Paidy, Samata; Schmitto, Jan D; Smith, Richard; Friedman, Mark; Slepian, Marvin J; Poston, Robert

    2015-01-01

    Left ventricular assist devices (LVADs) are commonly used as either a bridge-to-transplant or a destination therapy. The traditional approach for LVAD implantation is via median sternotomy, but many candidates for this procedure have a history of failed cardiac surgeries and previous sternotomy. Redo sternotomy increases the risk of heart surgery, particularly in the setting of advanced heart failure. Robotics facilitates a less invasive approach to LVAD implantation that circumvents some of the morbidity associated with a redo sternotomy. We compared the outcomes of all patients at our institution who underwent LVAD implantation via either a traditional sternotomy or using robotic assistance. The robotic cohort showed reduced resource utilization including length of hospital stay and use of blood products. As the appropriate candidates become elucidated, robotic assistance may improve the safety and cost-effectiveness of reoperative LVAD surgery.

  19. Miniscrew implants as temporary anchorage devices in orthodontics: a comprehensive review.

    PubMed

    Jasoria, Gaurav; Shamim, Wamiq; Rathore, Saurabh; Kalra, Amit; Manchanda, Mona; Jaggi, Nitin

    2013-09-01

    In recent times, the use of miniscrew implants to obtain absolute anchorage has gained momentum in clinical orthodontics as rigid anchorage modality. Miniscrew implants offers many advantages when used as temporary anchorage devices like, easy placement and removal, immediate loading, can be used in a variety of locations, provide absolute anchorage, economic and requires less patient cooperation. This makes them as a necessary treatment option in cases with critical anchorage that would have otherwise resulted in anchorage loss if treated with conventional means of anchorage. The aim of this comprehensive review is to highlight the gradual evolution, clinical use, advantages and disadvantages of the miniscrew implants when used to obtain a temporary but absolute skeletal anchorage for orthodontic applications.

  20. Implantable batteryless device for on-demand and pulsatile insulin administration

    NASA Astrophysics Data System (ADS)

    Lee, Seung Ho; Lee, Young Bin; Kim, Byung Hwi; Lee, Cheol; Cho, Young Min; Kim, Se-Na; Park, Chun Gwon; Cho, Yong-Chan; Choy, Young Bin

    2017-04-01

    Many implantable systems have been designed for long-term, pulsatile delivery of insulin, but the lifetime of these devices is limited by the need for battery replacement and consequent replacement surgery. Here we propose a batteryless, fully implantable insulin pump that can be actuated by a magnetic field. The pump is prepared by simple-assembly of magnets and constituent units and comprises a drug reservoir and actuator equipped with a plunger and barrel, each assembled with a magnet. The plunger moves to noninvasively infuse insulin only when a magnetic field is applied on the exterior surface of the body. Here we show that the dose is easily controlled by varying the number of magnet applications. Also, pump implantation in diabetic rats results in profiles of insulin concentration and decreased blood glucose levels similar to those observed in rats treated with conventional subcutaneous insulin injections.

  1. Development of a chipscale integrated microelectrode/microelectronic device for brain implantable neuroengineering applications.

    PubMed

    Song, Yoon-Kyu; Patterson, William R; Bull, Christopher W; Beals, Joseph; Hwang, Naejye; Deangelis, Andrew P; Lay, Christopher; McKay, J Lucas; Nurmikko, Arto V; Fellows, Matthew R; Simeral, John D; Donoghue, John P; Connors, Barry W

    2005-06-01

    An ultralow power analog CMOS chip and a silicon based microelectrode array have been fully integrated to a microminiaturized "neuroport" for brain implantable neuroengineering applications. The CMOS integrated circuit (IC) includes preamplifier and multiplexing circuitry, and a hybrid flip-chip bonding technique was developed to fabricate a functional, encapsulated microminiaturized neuroprobe device. Our neuroport has been evaluated using various methods, including pseudospike detection and local excitation measurement, and showed suitable characteristics for recording neural activities. As a proof-of-concept demonstration, we have measured local field potentials from thalamocortical brain slices of rats, suggesting that the new neuroport can form a prime platform for the development of a microminiaturized neural interface to the brain in a single implantable unit. An alternative power delivery scheme using photovoltaic power converter, and an encapsulation strategy for chronic implantation are also discussed.

  2. Safety considerations for wireless delivery of continuous power to implanted medical devices.

    PubMed

    Lucke, Lori; Bluvshtein, Vlad

    2014-01-01

    Wireless power systems for use with implants are referred to as transcutaneous energy transmission systems (TETS) and consist of an implanted secondary coil and an external primary coil along with supporting electronics. A TETS system could be used to power ventricular assist systems and eliminate driveline infections. There are both direct and indirect safety concerns that must be addressed when continuously transferring power through the skin. Direct safety concerns include thermal tissue damage caused by exposure to the electromagnetic fields, coil heating effects, and potential unwanted nerve stimulation. Indirect concerns are those caused by potential interference of the TETS system with other implanted devices. Wireless power systems are trending towards higher frequency operation. Understanding the limits for safe operation of a TETS system across a range of frequencies is important. A low frequency and a high frequency implementation are simulated to demonstrate the impact of this trend for a VAD application.

  3. A comprehensive model of human ear for analysis of implantable hearing devices.

    PubMed

    Zhang, Xiangming; Gan, Rong Z

    2011-10-01

    A finite element (FE) model of the human ear including the ear canal, middle ear, and spiral cochlea was constructed from histological sections of human temporal bone. Multiphysics analysis of the acoustics, structure, and fluid coupling in the ear was conducted in the model. The viscoelastic material behavior was applied to the middle ear soft tissues based on dynamic measurements of tissues in our laboratory. The FE model was first validated using the experimental data obtained in human cadaver ears, and then used to investigate the efficiency of the forward and reverse mechanical driving with middle ear implant, and the passive vibration of basilar membrane (BM) with cochlear implant placed in the cochlear scala tympani. The middle ear transfer function and the cochlear function of the BM vibration were derived from the model. This comprehensive ear model provides a novel computational tool to visualize and compute the implantable hearing devices and surgical procedures.

  4. Disease management: remote monitoring in heart failure patients with implantable defibrillators, resynchronization devices, and haemodynamic monitors.

    PubMed

    Abraham, William T

    2013-06-01

    Heart failure represents a major public health concern, associated with high rates of morbidity and mortality. A particular focus of contemporary heart failure management is reduction of hospital admission and readmission rates. While optimal medical therapy favourably impacts the natural history of the disease, devices such as cardiac resynchronization therapy devices and implantable cardioverter defibrillators have added incremental value in improving heart failure outcomes. These devices also enable remote patient monitoring via device-based diagnostics. Device-based measurement of physiological parameters, such as intrathoracic impedance and heart rate variability, provide a means to assess risk of worsening heart failure and the possibility of future hospitalization. Beyond this capability, implantable haemodynamic monitors have the potential to direct day-to-day management of heart failure patients to significantly reduce hospitalization rates. The use of a pulmonary artery pressure measurement system has been shown to significantly reduce the risk of heart failure hospitalization in a large randomized controlled study, the CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) trial. Observations from a pilot study also support the potential use of a left atrial pressure monitoring system and physician-directed patient self-management paradigm; these observations are under further investigation in the ongoing LAPTOP-HF trial. All these devices depend upon high-intensity remote monitoring for successful detection of parameter deviations and for directing and following therapy.

  5. Spatial memory in nonhuman primates implanted with the subdural pharmacotherapy device.

    PubMed

    Ludvig, Nandor; Tang, Hai M; Baptiste, Shirn L; Stefanov, Dimitre G; Kral, John G

    2015-06-01

    This study investigated the possible influence of the Subdural Pharmacotherapy Device (SPD) on spatial memory in 3 adult, male bonnet macaques (Macaca radiata). The device was implanted in and above the subdural/subarachnoid space and cranium overlaying the right parietal/frontal cortex: a circuitry involved in spatial memory processing. A large test chamber, equipped with four baited and four non-baited food-ports at different locations, was used: reaches into empty food ports were counted as spatial memory errors. In this study of within-subject design, before SPD implantation (control) the animals made mean 373.3 ± 114.9 (mean ± SEM) errors in the first spatial memory test session. This value dropped to 47.7 ± 18.4 by the 8th session. After SPD implantation and alternating cycles of transmeningeal saline delivery and local cerebrospinal fluid (CSF) drainage in the implanted cortex the spatial memory error count, with the same port locations, was 33.0 ± 12.2 during the first spatial memory test session, further decreasing to 5.7 ± 3.5 by the 8th post-implantation session (P<0.001 for trend). Replacing transmeningeal saline delivery with similar delivery of the GABAA receptor agonist muscimol (1.0mM) by the SPD did not affect the animals' spatial memory performance, which in fact included at least one completely error-free session per animal over time. The study showed that complication-free implantation and use of the SPD over the parietal and frontal cortices for months leave spatial memory processes intact in nonhuman primates.

  6. Predictors of fluoroscopy time and procedural failure during biventricular device implantation.

    PubMed

    Hsu, Jonathan C; Badhwar, Nitish; Lee, Byron K; Vedantham, Vasanth; Tseng, Zian H; Marcus, Gregory M

    2012-07-15

    Biventricular device implantation with the insertion of a transvenous left ventricular (LV) lead can be challenging. The aim of this study was to identify predictors of procedural difficulty measured by fluoroscopy time and predictors of LV lead implantation failure. A single-center, retrospective study of 272 consecutive patients who underwent biventricular device implantation from 2004 to 2011 was conducted. Multivariate linear regression was used to assess predictors of fluoroscopy time and logistic regression to identify predictors of LV lead implant failure. The median fluoroscopy time was 36.1 minutes (interquartile range 24.2 to 51.6). After multivariate adjustment, independent predictors of longer fluoroscopy time included a right-sided approach (21.8 minutes longer, 95% confidence interval [CI] 6.8 to 36.9, p = 0.005), previous congenital heart disease surgery (64.6 minutes longer, 95% CI 30.2 to 99.0, p <0.001), and previous failed attempt (30.3 minutes longer, 95% CI 6.0 to 54.5, p = 0.015). Predictors of shorter fluoroscopy time included an LV lead upgrade (7.5 minutes shorter, 95% CI 0.6 to 14.4, p = 0.033), electrophysiology fellow experience (5.4 minutes shorter/year, 95% CI 0.1 to 10.7, p = 0.047), and attending physician experience (1.4 minutes shorter/year, 95% CI 0.01 to 2.9, p = 0.049). Failed implantation occurred in 8% of patients (22 of 272); inability to cannulate the coronary sinus and absent or atretic coronary sinus veins were the most common reasons (8 of 22 failed implants each). A previous failed attempt was the only significant predictor of LV lead implantation failure (odds ratio 33.5, 95% CI 3.2 to 352.6, p = 0.003). In conclusion, 6 patient and operator characteristics predicted LV lead implantation difficulty measured by fluoroscopy time. LV lead implantation failed in 8% of cases, predicted only by a previous failed attempt.

  7. Predictors of Fluoroscopy Time and Procedural Failure During Biventricular Device Implantation

    PubMed Central

    Hsu, Jonathan C; Badhwar, Nitish; Lee, Byron K; Vedantham, Vasanth; Tseng, Zian H; Marcus, Gregory M

    2012-01-01

    Biventricular (BiV) device implantation with insertion of a transvenous left ventricular (LV) lead can be challenging. We sought to identify predictors of procedural difficulty measured by fluoroscopy time and predictors of LV lead implantation failure. We performed a single-center, retrospective study of 272 consecutive patients undergoing BiV device implantation between 2004 and 2011. We used multivariate linear regression to assess predictors of fluoroscopy time and logistic regression to identify predictors of LV lead implant failure. The median fluoroscopy time was 36.1 minutes (interquartile range [IQR] 24.2–51.6). After multivariable adjustment, independent predictors of longer fluoroscopy time included a right-sided approach (21.8 minutes longer, 95% confidence interval [CI] 6.8–36.9, p=0.005), prior congenital heart disease surgery (64.6 minutes longer, 95% CI 30.2–99.0, p<0.001), and previous failed attempt (30.3 minutes longer, 95% CI 6.0–54.5, p=0.015). Predictors of shorter fluoroscopy time included an LV lead upgrade (7.5 minutes shorter, 95% CI 0.6–14.4, p=0.033), electrophysiology fellow experience (5.4 minutes shorter/year, 95% CI 0.1-10.7, p=0.047) and attending physician experience (1.4 minutes shorter/year, 95% CI 0.01–2.9, p=0.049). Failed implantation occurred in 8% (22 of 272); inability to cannulate the coronary sinus (CS) and absent/atretic CS veins were the most common reasons (8 of 22 failed implants each). A previous failed attempt was the only significant predictor of LV lead implantation failure (odds ratio=33.5, 95% CI 3.2–352.6, p=0.003). In conclusion, six patient and operator characteristics predicted LV lead implantation difficulty measured by fluoroscopy time. LV lead implantation failed in 8% of cases, predicted only by a previous failed attempt. PMID:22483384

  8. Active implantable medical device EMI assessment for wireless power transfer operating in LF and HF bands

    NASA Astrophysics Data System (ADS)

    Hikage, Takashi; Nojima, Toshio; Fujimoto, Hiroshi

    2016-06-01

    The electromagnetic interference (EMI) imposed on active implantable medical devices by wireless power transfer systems (WPTSs) is discussed based upon results of in vitro experiments. The purpose of this study is to present comprehensive EMI test results gathered from implantable-cardiac pacemakers and implantable cardioverter defibrillators exposed to the electromagnetic field generated by several WPTSs operating in low-frequency (70 kHz-460 kHz) and high-frequency (6.78 MHz) bands. The constructed in vitro experimental test system based upon an Irnich’s flat torso phantom was applied. EMI test experiments are conducted on 14 types of WPTSs including Qi-compliant system and EV-charging WPT system mounted on current production EVs. In addition, a numerical simulation model for active implantable medical device (AIMD) EMI estimation based on the experimental test system is newly proposed. The experimental results demonstrate the risk of WPTSs emitting intermittent signal to affect the correct behavior of AIMDs when operating at very short distances. The proposed numerical simulation model is applicable to obtain basically the EMI characteristics of various types of WPTSs.

  9. Active implantable medical device EMI assessment for wireless power transfer operating in LF and HF bands.

    PubMed

    Hikage, Takashi; Nojima, Toshio; Fujimoto, Hiroshi

    2016-06-21

    The electromagnetic interference (EMI) imposed on active implantable medical devices by wireless power transfer systems (WPTSs) is discussed based upon results of in vitro experiments. The purpose of this study is to present comprehensive EMI test results gathered from implantable-cardiac pacemakers and implantable cardioverter defibrillators exposed to the electromagnetic field generated by several WPTSs operating in low-frequency (70 kHz-460 kHz) and high-frequency (6.78 MHz) bands. The constructed in vitro experimental test system based upon an Irnich's flat torso phantom was applied. EMI test experiments are conducted on 14 types of WPTSs including Qi-compliant system and EV-charging WPT system mounted on current production EVs. In addition, a numerical simulation model for active implantable medical device (AIMD) EMI estimation based on the experimental test system is newly proposed. The experimental results demonstrate the risk of WPTSs emitting intermittent signal to affect the correct behavior of AIMDs when operating at very short distances. The proposed numerical simulation model is applicable to obtain basically the EMI characteristics of various types of WPTSs.

  10. Catalyst-dependent drug loading of LDI-glycerol polyurethane foams leads to differing controlled release profiles.

    PubMed

    Sivak, Wesley N; Pollack, Ian F; Petoud, Stéphane; Zamboni, William C; Zhang, Jianying; Beckman, Eric J

    2008-09-01

    The purpose of the present study was to develop biodegradable and biocompatible polyurethane foams based on lysine diisocyanate (LDI) and glycerol to be used as drug-delivery systems for the controlled release of 7-tert-butyldimethylsilyl-10-hydroxy-camptothecin (DB-67). The impact of urethane catalysts on cellular proliferation was assessed in an attempt to enhance the biocompatibility of our polyurethane materials. DB-67, a potent camptothecin analog, was then incorporated into LDI-glycerol polyurethane foams with two different amine urethane catalysts: 1,4-diazobicyclo[2.2.2]-octane (DABCO) and 4,4'-(oxydi-2,1-ethane-diyl)bismorpholine (DMDEE). The material morphologies of the polyurethane foams were analyzed via scanning electron microscopy, and DB-67 distribution was assessed by way of fluorescence microscopy. Both foam morphology and drug distribution were found to correlate to the amine catalyst used. Hydrolytic release rates of DB-67 from the polyurethane foams were catalyst dependent and also demonstrated greater drug loads being released at higher temperatures. The foams were capable of delivering therapeutic concentrations of DB-67 in vitro over an 11week test period. Cellular proliferation assays demonstrate that empty LDI-glycerol foams did not significantly alter the growth of malignant human glioma cell lines (P<0.05). DB-67 loaded LDI-glycerol polyurethane foams were found to inhibit cellular proliferation by at least 75% in all the malignant glioma cell lines tested (P<1.0x10(-8)). These results clearly demonstrate the long-term, catalyst-dependent release of DB-67 from LDI-glycerol polyurethane foams, indicating their potential for use in implantable drug-delivery devices.

  11. Columnar transmitter based wireless power delivery system for implantable device in freely moving animals.

    PubMed

    Eom, Kyungsik; Jeong, Joonsoo; Lee, Tae Hyung; Lee, Sung Eun; Jun, Sang Bum; Kim, Sung June

    2013-01-01

    A wireless power delivery system is developed to deliver electrical power to the neuroprosthetic devices that are implanted into animals freely moving inside the cage. The wireless powering cage is designed for long-term animal experiments without cumbersome wires for power supply or the replacement of batteries. In the present study, we propose a novel wireless power transmission system using resonator-based inductive links to increase power efficiency and to minimize the efficiency variations. A columnar transmitter coil is proposed to provide lateral uniformity of power efficiency. Using this columnar transmitter coil, only 7.2% efficiency fluctuation occurs from the maximum transmission efficiency of 25.9%. A flexible polymer-based planar type receiver coil is fabricated and assembled with a neural stimulator and an electrode. Using the designed columnar transmitter coil, the implantable device successfully operates while it moves freely inside the cage.

  12. New risks inadequately managed: the case of smart implants and medical device regulation

    PubMed Central

    Haddow, Gill; Gilman, Leah

    2016-01-01

    Many emerging technologies are associated with ‘risk’. While the concept of risk is protean, it is usually conceived of as the potential of something damaging or harmful happening. Thus, risks are a primary target of many regulatory regimes. In this article, after articulating an understanding of risk, we assess the European medical devices regulatory regime from a risk perspective, focusing on its handling of ‘smart’ implantable medical devices. In doing so, we discuss the empirical evidence obtained from expert participants in the Implantable Smart Technologies Project, which evidence is framed around three risk typologies: materiality, geography and modality. We conclude that none of these risks are sufficiently addressed within the existing regime, which falls down not just from a standards perspective, but also from the perspective of transparency and balance. PMID:28058060

  13. Performance Enhancement of PFET Planar Devices by Plasma Immersion Ion Implantation (P3I)

    SciTech Connect

    Ortolland, Claude; Horiguchi, Naoto; Kerner, Christoph; Chiarella, Thomas; Eyben, Pierre; Everaert, Jean-Luc; Hoffmann, Thomas; Del Agua Borniquel, Jose Ignacio; Poon, Tze; Santhanam, Kartik; Porshnev, Peter; Foad, Majeed; Schreutelkamp, Robert; Absil, Philippe; Vandervorst, Wilfried; Felch, Susan

    2008-11-03

    A study of doping the pMOS Lightly Doped Drain (LDD) by Plasma Immersion Ion Implantation (P3i) with BF3 is presented which demonstrates a better transistor performance compared to standard beam line Ion Implantation (I/I). The benefit of P3i comes from the broad angular distribution of the impinging ions thereby doping the poly-silicon gate sidewall as well. Gate capacitance of short channel devices has been measured and clearly shows this improvement. This model is clearly supported by high resolution 2D-carrier profiles using Scanning Spreading Resistance Microscopy (SSRM) which shows this gate sidewall doping. The broad angular distribution also implies a smaller directional sensitivity (to for instance the detailed gate edge shape) and leads to devices which are perfectly balanced, when Source and Drain electrode are switched.

  14. Implantable and ingestible medical devices with wireless telemetry functionalities: a review of current status and challenges.

    PubMed

    Kiourti, Asimina; Psathas, Konstantinos A; Nikita, Konstantina S

    2014-01-01

    Wireless medical telemetry permits the measurement of physiological signals at a distance through wireless technologies. One of the latest applications is in the field of implantable and ingestible medical devices (IIMDs) with integrated antennas for wireless radiofrequency (RF) communication (telemetry) with exterior monitoring/control equipment. Implantable medical devices (MDs) perform an expanding variety of diagnostic and therapeutic functions, while ingestible MDs receive significant attention in gastrointestinal endoscopy. Design of such wireless IIMD telemetry systems is highly intriguing and deals with issues related to: operation frequency selection, electronics and powering, antenna design and performance, and modeling of the wireless channel. In this paper, we attempt to comparatively review the current status and challenges of IIMDs with wireless telemetry functionalities. Full solutions of commercial IIMDs are also recorded. The objective is to provide a comprehensive reference for scientists and developers in the field, while indicating directions for future research.

  15. New risks inadequately managed: the case of smart implants and medical device regulation.

    PubMed

    Harmon, Shawn H E; Haddow, Gill; Gilman, Leah

    2015-01-01

    Many emerging technologies are associated with 'risk'. While the concept of risk is protean, it is usually conceived of as the potential of something damaging or harmful happening. Thus, risks are a primary target of many regulatory regimes. In this article, after articulating an understanding of risk, we assess the European medical devices regulatory regime from a risk perspective, focusing on its handling of 'smart' implantable medical devices. In doing so, we discuss the empirical evidence obtained from expert participants in the Implantable Smart Technologies Project, which evidence is framed around three risk typologies: materiality, geography and modality. We conclude that none of these risks are sufficiently addressed within the existing regime, which falls down not just from a standards perspective, but also from the perspective of transparency and balance.

  16. Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices.

    PubMed

    Gagliardi, Anna R; Ducey, Ariel; Lehoux, Pascale; Turgeon, Thomas; Ross, Sue; Trvovich, Patricia; Easty, Anthony; Bell, Chaim; Urbach, David

    2017-08-02

    Postmarket surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Little is known about factors that influence whether and how physicians report AMDEs, an essential step in developing behaviour change interventions. This study explored factors that influence AMDE reporting. Qualitative interviews were conducted with physicians who differed by specialties that implant cardiovascular and orthopaedic devices prone to AMDEs, geography and years in practice. Participants were asked if and how they reported AMDEs, and the influencing factors. Themes were identified inductively using constant comparative technique, and reviewed and discussed by the research team on four occasions. Twenty-two physicians of varying specialty, region, organisation and career stage perceived AMDE reporting as unnecessary, not possible or futile due to multiple factors. Physicians viewed AMDEs as an expected part of practice that they could manage by switching to different devices or developing work-around strategies for problematic devices. Physician beliefs and behaviour were reinforced by limited healthcare system capacity and industry responsiveness. The healthcare system lacked processes and infrastructure to detect, capture, share and act on information about AMDEs, and constrained device choice through purchasing contracts. The device industry did not respond to reports of AMDEs from physicians or improve their products based on such reports. As a result, participants said they used devices that were less than ideal for a given patient, leading to suboptimal patient outcomes. There may be little point in solely educating or incentivising individual physicians to report AMDEs unless environmental conditions are conducive to doing so. Future research should explore policies that govern AMDEs and investigate how to design and implement postmarket surveillance systems. © Article author(s) (or their employer(s) unless otherwise stated in

  17. Electromagnetic and modeling analyses of an implanted device at 3 and 7 Tesla.

    PubMed

    Ibrahim, Tamer S; Tang, Lin; Kangarlu, Alayar; Abraham, Roney

    2007-11-01

    To study the specific absorption rates (SAR) associated with implantable devices at 3T and 7 T. Studies were carried out utilizing a finite difference time domain (FDTD) model that treats the radio frequency (RF) coil and an anatomically detailed human head mesh as a single system. Analyses were performed at 3 T and 7 T for different orientations and positions of an implanted (in the brain) aneurysm clip. Studies were also performed for two different types of FDTD mesh of the same aneurysm clip. The results showed that: 1) the electromagnetic effects of implanting the aneurysm clip (in the brain) is mostly local on SARs; and 2) orientations of the implanted aneurysm clip have considerable effect on the local SARs near the implanted clip; the level of such an effect can also vary significantly between 3 T and 7 T. In general, the presented study shows that the local SARs (in 1 g and in 10 g of tissue) near the implanted aneurysm clip are lower than the peak SARs (due to the standard RF coil operation) in other regions of the human head mesh/brain. For specific orientations, however, if the aneurysm clip is implanted in a region in which the brain peak-SAR occurs due the standard RF coil operation, the brain peak SAR increases further. This is more prevalent at 7T compared to 3T. Additionally, it was also found that basic structured and Cartesian FDTD modeling produces relatively higher local SARs than that obtained with simple non-Cartesian FDTD modeling.

  18. Capacity of dental equipment to interfere with cardiac implantable electrical devices.

    PubMed

    Lahor-Soler, Eduard; Miranda-Rius, Jaume; Brunet-Llobet, Lluís; Sabaté de la Cruz, Xavier

    2015-06-01

    Patients with cardiac implantable electrical devices should take precautions when exposed to electromagnetic fields. Possible interference as a result of proximity to electromagnets or electricity flow from electronic tools employed in clinical odontology remains controversial. The objective of this study was to examine in vitro the capacity of dental equipment to provoke electromagnetic interference in pacemakers and implantable cardioverter defibrillators. Six electronic dental instruments were tested on three implantable cardioverter defibrillators and three pacemakers from different manufacturers. A simulator model, submerged in physiological saline, with elements that reproduced life-size anatomic structures was used. The instruments were analyzed at differing distances and for different time periods of application. The dental instruments studied displayed significant differences in their capacity to trigger electromagnetic interference. Significant differences in the quantity of registered interference were observed with respect to the variables manufacturer, type of cardiac implant, and application distance but not with the variable time of application. The electronic dental equipment tested at a clinical application distance (20 cm) provoked only slight interference in the pacemakers and implantable cardioverter defibrillators employed, irrespective of manufacturer. © 2015 Eur J Oral Sci.

