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Sample records for drug implants

  1. Implantable Drug Dispenser

    NASA Technical Reports Server (NTRS)

    Collins, E. R. J.

    1983-01-01

    Drugs such as insulin are injected as needed directly into bloodstream by compact implantable dispensing unit. Two vapor cavities produce opposing forces on drug-chamber diaphragm. Heaters in cavities allow control of direction and rate of motion of bellows. Dispensing capsule fitted with coil so batteries can be recharged by induction.

  2. Drug-eluting medical implants.

    PubMed

    Zilberman, Meital; Kraitzer, Amir; Grinberg, Orly; Elsner, Jonathan J

    2010-01-01

    Drug-eluting medical implants are actually active implants that induce healing effects, in addition to their regular task of support. This effect is achieved by controlled release of active pharmaceutical ingredients (API) into the surrounding tissue. In this chapter we focus on three types of drug-eluting devices: drug-eluting vascular stents, drug-eluting wound dressings and protein-eluting scaffolds for tissue regeneration, thus describing both internal and external implants. Each of these drug-eluting devices also presents an approach for solving the drug release issue. Most drug-eluting vascular stents are loaded with water-insoluble antiproliferative agents, and their diffusion from the device to the surrounding tissue is relatively slow. In contrast, most drug-eluting wound dressings are loaded with highly water-soluble antibacterial agents and the issue of fast release must therefore be addressed. Growth factor release from scaffolds for tissue regeneration offers a new approach of incorporating high-molecular-weight bioactive agents which are very sensitive to process conditions and preserve their activity during the preparation stage. The drug-eluting medical implants are described here in terms of matrix formats and polymers, incorporated drugs and their release profiles from the implants, and implant functioning. Basic elements, such as new composite core/shell fibers and structured films, can be used to build new antibiotic-eluting devices. As presented in this chapter, the effect of the processing parameters on the microstructure and the resulting drug release profiles, mechanical and physical properties, and other relevant properties, must be elucidated in order to achieve the desired properties. Newly developed implants and novel modifications of previously developed approaches have enhanced the tools available for creating clinically important biomedical applications. PMID:20217535

  3. Biomedical Imaging in Implantable Drug Delivery Systems

    PubMed Central

    Zhou, Haoyan; Hernandez, Christopher; Goss, Monika; Gawlik, Anna; Exner, Agata A.

    2015-01-01

    Implantable drug delivery systems (DDS) provide a platform for sustained release of therapeutic agents over a period of weeks to months and sometimes years. Such strategies are typically used clinically to increase patient compliance by replacing frequent administration of drugs such as contraceptives and hormones to maintain plasma concentration within the therapeutic window. Implantable or injectable systems have also been investigated as a means of local drug administration which favors high drug concentration at a site of interest, such as a tumor, while reducing systemic drug exposure to minimize unwanted side effects. Significant advances in the field of local DDS have led to increasingly sophisticated technology with new challenges including quantification of local and systemic pharmacokinetics and implant-body interactions. Because many of these sought-after parameters are highly dependent on the tissue properties at the implantation site, and rarely represented adequately with in vitro models, new nondestructive techniques that can be used to study implants in situ are highly desirable. Versatile imaging tools can meet this need and provide quantitative data on morphological and functional aspects of implantable systems. The focus of this review article is an overview of current biomedical imaging techniques, including magnetic resonance imaging (MRI), ultrasound imaging, optical imaging, X-ray and computed tomography (CT), and their application in evaluation of implantable DDS. PMID:25418857

  4. 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

  5. Drug release mechanisms of cast lipid implants.

    PubMed

    Kreye, F; Siepmann, F; Willart, J F; Descamps, M; Siepmann, J

    2011-08-01

    The aim of this work was to better understand which physicochemical processes are involved in the control of drug release from lipid implants prepared by melting and casting. Lipid implants gain steadily in importance as controlled parenteral drug delivery systems: In contrast to PLGA-based devices, no acidic microclimates are created, which can inactivate incorporated drugs. The melting and casting method offers various advantages over the commonly used direct compression technique. For example, powder de-mixing during manufacturing and highly challenging scale-up due to poor powder flowability are avoided. Importantly, broad spectra of drug release patterns can be easily provided by varying the type of lipid. The resulting drug release rates are generally lower than those of implants prepared by direct compression. This is probably due to the differences in the microstructure of the pore network of the systems. Drug or water diffusion plays a dominant role for the control of drug release, potentially combined with limited drug solubility effects, caused by the low amounts of water available within the implants. In the case of pure diffusion control, a mechanistic realistic mathematical theory is proposed, which allows for quantitative predictions of the effects of formulation parameters on the resulting drug release kinetics. Importantly, these theoretical predictions could be successfully confirmed by independent experiments. Thus, the obtained new insight into the underlying drug release mechanisms can significantly facilitate the optimization of this type of advanced drug delivery systems. This is particularly helpful if long release periods are targeted, requiring time-consuming experimental studies. PMID:21352913

  6. Micro- and nano-fabricated implantable drug-delivery systems

    PubMed Central

    Meng, Ellis; Hoang, Tuan

    2013-01-01

    Implantable drug-delivery systems provide new means for achieving therapeutic drug concentrations over entire treatment durations in order to optimize drug action. This article focuses on new drug administration modalities achieved using implantable drug-delivery systems that are enabled by micro- and nano-fabrication technologies, and microfluidics. Recent advances in drug administration technologies are discussed and remaining challenges are highlighted. PMID:23323562

  7. Modified Titanium Implant as a Gateway to the Human Body: The Implant Mediated Drug Delivery System

    PubMed Central

    Park, Young-Seok; Cho, Joo-Youn; Hwang, Chee Il

    2014-01-01

    The aim of this study was to investigate the efficacy of a proposed new implant mediated drug delivery system (IMDDS) in rabbits. The drug delivery system is applied through a modified titanium implant that is configured to be implanted into bone. The implant is hollow and has multiple microholes that can continuously deliver therapeutic agents into the systematic body. To examine the efficacy and feasibility of the IMDDS, we investigated the pharmacokinetic behavior of dexamethasone in plasma after a single dose was delivered via the modified implant placed in the rabbit tibia. After measuring the plasma concentration, the areas under the curve showed that the IMDDS provided a sustained release for a relatively long period. The result suggests that the IMDDS can deliver a sustained release of certain drug components with a high bioavailability. Accordingly, the IMDDS may provide the basis for a novel approach to treating patients with chronic diseases. PMID:25136624

  8. 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.

  9. Suppression of scarring in peripheral nerve implants by drug elution

    NASA Astrophysics Data System (ADS)

    FitzGerald, James J.

    2016-04-01

    Objective. Medical implants made of non-biological materials provoke a chronic inflammatory response, resulting in the deposition of a collagenous scar tissue (ST) layer on their surface, that gradually thickens over time. This is a critical problem for neural interfaces. Scar build-up on electrodes results in a progressive decline in signal level because the scar tissue gradually separates axons away from the recording contacts. In regenerative sieves and microchannel electrodes, progressive scar deposition will constrict and may eventually choke off the sieve hole or channel lumen. Interface designs need to address this issue if they are to be fit for long term use. This study examines a novel method of inhibiting the formation and thickening of the fibrous scar. Approach. Research to date has mainly focused on methods of preventing stimulation of the foreign body response by implant surface modification. In this paper a pharmacological approach using drug elution to suppress chronic inflammation is introduced. Microchannel implants made of silicone doped with the steroid drug dexamethasone were implanted in the rat sciatic nerve for periods of up to a year. Tissue from within the microchannels was compared to that from control devices that did not release any drug. Main results. In the drug eluting implants the scar layer was significantly thinner at all timepoints, and unlike the controls it did not continue to thicken after 6 months. Control implants supported axon regeneration well initially, but axon counts fell rapidly at later timepoints as scar thickened. Axon counts in drug eluting devices were initially much lower, but increased rather than declined and by one year were significantly higher than in controls. Significance. Drug elution offers a potential long term solution to the problem of performance degradation due to scarring around neural implants.

  10. Subcutaneous implants for long-acting drug therapy in laboratory animals may generate unintended drug reservoirs

    PubMed Central

    Guarnieri, Michael; Tyler, Betty M.; DeTolla, Louis; Zhao, Ming; Kobrin, Barry

    2014-01-01

    Background: Long-acting therapy in laboratory animals offers advantages over the current practice of 2-3 daily drug injections. Yet little is known about the disintegration of biodegradable drug implants in rodents. Objective: Compare bioavailability of buprenorphine with the biodegradation of lipid-encapsulated subcutaneous drug pellets. Methods: Pharmacokinetic and histopathology studies were conducted in BALB/c female mice implanted with cholesterol-buprenorphine drug pellets. Results: Drug levels are below the level of detection (0.5 ng/mL plasma) within 4-5 days of implant. However, necroscopy revealed that interstitial tissues begin to seal implants within a week. Visual inspection of the implant site revealed no evidence of inflammation or edema associated with the cholesterol-drug residue. Chemical analyses demonstrated that the residues contained 10-13% of the initial opiate dose for at least two weeks post implant. Discussion: The results demonstrate that biodegradable scaffolds can become sequestered in the subcutaneous space. Conclusion: Drug implants can retain significant and unintended reservoirs of drugs. PMID:24459402

  11. Drug Delivery Implants in the Treatment of Vitreous Inflammation

    PubMed Central

    Wang, Jillian; Jiang, Angela; Joshi, Malav; Christoforidis, John

    2013-01-01

    The eye is a model organ for the local delivery of therapeutics. This proves beneficial when treating vitreous inflammation and other ophthalmic pathologies. The chronicity of certain diseases, however, limits the effectiveness of locally administered drugs. To maintain such treatments often requires frequent office visits and can result in increased risk of infection and toxicity to the patient. This paper focuses on the implantable devices and particulate drug delivery systems that are currently being implemented and investigated to overcome these challenges. Implants currently on the market or undergoing clinical trials include those made of nonbiodegradable polymers, containing ganciclovir, fluocinolone acetonide, triamcinolone acetonide, and ranibizumab, and biodegradable polymers, containing dexamethasone, triamcinolone acetonide, and ranibizumab. Investigational intravitreal implants and particulate drug delivery systems, such as nanoparticles, microparticles, and liposomes, are also explored in this review article. PMID:24191132

  12. Critical Assessment of Implantable Drug Delivery Devices in Glaucoma Management

    PubMed Central

    Manickavasagam, Dharani; Oyewumi, Moses O.

    2013-01-01

    Glaucoma is a group of heterogeneous disorders involving progressive optic neuropathy that can culminate into visual impairment and irreversible blindness. Effective therapeutic interventions must address underlying vulnerability of retinal ganglion cells (RGCs) to degeneration in conjunction with correcting other associated risk factors (such as elevated intraocular pressure). However, realization of therapeutic outcomes is heavily dependent on suitable delivery system that can overcome myriads of anatomical and physiological barriers to intraocular drug delivery. Development of clinically viable sustained release systems in glaucoma is a widely recognized unmet need. In this regard, implantable delivery systems may relieve the burden of chronic drug administration while potentially ensuring high intraocular drug bioavailability. Presently there are no FDA-approved implantable drug delivery devices for glaucoma even though there are several ongoing clinical studies. The paper critically assessed the prospects of polymeric implantable delivery systems in glaucoma while identifying factors that can dictate (a) patient tolerability and acceptance, (b) drug stability and drug release profiles, (c) therapeutic efficacy, and (d) toxicity and biocompatibility. The information gathered could be useful in future research and development efforts on implantable delivery systems in glaucoma. PMID:24066234

  13. Magnetic Nanoparticles for Local Drug Delivery Using Magnetic Implants

    NASA Astrophysics Data System (ADS)

    Fernández-Pacheco, Rodrigo; Valdivia, J. Gabriel; Ibarra, M. Ricardo

    This chapter is a brief description of the state of the art of the field of targeted drug delivery using magnetic implants. It describes the advantages and drawbacks of the use of internal magnets to concentrate magnetic nanoparticles near tumor locations, and the different approaches to this task performed in vitro and in vivo reviewed in literature are presented.

  14. Implantable microchip: the futuristic controlled drug delivery system.

    PubMed

    Sutradhar, Kumar Bishwajit; Sumi, Chandra Datta

    2016-01-01

    There is no doubt that controlled and pulsatile drug delivery system is an important challenge in medicine over the conventional drug delivery system in case of therapeutic efficacy. However, the conventional drug delivery systems often offer a limited by their inability to drug delivery which consists of systemic toxicity, narrow therapeutic window, complex dosing schedule for long term treatment etc. Therefore, there has been a search for the drug delivery system that exhibit broad enhancing activity for more drugs with less complication. More recently, some elegant study has noted that, a new type of micro-electrochemical system or MEMS-based drug delivery systems called microchip has been improved to overcome the problems related to conventional drug delivery. Moreover, micro-fabrication technology has enabled to develop the implantable controlled released microchip devices with improved drug administration and patient compliance. In this article, we have presented an overview of the investigations on the feasibility and application of microchip as an advanced drug delivery system. Commercial manufacturing materials and methods, related other research works and current advancement of the microchips for controlled drug delivery have also been summarized. PMID:24758139

  15. Experimental and theoretical studies of implant assisted magnetic drug targeting

    NASA Astrophysics Data System (ADS)

    Aviles, Misael O.

    One way to achieve drug targeting in the body is to incorporate magnetic nanoparticles into drug carriers and then retain them at the site using an externally applied magnetic field. This process is referred to as magnetic drug targeting (MDT). However, the main limitation of MDT is that an externally applied magnetic field alone may not be able to retain a sufficient number of magnetic drug carrier particles (MDCPs) to justify its use. Such a limitation might not exist when high gradient magnetic separation (HGMS) principles are applied to assist MDT by means of ferromagnetic implants. It was hypothesized that an Implant Assisted -- MDT (IA-MDT) system would increase the retention of the MDCPs at a target site where an implant had been previously located, since the magnetic forces are produced internally. With this in mind, the overall objective of this work was to demonstrate the feasibility of an IA-MDT system through mathematical modeling and in vitro experimentation. The mathematical models were developed and used to demonstrate the behavior and limitations of IA-MDT, and the in vitro experiments were designed and used to validate the models and to further elucidate the important parameters that affect the performance of the system. IA-MDT was studied with three plausible implants, ferromagnetic stents, seed particles, and wires. All implants were studied theoretically and experimentally using flow through systems with polymer particles containing magnetite nanoparticles as MDCPs. In the stent studies, a wire coil or mesh was simply placed in a flow field and the capture of the MDCPs was studied. In the other cases, a porous polymer matrix was used as a surrogate capillary tissue scaffold to study the capture of the MDCPs using wires or particle seeds as the implant, with the seeds either fixed within the polymer matrix or captured prior to capturing the MDCPs. An in vitro heart tissue perfusion model was also used to study the use of stents. In general, all

  16. Design of an implantable device for ocular drug delivery.

    PubMed

    Lee, Jae-Hwan; Pidaparti, Ramana M; Atkinson, Gary M; Moorthy, Ramana S

    2012-01-01

    Ocular diseases, such as, glaucoma, age-related macular degeneration (AMD), diabetic retinopathy, and retinitis pigmentosa require drug management in order to prevent blindness and affecting million of adults in USA and worldwide. There is an increasing need to develop devices for drug delivery to address ocular diseases. This study focuses on the design, simulation, and development of an implantable ocular drug delivery device consisting of micro-/nanochannels embedded between top and bottom covers with a drug reservoir made from polydimethylsiloxane (PDMS) which is silicon-based organic and biodegradable polymer. Several simulations were carried out with six different micro-channel configurations in order to see the feasibility for ocular drug delivery applications. Based on the results obtained, channel design of osmotic I and osmotic II satisfied the diffusion rates required for ocular drug delivery. Finally, a prototype illustrating the three components of the drug delivery design is presented. In the future, the device will be tested for its functionality and diffusion characteristics. PMID:22919500

  17. Antiarrhythmic Drug Therapy to Avoid Implantable Cardioverter Defibrillator Shocks

    PubMed Central

    Abboud, Jaber

    2016-01-01

    Implantable cardioverter defibrillators (ICDs) are effective in the prevention of arrhythmic sudden cardiac death. Many patients receiving an ICD are affected by heart failure and are at risk of ventricular arrhythmias, which may lead to appropriate shocks. On the other hand, in this population the incidence of atrial fibrillation, giving rise to inappropriate ICD shocks, is high. Accordingly, ICD discharges occur frequently and many patients with an ICD will need concomitant antiarrhythmic drug therapy to avoid or reduce the frequency of shocks. Therapeutic agents such as β-blockers, class I or class III antiarrhythmic drugs effectively suppress arrhythmias, but may have side-effects. Some drugs could eventually influence the function of ICDs by altering defibrillation or pacing threshold. Few prospective randomised trials are available, but current data suggest that amiodarone is most effective for prevention of appropriate or inappropriate ICD shocks. This review article summarises current knowledge regarding the antiarrhythmic management of patients with ICDs.

  18. Antiarrhythmic Drug Therapy to Avoid Implantable Cardioverter Defibrillator Shocks.

    PubMed

    Abboud, Jaber; R Ehrlich, Joachim

    2016-08-01

    Implantable cardioverter defibrillators (ICDs) are effective in the prevention of arrhythmic sudden cardiac death. Many patients receiving an ICD are affected by heart failure and are at risk of ventricular arrhythmias, which may lead to appropriate shocks. On the other hand, in this population the incidence of atrial fibrillation, giving rise to inappropriate ICD shocks, is high. Accordingly, ICD discharges occur frequently and many patients with an ICD will need concomitant antiarrhythmic drug therapy to avoid or reduce the frequency of shocks. Therapeutic agents such as β-blockers, class I or class III antiarrhythmic drugs effectively suppress arrhythmias, but may have side-effects. Some drugs could eventually influence the function of ICDs by altering defibrillation or pacing threshold. Few prospective randomised trials are available, but current data suggest that amiodarone is most effective for prevention of appropriate or inappropriate ICD shocks. This review article summarises current knowledge regarding the antiarrhythmic management of patients with ICDs. PMID:27617090

  19. Sustained local drug delivery from a radiopaque implanted reservoir.

    PubMed

    Koole, L H; Kruft, M A; Aldenhoff, Y B; van 't Oost, N E; van Kroonenburgh, M J; van der Veen, F H

    1998-02-01

    A new polymeric biomaterial that contains covalently bound iodine, and is therefore radiopaque, was used to construct a sustained local drug-delivery device. A polymeric wall was designed to be porous (i.e., passage of low-molecular-weight molecules across the wall is possible), self-healing, and biocompatible. Once implanted, the sphere cavity can be filled and refilled with a concentrated solution of a (cytostatic) drug, which is subsequently released by slow diffusion into the tissue region surrounding the sphere. This principle of sustained local drug delivery is shown by a series of in vitro experiments on the release of 5-fluorouracil, and in vivo animal experiments, using x-ray fluoroscopic and scintigraphic techniques. PMID:9487525

  20. Neoatherosclerosis after Drug-Eluting Stent Implantation: Roles and Mechanisms

    PubMed Central

    Cui, Yuanyuan; Shi, Dazhuo; Chen, Keji

    2016-01-01

    In-stent neoatherosclerosis (NA), characterized by a relatively thin fibrous cap and large volume of yellow-lipid accumulation after drug-eluting stents (DES) implantation, has attracted much attention owing to its close relationship with late complications, such as revascularization and late stent thrombosis (ST). Accumulating evidence has demonstrated that more than one-third of patients with first-generation DES present with NA. Even in the advent of second-generation DES, NA still occurs. It is indicated that endothelial dysfunction induced by DES plays a critical role in neoatherosclerotic development. Upregulation of reactive oxygen species (ROS) induced by DES implantation significantly affects endothelial cells healing and functioning, therefore rendering NA formation. In light of the role of ROS in suppression of endothelial healing, combining antioxidant therapies with stenting technology may facilitate reestablishing a functioning endothelium to improve clinical outcome for patients with stenting.

  1. In vivo organ specific drug delivery with implantable peristaltic pumps.

    PubMed

    Speed, Joshua S; Hyndman, Kelly A

    2016-01-01

    Classic methods for delivery of agents to specific organs are technically challenging and causes superfluous stress. The current study describes a method using programmable, implantable peristaltic pumps to chronically deliver drugs in vivo, while allowing animals to remain undisturbed for accurate physiological measurements. In this study, two protocols were used to demonstrate accurate drug delivery to the renal medulla. First, the vasopressin receptor-2 agonist, dDAVP, was delivered to the renal medulla resulting in a significant increase in water retention, urine osmolality and aquaporin-2 expression and phosphorylation. Second, in a separate group of rats, the histone deacetylase (HDAC) inhibitor, MS275, was delivered to the renal medulla. HDAC inhibition resulted in a significant increase in histone H3-acetylation, the hallmark for histone deacetylase inhibition. However, this was confined to the medulla, as the histone H3-acetylation was similar in the cortex of vehicle and MS275 infused rats, suggesting targeted drug delivery without systemic spillover. Thus, implantable, peristaltic pumps provide a number of benefits compared to externalized chronic catheters and confer specific delivery to target organs. PMID:27185292

  2. In vivo organ specific drug delivery with implantable peristaltic pumps

    PubMed Central

    Speed, Joshua S.; Hyndman, Kelly A.

    2016-01-01

    Classic methods for delivery of agents to specific organs are technically challenging and causes superfluous stress. The current study describes a method using programmable, implantable peristaltic pumps to chronically deliver drugs in vivo, while allowing animals to remain undisturbed for accurate physiological measurements. In this study, two protocols were used to demonstrate accurate drug delivery to the renal medulla. First, the vasopressin receptor-2 agonist, dDAVP, was delivered to the renal medulla resulting in a significant increase in water retention, urine osmolality and aquaporin-2 expression and phosphorylation. Second, in a separate group of rats, the histone deacetylase (HDAC) inhibitor, MS275, was delivered to the renal medulla. HDAC inhibition resulted in a significant increase in histone H3-acetylation, the hallmark for histone deacetylase inhibition. However, this was confined to the medulla, as the histone H3-acetylation was similar in the cortex of vehicle and MS275 infused rats, suggesting targeted drug delivery without systemic spillover. Thus, implantable, peristaltic pumps provide a number of benefits compared to externalized chronic catheters and confer specific delivery to target organs. PMID:27185292

  3. In vitro study of magnetic nanoparticles as the implant for implant assisted magnetic drug targeting

    NASA Astrophysics Data System (ADS)

    Mangual, Jan O.; Avilés, Misael O.; Ebner, Armin D.; Ritter, James A.

    2011-07-01

    Magnetic nanoparticle (MNP) seeds were studied in vitro for use as an implant in implant assisted-magnetic drug targeting (IA-MDT). The magnetite seeds were captured in a porous polymer, mimicking capillary tissue, with an external magnetic field (70 mT) and then used subsequently to capture magnetic drug carrier particles (MDCPs) (0.87 μm diameter) with the same magnetic field. The effects of the MNP seed diameter (10, 50 and 100 nm), MNP seed concentration (0.25-2.0 mg/mL), and fluid velocity (0.03-0.15 cm/s) on the capture efficiency (CE) of both the MNP seeds and the MDCPs were studied. The CE of the 10 nm MNP seeds was never more than 30%, while those of the 50 and 100 nm MNP seeds was always greater than 80% and in many cases exceeded 90%. Only the MNP seed concentration affected its CE. The 10 nm MNP seeds did not increase the MDCP CE over that obtained in the absence of the MNP seeds, while the 50 and 100 nm MNP seeds increased significantly, typically by more than a factor of two. The 50 and 100 nm MNP seeds also exhibited similar abilities to capture the MDCPs, with the MDCP CE always increasing with decreasing fluid velocity and generally increasing with increasing MNP seed concentration. The MNP seed size, magnetic properties, and capacity to self-agglomerate and form clusters were key properties that make them a viable implant in IA-MDT.

  4. Influence of cochleostomy and cochlear implant insertion on drug gradients following intratympanic application in guinea pigs

    PubMed Central

    King, EB; Hartsock, JJ; O'Leary, SJ; Salt, AN

    2013-01-01

    Locally-applied drugs can protect residual hearing following cochlear implantation. The influence of cochlear implantation on drug levels in scala tympani (ST) after round window application was investigated in guinea pigs using the marker trimethylphenlyammonium (TMPA) measured in real-time with TMPA-selective microelectrodes. TMPA concentration in the upper basal turn of ST rapidly increased during implantation and then declined due to cerebrospinal fluid entering ST at the cochlear aqueduct and exiting at the cochleostomy. The TMPA increase was found to be caused by the cochleostomy drilling, if the burr tip partially entered ST. TMPA distribution in the second turn was less affected by implantation procedures. These findings show that basal turn drug levels may be changed during implantation and the changes may need to be considered in the interpretation of therapeutic effects of drugs in conjunction with implantation. PMID:24008355

  5. Antiplatelet therapy after drug-eluting stent implantation.

    PubMed

    Warren, Josephine; Baber, Usman; Mehran, Roxana

    2015-02-01

    Dual antiplatelet therapy (DAPT), which is the combination of aspirin and a platelet P2Y12 inhibitor, is the cornerstone of secondary prevention in ischemic heart disease requiring intracoronary stenting. Although the efficacy of DAPT in the reduction of ischemic events has been well validated, the optimal duration, and indeed combination, of therapy is yet to be established. This area continues to attract debate with new developments in stent design and antiplatelet agents, as well as evolving clinical skill levels. Presently, clinical guidelines advocate the use of DAPT for 6-12 months following drug-eluting stent (DES) implantation, but this can vary according to clinical indication, bleeding risk, and country of practice. Concerns have arisen that unnecessary prolongation of DAPT may be associated with increased bleeding events, as well as cost. Whether these guidelines effectively cater to current stenting techniques, devices, and antiplatelet agents remains to be determined. This review analyzes contemporary issues surrounding DAPT following DES implantation, as researchers continue to seek to strike the optimal balance between bleeding and thrombotic risk. Although reduced DAPT durations continue to show promising results in preventing ischemic events while also mitigating bleeding risk, ultimately the consideration of clinical presentation as well as medical and social history is paramount to guiding the optimal duration and cessation of DAPT. PMID:25467922

  6. Drug-Eluting Nasal Implants: Formulation, Characterization, Clinical Applications and Challenges

    PubMed Central

    Parikh, Ankit; Anand, Utkarshini; Ugwu, Malachy C.; Feridooni, Tiam; Massoud, Emad; Agu, Remigius U.

    2014-01-01

    Chronic inflammation and infection of the nasal sinuses, also referred to as Chronic Rhinosinusitis (CRS), severely affects patients’ quality of life. Adhesions, ostial stenosis, infection and inflammation relapses complicate chronic sinusitis treatment strategies. Drug-eluting stents, packings or implants have been suggested as reasonable alternatives for addressing these concerns. This article reviewed potential drug candidates for nasal implants, formulation methods/optimization and characterization methods. Clinical applications and important considerations were also addressed. Clinically-approved implants (Propel™ implant, the Relieva stratus™ MicroFlow spacer, and the Sinu-Foam™ spacer) for CRS treatment was an important focus. The advantages and limitations, as well as future considerations, challenges and the need for additional research in the field of nasal drug implant development, were discussed. PMID:24871904

  7. Drug-eluting nasal implants: formulation, characterization, clinical applications and challenges.

    PubMed

    Parikh, Ankit; Anand, Utkarshini; Ugwu, Malachy C; Feridooni, Tiam; Massoud, Emad; Agu, Remigius U

    2014-01-01

    Chronic inflammation and infection of the nasal sinuses, also referred to as Chronic Rhinosinusitis (CRS), severely affects patients' quality of life. Adhesions, ostial stenosis, infection and inflammation relapses complicate chronic sinusitis treatment strategies. Drug-eluting stents, packings or implants have been suggested as reasonable alternatives for addressing these concerns. This article reviewed potential drug candidates for nasal implants, formulation methods/optimization and characterization methods. Clinical applications and important considerations were also addressed. Clinically-approved implants (Propel™ implant, the Relieva stratus™ MicroFlow spacer, and the Sinu-Foam™ spacer) for CRS treatment was an important focus. The advantages and limitations, as well as future considerations, challenges and the need for additional research in the field of nasal drug implant development, were discussed. PMID:24871904

  8. Characterization of drug-release kinetics in trabecular bone from titania nanotube implants

    PubMed Central

    Aw, Moom Sinn; Khalid, Kamarul A; Gulati, Karan; Atkins, Gerald J; Pivonka, Peter; Findlay, David M; Losic, Dusan

    2012-01-01

    Purpose The aim of this study was to investigate the application of the three-dimensional bone bioreactor for studying drug-release kinetics and distribution of drugs in the ex vivo cancellous bone environment, and to demonstrate the application of nanoengineered titanium (Ti) wires generated with titania nanotube (TNT) arrays as drug-releasing implants for local drug delivery Methods Nanoengineered Ti wires covered with a layer of TNT arrays implanted in bone were used as a drug-releasing implant. Viable bovine trabecular bone was used as the ex vivo bone substrate embedded with the implants and placed in the bone reactor. A hydrophilic fluorescent dye (rhodamine B) was used as the model drug, loaded inside the TNT–Ti implants, to monitor drug release and transport in trabecular bone. The distribution of released model drug in the bone was monitored throughout the bone structure, and concentration profiles at different vertical (0–5 mm) and horizontal (0–10 mm) distances from the implant surface were obtained at a range of release times from 1 hour to 5 days. Results Scanning electron microscopy confirmed that well-ordered, vertically aligned nanotube arrays were formed on the surface of prepared TNT–Ti wires. Thermogravimetric analysis proved loading of the model drug and fluorescence spectroscopy was used to show drug-release characteristics in-vitro. The drug release from implants inserted into bone ex vivo showed a consistent gradual release of model drug from the TNT–Ti implants, with a characteristic three-dimensional distribution into the surrounding bone, over a period of 5 days. The parameters including the flow rate of bone culture medium, differences in trabecular microarchitecture between bone samples, and mechanical loading were found to have the most significant influence on drug distribution in the bone. Conclusion These results demonstrate the utility of the Zetos™ system for ex vivo drug-release studies in bone, which can be applied to

  9. MEMS-enabled implantable drug infusion pumps for laboratory animal research, preclinical, and clinical applications

    PubMed Central

    Meng, Ellis; Hoang, Tuan

    2012-01-01

    Innovation in implantable drug delivery devices is needed for novel pharmaceutical compounds such as certain biologics, gene therapy, and other small molecules that are not suitable for administration by oral, topical, or intravenous routes. This invasive dosing scheme seeks to directly bypass physiological barriers presented by the human body, release the appropriate drug amount at the site of treatment, and maintain the drug bioavailability for the required duration of administration to achieve drug efficacy. Advances in microtechnologies have led to novel MEMS-enabled implantable drug infusion pumps with unique performance and feature sets. In vivo demonstration of micropumps for laboratory animal research and preclinical studies include acute rapid radiolabeling, short-term delivery of nanomedicine for cancer treatment, and chronic ocular drug dosing. Investigation of MEMS actuators, valves, and other microstructures for on-demand dosing control may enable next generation implantable pumps with high performance within a miniaturized form factor for clinical applications. PMID:22926321

  10. Polypyrrole-Based Implantable Electroactive Pump for Controlled Drug Microinjection.

    PubMed

    Yan, Bingxi; Li, Boyi; Kunecke, Forest; Gu, Zhen; Guo, Liang

    2015-07-15

    Implantable devices for long-lasting controlled insulin microinjection are of great value to diabetic patients. To address this need, we develop a flexible electroactive pump based on a biocompatible polypyrrole composite film that comprises a polypyrrole matrix and a macromolecular dopant of polycaprolactone-block-polytetrahydrofuran-block-polycaprolactone. Using phosphate-buffered saline as the electrolyte, this film demonstrates much higher electroactivity and reproducibility than conventional Cl--doped polypyrrole, making it an excellent actuator for driving an implantable pump. At a driving current density of 1 mA/cm2, the pump demonstrates a consistent output capacity of 10.5 at 0.35 μL/s over 20 cycles. This work paves the way for the development of an implantable electroactive pump to improve the quality of life of diabetics. PMID:26134590

  11. Adenosine-induced coronary vasospasm following drug-eluting stent implantation

    PubMed Central

    Matsumoto, Naoya; Nagao, Ken; Hirayama, Atsushi; Kasama, Shu

    2014-01-01

    We present the case of coronary vasospasm during adenosine stress in a patient with a prior drug-eluting stent implantation. The patient had a stent implantation in the left anterior descending coronary artery 3 years ago. Recently, he developed a chest pain and underwent adenosine stress myocardial perfusion single photon emission CT (SPECT). During the adenosine stress, he felt severe chest pain and ST elevation on electrocardiogram. An invasive coronary angiography showed no in-stent restenosis. This phenomenon deemed to be adenosine-induced coronary vasospasm after stent implantation. PMID:24518394

  12. A therapeutic delivery system for chronic osteomyelitis via a multi-drug implant based on three-dimensional printing technology.

    PubMed

    Wu, Weigang; Ye, Chenyi; Zheng, Qixin; Wu, Gui; Cheng, Zhaohui

    2016-08-01

    Chronic osteomyelitis is difficult to be cured and often relapses, which presents to be a great challenge to clinicians. We conducted this original study to explore the efficiency of therapeutic alliance for chronic osteomyelitis by a multi-drug implant based on three-dimensional printing technology. We designed and fabricated preciously a multi-drug implant with a multi-layered concentric cylinder construction by three-dimensional (3D) printing technology. Levofloxacin and tobramycin were incorporated into the drug implant in a specific sequence. The drug release property of the drug implant was assayed in vitro We also developed an animal model of chronic osteomyelitis to estimate the effect of the 3D printed multi-drug implant. The results showed that the multi-drug implant had a sustained and programmed drug release property. Levofloxacin and tobramycin which were released from the multi-drug implant worked in tandem to enhance pharmacodynamic action which was similar to a tumor chemotherapy program and were sufficient to treat chronic osteomyelitis. These findings imply that the administration of 3D printed multi-drug implant would be a potential therapeutic method for chronic osteomyelitis. Further studies are required. PMID:27013218

  13. An implantable microdevice to perform high-throughput in vivo drug sensitivity testing in tumors.

    PubMed

    Jonas, Oliver; Landry, Heather M; Fuller, Jason E; Santini, John T; Baselga, Jose; Tepper, Robert I; Cima, Michael J; Langer, Robert

    2015-04-22

    Current anticancer chemotherapy relies on a limited set of in vitro or indirect prognostic markers of tumor response to available drugs. A more accurate analysis of drug sensitivity would involve studying tumor response in vivo. To this end, we have developed an implantable device that can perform drug sensitivity testing of several anticancer agents simultaneously inside the living tumor. The device contained reservoirs that released microdoses of single agents or drug combinations into spatially distinct regions of the tumor. The local drug concentrations were chosen to be representative of concentrations achieved during systemic treatment. Local efficacy and drug concentration profiles were evaluated for each drug or drug combination on the device, and the local efficacy was confirmed to be a predictor of systemic efficacy in vivo for multiple drugs and tumor models. Currently, up to 16 individual drugs or combinations can be assessed independently, without systemic drug exposure, through minimally invasive biopsy of a small region of a single tumor. This assay takes into consideration physiologic effects that contribute to drug response by allowing drugs to interact with the living tumor in its native microenvironment. Because these effects are crucial to predicting drug response, we envision that these devices will help identify optimal drug therapy before systemic treatment is initiated and could improve drug response prediction beyond the biomarkers and in vitro and ex vivo studies used today. These devices may also be used in clinical drug development to safely gather efficacy data on new compounds before pharmacological optimization. PMID:25904741

  14. An implantable microdevice to perform high-throughput in vivo drug sensitivity testing in tumors

    PubMed Central

    Jonas, Oliver; Landry, Heather M.; Fuller, Jason E.; Santini, John T.; Baselga, Jose; Tepper, Robert I.; Cima, Michael J.; Langer, Robert

    2016-01-01

    Current anticancer chemotherapy relies on a limited set of in vitro or indirect prognostic markers of tumor response to available drugs. A more accurate analysis of drug sensitivity would involve studying tumor response in vivo. To this end, we have developed an implantable device that can perform drug sensitivity testing of several anticancer agents simultaneously inside the living tumor. The device contained reservoirs that released microdoses of single agents or drug combinations into spatially distinct regions of the tumor. The local drug concentrations were chosen to be representative of concentrations achieved during systemic treatment. Local efficacy and drug concentration profiles were evaluated for each drug or drug combination on the device, and the local efficacy was confirmed to be a predictor of systemic efficacy in vivo for multiple drugs and tumor models. Currently, up to 16 individual drugs or combinations can be assessed independently, without systemic drug exposure, through minimally invasive biopsy of a small region of a single tumor. This assay takes into consideration physiologic effects that contribute to drug response by allowing drugs to interact with the living tumor in its native microenvironment. Because these effects are crucial to predicting drug response, we envision that these devices will help identify optimal drug therapy before systemic treatment is initiated and could improve drug response prediction beyond the biomarkers and in vitro and ex vivo studies used today. These devices may also be used in clinical drug development to safely gather efficacy data on new compounds before pharmacological optimization. PMID:25904741

  15. In vitro study of ferromagnetic stents for implant assisted-magnetic drug targeting

    NASA Astrophysics Data System (ADS)

    Avilés, Misael O.; Chen, Haitao; Ebner, Armin D.; Rosengart, Axel J.; Kaminski, Michael D.; Ritter, James A.

    2007-04-01

    Implant-assisted-magnetic drug targeting (IA-MDT) was studied in vitro using a coiled ferromagnetic wire stent made from stainless steel 430 or 304, and magnetic drug carrier particle (MDCP) surrogates composed of poly(styrene/divinylbenzene) embedded with 20 wt% magnetite. The fluid velocity, particle concentration, magnetic field strength, and stent material all proved to be important for capturing the MDCP surrogates. Overall, this in vitro study further confirmed the important role of the ferromagnetic implant for attracting and retaining MDCPs at the target zone.

  16. An Implantable MEMS Micropump System for Drug Delivery in Small Animals

    PubMed Central

    Gensler, Heidi; Sheybani, Roya; Li, Po-Ying; Lo, Ronalee; Meng, Ellis

    2012-01-01

    We present the first implantable drug delivery system for controlled dosing, timing, and location in small animals. Current implantable drug delivery devices do not provide control over these factors or are not feasible for implantation in research animals as small as mice. Our system utilizes an integrated electrolysis micropump, is refillable, has an inert drug reservoir for broad drug compatibility, and is capable of adjustment to the delivery regimen while implanted. Electrochemical impedance spectroscopy (EIS) was used for characterization of electrodes on glass substrate and a flexible Parylene substrate. Benchtop testing of the electrolysis actuator resulted in flow rates from 1 to 34 μL/min on glass substrate and up to 6.8 μL/min on Parylene substrate. The fully integrated system generated a flow rate of 4.72 ± 0.35 μL/min under applied constant current of 1.0 mA while maintaining a power consumption of only ~3 mW. Finally, we demonstrated in vivo application of the system for anti-cancer drug delivery in mice. PMID:22273985

  17. Laser sclerectomy and 5-FU controlled-drug-release biodegradable implant for glaucoma therapy

    NASA Astrophysics Data System (ADS)

    Villain, Franck L.; Parel, Jean-Marie A.; Kiss, Katalin; Parrish, Richard K.; Kuhne, Francois; Takesue, Yoshiko; Hostyn, Patrick

    1993-06-01

    Laser sclerectomy, a simple filtering procedure performed to alleviate high intraocular pressure in glaucoma patients, was taught to offer longer lasting effect and therefore improve the patient's outcome when compared with the standard trabeculectomy procedure. Recent clinical trials have shown that this was not the case and pharmacologic wound healing modulation is also required with this new procedure. Five-Fluorouracil (5-FU) is useful as an adjunct treatment for glaucoma filtering surgery. However, efficacy depends upon maintaining sustained drug levels, currently achieved by repeated daily injection of the drug for several weeks. To overcome this limitation, we designed a biodegradable implant for the sustained release of 5-FU. After laser sclerectomy, the implant is inserted through the same 1 mm wide conjunctival snip incision and positioned below the open channel. Implantation takes less than a minute. The implant releases the drug for over 15 days and totally biodegrades in less than 100 days. The combined laser surgery and implantation procedure show great potentials for the treatment of glaucoma.

