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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. 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.

  3. 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

  4. 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

  5. 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

  6. 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.

  7. Implantable biomedical devices on bioresorbable substrates

    SciTech Connect

    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.

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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... 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...

  16. 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

  17. 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.

  18. [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.

  19. 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

  20. [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.

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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...

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 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.

  16. 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

  17. 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.

  18. [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.

  19. 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

  20. 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...

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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).

  13. 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

  14. 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.

  15. 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. 876.5270 Section 876.5270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the pelvic floor, and a battery-powered transmitter outside the body. (b) Classification. Class...

  16. 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. 876.5270 Section 876.5270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the pelvic floor, and a battery-powered transmitter outside the body. (b) Classification. Class...

  17. 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... the pelvic floor, and a battery-powered transmitter outside the body. (b) Classification. Class...

  18. [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.

  19. 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...

  20. 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...

  1. 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...

  2. 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....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...

  3. 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....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...

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. [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.

  14. 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.

  15. 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.

  16. 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

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  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. 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.

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. 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

  14. 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)...

  15. 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)...

  16. 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)...

  17. 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)...

  18. 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

  19. 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.

  20. 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)...

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

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

    DTIC Science & Technology

    2014-12-01

    experiments using cats . These results have laid the foundation for us to further design and develop an implantable stimulator for human application in...experiments using cats . These results have laid the foundation for us to further design and develop this implantable stimulator into human application in...stimulator system Our previous studies [1-4] in anesthetized chronic SCI cats showed that blocking pudendal nerves using high-frequency (6-10 kHz

  13. 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.

  14. 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.

  15. 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.

  16. 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

  17. 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

  18. 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

  19. [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.

  20. 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

  1. 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.

  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. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. "Pseudo" Faraday cage: a solution for telemetry link interaction between a left ventricular assist device and an implantable cardioverter defibrillator.

    PubMed

    Jacob, Sony; Cherian, Prasad K; Ghumman, Waqas S; Das, Mithilesh K

    2010-09-01

    Patients implanted with left ventricular assist devices (LVAD) may have implantable cardioverter defibrillators (ICD) implanted for sudden cardiac death prevention. This opens the possibility of device-device communication interactions and thus interferences. We present a case of such interaction that led to ICD communication failure following the activation of an LVAD. In this paper, we describe a practical solution to circumvent the communication interference and review the communication links of ICDs and possible mechanisms of ICD-LVAD interactions.

  12. 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

  13. 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.

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

    DTIC Science & Technology

    2013-10-01

    high frequency blocking stimulation has also been verified by recent clinical studies to block the vagus nerve for diabetes treatment. 12,13 The...alternating current on axonal conduction through the vagus nerve . J Neural Eng 2011; 8:056013. FIGURE CAPTIONS Fig.1. The implantable stimulator (A...on our previous studies, we propose in this project to use pudendal nerve stimulation and blockade to restore both continence and micturition after

  15. 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.

  16. [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.

  17. 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.

  18. 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.

  19. 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

  20. 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

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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

  15. 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

  16. 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.

  17. 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

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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).

  6. [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.

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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.

  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. An Implantable Neuroprosthetic Device to Normalize Bladder Function after SCI

    DTIC Science & Technology

    2012-10-01

    alternating Page 26 19 current on axonal conduction through the vagus nerve ,” J. Neural Eng., vol.8, 056031, 2011. [3] C. Tai, J.R. Roppolo, W.C. de...Wattaja, J.J., Tweden, K.S., Honda, C.N. (2011). Effects of high frequency alternating current on axonal conduction through the vagus nerve . Journal of...design the novel neuroprosthetic device. Based on our previous studies, we propose in this project to use pudendal nerve stimulation and blockade to

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  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. 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.

  5. 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

  6. 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.

  7. 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.

  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. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  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.

  19. 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

  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. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  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. 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.

  10. [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.

  11. 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.

  12. 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

  13. 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.

  14. 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...

  15. 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

  16. 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

  17. Wireless platform for controlled nitric oxide releasing optical fibers for mediating biological response to implanted devices.

    PubMed

    Starrett, Michael A; Nielsen, Matthew; Smeenge, David M; Romanowicz, Genevieve E; Frost, Megan C

    2012-12-01

    Despite the documented potential to leverage nitric oxide generation to improve in vivo performance of implanted devices, a key limitation to current NO releasing materials tested thus far is that there has not been a means to modulate the level of NO release after it has been initiated. We report the fabrication of a wireless platform that uses light to release NO from a polymethylmethacrylate (PMMA) optical fiber coated with an S-nitroso-N-acetylpenicillamine derivatized polydimethylsiloxane (SNAP-PDMS). We demonstrate that a VAOL-5GSBY4 LED (λ(dominant)=460 nm) can be used as a dynamic trigger to vary the level of NO released from 500 μm diameter coated PMMA. The ability to generate programmable sequences of NO flux from the surface of these coated fibers offers precise spatial and temporal control over NO release and provides a platform to begin the systematic study of in vivo physiological response to implanted devices. NO surface fluxes up to 3.88 ± 0.57 × 10(-10)mol cm(-2)min(-1) were achieved with -100 μm thick coatings on the fibers and NO flux was pulsed, ramped and held steady using the wireless platform developed. We demonstrate the NO release is linearly proportional to the drive current applied to the LED (and therefore level of light produced from the LED). This system allow the surface flux of NO from the fibers to be continuously changed, providing a means to determine the level and duration of NO needed to mediate physiological response to blood contacting and subcutaneous implants and will ultimately lead to the intelligent design of NO releasing materials tailored to specific patterns of NO release needed to achieve reliable in vivo performance for intravascular and subcutaneous sensors and potentially for a wide variety of other implanted biomedical devices.

  18. 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

  19. 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

  20. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. 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

  14. 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.

  15. 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.

  16. 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.

  17. 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.; Weatherwax, Kevin J.

    2015-01-01

    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. Post-printing 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

  18. 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.

  19. 77 FR 36951 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ... devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k... marketed by means of premarket notification procedures (510(k) process) without submission of a premarket..., Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th...

  20. 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.

  1. 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

  2. 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.

  3. 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

  4. 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

    2017-01-31

    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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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

  16. 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

  17. 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.

  18. 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

  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. 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

  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. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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

  10. 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

  11. 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

  12. Development of the Baylor Gyro permanently implantable centrifugal blood pump as a biventricular assist device.

    PubMed

    Nonaka, K; Linneweber, J; Ichikawa, S; Yoshikawa, M; Kawahito, S; Mikami, M; Motomura, T; Ishitoya, H; Nishimura, I; Oestmann, D; Glueck, J; Schima, H; Wolner, E; Shinohara, T; Nosé, Y

    2001-09-01

    The Baylor Gyro permanently implantable centrifugal blood pump (Gyro PI pump) has been under development since 1995 at Baylor College of Medicine. Excellent results were achieved as a left ventricular assist device (LVAD) with survival up to 284 days. Based on these results, we are now focusing on the development of a biventricular assist device (BVAD) system, which requires 2 pumps to be implanted simultaneously in the preperitoneal space. Our hypothesis was that the Gyro PI pump would be an appropriate device for an implantable BVAD system. The Gyro PI 700 pump is fabricated from titanium alloy and has a 25 ml priming volume, pump weight of 204 g, height of 45 mm, and pump diameter of 65 mm. This pump can provide 5 L/min against 100 mm Hg at 2,000 rpm. In this study, 6 half-Dexter healthy calves have been used as the experimental model. The right pump was applied between the infundibular of the right ventricle and the main pulmonary artery. The left pump was applied between the apex of the left ventricle and the thoracic descending aorta. As for anticoagulation, heparin was administered at the first postoperative week and then converted to warfarin sodium from the second week after surgery. Both pump flow rates were controlled maintaining a pulmonary arterial flow of less than 160 ml/kg/min for the sake of avoidance of pulmonary congestion. Blood sampling was done to assess visceral organ function, and the data regarding pump performance were collected. After encountering the endpoint, which the study could not keep for any reasons, necropsy and histopathological examinations were performed. The first 2 cases were terminated within 1 week. Deterioration of the pump flow due to suction phenomenon was recognized in both cases. To avoid the suction phenomenon, a flexible conduit attached on the inlet conduit was designed and implanted. After using the flexible inflow conduit, the required power and the rotational speed were reduced. Furthermore, the suction

  13. Complications after Surgical Procedures in Patients with Cardiac Implantable Electronic Devices: Results of a Prospective Registry

    PubMed Central

    da Silva, Katia Regina; Albertini, Caio Marcos de Moraes; Crevelari, Elizabeth Sartori; de Carvalho, Eduardo Infante Januzzi; Fiorelli, Alfredo Inácio; Martinelli Filho, Martino; Costa, Roberto

    2016-01-01

    Background: Complications after surgical procedures in patients with cardiac implantable electronic devices (CIED) are an emerging problem due to an increasing number of such procedures and aging of the population, which consequently increases the frequency of comorbidities. Objective: To identify the rates of postoperative complications, mortality, and hospital readmissions, and evaluate the risk factors for the occurrence of these events. Methods: Prospective and unicentric study that included all individuals undergoing CIED surgical procedures from February to August 2011. The patients were distributed by type of procedure into the following groups: initial implantations (cohort 1), generator exchange (cohort 2), and lead-related procedures (cohort 3). The outcomes were evaluated by an independent committee. Univariate and multivariate analyses assessed the risk factors, and the Kaplan-Meier method was used for survival analysis. Results: A total of 713 patients were included in the study and distributed as follows: 333 in cohort 1, 304 in cohort 2, and 76 in cohort 3. Postoperative complications were detected in 7.5%, 1.6%, and 11.8% of the patients in cohorts 1, 2, and 3, respectively (p = 0.014). During a 6-month follow-up, there were 58 (8.1%) deaths and 75 (10.5%) hospital readmissions. Predictors of hospital readmission included the use of implantable cardioverter-defibrillators (odds ratio [OR] = 4.2), functional class III­-IV (OR = 1.8), and warfarin administration (OR = 1.9). Predictors of mortality included age over 80 years (OR = 2.4), ventricular dysfunction (OR = 2.2), functional class III-IV (OR = 3.3), and warfarin administration (OR = 2.3). Conclusions: Postoperative complications, hospital readmissions, and deaths occurred frequently and were strongly related to the type of procedure performed, type of CIED, and severity of the patient's underlying heart disease. PMID:27579544

  14. Antibacterial Peptide-Based Gel for Prevention of Medical Implanted-Device Infection

    PubMed Central

    Mateescu, Mihaela; Baixe, Sébastien; Garnier, Tony; Jierry, Loic; Ball, Vincent; Haikel, Youssef; Metz-Boutigue, Marie Hélène; Nardin, Michel; Schaaf, Pierre; Etienne, Olivier; Lavalle, Philippe

    2015-01-01

    Implanted medical devices are prone to infection. Designing new strategies to reduce infection and implant rejection are an important challenge for modern medicine. To this end, in the last few years many hydrogels have been designed as matrices for antimicrobial molecules destined to fight frequent infection found in moist environments like the oral cavity. In this study, two types of original hydrogels containing the antimicrobial peptide Cateslytin have been designed. The first hydrogel is based on alginate modified with catechol moieties (AC gel). The choice of these catechol functional groups which derive from mussel’s catechol originates from their strong adhesion properties on various surfaces. The second type of gel we tested is a mixture of alginate catechol and thiol-terminated Pluronic (AC/PlubisSH), a polymer derived from Pluronic, a well-known biocompatible polymer. This PlubisSH polymer has been chosen for its capacity to enhance the cohesion of the composition. These two gels offer new clinical uses, as they can be injected and jellify in a few minutes. Moreover, we show these gels strongly adhere to implant surfaces and gingiva. Once gelled, they demonstrate a high level of rheological properties and stability. In particular, the dissipative energy of the (AC/PlubisSH) gel detachment reaches a high value on gingiva (10 J.m-2) and on titanium alloys (4 J.m-2), conferring a strong mechanical barrier. Moreover, the Cateslytin peptide in hydrogels exhibited potent antimicrobial activities against P. gingivalis, where a strong inhibition of bacterial metabolic activity and viability was observed, indicating reduced virulence. Gel biocompatibility tests indicate no signs of toxicity. In conclusion, these new hydrogels could be ideal candidates in the prevention and/or management of periimplant diseases. PMID:26659616

  15. Primary anticoagulation with bivalirudin for patients with implantable ventricular assist devices.

    PubMed

    Pieri, Marina; Agracheva, Natalia; Di Prima, Ambra Licia; Nisi, Teodora; De Bonis, Michele; Isella, Francesca; Zangrillo, Alberto; Pappalardo, Federico

    2014-04-01

    Bivalirudin is a direct thrombin inhibitor that is increasingly used in patients undergoing mechanical circulatory support as it presents many advantages compared with unfractionated heparin. The aim of this study was to describe our experience with bivalirudin as primary anticoagulant in patients undergoing ventricular assist device (VAD) implantation. An observational study was performed on 12 consecutive patients undergoing VAD implantation at our institution. Patients received a continuous infusion of bivalirudin, with a starting dose of 0.025 mg/kg/h; the target activated partial thromboplastin time (aPTT) was between 45 and 60 s. Patients never received heparin during hospitalization nor had a prior diagnosis of heparin-induced thrombocytopenia (HIT). All patients received a continuous flow pump except one. Preoperative platelets count was 134 000 ± 64 000 platelets/mm(3) . Mean bivalirudin dose was 0.040 ± 0.026 mg/kg/h over the course of therapy (5-12 days). Lowest platelets count during treatment was 73 000 ± 23 000 platelets/mm(3) . No thromboembolic complications occurred. Two episodes of minor bleeding from chest tubes that subsided after reduction or temporary suspension of bivalirudin infusion were observed. Intensive care unit stay was 8 (7-17) days, and hospital stay was 25 (21-33) days. Bivalirudin is a valuable option for anticoagulation in patients with a VAD and can be easily monitored with aPTT. The use of a bivalirudin-based anticoagulation strategy in the early postoperative period may overcome many limitations of heparin and, above all, the risk of HIT, which is higher in patients undergoing VAD implantation. Bivalirudin should no longer be regarded as a second-line therapy for anticoagulation in patients with VAD. [Correction added on 6 December 2013, after first online publication: The dose of bivalirudin in the Abstract to 0.025 mg/kg/h].

  16. Genetic Identification and Risk Factor Analysis of Asymptomatic Bacterial Colonization on Cardiovascular Implantable Electronic Devices

    PubMed Central

    Chu, Xian-Ming; An, Yi; Li, Xue-Bin; Guo, Ji-Hong

    2014-01-01

    Asymptomatic bacterial colonization of cardiovascular implantable electronic devices (CIEDs) is widespread and increases the risk of clinical CIED infection. The aim of the study was to evaluate the incidence of bacterial colonization of generator pockets in patients without signs of infection and to analyze the relationship with clinical infection and risk factors. From June 2011 to December 2012, 78 patients underwent CIED replacement or upgrade. Exclusion criteria included a clinical diagnosis of CIED infection, bacteremia, or infective endocarditis. All patients were examined for evidence of bacterial 16S rDNA on the device and in the surrounding tissues. Infection cases were recorded during follow-up. The bacterial-positive rate was 38.5% (30 cases); the coagulase-negative Staphylococcus detection rate was the highest (9 cases, 11.5%). Positive bacterial DNA results were obtained from pocket tissue in 23.1% of patients (18 cases), and bacterial DNA was detected on the device in 29.5% of patients (23 cases). During follow-up (median 24.6 months), two patients (6.7%, 2/30) became symptomatic with the same species of microorganism, S. aureus and S. epidermidis. Multivariable logistic regression analysis found that the history of bacterial infection, use of antibiotics, application of antiplatelet drugs, replacement frequency, and renal insufficiency were independent risk factors for asymptomatic bacterial colonization. PMID:25530969

  17. 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, 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.

  18. 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

  19. The insulation performance of reactive parylene films in implantable electronic devices.

    PubMed

    Seymour, John P; Elkasabi, Yaseen M; Chen, Hsien-Yeh; Lahann, Joerg; Kipke, Daryl R

    2009-10-01

    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 degrees 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 10kHz 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.

  20. 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

  1. Packaging and Non-Hermetic Encapsulation Technology for Flip Chip on Implantable MEMS Devices

    PubMed Central

    Sutanto, Jemmy; Anand, Sindhu; Sridharan, Arati; Korb, Robert; Zhou, Li; Baker, Michael S.; Okandan, Murat; Muthuswamy, Jit

    2013-01-01

    We report here a successful demonstration of a flip-chip packaging approach for a microelectromechanical systems (MEMS) device with in-plane movable microelectrodes implanted in a rodent brain. The flip-chip processes were carried out using a custom-made apparatus that was capable of the following: 1) creating Ag epoxy microbumps for first-level interconnect; 2) aligning the die and the glass substrate; and 3) creating non-hermetic encapsulation (NHE). The completed flip-chip package had an assembled weight of only 0.5 g significantly less than the previously designed wire-bonded package of 4.5 g. The resistance of the Ag bumps was found to be negligible. The MEMS micro-electrodes were successfully tested for its mechanical movement with microactuators generating forces of 450 μN with a displacement resolution of 8.8 μm/step. An NHE on the front edge of the package was created by patterns of hydrophobic silicone microstructures to prevent contamination from cerebrospinal fluid while simultaneously allowing the microelectrodes to move in and out of the package boundary. The breakdown pressure of the NHE was found to be 80 cm of water, which is significantly (4.5–11 times) larger than normal human intracranial pressures. Bench top tests and in vivo tests of the MEMS flip-chip packages for up to 75 days showed reliable NHE for potential long-term implantation. PMID:24431925

  2. A Comparative Study of Small Voltage Rectification Circuits for Implanted Devices

    NASA Astrophysics Data System (ADS)

    Haider, Samnan; Mansor, Hasmah; Khan, Sheroz; Arshad, Atika; Shobaki, Mohammed M.; Tasnim, Rumana

    2013-12-01

    Biomedical implants have acquired an invulnerable and significant importance over the recent years due to their low voltage requirements and trifling dimensions. Biomedical implants are being widely employed for the continuous monitoring of intended parameters as well as stimulation of target organs in patient's body. Being low power devices, the continuous powering without using battery dependent sources necessitates the alternative sources such as energy harvesting from the surroundings. Harvested output needs to be processed before using it for powering purposes, particularly in harsh and challenging premises. Even after processing, it needs to be made robust against the contiguous hazards so that maximum power is transferred to the load. A rectifier is employed to make this harvested energy usable. This paper compares the rectifier circuits, comparing their simulation output in terms of regulation, stability and power transferred. The rectification of small voltages is usually confronted by the threshold voltage drops that affect the output causing an effective drop in the power transfer efficiency and other parameters related. The solution to this problem has been suggested comparing the previous approaches with some modifications. Obtained results have been plotted in terms of ripple factor comparing them with the analytical calculations in order to show the role of capacitance in the reduction of ripple factor.

  3. A micropower miniature piezoelectric actuator for implantable middle ear hearing device.

    PubMed

    Wang, Zhigang; Mills, Robert; Luo, Hongyan; Zheng, Xiaolin; Hou, Wensheng; Wang, Lijun; Brown, Stuart I; Cuschieri, Alfred

    2011-02-01

    This paper describes the design and development of a small actuator using a miniature piezoelectric stack and a flextensional mechanical amplification structure for an implantable middle ear hearing device (IMEHD). A finite-element method was used in the actuator design. Actuator vibration displacement was measured using a laser vibrometer. Preliminary evaluation of the actuator for an IMEHD was conducted using a temporal bone model. Initial results from one temporal bone study indicated that the actuator was small enough to be implanted within the middle ear cavity, and sufficient stapes displacement can be generated for patients with mild to moderate hearing losses, especially at higher frequency range, by the actuator suspended onto the stapes. There was an insignificant mass-loading effect on normal sound transmission (<3 dB) when the actuator was attached to the stapes and switched off. Improved vibration performance is predicted by more firm attachment. The actuator power consumption and its generated equivalent sound pressure level are also discussed. In conclusion, the actuator has advantages of small size, lightweight, and micropower consumption for potential use as IMHEDs.

  4. Implantable nano-neurotechnological devices: consideration of ethical, legal, and social issues and implications.

    PubMed

    Giordano, James; Akhouri, Rohan; McBride, Dennis

    2009-01-01

    Over the past decades, there has been considerable progress in the capability and application(s) of technology in the neurosciences. The tools of neurotechnology conjoin advances made in other disciplines, including nanoscience, to offer somewhat unique properties and capabilities that affect multiple dimensions of neural systems via implantable devices that afford articulation and manipulation at the subcellular scale. However, while striving for good, it is equally important to regard potential to generate major ethical, legal, and social issues (ELSI) that arise in, and from the study and applications of implantable nano-neurotechnologies. This paper discusses specific properties and uses of various nano-neurotechnologies, and addresses proximate and distal ELSI. We argue that the fusion of nano- and neuroscience and technologies give rise to unique risks and burdens, but posit that a frank precautionary principle might be unrealistic given the demiurge of progress. Rather, we call for a dialectical approach that balances technological incentives with responsibility for inquiry, application, and consequences, and advocate that potential ELSI must be appreciated early and throughout the research and development process.

  5. Rechargeable membraneless glucose biobattery: Towards solid-state cathodes for implantable enzymatic devices

    NASA Astrophysics Data System (ADS)

    Yazdi, Alireza Ahmadian; Preite, Roberto; Milton, Ross D.; Hickey, David P.; Minteer, Shelley D.; Xu, Jie

    2017-03-01

    Enzymatic biobatteries can be implanted in living organisms to exploit the chemical energy stored in physiological fluids. Generally, commonly-used electron donors (such as sugars) are ubiquitous in physiological environments, while electron acceptors such as oxygen are limited due to many factors including solubility, temperature, and pressure. The wide range of solid-state cathodes, however, may replace the need for oxygen breathing electrodes and serve in enzymatic biobatteries for implantable devices. Here, we have fabricated a glucose biobattery suitable for in vivo applications employing a glucose oxidase (GOx) anode coupled to a solid-state Prussian Blue (PB) thin-film cathode. PB is a non-toxic material and its electrochemistry enables fast regeneration if used in a secondary cell. This novel biobattery can effectively operate in a membraneless architecture as PB can reduce the peroxide produced by some oxidase enzymes. The resulting biobattery delivers a maximum power and current density of 44 μW cm-2 and 0.9 mA cm-2 , respectively, which is ca. 37% and 180% higher than an equivalent enzymatic fuel cell equipped with a bilirubin oxidase cathode. Moreover, the biobattery demonstrated a stable performance over 20 cycles of charging and discharging periods with only ca. 3% loss of operating voltage.

  6. Neutrophil-to-Lymphocyte Ratio Predicts Outcomes in Patients Implanted with Left Ventricular Assist Devices.

    PubMed

    Yost, Gardner L; Joseph, Christine R; Tatooles, Antone J; Bhat, Geetha

    2015-01-01

    The neutrophil-to-lymphocyte ratio (NLR) has been used to predict mortality in a wide range of cardiovascular diseases including acute decompensated heart failure and non-ST-elevation myocardial infarction. We investigated the prognostic utility of the NLR in patients with advanced heart failure who received left ventricular assist devices (LVADs). Two hundred seventy-three patients implanted with LVADs at our institution were divided into tertiles based on their NLR and were retrospectively analyzed. Outcomes, including survival and right ventricular (RV) failure, were compared between tertiles. The NLR was found to be an independent predictor of postoperative mortality (odds ratio [OR] = 1.159, confidence interval [CI] = 1.022-1.314, p = 0.021) and of postoperative RV failure (OR = 1.117, CI = 1.039-1.201, p = 0.003). In addition, patients in the highest NLR tertile were found to have significantly increased postoperative length of stay (tertile 1 = 20.6 ± 10.7 days, tertile 2 = 24.2 ± 20.7 days, and tertile 3 = 28.8 ± 18.6 days, p = 0.001). In conclusion, the NLR is a simple and practical method for predicting adverse outcomes including all-cause mortality and RV failure after LVAD implantation.

  7. The implantable fuzzy controlled Helmholtz-left ventricular assist device: first in vitro testing.

    PubMed

    Kaufmann, R; Nix, C; Klein, M; Reul, H; Rau, G

    1997-02-01

    To perform first experimental tests for validation of a new left ventricular assist device (LVAD) with a high efficiency energy converter, a new pump design and a novel type of perfusion control, a functional labtype, were manufactured. With a stroke volume of 65 ml, a total pump housing volume of 450 ml (including valves and connectors), and a weight of 430 g, it is one of the smallest and lightest implantable pulsatile electromechanical LVADs. Pulsatile operation is generated by a special reduction and displacement gear which transforms a uniform rotational movement of a sensorless, electronically commutated DC motor into a translatory pusher plate movement. A prolonged duration for filling (60% of the cycle time) supports full-empty pumping and consequently a high overall pump efficiency. Active adaptation of output flow to organ perfusion demand is achieved by changing the rotational speed of the motor by means of a sensorless fuzzy controller, which detects preload and afterload induced effects at the motor current input. First in vitro test results obtained within a circulatory mock loop that simulates physiological preloads and afterloads are presented. They comprise preload sensitivity and the function of the novel perfusion controller as well as preload and afterload related flow data. The results prove the feasability of the energy conversion with the novel gear and control concept for an implantable electromechanical pulsatile LVAD.

  8. Design of a miniature implantable left ventricular assist device using CAD/CAM technology.

    PubMed

    Okamoto, Eiji; Hashimoto, Takuya; Mitamura, Yoshinori

    2003-01-01

    In this study, we developed a new miniature motor-driven pulsatile left ventricular assist device (LVAD) for implantation into a Japanese patient of average build by means of computer-aided design and manufacturing (CAD/CAM) technology. A specially designed miniature ball-screw and a high-performance brushless DC motor were used in an artificial heart actuator to allow miniaturization. A blood pump chamber (stroke volume 55 ml) and an inflow and outflow port were designed by computational fluid dynamics (CFD) analysis. The geometry of the blood pump was evaluated using the value of index of pump geometry (IPG) = (Reynolds shear stress) x (occupied volume) as a quantitative index for optimization. The calculated value of IPG varied from 20.6 Nm to 49.1 Nm, depending on small variations in pump geometry. We determined the optimum pump geometry based on the results of quantitative evaluation using IPG and qualitative evaluation using the flow velocity distribution with blood flow tracking. The geometry of the blood pump that gave lower shear stress had more optimum spiral flow around the diaphragm-housing (D-H) junction. The volume and weight of the new LVAD, made of epoxy resin, is 309 ml and 378 g, but further miniaturization will be possible by improving the geometry of both the blood pump and the back casing. Our results show that our new design method for an implantable LVAD using CAD/CAM promises to improve blood compatibility with greater miniaturization.

  9. Power loss measurement of implantable wireless power transfer components using a Peltier device balance calorimeter

    NASA Astrophysics Data System (ADS)

    Leung, Ho Yan; Budgett, David M.; Taberner, Andrew; Hu, Patrick

    2014-09-01

    Determining heat losses in power transfer components operating at high frequencies for implantable inductive power transfer systems is important for assessing whether the heat dissipated by the component is acceptable for implantation and medical use. However, this is a challenge at high frequencies and voltages due to limitations in electronic instrumentation. Calorimetric methods of power measurement are immune to the effects of high frequencies and voltages; hence, the measurement is independent of the electrical characteristics of the system. Calorimeters have been widely used to measure the losses of high power electrical components (>50 W), however it is more difficult to perform on low power components. This paper presents a novel power measurement method for components dissipating anywhere between 0.2 W and 1 W of power based on a heat balance calorimeter that uses a Peltier device as a balance sensor. The proposed balance calorimeter has a single test accuracy of ±0.042 W. The experimental results revealed that there was up to 35% difference between the power measurements obtained with electrical methods and the proposed calorimeter.

  10. An ontology-based annotation of cardiac implantable electronic devices to detect therapy changes in a national registry.

    PubMed

    Rosier, Arnaud; Mabo, Philippe; Chauvin, Michel; Burgun, Anita

    2015-05-01

    The patient population benefitting from cardiac implantable electronic devices (CIEDs) is increasing. This study introduces a device annotation method that supports the consistent description of the functional attributes of cardiac devices and evaluates how this method can detect device changes from a CIED registry. We designed the Cardiac Device Ontology, an ontology of CIEDs and device functions. We annotated 146 cardiac devices with this ontology and used it to detect therapy changes with respect to atrioventricular pacing, cardiac resynchronization therapy, and defibrillation capability in a French national registry of patients with implants (STIDEFIX). We then analyzed a set of 6905 device replacements from the STIDEFIX registry. Ontology-based identification of therapy changes (upgraded, downgraded, or similar) was accurate (6905 cases) and performed better than straightforward analysis of the registry codes (F-measure 1.00 versus 0.75 to 0.97). This study demonstrates the feasibility and effectiveness of ontology-based functional annotation of devices in the cardiac domain. Such annotation allowed a better description and in-depth analysis of STIDEFIX. This method was useful for the automatic detection of therapy changes and may be reused for analyzing data from other device registries.

  11. Integration of piezoelectric aluminum nitride and ultrananocrystalline diamond films for implantable biomedical microelectromechanical devices

    NASA Astrophysics Data System (ADS)

    Zalazar, M.; Gurman, P.; Park, J.; Kim, D.; Hong, S.; Stan, L.; Divan, R.; Czaplewski, D.; Auciello, O.

    2013-03-01

    The physics for integration of piezoelectric aluminum nitride (AlN) films with underlying insulating ultrananocrystalline diamond (UNCD), and electrically conductive grain boundary nitrogen-incorporated UNCD (N-UNCD) and boron-doped UNCD (B-UNCD) layers, as membranes for microelectromechanical system implantable drug delivery devices, has been investigated. AlN films deposited on platinum layers on as grown UNCD or N-UNCD layer (5-10 nm rms roughness) required thickness of ˜400 nm to induce (002) AlN orientation with piezoelectric d33 coefficient ˜1.91 pm/V at ˜10 V. Chemical mechanical polished B-UNCD films (0.2 nm rms roughness) substrates enabled (002) AlN film 200 nm thick, yielding d33 = 5.3 pm/V.

  12. Optimal position of the transmitter coil for wireless power transfer to the implantable device.

    PubMed

    Jinghui Jian; Stanaćević, Milutin

    2014-01-01

    The maximum deliverable power through inductive link to the implantable device is limited by the tissue exposure to the electromagnetic field radiation. By moving away the transmitter coil from the body, the maximum deliverable power is increased as the magnitude of the electrical field at the interface with the body is kept constant. We demonstrate that the optimal distance between the transmitter coil and the body is on the order of 1 cm when the current of the transmitter coil is limited to 1 A. We also confirm that the conditions on the optimal frequency of the power transmission and the topology of the transmission coil remain the same as if the coil was directly adjacent to the body.

  13. Implantable CMOS imaging device with absorption filters for green fluorescence imaging

    NASA Astrophysics Data System (ADS)

    Sunaga, Yoshinori; Haruta, Makito; Takehara, Hironari; Ohta, Yasumi; Motoyama, Mayumi; Noda, Toshihiko; Sasagawa, Kiyotaka; Tokuda, Takashi; Ohta, Jun

    2014-03-01

    Green fluorescent materials such as Green Fluorescence Protein (GFP) and fluorescein are often used for observing neural activities. Thus, it is important to observe the fluorescence in a freely moving state in order to understand neural activities corresponding to behaviors. In this work, we developed an implantable CMOS imaging device for in-vivo green fluorescence imaging with efficient excitation light rejection using a combination of absorption filters. An interference filter is usually used for a fluorescence microscope in order to achieve high fluorescence imaging sensitivity. However, in the case of the implantable device, interference filters are not suitable because their transmission spectra depend on incident angle. To solve this problem we used two kinds of absorption filters that do not have angle dependence. An absorption filter consisting of yellow dye (VARYFAST YELLOW 3150) was coated on the pixel array of an image sensor. The rejection ratio of ideal excitation light (490 nm) against green fluorescence (510 nm) was 99.66%. However, the blue LED as an excitation light source has a broad emission spectrum and its intensity at 510 nm is 2.2 x 10-2 times the emission peak intensity. By coating LEDs with the emission absorption filters, the intensity of the unwanted component of the excitation light was reduced to 1.4 x 10-4. Using the combination of absorption filters, we achieved excitation light transmittance of 10-5 onto the image sensor. It is expected that high-sensitivity green fluorescence imaging of neural activities in a freely moving mouse will be possible by using this technology.

  14. Porous orthopedic steel implant as an antibiotic eluting device: prevention of post-surgical infection on an ovine model.

    PubMed

    Gimeno, Marina; Pinczowski, Pedro; Vázquez, Francisco J; Pérez, Marta; Santamaría, Jesús; Arruebo, Manuel; Luján, Lluís

    2013-08-16

    Traumatology and orthopedic surgery can benefit from the use of efficient local antibiotic-eluting systems to avoid bacterial contamination of implanted materials. In this work a new percutaneous porous-wall hollow implant was successfully used as a local antibiotic-eluting device both in vitro and in vivo. The implant is a macroporous 316 L stainless steel filter tube with a nominal filtration cut-off size of 200 nm with one open end which was used to load the synthetic antibiotic linezolid and an opposite blind end. The antibiotic release kinetics from the device on a simulated biological fluid under in vitro conditions demonstrated an increased concentration during the first five days that subsequently was sustained for at least seven days, showing a kinetic close to a zero order release. Antibiotic-loaded implants were placed in the tibia of four sheep which were trans-surgically experimentally infected with a biofilm forming strain of Staphylococcus aureus. After 7 and 9 days post infection, sheep did not show any evidence of infection as demonstrated by clinical, pathological and microbiological findings. These results demonstrate the capability of such an antibiotic-loaded implant to prevent infection in orthopedic devices in vivo. Further research is needed to assess its possible use in traumatology and orthopedic surgery.

  15. Performance and management of implantable lithium battery systems for left ventricular assist devices and total artificial hearts

    NASA Astrophysics Data System (ADS)

    Dodd, J.; Kishiyama, C.; Mukainakano, Hiroshi; Nagata, M.; Tsukamoto, H.