  19. A New Trans-Tympanic Microphone Approach for Fully Implantable Hearing Devices.

    PubMed

    Woo, Seong Tak; Shin, Dong Ho; Lim, Hyung-Gyu; Seong, Ki-Woong; Gottlieb, Peter; Puria, Sunil; Lee, Kyu-Yup; Cho, Jin-Ho

    2015-09-09

    Fully implantable hearing devices (FIHDs) have been developed as a new technology to overcome the disadvantages of conventional acoustic hearing aids. The implantable microphones currently used in FIHDs, however, have difficulty achieving high sensitivity to environmental sounds, low sensitivity to body noise, and ease of implantation. In general, implantable microphones may be placed under the skin in the temporal bone region of the skull. In this situation, body noise picked up during mastication and touching can be significant, and the layer of skin and hair can both attenuate and distort sounds. The new approach presently proposed is a microphone implanted at the tympanic membrane. This method increases the microphone's sensitivity by utilizing the pinna's directionally dependent sound collection capabilities and the natural resonances of the ear canal. The sensitivity and insertion loss of this microphone were measured in human cadaveric specimens in the 0.1 to 16 kHz frequency range. In addition, the maximum stable gain due to feedback between the trans-tympanic microphone and a round-window-drive transducer, was measured. The results confirmed in situ high-performance capabilities of the proposed trans-tympanic microphone.

  20. A completely implanted left ventricular assist device. Chronic in vivo testing.

    PubMed

    Weiss, W J; Rosenberg, G; Snyder, A J; Donachy, J; Reibson, J; Kawaguchi, O; Sapirstein, J S; Pae, W E; Pierce, W S

    1993-01-01

    A completely implantable left ventricular assist device (LVAD) designed for permanent circulatory support has recently been tested in animals without the use of percutaneous leads, using transcutaneous energy transmission and wireless telemetry. The LVAD consists of a brushless DC motor and rollerscrew energy converter, a pusher plate actuated blood pump with a seamless segmented polyurethane blood sac, Bjork-Shiley Delrin disk monostrut valves, an implanted compliance chamber, an implanted electronic controller and battery, and a transcutaneous energy transmission system. The blood pump/energy converter assembly weighs 565 g and displaces 295 cc. The dynamic stroke volume is 60 ml, and the maximum output is 9 L/min. Pump output is automatically controlled to maintain full stroke volume as preload varies. Hall effect sensors for detecting rotary position of the motor are the only sensors used. Six bovine implants were performed, with durations of 84, 208, 244, 130, 70 (ongoing), and 15 (ongoing) days. Four animals used two-way telemetry, whereas the remaining two used one-way (outgoing) telemetry. These first chronic in vivo tests with the Penn State completely implanted LVAD system have demonstrated that it is a feasible solution to long-term ventricular support.

  1. A New Trans-Tympanic Microphone Approach for Fully Implantable Hearing Devices

    PubMed Central

    Woo, Seong Tak; Shin, Dong Ho; Lim, Hyung-Gyu; Seong, Ki-Woong; Gottlieb, Peter; Puria, Sunil; Lee, Kyu-Yup; Cho, Jin-Ho

    2015-01-01

    Fully implantable hearing devices (FIHDs) have been developed as a new technology to overcome the disadvantages of conventional acoustic hearing aids. The implantable microphones currently used in FIHDs, however, have difficulty achieving high sensitivity to environmental sounds, low sensitivity to body noise, and ease of implantation. In general, implantable microphones may be placed under the skin in the temporal bone region of the skull. In this situation, body noise picked up during mastication and touching can be significant, and the layer of skin and hair can both attenuate and distort sounds. The new approach presently proposed is a microphone implanted at the tympanic membrane. This method increases the microphone’s sensitivity by utilizing the pinna’s directionally dependent sound collection capabilities and the natural resonances of the ear canal. The sensitivity and insertion loss of this microphone were measured in human cadaveric specimens in the 0.1 to 16 kHz frequency range. In addition, the maximum stable gain due to feedback between the trans-tympanic microphone and a round-window-drive transducer, was measured. The results confirmed in situ high-performance capabilities of the proposed trans-tympanic microphone. PMID:26371007

  2. Centrifuge-simulated suborbital spaceflight in subjects with cardiac implanted devices.

    PubMed

    Blue, Rebecca S; Reyes, David P; Castleberry, Tarah L; Vanderploeg, James M

    2015-04-01

    Future commercial spaceflight participants (SFPs) with conditions requiring personal medical devices represent a unique challenge. The behavior under stress of cardiac implanted devices (CIDs) such as pacemakers is of special concern. No known data currently exist on how such devices may react to the stresses of spaceflight. We examined the responses of two volunteer subjects with CIDs to G forces in a centrifuge to evaluate how similar potential commercial SFPs might tolerate the forces of spaceflight. Two subjects, 75- and 79-yr-old men with histories of atrial fibrillation and implanted dual-lead, rate-responsive pacemakers, underwent seven centrifuge runs over 2 d. Day 1 consisted of two +Gz runs (peak = +3.5 Gz, run 2) and two +Gx runs (peak = +6.0 Gx, run 4). Day 2 consisted of three runs approximating suborbital spaceflight profiles (combined +Gx/+Gz). Data collected included blood pressures, electrocardiograms, pulse oximetry, neurovestibular exams, and postrun questionnaires regarding motion sickness, disorientation, greyout, and other symptoms. Despite both subjects' significant medical histories, neither had abnormal physiological responses. Post-spin analysis demonstrated no lead displacement, damage, or malfunction of either CID. Potential risks to SFPs with CIDs include increased arrhythmogenesis, lead displacement, and device damage. There are no known prior studies of individuals with CIDs exposed to accelerations anticipated during the dynamic phases of suborbital spaceflight. These cases demonstrate that even individuals with significant medical histories and implanted devices can tolerate the acceleration exposures of commercial spaceflight. Further investigation will determine which personal medical devices present significant risks during suborbital flight and beyond.

  3. Cardiovascular implantable electronic device infection in patients with Staphylococcus aureus bacteremia.

    PubMed

    Uslan, Daniel Z; Dowsley, Taylor F; Sohail, Muhammad R; Hayes, David L; Friedman, Paul A; Wilson, Walter R; Steckelberg, James M; Baddour, Larry M

    2010-04-01

    Staphylococcus aureus bacteremia (SAB) in patients with cardiovascular implantable electronic devices (CIED), including permanent pacemakers (PPMs) and implantable cardioverter-defibrillators (ICD), can be the sole manifestation of device infection. To assess clinical factors associated with CIED infection, we retrospectively reviewed all patients with both CIED and SAB seen at Mayo Clinic Rochester between 2001 through 2006. CIED infection was defined using microbiological and clinical criteria. Of the 62 patients with SAB and a CIED, 22 patients (35.5%) had CIED infection. The generator pocket was identified as the source of bacteremia in seven (11%) patients. The majority of CIED infections were device-related infective endocarditis (12 of 22, 55%). Thirty percent of patients presenting with SAB greater than 1 year after device implantation had CIED infection; all but one had CIED-related infective endocarditis. Sixty percent of ICD patients (12 of 20) with SAB had CIED infection, compared with 24% of PPM patients (10 of 42, P = 0.01). On univariate analysis factors associated with CIED-related infective endocarditis included device type [odds ratio (OR) for ICD 13.3, 95% confidence interval [CI] 2.1, 84.9) and presence of a prosthetic heart valve (OR 6.8 95% CI 1.1, 43.4). CIED infection is common in patients with SAB. The presence of an ICD and prosthetic heart valve were associated with CIED-related infective endocarditis. Subsequent work should focus on prospectively characterizing the subset of patients with CIED infection who present with SAB as the sole manifestation of their device infection. (PACE 2010; 407-413).

  4. Device Survival after Primary Implantation of an Artificial Urinary Sphincter for Male Stress Urinary Incontinence.

    PubMed

    Yafi, Faysal A; DeLay, Kenneth J; Stewart, Carrie; Chiang, Jason; Sangkum, Premsant; Hellstrom, Wayne J G

    2017-03-01

    The AMS 800™ artificial urinary sphincter remains the gold standard for the surgical management of male stress urinary incontinence. We reviewed artificial urinary sphincter device survival after primary implantation. Retrospective data were collected from the AMS 800 patient information form database. Since 1972, 77,512 patient information forms for primary artificial urinary sphincter implantation have been completed in the United States. Following exclusion of procedures performed in children and females, and those labeled with an unknown surgical technique, 27,096 artificial urinary sphincter cases were included in the analysis. Collected variables included patient age, surgical approach, number of cuffs and surgeon volume. Measured outcomes included device explantation, device revision, component revision and time to each event. Artificial urinary sphincter insertion was performed by low volume implanters in 22,165 (82.6%) cases. The approach was perineal in 18,373 cases (67.8%) and a tandem cuff was used in 2,224 cases (8.2%). Overall 5,723 cases required revision or explantation (21.1%). Younger age and penoscrotal approach were associated with higher device explantation and revision rates, while the use of a tandem cuff was associated with higher explantation rates. On multivariate analysis younger age, penoscrotal approach and use of a tandem cuff but not surgeon volume were significant factors associated with device explantation and component revision. These data provide a general overview of artificial urinary sphincter device survival and may serve urologists when counseling patients. Younger age, penoscrotal approach and use of a tandem cuff may be associated with inferior outcomes. Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  5. Results of remote follow-up and monitoring in young patients with cardiac implantable electronic devices.

    PubMed

    Silvetti, Massimo S; Saputo, Fabio A; Palmieri, Rosalinda; Placidi, Silvia; Santucci, Lorenzo; Di Mambro, Corrado; Righi, Daniela; Drago, Fabrizio

    2016-01-01

    Remote monitoring is increasingly used in the follow-up of patients with cardiac implantable electronic devices. Data on paediatric populations are still lacking. The aim of our study was to follow-up young patients both in-hospital and remotely to enhance device surveillance. This is an observational registry collecting data on consecutive patients followed-up with the CareLink system. Inclusion criteria were a Medtronic device implanted and patient's willingness to receive CareLink. Patients were stratified according to age and presence of congenital/structural heart defects (CHD). A total of 221 patients with a device - 200 pacemakers, 19 implantable cardioverter defibrillators, and two loop recorders--were enrolled (median age of 17 years, range 1-40); 58% of patients were younger than 18 years of age and 73% had CHD. During a follow-up of 12 months (range 4-18), 1361 transmissions (8.9% unscheduled) were reviewed by technicians. Time for review was 6 ± 2 minutes (mean ± standard deviation). Missed transmissions were 10.1%. Events were documented in 45% of transmissions, with 2.7% yellow alerts and 0.6% red alerts sent by wireless devices. No significant differences were found in transmission results according to age or presence of CHD. Physicians reviewed 6.3% of transmissions, 29 patients were contacted by phone, and 12 patients underwent unscheduled in-hospital visits. The event recognition with remote monitoring occurred 76 days (range 16-150) earlier than the next scheduled in-office follow-up. Remote follow-up/monitoring with the CareLink system is useful to enhance device surveillance in young patients. The majority of events were not clinically relevant, and the remaining led to timely management of problems.

  6. CT pre-operative planning of a new semi-implantable bone conduction hearing device.

    PubMed

    Law, Eric K C; Bhatia, Kunwar S S; Tsang, Willis S S; Tong, Michael C F; Shi, Lin

    2016-06-01

    Accommodating a novel semi-implantable bone conduction hearing device within the temporal bone presents challenges for surgical planning. This study describes the utility of CT in pre-operative assessment of such an implant. Retrospective review of pre-operative CT, clinical and surgical records of 16 adults considered for device implantation. Radiological suitability was assessed on CT using 3D simulation software. Antero-posterior (AP) dimensions of the mastoid bone and minimum skull thickness were measured. CT planning results were correlated with operative records. Eight and five candidates were suitable for device placement in the transmastoid and retrosigmoid positions, respectively, and three were radiologically unsuitable. The mean AP diameter of the mastoid cavity was 14.6 mm for the transmastoid group and 4.6 mm for the retrosigmoid group (p < 0.05). Contracted mastoid and/or prior surgery were predisposing factors for unsuitability. Four transmastoid and five retrosigmoid positions required sigmoid sinus/dural depression and/or use of lifts due to insufficient bone capacity. A high proportion of patients being considered have contracted or operated mastoids, which reduces the feasibility of the transmastoid approach. This finding combined with the complex temporal bone geometry illustrates the importance of careful CT evaluation using 3D software for precise device simulation. • Preoperative temporal bone CT is essential for determining Bonebridge device suitability. • Mastoid under-pneumatisation and prior mastoidectomy predict a retrosigmoid Bonebridge position. • 3D simulation software is recommended for precise device positioning.

  7. Revision total hip and knee arthroplasty implant identification: implications for use of Unique Device Identification 2012 AAHKS member survey results.

    PubMed

    Wilson, Natalia A; Jehn, Megan; York, Sally; Davis, Charles M

    2014-02-01

    FDA's Unique Device Identification (UDI) Rule will mandate manufacturers to assign unique identifiers to their marketed devices. UDI use is expected to improve implant documentation and identification. A 2012 American Association of Hip and Knee Surgeons membership survey explored revision total hip and knee arthroplasty implant identification processes. 87% of surgeons reported regularly using at least 3 methods to identify failed implants pre-operatively. Median surgeon identification time was 20 min; median staff time was 30 min. 10% of implants could not be identified pre-operatively. 2% could not be identified intra-operatively. UDI in TJA registry and UDI in EMR were indicated practices to best support implant identification and save time. FDA's UDI rule sets the foundation for UDI use in patient care settings as standard practice for implant documentation.

  8. Inappropriate implantable cardioverter defibrillator shock from a transcutaneous muscle stimulation device therapy.

    PubMed

    Siu, Chung-Wah; Tse, Hung-Fat; Lau, Chu-Pak

    2005-06-01

    Inappropriate shock from implantable cardioverter defibrillator (ICD) may result from external electromagnetic interference (EMI), especially for unipolar ventricle sensing. Previous case reports and small in-vitro safety study suggested that endocardial bipolar lead system may be immune from EMI resulting from transcutaneous electrical neuromuscle stimulation (TENS) therapy. This report presents an unusual case of inappropriate discharge in a patient with ICD of endocardial bipolar lead system, receiving TENS from a commercially available device.

  9. Organ donation following brain stem death after ventricular assist device implantation.

    PubMed

    Mohite, Prashant Nanasaheb; Popov, Aron Frederik; Zych, Bartlomeij; Dhar, Dhruva; Capoccia, Massimo; Simon, Andre Ruediger

    2014-03-01

    The availability of donor organs is the biggest limitation for lung transplantation, and a significant proportion of patients die on the waiting list. We describe a case of a 44-year-old lady who developed subarachnoid hemorrhage and cerebral edema on second postoperative day after left ventricular assist device implantation. She was declared brain stem dead 2 days later, and her organs were transplanted to suitable recipients on the waiting list for lung, liver and kidney transplantation.

  10. A practical approach to perioperative management of cardiac implantable electronic devices

    PubMed Central

    Chia, Pow-Li; Foo, David

    2015-01-01

    With the increased use of cardiac implantable electronic devices (CIEDs), it is increasingly important to recognise the unique challenges involved in the management of patients with CIEDs who are undergoing surgery. Practice advisories and consensus statements have been issued by the American Society of Anesthesiologists and the Heart Rhythm Society, advocating a multidisciplinary approach. This review discusses and presents a practical approach to perioperative CIED management in the Singapore context. PMID:26512144

  11. Processing of Silver-Implanted Aluminum Nitride for Energy Harvesting Devices

    NASA Astrophysics Data System (ADS)

    Alleyne, Fatima Sierre

    One of the more attractive sources of green energy has roots in the popular recycling theme of other green technologies, now known by the term "energy scavenging." In its most promising conformation, energy scavenging converts cyclic mechanical vibrations in the environment or random mechanical pressure pulses, caused by sources ranging from operating machinery to human footfalls, into electrical energy via piezoelectric transducers. While commercial piezoelectrics have evolved to favor lead zirconate titanate (PZT) for its combination of superior properties, the presence of lead in these ceramic compounds raises resistance to their application in anything "green" due to potential health implications during their manufacturing, recycling, or in-service application, if leaching occurs. Therefore in this study we have pursued the application of aluminum nitride (AlN) as a non-toxic alternative to PZT, seeking processing pathways to augment the modest piezoelectric performance of AlN and exploit its compatibility with complementary-metal-oxide semiconductor (CMOS) manufacturing. Such piezoelectric transducers have been categorized as microelectromechanical systems (MEMS), which despite more than a decade of research in this field, is plagued by delamination at the electrode/piezoelectric interface. Consequently the electric field essential to generate and sustain the piezoelectric response of these devices is lost, resulting in device failure. Working on the hypothesis that buried conducting layers can both mitigate the delamination problem and generate sufficient electric field to engage the operation of resonator devices, we have undertaken a study of silver ion implantation to experimentally assess its feasibility. As with most ion implantation procedures employed in semiconductor fabrication, the implanted sample is subjected to a thermal treatment, encouraging diffusion-assisted precipitation of the implanted species at high enough concentrations. The objective

  12. A power-efficient communication system between brain-implantable devices and external computers.

    PubMed

    Yao, Ning; Lee, Heung-No; Chang, Cheng-Chun; Sclabassi, Robert J; Sun, Mingui

    2007-01-01

    In this paper, we propose a power efficient communication system for linking a brain-implantable device to an external system. For battery powered implantable devices, the processor and the transmitter power should be reduced in order to both conserve battery power and reduce the health risks associated with transmission. To accomplish this, a joint source-channel coding/decoding system is devised. Low-density generator matrix (LDGM) codes are used in our system due to their low encoding complexity. The power cost for signal processing within the implantable device is greatly reduced by avoiding explicit source encoding. Raw data which is highly correlated is transmitted. At the receiver, a Markov chain source correlation model is utilized to approximate and capture the correlation of raw data. A turbo iterative receiver algorithm is designed which connects the Markov chain source model to the LDGM decoder in a turbo-iterative way. Simulation results show that the proposed system can save up to 1 to 2.5 dB on transmission power.

  13. Accelerated life-test methods and results for implantable electronic devices with adhesive encapsulation.

    PubMed

    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.

  14. Current Approaches to Device Implantation in Pediatric and Congenital Heart Disease Patients

    PubMed Central

    Miller, Jacob R; Lancaster, Timothy S; Eghtesady, Pirooz

    2015-01-01

    Summary The pediatric ventricular assist device (VAD) has recently shown substantial improvements in survival as a bridge to heart transplant for patients with end-stage heart failure. Since that time, its use has become much more frequent. With increasing utilization, additional questions have arisen including patient selection, timing of VAD implantation and device selection. These challenges are amplified by the uniqueness of each patient, the recent abundance of literature surrounding VAD use, as well as the technological advancements in the devices themselves. Ideal strategies for device placement must be sought, for not only improved patient care, but for optimal resource utilization. Here, we review the most relevant literature to highlight some of the challenges facing the heart failure specialist, and any physician, who will care for a child with a VAD. PMID:25732410

  15. [An implantable micro-device using wireless power transmission for measuring aortic aneurysm sac pressure].

    PubMed

    Guo, Xudong; Ge, Bin; Wang, Wenxing

    2013-08-01

    In order to detect endoleaks after endovascular aneurysm repair (EVAR), we developed an implantable micro-device based on wireless power transmission to measure aortic aneurysm sac pressure. The implantable micro-device is composed of a miniature wireless pressure sensor, an energy transmitting coil, a data recorder and a data processing platform. Power transmission without interconnecting wires is performed by a transmitting coil and a receiving coil. The coupling efficiency of wireless power transmission depends on the coupling coefficient between the transmitting coil and the receiving coil. With theoretical analysis and experimental study, we optimized the geometry of the receiving coil to increase the coupling coefficient. In order to keep efficiency balance and satisfy the maximizing conditions, we designed a closed loop power transmission circuit, including a receiving voltage feedback module based on wireless communication. The closed loop improved the stability and reliability of transmission energy. The prototype of the micro-device has been developed and the experiment has been performed. The experiments showed that the micro-device was feasible and valid. For normal operation, the distance between the transmitting coil and the receiving coil is smaller than 8cm. Besides, the distance between the micro-device and the data recorder is within 50cm.

  16. A flexible super-capacitive solid-state power supply for miniature implantable medical devices.

    PubMed

    Meng, Chuizhou; Gall, Oren Z; Irazoqui, Pedro P

    2013-12-01

    We present a high-energy local power supply based on a flexible and solid-state supercapacitor for miniature wireless implantable medical devices. Wireless radio-frequency (RF) powering recharges the supercapacitor through an antenna with an RF rectifier. A power management circuit for the super-capacitive system includes a boost converter to increase the breakdown voltage required for powering device circuits, and a parallel conventional capacitor as an intermediate power source to deliver current spikes during high current transients (e.g., wireless data transmission). The supercapacitor has an extremely high area capacitance of ~1.3 mF/mm(2), and is in the novel form of a 100 μm-thick thin film with the merit of mechanical flexibility and a tailorable size down to 1 mm(2) to meet various clinical dimension requirements. We experimentally demonstrate that after fully recharging the capacitor with an external RF powering source, the supercapacitor-based local power supply runs a full system for electromyogram (EMG) recording that consumes ~670 μW with wireless-data-transmission functionality for a period of ~1 s in the absence of additional RF powering. Since the quality of wireless powering for implantable devices is sensitive to the position of those devices within the RF electromagnetic field, this high-energy local power supply plays a crucial role in providing continuous and reliable power for medical device operations.

  17. Selection of electrical algorithms to treat obesity with intermittent vagal block using an implantable medical device.

    PubMed

    Camilleri, Michael; Toouli, James; Herrera, Miguel F; Kow, Lilian; Pantoja, Juan Pablo; Billington, Charles J; Tweden, Katherine S; Wilson, Richard R; Moody, Frank G

    2009-01-01

    A laparoscopically implantable electrical device that intermittently blocks both vagi near the esophagogastric junction led to significant excess weight loss (EWL) in an initial clinical trial in obese patients. The study objective was to optimize therapy algorithms and determine the EWL achieved with a second-generation device at university hospitals in Australia, Norway, and Switzerland. Data acquired during the initial clinical trial were analyzed and subsequently used to select alternative electrical algorithms. In the second trial, vagal blocking using one selected therapy algorithm was initiated 2 weeks after implanting the second-generation device. The patients were followed up for 6 months to assess the EWL and safety, including adverse events. In the initial clinical trial, vagal blocking algorithm durations of 90-150 s were associated with greater EWL compared with either shorter or longer algorithm durations (P<.01). The second trial enrolled 27 patients (mean body mass index 39.3+/-.8 kg/m2) to evaluate a 120-s blocking algorithm. At 6 months, greater EWL was achieved (22.7%+/-3.1%, n=24) compared with the initial study and first-generation device (14.2%+/-2.2%, n=29, P=.03). In both trials, an association was found between the number of 90-150-s algorithms delivered daily and greater EWL (P=.03). No deaths, unanticipated device-related adverse events, or medically serious adverse events were associated with the device. This second-generation vagal blocking device, using a therapy algorithm of 120-s duration, resulted in a clinically acceptable safety profile and significantly greater EWL compared with the first-generation device delivering a wider range of therapy algorithm durations.

  18. [Design of a computer program for the registration of implantable medical device, field safety corrective action and advers events, as a tool for medical device surveillance].

    PubMed

    Márquez-Peiró, Juan Francisco; Gaspar-Carreño, Marisa; Jiménez-Torres, José; Selva-Otaolaurruchi, Juan

    2016-03-01

    To describe the features of computer program to support the activity of the responsible for surveillance of medical devices. To evaluate their use after one year of implementation in a hospital. The stages of the process were: description of the activities of medical devices surveillance and implant registration, definition of functionality and data processing, creation of databases, implementation in a private hospital which manages PS, validation of the program and analysis of their usefulness. SIVIPS was developed using Acces. Main variables were described for all the activities of the responsible for medical device surveillance (implants, alert, medical device incidents, including for in vitro diagnostics) and all the functionalities of the computer program. SIVIPS was introduced in a pharmacy service with one pharmacist for the management of medical devices. One year after its implementation we had registered 564 implants with a description by type of implant, 31 alerts and 6 incidents. SIVIPS allow monitoring of the actions taken in these cases. SIVIPS is the first tool to support the activity of medical device surveillance. It is an easy tool that allows the registration of alerts and medical device related incidents, and registration of implants performed in the center, which will improve the traceability of the PS. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  19. PLA/PEG-PPG-PEG/dexamethasone implant prepared by hot-melt extrusion for controlled release of immunosuppressive drug to implantable medical devices, Part 2: in vivo evaluation.

    PubMed

    Li, DeXia; Guo, Gang; Deng, Xin; Fan, RangRang; Guo, QingFa; Fan, Min; Liang, Jian; Luo, Feng; Qian, ZhiYong

    2013-01-01

    Hot-melt extrusion (HME) plays an important role in preparing implants as local drug delivery systems in pharmaceutical fields. Here, a new PLA/PEG-PPG-PEG/Dexamethasone (PLA/F68/Dex) implant prepared by HME has been developed. Importantly, the implant was successfully achieved to control release of immunosuppressive drug to an implanted device. In particular, this implant has not been reported previously in pharmaceutical fields. FTIR and XRD were adopted to investigate the properties of the samples. The in vivo release study showed that the maximum value of Dex release from the implants was approximately 50% at 1 month. The in vivo degradation behavior was determined by UV spectrophotometer and scanning electron microscopy studies, and the weight loss rate of the implants were up to 25% at 1 month. Furthermore, complete blood count (CBC) test, serum chemistry and major organs were performed, and there is no significant lesion and side effects observed in these results. Therefore, the results elucidated that the new PLA/F68/Dex implant prepared by HME could deliver an immunosuppressive drug to control the inflammatory reaction at the implant site.