  18. Statins, glucocorticoids, and nonsteroidal anti-inflammatory drugs: their influence on implant healing.

    PubMed

    Fu, Jia-Hui; Bashutski, Jill D; Al-Hezaimi, Khalid; Wang, Hom-Lay

    2012-10-01

    This article aimed at exploring the effects of common systemic medications used in the United States and their effects on periimplant bone healing. An electronic search for articles evaluating the influence of systemic medications on periimplant bone healing was conducted using the PubMed (MEDLINE) database. Statins, when administered locally or systemically, were found to increase bone formation and density. A reduction in bone turnover and bone-to-implant contact was observed in animal models examining the effect of glucocorticoids on periimplant bone healing. Continued use of nonsteroidal anti-inflammatory drugs (NSAIDs) during or after implant placement was associated with reduced bone-to-implant contact, bone area, and bone density. Evidence seems to suggest that statins improve implant osseointegration. However, glucocorticoids and NSAIDs showed conflicting results. Therefore, more randomized clinical trials are needed to validate the effect of glucocorticoids and NSAIDs on periimplant bone healing. PMID:22968569

  19. Spectral Analysis Related to Bare-Metal and Drug-Eluting Coronary Stent Implantation

    PubMed Central

    da Silva, Rose Mary Ferreira Lisboa; Silva, Carlos Augusto Bueno; Greco, Otaviano José; Moreira, Maria da Consolação Vieira

    2014-01-01

    Background The autonomic nervous system plays a central role in cardiovascular regulation; sympathetic activation occurs during myocardial ischemia. Objective To assess the spectral analysis of heart rate variability during stent implantation, comparing the types of stent. Methods This study assessed 61 patients (mean age, 64.0 years; 35 men) with ischemic heart disease and indication for stenting. Stent implantation was performed under Holter monitoring to record the spectral analysis of heart rate variability (Fourier transform), measuring the low-frequency (LF) and high-frequency (HF) components, and the LF/HF ratio before and during the procedure. Results Bare-metal stent was implanted in 34 patients, while the others received drug-eluting stents. The right coronary artery was approached in 21 patients, the left anterior descending, in 28, and the circumflex, in 9. As compared with the pre-stenting period, all patients showed an increase in LF and HF during stent implantation (658 versus 185 ms2, p = 0.00; 322 versus 121, p = 0.00, respectively), with no change in LF/HF. During stent implantation, LF was 864 ms2 in patients with bare-metal stents, and 398 ms2 in those with drug-eluting stents (p = 0.00). The spectral analysis of heart rate variability showed no association with diabetes mellitus, family history, clinical presentation, beta-blockers, age, and vessel or its segment. Conclusions Stent implantation resulted in concomitant sympathetic and vagal activations. Diabetes mellitus, use of beta-blockers, and the vessel approached showed no influence on the spectral analysis of heart rate variability. Sympathetic activation was lower during the implantation of drug-eluting stents. PMID:25029473

  20. Theoretical analysis of a transdermal ferromagnetic implant for retention of magnetic drug carrier particles

    NASA Astrophysics Data System (ADS)

    Avilés, Misael O.; Ebner, Armin D.; Chen, Haitao; Rosengart, Axel J.; Kaminski, Michael D.; Ritter, James A.

    2005-05-01

    The use of a ferromagnetic wire implant placed near an artery to assist the collection of magnetic drug carrier particles (MDCPs) using an external magnet is theoretically studied. Three magnetic drug targeting (MDT) systems are evaluated in terms of their MDCP collection efficiency (CE): a permanent magnet and wire is better than a permanent magnet alone, which is better than a homogeneous magnetic field and wire.

  1. Clopidogrel discontinuation within the first year after coronary drug-eluting stent implantation: an observational study

    PubMed Central

    2014-01-01

    Background The impact of adherence to the recommended duration of dual antiplatelet therapy after first generation drug-eluting stent implantation is difficult to assess in real-world settings and limited data are available. Methods We followed 4,154 patients treated with coronary drug-eluting stents in Western Denmark for 1 year and obtained data on redeemed clopidogrel prescriptions and major adverse cardiovascular events (MACE, i.e., cardiac death, myocardial infarction, or stent thrombosis) from medical databases. Results Discontinuation of clopidogrel within the first 3 months after stent implantation was associated with a significantly increased rate of MACE at 1-year follow-up (hazard ratio (HR) 2.06; 95% confidence interval (CI): 1.08-3.93). Discontinuation 3-6 months (HR 1.29; 95% CI: 0.70-2.41) and 6-12 months (HR 1.29; 95% CI: 0.54-3.07) after stent implantation were associated with smaller, not statistically significant, increases in MACE rates. Among patients who discontinued clopidogrel, MACE rates were highest within the first 2 months after discontinuation. Conclusions Discontinuation of clopidogrel was associated with an increased rate of MACE among patients treated with drug-eluting stents. The increase was statistically significant within the first 3 months after drug-eluting stent implantation but not after 3 to 12 months. PMID:25125079

  2. Cochlear implants and drug delivery: In vitro evaluation of dexamethasone release.

    PubMed

    Astolfi, Laura; Guaran, Valeria; Marchetti, Nicola; Olivetto, Elena; Simoni, Edi; Cavazzini, Alberto; Jolly, Claude; Martini, Alessandro

    2014-02-01

    Anti-inflammatory drugs can minimize the trauma and inflammation in the inner ear caused by cochlear implantation surgery. For this reason, much effort has recently been devoted to finding the best way to administer these anti-inflammatory drugs for a prolonged time and in a personalized dosage. One solution is constructing an electrode with a dispenser filled with anti-inflammatory drugs with a dosage adapted to suit each new cochlear implant user. The purpose of this study was to measure in vitro, by high-performance liquid chromatography-mass spectrometry assay, the amount of dexamethasone released in 78 days in a physiological solution by a filled dispenser. The drug release continued for more than 2 months in three different phases: (1) during the first 1-5 days, (2) within about 2 weeks, and (3) from about 3 weeks until the end of experiment. This release trend is in accordance with the 3 main phases of damage caused by the cochlear implantation: (1) insertion trauma within the first 2 days, (2) inflammation within 2 weeks, and finally (3) an intracochlear chronic fibrosis reaction. Future animal model studies should consider using this dispenser in order to establish its effectiveness in preventing damage caused by cochlear implantation. PMID:23997036

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

    PubMed

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

    PubMed Central

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

    2016-01-01

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

  5. [Comparative test on puncture coring of two different needles used with the implantable drug-supplying device].

    PubMed

    Wan, Min; Wu, Ping; Song, Jinzi; Yu, Xin; Mou, Pengtao

    2010-11-01

    A comparison test on the number of puncture coring is conducted using the normal needle and the Huber needle in the injection area of the implantable drug-supplying device separately. The result indicates that the number of coring using the Huber needle is much less than that using the normal needle during the puncturing. So it is suggested to popularize the Huber needle in the drug transfusion of the implantable drug-supplying device. PMID:21360986

  6. Three-Dimensional Printed PCL-Based Implantable Prototypes of Medical Devices for Controlled Drug Delivery.

    PubMed

    Holländer, Jenny; Genina, Natalja; Jukarainen, Harri; Khajeheian, Mohammad; Rosling, Ari; Mäkilä, Ermei; Sandler, Niklas

    2016-09-01

    The goal of the present study was to fabricate drug-containing T-shaped prototypes of intrauterine system (IUS) with the drug incorporated within the entire backbone of the medical device using 3-dimensional (3D) printing technique, based on fused deposition modeling (FDM™). Indomethacin was used as a model drug to prepare drug-loaded poly(ε-caprolactone)-based filaments with 3 different drug contents, namely 5%, 15%, and 30%, by hot-melt extrusion. The filaments were further used to 3D print IUS. The results showed that the morphology and drug solid-state properties of the filaments and 3D prototypes were dependent on the amount of drug loading. The drug release profiles from the printed devices were faster than from the corresponding filaments due to a lower degree of the drug crystallinity in IUS in addition to the differences in the external/internal structure and geometry between the products. Diffusion of the drug from the polymer was the predominant mechanism of drug release, whereas poly(ε-caprolactone) biodegradation had a minor effect. This study shows that 3D printing is an applicable method in the production of drug-containing IUS and can open new ways in the fabrication of controlled release implantable devices. PMID:26906174

  7. Impact of Statin Treatment on Strut Coverage after Drug-Eluting Stent Implantation

    PubMed Central

    Suh, Yongsung; Kim, Byeong-Keuk; Shin, Dong-Ho; Kim, Jung-Sun; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo

    2015-01-01

    Purpose To evaluate the effect of statin treatment on strut coverage after drug-eluting stent (DES) implantation. Materials and Methods In this study, 60 patients were randomly assigned to undergo sirolimus-eluting stent (SES) or biolimus-eluting stent (BES) implantation, after which patients were randomly treated with pitavastatin 2 mg or pravastatin 20 mg for 6 months. The degree of strut coverage was assessed by 6-month follow-up optical coherence tomography, which was performed in 52 DES-implanted patients. Results The percentages of uncovered struts were 19.4±14.7% in pitavastatin-treated patients (n=25) and 19.1±15.2% in pravastatin-treated patients (n=27; p=0.927). A lower percentage of uncovered struts was significantly correlated with a lower follow-up low-density lipoprotein (LDL) cholesterol level (r=0.486; p=0.009) and a greater decline of the LDL cholesterol level (r=-0.456; p=0.015) in SES-implanted patients, but not in BES-implanted patients. In SES-implanted patients, the percentage of uncovered struts was significantly lower among those with LDL cholesterol levels of less than 70 mg/dL after 6 months of follow-up (p=0.025), but no significant difference in this variable according to the follow-up LDL cholesterol level was noted among BES-implanted patients (p=0.971). Conclusion Lower follow-up LDL cholesterol levels, especially those less than 70 mg/dL, might have a protective effect against delayed strut coverage after DES implantation. This vascular healing effect of lower LDL cholesterol levels could differ according to the DES type. PMID:25510746

  8. [Coronary aneurysm after drug-eluting stent implantation].

    PubMed

    Paulista, Paulo Paredes; Paulista, Paulo Henrique Dágola; Centemero, Marinella Patrizia; Feres, Fausto

    2008-01-01

    The use of drug-eluting stents aiming at by-pass the disadvantage of stainless steel stents have been associated to late thrombosis after withdrawal of anti-platelet agents. We report a case with another complication, the development of a coronary aneurysm in the stent area more than three years after index procedure. Late chronic local inflammatory responses may be responsible for the weakening, erosion and aneusrysm formation. PMID:18719840

  9. Development of a nanoporous and multilayer drug-delivery platform for medical implants

    PubMed Central

    Karagkiozaki, Varvara; Vavoulidis, Eleftherios; Karagiannidis, Panagiotis G; Gioti, Maria; Fatouros, Dimitrios G; Vizirianakis, Ioannis S; Logothetidis, Stergios

    2012-01-01

    Biodegradable polymers can be applied to a variety of implants for controlled and local drug delivery. The aim of this study is to develop a biodegradable and nanoporous polymeric platform for a wide spectrum of drug-eluting implants with special focus on stent-coating applications. It was synthesized by poly(DL-lactide-co-glycolide) (PLGA 65:35, PLGA 75:25) and polycaprolactone (PCL) in a multilayer configuration by means of a spin-coating technique. The antiplatelet drug dipyridamole was loaded into the surface nanopores of the platform. Surface characterization was made by atomic force microscopy (AFM) and spectroscopic ellipsometry (SE). Platelet adhesion and drug-release kinetic studies were then carried out. The study revealed that the multilayer films are highly nanoporous, whereas the single layers of PLGA are atomically smooth and spherulites are formed in PCL. Their nanoporosity (pore diameter, depth, density, surface roughness) can be tailored by tuning the growth parameters (eg, spinning speed, polymer concentration), essential for drug-delivery performance. The origin of pore formation may be attributed to the phase separation of polymer blends via the spinodal decomposition mechanism. SE studies revealed the structural characteristics, film thickness, and optical properties even of the single layers in the triple-layer construct, providing substantial information for drug loading and complement AFM findings. Platelet adhesion studies showed that the dipyridamole-loaded coatings inhibit platelet aggregation that is a prerequisite for clotting. Finally, the films exhibited sustained release profiles of dipyridamole over 70 days. These results indicate that the current multilayer phase therapeutic approach constitutes an effective drug-delivery platform for drug-eluting implants and especially for cardiovascular stent applications. PMID:23071394

  10. Biocompatible medical implant materials with binding sites for a biodegradable drug-delivery system

    PubMed Central

    Al-Dubai, Haifa; Pittner, Gisela; Pittner, Fritz; Gabor, Franz

    2011-01-01

    Feasibility studies have been carried out for development of a biocompatible coating of medical implant materials allowing the binding of biodegradable drug-delivery systems in a way that their reloading might be possible. These novel coatings, able to bind biodegradable nanoparticles, may serve in the long run as drug carriers to mediate local pharmacological activity. After biodegradation of the nanoparticles, the binding sites could be reloaded with fresh drug-delivering particles. As a suitable receptor system for the nanoparticles, antibodies are anchored. The design of the receptor is of great importance as any bio- or chemorecognitive interaction with other components circulating in the blood has to be avoided. Furthermore, the binding between receptor and the particles has to be strong enough to keep them tightly bound during their lifetime, but on the other hand allow reloading after final degradation of the particles. The nanoparticles suggested as a drug-delivery system for medical implants can be loaded with different pharmaceuticals such as antibiotics, growth factors, or immunosuppressives. This concept may enable the changing of medication, even after implantation of the medical device, if afforded by patients’ needs. PMID:24198488

  11. Implantable MicroPump for Drug Delivery in Patients with Diabetic Macular Edema

    PubMed Central

    Humayun, Mark; Santos, Arturo; Altamirano, Juan Carlos; Ribeiro, Ramiro; Gonzalez, Roberto; de la Rosa, Alejandro; Shih, Jason; Pang, Changling; Jiang, Fukang; Calvillo, Philip; Huculak, John; Zimmerman, Jenna; Caffey, Sean

    2014-01-01

    Purpose To demonstrate the safety and surgical feasibility of the first-in-man ocular implant of a novel Posterior MicroPump Drug Delivery System (PMP) in patients with diabetic macular edema (DME) and to report on the device capabilities for delivering a programmable microdose. Methods This was a single center, single arm, open-label, prospective study. Eleven patients with DME and visual acuity equal to or worse than 20/40 were included. The PMP prefilled with ranibizumab was implanted into the subconjunctival space. After implantation, the PMP was wirelessly controlled to deliver a programmed microdose. Comprehensive ophthalmic exams and optical coherence tomography were performed biweekly for 90 days. At the end of the study, the PMP was explanted and the subjects thereafter received standard of care for DME (i.e., laser or intravitreal injections). Results All 11 surgical implantations were without complications and within the skill sets of a retinal surgeon. No serious adverse events occurred during the follow-up period. At no point were visual acuity and central foveal thickness worse than baseline in the implanted eye. The PMP delivered the programmed ranibizumab dosage in seven subjects. The remaining four patients received a lower than target dose, and the treatment was complemented with standard intravitreal injection. Conclusions This study demonstrates the first-in-man safety of the Replenish MicroPump implant for a period of 90 days and its capability to deliver a microdose into the vitreous cavity. Further studies to enable longer-term safety and to demonstrate the feasibility of multiple programmable drug delivery are necessary. PMID:25653883

  12. Biocompatibility and Pharmacokinetic Analysis of an Intracameral Polycaprolactone Drug Delivery Implant for Glaucoma

    PubMed Central

    Kim, Jean; Kudisch, Max; Mudumba, Sri; Asada, Hiroyuki; Aya-Shibuya, Eri; Bhisitkul, Robert B.; Desai, Tejal A.

    2016-01-01

    Purpose We developed polycaprolactone (PCL) implants that achieve zero-order release of a proprietary ocular hypotensive agent (DE-117) over 6 months. Methods The release rates of DE-117–loaded PCL devices were tuned based on an established predictive model and confirmed by in vitro release studies. Devices containing DE-117 and empty devices were implanted intracamerally in normotensive rabbits for up to 8 weeks' duration. Devices were retrieved after rabbits were euthanized and evaluated for tissue adherence. The drug remaining in each device was analyzed by high performance liquid chromatography. Drug distribution in ocular tissues was measured by liquid chromatography coupled with a tandem mass spectrometry (LC/MS/MS). Results In vitro release of DE-117 showed zero-order release with a release rate of 0.5 μg/day over 6 months. Implantation in rabbit eyes demonstrated that the devices were well tolerated in the intracameral space. Quantification of DE-117 and hDE-117 (the hydrolyzed active form of DE-117) in ocular tissues (cornea, iris-ciliary body, aqueous humor, and vitreous humor) indicated sustained release of DE-117 and its conversion to hDE-117 when released from the device. Analysis of drug remaining in the device found that concentration of hDE-117 was below the limit of detection, indicating the encapsulated drug was protected from hydrolysis in the device. Conclusions Proof-of-concept PCL drug delivery devices containing DE-117 show promise as a long-term glaucoma treatment based on their zero-order drug release profile in vitro, biocompatibility in vivo, and effective distribution of released drug in relevant ocular tissues. PMID:27556217

  13. Healing of articular cartilage defects treated with a novel drug-releasing rod-type implant after microfracture surgery.

    PubMed

    Shim, In Kyong; Yook, Yeo Joo; Lee, Sang Young; Lee, Sang Hoon; Park, Ki Dong; Lee, Myung Chul; Lee, Seung Jin

    2008-08-01

    Microfracture therapy is a widely used technique for the repair of articular cartilage defects because it can be readily performed arthroscopically. However, the regenerated cartilage after microfracture surgery clearly differs from normal articular cartilage. This suggests that the clinical outcome of patients undergoing microfracture therapy could be improved. Dehydroepiandrosterone sulfate (DHEA-S) is known to protect against articular cartilage loss. Therefore, in an effort to achieve cartilage regeneration of high efficacy, we manufactured a DHEA-S-releasing rod-type implant for implantation into the holes produced by microfracture surgery. The polymeric rod-type implant was made of biodegradable poly (D, L-lactide-co-glycolide) (PLGA) and beta-tricalcium phosphate to enable controlled release of DHEA-S. The implant was dip-coated with a dilute PLGA solution to prevent the burst release of DHEA-S. The rod-type implant was sufficiently stiff to permit implantation into the holes made by microfracture. DHEA-S was released from the implant for more than four weeks. Furthermore, eight weeks after implantation into rabbit knees, the implants dramatically enhanced cartilage regeneration compared to control. Moreover, the degradation of the implant over the eight weeks from implantation into the knee did not induce any adverse effects. Therefore, this polymeric rod-type implant does not only provide an improvement in microfracture surgery, but also has great potential as a new formulation for drug delivery. PMID:18547670

  14. Wireless implantable chip with integrated nitinol-based pump for radio-controlled local drug delivery.

    PubMed

    Fong, Jeffrey; Xiao, Zhiming; Takahata, Kenichi

    2015-02-21

    We demonstrate an active, implantable drug delivery device embedded with a microfluidic pump that is driven by a radio-controlled actuator for temporal drug delivery. The polyimide-packaged 10 × 10 × 2 mm(3) chip contains a micromachined pump chamber and check valves of Parylene C to force the release of the drug from a 76 μL reservoir by wirelessly activating the actuator using external radio-frequency (RF) electromagnetic fields. The rectangular-shaped spiral-coil actuator based on nitinol, a biocompatible shape-memory alloy, is developed to perform cantilever-like actuation for pumping operation. The nitinol-coil actuator itself forms a passive 185 MHz resonant circuit that serves as a self-heat source activated via RF power transfer to enable frequency-selective actuation and pumping. Experimental wireless operation of fabricated prototypes shows successful release of test agents from the devices placed in liquid and excited by radiating tuned RF fields with an output power of 1.1 W. These tests reveal a single release volume of 219 nL, suggesting a device's capacity of ~350 individual ejections of drug from its reservoir. The thermal behavior of the activated device is also reported in detail. This proof-of-concept prototype validates the effectiveness of wireless RF pumping for fully controlled, long-lasting drug delivery, a key step towards enabling patient-tailored, targeted local drug delivery through highly miniaturized implants. PMID:25473933

  15. Stent thrombosis with an aneurysm 7 years after a drug eluting stent implantation

    PubMed Central

    Patil, Pritam; Sethi, Arvind; Kaul, Upendra

    2014-01-01

    We report a case of very late stent thrombosis 7 years post sirolimus eluting stent implantation presenting as ST elevation MI while on dual antiplatelet therapy. Angiography revealed an aneurysm at the proximal end of the stent. The patient was managed successfully by primary percutaneous coronary intervention (PCI) with adjunct thrombus aspiration and intracoronary abciximab administration followed by deploying a mesh-covered stent MGuard. This very late complication is a rare presentation after a drug illuting stent (DES). PMID:24814120

  16. Novel composite fiber structures to provide drug/protein delivery for medical implants and tissue regeneration.

    PubMed

    Zilberman, Meital

    2007-01-01

    A novel class of bioresorbable composite (core/shell) fiber structures loaded with bioactive agents was developed and studied. These unique polymeric structures are designed to combine good mechanical properties with a desired controlled release profile, in order to serve as scaffolds for tissue regeneration applications and as basic elements of medical implants. These core/shell fiber structures were formed by "coating" core polymer fibers with drug/protein-containing poly(dl-lactic-co-glycolic acid) porous structures. The shell preparation ("coating") was performed by the freeze-drying of water-in-oil emulsions. Both water soluble and water insoluble agents can be incorporated in these structures and their activity is preserved, since the fiber fabrication requires neither high temperatures nor harsh solvents in the vicinity of the bioactive agents. Examples for release profiles of protein (horseradish peroxidase) and drug (paclitaxel) are presented. We have demonstrated that appropriate selection of the emulsion's parameters can yield a variety of new core/shell fiber structures with desirable drug/protein release behavior. This will lead to the engineering of new implants and scaffolds, and will advance the field of tissue regeneration and medical implants. PMID:16956799

  17. Microparticle entrapment for drug release from porous-surfaced bone implants.

    PubMed

    Wang, Dongwei; Liu, Qing; Xiao, Dongqin; Guo, Tailin; Ma, Yunqing; Duan, Ke; Wang, Jianxin; Lu, Xiong; Feng, Bo; Weng, Jie

    2015-01-01

    Metallic bone implants face interfacial concerns, such as infection and insufficient bone formation. Combination of drug-loaded microparticles with the implant surface is a promising approach to reducing the concerns. The present study reports a simple method for this purpose. Drug-loaded chitosan and alginate microparticles were separately prepared by emulsion methods. Dry microparticles were introduced into porous titanium (Ti) coatings on Ti discs, and induced to agglomerate in pores by wetting with water. Agglomerates were stably entrapped in the pores: 77-82% retained in the coating after immersion in a water bath for 7 d. Discs carrying drug-loaded microparticles showed a rapid release within 6 h and a subsequent slow release up to 1 d. After coculture with Staphylococcus epidermidis for 24 h, the discs formed inhibition zones, confirming antibacterial properties. These suggest that the microparticle entrapment-based method is a promising method for reducing some of the bone-implant interfacial concerns. PMID:26057256

  18. In-Stent Restenosis Exacerbated by Drug-Induced Severe Eosinophilia after Second-Generation Drug-Eluting Stent Implantation

    PubMed Central

    Yagi, Hiroki; Amiya, Eisuke; Ando, Jiro; Watanabe, Masafumi; Yanaba, Koichi; Ikemura, Masako; Fukayama, Masashi; Komuro, Issei

    2014-01-01

    Patient: Male, 83 Final Diagnosis: In-stent restenosis Symptoms: Chest discomfort Medication: — Clinical Procedure: Cardiac catheterization Specialty: Cardiology Objective: Unusual clinical course Background: In-stent restenosis (ISR) is still a recognized clinical problem in the era of drug-eluting stent (DES). Some previous studies have suggested that circulating eosinophils play an important role in both restenosis and thrombosis after DES implantation. However, the contribution of eosinophils to the pathogenesis of ISR has not yet been concisely clarified. Case Report: We present the case of an 83-year-old male Japanese patient with ISR exacerbated by drug-induced severe eosinophilia. He had previous histories of coronary stent implantations by DES and was referred to our hospital because of erythema with severe eosinophilia (maximum was 6500/μl [48% of total white blood cell count]). Around the same time, the patient developed ISR, for which a stent was deployed 2 years earlier. Arterial wall injury due to the increase in circulating eosinophils was verified in several findings, such as the increase of D-dimer and brain natriuretic peptide. In addition, the histology of the resected tissue from erythema demonstrated that the nuclei of endothelial cells were swollen where eosinophils and lymphocytes heavily infiltrated into the extravascular space, suggesting the presence of vascular injury. This injury due to the increase in circulating eosinophils may have a marked impact on the pathologic process of ISR in DES implantation. Conclusions: Just a few anecdotal reports are available of ISR occurring in the setting of hypereosinophilia. The clarification of the mechanism in this patient provides a new effective therapeutic strategy against ISR in the setting of DES implantation. PMID:25227966

  19. Comparison of Full Lesion Coverage versus Spot Drug-Eluting Stent Implantation for Coronary Artery Stenoses

    PubMed Central

    Kim, Seunghwan; Yun, Kyeong Ho; Shin, Dong-Ho; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo

    2014-01-01

    Purpose The aim of this study was to evaluate and compare the long-term clinical outcomes of the spot drug-eluting stent (DES) implantation strategy, which is used to minimize implanted stent length and the number of stents, versus full lesion coverage for treatment of coronary artery stenoses. Materials and Methods We evaluated 1-year clinical outcomes of 1619 patients with stent implantation for a single coronary lesion. They were divided into two groups: those treated by full lesion coverage (n=1200) and those treated with the spot stenting strategy (n=419). The combined occurrence of 1-year target vessel failure (TVF), including cardiac death, target-vessel related myocardial infarction, or ischemia-driven target-vessel revascularization was evaluated. Results The spot DES implantation group had a shorter stent length (23.14±9.70 mm vs. 25.44±13.24 mm, respectively; p<0.001) and a fewer number of stents (1.09±0.30 vs. 1.16±0.41, respectively; p<0.001), even though the average lesion length was similar to the full lesion coverage group (21.36±10.30 mm vs. 20.58±10.97 mm, respectively; p=0.206). Spot DES implantation was superior to full DES coverage with respect to 1-year TVF (1.4% vs. 3.3%, p=0.044). Cox proportional hazard model analysis showed that the risk for 1-year TVF was almost 60% lower among patients who received spot DESs compared to those who received full DES coverage after adjustment for other risk factors (HR=0.40, 95% confidence interval=0.17-0.98; p=0.046). Conclusion Minimizing stent length and the number of stents with overlapping by spot DES implantation may result in reduced rates of 1-year TVF, compared with full DES coverage. PMID:24719123

  20. Fabrication of drug eluting implants: study of drug release mechanism from titanium dioxide nanotubes

    NASA Astrophysics Data System (ADS)

    Hamlekhan, Azhang; Sinha-Ray, Suman; Takoudis, Christos; Mathew, Mathew T.; Sukotjo, Cortino; Yarin, Alexander L.; Shokuhfar, Tolou

    2015-06-01

    Formation of titanium dioxide nanotubes (TNTs) on a titanium surface holds great potential for promoting desirable cellular response. However, prolongation of drug release from these nano-reservoirs remains to be a challenge. In our previous work TNTs were successfully loaded with a drug. In this study the effect of TNTs dimensions on prolongation of drug release is quantified aiming at the introduction of a simple novel technique which overcomes complications of previously introduced methods. Different groups of TNTs with different lengths and diameters are fabricated. Samples are loaded with a model drug and rate of drug release over time is monitored. The relation of the drug release rate to the TNT dimensions (diameter, length, aspect ratio and volume) is established. The results show that an increase in any of these parameters increases the duration of the release process. However, the strongest parameter affecting the drug release is the aspect ratio. In fact, TNTs with higher aspect ratios release drug slower. It is revealed that drug release from TNT is a diffusion-limited process. Assuming that diffusion of drug in (Phosphate-Buffered Saline) PBS follows one-dimensional Fick’s law, the theoretical predictions for drug release profile is compatible with our experimental data for release from a single TNT.

  1. PLGA in situ implants formed by phase inversion: critical physicochemical parameters to modulate drug release.

    PubMed

    Parent, Marianne; Nouvel, Cécile; Koerber, Martin; Sapin, Anne; Maincent, Philippe; Boudier, Ariane

    2013-11-28

    In situ forming implants (ISI) based on phase separation by solvent exchange represent an attractive alternative to conventional preformed implants and microparticles for parenteral applications. They are indeed easier to manufacture and their administration does not require surgery, therefore improving patient compliance. They consist of polymeric solutions precipitating at the site of injection and thus forming a drug eluting depot. Drug release from ISI is typically divided into three phases: burst during precipitation of the depot, diffusion of drug through the polymeric matrix and finally drug release by system degradation. This review gives a comprehensive overview on (i) the theoretical bases of these three phases, (ii) the parameters influencing them and (iii) the remaining drawbacks which have to be addressed to enlarge their commercial opportunities. Indeed, although some of them are already commercialized, ISI still suffer from limitations: mainly lack of reproducibility in depot shape, burst during solidification and potential toxicity. Nevertheless, depending on the targeted therapeutic application, these shortcomings may be transformed into advantages. As a result, keys are given in order to tailor these formulations in view of the desired application so that ISI could gain further clinical importance in the following years. PMID:24001947

  2. 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

  3. In vitro study of drug loading on polymer-free oxide films of metallic implants.

    PubMed

    Shih, Chun-Ming; Shih, Chun-Che; Su, Yea-Yang; Chang, Nen-Chung; Lin, Shing-Jong

    2005-12-01

    Traditionally, a drug that is loaded onto a metallic surface has to use various polymer bondings as its platform. Unfortunately, polymer coatings on a metallic surface cause numerous problems after implantation, such as late thrombosis, inflammation, and restenosis. This research was conducted to investigate whether an oxide layer can be used as a polymer-free platform for drug loading, especially for cardiovascular stents. The interaction and loading of heparin onto different oxide films on 316LVM stainless steel wire was confirmed in vitro by experimental studies using linear voltammetry, electrochemical impedance spectroscopy, and electron spectroscopy for chemical analysis. The eluting of heparin from heparinized surface was studied by using high-performance liquid chromatography, and activated clotting time in addition to linear voltammetry and electron spectroscopy for chemical analysis analyses. Experimental results show that amorphous oxide could be a potential substitute for the polymer coating of drug-loaded stents for minimizing metallic corrosion, inflammation, late thrombosis, and restenosis. PMID:16082699

  4. Predictors of diffuse-type in-stent restenosis following drug-eluting stent implantation

    PubMed Central

    PARK, CHANG-BUM; PARK, HOON-KI

    2013-01-01

    Diffuse-type in-stent restenosis (ISR) is known to be associated with a higher rate of restenosis than focal-type ISR. Therefore, it is clinically important to identify the determinants of diffuse-type ISR following drug-eluting stent (DES) implantation. We investigated the clinical, procedural and angiographic variables for predicting diffuse-type ISR following DES implantation. A total of 173 ISR lesions in 159 patients (diffuse-type: 61 lesions, focal-type: 112 lesions) following DES implantation from February 2003 to May 2008 were included in this study. Clinical, procedural and quantitative coronary angiographic variables were analyzed to determine predictors of diffuse-type ISR following DES implantation. Univariate analysis showed that the absence of hypertension [odds ratio (OR), 0.493; 95% confidence interval (CI), 1.025–4.103, P=0.042], use of a paclitaxel-eluting stent (PES) (OR, 3.318; 95% CI, 1.730–6.365, P<0.001) and smaller post-stenting minimal luminal diameter (MLD; OR, 0.368, 95% CI, 0.168–0.808, P=0.013) were significantly associated with diffuse-type ISR. However, use of a PES (OR, 3.957; 95% CI, 1.977–7.922, P<0.001) and smaller post-stenting MLD (OR, 0.320; CI, 0.140–0.731, P=0.007) were only independent predictors of diffuse-type ISR by multivariate analysis. Diabetes was not a predictor of diffuse-type ISR. The use of a PES and the post-stenting MLD were related to diffuse-type ISR following DES implantation. PMID:23737904

  5. Surface Modifications of Titanium Implants by Multilayer Bioactive Coatings with Drug Delivery Potential: Antimicrobial, Biological, and Drug Release Studies

    NASA Astrophysics Data System (ADS)

    Ordikhani, Farideh; Zustiak, Silviya Petrova; Simchi, Abdolreza

    2016-04-01

    Recent strategies to locally deliver antimicrobial agents to combat implant-associated infections—one of the most common complications in orthopedic surgery—are gaining interest. However, achieving a controlled release profile over a desired time frame remains a challenge. In this study, we present an innovative multifactorial approach to combat infections which comprises a multilayer chitosan/bioactive glass/vancomycin nanocomposite coating with an osteoblastic potential and a drug delivery capacity. The bioactive drug-eluting coating was prepared on the surface of titanium foils by a multistep electrophoretic deposition technique. The adopted deposition strategy allowed for a high antibiotic loading of 1038.4 ± 40.2 µg/cm2. The nanocomposite coating exhibited a suppressed burst release with a prolonged sustained vancomycin release for up to 6 weeks. Importantly, the drug release profile was linear with respect to time, indicating a zero-order release kinetics. An in vitro bactericidal assay against Staphylococcus aureus confirmed that releasing the drug reduced the risk of bacterial infection. Excellent biocompatibility of the developed coating was also demonstrated by in vitro cell studies with a model MG-63 osteoblast cell line.

  6. Pure and Strontium Doped Nano Hydroxyapatite: New Approach for Bone Implant and Drug Delivery System

    NASA Astrophysics Data System (ADS)

    Tank, Kashmira P.; Vasant, Sonal R.; Chudasama, Kiran S.; Thaker, Vrinda S.; Joshi, Mihir J.

    2011-07-01

    Hydroxyapatite, (Ca10(PO4)6(OH)2-Hap), an excellent inorganic biomaterial, find various applications. The chemical composition of Hap is similar to that of the inorganic matrix of human bone and dental enamel. It is also used in drug delivery system and coating of bone implant. In the present study, pure nano Hap and Strontium doped nano-Hap (Sr-Hap) with different concentrations were synthesized by surfactant mediated approach. The samples were characterized by EDAX, XRD and TEM. The hemolytic properties were also studied and it proved that all the samples were non-hemolytic.

  7. Cochlear Implants

    MedlinePlus

    ... electrodes are inserted. The electronic device at the base of the electrode array is then placed under ... FDA approval for implants The Food and Drug Administration (FDA) regulates cochlear implant devices for both adults ...

  8. A rapid method for creating drug implants: translating laboratory-based methods into a scalable manufacturing process.

    PubMed

    Wang, Cheng-Kuo; Wang, Wan-Yi; Meyer, Robert F; Liang, Yuling; Winey, Karen I; Siegel, Steven J

    2010-05-01

    Low compliance with medication is the major cause of poor outcome in schizophrenia treatment. While surgically implantable solvent-cast pellets were produced to improve outcome by increased compliance with medication, this process is laborious and time-consuming, inhibiting its broader application (Siegel et al., Eur J Pharm Biopharm 2006;64:287-293). In this study, the previous fabrication process was translated to a continuous and scalable extrusion method. Extrusion processes were modified based on in vitro release studies, drug load consistency examination, and surface morphology analysis using scanning electron microscopy. Afterward, optimized haloperidol implants were implanted into rats for preliminary analysis of biocompatibility. Barrel temperature, screw speed and resulting processing pressure influenced surface morphology and drug release. Data suggest that fewer surface pores shift the mechanism from bulk to surface PLGA degradation and longer lag period. Results demonstrate that extrusion is a viable process for manufacturing antipsychotic implants. PMID:20225251

  9. Graphene-based electroresponsive scaffolds as polymeric implants for on-demand drug delivery.

    PubMed

    Servant, Ania; Leon, Veronica; Jasim, Dhifaf; Methven, Laura; Limousin, Patricia; Fernandez-Pacheco, Ester Vazquez; Prato, Maurizio; Kostarelos, Kostas

    2014-08-01

    Stimuli-responsive biomaterials have attracted significant attention in the field of polymeric implants designed as active scaffolds for on-demand drug delivery. Conventional porous scaffolds suffer from drawbacks such as molecular diffusion and material degradation, allowing in most cases only a zero-order drug release profile. The possibility of using external stimulation to trigger drug release is particularly enticing. In this paper, the fabrication of previously unreported graphene hydrogel hybrid electro-active scaffolds capable of controlled small molecule release is presented. Pristine ball-milled graphene sheets are incorporated into a three dimensional macroporous hydrogel matrix to obtain hybrid gels with enhanced mechanical, electrical, and thermal properties. These electroactive scaffolds demonstrate controlled drug release in a pulsatile fashion upon the ON/OFF application of low electrical voltages, at low graphene concentrations (0.2 mg mL(-1) ) and by maintaining their structural integrity. Moreover, the in vivo performance of these electroactive scaffolds to release drug molecules without any "resistive heating" is demonstrated. In this study, an illustration of how the heat dissipating properties of graphene can provide significant and previously unreported advantages in the design of electroresponsive hydrogels, able to maintain optimal functionality by overcoming adverse effects due to unwanted heating, is offered. PMID:24799416

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

    PubMed

    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

  11. 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

  12. In vitro study of magnetic particle seeding for implant assisted-magnetic drug targeting

    NASA Astrophysics Data System (ADS)

    Avilés, Misael O.; Ebner, Armin D.; Ritter, James A.

    The concept of using magnetic particles (seeds) as the implant for implant assisted-magnetic drug targeting (IA-MDT) was analyzed in vitro. Since this MDT system is being explored for use in capillaries, a highly porous ( ɛ˜70%), highly tortuous, cylindrical, polyethylene polymer was prepared to mimic capillary tissue, and the seeds (magnetite nanoparticles) were already fixed within. The well-dispersed seeds were used to enhance the capture of 0.87 μm diameter magnetic drug carrier particles (MDCPs) (polydivinylbenzene embedded with 24.8 wt% magnetite) under flow conditions typically found in capillary networks. The effects of the fluid velocity (0.015-0.15 cm/s), magnetic field strength (0.0-250 mT), porous polymer magnetite content (0-7 wt%) and MDCP concentration ( C=5 and 50 mg/L) on the capture efficiency (CE) of the MDCPs were studied. In all cases, when the magnetic field was applied, compared to when it was not, large increases in CE resulted; the CE increased even further when the magnetite seeds were present. The CE increased with increases in the magnetic field strength, porous polymer magnetite content and MDCP concentration. It decreased only with increases in the fluid velocity. Large magnetic field strengths were not necessary to induce MDCP capture by the seeds. A few hundred mT was sufficient. Overall, this first in vitro study of the magnetic seeding concept for IA-MDT was very encouraging, because it proved that magnetic particle seeds could serve as an effective implant for MDT systems, especially under conditions found in capillaries.

  13. The implantable defibrillator and antiarrhythmic drugs--competitive and complementary treatment for severe ventricular arrhythmia.

    PubMed

    Dorian, P; Newman, D

    1993-11-01

    Most patients with a history of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) are at high risk of recurrence. Implanted defibrillators (ICDs) are highly effective in sensing and converting VT or VF to a perfusing rhythm. "Conventional" antiarrhythmic agents, which primarily block cardiac sodium channels, are relatively ineffective in preventing arrhythmia recurrence; amiodarone and sotalol appear to be effective in reducing recurrence and mortality rates, although the extent of benefit is not well understood. Despite the apparent advantage of ICDs, they have short- and long-term complications, are costly, and their benefit in prolonging the quantity or quality of life remains unproven. Randomized clinical trials which compare the effect of ICDs with that of antiarrhythmic drugs on mortality, cost, and quality of life will be necessary to understand how patients with malignant arrhythmias ought to be treated. If an ICD is implanted, adjunctive therapies need to be considered to treat the underlying heart disease and to derive optimum benefit from the device. Drugs may have beneficial or adverse interactions with devices, and the full understanding of these interactions requires further study. PMID:8269662

  14. Drug-releasing nano-engineered titanium implants: therapeutic efficacy in 3D cell culture model, controlled release and stability.