    A lithium ion cell designed for implantable medical devices was tested for its performance as a power source for left ventricular assist devices (LVAD) or total artificial hearts (TAH). These two cardiovascular devices require high power, and thus a high current (0.5-3 A) and high voltage (20-30 V). Since these are implantable medical devices, in addition to high power capability, the power source should have long cycle life and calendar life, as well as high safety. The QL0700I, a 700 mAh cell, was cycled at 0.5 C rate as well as at 1.5 C rate, and the cycle life capacity retention was evaluated after numerous cycles. A battery pack consisting of seven QL0700I cells in series, with a battery management system (BMS) connected, was tested for rate capability as well as safety protection.

  16. Antibacterial effect of acrylic dental devices after surface modification by fluorine and silver dual-ion implantation.

    PubMed

    Shinonaga, Yukari; Arita, Kenji

    2012-03-01

    The purpose of the present study was to examine the effectiveness of fluorine and silver ions implanted and deposited into acrylic resin (poly(methyl methacrylate)) using a hybrid process of plasma-based ion implantation and deposition. The surface characteristics were evaluated by X-ray photoelectron spectroscopy (XPS), contact angle measurements, and atomic force microscopy. In addition, an antibacterial activity test was performed by the adenosine-5'-triphosphate luminescence method. XPS spectra of modified specimens revealed peaks due to fluoride and silver. The water contact angle increased significantly due to implantation and deposition of both fluorine and silver ions. In addition, the presence of fluorine and silver was found to inhibit bacterial growth. These results suggest that fluorine and silver dual-ion implantation and deposition can provide antibacterial properties to acrylic medical and dental devices.

  17. Noninvasive control of the power transferred to an implanted device by an ultrasonic transcutaneous energy transfer link.

    PubMed

    Shmilovitz, Doron; Ozeri, Shaul; Wang, Chua-Chin; Spivak, Boaz

    2014-04-01

    Ultrasonic transcutaneous energy transfer is an effective method for powering implanted devices noninvasively. Nevertheless, the amount of power harvested by the implanted receiver is sensitive to the distance and orientation of the external transmitting transducer attached to the skin with respect to the implanted receiving transducer. This paper describes an ultrasonic power transfer link whose harvested power is controlled by an inductive link. A small (5 μF) storage capacitor voltage, which is part of the implanted unit, is allowed to swing between 3.8 and 3.5 V using hysteretic control. The two control states are indicated by excitation (while the implanted storage capacitor voltage decreases) or the absence of excitation of an implanted coil that is magnetically coupled to an external coil attached to the skin surface. A 35 mW Ultrasonic Transcutaneous Energy Transfer link was fabricated using two piezoelectric transducers of equal size (Fuji Ceramics C-2 PZT disc 15 mm × 3 mm) operated at a vibration frequency of 720 kHz. By applying the proposed hysteretic control, the captured power was effectively regulated for implantation depths of up to 85 mm.

  18. Divergent endometrial inflammatory cytokine expression at peri-implantation period and after the stimulation by copper intrauterine device.

    PubMed

    Chou, Chia-Hung; Chen, Shee-Uan; Shun, Chia-Tung; Tsao, Po-Nien; Yang, Yu-Shih; Yang, Jehn-Hsiahn

    2015-10-15

    Endometrial inflammation has contradictory effects. The one occurring at peri-implantation period is favourable for embryo implantation, whereas the other occurring after the stimulation by copper intrauterine device (Cu-IUD) prevents from embryo implantation. In this study, 8 week female ICR mice were used to investigate the endometrial inflammation, in which they were at proestrus stage (Group 1), at peri-implantation period (Group 2), and had a copper wire implanted into right uterine horn (Group 3). Cytokine array revealed that two cytokines were highly expressed in Group 2 and Group 3 as compared with Group 1, and seven cytokines, including tumour necrosis factor α (TNF-α), had selectively strong expression in Group 3. Immunohistochemistry demonstrated prominent TNF-α staining on the endometrium after Cu-IUD stimulation, and in vitro culture of human endometrial glandular cells with Cu induced TNF-α secretion. The increased TNF-α concentration enhanced in vitro THP-1 cells chemotaxis, and reduced embryo implantation rates. These results suggest that inflammatory cytokine profiles of endometrium are different between those at peri-implantation period and after Cu-IUD stimulation, and TNF-α is the one with selectively strong expression in the latter. It might account for the contradictory biological effects of endometrial inflammation.

  19. Divergent endometrial inflammatory cytokine expression at peri-implantation period and after the stimulation by copper intrauterine device

    PubMed Central

    Chou, Chia-Hung; Chen, Shee-Uan; Shun, Chia-Tung; Tsao, Po-Nien; Yang, Yu-Shih; Yang, Jehn-Hsiahn

    2015-01-01

    Endometrial inflammation has contradictory effects. The one occurring at peri-implantation period is favourable for embryo implantation, whereas the other occurring after the stimulation by copper intrauterine device (Cu-IUD) prevents from embryo implantation. In this study, 8 week female ICR mice were used to investigate the endometrial inflammation, in which they were at proestrus stage (Group 1), at peri-implantation period (Group 2), and had a copper wire implanted into right uterine horn (Group 3). Cytokine array revealed that two cytokines were highly expressed in Group 2 and Group 3 as compared with Group 1, and seven cytokines, including tumour necrosis factor α (TNF-α), had selectively strong expression in Group 3. Immunohistochemistry demonstrated prominent TNF-α staining on the endometrium after Cu-IUD stimulation, and in vitro culture of human endometrial glandular cells with Cu induced TNF-α secretion. The increased TNF-α concentration enhanced in vitro THP-1 cells chemotaxis, and reduced embryo implantation rates. These results suggest that inflammatory cytokine profiles of endometrium are different between those at peri-implantation period and after Cu-IUD stimulation, and TNF-α is the one with selectively strong expression in the latter. It might account for the contradictory biological effects of endometrial inflammation. PMID:26469146

  20. Feasibility of a tiny Gyro centrifugal pump as an implantable ventricular assist device.

    PubMed

    Yoshikawa, M; Nakata, K; Ohtsuka, G; Takano, T; Glueck, J; Fujisawa, A; Makinouchi, K; Yokokawa, M; Nosé, Y

    1999-08-01

    The Gyro pumps were developed for long-term circulatory support. The first generation Gyro pump (C1E3) achieved 1 month paracorporeal circulatory support in chronic animal experiments; the second generation (PI702) implantable ventricular assist device (VAD) was successful for over 6 months. The objective of the next generation Gyro pump is for use as a long-term totally implantable VAD and for pediatric circulatory support. This tiny Gyro pump (KP101) was fabricated with the same design concept as the other Gyro pumps. The possibility of an implantable VAD was determined after performance and hemolysis test results were compared to those of the other Gyro pumps. The pump housing and impeller were fabricated from polycarbonate with an impeller diameter of 35 mm. The diameter and height of the pump housings are 52.3 mm and 29.9 mm, respectively. At this time, a DC brushless motor drives the KP101, which is the same as that for the C1E3. The pump performance was measured in 37% glycerin water at 37 degrees C. Hemolysis tests were performed utilizing a compact mock loop filled with fresh bovine blood in a left ventricular assist device (LVAD) condition at 37 degrees C. The KP101 achieved the LVAD conditions of 5 L/min and 100 mm Hg at 2,900 rpm; generated 10 L/min against 100 mm Hg at 3,200 rpm; 3 L/min against 90 mm Hg at 2,600 rpm; and 2 L/min against 80 mm Hg at 2,400 rpm. In addition, the pump efficiency during this experiment was 12.5%. The other Gyro pumps. that is, the C1E3, PI601, and PI701, in an LVAD condition require 1,600, 2,000, and 2,000 rpm, respectively. The KP101 produced a normalized index of hemolysis (NIH) value of 0.005 g/100 L. With regard to the NIH, the other Gyro pumps, namely the C1E3, PI601, and PI701 demonstrated 0.0007, 0.0028, and 0.004 g/100 L, respectively. The KP101 produced an acceptable pressure flow curve for a VAD. The NIH value was higher than that of other Gyro pumps, but is in an acceptable range.

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. Design and simulation of printed spiral coil used in wireless power transmission systems for implant medical devices.

    PubMed

    Wu, Wei; Fang, Qiang

    2011-01-01

    Printed Spiral Coil (PSC) is a coil antenna for near-field wireless power transmission to the next generation implant medical devices. PSC for implant medical device should be power efficient and low electromagnetic radiation to human tissues. We utilized a physical model of printed spiral coil and applied our algorithm to design PSC operating at 13.56 MHz. Numerical and electromagnetic simulation of power transfer efficiency of PSC in air medium is 77.5% and 71.1%, respectively. The simulation results show that the printed spiral coil which is optimized for air will keep 15.2% power transfer efficiency in human subcutaneous tissues. In addition, the Specific Absorption Ratio (SAR) for this coil antenna in subcutaneous at 13.56 MHz is below 1.6 W/Kg, which suggests this coil is implantable safe based on IEEE C95.1 safety guideline.

  7. Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

    PubMed

    Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

    2017-01-01

    Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features

  8. Development of the NEDO implantable ventricular assist device with Gyro centrifugal pump.

    PubMed

    Yoshikawa, M; Nonaka, K; Linneweber, J; Kawahito, S; Ohtsuka, G; Nakata, K; Takano, T; Schulte-Eistrup, S; Glueck, J; Schima, H; Wolner, E; Nosé, Y

    2000-06-01

    The Gyro centrifugal pump, PI (permanently implantable) series, is being developed as a totally implantable artificial heart. Our final goal is to establish a "functional TAH," a totally implantable biventricular assist system (BiVAS) with centrifugal pumps. A plastic prototype pump, Gyro PI 601, was evaluated through in vitro and in vivo studies as a single ventricular assist device (VAD). Based upon these results, the pump head material was converted to a titanium alloy, and the actuator was modified. These titanium Gyro pumps, PI 700 series, also were subjected to in vitro and in vivo studies. The Gyro PI 601 and PI 700 series have the same inner dimensions and characteristics, such as the eccentric inlet port, double pivot bearing system, secondary vane, and magnet coupling system; however, the material of the PI 700 is different from the PI 601. The Gyro PI series is driven by the Vienna DC brushless motor actuator. The inlet cannula of the right ventricular assist system (RVAS) specially made for this system consists of 2 parts: a hat-shaped silicone tip biolized with gelatin and an angled wire reinforced tube made of polyvinylchloride. The pump-actuator package was implanted into 8 calves in the preperitoneal space, bypassing from the left ventricle apex to the descending aorta for the left ventricular assist system (LVAS) and bypassing the right ventricle to the main pulmonary artery for the RVAS. According to the PI 601 feasibility protocol, 2 LVAS cases were terminated after 2 weeks, and 1 LVAS case and 1 RVAS were terminated after 1 month. The PI 700 series was implanted into 4 cases: 3 LVAS cases survived for a long term, 2 of them over 200 days (72-283 days), and 1 RVAS case survived for 1 month and was terminated according to the protocol for a short-term antithrombogenic screening and system feasibility study. Regarding power consumption, the plastic pump cases demonstrated from 6.2 to 12.1 W as LVAS and 7.3 W as RVAS, the titanium pump cases showed

  9. Remote monitoring as a key innovation in the management of cardiac patients including those with implantable electronic devices.

    PubMed

    Sutton, Richard

    2013-06-01

    This Introduction to the Supplement provides a brief history of remote monitoring, discusses its current status, and indicates the bright future that it possesses with a broad application in many branches of cardiology, at least including arrhythmias, heart failure, and ischaemic heart disease in addition to the management of implantable electronic devices.

  10. Early healing events around titanium implant devices with different surface microtopography: a pilot study in an in vivo rabbit model.

    PubMed

    Orsini, Ester; Salgarello, Stefano; Martini, Désirée; Bacchelli, Beatrice; Quaranta, Marilisa; Pisoni, Luciano; Bellei, Emma; Joechler, Monika; Ottani, Vittoria

    2012-01-01

    In the present pilot study, the authors morphologically investigated sandblasted, acid-etched surfaces (SLA) at very early experimental times. The tested devices were titanium plate-like implants with flattened wide lateral sides and jagged narrow sides. Because of these implant shape and placement site, the device gained a firm mechanical stability but the largest portion of the implant surface lacked direct contact with host bone and faced a wide peri-implant space rich in marrow tissue, intentionally created in order to study the interfacial interaction between metal surface and biological microenvironment. The insertion of titanium devices into the proximal tibia elicited a sequence of healing events. Newly formed bone proceeded through an early distance osteogenesis, common to both surfaces, and a delayed contact osteogenesis which seemed to follow different patterns at the two surfaces. In fact, SLA devices showed a more osteoconductive behavior retaining a less dense blood clot, which might be earlier and more easily replaced, and leading to a surface-conditioning layer which promotes osteogenic cell differentiation and appositional new bone deposition at the titanium surface. This model system is expected to provide a starting point for further investigations which clarify the early cellular and biomolecular events occurring at the metal surface.

  11. 34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 2 2011-07-01 2010-07-01 true Routine checking of hearing aids and external components... Eligibility Other Fape Requirements § 300.113 Routine checking of hearing aids and external components of surgically implanted medical devices. (a) Hearing aids. Each public agency must ensure that hearing aids...

  12. 34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 2 2012-07-01 2012-07-01 false Routine checking of hearing aids and external... Eligibility Other Fape Requirements § 300.113 Routine checking of hearing aids and external components of surgically implanted medical devices. (a) Hearing aids. Each public agency must ensure that hearing aids...

  13. 34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 2 2013-07-01 2013-07-01 false Routine checking of hearing aids and external... Eligibility Other Fape Requirements § 300.113 Routine checking of hearing aids and external components of surgically implanted medical devices. (a) Hearing aids. Each public agency must ensure that hearing aids...

  14. 34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 2 2010-07-01 2010-07-01 false Routine checking of hearing aids and external... Eligibility Other Fape Requirements § 300.113 Routine checking of hearing aids and external components of surgically implanted medical devices. (a) Hearing aids. Each public agency must ensure that hearing aids...

  15. 34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 2 2014-07-01 2013-07-01 true Routine checking of hearing aids and external components... Eligibility Other Fape Requirements § 300.113 Routine checking of hearing aids and external components of surgically implanted medical devices. (a) Hearing aids. Each public agency must ensure that hearing aids...

  16. Pump Thrombosis following HeartMate II Left Ventricular Assist Device Implantation in a Patient with Aspirin and Plavix Resistance.

    PubMed

    Ghodsizad, Ali; Badiye, A; Zeriouh, M; Pae, W; Koerner, M M; Loebe, M

    2016-12-14

    Despite advances in pump technology, thromboembolic events and pump thrombosis are potentially life-threatening complications in patients with continuous flow ventricular assist devices. Here we describe a patient with pump thrombosis following LVAD HeartMate II implantation presenting with Aspirin and Plavix resistance and signs of acute hemolysis as manifested by high LDH, changing pump power, pulse index and reduced pump flows.

  17. 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.

  18. Continuous Flow Left Ventricular Assist Device Implant Significantly Improves Pulmonary Hypertension, Right Ventricular Contractility, and Tricuspid Valve Competence

    PubMed Central

    Atluri, Pavan; Fairman, Alexander S.; MacArthur, John W.; Goldstone, Andrew B.; Cohen, Jeffrey E.; Howard, Jessica L.; Zalewski, Christyna M.; Shudo, Yasuhiro; Woo, Y. Joseph

    2014-01-01

    Background Continuous flow left ventricular assist devices (CF LVAD) are being implanted with increasing frequency for end-stage heart failure. At the time of LVAD implant, a large proportion of patients have pulmonary hypertension, right ventricular (RV) dysfunction, and tricuspid regurgitation (TR). RV dysfunction and TR can exacerbate renal dysfunction, hepatic dysfunction, coagulopathy, edema, and even prohibit isolated LVAD implant. Repairing TR mandates increased cardiopulmonary bypass time and bicaval cannulation, which should be reserved for the time of orthotopic heart transplantation. We hypothesized that CF LVAD implant would improve pulmonary artery pressures, enhance RV function, and minimize TR, obviating need for surgical tricuspid repair. Methods One hundred fourteen continuous flow LVADs implanted from 2005 through 2011 at a single center, with medical management of functional TR, were retrospectively analyzed. Pulmonary artery pressures were measured immediately prior to and following LVAD implant. RV function and TR were graded according to standard echocardiographic criteria, prior to, immediately following, and long-term following LVAD. Results There was a significant improvement in post-VAD mean pulmonary arterial pressures (26.6 ± 4.9 vs. 30.2 ± 7.4 mmHg, p = 0.008) with equivalent loading pressures (CVP = 12.0 ± 4.0 vs. 12.1 ± 5.1 p = NS). RV function significantly improved, as noted by right ventricular stroke work index (7.04 ± 2.60 vs. 6.05 ± 2.54, p = 0.02). There was an immediate improvement in TR grade and RV function following LVAD implant, which was sustained long term. Conclusion Continuous flow LVAD implant improves pulmonary hypertension, RV function, and tricuspid regurgitation. TR may be managed nonoperatively during CF LVAD implant. PMID:24118109

  19. Remote monitoring of implantable devices: Should we continue to ignore it?

    PubMed

    Bertini, Matteo; Marcantoni, Lina; Toselli, Tiziano; Ferrari, Roberto

    2016-01-01

    The number of patients with implantable cardioverter defibrillators (ICDs) is increasing. In addition to improve survival, ICD can collect data related to device function and physiological parameters. Remote monitoring (RM) of these data allows early detection of technical or clinical problems and a prompt intervention (reprogramming device or therapy adjustment) before the patient require hospitalization. RM is not a substitute for emergency service and its consultation is now limited during working hours. Thus, a consent form is required to inform patients about benefits and limitations. The available studies indicate that remote monitoring is more effective than traditional calendar face to face based encounters. RM is safe, highly reliable, cost efficient, allows quick reply to failures, and reduces the number of scheduled visits and the incidence of inappropriate shocks with a positive impact on survival. It follows that RM has the credentials to be the standard of care for ICD management; however, unfortunately, there is a delay in physician acceptance and implementation. The recent observations from randomized IN-TIME study that showed a clear survival benefit with RM in heart failure patients have encouraged us to review both the negative and positive aspects of RM collected in a little more than a decade.

  20. Radiation exposure to operator and patients during cardiac electrophysiology study, radiofrequency catheter ablation and cardiac device implantation procedures

    NASA Astrophysics Data System (ADS)

    Lee, C. H.; Cho, J. H.; Park, S. J.; Kim, J. S.; On, Y. K.; Huh, J.

    2015-10-01

    The purpose of this study was to measure the radiation exposure to operator and patient during cardiac electrophysiology study, radiofrequency catheter ablation and cardiac device implantation procedures and to calculate the allowable number of cases per year. We carried out 9 electrophysiology studies, 40 radiofrequency catheter ablation and 11 cardiac device implantation procedures. To measure occupational radiation dose and dose-area product (DAP), 13 photoluminescence glass dosimeters were placed at eyes (inside and outside lead glass), thyroids (inside and outside thyroid collar), chest (inside and outside lead apron), wrists, genital of the operator (inside lead apron), and 6 of photoluminescence glass dosimeters were placed at eyes, thyroids, chest and genital of the patient. Exposure time and DAP values were 11.7 ± 11.8 min and 23.2 ± 26.2 Gy cm2 for electrophysiology study; 36.5 ± 42.1 min and 822.4 ± 125.5 Gy cm2 for radiofrequency catheter ablation; 16.2 ± 9.3 min and 27.8 ± 16.5 Gy cm2 for cardiac device implantation procedure, prospectively. 4591 electrophysiology studies can be conducted within the occupational exposure limit for the eyes (150 mSv), and 658-electrophysiology studies with radiofrequency catheter ablation can be carried out within the occupational exposure limit for the hands (500 mSv). 1654 cardiac device implantation procedure can be conducted within the occupational exposure limit for the eyes (150 mSv). The amounts of the operator and patient's radiation exposure were comparatively small. So, electrophysiology study, radio frequency catheter ablation and cardiac device implantation procedures are safe when performed with modern equipment and optimized protective radiation protect equipment.

  1. Cochlear Implants

    MedlinePlus

    ... NIDCD A cochlear implant is a small, complex electronic device that can help to provide a sense ... are better able to hear, comprehend sound and music, and speak than their peers who receive implants ...

  2. Cochlear implant

    MedlinePlus

    ... antenna. This part of the implant receives the sound, converts the sound into an electrical signal, and sends it to ... implants allow deaf people to receive and process sounds and speech. However, these devices do not restore ...

  3. Hip Implant Systems

    MedlinePlus

    ... Devices Products and Medical Procedures Implants and Prosthetics Metal-on-Metal Hip Implants Hip Implants Share Tweet Linkedin Pin ... devices available with different bearing surfaces. These are: Metal-on-Polyethylene: The ball is made of metal ...

  4. Mechanical stability of custom-made implants: Numerical study of anatomical device and low elastic Young's modulus alloy.

    PubMed

    Didier, P; Piotrowski, B; Fischer, M; Laheurte, P

    2017-05-01

    The advent of new manufacturing technologies such as additive manufacturing deeply impacts the approach for the design of medical devices. It is now possible to design custom-made implants based on medical imaging, with complex anatomic shape, and to manufacture them. In this study, two geometrical configurations of implant devices are studied, standard and anatomical. The comparison highlights the drawbacks of the standard configuration, which requires specific forming by plastic strain in order to be adapted to the patient's morphology and induces stress field in bones without mechanical load in the implant. The influence of low elastic modulus of the materials on stress distribution is investigated. Two biocompatible alloys having the ability to be used with SLM additive manufacturing are considered, commercial Ti-6Al-4V and Ti-26Nb. It is shown that beyond the geometrical aspect, mechanical compatibility between implants and bones can be significantly improved with the modulus of Ti-26Nb implants compared with the Ti-6Al-4V.

  5. Individual patient data network meta-analysis of mortality effects of implantable cardiac devices

    PubMed Central

    Woods, B; Hawkins, N; Mealing, S; Sutton, A; Abraham, W T; Beshai, J F; Klein, H; Sculpher, M; Plummer, C J; Cowie, M R

    2015-01-01

    Objective Implantable cardioverter defibrillators (ICD), cardiac resynchronisation therapy pacemakers (CRT-P) and the combination therapy (CRT-D) have been shown to reduce all-cause mortality compared with medical therapy alone in patients with heart failure and reduced EF. Our aim was to synthesise data from major randomised controlled trials to estimate the comparative mortality effects of these devices and how these vary according to patients’ characteristics. Methods Data from 13 randomised trials (12 638 patients) were provided by medical technology companies. Individual patient data were synthesised using network meta-analysis. Results Unadjusted analyses found CRT-D to be the most effective treatment (reduction in rate of death vs medical therapy: 42% (95% credible interval: 32–50%), followed by ICD (29% (20–37%)) and CRT-P (28% (15–40%)). CRT-D reduced mortality compared with CRT-P (19% (1–33%)) and ICD (18% (7–28%)). QRS duration, left bundle branch block (LBBB) morphology, age and gender were included as predictors of benefit in the final adjusted model. In this model, CRT-D reduced mortality in all subgroups (range: 53% (34–66%) to 28% (−1% to 49%)). Patients with QRS duration ≥150 ms, LBBB morphology and female gender benefited more from CRT-P and CRT-D. Men and those <60 years benefited more from ICD. Conclusions These data provide estimates for the mortality benefits of device therapy conditional upon multiple patient characteristics. They can be used to estimate an individual patient's expected relative benefit and thus inform shared decision making. Clinical guidelines should discuss age and gender as predictors of device benefits. PMID:26269413

  6. Design method of a foldable ventricular assist device for minimally invasive implantation.

    PubMed

    Hsu, Po-Lin; Wang, Yaxin; Amaral, Felipe; Parker, Jack; Schmitz-Rode, Thomas; Autschbach, Rüdiger; Steinseifer, Ulrich

    2014-04-01

    To date, ventricular assist devices (VADs) have become accepted as a therapeutic solution for end-stage heart failure patients when a donor heart is not available. Newer generation VADs allow for a significant reduction in size and an improvement in reliability. However, the invasive implantation still limits this technology to critically ill patients. Recently, expandable/deployable devices have been investigated as a potential solution for minimally invasive insertion. Such a device can be inserted percutaneously via peripheral vessels in a collapsed form and operated in an expanded form at the desired location. A common structure of such foldable pumps comprises a memory alloy skeleton covered by flexible polyurethane material. The material properties allow elastic deformation to achieve the folded position and withstand the hydrodynamic forces during operation; however, determining the optimal geometry for such a structure is a complex challenge. The numerical finite element method (FEM) is widely used and provides accurate structural analysis, but computation time is considerably high during the initial design stage where various geometries need to be examined. This article details a simplified two-dimensional analytical method to estimate the mechanical stress and deformation of memory alloy skeletons. The method was applied in design examples including two popular types of blade skeletons of a foldable VAD. Furthermore, three force distributions were simulated to evaluate the strength of the structures under different loading conditions experienced during pump operation. The results were verified with FEM simulations. The proposed two-dimensional method gives a close stress and deformation estimation compared with three-dimensional FEM simulations. The results confirm the feasibility of such a simplified analytical approach to reveal priorities for structural optimization before time-consuming FEM simulations, providing an effective tool in the initial

  7. Transaxillary Subpectoral Placement of Cardiac Implantable Electronic Devices in Young Female Patients

    PubMed Central

    Oh, Joo Hyun; Kim, Chae Min; Song, Seung Yong; Uhm, Jae Sun; Lew, Dae Hyun

    2017-01-01

    Background The current indications of cardiac implantable electronic devices (CIEDs) have expanded to include young patients with serious cardiac risk factors, but CIED placement has the disadvantage of involving unsightly scarring and bulging of the chest wall. A collaborative team of cardiologists and plastic surgeons developed a technique for the subpectoral placement of CIEDs in young female patients via a transaxillary approach. Methods From July 2012 to December 2015, subpectoral CIED placement via an axillary incision was performed in 10 young female patients, with a mean age of 25.9 years and mean body mass index of 20.1 kg/m2. In the supine position, with the patient's shoulder abducted, an approximately 5-cm linear incision was made along one of the deepest axillary creases. The submuscular plane was identified at the lateral border of the pectoralis major, and the dissection continued over the clavipectoral fascia until the subpectoral pocket could securely receive a pulse generator. Slight upward dissection also exposed an entrance to the subclavian vein, allowing the cardiology team to gain access to the vein. One patient with dilated cardiomyopathy underwent augmentation mammoplasty and CIED insertion simultaneously. Results One case of late-onset device infection occurred. All patients were highly satisfied with the results and reported that they would recommend the procedure to others. Conclusions With superior aesthetic outcomes compared to conventional methods, the subpectoral placement of CIEDs via a transaxillary approach is an effective, single-incision method to hide operative scarring and minimize bulging of the device, and is particularly beneficial for young female or lean patients. PMID:28194345

  8. Intense green-yellow electroluminescence from Tb+-implanted silicon-rich silicon nitride/oxide light emitting devices

    NASA Astrophysics Data System (ADS)

    Berencén, Y.; Wutzler, R.; Rebohle, L.; Hiller, D.; Ramírez, J. M.; Rodríguez, J. A.; Skorupa, W.; Garrido, B.

    2013-09-01

    High optical power density of 0.5 mW/cm2, external quantum efficiency of 0.1%, and population inversion of 7% are reported from Tb+-implanted silicon-rich silicon nitride/oxide light emitting devices. Electrical and electroluminescence mechanisms in these devices were investigated. The excitation cross section for the 543 nm Tb3+ emission was estimated under electrical pumping, resulting in a value of 8.2 × 10-14 cm2, which is one order of magnitude larger than one reported for Tb3+:SiO2 light emitting devices. These results demonstrate the potentiality of Tb+-implanted silicon nitride material for the development of integrated light sources compatible with Si technology.

  9. Practical and ethical considerations in the management of pacemaker and implantable cardiac defibrillator devices in terminally ill patients

    PubMed Central

    Sorkness, Christine A.

    2017-01-01

    More than 4.5 million people worldwide live with an implanted pacemaker, including >3 million in the USA alone. Also, >0.8 million people in the USA have an implantable cardioverter defibrillator (ICD). Knowing the principles of managing these devices towards the end of life is important, as the interruption of their function may have serious consequences. This article provides health care providers who are not specialized in cardiac electrophysiology with an introduction to the general principles of management of pacemakers or ICD devices towards the end of life, with a suggested algorithm for approaching this process. Also discussed are pertinent ethical and practical considerations in deciding on and implementing a management strategy for these devices during terminal illnesses.

  10. PRE-OPERATIVE HEALTH STATUS AND OUTCOMES FOLLOWING CONTINUOUS-FLOW LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION

    PubMed Central

    Flint, Kelsey M.; Matlock, Daniel D.; Sundareswaran, Kartik; Lindenfeld, JoAnn; Spertus, John A.; Farrar, David J.; Allen, Larry A.

    2013-01-01

    Background Health status predicts adverse outcomes in heart failure and cardiac surgery patients, but its prognostic value in left ventricular assist device (LVAD) placement is unknown. Methods We examined the association of pre-operative health status, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), with survival and hospitalization after LVAD using KCCQ as a continuous variable and stratified by KCCQ score quartile plus missing KCCQ in 1125 clinical trial participants receiving the HeartMate II as either destination therapy (n=635) or bridge to transplantation (n=490). Results Mean pre-operative KCCQ score was 29.4±18.7 among survivors (n=719), and 27.1±18.3 (n=406) in those who died. In time-to-event analysis for all available follow up using health status as a continuous variable, pre-operative KCCQ score did not correlate with overall mortality after LVAD implantation (p=0.178). Small absolute differences were seen between pre-operative KCCQ quartile and 30-day survival (Q4 95% vs. Q1 89% vs. missing 87%; p=0.0009 for trend), 180-day survival (Q4 83% vs. Q1 76% vs. missing 79%; p=0.060 for trend), and days hospitalized at 180 days (Q4 29.8±25.6 vs. Q1 34.1±27.1 vs. missing 36.5±29.9; p=0.009 for trend). Conclusion Our findings suggest that pre-operative health status has limited association with outcomes after LVAD implantation. Although these data require further study in a diverse population, mechanical circulatory support may represent a relatively unique clinical situation, distinct from heart failure and other cardiac surgeries, in which heart failure-specific health status measures may be largely reversed. PMID:24119729

  11. Design of a pulsatile flow facility to evaluate thrombogenic potential of implantable cardiac devices.

    PubMed

    Arjunon, Sivakkumar; Ardana, Pablo Hidalgo; Saikrishnan, Neelakantan; Madhani, Shalv; Foster, Brent; Glezer, Ari; Yoganathan, Ajit P

    2015-04-01

    Due to expensive nature of clinical trials, implantable cardiac devices should first be extensively characterized in vitro. Prosthetic heart valves (PHVs), an important class of these devices, have been shown to be associated with thromboembolic complications. Although various in vitro systems have been designed to quantify blood-cell damage and platelet activation caused by nonphysiological hemodynamic shear stresses in these PHVs, very few systems attempt to characterize both blood damage and fluid dynamics aspects of PHVs in the same test system. Various numerical modeling methodologies are also evolving to simulate the structural mechanics, fluid mechanics, and blood damage aspects of these devices. This article presents a completely hemocompatible small-volume test-platform that can be used for thrombogenicity studies and experimental fluid mechanics characterization. Using a programmable piston pump to drive freshly drawn human blood inside a cylindrical column, the presented system can simulate various physiological and pathophysiological conditions in testing PHVs. The system includes a modular device-mounting chamber, and in this presented case, a 23 mm St. Jude Medical (SJM) Regents® mechanical heart valve (MHV) in aortic position was used as the test device. The system was validated for its capability to quantify blood damage by measuring blood damage induced by the tester itself (using freshly drawn whole human blood). Blood damage levels were ascertained through clinically relevant assays on human blood while fluid dynamics were characterized using time-resolved particle image velocimetry (PIV) using a blood-mimicking fluid. Blood damage induced by the tester itself, assessed through Thrombin-anti-Thrombin (TAT), Prothrombin factor 1.2 (PF1.2), and hemolysis (Drabkins assay), was within clinically accepted levels. The hydrodynamic performance of the tester showed consistent, repeatable physiological pressure and flow conditions. In addition, the

  12. How to pass information and deliver energy to a network of implantable devices within the human body.

    PubMed

    Sun, Mingui; Hackworth, Steven A; Tang, Zhide; Gilbert, Gary; Cardin, Sylvain; Sclabassi, Robert J

    2007-01-01

    It has been envisioned that a body network can be built to collect data from, and transport information to, implanted miniature devices at multiple sites within the human body. Currently, two problems of utmost importance remain unsolved: 1) how to link information between a pair of implants at a distance? and 2) how to provide electric power to these implants allowing them to function and communicate? In this paper, we present new solutions to these problems by minimizing the intra-body communication distances. We show that, based on a study of human anatomy, the maximum distance from the body surface to the deepest point inside the body is approximately 15 cm. This finding provides an upper bound for the lengths of communication pathways required to reach the body's interior. We also show that these pathways do not have to cross any joins within the body. In order to implement the envisioned body network, we present the design of a new device, called an energy pad. This small-size, light-weight device can easily interface with the skin to perform data communication with, and supply power to, miniature implants.

  13. “It's Not Broke, So Let's Not Try to Fix It”: Why Patients Decline a Cardiovascular Implantable Electronic Device

    PubMed Central

    Ottenberg, Abigale L.; Mueller, Paul S.; Topazian, Rachel J.; Kaufman, Sharon; Swetz, Keith M.

    2014-01-01

    Background Few patients decline therapy of a cardiovascular implantable electronic device (CIED), and little is known about the characteristics or reasoning of those who do. Our objective was to describe the reasons why patients decline CIED implantation using qualitative methods. Methods Qualitative, engaging thematic analysis. Three patient focus groups led by 2 trained facilitators and 1 semistructured interview guide. Results Of the 13 patients, 2 were women and all were white (median age [range], 65 [44-88] years). Five themes emerged: 1) don't mess with a good thing, 2) my health is good enough, 3) independent decision making, 4) it's your job, but it's my choice, and 5) gaps in learning. Most patients who decline CIEDs are asymptomatic. Other reasons to decline included feeling well, enjoying life, acceptance of the future, desire to try to improve health through diet and exercise, hearing of negative CIED experiences, and unwillingness to take on associated risks of CIED implantation. A medical record review showed that clinicians understand patients’ reasons for declining CIED treatment. However, focus group data suggest that gaps in patients’ knowledge around the purpose and function of CIEDs exist and patients may benefit from targeted education. Conclusions Patients decline implantation of CIEDs for various reasons. Most patients who decline therapy are asymptomatic at the time of their device consult. Focus group information show data suggestive that device consultations should be enhanced to address gaps in patient learning and confirm knowledge transfer. Clinicians should revisit treatment options iteratively. PMID:24889010

  14. An Implantable Device for Manipulation of the in vivo Tumor Microenvironment

    NASA Astrophysics Data System (ADS)

    Williams, James K.