  20. A cranial window imaging method for monitoring vascular growth around chronically implanted micro-ECoG devices

    PubMed Central

    Schendel, Amelia A.; Thongpang, Sanitta; Brodnick, Sarah K.; Richner, Thomas J.; Lindevig, Bradley D.B.; Krugner-Higby, Lisa; Williams, Justin C.

    2013-01-01

    Implantable neural micro-electrode arrays have the potential to restore lost sensory or motor function to many different areas of the body. However, the invasiveness of these implants often results in scar tissue formation, which can have detrimental effects on recorded signal quality and longevity. Traditional histological techniques can be employed to study the tissue reaction to implanted micro-electrode arrays, but these techniques require removal of the brain from the skull, often causing damage to the meninges and cortical surface. This is especially unfavorable when studying the tissue response to electrode arrays such as the micro-electrocorticography (micro-ECoG) device, which sits on the surface of the cerebral cortex. In order to better understand the biological changes occurring around these types of devices, a cranial window implantation scheme has been developed, through which the tissue response can be studied in vivo over the entire implantation period. Rats were implanted with epidural micro-ECoG arrays, over which glass coverslips were placed and sealed to the skull, creating cranial windows. Vascular growth around the devices was monitored for one month after implantation. It was found that blood vessels grew through holes in the micro-ECoG substrate, spreading over the top of the device. Micro-hematomas were observed at varying time points after device implantation in every animal, and tissue growth between the micro-ECoG array and the window occurred in several cases. Use of the cranial window imaging technique with these devices enabled the observation of tissue changes that would normally go unnoticed with a standard device implantation scheme. PMID:23769960

  1. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

    ... HUMAN SERVICES Food and Drug Administration Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  2. Safety and utility of magnetic resonance imaging in patients with cardiac implantable electronic devices

    PubMed Central

    Strom, Jordan B.; Whelan, Jill B.; Shen, Changyu; Zheng, Shuang Qi; Mortele, Koenraad J.; Kramer, Daniel B.

    2017-01-01

    BACKGROUND Off-label magnetic resonance imaging (MRI) for patients with cardiac implantable electrical devices has been limited owing to concerns about safety and unclear diagnostic and prognostic utility. OBJECTIVE The purpose of this study was to define major and minor adverse events with off-label MRI scans. METHODS We prospectively evaluated patients with non–MRI-conditional cardiac implantable electrical devices referred for MRI scans under a strict clinical protocol. The primary safety outcome was incidence of major adverse events (loss of pacing, inappropriate shock or antitachycardia pacing, need for system revision, or death) or minor adverse events (inappropriate pacing, arrhythmias, power-on-reset events, heating at the generator site, or changes in device parameters at baseline or at 6 months). RESULTS A total of 189 MRI scans were performed in 123 patients (63.1% [78] men; median age 70 ± 18.5 years; 37.0% [70] patients with implantable cardioverter-defibrillators; 21.8% [41] pacemaker-dependent patients) predominantly for brain or spinal conditions. A minority of scans (22.7% [43]) were performed for urgent or emergent indications. Major adverse events were rare: 1 patient with loss of pacing, no deaths, or system revisions (overall rate 0.5%; 95% confidence interval 0.01–2.91). Minor adverse events were similarly rare (overall rate 1.6%; 95% confidence interval 0.3–4.6). Nearly all studies (98.4% [186]) were interpretable, while 74.9% [142] were determined to change management according to the prespecified criteria. No clinically significant changes were observed in device parameters acutely after MRI or at 6 months as compared with baseline across all patient and device categories. CONCLUSION Off-label MRI scans performed under a strict protocol demonstrated excellent short- and medium-term safety while providing interpretable imaging that frequently influenced clinical care. PMID:28385671

  3. Safety and utility of magnetic resonance imaging in patients with cardiac implantable electronic devices.

    PubMed

    Strom, Jordan B; Whelan, Jill B; Shen, Changyu; Zheng, Shuang Qi; Mortele, Koenraad J; Kramer, Daniel B

    2017-08-01

    Off-label magnetic resonance imaging (MRI) for patients with cardiac implantable electrical devices has been limited owing to concerns about safety and unclear diagnostic and prognostic utility. The purpose of this study was to define major and minor adverse events with off-label MRI scans. We prospectively evaluated patients with non-MRI-conditional cardiac implantable electrical devices referred for MRI scans under a strict clinical protocol. The primary safety outcome was incidence of major adverse events (loss of pacing, inappropriate shock or antitachycardia pacing, need for system revision, or death) or minor adverse events (inappropriate pacing, arrhythmias, power-on-reset events, heating at the generator site, or changes in device parameters at baseline or at 6 months). A total of 189 MRI scans were performed in 123 patients (63.1% [78] men; median age 70 ± 18.5 years; 56.9% [70] patients with implantable cardioverter-defibrillators; 33.3% [41] pacemaker-dependent patients) predominantly for brain or spinal conditions. A minority of scans (22.7% [43]) were performed for urgent or emergent indications. Major adverse events were rare: 1 patient with loss of pacing, no deaths, or system revisions (overall rate 0.5%; 95% confidence interval 0.01-2.91). Minor adverse events were similarly rare (overall rate 1.6%; 95% confidence interval 0.3-4.6). Nearly all studies (98.4% [186]) were interpretable, while 75.1% [142] were determined to change management according to the prespecified criteria. No clinically significant changes were observed in device parameters acutely after MRI or at 6 months as compared with baseline across all patient and device categories. Off-label MRI scans performed under a strict protocol demonstrated excellent short- and medium-term safety while providing interpretable imaging that frequently influenced clinical care. Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  4. Mechanical Reliability of Devices Subdermally Implanted into the Young of Long-Lived and Endangered Wildlife

    NASA Astrophysics Data System (ADS)

    Hori, Bryan; Petrell, Royann J.; Fernlund, Goran; Trites, Andrew

    2012-09-01

    Service data does not exist for the strength of enclosures for subdermally implanted biotelemetry devices intended for young wild animals. Developing adequate tests especially for implants intended for endangered species is difficult due to the very limited availability of live animals and cadaverous tissue, ethical concerns about using them, and high enclosure costs. In this research, these limitations were overcome by taking a conservative approach to design and testing. Reliability tests were developed and performed to establish the likelihood that a thin subdermally and cranially implanted alumina enclosure would fail due to typical external forces related to diving, fights, and falls over the expected 30-year life time of sea lions. Cyclic fatigue tests indicative of deep dives performed out of tissue and at the 90% reliability level indicated no failure after 70,000 stress cycles at stresses of approximately 15 MPa; dynamic fatigue tests indicated a 5% probability of failure at 250 MPa; and puncture tests indicative of fight bites showed a 5% probability of failure at 1500 N. These values were far outside of what the animals might expect to encounter in real life. On the other hand, the response of the enclosure to impact outside of the tissue was failure at a mean energy level of 6.7 J. Modeling results predict that head impacts due to trampling by fighting sea lion males and falls over 1 m onto a rocky ledge typical of haul out environments would likely fracture an infant's head as well as the implant. The device can be implanted under an impact absorbing 1 cm blubber layer for extra protection. More service data for enclosures can be made more available despite limited availability of test animals if a conservative approach to testing is taken.

  5. Aptamer-based liposomes improve specific drug loading and release.

    PubMed

    Plourde, Kevin; Derbali, Rabeb Mouna; Desrosiers, Arnaud; Dubath, Céline; Vallée-Bélisle, Alexis; Leblond, Jeanne

    2017-04-10

    Aptamer technology has shown much promise in cancer therapeutics for its targeting abilities. However, its potential to improve drug loading and release from nanocarriers has not been thoroughly explored. In this study, we employed drug-binding aptamers to actively load drugs into liposomes. We designed a series of DNA aptamer sequences specific to doxorubicin, displaying multiple binding sites and various binding affinities. The binding ability of aptamers was preserved when incorporated into cationic liposomes, binding up to 15equivalents of doxorubicin per aptamer, therefore drawing the drug into liposomes. Optimization of the charge and drug/aptamer ratios resulted in ≥80% encapsulation efficiency of doxorubicin, ten times higher than classical passively-encapsulating liposomal formulations and similar to a pH-gradient active loading strategy. In addition, kinetic release profiles and cytotoxicity assay on HeLa cells demonstrated that the release and therapeutic efficacy of liposomal doxorubicin could be controlled by the aptamer's structure. Our results suggest that the aptamer exhibiting a specific intermediate affinity is the best suited to achieve high drug loading while maintaining efficient drug release and therapeutic activity. This strategy was successfully applied to tobramycin, a hydrophilic drug suffering from low encapsulation into liposomes, where its loading was improved six-fold using aptamers. Overall, we demonstrate that aptamers could act, in addition to their targeting properties, as multifunctional excipients for liposomal formulations.

  6. Gastrointestinal bleed after left ventricular assist device implantation: incidence, management, and prevention

    PubMed Central

    Harvey, Laura; Holley, Christopher T.

    2014-01-01

    Background Continuous-flow left ventricular assist devices (CF-LVADs) have become the standard of care for patients with end-stage heart failure (HF). While these devices have improved durability compared to earlier generation left ventricular assist devices (LVADs), increased frequency in some complications has been seen, including gastrointestinal bleeding (GIB), pump thrombosis and hemolysis. We discuss the incidence, management and prevention of GIB after CF-LVAD implantation. Methods We reviewed the current literature available on the incidence, management and prevention of GIB after CF-LVAD implantation with a focus on our experience at the University of Minnesota, with data on nearly 300 patients who received a CF-LVAD from 2005 to 2013. Results The incidence of GIB after CF-LVAD varies between 18-40% in numerous studies. At the University of Minnesota, out of 233 patients who underwent HeartMate II (HMII) implantation between 2005-2013, 60 GIB episodes occurred in 51 patients (22%), with an event rate of 0.17 gastrointestinal bleeds/patient-year of support. The etiology of GIB appears to be multifactorial. The main factors which have been identified include the need for chronic anticoagulation, acquired von Willebrand syndrome, platelet dysfunction and increased incidence of arteriovenous malformations due to chronic low pulse pressure. When managing an LVAD patient with GIB, a multi-disciplinary approach is needed. The main goals of treatment are evaluating the location and severity of the bleed, holding anti-coagulants and resuscitation to maintain stable hemodynamics. Conclusions GIB is a complication with considerable morbidity. Future efforts to further understand the etiology of GIB and optimize anti-coagulation are needed to improve outcomes following CF-LVAD implantation. PMID:25452907

  7. Safe and Simplified Salvage Technique for Exposed Implantable Cardiac Electronic Devices under Local Anesthesia

    PubMed Central

    Jung, Chang Young; Kim, Sung-Eun

    2017-01-01

    Background Skin erosion is a dire complication of implantable cardiac pacemakers and defibrillators. Classical treatments involve removal of the entire generator and lead systems, however, these may result in fatal complications. In this study, we present our experience with a simplified salvage technique for exposed implantable cardiac electronic devices (ICEDs) without removing the implanted device, in an attempt to reduce the risks and complication rates associated with this condition. Methods The records of 10 patients who experienced direct ICED exposure between January 2012 and December 2015 were retrospectively reviewed. The following surgical procedure was performed in all patients: removal of skin erosion and capsule, creation of a new pocket at least 1.0–1.5 cm inferior to its original position, migration of the ICED to the new pocket, and insertion of closed-suction drainage. Patients with gross local sepsis or septicemia were excluded from this study. Results Seven patients had cardiac pacemakers and the other 3 had implantable cardiac defibrillators. The time from primary ICED placement to exposure ranged from 0.3 to 151 months (mean, 29 months. Postoperative follow-up in this series ranged from 8 to 31 months (mean follow-up, 22 months). Among the 10 patients, none presented with any signs of overt infection or cutaneous lesions, except 1 patient with hematoma on postoperative day 5. The hematoma was successfully treated by surgical removal and repositioning of the closed-suction drainage. Conclusions Based on our experience, salvage of exposed ICEDs is possible without removing the device in selected patients. PMID:28194346

  8. Constraining OCT with Knowledge of Device Design Enables High Accuracy Hemodynamic Assessment of Endovascular Implants

    PubMed Central

    Brown, Jonathan; Lopes, Augusto C.; Kunio, Mie; Kolachalama, Vijaya B.; Edelman, Elazer R.

    2016-01-01

    Background Stacking cross-sectional intravascular images permits three-dimensional rendering of endovascular implants, yet introduces between-frame uncertainties that limit characterization of device placement and the hemodynamic microenvironment. In a porcine coronary stent model, we demonstrate enhanced OCT reconstruction with preservation of between-frame features through fusion with angiography and a priori knowledge of stent design. Methods and Results Strut positions were extracted from sequential OCT frames. Reconstruction with standard interpolation generated discontinuous stent structures. By computationally constraining interpolation to known stent skeletons fitted to 3D ‘clouds’ of OCT-Angio-derived struts, implant anatomy was resolved, accurately rendering features from implant diameter and curvature (n = 1 vessels, r2 = 0.91, 0.90, respectively) to individual strut-wall configurations (average displacement error ~15 μm). This framework facilitated hemodynamic simulation (n = 1 vessel), showing the critical importance of accurate anatomic rendering in characterizing both quantitative and basic qualitative flow patterns. Discontinuities with standard approaches systematically introduced noise and bias, poorly capturing regional flow effects. In contrast, the enhanced method preserved multi-scale (local strut to regional stent) flow interactions, demonstrating the impact of regional contexts in defining the hemodynamic consequence of local deployment errors. Conclusion Fusion of planar angiography and knowledge of device design permits enhanced OCT image analysis of in situ tissue-device interactions. Given emerging interests in simulation-derived hemodynamic assessment as surrogate measures of biological risk, such fused modalities offer a new window into patient-specific implant environments. PMID:26906566

  9. Exposed Subcutaneous Implantable Devices: An Operative Protocol for Management and Salvage

    PubMed Central

    D’Arpa, Salvatore; Cordova, Adriana; Moschella, Francesco

    2015-01-01

    Background: Implantable venous and electrical devices are prone to exposure and infection. Indications for management are controversial, but—especially if infected—exposed devices are often removed and an additional operation is needed to replace the device, causing a delay in chemotherapy and prolonging healing time. We present our protocol for device salvage, on which limited literature is available. Methods: Between 2007 and 2013, 17 patients were treated (12 venous access ports, 3 cardiac pacemakers, and 2 subcutaneous neural stimulators). Most patients were operated within 7 days from exposure. All patients received only a single perioperative dose of prophylactic antibiotic. In cases of gross infection (n = 1), the device was immediately replaced. In the absence of clinical signs of infection: Complete capsulectomy and aggressive cleaning with an n-acetylcysteine solution and saline solution. Primary exposure of venous ports with sufficient skin coverage (n = 10): the device was covered with local skin flaps. Recurrent cases, cases with insufficient skin coverage or big devices (n = 7): the device was moved to a subpectoral pocket. Mean follow-up was 19 months. Results: Sixteen devices were saved. Only one grossly infected pacemaker was removed and replaced immediately. Only in 1 case, exposure of a venous port recurred after 18 months and was successfully moved to a subpectoral pocket. Chemotherapy was always restarted as scheduled and electrical devices remained functional. Conclusions: This protocol allows—with a straightforward operation and simple measures—to save exposed devices even several days after exposure. Submuscular placement or immediate replacement is indicated only in selected cases. PMID:26034650

  10. Antibiotic-eluting orthopedic device to prevent early implant associated infections: Efficacy, biocompatibility and biodistribution studies in an ovine model.

    PubMed

    Gimeno, Marina; Pinczowski, Pedro; Mendoza, Gracia; Asín, Javier; Vázquez, Francisco J; Vispe, Eugenio; García-Álvarez, Felícito; Pérez, Marta; Santamaría, Jesús; Arruebo, Manuel; Luján, Lluís

    2017-10-04

    Infection of orthopedic devices is a major complication in the postsurgical period generating important health issues and economic consequences. Prevention strategies could be based on local release of antibiotics from the orthopedic device itself to avoid adhesion and growth of bacteria. The purpose of this work is to demonstrate the efficiency to prevent these infections by a cefazolin-eluting, perforated stainless steel implant in an in vivo ovine model. The device was placed in the tibia of sheep, one group receiving cefazolin-loaded implants whereas the control group received empty implants. All implants were experimentally infected by direct inoculation of Staphylococcus aureus ATCC 6538. In vitro cytotoxicological studies were also performed to check the effect of antibiotic on cell viability, integrity, and cycle. Results showed that sheep receiving cefazolin-loaded devices were able to avoid implant-associated infections, with normal tissue healing process. The antibiotic release followed a local concentric pattern as demonstrated by high-performance liquid chromatography detection in tissues. The in vitro results indicate the lack of relevant cytotoxic effects for the maximum antibiotic concentration released by the device. These results demonstrate the efficiency and safety of cefazolin-eluting implants in an ovine model to prevent early postsurgical infections of orthopedic devices. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2017. © 2017 Wiley Periodicals, Inc.

  11. Accuracy of a manual torque application device for morse-taper implants: a technical note.

    PubMed

    Cehreli, Murat C; Akça, Kivang; Tönük, Ergin

    2004-01-01

    The objective of this study was to compare torques applied by new and used manual torque devices for Morse-taper implants. Fifteen ITI manual torque devices were tested. Those in group 1 (n = 5) were new (ie, never used), those in group 2 (n = 5) had been used 50 to 200 times, and those in group 3 (n = 5) had been used 500 to 1,000 times. The torques applied by each device were measured for 35 Ncm and 15 Ncm targets in an experimental setup by a custom-made wrench with strain gauges connected to a data acquisition system. The strain-gauge signals were simultaneously delivered to a computer at a sample rate of 10,000 Hz and converted to torque units. New devices applied higher torques than used devices for the 35-Ncm torque target (P < .05). The torques applied by group 3 devices were approximately 1.5 Ncm lower than those of other groups for the 35-Ncm target and approximately 1 Ncm lower for the 15-Ncm target. ITI manual torque devices deliver consistent torque output, although a slight decrease occurs as a consequence of clinical use.

  12. A Computational Model for Thrombus Formation in Response to Cardiovascular Implantable Devices

    NASA Astrophysics Data System (ADS)

    Horn, John; Ortega, Jason; Maitland, Duncan

    2014-11-01

    Cardiovascular implantable devices elicit complex physiological responses within blood. Notably, alterations in blood flow dynamics and interactions between blood proteins and biomaterial surface chemistry may lead to the formation of thrombus. For some devices, such as stents and heart valves, this is an adverse outcome. For other devices, such as embolic aneurysm treatments, efficient blood clot formation is desired. Thus a method to study how biomedical devices induce thrombosis is paramount to device development and optimization. A multiscale, multiphysics computational model is developed to predict thrombus formation within the vasculature. The model consists of a set of convection-diffusion-reaction partial differential equations for blood protein constituents involved in the progression of the clotting cascades. This model is used to study thrombus production from endovascular devices with the goal of optimizing the device design to generate the desired clotting response. This work was performed in part under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344.

  13. Inductive coupling links for lowest misalignment effects in transcutaneous implanted devices.

    PubMed

    Abbas, Saad Mutashar; Hannan, Mahammad A; Samad, Salina A; Hussain, Aini

    2014-06-01

    Use of transcutaneous inductive links is a widely known method for the wireless powering of bio-implanted devices such as implanted microsystems. The design of the coil for inductive links is generally not optimal. In this study, inductive links were used on the basis of the small loop antenna theory to reduce the effects of lateral coil misalignments on the biological human tissue model at 13.56 MHz. The tissue, which measures 60 mm×70 mm×5 mm, separates the reader and the implanted coils. The aligned coils and the lateral misalignment coils were investigated in different parametric x-distance misalignments. The optimal coil layout was developed on the basis of the layout rules presented in previous studies. Results show that the gain around the coils, which were separated by wet and dry skin, was constant and confirmed the omnidirectional radiation pattern even though the lateral misalignment between coils was smaller or greater than the implanted coil radius. This misalignment can be <4 mm or >6 mm up to 8 mm. Moreover, coil misalignments and skin condition do not affect the efficient performance of the coil.

  14. Effects of radiation and SAR from wireless implanted medical devices on the human body.

    PubMed

    Soontornpipit, Pichitpong

    2012-06-01

    To study the effect and impact from electromagnetic field radiation and specific absorption rate (SAR) on the human body. The present study describes a quasi-experimental research. The implanted antenna embedded to the medical device such as the cardiac pacemaker was designed in the human phantom using finite-difference time-domain method. The skin mimicking gels were developed as the tissue stimulant to realistically represent the human body. The dual-band implantable antenna is designed to operate at 400 MHz and 2.4 GHz and is used to determine the level of electromagnetic field radiated and SAR levels from implanted biosensors. The SAR limitations, maximum gain, maximum temperature rise in the body model and the radiation efficiency on each operating frequency are determined to provide the safety level. The research results indicate that SAR and safety limitations are body and frequency dependent. High-performance and low-operated power dual-band PIFA antenna for development of the next generation of medical implants operating on the MICS and the ISM bands will facilitate clinically significant improvements in healthcare.

  15. Dental management of a patient fitted with subcutaneous Implantable Cardioverter Defibrillator device and concomitant warfarin treatment.

    PubMed

    Shah, Altaf Hussain; Khalil, Hesham Saleh; Kola, Mohammed Zaheer

    2015-07-01

    Automated Implantable Cardioverter Defibrillators (AICD), simply known as an Implantable Cardioverter Defibrillator (ICD), has been used in patients for more than 30 years. An Implantable Cardioverter Defibrillator (ICD) is a small battery-powered electrical impulse generator that is implanted in patients who are at a risk of sudden cardiac death due to ventricular fibrillation, ventricular tachycardia or any such related event. Typically, patients with these types of occurrences are on anticoagulant therapy. The desired International Normalized Ratio (INR) for these patients is in the range of 2-3 to prevent any subsequent cardiac event. These patients possess a challenge to the dentist in many ways, especially during oral surgical procedures, and these challenges include risk of sudden death, control of post-operative bleeding and pain. This article presents the dental management of a 60 year-old person with an ICD and concomitant anticoagulant therapy. The patient was on multiple medications and was treated for a grossly neglected mouth with multiple carious root stumps. This case report outlines the important issues in managing patients fitted with an ICD device and at a risk of sudden cardiac death.

  16. Dental management of a patient fitted with subcutaneous Implantable Cardioverter Defibrillator device and concomitant warfarin treatment

    PubMed Central

    Shah, Altaf Hussain; Khalil, Hesham Saleh; Kola, Mohammed Zaheer

    2015-01-01

    Automated Implantable Cardioverter Defibrillators (AICD), simply known as an Implantable Cardioverter Defibrillator (ICD), has been used in patients for more than 30 years. An Implantable Cardioverter Defibrillator (ICD) is a small battery-powered electrical impulse generator that is implanted in patients who are at a risk of sudden cardiac death due to ventricular fibrillation, ventricular tachycardia or any such related event. Typically, patients with these types of occurrences are on anticoagulant therapy. The desired International Normalized Ratio (INR) for these patients is in the range of 2–3 to prevent any subsequent cardiac event. These patients possess a challenge to the dentist in many ways, especially during oral surgical procedures, and these challenges include risk of sudden death, control of post-operative bleeding and pain. This article presents the dental management of a 60 year-old person with an ICD and concomitant anticoagulant therapy. The patient was on multiple medications and was treated for a grossly neglected mouth with multiple carious root stumps. This case report outlines the important issues in managing patients fitted with an ICD device and at a risk of sudden cardiac death. PMID:26236132

  17. Left ventricular assist device implantation in patients after left ventricular reconstruction.

    PubMed

    Palmen, Meindert; Braun, Jerry; Beeres, Saskia L M A; Klautz, Robert J M

    2016-12-01

    Left ventricular assist device (LVAD) implantation can be challenging in patients with a prior surgical ventricular restoration (SVR). In this case series of heart failure patients with a history of SVR, we describe the surgical technique and outcome of a customized approach for inflow cannula orientation. Seven patients with a history of SVR with end-stage chronic heart failure were accepted for long-term LVAD support. In all patients, the Dacron patch was removed through left ventriculotomy and a Hegar 22 dilator was inserted at the estimated optimal position of the LVAD inflow cannula. The left ventricle was reconstructed around the dilator from the left ventricular (LV) apex to the base. Finally, the LVAD sewing ring was sutured onto the remaining apical defect and a HeartWare® LVAD was implanted. LVAD implantation was successful in all 7 patients. Transoesophageal echocardiography ensured an adequate LVAD position and inflow and outflow cannula Doppler flow recordings. The mean intensive care unit stay was 5.8 ± 2.6 days, and the hospital stay after surgery was 32 ± 16 days. All patients follow regular visits (follow-up 20 ± 16 months) at the outpatient clinic without any remarkable event. Using the technique described, LVAD implantation in patients after SVR is feasible and safe.

  18. Speech Intelligibility of Pediatric Cochlear Implant Recipients With 7 Years of Device Experience

    PubMed Central

    Peng, Shu-Chen; Spencer, Linda J.; Tomblin, J. Bruce

    2011-01-01

    Speech intelligibility of 24 prelingually deaf pediatric cochlear implant (CI) recipients with 84 months of device experience was investigated. Each CI participant's speech samples were judged by a panel of 3 listeners. Intelligibility scores were calculated as the average of the 3 listeners' responses. The average write-down intelligibility score was 71.54% (SD = 29.89), and the average rating-scale intelligibility score was 3.03 points (SD = 1.01). Write-down and rating-scale intelligibility scores were highly correlated (r = .91, p < .001). Linear regression analyses revealed that both age at implantation and different speech-coding strategies contribute to the variability of CI participants' speech intelligibility. Implantation at a younger age and the use of the spectral-peak speech-coding strategy yielded higher intelligibility scores than implantation at an older age and the use of the multipeak speech-coding strategy. These results serve as indices for clinical applications when long-term advancements in spoken-language development are considered for pediatric CI recipients. PMID:15842006

  19. Comparison of rechargeable lithium and nickel/cadmium battery cells for implantable circulatory support devices.

    PubMed

    MacLean, G K; Aiken, P A; Adams, W A; Mussivand, T

    1994-04-01

    Size and weight constraints are critical areas in the design of implantable medical devices. For this reason, a study of different rechargeable lithium and nickel/cadmium (Ni/Cd) battery cell types was undertaken to determine which cell type, when assembled into a multicell battery pack, would provide the smallest and lightest power source for implantation. The discharge rate and cycle life characteristics of 2 different rectangular prismatic Ni/Cd cells and 5 different rechargeable lithium cells were determined at 37 degrees C by charge/discharge cycling, the cells using a constant discharge load of 0.87 A. Using the observed discharge rate and cycle life characteristics of the cells, along with the desired performance criteria of 30 min operating time at the end of a 1-year implant period, the projected weight and volume of the various 12-V battery packs were determined. These results showed that one of the rectangular prismatic Ni/Cd cells would yield the smallest (53 ml) and lightest (189 g) 12-V battery pack that met the performance criteria specified. The results also indicate that, for applications requiring long implant times, cycle life can be more important in the selection of cells for a small, lightweight battery pack than specific energy or energy density.