    PubMed

    Gulati, Karan; Kogawa, Masakazu; Prideaux, Matthew; Findlay, David M; Atkins, Gerald J; Losic, Dusan

    2016-12-01

    There is an ongoing demand for new approaches for treating localized bone pathologies. Here we propose a new strategy for treatment of such conditions, via local delivery of hormones/drugs to the trauma site using drug releasing nano-engineered implants. The proposed implants were prepared in the form of small Ti wires/needles with a nano-engineered oxide layer composed of array of titania nanotubes (TNTs). TNTs implants were inserted into a 3D collagen gel matrix containing human osteoblast-like, and the results confirmed cell migration onto the implants and their attachment and spread. To investigate therapeutic efficacy, TNTs/Ti wires loaded with parathyroid hormone (PTH), an approved anabolic therapeutic for the treatment of severe bone fractures, were inserted into 3D gels containing osteoblast-like cells. Gene expression studies revealed a suppression of SOST (sclerostin) and an increase in RANKL (receptor activator of nuclear factor kappa-B ligand) mRNA expression, confirming the release of PTH from TNTs at concentrations sufficient to alter cell function. The performance of the TNTs wire implants using an example of a drug needed at relatively higher concentrations, the anti-inflammatory drug indomethacin, is also demonstrated. Finally, the mechanical stability of the prepared implants was tested by their insertion into bovine trabecular bone cores ex vivo followed by retrieval, which confirmed the robustness of the TNT structures. This study provides proof of principle for the suitability of the TNT/Ti wire implants for localized bone therapy, which can be customized to cater for specific therapeutic requirements. PMID:27612777

  15. Impact of Coronary Plaque Characteristics on Late Stent Malapposition after Drug-Eluting Stent Implantation

    PubMed Central

    Hong, Sung-Jin; Kim, Byeong-Keuk; Shin, Dong-Ho; Kim, Jung-Sun; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo

    2015-01-01

    Purpose To evaluate the impact of pre-procedural coronary plaque composition assessed by virtual histology intravascular ultrasound (VH-IVUS) on late stent malapposition assessed by optical coherence tomography (OCT) following drug-eluting stent (DES) implantation. Materials and Methods The study population consisted of 121 patients (121 lesions) who underwent both pre-procedural VH-IVUS and follow-up OCT after DES implantation. The association between pre-procedural plaque composition [necrotic core (NC), dense calcium (DC), fibrotic (FT), and fibro-fatty (FF) volumes] assessed by VH-IVUS and late stent malapposition (percent malapposed struts) or strut coverage (percent uncovered struts) assessed by follow-up OCT was evaluated. Results Pre-procedural absolute total NC, DC, FT, and FF plaque volumes were 22.9±19.0, 7.9±9.6, 63.8±33.8, and 16.5±12.4 mm3, respectively. At 6.3±3.1 months post-intervention, percent malapposed and uncovered struts were 0.8±2.5% and 15.3±16.7%, respectively. Pre-procedural absolute total NC and DC plaque volumes were positively correlated with percent malapposed struts (r=0.44, p<0.001 and r=0.45, p<0.001, respectively), while pre-procedural absolute total FT plaque volume was weakly associated with percent malapposed struts (r=0.220, p=0.015). Pre-procedural absolute total DC plaque volume was the only independent predictor of late stent malapposition on multivariate analysis (β=1.12, p=0.002). There were no significant correlations between pre-intervention plaque composition and percent uncovered struts. Conclusion Pre-procedural plaque composition was associated with late stent malapposition but not strut coverage after DES implantation. Larger pre-procedural absolute total DC plaque volumes were associated with greater late stent malapposition. PMID:26446634

  16. Relationship between Angiographic Late Loss and 5-Year Clinical Outcome after Drug-Eluting Stent Implantation

    PubMed Central

    Yang, Young-June; Shin, Sanghoon; Kim, Byeong-Keuk; Kim, Jung-Sun; Shin, Dong-Ho; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo

    2013-01-01

    Purpose Currently, insufficient data exist to evaluate the relationship between angiographic late loss (LL) and long-term clinical outcome after drug-eluting stent (DES) implantation. In this study, we hypothesized that angiographic LL between 0.3 and 0.6 mm correlate with favorable long-term clinical outcomes. Materials and Methods Patients were enrolled in the present study if they had undergone both DES implantation in single coronary vessel and a subsequent follow-up angiogram (n=634). These individuals were then subdivided into three groups based on their relative angiographic LL: group I (angiographic LL <0.3 mm, n=378), group II (angiographic LL between 0.3 and 0.6 mm, n=124), and group III (angiographic LL >0.6 mm, n=134). During a 5-year follow-up period, all subjects were tracked for critical events, defined as any cause of death or myocardial infarction, which were then compared among the three groups. Results Mean follow-up duration was 63.0±10.0 months. Critical events occurred in 25 subjects in group I (6.6%), 5 in group II (4.0%), and 17 in group III (12.7%), (p=0.020; group I vs. group II, p=0.293; group II vs. group III, p=0.013). In a subsequent multivariate logistic regression analysis, chronic renal failure [odds ratio (OR)=3.29, 95% confidence interval (CI): 1.48-7.31, p=0.003] and long lesion length, defined as lesion length >28 mm (OR=1.88, 95% CI: 1.02-3.46, p=0.042) were independent predictors of long-term critical events. Conclusion This retrospective analysis fails to demonstrate that post-DES implantation angiographic LL between 0.3 and 0.6 mm is protective against future critical events. PMID:23225797

  17. Dialysis Patients with Implanted Drug-Eluting Stents Have Lower Major Cardiac Events and Mortality than Those with Implanted Bare-Metal Stents: A Taiwanese Nationwide Cohort Study

    PubMed Central

    Lee, Hsin-Fu; Wu, Lung-Sheng; Chan, Yi-Hsin; Lee, Cheng-Hung; Liu, Jia-Rou; Tu, Hui-Tzu; Wen, Ming-Shien; Kuo, Chi-Tai; Chen, Wei-Jan; Yeh, Yung-Hsin; See, Lai-Chu; Chang, Shang-Hung

    2016-01-01

    Objective To investigate the efficacy and long-term clinical benefits of DES for dialysis patients. Background It is unclear whether percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is associated with lower rates of major adverse cardiovascular events (MACE) or mortality compared to bare-metal stents (BMS). Methods From a nationwide cohort selected from Taiwan’s National Health Insurance Research Database, we enrolled 2,835 dialysis patients who were hospitalized for PCI treatment with stent implantation from Dec 1, 2006. Follow-up was from the date of index hospitalization for PCI until the first MACE, date of death, or December 31, 2011, whichever came first. Results A total of 738 patients (26.0%) had DES implanted, and 2,097 (74%) had BMS implanted. The medium time to the first MACE was 0.53 years (interquartile range: 0.89 years; range: 0–4.62 years). At 1-year follow-up, patients treated with BMS had significantly, non-fatal myocardial infarction (MI), all-cause mortality, and composite MACE compared to those treated with DES. The overall repeat revascularization with coronary artery bypass graft (CABG), non-fatal MI, all-cause mortality, and composite MACE were significantly lower in patients treated with DES than those treated with BMS. Multivariate cox regression analysis showed that older age, history of diabetes, history of heart failure, history of stroke, and DES vs. BMS were independent significant predictors of MACE. Conclusions DES implantation conferred survival benefits in dialysis patients compared with BMS implantation. PMID:26731408

  18. 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.

  19. Implant assisted-magnetic drug targeting: Comparison of in vitro experiments with theory

    NASA Astrophysics Data System (ADS)

    Avilés, Misael O.; Ebner, Armin D.; Ritter, James A.

    Implant assisted-magnetic drug targeting (IA-MDT) was studied both in vitro and theoretically, with extensive comparisons made between model and experiment. Magnetic drug carrier particles (MDCPs) comprised of magnetite encased in a polymer were collected magnetically using a ferromagnetic, coiled, wire stent as the implant and a NdFeB permanent magnet for the applied magnetic field. A 2-D mathematical model with no adjustable parameters was developed and compared to the 3-D experimental results. The effects of the fluid velocity, stent and MDCP properties, and magnetic field strength on the performance of the system were evaluated in terms of the capture efficiency (CE) of the MDCPs. In nearly all cases, the parametric trends predicted by the model were in good agreement with the experimental results: the CE always increased with decreasing velocity, increasing magnetic field strength, increasing MDCP size or magnetite content, or increasing wire size. The only exception was when experiments showed an increase in the CE with an increase in the number of loops in the wire, while the model showed no dependence. The discrepancies between experiment and theory were attributed to phenomena not accounted for by the model, such as 3-D to 2-D geometric and magnetic field orientation differences, and interparticle interactions between the MDCPs that lead to magnetic agglomeration and shearing force effects. Overall, this work showed the effectiveness of a stent-based IA-MDT system through both in vitro experimentation and corroborated theory, with the designs of the ferromagnetic wire and the MDCPs both being paramount to the CE.

  20. Hybrid nanocomposite coatings from metal (Mg alloy)-drug deposited onto medical implant by laser adaptive ablation deposition technique

    NASA Astrophysics Data System (ADS)

    Serbezov, Valery; Sotirov, Sotir; Serbezov, Svetlin

    2013-03-01

    Drug-eluting medical implants are active implants whose function is to create healing effects. The current requirements for active medical coatings for Drug-eluting medical implants are to be biocompatible, biodegradable, polymer free, mechanically stable and enable a controlled release of one or more drugs and defined degradation. This brings hybrid nanocomposite coatings into focus especially in the field of cardiovascular implants. We studied the properties of Metal (Mg alloy)-Paclitaxel coatings obtained by novel Laser Adaptive Ablation Deposition Technique (LAAD) onto cardiovascular stents from 316 LVM stainless steel material. The morphology and topology of coatings were studied by Bright field / Fluorescence optical microscope and Scanning Electron Microscope (SEM). Comparative measurements were made of the morphology and topology of hybrid, polymer free nanocomposite coatings deposited by LAAD and polymerdrug coatings deposited by classical spray technique. The coatings obtained by LAAD are homogeneous without damages and cracks. Metal nanoparticles with sizes from 40 nm to 230 nm were obtained in drug matrixes. Energy Dispersive X-ray Spectroscopy (EDX) was used for identification of metal nanoparticles presence in hybrid nanocomposites coatings. The new technology opens up possibilities to obtain new hybrid nanocomposite coatings with applications in medicine, pharmacy and biochemistry.

  1. Assessment of surface concentrations in resorbable ocular implants: controlled drug delivery devices for 5-fluorouracil (5-FU)

    NASA Astrophysics Data System (ADS)

    Milne, Peter J.; Gautier, Sandrine; Parel, Jean-Marie A.; Jallet, Valerie

    1997-05-01

    The antineoplastic drug 5-fluorouracil (5-fluoro- 2,4,(1H,3H)-pyrimidinedione; 5-FU) has been used to control proliferation of penetrating fibroblasts and to prevent channel closure following glaucoma filtration surgery (trabeculectomy) or laser sclerectomy. Because of the toxicity of the drug, administration of low dosages slowly over time, at the site of the desired treatment, is indicated for optimum efficacy. Repeated injections of low dosages of the drug represent an undesirable intervention and may also result in unwanted toxicity to the corneal epithelium. A suitable biocompatible and resorbable polymer matrix composed of a poly (D,L-lactic-co-glycolic acid: PLGA) has been admixed with varying amounts of 5-FU and cast as shapes suitable for intracorneal implantation. Slow biodegradation of this polymer over a one to two week period has been shown to result in an acceptably slow drug release mechanism. An issue arising during the clinical evaluation of the efficacy of this drug delivery system was how best to quantify the concentration of 5-FU and its distribution spatially in the solid implant. FT-IR and FT-Raman spectroscopies distinguishes between the drug and the polymer matrix and were used to differentiate and quantitate the 5-FU concentration of the implants.

  2. 'Breath figure' PLGA films as implant coatings for controlled drug release

    NASA Astrophysics Data System (ADS)

    Ponnusamy, Thiruselvam

    The breath figure method is a versatile and facile approach of generating ordered micro and nanoporous structures in polymeric materials. When a polymer solution (dissolved in a high vapor pressure organic solvent) is evaporated out in the presence of a moist air stream, the evaporative cooling effect causes the condensation and nucleation of water droplets onto the polymer solution surface. This leads to the formation of an imprinted porous structure upon removal of the residual solvent and water. The facile removal of the water droplet template leaving its structural imprint is a specifically appealing aspect of the breath figure film technology. The first part of the dissertation work involves the fabrication of drug loaded breath figure thin films and its utilization as a controlled drug release carrier and biomaterial scaffold. In a single fabrication step, single layer/multilayer porous thin films were designed and developed by combining the breath figure process and a modified spin or dip coating technique. Using biodegradable polymers such as poly (lactic-co-glycolic acid) (PLGA) and poly (ethylene glycol) (PEG), drug loaded films were fabricated onto FDA approved medical devices (the Glaucoma drainage device and the Surgical hernia mesh). The porosity of the films is in the range of 2-4 microm as characterized by scanning electron microscope. The drug coated medical implants were characterized for their surface and bulk morphology, the degradation rate of the film, drug release rate and cell cytotoxicity. The results suggest that the use of breath figure morphologies in biodegradable polymer films adds an additional level of control to drug release. In comparison to non-porous films, the breath figure films showed an increased degradation and enhanced drug release. Furthermore, the porous nature of the film was investigated as a biomaterial scaffold to construct three dimensional in vitro tissue model systems. The breath figure film with interconnected

  3. Biodegradable nanocomposite magnetite stent for implant-assisted magnetic drug targeting

    NASA Astrophysics Data System (ADS)

    Mangual, Jan O.; Li, Shigeng; Ploehn, Harry J.; Ebner, Armin D.; Ritter, James A.

    2010-10-01

    This study shows, for the first time, the fabrication of a biodegradable polymer nanocomposite magnetic stent and the feasibility of its use in implant-assisted-magnetic drug targeting (IA-MDT). The nanocomposite magnetic stent was made from PLGA, a biodegradable copolymer, and iron oxide nanopowder via melt mixing and extrusion into fibers. Degradation and dynamic mechanical thermal analyses showed that the addition of the iron oxide nanopowder increased the polymer's glass transition temperature ( Tg) and its modulus but had no notable effect on its degradation rate in PBS buffer solution. IA-MDT in vitro experiments were carried out with the nanocomposite magnetic fiber molded into a stent coil. These stent prototypes were used in the presence of a homogeneous magnetic field of 0.3 T to capture 100 nm magnetic drug carrier particles (MDCPs) from an aqueous solution. Increasing the amount of magnetite in the stent nanocomposite (0, 10 and 40 w/w%) resulted in an increase in the MDCP capture efficiency (CE). Reducing the MDCP concentrations (0.75 and 1.5 mg/mL) in the flowing fluid and increasing the fluid velocities (20 and 40 mL/min) both resulted in decrease in the MDCP CE. These results show that the particle capture performance of PLGA-based, magnetic nanocomposite stents are similar to those exhibited by a variety of different non-polymeric magnetic stent materials studied previously.

  4. Implantable drug delivery device using frequency-controlled wireless hydrogel microvalves.

    PubMed

    Rahimi, Somayyeh; Sarraf, Elie H; Wong, Gregory K; Takahata, Kenichi

    2011-04-01

    This paper reports a micromachined drug delivery device that is wirelessly operated using radiofrequency magnetic fields for implant applications. The controlled release from the drug reservoir of the device is achieved with the microvalves of poly(N-isopropylacrylamide) thermoresponsive hydrogel that are actuated with a wireless resonant heater, which is activated only when the field frequency is tuned to the resonant frequency of the heater circuit. The device is constructed by bonding a 1-mm-thick polyimide component with the reservoir cavity to the heater circuit that uses a planar coil with the size of 5-10 mm fabricated on polyimide film, making all the outer surfaces to be polyimide. The release holes created in a reservoir wall are opened/closed by the hydrogel microvalves that are formed inside the reservoir by in-situ photolithography that uses the reservoir wall as a photomask, providing the hydrogel structures self-aligned to the release holes. The wireless heaters exhibit fast and strong response to the field frequency, with a temperature increase of up to 20°C for the heater that has the 34-MHz resonant frequency, achieving 38-% shrinkage of swelled hydrogel when the heater is excited at its resonance. An active frequency range of ~2 MHz is observed for the hydrogel actuation. Detailed characteristics in the fabrication and actuation of the hydrogel microvalves as well as experimental demonstrations of frequency-controlled temporal release are reported. PMID:21161600

  5. Very Late Stent Thrombosis 11 Years after Implantation of a Drug-Eluting Stent

    PubMed Central

    Jepson, Nigel

    2015-01-01

    Very late stent thrombosis is an infrequent yet potentially fatal complication associated with drug-eluting stents. We report the case of an 88-year-old man who sustained an ST-segment-elevation myocardial infarction 11 years after initial sirolimus-eluting stent implantation. Optical coherence tomograms of the lesion showed that the focal incomplete endothelialization of the stent struts was the likely cause; neointimal formation, neoatherosclerosis, and late stent malapposition might also have contributed. To our knowledge, this is the longest reported intervening period between stent insertion and the development of an acute coronary event secondary to very late stent thrombosis. The associated prognostic and therapeutic implications are considerable, because they illuminate the uncertainties surrounding the optimal duration of antiplatelet therapy in patients who have drug-eluting stents. Clinicians face challenges in treating these patients, particularly when competing medical demands necessitate the discontinuation of antiplatelet therapy. In addition to the patient's case, we discuss factors that can contribute to very late stent thrombosis. PMID:26504449

  6. Evaluation of an injectable thermosensitive hydrogel as drug delivery implant for ocular glaucoma surgery.

    PubMed

    Xi, Lei; Wang, Tao; Zhao, Feng; Zheng, Qiongjuan; Li, Xiaoning; Luo, Jing; Liu, Ji; Quan, Daping; Ge, Jian

    2014-01-01

    In this study, a biodegradable thermo-sensitive hydrogel from poly(trimethylene carbonate)15-F127-poly(trimethylene carbonate)15 (PTMC15-F127-PTMC15) was designed and evaluated as an injectable implant during ocular glaucoma filtration surgery in vivo and in vitro. Mitomycin C (MMC) was loaded into this hydrogel for controlled released to prolong the efficacy and to reduce the long-term toxicity. The properties of the hydrogel were confirmed using 1H NMR and gel permeation chromatography (GPC). Compared to the Pluronic F127 hydrogel, the PTMC15-F127-PTMC15 hydrogel showed a good solution-gel transition temperature at 37°C, a lower work concentration of 5% w/v and a longer mass loss time of more than 2 weeks. The in vitro study showed that the drug could be released from PTMC15-F127-PTMC15 (5% w/v) hydrogel for up to 16 days with only 57% of drug released in the first day. Moreover, the cell toxicity, which was tested via LDH and ANNEXIN V/PI, decreased within 72 h in human tenon's fibroblast cells (HTFs). The in vivo behavior in a rabbit glaucoma filtration surgery model indicated that this hydrogel loaded with 0.1 mg/ml MMC led to a better functional bleb with a prolonged mean bleb survival time (25.5±2.9 days). The scar tissue formation, new collagen deposition and myofibroblast generation appeared to be reduced upon histological and immunohistochemistry examinations, with no obvious side effects and inflammatory reactions. The in vitro and in vivo results demonstrated that this novel hydrogel is a safe and effective drug delivery candidate in ocular glaucoma surgery. PMID:24950176

  7. Evaluation of an Injectable Thermosensitive Hydrogel As Drug Delivery Implant for Ocular Glaucoma Surgery

    PubMed Central

    Zhao, Feng; Zheng, Qiongjuan; Li, Xiaoning; Luo, Jing; Liu, Ji; Quan, Daping; Ge, Jian

    2014-01-01

    In this study, a biodegradable thermo-sensitive hydrogel from poly(trimethylene carbonate)15-F127-poly(trimethylene carbonate)15 (PTMC15-F127-PTMC15) was designed and evaluated as an injectable implant during ocular glaucoma filtration surgery in vivo and in vitro. Mitomycin C (MMC) was loaded into this hydrogel for controlled released to prolong the efficacy and to reduce the long-term toxicity. The properties of the hydrogel were confirmed using 1H NMR and gel permeation chromatography (GPC). Compared to the Pluronic F127 hydrogel, the PTMC15-F127-PTMC15 hydrogel showed a good solution-gel transition temperature at 37°C, a lower work concentration of 5% w/v and a longer mass loss time of more than 2 weeks. The in vitro study showed that the drug could be released from PTMC15-F127-PTMC15 (5% w/v) hydrogel for up to 16 days with only 57% of drug released in the first day. Moreover, the cell toxicity, which was tested via LDH and ANNEXIN V/PI, decreased within 72 h in human tenon's fibroblast cells (HTFs). The in vivo behavior in a rabbit glaucoma filtration surgery model indicated that this hydrogel loaded with 0.1 mg/ml MMC led to a better functional bleb with a prolonged mean bleb survival time (25.5±2.9 days). The scar tissue formation, new collagen deposition and myofibroblast generation appeared to be reduced upon histological and immunohistochemistry examinations, with no obvious side effects and inflammatory reactions. The in vitro and in vivo results demonstrated that this novel hydrogel is a safe and effective drug delivery candidate in ocular glaucoma surgery. PMID:24950176

  8. Advanced biopolymer-coated drug-releasing titania nanotubes (TNTs) implants with simultaneously enhanced osteoblast adhesion and antibacterial properties.

    PubMed

    Kumeria, Tushar; Mon, Htwe; Aw, Moom Sinn; Gulati, Karan; Santos, Abel; Griesser, Hans J; Losic, Dusan

    2015-06-01

    Here, we report on the development of advanced biopolymer-coated drug-releasing implants based on titanium (Ti) featuring titania nanotubes (TNTs) on its surface. These TNT arrays were fabricated on the Ti surface by electrochemical anodization, followed by the loading and release of a model antibiotic drug, gentamicin. The osteoblastic adhesion and antibacterial properties of these TNT-Ti samples are significantly improved by loading antibacterial payloads inside the nanotubes and modifying their surface with two biopolymer coatings (PLGA and chitosan). The improved osteoblast adhesion and antibacterial properties of these drug-releasing TNT-Ti samples are confirmed by the adhesion and proliferation studies of osteoblasts and model Gram-positive bacteria (Staphylococcus epidermidis). The adhesion of these cells on TNT-Ti samples is monitored by fluorescence and scanning electron microscopies. Results reveal the ability of these biopolymer-coated drug-releasing TNT-Ti substrates to promote osteoblast adhesion and proliferation, while effectively preventing bacterial colonization by impeding their proliferation and biofilm formation. The proposed approach could overcome inherent problems associated with bacterial infections on Ti-based implants, simultaneously enabling the development of orthopedic implants with enhanced and synergistic antibacterial functionalities and bone cell promotion. PMID:25944564

  9. Therapeutic effect of rotational atherectomy with implantation of drug eluting stent in heavily coronary calcified patients

    PubMed Central

    Wei, Zhong-Hai; Xie, Jun; Wang, Lian; Huang, Wei; Wang, Kun; Kang, Li-Na; Zhang, Jing-Mei; Song, Jie; Xu, Biao

    2016-01-01

    Background Rotational atherectomy (RA) could facilitate the percutaneous coronary intervention (PCI) in heavily coronary calcified patients. The effectiveness and safety of this technique needs to be further evaluated. Methods & Results Eighty patients who underwent RA in our center from September 2011 to June 2014 were enrolled. The mean age was 72.4 ± 10.4 years. The left ventricular ejection fraction (LVEF) was average 52.3% ± 8.48% and the estimated glomerular filtration rate was 73.2 ± 3.20 mL/min per 1.73 m2. The coronary lesions were complex, with Syntax score 29.5 ± 9.86. The diameter of reference vessel was 3.4 ± 0.45 mm and the average diameter stenosis of target vessels was 80% ± 10%. All the patients were deployed with drug eluting stents (DES) successfully after RA. The patients were followed up for 12–18 months. Kaplan-Meier plots estimated the survival rate was 93.4% and the cumulative incidence of major adverse cardiac and cerebral events (MACCE) was 25.4%. Bleeding and procedural-related complications were quite low. COX proportional hazards model for multivariate analysis demonstrated that diabetes, LVEF and maximum pressure of postdilatation were the predictors of MACCE. Conclusions RA followed by implantation of DES was effective and safe for heavily coronary calcified patients. Diabetes, LVEF and maximum pressure of postdilatation were predictive for MACCE. PMID:27103918

  10. Secure wireless actuation of an implanted microvalve for drug delivery applications

    NASA Astrophysics Data System (ADS)

    Tikka, Ajay C.; Faulkner, Michael; Al-Sarawi, Said F.

    2011-10-01

    The capability to wirelessly control fluid flow through a microvalve can emerge as an attractive technology enabling various biomedical applications such as remote drug delivery and in vitro diagnostics. Contactless powering of such a microvalve is best addressed by near-field inductive coupling due to its close proximity to the external interrogator. In this paper, we propose the use of the same technique for secure remote interrogation and powering of a human implantable, surface acoustic wave (SAW) correlation-based, passive microvalve. This is carried out by interrogating the microvalve with a Barker sequence-encoded BPSK signal. A numerical and experimental analysis of the biotelemetry link for the microvalve was undertaken in the vicinity of numerical and physical human body phantoms, respectively. To accurately account for the path losses and to address the design optimization, the receiver coil/antenna was solved simultaneously with the transmitter coil/antenna in the presence of a human body simulant using three-dimensional, high frequency electromagnetic FEM modelling. The received relative signal strength was numerically and experimentally derived for a miniature (6 mm × 6 mm × 0.5 mm), square spiral antenna/coil when interrogated by a handheld 8 cm × 5 cm × 0.2 cm square spiral antenna/coil in the near-field. Finally, the experimental results agreed well with the FEM analysis predictions and hence ascertained the applicability of the developed system for secure interrogation and remote powering of the newly proposed microvalve.

  11. Optical Coherence Tomographic Observation of Morphological Features of Neointimal Tissue after Drug-Eluting Stent Implantation

    PubMed Central

    Lee, Seung-Yul; Shin, Dong-Ho; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo

    2014-01-01

    Purpose The impacts of different time courses and the degree of neointimal growth on neointimal morphology have not yet been sufficiently investigated. Therefore, we evaluated the morphological features of neointimal tissue after drug-eluting stent (DES) implantation using optical coherence tomography (OCT). Materials and Methods The morphological features of neointimal tissue in stented segments with a maximal percentage of cross-sectional area (CSA) stenosis of neointima were evaluated in 507 DES-treated lesions with >100 µm mean neointimal thickness on follow-up OCT. Neointimal tissue was categorized as homogeneous, heterogeneous, layered, or neoatherosclerotic. Results In lesions with <50% of neointimal CSA stenosis, homogeneous neointima (68.2%) was predominant, followed by heterogeneous neointima (14.1%) and layered neointima (14.1%). In lesions with ≥50% of neointimal CSA stenosis, layered neointima was most frequently observed (68.3%), followed by neoatherosclerotic neointima (25.2%). In subgroup analysis of lesions with ≥50% of neointimal CSA stenosis, 89.5% of the lesions with a stent age <30 months were layered neointima, while 62.3% of the lesions with a stent age ≥30 months were neoatherosclerotic neointima. Conclusion This study suggests that the OCT-detected morphology of DES neointimal tissue was different according to the follow-up time course and degree of neointimal hyperplasia. PMID:24954322

  12. Implant-Assisted Intrathecal Magnetic Drug Targeting to Aid in Therapeutic Nanoparticle Localization for Potential Treatment of Central Nervous System Disorders.

    PubMed

    Lueshen, Eric; Venugopal, Indu; Soni, Tejen; Alaraj, Ali; Linninger, Andreas

    2015-02-01

    There is an ongoing struggle to develop efficient drug delivery and targeting methods within the central nervous system. One technique known as intrathecal drug delivery, involves direct drug infusion into the spinal canal and has become standard practice for treating many central nervous system diseases due to reduced systemic toxicity from the drug bypassing the blood-brain barrier. Although intrathecal drug delivery boasts the advantage of reduced systemic toxicity compared to oral and intravenous drug delivery techniques, current intrathecal delivery protocols lack a means of sufficient drug targeting at specific locations of interest within the central nervous system. We previously proposed the method of intrathecal magnetic drug targeting in order to overcome the limited targeting capabilities of standard intrathecal drug delivery protocols, while simultaneously reducing the systemic toxicity as well as the amount of drug required to produce a therapeutic effect. Building off of our previous work, this paper presents the concept of implant-assisted intrathecal magnetic drug targeting. Ferritic stainless steel implants were incorporated within the subarachnoid space of our in vitro human spine model, and the targeting magnet was placed at a physiological distance away from the model and implant to mimic the distance between the epidermis and spinal canal. Computer simulations were performed to optimize implant design for generating high gradient magnetic fields and to study how these fields may aid in therapeutic nanoparticle localization. Experiments aiming to determine the effects of different magnetically-susceptible implants placed within an external magnetic field on the targeting efficiency of gold-coated magnetite nanoparticles were then performed on our in vitro human spine model. Our results indicate that implant-assisted intrathecal magnetic drug targeting is an excellent supplementary technique to further enhance the targeting capabilities of our

  13. An implantable and controlled drug-release silk fibroin nanofibrous matrix to advance the treatment of solid tumour cancers.

    PubMed

    Xie, Maobin; Fan, Dejun; Chen, Yufeng; Zhao, Zheng; He, Xiaowen; Li, Gang; Chen, Aizheng; Wu, Xiaojian; Li, Jiashen; Li, Zhi; Hunt, John A; Li, Yi; Lan, Ping

    2016-10-01

    The development of more effective cancer therapeutic strategies are still critically required. The maximization of the therapeutic effect in combination with avoiding the severe side effects on normal tissues when using chemotherapy drugs is still an urgent problem that requires improvements urgently. Here we provide implantable and controllable drug-release that utilises silk fibroin (SF) as a nanofibrous drug delivery system (DDS) for cancer treatment. A nanofibrous structure with controllable fibre diameter (<100 nm) was produced. The drug release rate of the SF DDS was controlled by applying a post-treatment process. In vitro anti-cancer (HCT116) results indicated that curcumin (CM)-SF nanofibrous matrix had a superior anti-cancer potential when the concentration was >5 μg/mL. The mechanism could be explained by the cell cycle being held in the S phase. The toxic effect on normal cells (NCM460) was minimized by using a treatment concentration range (5-20 μg/mL). Implantation of this DDS into the tumour site inhibited the growth of solid tumour; this offers an alternative approach for novel cancer therapy. PMID:27376557

  14. Implantable intrathecal pumps for the treatment of noncancer chronic pain in elderly population: drug dose and clinical efficacy.

    PubMed

    Raffaeli, William; Righetti, Donatella; Caminiti, Alessandro; Ingardia, Alessandro; Balestri, Marco; Pambianco, Lucia; Fanelli, Guido; Facondini, Francesca; Pantazopoulos, Pantazis

    2008-01-01

    Objective.   This study aims to assess long-term follow-up of efficacy and quality of life for 34 geriatric patients (10 men, 24 women, mean age 72.3 ± 11.6 years) with intrathecal (IT) drug delivery systems (IDDS), implanted between 1994 and 2002, for the treatment of severe noncancer chronic pain. Methods.   Patients equal to or older than 64 years, who had no pain relief after administration of a placebo injection (subcutaneous saline), and who responded positively to an IT trial (morphine and bupivacaine at low doses) with pain relief greater 70% without intolerable adverse effects were included into our study. Clinical assessment forms and questionnaires assessing pain intensity, adverse events, complications, concommitent use of analgesics, and doses of IT drugs administered were filled out by our patients prior to and after IT drug delivery implantation. Results.   Pain intensity was substantially reduced (60%) at three-month follow-up after commencing IT therapy and was consistently reduced at 48-month follow-up. The mean visual analog scale (VAS) value decreased from 8.09 (± 1.25) before implantation to 1.68 (± 0.63) after implantation at 48-month follow-up. This benefit, at 48 months, was achieved using mean low doses of IT morphine and bupivacaine, 1.03 ± 0.61 mg and 1.15 ± 0.58 mg, respectively. Only two out of 34 patients (5.9%) had complications related to the implantation procedure, itself. Side-effects of therapy were reported by 50% of the patients, the most frequent being constipation (34.4%), drowsiness (21.9%), nausea (21.9%), and urinary retention (18.8%). No side-effects of therapy resulted in removal of the IDDS. Conclusion.   The use of IT drug delivery through IDDS for the treatment of non-cancer- and cancer-related pain in geriatric patients is successful. PMID:22150989

  15. 75 FR 20268 - Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Propofol

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-19

    ... Animal Drugs; Change of Sponsor; Propofol AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Intervet, Inc., to Teva Animal...

  16. 77 FR 39390 - Implantation or Injectable Dosage Form New Animal Drugs; Maropitant; Tildipirosin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-03

    ... Form New Animal Drugs; Maropitant; Tildipirosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal...

  17. 77 FR 4226 - Implantation or Injectable Dosage Form New Animal Drugs; Danofloxacin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-27

    ... Animal Drugs; Danofloxacin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA provides for...

  18. Impact of Insulin Resistance on Neointimal Tissue Proliferation after 2nd-Generation Drug-Eluting Stent Implantation

    PubMed Central

    Yaguchi, Isao; Komatsu, Sachiko; Nakahara, Shiro; Kobayashi, Sayuki; Sakai, Yoshihiko; Taguchi, Isao

    2015-01-01

    Percutaneous coronary intervention is established as an effective treatment for patients with ischemic heart disease; in particular, drug-eluting stent implantation is known to suppress in-stent restenosis. Diabetes mellitus is an independent risk factor for restenosis, so reducing insulin resistance is being studied as a new treatment approach. In this prospective study, we sought to clarify the factors associated with in-stent restenosis after percutaneous coronary intervention, and we evaluated the homeostasis model assessment of insulin resistance (HOMA-IR) index as a predictor of restenosis. We enrolled 136 consecutive patients who underwent elective percutaneous coronary intervention at our hospital from February 2010 through April 2013. All were implanted with a 2nd-generation drug-eluting stent. We distributed the patients in accordance with their HOMA-IR index values into insulin-resistant Group P (HOMA-IR, ≥2.5; n=77) and noninsulin-resistant Group N (HOMA-IR, <2.5; n=59). Before and immediately after stenting, we measured reference diameter, minimal lumen diameter, and percentage of stenosis, and after 8 months we measured the last 2 factors and late lumen loss, all by means of quantitative coronary angiography. After 8 months, the mean minimal lumen diameter was smaller in Group P than that in Group N (1.85 ± 1.02 vs 2.37 ± 0.66 mm; P=0.037), and the mean late lumen loss was larger (0.4 ± 0.48 vs 0.16 ± 0.21 mm; P=0.025). These results suggest that insulin resistance affects neointimal tissue proliferation after 2nd-generation drug-eluting stent implantation. PMID:26413014

  19. Black hole restenosis after drug-eluting stent implantation for in-stent restenosis: potential mechanism and optimal strategy.

    PubMed

    Otsuka, Yoritaka; Murata, Takashi; Kono, Michiaki; Imoto, Hiroki; Koyama, Taku; Nakamura, Keita; Kadama, Sunao; Noguchi, Hiroo; Saito, Taro

    2015-09-01

    In-stent restenosis (ISR) has long remained as the major limitation of coronary stenting. The use of drug-eluting stent (DES) reduces the risk of repeat revascularization without an increase of death and myocardial infarction, compared to the standard bare metal stents. DES has also demonstrated markedly to reduce ISR for complex lesions. However, ISR after DES implantation still occurs and optimal treatment for ISR after DES has not been established. Herein, we report 3 cases with black hole restenosis confirmed by intravascular ultrasound at the site of overlapped DES and discuss potential mechanism and optimal strategy for this phenomenon. PMID:24906987

  20. 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.

  1. Longevity and Cost of Implantable Intrathecal Drug Delivery Systems for Chronic Pain Management: A Retrospective Analysis of 365 Patients

    PubMed Central

    Bolash, Robert; Udeh, Belinda; Saweris, Youssef; Guirguis, Maged; Dalton, Jarrod E.; Makarova, Natalya; Mekhail, Nagy

    2016-01-01

    Objectives Intrathecal drug delivery systems represent an important component of interventional strategies for refractory chronic pain syndromes. Continuous intrathecal administration of opioids results in higher subarachnoid drug concentrations, improved pain scores, and less frequent side effects when compared with systemic opioid administration. Substantial costs arise at the time of surgical implantation and at revision for battery depletion or treatment of a complication. Despite current widespread use, the real-world longevity and cost of implanted intrathecal pumps (ITP) has not been fully quantified. Materials and Methods Patients with an ITP implanted at Cleveland Clinic Pain Management Center between January 1998 and December 2012 were included. ITP longevity was calculated as the time between implant and explant for depletion of the system's battery. Using the 2013 fee schedule of the Centers for Medicare & Medicaid Services, the daily cost of having a functioning ITP was calculated. The costs of office visits for pump refills and the cost of intrathecal medications were not included, nor were the possible savings due to decreased utilization of alternate medical services. Results Three hundred sixty-five patients had 559 pumps implanted. Postlaminectomy syndrome was the most common indication (40%). The median system longevity for all pumps was 5.4 years (97.5% confidence interval: [5.0, 5.8]), including pumps extracted prematurely, as well as those that reached the elective replacement interval. The median ITP longevity was 5.9 years (95% confidence interval: [5.6, 6.1]) for pumps explanted for end of battery life. The median system cost per day was $10.46. The median cost per day of pumps explanted for end of battery life was $9.26, versus $44.59 for pumps explanted prematurely due to complications. Conclusions Overall, the cohort experienced an increased incidence of pump-related complications and a device longevity that was within the range of the

  2. Prognostic Value of Plasma Pentraxin-3 Levels in Patients with Stable Coronary Artery Disease after Drug-Eluting Stent Implantation

    PubMed Central

    Haibo, Liu; Xiaofang, Guo; Chunming, Wang; Jie, Yuan; Guozhong, Chen; Limei, Zhang; Yong, Cao; Yu, Fang; Yingchun, Bao; Wangjun, Yu; Junbo, Ge

    2014-01-01

    Pentraxin-3 (PTX3) is an inflammatory marker thought to be more specific to cardiovascular inflammation than C-reactive protein (CRP). Our aim was to assess the prognostic value of PTX3 in patients with stable coronary artery disease (CAD) after drug eluting stent (DES) implantation. Plasma PTX3 levels were measured before percutaneous coronary intervention (PCI) and at 24 h post-PCI in 596 consecutive patients with stable CAD. Patients were followed up for a median of 3 years (range 1–5) for major adverse cardiovascular events (MACEs). We found that the post-PCI plasma PTX3 levels were significantly higher at 24 h after PCI than pre-PCI, patients with MACEs had higher post-PCI PTX3 levels compared with MACEs-free patients, patients with higher post-PCI PTX3 levels (median > 4.384 ng/mL) had a higher risk for MACEs than those with PTX3 < 4.384 ng/mL, and post-PCI PTX3, cTnI, multiple stents, and age but not high-sensitivity CRP (hsCRP) were independently associated with the prevalence of MACEs after DES implantation. The present study shows that post-PCI PTX3 may be a more reliable inflammatory predictor of long-term MACEs in patients with stable CAD undergoing DES implantation than CRP. Measurement of post-PCI PTX3 levels could provide a rationale for risk stratification of patients with stable CAD after DES implantation. PMID:25538378

  3. An Implantable Depot That Can Generate Oxygen in Situ for Overcoming Hypoxia-Induced Resistance to Anticancer Drugs in Chemotherapy.