    In the past decade, it has become increasingly recognized that interactions between cancer cells and the tumor microenvironment (TME) regulate metastasis. One such interaction is the paracrine loop between macrophages and cancer cells which drives metastatic invasion in mammary tumors. Tumor associated macrophages release epidermal growth factor (EGF), a chemoattractant which induces the migration of cancer cells toward the blood vessels. The cancer cells reciprocate by releasing a macrophage chemoattractant, colony-stimulating factor 1 (CSF-1), resulting in the co-migration of both cell types and subsequent intravasation. In this work, a new technology has been developed for studying the mechanisms by which invasive tumor cells migrate in vivo toward gradients of EGF. Conventional in vitro methods used for studying tumor cell migration lack the complexity found in the TME and are therefore of limited relevance to in vivo metastasis. The Nano Intravital Device (NANIVID) has been designed as an implantable tool to manipulate the TME through the generation of soluble factor gradients. The NANIVID consists of two etched glass substrates, loaded with a hydrogel containing EGF, and sealed together using a polymer membrane. When implanted in vivo, the hydrogel will swell and release the entrapped EGF, forming a diffusion gradient in the tumor over many hours. The NANIVID design has been optimized for use with multiphoton-based intravital imaging, to monitor migration toward the device at single-cell resolution. Stabilization techniques have been developed to minimize imaging artifacts caused by breathing and specimen movement over the course of the experiment. The NANIVID has been validated in vivo using a mouse model of metastasis. When implanted in MDA-MB-231 xenograft tumors grown in SCID mice, chemotaxis of tumor cells was induced by the EGF gradient generated by the device. Cell motility parameters including velocity, directionality, and chemotactic index were

  15. The mismatch between patient life expectancy and the service life of implantable devices in current cardioverter-defibrillator therapy: a call for larger device batteries.

    PubMed

    Neuzner, Jörg

    2015-06-01

    In 2005, Bob Hauser published a paper in the Journal of the American College of Cardiology entitled "The growing mismatch between patient longevity and the service life of Implantable Cardioverter-Defibrillators". Now, nearly a decade later, I would like to perform a second look on the problem of a mismatching between ICD device service life and the survival of ICD recipients. Since 2005, the demographics of the ICD population has changed significantly. Primary prevention has become the dominant indication in defibrillator therapy and device implantation is indicated more and more in earlier stages of cardiac diseases. In former larger scale ICD trials, the patient average 5-year survival probability was in a range of 68-71%; in newer CRT-D trials in a range of 72-88%. Due to a progressively widened ICD indication and implantation preferentially performed in patients with better life expectancy, the problem of inadequate device service life is of growing importance. The early days of defibrillator therapy started with a generator volume of 145 ccm and a device service life <18 months. In this early period, the device miniaturization and extension of service life were similar challenges for the technicians. Today, we have reached a formerly unexpected extent of device miniaturization. However, technologic improvements were often preferentially translated in further device miniaturization and not in prolonging device service life. In his analysis, Bob Hauser reported a prolonged device service life of 2.3 years in ICD models with a larger battery capacity of 0.54 up to 0.69 Ah. Between 2008 and 2014, several studies had been published on the problem of ICD longevity in clinical scenarios. These analyses included "older" and currently used single chamber, dual chamber and CRT devices. The reported average 5-year device service life ranged from 0 to 75%. Assuming today technology, larger battery capacities will only result in minimal increase in device volume. Selected

  16. Predictors of Hospital Length of Stay Following Implantation of a Left Ventricular Assist Device: An Analysis of the INTERMACS Registry

    PubMed Central

    Cotts, William G.; McGee, Edwin C.; Myers, Susan L.; Naftel, David C.; Young, James B.; Kirklin, James K.; Grady, Kathleen L.

    2014-01-01

    Introduction Few studies have reported on hospital length of stay (LOS) after left ventricular assist device (LVAD) implantation. The purpose of this study was to determine pre-operative and peri-operative predictors of hospital LOS after LVAD implantation. Methods and Materials We analyzed adult primary continuous flow LVAD patients implanted between 6/23/06 and 12/31/10 at 105 institutions from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Retrospective analyses included measures of central tendency, frequencies, correlations, and step-wise multivariable regression modeling (p≤0.05). Independent variables included demographic characteristics, pre-implant clinical and behavioral variables, and concomitant surgery. Results Characteristics of the patients (n=2,200) included a mean age of 54.6 ± 12.6 years, with 79% male, 69% white, 57% INTERMACS profile 1 or 2, 37% diabetic, 21% with history of CABG, 7% with history of valve surgery and 37% with concomitant surgery. Median hospital LOS (implant to discharge) was 20 days. Significant predictors of an increased hospital LOS included: demographic characteristics (older age and non-white), pre-implant clinical variables (history of CABG or valve surgery, diabetes, ascites, INTERMACS profiles 1 and 2, low albumin, high BUN, and high right atrial pressure), and concomitant surgery, explaining 12% variance, F=22.65, p<0.001. Conclusions Demographic characteristics, pre-implant variables and concomitant surgery partially explained hospital LOS after continuous flow LVAD implant. These variables have implications regarding selection of patients for mechanical circulatory support. PMID:24819987

  17. Sinus implants stabilization in Misch IV Class by means of S.I.S. device: A Clinical Study

    PubMed Central

    GRANDI, C.; PACIFICI, L.

    2010-01-01

    SUMMARY Aims. In Misch Class IV dental implants are not normally placed at the same time as the sinus lift procedure. For this type of situation the use of several devices to immediately stabilise implants lacking in primary stability is proposed. Among these, the titanium S.I.S. plate results as being the most straightforward. This study proposes the evaluation of the effectiveness and stability of the results of this method in the short term on a greater number of patients, monitoring bones levels and implant stability. Method. 14 patients were selected, 9 males and 5 females, aged between 43 and 75 years of age. Overall, 42 implants were placed in the upper posterior edentulous zones with Misch Class IV atrophy including first and second premolars and first molars, opposite fixed teeth, and were stabilised using the S.I.S. plate. Results. Radiographic controls and ISQ measurements with AFR at 1, 6 and 12 months after loading testify to the stability of the bone levels which concur with success criteria found in literature. The technique described seems to be able to ensure success in cases of Misch Class IV with contemporaneous placement of the osseo-integrated implants. Conclusion. This clinical study, even if carried out on a small number of patients (14) and implants (42) represents the largest case history published. The technique described seems to ensure the success of cases of Misch Class IV with contemporaneous placement of osseo-integrated implants. The technique is straightforward and reproducible and does not cause further trauma. The S.I.S. allows for the stabilisation of the dental implants and the residual crest when there is a lack of primary stability. In Misch Class IV this means a considerable reduction in treatment times. PMID:23285369

  18. Controlled release of triamcinolone acetonide from polyurethane implantable devices: application for inhibition of inflammatory-angiogenesis.

    PubMed

    Pinto, Flávia Carmo Horta; Da Silva-Cunha Junior, Armando; Oréfice, Rodrigo Lambert; Ayres, Eliane; Andrade, Silvia Passos; Lima, Luiza Dias C; Moura, Sandra A Lima; Da Silva, Gisele Rodrigues

    2012-06-01

    The purpose of this study was to develop triamcinolone acetonide-loaded polyurethane implants (TA PU implants) for the local treatment of different pathologies including arthritis, ocular and neuroinflammatory disorders. The TA PU implants were characterized by FTIR, SAXS and WAXS. The in vitro and in vivo release of TA from the PU implants was evaluated. The efficacy of TA PU implants in suppressing inflammatory-angiogenesis in a murine sponge model was demonstrated. FTIR results revealed no chemical interactions between polymer and drug. SAXS results indicated that the incorporation of the drug did not disturb the polymer morphology. WAXS showed that the crystalline nature of the TA was preserved after incorporation into the PU. The TA released from the PU implants efficiently inhibited the inflammatory-angiogenesis induced by sponge discs in an experimental animal model. Finally, TA PU implants could be used as local drug delivery systems because of their controlled delivery of TA.

  19. Surgical implantation of a cardiac resynchronization therapy device in a western lowland gorilla (Gorilla gorilla gorilla) with fibrosing cardiomyopathy.

    PubMed

    Rush, Elizabeth Marie; Ogburn, Anna L; Hall, Jeffrey; Rush, Dwain; Lau, Yung; Dillon, A R; Garmon, Linda; Tillson, D M; Kay, G Neal

    2010-09-01

    A 24-yr-old, male western lowland gorilla (Gorilla gorilla gorilla) was diagnosed in March of 2003 with congestive heart failure (CHF). Transesophageal and transthoracic echocardiography demonstrated global left and right ventricular hypokinesia with a left ventricular ejection fraction of 0.20. At the time of diagnosis, the animal exhibited symptoms and signs of CHF with minimal exertion (New York Heart Association class III). Over a 16-mo period, the severity of CHF progressed to class IV (resting signs and symptoms) despite angiotensin-converting enzyme inhibition, beta-blockers, and diuretics. Because of intractable CHF and a QRS duration that was markedly prolonged compared with the normal range for this species, a cardiac resynchronization therapy (CRT) device was implanted using implantation techniques based on human surgical procedures. Placement of the right ventricular, right atrial, and left ventricular leads and pulse generator were accomplished in 5.5 hr. Telemetry of the device postoperatively via wand or remote radio frequency has allowed for noninvasive programming and interrogation. The clinical improvement in CHF with this therapy was immediate and dramatic for this animal. Six months after CRT device implantation, the device leads became dislodged during an altercation with another gorilla, with the rapid development of CHF upon cessation of biventricular pacing. A second procedure to replace the leads returned the gorilla to his previous level of activity. In 2007, the pulse generator was electively replaced for battery depletion with a device capable of remote radiofrequency programming and interrogation. CRT implantation, although requiring specialized equipment and surgical skill, appears to be a viable option for treatment of dilated cardiomyopathy in gorillas.

  20. Wireless miniature implantable devices and ASICs for monitoring, treatment, and study of glaucoma and cardiac disease

    NASA Astrophysics Data System (ADS)

    Chow, Eric Y.

    Glaucoma affects about 65 million people and is the second leading cause of blindness in the world. Although the condition is irreversible and incurable, early detection is vital to slowing and even stopping the progression of the disease. Our work focuses on the design, fabrication, and assembly of a continuous active glaucoma intraocular pressure (IOP) monitor that provides clinicians with the necessary data to more accurately diagnose and treat patients. Major benefits of an active monitoring device include the potential to develop a closed-loop treatment system and to operate independently for extended periods of time. The fully wireless operation uses gigahertzfrequency electromagnetic wave propagation, which allows for an orientation independent transfer of power and data over reasonable distances. Our system is comprised of a MEMS capacitive sensor, capacitive power storage array, ASIC, and monopole antenna assembled into a biocompatible liquid crystal polymer (LCP) package. We have performed in vivo trials on rabbits, both chronic and acute, to validate system functionality, fully wireless feasibility, and biocompatibility. Heart failure (HF) affects approximately 2% of the adult population in developed countries and 6-10% of people over the age of 65. Continuous monitoring of blood pressure, flow, and chemistry from a minimally invasive device can serve as a diagnostic and early-warning system for cardiac health. We developed a miniaturized system attached to the outer surface of an FDA approved stent, used as both the antenna for wireless telemetry/powering and structural support. The system comprises of a MEMS pressure sensor, ASIC for the sensor interface and wireless capabilities, LCP substrate, and FDA approved stent. In vivo studies on pigs validated functionality and fully wireless operation and demonstrate the feasibility of a stent-based wireless implant for continuous monitoring of blood pressure as well as other parameters including oxygen, flow

  1. Ultracompact, completely implantable permanent use electromechanical ventricular assist device and total artificial heart.

    PubMed

    Honda, N; Inamoto, T; Nogawa, M; Takatani, S

    1999-03-01

    An ultracompact, completely implantable permanent use electromechanical ventricular assist device (VAD) and total artificial heart (TAH) intended for 50-60 kg size patients have been developed. The TAH and VAD share a miniature electromechanical actuator that comprises a DC brushless motor and a planetary roller screw. The rotational force of the motor is converted into the rectilinear force of the roller screw to actuate the blood pump. The TAH is a one piece design with left and right pusher plate type blood pumps sandwiching an electromechanical actuator. The VAD is one half of the TAH with the same actuator but a different pump housing and a backplate. The blood contacting surfaces, including those of the flexing diaphragm and pump housing, of both the VAD and TAH were made of biocompatible polyurethane. The diameter, thickness, volume, and weight of the VAD are 90 mm, 56 mm, 285 cc, and 380 g, respectively, while those of the TAH are 90 mm, 73 mm, 400 cc, and 440 g, respectively. The design stroke volume of both the VAD and TAH is 60 cc with the stroke length being 12 mm. The stroke length and motor speed are controlled solely based on the commutation signals of the motor. An in vitro study revealed that a maximum pump flow of 7.5 L/min can be obtained with a pump rate of 140 bpm against a mean afterload of 100 mm Hg. The power requirement ranged from 4 to 6 W to deliver a 4-5 L/min flow against a 100 mm Hg afterload with the electrical-to-hydraulic efficiency being 19-20%. Our VAD and TAH are the smallest of the currently available devices and suitable for bridge to transplant application as well as for permanent circulatory support of 50-60 kg size patients.

  2. Cost-effectiveness of implantable cardiac devices in patients with systolic heart failure

    PubMed Central

    Mealing, Stuart; Woods, Beth; Hawkins, Neil; Cowie, Martin R; Plummer, Christopher J; Abraham, William T; Beshai, John F; Klein, Helmut; Sculpher, Mark

    2016-01-01

    Objective To evaluate the cost-effectiveness of implantable cardioverter defibrillators (ICDs), cardiac resynchronisation therapy pacemakers (CRT-Ps) and combination therapy (CRT-D) in patients with heart failure with reduced ejection fraction based on a range of clinical characteristics. Methods Individual patient data from 13 randomised trials were used to inform a decision analytical model. A series of regression equations were used to predict baseline all-cause mortality, hospitalisation rates and health-related quality of life and device-related treatment effects. Clinical variables used in these equations were age, QRS duration, New York Heart Association (NYHA) class, ischaemic aetiology and left bundle branch block (LBBB). A UK National Health Service perspective and a lifetime time horizon were used. Benefits were expressed as quality-adjusted life-years (QALYs). Results were reported for 24 subgroups based on LBBB status, QRS duration and NYHA class. Results At a threshold of £30 000 per QALY gained, CRT-D was cost-effective in 10 of the 24 subgroups including all LBBB morphology patients with NYHA I/II/III. ICD is cost-effective for all non-NYHA IV patients with QRS duration <120 ms and for NYHA I/II non-LBBB morphology patients with QRS duration between 120 ms and 149 ms. CRT-P was also cost-effective in all NYHA III/IV patients with QRS duration >120 ms. Device therapy is cost-effective in most patient groups with LBBB at a threshold of £20 000 per QALY gained. Results were robust to altering key model parameters. Conclusions At a threshold of £30 000 per QALY gained, CRT-D is cost-effective in a far wider group than previously recommended in the UK. In some subgroups ICD and CRT-P remain the cost-effective choice. PMID:27411837

  3. Successful Implantation of a Left Ventricular Assist Device in a Patient with Heparin-Induced Thrombocytopenia and Thrombosis

    PubMed Central

    Garland, Cassandra; Somogyi, David

    2014-01-01

    Abstract: We report the case of a 27-year-old woman with signs of heparin-induced thrombocytopenia and thrombosis (HITT) and left heart failure presenting for urgent implantation of a left ventricular assist device (LVAD). HITT can occur in 4.2–6.1% of patients with LVADs. If the patient remains hemodynamically stable, implantation can be delayed for several months until the heparin/PF-4 antibodies decline allowing the use of heparin on cardiopulmonary bypass, However, in most cases related to cardiogenic shock, surgery cannot be delayed. We present the case of a patient who underwent implantation of a HeartMate II LVAD and discuss management strategy using bivalirudin during cardiopulmonary bypass. PMID:25208434

  4. New analysis and design of a RF rectifier for RFID and implantable devices.

    PubMed

    Liu, Dong-Sheng; Li, Feng-Bo; Zou, Xue-Cheng; Liu, Yao; Hui, Xue-Mei; Tao, Xiong-Fei

    2011-01-01

    New design and optimization of charge pump rectifiers using diode-connected MOS transistors is presented in this paper. An analysis of the output voltage and Power Conversion Efficiency (PCE) is given to guide and evaluate the new design. A novel diode-connected MOS transistor for UHF rectifiers is presented and optimized, and a high efficiency N-stage charge pump rectifier based on this new diode-connected MOS transistor is designed and fabricated in a SMIC 0.18-μm 2P3M CMOS embedded EEPROM process. The new diode achieves 315 mV turn-on voltage and 415 nA reverse saturation leakage current. Compared with the traditional rectifier, the one based on the proposed diode-connected MOS has higher PCE, higher output voltage and smaller ripple coefficient. When the RF input is a 900-MHz sinusoid signal with the power ranging from -15 dBm to -4 dBm, PCEs of the charge pump rectifier with only 3-stage are more than 30%, and the maximum output voltage is 5.5 V, and its ripple coefficients are less than 1%. Therefore, the rectifier is especially suitable to passive UHF RFID tag IC and implantable devices.

  5. New Analysis and Design of a RF Rectifier for RFID and Implantable Devices

    PubMed Central

    Liu, Dong-Sheng; Li, Feng-Bo; Zou, Xue-Cheng; Liu, Yao; Hui, Xue-Mei; Tao, Xiong-Fei

    2011-01-01

    New design and optimization of charge pump rectifiers using diode-connected MOS transistors is presented in this paper. An analysis of the output voltage and Power Conversion Efficiency (PCE) is given to guide and evaluate the new design. A novel diode-connected MOS transistor for UHF rectifiers is presented and optimized, and a high efficiency N-stage charge pump rectifier based on this new diode-connected MOS transistor is designed and fabricated in a SMIC 0.18-μm 2P3M CMOS embedded EEPROM process. The new diode achieves 315 mV turn-on voltage and 415 nA reverse saturation leakage current. Compared with the traditional rectifier, the one based on the proposed diode-connected MOS has higher PCE, higher output voltage and smaller ripple coefficient. When the RF input is a 900-MHz sinusoid signal with the power ranging from −15 dBm to −4 dBm, PCEs of the charge pump rectifier with only 3-stage are more than 30%, and the maximum output voltage is 5.5 V, and its ripple coefficients are less than 1%. Therefore, the rectifier is especially suitableto passive UHF RFID tag IC and implantable devices. PMID:22163968

  6. External unit for a semi-implantable middle ear hearing device.

    PubMed

    Garverick, S L; Kane, M; Ko, W H; Maniglia, A J

    1997-06-01

    A miniaturized, low-power external unit has been developed for the clinical trials of a semi-implantable middle ear electromagnetic hearing device (SIMEHD) which uses radio-frequency telemetry to couple sound signals to the internal unit. The external unit is based on a commercial hearing aid which provides proven audio amplification and compression. Its receiver is replaced by an application-specific integrated circuit (ASIC) which: 1) adjusts the direct-current bias of the audio input according to its peak value; 2) converts the audio signal to a one-bit digital form using sigma-delta modulation; 3) modulates the sigma-delta output with a radio-frequency (RF) oscillator; and 4) drives the external RF coil and tuning capacitor using a field-effect transistor operated in class D. The external unit functions as expected and has been used to operate bench-top tests to the SIMEHD. Measured current consumption is 1.65-2.15 mA, which projects to a battery lifetime of about 15 days. Bandwidth is 6 kHz and harmonic distortion is about 2%.

  7. Detection of atrial arrhythmia for cardiac rhythm management by implantable devices.

    PubMed

    Morris, M M; KenKnight, B H; Lang, D J

    2000-01-01

    Implantable atrial defibrillators (IAD) should provide pacing therapy whenever appropriate (ie, typical atrial flutter) to minimize shock-related patient discomfort. Additionally, IADs should provide diagnostics regarding atrial arrhythmia type and frequency of occurrence to enable improved physician management of atrial arrhythmia. To achieve this, IADs should accurately classify atrial arrhythmia such as atrial fibrillation (AF) and atrial flutter (AFL) This article evaluates the performance of an algorithm, atrial rhythm classification (ARC), designed to classify AF and AFL. The ARC algorithm uses maximum rate, standard deviation, and range of the 12 most recent atrial cycle lengths to plot a point in a three-dimensional space. A decision boundary divides the space into 2 regions--faster/unstable atrial cycle lengths (AF) or slower/stable cycle lengths (AFL). Classifications are made on a sliding window of 12 consecutive cycles until the end of the episode is reached. In this way, continuous episode feedback is provided that can be used to help guide device therapy, measure arrhythmia type and frequency of occurrence. Bipolar (1-cm) electrogram episodes of AF (n = 16) and AFL (n = 7) were acquired from 20 patients and retrospectively analyzed using the ARC algorithm. The sensitivity and specificity in this study was 0.993 and 0.982, respectively. The ARC algorithm would have appropriately guided atrial therapy and minimized discomfort associated with defibrillation shocks in this small patient data set warranting further studies. The ARC algorithm may also be beneficial as a diagnostic tool to assist physician management of atrial arrhythmia.

  8. Hemodynamic effects of a counterpulsation device implanted on the ascending aorta in severe cardiogenic shock.

    PubMed

    Nanas, J N; Nanas, S N; Charitos, C E; Kontoyiannis, D; Poyiadjis, A D; Stamatopoulos, G; Melkaoui, A; Kokollis, G; Moulopoulos, S D

    1988-01-01

    A valveless, single orifice counterpulsation device (CD) with maximum stroke volume of 100 ml was implanted on the ascending aorta of nine dogs. Its pneumatic driver was gaited by the ECG to provide aortic diastolic augmentation, with a stroke volume of 60-70 ml. In the same animals a 20 ml intraaortic balloon (IAB) was placed into the descending aorta. An attempt was made to evaluate the effectiveness of the CD on severe cardiogenic shock and to compare its hemodynamic effects with those of the IABP. Severe cardiogenic shock was induced by coronary artery ligation, propranolol administration, and fluid infusion and was characterized by a LVEDP of 22.2 +/- 6.4 mmHg, ASP less than 70 mmHg and greater than or equal to 30 mmHg, and a reduction of CI by 71.7%. The CD had a significant beneficial effect in all measured parameters. The LVEDP decreased by a mean of 44.3% (P less than 0.001) below control value, and the AEDP by 60.2% (P less than 0.001). The PADA increased by 108.5% (P less than 0.001), and the CI by 155.8% (P less than 0.004). The IABP did not significantly change any of the hemodynamic variables. In conclusion, the CD has significant salutary hemodynamic effects in severe cardiogenic shock where IABP is ineffective.

  9. "Optical communication with brain cells by means of an implanted duplex micro-device with optogenetics and Ca(2+) fluoroimaging".

    PubMed

    Kobayashi, Takuma; Haruta, Makito; Sasagawa, Kiyotaka; Matsumata, Miho; Eizumi, Kawori; Kitsumoto, Chikara; Motoyama, Mayumi; Maezawa, Yasuyo; Ohta, Yasumi; Noda, Toshihiko; Tokuda, Takashi; Ishikawa, Yasuyuki; Ohta, Jun

    2016-02-16

    To better understand the brain function based on neural activity, a minimally invasive analysis technology in a freely moving animal is necessary. Such technology would provide new knowledge in neuroscience and contribute to regenerative medical techniques and prosthetics care. An application that combines optogenetics for voluntarily stimulating nerves, imaging to visualize neural activity, and a wearable micro-instrument for implantation into the brain could meet the abovementioned demand. To this end, a micro-device that can be applied to the brain less invasively and a system for controlling the device has been newly developed in this study. Since the novel implantable device has dual LEDs and a CMOS image sensor, photostimulation and fluorescence imaging can be performed simultaneously. The device enables bidirectional communication with the brain by means of light. In the present study, the device was evaluated in an in vitro experiment using a new on-chip 3D neuroculture with an extracellular matrix gel and an in vivo experiment involving regenerative medical transplantation and gene delivery to the brain by using both photosensitive channel and fluorescent Ca(2+) indicator. The device succeeded in activating cells locally by selective photostimulation, and the physiological Ca(2+) dynamics of neural cells were visualized simultaneously by fluorescence imaging.

  10. Improved Systemic Saturation after Ventricular Assist Device Implantation in a Patient with Decompensated Dextro-Transposition of the Great Arteries after the Fontan Procedure

    PubMed Central

    Jabbar, Ali Abdul; Franklin, Wayne J.; Simpson, Leo; Civitello, Andrew B.; Delgado, Reynolds M.

    2015-01-01

    We report the successful implantation of a HeartMate II left ventricular assist device after a failed Fontan procedure in a patient with dextro-transposition of the great arteries. The patient had developed significant intrapulmonary arteriovenous shunting. Despite the theoretical risk of worsening intrapulmonary shunting due to the decrease in systemic vascular resistance after device implantation, our patient did well. He was discharged from the hospital in stable condition and had better oxygen saturation than before the device was implanted. To our knowledge, ours is the 2nd report of the use of a ventricular assist device after the failure of a Fontan procedure, and the first report concerning the effect of ventricular assist device implantation on intrapulmonary shunting. PMID:25873797

  11. Survival results after implantation of intrapericardial third-generation centrifugal assist device: an INTERMACS-matched comparison analysis.

    PubMed

    Dell'Aquila, Angelo M; Schneider, Stefan R B; Stypmann, Jörg; Ellger, Björn; Redwan, Bassam; Schlarb, Dominik; Martens, Sven; Sindermann, Jürgen R

    2014-05-01

    Reports on third-generation centrifugal intrapericardial pumps (HeartWare International, Inc., Framingham, MA, USA) have shown better survival results than the previous-generation devices. However, outcomes depending on the preoperative level of stability can substantially differ, resulting in a limited analysis of potentialities and drawbacks of a given device. In the present study we sought to compare in our single-center experience the survival results of this third-generation device with previous left ventricular systems taking into account the different preoperative Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) levels. Between February 1993 and March 2012, 287 patients underwent assist device implantation in our university hospital (INTERMACS Level 1-2 = 158 patients; INTERMACS Level 3-4-5 = 129 patients). Assist devices implanted were: Group A (HVAD HeartWare, n = 52), group B (previous continuous-flow ventricular assist device [VAD], InCor [Berlin Heart, Berlin, Germany], n = 37; VentrAssist [VentraCor, Inc., Chatswood, NSW, Australia], n = 7; DeBakey [MicroMed Cardiovascular, Inc., Houston, TX, USA], n = 32), and group C (pulsatile systems, n = 159). After cumulative support duration of 54 436 days and a mean follow-up of 6.21 ± 7.46 months (range 0-45.21 months), log-rank analysis revealed a survival for group A of 82.0%, 70.4%, and 70.4%; for group B of 84.0%, 48.2%, 33.7%; and for group C of 71.6%, 46.1%, 33.8%, at 1, 12, and 24 months respectively, with a significantly (P = 0.013) better outcome for group A. When stratifying the survival on the basis of INTERMACS level, no significant survival improvement was observed among all patients who underwent VAD implantation in INTERMACS 1-2 (P = 0.47). However, among patients who underwent elective VAD implantation (INTERMACS 3-4-5), group A had a significantly better outcome (P = 0.005) compared with the other INTERMACS

  12. The effect of steam sterilization on the accuracy of spring-style mechanical torque devices for dental implants

    PubMed Central

    Mahshid, Minoo; Saboury, Aboulfazl; Fayaz, Ali; Sadr, Seyed Jalil; Lampert, Friedrich; Mir, Maziar

    2012-01-01

    Background Mechanical torque devices (MTDs) are one of the most commonly recommended devices used to deliver optimal torque to the screw of dental implants. Recently, high variability has been reported about the accuracy of spring-style mechanical torque devices (S-S MTDs). Joint stability and survival rate of fixed implant supported prosthesis depends on the accuracy of these devices. Currently, there is limited information on the steam sterilization influence on the accuracy of MTDs. The purpose of this study was to assess the effect of steam sterilization on the accuracy (±10% of the target torque) of spring-style mechanical torque devices for dental implants. Materials and methods Fifteen new S-S MTDs and their appropriate drivers from three different manufacturers (Nobel Biocare, Straumann [ITI], and Biomet 3i [3i]) were selected. Peak torque of devices (5 in each subgroup) was measured before and after autoclaving using a Tohnichi torque gauge. Descriptive statistical analysis was used and a repeated-measures ANOVA with type of device as a between-subject comparison was performed to assess the difference in accuracy among the three groups of spring-style mechanical torque devices after sterilization. A Bonferroni post hoc test was used to assess pairwise comparisons. Results Before steam sterilization, all the tested devices stayed within 10% of their target values. After 100 sterilization cycles, results didn’t show any significant difference between raw and absolute error values in the Nobel Biocare and ITI devices; however the results demonstrated an increase of error values in the 3i group (P < 0.05). Raw error values increased with a predictable pattern in 3i devices and showed more than a 10% difference from target torque values (maximum difference of 14% from target torque was seen in 17% of peak torque measurements). Conclusion Within the limitation of this study, steam sterilization did not affect the accuracy (±10% of the target torque) of the

  13. Vibrant Soundbridge implantable hearing device: critical review and single-surgeon short- and long-term results.

    PubMed

    Luetje, Charles M; Brown, Sandra A; Cullen, Robert D

    2010-09-01

    We conducted a retrospective descriptive study of a series of 31 consecutively presenting patients who had been implanted with the Vibrant Soundbridge middle ear hearing device. All implantations had been performed by the senior author. Three of these patients had undergone bilateral implantation, and 4 others had undergone subsequent explantation and reimplantation in response to known or suspected device failure, giving us a total of 34 ears and 38 implants. Our goal was to ascertain short- and long-term outcomes as measured by conventional audiometry (pure-tone average at 1 to 6 kHz) and long-term benefit as defined by the use or nonuse of the device. We found that at the initial activation session 2 months postoperatively, the average hearing thresholds were within 3 dB of the preoperative thresholds in all 34 ears and all 38 implants. The mean short-term gain at activation in the 38 implants was 28.1 dB. Nineteen patients (20 ears) were available for long-term evaluation, with the length of follow-up ranging from less than 1 year to 11 years (mean: 7.3). Of these 20 ears, 9 demonstrated further gain (mean: 10.8 dB) despite any natural hearing deterioration; of the remaining 11 ears, gain was unchanged in 2, diminished in 7 (mean: -3.6 dB), and gain data were unavailable in 2. In the final analysis, there were 20 user ears and 10 nonuser ears; 4 ears were lost to all follow-up. We conclude that direct-drive hearing with the Vibrant Soundbridge middle ear hearing device is beneficial and provides sustained audiometric gain. Factors that have a significant impact on patient use or nonuse include difficulty in obtaining audiologic support and the direct and indirect costs of the device. Without audiologic or financial support, some patients may choose to become nonusers and to either switch to conventional hearing aid amplification or become apathetic about hearing improvement.

  14. In vivo demonstration of ultrasound power delivery to charge implanted medical devices via acute and survival porcine studies.

    PubMed

    Radziemski, Leon; Makin, Inder Raj S

    2016-01-01

    Animal studies are an important step in proving the utility and safety of an ultrasound based implanted battery recharging system. To this end an Ultrasound Electrical Recharging System (USER™) was developed and tested. Experiments in vitro demonstrated power deliveries at the battery of up to 600 mW through 10-15 mm of tissue, 50 mW of power available at tissue depths of up to 50 mm, and the feasibility of using transducers bonded to titanium as used in medical implants. Acute in vivo studies in a porcine model were used to test reliability of power delivery, temperature excursions, and cooling techniques. The culminating five-week survival study involved repeated battery charging, a total of 10.5h of ultrasound exposure of the intervening living tissue, with an average RF input to electrical charging efficiency of 20%. This study was potentially the first long term cumulative living-tissue exposure using transcutaneous ultrasound power transmission to an implanted receiver in situ. Histology of the exposed tissue showed changes attributable primarily due to surgical implantation of the prototype device, and no damage due to the ultrasound exposure. The in vivo results are indicative of the potential safe delivery of ultrasound energy for a defined set of source conditions for charging batteries within implants.

  15. Ion implantation to reduce wear on polyethylene prosthetic devices. Rept. for Aug 89-Jan 91

    SciTech Connect

    Not Available

    1991-05-01

    Researchers studied the use of ion implantation to improve the wear performance of ultra high molecular weight polyethylene (UHMWPE). UHMWPE samples were implanted with high energy ions, tested for wear performance, and compared to unimplanted control samples. Surface friction and hardness measurements, Raman scattering, Rutherford backscattering (RBS), water contact angle, and film transfer tests were performed to characterize the surface property changes of implanted UHMWPE samples. Results indicated a 90% reduction in wear on implanted UHMWPE disks. Implantation increased surface microhardness and surface energy. The Raman spectrum revealed a diamond-like signature, indicting carbon bonds of a different nature than those found in unimplanted polyehtylene. Photographic analysis of pins used in wear testing revealed differences between implanted and unimplanted samples in the polyethylene film transferred in the initial stages of wear from the disk to the pin.

  16. Implantable Microimagers

    PubMed Central

    Ng, David C.; Tokuda, Takashi; Shiosaka, Sadao; Tano, Yasuo; Ohta, Jun

    2008-01-01

    Implantable devices such as cardiac pacemakers, drug-delivery systems, and defibrillators have had a tremendous impact on the quality of live for many disabled people. To date, many devices have been developed for implantation into various parts of the human body. In this paper, we focus on devices implanted in the head. In particular, we describe the technologies necessary to create implantable microimagers. Design, fabrication, and implementation issues are discussed vis-à-vis two examples of implantable microimagers; the retinal prosthesis and in vivo neuro-microimager. Testing of these devices in animals verify the use of the microimagers in the implanted state. We believe that further advancement of these devices will lead to the development of a new method for medical and scientific applications. PMID:27879873

  17. Bibliometric analysis of the literature from the mainland of China on animal-derived regenerative implantable medical devices

    NASA Astrophysics Data System (ADS)

    Wang, Hong-Man; Li, Fu-Yao

    2014-12-01

    Choosing animal-derived regenerative implantable medical devices based on tissue engineering technology as a research theme, this paper presents bibliometric analysis of relative literature from the mainland of China to understand such data as publication year and journal preference, authors' geographic location, research topics and core expertise to predict the research trends and provide an informed basis of decision making for researchers and clinicians.