  20. Corrosion of silicon integrated circuits and lifetime predictions in implantable electronic devices

    NASA Astrophysics Data System (ADS)

    Vanhoestenberghe, A.; Donaldson, N.

    2013-06-01

    Corrosion is a prime concern for active implantable devices. In this paper we review the principles underlying the concepts of hermetic packages and encapsulation, used to protect implanted electronics, some of which remain widely overlooked. We discuss how technological advances have created a need to update the way we evaluate the suitability of both protection methods. We demonstrate how lifetime predictability is lost for very small hermetic packages and introduce a single parameter to compare different packages, with an equation to calculate the minimum sensitivity required from a test method to guarantee a given lifetime. In the second part of this paper, we review the literature on the corrosion of encapsulated integrated circuits (ICs) and, following a new analysis of published data, we propose an equation for the pre-corrosion lifetime of implanted ICs, and discuss the influence of the temperature, relative humidity, encapsulation and field-strength. As any new protection will be tested under accelerated conditions, we demonstrate the sensitivity of acceleration factors to some inaccurately known parameters. These results are relevant for any application of electronics working in a moist environment. Our comparison of encapsulation and hermetic packages suggests that both concepts may be suitable for future implants.

  1. Design of a semi-implantable hearing device for direct acoustic cochlear stimulation.

    PubMed

    Bernhard, Hans; Stieger, Christof; Perriard, Yves

    2011-02-01

    A new hearing therapy based on direct acoustic cochlear stimulation was developed for the treatment of severe to profound mixed hearing loss. The device efficacy was validated in an initial clinical trial with four patients. This semi-implantable investigational device consists of an externally worn audio processor, a percutaneous connector, and an implantable microactuator. The actuator is placed in the mastoid bone, right behind the external auditory canal. It generates vibrations that are directly coupled to the inner ear fluids and that, therefore, bypass the external and the middle ear. The system is able to provide an equivalent sound pressure level of 125 dB over the frequency range between 125 and 8000 Hz. The hermetically sealed actuator is designed to provide maximal output power by keeping its dimensions small enough to enable implantation. A network model is used to simulate the dynamic characteristics of the actuator to adjust its transfer function to the characteristics of the middle ear. The geometry of the different actuator components is optimized using finite-element modeling.

  2. Er- and Nd-implanted MOS light emitting devices and their use for integrated photonic applications

    NASA Astrophysics Data System (ADS)

    Rebohle, L.; Wutzler, R.; Germer, S.; Lehmann, J.; Helm, M.; Skorupa, W.

    2012-06-01

    In the past, the suitability of Er for Si-based light emission was already investigated in detail. However, much less attention has been paid to Nd with its main electroluminescence (EL) line around 900 nm. In this study we compare the electrical and EL properties of Er- and Nd-implanted metal-oxide-semiconductor (MOS) structures where the dielectric stack is composed of the implanted SiO2 layer and a SiON buffer layer. Regarding the EL, the EL spectrum, the EL decay time and the EL efficiency were measured. The electrical characterization comprises current-voltage and capacitance-voltage measurements. Although the EL efficiency of Nd-implanted devices is by a factor of 5 to 10 lower than that of Er-based, the emission wavelength of Nd has some advantages compared to that of Er. Finally, based on these results the suitability of these two types of light emitters for integrated photonic devices is discussed.

  3. Clinical features and outcomes of cardiovascular implantable electronic device infections due to staphylococcal species.

    PubMed

    Le, Katherine Y; Sohail, Muhammad R; Friedman, Paul A; Uslan, Daniel Z; Cha, Stephen S; Hayes, David L; Wilson, Walter R; Steckelberg, James M; Baddour, Larry M

    2012-10-15

    Staphylococci account for the bulk of cardiovascular implantable electronic device (CIED) infections. However, a detailed analysis of clinical features and outcomes of CIED infections due to staphylococcal species has not been published. We retrospectively reviewed all cases of CIED infection seen at the Mayo Clinic from 1991 through 2008. Differences in device and host factors, clinical features, and patient outcomes were compared between cases of early and late Staphylococcus aureus and coagulase-negative staphylococci (CoNS) CIED infections. Of 280 cases of staphylococcal CIED infections, 43.9% were due to S. aureus and 56.0% were due to CoNS. Staphylococcus aureus CIED infection cases more frequently involved initially implanted devices. Late S. aureus CIED infection cases compared to late CoNS cases were associated with corticosteroid therapy, hemodialysis, implanted catheters, prosthetic valves, and remote sources of bacteremia. Cases of S. aureus endovascular infections had longer duration of bacteremia (56.0% vs 20.3% ≥3 days), longer hospitalization (37.4% vs 15.2% >20 days), and increased mortality (25.2% vs 9.5%) compared to cases of CoNS endovascular infections (p <0.001 for all comparisons). Overall, CoNS CIED infections compared to S. aureus were associated with a history of multiple device revisions and a higher number of total and abandoned leads at presentation (p <0.001 for all comparisons). In conclusion, CIED infections due to S. aureus and CoNS have distinct clinical features and outcomes. Copyright © 2012 Elsevier Inc. All rights reserved.

  4. BION microstimulators: a case study in the engineering of an electronic implantable medical device.

    PubMed

    Kane, Michael J; Breen, Paul P; Quondamatteo, Fabio; ÓLaighin, Gearóid

    2011-01-01

    The BION (Bionic Neuron) is a single channel implantable neurostimulator of unique design that can be delivered by injection. The development of the BION injectable neurostimulators exemplifies a challenging, but well posed medical design problem addressed with a successful strategy for prioritizing and resolving the biomedical and technological challenges. Though some performance requirements required post-evaluation revision, all fundamental goals were realized. A small number of significant design corrections occurred because the device requirements did not include the full scope of environmental demands. The design has spawned a number of variants optimized for diverse biomedical applications, and its clinical applications continue to evolve. The BION development history demonstrates design successes worth emulating and design pitfalls that may be avoidable for future medical device development teams. This paper serves as an introduction to the BION microstimulator technology and as an analysis of the design process used to develop the early clinical devices. Copyright © 2010 IPEM. Published by Elsevier Ltd. All rights reserved.

  5. Percutaneous implantation of a ventricular partitioning device for treatment of ischemic heart failure: initial experience of a center.

    PubMed

    Silva, Guida; Melica, Bruno; Pires de Morais, Gustavo; Sousa, Olga; Bettencourt, Nuno; Ribeiro, José; Simões, Lino; Gama, Vasco

    2012-12-01

    The Parachute is a novel left ventricular (LV) partitioning device that is deployed percutaneously in the left ventricle in patients with anteroapical regional wall motion abnormalities, dilated LV and systolic dysfunction after anterior myocardial infarction (MI). The implantable device is a partitioning membrane that isolates the dysfunctional region of the ventricle and decreases chamber volume. Data from the first-in-human clinical trial - the Percutaneous Ventricular Restoration in Chronic Heart Failure (PARACHUTE) trial- has shown that this new device is associated with significant and sustained LV volume reduction and improvement in LV hemodynamics and functional capacity in the 12 months after implantation, with a relatively low rate of clinical events, indicating that it may have a beneficial effect in the treatment of ischemic heart failure. We aim to describe our initial experience with implantation of the Parachute LV partitioning device and its short-term safety, defined as the successful delivery and deployment of the device.

  6. Prolonged antibiotic delivery from anodized nanotubular titanium using a co-precipitation drug loading method.

    PubMed

    Yao, Chang; Webster, Thomas J

    2009-11-01

    Advances in nanotechnology have led to the development of novel orthopedic implant materials that not only have better cytocompatibility properties but can also be used as unique drug delivery platforms. In the present study, currently used titanium was anodized to possess nanotubular surface structures (80 nm inner diameter and 200 nm deep) capable of drug delivery. Such anodized nanotubular titanium surfaces promote bone cell functions (such as adhesion and differentiation) in vitro and in vivo compared with unanodized titanium. To achieve local drug delivery, anodized titanium with nanotubular structures were loaded with penicillin-based antibiotics using a co-precipitation method in which drug molecules were mixed in simulated body fluid to collectively precipitate with calcium phosphate crystals. Results showed for the first time that such co-precipitated coatings on anodized nanotubular titanium could release drug molecules for up to 3 weeks whereas previous studies have demonstrated only a 150-minute release of antibiotics through simple physical adsorption. Furthermore, drug release using co-precipitation from anodized nanotubular titanium was determined to be a diffusion process dependent on first-order kinetics. In addition, contrary to conventional thinking that penicillin-based drug release should decrease cell functions (including both bacteria and mammalian cells), results of this study showed similar osteoblast (bone-forming cell) adhesion between non-drug loaded and drug loaded precipitated calcium phosphate coatings on anodized titanium. Due to the above, these findings represent a promising surface treatment for titanium that could be used for local drug delivery for improving orthopedic applications and, thus, should be studied further.

  7. Feasibility evaluation of a remote monitoring system for implantable cardiac devices in Japan.

    PubMed

    Ando, Kenji; Koyama, Junjiroh; Abe, Yoshihisa; Sato, Toshiaki; Shoda, Morio; Soga, Yoshimitsu; Nobuyoshi, Masakiyo; Honda, Toshihiro; Nakao, Koichi; Terata, Ken; Kadowaki, Ken; Maeda, Akiko; Ogawa, Satoshi; Manaka, Tetsuyuki; Hagiwara, Nobuhisa; Doi, Kentaro

    2011-01-01

    The number of implanted cardiac devices has been growing steadily over the last several years. Systems to monitor device data remotely have been introduced with the goal of reducing follow-up burden for both patients and physicians. Since the introduction of telemedicine depends greatly on the situations that are unique to each country, the acceptance of cardiac device remote monitoring in Japan was analyzed.A total of 203 patients who had previously undergone cardiac device implantation were enrolled. The subjects were provided with a CareLink Monitor that performed interrogation and transmission of device data at home, and then the physicians reviewed the data via a website at one and 3 months after baseline visits. A total of 470 transmissions were made. Questionnaires were completed by subjects and physicians to evaluate acceptance, ease of use, and satisfaction with the system. More than 87% of the subjects felt the Monitor was easy to use and nearly all of the physicians were satisfied with the system. A majority of patients felt reassured by having their devices assessed from a remote location and preferred the decreased number of clinic visits that were possible when using the Monitor. The patients spent an average of 168.2 minutes per clinic visit, whereas follow-up time was reduced to 13.0 minutes by remote monitoring. Physician consultation time was reduced by 2.7 minutes.The CareLink Network was well accepted by both the patients and physicians. Underlying issues did emerge, but once they are overcome, the system appears to have great potential to improve the quality of care given by healthcare providers.

  8. Implantable physiologic controller for left ventricular assist devices with telemetry capability.

    PubMed

    Asgari, Siavash S; Bonde, Pramod

    2014-01-01

    Rotary type left ventricular assist devices have mitigated the problem of durability associated with earlier pulsatile pumps and demonstrated improved survival. However, the compromise is the loss of pulsatility due to continuous flow and retained percutaneous driveline leading to increased mortality and morbidity. Lack of pulsatility is implicated in increased gastrointestinal bleeding, aortic incompetence, and diastolic hypertension. We present a novel, wirelessly powered, ultra-compact, implantable physiologic controller capable of running a left ventricular assist device in a pulsatile mode with wireless power delivery. The schematic of our system was laid out on a circuit board to wirelessly receive power and run a left ventricular assist device with required safety and backup measures. We have embedded an antenna and wireless network for telemetry. Multiple signal processing steps and controlling algorithm were incorporated. The controller was tested in in vitro and in vivo experiments. The controller drove left ventricular assist devices continuously for 2 weeks in an in vitro setup and in vivo without any failure. Our controller is more power efficient than the current Food and Drug Administration-approved left ventricular assist device controllers. When used with electrocardiography synchronization, the controller allowed on-demand customization of operation with instantaneous flow and revolutions per minute changes, resulting in a pulsatile flow with adjustable pulse pressure. Our test results prove the system to be remarkably safe, accurate, and efficient. The unique combination of wireless powering and small footprint makes this system an ideal totally implantable physiologic left ventricular assist device system. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  9. The Potential Role of Polymethyl Methacrylate as a New Packaging Material for the Implantable Medical Device in the Bladder

    PubMed Central

    Kim, Su Jin; Choi, Bumkyoo; Kim, Kang Sup; Bae, Woong Jin; Hong, Sung Hoo; Lee, Ji Youl; Hwang, Tae-Kon; Kim, Sae Woong

    2015-01-01

    Polydimethylsiloxane (PDMS) is used in implantable medical devices; however, PDMS is not a completely biocompatible material for electronic medical devices in the bladder. To identify novel biocompatible materials for intravesical implanted medical devices, we evaluated the biocompatibility of polymethyl methacrylate (PMMA) by analyzing changes in the levels of macrophages, macrophage migratory inhibitory factor (MIF), and inflammatory cytokines in the bladder. A ball-shaped metal coated with PMMA or PDMS was implanted into the bladders of rats, and after intravesical implantation, the inflammatory changes induced by the foreign body reaction were evaluated. In the early period after implantation, increased macrophage activity and MIF in the urothelium of the bladder were observed. However, significantly decreased macrophage activity and MIF in the bladder were observed after implantation with PMMA- or PDMS-coated metal in the later period. In addition, significantly decreased inflammatory cytokines such as IL-1β, IL-6, and TNF-α were observed with time. Based on these results, we suggest that MIF plays a role in the foreign body reaction and in the biocompatible packaging with PMMA for the implanted medical devices in the bladder. PMID:25705692

  10. The potential role of polymethyl methacrylate as a new packaging material for the implantable medical device in the bladder.

    PubMed

    Kim, Su Jin; Choi, Bumkyoo; Kim, Kang Sup; Bae, Woong Jin; Hong, Sung Hoo; Lee, Ji Youl; Hwang, Tae-Kon; Kim, Sae Woong

    2015-01-01

    Polydimethylsiloxane (PDMS) is used in implantable medical devices; however, PDMS is not a completely biocompatible material for electronic medical devices in the bladder. To identify novel biocompatible materials for intravesical implanted medical devices, we evaluated the biocompatibility of polymethyl methacrylate (PMMA) by analyzing changes in the levels of macrophages, macrophage migratory inhibitory factor (MIF), and inflammatory cytokines in the bladder. A ball-shaped metal coated with PMMA or PDMS was implanted into the bladders of rats, and after intravesical implantation, the inflammatory changes induced by the foreign body reaction were evaluated. In the early period after implantation, increased macrophage activity and MIF in the urothelium of the bladder were observed. However, significantly decreased macrophage activity and MIF in the bladder were observed after implantation with PMMA- or PDMS-coated metal in the later period. In addition, significantly decreased inflammatory cytokines such as IL-1β, IL-6, and TNF-α were observed with time. Based on these results, we suggest that MIF plays a role in the foreign body reaction and in the biocompatible packaging with PMMA for the implanted medical devices in the bladder.

  11. Zirconia to Ti-6Al-4V braze joint for implantable biomedical device.

    PubMed

    Jiang, Guangqiang; Mishler, Delta; Davis, Ross; Mobley, Jon Phil; Schulman, Joseph H

    2005-02-15

    A strong, hermetic, reliable, and biocompatible ceramic-to-metal seal is essential for many implantable medical devices. Yttria-stabilized tetragonal zirconia polycrystals (Y-TZPs) and a titanium alloy Ti-6Al-4V were selected as the ceramic and metal components of the seal because both materials have excellent mechanical properties and favorable biocompatibility. A brazing method using titanium nickel (TiNi)-clad braze filler material is presented to bond the components together forming a seal. Laboratory tests show that the ceramic-to-metal seal is hermetic, strong, and resistant to electrochemical corrosion. Twenty-eight microstimulators utilizing the ceramic-to-metal seals were implanted in seven sheep to stimulate the hypoglossal nerve. When the tissue was evaluated by gross inspection at necropsy and examined histologically by a pathologist, there were no signs of local hemorrhage, infection, or hypoglossal nerve tissue damage.

  12. Centrifugal blood pump with a hydraulically-levitated impeller for a permanently implantable biventricular assist device.

    PubMed

    Watanabe, Kuniyoshi; Ichikawa, Seiji; Asai, Toshimasa; Motomura, Tadashi; Hata, Atsushi; Ito, Seiichi; Shinohara, Toshiyuki; Tsujimura, Shinichi; Glueck, Julia A; Oestmann, Daniel J; Nosé, Yukihiko

    2004-06-01

    A permanently implantable biventricular assist device (BVAD) system has been developed with a centrifugal pump which is activated by a hydraulically-levitated impeller. The pump impeller floats hydraulically into the top contact position; this position prevents thrombus formation by creating a washout effect at the bottom bearing area, a common stagnant region. The pump was subjected to in vitro studies using a pulsatile mock circulation loop to confirm the impeller's top contact position and the swinging motion produced by the pulsation. Eleven in vivo BVAD studies confirmed that this swinging motion eliminated blood clot formation. Twenty-one pumps im-planted for up to three months did not reveal any thrombosis in the pumps or downstream organs. One exception was a right pump which was exposed to severe low flow due to the kinking of the outflow graft by the accidental pulling of the flow meter cable. Three ninety-day BVAD studies were achieved without thrombus formation.

  13. Macrotextured Breast Implants with Defined Steps to Minimize Bacterial Contamination around the Device: Experience in 42,000 Implants.

    PubMed

    Adams, William P; Culbertson, Eric J; Deva, Anand K; R Magnusson, Mark; Layt, Craig; Jewell, Mark L; Mallucci, Patrick; Hedén, Per

    2017-09-01

    Bacteria/biofilm on breast implant surfaces has been implicated in capsular contracture and breast implant-associated anaplastic large-cell lymphoma (ALCL). Macrotextured breast implants have been shown to harbor more bacteria than smooth or microtextured implants. Recent reports also suggest that macrotextured implants are associated with a significantly higher incidence of breast implant-associated ALCL. Using techniques to reduce the number of bacteria around implants, specifically, the 14-point plan, has successfully minimized the occurrence of capsular contracture. The authors hypothesize that a similar effect may be seen in reducing the risk of breast implant-associated ALCL. Pooled data from eight plastic surgeons assessed the use of macrotextured breast implants (Biocell and polyurethane) and known cases of breast implant-associated ALCL. Surgeon adherence to the 14-point plan was also analyzed. A total of 42,035 Biocell implants were placed in 21,650 patients; mean follow-up was 11.7 years (range, 1 to 14 years). A total of 704 polyurethane implants were used, with a mean follow-up of 8.0 years (range, 1 to 20 years). The overall capsular contracture rate was 2.2 percent. There were no cases of implant-associated ALCL. All surgeons routinely performed all 13 perioperative components of the 14-point plan; two surgeons do not routinely prescribe prophylaxis for subsequent unrelated procedures. Mounting evidence implicates the role of a sustained T-cell response to implant bacteria/biofilm in the development of breast implant-associated ALCL. Using the principles of the 14-point plan to minimize bacterial load at the time of surgery, the development and subsequent sequelae of capsular contracture and breast implant-associated ALCL may be reduced, especially with higher-risk macrotextured implants. Therapeutic, IV.

  14. Enhancing the Efficacy of Drug-loaded Nanocarriers against Brain Tumors by Targeted Radiation Therapy

    PubMed Central

    Baumann, Brian C.; Kao, Gary D.; Mahmud, Abdullah; Harada, Takamasa; Swift, Joe; Chapman, Christina; Xu, Xiangsheng; Discher, Dennis E.; Dorsey, Jay F.

    2013-01-01

    Glioblastoma multiforme (GBM) is a common, usually lethal disease with a median survival of only ~15 months. It has proven resistant in clinical trials to chemotherapeutic agents such as paclitaxel that are highly effective in vitro, presumably because of impaired drug delivery across the tumor's blood-brain barrier (BBB). In an effort to increase paclitaxel delivery across the tumor BBB, we linked the drug to a novel filomicelle nanocarrier made with biodegradable poly(ethylene-glycol)-block-poly(ε-caprolactone-r-D,L-lactide) and used precisely collimated radiation therapy (RT) to disrupt the tumor BBB's permeability in an orthotopic mouse model of GBM. Using a non-invasive bioluminescent imaging technique to assess tumor burden and response to therapy in our model, we demonstrated that the drug-loaded nanocarrier (DLN) alone was ineffective against stereotactically implanted intracranial tumors yet was highly effective against GBM cells in culture and in tumors implanted into the flanks of mice. When targeted cranial RT was used to modulate the tumor BBB, the paclitaxel-loaded nanocarriers became effective against the intracranial tumors. Focused cranial RT improved DLN delivery into the intracranial tumors, significantly improving therapeutic outcomes. Tumor growth was delayed or halted, and survival was extended by >50% (p<0.05) compared to the results obtained with either RT or the DLN alone. Combinations of RT and chemotherapeutic agents linked to nanocarriers would appear to be an area for future investigations that could enhance outcomes in the treatment of human GBM. PMID:23296073

  15. Persistent Left Superior Vena Cava in Patients Undergoing Cardiac Device Implantation: Clinical and Long-Term Data

    PubMed Central

    Petrac, Dubravko; Radeljic, Vjekoslav; Pavlovic, Nikola; Manola, Sime; Delic-Brkljacic, Diana

    2013-01-01

    Background Persistent left superior vena cava (LSVC) is a rare congenital venous anomaly that may be found at the time of cardiac device lead insertion. Methods In this case series, we present clinical and long-term data of five patients with LSVC who underwent pacemaker (PM) or cardioverter defibrillator (ICD) implantation during the period of 10 years. Results Left-sided venous approach was used for device implantation in 3 patients with standard PM indications, whereas a right-sided venous approach and an epicardial approach had to be used in 2 patients who needed an ICD and biventricular PM, respectively. In post implantation period of 44 ± 29 months, one patient died due to stroke, one underwent heart transplantation, and 3 had atrial fibrillation. Conclusion The long-term outcome of patients with persistent LSVC and implanted cardiac devices is mostly influenced by the presence of underlying heart disease.

  16. Patch Testing for Evaluation of Hypersensitivity to Implanted Metal Devices: A Perspective From the American Contact Dermatitis Society.

    PubMed

    Schalock, Peter C; Crawford, Glen; Nedorost, Susan; Scheinman, Pamela L; Atwater, Amber Reck; Mowad, Christen; Brod, Bruce; Ehrlich, Alison; Watsky, Kalman L; Sasseville, Denis; Silvestri, Dianne; Worobec, Sophie M; Elliott, John F; Honari, Golara; Powell, Douglas L; Taylor, James; DeKoven, Joel

    2016-01-01

    The American Contact Dermatitis Society recognizes the interest in the evaluation and management of metal hypersensitivity reactions. Given the paucity of robust evidence with which to guide our practices, we provide reasonable evidence and expert opinion-based guidelines for clinicians with regard to metal hypersensitivity reaction testing and patient management. Routine preoperative evaluation in individuals with no history of adverse cutaneous reactions to metals or history of previous implant-related adverse events is not necessary. Patients with a clear self-reported history of metal reactions should be evaluated by patch testing before device implant. Patch testing is only 1 element in the assessment of causation in those with postimplantation morbidity. Metal exposure from the implanted device can cause sensitization, but a positive metal test does not prove symptom causality. The decision to replace an implanted device must include an assessment of all clinical factors and a thorough risk-benefit analysis by the treating physician(s) and patient.

  17. Regulatory Considerations in the Design and Manufacturing of Implantable 3D-Printed Medical Devices.

    PubMed

    Morrison, Robert J; Kashlan, Khaled N; Flanangan, Colleen L; Wright, Jeanne K; Green, Glenn E; Hollister, Scott J; Weatherwax, Kevin J

    2015-10-01

    Three-dimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D-printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D-printed medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3D-printed devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3D-printed bioresorbable implantable device.

  18. Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices

    PubMed Central

    Morrison, Robert J.; Kashlan, Khaled N.; Flanangan, Colleen L.; Wright, Jeanne K.; Green, Glenn E.; Hollister, Scott J.