    PubMed

    Huang, Chieh-Cheng; Chia, Wei-Tso; Chung, Ming-Fan; Lin, Kun-Ju; Hsiao, Chun-Wen; Jin, Chuan; Lim, Woon-Hui; Chen, Chun-Chieh; Sung, Hsing-Wen

    2016-04-27

    In the absence of adequate oxygen, cancer cells that are grown in hypoxic solid tumors resist treatment using antitumor drugs (such as doxorubicin, DOX), owing to their attenuated intracellular production of reactive oxygen species (ROS). Hyperbaric oxygen (HBO) therapy favorably improves oxygen transport to the hypoxic tumor tissues, thereby increasing the sensitivity of tumor cells to DOX. However, the use of HBO with DOX potentiates the ROS-mediated cytotoxicity of the drug toward normal tissues. In this work, we hypothesize that regional oxygen treatment by an implanted oxygen-generating depot may enhance the cytotoxicity of DOX against malignant tissues in a highly site-specific manner, without raising systemic oxygen levels. Upon implantation close to the tumor, the oxygen-generating depot reacts with the interstitial medium to produce oxygen in situ, effectively shrinking the hypoxic regions in the tumor tissues. Increasing the local availability of oxygen causes the cytotoxicity of DOX that is accumulated in the tumors to be significantly enhanced by the elevated production of ROS, ultimately allaying the hypoxia-induced DOX resistance in solid malignancies. Importantly, this enhancement of cytotoxicity is limited to the site of the tumors, and this feature of the system that is proposed herein is unique. PMID:27075956

  4. Cutting-balloon angioplasty before drug-eluting stent implantation for the treatment of severely calcified coronary lesions

    PubMed Central

    Tang, Zhe; Bai, Jing; Su, Shao-Ping; Wang, Yu; Liu, Mo-Han; Bai, Qi-Cai; Tian, Jin-Wen; Xue, Qiao; Gao, Lei; An, Chun-Xiu; Liu, Xiao-Juan

    2014-01-01

    Background Severely calcified coronary lesions respond poorly to balloon angioplasty, resulting in incomplete and asymmetrical stent expansion. Therefore, adequate plaque modification prior to drug-eluting stent (DES) implantation is the key for calcified lesion treatment. This study was to evaluate the safety and efficacy of cutting balloon angioplasty for severely calcified coronary lesions. Methods Ninety-two consecutive patients with severely calcified lesions (defined as calcium arc ≥ 180° calcium length ratio ≥ 0.5) treated with balloon dilatation before DES implantation were randomly divided into two groups based on the balloon type: 45 patients in the conventional balloon angioplasty (BA) group and 47 patients in the cutting balloon angioplasty (CB) group. Seven cases in BA group did not satisfactorily achieve dilatation and were transferred into the CB group. Intravascular ultrasound (IVUS) was performed before balloon dilatation and after stent implantation to obtain qualitative and quantitative lesion characteristics and evaluate the stent, including minimum lumen cross-sectional area (CSA), calcified arc and length, minimum stent CSA, stent apposition, stent symmetry, stent expansion, vessel dissection, and branch vessel jail. In-hospital, 1-month, and 6-month major adverse cardiac events (MACE) were reported. Results There were no statistical differences in clinical characteristics between the two groups, including calcium arc (222.2° ± 22.2° vs. 235.0° ± 22.1°, P = 0.570), calcium length ratio (0.67 ± 0.06 vs. 0.77 ± 0.05, P = 0.130), and minimum lumen CSA before PCI (2.59 ± 0.08 mm2 vs. 2.52 ± 0.08 mm2, P = 0.550). After stent implantation, the final minimum stent CSA (6.26 ± 0.40 mm2 vs. 5.03 ± 0.33 mm2; P = 0.031) and acute lumen gain (3.74 ± 0.38 mm2 vs. 2.44 ± 0.29 mm2, P = 0.015) were significantly larger in the CB group than that of the BA group. There were not statistically differences in stent expansion, stent symmetry

  5. Everolimus-induced Pneumonitis after Drug-eluting Stent Implantation: A Case Report

    SciTech Connect

    Sakamoto, Susumu Kikuchi, Naoshi; Ichikawa, Atsuo; Sano, Go; Satoh, Keita; Sugino, Keishi; Isobe, Kazutoshi; Takai, Yujiro; Shibuya, Kazutoshi; Homma, Sakae

    2013-08-01

    Despite the wide use of everolimus as an antineoplastic coating agent for coronary stents to reduce the rate of restenosis, little is known about the health hazards of everolimus-eluting stents (EES). We describe a case of pneumonitis that developed 2 months after EES implantation for angina. Lung pathology demonstrated an organizing pneumonia pattern that responded to corticosteroid therapy. Although the efficacy of EES for ischemic heart disease is well established, EES carries a risk of pneumonitis.

  6. Three-dimensional printing of drug-eluting implants: preparation of an antimicrobial polylactide feedstock material.

    PubMed

    Water, Jorrit Jeroen; Bohr, Adam; Boetker, Johan; Aho, Johanna; Sandler, Niklas; Nielsen, Hanne Mørck; Rantanen, Jukka

    2015-03-01

    The aim of the present work was to investigate the potential of three-dimensional (3D) printing as a manufacturing method for products intended for personalized treatments by exploring the production of novel polylactide-based feedstock materials for 3D printing purposes. Nitrofurantoin (NF) and hydroxyapatite (HA) were successfully mixed and extruded with up to 30% drug load with and without addition of 5% HA in polylactide strands, which were subsequently 3D-printed into model disc geometries (10 × 2 mm). X-ray powder diffraction analysis showed that NF maintained its anhydrate solid form during the processing. Release of NF from the disks was dependent on the drug loading in a concentration-dependent manner as a higher level of released drug was observed from disks with higher drug loads. Disks with 30% drug loading were able to prevent surface-associated and planktonic growth of Staphylococcus aureus over a period of 7 days. At 10% drug loading, the disks did not inhibit planktonic growth, but still inhibited surface-associated growth. Elemental analysis indicated the presence of microdomains of solid drug supporting the observed slow and partial drug release. This work demonstrates the potential of custom-made, drug-loaded feedstock materials for 3D printing of pharmaceutical products for controlled release. PMID:25640314

  7. Antibiotic-loaded chitosan-Laponite films for local drug delivery by titanium implants: cell proliferation and drug release studies.

    PubMed

    Ordikhani, Farideh; Dehghani, Mehdi; Simchi, Arash

    2015-12-01

    In this study, chitosan-Laponite nanocomposite coatings with bone regenerative potential and controlled drug-release capacity are prepared by electrophoretic deposition technique. The controlled release of a glycopeptide drug, i.e. vancomycin, is attained by the intercalation of the polymer and drug macromolecules into silicate galleries. Fourier-transform infrared spectrometry reveals electrostatic interactions between the charged structure of clay and the amine and hydroxyl groups of chitosan and vancomycin, leading to a complex positively-charged system with high electrophoretic mobility. By applying electric field the charged particles are deposited on the surface of titanium foils and uniform chitosan films containing 25-55 wt% Laponite and 937-1655 µg/cm(2) vancomycin are obtained. Nanocomposite films exhibit improved cell attachment with higher cell viability. Alkaline phosphatase assay reveals enhanced cell proliferation due the gradual dissolution of Laponite particles into the culture medium. In-vitro drug-release studies show lower release rate through a longer period for the nanocomposite compared to pristine chitosan. PMID:26507202

  8. Intracranial biodegradable silica-based nimodipine drug release implant for treating vasospasm in subarachnoid hemorrhage in an experimental healthy pig and dog model.

    PubMed

    Koskimäki, Janne; Tarkia, Miikka; Ahtola-Sätilä, Tuula; Saloranta, Lasse; Simola, Outi; Forsback, Ari-Pekka; Laakso, Aki; Frantzén, Janek

    2015-01-01

    Nimodipine is a widely used medication for treating delayed cerebral ischemia (DCI) after subarachnoid hemorrhage. When administrated orally or intravenously, systemic hypotension is an undesirable side effect. Intracranial subarachnoid delivery of nimodipine during aneurysm clipping may be more efficient way of preventing vasospasm and DCI due to higher concentration of nimodipine in cerebrospinal fluid (CSF). The risk of systemic hypotension may also be decreased with intracranial delivery. We used animal models to evaluate the feasibility of surgically implanting a silica-based nimodipine releasing implant into the subarachnoid space through a frontotemporal craniotomy. Concentrations of released nimodipine were measured from plasma samples and CSF samples. Implant degradation was followed using CT imaging. After completing the recovery period, full histological examination was performed on the brain and meninges. The in vitro characteristics of the implant were determined. Our results show that the biodegradable silica-based implant can be used for an intracranial drug delivery system and no major histopathological foreign body reactions were observed. CT imaging is a feasible method for determining the degradation of silica implants in vivo. The sustained release profiles of nimodipine in CSF were achieved. Compared to a traditional treatment, higher nimodipine CSF/plasma ratios can be obtained with the implant. PMID:25685803

  9. Powering an Implantable Minipump with a Multi-layered Printed Circuit Coil for Drug Infusion Applications in Rodents

    PubMed Central

    Givrad, Tina K.; Maarek, Jean-Michel I.; Moore, William H.; Holschneider, Daniel P.

    2014-01-01

    We report the use of a multi-layer printed coil circuit for powering (36–94 mW) an implantable microbolus infusion pump (MIP) that can be activated remotely for use in drug infusion in nontethered, freely moving small animals. This implantable device provides a unique experimental tool with applications in the fields of animal behavior, pharmacology, physiology, and functional brain imaging. Two different designs are described: a battery-less pump usable when the animal is inside a home-cage surrounded by a primary inductive coil and a pump powered by a rechargeable battery that can be used for studies outside the homecage. The use of printed coils for powering of small devices by inductive power transfer presents significant advantages over similar approaches using hand-wound coils in terms of ease of manufacturing and uniformity of design. The high efficiency of a class-E oscillator allowed powering of the minipumps without the need for close physical contact of the primary and secondary coils, as is currently the case for most devices powered by inductive power transfer. PMID:20033778

  10. Experimental study of PLLA/INH slow release implant fabricated by three dimensional printing technique and drug release characteristics in vitro

    PubMed Central

    2014-01-01

    Background Local slow release implant provided long term and stable drug release in the lesion. The objective of this study was to fabricate biodegradable slow release INH/PLLA tablet via 3 dimensional printing technique (3DP) and to compare the drug release characteristics of three different structured tablets in vitro. Methods Three different drug delivery systems (columnar-shaped tablet (CST), doughnut-shaped tablet (DST) and multilayer doughnut-shaped tablet (MDST)) were manufactured by the three dimensional printing machine and isoniazid was loaded into the implant. Dynamic soaking method was used to study the drug release characteristics of the three implants. MTT cytotoxicity test and direct contact test were utilized to study the biocompatibility of the implant. The microstructures of the implants’ surfaces were observed with electron microscope. Results The PLLA powder in the tablet could be excellently combined through 3DP without disintegration. Electron microscope observations showed that INH distributed evenly on the surface of the tablet in a “nest-shaped” way, while the surface of the barrier layer in the multilayer doughnut shaped tablet was compact and did not contain INH. The concentration of INH in all of the three tablets were still higher than the effective bacteriostasis concentration (Isoniazid: 0.025 ~ 0.05 μg/ml) after 30 day’s release in vitro. All of the tablets showed initial burst release of the INH in the early period. Drug concentration of MDST became stable and had little fluctuation starting from the 6th day of the release. Drug concentration of DST and CST decreased gradually and the rate of decrease in concentration was faster in DST than CST. MTT cytotoxicity test and direct contact test indicated that the INH-PLLA tablet had low cytotoxicity and favorable biocompatibility. Conclusions Three dimensional printing technique was a reliable technique to fabricate complicated implants. Drug release pattern in MDST was

  11. Vancomycin-chitosan composite deposited on post porous hydroxyapatite coated Ti6Al4V implant for drug controlled release.

    PubMed

    Yang, Chi-Chuan; Lin, Chien-Chung; Liao, Jiunn-Wang; Yen, Shiow-Kang

    2013-05-01

    Through the hydrogen bonds and the deprotonation, the vancomycin-chitosan composite has been originally deposited on Ti4Al4V by electrochemical technology. However, the rapid destruction of the hydrogen bonding between them by polar water molecules during immersion tests revealed 80% drug burst in a few hours. In this study, the post porous hydroxyapatite (HA) coated Ti4Al4V is prepared for the subsequent electrolytic deposition of vancomycin-chitosan composite to control the drug release. As expected, the initial burst is reduced to 55%, followed by a steady release about 20% from day 1 to day 5 and a slower release of the retained 25% after day 6, resulting in bacterial inhibition zone diameter of 30 mm which can last for more than a month in antibacterial tests, compared with the coated specimen without HA gradually loosing inhibition zone after 21 days. Besides, the cell culture indicates that the vancomycin-chitosan/HA composite coated has enhanced the proliferation, the differentiation and the mineralization of the osteoblast-like cell. In general, it is helpful for the osteointegration on permanent implants. Consistently, it effectively provides the prophylaxis and therapy of osteomyelitis according to the results of the rabbit infection animal model. PMID:23498249

  12. Valproic acid pharmacokinetics in the mouse following controlled-release of pharmacologic and toxic doses via novel implantable and refillable drug reservoirs.

    PubMed

    Nau, H; Finley, P; Williams, J; Brendel, K

    1983-01-01

    Novel drug reservoirs are described which, after their implantation under mouse skin, continuously released organic liquids such as the anti-epileptic drug valproic acid at preselected rates for periods up to several weeks. The liquids, which were filled into the reservoirs, diffused through silastic membranes. The area and thickness of these membranes determined the administered dose. Administration of the anti-epileptic drug valproic acid at various selected doses resulted in persistent drug concentrations spanning from subtherapeutic to toxic levels. The drug reservoirs were easily refillable in situ which greatly extended the duration of the experiment. The dose administered could be determined within 5-15 per cent (rel. S.D.). It is suggested that the maintenance of persistent drug levels in small laboratory animals may be an appropriate model for the pharmacological and toxicological study of those compounds with short half-lives and high clearance rates in these species. PMID:6411139

  13. Gastroenterology and urology devices; effective date of requirement for premarket approval of the implanted mechanical/hydraulic urinary continence device. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-09-26

    The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the implanted mechanical/hydraulic urinary continence device, a generic type of medical device intended for the treatment of urinary incontinence. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997. PMID:11503643

  14. Long-term experience with implanted intrathecal drug administration systems for failed back syndrome and chronic mechanical low back pain

    PubMed Central

    Raphael, JH; Southall, JL; Gnanadurai, TV; Treharne, GJ; Kitas, GD

    2002-01-01

    Background Continuous intrathecal drug delivery has been shown in open studies to improve pain and quality of life in those with intractable back pain who have had spinal surgery. There is limited data on long term effects and and even less for patients with mechanical back pain without prior spinal surgery. Methods We have investigated spinal drug administration systems for patients with failed back syndrome and chronic mechanical low back pain by patient questionnaire study of the efficacy of this therapy and a case notes review. Results 36 patients (97% of 37 approached) completed questionnaires, 24 with failed back syndrome and 12 with chronic mechanical low back pain. Recalled pre-treatment levels with current post-treatment levels of pain and a range of quality of life measures (recorded on 11-point numerical rating scales) were compared. Pain improved significantly in both groups (Wilcoxan signed ranks test, p < 0.005). The majority of quality of life measures improved significantly in the failed back syndrome group (Wilcoxan signed ranks test, p < 0.005) although work interruption and the effect of pain on sex life did not change. There was a trend towards improvement in the majority of quality of life measures in the mechanical back pain group but this did not reach statistical significance due to the smaller numbers in this cohort (p > 0.005, Wilcoxan signed ranks test with Bonferroni correction). Diamorphine was used in all 37 patients, bupivacaine in 32, clonidine in 27 and baclofen in 3. The mean dose of diamorphine increased for the first 2 years but did not change 2–6 years post implant, averaging 4.5 mg/day. Revision surgery was required in 24% of cases, but reduced to 12% in the later years of our experience. Conclusions We conclude that spinal drug administration systems appear to be of benefit in alleviating pain in the failed back syndrome and chronic mechanical low back pain but need to be examined prospectively. PMID:12076357

  15. Aspiration Thrombectomy and Drug-Eluting Stent Implantation Decrease the Occurrence of Angina Pectoris One Year After Acute Myocardial Infarction.

    PubMed

    Lee, Wei-Chieh; Fang, Chih-Yuan; Chen, Huang-Chung; Hsueh, Shu-Kai; Chen, Chien-Jen; Yang, Cheng-Hsu; Yip, Hon-Kan; Hang, Chi-Ling; Wu, Chiung-Jen; Fang, Hsiu-Yu

    2016-04-01

    Angina pectoris is a treatable symptom that is associated with mortality and decreased quality of life. Angina eradication is a primary care goal of care after an acute myocardial infarction (AMI). Our aim was to evaluate factors influencing angina pectoris 1 year after an AMI.From January 2005 to December 2013, 1547 patient received primary percutaneous intervention in our hospital for an acute ST-segment elevation myocardial infarction (MI). Of these patients, 1336 patients did not experience post-MI angina during a 1-year follow-up, and 211 patients did. Univariate and multivariate logistic regression analyses were performed to identify the factors influencing angina pectoris 1 year after an AMI. Propensity score matched analyses were performed for subgroups analyses.The average age of the patients was 61.08 ± 12.77 years, with a range of 25 to 97 years, and 82.9% of the patients were male. During 1-year follow-up, 13.6% of the patients experienced post-MI angina. There was a longer chest pain-to-reperfusion time in the post-MI angina group (P = 0.01), as well as a higher fasting sugar level, glycohemoglobin (HbA1C), serum creatinine, troponin-I and creatine kinase MB (CK-MB). The post-MI angina group also had a higher prevalence of multiple-vessel disease. Manual thrombectomy, and distal protective device and intracoronary glycoprotein IIb/IIIa inhibitor injection were used frequently in the no post-MI angina group. Antiplatelet agents and post-MI medication usage were similar between the 2 groups. Multivariate logistic regression analyses demonstrated that prior MI was a positive independent predictor of occurrence of post-MI angina. Manual thrombectomy use and drug-eluting stent implantation were negative independent predictors of post-MI angina. Higher troponin-I and longer chest pain-to-reperfusion time exhibited a trend toward predicting post-MI angina.Prior MIs were strong, independent predictors of post-MI angina. Manual thrombectomy and drug

  16. Aspiration Thrombectomy and Drug-Eluting Stent Implantation Decrease the Occurrence of Angina Pectoris One Year After Acute Myocardial Infarction

    PubMed Central

    Lee, Wei-Chieh; Fang, Chih-Yuan; Chen, Huang-Chung; Hsueh, Shu-Kai; Chen, Chien-Jen; Yang, Cheng-Hsu; Yip, Hon-Kan; Hang, Chi-Ling; Wu, Chiung-Jen; Fang, Hsiu-Yu

    2016-01-01

    Abstract Angina pectoris is a treatable symptom that is associated with mortality and decreased quality of life. Angina eradication is a primary care goal of care after an acute myocardial infarction (AMI). Our aim was to evaluate factors influencing angina pectoris 1 year after an AMI. From January 2005 to December 2013, 1547 patient received primary percutaneous intervention in our hospital for an acute ST-segment elevation myocardial infarction (MI). Of these patients, 1336 patients did not experience post-MI angina during a 1-year follow-up, and 211 patients did. Univariate and multivariate logistic regression analyses were performed to identify the factors influencing angina pectoris 1 year after an AMI. Propensity score matched analyses were performed for subgroups analyses. The average age of the patients was 61.08 ± 12.77 years, with a range of 25 to 97 years, and 82.9% of the patients were male. During 1-year follow-up, 13.6% of the patients experienced post-MI angina. There was a longer chest pain-to-reperfusion time in the post-MI angina group (P = 0.01), as well as a higher fasting sugar level, glycohemoglobin (HbA1C), serum creatinine, troponin-I and creatine kinase MB (CK-MB). The post-MI angina group also had a higher prevalence of multiple-vessel disease. Manual thrombectomy, and distal protective device and intracoronary glycoprotein IIb/IIIa inhibitor injection were used frequently in the no post-MI angina group. Antiplatelet agents and post-MI medication usage were similar between the 2 groups. Multivariate logistic regression analyses demonstrated that prior MI was a positive independent predictor of occurrence of post-MI angina. Manual thrombectomy use and drug-eluting stent implantation were negative independent predictors of post-MI angina. Higher troponin-I and longer chest pain-to-reperfusion time exhibited a trend toward predicting post-MI angina. Prior MIs were strong, independent predictors of post-MI angina. Manual thrombectomy

  17. New drug-eluting lenses to be applied as bandages after keratoprosthesis implantation.

    PubMed

    Carreira, A S; Ferreira, P; Ribeiro, M P; Correia, T R; Coutinho, P; Correia, I J; Gil, M H

    2014-12-30

    Corneal tissue is the most commonly transplanted tissue worldwide. This work aimed to develop a new drug-eluting contact lens that may be used as a bandage after keratoprosthesis. During this work, films were produced using poly(vinyl alcohol) (PVA) and chitosan (CS) crosslinked with glyoxal (GL). Vancomycin chlorhydrate (VA) was impregnated in these systems by soaking. Attenuated total reflectance - Fourier transform infrared spectroscopy was used to confirm crosslinking. The cytotoxic and drug release profile, hydrophilicity, thermal and biodegradation as well as swelling capacity of the samples were assessed through in vitro studies. PVA and PVA/CS films were obtained by crosslinking with GL. The films were transparent, flexible with smooth surfaces, hydrophilic and able to load and release vancomycin for more than 8h. Biodegradation in artificial lachrymal fluid (ALF) with lysozyme at 37°C showed that mass loss was higher for the samples containing CS. Also, the samples prepared with CS showed the formation of pores which were visualized by SEM. All samples revealed a biocompatible character after 24h in contact with cornea endothelial cells. As a general conclusion it was possible to determine that the 70PVA/30CS film showed to combine the necessary features to prepare vancomycin-eluting contact lenses to prevent inflammation after corneal substitution. PMID:25455772

  18. Low-Power, Low-Voltage Electroosmotic Actuator for an Implantable Micropumping System Intended for Drug Delivery Applications

    NASA Astrophysics Data System (ADS)

    Getpreecharsawas, Jirachai

    An electroosmotic (EO) actuator offers a low-power, low-voltage alternative in a diaphragm-based periodic displacement micropump intended for an implantable drug delivery system. The actuator utilizes an electroosmosis mechanism to transport liquid across a membrane to deflect the pumping diaphragms in a reciprocating manner. In the study, the membrane made of porous nanocrystalline silicon (pnc-Si) tens of nanometers in thickness was used as the promising EO generator with low power consumption and small package size. This ultrathin membrane provides the opportunity for electrode integration such that the very high electric field can be generated across the membrane with the applied potential under 1 volt for low flow rate applications like drug delivery. Due to such a low applied voltage, the challenge, however, imposes on the capability of generating the pumping pressure high enough to deflect the pumping diaphragms and overcome the back pressure normally encountered in the biological tissue and organ. This research identified the cause of weak pumping pressure that the electric field inside the orifice-like nanopores of the ultrathin membrane is weaker than conventional theory would predict. It no longer scales uniformly with the thickness of membrane, but with the pore length-to-diameter aspect ratio for each nanopore. To enhance the pumping performance, the pnc-Si membrane was coated with an ultrathin Nafion film. As a result, the induced concentration difference across the Nafion film generates the osmotic pressure against the back pressure allowing the EO actuator to maintain the target pumping flow rate under 1 volt.

  19. The use of bivalirudin to prevent subacute thrombosis during drug-eluting stent implantation.

    PubMed

    Medina, Roberto P; Foto, Denise

    2004-05-01

    Subacute thrombosis is an infrequent but potentially life-threatening complication of percutaneous coronary intervention (PCI) that has received much attention in association with drug-eluting stent (DES) deployment. We performed a retrospective case record review of 186 patients receiving PCI with DES placement at our facility. Patients received either bivalirudin (n=115) or heparin (n=71) as the foundation anticoagulant, with additional antiplatelet therapy as warranted. Two subacute thrombosis complications occurred and are described in detail. There were no deaths, major bleeding episodes or other significant complications. We report our findings and conclude that the addition of a glycoprotein IIb/IIIa inhibitor does not eliminate the risk of subacute thrombosis and that bivalirudin appears to provide effective anticoagulation for patients undergoing PCI with placement of a DES. PMID:15152125

  20. Influence of proximal drug eluting stent (DES) on distal bare metal stent (BMS) in multi-stent implantation strategies in coronary arteries.

    PubMed

    Sun, Anqiang; Wang, Zhenze; Fan, Zhenmin; Tian, Xiaopeng; Zhan, Fan; Deng, Xiaoyan; Liu, Xiao

    2015-09-01

    The aim of this study was to investigate the drug distribution in arteries treated with DES-BMS stenting strategy and to analyze the influence of proximal DES on distal segments of BMS. A straight artery model (Straight Model) and a branching artery model (Branching Model) were constructed in this study. In each model, the DES was implanted at the proximal position and the BMS was implanted distally. Hemodynamic environments, drug delivery and distribution features were simulated and analyzed in each model. The results showed that blood flow would contribute to non-uniform drug distribution in arteries. In the Straight Model the proximal DES would cause drug concentration in BMS segments. While in the Branching Model the DES in the main artery has slight influence on the BMS segments in the branch artery. In conclusion, due to the blood flow washing effect the uniformly released drug from DES would distribute focally and distally. The proximal DES would have greater influence on the distal BMS in straight artery than that in branching artery. This preliminary study would provide good reference for atherosclerosis treatment, especially for some complex cases, like coronary branching stenting. PMID:26149391

  1. Coronary Artery Bypass Grafting Versus Drug-Eluting Stents Implantation for Previous Myocardial Infarction.

    PubMed

    Chang, Mineok; Lee, Cheol Whan; Ahn, Jung-Min; Cavalcante, Rafael; Sotomi, Yohei; Onuma, Yoshinobu; Zeng, Yaping; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Serruys, Patrick W; Park, Seung-Jung

    2016-07-01

    Patients with previous myocardial infarction (MI) have a high risk of recurrence. Little is known about the effectiveness of coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in patients with a previous MI and left main or multivessel coronary artery disease (CAD). We compared long-term outcomes of these 2 strategies in 672 patients with previous MI and left main or multivessel CAD, who underwent CABG (n = 349) or PCI with DES (n = 323). A pooled database from the BEST, PRECOMBAT, and SYNTAX trials was analyzed, and the primary outcome was a composite of death from any causes, MI, or stroke. Baseline characteristics were similar between the 2 groups. The median follow-up duration was 59.8 months. The rate of the primary outcome was significantly lower with CABG than PCI (hazard ratio [HR] 0.59, 95% CI 0.42 to 0.82; p = 0.002). This difference was driven by a marked reduction in the rate of MI (HR 0.29, 95% CI 0.16 to 0.55, p <0.001). The benefit of CABG over PCI was consistent across all major subgroups. The individual risks of death from any causes or stroke were comparable between the 2 groups. Conversely, the rate of repeat revascularization was significantly lower with CABG than PCI (HR 0.34, 95% CI 0.22 to 0.51, p <0.001). In conclusion, in the patients with previous MI and left main or multivessel CAD, compared to PCI with DES, CABG significantly reduces the risk of death from any causes, MI, or stroke. PMID:27181565

  2. Efficacy and safety of antiplatelet-combination therapy after drug-eluting stent implantation

    PubMed Central

    Cho, Yun-Kyeong; Park, Hyoung-Seob; Yoon, Hyuck-Jun; Kim, Hyungseop; Hur, Seung-Ho; Kim, Yoon-Nyun; Lee, Jang-Hoon; Yang, Dong-Heon; Lee, Bong-Ryeol; Jung, Byung-Chun; Kim, Woong; Park, Jong-Seon; Lee, Jin-Bae; Kim, Kee-Sik; Kim, Kwon-Bae

    2014-01-01

    Background/Aims Combination single-pill therapy can improve cost-effectiveness in a typical medical therapy. However, there is a little evidence about the efficacy and tolerability of combination single-pill antiplatelet therapy after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Methods From June to November 2012, in total, 142 patients who met the following criteria were enrolled: at least 18 years old; successful PCI with DES at least 3 months earlier; and regular medication of aspirin and clopidogrel with no side effects. After VerifyNow P2Y12 and aspirin assays, the combination single pill of aspirin and clopidogrel was given and laboratory tests were repeated 6 weeks later. Results At baseline, the incidence of aspirin resistance, defined as aspirin reaction unit (ARU) ≥ 550, was 9.2%, that of clopidogrel resistance, defined as P2Y12 reaction unit (PRU) ≥ 230, was 46.5%, and that of percent inhibition of PRU < 20% was 32.4%. At follow-up, the incidence of resistance by ARU value was 7.0%, 50.0% by PRU value, and 35.9% by percentage inhibition of PRU, respectively. The mean values of ARU (431.5 ± 63.6 vs. 439.8 ± 55.2; p = 0.216) and PRU (227.5 ± 71.4 vs. 223.3 ± 76.0; p = 0.350) were not significantly different before versus after antiplatelet-combination single-pill therapy. Five adverse events (3.5%) were observed during the study period. Conclusions Combination single-pill antiplatelet therapy, which may reduce daily pill burden for patients after PCI with DES, demonstrated similar efficacy to separate dual-pill antiplatelet therapy. PMID:24648804

  3. Effect of Neurohormonal Blockade Drug Therapy on Outcomes and Left Ventricular Function and Structure After Left Ventricular Assist Device Implantation.

    PubMed

    Grupper, Avishay; Zhao, Yanjun M; Sajgalik, Pavol; Joyce, Lyle D; Park, Soon J; Pereira, Naveen L; Stulak, John M; Burnett, John C; Edwards, Brooks S; Daly, Richard C; Kushwaha, Sudhir S; Schirger, John A

    2016-06-01

    Neurohormonal blockade drug therapy (NHBDT) is the cornerstone therapy in heart failure (HF) management for promoting reverse cardiac remodeling and improving outcomes. It's utility in left ventricular assist device (LVAD) supported patients remains undefined. Sixty-four patients who received continuous flow LVAD at our institution were retrospectively reviewed and divided into 2 groups: no-NHBDT group (n = 33) received LVAD support only and NHBDT group (n = 31) received concurrent NHBDT based on the clinical judgment of the attending physicians. Cardiac remodeling (echocardiographic parameters and biomarkers) and clinical outcome (functional status, HF-related hospital readmissions, and mortality) data were collected. A statistically significant increase in ejection fraction, decrease in LV end-diastolic diameter index and LV mass index, and a sustained reduction in N-terminal pro B-type natriuretic peptide (NTproBNP) were observed in the NHBDT group at 6 months after LVAD implant (p <0.05). NHBDT-treated patients experienced significantly greater improvement in New York Heart Association functional classification and 6-minute-walk distance throughout the study. The combined end point of cardiovascular death or HF hospitalization was significantly reduced in patients receiving NHBDT (p = 0.013) associated primarily with a 12.1% absolute reduction in HF-related hospitalizations (p = 0.046). In conclusion, NHBDT in LVAD-supported patients is associated with a significant reversal in adverse cardiac remodeling and a reduction in morbidity and mortality compared with LVAD support alone. PMID:27079215

  4. Duration of dual antiplatelet therapy after drug-eluting stent implantation: Meta-analysis of large randomised controlled trials

    PubMed Central

    Tsoi, Man-Fung; Cheung, Ching-Lung; Cheung, Tommy Tsang; Wong, Ian Chi-Kei; Kumana, Cyrus Rustam; Tse, Hung-Fat; Cheung, Bernard Man-Yung

    2015-01-01

    Patients receive dual antiplatelet therapy (DAPT) for 6–12 months after drug-eluting stents (DES) implantation. The efficacy and safety of prolonged DAPT has been questioned. Therefore, we performed a meta-analysis on randomised trials comparing different DAPT durations. Literature was searched on trials comparing different DAPT durations. For inclusion, reports must report frequency of cardiovascular and bleeding events. Ten trials were included. Compared to 12 months, DAPT beyond 12 months was associated with fewer myocardial infarctions (OR 0.58 95%CI: 0.40–0.84) and stent thrombosis (OR 0.35 95%CI: 0.20–0.62), but more major bleeds (OR 1.60 95%CI: 1.22–2.11) and all-cause (OR 1.30 95%CI: 1.02–1.66) mortality. There was no significant alteration in risk of stroke (OR 0.93 95%CI: 0.66–1.31) or cardiac (OR 1.12 95%CI: 0.73–1.71) mortality. Compared to less than 12 months DAPT, 12 months DAPT did not reduce risk of myocardial infarction, stent thrombosis, strokes, cardiac or all-cause mortality, but increased the risk of major bleeds (OR 1.60 95%CI: 1.22–2.11). DAPT beyond 12 months reduce risk of myocardial infarction and stent thrombosis, but there is substantial increase in major bleeding risk and all-cause mortality which need to be addressed. DAPT beyond 12 months does not appear to alter the risk of stroke. PMID:26278959

  5. Percutaneous Coronary Intervention Rates and Associated Independent Predictors for Progression of Nontarget Lesions in Patients With Diabetes Mellitus After Drug-Eluting Stent Implantation.

    PubMed

    Wang, Le; Zhou, Yujie; Peng, Pingan; Xu, Xiaohan; Yang, Shiwei; Liu, Wei; Han, Hongya; Jia, Dean; Wang, Jianlong; Ji, Qingwei; Ge, Hailong; Liu, Yuyang; Shi, Dongmei; Zhao, Yingxin

    2016-01-01

    Little is known about clinically driven percutaneous coronary intervention (PCI) rates and predictors for progression of nontarget lesions in diabetic patients who have undergone drug-eluting stent (DES) implantation. We retrospectively analyzed the clinical and angiographic data of 2187 diabetic patients undergoing DES implantation. The cumulative rate of nontarget lesion PCI was 6.3% at 1 year, 14.3% at 2 years, and 19.8% at 3 years. The independent predictors of need for clinically driven PCI in patients with diabetes mellitus after DES implantation included obesity (odds ratio [OR] 2.303, 95% confidence interval [CI] 1.657-3.199, P < .001), low levels of high-density lipoprotein cholesterol (OR 1.412, 95% CI 1.114-1.789, P = .004), statin use (OR 0.669, 95% CI 0.454-0.986, P = .042), insulin use (OR 1.310, 95% CI 1.030-1.665, P = .027), and Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score (OR 1.061, 95% CI 1.045-1.077, P < .001) at baseline PCI. These findings may facilitate prediction of the risk of repeat revascularization and improve repeat revascularization rates in diabetic patients after DES implantation. PMID:25897149

  6. Treatment of Refractory Postdural Puncture Headache after Intrathecal Drug Delivery System Implantation with Epidural Blood Patch Procedures: A 20-Year Experience.

    PubMed

    Bendel, Markus A; Moeschler, Susan M; Qu, Wenchun; Hanley, Eugerie; Neuman, Stephanie A; Eldrige, Jason S; Hoelzer, Bryan C

    2016-01-01

    A recent publication reported the incidence of postdural puncture headache (PDPH) in conjunction with intrathecal drug delivery system (IDDS) implantation to be nearly 23 percent. Many patients responded to conservative measures but a percentage needed invasive treatment with an epidural blood patch (EBP). There is limited data to describe the technical details, success rates, and complications associated with EBP in this population. This study aims to provide a retrospective report of EBP for patients suffering from PDPH related to IDDS implantation. A chart review established a cohort of patients that required EBP in relation to a PDPH after IDDS implantation. This cohort was evaluated for demographic data as well as details of the EBP including technical procedural data, success rates, and complications. All patients received a trial of conservative therapy. Standard sterile technique and skin preparation were utilized with no infectious complications. The EBP was placed below the level of the IDDS catheter in 94% of procedures. Fluoroscopy was utilized in each case. The mean EBP volume was 18.6 cc and median time of EBP was day 7 after implant. There were no complications associated with EBP. EBP appears to be an effective intervention in this subset of PDPH patients. PMID:27597897

  7. Treatment of Refractory Postdural Puncture Headache after Intrathecal Drug Delivery System Implantation with Epidural Blood Patch Procedures: A 20-Year Experience

    PubMed Central

    Moeschler, Susan M.; Qu, Wenchun; Hanley, Eugerie; Neuman, Stephanie A.; Eldrige, Jason S.; Hoelzer, Bryan C.

    2016-01-01

    A recent publication reported the incidence of postdural puncture headache (PDPH) in conjunction with intrathecal drug delivery system (IDDS) implantation to be nearly 23 percent. Many patients responded to conservative measures but a percentage needed invasive treatment with an epidural blood patch (EBP). There is limited data to describe the technical details, success rates, and complications associated with EBP in this population. This study aims to provide a retrospective report of EBP for patients suffering from PDPH related to IDDS implantation. A chart review established a cohort of patients that required EBP in relation to a PDPH after IDDS implantation. This cohort was evaluated for demographic data as well as details of the EBP including technical procedural data, success rates, and complications. All patients received a trial of conservative therapy. Standard sterile technique and skin preparation were utilized with no infectious complications. The EBP was placed below the level of the IDDS catheter in 94% of procedures. Fluoroscopy was utilized in each case. The mean EBP volume was 18.6 cc and median time of EBP was day 7 after implant. There were no complications associated with EBP. EBP appears to be an effective intervention in this subset of PDPH patients. PMID:27597897

  8. Effect of Pioglitazone on In-Stent Restenosis after Coronary Drug-Eluting Stent Implantation: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Zhang, Ming-duo; Zhang, Yu-hui; Zhu, En-jun; Qiao, Shi-bin

    2014-01-01

    Background In-stent restenosis (ISR) remains a common life-threatening complication and some studies have shown that pioglitazone can reduce the incidence of ISR in patients with drug-eluting stents (DES) implantation. We conducted a meta-analysis to assess the effect of pioglitazone in preventing ISR after DES implantation. Methods Randomized controlled trials (RCTs) investigating the effects of pioglitazone for ISR after DES implantation were identified by systematic searches of multiple online databases and manual searches of related reference lists of identified trials through May 2014. The primary endpoint was the rate of ISR. Secondary endpoints included minimum lumen diameter, percentage stenosis of stented vessels, late loss, in-stent neointimal volume, target vessel revascularization (TVR), target lesion revascularization, myocardial infarction, stent thrombosis and death. Results Five studies, comprising 255 pioglitazone-treated patients and 245 controls, were identified in the current meta-analysis. Pioglitazone did not significantly reduce the rate of ISR (P = 0.20) with low heterogeneity (I2 = 13.3%, P = 0.32). For the secondary outcomes, pioglitazone did not substantially affect the pooled estimates of these endpoints except late loss (P = 0.01) and TVR (P = 0.04). Conclusions The limited evidence indicates that pioglitazone does not demonstrate markedly beneficial effect in patients subjected to coronary DES implantation. However, the results should be interpreted with care given the small sample size. Further large-scale RCTs are needed. PMID:25279761

  9. 21 CFR 522.1350 - Melatonin implant.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Melatonin implant. 522.1350 Section 522.1350 Food... Melatonin implant. (a) Specifications. The drug is a silicone rubber elastomer implant containing 2.7...—(1) Amount. One implant per mink. (2) Indications for use. For use in healthy male and female kit...

  10. 21 CFR 522.1350 - Melatonin implant.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Melatonin implant. 522.1350 Section 522.1350 Food... Melatonin implant. (a) Specifications. The drug is a silicone rubber elastomer implant containing 2.7...—(1) Amount. One implant per mink. (2) Indications for use. For use in healthy male and female kit...

  11. 21 CFR 522.1350 - Melatonin implant.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Melatonin implant. 522.1350 Section 522.1350 Food... Melatonin implant. (a) Specifications. The drug is a silicone rubber elastomer implant containing 2.7...—(1) Amount. One implant per mink. (2) Indications for use. For use in healthy male and female kit...

  12. 21 CFR 522.1350 - Melatonin implant.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Melatonin implant. 522.1350 Section 522.1350 Food... Melatonin implant. (a) Specifications. The drug is a silicone rubber elastomer implant containing 2.7...—(1) Amount. One implant per mink. (2) Indications for use. For use in healthy male and female kit...

  13. An implantable triple-function device for local drug delivery, cerebrospinal fluid removal and EEG recording in the cranial subdural/subarachnoid space of primates.