  18. Beneficial Effect of Covalently Grafted α-MSH on Endothelial Release of Inflammatory Mediators for Applications in Implantable Devices

    PubMed Central

    Le Saux, Guillaume; Plawinski, Laurent; Nlate, Sylvain; Ripoche, Jean; Buffeteau, Thierry; Durrieu, Marie-Christine

    2016-01-01

    Intravascular devices for continuous glucose monitoring are promising tools for the follow up and treatment of diabetic patients. Limiting the inflammatory response to the implanted devices in order to achieve better biocompatibility is a critical challenge. Herein we report on the production and the characterization of gold surfaces covalently derivatized with the peptide α-alpha-melanocyte stimulating hormone (α-MSH), with a quantifiable surface density. In vitro study demonstrated that the tethered α-MSH is able to decrease the expression of an inflammatory cytokine produced by endothelial cells. PMID:26939131

  19. In vivo distribution of 5-Fluorouracil after peritumoral implantation using a biodegradable micro-device in tumor-bearing mice.

    PubMed

    Zheng, Na; Zhou, Mingyao; Lu, Wen

    2013-09-01

    A novel implantable micro-device was used for delivery of 5-Fluorouracil (5-Fu), which was often used in the treatment of various human malignancies. The biodegradable poly(lactic-co-glycolic) acid (PLGA) was used as material. The purpose of this study was to investigate the efficiency of delivery of 5-Fu to the tumor via this delivery system. The distribution characters of the 5-Fu in tumor, plasma, peritumoral tissue, liver and kidney were compared after peritumoral implantation of micro-device and intraperitoneal injection of solution. After administration of micro-device, the 5-Fu was absorbed into the tumor on Day 1, and Cmax (4.14 μg/g) was reached on Day 6. The half life for the elimination was 4.48 d and the AUC was 46.78 μg × d/g. Similar pharmacokinetic behaviors were observed in plasma, peritumoral tissue, kidney and liver, while the Cmax and the AUC of plasma and these tissues were lower than those of tumor. When administered the solution, 5-Fu was rapidly absorbed into plasma, liver, kidney, spleen and tumor, and rapidly cleared from these tissues after 2 or 4 h. And the AUC in tumor of 5-Fu solution was significantly lower than that of the micro-device. These results indicated that 5-Fu loaded biodegradable micro-device offered a relatively high concentration and long-term delivery of the drug to the tumor site.

  20. Capsule endoscopy in patients with cardiac pacemakers, implantable cardioverter defibrillators, and left heart devices: a review of the current literature.

    PubMed

    Bandorski, Dirk; Keuchel, Martin; Brück, Martin; Hoeltgen, Reinhard; Wieczorek, Marcus; Jakobs, Ralf

    2011-01-01

    Background and Study Aims. Capsule endoscopy is an established tool for investigation of the small intestine. Because of limited clinical experience in patients with cardiac devices, the Food and Drug Administration and the manufacturer recommended not to use capsule endoscopy in these patients. The vast majority of investigations did not reveal any interference between capsule endoscopy and cardiac devices. Methods. Studies investigating interference between CE and cardiac devices were analysed. For the review we considered studies published in English or German and indexed in Medline, as well as highly relevant abstracts. Results. In vitro and in vivo studies mainly revealed no interference between capsule endoscopy and cardiac devices. Technical data of capsule endoscopy (Given Imaging) reveal that interference with cardiac pacemakers and implantable cardioverter defibrillator is impossible. Telemetry can interfere with CE video. Conclusion. The clinical use of capsule endoscopy (Given Imaging) is unproblematic in patients with cardiac pacemakers.

  1. Functionalized silica nanoparticles as a carrier for Betamethasone Sodium Phosphate: Drug release study and statistical optimization of drug loading by response surface method.

    PubMed

    Ghasemnejad, M; Ahmadi, E; Mohamadnia, Z; Doustgani, A; Hashemikia, S

    2015-11-01

    Mesoporous silica nanoparticles with a hexagonal structure (SBA-15) were synthesized and modified with (3-aminopropyl) triethoxysilane (APTES), and their performance as a carrier for drug delivery system was studied. Chemical structure and morphology of the synthesized and modified SBA-15 were characterized by SEM, BET, TEM, FT-IR and CHN technique. Betamethasone Sodium Phosphate (BSP) as a water soluble drug was loaded on the mesoporous silica particle for the first time. The response surface method was employed to obtain the optimum conditions for the drug/silica nanoparticle preparation, by using Design-Expert software. The effect of time, pH of preparative media, and drug/silica ratio on the drug loading efficiency was investigated by the software. The maximum loading (33.69%) was achieved under optimized condition (pH: 1.8, time: 3.54 (h) and drug/silica ratio: 1.7). The in vitro release behavior of drug loaded particles under various pH values was evaluated. Finally, the release kinetic of the drug was investigated using the Higuchi and Korsmeyer-Peppas models. Cell culture and cytotoxicity assays revealed the synthesized product doesn't have any cytotoxicity against human bladder cell line 5637. Accordingly, the produced drug-loaded nanostructures can be applied via different routes, such as implantation and topical or oral administration.

  2. Cerebral Blood Flow Autoregulation Is Preserved After Continuous Flow Left Ventricular Assist Device Implantation

    PubMed Central

    Ono, Masahiro; Joshi, Brijen; Brady, Kenneth; Easley, R. Blaine; Kibler, Kathy; Conte, John; Shah, Ashish; Russell, Stuart D.; Hogue, Charles W.

    2012-01-01

    Objective To compare cerebral blood flow (CBF) autoregulation in patients undergoing continuous flow left ventricular assist device (LVAD) implantation with that in patients undergoing coronary artery bypass graft (CABG) surgery. Design Prospective, observational, controlled study. Setting Academic medical center. Participants Fifteen patients undergoing LVAD insertion and 10 patients undergoing CABG surgery. Measurements and Main Results Cerebral autoregulation was monitored with transcranial Doppler and near-infrared spectroscopy (NIRS). A continuous, Pearson's correlation coefficient was calculated between mean arterial pressure (MAP) and CBF velocity, and between MAP and NIRS data rendering the variables mean velocity index (Mx) and cerebral oximetry index (COx), respectively. Mx and COx approach zero when autoregulation is intact (no correlation between CBF and MAP), but approach 1 when autoregulation is impaired. Mx was lower during and immediately after cardiopulmonary bypass (CPB) in the LVAD group than it was in the CABG surgery patients, indicating better preserved autoregulation. Based on COx monitoring, autoregulation tended to be better preserved in the LVAD group than in the CABG group immediately after surgery (p=0.0906). On postoperative day 1, COx was lower in LVAD patients than in CABG surgery patients, again indicating preserved CBF autoregulation (p=0.0410). Based on COx monitoring, 3 (30%) of the CABG patients had abnormal autoregulation (COx ≥ 0.3) on the first postoperative day but none of the LVAD patients had this abnormality (p=0.037). Conclusion These data suggest that CBF autoregulation is preserved during and immediately after surgery in patients undergoing LVAD insertion. PMID:23122299

  3. The contributions of William F. House to the field of implantable auditory devices.

    PubMed

    Eisenberg, Laurie S

    2015-04-01

    William F. House was a pioneer in the evolving field of cochlear implants and auditory brainstem implants. Because of his vision, innovation and perseverance, the way was paved for future clinicians and researchers to carry on the work and advance a field that has been dedicated to serving adults and children with severe to profound hearing loss. Several of William House's contributions are highlighted in this prestigious volume to honor the recipients of the 2013 Lasker-Debakey Clinical Medical Research Award. Discussed are the early inventive years, clinical trials with the single-channel cochlear implant, the team approach, pediatric cochlear implantation, and the auditory brainstem implant. Readers may be surprised to learn that those early contributions continue to have relevance today. This article is part of a Special Issue entitled .

  4. Influence of electromagnetic interference on implanted cardiac arrhythmia devices in and around a magnetically levitated linear motor car.

    PubMed

    Fukuta, Motoyuki; Mizutani, Noboru; Waseda, Katsuhisa

    2005-01-01

    This study was designed to determine the susceptibility of implanted cardiac arrhythmia devices to electromagnetic interference in and around a magnetically levitated linear motor car [High-Speed Surface Transport (HSST)]. During the study, cardiac devices were connected to a phantom model that had similar characteristics to the human body. Three pacemakers from three manufacturers and one implantable cardioverter-defibrillator (ICD) were evaluated in and around the magnetically levitated vehicle. The system is based on a normal conductive system levitated by the attractive force of magnets and propelled by a linear induction motor without wheels. The magnetic field strength at 40 cm from the vehicle in the nonlevitating state was 0.12 mT and that during levitation was 0.20 mT. The magnetic and electric field strengths on a seat close to the variable voltage/variable frequency inverter while the vehicle was moving and at rest were 0.13 mT, 2.95 V/m and 0.04 mT, 0.36 V/m, respectively. Data recorded on a seat close to the reactor while the vehicle was moving and at rest were 0.09 mT, 2.45 V/m and 0.05 mT, 1.46 V/m, respectively. Measured magnetic and electric field strengths both inside and outside the linear motor car were too low to result in device inactivation. No sensing, pacing, or arrhythmic interactions were noted with any pacemaker or ICD programmed in either bipolar and unipolar configurations. In conclusion, our data suggest that a permanent programming change or a device failure is unlikely to occur and that the linear motor car system is probably safe for patients with one of the four implanted cardiac arrhythmia devices used in this study under the conditions tested.

  5. Radiotherapy-Induced Cardiac Implantable Electronic Device Dysfunction in Patients With Cancer.

    PubMed

    Bagur, Rodrigo; Chamula, Mathilde; Brouillard, Émilie; Lavoie, Caroline; Nombela-Franco, Luis; Julien, Anne-Sophie; Archambault, Louis; Varfalvy, Nicolas; Gaudreault, Valérie; Joncas, Sébastien X; Israeli, Zeev; Parviz, Yasir; Mamas, Mamas A; Lavi, Shahar

    2017-01-15

    Radiotherapy can affect the electronic components of a cardiac implantable electronic device (CIED) resulting in malfunction and/or damage. We sought to assess the incidence, predictors, and clinical impact of CIED dysfunction (CIED-D) after radiotherapy for cancer treatment. Clinical characteristics, cancer, different types of CIEDs, and radiation dose were evaluated. The investigation identified 230 patients, mean age 78 ± 8 years and 70% were men. A total of 199 patients had pacemakers (59% dual chamber), 21 (9%) cardioverter-defibrillators, and 10 (4%) resynchronizators or defibrillators. The left pectoral (n = 192, 83%) was the most common CIED location. Sixteen patients (7%) experienced 18 events of CIED-D after radiotherapy. Reset to backup pacing mode was the most common encountered dysfunction, and only 1 (6%) patient of those with CIED-D experienced symptoms of atrioventricular dyssynchrony. Those who had CIED-D tended to have a shorter device age at the time of radiotherapy compared to those who did not (2.5 ± 1.5 vs 3.8 ± 3.4 years, p = 0.09). The total dose prescribed to the tumor was significantly greater among those who had CIED-D (66 ± 30 vs 42 ± 23 Gy, p <0.0001). Multivariate logistic regression analysis identified the total dose prescribed to the tumor as the only independent predictor for CIED-D (odds ratio 1.19 for each increase in 5 Gy, 95% confidence interval 1.08 to 1.31, p = 0.0005). In conclusion, in this large population of patients with CIEDs undergoing radiotherapy for cancer treatment, the occurrence of newly diagnosed CIED-D was 7%, and the reset to backup pacing mode was the most common encountered dysfunction. The total dose prescribed to the tumor was a predictor of CIED-D. Importantly, although the unpredictability of CIEDs under radiotherapy is still an issue, none of our patients experienced significant symptoms, life-threatening arrhythmias, or conduction disorders.

  6. Survival Benefit of Implantable Cardioverter-Defibrillators in Left Ventricular Assist Device-Supported Heart Failure Patients

    PubMed Central

    Refaat, Marwan M.; Tanaka, Toshikazu; Kormos, Robert L; McNamara, Dennis; Teuteberg, Jeffrey; Winowich, Steve; London, Barry; Simon, Marc A

    2012-01-01

    Background Implantable Cardioverter-Defibrillators (ICDs) reduce mortality in heart failure (HF). In patients requiring ventricular assist device (VAD), the benefit from ICD therapy is not well established. The aim of the study is to define the impact of ICD on outcomes in VAD - supported patients. Methods and Results We reviewed data for consecutive adult HF patients receiving VAD as bridge-to-transplantation from 1996 to 2003. Primary outcome was survival to transplantation. A total of 144 VADs were implanted [85 left ventricular (LVAD), 59 biventricular (BIVAD), age 50±12 years, 77% male, LVEF 18±9%, 54% ischemic]. Mean length of support was 119 days (range 1–670); 103 (72%) patients survived to transplantation. Forty-five patients had an ICD (33 LVAD, 12 BIVAD). More LVAD patients had an appropriate ICD shock before implantation than afterwards (16 vs. 7, p=0.02). There was a trend towards higher shock frequency before LVAD implant than after (3.3±5.2 vs 1.1±3.8 shocks/year, p=0.06). Mean time to first shock after VAD implant was 129±109 days. LVAD-supported patients with an ICD were significantly more likely to survive to transplantation (LVAD: 1-year actuarial survival to transplantation 91% with ICD vs. 57% without ICD, log-rank p=0.01; BIVAD: 54% vs. 47%, log-rank p=NS). An ICD was associated with significantly increased survival in a multivariate model controlling for confounding variables (OR 2.54, 95% CI 1.04-6.21, p=0.04). Conclusions Shock frequency decreases after VAD implantation, likely due to ventricular unloading, but appropriate ICD shocks still occur in 21% of patients. An ICD is associated with improved survival in LVAD-supported HF patients. PMID:22300782

  7. Extracorporeal life support prior to left ventricular assist device implantation leads to improvement of the patients INTERMACS levels and outcome

    PubMed Central

    Schibilsky, David; Lange, Bruno; Schibilsky, Barbara; Haeberle, Helene; Seizer, Peter; Gawaz, Meinrad; Rosenberger, Peter; Walker, Tobias; Schlensak, Christian

    2017-01-01

    Background The objective of this study was to evaluate the outcome of left ventricular assist device (LVAD) implantation after initial extracorporeal life support (ECLS) in patients with cardiogenic shock and the incidence of post implantation right ventricular failure. Methods & results All patients on ECLS therapy for cardiogenic shock prior to LVAD implantation (n = 15) between October 2011 and January 2014 were analyzed. Baseline patient characteristics, as well as detailed pre-operative treatment and postoperative outcome data were collected retrospectively. At time of admission to our unit all patients were classified INTERMACS II or higher (12 [80%] INTERMACS I). Improvement to INTERMACS III temporary cardiac support (TCS) at time of LVAD implantation was successful in 14 patients (93.3%). End-organ function recovered during ECLS support. No patient needed ongoing ECLS or additional right ventricular support after LVAD implantation. Both in-hospital and 30-day mortality was 6.7% (n = 1). The median duration of LVAD support was 687.9 ± 374.5 days. At the end of the study (follow-up 810.7 +/- 338.9 days), 13 (86.7%) patients were alive. The majority of patients (10 [66.7%]) remained on LVAD support. Transplantation could be performed in 1 (6.7%) patient, 2 (13.3%) patients could be successfully weaned. Conclusion LVAD implantation in ECLS patients leads to improvement of INTERMACS level to INTERMACS III TCS status. Excellent mid-term survival comparable to true INTERMACS III-IV patients could be shown. ECLS prior to LVAD as a bridge-to-bridge therapy may help to lower mortality in primarily unstable patients. PMID:28358849

  8. Identifying Physiologically Significant Pumping State Transitions in Implantable Rotary Blood Pumps Used as Left Ventricular Assist Devices: An In-Vivo Study

    DTIC Science & Technology

    2007-11-02

    bearing to support its impeller. The pump is to be used as a left ventricular assist device ( LVAD ). Varying pump speed can control the degree of left...These data indicate that the STI may be a valuable mechanism to in optimal LVAD control. Keywords - Implantable rotary blood pump, pumping states...as a left ventricular assist device ( LVAD ) with both bridge-to-transplant and long-term implantation anticipated. Current commercially used rotary

  9. Standardized MR terminology and reporting of implants and devices as recommended by the American College of Radiology Subcommittee on MR Safety.

    PubMed

    Kanal, Emanuel; Froelich, Jerry; Barkovich, A James; Borgstede, James; Bradley, William; Gimbel, J Rod; Gosbee, John; Greenberg, Todd; Jackson, Edward; Larson, Paul; Lester, James; Sebek, Elizabeth; Shellock, Frank G; Weinreb, Jefrey; Wilkoff, Bruce L; Hernandez, Dina

    2015-03-01

    Considerable confusion exists among the magnetic resonance (MR) imaging user community as to how to determine whether a patient with a metal implanted device can be safely imaged in an MR imaging unit. Although there has been progress by the device manufacturers in specifying device behavior in a magnetic field, and some MR imaging manufacturers provide maps of the "spatial gradients," there remains significant confusion because of the lack of standardized terminology and reporting guidelines. The American College of Radiology, through its Subcommittee on MR Safety, has proposed standardized terminology that will contribute to greater safety and understanding for screening metal implants and/or devices prior to MR imaging.

  10. First audiometric results with the Vibrant soundbridge, a semi-implantable hearing device for sensorineural hearing loss.

    PubMed

    Snik, A F; Cremers, C W

    1999-01-01

    The Vibrant soundbridge is a semi-implantable hearing device. The implanted electromagnetic transducer is attached to the incus and it is linked by telemetry to the externally worn audio processor. In Nijmegen, this device has been applied to seven patients with moderate or severe sensorineural hearing loss (PTA between 43 and 71 dB HL) who could not tolerate ear moulds. As the amplification of the device depends on the input level (amplifier with wide dynamic range compression), loudness scaling measurements were performed. The gain as a function of input level was determined from aided and unaided loudness growth curves. The mean gain was 21 dB at an input level of 40 dB SPL. The mean gain decreased to 5 dB at an input level of 90 dB SPL. Measured gain values were lower than target values prescribed by the FIG6 method, mainly however for the low-frequency range and for low-level sounds. It was concluded that this device is very promising for patients who cannot tolerate an ear mould.

  11. The role of the registered nurse-first assistant in the implantable left ventricular assist device program.

    PubMed

    Hlozek, C C; Zacharias, W M; Vargo, R L; Elias, B A; Yeager, M; McCarthy, P M

    1995-01-01

    Successful support of patients using the implantable left ventricular assist device requires sustained and coordinated efforts by physicians and medical personnel. The authors describe the role of their registered nurse-first assistant (RNFA) as it has evolved through caring for 43 implantable pneumatic left ventricular assist device patients and 8 vented-electric left ventricular assist system patients during a 3 year period. Intraoperatively, the RNFA is responsible for pump assembly, including pre sealing all grafts and connecting areas of the pump using a combination of cryoprecipitate and thrombin. The RNFA assists with pump insertion during surgery. At device explantation, the RNFA dismantles the pump according to the FDA protocol for disassembly. Post operatively, the RNFA assesses and maintains patient hemodynamic stability and intervenes to manage hemodynamic and mechanical problems. Of the 51 patients, 13 are still on support, 9 died before transplantation (17.6%), and post transplant survival is 96.0%. In conclusion, an active left ventricular assist device program requires skilled personnel to manage complex problems and contributes to a successful patient outcome.

  12. B-type natriuretic peptide-guided therapy and length of hospital stay 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; Shaukat, Arslan; Pickrell, Jeanette; Caccamo, Marco A; Gradus-Pizlo, Irmina; Hadi, Azam

    2015-01-01

    B-type natriuretic peptide (BNP)-guided therapy during the early postoperative period following left ventricular assist device (LVAD) implantation has not been well described in the literature. We conducted a retrospective cohort study consisting of consecutive patients who underwent LVAD implantation at our institution during May 2009 to March 2013. The study was limited to patients receiving HeartMate II (Thoratec) or HVAD (HeartWare) LVADs. Patients with acute myocardial infarction were excluded. We compared between patients with multiple postoperative BNP tests (BNP-guided therapy) and earlier period patients who typically had only a baseline BNP measurement (non-BNP-guided therapy). A total of 85 patients underwent LVAD implantation during the study period. Eight patients were excluded (five acute myocardial infarction, three without BNP measurements). The only differences in the baseline characteristics of BNP versus non-BNP-guided therapy included age and female gender. The postoperative length of hospital stay (LOS) in the BNP-guided therapy group was 5 days shorter when compared with the non-BNP-guided therapy group. In multivariate analysis, BNP-guided therapy remained a significant predictor of reduced LOS. The use of repeated BNP measurements during the early postoperative period was associated with a significantly lower LOS post LVAD implantation.

  13. Numerical evaluation of implantable hearing devices using a finite element model of human ear considering viscoelastic properties.

    PubMed

    Zhang, Jing; Tian, Jiabin; Ta, Na; Huang, Xinsheng; Rao, Zhushi

    2016-08-01

    Finite element method was employed in this study to analyze the change in performance of implantable hearing devices due to the consideration of soft tissues' viscoelasticity. An integrated finite element model of human ear including the external ear, middle ear and inner ear was first developed via reverse engineering and analyzed by acoustic-structure-fluid coupling. Viscoelastic properties of soft tissues in the middle ear were taken into consideration in this model. The model-derived dynamic responses including middle ear and cochlea functions showed a better agreement with experimental data at high frequencies above 3000 Hz than the Rayleigh-type damping. On this basis, a coupled finite element model consisting of the human ear and a piezoelectric actuator attached to the long process of incus was further constructed. Based on the electromechanical coupling analysis, equivalent sound pressure and power consumption of the actuator corresponding to viscoelasticity and Rayleigh damping were calculated using this model. The analytical results showed that the implant performance of the actuator evaluated using a finite element model considering viscoelastic properties gives a lower output above about 3 kHz than does Rayleigh damping model. Finite element model considering viscoelastic properties was more accurate to numerically evaluate implantable hearing devices.

  14. A Rat Model of Thrombosis in Common Carotid Artery Induced by Implantable Wireless Light-Emitting Diode Device

    PubMed Central

    Huang, Kuo-Lun; Hsiao, Yung-Chin; Lin, Yun-Han; Lou, Shyh-Liang; Lee, Tsong-Hai

    2014-01-01

    This work has developed a novel approach to form common carotid artery (CCA) thrombus in rats with a wireless implantable light-emitting diode (LED) device. The device mainly consists of an external controller and an internal LED assembly. The controller was responsible for wirelessly transmitting electrical power. The internal LED assembly served as an implant to receive the power and irradiate light on CCA. The thrombus formation was identified with animal sonography, 7T magnetic resonance imaging, and histopathologic examination. The present study showed that a LED assembly implanted on the outer surface of CCA could induce acute occlusion with single irradiation with 6 mW/cm2 LED for 4 h. If intermittent irradiation with 4.3–4.5 mW/cm2 LED for 2 h was shut off for 30 min, then irradiation for another 2 h was applied; the thrombus was observed to grow gradually and was totally occluded at 7 days. Compared with the contralateral CCA without LED irradiation, the arterial endothelium in the LED-irradiated artery was discontinued. Our study has shown that, by adjusting the duration of irradiation and the power intensity of LED, it is possible to produce acute occlusion and progressive thrombosis, which can be used as an animal model for antithrombotic drug development. PMID:25045695

  15. Fully implantable Otologics MET Carina™ device for the treatment of sensorineural hearing loss. Preliminary surgical and clinical results

    PubMed Central

    Bruschini, L; Forli, F; Santoro, A; Bruschini, P; Berrettini, S

    2009-01-01

    Summary Middle ear implants overcome some of the common problems of conventional hearing aid technology, such as feedback, signal distortion, ear canal occlusion and associated issues. The Otologics MET Carina™, Boulder, CO, USA, is a fully implantable hearing prosthesis designed to address the amplification needs of adults (> 18 years of age), with moderate to severe sensorineural hearing loss and normal middle ears, providing a mechanical direct stimulation of middle ear ossicles. Recently, it has been successfully used also in patients with conductive hearing loss. In the present report, personal surgical and clinical experience with the fully implantable Carina™ is described in 5 adults with moderate to severe sensorineural hearing loss, operated upon between November 2007 and May 2008 in the ENT Unit, University of Pisa. Mean follow-up was 10.2 months of device use (range 7-13). Surgery was performed under general anaesthesia, in ~3 hours, with no surgical complications in any of the patients. In these 5 cases, no significant post-operative variation was observed in hearing thresholds, either for air or bone conduction, indicating absence of surgical damage to the cochlea. All patients showed improvements in hearing thresholds, in free field and in speech perception abilities, with the device functioning, moreover, they reported subjective benefits. With regard to post-operative adverse effects, no cases of extrusion of the device, device failure, loss of external communication or increased charging times were observed. Problems of feedback noise occurred, which were resolved with minor fitting adjustments in 4 cases, while a second operation was required to change the microphone position in the other patient. The present results, in agreement with those reported in the literature, confirm that the Otologics MET Carina™ is viable treatment for moderate to severe sensorineural hearing loss and, in selected cases, may represent an alternative to

  16. A Longitudinal Study of Speech Perception Skills and Device Characteristics of Adolescent Cochlear Implant Users

    PubMed Central

    Robinson, Elizabeth J.; Davidson, Lisa S.; Uchanski, Rosalie M.; Brenner, Christine M.; Geers, Ann E.

    2012-01-01

    Background For pediatric cochlear implant (CI) users, CI processor technology, map characteristics and fitting strategies are known to have a substantial impact on speech perception scores at young ages. It is unknown whether these benefits continue over time as these children reach adolescence. Purpose To document changes in CI technology, map characteristics, and speech perception scores in children between elementary grades and high school, and to describe relations between map characteristics and speech perception scores over time. Research Design A longitudinal design with participants 8–9 years old at session 1 and 15–18 years old at session 2. Study Sample Participants were 82 adolescents with unilateral CIs, who are a subset of a larger longitudinal study. Mean age at implantation was 3.4 years (range: 1.7 – 5.4), and mean duration of device use was 5.5 years (range: 3.8–7.5) at session 1 and 13.3 years (range: 10.9–15) at session 2. Data Collection and Analysis Speech perception tests at sessions 1 and 2 were the Lexical Neighborhood word Test (LNT-70) and Bamford-Kowal-Bench sentences in quiet (BKB-Q), presented at 70 dB SPL. At session 2, the LNT was also administered at 50 dB SPL (LNT-50) and BKB sentences were administered in noise with a +10 dB SNR (BKB-N). CI processor technology type and CI map characteristics (coding strategy, number of electrodes, map threshold levels [T levels], and map comfort levels [C levels]) were obtained at both sessions. Electrical dynamic range [EDR] was computed [C level – T level], and descriptive statistics, correlations, and repeated-measures ANOVAs were employed. Results Participants achieved significantly higher LNT and BKB scores, at 70 dB SPL, at ages 15-18 than at ages 8-9 years. Forty-two participants had 1-3 electrodes either activated or deactivated in their map between test sessions, and 40 had no change in number of active electrodes (mean change: -0.5; range: -3 to +2). After conversion from

  17. Ion implantation reduces radiation sensitivity of metal oxide silicon /MOS/ devices

    NASA Technical Reports Server (NTRS)

    1971-01-01

    Implanting nitrogen ions improves hardening of silicon oxides 30 percent to 60 percent against ionizing radiation effects. Process reduces sensitivity, but retains stability normally shown by interfaces between silicon and thermally grown oxides.

  18. Energy-efficient adaptive modulation in wireless communication for implanted medical devices.

    PubMed

    Qiu, Yinyue; Haley, David; Chen, Ying

    2014-01-01

    In contrast to conventional wireless communication which takes place over the air, Radio Frequency (RF) communication through the human body poses unique challenges. Studies on RF propagation through human body indicate that the heterogeneous body tissues with different dielectric properties constitute a complicated and lossy environment for signal propagation. This environment also varies with different implant positions, individuals, body shapes and postures. As a result, there is a large variation in the path loss value of the in-body communication channel. In this paper, we first examine the energy efficiency of different digital modulation schemes in a basic wireless implant system. We point out that using a fixed type of modulation does not help to achieve the best energy efficiency in the implant system that has varying channel conditions. We then propose an adaptive communication system model which is suitable for wireless medical implant. Simulations results show that adopting adaptive modulation can provide a considerable amount of energy saving.

  19. Translation of First North American 50 and 70 cc Total Artificial Heart Virtual and Clinical Implantations: Utility of 3D Computed Tomography to Test Fit Devices.

    PubMed

    Ferng, Alice S; Oliva, Isabel; Jokerst, Clinton; Avery, Ryan; Connell, Alana M; Tran, Phat L; Smith, Richard G; Khalpey, Zain

    2016-11-10

    Since the creation of SynCardia's 50 cc Total Artificial Hearts (TAHs), patients with irreversible biventricular failure now have two sizing options. Herein, a case series of three patients who have undergone successful 50 and 70 cc TAH implantation with complete closure of the chest cavity utilizing preoperative "virtual implantation" of different sized devices for surgical planning are presented. Computed tomography (CT) images were used for preoperative planning prior to TAH implantation. Three-dimensional (3D) reconstructions of preoperative chest CT images were generated and both 50 and 70 cc TAHs were virtually implanted into patients' thoracic cavities. During the simulation, the TAHs were projected over the native hearts in a similar position to the actual implantation, and the relationship between the devices and the atria, ventricles, chest wall, and diaphragm were assessed. The 3D reconstructed images and virtual modeling were used to simulate and determine for each patient if the 50 or 70 cc TAH would have a higher likelihood of successful implantation without complications. Subsequently, all three patients received clinical implants of the properly sized TAH based on virtual modeling, and their chest cavities were fully closed. This virtual implantation increases our confidence that the selected TAH will better fit within the thoracic cavity allowing for improved surgical outcome. Clinical implantation of the TAHs showed that our virtual modeling was an effective method for determining the correct fit and sizing of 50 and 70 cc TAHs.

  20. Candida and cardiovascular implantable electronic devices: a case of lead and native aortic valve endocarditis and literature review.

    PubMed

    Glavis-Bloom, Justin; Vasher, Scott; Marmor, Meghan; Fine, Antonella B; Chan, Philip A; Tashima, Karen T; Lonks, John R; Kojic, Erna M

    2015-11-01

    Use of cardiovascular implantable electronic devices (CIED), including permanent pacemakers (PPM) and implantable cardioverter defibrillators (ICD), has increased dramatically over the past two decades. Most CIED infections are caused by staphylococci. Fungal causes are rare and their prognosis is poor. To our knowledge, there has not been a previously reported case of multifocal Candida endocarditis involving both a native left-sided heart valve and a CIED lead. Here, we report the case of a 70-year-old patient who presented with nausea, vomiting, and generalised fatigue, and was found to have Candida glabrata endocarditis involving both a native aortic valve and right atrial ICD lead. We review the literature and summarise four additional cases of CIED-associated Candida endocarditis published from 2009 to 2014, updating a previously published review of cases prior to 2009. We additionally review treatment guidelines and discuss management of CIED-associated Candida endocarditis.

  1. A dynamic Bayesian network approach for time-specific survival probability prediction in patients after ventricular assist device implantation.

    PubMed

    Exarchos, Themis P; Rigas, George; Goletsis, Yorgos; Stefanou, Kostas; Jacobs, Steven; Trivella, Maria-Giovanna; Fotiadis, Dimitrios I

    2014-01-01

    In this work we present a decision support tool for the calculation of time-dependent survival probability for patients after ventricular assist device implantation. Two different models have been developed, a short term one which predicts survival for the first three months and a long term one that predicts survival for one year after implantation. In order to model the time dependencies between the different time slices of the problem, a dynamic Bayesian network (DBN) approach has been employed. DBNs order to capture the temporal events of the patient disease and the temporal data availability. High accuracy results have been reported for both models. The short and long term DBNs reached an accuracy of 96.97% and 93.55% respectively.

  2. Multicenter audiometric results with the Vibrant Soundbridge, a semi-implantable hearing device for sensorineural hearing impairment.

    PubMed

    Snik, A F; Mylanus, E A; Cremers, C W; Dillier, N; Fisch, U; Gnadeberg, D; Lenarz, T; Mazolli, M; Babighian, G; Uziel, A S; Cooper, H R; O'Connor, A F; Fraysse, B; Charachon, R; Shehata-Dieler, W E

    2001-04-01

    The Vibrant Soundbridge, a semi-implantable hearing device for subjects with moderate to severe sensorineural hearing impairment was introduced commercially. First audiologic results are presented on 63 patients from 10 European implant centers. Hearing loss was at 0.5, 1, 2, and 4 kHz varying between 43 and 81 dB HL. The patients used the analogue audio processor, type 302. Measured sound-field gain was compared with NAL-R target values. For most patients an acceptable agreement was found. There was a subgroup of patients, however, with relatively low gain. The results suggest that this was related to the suboptimal positioning and fixation of the transducer to the incus.

  3. Characterization of Porous Mg-Zn Alloy Using X-Ray Tomography and its Drug-Loading Behavior

    NASA Astrophysics Data System (ADS)

    Wang, Bing; Li, Kaikai; Zhang, Yuhong; Yan, Biao; Lu, Wei

    2013-07-01

    Porous Mg alloys will be promising orthopedic implants materials. In this study, porous Mg-Zn alloy with a porosity of 30% was prepared by powder metallurgy process. XRD was used to examine the composition of the sample and synchrotron radiation-based X-ray micro-computed tomography (SR-μCT) was used to investigate the pore properties of the sample. The results showed that the sample comprised a single Mg phase and a Mg2Zn11 phase. The SR-μCT results showed that the porosity of the sample is about 30% which is approximate to the theoretical porosity. The pore morphology was irregular and the largest pore was about 200 μm in diameter. And a large pore cluster was identified meaning that most of the pores in the sample were interconnected with each other. This is beneficial for the materials transformation after the implantation of the sample in human body, which will boost the bone regeneration. Drug-loading experiment showed that Ibuprofen can be successfully loaded in porous Mg-Zn alloy, which means that porous Mg-Zn alloy could be an orthopedic drug delivery system (DDS).