    2015-01-01

    Abstract Three‐dimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D‐printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D‐printed medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3D‐printed devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3D‐printed bioresorbable implantable device. PMID:26243449

  19. Optimized Axillary Vein Technique versus Subclavian Vein Technique in Cardiovascular Implantable Electronic Device Implantation: A Randomized Controlled Study

    PubMed Central

    Liu, Peng; Zhou, Yi-Feng; Yang, Peng; Gao, Yan-Sha; Zhao, Gui-Ru; Ren, Shi-Yan; Li, Xian-Lun

    2016-01-01

    Background: The conventional venous access for cardiovascular implantable electronic device (CIED) is the subclavian vein, which is often accompanied by high complication rate. The aim of this study was to assess the efficacy and safety of optimized axillary vein technique. Methods: A total of 247 patients undergoing CIED implantation were included and assigned to the axillary vein group or the subclavian vein group randomly. Success rate of puncture and complications in the perioperative period and follow-ups were recorded. Results: The overall success rate (95.7% vs. 96.0%) and one-time success rate (68.4% vs. 66.1%) of punctures were similar between the two groups. In the subclavian vein group, pneumothorax occurred in three patients. The subclavian gaps of three patients were too tight to allow operation of the electrode lead. In contrast, there were no puncture-associated complications in the axillary vein group. In the patient follow-ups, two patients in the subclavian vein group had subclavian crush syndrome and both of them received lead replacement. The incidence of complications during the perioperative period and follow-ups of the axillary vein group and the subclavian vein group was 1.6% (2/125) and 8.2% (10/122), respectively (χ2 = 5.813, P = 0.016). Conclusion: Optimized axillary vein technique may be superior to the conventional subclavian vein technique for CIED lead placement. Trial Registration: www.clinicaltrials.gov, NCT02358551; https://clinicaltrials.gov/ct2/show/NCT02358551?term=NCT02358551& rank=1. PMID:27823994

  20. Formulation and Drug Loading Features of Nano-Erythrocytes

    NASA Astrophysics Data System (ADS)

    Dong, Xiaoting; Niu, Yawei; Ding, Yi; Wang, Yuemin; Zhao, Jialan; Leng, Wei; Qin, Linghao

    2017-03-01

    Nano erythrocyte ghosts have recently been used as drug carriers of water-soluble APIs due to inherit biological characteristics of good compatibility, low toxicity, and small side-effect. In this study, we developed a novel drug delivery system based on nano erythrocyte ghosts (STS-Nano-RBCs) to transport Sodium Tanshinone IIA sulfonate (STS) for intravenous use in rat. STS-Nano-RBCs were prepared by hypotonic lysis and by extrusion methods, and its biological properties were investigated compared with STS injection. The results revealed that STS-Nano-RBCs have narrow particle size distribution, good drug loading efficiency, and good stability within 21 days. Compared with STS injection, STS-Nano-RBCs extended the drug release time in vitro and in vivo with better repairing effect on oxidative stress-impaired endothelial cells. These results suggest that the nano erythrocyte ghosts system could be used to deliver STS.

  1. Novel Methods of Lipidic Nanoparticle Preparation and Drug Loading

    NASA Astrophysics Data System (ADS)

    Maitani, Y.

    2013-09-01

    In improving cancer chemotherapy, lipidic nanoparticle systems for drug delivery, such as liposomes and emulsions, have received much attention because they are capable of delivering their drug payload selectively to cancer cells and of circulating for a long period in the bloodstream. In addition, lipidic nanoparticles have been examined for use in gene delivery as a non-viral vector. Preparation methods of particles and drug loading methods are crucial for the physicochemical properties of nanoparticles, which are the key aspects for pharmaceutical applications. This review describes new preparation methods for nanoparticles and a loading method for drugs using nanotechnology, including an evaluation of nanoparticles from the point of drug release for applications in cancer therapy and gene delivery.

  2. A 100-Channel Hermetically Sealed Implantable Device for Chronic Wireless Neurosensing Applications

    PubMed Central

    Yin, Ming; Borton, David A.; Aceros, Juan; Patterson, William R.; Nurmikko, Arto V.

    2014-01-01

    A 100-channel fully implantable wireless broadband neural recording system was developed. It features 100 parallel broadband (0.1 Hz–7.8 kHz) neural recording channels, a medical grade 200 mAh Li-ion battery recharged inductively at 150 kHz, and data telemetry using 3.2 GHz to 3.8 GHz FSK modulated wireless link for 48 Mbps Manchester encoded data. All active electronics are hermetically sealed in a titanium enclosure with a sapphire window for electromagnetic transparency. A custom, high-density configuration of 100 individual hermetic feedthrough pins enable connection to an intracortical neural recording microelectrode array. A 100 MHz bandwidth custom receiver was built to remotely receive the FSK signal and achieved −77.7 dBm sensitivity with 10−8 BER at 48 Mbps data rate. ESD testing on all the electronic inputs and outputs has proven that the implantable device satisfies the HBM Class-1B ESD Standard. In addition, the evaluation of the worst-case charge density delivered to the tissue from each I/O pin verifies the patient safety of the device in the event of failure. Finally, the functionality and reliability of the complete device has been tested on-bench and further validated chronically in ongoing freely moving swine and monkey animal trials for more than one year to date. PMID:23853294

  3. A 100-channel hermetically sealed implantable device for chronic wireless neurosensing applications.

    PubMed

    Yin, Ming; Borton, David A; Aceros, Juan; Patterson, William R; Nurmikko, Arto V

    2013-04-01

    A 100-channel fully implantable wireless broadband neural recording system was developed. It features 100 parallel broadband (0.1 Hz-7.8 kHz) neural recording channels, a medical grade 200 mAh Li-ion battery recharged inductively at 150 kHz , and data telemetry using 3.2 GHz to 3.8 GHz FSK modulated wireless link for 48 Mbps Manchester encoded data. All active electronics are hermetically sealed in a titanium enclosure with a sapphire window for electromagnetic transparency. A custom, high-density configuration of 100 individual hermetic feedthrough pins enable connection to an intracortical neural recording microelectrode array. A 100 MHz bandwidth custom receiver was built to remotely receive the FSK signal and achieved -77.7 dBm sensitivity with 10(-8) BER at 48 Mbps data rate. ESD testing on all the electronic inputs and outputs has proven that the implantable device satisfies the HBM Class-1B ESD Standard. In addition, the evaluation of the worst-case charge density delivered to the tissue from each I/O pin verifies the patient safety of the device in the event of failure. Finally, the functionality and reliability of the complete device has been tested on-bench and further validated chronically in ongoing freely moving swine and monkey animal trials for more than one year to date.

  4. Radiofrequency identification and medical devices: the regulatory framework on electromagnetic compatibility. Part II: active implantable medical devices.

    PubMed

    Mattei, Eugenio; Censi, Federica; Triventi, Michele; Bartolini, Pietro; Calcagnini, Giovanni

    2012-05-01

    The number and the types of electromagnetic emitters to which patients with active implantable medical devices (AIMD) are exposed to in their daily activities have proliferated over the last decade. Radiofrequency identification (RFID) is an example of wireless technology applied in many fields. The interaction between RFID emitters and AIMD is an important issue for patients, industry and regulators, because of the risks associated with such interactions. The different AIMDs refer to different standards that address the electromagnetic immunity issue in different ways. Indeed, different test setups, immunity levels and rationales are used to guarantee that AIMDs are immune to electromagnetic nonionizing radiation. In this article, the regulatory framework concerning electromagnetic compatibility between RFID systems and AIMDs is analyzed to understand whether and how the application of the current AIMD standards allows for the effective control of the possible risks associated with RFID technology.

  5. "Power-on resets" in cardiac implantable electronic devices during magnetic resonance imaging.

    PubMed

    Higgins, John V; Sheldon, Seth H; Watson, Robert E; Dalzell, Connie; Acker, Nancy; Cha, Yong-Mei; Asirvatham, Samuel J; Kapa, Suraj; Felmlee, Joel P; Friedman, Paul A

    2015-03-01

    Magnetic resonance imaging (MRI) has been safely performed in some patients with cardiac implantable electronic devices (CIEDs) under careful monitoring and prespecified conditions. Pacemaker-dependent patients are often excluded, partly because of the potential for "power-on reset" (PoR), which can lead to a change from asynchronous to inhibited pacing with consequent inhibition of pacing due to electromagnetic interference during MRI. The purpose of this study was to review risk factors for PoR during MRI. A prospective study was performed between January 2008 and May 2013 in patients with CIEDs undergoing clinically indicated MRI. Eligible patients were not pacemaker dependent. Devices were interrogated before and after MRI, programmed to an asynchronous mode or an inhibition mode with tachyarrhythmia therapies turned off, and reprogrammed to their original settings after MRI. MRI scans (n = 256) were performed in 198 patients with non-MRI-conditional CIEDs between 2008 and 2013 (median age 66 years; interquartile range 57-77 years; 59% men). PoR occurred during 9 MRI scans (3.5%) in 8 patients. PoR was more frequent with Medtronic devices than with other generator brands (n = 9/139 vs 0/117 [6% vs 0%]; P = .005). Devices with PoR were all released before 2002 and were implanted from 1999 to 2004. Effects of PoR included a decrease in heart rate during MRI (n = 4) and transient anomalous battery life indication (n = 1). All devices functioned normally after MRI. PoR occurs infrequently but can cause deleterious changes in pacing mode and heart rate. MRI should not be performed in pacemaker-dependent patients with older at-risk generators. Continuous monitoring during MRI is essential because unrecognized PoR may inhibit pacing or accelerate battery depletion due to high pacing output. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  6. Computed tomographic analysis of left ventricular volumes and function after implantation of the Parachute® endoventricular partitioning device.

    PubMed

    Menon, Prahlad G; Ludwig, Daniel; Lacomis, Joan; Schwartzman, David; Toma, Catalin

    2014-12-01

    Preliminary clinical experience with a percutaneous endoventricular partitioning device (Parachute®, CardioKinetix Inc., Menlo Park, CA, USA) suggests that it ameliorates global LV dysfunction and heart failure symptoms in selected patients who have suffered previous anterior myocardial infarction. Less is known of its effect on regional LV function. To gain insight into device effect on regional LV function by analysis of cardiac computed tomographic (CT) images obtained before and after device implantation. Comparative analysis of pre and 6 months post-implantation contrast-enhanced CT images from 6 subjects enrolled in the phase 1 Parachute clinical trials, including regional LV volume and systolic excursion, as well as device motion. After implantation, a significant reduction in volume of the "dynamic" LV compartment (that which was not excluded by the device) was accompanied by a significant reduction in dykinetic motion and a trend toward an improved ejection fraction. Penetration of contrast into the excluded compartment was still present at 6 months, however the apical motion was significantly less dyskinetic in 3 subjects and unchanged in the other 3. Overall device surface motion was inward in systole, a significant improvement relative to the overall dyskinetic LV apex pre-implantation. Device motion was spatially heterogeneous, which appeared to be dependent on the motility of the myocardium that anchored its individual splines. Our data suggest that the Parachute device acts as a functional impediment to flow and stretch, effectively depressurizing the apical segment. © 2014, Wiley Periodicals, Inc.

  7. Penile Implants

    MedlinePlus

    Penile Implants Overview By Mayo Clinic Staff Penile implants are devices placed inside the penis to allow men with erectile dysfunction (ED) to get an erection. Penile implants are typically recommended after other treatments for ED ...

  8. Analysis of intellectual properties on animal-derived regenerative, implantable medical devices

    PubMed Central

    Wang, Hongman; Li, Chunying

    2016-01-01

    This article analyses and summarizes issues of intellectual property involved in animal-derived regenerative, implantable medical devices (ADRIMD) in order to better understand global trends in patent applications and disclosures, the legal status of patent families (i.e. sets of patents filed in various countries to protect a single invention), and International Patent Classification topics such as main assignee and core expertise. Analysis of research trends will enhance and inform the decision-making capacity of researchers, investors, government regulators and other stake-holders as they undertake to develop, deploy, invest in or regulate ADRIMD. PMID:26816653

  9. New skin closure system facilitates wound healing after cardiovascular implantable electronic device surgery.

    PubMed

    De Maria, Elia

    2015-08-16

    The manuscript describes the efficacy of a new skin closure system (ZipLine™) for wound closure after pacemaker/implantable cardioverter defibrillator surgery. The system is particularly useful when wound healing is difficult with traditional methods and in patients at high risk for surgical site infections (SSIs). This skin closure option is easy and quick to apply and remove, and produces excellent cosmetic results. Although it is associated with a minimal expense upcharge, the benefits, including the potential for decrease in SSI, make it attractive and worth considering for skin closure in device patients, particularly those at increased risk of complications.

  10. Laser fabrication of electrical feedthroughs in polymer encapsulations for active implantable medical devices.

    PubMed

    Gough, Zara; Chaminade, Cedric; Barclay-Monteith, Philip; Kallinen, Annukka; Lei, Wenwen; Ganesan, Rajesh; Grace, John; McKenzie, David R

    2017-04-01

    Hermetic electrical feedthroughs are essential for safe and functional active implantable biomedical devices and for a wide range of other applications such as batteries, supercapacitors, OLEDs and solar cells. Ceramics and metals have previously been the materials of choice for encapsulations, while polymers have advantages of ease of mass production and end user compatibility. We demonstrate a laser sealing technology that gives hermetic, mechanically strong feedthroughs with low electrical resistance in a polyetheretherketone (PEEK) encapsulation. The conductive pathways are wires and sputtered thin films. The water vapor transmission rate through the fabricated encapsulations is comparable to that of PEEK itself.

  11. Hemodynamic sensor in cardiac implantable electric devices: the endocardial accelaration technology.

    PubMed

    Sacchi, Stefania; Contardi, Danilo; Pieragnoli, Paolo; Ricciardi, Giuseppe; Giomi, Andrea; Padeletti, Luigi

    2013-01-01

    There have been substantial progresses in the technology of cardiac implantable electric devices (CIEDs) during the past decades. One of the progresses is represented by the development of a hemodynamic sensor embedded at the tip of a pacing lead that measures myocardial contractility by the analysis of myocardial mechanical vibrations occurring during the cardiac cycle. This sensor, providing continuous hemodynamic monitoring, could play an important role in clinical practice because of several clinical applications in CIEDs recipients. The objectives of this work are to report how this sensor operates and to review the main findings about its clinical applications.

  12. Synergistic Effect of Cold Atmospheric Plasma and Drug Loaded Core-shell Nanoparticles on Inhibiting Breast Cancer Cell Growth.

    PubMed

    Zhu, Wei; Lee, Se-Jun; Castro, Nathan J; Yan, Dayun; Keidar, Michael; Zhang, Lijie Grace

    2016-02-26

    Nano-based drug delivery devices allowing for effective and sustained targeted delivery of therapeutic agents to solid tumors have revolutionized cancer treatment. As an emerging biomedical technique, cold atmospheric plasma (CAP), an ionized non-thermal gas mixture composed of various reactive oxygen species, reactive nitrogen species, and UV photons, shows great potential for cancer treatment. Here we seek to develop a new dual cancer therapeutic method by integrating promising CAP and novel drug loaded core-shell nanoparticles and evaluate its underlying mechanism for targeted breast cancer treatment. For this purpose, core-shell nanoparticles were synthesized via co-axial electrospraying. Biocompatible poly (lactic-co-glycolic acid) was selected as the polymer shell to encapsulate anti-cancer therapeutics. Results demonstrated uniform size distribution and high drug encapsulation efficacy of the electrosprayed nanoparticles. Cell studies demonstrated the effectiveness of drug loaded nanoparticles and CAP for synergistic inhibition of breast cancer cell growth when compared to each treatment separately. Importantly, we found CAP induced down-regulation of metastasis related gene expression (VEGF, MTDH, MMP9, and MMP2) as well as facilitated drug loaded nanoparticle uptake which may aid in minimizing drug resistance-a major problem in chemotherapy. Thus, the integration of CAP and drug encapsulated nanoparticles provides a promising tool for the development of a new cancer treatment strategy.

  13. Synergistic Effect of Cold Atmospheric Plasma and Drug Loaded Core-shell Nanoparticles on Inhibiting Breast Cancer Cell Growth

    PubMed Central

    Zhu, Wei; Lee, Se-Jun; Castro, Nathan J.; Yan, Dayun; Keidar, Michael; Zhang, Lijie Grace

    2016-01-01

    Nano-based drug delivery devices allowing for effective and sustained targeted delivery of therapeutic agents to solid tumors have revolutionized cancer treatment. As an emerging biomedical technique, cold atmospheric plasma (CAP), an ionized non-thermal gas mixture composed of various reactive oxygen species, reactive nitrogen species, and UV photons, shows great potential for cancer treatment. Here we seek to develop a new dual cancer therapeutic method by integrating promising CAP and novel drug loaded core-shell nanoparticles and evaluate its underlying mechanism for targeted breast cancer treatment. For this purpose, core-shell nanoparticles were synthesized via co-axial electrospraying. Biocompatible poly (lactic-co-glycolic acid) was selected as the polymer shell to encapsulate anti-cancer therapeutics. Results demonstrated uniform size distribution and high drug encapsulation efficacy of the electrosprayed nanoparticles. Cell studies demonstrated the effectiveness of drug loaded nanoparticles and CAP for synergistic inhibition of breast cancer cell growth when compared to each treatment separately. Importantly, we found CAP induced down-regulation of metastasis related gene expression (VEGF, MTDH, MMP9, and MMP2) as well as facilitated drug loaded nanoparticle uptake which may aid in minimizing drug resistance-a major problem in chemotherapy. Thus, the integration of CAP and drug encapsulated nanoparticles provides a promising tool for the development of a new cancer treatment strategy. PMID:26917087

  14. Remote Monitoring for Follow-up of Patients with Cardiac Implantable Electronic Devices

    PubMed Central

    Morichelli, Loredana; Varma, Niraj

    2014-01-01

    Follow-up of patients with cardiac implantable electronic devices is challenging due to the increasing number and technical complexity of devices coupled to increasing clinical complexity of patients. Remote monitoring (RM) offers the opportunity to optimise clinic workflow and to improve device monitoring and patient management. Several randomised clinical trials and registries have demonstrated that RM may reduce number of hospital visits, time required for patient follow-up, physician and nurse time, hospital and social costs. Furthermore, patient retention and adherence to follow-up schedule are significantly improved by RM. Continuous wireless monitoring of data stored in the device memory with automatic alerts allows early detection of device malfunctions and of events requiring clinical reaction, such as atrial fibrillation, ventricular arrhythmias and heart failure. Early reaction may improve patient outcome. RM is easy to use and patients showed a high level of acceptance and satisfaction. Implementing RM in daily practice may require changes in clinic workflow. To this purpose, new organisational models have been introduced. In spite of a favourable cost:benefit ratio, RM reimbursement still represents an issue in several European countries. PMID:26835079

  15. Reimplantation and Repeat Infection After Cardiac-Implantable Electronic Device Infections: Experience From the MEDIC (Multicenter Electrophysiologic Device Infection Cohort) Database.

    PubMed

    Boyle, Thomas A; Uslan, Daniel Z; Prutkin, Jordan M; Greenspon, Arnold J; Baddour, Larry M; Danik, Stephan B; Tolosana, Jose M; Le, Katherine; Miro, Jose M; Peacock, James; Sohail, Muhammad R; Vikram, Holenarasipur R; Carrillo, Roger G

    2017-03-01

    Infection is a serious complication of cardiovascular-implantable electronic device implantation and necessitates removal of all hardware for optimal treatment. Strategies for reimplanting hardware after infection vary widely and have not previously been analyzed using a large, multicenter study. The MEDIC (Multicenter Electrophysiologic Device Infection Cohort) prospectively enrolled subjects with cardiovascular-implantable electronic device infections at multiple institutions in the United States and abroad between 2009 and 2012. Reimplantation strategies were evaluated overall, and every patient who relapsed within 6 months was individually examined for clinical information that could help explain the negative outcome. Overall, 434 patients with cardiovascular-implantable electronic device infections were prospectively enrolled at participating centers. During the initial course of therapy, complete device removal was done in 381 patients (87.8%), and 220 of them (57.7%) were ultimately reimplanted with new devices. Overall, the median time between removal and reimplantation was 10 days, with an interquartile range of 6 to 19 days. Eleven of the 434 patients had another infection within 6 months, but only 4 of them were managed with cardiovascular-implantable electronic device removal and reimplantation during the initial infection. Thus, the repeat infection rate was low (1.8%) in those who were reimplanted. Patients who retained original hardware had a 11.3% repeat infection rate. Our study findings confirm that a broad range of reimplant strategies are used in clinical practice. They suggest that it is safe to reimplant cardiac devices after extraction of previously infected hardware and that the risk of a second infection is low, regardless of reimplant timing. © 2017 American Heart Association, Inc.

  16. Intra-operative evaluation of cementless hip implant stability: a prototype device based on vibration analysis.

    PubMed

    Lannocca, Maurizio; Varini, Elena; Cappello, Angelo; Cristofolini, Luca; Bialoblocka, Ewa

    2007-10-01

    Cementless implants are mechanically stabilized during surgery by a press-fitting procedure. Good initial stability is crucial to avoid stem loosening and bone cracking, therefore, the surgeon must achieve optimal press-fitting. A possible approach to solve this problem and assist the surgeon in achieving the optimal compromise, involves the use of vibration analysis. The present study aimed to design and test a prototype device able to evaluate the primary mechanical stability of a cementless prosthesis, based on vibration analysis. In particular, the goal was to discriminate between stable and quasi-stable implants; thus the stem-bone system was assumed to be linear in both cases. For that reason, it was decided to study the frequency responses of the system, instead of the harmonic distortion. The prototype developed consists of a piezoelectric exciter connected to the stem and an accelerometer attached to the femur. Preliminary tests were performed on four composite femurs implanted with a conventional stem. The results showed that the input signal was repeatable and the output could be recorded accurately. The most sensitive parameter to stability was the shift in resonance frequency of the stem-bone system, which was highly correlated with residual micromotion on all four specimens.

  17. Results of a New Technique for Implantation of Nonrestrictive Glaucoma Devices.

    PubMed

    Ortiz Arismendi, Gabriel Enrique; Peña Valderrama, Cristina Del Pilar; Albis-Donado, Oscar

    2013-01-01

    To describe and present results of an original technique for nonvalved glaucoma implants. Thirty-five eyes of 34 patients with aggressive and/or advanced glaucomas of different causes were included. A Baerveldt implant was used in all cases, using an absorbable ligature that had been titrated to allow fow from day 1, but avoiding hypotony. Intraocular pressure (IOP) during the first 8 weeks, final IOP, visual acuity and complications were analyzed. Mean preoperative IOP was 42.8 mm Hg (range: 24-64 mm Hg). IOP was 14.4, 17.2, 18.6, 19 and 16.4 mm Hg during the 1, 2, 4, 6 and 8 postoperative weeks. Mean final IOP was 13.8 ± 4.25 mm Hg, a 67.8% reduction, after a mean follow-up time of 13 months (range: 8-29 months). Twenty-nine eyes (82.9%) had complete success, two had qualifed success (5.7%) and four were failures (11.4%). Choroidal detachments and transient tube obstructions were the most frequent complications. Titrated ligature of Baerveldt tubes was effective for controlling IOP during both the early and late postoperative phases in eyes with severe glaucomas. How to cite this article: Arismendi GEO, del Pilar Peña Valderrama C, Albis-Donado O. RESULTS of a New Technique for Implantation of Nonrestrictive Glaucoma Devices. J Current Glau Prac 2013;7(3):130-135.

  18. Splenic abcesses as infectious complication following implantation of left ventricular asssist device - case report.

    PubMed

    Gajda, Sławomir; Szczepanik, Anna M; Religa, Grzegorz; Misiak, Andrzej; Szczepanik, Andrzej B

    2017-02-28

    Left ventricular assist device (LVAD) is one of the modern management therapies in patients with advanced heart failure, and it serves as a bridge to heart transplantation or even as destination therapy. However, it is burdened with a high risk of thromboembolic, hemorrhagic, and infectious complications despite prophylactic management. Splenic abscesses, as septic complications following implantation of mechanical ventricular support, have not yet been described in the literature. We report of a patient with severe left ventricular insufficiency (NYHA II/III), pulmonary hypertension, and arrhythmia who underwent implantation of the Heart Ware® pump for left ventricular support with simultaneous tricuspidvalvoplasty, as a bridge therapy to heart transplantation. During two years after LVAD implantation, the patient had three MRSA skin infections, localized at the exit site of the drive-line connecting the artificial ventricle with external unit, that were complicated by sepsis and treated with broad-spectrum antibiotics. A few months later, abdominal CT revealed two abscesses in the spleen, and the patient was qualified for splenectomy. Open splenectomy was performed under full-dose anticoagulant therapy with continuous intravenous infusions of unfractionated heparin (UFH). The intra- and postoperative course was uneventful. UFH therapy was continued for 6 days, and oral anticoagulation was re-administered on day 4 after surgery. The patient was discharged on day 7 after surgery with primary healed wound. Open splenectomy, performed with full-dose anticoagulant therapy, proved to be an effective and definitive method of treatment without any complications.

  19. Active Clearance of Chest Tubes Reduces Re-Exploration for Bleeding After Ventricular Assist Device Implantation

    PubMed Central

    Davis, Mary E.; Haglund, Nicholas A.; Perrault, Louis; Kushwaha, Sudhir S.; Stulak, John M.; Boyle, Edward M.

    2016-01-01

    Chest tubes are utilized to evacuate shed blood after left ventricular assist device (LVAD) implantation, however, they can become clogged, leading to retained blood. We implemented a protocol for active tube clearance (ATC) of chest tubes to determine if this might reduce interventions for retained blood. A total of 252 patients underwent LVAD implantation. Seventy-seven patients had conventional chest tube drainage (group 1), whereas 175 patients had ATC (group 2). A univariate and multivariate analysis adjusting for the use of conventional sternotomy (CS) and minimally invasive left thoracotomy (MILT) was performed. Univariate analysis revealed a 65% reduction in re-exploration (43–15%, p < 0.001), and an 82% reduction in delayed sternal closure (DSC; 34–6%, p <0.001). In a sub-analysis of CS only, there continued to be statistically significant 53% reduction in re-exploration (45% vs. 21%, p = 0.0011), and a 77% reduction in DSC (35% vs. 8%, p < 0.001) in group 2. Using a logistic regression model adjusting for CS versus MILT, there was a significant reduction in re-exploration (odds ratio [OR] = 0.44 [confidence interval {CI} = 0.23–0.85], p = 0.014) and DSC (OR = 0.20 [CI = 0.08–0.46], p <0.001) in group 2. Actively maintaining chest tube patency after LVAD implantation significantly reduces re-exploration and DSC. PMID:27556153

  20. Active Clearance of Chest Tubes Reduces Re-Exploration for Bleeding After Ventricular Assist Device Implantation.

    PubMed

    Maltais, Simon; Davis, Mary E; Haglund, Nicholas A; Perrault, Louis; Kushwaha, Sudhir S; Stulak, John M; Boyle, Edward M

    Chest tubes are utilized to evacuate shed blood after left ventricular assist device (LVAD) implantation, however, they can become clogged, leading to retained blood. We implemented a protocol for active tube clearance (ATC) of chest tubes to determine if this might reduce interventions for retained blood. A total of 252 patients underwent LVAD implantation. Seventy-seven patients had conventional chest tube drainage (group 1), whereas 175 patients had ATC (group 2). A univariate and multivariate analysis adjusting for the use of conventional sternotomy (CS) and minimally invasive left thoracotomy (MILT) was performed. Univariate analysis revealed a 65% reduction in re-exploration (43-15%, p < 0.001), and an 82% reduction in delayed sternal closure (DSC; 34-6%, p <0.001). In a sub-analysis of CS only, there continued to be statistically significant 53% reduction in re-exploration (45% vs. 21%, p = 0.0011), and a 77% reduction in DSC (35% vs. 8%, p < 0.001) in group 2. Using a logistic regression model adjusting for CS versus MILT, there was a significant reduction in re-exploration (odds ratio [OR] = 0.44 [confidence interval {CI} = 0.23-0.85], p = 0.014) and DSC (OR = 0.20 [CI = 0.08-0.46], p <0.001) in group 2. Actively maintaining chest tube patency after LVAD implantation significantly reduces re-exploration and DSC.