    PubMed

    Ludvig, Nandor; Medveczky, Geza; Rizzolo, Richard; Tang, Hai M; Baptiste, Shirn L; Doyle, Werner K; Devinsky, Orrin; Carlson, Chad; French, Jacqueline A; Kral, John G; Charchaflieh, Jean; Kuzniecky, Ruben I

    2012-01-30

    Transmeningeal pharmacotherapy for cerebral cortical disorders requires drug delivery through the subdural/subarachnoid space, ideally with a feedback controlled mechanism. We have developed a device suitable for this function. The first novel component of the apparatus is a silicone rubber strip equipped with (a) fluid-exchange ports for both drug delivery and local cerebrospinal fluid (CSF) removal, and (b) EEG recording electrode contacts. This strip can be positioned between the dura and pia maters. The second novel component is an implantable dual minipump that directs fluid movement to and from the silicone strip and is accessible for refilling and emptying the drug and CSF reservoirs, respectively. This minipump is regulated by a battery-powered microcontroller integrating a bi-directional radiofrequency (RF) communication module. The entire apparatus was implanted in 5 macaque monkeys, with the subdural strip positioned over the frontal cortex and the minipump assembly secured to the cranium under a protective cap. The system was successfully tested for up to 8 months for (1) transmeningeal drug delivery using acetylcholine (ACh) and muscimol as test compounds, (2) RF-transmission of neocortical EEG data to assess the efficacy of drug delivery, and (3) local CSF removal for subsequent diagnostic analyses. The device can be used for (a) monitoring neocortical electrophysiology and neurochemistry in freely behaving nonhuman primates for more than 6 months, (b) determining the neurobiological impact of subdural/subarachnoid drug delivery interfaces, (c) obtaining novel neuropharmacological data on the effects of central nervous system (CNS) drugs, and (d) performing translational studies to develop subdural pharmacotherapy devices. PMID:22027491

  14. Biodegradable drug-eluting nanofiber-enveloped implants for sustained release of high bactericidal concentrations of vancomycin and ceftazidime: in vitro and in vivo studies

    PubMed Central

    Hsu, Yung-Heng; Chen, Dave Wei-Chih; Tai, Chun-Der; Chou, Ying-Chao; Liu, Shih-Jung; Ueng, Steve Wen-Neng; Chan, Err-Cheng

    2014-01-01

    We developed biodegradable drug-eluting nanofiber-enveloped implants that provided sustained release of vancomycin and ceftazidime. To prepare the biodegradable nanofibrous membranes, poly(D,L)-lactide-co-glycolide and the antibiotics were first dissolved in 1,1,1,3,3,3-hexafluoro-2-propanol. They were electrospun into biodegradable drug-eluting membranes, which were then enveloped on the surface of stainless plates. An elution method and a high-performance liquid chromatography assay were employed to characterize the in vivo and in vitro release rates of the antibiotics from the nanofiber-enveloped plates. The results showed that the biodegradable nanofiber-enveloped plates released high concentrations of vancomycin and ceftazidime (well above the minimum inhibitory concentration) for more than 3 and 8 weeks in vitro and in vivo, respectively. A bacterial inhibition test was carried out to determine the relative activity of the released antibiotics. The bioactivity ranged from 25% to 100%. In addition, the serum creatinine level remained within the normal range, suggesting that the high vancomycin concentration did not affect renal function. By adopting the electrospinning technique, we will be able to manufacture biodegradable drug-eluting implants for the long-term drug delivery of different antibiotics. PMID:25246790

  15. Gastroenterology-urology devices; effective date of requirement for premarket approval of the penile inflatable implant. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-04-12

    The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the penile inflatable implant, a generic type of medical device intended for the treatment of erectile dysfunction. This regulation reflects FDA's exercise of its discretion to require PMA's or PDP's for preamendments devices and is consistent with FDA's stated priorities and Congress' requirement that class III devices are to be regulated by FDA's premarket review. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. PMID:11010632

  16. Prospective and Systematic Analysis of Unexpected Requests for Non-Cardiac Surgery or Other Invasive Procedures during the First Year after Drug-Eluting Stent Implantation

    PubMed Central

    Kim, Byeong-Keuk; Yoon, Jung-Han; Shin, Dong-Ho; Kim, Jung-Sun; Ko, Young-Guk; Choi, Donghoon; Lee, Seung-Hwan; Mintz, Gary S.; Jang, Yangsoo

    2014-01-01

    Purpose Unexpected requests for non-cardiac surgery requiring discontinuation of dual antiplatelet therapy (DAPT) frequently occur in daily clinical practice. The objectives of this study were to evaluate prevalence, timing and clinical outcomes of such unexpected requests for non-cardiac surgery or other invasive procedures during the first year after drug-eluting stents (DESs) implantation. Materials and Methods We prospectively investigated the prevalence, timing and clinical outcomes of unexpected requests for non-cardiac surgery or other procedures during the first year after DESs implantation in 2117 patients. Results The prevalence of requested non-cardiac surgery or invasive procedures was 14.6% in 310 requests and 12.3% in 261 patients. Among 310 requests, those were proposed in 11.3% <1 month, 30.0% between 1 and 3 months, 36.8% between 4 and 6 months and 21.9% between 7 and 12 months post-DES implantation. The rates of actual discontinuation of DAPT and non-cardiac surgery or procedure finally performed were 35.8% (111 of 310 requests) and 53.2% (165 of 310 requests), respectively. On multivariate regression analysis, the most significant determinants for actual discontinuation of DAPT were Endeavor zotarolimus-eluting stent implantation with 3-month DAPT (OR=5.54, 95% CI 2.95-10.44, p<0.001) and timing of request (OR=2.84, 95% CI 1.97-4.11, p<0.001). There were no patients with any death, myocardial infarction, or stent thrombosis related with actual discontinuation of DAPT. Conclusion Those unexpected requests with premature discontinuation of DAPT were relatively common and continuously proposed during the first year following DES implantation. No death, myocardial infarction or stent thrombosis occurred in patients with actual discontinuation of DAPT. PMID:24532502

  17. First In Vivo Testing of Compounds Targeting Group 3 Medulloblastomas Using an Implantable Microdevice as a New Paradigm for Drug Development.

    PubMed

    Jonas, Oliver; Calligaris, David; Methuku, Kashi Reddy; Poe, Michael M; Francois, Jessica Pierre; Tranghese, Frank; Changelian, Armen; Sieghart, Werner; Ernst, Margot; Krummel, Daniel A Pomeranz; Cook, James M; Pomeroy, Scott L; Cima, Michael; Agar, Nathalie Y R; Langer, Robert; Sengupta, Soma

    2016-06-01

    Medulloblastoma is the most common childhood malignant brain tumor. The most lethal medulloblastoma subtype exhibits a high expression of the GABAA receptor α5 subunit gene and MYC amplification. New benzodiazepines have been synthesized to function as α5-GABAA receptor ligands. To compare their efficacy with that of standard-of-care treatments, we have employed a newly developed microscale implantable device that allows for high-throughput localized intratumor drug delivery and efficacy testing. Microdoses of each drug were delivered into small distinct regions of tumors, as confirmed by tissue mass spectrometry, and the local drug effect was determined by immunohistochemistry. We have identified a benzodiazepine derivative, KRM-II-08, as a new potent inhibitor in several α5-GABAA receptor expressing tumor models. This is the first instance of in vivo testing of several benzodiazepine derivatives and standard chemotherapeutic drugs within the same tumor. Obtaining high-throughput drug efficacy data within a native tumor microenvironment as detailed herein, prior to pharmacological optimization for bioavailability or safety and without systemic exposure or toxicity, may allow for rapid prioritization of drug candidates for further pharmacological optimization. PMID:27319222

  18. Coronary vasomotion one year after drug-eluting stent implantation: comparison of everolimus-eluting and paclitaxel-eluting coronary stents.

    PubMed

    Hamilos, Michalis; Ribichini, Flavio; Ostojic, Miodrag C; Ferrero, Valeria; Orlic, Dejan; Vassanelli, Corrado; Karanovic, Nevena; Sarno, Giovanna; Cuisset, Thomas; Vardas, Panos E; Wijns, William

    2014-06-01

    First-generation drug-eluting stents (DES) have been associated with impaired localized coronary vasomotion and delayed endothelialization. We aimed to compare coronary vasomotion after implantation of a newer-generation everolimus-eluting stent (EES), with a first-generation paclitaxel-eluting stent (PES). Coronary vasomotion was studied in 19 patients with EES and 13 with PES. Vasomotor response was measured proximally and distally to the stent and in a remote vessel (reference segment). Quantitative coronary angiography was performed offline. Endothelium independent vasomotion did not differ significantly between the two groups. EES showed significant vasodilatation while PES showed vasoconstriction at both proximal (+4.5 ± 3.6 vs -4.2 ± 6.9, p < 0.001) and distal (+4.6 ± 7.9 vs -4.8 ± 9.3, p = 0.003) segments. The reference segment did not show any significant difference in vasodilatation between the two groups (+9.8 ± 6.4 vs +7.2 ± 5.2, p = 0.17). Endothelium-dependent vasomotion at adjacent stent segments is relatively preserved after EES implantation while vasoconstriction was observed after PES implantation. PMID:24794876

  19. Feasibility of poly (ϵ-caprolactone-co-DL-lactide) as a biodegradable material for in situ forming implants: evaluation of drug release and in vivo degradation.

    PubMed

    Zhang, Xiaowei; Zhang, Chong; Zhang, Wei; Meng, Shu; Liu, Danhua; Wang, Ping; Guo, Jing; Li, Jianxin; Guan, Yanmin; Yang, Dan

    2015-02-01

    The purpose of this study was to evaluate the technical feasibility of poly (ϵ-caprolactone-co-DL-lactide), P (CL/DL-LA), for injectable in situ forming implants (ISFI). The ISFI was prepared by dissolving P (CL/DL-LA) in N-methyl-2-pyrrolidone (NMP), and Testosterone undecanoate (TU) was used as model drug. The effect of various polymer concentrations, molecular weights (Mws) and drug loads on the drug release from the TU-loaded ISFI systems was investigated in vitro. The release of TU-loaded ISFI was also evaluated in rats. In addition, a subcutaneous rabbit model was used to evaluate the degradation and foreign-body reaction of P (CL/DL-LA) ISFI. The use of higher concentration of P (CL/DL-LA) with higher molecule weight and larger CL:DL-LA monomer ratio for the TU-loaded ISFI gave a slower drug release. The ISFI of 80/20 P (CL/DL-LA) (Mw 61 753):NMP 20:80 with 16% TU formulation increased serum testosterone levels in rats over a period of three months. The in vivo degradation and biocompatibility study of ISFI shows that P (CL/DL-LA) degrades by a process of bulk degradation and that the foreign-body reaction of this biomaterial is relatively mild. In summary, our investigations demonstrate that in situ parenteral drug delivery systems can be obtained from P (CL/DL-LA) solutions. PMID:24320881

  20. Clinical outcomes of various continued antiplatelet therapies in patients who were administered DAPT following the implantation of drug-eluting stents and developed gastrointestinal hemorrhage

    PubMed Central

    Guo, Yujie; Wei, Jinru

    2016-01-01

    Although an increasing number of patients accept dual antiplatelet therapy (DAPT) following implantation of drug-eluting stents (DES) for coronary heart disease (CHD), the proportion of patients with DAPT who subsequently develop gastrointestinal hemorrhage continues to increase. To ensure the clinical outcomes from DES, it is important to formulate a novel continued antiplatelet therapy for patients who were administered DAPT and subsequently develop gastrointestinal hemorrhage following DES implantation. The present study aimed to evaluate the effects of continued aspirin, clopidogrel or DAPT use on the incidence of clinical adverse events and gastrointestinal rebleeding in patients who received DAPT and subsequently developed gastrointestinal hemorrhage following implantation of DES for CHD. Between 2004 and 2010, 108 consecutive patients receiving DAPT developed gastrointestinal hemorrhage following DES implantation for CHD at Liuzhou General Hospital (Liuzhou, Guangxi). These patients were divided into three groups according to the novel antiplatelet therapy. The occurrence of major adverse cardiac events (MACE), including cardiac death, non-fatal myocardial infarction, heart failure or target vessel revascularization, net adverse clinical events (NACE), including major bleeding, stroke or MACE, and gastrointestinal rebleeding during clinical follow-up following the initial procedure were compared among these three groups. The results of this analysis demonstrated that the occurrence rate of MACE, NECE and gastrointestinal rebleeding was not significantly different among these groups (P>0.05). Furthermore, survival analysis was performed and although the survival curves of MACE and NECE were not significantly different among these groups, gastrointestinal rebleeding was demonstrated to be significantly different among the three groups (P<0.05), and continued aspirin or clopidogrel use was superior to continued DAPT. In conclusion, the results of the present

  1. Identification of independent risk factors for restenosis following bare-metal stent implantation: Role of bare-metal stents in the era of drug-eluting stents

    PubMed Central

    PARK, CHANG-BUM; PARK, HOON-KI

    2013-01-01

    In the era of drug-eluting stents (DESs), the ability of clinicians to predict which patients have a low risk of coronary restenosis following bare-metal stent (BMS) implantion is likely to be of benefit. The study population consisted of 2,711 patients who underwent BMS implantation in 3,770 lesions between 1995 and 2004. With clinical and 6 month follow-up angiographic data, we retrospectively sought to identify the independent risk predictors of restenosis, applied a previously proposed prediction model and assessed the characteristics of patients with a low likelihood of coronary restenosis within 6 months of BMS implantation. A 6-month follow-up coronary angiography was performed in 65.0% of the patients who had undergone the BMS implantation and the rate of restenosis was 26.6%. Using multivariate analysis, diabetes [odds ratio (OR), 1.294; 95% confidence interval (CI), 1.094–1.483; P=0.005], current smoking (OR, 1.294; 95% CI, 1.094–1.483; P=0.002), a reference vessel diameter of <3.25 mm (OR, 1.238; 95% CI, 1.021–1.501; P<0.001), a lesion length of >30 mm (OR, 1.645; 95% CI, 1.336–2.026; P<0.001), ostial lesion (OR, 1.858; 95% CI, 1.437–2.402; P<0.001), post-stenting minimal luminal diameter (OR, 0.576; 95% CI, 0.484–0.685; P<0.001) and bifurcation lesion (OR, 1.353; 95% CI, 1.070–1.711; P=0.012) were identified as significant independent predictors of restenosis. However, the accuracy of the prediction obtained with the current model, which used the clinical and angiographic variables correlated with the risk of restenosis, was poor. Various clinical and angiographic independent risk variables were revealed to be correlated with the risk of restenosis following BMS implantation in the present large dataset. Certain groups of patients with a relatively low risk of restenosis may be considered for BMS implantation as an alternative to DESs. However, the prediction models used at present are incomplete and further studies are required. PMID

  2. Impact of Dual Antiplatelet Therapy with Proton Pump Inhibitors on the Outcome of Patients with Acute Coronary Syndrome Undergoing Drug-Eluting Stent Implantation

    PubMed Central

    Macaione, Francesca; Montaina, Carla; Evola, Salvatore; Novo, Giuseppina; Novo, Salvatore

    2012-01-01

    This study aimed to assess if proton pump inhibitors (PPIs) may reduce the effectiveness of clopidogrel, than H2 antagonist (anti-H2) in order to determine rehospitalization for acute coronary syndrome (re-ACS), target vessel revascularization (TVR) and cardiac death. This case-control study included 176 patients with ACS undergoing angioplasty (PCI) with drug-eluting stent implantation. The population was divided into two groups: PPI group (n = 121) consisting of patients receiving at discharge dual antiplatelet therapy (DAT) plus PPI and anti-H2 group (n = 55), consisting of patients receiving at discharge DAT + H2 receptor antagonist (H2RA). In a followup of 36 months the prevalence of ACS event (P = 0.014), TVR (P = 0.031) was higher in the PPI group than in the anti-H2 group; instead there was no statistically significant difference between groups for death. The variables independently associated with ACS were the diabetes, omeprazole, and esomeprazole; instead the variables independently associated with TVR were only omeprazole. Our data shows that the use of omeprazole and esomeprazole, with clopidogrel, is associated with increased risk of adverse outcomes after PCI with drug-eluting stent implantation. PMID:22792485

  3. Scanning electron image analysis to monitor of implant degradation and host healing following implantation of a drug-eluting bone graft void filler - biomed 2013.

    PubMed

    Davidoff, Sherry N; Lawson, Scott T; Grainger, David W; Brooks, Amanda E

    2013-01-01

    Osteomyelitis is most commonly caused by Staphylococcus aureus and often sourced during orthopedic surgical intervention. Successful treatment or prevention of this bone penetrating infection requires antibiotics be delivered in excess of the minimal inhibitory concentration to prohibit the growth of the causative organism for sufficient duration. Unfortunately, current standard-of-care antibiotic therapies, administered via intravenous or oral delivery, suffer not only from systemic toxicity and low patient compliance but also provide insufficient local concentrations for therapy. To overcome these clinical inadequacies, a synthetic bone graft material was coated with an antibiotic (tobramycin)-releasing polymer (polycaprolactone) matrix to create a polymer-controlled antibiotic- releasing combination therapy for use as a bone void filler in orthopedic surgeries. Even though this local delivery strategy allows antibiotic delivery over a clinically relevant time frame to prevent infection, complete healing requires the host bone to infiltrate and reabsorb the bone void filler, ultimately replacing the defect with healthy tissue. Unfortunately, the same polymer matrix that allows for controlled local antibiotic delivery may also discourage host bone healing. Efficient orthopedic healing requires the rate of polymer degradation to match the rate of host-bone infiltration. Current imaging techniques, such as histological staining and x-ray imaging, are insufficient to simultaneously assess polymer degradation and host bone integration. Alternative techniques relying on backscatter electron detection during scanning electron microscopy (SEM) imaging may allow a visual differentiation between host bone, synthetic bone, and polymer. Analysis of backscattered SEM images was automated using a custom MATLAB program to determine the ratio of bone to polymer based upon the contrast between the bone (white) and polymer (dark grey). By collecting images of the implant over time

  4. Optimization of the route of platinum drugs administration to optimize the concomitant treatment with radiotherapy for glioblastoma implanted in the Fischer rat brain

    PubMed Central

    Charest, Gabriel; Sanche, Léon; Fortin, David; Mathieu, David; Paquette, Benoit

    2013-01-01

    Treatment of glioblastoma with platinum compounds modestly improves progression-free survival and may cause toxic effects which prevent use at higher dose that would otherwise improve the antineoplastic effect. To reduce toxicity, we propose to encapsulate the platinum drug in a liposome. We have also tested three methods of drug administration (intra-venous, intra-arterial and intra-arterial combined with blood brain barrier disruption) to determine which one optimizes the tumor cell uptake, limits the toxicity and delivers the best concomitance effect with radiotherapy. Cisplatin, oxaliplatin, their respective liposomal formulations, Lipoplatin™ and Lipoxal™, and carboplatin were assessed in F98 glioma, orthotopically implanted in Fischer rats. We found that the modest accumulation of drugs in tumor cells after intra-venous injection was significantly improved when the intra-arterial route was used and further increased after the transient opening of the blood brain barrier with mannitol. The liposomal formulations have largely reduced the toxicity and have allowed a better exploitation of the anti-cancer activity of platinum agent. Although the liposomes Lipoplatin™ and Lipoxal™ have shown a similar ability to that of carboplatin, to accumulate in brain tumors, the highest additive effect with radiotherapy was obtained with carboplatin. We conclude that the intra-arterial infusion of carboplatin or Lipoxal™ in concomitance with radiation therapy leads to the best tumor control as measured by an increase of mean survival time in Fischer rats implanted with the F98 glioma with a benefit in survival time of 13.4 and 6.5 days respectively compared to intra-venous. PMID:24026531

  5. Efficacy and safety of low-dose clopidogrel after 12-month dual antiplatelet therapy for patients having drug-eluting stent implantation

    PubMed Central

    Zhuang, Xiao-Dong; Long, Ming; Li, Cui-Ling; Hu, Cheng-Heng

    2014-01-01

    Background To prevent stent thrombosis (ST) after implantation of drug-eluting stents (DESs) in patients with coronary heart disease, 12-month dual antiplatelet therapy (DAPT) is recommended. However, the optimal long-term antiplatelet regimen is not clear for the patients who have completed the 12-month DAPT. Methods We reviewed the data of 755 consecutive patients who had undergone percutaneous coronary intervention (PCI) three years ago and completed 12-month DAPT. They were divided into three groups according to the antiplatelet medication they had used for two years after 12-month DAPT [low-dose clopidogrel (Talcom®, 25mg/d), clopidogrel (Plavix®, 75mg/d) and aspirin (100 mg/d)]. The efficacy (a composite incidence of cardiac death, myocardial infarction and target vessel revascularization) and safety (incidences of bleeding, gastrointestinal trouble and drug discontinuation) were compared among the three groups. Results The rates of multi-vessel lesions, prior MI, hemoglobin A1C (HbA1c) and low-density lipoprotein cholesterol were significantly higher in the clopidogrel (75 mg/day) group than in the other two groups (P>0.05 for both comparisons). There was no significant difference in the overall composite incidence of cardiac death, myocardial infarction and target vessel revascularization in the three groups at three years after PCI. The rates of bleeding (especially minor bleeding), gastrointestinal trouble, drug discontinuation and any blood transfusion were markedly lower in the low-dose clopidogrel (25 mg/d) group than in the other two treatment groups (P<0.05). Conclusions The 25-mg maintenance dose of clopidogrel after 12-month DAPT may be more preferable to Chinese patients who have undergone DES implantation, because of its lower cost but no less efficacy and safety. PMID:24822103

  6. 21 CFR 522.1350 - Melatonin implant.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Melatonin implant. 522.1350 Section 522.1350 Food... Melatonin implant. (a) Specifications. The drug is a silicone rubber elastomer implant containing 2.7 milligrams of melatonin. (b) Sponsor. See No. 053923 in § 510.600(c) of this chapter. (c) Conditions of...

  7. A novel pressed porous silicon-polycaprolactone composite as a dual-purpose implant for the delivery of cells and drugs to the eye.

    PubMed

    Irani, Yazad D; Tian, Yuan; Wang, Mengjia; Klebe, Sonja; McInnes, Steven J; Voelcker, Nicolas H; Coffer, Jeffery L; Williams, Keryn A

    2015-10-01

    Dysfunction of corneal epithelial stem cells can result in painful and blinding disease of the ocular surface. In such cases, treatment may involve transfer of growth factor and normal adult stem cells to the ocular surface. Our purpose was to develop an implantable scaffold for the delivery of drugs and cells to the ocular surface. We examined the potential of novel composite biomaterials fabricated from electrospun polycaprolactone (PCL) fibres into which nanostructured porous silicon (pSi) microparticles of varying sizes (150-250 μm or <40 μm) had been pressed. The PCL fabric provided a flexible support for mammalian cells, whereas the embedded pSi provided a substantial surface area for efficient delivery of adsorbed drugs and growth factors. Measurements of tensile strength of these composites revealed that the pSi did not strongly influence the mechanical properties of the polymer microfiber component for the Si loadings evaluated. Human lens epithelial cells (SRA01/04) attached to the composite materials, and exhibited enhanced attachment and growth when the materials were coated with foetal bovine serum. To examine the ability of the materials to deliver a small-drug payload, pSi microparticles were loaded with fluorescein diacetate prior to cell attachment. After 6 hours (h), cells exhibited intracellular fluorescence, indicative of transfer of the fluorescein diacetate into viable cells and its subsequent enzymatic conversion to fluorescein. To investigate loading of large-molecule biologics, murine BALB/c 3T3 cells, responsive to epidermal growth factor, insulin and transferrin, were seeded on composite materials. The cells showed significantly more proliferation at 48 h when seeded on composites loaded with these biologics, than on unloaded composites. No cell proliferation was observed on PCL alone, indicating the biologics had loaded into the pSi microparticles. Drug release, measured by ELISA for insulin, indicated a burst followed by a slower

  8. Cochlear Implants.

    ERIC Educational Resources Information Center

    Clark, Catherine; Scott, Larry

    This brochure explains what a cochlear implant is, lists the types of individuals with deafness who may be helped by a cochlear implant, describes the process of evaluating people for cochlear implants, discusses the surgical process for implanting the aid, traces the path of sound through the cochlear implant to the brain, notes the costs of…

  9. Optical coherence tomography derived cut-off value of uncovered stent struts to predict adverse clinical outcomes after drug-eluting stent implantation.

    PubMed

    Won, Hoyoun; Shin, Dong-Ho; Kim, Byeong-Keuk; Mintz, Gary S; Kim, Jung-Sun; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong-Ki

    2013-08-01

    Although the presence of uncovered struts may be associated with occurrence of stent thrombosis, the impact of uncovered struts detected routinely by optical coherence tomography (OCT) on subsequent long-term clinical outcomes remains unclear. The objective of this study was to determine the cut-off value of uncovered struts that predicted adverse clinical outcomes after drug eluting stent (DES) implantation. Major safety events (MSEs, a composite occurrence of cardiovascular death, myocardial infarction, and stent thrombosis) were evaluated in 489 DES-treated patients (535 lesions) during the median 851 days after follow-up OCT. MSEs occurred in six patients (four definite stent thrombosis and two sudden cardiac death). The best cut-off value of percentage of uncovered struts for predicting MSE was 5.9 % using the maximal χ(2) method: area under the receiver-operating characteristic curve = 0.779, 95 % confidence interval (CI) = 0.648-0.910, p = 0.019, a sensitivity of 83.3 % and a specificity of 70.3 %. Independent predictors for MSE were post-intervention minimal lumen diameter (odds ratio 0.019, 95 % CI = 0.001-0.513, p = 0.018) and percentage of uncovered struts ≥5.9 % (odds ratio 19.781, 95 % CI = 2.071-188.968, p = 0.010). A greater percentage of uncovered struts (the cut-off value of ≥5.9 % uncovered struts) might be significantly associated with occurrence of MSE after DES implantation. PMID:23615849

  10. Comparison of Long-Term Clinical Outcomes after Drug-Eluting Stent Implantation in Patients with Coronary Artery Disease with and without Prior Cerebral Infarction

    PubMed Central

    Fujiwara, Hidetoshi; Horiuchi, Naruyoshi; Shirasaki, Shuichi; Sakai, Ichiro; Tsuchida, Kazuyuki; Murai, Hiroshi

    2015-01-01

    Objective: To compare the clinical and angiographic outcomes after implantation of drug-eluting stents (DESs) in patients with coronary artery disease (CAD) with or without prior cerebral infarction. Materials and Methods: Ninety-eight consecutive patients (130 lesions) who underwent successful coronary DES implantation were prospectively classified into two groups: those with a clinical history of symptomatic cerebral infarction (cerebral infarction group, 49 patients, 69 lesions) and those without a clinical history of symptomatic cerebral infarction (noncerebral infarction group, 49 patients, 61 lesions). The primary endpoint was defined as death, nonfatal myocardial infarction, and cerebrovascular events. Results: The Kaplan–Meier method was used to create a primary endpoint curves to determine the time-dependent cumulative primary endpoint-free rate, which were compared using the log-rank test. The incidence of primary endpoints was higher in the cerebral infarction group than in the noncerebral infarction group (p = 0.0075). The Cox proportional hazards regression model for primary endpoint identified prior cerebral infarction (p = 0.0331, hazard ratio = 2.827) and patients with peripheral artery disease (p = 0.0271, hazard ratio = 2.757) as explanatory factors. Conclusion: The results showed that clinical outcomes were poorer in patients with CAD who had prior cerebral infarctions than in those who did not have infarction. PMID:26131026

  11. Intractable intraoperative bleeding requiring platelet transfusion during emergent cholecystectomy in a patient with dual antiplatelet therapy after drug-eluting coronary stent implantation (with video)

    PubMed Central

    Fujikawa, Takahisa; Noda, Tomohiro; Tada, Seiichiro; Tanaka, Akira

    2013-01-01

    We report a case of a 76-year-old man, receiving dual antiplatelet therapy (DAPT) with aspirin and ticlopidine for the past 6 years after implantation of drug-eluting coronary stent, developed a severe hypochondriac pain. After diagnosing severe acute cholecystitis by an enhanced CT, emergent laparotomy under continuation of DAPT was attempted. During the operation, intractable bleeding from the adhesiolysed liver surface was encountered, which required platelet transfusion. Subtotal cholecystectomy with abdominal drainage was performed, and the patient recovered without any postoperative bleeding or thromboembolic complications. Like the present case, the final decision should be made to perform platelet transfusion when life-threatening DAPT-induced intraoperative bleeding occurs during an emergent surgery, despite the elevated risk of stent thrombosis. PMID:23536626

  12. Successful treatment of bleeding large duodenal gastrointestinal stromal tumour in a patient under dual antiplatelet therapy after recent drug-eluting coronary stent implantation

    PubMed Central

    Fukuyama, Keita; Fujikawa, Takahisa; Kuramitsu, Shoichi; Tanaka, Akira

    2014-01-01

    We report a case of a 69-year-old man who started dual antiplatelet therapy (APT) with aspirin and clopidogrel after recent implantation of drug-eluting coronary stent and developed massive bleeding due to large duodenal gastrointestinal stromal tumour (GIST). Following endoscopic haemostasis and discontinuation of dual APT, neoadjuvant chemotherapy with imatinib was started under continuation of ‘single’ APT with aspirin. A good chemotherapeutic response was achieved without recurrence of bleeding, and subsequent less invasive surgical resection of the tumour was performed, while preoperative single APT was continued for prevention of stent thrombosis. The patient recovered well without any thromboembolic or bleeding events. Neoadjuvant imatinib therapy and subsequent less invasive surgery under continuation of APT is one of the preferred approaches for patients with duodenal GIST with severe thromboembolic comorbidities, as in the current case. PMID:24777088

  13. Assessment of vascular response after drug-eluting stents implantation in patients with diabetes mellitus: an optical coherence tomography sub-study of the J-DESsERT.

    PubMed

    Kubo, Takashi; Akasaka, Takashi; Tanimoto, Takashi; Takano, Masamichi; Seino, Yoshitane; Nasu, Kenya; Itoh, Tomonori; Mizuno, Kyoichi; Okura, Hiroyuki; Shinke, Toshiro; Kotani, Jun-Ichi; Ito, Shigenori; Yokoi, Hiroyoshi; Muramatsu, Toshiya; Nakamura, Masato; Nanto, Shinsuke

    2016-04-01

    Even in the drug-eluting stent era, diabetes mellitus (DM) patients have high incidences of restenosis and repeat revascularization after percutaneous coronary intervention. The aim of this study was to compare vascular response after stent implantation between sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) by using optical coherence tomography (OCT) in DM patients as well as in non-DM patients. In the Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT), the OCT sub-study enrolled 75 patients who underwent 8 months follow-up imaging after SES or PES implantation. Mean neointimal hyperplasia (NIH) thickness was significantly thinner in SES than PES in the DM group (77 ± 47 vs. 201 ± 114 μm, p < 0.001) and in the non-DM group (84 ± 37 vs. 212 ± 128 μm, p < 0.001). Unevenness of NIH thickness in longitudinal axis was significantly smaller in SES than PES in the DM group (348 ± 191 vs. 726 ± 385 μm, p < 0.001) and in the non-DM group (344 ± 174 vs. 679 ± 314 μm, p < 0.001). The percentage of uncovered struts was significantly greater in SES than PES in the DM group (24 ± 4 vs. 9 ± 14 %, p < 0.001) and in the non-DM group (16 ± 16 vs. 3 ± 4 %, p = 0.002). Compared with PES, SES showed more potent NIH inhibition in DM patients as well as in non-DM patients. PMID:25630713

  14. Intravascular ultrasound-guided drug-eluting stent implantation: An updated meta-analysis of randomized control trials and observational studies.

    PubMed

    Steinvil, Arie; Zhang, Yao-Jun; Lee, Sang Yeub; Pang, Si; Waksman, Ron; Chen, Shao-Liang; Garcia-Garcia, Hector M

    2016-08-01

    The use of intravascular ultrasound (IVUS) guidance for drug-eluting stent (DES) optimization is limited by the number of adequately powered randomized control trials (RCTs). We performed an updated meta-analysis, including data from recently published RCTs and observational studies, by reviewing the literature in Medline and the Cochrane Library to identify studies that compared clinical outcomes between IVUS-guided and angiography-guided DES implantation from January 1995 to January 2016. This meta-analysis included 25 eligible studies, including 31,283 patients, of whom 3192 patients were enrolled in 7 RCTs. In an analysis of all 25 studies, the summary results for all the events analyzed were significantly in favor of IVUS-guided DES implantation [major adverse cardiac events (MACE, odds ratio [OR] 0.76, 95% confidence intervals [CI]: 0.70-0.82, P<0.001); death (OR 0.62, 95% CI: 0.54-0.72, P<0.001); myocardial infarction (OR 0.67, 95% CI: 0.56-0.80, P<0.001); stent thrombosis (OR 0.58, 95% CI: 0.47-0.73, P<0.001); target lesion revascularization (TLR, OR 0.77, 95% CI: 0.67-0.89, P=0.005); target vessel revascularization (TVR, OR 0.85, 95% CI: 0.76-0.95, P<0.001)]. However, in a separate analysis of RCTs, a favorable result for IVUS-guided DES implantation was found only for MACE (OR 0.66, 95% CI: 0.52-0.84, P=0.001), TLR (OR 0.61, 95% CI: 0.43-0.87, P=0.006), and TVR (OR 0.61, 95% CI: 0.41-0.90, P=0.013). IVUS-guided percutaneous coronary intervention was associated with better overall clinical outcomes than angiography-guided DES implantation. However, in a solely RCT meta-analysis, this benefit was mainly driven by reduced rates of revascularizations. PMID:27153138

  15. A study of chitosan hydrogel with embedded mesoporous silica nanoparticles loaded by ibuprofen as a dual stimuli-responsive drug release system for surface coating of titanium implants.

    PubMed

    Zhao, Pengkun; Liu, Hongyu; Deng, Hongbing; Xiao, Ling; Qin, Caiqin; Du, Yumin; Shi, Xiaowen

    2014-11-01

    In this study, the complex pH and electro responsive system made of chitosan hydrogel with embedded mesoporous silica nanoparticles (MSNs) was evaluated as a tunable drug release system. As a model drug, ibuprofen (IB) was used; its adsorption in MSNs was evidenced by Fourier transform infrared spectroscopy (FT-IR), scanning electron microscopy (SEM) and thermogravimetric analysis (TG). In order to prepare the complex drug release system, the loaded particles IB-MSNs were dispersed in chitosan solution and then the complex IB-MSNs/chitosan film of 2mm thickness was deposited as a hydrogel on the titanium electrode. The codeposition of components was performed under a negative biasing of the titanium electrode at -0.75 mA/cm2 current density during 30 min. The IB release from the IB-MSNs/chitosan hydrogel film was studied as dependent on pH of the release media and electrical conditions applied to the titanium plate. When incubating the complex hydrogel film in buffers with different pH, the IB release followed a near zero-order profile, though its kinetics varied. Compared to the spontaneous IB release from the hydrogel in 0.9% NaCl solution (at 0 V), the application of negative biases to the coated titanium plate had profound effluences on the release behavior. The release was retarded when -1.0 V was applied, but a faster kinetics was observed at -5.0 V. These results imply that a rapid, mild and facile electrical process for covering titanium implants by complex IB-MSNs/chitosan hydrogel films can be used for controlled drug delivery applications. PMID:25456989

  16. [Laser flare measurement with 3 different nonsteroidal anti-inflammatory drugs after phacoemulsification with posterior chamber lens implantation].

    PubMed

    Schmidl, B; Mester, U; Diestelhorst, M; Konen, W

    1997-01-01

    In a prospective, randomised, double-masked, parallel-group study we compared the antiinflammatory effect of diclofenac sodium 0.1%, flurbiprofen 0.03%, and indomethacin 1.0% ophthalmic suspension in 99 patients undergoing phacoemulsification and posterior chamber lens implantation. The reduction in anterior chamber flare from day 1, as measured with the laser flare-meter (FM-500, KOWA) on day 4-5 postoperatively was significantly greater in the diclofenac group than with flurbiprofen (p = 0.022). Patients treated with diclofenac had significantly less burning and stinging than patients on flurbiprofen and indomethacin on postoperative days 4-5 (p < 0.0001) and 12-14 (p = 0.001). Diclofenac sodium appears to be more potent than flurbiprofen in controlling intraocular inflammation after cataract surgery, while having better local tolerance than flurbiprofen or indomethacin. PMID:9132126

  17. 21 CFR 878.4750 - Implantable staple.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implantable staple. 878.4750 Section 878.4750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4750 Implantable staple....

  18. 21 CFR 878.4750 - Implantable staple.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implantable staple. 878.4750 Section 878.4750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4750 Implantable staple....

  19. 21 CFR 878.4750 - Implantable staple.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implantable staple. 878.4750 Section 878.4750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4750 Implantable staple....

  20. 21 CFR 878.4300 - Implantable clip.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implantable clip. 878.4300 Section 878.4300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4300 Implantable clip....

  1. 21 CFR 878.4300 - Implantable clip.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implantable clip. 878.4300 Section 878.4300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4300 Implantable clip....

  2. 21 CFR 878.4300 - Implantable clip.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implantable clip. 878.4300 Section 878.4300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4300 Implantable clip....

  3. 21 CFR 878.4750 - Implantable staple.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implantable staple. 878.4750 Section 878.4750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4750 Implantable staple....

  4. 21 CFR 878.4750 - Implantable staple.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implantable staple. 878.4750 Section 878.4750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4750 Implantable staple....

  5. 21 CFR 878.4300 - Implantable clip.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implantable clip. 878.4300 Section 878.4300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4300 Implantable clip....

  6. 21 CFR 878.4300 - Implantable clip.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implantable clip. 878.4300 Section 878.4300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4300 Implantable clip....

  7. Long-term outcomes of intravascular ultrasound-guided implantation of bare metal stents versus drug-eluting stents in primary percutaneous coronary intervention

    PubMed Central

    Cho, Yun-Kyeong; Park, Nam-Hee; Choi, Sang-Woong; Sohn, Ji-Hyun; Cho, Hyun-Ok; Park, Hyoung-Seob; Yoon, Hyuck-Jun; Kim, Hyungseop; Nam, Chang-Wook; Kim, Yoon-Nyun; Kim, Kwon-Bae

    2014-01-01

    Background/Aims While drug-eluting stents (DESs) have shown favorable outcomes in ST-segment elevation myocardial infarction (STEMI) compared to bare metal stents (BMSs), there are concerns about the risk of stent thrombosis (ST) with DESs. Because intravascular ultrasound (IVUS) guidance may help optimize stent placement and improve outcomes in percutaneous coronary intervention (PCI) patients, we evaluated the impact of IVUS-guided BMS versus DES implantation on long-term outcomes in primary PCI. Methods In all, 239 STEMI patients received DES (n = 172) or BMS (n = 67) under IVUS guidance in primary PCI. The 3-year incidence of major adverse cardiac events (MACEs) including death, myocardial infarction (MI), target vessel revascularization (TVR), and ST was evaluated. Results There was no difference in all cause mortality or MI. However, the incidence of TVR was 23.9% with BMS versus 9.3% with DES (p = 0.005). Thus, the number of MACEs was significantly lower with DES (11.0% vs. 29.9%; p = 0.001). The incidence of definite or probable ST was not different (1.5% vs. 2.3%; p = 1.0). IVUS-guided DES implantation (hazard ratio [HR], 0.25; 95% confidence interval [CI], 0.08 to 0.78; p = 0.017), stent length (HR, 1.03; 95% CI, 1.00 to 1.06; p = 0.046), and multivessel disease (HR, 3.01; 95% CI, 1.11 to 8.15; p = 0.030) were independent predictors of MACE. Conclusions In patients treated with primary PCI under IVUS guidance, the use of DES reduced the incidence of 3-year TVR versus BMS. However, all cause mortality and MI were similar between the groups. The incidence of ST was low in both groups. PMID:24574835

  8. Effect of Pretreatment of Ezetimibe/Simvastatin on Arterial Healing and Endothelialization after Drug-Eluting Stent Implantation in a Porcine Coronary Restenosis Model

    PubMed Central

    Sim, Doo Sun; Park, Dae Sung; Kim, Jung Ha; Lim, Kyung Seob; Kim, Hyun Kuk; Kim, Sung Soo; Cho, Jae Yeong; Jeong, Hae Chang; Park, Keun Ho; Hong, Young Joon; Kim, Ju Han; Ahn, Youngkeun; Cho, Jeong Gwan; Park, Jong Chun

    2015-01-01

    Background and Objectives We sought to evaluate the effect of the early use of ezetimibe/simvastatin (Vytorin®) on arterial healing and endothelialization after the implantation of a drug-eluting stent (DES) in a porcine model of coronary restenosis. Materials and Methods A total of 20 pigs (40 coronary arteries) were randomly allocated to a pretreatment or no treatment group. The pretreatment group (n=20) received oral ezetimibe/simvastatin (10/20 mg) daily for 7 days before stenting and the no pretreatment group (n=20) did not. All pigs were treated with ezetimibe/simvastatin (10/20 mg) daily after stenting for 4 weeks. Stenting was performed using a bare-metal stent (BMS, n=10) and three types of DES: biolimus A9-eluting stent (BES, n=10), zotarolimus-eluting stent (ZES, n=10), and everolimus-eluting stents (EES, n=10). Four weeks later, pigs underwent a follow-up coronary angiography and were sacrificed for histopathologic analysis. Results There were no significant differences between the pretreatment and no pretreatment groups in the internal elastic lamina area, lumen area, neointima area, stenotic area, injury score, fibrin score, and inflammation score. In both groups, the fibrin score was higher in pigs with DES than in BMS, particularly in ZES and EES. The inflammatory score was not different between DES and BMS. Conclusion In a porcine model of coronary restenosis, pretreatment with ezetimibe/simvastatin before DES implantation failed to improve arterial healing and endothelialization compared to treatment after stenting. PMID:25810732

  9. 21 CFR 872.3645 - Subperiosteal implant material.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Subperiosteal implant material. 872.3645 Section 872.3645 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3645 Subperiosteal implant material. (a) Identification. Subperiosteal implant...