  4. Telemetry and Telestimulation via Implanted Devices Necessary in Long-Term Experiments Using Conscious Untethered Animals for the Development of New Medical Treatments

    NASA Astrophysics Data System (ADS)

    Sugimachi, Masaru; Kawada, Toru; Uemura, Kazunori

    Effective countermeasures against explosive increase in healthcare expenditures are urgently needed. A paradigm shift in healthcare is called for, and academics and governments worldwide are working hard on the application of information and communication technologies (ICT) as a feasible and effective measure for reducing medical cost. The more prevalent the disease and the easier disease outcome can be improved, the more efficient is medical ICT in reducing healthcare cost. Hypertension and diabetes mellitus are such examples. Chronic heart failure is another disease in which patients may benefit from ICT-based medical practice. It is conceivable that daily monitoring of hemodynamics together with appropriate treatments may obviate the expensive hospitalization. ICT potentially permit continuous monitoring with wearable or implantable medical devices. ICT may also help accelerate the development of new therapeutic devices. Traditionally effectiveness of treatments is sequentially examined by sacrificing a number of animals at a given time point. These inefficient and inaccurate methods can be replaced by applying ICT to the devices used in chronic animal experiments. These devices allow researchers to obtain biosignals and images from live animals without killing them. They include implantable telemetric devices, implantable telestimulation devices, and imaging devices. Implanted rather than wired monitoring and stimulation devices permit experiments to be conducted under even more physiological conditions, i.e., untethered, free-moving states. Wireless communication and ICT are indispensible technologies for the development of such telemetric and telestimulation devices.

  5. Clinical Outcomes of Patients Treated With Pulmonary Vasodilators Early and in High Dose After Left Ventricular Assist Device Implantation.

    PubMed

    Critoph, Christopher; Green, Gillian; Hayes, Helen; Baumwol, Jay; Lam, Kaitlyn; Larbalestier, Robert; Chih, Sharon

    2016-01-01

    Right ventricular failure (RVF) is common after left ventricular assist device (LVAD) implantation and a major determinant of adverse outcomes. Optimal perioperative right ventricular (RV) management is not well defined. We evaluated the use of pulmonary vasodilator therapy during LVAD implantation. We performed a retrospective analysis of continuous-flow LVAD implants and pulmonary vasodilator use at our institution between September 2004 and June 2013. Preoperative RVF risk was assessed using recognized variables. Sixty-five patients (80% men, 50 ± 14 years) were included: 52% HeartWare ventricular assist device (HVAD), 11% HeartMate II (HMII), 17% VentrAssist, 20% Jarvik. Predicted RVF risk was comparable with contemporary LVAD populations: 8% ventilated, 14% mechanical support, 86% inotropes, 25% BUN >39 mg/dL, 23% bilirubin ≥2 mg/dL, 31% RV : LV (left ventricular) diameter ≥0.75, 27% RA : PCWP (right atrium : pulmonary capillary wedge pressure) >0.63, 36% RV stroke work index <6 gm-m/m(2)/beat. The majority (91%) received pulmonary vasodilators early and in high dose: 72% nitric oxide, 77% sildenafil (max 200 ± 79 mg/day), 66% iloprost (max 126 ± 37 μg/day). Median hospital stay was 26 (21) days. No patient required RV mechanical support. Of six (9%) patients meeting RVF criteria based on prolonged need for inotropes, four were transplanted, one is alive with an LVAD at 3 years, and one died on day 35 of intracranial hemorrhage. Two-year survival was 77% (92% for HMII/HVAD): transplanted 54%, alive with LVAD 21%, recovery/explanted 2%. A low incidence of RVF and excellent outcomes were observed for patients treated early during LVAD implantation with combination, high-dose pulmonary vasodilators. The results warrant further investigation in a randomized controlled study.

  6. Ventricular Assist Device Implantation Corrects Myocardial Lipotoxicity, Reverses Insulin Resistance and Normalizes Cardiac Metabolism in Patients with Advanced Heart Failure

    PubMed Central

    Chokshi, Aalap; Drosatos, Konstantinos; Cheema, Faisal H.; Ji, Ruiping; Khawaja, Tuba; Yu, Shuiqing; Kato, Tomoko; Khan, Raffay; Takayama, Hiroo; Knöll, Ralph; Milting, Hendrik; Chung, Christine S.; Jorde, Ulrich; Naka, Yoshifumi; Mancini, Donna M.; Goldberg, Ira J.; Schulze, P. Christian

    2012-01-01

    Background Heart failure is associated with impaired myocardial metabolism with a shift from fatty acids to glucose utilization for ATP generation. We hypothesized that cardiac accumulation of toxic lipid intermediates inhibits insulin signaling in advanced heart failure and that mechanical unloading of the failing myocardium corrects impaired cardiac metabolism. Methods and Results We analyzed myocardium and serum of 61 patients with heart failure (BMI 26.5±5.1 kg/m2, age 51±12 years) obtained during left ventricular assist device (LVAD) implantation and at explantation (mean duration 185±156 days) and from 9 controls. Systemic insulin resistance in heart failure was accompanied by decreased myocardial triglyceride and overall fatty acid content but increased toxic lipid intermediates, diacylglycerol and ceramide. Increased membrane localization of protein kinase C isoforms, inhibitors of insulin signaling, and decreased activity of insulin signaling molecules Akt and FOXO, were detectable in heart failure compared to controls. LVAD implantation improved whole body insulin resistance (HOMA-IR: 4.5±0.6 to 3.2±0.5; p<0.05) and decreased myocardial levels of diacylglycerol and ceramide while triglyceride and fatty acid content remained unchanged. Improved activation of the insulin/PI3kinase/Akt signaling cascade after LVAD implantation was confirmed by increased phosphorylation of Akt and FOXO, which was accompanied by decreased membrane localization of protein kinase C isoforms after LVAD implantation. Conclusions Mechanical unloading after LVAD implantation corrects systemic and local metabolic derangements in advanced heart failure leading to reduced myocardial levels of toxic lipid intermediates and improved cardiac insulin signaling. PMID:22586279

  7. Optimization of drug loading to improve physical stability of paclitaxel-loaded long-circulating liposomes.

    PubMed

    Kannan, Vinayagam; Balabathula, Pavan; Divi, Murali K; Thoma, Laura A; Wood, George C

    2015-01-01

    The effect of formulation and process parameters on drug loading and physical stability of paclitaxel-loaded long-circulating liposomes was evaluated. The liposomes were prepared by hydration-extrusion method. The formulation parameters such as total lipid content, cholesterol content, saturated-unsaturated lipid ratio, drug-lipid ratio and process parameters such as extrusion pressure and number of extrusion cycles were studied and their impact on drug loading and physical stability was evaluated. A proportionate increase in drug loading was observed with increase in the total phospholipid content. Cholesterol content and saturated lipid content in the bilayer showed a negative influence on drug loading. The short-term stability evaluation of liposomes prepared with different drug-lipid ratios demonstrated that 1:60 as the optimum drug-lipid ratio to achieve a loading of 1-1.3 mg/mL without the risk of physical instability. The vesicle size decreased with an increase in the extrusion pressure and number of extrusion cycles, but no significant trends were observed for drug loading with changes in process pressure or number of cycles. The optimization of formulation and process parameters led to a physically stable formulation of paclitaxel-loaded long-circulating liposomes that maintain size, charge and integrity during storage.

  8. Is the daily use of vacuum erection device for a month before penile prosthesis implantation beneficial? a randomized controlled trial.

    PubMed

    Canguven, O; Talib, R A; Campbell, J; De Young, L; El Ansari, W; Al-Ansari, A

    2017-01-01

    Patient concerns about penile length after penile prosthesis (PP) implantation for erectile dysfunction (ED) have significant impact on patients and their partners. In addition, corporal fibrosis is associated with difficult PP implantation. The preoperative use of vacuum erectile devices (VED) is an uncommon physical treatment for such concerns. Therefore, the current randomized controlled study assessed two outcomes: whether pre-operative VED use for a month before surgery would significantly increase flaccid stretched penile length (SPL) on the day of surgery, and facilitate easier corporal dilatation intraoperatively. Fifty-one patients scheduled for PP implantation for ED were randomized to either intervention group (pre-operative VED use; 10-15 min/day for ≥30 days; Group A; n = 25), or control group (no intervention; Group B; n = 26). A research assistant (blinded to the treatment assignments) recorded SPL at baseline (initial consultation) and on day of surgery. The surgeons performing the PP implantation (also blinded to the treatment assignments) provided subjective assessments of the ease of corporal dilatation. Baseline patient characteristics, demographics, and comorbidities were the same in both groups. Baseline measurements (SPL-1) were 10.71 ± 1.28 and 10.87 ± 1.26 cm in Group A and Group B, respectively; and the day of surgery measurements (SPL-2) were 11.50 ± 1.33 and 11.06 ± 1.34 cm in Group A and Group B, respectively. In terms of outcomes: mean SPL increase in Group A was significantly more by a mean of 0.80 ± 0.38 cm (p < 0.05) compared to Group B; and surgeons' subjective report of surgical ease indicated smoother corporal dilatation for Group A compared to Group B. VED use (10-15 min/day during the month prior to PP implantation) was associated with significantly increased SPL on day of surgery, and facilitated easier corporal dilatation intraoperatively. Future studies should examine the long-term outcomes of

  9. Challenges facing academic research in commercializing event-detector implantable devices for an in-vivo biomedical subcutaneous device for biomedical analysis

    NASA Astrophysics Data System (ADS)

    Juanola-Feliu, E.; Colomer-Farrarons, J.; Miribel-Català, P.; Samitier, J.; Valls-Pasola, J.

    2011-05-01

    It is widely recognized that the welfare of the most advanced economies is at risk, and that the only way to tackle this situation is by controlling the knowledge economies and dealing with. To achieve this ambitious goal, we need to improve the performance of each dimension in the "knowledge triangle": education, research and innovation. Indeed, recent findings point to the importance of strategies of adding-value and marketing during R+D processes so as to bridge the gap between the laboratory and the market and so ensure the successful commercialization of new technology-based products. Moreover, in a global economy in which conventional manufacturing is dominated by developing economies, the future of industry in the most advanced economies must rely on its ability to innovate in those high-tech activities that can offer a differential added-value, rather than on improving existing technologies and products. It seems quite clear, therefore, that the combination of health (medicine) and nanotechnology in a new biomedical device is very capable of meeting these requisites. This work propose a generic CMOS Front-End Self-Powered In-Vivo Implantable Biomedical Device, based on a threeelectrode amperometric biosensor approach, capable of detecting threshold values for targeted concentrations of pathogens, ions, oxygen concentration, etc. Given the speed with which diabetes can spread, as diabetes is the fastest growing disease in the world, the nano-enabled implantable device for in-vivo biomedical analysis needs to be introduced into the global diabetes care devices market. In the case of glucose monitoring, the detection of a threshold decrease in the glucose level it is mandatory to avoid critic situations like the hypoglycemia. Although the case study reported in this paper is complex because it involves multiple organizations and sources of data, it contributes to extend experience to the best practices and models on nanotechnology applications and

  10. Generation of electrical power under human skin by subdermal solar cell arrays for implantable bioelectronic devices.

    PubMed

    Song, Kwangsun; Han, Jung Hyun; Yang, Hyung Chae; Nam, Kwang Il; Lee, Jongho

    2017-06-15

    Medical electronic implants can significantly improve people's health and quality of life. These implants are typically powered by batteries, which usually have a finite lifetime and therefore must be replaced periodically using surgical procedures. Recently, subdermal solar cells that can generate electricity by absorbing light transmitted through skin have been proposed as a sustainable electricity source to power medical electronic implants in bodies. However, the results to date have been obtained with animal models. To apply the technology to human beings, electrical performance should be characterized using human skin covering the subdermal solar cells. In this paper, we present electrical performance results (up to 9.05mW/cm(2)) of the implantable solar cell array under 59 human skin samples isolated from 10 cadavers. The results indicate that the power densities depend on the thickness and tone of the human skin, e.g., higher power was generated under thinner and brighter skin. The generated power density is high enough to operate currently available medical electronic implants such as pacemakers that require tens of microwatt.

  11. Nanoparticle Drug Loading as a Design Parameter to Improve Docetaxel Pharmacokinetics and Efficacy

    PubMed Central

    Chu, Kevin S.; Schorzman, Allison N.; Finniss, Mathew C.; Bowerman, Charles J.; Peng, Lei; Luft, J. Christopher; Madden, Andrew; Wang, Andrew Z.; Zamboni, William C.; DeSimone, Joseph M.

    2013-01-01

    Nanoparticle (NP) drug loading is one of the key defining characteristics of a NP formulation. However, the effect of NP drug loading on therapeutic efficacy and pharmacokinetics has not been thoroughly evaluated. Herein, we characterized the efficacy, toxicity and pharmacokinetic properties of NP docetaxel formulations that have differential drug loading but are otherwise identical. Particle Replication in Non-wetting Templates (PRINT®), a soft-lithography fabrication technique, was used to formulate NPs with identical size, shape and surface chemistry, but with variable docetaxel loading. The lower weight loading (9%-NP) of docetaxel was found to have a superior pharmacokinetic profile and enhanced efficacy in a murine cancer model when compared to that of a higher docetaxel loading (20%-NP). The 9%-NP docetaxel increased plasma and tumor docetaxel exposure and reduced liver, spleen and lung exposure when compared to that of 20%-NP docetaxel. PMID:23899444

  12. Drug-loaded biodegradable microspheres for image-guided combinatory epigenetic therapy in cells

    NASA Astrophysics Data System (ADS)

    Xu, Ronald X.; Xu, Jeff S.; Zuo, Tao; Shen, Rulong; Huang, Tim H.; Tweedle, Michael F.

    2011-02-01

    We synthesize drug-loaded poly (lactic-co-glycolic acid) (PLGA) microspheres for image-guided combinatory epigenetic therapy in MCF-10A human mammary epithelial cells. LY294002 and Nile Red are encapsulated in microspheres for sustained drug release and fluorescence microscopic imaging. Drug-loaded microspheres target MCF-10A cells through a three-step binding process involving biotinylated antibody, streptavidin, and biotinylated microspheres. LY294002 loaded microspheres and 5-Aza-2-deoxycytidine are applied to MCF-10A cells for combinatory PI3K/AKT inhibition and deoxyribonucleic acid (DNA) demethylation. Our study implies the technical potential of disease targeting and image-guided combinatory epigenetic therapy using drug-loaded multifunctional biodegradable PLGA microspheres.

  13. Cardiac Resynchronization Therapy Device Implantation in a Patient with Cardiogenic Shock under Percutaneous Mechanical Circulatory Support

    PubMed Central

    Lim, Kyunghee; Yang, Jeong Hoon; Park, Seung-Jung; Kim, Sun Hwa; Kang, Jiseok; Joh, Hyun Sung; Shin, Sun Hye

    2017-01-01

    65-year-old woman was admitted to our hospital with acute decompensated heart failure with reduced left ventricular ejection fraction and severe mitral regurgitation. Electrocardiography revealed a typical left bundle branch block and atrial fibrillation. Her condition deteriorated despite administering high-doses of inotropes and vasopressors. Pending a decision to therapy, venoarterial extracorporeal membrane oxygenation (ECMO) was performed when the patient underwent a cardiogenic shock. Although the hemodynamic status stabilized with ECMO support, weaning the patient from ECMO was not possible. Thus, we decided to perform cardiac resynchronization with defibrillator implantation as a “rescue” therapy. Five days post-implantation, the patient was successfully weaned from ECMO. PMID:28154601

  14. Preparation of dexamethasone ophthalmic implants: a comparative study of in vitro release profiles.

    PubMed

    Prata, Ana I; Coimbra, Patrícia; Pina, M Eugénia

    2017-03-16

    Diseases affecting the posterior segment of the eye are the most common cause of visual disorders in industrialized countries. This scenario has encouraged the development of new treatment modalities for these diseases, such as drug loaded implants with prolonged drug release. The aim of the present work was to create a polymeric based biodegradable ophthalmic implant for the delivery of dexamethasone. For this purpose, we prepared and compared the in vitro release profiles of dexamethasone ophthalmic implants produced by two methods: melting casting and solvent casting. The type of the biodegradable polymer used - poly (ε-caprolactone) (PCL) and poly(lactic acid) (PLA); the drug loading (10% and 25%, w/w), the molecular weight of PCL (37 kDa and 14 kDa) and the form of the drug (dexamethasone and dexamethasone disodium phosphate) were also investigated. The results show that the preparation method has little influence on the obtained release profiles, being the type of polymer the most significant factor affecting the release profiles; nonetheless, a better distribution of dexamethasone was obtained for the devices prepared by melting casting.

  15. Device Strategies for Patients in INTERMACS Profiles 1 and 2 Cardiogenic Shock: Double Bridge With Extracorporeal Membrane Oxygenation and Initial Implant of More Durable Devices.

    PubMed

    Cheng, Richard; Ramzy, Danny; Azarbal, Babak; Arabia, Francisco A; Esmailian, Fardad; Czer, Lawrence S; Kobashigawa, Jon A; Moriguchi, Jaime D

    2017-03-01

    For Interagency Registry for Mechanically Assisted Circulatory Support profiles 1 and 2 cardiogenic shock patients initially placed on extracorporeal membrane oxygenation (ECMO), whether crossover to more durable devices is associated with increased survival, and its optimal timing, are not established. Profiles 1 and 2 patients placed on mechanical support were prospectively registered. Survival and successful hospital discharge were compared between patients placed on ECMO only, ECMO with early crossover, and ECMO with delayed crossover. Survival of patients directly implanted with non-ECMO devices was also reported. One-hundred and sixty-two patients were included. Mean age was 52.2 ± 13.8 years. Seventy-three of 162 (45.1%) were initiated on ECMO. Of these, 43 were supported with ECMO only, 11 were crossed-over early <4 days, and 19 were crossed-over in a delayed fashion. Survival was different across groups (Log-rank P < 0.002). In multivariate analysis, early crossover was associated with decreased mortality as compared with no crossover (hazard ratio [HR] 0.201, 95% confidence interval [95%CI] 0.058-0.697, P = 0.011) or with delayed crossover (HR 0.255, 95%CI 0.073-0.894, P = 0.033). Mortality was not different between delayed crossover and no crossover (P = 0.473). In patients with early crossover there were no deaths at 30 days, and 60-day survival was 90.0 ± 9.5%. Survival to hospital discharge was 72.8%. For patients directly implanted with non-ECMO devices, 30-day and 60-day survival was 90.9 ± 3.1% and 87.3 ± 3.8%, respectively, and survival to hospital discharge was 78.7%. Both initial implant of durable devices and double bridge strategy was associated with improved outcomes. If the double bridge strategy is chosen, early crossover is associated with improved survival and successful hospital discharge.

  16. Development of an implantable wireless ECoG 128ch recording device for clinical brain machine interface.

    PubMed

    Matsushita, Kojiro; Hirata, Masayuki; Suzuki, Takafumi; Ando, Hiroshi; Ota, Yuki; Sato, Fumihiro; Morris, Shyne; Yoshida, Takeshi; Matsuki, Hidetoshi; Yoshimine, Toshiki

    2013-01-01

    Brain Machine Interface (BMI) is a system that assumes user's intention by analyzing user's brain activities and control devices with the assumed intention. It is considered as one of prospective tools to enhance paralyzed patients' quality of life. In our group, we especially focus on ECoG (electro-corti-gram)-BMI, which requires surgery to place electrodes on the cortex. We try to implant all the devices within the patient's head and abdomen and to transmit the data and power wirelessly. Our device consists of 5 parts: (1) High-density multi-electrodes with a 3D shaped sheet fitting to the individual brain surface to effectively record the ECoG signals; (2) A small circuit board with two integrated circuit chips functioning 128 [ch] analogue amplifiers and A/D converters for ECoG signals; (3) A Wifi data communication & control circuit with the target PC; (4) A non-contact power supply transmitting electrical power minimum 400[mW] to the device 20[mm] away. We developed those devices, integrated them, and, investigated the performance.

  17. Occurrence of discal and non-discal changes after sequestrectomy alone versus sequestrectomy and implantation of an anulus closure device.

    PubMed

    Barth, Martin; Fontana, Johann; Thomé, Claudius; Bouma, Gerrit J; Schmieder, Kirsten

    2016-12-01

    Sequestrectomy alone represents a procedure for the treatment of lumbar disc herniation. For selected cases, an anulus closure device (ACD) can be implanted which may result in lower reoperation rates. However, comparative magnetic resonance imaging (MRI) changes and their clinical relevance of both procedures are unclear and have not been reported so far. Clinical and MRI data of patients after limited discectomy with ACD implantation (group ACD; N=45) and patients after sequestrectomy alone (group S; N=40) with primary lumbar disc herniation were compared retrospectively. Pain intensity on the visual analogue pain scale (VAS), oswestry disability index (ODI) or the patient satisfaction index (PSI) were collected. Disc signal intensity, Modic type changes, endplate reactions, anular tears and reherniations were investigated using MRI before and <18months postoperative. Morphologic changes were correlated with clinical outcome. There was no difference in VAS back, VAS leg or ODI/PSI after the operation although group S showed significantly more reherniations in MRI. The overall rate of repeated surgery at the same level was similar with a trend in favour of the ACD group (P=0.729). Significantly more patients of the ACD group experienced endplate erosions after surgery (P<0.001). Both groups experienced progression of disc signal intensity, Modic type changes, and anular tears with most MRI signs being without clinical relevance. ACD implantation is associated with a significantly lower reherniation rate in MRI but showed a significantly higher rate of endplate erosions. The structural changes do not appear to be clinically relevant.

  18. Interhospital Air Transport of a Blind Patient on Extracorporeal Life Support with Consecutive and Successful Left Ventricular Assist Device Implantation

    PubMed Central

    Bauer, Adrian; Schaarschmidt, Jan; Grosse, F. Oliver; Al Alam, Nidal; Hausmann, Harald; Krämer, Klaus; Strüber, Martin; Mohr, Friedrich W.

    2014-01-01

    Abstract: The use of extracorporeal life support systems (ECLS) in patients with postcardiotomy low cardiac output syndrome (LCO) as a bridge to recovery and bridge to implantation of ventricular assist device (VAD) is common nowadays. A 59-year-old patient with acute myocardial infarction received a percutaneous transluminal angioplasty and stenting of the circumflex artery. During catheterization of the left coronary artery (LAD), the patient showed ventricular fibrillation and required defibrillation and cardiopulmonary resuscitation. After implantation of an intra-aortic balloon pump, the patient immediately was transmitted to the operating room. He received emergency coronary artery bypass grafting in a beating heart technique using pump-assisted minimal extracorporeal circulation circuit (MECC). Two bypass grafts were performed to the LAD and the right posterior descending artery. Despite initial successful weaning off cardiopulmonary bypass with high-dose inotropic support, the patient presented postcardiotomy LCO and an ECLS was implanted. The primary setup of the heparin-coated MECC system was modified and used postoperatively. As a result of the absence of an in-house VAD program, the patient was switched to a transportable ECLS the next day and was transferred by helicopter to the nearest VAD center where the patient received a successful insertion of a left VAD 3 days later. PMID:25208435

  19. Lab-on-a-brain: Implantable micro-optical fluidic devices for neural cell analysis in vivo

    NASA Astrophysics Data System (ADS)

    Takehara, Hiroaki; Nagaoka, Akira; Noguchi, Jun; Akagi, Takanori; Kasai, Haruo; Ichiki, Takanori

    2014-10-01

    The high-resolution imaging of neural cells in vivo has brought about great progress in neuroscience research. Here, we report a novel experimental platform, where the intact brain of a living mouse can be studied with the aid of a surgically implanted micro-optical fluidic device; acting as an interface between neurons and the outer world. The newly developed device provides the functions required for the long-term and high-resolution observation of the fine structures of neurons by two-photon laser scanning microscopy and the microfluidic delivery of chemicals or drugs directly into the brain. A proof-of-concept experiment of single-synapse stimulation by two-photon uncaging of caged glutamate and observation of dendritic spine shrinkage over subsequent days demonstrated a promising use for the present technology.

  20. A Novel Technique Using a Protection Filter During Fibrin Sheath Removal for Implanted Venous Access Device Dysfunction.

    PubMed

    Sotiriadis, Charalampos; Hajdu, Steven David; Degrauwe, Sophie; Barras, Heloise; Qanadli, Salah Dine

    2016-08-01

    With the increased use of implanted venous access devices (IVADs) for continuous long-term venous access, several techniques such as percutaneous endovascular fibrin sheath removal, have been described, to maintain catheter function. Most standard techniques do not capture the stripped fibrin sheath, which is subsequently released in the pulmonary circulation and may lead to symptomatic pulmonary embolism. The presented case describes an endovascular technique which includes stripping, capture, and removal of fibrin sheath using a novel filter device. A 64-year-old woman presented with IVAD dysfunction. Stripping was performed using a co-axial snare to the filter to capture the fibrin sheath. The captured fragment was subsequently removed for visual and pathological verification. No immediate complication was observed and the patient was discharged the day of the procedure.

  1. Implantation of an ultrafiltration device in the ileum and spiral colon of steers to continuously collect intestinal fluid.

    PubMed

    Warren, Chelsea D; Prange, Timo; Campbell, Nigel B; Gerard, Mat P; Martin, Luke G; Jacob, Megan E; Smith, Geof W; Papich, Mark G; Foster, Derek M

    2014-12-01

    Collection of fluid from the lumen of the gastrointestinal tract is commonly necessary for research projects, but presents challenges including intestinal motility and potential for leakage of intestinal contents. In this study, ultrafiltration collection devices were surgically implanted in the ileum and spiral colon of 12 steers for repeated collection of intestinal fluid over 48 hours. There were no significant complications associated with surgery or during the post-operative period, nor were there any significant pathologic changes found at necropsy 3 or 4 days post-surgery. Over 48 hours, we obtained 88% of the desired 212 samples. Only two devices failed to routinely collect samples. Use of ultrafiltration probes is a novel, consistent and humane method to repeatedly sample the gastrointestinal contents.

  2. Efficacy of intrathoracic impedance and remote monitoring in patients with an implantable device after the 2011 great East Japan earthquake.

    PubMed

    Suzuki, Hitoshi; Yamada, Shinya; Kamiyama, Yoshiyuki; Takeishi, Yasuchika

    2014-01-01

    Several studies have revealed that stress after catastrophic disasters can trigger cardiovascular events, however, little is known about its association with the occurrence of heart failure in past earthquakes. The objective of the present study was to determine whether the Great East Japan Earthquake on March 11, 2011, increased the incidence of worsening heart failure in chronic heart failure (CHF) patients with implantable devices. Furthermore, we examined whether intrathoracic impedance using remote monitoring was effective for the management of CHF.We enrolled 44 CHF patients (32 males, mean age 63 ± 12 years) with implantable devices that can check intrathoracic impedance using remote monitoring. We defined the worsening heart failure as accumulated impedance under reference impedance exceeding 60 ohms-days (fluid index threshold), and compared the incidence of worsening heart failure and arrhythmic events 30 days before and after March 11.Within the 30 days after March 11, 10 patients exceeded the threshold compared with only 2 patients in the preceding 30 days (P < 0.05). Although 9 patients using remote monitoring among the 10 patients with threshold crossings were not hospitalized, one patient without the system was hospitalized due to acute decompensated heart failure. On the contrary, arrhythmic events did not change between before and after March 11.Our results suggest that earthquake-induced stress causes an increased risk of worsening heart failure without changes in arrhythmia. Furthermore, intrathoracic impedance using remote monitoring may be a useful tool for the management of CHF in catastrophic disasters.

  3. Improved anticoagulation management after Palmaz Schatz coronary stent implantation by sealing the arterial puncture site with a vascular hemostasis device.

    PubMed

    Kiemeneij, F; Laarman, G J

    1993-12-01

    Sealing the arterial puncture site with a vascular hemostasis device has the potential to maintain optimal anticoagulation after stent implantation. The level of heparinization during the first 3 days after successful stent implantation was retrospectively compared between 2 groups of medically treated patients with (group A; n = 18) and without (group B; n = 17) a Vasoseal after sheath removal. The number of APTTs sampled in group A and B was 233 and 168, respectively. Respective mean values of APTT (seconds) in group A and B were 180 +/- 79 and 172 +/- 91 at day 1 (p = NS), 132 +/- 43 and 125 +/- 61 at day 2 (p = NS) and 123 +/- 36 and 116 +/- 48 at day 3 (p = NS). More APTTs were suboptimal (< 80 secs) in group B (34/168; 20%) compared to group A (17/233; 7%) [p < 0.001]. More patients in group B compared to group A had 1 or more (14/17; 82% vs. 8/18; 44%; p = 0.04), 2 or more (10/17; 59% versus 3/18; 17%; p = 0.02) and 3 or more (8/17; 47% vs. 2/18; 11%; p = 0.03) suboptimal APTTs. Bleeding complications were seen in 4 patients without and in 3 patients with a Vasoseal. Thus application of a vascular hemostasis device results in a less variable anticoagulation after coronary stenting, but it does not abolish entry site-related bleeding complications.

  4. Titanium coated with functionalized carbon nanotubes--a promising novel material for biomedical application as an implantable orthopaedic electronic device.

    PubMed

    Przekora, Agata; Benko, Aleksandra; Nocun, Marek; Wyrwa, Jan; Blazewicz, Marta; Ginalska, Grazyna

    2014-12-01

    The aim of the study was to fabricate titanium (Ti) material coated with functionalized carbon nanotubes (f-CNTs) that would have potential medical application in orthopaedics as an implantable electronic device. The novel biomedical material (Ti-CNTs-H2O) would possess specific set of properties, such as: electrical conductivity, non-toxicity, and ability to inhibit connective tissue cell growth and proliferation protecting the Ti-CNTs-H2O surface against covering by cells. The novel material was obtained via an electrophoretic deposition of CNTs-H2O on the Ti surface. Then, physicochemical, electrical, and biological properties were evaluated. Electrical property evaluation revealed that a Ti-CNTs-H2O material is highly conductive and X-ray photoelectron spectroscopy analysis demonstrated that there are mainly COOH groups on the Ti-CNTs-H2O surface that are found to inhibit cell growth. Biological properties were assessed using normal human foetal osteoblast cell line (hFOB 1.19). Conducted cytotoxicity tests and live/dead fluorescent staining demonstrated that Ti-CNTs-H2O does not exert toxic effect on hFOB cells. Moreover, fluorescence laser scanning microscope observation demonstrated that Ti-CNTs-H2O surface retards to a great extent cell proliferation. The study resulted in successful fabrication of highly conductive, non-toxic Ti-CNTs-H2O material that possesses ability to inhibit osteoblast proliferation and thus has a great potential as an orthopaedic implantable electronic device.

  5. Left ventricular diastolic filling with an implantable ventricular assist device: beat to beat variability with overall improvement

    NASA Technical Reports Server (NTRS)

    Nakatani, S.; Thomas, J. D.; Vandervoort, P. M.; Zhou, J.; Greenberg, N. L.; Savage, R. M.; McCarthy, P. M.

    1997-01-01

    OBJECTIVES: We studied the effects of left ventricular (LV) unloading by an implantable ventricular assist device on LV diastolic filling. BACKGROUND: Although many investigators have reported reliable systemic and peripheral circulatory support with implantable LV assist devices, little is known about their effect on cardiac performance. METHODS: Peak velocities of early diastolic filling, late diastolic filling, late to early filling ratio, deceleration time of early filling, diastolic filling period and atrial filling fraction were measured by intraoperative transesophageal Doppler echocardiography before and after insertion of an LV assist device in eight patients. A numerical model was developed to simulate this situation. RESULTS: Before device insertion, all patients showed either a restrictive or a monophasic transmitral flow pattern. After device insertion, transmitral flow showed rapid beat to beat variation in each patient, from abnormal relaxation to restrictive patterns. However, when the average values obtained from 10 consecutive beats were considered, overall filling was significantly normalized from baseline, with early filling velocity falling from 87 +/- 31 to 64 +/- 26 cm/s (p < 0.01) and late filling velocity rising from 8 +/- 11 to 32 +/- 23 cm/s (p < 0.05), resulting in an increase in the late to early filling ratio from 0.13 +/- 0.18 to 0.59 +/- 0.38 (p < 0.01) and a rise in the atrial filling fraction from 8 +/- 10% to 26 +/- 17% (p < 0.01). The deceleration time (from 112 +/- 40 to 160 +/- 44 ms, p < 0.05) and the filling period corrected by the RR interval (from 39 +/- 8% to 54 +/- 10%, p < 0.005) were also significantly prolonged. In the computer model, asynchronous LV assistance produced significant beat to beat variation in filling indexes, but overall a normalization of deceleration time as well as other variables. CONCLUSIONS: With LV assistance, transmitral flow showed rapidly varying patterns beat by beat in each patient, but

  6. Systematic Evaluation of Drug-Loaded Hydrogels for Application in Osteosarcoma Treatment.

    PubMed

    Ali Gumustas, Seyit; Isyar, Mehmet; Topuk, Savas; Yilmaz, Ibrahim; Oznam, Kadir; Onay, Tolga; Ofluoglu, Onder; Mahirogullari, Mahir

    This is a literature review of studies focusing on the preparation of hydrogels for use as oncological drug delivery systems in the treatment of osteosarcoma (OS). The databases of the US National Library of Medicine National Institutes of Health, Embase, OVID, and Cochrane Library, and the references of retrieved studies, were traced from 1843 to December 21, 2015, without language restrictions. The obtained data were evaluated by complementary statistical methods. Potentially relevant studies were found and included in the analysis. OS-specific chemotherapeutic agents can be successfully embedded within the hydrogels and these drug-loaded hydrogels can be applied locally, rather than systemically, without organ tissue toxicity. Further, OS-specific drug-loaded hydrogels significantly increased tumor inhibition and decreased osteolysis and lung metastases. Drug-loaded hydrogels could be useful in the treatment of OS, although their development remains at the experimental phase. Following evaluation of their application in surgery and the completion of drug release kinetics studies, drug-loaded hydrogels could be tested on living mammals in large samples with the aim of applying these in clinical settings. In the future, development of such drug delivery systems and application of targeted approaches against osteosarcoma and other malignancies may render surgery, radiotherapy and chemotherapy unnecessary.