  1. A microelectrode/microelectronic hybrid device for brain implantable neuroprosthesis applications.

    PubMed

    Patterson, William R; Song, Yoon-Kyu; Bull, Christopher W; Ozden, Ilker; Deangellis, Andrew P; Lay, Christopher; McKay, J Lucas; Nurmikko, Arto V; Donoghue, John D; Connors, Barry W

    2004-10-01

    We have designed, fabricated, and characterized a microminiaturized "neuroport" for brain implantable neuroprosthesis applications, using an analog CMOS integrated circuit and a silicon based microelectrode array. An ultra-low power, low-noise CMOS preamplifier array with integral multiplexing was designed to accommodate stringent thermal and electrophysiological requirements for implantation in the brain, and a hybrid integration approach was developed to fabricate a functional microminiaturized neuroprobe device. Measurements showed that our fully scalable 16-channel CMOS amplifier chip had an average gain of 44 dB, bandwidth from 10 Hz to 7.3 kHz, and an equivalent input noise of approximately 9 microVrms with an average power consumption per preamplifier of 52 microW, which is consistent with simulation results. As a proof-of-concept demonstration, we have measured local field potentials from thalamocortical brain slices of rats, showing oscillatory behavior with an amplitude about 0.5 mV and a period ranging 80-120 ms. The results suggest that the hybrid integrated neuroport can form a prime platform for the development of a next level microminiaturized neural interface to the brain in a single implantable unit.

  2. Improvement of wireless power transmission efficiency of implantable subcutaneous devices by closed magnetic circuit mechanism.

    PubMed

    Jo, Sung-Eun; Joung, Sanghoon; Suh, Jun-Kyo Francis; Kim, Yong-Jun

    2012-09-01

    Induction coils were fabricated based on flexible printed circuit board for inductive transcutaneous power transmission. The coil had closed magnetic circuit (CMC) structure consisting of inner and outer magnetic core. The power transmission efficiency of the fabricated device was measured in the air and in vivo condition. It was confirmed that the CMC coil had higher transmission efficiency than typical air-core coil. The power transmission efficiency during a misalignment between primary coil and implanted secondary coil was also evaluated. The decrease of mutual inductance between the two coils caused by the misalignment led to a low efficiency of the inductive link. Therefore, it is important to properly align the primary coil and implanted secondary coil for effective power transmission. To align the coils, a feedback coil was proposed. This was integrated on the backside of the primary coil and enabled the detection of a misalignment of the primary and secondary coils. As a result of using the feedback coil, the primary and secondary coils could be aligned without knowledge of the position of the implanted secondary coil.

  3. Intractable Hematuria After Left Ventricular Assist Device Implantation: Can Lessons Learned from Gastrointestinal Bleeding Be Applied?

    PubMed

    Son, Andre Y; Zhao, Lee; Reyentovich, Alex; Deanda, Abe; Balsam, Leora B

    2016-01-01

    Patients with continuous-flow left ventricular assist devices (CF-LVADs) are at increased risk of bleeding. We reviewed our institutional experience with bleeding in the urinary tract after CF-LVAD implantation and quantified the impact on hospital resource utilization in comparison with bleeding in the gastrointestinal (GI) tract, the most commonly reported mucosal site of bleeding after LVAD implantation. Records were retrospectively reviewed for patients undergoing CF-LVAD implantation at our institution between October 2011 and April 2015. Major adverse events of gross hematuria and GI bleeding were identified, and patient demographics and hospital course were reviewed. Gross hematuria occurred in 3 of the 35 patients (8.6%) and in 5.1% of all hospitalizations for CF-LVAD patients. Severe hematuria occurred after traumatic urethral catheterization, urinary retention, or urologic surgery. Hospitalization for hematuria was six times less likely than hospitalization for GI bleeding; however, hematuria hospitalizations lasted 3.2 times longer than GI bleeding hospitalizations (17.0 vs. 5.3 days). Late recurrent gross hematuria occurred in all cases, with rehospitalization occurring after 109 ± 53 days. In conclusion, gross hematuria is an infrequent but morbid bleeding complication in CF-LVAD patients. Strategies to avoid this complication include strict avoidance of traumatic urethral catheterization and urinary retention in high-risk patients.

  4. Results of a New Technique for Implantation of Nonrestrictive Glaucoma Devices

    PubMed Central

    Peña Valderrama, Cristina Del Pilar; Albis-Donado, Oscar

    2013-01-01

    ABSTRACT Objective: To describe and present results of an original technique for nonvalved glaucoma implants. Patients and methods: Thirty-five eyes of 34 patients with aggressive and/or advanced glaucomas of different causes were included. A Baerveldt implant was used in all cases, using an absorbable ligature that had been titrated to allow fow from day 1, but avoiding hypotony. Intraocular pressure (IOP) during the first 8 weeks, final IOP, visual acuity and complications were analyzed. Results: Mean preoperative IOP was 42.8 mm Hg (range: 24-64 mm Hg). IOP was 14.4, 17.2, 18.6, 19 and 16.4 mm Hg during the 1, 2, 4, 6 and 8 postoperative weeks. Mean final IOP was 13.8 ± 4.25 mm Hg, a 67.8% reduction, after a mean follow-up time of 13 months (range: 8-29 months). Twenty-nine eyes (82.9%) had complete success, two had qualifed success (5.7%) and four were failures (11.4%). Choroidal detachments and transient tube obstructions were the most frequent complications. Conclusion: Titrated ligature of Baerveldt tubes was effective for controlling IOP during both the early and late postoperative phases in eyes with severe glaucomas. How to cite this article: Arismendi GEO, del Pilar Peña Valderrama C, Albis-Donado O. Results of a New Technique for Implantation of Nonrestrictive Glaucoma Devices. J Current Glau Prac 2013;7(3):130-135. PMID:26997797

  5. Remote Monitoring of Cardiac Implantable Devices: Ontology Driven Classification of the Alerts.

    PubMed

    Rosier, Arnaud; Mabo, Philippe; Temal, Lynda; Van Hille, Pascal; Dameron, Olivier; Deleger, Louise; Grouin, Cyril; Zweigenbaum, Pierre; Jacques, Julie; Chazard, Emmanuel; Laporte, Laure; Henry, Christine; Burgun, Anita

    2016-01-01

    The number of patients that benefit from remote monitoring of cardiac implantable electronic devices, such as pacemakers and defibrillators, is growing rapidly. Consequently, the huge number of alerts that are generated and transmitted to the physicians represents a challenge to handle. We have developed a system based on a formal ontology that integrates the alert information and the patient data extracted from the electronic health record in order to better classify the importance of alerts. A pilot study was conducted on atrial fibrillation alerts. We show some examples of alert processing. The results suggest that this approach has the potential to significantly reduce the alert burden in telecardiology. The methods may be extended to other types of connected devices.

  6. Signal transmission through human muscle for implantable medical devices using galvanic intra-body communication technique.

    PubMed

    Chen, Xi Mei; Mak, Peng Un; Pun, Sio Hang; Gao, Yue Ming; Vai, Mang I; Du, Min

    2012-01-01

    Signal transmission over human tissues has long been the center research topic for biomedical engineering in both academic and industrial arenas. This is particular important for implantable medical devices (IMD) to communicate with other sensor devices in achieving health care and monitoring functions. Traditional Radio Frequency (RF) transmission technique suffers from not only high attenuation but also potential interference & eavesdropping. This paper has examined the alternate galvanic type Intra-Body Communication Technique (IBC) in transmitting signal across the body tissue (mainly muscle) in both analytical electromagnetic model with simulation results. Comparisons of these results with traditional RF data in literatures show a high promising potential (saving over 10 dB or more in path loss) for IBC transmission. Concrete discussions and several further research directions are also given out at the end of this paper.

  7. Theoretical study for safe and efficient energy transfer to deeply implanted devices using ultrasound.

    PubMed

    Cotté, Benjamin; Lafon, Cyril; Dehollain, Catherine; Chapelon, Jean-Yves

    2012-08-01

    The goal of this paper is to prove that a safe and efficient energy transfer is possible between an external transducer located on the patient's skin and a device deeply implanted in the abdomen. An ultrasound propagation model based on the Rayleigh-Sommerfeld diffraction integral is coupled with the data from the Visible Human Project to account for the geometry of the organs in the body. The model is able to predict the amount of acoustic power received by the device for different acoustic paths. The acoustic model is validated by comparison with measurements in water and in heterogeneous liquid phantoms. Care is taken to minimize adverse bioeffects-mainly temperature rise and cavitation in tissues. Simulations based on the bio-heat transfer equation are performed to check that thermal effects are indeed small.

  8. Bailout transcatheter closure of patent foramen ovale for refractory hypoxaemia after left ventricular assist device implantation.

    PubMed

    Fischer, Quentin; Kirsch, Matthias; Brochet, Eric; Juliard, Jean-Michel

    2015-08-01

    We describe the interdisciplinary management of a 59-year old man with ischaemic cardiomyopathy on a HeartMate II left ventricular assist device (LVAD) and temporary right extracorporeal membrane oxygenation (ECMO) as a bridge-to-heart transplantation. He suffered refractory hypoxaemia due to massive right-to-left shunting by a patent foramen ovale (PFO), diagnosed after weaning off of temporary right ECMO. Percutaneous closure of the PFO was successfully achieved with an Amplatzer septal occluder device, which allowed the patient's extubation and departure from hospital. The patient received heart transplantation 7 weeks after LVAD implantation and was discharged from the intensive care unit 2 weeks after transplantation. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  9. Achieving more frequent and longer dialysis for the majority: wearable dialysis and implantable artificial kidney devices.

    PubMed

    Fissell, William H; Roy, Shuvo; Davenport, Andrew

    2013-08-01

    The long-term survival for many chronic kidney failure patients who remain treated by dialysis in economically advanced countries remains similar to that of those with solid-organ malignancy, despite a disproportionate amount of health-care expenditure. As such, the current paradigm of three times weekly in-center hemodialysis for 4 h or shorter sessions needs to change to improve patient outcomes. Although more frequent and longer dialysis sessions have been reported to improve cardiovascular risk surrogates and short-term outcomes, these options are only practically available to a very small fraction of the total dialysis population. As such, radically new approaches are required to improve patient outcomes and quality of life for the majority of dialysis patients. Currently, two different approaches are being developed, wearable devices based on current dialysis techniques and more futuristic implantable devices modeled on the natural nephron.

  10. Malfunctions of implantable cardiac devices in patients receiving proton beam therapy: incidence and predictors

    PubMed Central

    Gomez, Daniel R.; Poenisch, Falk; Pinnix, Chelsea C.; Sheu, Tommy; Chang, Joe Y.; Memon, Nada; Mohan, Radhe; Rozner, Marc A.; Dougherty, Anne H.

    2014-01-01

    Purpose Photon therapy has been reported to induce resets of implanted cardiac devices, but the clinical sequelae of treating patients with such devices with proton beam therapy (PBT) are not well known. We reviewed the incidence of device malfunctions among patients undergoing PBT. Methods From March 2009 through July 2012, 42 patients with implanted cardiac implantable electronic devices (CIEDs) (28 pacemakers and 14 cardioverter-defillibrators) underwent 42 courses of PBT for thoracic (23 [55%]), prostate (15 [36%]), liver (3[7%]), or base of skull (1 [2%]) tumors at a single institution. The median prescribed dose was 74 Gy(RBE) [range 46.8–87.5 Gy(RBE)], and the median distance from the treatment field to the CIED was 10 cm (range 0.8–40 cm). Maximum proton and neutron doses were estimated for each treatment course. All CIEDs were checked before radiation delivery and monitored throughout treatment. Results Median estimated peak proton and neutron doses to the CIED in all patients were 0.8 Gy (range 0.13–21 Gy) and 346 Sv (range 11–1100 mSv). Six CIED malfunctions occurred in five patients (2 pacemakers and 3 defibrillators). Five of these malfunctions were CIED resets, and one patient with a defibrillator (in a patient with a liver tumor) had an elective replacement indicator (ERI) after therapy that was not influenced by radiation. The mean distance from the proton beam to the CIED among devices that reset was 7.0 cm (range 0.9–8 cm), and the mean maximum neutron dose was 655 mSv (range 330–1100 mSv). All resets occurred in patients receiving thoracic PBT and were corrected without clinical incident. The generator for the defibrillator with the ERI message was replaced uneventfully after treatment. Conclusions The incidence of CIED resets was about 20% among patients receiving PBT to the thorax. We recommend that PBT be avoided in pacing-dependent patients and that patients with any type of CIED receiving thoracic PBT be followed closely. PMID

  11. Malfunctions of Implantable Cardiac Devices in Patients Receiving Proton Beam Therapy: Incidence and Predictors

    SciTech Connect

    Gomez, Daniel R.; Poenisch, Falk; Pinnix, Chelsea C.; Sheu, Tommy; Chang, Joe Y.; Memon, Nada; Mohan, Radhe; Rozner, Marc A.; Dougherty, Anne H.

    2013-11-01

    Purpose: Photon therapy has been reported to induce resets of implanted cardiac devices, but the clinical sequelae of treating patients with such devices with proton beam therapy (PBT) are not well known. We reviewed the incidence of device malfunctions among patients undergoing PBT. Methods and Materials: From March 2009 through July 2012, 42 patients with implanted cardiac implantable electronic devices (CIED; 28 pacemakers and 14 cardioverter-defibrillators) underwent 42 courses of PBT for thoracic (23, 55%), prostate (15, 36%), liver (3, 7%), or base of skull (1, 2%) tumors at a single institution. The median prescribed dose was 74 Gy (relative biological effectiveness; range 46.8-87.5 Gy), and the median distance from the treatment field to the CIED was 10 cm (range 0.8-40 cm). Maximum proton and neutron doses were estimated for each treatment course. All CIEDs were checked before radiation delivery and monitored throughout treatment. Results: Median estimated peak proton and neutron doses to the CIED in all patients were 0.8 Gy (range 0.13-21 Gy) and 346 Sv (range 11-1100 mSv). Six CIED malfunctions occurred in 5 patients (2 pacemakers and 3 defibrillators). Five of these malfunctions were CIED resets, and 1 patient with a defibrillator (in a patient with a liver tumor) had an elective replacement indicator after therapy that was not influenced by radiation. The mean distance from the proton beam to the CIED among devices that reset was 7.0 cm (range 0.9-8 cm), and the mean maximum neutron dose was 655 mSv (range 330-1100 mSv). All resets occurred in patients receiving thoracic PBT and were corrected without clinical incident. The generator for the defibrillator with the elective replacement indicator message was replaced uneventfully after treatment. Conclusions: The incidence of CIED resets was about 20% among patients receiving PBT to the thorax. We recommend that PBT be avoided in pacing-dependent patients and that patients with any type of CIED receiving

  12. Fully implantable, battery-free wireless optoelectronic devices for spinal optogenetics.

    PubMed

    Samineni, Vijay K; Yoon, Jangyeol; Crawford, Kaitlyn E; Jeong, Yu Ra; McKenzie, Kajanna C; Shin, Gunchul; Xie, Zhaoqian; Sundaram, Saranya S; Li, Yuhang; Yang, Min Young; Kim, Jeonghyun; Wu, Di; Xue, Yeguang; Feng, Xue; Huang, Yonggang; Mickle, Aaron D; Banks, Anthony; Ha, Jeong Sook; Golden, Judith P; Rogers, John A; Gereau, Robert W

    2017-06-08

    The advent of optogenetic tools has allowed unprecedented insights into the organization of neuronal networks. Although recently developed technologies have enabled implementation of optogenetics for studies of brain function in freely moving, untethered animals, wireless powering and device durability pose challenges in studies of spinal cord circuits where dynamic, multidimensional motions against hard and soft surrounding tissues can lead to device degradation. We demonstrate here a fully implantable optoelectronic device powered by near-field wireless communication technology, with a thin and flexible open architecture that provides excellent mechanical durability, robust sealing against biofluid penetration and fidelity in wireless activation, thereby allowing for long-term optical stimulation of the spinal cord without constraint on the natural behaviors of the animals. The system consists of a double-layer, rectangular-shaped magnetic coil antenna connected to a microscale inorganic light-emitting diode (μ-ILED) on a thin, flexible probe that can be implanted just above the dura of the mouse spinal cord for effective stimulation of light-sensitive proteins expressed in neurons in the dorsal horn. Wireless optogenetic activation of TRPV1-ChR2 afferents with spinal μ-ILEDs causes nocifensive behaviors and robust real-time place aversion with sustained operation in animals over periods of several weeks to months. The relatively low-cost electronics required for control of the systems, together with the biocompatibility and robust operation of these devices will allow broad application of optogenetics in future studies of spinal circuits, as well as various peripheral targets, in awake, freely moving and untethered animals, where existing approaches have limited utility.

  13. A cardiac implantable device infection by Raoultella planticola in an immunocompromized patient

    PubMed Central

    D'Ivernois, Chistophe; Leyssene, David; Berneau, Jean-Baptiste; Hemery, Yann

    2017-01-01

    Introduction. Infection of cardiac implantable electronic devices is a severe condition associated with high mortality, particularly in patients who are dependent upon heart-pacing devices. Staphylococci are found in 70 % of reported cases. Case presentation. We report the case of a cardiac-pacemaker infection in a 79-year-old man, cumulating a history of rheumatoid arthritis treated by corticosteroids and methotrexate by a recently identified micro-organism: Raoultella planticola. He presented local signs of infection on his VVI pacemaker implantation site and underwent urgent pocket device replacement under cefamandole antibioprophylaxis. On incision thick pus oozed out. It was necessary to perform a complete hardware extraction comprising the pulse generator and the ancient lead. Pus was inoculated into aerobic and anaerobic culture vials and Gram staining unveiled Gram-negative rods. Microbiology analysis identified the organism as R. planticola. A new pacing device was inserted on the contrlateral pectoral region. Ciprofloxacin enabled full recovery. A literature review concerning this pathogen revealed that it is involved in severe infections such as bloodstream infections, peritonitis, cellulitis, pneumonia and lung abscesses, and urinary tract infections. In these case reports, underlying co-morbidities were identified such as solid active neoplasia, recent chemotherapy, corticosteroids, solid-organ-recipient patients and recent open surgery. Conclusion. R. planticola is a serious emerging pathogen and contributes to the burden of various infectious conditions. Its pathogenicity and occurrence should be known by clinicians and a high level of awareness is necessary to precisely identify it provide the correct antibiotic regimen. PMID:28348805

  14. [Quality of life in patients after anti-arrhythmic devices implantation].

    PubMed

    Lełakowska-Piela, Maria; Pudło, Joanna; Rydlewska, Anna; Senderek, Tomasz; Lelakowski, Jacek

    2013-12-01

    To assess changes in quality of life in patients with advanced heart failure before ICD or CRTD implantation and after 6 months follow-up period. The quality of life study was performed in group consisting of 98 patients (69 male, mean age 70.4 +/- 8.60 years), who underwent CRTD implantation (48 patients, 33 male, mean age 70.6 +/- 9.12 years) or ICD implantation (50 patients, 36 male, mean age 70.3 +/- 8.16 years) before the procedure and after 6 months of follow-up. Inclusion criteria were as follows: patients with indications to ICD or CRTD implantation, complete quality of life questionnaires before the procedure and after 6 months follow-up, lack of diagnosed dementia. The quality of life assessment was performed using patient's self-assessment with SF-36 and DASI questionnaires. Patients' self-assessment, NYHA class and ejection fraction was compared before the implantation and after 6 months. Additionally, co-morbidities and experiencing of high voltage therapy were analyzed. In the whole group after 6 months NYHA class improved from mean 2.9 +/- 0.5 to 2.3 +/- 0.84, p < 0.001; in CRTD group from mean 3.0 +/- 0.62 to 2.3 +/- 0.95, p < 0.001; in ICD group from mean 2.9 +/- 0.35 to 2.2 +/- 0.74, p < 0.001. In the whole group after 6 months ejection fraction improved from mean 27.7 +/- 6.92 to 31.0 +/- 7.23%, p < 0.001; in CRTD group from mean 25.3 +/- 7.85 to 32.4 +/- 8.98%, p < 0.001; in ICD group there was no significant improvement of ejection fraction. After CRTD implantation improvement of quality of life was achieved in SF36 and DASI questionnaires. There was no significant improvement in ICD group. DASI index is deteriorated by device's interventions (cardioversions) (regression index=3.45, odds ratio OR = 31.5, 95% confidence interval OR = 8.2-121, p < 0.001) and presence of permanent atrial fibrillation (regression index = 1,243, odds ratio OR = 3.45, 95% confidence interval OR = 1.03-11.7, p < 0.042). SF36 index is deteriorated by presence of kidney

  15. Carina® and Esteem®: A Systematic Review of Fully Implantable Hearing Devices

    PubMed Central

    Pulcherio, Janaina Oliveira Bentivi; Bittencourt, Aline Gomes; Burke, Patrick Rademaker; Monsanto, Rafael da Costa; de Brito, Rubens; Tsuji, Robinson Koji; Bento, Ricardo Ferreira

    2014-01-01

    Objective To review the outcomes of the fully implantable middle ear devices Carina and Esteem regarding the treatment of hearing loss. Data Sources PubMed, Embase, Scielo, and Cochrane Library databases were searched. Study Selection Abstracts of 77 citations were screened, and 43 articles were selected for full review. From those, 22 studies and two literature reviews in English directly demonstrating the results of Carina and Esteem were included. Data Extraction There were a total of 244 patients ranging from 18 to 88 years. One hundred and 10 patients were implanted with Carina and with 134 Esteem. There were registered 92 males and 67 females. Five studies provided no information about patients’ age or gender. From the data available, the follow-up ranged from 2 to 29.4 months. Data Synthesis The comparison of the results about word recognition is difficult as there was no standardization of measurement. The results were obtained from various sound intensities and different frequencies. The outcomes comparing to conventional HAs were conflicting. Nevertheless, all results comparing to unaided condition showed improvement and showed a subjective improvement of quality of life. Conclusion There are still some problems to be solved, mainly related to device functioning and price. Due to the relatively few publications available and small sample sizes, we must be careful in extrapolating these results to a broader population. Additionally, none of all these studies represented level high levels of evidence (i.e. randomized controlled trials). PMID:25329463

  16. Carina® and Esteem®: a systematic review of fully implantable hearing devices.

    PubMed

    Pulcherio, Janaina Oliveira Bentivi; Bittencourt, Aline Gomes; Burke, Patrick Rademaker; Monsanto, Rafael da Costa; de Brito, Rubens; Tsuji, Robinson Koji; Bento, Ricardo Ferreira

    2014-01-01

    To review the outcomes of the fully implantable middle ear devices Carina and Esteem regarding the treatment of hearing loss. PubMed, Embase, Scielo, and Cochrane Library databases were searched. Abstracts of 77 citations were screened, and 43 articles were selected for full review. From those, 22 studies and two literature reviews in English directly demonstrating the results of Carina and Esteem were included. There were a total of 244 patients ranging from 18 to 88 years. One hundred and 10 patients were implanted with Carina and with 134 Esteem. There were registered 92 males and 67 females. Five studies provided no information about patients' age or gender. From the data available, the follow-up ranged from 2 to 29.4 months. The comparison of the results about word recognition is difficult as there was no standardization of measurement. The results were obtained from various sound intensities and different frequencies. The outcomes comparing to conventional HAs were conflicting. Nevertheless, all results comparing to unaided condition showed improvement and showed a subjective improvement of quality of life. There are still some problems to be solved, mainly related to device functioning and price. Due to the relatively few publications available and small sample sizes, we must be careful in extrapolating these results to a broader population. Additionally, none of all these studies represented level high levels of evidence (i.e. randomized controlled trials).

  17. The pathway to physician reimbursement for cardiac implantable electronic devices (CIEDs): a history and brief synopsis.

    PubMed

    Roka, Attila; Schoenfeld, Mark H

    2013-03-01

    Cardiac implantable electronic devices (CIEDs), despite their proven effectiveness in large clinical trials for a wide range of patients with arrhythmia and heart failure, are frequent targets for criticism regarding cost-efficiency and alleged overuse. Newer indications, such as sinus node dysfunction for pacemakers and primary prevention for implantable cardioverter-defibrillators, increased eligible patient population significantly. This lead to heightened scrutiny from payors and legislative agencies, such as prior authorization and mandatory registry participation. Despite the significant administrative burden, the efficiency of these measures to decrease abuse is not clear. In addition, professional societies, regulatory agencies, and payors may not always agree whether use of a device is appropriate for a given patient. The review focuses on past and current issues related to utilization of CIEDs, which lead to increased regulatory oversight, and the effort of professional societies, payors, and governmental agencies to improve access to these life-saving therapeutical modalities while maintaining a just and cost-efficient healthcare system.

  18. Nanomaterial-Based Approaches for Prevention of Biofilm-Associated Infections on Medical Devices and Implants.

    PubMed

    Naik, Kshipra; Srivastava, Pallavee; Deshmukh, Ketaki; Monsoor, M S; Kowshik, Meenal

    2015-12-01

    Biofilm formation is a major problem in medical device-related infections leading to failure of implant-based therapies. Though various conventional approaches to counter biofilm formation like physical and/or mechanical removal, chemical removal, and the use of antimicrobials exist, they fail due to increased resistance of biofilms. This review discusses various nanomaterial-based approaches such as the use of metallic and metal oxide nanoparticles- and polymer-based nanocomposites, which are currently being developed for prevention and treatment of biofilms. Nanoparticles of transition metals and their oxides are toxic to microorganisms and exhibit their toxicity through the generation of reactive oxygen species at concentrations that are non-toxic to eukaryotic cells. Other approaches include the entrapment of bioactive agents in polymer/ceramic nanoparticles, for enhanced anti-biofilm activity due to the synergistic effect between them. These nanomaterial-based approaches could play an important role in control and eradication of biofilm related infections and complications associated with medical devices and implants.