  10. 21 CFR 872.3645 - Subperiosteal implant material.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Subperiosteal implant material. 872.3645 Section 872.3645 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3645 Subperiosteal implant material. (a) Identification. Subperiosteal implant...

  11. 21 CFR 872.3645 - Subperiosteal implant material.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Subperiosteal implant material. 872.3645 Section 872.3645 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3645 Subperiosteal implant material. (a) Identification. Subperiosteal implant...

  12. [Prognostic value of markers of inflammation in patients with stable ischemic heart disease after implantation of stents with drug covering at the background of long-term therapy with statins (inhospital period)].

    PubMed

    Karpov, Iu A; Buza, V V

    2012-01-01

    The objective of this study was to examine the prognostic value of C-reactive protein, erythrocyte sedimentation rate (ESR), white blood count, phospholipase A2 in patients with stable ischemic disease on long-term statin therapy undergoing percutaneous coronary intervention (PCI) with drug-eluting stent implantation. In the interim analysis in- hospital outcomes were assessed a total of 602 patients from December 2009 through December 2010 underwent successful PCI with at least one DES implanted. They were prospectively followed before discharge. MACE (death, myocardial infarction [MI], stroke, stent thrombosis [ST] which did not lead to MI) occurred in 10,6% of the patients. There was no death or stroke before discharge. MI (including 0,3% of Q-MI) occurred in 10,3% of the patients. 6 patients had verified ST. Multivariate logistic regression identified ESR level before PCI and total length of stents implanted as independent predictors of MACE. PMID:22839437

  13. Effects of Clopidogrel and Proton Pump Inhibitors on Cardiovascular Events in Patients with Type 2 Diabetes Mellitus after Drug-Eluting Stent Implantation: A Nationwide Cohort Study

    PubMed Central

    Hsieh, Chi-Feng; Huang, Weng-Foung; Chiang, Yi-Ting; Chen, Chun-Yen

    2015-01-01

    Objective To investigate whether there is an increased risk of cardiac events in diabetic patients with a combined therapy of clopidogrel (CLO) and proton pump inhibitors (PPIs) after drug-eluting stent (DES) deployment. Methods By using National Health Insurance Research Database, all patients who received CLO with or without PPI therapy within 90 days after undergoing DES (limus-eluting or paclitaxel-eluting stents) deployment were enrolled. Endpoints were acute coronary syndrome (ACS) and readmission for revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery) after 3, 6, and 12 months. Results A total of 6,603 diabetic patients received LESs (5,933 in the CLO subgroup and 670 in the CLO plus PPIs subgroup), and 3,202 patients received PESs (2,923 in the CLO subgroup and 279 in the CLO plus PPIs subgroup). The patients who received CLO plus PPIs were at higher risk of ACS than those receiving CLO within 1 year after DES deployment (LESs: 6-month hazard ratio [HR] = 1.63, and 1-year HR = 1.37; PESs: 3-month HR = 1.72). Patients with a history of ACS who received CLO plus PPIs were at higher risk of ACS after LES implantation (HR = 1.55) than those in the CLO group. Conclusion In “real-world” diabetic patients with LES deployment, the combination of PPIs and CLO is associated with higher rates of ACS after 6 months and 1 year. Even after correction for confounding factors, concomitant PPI use remained an independent predictor of cardiac events, emphasizing the clinical importance of this drug—drug interaction. PMID:26313000

  14. Goserelin Implant

    MedlinePlus

    Goserelin implant is used in combination with radiation therapy and other medications to treat localized prostate cancer and is ... treatment of abnormal bleeding of the uterus. Goserelin implant is in a class of medications called gonadotropin- ...

  15. Cochlear Implants

    MedlinePlus

    A cochlear implant is a small, complex electronic device that can help to provide a sense of sound. People who are ... of-hearing can get help from them. The implant consists of two parts. One part sits on ...

  16. Carmustine Implant

    MedlinePlus

    Carmustine implant is used along with surgery and sometimes radiation therapy to treat malignant glioma (a certain type of ... Carmustine implant comes as a small wafer that is placed in the brain by a doctor during surgery to ...

  17. 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 ...

  18. Breast Implants

    MedlinePlus

    ... Updated Safety Information (Consumer Article) FDA Provides Updated Safety Data on Silicone Gel-Filled Breast Implants (Press Announcement) [ARCHIVED] Breast Implant Guidance for Industry (2006) Post Approval Studies Webpage Freedom of Information ...

  19. Effects of Low Dose Pioglitazone on Restenosis and Coronary Atherosclerosis in Diabetic Patients Undergoing Drug Eluting Stent Implantation

    PubMed Central

    Lee, Hye Won; Kim, Bo Won; Yang, Mi Jin; Park, Jin Sup; Oh, Jun Hyok; Choi, Jung Hyun; Cha, Kwang Soo; Hong, Taek Jong; Kim, Sang-Pil; Song, Seunghwan; Park, Jong-Ha

    2013-01-01

    Purpose Thiazolidinediones are insulin-sensitizing agents that reduce neointimal proliferation and the adverse clinical outcomes associated with percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM). There is little data on whether or not low dose pioglitazone reduces adverse clinical outcomes. Materials and Methods The study population included 121 DM patients with coronary artery disease and they were randomly assigned to 60 patients taking 15 mg of pioglitazone daily in addition to their diabetic medications and 61 patients with placebo after the index procedure with drug-eluting stents (DESs). The primary end points were rate of in-stent restenosis (ISR) and change in atheroma volume and in-stent neointimal volume. The secondary end points were all-cause death, myocardial infarction (MI), stent thrombosis and re-PCI. Results There were no statistical differences in the clinical outcomes and the rate of ISR between the two groups [all-cause death; n=0 (0%) in the pioglitazone group vs. n=1 (1.6%) in the control group, p=0.504, MI; n=2 (3.3%) vs. n=1 (1.6%), p=0.465, re-PCI; n=6 (10.0%) vs. n=6 (9.8%), p=0.652, ISR; n=4 (9.3%) vs. n=4 (7.5%), p=1.000, respectively]. There were no differences in changes in neointimal volume, percent neointimal volume, total plaque volume and percent plaque volume between the two groups on intravascular ultrasonography (IVUS) study. Conclusion Our study demonstrated that low dose pioglitazone does not reduce rate of ISR, neointimal volume nor atheroma volume in DM patients who have undergone PCI with DESs, despite the limitations of the study. PMID:24142633

  20. 21 CFR 886.3340 - Extraocular orbital implant.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Extraocular orbital implant. 886.3340 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3340 Extraocular orbital implant. (a) Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during...

  1. 21 CFR 886.3320 - Eye sphere implant.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Eye sphere implant. 886.3320 Section 886.3320 Food... DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3320 Eye sphere implant. (a) Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the...

  2. 21 CFR 886.3340 - Extraocular orbital implant.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Extraocular orbital implant. 886.3340 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3340 Extraocular orbital implant. (a) Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during...

  3. 21 CFR 886.3340 - Extraocular orbital implant.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Extraocular orbital implant. 886.3340 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3340 Extraocular orbital implant. (a) Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during...

  4. 21 CFR 876.3630 - Penile rigidity implant.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Penile rigidity implant. 876.3630 Section 876.3630...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3630 Penile rigidity implant. (a) Identification. A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in...

  5. 21 CFR 886.3340 - Extraocular orbital implant.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Extraocular orbital implant. 886.3340 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3340 Extraocular orbital implant. (a) Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during...

  6. 21 CFR 876.3630 - Penile rigidity implant.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Penile rigidity implant. 876.3630 Section 876.3630...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3630 Penile rigidity implant. (a) Identification. A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in...

  7. 21 CFR 886.3340 - Extraocular orbital implant.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Extraocular orbital implant. 886.3340 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3340 Extraocular orbital implant. (a) Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during...

  8. 21 CFR 876.3630 - Penile rigidity implant.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Penile rigidity implant. 876.3630 Section 876.3630...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3630 Penile rigidity implant. (a) Identification. A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in...

  9. 21 CFR 876.3630 - Penile rigidity implant.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Penile rigidity implant. 876.3630 Section 876.3630...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3630 Penile rigidity implant. (a) Identification. A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in...

  10. 21 CFR 886.3320 - Eye sphere implant.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Eye sphere implant. 886.3320 Section 886.3320 Food... DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3320 Eye sphere implant. (a) Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the...

  11. 21 CFR 886.3320 - Eye sphere implant.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Eye sphere implant. 886.3320 Section 886.3320 Food... DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3320 Eye sphere implant. (a) Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the...

  12. 21 CFR 882.4545 - Shunt system implantation instrument.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... implantation instrument. (a) Identification. A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Shunt system implantation instrument....

  13. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  14. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  15. Optical coherence tomography analysis of the stent strut and prediction of resolved strut malapposition at 3 months after 2nd-generation drug-eluting stent implantation.

    PubMed

    Izumi, Daisuke; Miyahara, Masatoshi; Fujimoto, Naoki; Fukuoka, Shusuke; Sakai, Masataka; Dohi, Kaoru; Ito, Masaaki

    2016-08-01

    Our objective was to clarify whether thrombogenic problems with stent struts are resolved at 3 months after 2nd-generation drug-eluting stent implantation. Twenty-one patients with stable angina pectoris having 28 (22 zotarolimus-eluting, 6 everolimus-eluting) stents with optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) were evaluated. Stent strut coverage and malapposition were evaluated by OCT immediately after PCI and at 3-month follow-up. Acute strut malapposition was observed in 26 out of 28 analyzed stents (92.9 %). At 3-month follow-up, 7 (26.9 %) of those 26 stents with strut malapposition were completely resolved, and the mean percentages of uncovered struts and malapposed struts were 8.3 and 2.0 % when analyzed by each individual stent. When analyzing a total of 30,060 struts, 807 struts (2.7 %) demonstrated acute strut malapposition. Among these, 219 struts (27.1 %) demonstrated persistent strut malapposition. On the basis of receiver-operating characteristic curve analysis, a strut-to-vessel (S-V) distance ≤160 µm on post-stenting OCT images was the corresponding cutoff point for resolved malapposed struts (sensitivity 78.1 %, specificity 62.8 %, area under the curve 0.758). The S-V distance of persistent malapposed struts on post-stenting OCT images was longer than that of resolved malapposed struts (235 ± 112 vs. 176 ± 93 µm, p < 0.01). At 3 months after PCI, the prevalence rates of uncovered and malapposed struts were relatively low in 2nd-generation drug-eluting stent. Our results suggest that OCT-guide PCI with an S-V distance ≤160 µm may be recommended especially in patients with planed short-term DAPT. PMID:26334709

  16. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... implant). 872.3970 Section 872.3970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... disc prosthesis (interpositional implant). (a) Identification. An interarticular disc prosthesis (interpositional implant) is a device that is intended to be an interface between the natural articulating...

  17. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... implant). 872.3970 Section 872.3970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... disc prosthesis (interpositional implant). (a) Identification. An interarticular disc prosthesis (interpositional implant) is a device that is intended to be an interface between the natural articulating...

  18. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... implant). 872.3970 Section 872.3970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... disc prosthesis (interpositional implant). (a) Identification. An interarticular disc prosthesis (interpositional implant) is a device that is intended to be an interface between the natural articulating...

  19. High Productivity Implantation ''PARTIAL IMPLANT''

    SciTech Connect

    Hino, Masayoshi; Miyamoto, Naoki; Sakai, Shigeki; Matsumoto, Takao

    2008-11-03

    The patterned ion implantation 'PARTIAL IMPLANT' has been developed as a productivity improvement tool. The Partial Implant can form several different ion dose areas on the wafer surface by controlling the speed of wafer moving and the stepwise rotation of twist axis. The Partial Implant system contains two implant methods. One method is 'DIVIDE PARTIAL IMPLANT', that is aimed at reducing the consumption of the wafer. The Divide Partial Implant evenly divides dose area on one wafer surface into two or three different dose part. Any dose can be selected in each area. So the consumption of the wafer for experimental implantation can be reduced. The second method is 'RING PARTIAL IMPLANT' that is aimed at improving yield by correcting electrical characteristic of devices. The Ring Partial Implant can form concentric ion dose areas. The dose of wafer external area can be selected to be within plus or minus 30% of dose of wafer central area. So the electrical characteristic of devices can be corrected by controlling dose at edge side on the wafer.

  20. The use of a dual PEDOT and RGD-functionalized alginate hydrogel coating to provide sustained drug delivery and improved cochlear implant function

    PubMed Central

    Chikar, JA; Hendricks, JL; Richardson-Burns, SM; Raphael, Y; Pfingst, BE; Martin, DC

    2011-01-01

    Cochlear implants provide hearing by electrically stimulating the auditory nerve. Implant function can be hindered by device design variables, including electrode size and electrode-to-nerve distance, and cochlear environment variables, including the degeneration of the auditory nerve following hair cell loss. We have developed a dual component cochlear implant coating to improve both the electrical function of the implant and the biological stability of the inner ear, thereby facilitating the long-term perception of sound through a cochlear implant. This coating is a combination of an arginine-glycine-aspartic acid (RGD)-functionalized alginate hydrogel and the conducting polymer poly(3, 4-ethylenedioxythiophene) (PEDOT). Both in vitro and in vivo assays on the effects of these electrode coatings demonstrated improvements in device performance. We found that the coating reduced electrode impedance, improved charge delivery, and locally released significant levels of a trophic factor into cochlear fluids. This coating is non-cytotoxic, clinically relevant, and has the potential to significantly improve the cochlear implant user’s experience. PMID:22182748

  1. [Implant allergies].

    PubMed

    Thomas, P; Thomsen, M

    2010-03-01

    An increasing number of patients receive and benefit from osteosynthesis materials or artificial joint replacement. The most common complications are mechanical problems or infection. Metals like nickel, chromium and cobalt as well as bone cement components like acrylates and gentamicin are potential contact allergens which can cause intolerance reactions to implants. Eczema, delayed wound/bone healing, recurrent effusions, pain and implant loosening all have been described as manifestation of implant allergy. In contrast to the high incidence of cutaneous metal allergy, allergies associated with implants are rare. Diagnosis of metal implant allergy is still difficult. Thus differential diagnoses--in particular infection--have to be excluded and a combined approach of allergologic diagnostics by patch test and histopathology of peri-implant tissue is recommended. It is still unknown which conditions induce allergic sensitization to implants or trigger peri-implant allergic reactions in the case of preexisting cutaneous metal allergy. Despite the risk of developing complications being unclear, titanium based osteosynthesis materials are recommended for metal allergic patients and the use of metal-metal couplings in arthroplasty is not recommended for such patients. If the regular CoCr-polyethylene articulation is employed, the patient should give informed written consent. PMID:20204719

  2. 21 CFR 886.3320 - Eye sphere implant.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Eye sphere implant. 886.3320 Section 886.3320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3320 Eye sphere implant. (a) Identification. An...

  3. 21 CFR 886.3320 - Eye sphere implant.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Eye sphere implant. 886.3320 Section 886.3320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3320 Eye sphere implant. (a) Identification. An...

  4. 21 CFR 882.4545 - Shunt system implantation instrument.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Shunt system implantation instrument. 882.4545 Section 882.4545 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Surgical Devices § 882.4545 Shunt system implantation instrument. (a) Identification....

  5. 21 CFR 876.3630 - Penile rigidity implant.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Penile rigidity implant. 876.3630 Section 876.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3630 Penile rigidity implant....

  6. 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 SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Therapeutic Devices § 876.5270 Implanted electrical urinary continence device....

  7. 21 CFR 870.3610 - Implantable pacemaker pulse generator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implantable pacemaker pulse generator. 870.3610 Section 870.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... pacemaker pulse generator. (a) Identification. An implantable pacemaker pulse generator is a device that...

  8. 21 CFR 870.3610 - Implantable pacemaker pulse generator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implantable pacemaker pulse generator. 870.3610 Section 870.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... pacemaker pulse generator. (a) Identification. An implantable pacemaker pulse generator is a device that...

  9. 21 CFR 870.3610 - Implantable pacemaker pulse generator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implantable pacemaker pulse generator. 870.3610 Section 870.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... pacemaker pulse generator. (a) Identification. An implantable pacemaker pulse generator is a device that...

  10. Cochlear Implants

    MedlinePlus

    ... additional visits are needed for activating, adjusting, and programming the various electrodes that have been implanted. Also, ... to the center for checkups once the final programming is made to the speech processor. Both children ...

  11. Histrelin Implant

    MedlinePlus

    ... bone growth and development of sexual characteristics) in girls usually between 2 and 8 years of age ... MRI scans (radiology techniques designed to show the images of body structures) to find the implant when ...

  12. Goserelin Implant

    MedlinePlus

    ... which the type of tissue that lines the uterus [womb] grows in other areas of the body ... with the treatment of abnormal bleeding of the uterus. Goserelin implant is in a class of medications ...

  13. Ion Implantation

    NASA Astrophysics Data System (ADS)

    Langouche, G.; Yoshida, Y.

    In this tutorial we describe the basic principles of the ion implantation technique and we demonstrate that emission Mössbauer spectroscopy is an extremely powerful technique to investigate the atomic and electronic configuration around implanted atoms. The physics of dilute atoms in materials, the final lattice sites and their chemical state as well as diffusion phenomena can be studied. We focus on the latest developments of implantation Mössbauer spectroscopy, where three accelerator facilities, i.e., Hahn-Meitner Institute Berlin, ISOLDE-CERN and RIKEN, have intensively been used for materials research in in-beam and on-line Mössbauer experiments immediately after implantation of the nuclear probes.

  14. Dental Implants

    MedlinePlus Videos and Cool Tools

    ... facts so you can make an informed decision as to whether dental implants are right for your ... the jaw bone. It’s obviously not the same as the original connection , but functions just the same. ...

  15. Magnetic Beads Enhance Adhesion of NIH 3T3 Fibroblasts: A Proof-of-Principle In Vitro Study for Implant-Mediated Long-Term Drug Delivery to the Inner Ear

    PubMed Central

    Aliuos, Pooyan; Schulze, Jennifer; Schomaker, Markus; Reuter, Günter; Stolle, Stefan R. O.; Werner, Darja; Ripken, Tammo; Lenarz, Thomas; Warnecke, Athanasia

    2016-01-01

    Introduction Long-term drug delivery to the inner ear may be achieved by functionalizing cochlear implant (CI) electrodes with cells providing neuroprotective factors. However, effective strategies in order to coat implant surfaces with cells need to be developed. Our vision is to make benefit of electromagnetic field attracting forces generated by CI electrodes to bind BDNF-secreting cells that are labelled with magnetic beads (MB) onto the electrode surfaces. Thus, the effect of MB-labelling on cell viability and BDNF production were investigated. Materials and Methods Murine NIH 3T3 fibroblasts—genetically modified to produce BDNF—were labelled with MB. Results Atomic force and bright field microscopy illustrated the internalization of MB by fibroblasts after 24 h of cultivation. Labelling cells with MB did not expose cytotoxic effects on fibroblasts and allowed adhesion on magnetic surfaces with sufficient BDNF release. Discussion Our data demonstrate a novel approach for mediating enhanced long-term adhesion of BDNF-secreting fibroblasts on model electrode surfaces for cell-based drug delivery applications in vitro and in vivo. This therapeutic strategy, once transferred to cells suitable for clinical application, may allow the biological modifications of CI surfaces with cells releasing neurotrophic or other factors of interest. PMID:26918945

  16. Antimicrobial technology in orthopedic and spinal implants.

    PubMed

    Eltorai, Adam Em; Haglin, Jack; Perera, Sudheesha; Brea, Bielinsky A; Ruttiman, Roy; Garcia, Dioscaris R; Born, Christopher T; Daniels, Alan H

    2016-06-18

    Infections can hinder orthopedic implant function and retention. Current implant-based antimicrobial strategies largely utilize coating-based approaches in order to reduce biofilm formation and bacterial adhesion. Several emerging antimicrobial technologies that integrate a multidisciplinary combination of drug delivery systems, material science, immunology, and polymer chemistry are in development and early clinical use. This review outlines orthopedic implant antimicrobial technology, its current applications and supporting evidence, and clinically promising future directions. PMID:27335811

  17. Antimicrobial technology in orthopedic and spinal implants

    PubMed Central

    Eltorai, Adam EM; Haglin, Jack; Perera, Sudheesha; Brea, Bielinsky A; Ruttiman, Roy; Garcia, Dioscaris R; Born, Christopher T; Daniels, Alan H

    2016-01-01

    Infections can hinder orthopedic implant function and retention. Current implant-based antimicrobial strategies largely utilize coating-based approaches in order to reduce biofilm formation and bacterial adhesion. Several emerging antimicrobial technologies that integrate a multidisciplinary combination of drug delivery systems, material science, immunology, and polymer chemistry are in development and early clinical use. This review outlines orthopedic implant antimicrobial technology, its current applications and supporting evidence, and clinically promising future directions. PMID:27335811

  18. 21 CFR 522.960 - Flumethasone implantation or injectable dosage forms.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Flumethasone implantation or injectable dosage... HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS § 522.960 Flumethasone implantation or injectable dosage forms....

  19. 21 CFR 522.90 - Ampicillin implantation and injectible dosage forms.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Ampicillin implantation and injectible dosage... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS § 522.90 Ampicillin implantation and injectible dosage forms....

  20. 21 CFR 522.2444 - Sodium thiopental implantation or injectable dosage forms.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Sodium thiopental implantation or injectable... AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS § 522.2444 Sodium thiopental implantation or injectable dosage forms....

  1. Multicomponent Implant Releasing Dexamethasone

    NASA Astrophysics Data System (ADS)

    Nikkola, L.; Vapalahti, K.; Ashammakhi, N.

    2008-02-01

    Several inflammatory conditions are usually treated with corticosteroids. There are various problems like side effects with traditional applications of steroids, e.g. topical, or systemic routes. Local drug delivery systems have been studied and developed to gain more efficient administration with fewer side effects. Earlier, we reported on developing Dexamethasone (DX) releasing biodegradable fibers. However, their drug release properties were not satisfactory in terms of onset of drug release. Thus, we assessed the development of multicomponent (MC) implant to enhance earlier drug release from such biodegradable fibers. Poly (lactide-co-glycolide) (PLGA) and 2 wt-% and 8 wt-% DX were compounded and extruded with twin-screw extruder to form of fibers. Some of the fibers were sterilized to obtain a change in drug release properties. Four different fiber classes were studied: 2 wt-%, 8 wt-%, sterilized 2 wt-%, and sterilized 8 wt-%. 3×4 different DX-releasing fibers were then heat-pressed to form one multicomponent rod. Half of the rods where sterilized. Drug release was measured from initial fibers and multicomponent rods using a UV/VIS spectrometer. Shear strength and changes in viscosity were also measured. Drug release studies showed that drug release commenced earlier from multicomponent rods than from component fibers. Drug release from multicomponent rods lasted from day 30 to day 70. The release period of sterilized rods extended from day 23 to day 57. When compared to the original component fibers, the drug release from MC rods commenced earlier. The initial shear strength of MC rods was 135 MPa and decreased to 105 MPa during four weeks of immersion in phosphate buffer solution. Accordingly, heat pressing has a positive effect on drug release. After four weeks in hydrolysis, no disintegration was observed.

  2. Effects of cigarette smoking on platelet reactivity during P2Y12 inhibition in patients with myocardial infarction undergoing drug-eluting stent implantation: results from the prospective cigarette smoking on platelet reactivity (COPTER) study.

    PubMed

    Patti, Giuseppe; Polacco, Marina; Taurino, Ester; Gaudio, Carlo; Greco, Cesare

    2016-05-01

    Interaction between cigarette smoking and efficacy of oral antiplatelet drugs is not definitely elucidated. We evaluated the effects of cigarette smoking on platelet reactivity in patients receiving different oral P2Y12 antagonists after myocardial infarction (MI) and drug-eluting stent (DES) implantation. Two-hundred-five consecutive current smokers receiving DES implantation after ST-segment elevation MI were enrolled. All patients were aspirin-treated and were on chronic therapy with clopidogrel (N = 59), prasugrel (N = 71) or ticagrelor (N = 75); by protocol, all patients at baseline had no high on-treatment platelet reactivity by the VerifyNow P2Y12 assay. Platelet reactivity, expressed by P2Y12 reaction units (PRU), was measured in all patients at baseline (T0), after a 15-day period of smoking cessation (T1) and after further 15 days of smoking resumption (T2). In the overall population there was a modest, albeit significant, reduction of PRU values from T0 to T1 (from 173 ± 14 to 165 ± 17, P < 0.0001); resumption of cigarette smoking was associated with re-increase of platelet reactivity (from 165 ± 17 at T1 to 170 ± 17 at T2, P = 0.0002). These variations were consistent in the subgroups receiving clopidogrel, prasugrel or ticagrelor and were irrespective of the number of cigarettes smoked. In conclusion, cigarette smoking weakly influences antiplatelet effects of oral P2Y12 inhibition and this was irrespective of the type of antiplatelet agent; thus, interaction between cigarette smoking and efficacy of oral antiplatelet drugs is modest and unlikely translates into clinical effects (ClinicalTrials.gov Identifier: NCT02026713). PMID:26849144

  3. FDA Approves Implant to Battle Opioid Addiction

    MedlinePlus

    ... 159050.html FDA Approves Implant to Battle Opioid Addiction Experts say steady dosing eliminates need to take ... U.S. Food and Drug Administration. "Opioid abuse and addiction have taken a devastating toll on American families. ...

  4. 21 CFR 886.3300 - Absorbable implant (scleral buckling method).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Absorbable implant (scleral buckling method). 886... SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3300 Absorbable implant (scleral buckling method). (a) Identification. An absorbable implant (scleral buckling method) is a...

  5. 21 CFR 882.5225 - Implanted malleable clip.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted malleable clip. 882.5225 Section 882...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5225 Implanted malleable clip. (a) Identification. An implanted malleable clip is a bent wire or staple that is forcibly closed...

  6. 21 CFR 882.4545 - Shunt system implantation instrument.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shunt system implantation instrument. 882.4545... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Surgical Devices § 882.4545 Shunt system implantation instrument. (a) Identification. A shunt system implantation instrument is an instrument used...

  7. 21 CFR 882.5860 - Implanted neuromuscular stimulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted neuromuscular stimulator. 882.5860... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5860 Implanted neuromuscular stimulator. (a) Identification. An implanted neuromuscular stimulator is a device that...

  8. 21 CFR 882.5860 - Implanted neuromuscular stimulator.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted neuromuscular stimulator. 882.5860... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5860 Implanted neuromuscular stimulator. (a) Identification. An implanted neuromuscular stimulator is a device that...

  9. 21 CFR 882.5820 - Implanted cerebellar stimulator.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted cerebellar stimulator. 882.5820 Section... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5820 Implanted cerebellar stimulator. (a) Identification. An implanted cerebellar stimulator is a device used to...

  10. 21 CFR 882.5225 - Implanted malleable clip.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted malleable clip. 882.5225 Section 882...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5225 Implanted malleable clip. (a) Identification. An implanted malleable clip is a bent wire or staple that is forcibly closed...

  11. 21 CFR 882.5820 - Implanted cerebellar stimulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted cerebellar stimulator. 882.5820 Section... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5820 Implanted cerebellar stimulator. (a) Identification. An implanted cerebellar stimulator is a device used to...

  12. 21 CFR 886.3300 - Absorbable implant (scleral buckling method).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Absorbable implant (scleral buckling method). 886... SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3300 Absorbable implant (scleral buckling method). (a) Identification. An absorbable implant (scleral buckling method) is a...

  13. 21 CFR 882.5225 - Implanted malleable clip.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted malleable clip. 882.5225 Section 882...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5225 Implanted malleable clip. (a) Identification. An implanted malleable clip is a bent wire or staple that is forcibly closed...

  14. 21 CFR 876.3350 - Penile inflatable implant.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Penile inflatable implant. 876.3350 Section 876...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3350 Penile inflatable implant. (a) Identification. A penile inflatable implant is a device that consists of two inflatable...

  15. 21 CFR 886.3300 - Absorbable implant (scleral buckling method).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Absorbable implant (scleral buckling method). 886... SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3300 Absorbable implant (scleral buckling method). (a) Identification. An absorbable implant (scleral buckling method) is a...

  16. 21 CFR 886.3300 - Absorbable implant (scleral buckling method).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Absorbable implant (scleral buckling method). 886... SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3300 Absorbable implant (scleral buckling method). (a) Identification. An absorbable implant (scleral buckling method) is a...

  17. 21 CFR 882.5860 - Implanted neuromuscular stimulator.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted neuromuscular stimulator. 882.5860... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5860 Implanted neuromuscular stimulator. (a) Identification. An implanted neuromuscular stimulator is a device that...

  18. 21 CFR 882.5820 - Implanted cerebellar stimulator.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted cerebellar stimulator. 882.5820 Section... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5820 Implanted cerebellar stimulator. (a) Identification. An implanted cerebellar stimulator is a device used to...

  19. 21 CFR 876.3350 - Penile inflatable implant.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Penile inflatable implant. 876.3350 Section 876...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3350 Penile inflatable implant. (a) Identification. A penile inflatable implant is a device that consists of two inflatable...

  20. 21 CFR 882.5225 - Implanted malleable clip.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted malleable clip. 882.5225 Section 882...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5225 Implanted malleable clip. (a) Identification. An implanted malleable clip is a bent wire or staple that is forcibly closed...

  1. 21 CFR 886.3300 - Absorbable implant (scleral buckling method).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Absorbable implant (scleral buckling method). 886... SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3300 Absorbable implant (scleral buckling method). (a) Identification. An absorbable implant (scleral buckling method) is a...

  2. 21 CFR 872.3645 - Subperiosteal implant material.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Subperiosteal implant material. 872.3645 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3645 Subperiosteal implant material. (a) Identification. Subperiosteal implant material is a device composed of titanium or cobalt chrome...

  3. 21 CFR 876.3350 - Penile inflatable implant.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Penile inflatable implant. 876.3350 Section 876...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3350 Penile inflatable implant. (a) Identification. A penile inflatable implant is a device that consists of two inflatable...

  4. 21 CFR 872.3645 - Subperiosteal implant material.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Subperiosteal implant material. 872.3645 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3645 Subperiosteal implant material. (a) Identification. Subperiosteal implant material is a device composed of titanium or cobalt chrome...

  5. 21 CFR 882.5225 - Implanted malleable clip.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted malleable clip. 882.5225 Section 882...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5225 Implanted malleable clip. (a) Identification. An implanted malleable clip is a bent wire or staple that is forcibly closed...

  6. 21 CFR 872.3980 - Endosseous dental implant accessories.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices...

  7. 21 CFR 872.3640 - Endosseous dental implant.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endosseous dental implant. 872.3640 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3640 Endosseous dental implant. (a) Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy,...

  8. 21 CFR 872.3630 - Endosseous dental implant abutment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic...

  9. 21 CFR 872.3980 - Endosseous dental implant accessories.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices...

  10. 21 CFR 872.3630 - Endosseous dental implant abutment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic...

  11. 21 CFR 872.3980 - Endosseous dental implant accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices...

  12. 21 CFR 872.3630 - Endosseous dental implant abutment.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic...

  13. 21 CFR 872.3630 - Endosseous dental implant abutment.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic...

  14. 21 CFR 872.3640 - Endosseous dental implant.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Endosseous dental implant. 872.3640 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3640 Endosseous dental implant. (a) Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy,...

  15. 21 CFR 872.3980 - Endosseous dental implant accessories.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices...

  16. 21 CFR 872.3640 - Endosseous dental implant.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Endosseous dental implant. 872.3640 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3640 Endosseous dental implant. (a) Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy,...

  17. 21 CFR 872.3980 - Endosseous dental implant accessories.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices...

  18. 21 CFR 872.3630 - Endosseous dental implant abutment.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic...

  19. 21 CFR 870.3610 - Implantable pacemaker pulse generator.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implantable pacemaker pulse generator. 870.3610... pacemaker pulse generator. (a) Identification. An implantable pacemaker pulse generator is a device that has... implantable pacemaker pulse generator device that was in commercial distribution before May 28, 1976, or...

  20. 21 CFR 870.3610 - Implantable pacemaker pulse generator.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implantable pacemaker pulse generator. 870.3610... pacemaker pulse generator. (a) Identification. An implantable pacemaker pulse generator is a device that has... implantable pacemaker pulse generator device that was in commercial distribution before May 28, 1976, or...

  1. POLYMERIC IMPLANTS FOR DELIVERY OF GREEN TEA POLYPHENOLS

    PubMed Central

    Cao, Pengxiao; Aqil, Farrukh; Ravoori, Srivani; Gupta, Ramesh C.; Vadhanam, Manicka V.

    2014-01-01

    Polymeric implants (millirods) have been tested for local delivery of chemotherapeutic agents in cancer treatment. Modeling of drug release profiles is critical as it may provide theoretical insights on rational implant design. In this study, a biodegradable poly (ε-caprolactone) (PCL) polymeric implant delivery system was tested to deliver green tea polyphenols (GTPs), both in vitro and in vivo. Factors including polymer compositions, supplements, drug loads and surface area of implants were investigated. Our data showed that GTPs were released from PCL implants continuously for long durations, and drug load was the main determining factor of GTPs release. Furthermore, the rates of in vitro release and in vivo release in the rat model followed similar kinetics for up to 16 months. A mathematical model was deduced and discussed. GTPs implants have the potential to be used locally as an alternative strategy. GTP implants have the potential to be used systemically and locally at the tumor site as an alternative strategy. PMID:24464784

  2. Cochlear Implants

    MedlinePlus

    ... outside of the body, behind the ear. A second part is surgically placed under the skin. An implant does not restore normal hearing. It can help a person understand speech. Children and adults can benefit from them. National Institute on Deafness and Other Communication Disorders

  3. Cochlear implant

    MedlinePlus

    ... are sent along the auditory nerve to the brain. A deaf person does not have a functioning inner ear. A cochlear implant tries to replace the function of the inner ear by ... signals to the brain. Sound is picked up by a microphone worn ...

  4. Prognostic Impact of 9-Month High-Sensitivity C-Reactive Protein Levels on Long-Term Clinical Outcomes and In-Stent Restenosis in Patients at 9 Months after Drug-Eluting Stent Implantation

    PubMed Central

    Hsieh, I-Chang; Chen, Chun-Chi; Hsieh, Ming-Jer; Yang, Chia-Hung; Chen, Dong-Yi; Chang, Shang-Hung; Wang, Chao-Yung; Lee, Cheng-Hung; Tsai, Ming-Lung

    2015-01-01

    Introduction The level of 9-month high-sensitivity C-reactive protein (hsCRP) in predicting cardiovascular outcomes is scanty in patients at 9 months after receiving drug-eluting stent (DES) implantations. This study aims to evaluate the relationship between 9-month follow-up hsCRP levels and long-term clinical outcomes in patients at 9 months after receiving DES. Methods A total of 1,763 patients who received 9-month follow-up angiography were enrolled and grouped according to hsCRP level 9 months after the DES implantation: group I (718 patients, hsCRP<1.0 mg/L), group II (639 patients, 1.0≦hsCRP≦3.0 mg/L), and group III (406 patients, hsCRP>3.0 mg/L). Results Group III patients had a lower cardiovascular event-free survival rate than group I or II patients during a follow-up of 64±45 months (64.5% vs. 71.6% vs. 72.8%, respectively, p = 0.012). Multivariate analysis showed that a follow-up hsCRP level <3.0 mg/L was an independent predictor of a major adverse cardiovascular event (cardiac death, reinfarction, target lesion revascularization, stenting in a new lesion, or coronary bypass surgery). Group III patients had a higher restenosis rate (11.3% vs. 5.8% vs. 6.6%, respectively, p = 0.002) and loss index (0.21±0.32 vs. 0.16±0.24 vs. 0.18±0.28, respectively, p = 0.001) than group I or II patients in 9-month follow-up angiography. Conclusions A high 9-month follow-up hsCRP level is an independent predictor of long-term clinical cardiovascular outcomes in patients at 9 months after DES implantation. It is also associated with a higher restenosis rate, larger late loss and loss index at 9 months after DES implantation. PMID:26406989

  5. Therapy using implanted organic bioelectronics

    PubMed Central

    Jonsson, Amanda; Song, Zhiyang; Nilsson, David; Meyerson, Björn A.; Simon, Daniel T.; Linderoth, Bengt; Berggren, Magnus

    2015-01-01

    Many drugs provide their therapeutic action only at specific sites in the body, but are administered in ways that cause the drug’s spread throughout the organism. This can lead to serious side effects. Local delivery from an implanted device may avoid these issues, especially if the delivery rate can be tuned according to the need of the patient. We turned to electronically and ionically conducting polymers to design a device that could be implanted and used for local electrically controlled delivery of therapeutics. The conducting polymers in our device allow electronic pulses to be transduced into biological signals, in the form of ionic and molecular fluxes, which provide a way of interfacing biology with electronics. Devices based on conducting polymers and polyelectrolytes have been demonstrated in controlled substance delivery to neural tissue, biosensing, and neural recording and stimulation. While providing proof of principle of bioelectronic integration, such demonstrations have been performed in vitro or in anesthetized animals. Here, we demonstrate the efficacy of an implantable organic electronic delivery device for the treatment of neuropathic pain in an animal model. Devices were implanted onto the spinal cord of rats, and 2 days after implantation, local delivery of the inhibitory neurotransmitter γ-aminobutyric acid (GABA) was initiated. Highly localized delivery resulted in a significant decrease in pain response with low dosage and no observable side effects. This demonstration of organic bioelectronics-based therapy in awake animals illustrates a viable alternative to existing pain treatments, paving the way for future implantable bioelectronic therapeutics. PMID:26601181

  6. Microfabricated injectable drug delivery system

    DOEpatents

    Krulevitch, Peter A.; Wang, Amy W.

    2002-01-01

    A microfabricated, fully integrated drug delivery system capable of secreting controlled dosages of multiple drugs over long periods of time (up to a year). The device includes a long and narrow shaped implant with a sharp leading edge for implantation under the skin of a human in a manner analogous to a sliver. The implant includes: 1) one or more micromachined, integrated, zero power, high and constant pressure generating osmotic engine; 2) low power addressable one-shot shape memory polymer (SMP) valves for switching on the osmotic engine, and for opening drug outlet ports; 3) microfabricated polymer pistons for isolating the pressure source from drug-filled microchannels; 4) multiple drug/multiple dosage capacity, and 5) anisotropically-etched, atomically-sharp silicon leading edge for penetrating the skin during implantation. The device includes an externally mounted controller for controlling on-board electronics which activates the SMP microvalves, etc. of the implant.

  7. 21 CFR 522.1696 - Penicillin G procaine implantation and injectable dosage forms.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Penicillin G procaine implantation and injectable dosage forms. 522.1696 Section 522.1696 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... DOSAGE FORM NEW ANIMAL DRUGS § 522.1696 Penicillin G procaine implantation and injectable dosage forms....

  8. 21 CFR 522.1696 - Penicillin G procaine implantation and injectable dosage forms.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Penicillin G procaine implantation and injectable dosage forms. 522.1696 Section 522.1696 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... DOSAGE FORM NEW ANIMAL DRUGS § 522.1696 Penicillin G procaine implantation and injectable dosage forms....

  9. 21 CFR 522.1696 - Penicillin G procaine implantation and injectable dosage forms.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Penicillin G procaine implantation and injectable dosage forms. 522.1696 Section 522.1696 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... DOSAGE FORM NEW ANIMAL DRUGS § 522.1696 Penicillin G procaine implantation and injectable dosage forms....