  7. Dual drug-loaded nanoparticles on self-integrated scaffold for controlled delivery

    PubMed Central

    Bennet, Devasier; Marimuthu, Mohana; Kim, Sanghyo; An, Jeongho

    2012-01-01

    Antioxidant (quercetin) and hypoglycemic (voglibose) drug-loaded poly-D,L-lactideco-glycolide nanoparticles were successfully synthesized using the solvent evaporation method. The dual drug-loaded nanoparticles were incorporated into a scaffold film using a solvent casting method, creating a controlled transdermal drug-delivery system. Key features of the film formulation were achieved utilizing several ratios of excipients, including polyvinyl alcohol, polyethylene glycol, hyaluronic acid, xylitol, and alginate. The scaffold film showed superior encapsulation capability and swelling properties, with various potential applications, eg, the treatment of diabetes-associated complications. Structural and light scattering characterization confirmed a spherical shape and a mean particle size distribution of 41.3 nm for nanoparticles in the scaffold film. Spectroscopy revealed a stable polymer structure before and after encapsulation. The thermoresponsive swelling properties of the film were evaluated according to temperature and pH. Scaffold films incorporating dual drug-loaded nanoparticles showed remarkably high thermoresponsivity, cell compatibility, and ex vivo drug-release behavior. In addition, the hybrid film formulation showed enhanced cell adhesion and proliferation. These dual drug-loaded nanoparticles incorporated into a scaffold film may be promising for development into a transdermal drug-delivery system. PMID:22888222

  8. Counter-ion complexes for enhanced drug loading in nanocarriers: Proof-of-concept and beyond.

    PubMed

    Günday Türeli, Nazende; Türeli, Akif E; Schneider, Marc

    2016-09-25

    Enhanced drug loading is an important prerequisite of nanomedicines, to reach administration dose while reducing the amount of excipient. Considering biocompatible and biodegradable polymers such as PLGA, pH dependent solubility characteristics along with limited organic solvent solubility of the drug hampers nanoparticle (NP) preparation. To improve loading of such molecules, a method based on using counter ions for complex formation is proposed. Formed complex alters the intrinsic solubility of active substance via electrostatic interaction without chemical modification. A proof-of-concept study was conducted with sodium dodecyl sulfate as counter-ion to fluoroquinolone antibiotic ciprofloxacin. Complex formation resulted in suppressed pH dependent solubility over pH 1.2-9.0 and an additional -80 fold increase in organic solubility was achieved. In consequence, NPs prepared by microjet reactor technology have shown enhanced drug loading efficiencies (-78%) and drug loading of 14%. Moreover, the counter-ion concept was also demonstrated with another class of antibiotics, water soluble aminoglycosides gentamycin and tobramycin. In addition, the counter ion was substituted by degradable excipients such as phosphatidic acid derivatives. Successful implementation has proven the counter-ion concept to be a platform concept that can be successfully implemented for a variety of active substances and counter-ions to enhance drug loading in nanocarriers.

  9. A new process for drug loaded nanocapsules preparation using a membrane contactor.

    PubMed

    Charcosset, Catherine; Fessi, Hatem

    2005-12-01

    In this paper, we describe a new process for the preparation of drug loaded nanocapsules using a membrane contactor which may be scaled up for industrial applications. Nanocapsules are prepared according to the nanoprecipitation method. The organic phase (solvent, polymer, oil, and drug) is pressed through the pores of an ultrafiltration membrane via the filtrate side. The aqueous phase (water and surfactant) circulates inside the membrane module, and sweeps away the nanocaspules forming at the pore outlets. Two model drugs are selected for the preparation of drug loaded nanocapsules: indomethacin and vitamin E. It is shown that indomethacin loaded nanocapsules with a mean diameter of 240 nm and vitamin E loaded nanocapsules with a mean diameter of 230 nm are obtained with a 150,000 daltons ultrafiltration membrane, a transmembrane pressure of 3 bar, and a crossflow rate of 1.7 m.s(- 1). High fluxes are also obtained (around 0.6 m3/h.m2), leading to the preparation of 1.8 10(- 3) m3 drug loaded nanocapsules in 8 min. The advantage of this membrane contactor compared to other processes for drug loaded nanocapsules preparation is shown to be its scale-up ability.

  10. Energy transmission and power sources for mechanical circulatory support devices to achieve total implantability.

    PubMed

    Wang, Jake X; Smith, Joshua R; Bonde, Pramod

    2014-04-01

    Left ventricular assist device therapy has radically improved congestive heart failure survival with smaller rotary pumps. The driveline used to power today's left ventricular assist devices, however, continues to be a source of infection, traumatic damage, and rehospitalization. Previous attempts to wirelessly power left ventricular assist devices using transcutaneous energy transfer systems have been limited by restrictions on separation distance and alignment between the transmit and receive coils. Resonant electrical energy transfer allows power delivery at larger distances without compromising safety and efficiency. This review covers the efforts to wirelessly power mechanical circulatory assist devices and the progress made in enhancing their energy sources.

  11. Integration of Advanced Source and Drain Extension Process Using Carbon/Fluorine Co-Implants and Spike Anneal in 65nm PMOS Devices

    NASA Astrophysics Data System (ADS)

    Li, C. I.; Wang, H. Y.; Chien, C. C.; Chain, M.; Yang, C. L.; Tzou, S. F.; Graoui, H.; Foad, M. A.; Ting, Richard

    2006-11-01

    Carbon and fluorine co-implantation have shown encouraging junction formation improvement, especially for P-type junctions. In this paper, Xj of 20 nm, Rs of 730 ohms/sq and abruptness of 3.5 nm/decade were obtained using carbon co-implantation at 6 keV, 2×1015 ions/cm2, BF2 implant and spike annealing. With LSA, the sheet resistance decreases to 640 ohm/sq. Rs decreased 7% at 1050°C RTP and decreased 13% at 1000°C RTP combined with laser spike annealing. We implemented germanium, carbon, and fluorine co-implanted junctions for SDE fabrication for 65 nm node devices. Results indicated that both decrease in overlap capacitance and junction leakage have proportional correlation with C co-implant dosage. However, Vt needs to be optimized. Device optimization by combining C co-implantation with LSA can yield better control of short channel effects due to the co-implantation and better activation due to the LSA.

  12. Titanium-Based Biomaterials for Preventing Stress Shielding between Implant Devices and Bone

    PubMed Central

    Niinomi, M.; Nakai, M.

    2011-01-01

    β-type titanium alloys with low Young's modulus are required to inhibit bone atrophy and enhance bone remodeling for implants used to substitute failed hard tissue. At the same time, these titanium alloys are required to have high static and dynamic strength. On the other hand, metallic biomaterials with variable Young's modulus are required to satisfy the needs of both patients and surgeons, namely, low and high Young's moduli, respectively. In this paper, we have discussed effective methods to improve the static and dynamic strength while maintaining low Young's modulus for β-type titanium alloys used in biomedical applications. Then, the advantage of low Young's modulus of β-type titanium alloys in biomedical applications has been discussed from the perspective of inhibiting bone atrophy and enhancing bone remodeling. Further, we have discussed the development of β-type titanium alloys with a self-adjusting Young's modulus for use in removable implants. PMID:21765831

  13. Wound Dehiscence and Device Migration after Subconjunctival Bevacizumab Injection with Ahmed Glaucoma Valve Implantation

    PubMed Central

    Miraftabi, Arezoo; Nilforushan, Naveed

    2016-01-01

    Purpose: To report a complication pertaining to subconjunctival bevacizumab injection as an adjunct to Ahmed Glaucoma Valve (AGV) implantation. Case Report: A 54-year-old woman with history of complicated cataract surgery was referred for advanced intractable glaucoma. AGV implantation with adjunctive subconjunctival bevacizumab (1.25 mg) was performed with satisfactory results during the first postoperative week. However, 10 days after surgery, she developed wound dehiscence and tube exposure. The second case was a 33-year-old man with history of congenital glaucoma and uncontrolled IOP who developed AGV exposure and wound dehiscence after surgery. In both cases, for prevention of endophthalmitis and corneal damage by the unstable tube, the shunt was removed and the conjunctiva was re-sutured. Conclusion: The potential adverse effect of subconjunctival bevacizumab injection on wound healing should be considered in AGV surgery. PMID:27195095

  14. Seizure detection methods using a cascade architecture for real-time implantable devices.

    PubMed

    Kim, Taehoon; Artan, N Sertac; Selesnick, Ivan W; Chao, H Jonathan

    2013-01-01

    Implantable high-accuracy, and low-power seizure detection is a challenge. In this paper, we propose a cascade architecture to combine different seizure detection algorithms to optimize power and accuracy of the overall seizure detection system. The proposed architecture consists of a cascade of two seizure detection stages. In the first-stage detector, a lightweight (low-power) algorithm is used to detect seizure candidates with the understanding that there will be a high number of false positives. In the second-stage detector-and only for the seizure candidates detected in the first detector-a high-accuracy algorithm is used to eliminate the false positives. We show that the proposed cascade architecture can reduce power consumption of seizure detection by 80% with high accuracy, offering a suitable option for real-time implantable seizure detectors.

  15. Safe inductive power transmission to millimeter-sized implantable microelectronics devices.

    PubMed

    Ibrahim, Ahmed; Kiani, Mehdi

    2015-08-01

    Power transfer efficiency (PTE) and power delivered to the load (PDL) are key inductive link design parameters for powering millimeter-sized implants. While several groups have suggested increasing the power carrier frequency (fp) of inductive links to 100s of MHz to maximize PTE, we have demonstrated that operating at 10s of MHz offers higher allowable PDL under the safety absorption rate (SAR) constraints. We have proposed a closed-form power function that relates maximum power levels that can safely be transferred at different frequencies under the SAR constraints. Three sets of inductive links at different frequencies of 50 MHz, 200 MHz, and 400 MHz have been optimized for powering a 1 mm(3)-sized implant. We have shown in simulations that reducing fp from 200 MHz to 50 MHz along with shrinking the size of the transmitter coil results in ~7.8 times higher PDL under SAR constraints, at the cost of only 52% drop in PTE.

  16. Implantable devices having ceramic coating applied via an atomic layer deposition method

    DOEpatents

    Liang, Xinhua; Weimer, Alan W.; Bryant, Stephanie J.

    2016-03-08

    Substrates coated with films of a ceramic material such as aluminum oxides and titanium oxides are biocompatible, and can be used in a variety of applications in which they are implanted in a living body. The substrate is preferably a porous polymer, and may be biodegradable. An important application for the ceramic-coated substrates is as a tissue engineering scaffold for forming artificial tissue.

  17. Design of a radio-linked implantable cochlear prosthesis using surface acoustic wave devices.

    PubMed

    Jeutter, D C; Josse, F

    1993-01-01

    Cochlear prosthesis systems for postlingually deaf individuals (those who have become deaf due to disease or injury after having developed mature speech capability) are considered. These systems require the surgical implantation of an array of electrodes within the cochlea and are driven by processed sound signals from outside the body. A system that uses an analog signal approach for transcutaneous transfer of six processed speech data channels using frequency multiplexing is described. The system utilizes a filterbank of six narrowband surface acoustic wave (SAW) filters in the range 72-78 MHz with a 1.2-MHz channel spacing to multiplex the six carrier signals, frequency modulated, by the processed speech signals, onto a composite signal. The same SAW filters are used in the receiver filterbank for signal separation, but are housed in a miniaturized package. The system includes a portable transmitter and a receiver package which is to be implanted in the patient. The implanted circuits are supplied exclusively from power transferred from outside the body via a separate 10-MHz transcutaneous link.

  18. Inductive and ultrasonic multi-tier interface for low-power, deeply implantable medical devices.

    PubMed

    Sanni, Ayodele; Vilches, Antonio; Toumazou, C

    2012-08-01

    We report the development of a novel multi-tier interface which enables the wireless, noninvasive transfer of sufficient amounts of power as well as the collection and transmission of data from low-power, deeply implantable analog sensors. The interface consists of an inductive coupling subsystem and an ultrasonic subsystem. The designed and experimentally verified inductive subsystem ensures that 5 W of power is transferred across 10 mm of air gap between a single pair of PCB spiral coils with an efficiency of 83% using our prototype CMOS logic gate-based driver circuit. The implemented ultrasonic subsystem, based on ultrasonic PZT ceramic discs driven in their low-frequency, radial/planar-excitation mode, further ensures that 29 μW of power is delivered 70 mm deeper inside a homogenous liquid environment-with no acoustic matching layer employed-with an efficiency of 1%. Overall system power consumption is 2.3 W. The implant is intermittently powered every 800 msec; charging a capacitor which provides sufficient power for a duration of ~ 18 msec; sufficient for an implant μC operating at a frequency of 500 KHz to transmit a nibble (4 bits) of digitized sensed data.

  19. Comparative Clinical and Histologic Assessments of Dental Implants Delivered with a Manual Torque Limiting Wrench Versus with an Electronically Controlled Torque Limiting Device.

    PubMed

    Nevins, Myron; Nevins, Marc; De Angelis, Nicola; Ghaffari, Sasan; Bassir, Hossein; Kim, David M

    2015-01-01

    The goal of this preclinical investigation was to evaluate the healing of tapered roughened surfaced dental implants that were delivered by either a manual torque limiting wrench or an electronically controlled torque limiting device. Three canines underwent bilateral extraction of third and fourth premolars and first molar. The extraction sites were allowed to heal for 2 months before two dental implants were placed bilaterally. All animals underwent a normal healing process. One animal was sacrificed at 1 month and the remaining two animals were sacrificed at 2 months to perform histologic evaluations including bone-to-implant contact (BIC) and soft tissue healing. The clinical stability and histologic osseointegration were similar when the results obtained with the manual torque limiting wrench were compared to those delivered by the electronically controlled torque limiting device. However, BIC and maintenance of the crestal bone level achieved appeared to be higher in the electronically controlled torque limiting device groups.

  20. Poly(lactide-co-glycolide)-methoxy-poly(ethylene glycol) nanoparticles: drug loading and release properties.

    PubMed

    Katsikogianni, Georgia; Avgoustakis, Konstantinos

    2006-01-01

    In this work, the drug loading and in vitro release properties of PLGA-mPEG nanoparticles were studied. Three methyl-xanthine derivatives differing significantly in aqueous solubility, i.e., caffeine, theophylline, and theobromine, were employed as model drugs. Two different PLGA-mPEG copolymer compositions, namely PLGA(40)mPEG(5) and PLGA(136)mPEG(5), were included in the study. The nanoparticles were prepared by a double emulsion technique. The drug release properties of the nanoparticles in phosphate buffered saline (PBS) and in human plasma were determined. An increase of the drug proportion in the feed led to increased drug loading. The composition of the PLGA-mPEG copolymer (PLGA/mPEG molar ratio) did not appear to affect drug loading and encapsulation. Caffeine exhibited higher loading in the nanoparticles than theobromine and this exhibited a little higher loading than theophylline. Solid-state solubility of the drug in PLGA-mPEG did not affect drug loading. Drug loading and encapsulation in the PLGA-mPEG nanoparticles appeared to be governed by the partition coefficient of the drug between the organic phase and the external aqueous phase employed in nanoparticle preparation. Relatively low loading and encapsulation values were obtained, suggesting that the physical entrapment of drugs in PLGA-mPEG nanoparticles could only be an option in the development of formulations of potent drugs. Only the release of the least water-soluble theobromine was efficiently sustained by its entrapment in the nanoparticles, indicating that the physical entrapment of drugs provides the means for the development of controlled-release PLGA-mPEG nanoparticulate formulations only in the case of drugs with low aqueous solubility.

  1. Hollow mesoporous silica as a high drug loading carrier for regulation insoluble drug release.

    PubMed

    Geng, Hongjian; Zhao, Yating; Liu, Jia; Cui, Yu; Wang, Ying; Zhao, Qinfu; Wang, Siling

    2016-08-20

    The purpose of this study was to develop a high drug loading hollow mesoporous silica nanoparticles (HMS) and apply for regulation insoluble drug release. HMS was synthesized using hard template phenolic resin nanoparticles with the aid of cetyltrimethyl ammonium bromide (CTAB), which was simple and inexpensive. To compare the difference between normal mesoporous silica (NMS) and hollow mesoporous silica in drug loading efficiency, drug release behavior and solid state, NMS was also prepared by soft template method. Transmission electron microscopy (TEM), specific surface area analysis, FT-IR and zeta potential were employed to characterize the morphology structure and physicochemical property of these carriers. The insoluble drugs, carvedilol and fenofibrate(Car and Fen), were chosen as the model drug to be loaded into HMS and NMS. We also chose methylene blue (MB) as a basic dye to estimate the adsorption ability of these carriers from macroscopic and microscopic view, and the drug-loaded carriers were systematically studied by differential scanning calorimetry (DSC), X-ray diffraction (XRD) and UV-vis spectrophotometry. What' more, the in vivo process of HMS was also study by confocal microscopy and in vivo fluorescence imaging. In order to confirm the gastrointestinal safety of HMS, the pathological examination of stomach and intestine also be evaluated. HMS allowed a higher drug loading than NMS and exhibited a relative sustained release curve, while NMS was immediate-release. And the effect of preventing drugs crystallization was weaker than NMS. As for in vivo process, HMS was cleared relatively rapidly from the mouse gastrointestinal and barely uptake by intestinal epithelial cell in this study due to its large particle size. And the damage of HMS to gastrointestinal could be ignored. This study provided a simple method to obtain high drug loading and regulation insoluble drug release, expanded the application of inorganic carriers in drug delivery system

  2. 78 FR 2647 - Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 CFR part 807. A preamendments device that has been classified into class III may be marketed by means of premarket notification procedures (510(k) process) without...

  3. Incidence and Patterns of Adverse Event Onset During the First 60 Days After Ventricular Assist Device Implantation

    PubMed Central

    Genovese, Elizabeth A.; Dew, Mary Amanda; Teuteberg, Jeffrey J.; Simon, Marc A.; Kay, Joy; Siegenthaler, Michael P.; Bhama, Jay K.; Bermudez, Christian A.; Lockard, Kathleen L; Winowich, Steve; Kormos, Robert L.

    2009-01-01

    Background Although ventricular assist devices (VADs) provide effective treatment for end-stage heart failure, VAD support remains associated with significant risk for adverse events (AEs). To date there has been no detailed assessment of the incidence of a full range of AEs using standardized event definitions. We sought to characterize the frequency and timing of AE onset during the first 60 days of VAD support, a period during which clinical observation suggests the risk of incident AEs is high. Methods A retrospective analysis was performed utilizing prospectively collected data from a single-site clinical database including 195 patients aged ≥18 receiving VADs between 1996 and 2006. AEs were coded using standardized criteria. Cumulative incidence rates were determined, controlling for competing risks (death, transplantation, recovery/wean). Results During the first 60 days after implantation, the most common AEs were bleeding, infection, and arrhythmias (cumulative incidence rates, 36%–48%), followed by tamponade, respiratory events, reoperations, and neurologic events (24%–31%). Other events (e.g., hemolysis, renal, hepatic events) were less common (rates <15%). Some events (e.g., bleeding, arrhythmias) showed steep onset rates early after implantation. Others (e.g., infections, neurologic events) had gradual onsets during the 60-day period. Incidence of most events did not vary by implant era (1996–2000 vs. 2001–2006) or by left ventricular vs. biventricular support. Conclusions Understanding differential temporal patterns of AE onset will allow preventive strategies to be targeted to the time periods when specific AE risks are greatest. The AE incidence rates provide benchmarks against which future studies of VAD-related risks may be compared. PMID:19766801

  4. Outcomes in Patients with Severe Preexisting Renal Dysfunction After Continuous-Flow Left Ventricular Assist Device Implantation.

    PubMed

    Raichlin, Eugenia; Baibhav, Bipul; Lowes, Brian D; Zolty, Ronald; Lyden, Elizabeth R; Vongooru, Hareeprasad R; Siddique, Aleem; Moulton, Michael J; Um, John Y

    2016-01-01

    The aim of this study was to evaluate clinical outcomes after left ventricular assist device (LVAD) implantation in patients with severe pre-LVAD renal dysfunction (RD). The cohort of 165 consecutive patients implanted with HeartMate II LVADs was divided into two groups: 1) baseline glomerular filtration rate (bGFR) ≤ 40 ml/min/1.73 m (n = 30), and 2) GFR > 40 ml/min/1.73 m (n = 135). In both groups, GFR increased significantly at 1 month and then declined, remaining higher than the pre-LVAD level in the bGFR ≤ 40 group and returning back to the pre-LVAD level in the bGFR > 40 group by 1 year post-LVAD follow-up. Post-LVAD dialysis was used in 20% of the bGFR ≤ 40 patients and 7% of the bGFR > 40 patients (p = 0.02). By 3 months, 14% patients had GFR ≤ 40 ml/min/1.73 m. Grade ≥2 tricuspid regurgitation (TR) (odds ratio [OR], 3.4; 95% confidence interval [CI], 1.23-10.28; p = 0.02) and model for end-stage liver disease-XI score ≥ 17 (OR, 4.2; 95% CI, 1.45-12.24; p = 0.01) were risk factors for severe RD at 3 months after LVAD implantation. Eight bGFR ≤ 40 patients underwent heart transplantation. Carefully selected patients with advanced heart dysfunction and bGFR ≤ 40 ml/min/1.73 m can improve kidney function with LVAD support and be able to bridge to isolated heart transplantation. Additional research is needed to refine patient selection for LVAD.

  5. Fabrication of an inexpensive, implantable cooling device for reversible brain deactivation in animals ranging from rodents to primates

    PubMed Central

    Cooke, Dylan F.; Goldring, Adam B.; Yamayoshi, Itsukyo; Tsourkas, Phillippos; Recanzone, Gregg H.; Tiriac, Alex; Pan, Tingrui; Simon, Scott I.

    2012-01-01

    We have developed a compact and lightweight microfluidic cooling device to reversibly deactivate one or more areas of the neocortex to examine its functional macrocircuitry as well as behavioral and cortical plasticity. The device, which we term the “cooling chip,” consists of thin silicone tubing (through which chilled ethanol is circulated) embedded in mechanically compliant polydimethylsiloxane (PDMS). PDMS is tailored to compact device dimensions (as small as 21 mm3) that precisely accommodate the geometry of the targeted cortical area. The biocompatible design makes it suitable for both acute preparations and chronic implantation for long-term behavioral studies. The cooling chip accommodates an in-cortex microthermocouple measuring local cortical temperature. A microelectrode may be used to record simultaneous neural responses at the same location. Cortex temperature is controlled by computer regulation of the coolant flow, which can achieve a localized cortical temperature drop from 37 to 20°C in less than 3 min and maintain target temperature to within ±0.3°C indefinitely. Here we describe cooling chip fabrication and performance in mediating cessation of neural signaling in acute preparations of rodents, ferrets, and primates. PMID:22402651

  6. A microfabricated low cost enzyme-free glucose fuel cell for powering low-power implantable devices

    NASA Astrophysics Data System (ADS)

    Oncescu, Vlad; Erickson, David

    In the past decade the scientific community has showed considerable interest in the development of implantable medical devices such as muscle stimulators, neuroprosthetic devices, and biosensors. Those devices have low power requirements and can potentially be operated through fuel cells using reactants present in the body such as glucose and oxygen instead of non-rechargeable lithium batteries. In this paper, we present a thin, enzyme-free fuel cell with high current density and good stability at a current density of 10 μA cm -2. A non-enzymatic approach is preferred because of higher long term stability. The fuel cell uses a stacked electrode design in order to achieve glucose and oxygen separation. An important characteristic of the fuel cell is that it has no membrane separating the electrodes, which results in low ohmic losses and small fuel cell volume. In addition, it uses a porous carbon paper support for the anodic catalyst layer which reduces the amount of platinum or other noble metal catalysts required for fabricating high surface area electrodes with good reactivity. The peak power output of the fuel cell is approximately 2 μW cm -2 and has a sustainable power density of 1.5 μW cm -2 at 10 μA cm -2. An analysis on the effects of electrode thickness and inter electrode gap on the maximum power output of the fuel cell is also performed.

  7. Guideline-driven telemonitoring and follow-up of cardiovascular implantable electronic devices using IEEE 11073, HL7 & IHE profiles.

    PubMed

    Yang, Maohua; Chronaki, Catherine E; Lüpkes, Christian; Thiel, Andreas; Plössnig, Manuela; Hinterbuchner, Lynne; Arbelo, Elena; Laleci, Gokce Banu; Kabak, Yildiray; Duarte, Fernandez; Guillén, Alejandra; Navarro, Xavier; Dogac, Asuman; Eichelberg, Marco; Hein, Andreas

    2011-01-01

    For patients with Cardiovascular Implantable Electronic Devices (CIEDs), telemonitoring promises improved quality of life and safety, since events recorded by the device or observed by the patient can alert a health professional. Taking into account the latest clinical guidelines when responding to such alerts, is a topic of active research addressed by the iCARDEA project. A key technical challenge is correlating telemonitoring CIED report data in a vendor-independent format with Electronic Health Record (EHR) data collected in the hospital and Personal Health Record (PHR) data entered by the patient, in guideline-driven care processes. The iCARDEA CIED exposure service component presented in this paper employs standards specifications from ISO/IEEE 11073 (Health Informatics, Point-of-care Medical Device Communication) and HL7v2.x in the context of Integrating the Healthcare Enterprise (IHE) profiles to deliver telemonitoring CIED report data from two different CIED vendors to the adaptive care planner that implements guideline-driven care plans. Experience gained with implementation and initial component testing is discussed, while challenges and expectations for future health information standards to effectively support EHR-integrated guide-line-driven telemonitoring services are highlighted.

  8. Fabrication of an inexpensive, implantable cooling device for reversible brain deactivation in animals ranging from rodents to primates.

    PubMed

    Cooke, Dylan F; Goldring, Adam B; Yamayoshi, Itsukyo; Tsourkas, Phillippos; Recanzone, Gregg H; Tiriac, Alex; Pan, Tingrui; Simon, Scott I; Krubitzer, Leah

    2012-06-01

    We have developed a compact and lightweight microfluidic cooling device to reversibly deactivate one or more areas of the neocortex to examine its functional macrocircuitry as well as behavioral and cortical plasticity. The device, which we term the "cooling chip," consists of thin silicone tubing (through which chilled ethanol is circulated) embedded in mechanically compliant polydimethylsiloxane (PDMS). PDMS is tailored to compact device dimensions (as small as 21 mm(3)) that precisely accommodate the geometry of the targeted cortical area. The biocompatible design makes it suitable for both acute preparations and chronic implantation for long-term behavioral studies. The cooling chip accommodates an in-cortex microthermocouple measuring local cortical temperature. A microelectrode may be used to record simultaneous neural responses at the same location. Cortex temperature is controlled by computer regulation of the coolant flow, which can achieve a localized cortical temperature drop from 37 to 20°C in less than 3 min and maintain target temperature to within ±0.3°C indefinitely. Here we describe cooling chip fabrication and performance in mediating cessation of neural signaling in acute preparations of rodents, ferrets, and primates.

  9. Microbial fuel cell as power supply for implantable medical devices: a novel configuration design for simulating colonic environment.

    PubMed

    Dong, Kun; Jia, Boyang; Yu, Chaoling; Dong, Wenbo; Du, Fangzhou; Liu, Hong

    2013-03-15

    This study focused on providing power for implantable medical devices (IMDs) using a microbial fuel cell (MFC) implanted in human transverse colon. Considering the condition of colonic environment, a continuous-flow single-chamber MFC without membrane was set up. The performance of the MFC was investigated. The power output of 1.6 mW under the steady state was not rich enough for some high energy-consuming IMDs. Moreover, the parameters of the simulated colonic environment, such as pH and ORP value, varied along with the time. Hence, a new MFC configuration was developed. In this novel model, pH transducers were placed in cathodic and anodic areas, so as to regulate the reactor operation timely via external intervention. And two ORP transducers were inserted next to the pH transducers, for monitoring and adjusting the MFC operation efficiently. Besides, colonic haustra were designed in order to increase the difference between cathodic and anodic areas.

  10. Bio-based hyperbranched polyurethane/Fe3O4 nanocomposites: smart antibacterial biomaterials for biomedical devices and implants.

    PubMed

    Das, Beauty; Mandal, Manabendra; Upadhyay, Aadesh; Chattopadhyay, Pronobesh; Karak, Niranjan

    2013-06-01

    The fabrication of a smart magnetically controllable bio-based polymeric nanocomposite (NC) has immense potential in the biomedical domain. In this context, magneto-thermoresponsive sunflower oil modified hyperbranched polyurethane (HBPU)/Fe3O4 NCs with different wt.% of magnetic nanoparticles (Fe3O4) were prepared by an in situ polymerization technique. Fourier-transform infrared, x-ray diffraction, vibrating sample magnetometer, scanning electron microscope, transmission electron microscope, thermal analysis and differential scanning calorimetric were used to analyze various physico-chemical structural attributes of the prepared NC. The results showed good interfacial interactions between HBPU and well-dispersed superparamagnetic Fe3O4, with an average diameter of 7.65 nm. The incorporation of Fe3O4 in HBPU significantly improved the thermo-mechanical properties along with the shape-memory behavior, antibacterial activity, biocompatibility as well as biodegradability in comparison to the pristine system. The cytocompatibility of the degraded products of the NC was also verified by in vitro hemolytic activity and MTT assay. In addition, the in vivo biocompatibility and non-immunological behavior, as tested in Wistar rats after subcutaneous implantation, show promising signs for the NC to be used as antibacterial biomaterial for biomedical device and implant applications.

  11. Few-Layer MoS₂ p-Type Devices Enabled by Selective Doping Using Low Energy Phosphorus Implantation.

    PubMed

    Nipane, Ankur; Karmakar, Debjani; Kaushik, Naveen; Karande, Shruti; Lodha, Saurabh

    2016-02-23

    P-type doping of MoS2 has proved to be a significant bottleneck in the realization of fundamental devices such as p-n junction diodes and p-type transistors due to its intrinsic n-type behavior. We report a CMOS compatible, controllable and area selective phosphorus plasma immersion ion implantation (PIII) process for p-type doping of MoS2. Physical characterization using SIMS, AFM, XRD and Raman techniques was used to identify process conditions with reduced lattice defects as well as low surface damage and etching, 4X lower than previous plasma based doping reports for MoS2. A wide range of nondegenerate to degenerate p-type doping is demonstrated in MoS2 field effect transistors exhibiting dominant hole transport. Nearly ideal and air stable, lateral homogeneous p-n junction diodes with a gate-tunable rectification ratio as high as 2 × 10(4) are demonstrated using area selective doping. Comparison of XPS data from unimplanted and implanted MoS2 layers shows a shift of 0.67 eV toward lower binding energies for Mo and S peaks indicating p-type doping. First-principles calculations using density functional theory techniques confirm p-type doping due to charge transfer originating from substitutional as well as physisorbed phosphorus in top few layers of MoS2. Pre-existing sulfur vacancies are shown to enhance the doping level significantly.

  12. Listening to Brain Microcircuits for Interfacing With External World—Progress in Wireless Implantable Microelectronic Neuroengineering Devices

    PubMed Central

    Nurmikko, Arto V.; Donoghue, John P.; Hochberg, Leigh R.; Patterson, William R.; Song, Yoon-Kyu; Bull, Christopher W.; Borton, David A.; Laiwalla, Farah; Park, Sunmee; Ming, Yin; Aceros, Juan

    2011-01-01

    Acquiring neural signals at high spatial and temporal resolution directly from brain microcircuits and decoding their activity to interpret commands and/or prior planning activity, such as motion of an arm or a leg, is a prime goal of modern neurotechnology. Its practical aims include assistive devices for subjects whose normal neural information pathways are not functioning due to physical damage or disease. On the fundamental side, researchers are striving to decipher the code of multiple neural microcircuits which collectively make up nature’s amazing computing machine, the brain. By implanting biocompatible neural sensor probes directly into the brain, in the form of microelectrode arrays, it is now possible to extract information from interacting populations of neural cells with spatial and temporal resolution at the single cell level. With parallel advances in application of statistical and mathematical techniques tools for deciphering the neural code, extracted populations or correlated neurons, significant understanding has been achieved of those brain commands that control, e.g., the motion of an arm in a primate (monkey or a human subject). These developments are accelerating the work on neural prosthetics where brain derived signals may be employed to bypass, e.g., an injured spinal cord. One key element in achieving the goals for practical and versatile neural prostheses is the development of fully implantable wireless microelectronic “brain-interfaces” within the body, a point of special emphasis of this paper. PMID:21654935

  13. Preoperative liver dysfunction influences blood product administration and alterations in circulating haemostatic markers following ventricular assist device implantation

    PubMed Central

    Woolley, Joshua R.; Kormos, Robert L.; Teuteberg, Jeffrey J.; Bermudez, Christian A.; Bhama, Jay K.; Lockard, Kathleen L.; Kunz, Nicole M.; Wagner, William R.