  19. Long-acting reversible contraceptives: intrauterine devices and the contraceptive implant.

    PubMed

    Espey, Eve; Ogburn, Tony

    2011-03-01

    The provision of effective contraception is fundamental to the practice of women's health care. The most effective methods of reversible contraception are the so-called long-acting reversible contraceptives, intrauterine devices and implants. These methods have multiple advantages over other reversible methods. Most importantly, once in place, they do not require maintenance and their duration of action is long, ranging from 3 to 10 years. Despite the advantages of long-acting reversible contraceptive methods, they are infrequently used in the United States. Short-acting methods, specifically oral contraceptives and condoms, are by far the most commonly used reversible methods. A shift from the use of short-acting methods to long-acting reversible contraceptive methods could help reduce the high rate of unintended pregnancy in the United States. In this review of long-acting reversible contraceptive methods, we discuss the intrauterine devices and the contraceptive implant available in the United States, and we describe candidates for each method, noncontraceptive benefits, and management of complications.

  20. Health Care Utilization and Expenditures Associated With Remote Monitoring in Patients With Implantable Cardiac Devices.

    PubMed

    Ladapo, Joseph A; Turakhia, Mintu P; Ryan, Michael P; Mollenkopf, Sarah A; Reynolds, Matthew R

    2016-05-01

    Several randomized trials and decision analysis models have found that remote monitoring may reduce health care utilization and expenditures in patients with cardiac implantable electronic devices (CIEDs), compared with in-office monitoring. However, little is known about the generalizability of these findings to unselected populations in clinical practice. To compare health care utilization and expenditures associated with remote monitoring and in-office monitoring in patients with CIEDs, we used Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases. We selected patients newly implanted with an implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy defibrillator (CRT-D), or permanent pacemaker (PPM), in 2009, who had continuous health plan enrollment 2 years after implantation. Generalized linear models and propensity score matching were used to adjust for confounders and estimate differences in health care utilization and expenditures in patients with remote or in-office monitoring. We identified 1,127; 427; and 1,295 pairs of patients with a similar propensity for receiving an ICD, CRT-D, or PPM, respectively. Remotely monitored patients with ICDs experienced fewer emergency department visits resulting in discharge (p = 0.050). Remote monitoring was associated with lower health care expenditures in office visits among patients with PPMs (p = 0.025) and CRT-Ds (p = 0.006) and lower total inpatient and outpatient expenditures in patients with ICDs (p <0.0001). In conclusion, remote monitoring of patients with CIEDs may be associated with reductions in health care utilization and expenditures compared with exclusive in-office care.

  1. Cost-effectiveness of early detection of atrial fibrillation via remote control of implanted devices.

    PubMed

    Lorenzoni, Giulia; Folino, Franco; Soriani, Nicola; Iliceto, Sabino; Gregori, Dario

    2014-10-01

    Atrial fibrillation (AF) is an independent risk factor for stroke, and its incidence is high in patients implanted with pacemakers (PMs) and implantable cardioverter defibrillators (ICDs). The aim of our study is to evaluate the potential benefit of remote control (RC) on the incidence of stroke related to AF in patients with new-onset AF implanted with PMs and ICDs and to evaluate the impact of RC on the consumption of medical resources. The study consisted of two cohorts of patients: group AMB (patients attending ambulatory care clinics from August to October 2013) and group RC (patients followed remotely). All detected cases of new-onset AF were confirmed by the electrogram stored in the device's memory or by standard electrocardiogram recording. Monte Carlo simulations were performed in order to evaluate the potential risk reduction of stroke related to AF. The costs were estimated from the perspectives of the hospital, the patients and the National Health Service. We enrolled 223 patients in group RC and 359 in group AMB. We detected 20 new-onset cases of AF, and the median time to AF detection was 2 days in the RC and 78 days in the ambulatory care clinic control. Management of patients was more efficient with RC, with an average savings in direct costs of €40.88 per year per patient. Through the use of Monte Carlo simulations, we showed that the early detection of new-onset AF may provide a relative risk reduction of 94.3% for stroke in PM-implanted patients older than 55 years. RC potentially provides a risk reduction for stroke because it allows an early detection of new-onset AF. Moreover, it is also a cost-saving means of follow-up. © 2014 John Wiley & Sons, Ltd.

  2. Feasibility and Safety of Endovascular Stripping of Totally Implantable Venous Access Devices

    SciTech Connect

    Heye, Sam Maleux, Geert; Goossens, G. A.; Vaninbroukx, Johan; Jerome, M.; Stas, M.

    2012-06-15

    Purpose: To evaluate the safety and feasibility of percutaneous stripping of totally implantable venous access devices (TIVAD) in case of catheter-related sleeve and to report a technique to free the catheter tip from vessel wall adherence. Materials and Methods: A total of 37 stripping procedures in 35 patients (14 men, 40%, and 21 women, 60%, mean age 53 {+-} 14 years) were reviewed. Totally implantable venous access devices were implanted because of malignancy in most cases (85.7%). Catheter-related sleeve was confirmed as cause of persistent catheter dysfunction despite instillation of thrombolytics. A technique to mobilize the catheter tip from the vessel wall was used when stripping with the snare catheter was impossible. Technical success, complication rate, and outcome were noted. Results: A total of 55.9% (n = 19) of the 34 technically successful procedures (91.9%) could be done with the snare catheter. In 15 cases (44.1%), additional maneuvers to free the TIVAD's tip from the vessel wall were needed. Success rate was not significantly lower before (72.4%) than after (96.7%) implementation of the new technique (P = 0.09). No complications were observed. Follow-up was available in 67.6% of cases. Recurrent catheter dysfunction was found in 17 TIVADs (78.3%) at a mean of 137.7 days and a median of 105 days. Conclusions: Stripping of TIVADs is technically feasible and safe, with an overall success rate of 91.9%. Additional endovascular techniques to mobilize the distal catheter tip from the wall of the superior vena cava or right atrium to allow encircling the TIVAD tip with the snare catheter may be needed in 44.1% of cases.

  3. Cellular uptake of drug loaded spider silk particles.

    PubMed

    Schierling, Martina B; Doblhofer, Elena; Scheibel, Thomas

    2016-09-20

    Medical therapies are often accompanied by un-wanted side-effects or, even worse, targeted cells can develop drug resistance leading to an ineffective treatment. Therefore, drug delivery systems are under investigation to lower the risk thereof. Drug carriers should be biocompatible, biodegradable, nontoxic, non-immunogenic, and should show controllable drug loading and release properties. Previous studies qualified spider silk particles as drug delivery carriers, however, cellular uptake was only tested with unloaded spider silk particles. Here, the effect of drug loading on cellular uptake of previously established spider silk-based particles made of eADF4(C16), eADF4(C16)RGD, eADF4(C16)R8G and eADF4(κ16) was investigated. Fluorescently labelled polyethylenimine was used as a model substance for loading eADF4(C16), eADF4(C16)RGD or eADF4(C16)R8G particles, and fluorescently labelled ssDNA was used for loading eADF4(κ16) particles. Upon loading polyanionic eADF4(C16) and eADF4(C16)RGD particles with polycationic polyethylenimine the cellular uptake efficiency was increased, while the uptake of eADF4(C16)R8G and polycationic eADF4(κ16) particles was decreased upon substance loading. The latter could be circumvented by coating substance-loaded eADF4(κ16) particles with an additional layer of eADF4(κ16) (layer-by-layer coating). Further, it could be shown that eADF4(C16)RGD and eADF4(κ16) uptake was based on clathrin-mediated endocytosis, whereas macropinocytosis was more important in case of eADF4(C16) and eADF4(C16)R8G particle uptake. Finally, it was confirmed that drugs, such as doxorubicin, can be efficiently delivered into and released within cells when spider silk particles were used as a carrier.

  4. Electromagnetic device-device interaction between a new generation implantable pacemaker and left ventricular assist device: recognition and potential solutions.

    PubMed

    Reddy, Preetham; Benditt, David G; Adabag, Selcuk

    2012-03-01

    An electromagnetic interaction between St. Jude Medical Inc. (St. Paul, MN, USA) permanent pacemakers and HeartMate II left ventricular assist devices (LVADs) (Thoratec Inc., Pleasanton, CA, USA) has been reported before, but the problem was thought to be resolved in the St. Jude Medical's most recently released pacemaker platform. We report a case of interference between the HeartMate II LVAD and the most recently released St. Jude Medical pacemaker (model no. PM3210; Anthem) and review new developments to overcome the electromagnetic interference problem in this setting. ©2010, The Authors. Journal compilation ©2010 Wiley Periodicals, Inc.

  5. Totally implantable venous access devices: retrospective analysis of different insertion techniques and predictors of complications in 796 devices implanted in a single institution

    PubMed Central

    2014-01-01

    Background The aim of this study was to assess the efficacy and safety of totally implanted vascular devices (TIVAD) using different techniques of insertion. Methods We performed a retrospective study using a prospective collected database of 796 consecutive oncological patients in which TIVADs were inserted. We focused on early and late complications following different insertion techniques (surgical cutdown, blind and ultrasound guided percutaneous) according to different techniques. Results Ultrasound guided technique was used in 646 cases, cephalic vein cutdown in 102 patients and percutaneous blind technique in 48 patients. The overall complication rate on insertion was 7.2% (57 of 796 cases). Early complications were less frequent using the ultrasound guided technique: arterial puncture (p = 0.009), technical failure (p = 0.009), access site change after first attempt (p = 0.002); pneumothorax occurred in 4 cases, all using the blind percutaneus technique. Late complications occurred in 49 cases (6.1%) which required TIVAD removal in 43 cases and included: sepsis (29 cases), thrombosis (3 cases), dislocation (7 cases), skin dehiscence (3 cases), and severe pain (1 case). Conclusion Ultrasound guided technique is the safest option for TIVAD insertion, with the lowest rates of immediate complications. PMID:24886342

  6. Perspectives of Patients With Cardiovascular Implantable Electronic Devices Who Received Advisory Warnings

    PubMed Central

    Ottenberg, Abigale L.; Mueller, Luke A.; Mueller, Paul S.

    2013-01-01

    Objective To learn the perspectives of patients with cardiovascular implantable electronic devices (CIEDs) who received device-related advisories. Background CIEDs are placed under advisory because of potential malfunctions. Methods Qualitative methods were used. Focus groups were conducted of 10 patients who had CIEDs under advisory. Audio recordings of the focus group discussions were transcribed and analyzed for content in accordance with qualitative analysis methods, specifically thematic analysis. Results Major themes were identified: patients’ attitudes toward their devices under advisory, education about advisories, emotional responses to advisories, impact on loved ones, and what affected patients would say to the chief executive officers of CIED manufacturers. Although the patients felt “fortunate and blessed” to have their devices, they reported a range of emotional responses to the advisories (from no concern to “outrage”). Patients preferred to learn about advisories from their physicians, not from news media. Loved ones had as many, if not more, advisory-related concerns than the patients. Patients had recommendations for chief executive officers of CIED manufacturers regarding advisories, including providing timely and comprehensible information and emotional support, taking responsibility, and collaborating with health care providers. Patients wanted to know what prompted the advisory and what will be done to fix the problem. Conclusions The experiences and perspectives of patients with CIEDs under advisory not only encompass their emotional responses to advisories, but also their views on how the advisory notification process can be improved. These findings should be informative to CIED manufacturers and clinicians. PMID:23305915

  7. Detection of bacterial biofilm on cochlear implants removed because of device failure, without evidence of infection.

    PubMed

    Ruellan, Katell; Frijns, Johan H M; Bloemberg, Guido V; Hautefort, Charlotte; Van den Abbeele, Thierry; Lamers, Gerda E M; Herman, Philippe; Huy, Patrice Tran Ba; Kania, Romain E

    2010-10-01

    To investigate the formation of bacterial biofilms on the surface of the electrode array of cochlear implants (CI) explanted because of device failure, without evidence of infection, by use of scanning electron microscopy (SEM) and confocal laser scanning microscopy (CLSM). Prospective study. Patients from 2 tertiary-care referral centers. CIs were explanted from 9 patients because of device failure. Specimens were immediately snap-frozen in cold isopenthane, stored at -80°C and examined with SEM and CLSM by 3 investigators. Presence of bacterial biofilm ascertained by SEM and CSLM. One specimen showed the formation of a bacterial biofilm on the middle ear part of the electrode array. No biofilm formation was found in the inner-ear part of electrode arrays. In the middle-ear part of the electrode array, a cylindrical cover of human muscular tissue was seen plugging the cochleostomy. This is the first study demonstrating that bacterial biofilms may exist on the surface of the electrode array of CIs explanted because of device failure but not infection. We found 1 case of biofilm formation in 9 explanted CIs. Further studies with larger series of CIs are required to investigate biofilm formation on the surface of CI electrode arrays to address both the pathophysiology of bacterial biofilms and prevention of device-related infections in CI patients.

  8. Complement activation by candidate biomaterials of an implantable microfabricated medical device.

    PubMed

    Sokolov, Andrey; Hellerud, Bernt C; Pharo, Anne; Johannessen, Erik A; Mollnes, Tom E

    2011-08-01

    Implantable devices realized by microfabrication have introduced a new class of potential biomaterials whose properties would need to be assessed. Such devices include sensors for measuring biological substances like glucose. Thus, 14 different candidate materials intended for design of such a device were investigated with respect to their complement activation potential in human serum. The fluid-phase activation was measured by the products C4d, Bb, C3bc, and the terminal complement complex (TCC), whereas solid-phase activation was measured by deposition of TCC on the material surfaces. No fluid-phase activation was found for materials related to the capsule, carrier, or sealing. Fluid-phase activation was, however, triggered to a various extent in three of the four nanoporous membranes (cellulose, polyamide, and aluminium oxide), whereas polycarbonate was rendered inactive. Solid-phase activation discriminated more sensitively between all the materials, revealing that the capsule candidate polydimethylsiloxane and sealing candidate silicone 3140 were highly compatible, showing significantly lower TCC deposition than the negative control (p < 0.01). Three of the candidate materials were indifferent, whereas the remaining nine showed significantly higher deposition of TCC than the negative control (p < 0.01). In conclusion, complement activation, in particular when examined on the solid phase, discriminated well between the different candidate materials tested and could be used as a guide for the selection of the best-suited materials for further investigation and development of the device.

  9. Phantom-based evaluation method for surgical assistance devices in minimally invasive cochlear implantation

    NASA Astrophysics Data System (ADS)

    Lexow, G. Jakob; Kluge, Marcel; Majdani, Omid; Lenarz, Thomas; Rau, Thomas S.

    2017-03-01

    Several research groups have proposed individual solutions for surgical assistance devices to perform minimally invasive cochlear implantation. The main challenge is the drilling of a small bore hole from the surface of the skull to the inner ear at submillimetric accuracy. Each group tested the accuracy of their device in their respective test bench or in a small number of temporal bone specimens. This complicates the comparison of the different approaches. Thus, a simple and inexpensive phantom based evaluation method is proposed which resembles clinical conditions. The method is based on half-skull phantoms made of bone-substitute material - optionally equipped with an artificial skin replica to include skin incision within the evaluation procedure. Anatomical structures of the temporal bone derived from segmentations using clinical imaging data are registered into a computer tomographic scan of the skull phantom and used for the planning of the drill trajectory. Drilling is performed with the respective device under conditions close to the intraoperative setting. Evaluation of accuracy can either be performed through postoperative imaging or by means of added targets on the inside of the skull model. Two different targets are proposed: simple reference marks only for measuring the accuracy of the device and a target containing a scala tympani model for evaluation of the complete workflow including the insertion of the electrode carrier. Experiments using the presented method take place under reproducible conditions thus allowing the comparison of the different approaches. In addition, artificial phantoms are easier to obtain and handle than human specimens.

  10. The channeling effect of Al and N ion implantation in 4H-SiC during JFET integrated device processing

    NASA Astrophysics Data System (ADS)

    Lazar, M.; Laariedh, F.; Cremillieu, P.; Planson, D.; Leclercq, J.-L.

    2015-12-01

    A strong channeling effect is observed for the ions of Al and N implanted in 4H-SiC due to its crystalline structure. This effect causes difficulties in subsequent accurate estimation of the depth of junctions formed by multiple ion implantation steps. A variety of lateral JFET transistors integrated on the same 4H-SiC wafer have been fabricated. Secondary Ion Mass Spectrometry measurements and Monte-Carlo simulations were performed in order to quantify and control the channeling effect of the implanted ions. A technological process was established enabling to obtain devices working with the presence of the channeling effect.

  11. Implantable left ventricular assist devices: an evolving long-term cardiac replacement therapy.

    PubMed Central

    DeRose, J J; Argenziano, M; Sun, B C; Reemtsma, K; Oz, M C; Rose, E A

    1997-01-01

    OBJECTIVE: The authors' 8-year experience with both inpatient and outpatient left ventricular assist device (LVAD) support is presented to show the possibilities and limitations of long-term outpatient mechanical circulatory assistance. SUMMARY BACKGROUND DATA: The limitation of suitable cardiac donors has led to the use of LVADs as a temporizing measure for patients awaiting cardiac transplantation. The success of such devices in the short and medium term as a bridge to transplantation has led to their evaluation as a long-term destination therapy for end-stage heart disease. METHODS: Between August 1990 and February 1997, 85 patients with end-stage heart disease underwent insertion of implantable LVADs. Fifty-two patients underwent pneumatic device insertion and 32 patients received a vented electric device. RESULTS: Patients were supported for a mean of 109+/-13 days for an overall survival to transplant (54) or explant (3) of 73%. Nineteen patients were discharged from the hospital on a mean of postoperative day 41+/-4 (range, 17-68) for an outpatient support time of 108+/-30 days (range, 2-466). Of 12 patients supported after postcardiotomy cardiogenic shock, 10 (82%) survived to hospital discharge. Perioperative right ventricular failure was treated in most patients with inotropic agents and inhaled nitric oxide with only six patients requiring right ventricular assist device support. Thromboembolic rate was low (0.016 events/patient-month) despite minimal or no anticoagulation in all cases. CONCLUSIONS: Left ventricular assist device support has evolved to become an outpatient therapy with excellent survival rates and an acceptable morbidity. Accordingly, wearable LVADs should be studied as permanent treatment options for patients who are not transplant candidates. Images Figure 2. PMID:9351714

  12. Drug-loaded erythrocytes: on the road toward marketing approval

    PubMed Central

    Bourgeaux, Vanessa; Lanao, José M; Bax, Bridget E; Godfrin, Yann

    2016-01-01

    Erythrocyte drug encapsulation is one of the most promising therapeutic alternative approaches for the administration of toxic or rapidly cleared drugs. Drug-loaded erythrocytes can operate through one of the three main mechanisms of action: extension of circulation half-life (bioreactor), slow drug release, or specific organ targeting. Although the clinical development of erythrocyte carriers is confronted with regulatory and development process challenges, industrial development is expanding. The manufacture of this type of product can be either centralized or bedside based, and different procedures are employed for the encapsulation of therapeutic agents. The major challenges for successful industrialization include production scalability, process validation, and quality control of the released therapeutic agents. Advantages and drawbacks of the different manufacturing processes as well as success key points of clinical development are discussed. Several entrapment technologies based on osmotic methods have been industrialized. Companies have already achieved many of the critical clinical stages, thus providing the opportunity in the future to cover a wide range of diseases for which effective therapies are not currently available. PMID:26929599

  13. Physicochemical characterization of drug-loaded rigid and elastic vesicles.

    PubMed

    Uchino, Tomonobu; Lefeber, Fons; Gooris, Gert; Bouwstra, Joke

    2011-06-30

    Ketorolac loaded rigid and elastic vesicles were prepared by sonication and the physicochemical properties of the drug loaded-vesicle formulations were examined. Rigid and elastic vesicles were prepared from the double chain surfactant sucrose-ester laurate (L-595) and the single chain surfactant octaoxyethylene-laurate ester (PEG-8-L). Sulfosuccinate (TR-70) was used as a negative charge inducer. Evaluation of the prepared vesicle was performed by dynamic light scattering, extrusion and by (1)H NMR (T(2) relaxation studies). The vesicles mean size varied between 90 and 150 nm. The elasticity of the vesicles was enhanced with increasing PEG-8-L/L-595 ratio, while an increase in loading of ketorolac resulted in a reduction in vesicle elasticity. (1)H NMR measurements showed that the molecular mobility of ketorolac was restricted, which indicates that ketorolac molecules were entrapped within the vesicle bilayers. The T(2) values of the aromatic protons of ketorolac increased gradually at higher PEG-8-L levels, indicating that ketorolac mobility increased in the vesicle bilayer. The chemical stability of ketorolac was dramatically improved in the vesicle formulation compared to a buffer solution. The strong interactions of ketorolac with the bilayers of the vesicles might be the explanation for this increased stability of ketorolac.

  14. Drug-loaded erythrocytes: on the road toward marketing approval.

    PubMed

    Bourgeaux, Vanessa; Lanao, José M; Bax, Bridget E; Godfrin, Yann

    2016-01-01

    Erythrocyte drug encapsulation is one of the most promising therapeutic alternative approaches for the administration of toxic or rapidly cleared drugs. Drug-loaded erythrocytes can operate through one of the three main mechanisms of action: extension of circulation half-life (bioreactor), slow drug release, or specific organ targeting. Although the clinical development of erythrocyte carriers is confronted with regulatory and development process challenges, industrial development is expanding. The manufacture of this type of product can be either centralized or bedside based, and different procedures are employed for the encapsulation of therapeutic agents. The major challenges for successful industrialization include production scalability, process validation, and quality control of the released therapeutic agents. Advantages and drawbacks of the different manufacturing processes as well as success key points of clinical development are discussed. Several entrapment technologies based on osmotic methods have been industrialized. Companies have already achieved many of the critical clinical stages, thus providing the opportunity in the future to cover a wide range of diseases for which effective therapies are not currently available.

  15. Organic nanotubes for drug loading and cellular delivery.

    PubMed

    Wakasugi, Ai; Asakawa, Masumi; Kogiso, Masaki; Shimizu, Toshimi; Sato, Mamiko; Maitani, Yoshie

    2011-07-15

    Organic nanotubes made of synthetic amphiphilic molecules are novel materials that form by self-assembly. In this study, organic nanotubes with a carboxyl group (ONTs) at the surface were used as a carrier for the anticancer drug doxorubicin, which has a weak amine group. The IC(50) values of ONT for cells were higher than that of conventional liposomes, suggesting that ONTs are safe. The results showed that the drug loading of ONTs was susceptible to the effect of ionic strength and H(+) concentration in the medium, and drug release from ONTs was promoted at lower pH, which is favorable for the release of drugs in the endosome after cellular uptake. ONTs loaded with the drug were internalized, and the drug was released quickly in the cells, as demonstrated on transmission electron microscopy images of ONTs and the detection of a 0.05% dose of ONT chelating gadolinium in the cells. Moreover, ONT could be modified chemically with folate by simply mixing with a folate-conjugate lipid. Therefore, these novel, biodegradable organic nanotubes have the potential to be used as drug carriers for controlled and targeting drug delivery.

  16. Drug loading to lipid-based cationic nanoparticles

    NASA Astrophysics Data System (ADS)

    Cavalcanti, Leide P.; Konovalov, Oleg; Torriani, Iris L.; Haas, Heinrich

    2005-08-01

    Lipid-based cationic nanoparticles are a new promising option for tumor therapy, because they display enhanced binding and uptake at the neo-angiogenic endothelial cells, which a tumor needs for its nutrition and growth. By loading suitable cytotoxic compounds to the cationic carrier, the tumor endothelial and consequently also the tumor itself can be destroyed. For the development of such novel anti-tumor agents, the control of drug loading and drug release from the carrier matrix is essential. We have studied the incorporation of the hydrophobic anti-cancer agent Paclitaxel (PXL) into a variety of lipid matrices by X-Ray reflectivity measurements. Liposome suspensions from cationic and zwitterionic lipids, comprising different molar fractions of Paclitaxel, were deposited on planar glass substrates. After drying at controlled humidity, well ordered, oriented multilayer stacks were obtained, as proven by the presence of bilayer Bragg peaks to several orders in the reflectivity curves. The presence of the drug induced a decrease of the lipid bilayer spacing, and with an excess of drug, also Bragg peaks of drug crystals could be observed. From the results, insight into the solubility of Paclitaxel in the model membranes was obtained and a structural model of the organization of the drug in the membrane was derived. Results from subsequent pressure/area-isotherm and grazing incidence diffraction (GID) measurements performed with drug/lipid Langmuir monolayers were in accordance with these conjectures.