  10. 21 CFR 522.1696 - Penicillin G procaine implantation and injectable dosage forms.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Penicillin G procaine implantation and injectable dosage forms. 522.1696 Section 522.1696 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... DOSAGE FORM NEW ANIMAL DRUGS § 522.1696 Penicillin G procaine implantation and injectable dosage forms....

  11. 21 CFR 522.1662 - Oxytetracycline hydrochloride implantation or injectable dosage forms.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Oxytetracycline hydrochloride implantation or injectable dosage forms. 522.1662 Section 522.1662 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS § 522.1662 Oxytetracycline hydrochloride implantation or...

  12. Implantable, multifunctional, bioresorbable optics

    PubMed Central

    Tao, Hu; Kainerstorfer, Jana M.; Siebert, Sean M.; Pritchard, Eleanor M.; Sassaroli, Angelo; Panilaitis, Bruce J. B.; Brenckle, Mark A.; Amsden, Jason J.; Levitt, Jonathan; Fantini, Sergio; Kaplan, David L.; Omenetto, Fiorenzo G.

    2012-01-01

    Advances in personalized medicine are symbiotic with the development of novel technologies for biomedical devices. We present an approach that combines enhanced imaging of malignancies, therapeutics, and feedback about therapeutics in a single implantable, biocompatible, and resorbable device. This confluence of form and function is accomplished by capitalizing on the unique properties of silk proteins as a mechanically robust, biocompatible, optically clear biomaterial matrix that can house, stabilize, and retain the function of therapeutic components. By developing a form of high-quality microstructured optical elements, improved imaging of malignancies and of treatment monitoring can be achieved. The results demonstrate a unique family of devices for in vitro and in vivo use that provide functional biomaterials with built-in optical signal and contrast enhancement, demonstrated here with simultaneous drug delivery and feedback about drug delivery with no adverse biological effects, all while slowly degrading to regenerate native tissue. PMID:23150544

  13. Mechanical properties, biological behaviour and drug release capability of nano TiO2-HAp-Alginate composite scaffolds for potential application as bone implant material.

    PubMed

    Naik, Kshipra; Chandran, V Girish; Rajashekaran, Raghavan; Waigaonkar, Sachin; Kowshik, Meenal

    2016-09-01

    Nanocomposite scaffolds of TiO2 and hydroxyapatite nanoparticles with alginate as the binding agent were fabricated using the freeze drying technique. TiO2, hydroxyapatite and alginate were used in the ratio of 1:1:4. The scaffolds were characterized using X-ray diffraction, fourier transform infrared spectroscopy, and scanning electron microscopy. The biocompatibility of the scaffolds was evaluated using cell adhesion and MTT assay on osteosarcoma (MG-63) cells. Scanning electron microscopy analysis revealed that cells adhered to the surface of the scaffolds with good spreading. The mechanical properties of the scaffolds were investigated using dynamic mechanical analysis. The swelling ability, porosity, in vitro degradation, and biomineralization of the scaffolds were also evaluated. The results indicated controlled swelling, limited degradation, and enhanced biomineralization. Further, drug delivery studies of the scaffolds using the chemotherapeutic drug methotrexate exhibited an ideal drug release profile. These scaffolds are proposed as potential candidates for bone tissue engineering and drug delivery applications. PMID:27485954

  14. Macrophage responses to implants: prospects for personalized medicine.

    PubMed

    Kzhyshkowska, Julia; Gudima, Alexandru; Riabov, Vladimir; Dollinger, Camille; Lavalle, Philippe; Vrana, Nihal Engin

    2015-12-01

    Implants, transplants, and implantable biomedical devices are mainstream solutions for a wide variety of human pathologies. One of the persistent problems around nondegradable metallic and polymeric implants is failure of macrophages to resolve the inflammation and their tendency to stay in a state, named "frustrated phagocytosis." During the initial phase, proinflammatory macrophages induce acute reactions to trauma and foreign materials, whereas tolerogenic anti-inflammatory macrophages control resolution of inflammation and induce the subsequent healing stage. However, implanted materials can induce a mixed pro/anti-inflammatory phenotype, supporting chronic inflammatory reactions accompanied by microbial contamination and resulting in implant failure. Several materials based on natural polymers for improved interaction with host tissue or surfaces that release anti-inflammatory drugs/bioactive agents have been developed for implant coating to reduce implant rejection. However, no definitive, long-term solution to avoid adverse immune responses to the implanted materials is available to date. The prevention of implant-associated infections or chronic inflammation by manipulating the macrophage phenotype is a promising strategy to improve implant acceptance. The immunomodulatory properties of currently available implant coatings need to be improved to develop personalized therapeutic solutions. Human primary macrophages exposed to the implantable materials ex vivo can be used to predict the individual's reactions and allow selection of an optimal coating composition. Our review describes current understanding of the mechanisms of macrophage interactions with implantable materials and outlines the prospects for use of human primary macrophages for diagnostic and therapeutic approaches to personalized implant therapy. PMID:26168797

  15. Polymeric implants for the delivery of green tea polyphenols.

    PubMed

    Cao, Pengxiao; Jeyabalan, Jeyaprakash; Aqil, Farrukh; Ravoori, Srivani; Gupta, Ramesh C; Vadhanam, Manicka V

    2014-03-01

    Polymeric implants (millirods) have been tested for local delivery of chemotherapeutic agents in cancer treatment. Modeling of drug release profiles is critical as it may provide theoretical insights on rational implant design. In this study, a biodegradable poly (ε-caprolactone) (PCL) polymeric implant delivery system was tested to deliver green tea polyphenols (GTPs), both in vitro and in vivo. Factors including polymer compositions, supplements, drug loads, and surface area of implants were investigated. Our data showed that GTPs were released from PCL implants continuously for long durations, and drug load was the main determining factor of GTPs release. Furthermore, rates of in vitro release and in vivo release in the rat model followed similar kinetics for up to 16 months. A mathematical model was deduced and discussed. GTP implants have the potential to be used systemically and locally at the tumor site as an alternative strategy. PMID:24464784

  16. Comparison of Fusion Imaging Using a Combined SPECT/CT System and Intra-arterial CT: Assessment of Drug Distribution by an Implantable Port System in Patients Undergoing Hepatic Arterial Infusion Chemotherapy

    SciTech Connect

    Ikeda, Osamu Kusunoki, Shinichiroh; Nakaura, Takeshi; Shiraishi, Shinya; Kawanaka, Kouichi; Tomiguchi, Seiji; Yamashita, Yasuyuki; Takamori, Hiroshi; Chikamoto, Akira; Kanemitsu, Keiichiro

    2006-06-15

    Hepatic arterial infusion (HAI) chemotherapy is effective for treating primary and metastatic carcinoma of the liver. We compared the perfusion patterns of HAI chemotherapy on intra-arterial port-catheter computed tomography (iapc-CT) and fused images obtained with a combined single-photon emission computed tomography/computed tomography (SPECT/CT) system. We studied 28 patients with primary or metastatic carcinoma of the liver who bore an implantable HAI port system. All underwent abdominal SPECT using Tc-99m-MAA (185 Mbq); the injection rate was 1 mL/min, identical to the chemotherapy infusion rate, and 0.5 mL/sec for iapc-CT. Delivery was through an implantable port. We compared the intrahepatic perfusion (IHP) and extrahepatic perfusion (EHP) patterns of HAI chemotherapy on iapc-CT images and fused images obtained with a combined SPECT/CT system. In 23 of 28 patients (82%), IHP patterns on iapc-CT images and fused images were identical. In 5 of the 28 patients (18%), IHP on fusion images was different from IHP on iapc-CT images. EHP was seen on fused images in 12 of the 28 patients (43%) and on iapc-CT images in 8 patients (29%). In 17 patients (61%), upper gastrointestinal endoscopy revealed gastroduodenal mucosal lesions. EHP was revealed on fused images in 10 of these patients; 9 of them manifested gastroduodenal toxicity at the time of subsequent HAI chemotherapy. Fusion imaging using the combined SPECT/CT system reflects the actual distribution of the infused anticancer agent. This information is valuable not only for monitoring adequate drug distribution but also for avoiding potential extrahepatic complications.

  17. Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Dual antiplatelet therapy with aspirin and thienopyridine is required after placement of coronary drug-eluting stents (DES) to prevent thrombotic complications. Current clinical guidelines recommend at least 6 to 12 months of treatment after a DES implantation, but it may be beneficial to apply dual antiplatelet therapy for a longer duration. Methods/design The optimal dual antiplatelet therapy (OPTIDUAL) study aims to compare the benefits and risks of dual antiplatelet therapy applied for either 12 or 48 months. We will examine the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) in patients undergoing percutaneous coronary intervention with DES for the treatment of coronary lesions. The OPTIDUAL study is an open-label multicenter, randomized, national trial that will include 1,966 patients treated with DES. All patients will be treated with dual antiplatelet therapy for 12 months (+/− 3). Then, patients with no MACCE or major bleeding will be randomized to receive either 36 additional months of clopidogrel plus aspirin or aspirin only. The primary end-point is the combination of death from all causes, myocardial infarction, stroke and major bleeding. The secondary end points include the individual components of the primary end-point, stent thrombosis, repeat revascularization of the treated vessel and minor bleeding. Discussion This randomized trial is designed to assess the benefits and safety of 12 versus 48 months of dual antiplatelet therapy in patients that receive a DES. We aim to determine whether substantial prolongation of clopidogrel (a thienopyridine) after DES implantation offers an advantage over its discontinuation. Trial registration ClinicalTrials.gov Identifier: NCT00822536 PMID:23433461

  18. On the Horizon: Cochlear Implant Technology.

    PubMed

    Roche, Joseph P; Hansen, Marlan R

    2015-12-01

    Cochlear implantation and cochlear implants (CIs) have a long history filled with innovations that have resulted in the high-performing device's currently available. Several promising technologies have been reviewed in this article, which hold the promise to drive performance even higher. Remote CI programming, totally implanted devices, improved neural health and survival through targeted drug therapy and delivery, intraneural electrode placement, electroacoustical stimulation and hybrid CIs, and methods to enhance the neural-prosthesis interface are evolving areas of innovation reviewed in this article. PMID:26443490

  19. Retrograde peri-implantitis.

    PubMed

    Mohamed, Jumshad B; Shivakumar, B; Sudarsan, Sabitha; Arun, K V; Kumar, T S S

    2010-01-01

    Retrograde peri-implantitis constitutes an important cause for implant failure. Retrograde peri-implantitis may sometimes prove difficult to identify and hence institution of early treatment may not be possible. This paper presents a report of four cases of (the implant placed developing to) retrograde peri-implantitis. Three of these implants were successfully restored to their fully functional state while one was lost due to extensive damage. The paper highlights the importance of recognizing the etiopathogenic mechanisms, preoperative assessment, and a strong postoperative maintenance protocol to avoid retrograde peri-implant inflammation. PMID:20922082

  20. Diclofenac Sodium Loaded Multicomponent Implant

    NASA Astrophysics Data System (ADS)

    Nikkola, Lila; Viitanen, Petrus; Ashammakhi, Nureddin

    2008-02-01

    Earlier we have reported on developing DS releasing bioabsorbable rods for inhibition of osteolysis [l]. Due to their unsatisfactory drug release profiles we assessed the use of sintering technique of enhancement of drug release in the current study. Melt extruded PLGA 80/20 rods were compounded 8 wt-% DS. Some rods were self reinforced (SR) and some of them were sterilized to get three different components with different drug release profiles. Different rods were sintered together with heat and pressure. Three different specimen groups with different construction were studied. Thermal properties were analyzed using differential scanning calorimetry (DSC). Changes of IV were performed with capillary analysis and drug release measurements with UV-Vis spectrophotometer. Mechanical strength were measured two weeks, when disintegration occurred. Release rate consisted of 1) sharp jump start peak, 2) second smoother peak, and 3) third smooth peak. Released DS concentrations reached local therapeutic levels and maintained at that stage for 24-36 days. All DS was released during 50-70 days. The drug release from multicomponent implant was more stable and commenced earlier than from initial rods. Such properties were favored ones. Initial shear strength was 82 MPa and it decreased to 15 MPa. The mechanical bonding was sufficient although the components disintegrated relatively fast. By sintering different PLGA/DS components with different release rates it is possible to construct a truly controlled release implant for bone fixation with anti-inflammatory properties.

  1. 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)...

  2. 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 device. 876.5280 Section 876.5280 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Therapeutic Devices § 876.5280 Implanted mechanical/hydraulic...

  3. Relation of genetic polymorphisms in the cytochrome P450 gene with clopidogrel resistance after drug-eluting stent implantation in Koreans.

    PubMed

    Lee, Jung Myung; Park, Sungha; Shin, Dong-Jik; Choi, Donghoon; Shim, Chi Young; Ko, Young-Guk; Kim, Jung-Sun; Shin, Eun-Soon; Chang, Chong Won; Lee, Jong-Eun; Jang, Yangsoo

    2009-07-01

    Clopidogrel is a prodrug that has to be converted to an active metabolite by hepatic cytochrome P450 (CYP) isoenzymes to inhibit platelet aggregation. Individual variability of platelet inhibition by clopidogrel suggests a possibility for genetic factors having a significant influence on clopidogrel responsiveness. In this study, we sought to determine the relation of genetic polymorphisms of CYP genes to clopidogrel resistance in Koreans. Four hundred fifty patients who underwent successful percutaneous coronary intervention with drug-eluting stents were randomly assigned to treatment with dual antiplatelet regimen (aspirin plus clopidogrel) or triple antiplatelet regimen (aspirin plus clopidogrel plus cilostazol). Clopidogrel resistance using VerifyNow P2Y12 assay and genetic analysis were performed in 387 patients. Clopidogrel resistance was found in 112 patients (28.9%). In the clopidogrel-responsive group, there was a significantly higher proportion of cilostazol use. Because cilostazol showed a significant influence on clopidogrel resistance, we examined the association of single-nucleotide polymorphisms and clopidogrel resistance in the dual and triple antiplatelet therapy groups, respectively. In all subjects, the CYP2C19*3A allele was significantly more prevalent in the clopidogrel-resistant group compared with the clopidogrel-responsive group. Multiple logistic regression analysis demonstrated that CYP2C19*3 is an independent predictor of clopidogrel resistance. In conclusion, CYP2C19*3 single-nucleotide polymorphisms is an independent risk factor of clopidogrel resistance in Korean subjects with coronary artery disease. PMID:19576320

  4. Temporal variability in the antiplatelet effects of clopidogrel and aspirin after elective drug-eluting stent implantation. An ADAPT-DES substudy.

    PubMed

    Nührenberg, Thomas G; Stratz, Christian; Leggewie, Stefan; Hochholzer, Willibald; Valina, Christian M; Gick, Michael; Kirtane, Ajay J; Stone, Gregg W; Neumann, Franz-Josef; Trenk, Dietmar

    2015-11-01

    Given conflicting data on temporal variability in pharmacodynamic platelet responses to clopidogrel, we investigated platelet reactivity on clopidogrel and aspirin for up to six months after elective percutaneous coronary intervention (PCI) with drug-eluting stents. Platelet reactivity was determined in 102 patients before loading with clopidogrel and aspirin, and on maintenance therapy after PCI on day 1, at one month and six months by VerifyNow™ P2Y12 and Aspirin assays and by residual platelet aggregation (RPA) on light transmission aggregometry using adenosine diphosphate and arachidonic acid. By VerifyNow testing, median (interquartile range) P2Y12 reaction units (PRU) on clopidogrel were 166 (90-234), 195 (124-257), and 198 (141-252) on day 1, one month and six months after PCI, respectively (p=0.005 day 1 to 1 month, and p=0.86 1 month to 6 months). Using a cut-off of > 208 PRU, 35 % of patients had high platelet reactivity (HPR) to clopidogrel on day 1, 43 % at one month, and 46 % at six months after PCI. Between day 1 and six months after PCI, 38.2 % of patients changed clopidogrel responder status at least once. Other cut-offs and RPA yielded similar results. Platelet inhibition by aspirin was consistent over time with only five patients being characterised as having HPR. Considerable variation in individual on-clopidogrel platelet reactivity was present during both the subacute and the late phases of maintenance therapy after elective PCI. Hence, the utility of contemporary platelet function testing to guide antiplatelet therapy may be limited. PMID:26305340

  5. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Mandibular implant facial prosthesis. 874.3695 Section 874.3695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3695 Mandibular...

  6. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Mandibular implant facial prosthesis. 874.3695 Section 874.3695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3695 Mandibular...

  7. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Mandibular implant facial prosthesis. 874.3695 Section 874.3695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3695 Mandibular...

  8. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Mandibular implant facial prosthesis. 874.3695 Section 874.3695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3695 Mandibular...

  9. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mandibular implant facial prosthesis. 874.3695 Section 874.3695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3695 Mandibular...

  10. Therapies targeting inflammation after stent implantation.

    PubMed

    Okura, Hiroyuki; Takagi, Tsutomu; Yoshida, Kiyoshi

    2013-07-01

    Since the introduction of coronary vessel scaffold by metallic stent, percutaneous coronary intervention has become widely performed all over the world. Although drug-eluting stent technology has further decrease the incidence of in-stent restenosis, there still remaining issues related to stent implantation. Vessel inflammation is one of the causes that may be related to stent restenosis as well as stent thrombosis. Therefore, systemic therapies targeting inflammation emerged as adjunctive pharmacological intervention to improve outcome. Statins, corticosteroids, antiplatelets, and immunosuppresive or anti-cancer drugs are reported to favorably impact outcome after bare-metal stent implantation. In type 2 diabetic patients, pioglitazone may be the most promising drug that can lower neointimal proliferation and, as a result, lower incidence of restenosis and target lesion revascularization. On the other hand, several new stent platforms that might decrease inflammatory response after drug-eluting stent implantation have been introduced. Because durable polymer used in the first generation drug-eluting stents are recognized to be responsible for unfavorable vessel response, biocompatible or bioabsorbable polymer has been introduce and already used clinically. Furthermore, polymer-free drug-eluting stent and bioresorbable scaffold are under investigation. Although vessel inflammation may be reduced by using these new drug-eluting stents or scaffold, long-term impact needs to be investigated further. PMID:23905635

  11. An implantable blood pressure and flow transmitter.

    NASA Technical Reports Server (NTRS)

    Rader, R. D.; Meehan, J. P.; Henriksen, J. K. C.

    1973-01-01

    A miniature totally implantable FM/FM telemetry system has been developed to simultaneously measure blood pressure and blood flow, thus providing an appreciation of the hemodynamics of the circulation to the entire body or to a particular organ. Developed for work with animal subjects, the telemetry system's transmission time is controlled by an RF signal that permits an operating life of several months. Pressure is detected by a miniature intravascular transducer and flow is detected by an extravascular interferometric ultrasonic technique. Both pressure and flow are calibrated prior to implanting. The pressure calibration can be checked after the implanting by cannulation; flow calibration can be verified only at the end of the experiment by determining the voltage output from the implanted sensing system as a function of several measured flow rates. The utility of this device has been established by its use in investigating canine renal circulation during exercise, emotional encounters, administration of drugs, and application of accelerative forces.

  12. Duration of Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Patients With and Without Acute Coronary Syndrome: A Systematic Review of Randomized Controlled Trials.

    PubMed

    Sharma, Abhishek; Lavie, Carl J; Sharma, Samin K; Garg, Akash; Vallakati, Ajay; Mukherjee, Debabrata; Marmur, Jonathan D

    2016-08-01

    In this systemic review we evaluated the efficacy and safety of long duration dual anti-platelet therapy (DAPT) (L-DAPT) compared with short duration DAPT (S-DAPT) after drug-eluting stent (DES) implantation in patients who presented with or without acute coronary syndromes (ACS). We identified 8 randomized controlled trials in which 30,975 patients were randomized to S-DAPT versus L-DAPT (12,421 ACS and 18,554 non-ACS). Short duration dual anti-platelet therapy was associated with an increase in target vessel revascularization (TVR) in ACS patients, but the difference was not significant for non-ACS patients (odds ratio [OR] 5.04 [95% CI, 1.28-19.76], and OR, 0.89 [95% CI, 0.51-1.55], respectively). The risk of cardiac mortality was not significantly different with S-DAPT and L-DAPT for ACS (OR, 1.69 [95% CI, 0.82-3.50]) and non-ACS patients (OR, 0.89 [95% CI, 0.57-1.37]). For all cause mortality, myocardial infarction, and stent thrombosis, most of the events were derived from the DAPT study, thus a meta-analysis was not performed for these end points. Based on our review of the literature, we conclude that S-DAPT was associated with higher rates of stent thrombosis and myocardial infarction, and non-significant differences in all-cause mortality, with no significant interactions according to ACS vs non-ACS. However, in non-ACS patients, the benefit-risk profile favored S-DAPT, with lower all-cause mortality, whereas the trends were reversed in ACS. Additional studies are required to determine if the benefit-risk profile of S-DAPT vs L-DAPT varies according to clinical syndrome. PMID:27492914

  13. Foreign Body Reaction to Implantable Biosensors

    PubMed Central

    Wang, Yan; Vaddiraju, Santhisagar; Gu, Bing; Papadimitrakopoulos, Fotios; Burgess, Diane J.

    2015-01-01

    Background: Implantable biosensors for continuous glucose monitoring can greatly improve diabetes management. However, their applications are still associated with some challenges and one of these is the gradual functionality loss postimplantation as a consequence of the foreign body response (FBR). Sensor miniaturization in combination with drug-eluting biocompatible coatings is a promising strategy to enhance in vivo performance. However, limited study has been performed to understand the effect of initial trauma and implant size on foreign body reaction as well as in vivo performance of implantable glucose sensors. Methods: Different initial trauma was induced by implanting composite coated dummy sensors into rats using various sized needles and 3 different-sized dummy sensors were implanted to examine the size effect. Histological evaluation was performed to relate the inflammatory cell counts and foreign body capsule thickness with the implantation needle size and sensor size respectively. The effect of biocompatible coating on the performance of implantable glucose sensors was determined using both coated amperometric glucose sensors and microdialysis probes. Results: The results revealed that the degree of acute inflammation was mainly controlled by the extent of the initial trauma: the greater the trauma, the greater the acute inflammatory response. Implant size did not affect the acute inflammatory phase. However, the extent of chronic inflammation and fibrous encapsulation were affected by sensor size: the smaller the size the less the extent of chronic inflammation and fibrous encapsulation. Glucose sensors implanted using 14 gauge needles showed significantly lower initial in vivo response compared to those implanted using 16 gauge needles. This was not observed for sensors with dexamethasone-eluting biocompatible coatings since inflammation was suppressed. Conclusions: The results of the current study indicate that the extent of the inflammatory

  14. 21 CFR 1308.25 - Exclusion of a veterinary anabolic steroid implant product; application.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Exclusion of a veterinary anabolic steroid implant... OF JUSTICE SCHEDULES OF CONTROLLED SUBSTANCES Excluded Veterinary Anabolic Steroid Implant Products § 1308.25 Exclusion of a veterinary anabolic steroid implant product; application. (a) Any person...

  15. 21 CFR 1308.26 - Excluded veterinary anabolic steroid implant products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Excluded veterinary anabolic steroid implant... SCHEDULES OF CONTROLLED SUBSTANCES Excluded Veterinary Anabolic Steroid Implant Products § 1308.26 Excluded veterinary anabolic steroid implant products. (a) Products containing an anabolic steroid, that are...

  16. 21 CFR 1308.25 - Exclusion of a veterinary anabolic steroid implant product; application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Exclusion of a veterinary anabolic steroid implant... OF JUSTICE SCHEDULES OF CONTROLLED SUBSTANCES Excluded Veterinary Anabolic Steroid Implant Products § 1308.25 Exclusion of a veterinary anabolic steroid implant product; application. (a) Any person...

  17. 21 CFR 1308.26 - Excluded veterinary anabolic steroid implant products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 9 2014-04-01 2014-04-01 false Excluded veterinary anabolic steroid implant... SCHEDULES OF CONTROLLED SUBSTANCES Excluded Veterinary Anabolic Steroid Implant Products § 1308.26 Excluded veterinary anabolic steroid implant products. (a) Products containing an anabolic steroid, that are...

  18. 21 CFR 1308.26 - Excluded veterinary anabolic steroid implant products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Excluded veterinary anabolic steroid implant... SCHEDULES OF CONTROLLED SUBSTANCES Excluded Veterinary Anabolic Steroid Implant Products § 1308.26 Excluded veterinary anabolic steroid implant products. (a) Products containing an anabolic steroid, that are...

  19. 21 CFR 1308.26 - Excluded veterinary anabolic steroid implant products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Excluded veterinary anabolic steroid implant... SCHEDULES OF CONTROLLED SUBSTANCES Excluded Veterinary Anabolic Steroid Implant Products § 1308.26 Excluded veterinary anabolic steroid implant products. (a) Products containing an anabolic steroid, that are...

  20. 21 CFR 1308.25 - Exclusion of a veterinary anabolic steroid implant product; application.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 9 2014-04-01 2014-04-01 false Exclusion of a veterinary anabolic steroid implant... OF JUSTICE SCHEDULES OF CONTROLLED SUBSTANCES Excluded Veterinary Anabolic Steroid Implant Products § 1308.25 Exclusion of a veterinary anabolic steroid implant product; application. (a) Any person...

  1. 21 CFR 1308.25 - Exclusion of a veterinary anabolic steroid implant product; application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Exclusion of a veterinary anabolic steroid implant... OF JUSTICE SCHEDULES OF CONTROLLED SUBSTANCES Excluded Veterinary Anabolic Steroid Implant Products § 1308.25 Exclusion of a veterinary anabolic steroid implant product; application. (a) Any person...

  2. 21 CFR 880.5970 - Percutaneous, implanted, long-term intravascular catheter.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Percutaneous, implanted, long-term intravascular... and Personal Use Therapeutic Devices § 880.5970 Percutaneous, implanted, long-term intravascular catheter. (a) Identification. A percutaneous, implanted, long-term intravascular catheter is a device...

  3. 21 CFR 880.5965 - Subcutaneous, implanted, intravascular infusion port and catheter.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Subcutaneous, implanted, intravascular infusion... Hospital and Personal Use Therapeutic Devices § 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter. (a) Identification. A subcutaneous, implanted, intravascular infusion port...

  4. 21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implantable Intra-aneurysm Pressure Measurement... § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a...

  5. 21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implantable Intra-aneurysm Pressure Measurement... § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a...

  6. 21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implantable Intra-aneurysm Pressure Measurement... § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a...

  7. 21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implantable Intra-aneurysm Pressure Measurement... § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a...

  8. 21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implantable Intra-aneurysm Pressure Measurement... § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a...

  9. 21 CFR 882.5880 - Implanted spinal cord stimulator for pain relief.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted spinal cord stimulator for pain relief... Implanted spinal cord stimulator for pain relief. (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to...

  10. 21 CFR 882.5870 - Implanted peripheral nerve stimulator for pain relief.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted peripheral nerve stimulator for pain....5870 Implanted peripheral nerve stimulator for pain relief. (a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral...

  11. 21 CFR 882.5880 - Implanted spinal cord stimulator for pain relief.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted spinal cord stimulator for pain relief... Implanted spinal cord stimulator for pain relief. (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to...

  12. 21 CFR 882.5870 - Implanted peripheral nerve stimulator for pain relief.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted peripheral nerve stimulator for pain....5870 Implanted peripheral nerve stimulator for pain relief. (a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral...

  13. 21 CFR 882.5870 - Implanted peripheral nerve stimulator for pain relief.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted peripheral nerve stimulator for pain....5870 Implanted peripheral nerve stimulator for pain relief. (a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral...

  14. 21 CFR 882.5870 - Implanted peripheral nerve stimulator for pain relief.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted peripheral nerve stimulator for pain....5870 Implanted peripheral nerve stimulator for pain relief. (a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral...

  15. 21 CFR 882.5880 - Implanted spinal cord stimulator for pain relief.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted spinal cord stimulator for pain relief... Implanted spinal cord stimulator for pain relief. (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to...

  16. 21 CFR 882.5880 - Implanted spinal cord stimulator for pain relief.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted spinal cord stimulator for pain relief... Implanted spinal cord stimulator for pain relief. (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to...

  17. 21 CFR 1308.25 - Exclusion of a veterinary anabolic steroid implant product; application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Exclusion of a veterinary anabolic steroid implant... OF JUSTICE SCHEDULES OF CONTROLLED SUBSTANCES Excluded Veterinary Anabolic Steroid Implant Products § 1308.25 Exclusion of a veterinary anabolic steroid implant product; application. (a) Any person...

  18. 21 CFR 1308.26 - Excluded veterinary anabolic steroid implant products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Excluded veterinary anabolic steroid implant... SCHEDULES OF CONTROLLED SUBSTANCES Excluded Veterinary Anabolic Steroid Implant Products § 1308.26 Excluded veterinary anabolic steroid implant products. (a) Products containing an anabolic steroid, that are...

  19. 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... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a) The classification panel will recommend classification into class III of any implant or life-supporting or...

  20. 21 CFR 880.5965 - Subcutaneous, implanted, intravascular infusion port and catheter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Subcutaneous, implanted, intravascular infusion... Hospital and Personal Use Therapeutic Devices § 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter. (a) Identification. A subcutaneous, implanted, intravascular infusion port...

  1. 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... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a) The classification panel will recommend classification into class III of any implant or life-supporting or...

  2. 21 CFR 880.5965 - Subcutaneous, implanted, intravascular infusion port and catheter.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Subcutaneous, implanted, intravascular infusion... Hospital and Personal Use Therapeutic Devices § 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter. (a) Identification. A subcutaneous, implanted, intravascular infusion port...

  3. 21 CFR 880.5965 - Subcutaneous, implanted, intravascular infusion port and catheter.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Subcutaneous, implanted, intravascular infusion... Hospital and Personal Use Therapeutic Devices § 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter. (a) Identification. A subcutaneous, implanted, intravascular infusion port...

  4. 21 CFR 880.5965 - Subcutaneous, implanted, intravascular infusion port and catheter.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Subcutaneous, implanted, intravascular infusion... Hospital and Personal Use Therapeutic Devices § 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter. (a) Identification. A subcutaneous, implanted, intravascular infusion port...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Classification of implants, life-supporting or... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a) The classification panel will recommend classification into class III of any implant or life-supporting or...

  6. 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... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a) The classification panel will recommend classification into class III of any implant or life-supporting or...

  7. Educational Interpreters: Meeting the Communication Needs of Children with Cochlear Implants

    ERIC Educational Resources Information Center

    Melton, Julie; Higbee, Renee

    2013-01-01

    Since the early 1990s, when the U.S. Food and Drug Administration approved cochlear implants for deaf and hard of hearing children, the number of children who have cochlear implants has increased in mainstream settings. Recent research suggests that these students, like their deaf and hard of hearing peers without implants who use sign language,…

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ....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 the... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted mechanical/hydraulic urinary...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ....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 the... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted mechanical/hydraulic urinary...

  10. 21 CFR 882.5870 - Implanted peripheral nerve stimulator for pain relief.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted peripheral nerve stimulator for pain....5870 Implanted peripheral nerve stimulator for pain relief. (a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral...

  11. 21 CFR 882.5880 - Implanted spinal cord stimulator for pain relief.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted spinal cord stimulator for pain relief... Implanted spinal cord stimulator for pain relief. (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to...

  12. 21 CFR 882.5850 - Implanted spinal cord stimulator for bladder evacuation.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted spinal cord stimulator for bladder....5850 Implanted spinal cord stimulator for bladder evacuation. (a) Identification. An implanted spinal... paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or...

  13. 21 CFR 882.5850 - Implanted spinal cord stimulator for bladder evacuation.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted spinal cord stimulator for bladder....5850 Implanted spinal cord stimulator for bladder evacuation. (a) Identification. An implanted spinal... paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or...

  14. 21 CFR 882.5850 - Implanted spinal cord stimulator for bladder evacuation.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted spinal cord stimulator for bladder....5850 Implanted spinal cord stimulator for bladder evacuation. (a) Identification. An implanted spinal... paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or...

  15. 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...

  16. Urinary incontinence - injectable implant

    MedlinePlus

    Injectable implants are injections of material into the urethra to help control urine leakage ( urinary incontinence ) caused by a ... into the tissue next to the sphincter. The implant procedure is usually done in the hospital. Or ...

  17. Hair implant complications.

    PubMed

    Hanke, C W; Norins, A L; Pantzer, J G; Bennett, J E

    1981-04-01

    Four men who underwent hair implantation for pattern baldness were treated for complications such as infection, foreign-body reaction, pruritus, and scarring. The complications were similar to those reported with synthetic modacrylic fiber implants that have been used for the same purpose. Although we believe this is the first article to report complications from hair implants, the illogical basis of the procedure suggests that complications will occur in many unsuspecting patients who undergo hair implantation. PMID:7009899

  18. Implantable Heart Aid

    NASA Technical Reports Server (NTRS)

    1984-01-01

    CPI's human-implantable automatic implantable defibrillator (AID) is a heart assist system, derived from NASA's space circuitry technology, that can prevent erratic heart action known as arrhythmias. Implanted AID, consisting of microcomputer power source and two electrodes for sensing heart activity, recognizes onset of ventricular fibrillation (VF) and delivers corrective electrical countershock to restore rhythmic heartbeat.

  19. Strontium in the bone-implant interface.

    PubMed

    Vestermark, Marianne Toft

    2011-05-01

    Total hip replacement surgery is being performed on an increasingly large part of the population and at increasingly younger age. Because we live and stay physically active longer, and since hip replacement surgery has become quite successful, the treatment is being offered to progressively more patients. Unfortunately, about 17% of hip replacement surgeries currently involve revisions. Consequently, the longevity of both the primary and revision implant is an issue and warrants further investigation. Implants undergoing early instability or even subsidence correlate with an increased risk of aseptic loosening, subsequently requiring revision. Thus, the goal is early fixation by osseointegration of the implant. For revision implants, this is an even greater challenge since an allograft is often needed during surgery to obtain immediate stability of the implant. Bone grafts are rapidly resorbed. Thus, instability of the prosthesis may develop before new bone formation is well established and can mechanically secure the prosthesis. Strontium is a dual action drug; being both bone anabolic and anti-catabolic. In the form of strontiumranelate, it is used in the treatment of osteoporosis. Strontium may potentially improve the early osseointegration and fixation of implants. This dissertation consists of three studies investigating the effect of strontium at the bone-implant interface. The questions were firstly, what is the optimal delivery method for strontium to the interface, and secondly, can strontium exercise its dual action at the interface? The studies were performed in a cementless, experimental gap model in canine. The effects of strontium were evaluated by histomorphometrical analysis of the osseointegration and mechanical push-out test of implant fixation. Different stereological methods were used for the histomorphometrical analysis of each study. The methods used were reviewed critically and found valid. Study I compared a 5% strontium

  20. Trends in Cochlear Implants

    PubMed Central

    Zeng, Fan-Gang

    2004-01-01

    More than 60,000 people worldwide use cochlear implants as a means to restore functional hearing. Although individual performance variability is still high, an average implant user can talk on the phone in a quiet environment. Cochlear-implant research has also matured as a field, as evidenced by the exponential growth in both the patient population and scientific publication. The present report examines current issues related to audiologic, clinical, engineering, anatomic, and physiologic aspects of cochlear implants, focusing on their psychophysical, speech, music, and cognitive performance. This report also forecasts clinical and research trends related to presurgical evaluation, fitting protocols, signal processing, and postsurgical rehabilitation in cochlear implants. Finally, a future landscape in amplification is presented that requires a unique, yet complementary, contribution from hearing aids, middle ear implants, and cochlear implants to achieve a total solution to the entire spectrum of hearing loss treatment and management. PMID:15247993

  1. Burnishing Techniques Strengthen Hip Implants

    NASA Technical Reports Server (NTRS)

    2010-01-01

    In the late 1990s, Lambda Research Inc., of Cincinnati, Ohio, received Small Business Innovation Research (SBIR) awards from Glenn Research Center to demonstrate low plasticity burnishing (LPB) on metal engine components. By producing a thermally stable deep layer of compressive residual stress, LPB significantly strengthened turbine alloys. After Lambda patented the process, the Federal Aviation Administration accepted LPB for repair and alteration of commercial aircraft components, the U.S. Department of Energy found LPB suitable for treating nuclear waste containers at Yucca Mountain. Data from the U.S. Food and Drug Administration confirmed LPB to completely eliminate the occurrence of fretting fatigue failures in modular hip implants.

  2. Noninvasive Characterization of In situ Forming Implants Using Diagnostic Ultrasound

    PubMed Central

    Solorio, Luis; Babin, Brett M.; Patel, Ravi B.; Mach, Justyna; Azar, Nami

    2010-01-01

    In situ forming drug delivery systems provide a means by which a controlled release depot can be physically inserted into a target site without the use of surgery. The release rate of drugs from these systems is often related to the rate of implant formation. Currently, only a limited number of techniques are available to monitor phase inversion, and none of these methods can be used to visualize the process directly and noninvasively. In this study, diagnostic ultrasound was used to visualize and quantify the process of implant formation in a phase inversion based system both in vitro and in vivo. Concurrently, sodium fluorescein was used as a mock drug to evaluate the drug release profiles and correlate drug release and implant formation processes. Implants comprised of three different molecular weight poly(lactic-co-glycolic acid) (PLGA) polymers dissolved in 1-methyl-2-pyrrolidinone (NMP) were studied in vitro and a 29 kDa PLGA solution was evaluated in vivo. The implants were encapsulated in a 1% agarose tissue phantom for five days, or injected into a rat subcutaneously and evaluated for 48 hrs. Quantitative measurements of the gray-scale value (corresponding to the rate of implant formation), swelling, and precipitation were evaluated using image analysis techniques, showing that polymer molecular weight has a considerable effect on the swelling and formation of the in situ drug delivery depots. A linear correlation was also seen between the in vivo release and depot formation (R2=0.93). This study demonstrates, for the first time, that ultrasound can be used to noninvasively and nondestructively monitor and evaluate the phase inversion process of in situ forming drug delivery implants, and that the formation process can be directly related to the initial phase of drug release dependent on this formation. PMID:20060859

  3. Action against contraceptive implant threatened.

    PubMed

    Dyer, C

    1995-08-19

    Norplant provides contraception over a five-year period through the gradual subcutaneous release of the progestogen levonorgestrel. It has been on the US market since 1991 and available in Great Britain since 1993. Already the subject of group legal actions in several US states, Norplant may soon be the target of lawyers in Britain for litigation. The lawyers allege that insertion of the implant under the skin of the upper arm by untrained doctors has led to painful and difficult removals and left women with scarred arms. Moreover, insufficient warning has been given about possible side effects such as mood swings and continuous vaginal bleeding. Hoechst Roussel, marketer of the implant in Britain, however, argues that only doctors trained in Norplant insertion and removal should attempt either procedure. Removal will be problematic only if preceded by a problem insertion. Hoechst Roussel recently advised gynecologists, in writing, not to attempt to extract the implant unless they are trained in the removal technique. By British law, the application of a drug product once approved for general release to general practitioners and family planning doctors cannot be restricted by a pharmaceutical company. PMID:7647639

  4. Silicone breast implant materials.

    PubMed

    Daniels, A U

    2012-01-01

    This opinion article has been written on request because of the recent public controversy over silicone breast implants produced by a now-defunct company, Poly Implant Prosthese (PIP) in France. More than 300,000 PIP devices have been implanted. The purposes of my article are to (1.) provide a general overview of silicone breast implant materials, (2.) to describe the general safety of these materials as reported to date, and (3.) to summarise current publicly available information about these aspects of the PIP prostheses. The materials covered are the silicone rubber from which the implant shells are made and the silicone gel used to fill the shell. The materials safety issues are biocompatibility (especially of the gel) and biodurability of the shell. The literature reviewed indicates that biocompatibility is not an issue with other current generation implants. However, biodurability is. A rough estimate of implant shell rupture rate is ~10+% at 10 years. Information is still emerging about the PIP implants. Initial regulatory disclosures suggest the PIP implants may have both biocompatibility and biodurability problems. They also suggest that PIP implants may have been produced using silicone materials not certified as medical grade. Governmental health and regulatory agencies are just now in the process of deciding what actions should be taken to protect patients. PMID:22826101

  5. Implants in adolescents

    PubMed Central

    Shah, Rohit A.; Mitra, Dipika K.; Rodrigues, Silvia V.; Pathare, Pragalbha N.; Podar, Rajesh S.; Vijayakar, Harshad N.