    2015-01-01

    OBJECTIVES Preoperative liver dysfunction may influence haemostasis following ventricular assist device (VAD) implantation. The Model for End-stage Liver Disease (MELD) score was assessed as a predictor of bleeding and levels of haemostatic markers in patients with currently utilized VADs. METHODS Sixty-three patients (31 HeartMate II, 15 HeartWare, 17 Thoratec paracorporeal ventricular assist device) implanted 2001–11 were analysed for preoperative liver dysfunction (MELD) and blood product administration. Of these patients, 21 had additional blood drawn to measure haemostatic marker levels. Cohorts were defined based on high (≥18.0, n = 7) and low (<18.0, n = 14) preoperative MELD scores. RESULTS MELD score was positively correlated with postoperative administration of red blood cell (RBC), platelet, plasma and total blood product units (TBPU) , as well as chest tube drainage and cardiopulmonary bypass time. Age and MELD were preoperative predictors of TBPU by multivariate analysis. The high-MELD cohort had higher administration of TBPU, RBC and platelet units and chest tube drainage postimplant. Similarly, patients who experienced at least one bleeding adverse event were more likely to have had a high preoperative MELD. The high-MELD group exhibited different temporal trends in F1 + 2 levels and platelet counts to postoperative day (POD) 55. D-dimer levels in high-MELD patients became elevated versus those for low-MELD patients on POD 55. CONCLUSIONS Preoperative MELD score predicts postoperative bleeding in contemporary VADs. Preoperative liver dysfunction may also alter postoperative subclinical haemostasis through different temporal trends of thrombin generation and platelet counts, as well as protracted fibrinolysis. PMID:24810756

  14. Bioacceptable and calcification-resistant membranes and interfaces for implantable sensors and devices

    NASA Astrophysics Data System (ADS)

    Galeska, Izabela Ewa

    The rational design and characterization of biocompatible, semipermeable and calcification resistant materials to serve as an outer membrane for implantable glucose biosensors, was the primary focus of this research. Multilayered films of polyanions (i.e. Nafion(TM), a perfluorinated ionomer, and Humic Acids (HAs), naturally occurring biopolymers), fabricated by layer-by-layer self-assembly with oppositely charged ferric ions were investigated as potential membranes. Spectroscopic ellipsometry and quartz crystal microbalance studies point towards a stepwise film growth, with growth rates of 47 and 24.3 nm per layer (for Nafion and HAs respectively) that can be altered depending on the pH and ionic strength of the polyanion solution. Nafion/Fe3+ assembled films exhibited an order of magnitude lower calcification as compared to dip-coated Nafion films and did not require annealing to impart insolubility. Similarly the HAs/Fe3+ films were also devoid of calcification, even after four-week immersion in DMEM cell culture media. Significantly, in vivo studies on the HAs/Fe3 films point to their biocompatibility as demonstrated by mild tissue reaction. These results, along with controllable glucose permeability, could prove vital in prolonging the lifetime of implantable biosensors. Additionally in effort to minimize tissue trauma upon implantation, novel poly(lactic-co-glycolic acid) (PLGA) microsphere/poly(vinyl alcohol) (PVA) hydrogel composites were investigated for dexamethasone delivery. A release rate of 25 to 40% over one month, following a zero order profile, was achieved by preferential adsorption of surface active polyacids (poly(acrylic acid), Nafion and HAs) on the hydrogel dispersed microspheres. Environmental scanning electron microscopy investigation on the degradation mechanism of the microspheres pointed towards their slow homogeneous degradation in the PVA hydrogels that was significantly surface-accelerated in the presence of polyacids. The physico

  15. A Review of the Development of a Vehicle for Localized and Controlled Drug Delivery for Implantable Biosensors

    PubMed Central

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

    2008-01-01

    A major obstacle to the development of implantable biosensors is the foreign body response (FBR) that results from tissue trauma during implantation and the continuous presence of the implant in the body. The in vivo stability and functionality of biosensors are compromised by damage to sensor components and decreased analyte transport to the sensor. This paper summarizes research undertaken by our group since 2001 to control the FBR toward implanted sensors. Localized and sustained delivery of the anti-inflammatory drug, dexamethasone, and the angiogenic growth factor, vascular endothelial growth factor (VEGF), was utilized to inhibit inflammation as well as fibrosis and provide a stable tissue–device interface without producing systemic adverse effects. The drug-loaded polylactic-co-glycolic acid (PLGA) microspheres were embedded in a polyvinyl alcohol (PVA) hydrogel composite to fabricate a drug-eluting, permeable external coating for implantable devices. The composites were fabricated using the freeze–thaw cycle method and had mechanical properties similar to soft body tissue. Dexamethasone-loaded microsphere/hydrogel composites were able to provide anti-inflammatory protection, preventing the FBR. Moreover, concurrent release of dexamethasone with VEGF induced neoangiogenesis in addition to providing anti-inflammatory protection. Sustained release of dexamethasone is required for the entire sensor lifetime, as a delayed inflammatory response developed after depletion of the drug from the composites. These studies have shown the potential of PLGA microsphere/PVA hydrogel-based composites as drug-eluting external coatings for implantable biosensors. PMID:19885291

  16. Device-based local delivery of siRNA against mammalian target of rapamycin (mTOR) in a murine subcutaneous implant model to inhibit fibrous encapsulation

    PubMed Central

    Takahashi, Hironobu; Wang, Yuwei; Grainger, David W.

    2010-01-01

    Fibrous encapsulation of surgically implant devices is associated with elevated proliferation and activation of fibroblasts in tissues surrounding these implants, frequently causing foreign body complications. Here we test the hypothesis that inhibition of the expression of mammalian target of rapamycin (mTOR) in fibroblasts can mitigate the soft tissue implant foreign body response by suppressing fibrotic responses around implants. In this study, mTOR was knocked down using small interfering RNA conjugated with branched cationic polyethylenimine (bPEI) in fibroblastic lineage cells in serum-based cell culture as shown by both gene and protein analysis. This mTOR knockdown led to an inhibition in fibroblast proliferation by 70% and simultaneous down-regulation in the expression of type I collagen in fibroblasts in vitro. These siRNA/bPEI complexes were released from poly(ethylene glycol) (PEG)-based hydrogel coatings surrounding model polymer implants in a subcutaneous rodent model in vivo. No significant reduction in fibrous capsule thickness and mTOR expression in the foreign body capsules was observed. Observed siRNA inefficacy in this in vivo implant model was attributed to siRNA dosing limitations in the gel delivery system, and lack of targeting ability of the siRNA complex specifically to fibroblasts. While in vitro data supported mTOR knock-down in fibroblast cultures, in vivo siRNA delivery must be further improved to produce clinically relevant effects on fibrotic encapsulation around implants. PMID:20727922

  17. Catheter fracture: a rare complication of totally implantable subclavian venous access devices.

    PubMed

    Klotz, H P; Schöpke, W; Kohler, A; Pestalozzi, B; Largiadèr, F

    1996-07-01

    Catheter fracture represents a rare problem among non-infectious complications following the insertion of totally implantable long-term central venous access systems for the application of chemotherapeutic agents. A literature survey revealed a total incidence of catheter fractures of 0-2.1%. Imminent catheter fracture can be identified radiologically, using different degrees of catheter narrowing between the clavicle and the first rib, called pinch-off sign. Two cases of catheter fracture are described and potential causes are discussed. Recommendations to avoid the pinch-off sign with the subsequent risk of catheter fracture and migration include a more lateral and direct puncture of the subclavian vein. In case of catheter narrowing in the clavicular-first rib angle, patients should be followed carefully by chest X-rays every 4 weeks. Whenever possible, the system should be removed within 6 months following insertion.

  18. Effect of high energy proton implantation on the device characteristics of InAlGaAs-capped InGaAs/GaAs quantum dot based infrared photodetectors

    NASA Astrophysics Data System (ADS)

    Upadhyay, S.; Mandal, A.; Ghadi, H.; Pal, D.; Subrahmanyam, N. B. V.; Singh, P.; Chakrabarti, S.

    2015-05-01

    Self-assembled In(Ga)As/GaAs quantum dot infrared photodetectors (QDIPs) have promising applications in the midwavelength infrared and long-wavelength infrared regions for various defense and space application purposes. It has been demonstrated that the performance of QDIPs has improved significantly by using architectures such as dots-in-awell, different combinational capping or post growth treatment with high energy hydrogen ions. In this work, we enhanced the electrical properties InGaAs/GaAs using high energy proton implantation. Irradiation with proton resulted suppression in field assisted tunnelling of dark current by three orders for implanted devices. Photoluminescence (PL) enhancement was observed up to certain dose of protons due to eradication of as-grown defects and non radiative recombination centers. In addition, peak detectivity (D*) increased up to two orders of magnitude from 6.1 x108 to 1.0 × 1010 cm-Hz1/2/W for all implanted devices.

  19. Chronic cortical and electromyographic recordings from a fully implantable device: preclinical experience in a nonhuman primate

    NASA Astrophysics Data System (ADS)

    Ryapolova-Webb, Elena; Afshar, Pedram; Stanslaski, Scott; Denison, Tim; de Hemptinne, Coralie; Bankiewicz, Krystof; Starr, Philip A.

    2014-02-01

    Objective. Analysis of intra- and perioperatively recorded cortical and basal ganglia local field potentials in human movement disorders has provided great insight into the pathophysiology of diseases such as Parkinson's, dystonia, and essential tremor. However, in order to better understand the network abnormalities and effects of chronic therapeutic stimulation in these disorders, long-term recording from a fully implantable data collection system is needed. Approach. A fully implantable investigational data collection system, the Activa® PC + S neurostimulator (Medtronic, Inc., Minneapolis, MN), has been developed for human use. Here, we tested its utility for extended intracranial recording in the motor system of a nonhuman primate. The system was attached to two quadripolar paddle arrays: one covering sensorimotor cortex, and one covering a proximal forelimb muscle, to study simultaneous cortical field potentials and electromyography during spontaneous transitions from rest to movement. Main results. Over 24 months of recording, movement-related changes in physiologically relevant frequency bands were readily detected, including beta and gamma signals at approximately 2.5 μV/\\sqrtHz and 0.7 μV/\\sqrt{Hz}, respectively. The system architecture allowed for flexible recording configurations and algorithm triggered data recording. In the course of physiological analyses, sensing artifacts were observed (˜1 μVrms stationary tones at fixed frequency), which were mitigated either with post-processing or algorithm design and did not impact the scientific conclusions. Histological examination revealed no underlying tissue damage; however, a fibrous capsule had developed around the paddles, demonstrating a potential mechanism for the observed signal amplitude reduction. Significance. This study establishes the usefulness of this system in measuring chronic brain and muscle signals. Use of this system may potentially be valuable in human trials of chronic brain

  20. Adipogenic healing in adult mice by implantation of hollow devices in muscle.

    PubMed

    Xaymardan, Munira; Gibbins, John R; Zoellner, Hans

    2002-05-01

    In mammals, wound healing is thought to result in the formation of scar tissue, with the exception of bony healing after fractures. Here we describe a previously unknown pattern of wound healing in which adipose rather than scar tissue is formed. Adipogenesis is normally confined to the embryo, although there are several experimental models for adipogenesis with highly specific dietary, cytokine, matrix, sex, or age requirements. The adipogenic healing described in this work provides a simple and reproducible experimental mouse model for adipogenesis without these limitations. Mice received intramuscular implants of nylon mesh material. Fibrinous material impregnated implants and within 4 weeks was replaced with highly vascular granulation tissue, typical of wound healing. Also consistent with wound healing was a reduction in vascularity of the newly formed tissue over time (P < 0.05). Lipoblasts were prevalent in granulation tissue, reaching a maximum in week 2 (P < 0.001) but falling to very low levels by week 9. These cells matured to adipocytes, with intermediate forms being seen. The identity of lipoblasts and adipocytes was confirmed by Oil Red O staining and electron microscopy. Control experiments confirmed that adipogenesis was independent of the materials used as well as of the sex and age of the animals. Rather, adipogenesis appeared to be due to replacement of fibrinous material in a space created within muscle. It is possible that adipogenic healing represents an adaptation for limiting the formation of restrictive scar tissues within muscle, and that this is the basis for the formation of traumatic lipomas in humans. Also, muscle tissue is replaced by adipose cells, seemingly derived from pluripotential satellite cells, in several degenerative muscle conditions, suggesting a role for adipogenic healing in these conditions.

  1. Left ventricular assist device implantation via left thoracotomy: alternative to repeat sternotomy.

    PubMed

    Pierson, Richard N; Howser, Renee; Donaldson, Terri; Merrill, Walter H; Dignan, Rebecca J; Drinkwater, Davis C; Christian, Karla G; Butler, Javed; Chomsky, Don; Wilson, John R; Clark, Rick; Davis, Stacy F

    2002-03-01

    Repeat sternotomy for left ventricular assist device insertion may result in injury to the right heart or patent coronary grafts, complicating intraoperative and postoperative management. In 4 critically ill patients, left thoracotomy was used as an alternative to repeat sternotomy. Anastomosis of the outflow conduit to the descending thoracic aorta provided satisfactory hemodynamic support.

  2. Dual drug-loaded paclitaxel-thymoquinone nanoparticles for effective breast cancer therapy

    NASA Astrophysics Data System (ADS)

    Soni, Parth; Kaur, Jasmine; Tikoo, Kulbhushan

    2015-01-01

    The present study highlights the beneficial synergistic blend of anticancer drug paclitaxel (PTX) and thymoquinone (TQ) in MCF-7 breast cancer cells. We aimed to augment the therapeutic index of PTX using a polymeric nanoparticle system loaded with PTX and TQ. PLGA nanoparticles encapsulating the two drugs, individually or in combination, were prepared by single emulsion solvent evaporation method. The formulated nanoparticles were homogenous with an overall negative charge and their size ranging between 200 and 300 nm. Entrapment efficiency of PTX and TQ in the dual drug-loaded nanoparticles was found to be 82.4 ± 2.18 and 65.8 ± 0.45 %, respectively. The release kinetics of PTX and TQ from the nanoparticles exhibited a biphasic pattern characterised by an initial burst, followed by a gradual and continuous release. The anticancer activity of nanoparticles encapsulating both the drugs was higher as compared to the free drugs in MCF-7 breast cancer cells. The combination index for the dual drug-loaded NPs was found to be 0.688 which is indicative of synergistic interaction. Thus, here, we propose the synthesis and use of dual drug-loaded TQ and PTX NPs which exhibits enhanced anticancer activity and can additionally help to alleviate the toxic effects of PTX by lowering its effective dose.

  3. Engineered particles demonstrate improved flow properties at elevated drug loadings for direct compression manufacturing.

    PubMed

    Trementozzi, Andrea N; Leung, Cheuk-Yui; Osei-Yeboah, Frederick; Irdam, Erwin; Lin, Yiqing; MacPhee, J Michael; Boulas, Pierre; Karki, Shyam B; Zawaneh, Peter N

    2017-03-08

    Optimizing powder flow and compaction properties are critical for ensuring a robust tablet manufacturing process. The impact of flow and compaction properties of the active pharmaceutical ingredient (API) becomes progressively significant for higher drug load formulations, and for scaling up manufacturing processes. This study demonstrated that flow properties of a powder blend can be improved through API particle engineering, without critically impacting blend tabletability at elevated drug loadings. In studying a jet milled API (D50=24μm) and particle engineered wet milled API (D50=70μm and 90μm), flow functions of all API lots were similarly poor despite the vast difference in average particle size (ffc<4). This finding strays from the common notion that powder flow properties are directly correlated to particle size distribution. Upon adding excipients, however, clear trends in flow functions based on API particle size were observed. Wet milled API blends had a much improved flow function (ffc>10) compared with the jet milled API blends. Investigation of the compaction properties of both wet and jet milled powder blends also revealed that both jet and wet milled material produced robust tablets at the drug loadings used. The ability to practically demonstrate this uncommon observation that similarly poor flowing APIs can lead to a marked difference upon blending is important for pharmaceutical development. It is especially important in early phase development during API selection, and is advantageous particularly when material-sparing techniques are utilized.

  4. Salt and cosolvent effects on ionic drug loading into microspheres using an O/W method.

    PubMed

    Al-Maaieh, A; Flanagan, D R

    2001-01-29

    Salt effects on aqueous solubility and microsphere entrapment efficiency of a model ionic drug (quinidine sulfate) were studied. Poly-D,L-lactic acid (PLA) microspheres were prepared using an O/W solvent evaporation method with various electrolytes added in different concentrations to the aqueous phase. Salts affect microsphere drug loading by changing the aqueous solubility of both the drug and the organic solvent (dichloromethane, DCM). Quinidine sulfate solubility was depressed by either a common ion effect (Na(2)SO(4)) or by formation of new, less soluble drug salts (e.g., bromide, perchlorate, thiocyanate) for which solubility products (K(sp)) were estimated. Inorganic salts depress DCM aqueous solubility to different extents as described by the Hofmeister series. NaClO(4) and NaSCN depressed drug solubility to the highest extent, resulting in microspheres with high drug loading (e.g., >90%). Other salts such as Na(2)SO(4) did not depress quinidine sulfate solubility to the same extent and did not improve loading. The use of a cosolvent (ethanol) in the organic phase improved microsphere drug loading and resulted in a uniform microsphere drug distribution with smooth release profiles.

  5. Time-programmed dual release formulation by multilayered drug-loaded nanofiber meshes.

    PubMed

    Okuda, Tatsuya; Tominaga, Kengo; Kidoaki, Satoru

    2010-04-19

    To develop a drug carrier that enables time-programmed dual release in a single formulation, multilayered drug-loaded biodegradable nanofiber meshes were designed using sequential electrospinning with the following construction: (i) first drug-loaded mesh (top), (ii) barrier mesh, (iii) second drug-loaded mesh, and (iv) basement mesh (bottom). The drug release speed and duration were controlled by designing morphological features of the electrospun meshes such as the fiber diameter and mesh thickness. Control of the timed release of the second drug-the retardation period-was accomplished by appropriate design of the barrier mesh thickness. An in vitro release experiment demonstrated that the tetra-layered construction described above with appropriate morphological features of each component mesh can provide timed dual release of the respective drugs. The time-programmed dual release system using the multilayered electrospun nanofiber meshes was demonstrated as a useful formulation for advanced multidrug combination therapy requiring regiospecific administration of different drugs at different times. The potential use of the present multilayered formulation is discussed for application to biochemical modulation as one administrative strategy for use in sequential chemotherapy employing multiple anti-tumor drugs.

  6. Electrospun microfiber membranes embedded with drug-loaded clay nanotubes for sustained antimicrobial protection.

    PubMed

    Xue, Jiajia; Niu, Yuzhao; Gong, Min; Shi, Rui; Chen, Dafu; Zhang, Liqun; Lvov, Yuri

    2015-02-24

    Guided tissue regeneration/guided bone regeneration membranes with sustained drug delivery were developed by electrospinning drug-loaded halloysite clay nanotubes doped into poly(caprolactone)/gelatin microfibers. Use of 20 wt % nanotube content in fiber membranes allowed for 25 wt % metronidazole drug loading in the membrane. Nanotubes with a diameter of 50 nm and a length of 600 nm were aligned within the 400 nm diameter electrospun fibers, resulting in membranes with doubling of tensile strength along the collector rotating direction. The halloysite-doped membranes acted as barriers against cell ingrows and have good biocompatibility. The metronidazole-loaded halloysite nanotubes incorporated in the microfibers allowed for extended release of the drugs over 20 days, compared to 4 days when directly admixed into the microfibers. The sustained release of metronidazole from the membranes prevented the colonization of anaerobic Fusobacteria, while eukaryotic cells could still adhere to and proliferate on the drug-loaded composite membranes. This indicates the potential of halloysite clay nanotubes as drug containers that can be incorporated into electrospun membranes for clinical applications.

  7. Accurate estimation of entropy in very short physiological time series: the problem of atrial fibrillation detection in implanted ventricular devices.

    PubMed

    Lake, Douglas E; Moorman, J Randall

    2011-01-01

    Entropy estimation is useful but difficult in short time series. For example, automated detection of atrial fibrillation (AF) in very short heart beat interval time series would be useful in patients with cardiac implantable electronic devices that record only from the ventricle. Such devices require efficient algorithms, and the clinical situation demands accuracy. Toward these ends, we optimized the sample entropy measure, which reports the probability that short templates will match with others within the series. We developed general methods for the rational selection of the template length m and the tolerance matching r. The major innovation was to allow r to vary so that sufficient matches are found for confident entropy estimation, with conversion of the final probability to a density by dividing by the matching region volume, 2r(m). The optimized sample entropy estimate and the mean heart beat interval each contributed to accurate detection of AF in as few as 12 heartbeats. The final algorithm, called the coefficient of sample entropy (COSEn), was developed using the canonical MIT-BIH database and validated in a new and much larger set of consecutive Holter monitor recordings from the University of Virginia. In patients over the age of 40 yr old, COSEn has high degrees of accuracy in distinguishing AF from normal sinus rhythm in 12-beat calculations performed hourly. The most common errors are atrial or ventricular ectopy, which increase entropy despite sinus rhythm, and atrial flutter, which can have low or high entropy states depending on dynamics of atrioventricular conduction.

  8. Real-time monitoring of brain tissue oxygen using a miniaturized biotelemetric device implanted in freely moving rats.

    PubMed

    Bazzu, Gianfranco; Puggioni, Giulia G M; Dedola, Sonia; Calia, Giammario; Rocchitta, Gaia; Migheli, Rossana; Desole, Maria S; Lowry, John P; O'Neill, Robert D; Serra, Pier A

    2009-03-15

    A miniaturized biotelemetric device for the amperometric detection of brain tissue oxygen is presented. The new system, derived from a previous design, has been coupled with a carbon microsensor for the real-time detection of dissolved O(2) in the striatum of freely moving rats. The implantable device consists of a single-supply sensor driver, a current-to-voltage converter, a microcontroller, and a miniaturized data transmitter. The oxygen current is converted to a digital value by means of an analog-to-digital converter integrated in a peripheral interface controller (PIC). The digital data is sent to a personal computer using a six-byte packet protocol by means of a miniaturized 434 MHz amplitude modulation (AM) transmitter. The receiver unit is connected to a personal computer (PC) via a universal serial bus. Custom developed software allows the PC to store and plot received data. The electronics were calibrated and tested in vitro under different experimental conditions and exhibited high stability, low power consumption, and good linear response in the nanoampere current range. The in vivo results confirmed previously published observations on oxygen dynamics in the striatum of freely moving rats. The system serves as a rapid and reliable model for studying the effects of different drugs on brain oxygen and brain blood flow and it is suited to work with direct-reduction sensors or O(2)-consuming biosensors.

  9. Rupture of totally implantable central venous access devices (Intraports) in patients with cancer: report of four cases

    PubMed Central

    Filippou, Dimitrios K; Tsikkinis, Christoforos; Filippou, Georgios K; Nissiotis, Athanasios; Rizos, Spiros

    2004-01-01

    Background Totally implantable central venous access devices (intraports) are commonly used in cancer patients to administer chemotherapy or parenteral nutrition. Rupture of intraport is a rare complication. Patients and methods During 3 years period, a total of 245 intraports were placed in cancer patients for chemotherapy. Four of these cases (two colon cancer and one each of pancreas and breast cancer) had rupture of the intraport catheter, these forms the basis of present report. Results Mean time insitu for intraports was 164∀35 days. Median follow-up time was 290 days and total port time in situ was 40180 days. The incidence of port rupture was 1 per 10,000 port days. Three of the 4 cases were managed by successful removal of catheters. In two of these the catheter was removed under fluoroscopic control using femoral route, while in the third patient the catheter (partial rupture) was removed surgically. One of the catheters could not be removed and migrated to right ventricle on manipulations. Conclusion Port catheter rupture is a rare but dreaded complication associated with subcutaneous port catheter device placement for chemotherapy. In case of such an event the patient should be managed by an experienced vascular surgeon and interventional radiologist, as in most cases the ruptured catheter can be retrieved by non operative interventional measures. PMID:15494075

  10. A figure-of-merit for design of high performance inductive power transmission links for implantable microelectronic devices.

    PubMed

    Kiani, Mehdi; Ghovanloo, Maysam

    2012-01-01

    Wireless power transfer through inductive coupling is used in many applications such as high performance implantable microelectronic devices (IMDs). Power transfer efficiency (PTE) and power delivered to the load (PDL) are two conventional inductive link design merits that determine the energy source and driver specifications, heat dissipation, power transmission range, and risk of interference with other devices. Unfortunately designing the inductive link to achieve a high PTE will drastically reduce the PDL and vice versa. Therefore, we are proposing a new figure-of-merit (FoM), which includes both PTE and PDL with proper weights, to help designers of inductive power transfer links to strike a balance between high PTE and PDL at the same time. Three design examples based on the PTE, PDL, and the new FoM have been presented for IMDs to demonstrate the usage and efficacy of the FoM. Our measurement results show that the inductive link optimized based on the FoM can achieved 1.65 times higher PTE than the one optimized for the PDL (72.5% vs. 44%) and at the same time provide 20.8 times larger PDL compared to the one optimized for the PTE (177 mW vs. 8.5 mW for 1 V driving voltage). The inductive links optimized for the PTE and PDL provide 24% higher PTE and PDL compared to the one optimized based on the FoM, respectively.

  11. Committee opinion no. 539: adolescents and long-acting reversible contraception: implants and intrauterine devices.

    PubMed

    2012-10-01

    Long-acting reversible contraception (LARC)—intrauterine devices and the contraceptive implant—are safe and appropriate contraceptive methods for most women and adolescents. The LARC methods are top-tier contraceptives based on effectiveness, with pregnancy rates of less than 1% per year for perfect use and typical use. These contraceptives have the highest rates of satisfaction and continuation of all reversible contraceptives. Adolescents are at high risk of unintended pregnancy and may benefit from increased access to LARC methods.

  12. Fully Implantable Arterial Blood Glucose Device for Metabolic Research Applications in Rats for Two Months

    PubMed Central

    Brockway, Robert; Tiesma, Scott; Bogie, Heather; White, Kimberly; Fine, Megan; O’Farrell, Libbey; Michael, Mervyn; Cox, Amy; Coskun, Tamer

    2015-01-01

    Background: Chronic continuous glucose monitoring options for animal research have been very limited due to various technical and biological challenges. We provide an evaluation of a novel telemetry device for continuous monitoring of temperature, activity, and plasma glucose levels in the arterial blood of rats for up to 2 months. Methods: In vivo testing in rats including oral glucose tolerance tests (OGTTs) and intraperitoneal glucose tolerance tests (IPGTTs) and ex vivo waterbath testing were performed to evaluate acute and chronic sensor performance. Animal studies were in accordance with the guidelines for the care and use of laboratory animals and approved by the corresponding animal care and use committees (Data Sciences International, Eli Lilly). Results: Results demonstrated the ability to record continuous measurements for 75 days or longer. Bench testing demonstrated a high degree of linearity over a range of 20-850 mg/dL with R2 = .998 for linear fit and .999 for second order fit (n = 8 sensors). Evaluation of 6 rats over 28 days with 52 daily and OGTT test strip measurements each resulted in mean error of 3.8% and mean absolute relative difference of 16.6%. Conclusions: This device provides significant advantages in the quality and quantity of data that can be obtained relative to existing alternatives such as intermittent blood sampling. These devices provide the opportunity to expand the understanding of both glucose metabolism and homeostasis and to work toward improved therapies and cures for diabetes. PMID:26021562

  13. Curative surgery for gastric cancer in a patient with an implantable left ventricular assist device.

    PubMed

    Nakamura, Yuki; Toda, Koichi; Nakamura, Teruya; Miyagawa, Shigeru; Yoshikawa, Yasushi; Fukushima, Satsuki; Saito, Shunsuke; Yoshioka, Daisuke; Domae, Keitaro; Takahashi, Tsuyoshi; Hashimoto, Tadayoshi; Doki, Yuichiro; Sawa, Yoshiki

    2017-02-04

    The number of patients with end-stage heart failure treated by a left ventricular assist device (LVAD) is dramatically increasing, because the LVAD has been widely accepted for its clinical results. According to the initiation of destination therapy, the prevalence of malignancy in patients with an LVAD is estimated to increase. In patients with LVADs, abdominal surgery for visceral malignancy is associated with technical difficulties because of the presence of an LVAD pump or the driveline which is located transversely in the preperitoneal space. Herein, we describe the technical management for complete resection of gastric cancer in a patient with an LVAD.

  14. Sutureless Aortic Prosthesis Implantation: the First Brazilian Experience with Perceval Device

    PubMed Central

    Tagliari, Ana Paula; de Moura, Leandro; Dussin, Luiz Henrique; Saadi, Eduardo Keller

    2016-01-01

    This is a report of the first Brazilian experience with the Perceval sutureless aortic prosthesis in two patients with severe aortic stenosis. Transesophageal echocardiography was used during the procedure. The aortotomy was performed 1 cm above the sinotubular junction, followed by leaflets removal and decalcification. Correct valve size was selected, device released and an accommodation balloon used. The cardiopulmonary bypass times were 47 and 38 min and the cross-clamp times were 38 and 30 min. There was a significant decrease in mean gradients (41 and 75 mmHg preoperatively; 7 and 8 mmHg postoperatively). There was no major complication or paravalvular leak. PMID:27849308

  15. Dynamic device properties of pulse contour cardiac output during transcatheter aortic valve implantation.

    PubMed

    Petzoldt, Martin; Riedel, Carsten; Braeunig, Jan; Haas, Sebastian; Goepfert, Matthias S; Treede, Hendrik; Baldus, Stephan; Goetz, Alwin E; Reuter, Daniel A

    2015-06-01

    This prospective single-center study aimed to determine the responsiveness and diagnostic performance of continuous cardiac output (CCO) monitors based on pulse contour analysis compared with invasive mean arterial pressure (MAP) during predefined periods of acute circulatory deterioration in patients undergoing transcatheter aortic valve implantation (TAVI). The ability of calibrated (CCO(CAL)) and self-calibrated (CCO(AUTOCAL)) pulse contour analysis to detect the hemodynamic response to 37 episodes of balloon aortic valvuloplasty enabled by rapid ventricular pacing was quantified in 13 patients undergoing TAVI. A "low" and a "high" cut-off limit were predefined as a 15 or 25 % decrease from baseline respectively. We found no significant differences between CCO(CAL) and MAP regarding mean response time [low cut-off: 8.6 (7.1-10.5) vs. 8.9 (7.3-10.8) s, p = 0.76; high cut-off: 11.4 (9.7-13.5) vs. 12.6 (10.7-14.9) s, p = 0.32] or diagnostic performance [area under the receiver operating characteristics curve (AUC): 0.99 (0.98-1.0) vs. 1.0 (0.99-1.0), p = 0.46]. But CCOCAL had a significantly higher amplitude response [95.0 (88.7-98.8) % decrease from baseline] than MAP [41.2 (30.0-52.9) %, p < 0.001]. CCOAUTOCAL had a significantly lower AUC [0.83 (0.73-0.93), p < 0.001] than MAP. Moreover, CCO(CAL) detected hemodynamic recovery significantly earlier than MAP. In conclusion, CCO(CAL) and MAP provided equivalent responsiveness and diagnostic performance to detect acute circulatory depression, whereas CCO(AUTOCAL) appeared to be less appropriate. In contrast to CCO(CAL) the amplitude response of MAP was poor. Consequently even small response amplitudes of MAP could indicate severe decreases in CO.

  16. Concurrent Left Ventricular Assist Device (LVAD) Implantation and Percutaneous Temporary RVAD Support via CardiacAssist Protek-Duo TandemHeart to Preempt Right Heart Failure.

    PubMed

    Schmack, Bastian; Weymann, Alexander; Popov, Aron-Frederik; Patil, Nikhil Prakash; Sabashnikov, Anton; Kremer, Jamila; Farag, Mina; Brcic, Andreas; Lichtenstern, Christoph; Karck, Matthias; Ruhparwar, Arjang

    2016-05-05

    Right ventricular failure (RVF) is an unfortunate complication that continues to limit outcomes following durable left ventricular assist device (LVAD) implantation. Despite several 'RVF risk scores' having been proposed, preoperative prediction of post-LVAD RVF remains a guesstimate at best. Current strategies for institution of temporary RVAD support are invasive, necessitate additional re-thoracotomy, restrict postoperative mobilization, and/or entail prolonged retention of prosthetic material in-situ. The authors propose a novel surgical strategy comprising simultaneous implantation of a permanent LVAD and percutaneous TandemHeart® plus ProtekDuo® to provide temporary RVAD support and preempt RVF in patients with impaired RV function.

  17. Highly Sensitive and Long Term Stable Electrochemical Microelectrodes for Implantable Glucose Monitoring Devices

    NASA Astrophysics Data System (ADS)

    Qiang, Liangliang

    A miniature wireless implantable electrochemical glucose system for continuous glucose monitoring with good selectivity, sensitivity, linearity and long term stability was developed. First, highly sensitive, long-term stable and reusable planar H2O2 microelectrodes have been fabricated by microlithography. These electrodes composed of a 300 nm Pt black layer situated on a 5 um thick Au layer, provide effective protection to the underlying chromium adhesion layer. Using repeated cyclic voltammetric sweeps in flowing buffer solution, highly sensitive Pt black working electrodes were realized with five-decade linear dynamic range and low detection limit (10 nM) for H2O2 at low oxidation potentials. Second, a highly sensitive, low cost and flexible microwire biosensor was described using 25-mum thick gold wire as working electrode together with 125-mum thick Pt/Ir and Ag wires as counter and reference electrode, embedded within a PDMS-filled polyethylene tube. Surface area and activity of sensor was enhanced by converting gold electrode to nanoporous configuration followed by electrodeposition of platinum black. Glucose oxidase based biosensors by electrodeposition of poly(o-phenylenediamine) and glucose oxidase on the working electrode, displayed a higher glucose sensitivity (1.2 mA mM-1 cm-2) than highest literature reported. In addition it exhibits wide detection range (up to 20 mM) and selectivity (>95%). Third, novel miniaturized and flexible microelectrode arrays with 8 of 25 mum electrodes displayed the much needed 3D diffusion profiles similar to a single 25 mum microelectrode, but with one order increase in current levels. These microelectrode arrays displayed a H2O2 sensitivity of 13 mA mM-1 cm-2, a wide dynamic range of 100 nM to 10 mM, limit of detection of 10 nM. These microwire based edge plane microsensors incorporated flexibility, miniaturization and low operation potential are an promising approach for continuous in vivo metabolic monitoring. Fourth

  18. Implantation of radio frequency identification device (RFID) microchip in disaster victim identification (DVI).

    PubMed

    Meyer, Harald J; Chansue, Nantarika; Monticelli, Fabio

    2006-03-10

    The tsunami catastrophe of December 2004 left more than 200,000 dead. Disaster victim identification (DVI) teams were presented with the unprecedented challenge of identifying thousands of mostly markedly putrefied and partially skeletised bodies. To this end, an adequate body tagging method is essential. Conventional body bag tagging in terms of writing on body bags and placing of tags inside body bags proved unsatisfactory and problem prone due to consequences of cold storage, formalin (formaldehyde) embalming and body numbers inside storage facilities. The placement of radio frequency identification device (RFID) microchips inside victim bodies provided a practical solution to problems of body tagging and attribution in the DVI setting encountered by the Austrian DVI team in Thailand in early 2005.

  19. Cryogenic ion implantation near amorphization threshold dose for halo/extension junction improvement in sub-30 nm device technologies

    SciTech Connect

    Park, Hugh; Todorov, Stan; Colombeau, Benjamin; Rodier, Dennis; Kouzminov, Dimitry; Zou Wei; Guo Baonian; Khasgiwale, Niranjan; Decker-Lucke, Kurt

    2012-11-06

    We report on junction advantages of cryogenic ion implantation with medium current implanters. We propose a methodical approach on maximizing cryogenic effects on junction characteristics near the amorphization threshold doses that are typically used for halo implants for sub-30 nm technologies. BF{sub 2}{sup +} implant at a dose of 8 Multiplication-Sign 10{sup 13}cm{sup -2} does not amorphize silicon at room temperature. When implanted at -100 Degree-Sign C, it forms a 30 - 35 nm thick amorphous layer. The cryogenic BF{sub 2}{sup +} implant significantly reduces the depth of the boron distribution, both as-implanted and after anneals, which improves short channel rolloff characteristics. It also creates a shallower n{sup +}-p junction by steepening profiles of arsenic that is subsequently implanted in the surface region. We demonstrate effects of implant sequences, germanium preamorphization, indium and carbon co-implants for extension/halo process integration. When applied to sequences such as Ge+As+C+In+BF{sub 2}{sup +}, the cryogenic implants at -100 Degree-Sign C enable removal of Ge preamorphization, and form more active n{sup +}-p junctions and steeper B and In halo profiles than sequences at room temperature.