  17. Cancer Therapy Using Ultrahigh Hydrophobic Drug-Loaded Graphene Derivatives

    PubMed Central

    Some, Surajit; Gwon, A-Ryeong; Hwang, Eunhee; Bahn, Ga-hee; Yoon, Yeoheung; Kim, Youngmin; Kim, Seol-Hee; Bak, Sora; Yang, Junghee; Jo, Dong-Gyu; Lee, Hyoyoung

    2014-01-01

    This study aimed to demonstrate that curcumin (Cur)-containing graphene composites have high anticancer activity. Specifically, graphene-derivatives were used as nanovectors for the delivery of the hydrophobic anticancer drug Cur based on pH dependence. Different Cur-graphene composites were prepared based on polar interactions between Cur and the number of oxygen-containing functional groups of respective starting materials. The degree of drug-loading was found to be increased by increasing the number of oxygen-containing functional groups in graphene-derivatives. We demonstrated a synergistic effect of Cur-graphene composites on cancer cell death (HCT 116) both in vitro and in vivo. As-prepared graphene quantum dot (GQD)-Cur composites contained the highest amount of Cur nano-particles and exhibited the best anticancer activity compared to the other composites including Cur alone at the same dose. This is the first example of synergistic chemotherapy using GQD-Cur composites simultaneous with superficial bioprobes for tumor imaging. PMID:25204358

  18. Critical factors in the translation of improved antimicrobial strategies for medical implants and devices.

    PubMed

    Grainger, David W; van der Mei, Henny C; Jutte, Paul C; van den Dungen, Jan J A M; Schultz, Marcus J; van der Laan, Bernard F A M; Zaat, Sebastian A J; Busscher, Henk J

    2013-12-01

    Biomaterials-associated infection incidence represents an increasing clinical challenge as more people gain access to medical device technologies worldwide and microbial resistance to current approaches mounts. Few reported antimicrobial approaches to implanted biomaterials ever get commercialized for physician use and patient benefit. This is not for lack of ideas since many thousands of claims to new approaches to antimicrobial efficacy are reported. Lack of translation of reported ideas into medical products approved for use, results from conflicting goals and purposes between the various participants involved in conception, validation, development, commercialization, safety and regulatory oversight, insurance reimbursement, and legal aspects of medical device innovation. The scientific causes, problems and impressive costs of the limiting clinical options for combating biomaterials-associated infection are well recognized. Demands for improved antimicrobial technologies constantly appear. Yet, the actual human, ethical and social costs and consequences of their occurrence are less articulated. Here, we describe several clinical cases of biomaterials-associated infections to illustrate the often-missing human elements of these infections. We identify the current societal forces at play in translating antimicrobial research concepts into clinical implant use and their often-orthogonal constituencies, missions and policies. We assert that in the current complex environment between researchers, funding agencies, physicians, patients, providers, producers, payers, regulatory agencies and litigators, opportunities for translatable successes are minimized under the various risks assumed in the translation process. This argues for an alternative approach to more effectively introduce new biomaterials and device technologies that can address the clinical issues by providing patients and medical practitioners new options for desperate clinical conditions ineffectively

  19. Do we need to establish guidelines for patients with neuromodulation implantable devices, including spinal cord stimulators undergoing nonspinal surgeries?

    PubMed Central

    Ghaly, Ramsis F.; Tverdohleb, Tatiana; Candido, Kenneth D.; Knezevic, Nebojsa Nick

    2016-01-01

    Background: Spinal cord stimulation is currently approved to treat chronic intractable pain of the trunk and limbs. However, such implantable electronic devices are vulnerable to external electrical currents and magnetic fields. Within the hospitals and modern operating rooms (ORs), there is an abundance of electrical devices and other types of equipment that could interfere with such devices. Despite the increasing number of patients with neuromodulation implantable devices, there are no written guidelines available or consensus of cautions for such patients undergoing unrelated surgery. Case Descriptions: A 60-year-old female with a permanent St. Jude's spinal cord stimulator (SCS) presented for open total abdominal hysterectomy. Both the anesthesia and gynecology staffs were aware of the device presence, but were unaware of any precautions regarding intraoperative management. The device was found to be nonmagnetic resonance imaging compatible, and bipolar cautery was used instead of monopolar cautery. A 59-year-old female with a 9-year-old permanent Medtronic SCS, presented for right total hip arthroplasty. The device was switched off prior to entering the OR, bipolar cautery was used, and grounding pads were placed away from her battery site. In each case, the manufacturer's representative was contacted preoperative. Both surgeries proceeded uneventfully. Conclusions: The Food and Drug Administration safety information manual warns about the use of diathermy, concomitant implanted stimulation devices, lithotripsy, external defibrillation, radiation therapy, ultrasonic scanning, and high-output ultrasound, all of which can lead to permanent implant damage if not turned off prior to undertaking procedures. Lack of uniform guidelines makes intraoperative management, as well as remote anesthesia care of patients with previously implanted SCSs unsafe. PMID:26958424

  20. Pulmonary artery pulsatility index predicts right ventricular failure after left ventricular assist device implantation.

    PubMed

    Kang, Guson; Ha, Richard; Banerjee, Dipanjan

    2016-01-01

    Right ventricular failure (RVF) is a major cause of morbidity and mortality after left ventricular assist device (LVAD) implantation. The pulmonary artery pulsatility index (PAPi) is a novel hemodynamic index that predicts RVF in the setting of myocardial infarction, although it has not been shown to predict RVF after LVAD implantation. We performed a retrospective, single-center analysis to examine the utility of the PAPi in predicting RVF and RV assist device (RVAD) implantation in 85 continuous-flow LVAD recipients. We performed a multivariate logistic regression analysis incorporating previously identified predictors of RVF after LVAD placement, including clinical and echocardiographic variables, to determine the independent effect of PAPi in predicting RVF or RVAD after LVAD placement. In this cohort, the mean PAPi was 3.4 with a standard deviation of 2.9. RVF occurred in 33% of patients, and 11% required a RVAD. Multivariate analysis, adjusting for age, blood urea nitrogen (BUN), and Interagency Registry for Mechanically Assisted Circulatory Support profile, revealed that higher PAPi was independently associated with a reduced risk of RVAD placement (odds ratio [OR], 0.30; 95% confidence interval [CI], 0.07-0.89). This relationship did not change significantly when echocardiographic measures were added to the analysis. Stratifying the analysis by the presence of inotropes during catheterization revealed that PAPi was more predictive of RVAD requirement when measured on inotropes (OR, 0.21; 95% CI, 0.02-0.97) than without (OR, 0.49; 95% CI, 0.01-1.94). Furthermore, time from catheterization to LVAD did not significantly affect the predictive value of the PAPi (maximum time, 6 months). Receiver operating characteristic curve analysis revealed that optimal sensitivity and specificity were achieved using a PAPi threshold of 2.0. In LVAD recipients, the PAPi is an independent predictor of RVF and the need for RVAD support after LVAD implantation. This index

  1. Radiotherapy-Induced Malfunction in Contemporary Cardiovascular Implantable Electronic Devices: Clinical Incidence and Predictors.

    PubMed

    Grant, Jonathan D; Jensen, Garrett L; Tang, Chad; Pollard, Julianne M; Kry, Stephen F; Krishnan, Sunil; Dougherty, Anne H; Gomez, Daniel R; Rozner, Marc A

    2015-08-01

    Risk stratification and management paradigms for patients with cardiovascular implantable electronic devices (CIEDs) requiring radiotherapy (RT) vary widely and are based on limited clinical data. To identify the incidence and predictors of CIED malfunction and describe associated clinical consequences in a large cohort of patients treated with photon- and electron-based RT. Retrospective analysis of all patients with a functioning CIED who underwent RT between August 2005 and January 2014 with CIED interrogation data following RT at an academic cancer center. We identified 249 courses of photon- and electron-based RT in 215 patients (123 pacemakers [57%]; 92 implantable cardioverter-defibrillators [43%]). Substantial neutron production was generated in 71 courses (29%). Implantation of CIED with subsequent therapeutic radiation treatment (neutron producing with 15- or 18-MV photons and non-neutron producing with electrons, GammaKnife, or 6-MV photons). Malfunction of CIED, characterized as single-event upset (data loss, parameter resets, unrecoverable resets), and delayed effects including signal interference, pacing threshold changes, and premature battery depletion. Malfunction of CIED attributable to RT occurred during 18 courses (7%), with 15 CIEDs experiencing single-event upsets, and 3, transient signal interference. All single-event upsets occurred during neutron-producing RT, at a rate of 21%, 10%, and 34% per neutron-producing course for CIEDs, pacemakers, and implantable cardioverter-defibrillators, respectively. No single-event upsets were found among 178 courses of non-neutron-producing RT. Incident CIED dose did not correlate with device malfunction. Patients treated to the abdomen and pelvis region were more likely to undergo a single-event upset (hazard ratio, 5.2 [95% CI, 1.2-22.6]; P = .03). Six patients with a CIED parameter reset developed clinical symptoms: 3 experienced hypotension and/or bradycardia, 2 experienced abnormal chest ticking

  2. Temperature rise during removal of fractured components out of the implant body: an in vitro study comparing two ultrasonic devices and five implant types.

    PubMed

    Meisberger, Eric W; Bakker, Sjoerd J G; Cune, Marco S

    2015-12-01

    Ultrasonic instrumentation under magnification may facilitate mobilization of screw remnants but may induce heat trauma to surrounding bone. An increase of 5°C is considered detrimental to osseointegration. The objective of this investigation was to examine the rise in temperature of the outer implant body after 30 s of ultrasonic instrumentation to the inner part, in relation to implant type, type of ultrasonic equipment, and the use of coolants in vitro. Two ultrasonic devices (Satelec Suprasson T Max and Electro Medical Systems (EMS) miniMaster) were used on five different implant types that were provided with a thermo couple (Astra 3.5 mm, bone level Regular CrossFit (RC) 4.1 mm, bone level Narrow CrossFit (NC) 3.3 mm, Straumann tissue level regular body regular neck 3.3 mm, and Straumann tissue level wide body regular neck 4.8 mm), either with or without cooling during 30 s. Temperature rise at this point in time is the primary outcome measure. In addition, the mean maximum rise in temperature (all implants combined) was assessed and statistically compared among devices, implant systems, and cooling mode (independent t-tests, ANOVA, and post hoc analysis). The Satelec device without cooling induces the highest temperature change of up to 13°C, particularly in both bone level implants (p < 0.05) but appears safe for approximately 10 s of continuous instrumentation, after which a cooling down period is rational. Cooling is effective for both devices. However, when the Satelec device is used with coolant for a longer period of time, a rise in temperature must be anticipated after cessation of instrumentation, and post-operational cooling is advised. The in vitro setup used in this experiment implies that care should be taken when translating the observations to clinical recommendations, but it is carefully suggested that the EMS device causes limited rise in temperature, even without coolant.

  3. A Contemporary Medicolegal Analysis of Implanted Devices for Chronic Pain Management.

    PubMed

    Abrecht, Christopher R; Greenberg, Penny; Song, Ellen; Urman, Richard D; Rathmell, James P

    2017-04-01

    Analysis of closed malpractice claims allows the study of rare but serious complications and likely results in improved patient safety by raising awareness of such complications. Clinical studies and closed claims analyses have previously reported on the common complications associated with intrathecal drug delivery systems (IDDS) and spinal cord stimulators (SCS). This study provides a contemporary analysis of claims from within the past 10 years. We performed a closed claims analysis for a period January 1, 2009 to December 31, 2013 for cases with pain medicine as the primary service. These cases were identified using the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System (CBS), a database containing more than 300,000 malpractice claims from more than 400 academic and community institutions, representing approximately 30% of malpractice cases in the United States. The clinical narratives, which included medical files, claims files, depositions, and expert witness testimony, were reviewed by the authors, as were the CRICO coded variables, which included algorithmically determined contributing factors to the patient injury. Intrathecal drug delivery systems represented 17 of the closed claims; spinal cord stimulators represented 11 of the closed claims. The most common chronic pain diagnoses for which a device was implanted included failed back surgery syndrome and spasticity. The average total incurred for pain medicine claims was $166,028. Damaging events included IDDS refill errors (eg, subcutaneous administration of medication, reprogramming errors), intraoperative nerve damage, and postoperative infection (eg, epidural abscess, meningitis). High-severity outcomes included nerve damage (eg, paraplegia) and death. Medium-severity outcomes included drug reactions (eg, respiratory arrest from opioid overdose) and the need for reoperation. For both IDDS and SCS, deficits in technical skill were the most common contributing factor to injury

  4. Minimally Invasive Cochlear Implantation Assisted by Bi-planar Device: An Exploratory Feasibility Study in vitro

    PubMed Central

    Ke, Jia; Zhang, Shao-Xing; Hu, Lei; Li, Chang-Sheng; Zhu, Yun-Feng; Sun, Shi-Long; Wang, Li-Feng; Ma, Fu-Rong

    2016-01-01

    Background: A single drilled tunnel from the lateral mastoid cortex to the cochlea via the facial recess is essential for minimally invasive cochlear implant surgery. This study aimed to explore the safety profile of this kind of new image-guided and bi-planar device-assisted surgery procedure in vitro. Methods: Image-guided minimally invasive cochlear implantations were performed on eight cadaveric temporal bone specimens. The main procedures were: (1) temporal bone specimens were prepared for surgery and fiducial markers were registered. (2) computed tomography (CT) scans were performed for future reference. (3) CT scan images were processed and drill path was planned to minimize cochlear damage. (4) bi-planar device-assisted drilling was performed on the specimens using the registration. (5) surgical safety was evaluated by calculating the deviation between the drill and the planned paths, and by measuring the closest distance between the drilled path and critical anatomic structures. Results: Eight cases were operated successfully to the basal turn of the cochlear with intact facial nerves (FNs). The deviations from target points and entrance points were 0.86 mm (0.68–1.00 mm) and 0.44 mm (0.30–0.96 mm), respectively. The angular error between the planned and the drilled trajectory was 1.74° (1.26–2.41°). The mean distance from the edge of the drilled path to the FN and to the external canal was 0.60 mm (0.35–0.83 mm) and 1.60 mm (1.30–2.05 mm), respectively. In five specimens, the chorda tympani nerves were well preserved. In all cases, no injury happened to auditory ossicles. Conclusions: This exploratory study demonstrated the safety of the newly developed image-guided minimally invasive cochlear implantation assisted by the bi-planar device and established the operational procedures. Further, more in vitro experiments are needed to improve the system operation and its safety. PMID:27748341

  5. Superhydrophobic coating to delay drug release from drug-loaded electrospun fibrous materials

    NASA Astrophysics Data System (ADS)

    Song, Botao; Xu, Shichen; Shi, Suqing; Jia, Pengxiang; Xu, Qing; Hu, Gaoli; Zhang, Hongxin; Wang, Cuiyu

    2015-12-01

    The drug-loaded electrospun fibrous materials showed attractive applications in biomedical fields; however, the serve burst release of drug from this kind of drug carrier limited its further applications. In this study, inspired by water strong repellency of superhydrophobic surface, the drug-loaded electrospun fibrous mat coated with superhydrophobic layer was constructed to retard and control drug release. The results indicated that the superhydrophobic coating could be simply fabricated on the drug-loaded electrospun mat by the electrospray approach, and the thickness of the superhydrophobic coating could be finely controlled by varying the deposition time. It was further found that, as compared with drug-loaded electrospun mats, drug released sustainably from the samples coated with superhydrophobic layer, and the drug release rate could be controlled by the thickness of superhydrophobic layer. In summary, the current approach of coating a superhydrophobic layer on the drug-loaded electrospun fibrous materials offered a fundament for drug sustained release.

  6. Incidence and Costs Related to Lead Damage Occurring Within the First Year After a Cardiac Implantable Electronic Device Replacement Procedure.

    PubMed

    Nichols, Christine I; Vose, Joshua G; Mittal, Suneet

    2016-02-12

    Inadvertent damage to leads for transvenous pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy defibrillators is an important complication associated with generator-replacement procedures. We sought to estimate the incidence and costs associated with transvenous lead damage following cardiac implantable electronic device replacement. Using the Truven Health Analytics MarketScan Commercial Research Database, we identified health care claims between 2009 and 2013 for lead damage following generator replacement. Patients were identified by claims with a procedure code for cardiac implantable electronic device replacement and then evaluated for 1 year. All follow-up visits for lead damage were identified, and incidence, risk factors, and hospitalization costs were determined. A total of 22 557 patients with pacemakers, 20 632 with implantable cardioverter-defibrillators, and 2063 with cardiac resynchronization therapy defibrillators met selection criteria. Incidence of lead damage was 0.46% for pacemaker replacement, 1.27% for implantable cardioverter-defibrillator replacement, and 1.94% for cardiac resynchronization therapy defibrillator replacement procedures (P<0.001). After adjusting for patient characteristics, patients with implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators demonstrated risk of lead damage that was, respectively, double (hazard ratio 2.00, 95% CI 1.57-2.55) and >2.5 times (hazard ratio 2.58, 95% CI 1.73-3.83) that of patients with pacemakers. Lead revision or repair procedures were associated with increased inpatient hospitalization costs (mean $19 959 for pacemaker, $24 885 for implantable cardioverter-defibrillator, and $46 229 for cardiac resynchronization therapy defibrillator; P=0.048, Kruskal-Wallis test). These findings establish the first objective assessment of the incidence, risk factors, and economic burden of lead damage following cardiac implantable

  7. BAYESIAN META-ANALYSIS ON MEDICAL DEVICES: APPLICATION TO IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

    PubMed Central

    Youn, Ji-Hee; Lord, Joanne; Hemming, Karla; Girling, Alan; Buxton, Martin

    2012-01-01

    Objectives: The aim of this study is to describe and illustrate a method to obtain early estimates of the effectiveness of a new version of a medical device. Methods: In the absence of empirical data, expert opinion may be elicited on the expected difference between the conventional and modified devices. Bayesian Mixed Treatment Comparison (MTC) meta-analysis can then be used to combine this expert opinion with existing trial data on earlier versions of the device. We illustrate this approach for a new four-pole implantable cardioverter defibrillator (ICD) compared with conventional ICDs, Class III anti-arrhythmic drugs, and conventional drug therapy for the prevention of sudden cardiac death in high risk patients. Existing RCTs were identified from a published systematic review, and we elicited opinion on the difference between four-pole and conventional ICDs from experts recruited at a cardiology conference. Results: Twelve randomized controlled trials were identified. Seven experts provided valid probability distributions for the new ICDs compared with current devices. The MTC model resulted in estimated relative risks of mortality of 0.74 (0.60–0.89) (predictive relative risk [RR] = 0.77 [0.41–1.26]) and 0.83 (0.70–0.97) (predictive RR = 0.84 [0.55–1.22]) with the new ICD therapy compared to Class III anti-arrhythmic drug therapy and conventional drug therapy, respectively. These results showed negligible differences from the preliminary results for the existing ICDs. Conclusions: The proposed method incorporating expert opinion to adjust for a modification made to an existing device may play a useful role in assisting decision makers to make early informed judgments on the effectiveness of frequently modified healthcare technologies. PMID:22559753

  8. Differences of Mortality Rates between Pocket and Nonpocket Cardiovascular Implantable Electronic Device Infections.

    PubMed

    Lee, Dong Heun; Gracely, Edward J; Aleem, Sarah Y; Kutalek, Steven P; Vielemeyer, Ole

    2015-12-01

    A steady rise in the use of cardiovascular implantable electronic devices (CIEDs), particularly in the elderly, has led to an increase in device-related infections. Although often studied and reported as a single entity, these complications in fact comprise a heterogeneous group. Specific subgroups may be associated with distinct mortality risks. Medical records of all patients who underwent device extraction for CIED-related infection at a single tertiary referral center between 1991 and 2007 were reviewed. Infections were divided into four subgroups: primary pocket site infection (PPSI), pocket site infection with bacteremia, primary/isolated bacteremia (PIB), and device-related infective endocarditis (DRIE). Clinical presentation, laboratory data, and mortality rates were obtained by chart review and by querying the Social Security Death Index. A total of 387 cases were analyzed. The overall in-hospital and 1-year all-cause mortality rates were 7.2% and 25.3%, respectively. Patients with PIB or DRIE had significantly higher mortality rates (hazard ratio [HR] 2.3; 95% confidence interval [CI] 1.2-4.6 and HR 2.5; 95% CI 1.6-4.1, respectively) when compared with patients in the PPSI group. Patients who did not receive a new device during the initial admission also had a higher 1-year mortality rate compared to those who did (HR 2.7; 95% CI 1.8-4.1). Our patients with CIED-related infections requiring extraction/hospitalization had a significant mortality risk. Presence of pocket site infection carried a more favorable prognosis, regardless of the presence of bacteremia. Early detection and prevention of CIED-related infections with PIB (i.e., no pocket site involvement), especially for high-risk populations, is needed. ©2015 Wiley Periodicals, Inc.

  9. Optoelectronic characteristics and applications of helium ion-implanted silicon devices

    NASA Astrophysics Data System (ADS)

    Liu, Yang

    Silicon-on-insulator (SOI) wafers are an attractive platform for the fabrication of planar lightwave circuits (PLCs) because they offer the potential for low-cost fabrication using mature complementary metal--organic--semiconductor (CMOS) compatible processes developed in the microelectronics industry. At the wavelengths of interest for telecommunications, SOI waveguides can have low optical losses (0.1dB/cm). Besides, the strong optical confinement offered by the high index contrast between silicon (Si) (n=3.45) and silicon dioxide (SiO2) (n=1.45) makes it possible to scale photonic devices to sub-micron level. In addition, the high optical intensity arising from the strong optical confinement inside the waveguide makes it possible to observe nonlinear optical effects, such as Raman and Kerr effects, in chip-scale devices. Helium ion implantation can not only reduce the free-carrier loss, but can also enhance the detection responsivity of below-bandgap wavelengths (1440 1590 nm). We propose and demonstrate an in-line channel power monitor (ICPM) based on helium ion implanted silicon waveguides. The implanted waveguide can detect light at 1440 1590 nm which are normally not detectable by silicon. We study the enhanced photoresponse of helium ion implanted waveguide samples which were annealed at different temperatures and for different durations. We then make use of the ICPM to perform a system application, called optical-burst-and-transient-equalizer (OBTE). The OBTE may provide a compact and low-cost solution to compensate gain-transient, gain-spectrum-tilt and to equalize the upstream packet amplitude in erbium doped fiber amplifier (EDFA) amplified hybrid dense-wavelength-division-multiplexed (DWDM) and time-division-multiplexed (TDM) passive-optical-networks (PONs). The OBTE may be monolithically integrated on SOI platform and is potentially low cost and compact. The OBTE can compensate complicated gain slope shape, which may be generated in cascaded EDFAs or

  10. Security Mechanism Based on Hospital Authentication Server for Secure Application of Implantable Medical Devices

    PubMed Central

    2014-01-01

    After two recent security attacks against implantable medical devices (IMDs) have been reported, the privacy and security risks of IMDs have been widely recognized in the medical device market and research community, since the malfunctioning of IMDs might endanger the patient's life. During the last few years, a lot of researches have been carried out to address the security-related issues of IMDs, including privacy, safety, and accessibility issues. A physician accesses IMD through an external device called a programmer, for diagnosis and treatment. Hence, cryptographic key management between IMD and programmer is important to enforce a strict access control. In this paper, a new security architecture for the security of IMDs is proposed, based on a 3-Tier security model, where the programmer interacts with a Hospital Authentication Server, to get permissions to access IMDs. The proposed security architecture greatly simplifies the key management between IMDs and programmers. Also proposed is a security mechanism to guarantee the authenticity of the patient data collected from IMD and the nonrepudiation of the physician's treatment based on it. The proposed architecture and mechanism are analyzed and compared with several previous works, in terms of security and performance. PMID:25276797

  11. The insulation performance of reactive parylene films in implantable electronic devices

    PubMed Central

    Seymour, John P.; Elkasabi, Yaseen; Chen, Hsien-yeh; Lahann, Joerg; Kipke, Daryl R.

    2009-01-01

    Parylene-C (poly-chloro-p-xylylene) is an appropriate material for use in an implantable, microfabricated device. It is hydrophobic, conformally deposited, has a low dielectric constant, and superb biocompatibility. Yet for many bioelectrical applications, its poor wet adhesion may be an impassable shortcoming. This research contrasts parylene-C and poly(p-xylylene) functionalized with reactive group X (PPX-X) layers using long-term electrical soak and adhesion tests. The reactive parylene was made of complementary derivatives having aldehyde and aminomethyl side groups (PPX-CHO and PPX-CH2NH2 respectively). These functional groups have previously been shown to covalently react together after heating. Electrical testing was conducted in saline at 37°C on interdigitated electrodes with either parylene-C or reactive parylene as the metal layer interface. Results showed that reactive parylene devices maintained the highest impedance. Heat-treated PPX-X device impedance was 800% greater at 10 kHz and 70% greater at 1Hz relative to heated parylene-C controls after 60 days. Heat treatment proved to be critical for maintaining high impedance of both parylene-C and the reactive parylene. Adhesion measurements showed improved wet metal adhesion for PPX-X, which corresponds well with its excellent high frequency performance. PMID:19703712

  12. Interference of cardiac pacemaker and implantable cardioverter-defibrillator activity during electronic dental device use.

    PubMed

    Roedig, Jason J; Shah, Jignesh; Elayi, Claude Samy; Miller, Craig S

    2010-05-01

    The authors conducted a study to determine if electromagnetic interference of cardiac pacemaker and implantable cardioverter-defibrillator (ICD) activity occurs during the operation of electronic dental devices. The authors tested nine electronic dental devices in vitro to assess their ability to interfere with the function of two pacemakers and two ICDs as determined by electrocardiographic telemetry. The pacing activity of both pacemakers and the dual-chamber ICD were inhibited during operation of the battery-operated composite curing light at between 2 and 10 centimeters from the generator or leads. The use of the ultrasonic scaler interfered with the pacing activity of the dual-chamber pacemaker at between 17 and 23 cm from the generator or leads, the single-chamber pacemaker at 15 cm from the generator or leads and both ICDs at 7 cm from the leads. The operation of the ultrasonic cleaning system interfered with the activity of the dual-chamber pacemaker at between 15 and 23 cm from the generator or leads, and of the single-chamber pacemaker at 12 cm. Operation of the electric toothbrush, electrosurgical unit, electric pulp tester, high- and low-speed handpieces, and an amalgamator did not alter pacing function. Select electronic dental devices interfere with pacemakers' and ICDs' sensing and pacing activity in vitro. Use of the ultrasonic scaler, ultrasonic cleaning system and battery-operated composite curing light may produce deleterious effects in patients who have pacemakers or ICDs.

  13. Security mechanism based on Hospital Authentication Server for secure application of implantable medical devices.

    PubMed

    Park, Chang-Seop

    2014-01-01

    After two recent security attacks against implantable medical devices (IMDs) have been reported, the privacy and security risks of IMDs have been widely recognized in the medical device market and research community, since the malfunctioning of IMDs might endanger the patient's life. During the last few years, a lot of researches have been carried out to address the security-related issues of IMDs, including privacy, safety, and accessibility issues. A physician accesses IMD through an external device called a programmer, for diagnosis and treatment. Hence, cryptographic key management between IMD and programmer is important to enforce a strict access control. In this paper, a new security architecture for the security of IMDs is proposed, based on a 3-Tier security model, wh