  20. Cryogenic ion implantation near amorphization threshold dose for halo/extension junction improvement in sub-30 nm device technologies

    NASA Astrophysics Data System (ADS)

    Park, Hugh; Todorov, Stan; Colombeau, Benjamin; Rodier, Dennis; Kouzminov, Dimitry; Zou, Wei; Guo, Baonian; Khasgiwale, Niranjan; Decker-Lucke, Kurt

    2012-11-01

    We report on junction advantages of cryogenic ion implantation with medium current implanters. We propose a methodical approach on maximizing cryogenic effects on junction characteristics near the amorphization threshold doses that are typically used for halo implants for sub-30 nm technologies. BF2+ implant at a dose of 8×1013cm-2 does not amorphize silicon at room temperature. When implanted at -100°C, it forms a 30 - 35 nm thick amorphous layer. The cryogenic BF2+ implant significantly reduces the depth of the boron distribution, both as-implanted and after anneals, which improves short channel rolloff characteristics. It also creates a shallower n+-p junction by steepening profiles of arsenic that is subsequently implanted in the surface region. We demonstrate effects of implant sequences, germanium preamorphization, indium and carbon co-implants for extension/halo process integration. When applied to sequences such as Ge+As+C+In+BF2+, the cryogenic implants at -100°C enable removal of Ge preamorphization, and form more active n+-p junctions and steeper B and In halo profiles than sequences at room temperature.

  1. "Smart" drug loaded nanoparticle delivery from a self-healing hydrogel enabled by dynamic magnesium-biopolymer chemistry.

    PubMed

    Shi, Liyang; Han, Yuanyuan; Hilborn, Jöns; Ossipov, Dmitri

    2016-09-25

    We report a strategy to generate a self-healing and pH responsive hydrogel network between drug-loaded nanoparticles and natural polysaccharides via magnesium-bisphosphonate ligand interactions. The injectable drug depot disassembles in a tumor-specific environment, providing localized uptake of the nanoparticles, which is highly appreciated in drug delivery applications and manufacturing of drug-loaded biomaterials using a syringe-based deposition technique.

  2. Ophthalmic drug-loaded N,O-carboxymethyl chitosan hydrogels: synthesis, in vitro and in vivo evaluation

    PubMed Central

    Yang, Li-qun; Lan, Yu-qing; Guo, Hui; Cheng, Liang-zheng; Fan, Ji-zhou; Cai, Xiang; Zhang, Li-ming; Chen, Ru-fu; Zhou, Huai-sheng

    2010-01-01

    Aim: To investigate the ability of drug-loaded N,O-carboxymethyl chitosan (CMCS) hydrogels to modulate wound healing after glaucoma filtration surgery. Methods: The drug-loaded CMCS hydrogels were in situ synthesized using genipin as the crosslinker in the presence of 5-fluorouracil (5FU) or bevacizumab. Their structures were characterized by FTIR, ultraviolet-visible (UV-vis) spectroscopy and scanning electron microscopy (SEM). In-vitro drug release experiments and in vivo evaluation in rabbits were performed. Results: The results of FTIR, UV-vis spectroscopy and SEM analyses indicated that 5FU was encapsulated into the CMCS hydrogels that were crosslinked by genipin. The in vitro drug release experiments showed that nearly 100% of 5FU was released from the drug-loaded hydrogels within 8 h, but less than 20% bevacizumab was released after 53 h. The in vivo evaluation in rabbits indicated that the drug-loaded CMCS hydrogels were nontoxic to the cornea and were gradually biodegraded in the eyes. Furthermore, the drug-loaded CMCS hydrogels effectively inhibited conjunctival scarring after glaucoma filtration surgery and controlled postoperative intraocular pressure (IOP). Conclusion: The drug-loaded CMCS hydrogels provide a great opportunity to increase the therapeutic efficacy of glaucoma filtration surgery. PMID:21042284

  3. Evaluation of drug loading, pharmacokinetic behavior, and toxicity of a cisplatin-containing hydrogel nanoparticle

    PubMed Central

    Kai, Marc P.; Keeler, Amanda W.; Perry, Jillian L.; Reuter, Kevin G.; Luft, J. Christopher; O’Neal, Sara K.; Zamboni, William C.

    2015-01-01

    Cisplatin is a cytotoxic drug used as a first-line therapy for a wide variety of cancers. However, significant renal and neurological toxicities limits it clinical use. It has been documented that drug toxicities can be mitigated through nanoparticle formulation, while simultaneously increasing tumor accumulation through the enhanced permeation and retention effect. Circulation persistence is a key characteristic for exploiting this effect, and to that end we have developed long-circulating, PEGylated, polymeric hydrogels using the Particle Replication In Non-wetting Templates (PRINT®) platform and complexed cisplatin into the particles (PRINT-Platin). Sustained release was demonstrated, and drug loading correlated to surface PEG density. A PEG Mushroom conformation showed the best compromise between particle pharmacokinetic (PK) parameters and drug loading (16 wt %). While the PK profile of PEG Brush was superior, the loading was poor (2 wt %). Conversely, the drug loading in non-PEGylated particles was better (20 wt %), but the PK was not desirable. We also showed comparable cytotoxicity to cisplatin in several cancer cell lines (non-small cell lung, A549; ovarian, SKOV-3; breast, MDA-MB-468) and a higher MTD in mice (10 mg/kg versus 5 mg/kg). The pharmacokinetic profiles of drug in plasma, tumor, and kidney indicate improved exposure in the blood and tumor accumulation, with concurrent renal protection, when cisplatin was formulated in a nanoparticle. PK parameters were markedly improved: a 16.4-times higher area-under-the-curve (AUC), a reduction in clearance (CL) by a factor of 11.2, and a 4.20-times increase in the volume of distribution (Vd). Additionally, non-small cell lung and ovarian tumor AUC was at least twice that of cisplatin in both models. These findings suggest the potential for PRINT-Platin to improve efficacy and reduce toxicity compared to current cisplatin therapies. PMID:25744827

  4. Evaluation of drug loading, pharmacokinetic behavior, and toxicity of a cisplatin-containing hydrogel nanoparticle.

    PubMed

    Kai, Marc P; Keeler, Amanda W; Perry, Jillian L; Reuter, Kevin G; Luft, J Christopher; O'Neal, Sara K; Zamboni, William C; DeSimone, Joseph M

    2015-04-28

    Cisplatin is a cytotoxic drug used as a first-line therapy for a wide variety of cancers. However, significant renal and neurological toxicities limit its clinical use. It has been documented that drug toxicities can be mitigated through nanoparticle formulation, while simultaneously increasing tumor accumulation through the enhanced permeation and retention effect. Circulation persistence is a key characteristic for exploiting this effect, and to that end we have developed long-circulating, PEGylated, polymeric hydrogels using the Particle Replication In Non-wetting Templates (PRINT®) platform and complexed cisplatin into the particles (PRINT-Platin). Sustained release was demonstrated, and drug loading correlated to surface PEG density. A PEG Mushroom conformation showed the best compromise between particle pharmacokinetic (PK) parameters and drug loading (16wt.%). While the PK profile of PEG Brush was superior, the loading was poor (2wt.%). Conversely, the drug loading in non-PEGylated particles was better (20wt.%), but the PK was not desirable. We also showed comparable cytotoxicity to cisplatin in several cancer cell lines (non-small cell lung, A549; ovarian, SKOV-3; breast, MDA-MB-468) and a higher MTD in mice (10mg/kg versus 5mg/kg). The pharmacokinetic profiles of drug in plasma, tumor, and kidney indicate improved exposure in the blood and tumor accumulation, with concurrent renal protection, when cisplatin was formulated in a nanoparticle. PK parameters were markedly improved: a 16.4-times higher area-under-the-curve (AUC), a reduction in clearance (CL) by a factor of 11.2, and a 4.20-times increase in the volume of distribution (Vd). Additionally, non-small cell lung and ovarian tumor AUC was at least twice that of cisplatin in both models. These findings suggest the potential for PRINT-Platin to improve efficacy and reduce toxicity compared to current cisplatin therapies.

  5. Fabrication of magnetic nanoparticles with controllable drug loading and release through a simple assembly approach.

    PubMed

    Fang, Chen; Kievit, Forrest M; Veiseh, Omid; Stephen, Zachary R; Wang, Tingzhong; Lee, Donghoon; Ellenbogen, Richard G; Zhang, Miqin

    2012-08-20

    Nanoparticle-based cancer therapeutics promises to improve drug delivery safety and efficacy. However, fabrication of consistent theranostic nanoparticles with high and controllable drug loading remains a challenge, primarily due to the cumbersome, multi-step synthesis processes conventionally applied. Here, we present a simple and highly controllable method for assembly of theranostic nanoparticles, which may greatly reduce batch-to-batch variation. The major components of this nanoparticle system include a superparamagnetic iron oxide nanoparticle (SPION), a biodegradable and pH-sensitive poly (beta-amino ester) (PBAE) copolymer, a chemotherapeutic agent doxorubicin (DOX). Here the polymer pre-loaded with drug is directly assembled to the surface of SPIONs forming a drug loaded nanoparticle (NP-DOX). NP-DOX demonstrated a high drug loading efficiency of 679 μg DOX per mg iron, sustained stability in cell culture media up to 7 days, and a strong r(2) relaxivity of 146 mM(-1)•s(-1) for magnetic resonance imaging (MRI). The drug release analysis of NP-DOX showed fast DOX release at pH 5.5 and 6.4 (as in endosomal environment) and slow release at pH 7.4 (physiological condition), demonstrating pH-sensitive drug release kinetics. In vitro evaluation of NP-DOX efficacy using drug-resistant C6 glioma cells showed a 300% increase in cellular internalization at 24h post-treatment and 65% reduction of IC50 at 72 h post-treatment when compared to free DOX. These nanoparticles could serve as a foundation for building smart theranostic formulations for sensitive detection through MRI and effective treatment of cancer by controlled drug release.

  6. Large-scale automated image analysis for computational profiling of brain tissue surrounding implanted neuroprosthetic devices using Python

    PubMed Central

    Rey-Villamizar, Nicolas; Somasundar, Vinay; Megjhani, Murad; Xu, Yan; Lu, Yanbin; Padmanabhan, Raghav; Trett, Kristen; Shain, William; Roysam, Badri

    2014-01-01

    In this article, we describe the use of Python for large-scale automated server-based bio-image analysis in FARSIGHT, a free and open-source toolkit of image analysis methods for quantitative studies of complex and dynamic tissue microenvironments imaged by modern optical microscopes, including confocal, multi-spectral, multi-photon, and time-lapse systems. The core FARSIGHT modules for image segmentation, feature extraction, tracking, and machine learning are written in C++, leveraging widely used libraries including ITK, VTK, Boost, and Qt. For solving complex image analysis tasks, these modules must be combined into scripts using Python. As a concrete example, we consider the problem of analyzing 3-D multi-spectral images of brain tissue surrounding implanted neuroprosthetic devices, acquired using high-throughput multi-spectral spinning disk step-and-repeat confocal microscopy. The resulting images typically contain 5 fluorescent channels. Each channel consists of 6000 × 10,000 × 500 voxels with 16 bits/voxel, implying image sizes exceeding 250 GB. These images must be mosaicked, pre-processed to overcome imaging artifacts, and segmented to enable cellular-scale feature extraction. The features are used to identify cell types, and perform large-scale analysis for identifying spatial distributions of specific cell types relative to the device. Python was used to build a server-based script (Dell 910 PowerEdge servers with 4 sockets/server with 10 cores each, 2 threads per core and 1TB of RAM running on Red Hat Enterprise Linux linked to a RAID 5 SAN) capable of routinely handling image datasets at this scale and performing all these processing steps in a collaborative multi-user multi-platform environment. Our Python script enables efficient data storage and movement between computers and storage servers, logs all the processing steps, and performs full multi-threaded execution of all codes, including open and closed-source third party libraries. PMID:24808857

  7. Large-scale automated image analysis for computational profiling of brain tissue surrounding implanted neuroprosthetic devices using Python.

    PubMed

    Rey-Villamizar, Nicolas; Somasundar, Vinay; Megjhani, Murad; Xu, Yan; Lu, Yanbin; Padmanabhan, Raghav; Trett, Kristen; Shain, William; Roysam, Badri

    2014-01-01

    In this article, we describe the use of Python for large-scale automated server-based bio-image analysis in FARSIGHT, a free and open-source toolkit of image analysis methods for quantitative studies of complex and dynamic tissue microenvironments imaged by modern optical microscopes, including confocal, multi-spectral, multi-photon, and time-lapse systems. The core FARSIGHT modules for image segmentation, feature extraction, tracking, and machine learning are written in C++, leveraging widely used libraries including ITK, VTK, Boost, and Qt. For solving complex image analysis tasks, these modules must be combined into scripts using Python. As a concrete example, we consider the problem of analyzing 3-D multi-spectral images of brain tissue surrounding implanted neuroprosthetic devices, acquired using high-throughput multi-spectral spinning disk step-and-repeat confocal microscopy. The resulting images typically contain 5 fluorescent channels. Each channel consists of 6000 × 10,000 × 500 voxels with 16 bits/voxel, implying image sizes exceeding 250 GB. These images must be mosaicked, pre-processed to overcome imaging artifacts, and segmented to enable cellular-scale feature extraction. The features are used to identify cell types, and perform large-scale analysis for identifying spatial distributions of specific cell types relative to the device. Python was used to build a server-based script (Dell 910 PowerEdge servers with 4 sockets/server with 10 cores each, 2 threads per core and 1TB of RAM running on Red Hat Enterprise Linux linked to a RAID 5 SAN) capable of routinely handling image datasets at this scale and performing all these processing steps in a collaborative multi-user multi-platform environment. Our Python script enables efficient data storage and movement between computers and storage servers, logs all the processing steps, and performs full multi-threaded execution of all codes, including open and closed-source third party libraries.

  8. Development and Evaluation of Cefadroxil Drug Loaded Biopolymeric Films Based on Chitosan-Furfural Schiff Base

    PubMed Central

    Dixit, Ritu B.; Uplana, Rahul A.; Patel, Vishnu A.; Dixit, Bharat C.; Patel, Tarosh S.

    2010-01-01

    Cefadroxil drug loaded biopolymeric films of chitosan-furfural schiff base were prepared by reacting chitosan with furfural in presence of acetic acid and perchloric acid respectively for the external use. Prepared films were evaluated for their strength, swelling index, thickness, drug content, uniformity, tensile strength, percent elongation, FTIR spectral analysis and SEM. The results of in vitro diffusion studies revealed that the films exhibited enhanced drug diffusion as compared to the films prepared using untreated chitosan. The films also demonstrated good to moderate antibacterial activities against selective gram positive and gram negative bacteria. PMID:21179325

  9. Implantable Subcutaneous Venous Access Devices: Is Port Fixation Necessary? A Review of 534 Cases

    SciTech Connect

    McNulty, Nancy J. Perrich, Kiley D.; Silas, Anne M.; Linville, Robert M.; Forauer, Andrew R.

    2010-08-15

    Conventional surgical technique of subcutaneous venous port placement describes dissection of the port pocket to the pectoralis fascia and suture fixation of the port to the fascia to prevent inversion of the device within the pocket. This investigation addresses the necessity of that step. Between October 8, 2004 and October 19, 2007, 558 subcutaneous chest ports were placed at our institution; 24 cases were excluded from this study. We performed a retrospective review of the remaining 534 ports, which were placed using standard surgical technique with the exception that none were sutured into the pocket. Mean duration of port use, total number of port days, indications for removal, and complications were recorded and compared with the literature. Mean duration of port use was 341 days (182,235 total port days, range 1-1279). One port inversion/flip occurred, which resulted in malfunction and necessitated port revision (0.2%). Other complications necessitating port removal included infection 26 (5%), thrombosis n = 2 (<1%), catheter fracture/pinch n = 1 (<1%), pain n = 2 (<1%), and skin erosion n = 3 (1%). There were two arrhythmias at the time of placement; neither required port removal. The overall complication rate was 7%. The 0.2% incidence of port inversion we report is concordant with that previously published, although many previous reports do not specify if suture fixation of the port was performed. Suture fixation of the port, in our experience, is not routinely necessary and may negatively impact port removal.

  10. Fabrication of biocompatible hydrogel coatings for implantable medical devices using Fenton-type reaction.

    PubMed

    Butruk, Beata; Trzaskowski, Maciej; Ciach, Tomasz

    2012-08-01

    In this paper the authors present a simple method of coating polyurethane (PU) surface with poly(vinyl pirrolidone) (PVP) hydrogel. The hydrogel-coated materials were designed for use in biomedical applications, especially in blood-contacting devices. The coating is formed due to free radical macromolecular grafting-crosslinking. Polymer surface was first immersed in an organic solution containing radical source: cumene hydroperoxide (CHP) with an addition of a branching and anchoring agent: ethylene glycol dimethylacrylate (EGDMA). In the second step, the substrate was immersed in a water solution containing given concentration of PVP and Fe(2+). The novelty of the process consists in the fact that free radicals are formed mostly at the polymer/solution interface, what assures high grafting efficiency together with the formation of covalent bonds between polymer substrate and modifying layer. The process was optimized for reagents concentrations. The coating properties: thickness and the swelling ratio were strongly influenced by CHP, Fe(2+), PVP and EGMDA concentrations. The chemical composition of the surface analyzed with FTIR-ATR spectroscopy confirmed the presence of PVP coating. In vitro biocompatibility tests with L929 fibroblasts confirmed non-cytotoxicity of the coatings. Hydrogel coating significantly improved polyurethane hemocompatibility. Studies with human whole blood revealed that both, the platelet consumption and the level of platelet activation were as low as for negative control.

  11. Cora rotary pump for implantable left ventricular assist device: biomaterial aspects.

    PubMed

    Montiès, J R; Dion, I; Havlik, P; Rouais, F; Trinkl, J; Baquey, C

    1997-07-01

    Our group is developing a left ventricular assist device based on the principle of the Maillard-Wankel rotative compressor: it is a rotary, not centrifugal, pump that produces a pulsatile flow. Stringent requirements have been defined for construction materials. They must be light, yet sufficiently hard and rigid, and able to be machined with high precision. The friction coefficient must be low and the wear resistance high. The materials must be chemically inert and not deformable. Also, the materials must be biocompatible, and the blood contacting surface must be hemocompatible. We assessed the materials in terms of physiochemistry, mechanics, and tribology to select the best for hemocompatibility (determined by studies of protein adsorption; platelet, leukocyte, and red cell retention; and hemolysis, among other measurements) and biocompatibility (determined by measurement of complement activation and toxicity, among other criteria). Of the materials tested, for short- and middle-term assistance, we chose titanium alloy (Ti6Al4V) and alumina ceramic (Al2O3) and for long-term and permanent use, composite materials (TiN coating on graphite). We saw that the polishing process of the substrate must be improved. For the future, the best coating material would be diamond-like carbon (DLC) or crystalline diamond coating.

  12. Cochlear implants.

    PubMed

    Connell, Sarah S; Balkany, Thomas J

    2006-08-01

    Cochlear implants are cost-effective auditory prostheses that safely provide a high-quality sensation of hearing to adults who are severely or profoundly deaf. In the past 5 years, progress has been made in hardware and software design, candidate selection, surgical techniques, device programming, education and rehabilitation,and, most importantly, outcomes. Cochlear implantation in the elderly is well tolerated and provides marked improvement in auditory performance and psychosocial functioning.

  13. Scientific collaboration: a social network analysis based on literature of animal-derived regenerative implantable medical devices

    PubMed Central

    Yu, Shu-Yang; Wang, Hong-Man

    2016-01-01

    The collaboration network of English publications on animal-derived regenerative implantable medical devices based on tissue engineering technology and its evolving processes and current states were mapped in this paper. A total of 10 159 English papers published before 1 January 2015 were obtained in eight databases. Social network analysis was conducted on these papers by utilizing UCINET software and Statistical Analysis Software for Informatics researched and developed by Peking University. The collaboration network has evolved from scattered formation to single-core dominated, and then to a core-edge one; collaboration has become more frequent and wider; network density and centrality have decreased; USA, UK and China are the top three countries with Wake Forest University, Harvard University and Tufts University being the top three contributing institutions cooperated mostly during the period between 2010 and 2014; plenty of edge institutes exist. In conclusion, more collaboration among different institutions and countries is needed; Edge institutions and developing countries should expand their scope of collaboration. PMID:27252889

  14. Perspectives from Mechanical Circulatory Support Coordinators on the Pre-Implantation Decision Process for Destination Therapy Left Ventricular Assist Devices

    PubMed Central

    McIlvennan, Colleen K.; Matlock, Daniel D.; Narayan, Madhav P.; Nowels, Carolyn; Thompson, Jocelyn S.; Cannon, Anne; Bradley, William J.; Allen, Larry A.

    2015-01-01

    Objective To understand mechanical circulatory support (MCS) coordinators’ perspectives related to destination therapy left ventricular assist devices (DT LVAD) decision making Background MCS coordinators are central to the team that interacts with patients considering DT LVAD, and are well positioned to comment upon the pre-implantation process. Methods From August 2012–January 2013, MCS coordinators were recruited to participate in semi-structured, in-depth interviews. Established qualitative approaches were used to analyze and interpret data. Results Eighteen MCS coordinators from 18 programs were interviewed. We found diversity in coordinators’ roles and high programmatic variability in how DT LVAD decisions are approached. Despite these differences, three themes were consistently recommended: 1) DT LVAD is a major patient-centered decision: “you’re your best advocate…this may not be the best choice for you”; 2) this decision benefits from an iterative, multidisciplinary process: “It is not a one-time conversation”; and 3) this process involves a tension between conveying enough detail about the process yet not overwhelming patients: “It’s sometimes hard to walk that line to not scare them but not paint a rainbow and butterflies picture.” Conclusions MCS coordinators endorsed a shared decision-making process that starts early, uses non-biased educational materials, and involves a multidisciplinary team sensitive to the tension between conveying enough detail about the therapy yet not overwhelming patients. PMID:25724116

  15. Trustworthy data collection from implantable medical devices via high-speed security implementation based on IEEE 1363.

    PubMed

    Hu, Fei; Hao, Qi; Lukowiak, Marcin; Sun, Qingquan; Wilhelm, Kyle; Radziszowski, Stanisław; Wu, Yao

    2010-11-01

    Implantable medical devices (IMDs) have played an important role in many medical fields. Any failure in IMDs operations could cause serious consequences and it is important to protect the IMDs access from unauthenticated access. This study investigates secure IMD data collection within a telehealthcare [mobile health (m-health)] network. We use medical sensors carried by patients to securely access IMD data and perform secure sensor-to-sensor communications between patients to relay the IMD data to a remote doctor's server. To meet the requirements on low computational complexity, we choose N-th degree truncated polynomial ring (NTRU)-based encryption/decryption to secure IMD-sensor and sensor-sensor communications. An extended matryoshkas model is developed to estimate direct/indirect trust relationship among sensors. An NTRU hardware implementation in very large integrated circuit hardware description language is studied based on industry Standard IEEE 1363 to increase the speed of key generation. The performance analysis results demonstrate the security robustness of the proposed IMD data access trust model.

  16. Scientific collaboration: a social network analysis based on literature of animal-derived regenerative implantable medical devices.

    PubMed

    Yu, Shu-Yang; Wang, Hong-Man

    2016-09-01

    The collaboration network of English publications on animal-derived regenerative implantable medical devices based on tissue engineering technology and its evolving processes and current states were mapped in this paper. A total of 10 159 English papers published before 1 January 2015 were obtained in eight databases. Social network analysis was conducted on these papers by utilizing UCINET software and Statistical Analysis Software for Informatics researched and developed by Peking University. The collaboration network has evolved from scattered formation to single-core dominated, and then to a core-edge one; collaboration has become more frequent and wider; network density and centrality have decreased; USA, UK and China are the top three countries with Wake Forest University, Harvard University and Tufts University being the top three contributing institutions cooperated mostly during the period between 2010 and 2014; plenty of edge institutes exist. In conclusion, more collaboration among different institutions and countries is needed; Edge institutions and developing countries should expand their scope of collaboration.

  17. Symbolic Dynamics Analysis of Short Data Sets: an Application to Heart Rate Variability from Implantable Defibrillator Devices

    NASA Astrophysics Data System (ADS)

    Zebrowski, Jan J.; Baranowski, Rafal; Przybylski, Andrzej

    2003-07-01

    A method is described for the assessment of the complexity of short data sets by nonlinear dynamics. The method was devised for and tested on human heart rate recordings approximately 2000 to 9000 RR intervals long which were extracted from the memory of implantable defibrillator devices (ICD). It is, however, applicable in a more general context. The ICDs are meant to control life-threatening episodes of ventricular tachycardia and/or ventricular fibrillation by applying a electric shock to the heart through intracardiac electrodes. It is well known that conventional ICD algorithms yield approximately 20--30 % of spurious interventions. The main aim of this work is to look for nonlinear dynamics methods to enhance the appropriateness of the ICD intervention. We first showed that nonlinear dynamics methods first applied to 24-hour heart rate variability analysis were able to detect the need for the ICD intervention. To be applicable to future ICD use, the methods must also be low in computational requirements. Methods to analyse the complexity of the short and non-stationary sets were devised. We calculated the Shannon entropy of symbolic words obtained in a sliding 50 beat window and analysed the dependence of this complexity measure on the time. Precursors were found extending much earlier time than the time the standard ICD algorithms span.

  18. “Optical communication with brain cells by means of an implanted duplex micro-device with optogenetics and Ca2+ fluoroimaging”

    PubMed Central

    Kobayashi, Takuma; Haruta, Makito; Sasagawa, Kiyotaka; Matsumata, Miho; Eizumi, Kawori; Kitsumoto, Chikara; Motoyama, Mayumi; Maezawa, Yasuyo; Ohta, Yasumi; Noda, Toshihiko; Tokuda, Takashi; Ishikawa, Yasuyuki; Ohta, Jun

    2016-01-01

    To better understand the brain function based on neural activity, a minimally invasive analysis technology in a freely moving animal is necessary. Such technology would provide new knowledge in neuroscience and contribute to regenerative medical techniques and prosthetics care. An application that combines optogenetics for voluntarily stimulating nerves, imaging to visualize neural activity, and a wearable micro-instrument for implantation into the brain could meet the abovementioned demand. To this end, a micro-device that can be applied to the brain less invasively and a system for controlling the device has been newly developed in this study. Since the novel implantable device has dual LEDs and a CMOS image sensor, photostimulation and fluorescence imaging can be performed simultaneously. The device enables bidirectional communication with the brain by means of light. In the present study, the device was evaluated in an in vitro experiment using a new on-chip 3D neuroculture with an extracellular matrix gel and an in vivo experiment involving regenerative medical transplantation and gene delivery to the brain by using both photosensitive channel and fluorescent Ca2+ indicator. The device succeeded in activating cells locally by selective photostimulation, and the physiological Ca2+ dynamics of neural cells were visualized simultaneously by fluorescence imaging. PMID:26878910

  19. “Optical communication with brain cells by means of an implanted duplex micro-device with optogenetics and Ca2+ fluoroimaging”

    NASA Astrophysics Data System (ADS)

    Kobayashi, Takuma; Haruta, Makito; Sasagawa, Kiyotaka; Matsumata, Miho; Eizumi, Kawori; Kitsumoto, Chikara; Motoyama, Mayumi; Maezawa, Yasuyo; Ohta, Yasumi; Noda, Toshihiko; Tokuda, Takashi; Ishikawa, Yasuyuki; Ohta, Jun

    2016-02-01

    To better understand the brain function based on neural activity, a minimally invasive analysis technology in a freely moving animal is necessary. Such technology would provide new knowledge in neuroscience and contribute to regenerative medical techniques and prosthetics care. An application that combines optogenetics for voluntarily stimulating nerves, imaging to visualize neural activity, and a wearable micro-instrument for implantation into the brain could meet the abovementioned demand. To this end, a micro-device that can be applied to the brain less invasively and a system for controlling the device has been newly developed in this study. Since the novel implantable device has dual LEDs and a CMOS image sensor, photostimulation and fluorescence imaging can be performed simultaneously. The device enables bidirectional communication with the brain by means of light. In the present study, the device was evaluated in an in vitro experiment using a new on-chip 3D neuroculture with an extracellular matrix gel and an in vivo experiment involving regenerative medical transplantation and gene delivery to the brain by using both photosensitive channel and fluorescent Ca2+ indicator. The device succeeded in activating cells locally by selective photostimulation, and the physiological Ca2+ dynamics of neural cells were visualized simultaneously by fluorescence imaging.

  20. Contraceptive implants.

    PubMed

    McDonald-Mosley, Raegan; Burke, Anne E

    2010-03-01

    Implantable contraception has been extensively used worldwide. Implants are one of the most effective and reversible methods of contraception available. These devices may be particularly appropriate for certain populations of women, including women who cannot use estrogen-containing contraception. Implants are safe for use by women with many chronic medical problems. The newest implant, Implanon (Organon International, Oss, The Netherlands), is the only device currently available in the United States and was approved in 2006. It is registered for 3 years of pregnancy prevention. Contraceptive implants have failure rates similar to tubal ligation, and yet they are readily reversible with a return to fertility within days of removal. Moreover, these contraceptive devices can be safely placed in the immediate postpartum period, ensuring good contraceptive coverage for women who may be at risk for an unintended pregnancy. Irregular bleeding is a common side effect for all progestin-only contraceptive implants. Preinsertion counseling should address possible side effects, and treatment may be offered to women who experience prolonged or frequent bleeding.

  1. Totally implantable total artificial heart and ventricular assist device with multipurpose miniature electromechanical energy system.

    PubMed

    Takatani, S; Orime, Y; Tasai, K; Ohara, Y; Naito, K; Mizuguchi, K; Makinouchi, K; Damm, G; Glueck, J; Ling, J

    1994-01-01

    A multipurpose miniature electromechanical energy system has been developed to yield a compact, efficient, durable, and biocompatible total artificial heart (TAH) and ventricular assist device (VAD). Associated controller-driver electronics were recently miniaturized and converted into hybrid circuits. The hybrid controller consists of a microprocessor and controller, motor driver, Hall sensor, and commutation circuit hybrids. The sizing study demonstrated that all these components can be incorporated in the pumping unit of the TAH and VAD, particularly in the centerpiece of the TAH and the motor housing of the VAD. Both TAH and VAD pumping units will start when their power line is connected to either the internal power pack or the external battery unit. As a redundant driving and diagnostic port, an emergency port was newly added and will be placed in subcutaneous location. In case of system failure, the skin will be cut down, and an external motor drive or a pneumatic driver will be connected to this port to run the TAH. This will minimize the circulatory arrest time. Overall efficiency of the TAH without the transcutaneous energy transmission system was 14-18% to deliver pump outputs of 4-9 L/min against the right and left afterload pressures of 25 and 100 mm Hg. The internal power requirement ranged from 6 to 13 W. The rechargeable batteries such as NiCd or NiMH with 1 AH capacity can run the TAH for 30-45 min. The external power requirement, when TETS efficiency of 75% was assumed, ranged from 8 to 18 W. The accelerated endurance test in the 42 degrees C saline bath demonstrated stable performance over 4 months. Long-term endurance and chronic animal studies will continue toward a system with 5 years durability by the year 2000.

  2. Replacement of the aortic valve with a bioprosthesis at the time of continuous flow ventricular assist device implantation for preexisting aortic valve dysfunction

    PubMed Central

    Chamogeorgakis, Themistokles; Mountis, Maria; Gonzalez-Stawinski, Gonzalo V.

    2015-01-01

    Left ventricular assist device (LVAD) implantation has become a mainstay of therapy for advanced heart failure patients who are either ineligible for, or awaiting, cardiac transplantation. Controversy remains over the optimal therapeutic strategy for preexisting aortic valvular dysfunction in these patients at the time of LVAD implant. In patients with moderate to severe aortic regurgitation, surgical approaches are center specific and range from variable leaflet closure techniques to concomitant aortic valve replacement (AVR) with a bioprosthesis. In the present study, we retrospectively analyzed our outcomes in patients who underwent simultaneous AVR and LVAD implantation secondary to antecedent aortic valve pathology. Between January 2004 and June 2010, 144 patients underwent LVAD implantation at a single institution. Of these, 7 patients (4.8%) required concomitant AVR. Five of the 7 patients (71%) survived to hospital discharge and suffered no adverse events in the perioperative period. One-year survival for the discharged patients was 80%, and no prosthetic valve-related adverse events were observed in long-term follow-up. Given our experience, we conclude that bioprosthetic AVR is a plausible alternative for end-stage heart failure patients at the time of LVAD implantation. PMID:26424939

  3. The Safety of Using Body-Transmit MRI in Patients with Implanted Deep Brain Stimulation Devices

    PubMed Central

    Kahan, Joshua; Papadaki, Anastasia; White, Mark; Mancini, Laura; Yousry, Tarek; Zrinzo, Ludvic; Limousin, Patricia; Hariz, Marwan; Foltynie, Tom; Thornton, John

    2015-01-01

    Background Deep brain stimulation (DBS) is an established treatment for patients with movement disorders. Patients receiving chronic DBS provide a unique opportunity to explore the underlying mechanisms of DBS using functional MRI. It has been shown that the main safety concern with MRI in these patients is heating at the electrode tips – which can be minimised with strict adherence to a supervised acquisition protocol using a head-transmit/receive coil at 1.5T. MRI using the body-transmit coil with a multi-channel receive head coil has a number of potential advantages including an improved signal-to-noise ratio. Study outline We compared the safety of cranial MRI in an in vitro model of bilateral DBS using both head-transmit and body-transmit coils. We performed fibre-optic thermometry at a Medtronic ActivaPC device and Medtronic 3389 electrodes during turbo-spin echo (TSE) MRI using both coil arrangeme