    2013-01-01

    Implants have gained tremendous popularity as a treatment modality for replacement of missing teeth in adults. There is extensive research present on the use of implants in adults, but there is a dearth of data available on the same in adolescents. The treatment planning and execution of implant placement in adolescents is still in its infancy. This review article is an attempt to bring together available literature. PMID:24174743

  6. Larynx: implants and stents

    PubMed Central

    Sittel, Christian

    2011-01-01

    In the human larynx, implants a primarily used for the correction of glottis insufficiency. In a broader sense laryngeal stents may be considered as implants as well. Laryngeal implants can be differentiated into injectable and solid. The most important representatives of both groups are discussed in detail along with the respective technique of application. Laryngeal stents are primarily used perioperatively. Different types and their use are presented. PMID:22073097

  7. Penile Implants among Prisoners—A Cause for Concern?

    PubMed Central

    Yap, Lorraine; Butler, Tony; Richters, Juliet; Malacova, Eva; Wand, Handan; Smith, Anthony M. A.; Grant, Luke; Richards, Alun; Donovan, Basil

    2013-01-01

    Background We report the prevalence of penile implants among prisoners and determine the independent predictors for having penile implants. Questions on penile implants were included in the Sexual Health and Attitudes of Australian Prisoners (SHAAP) survey following concerns raised by prison health staff that increasing numbers of prisoners reported having penile implants while in prison. Methods Computer-Assisted Telephone Interviewing (CATI) of a random sample of prisoners was carried out in 41 prisons in New South Wales and Queensland (Australia). Men were asked, “Have you ever inserted or implanted an object under the skin of your penis?” If they responded Yes: “Have you ever done so while you were in prison?” Univariate logistic regression and logistic regression were used to determine the factors associated with penile implants. Results A total of 2,018 male prisoners were surveyed, aged between 18 and 65 years, and 118 (5.8%) reported that they had inserted or implanted an object under the skin of their penis. Of these men, 87 (73%) had this done while they were in prison. In the multivariate analysis, a younger age, birth in an Asian country, and prior incarceration were all significantly associated with penile implants (p<0.001). Men with penile implants were also more likely to report being paid for sex (p<0.001), to have had body piercings (p<0.001) or tattoos in prison (p<0.001), and to have taken non-prescription drugs while in prison (p<0.05). Conclusions Penile implants appear to be fairly common among prisoners and are associated with risky sexual and drug use practices. As most of these penile implants are inserted in prison, these men are at risk of blood borne viruses and wound infection. Harm reduction and infection control strategies need to be developed to address this potential risk. PMID:23326383

  8. Indications for an implantable cardioverter defibrillator (ICD).

    PubMed

    Aizawa, Yoshifusa; Chinushi, Masaomi; Washizuka, Takashi

    2004-05-01

    Since the first clinical use of implantable defibrillator in human, the technology and the function of implantable cardioverter-defibrillator (ICD) have been much improved and now, ICD can be implanted within the chest wall. ICD is the most reliable therapy to prevent sudden cardiac death (SCD) in patients with documented VT/VF and the efficacy is most clear in patients with depressed heart function. It is now extended as a tool of the primary prevention of SCD in high risk patients after myocardial infarction. However, such beneficial effect is not applicable to DCM though patients might have depressed heart function. ICD is not free from procedure- or device-related problems which need to be resolved. From unknown causes, VT/VF might recur in an incessant form and an emergency admission is needed. Therefore, even during ICD therapy, patients often require antiarrhythmic drugs or catheter ablation. PMID:15206546

  9. Bisphosphonate and Implant Dentistry - Is it Safe?

    PubMed

    Thirunavukarasu, Ananthi; Pinto, Hugo Grancho; Seymour, Kevin Guy

    2015-08-01

    Bisphosphonates are a group of drugs that are commonly used to alter bone metabolism in order to prevent bone loss in diseases such as osteoporosis and bone cancers. Unfortunately, the use of bisphosphonates has been associated with bisphosphonate-related osteonecrosis of the jaws. The debate as to whether it is wise to consider implant therapy in patients being treated with bisphosphonate therapy remains a grey area. This review will present the latest evidence and guidelines available on bisphosphonates and their possible effects on implant dentistry. The risk factors, co-morbidities, clinical presentation and findings from various imaging modalities for bisphosphonate-related osteonecrosis of the jaws are highlighted. The management of patients being treated with bisphosphonates, in whom dental implants might be considered or have already been placed, will also be discussed. Finally, the areas requiring future research are considered. PMID:26556516

  10. TOPICAL REVIEW: Microsystem technologies for implantable applications

    NASA Astrophysics Data System (ADS)

    Receveur, Rogier A. M.; Lindemans, Fred W.; de Rooij, Nicolaas F.

    2007-05-01

    Microsystem technologies (MST) have become the basis of a large industry. The advantages of MST compared to other technologies provide opportunities for application in implantable biomedical devices. This paper presents a general and broad literature review of MST for implantable applications focused on the technical domain. A classification scheme is introduced to order the examples, basic technological building blocks relevant for implantable applications are described and finally a case study on the role of microsystems for one clinical condition is presented. We observe that the microfabricated parts span a wide range for implantable applications in various clinical areas. There are 94 active and 67 commercial 'end items' out of a total of 142. End item refers to the total concept, of which the microsystem may only be a part. From the 105 active end items 18 (13% of total number of end items) are classified as products. From these 18 products, there are only two for chronic use. The number of active end items in clinical, animal and proto phase for chronic use is 17, 13 and 20, respectively. The average year of first publication of chronic end items that are still in the animal or clinical phase is 1994 (n = 7) and 1993 (n = 11), respectively. The major technology market combinations are sensors for cardiovascular, drug delivery for drug delivery and electrodes for neurology and ophthalmology. Together these form 51% of all end items. Pressure sensors form the majority of sensors and there is just one product (considered to be an implantable microsystem) in the neurological area. Micro-machined ceramic packages, glass sealed packages and polymer encapsulations are used. Glass to metal seals are used for feedthroughs. Interconnection techniques such as flip chip, wirebonding or conductive epoxy as used in the semiconductor packaging and assembly industry are also used for manufacturing of implantable devices. Coatings are polymers or metal. As an alternative to

  11. 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

  12. Smoking and dental implants

    PubMed Central

    Kasat, V.; Ladda, R.

    2012-01-01

    Smoking is a prevalent behaviour in the population. The aim of this review is to bring to light the effects of smoking on dental implants. These facts will assist dental professionals when implants are planned in tobacco users. A search of “PubMed” was made with the key words “dental implant,” “nicotine,” “smoking,” “tobacco,” and “osseointegration.” Also, publications on tobacco control by the Government of India were considered. For review, only those articles published from 1988 onward in English language were selected. Smoking has its influence on general as well as oral health of an individual. Tobacco negatively affects the outcome of almost all therapeutic procedures performed in the oral cavity. The failure rate of implant osseointegration is considerably higher among smokers, and maintenance of oral hygiene around the implants and the risk of peri-implantitis are adversely affected by smoking. To increase implant survival in smokers, various protocols have been recommended. Although osseointegrated dental implants have become the state of the art for tooth replacement, they are not without limitations or complications. In this litigious era, it is extremely important that the practitioner clearly understands and is able and willing to convey the spectrum of possible complications and their frequency to the patients. PMID:24478965

  13. Implantable, Ingestible Electronic Thermometer

    NASA Technical Reports Server (NTRS)

    Kleinberg, Leonard

    1987-01-01

    Small quartz-crystal-controlled oscillator swallowed or surgically implanted provides continuous monitoring of patient's internal temperature. Receiver placed near patient measures oscillator frequency, and temperature inferred from previously determined variation of frequency with temperature. Frequency of crystal-controlled oscillator varies with temperature. Circuit made very small and implanted or ingested to measure internal body temperature.

  14. Synthetic facial implants.

    PubMed

    Quatela, Vito C; Chow, Jen

    2008-02-01

    This article presents a range of synthetic implant materials for use in facial plastic surgery. The authors discuss alternatives to autogenous tissue transfer in terms of biocompatibility, technique, complications, controversies, and cautions. The reader is presented information about a range of synthetic implant materials such as silicone, polyester fiber, polyamide mesh, metal, polyethylene, polyacrylamide gel, hydroxyapatite, polylactic acid, collagen, and others. PMID:18063244

  15. 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

  16. Batteryless implanted echosonometer

    NASA Technical Reports Server (NTRS)

    Kojima, G. K.

    1977-01-01

    Miniature ultrasonic echosonometer implanted within laboratory animals obtains energy from RF power oscillator that is electronically transduced via induction loop to power receiving loop located just under animal's skin. Method of powering device offers significant advantages over those in which battery is part of implanted package.

  17. Gold bead implants.

    PubMed

    Durkes, T E

    1992-03-01

    Gold bead implantation is an experimental area of study in the acupuncture field dealing with chronic diseases. Special acupuncture techniques are required to implant the gold beads successfully in the proper location. Gold beads are used to treat degenerative joint disease, osteochondritis, osteochondritis dessicans, ventral spondylosis, and seizures. PMID:1581658

  18. Percutaneous and skeletal biocarbon implants

    NASA Technical Reports Server (NTRS)

    Mooney, V.

    1977-01-01

    Review of carbon implants developed by NASA discussed four different types of implants and subsequent improvements. Improvements could be of specific interest to rehabilitation centers and similar organizations.

  19. Number of implants for mandibular implant overdentures: a systematic review

    PubMed Central

    Lee, Jeong-Yol; Kim, Ha-Young; Bryant, S. Ross

    2012-01-01

    PURPOSE The aim of this systematic review is to address treatment outcomes of Mandibular implant overdentures relative to implant survival rate, maintenance and complications, and patient satisfaction. MATERIALS AND METHODS A systematic literature search was conducted by a PubMed search strategy and hand-searching of relevant journals from included studies. Randomized Clinical Trials (RCT) and comparative clinical trial studies on mandibular implant overdentures until August, 2010 were selected. Eleven studies from 1098 studies were finally selected and data were analyzed relative to number of implants. RESULTS Six studies presented the data of the implant survival rate which ranged from 95% to 100% for 2 and 4 implant group and from 81.8% to 96.1% for 1 and 2 implant group. One study, which statistically compared implant survival rate showed no significant differences relative to the number of implants. The most common type of prosthetic maintenance and complications were replacement or reattaching of loose clips for 2 and 4 implant group, and denture repair due to the fracture around an implant for 1 and 2 implant groups. Most studies showed no significant differences in the rate of prosthetic maintenance and complication, and patient satisfaction regardless the number of implants. CONCLUSION The implant survival rate of mandibular overdentures is high regardless of the number of implants. Denture maintenance is likely not inflenced substantially by the number of implants and patient satisfaction is typically high again regardless os the number of implants. PMID:23236572

  20. Electrodeposited silk coatings for functionalized implant applications

    NASA Astrophysics Data System (ADS)

    Elia, Roberto

    The mechanical and morphological properties of titanium as well as its biocompatibility and osteoinductive characteristics have made it the material of choice for dental implant systems. Although the success rate of titanium implants exceeds 90% in healthy individuals, a large subset of the population has one or more risk factors that inhibit implant integration. Treatments and coatings have been developed to improve clinical outcomes via introduction of appropriate surface topography, texture and roughness or incorporation of bioactive molecules. It is essential that the coatings and associated deposition techniques are controllable and reproducible. Currently, methods of depositing functional coatings are dictated by numerous parameters (temperature, particle size distribution, pH and voltage), which result in variable coating thickness, strength, porosity and weight, and hinder or preclude biomolecule incorporation. Silk is a highly versatile protein with a unique combination of mechanical and physical properties, including tunable degradation, biocompatibility, drug stabilizing capabilities and mechanical properties. Most recently an electrogelation technique was developed which allows for the deposition of gels which dry seamlessly over the contoured topography of the conductive substrate. In this work we examine the potential use of silk electrogels as mechanically robust implant coatings capable of sequestering and releasing therapeutic agents. Electrodeposition of silk electrogels formed in uniform electric fields was characterized with respect to field intensity and deposition time. Gel formation kinetics were used to derive functions which allowed for the prediction of coating deposition over a range of process and solution parameters. Silk electrogel growth orientation was shown to be influenced by the applied electric field. Coatings were reproducible and tunable via intrinsic silk solution properties and extrinsic process parameters. Adhesion was

  1. Graphene for Biomedical Implants

    NASA Astrophysics Data System (ADS)

    Moore, Thomas; Podila, Ramakrishna; Alexis, Frank; Rao, Apparao; Clemson Bioengineering Team; Clemson Physics Team

    2013-03-01

    In this study, we used graphene, a one-atom thick sheet of carbon atoms, to modify the surfaces of existing implant materials to enhance both bio- and hemo-compatibility. This novel effort meets all functional criteria for a biomedical implant coating as it is chemically inert, atomically smooth and highly durable, with the potential for greatly enhancing the effectiveness of such implants. Specifically, graphene coatings on nitinol, a widely used implant and stent material, showed that graphene coated nitinol (Gr-NiTi) supports excellent smooth muscle and endothelial cell growth leading to better cell proliferation. We further determined that the serum albumin adsorption on Gr-NiTi is greater than that of fibrinogen, an important and well understood criterion for promoting a lower thrombosis rate. These hemo-and biocompatible properties and associated charge transfer mechanisms, along with high strength, chemical inertness and durability give graphene an edge over most antithrombogenic coatings for biomedical implants and devices.

  2. Cochlear implants in children.

    PubMed

    Young, N M

    1994-04-01

    Children with such profound deafness that they are not helped by hearing aids are now candidates for cochlear implantation. This technology permits us to provide these children with a significant degree of useful hearing. The degree of improvement in speech perception and spoken language in pediatric cochlear implant recipients varies. However, the younger the children and the less time they have been completely deprived of auditory stimuli, the more likely they are to make significant progress. The evaluation of the deaf child for implantation is best done by a multidisciplinary team who understands the needs of hearing-impaired children and who can work with the family, the child, and classroom teachers, as well as other school professionals. The decision to proceed with cochlear implantation in a child is one that requires long-term commitment on the part of the family and the cochlear implant team. PMID:8039409

  3. [Implantable medical devices].

    PubMed

    Crickx, B; Arrault, X

    2008-01-01

    Medical devices have been individualized to include a category of implantable medical devices, "designed to be totally implanted in the human body or to replace an epithelial surface or a surface of the eye, through surgery, and remain in place after the intervention" (directive 93/42/CEE and decree of 20 April 206). Each implantable medical device has a common name and a commercial name for precise identification of the model (type/references). The users' service and the implanting physician should be clearly identified. There are a number of rules concerning health traceability to rapidly identify patients exposed to risks in which the implantable medical devices of a particular batch or series were used and to monitor the consequences. The traceability data should be preserved 10 years and the patient's medical file for 20 years. PMID:18442666

  4. Antimicrobial dental implant functionalization strategies -A systematic review.

    PubMed

    Grischke, Jasmin; Eberhard, Jörg; Stiesch, Meike

    2016-01-01

    Biofilm formation on dental implant surfaces is a serious threat. Up to 50% of all implants show signs of irreversible tissue destruction. The aim of the present systematic review was to summarize the state of the art of strategies to functionalize antimicrobial dental implant surfaces. We searched the following electronic database: SCOPUS, MEDLINE and GOOGLE SCHOLAR and identified relevant controlled trials that evaluated the efficiency of new biomaterial strategies to modify dental implant surfaces, in such a way that biofilm formation was inhibited. The search yielded 2,990 potentially relevant publications. A total of 142 publications met the inclusion criteria. Analysis found that it may be concluded that silver-implanted surfaces, drug-loaded surfaces, surfaces with antimicrobial peptides, bioactive and biopassive polymer coatings as well as nanoscale or UV-activatable surfaces enhance antimicrobial activity compared to commercial pure titanium. PMID:27477219

  5. A case of coronary rupture and pseudoaneurysm formation after fracture of implanted paclitaxel-eluting stents.

    PubMed

    Kawai, Yasuyuki; Kitayama, Michihiko; Akao, Hironobu; Motoyama, Atsushi; Tsuchiya, Taketsugu; Kajinami, Kouji

    2016-07-01

    A 48-year-old man who had undergone implantation of two paclitaxel-eluting stents (PESs) at the right coronary artery was admitted to our hospital with progressive dyspnea. In the coronary care unit, he developed cardiogenic shock due to cardiac tamponade treated by pericardiocentesis. A coronary angiogram showed a large pseudoaneurysm at the site of the previously implanted stents, suggesting coronary rupture due to implanted stent fracture. The pseudoaneurysm was completely sealed by polytetrafluoroethylene-covered stent implantation. Although this case is very rare, coronary rupture by stent fracture should be considered when cardiac tamponade occurs after drug-eluting stent implantation, especially PES. PMID:25998891

  6. Dental Implant Systems

    PubMed Central

    Oshida, Yoshiki; Tuna, Elif B.; Aktören, Oya; Gençay, Koray

    2010-01-01

    Among various dental materials and their successful applications, a dental implant is a good example of the integrated system of science and technology involved in multiple disciplines including surface chemistry and physics, biomechanics, from macro-scale to nano-scale manufacturing technologies and surface engineering. As many other dental materials and devices, there are crucial requirements taken upon on dental implants systems, since surface of dental implants is directly in contact with vital hard/soft tissue and is subjected to chemical as well as mechanical bio-environments. Such requirements should, at least, include biological compatibility, mechanical compatibility, and morphological compatibility to surrounding vital tissues. In this review, based on carefully selected about 500 published articles, these requirements plus MRI compatibility are firstly reviewed, followed by surface texturing methods in details. Normally dental implants are placed to lost tooth/teeth location(s) in adult patients whose skeleton and bony growth have already completed. However, there are some controversial issues for placing dental implants in growing patients. This point has been, in most of dental articles, overlooked. This review, therefore, throws a deliberate sight on this point. Concluding this review, we are proposing a novel implant system that integrates materials science and up-dated surface technology to improve dental implant systems exhibiting bio- and mechano-functionalities. PMID:20480036

  7. Pacemakers and implantable cardioverter defibrillators--general and anesthetic considerations.

    PubMed

    Rapsang, Amy G; Bhattacharyya, Prithwis

    2014-01-01

    A pacemaking system consists of an impulse generator and lead or leads to carry the electrical impulse to the patient's heart. Pacemaker and implantable cardioverter defibrillator codes were made to describe the type of pacemaker or implantable cardioverter defibrillator implanted. Indications for pacing and implantable cardioverter defibrillator implantation were given by the American College of Cardiologists. Certain pacemakers have magnet-operated reed switches incorporated; however, magnet application can have serious adverse effects; hence, devices should be considered programmable unless known otherwise. When a device patient undergoes any procedure (with or without anesthesia), special precautions have to be observed including a focused history/physical examination, interrogation of pacemaker before and after the procedure, emergency drugs/temporary pacing and defibrillation, reprogramming of pacemaker and disabling certain pacemaker functions if required, monitoring of electrolyte and metabolic disturbance and avoiding certain drugs and equipments that can interfere with pacemaker function. If unanticipated device interactions are found, consider discontinuation of the procedure until the source of interference can be eliminated or managed and all corrective measures should be taken to ensure proper pacemaker function should be done. Post procedure, the cardiac rate and rhythm should be monitored continuously and emergency drugs and equipments should be kept ready and consultation with a cardiologist or a pacemaker-implantable cardioverter defibrillator service may be necessary. PMID:24907883

  8. [Cochlear implant in children: rational, indications and cost/efficacy].

    PubMed

    Martini, A; Bovo, R; Trevisi, P; Forli, F; Berrettini, S

    2013-06-01

    A cochlear implant (CI) is a partially implanted electronic device that can help to provide a sense of sound and support speech to severely to profoundly hearing impaired patients. It is constituted by an external portion, that usually sits behind the ear and an internal portion surgically placed under the skin. The external components include a microphone connected to a speech processor that selects and arranges sounds pucked up by the microphone. This is connected to a transmitter coil, worn on the side of the head, which transmits data to an internal receiver coil placed under the skin. The received data are delivered to an array of electrodes that are surgically implanted within the cochlea. The primary neural targets of the electrodes are the spiral ganglion cells which innervate fibers of the auditory nerve. When the electrodes are activated by the signal, they send a current along the auditory nerve and auditory pathways to the auditory cortex. Children and adults who are profoundly or severely hearing impaired can be fitted with cochlear implants. According to the Food and Drug Administration, approximately 188,000 people worldwide have received implants. In Italy it is extimated that there are about 6-7000 implanted patients, with an average of 700 CI surgeries per year. Cochlear implantation, followed by intensive postimplantation speech therapy, can help young children to acquire speech, language, and social skills. Early implantation provides exposure to sounds that can be helpful during the critical period when children learn speech and language skills. In 2000, the Food and Drug Administration lowered the age of eligibility to 12 months for one type of CI. With regard to the results after cochlear implantation in relation to early implantation, better linguistic results are reported in children implanted before 12 months of life, even if no sufficient data exist regarding the relation between this advantage and the duration of implant use and how long

  9. Reflections on Rodent Implantation.

    PubMed

    Cha, Jeeyeon M; Dey, Sudhansu K

    2015-01-01

    Embryo implantation is a complex process involving endocrine, paracrine, autocrine, and juxtacrine modulators that span cell-cell and cell-matrix interactions. The quality of implantation is predictive for pregnancy success. Earlier observational studies formed the basis for genetic and molecular approaches that ensued with emerging technological advances. However, the precise sequence and details of the molecular interactions involved have yet to be defined. This review reflects briefly on aspects of our current understanding of rodent implantation as a tribute to Roger Short's lifelong contributions to the field of reproductive physiology. PMID:26450495

  10. [Implantable hearing aids].

    PubMed

    Luers, J C; Beutner, D; Hüttenbrink, K-B

    2011-10-01

    Strictly speaking, implantable hearing aids are technical systems that process audiological signals and convey these by direct mechanical stimulation of the ossicular chain or cochlea. They have certain benefits over conventional hearing aids in terms of wearing comfort and general acceptance. As current studies lack convincing audiological results, the indications for implantable hearing aids are primarily of medical or cosmetic nature. To date, three systems are available in Germany: Vibrant Soundbridge®, Carina®, and Esteem®. Because the performance of the different implantable and nonimplantable hearing systems together with various surgical procedures are currently undergoing major changes, audiological indications may also develop in the future. PMID:21956678

  11. Transcatheter aortic valve implantation

    PubMed Central

    Oliemy, Ahmed

    2014-01-01

    Transcatheter aortic valve implantation was developed to offer a therapeutic solution to patients with severe symptomatic aortic stenosis who are not candidates for conventional aortic valve replacement. The improvement in transcatheter aortic valve implantation outcomes is still of concern in the areas of stroke, vascular injury, heart block, paravalvular regurgitation and valve durability. Concomitantly, the progress, both technical and in terms of material advances of transcatheter valve systems, as well as in patient selection, renders transcatheter aortic valve implantation an increasingly viable treatment for more and more patients with structural heart disease. PMID:25374670

  12. The evolution of embryo implantation.

    PubMed

    McGowen, Michael R; Erez, Offer; Romero, Roberto; Wildman, Derek E

    2014-01-01

    Embryo implantation varies widely in placental mammals. We review this variation in mammals with a special focus on two features: the depth of implantation and embryonic diapause. We discuss the two major types of implantation depth, superficial and interstitial, and map this character on a well-resolved molecular phylogenetic tree of placental mammals. We infer that relatively deep interstitial implantation has independently evolved at least eight times within placental mammals. Moreover, the superficial type of implantation represents the ancestral state for placental mammals. In addition, we review the genes involved in various phases of implantation, and suggest a future direction in investigating the molecular evolution of implantation-related genes. PMID:25023681

  13. Subcutaneous Implants of Buprenorphine-Cholesterol-Triglyceride Powder in Mice

    PubMed Central

    DeTolla, L.; Sanchez, R.; Khan, E.; Tyler, B.; Guarnieri, M.

    2014-01-01

    Subcutaneous drug implants are convenient systems for the long-term delivery of drugs in animals. Lipid carriers are logical tools because they generally allow for higher doses and low toxicity. The present study used an US Food and Drug Administration Target Animal Safety test system to evaluate the safety of a subcutaneous implant of a cholesterol-triglyceride-buprenorphine powder in 120 BALB/c mice. Mice were evaluated in 4- and 12-day trials with 1- and 5-fold doses of the intended 3 mg/kg dose of drug. One male mouse treated with three 3 mg/kg doses and surgery on days 0, 4, and 8 died on day 9. The cause of death was not determined. In the surviving 119 mice there was no evidence of skin reaction at the site of the implant. Compared to control animals treated with saline, weight measurements, clinical pathology, histopathology, and clinical observations were unremarkable. These results demonstrate that the lipid carrier is substantially safe. Cholesterol-triglyceride-drug powders may provide a valuable research tool for studies of analgesic and inflammatory drug implants in veterinary medicine. PMID:26464927

  14. Multiple Stent Fractures After Everolimus-Eluting Stent Implantation Causing Acute Myocardial Infarction

    PubMed Central

    Ji, Eun Young; Park, Gyung-Min; Kim, Dae Won; Kim, Tae-Seok; Kim, Chan Joon; Cho, Jung Sun; Park, Mahn-Won; Her, Sung Ho

    2016-01-01

    Abstract Stent fracture is an uncommon complication of drug-eluting stent implantation, but it has a clinical significance because of its potential association with adverse cardiac events such as in-stent restenosis, target lesion revascularization, and stent thrombosis. Multiple stent fractures account for a small proportion, but they may lead to more serious complications. Newer generation drug-eluting stents are designed for improved safety and efficacy compared with early generation drug-eluting stents. Multiple stent fractures after newer generation drug-eluting stent implantation are a rare case. We report a case of 25-year-old male who presented with acute myocardial infarction caused by multiple stent fractures after everolimus-eluting stents implantation and was treated by balloon angioplasty. Physicians should be aware of the possibility of multiple stent fractures even after newer generation drug-eluting stent implantation. PMID:26871806

  15. [Silicone breast implants].

    PubMed

    Nielsen, M; Brandt, B; Breiting, V B; Christensen, L H; Thomsen, J L

    1989-12-18

    A brief review of the use of silicone breast implants, their structure, methods of implantation and complications is presented. Acute complications are rare, being mainly infection and hematoma. Long-term complications, on the contrary, are common, consisting mainly of capsular contracture around the prosthesis with subsequent pain and deformation of the breast. More rarely silicone granulomas form, and prosthesis rupture or herniation occurs. The importance of silicone leakage for these complications is discussed separately as well as the treatment of and prevention of capsular contracture and demonstration of silicone in tissue. A critical attitude towards the use of silicone breast implants, when these are used for purely cosmetic purposes, is recommended at present. New improved types of silicone breast implants are currently being tested clinically. PMID:2692262

  16. Peri-Implant Diseases

    MedlinePlus

    ... and flossing and regular check-ups from a dental professional. Other risks factors for developing peri-implant disease include previous periodontal disease diagnosis, poor plaque control, smoking , and diabetes . It is essential to routinely ...

  17. Biocompatibility of surgical implants

    NASA Technical Reports Server (NTRS)

    Kaelble, D. H.

    1979-01-01

    Method of selecting biocompatible materials for surgical implants uses fracture mechanic relationships and surface energies of candidate materials in presence of blood plasma. Technique has been used to characterize 190 materials by parameters that reflect their biocompatibility.

  18. Risks of Breast Implants

    MedlinePlus

    ... larger and longer than these conducted so far. Breastfeeding Some women who undergo breast augmentation can successfully ... breast implant silicone shell into breast milk during breastfeeding. Although there are currently no established methods for ...

  19. Clinically based implant selection.

    PubMed

    Fugazzotto, P A

    1999-01-01

    A hierarchy of implant selection is presented, based on overcoming specific clinical challenges in a variety of situations, including maximization of the esthetic, comfort, and functional potentials of therapy. PMID:10709488

  20. Breast reconstruction - implants

    MedlinePlus

    ... stages, or surgeries. During the first stage, a tissue expander is used. An implant is placed during the ... a pouch under your chest muscle. A small tissue expander is placed in the pouch. The expander is ...

  1. Superelastic Orthopedic Implant Coatings

    NASA Astrophysics Data System (ADS)

    Fournier, Eric; Devaney, Robert; Palmer, Matthew; Kramer, Joshua; El Khaja, Ragheb; Fonte, Matthew

    2014-07-01

    The demand for hip and knee replacement surgery is substantial and growing. Unfortunately, most joint replacement surgeries will fail within 10-25 years, thereby requiring an arduous, painful, and expensive revision surgery. To address this issue, a novel orthopedic implant coating material ("eXalt") has been developed. eXalt is comprised of super elastic nitinol wire that is knit into a three-dimensional spacer fabric structure. eXalt expands in vivo to conform to the implantation site and is porous to allow for bone ingrowth. The safety and efficacy of eXalt were evaluated through structural analysis, mechanical testing, and a rabbit implantation model. The results demonstrate that eXalt meets or exceeds the performance of current coating technologies with reduced micromotion, improved osseointegration, and stronger implant fixation in vivo.

  2. Implantable microscale neural interfaces.

    PubMed

    Cheung, Karen C

    2007-12-01

    Implantable neural microsystems provide an interface to the nervous system, giving cellular resolution to physiological processes unattainable today with non-invasive methods. Such implantable microelectrode arrays are being developed to simultaneously sample signals at many points in the tissue, providing insight into processes such as movement control, memory formation, and perception. These electrode arrays have been microfabricated on a variety of substrates, including silicon, using both surface and bulk micromachining techniques, and more recently, polymers. Current approaches to achieving a stable long-term tissue interface focus on engineering the surface properties of the implant, including coatings that discourage protein adsorption or release bioactive molecules. The implementation of a wireless interface requires consideration of the necessary data flow, amplification, signal processing, and packaging. In future, the realization of a fully implantable neural microsystem will contribute to both diagnostic and therapeutic applications, such as a neuroprosthetic interface to restore motor functions in paralyzed patients. PMID:17252207

  3. Implant treatment planning: endodontic considerations.

    PubMed

    Simonian, Krikor; Frydman, Alon; Verdugo, Fernando; Roges, Rafael; Kar, Kian

    2014-12-01

    Implants are a predictable and effective method for replacing missing teeth. Some clinicians have advocated extraction and replacement of compromised but treatable teeth on the assumption that implants will outperform endodontically and/or periodontally treated teeth. However, evidence shows that conventional therapy is as effective as implant treatment. With data on implants developing complications long term and a lack of predictable treatment for peri-implantitis, retaining and restoring the natural dentition should be the first choice when possible. PMID:25928961

  4. Ion implantation at elevated temperatures

    SciTech Connect

    Lam, N.Q.; Leaf, G.K.

    1985-11-01

    A kinetic model has been developed to investigate the synergistic effects of radiation-enhanced diffusion, radiation-induced segregation and preferential sputtering on the spatial redistribution of implanted solutes during implantation at elevated temperatures. Sample calculations were performed for Al and Si ions implanted into Ni. With the present model, the influence of various implantation parameters on the evolution of implant concentration profiles could be examined in detail.

  5. Development, Characterizations and Biocompatibility Evaluations of Intravitreal Lipid Implants

    PubMed Central

    Tamaddon, Lana; Mostafavi, Abolfazl; Riazi-esfahani, Mohammad; Karkhane, Reza; Aghazadeh, Sara; Rafiee-Tehrani, Morteza; Abedin Dorkoosh, Farid; Asadi Amoli, Fahimeh

    2014-01-01

    Background: The treatment of posterior eye diseases is always challenging mainly due to inaccessibility of the region. Many drugs are currently delivered by repeated intraocular injections. Objectives: The purpose of this study was to investigate the potential applications of natural triglycerides as alternative carriers to synthetic polymers in terms of drug release profile and also biocompatibility for intraocular use. Materials and Methods: In vitro/in vivo evaluations of intravitreal implants fabricated from the physiological lipid, glyceride tripalmitate containing clindamycin phosphate as a model drug was performed. The micro-implants with average diameter of 0.4 mm were fabricated via a hot melt extrusion method. The extrudates were analyzed using scanning electron microscopy, differential scanning calorimetry, and in vitro drug dissolution studies. For biocompatibility, the implants were implanted into rabbit eyes. Clinical investigations including fundus observations, electroretinography as well as histological evaluations were performed. Results: In vitro tests guaranteed usefulness of the production method for preparing the homogenous mixture of the drug and lipid without affecting thermal and crystalinity characteristics of the components. In vitro releases indicated a bi-phasic pattern for lower lipid ratios, which were completed by the end of day three. With higher lipid ratios, more controlled release profiles were achieved until about ten days for a lipid ratio of 95%. Clinical observations did not show any abnormalities up to two months after implantation into the rabbit eye. Conclusions: These results suggest that although the implant could not adequately retard release of the present drug model yet, due to good physical characteristics and in vivo biocompatibility, it can represent a suitable device for loading wide ranges of therapeutics in treatment of many kinds of retinochoroidal disorders. PMID:24872944

  6. MED-EL Cochlear Implants: State of the Art and a Glimpse Into the Future

    PubMed Central

    Hochmair, Ingeborg; Nopp, Peter; Jolly, Claude; Schmidt, Marcus; Schößer, Hansjörg; Garnham, Carolyn; Anderson, Ilona

    2006-01-01

    Cochlear implantation is an accepted treatment method for adults and children with severe to profound hearing loss. Confidence in technology has led to changes in individuals who can receive a cochlear implant and changes in expected benefit with a cochlear implant. This article describes the research and development activities at MED-EL, which make possible the implementation of new speech-coding strategies as well as the application of acoustic and electric stimulation via a combined speech processor in MED-EL devices. Research on benefits from bilateral cochlear implantation and electric-acoustic stimulation are also reviewed. Finally, the potential of drug delivery systems is considered as a way to improve cochlear implant outcomes, and results from preliminary evaluations of a hybrid cochlear implant system with drug delivery capabilities are reported. PMID:17172548

  7. Biomaterials in cochlear implants

    PubMed Central

    Stöver, Timo; Lenarz, Thomas

    2011-01-01

    The cochlear implant (CI) represents, for almost 25 years now, the gold standard in the treatment of children born deaf and for postlingually deafened adults. These devices thus constitute the greatest success story in the field of ‘neurobionic’ prostheses. Their (now routine) fitting in adults, and especially in young children and even babies, places exacting demands on these implants, particularly with regard to the biocompatibility of a CI’s surface components. Furthermore, certain parts of the implant face considerable mechanical challenges, such as the need for the electrode array to be flexible and resistant to breakage, and for the implant casing to be able to withstand external forces. As these implants are in the immediate vicinity of the middle-ear mucosa and of the junction to the perilymph of the cochlea, the risk exists – at least in principle – that bacteria may spread along the electrode array into the cochlea. The wide-ranging requirements made of the CI in terms of biocompatibility and the electrode mechanism mean that there is still further scope – despite the fact that CIs are already technically highly sophisticated – for ongoing improvements to the properties of these implants and their constituent materials, thus enhancing the effectiveness of these devices. This paper will therefore discuss fundamental material aspects of CIs as well as the potential for their future development. PMID:22073103

  8. [Implantable materials (author's transl)].

    PubMed

    Schaldach, M

    1975-11-01

    There is a steadily increasing importance of implants used as substitutions for body functions which have been impaired due to disease, natural abrasion or accident. With the present state of the art, the limitations for the application of surgical substitutions are due to insufficient properties of biomaterials with regard to specific applications as well as to deficiencies in design and function of the implants used. The basis for the improvement and new development of implants is therefore a functionally adequate design in which the specific properties of the material are taken into account with regard to the individual requirements of the implantation site. For orthopedic implants, materials have to be developed which are to a large extent corrosion and degradation resistant, and withstand high mechanical stress. For implants in the cardiovascular system, compatibility with blood is most significant. Present research in this field is concentrated on efforts to improve the thromboresistivity of conventional polymers by different kinds of surface treatments. One possibility is to influence actively the electrochemical interactions between material and blood components, e.g. by the use of redox catalysts. PMID:1107653

  9. Role of implants in the treatment of diabetic macular edema: focus on the dexamethasone intravitreal implant

    PubMed Central

    Cebeci, Zafer; Kir, Nur

    2015-01-01

    Diabetic macular edema (DME) is the leading cause of sight-threatening complication in diabetic patients, and several treatment modalities have been developed and evaluated to treat this pathology. Intravitreal agents, such as anti-vascular endothelial growth factors (anti-VEGF) or corticosteroids, have become more popular in recent years and are widely used for treating DME. Sustained release drugs appear to be mentioned more often nowadays for extending the period of intravitreal activity, and corticosteroids play a key role in inhibiting the inflammatory process in DME. A potent corticosteroid, dexamethasone (Ozurdex®), in the form of an intravitreal implant, has been approved for various ocular etiologies among which DME is also one. This review evaluates the role of implants in the treatment of DME, mainly focusing on the dexamethasone intravitreal implant. PMID:26604809

  10. Drug delivery systems.

    PubMed

    Robinson, D H; Mauger, J W

    1991-10-01

    New and emerging drug delivery systems for traditional drugs and the products of biotechnology are discussed, and the role of the pharmacist in ensuring the appropriate use of these systems is outlined. Advantages of advanced drug delivery systems over traditional systems are the ability to deliver a drug more selectively to a specific site; easier, more accurate, less frequent dosing; decreased variability in systemic drug concentrations; absorption that is more consistent with the site and mechanism of action; and reductions in toxic metabolites. Four basic strategies govern the mechanisms of advanced drug delivery: physical, chemical, biological, and mechanical. Oral drug delivery systems use natural and synthetic polymers to deliver the product to a specific region in the gastrointestinal tract in a timely manner that minimizes adverse effects and increases drug efficacy. Innovations in injectable and implantable delivery systems include emulsions, particulate delivery systems, micromolecular products and macromolecular drug adducts, and enzymatic-controlled delivery. Options for noninvasive drug delivery include the transdermal, respiratory, intranasal, ophthalmic, lymphatic, rectal, intravaginal, and intrauterine routes as well as topical application. Rapid growth is projected in the drug delivery systems market worldwide in the next five years. Genetic engineering has mandated the development of new strategies to deliver biotechnologically derived protein and peptide drugs and chemoimmunoconjugates. The role of the pharmacist in the era of advanced drug delivery systems will be broad based, including administering drugs, compounding, calculating dosages based on pharmacokinetic and pharmacodynamic monitoring, counseling, and research. The advent of advanced drug delivery systems offers pharmacists a new opportunity to assume an active role in patient care. PMID:1772110

  11. [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. PMID:22379772

  12. Mini Drug Pump for Ophthalmic Use

    PubMed Central

    Saati, Saloomeh; Lo, Ronalee; Li, Po-Ying; Meng, Ellis; Varma, Rohit; Humayun, Mark S.

    2009-01-01

    Purpose: To evaluate the feasibility of developing a novel mini drug pump for ophthalmic use. Methods: Using principles of microelectromechanical systems engineering, a mini drug pump was fabricated. The pumping mechanism is based on electrolysis, and the pump includes a drug refill port as well as a check valve to control drug delivery. Drug pumps were tested first on the benchtop and then after implantation in rabbits. For the latter, we implanted 4 elliptical (9.9 × 7.7 × 1.8 mm) non-electrically active pumps into 4 rabbits. The procedure is similar to implantation of a glaucoma seton. To determine the ability to refill and also the patency of the cannula, at intervals of 4 to 6 weeks after implantation, we accessed the drug reservoir with a transconjunctival needle and delivered approximately as low as 1 μL of trypan blue solution (0.06%) into the anterior chamber. Animals were followed up by slit-lamp examination, photography, and fluorescein angiography. Results: Benchtop testing showed 2.0 μL/min delivery when using 0.4 mW of power for electrolysis. One-way valves showed reliable opening pressures of 470 mm Hg. All implanted devices refilled at 4- to 6-week intervals for 4 to 6 months. No infection was seen. No devices extruded. No filtering bleb formed over the implant. Conclusions: A prototype ocular mini drug pump was built, implanted, and refilled. Such a platform needs more testing to determine the long-term biocompatibility of an electrically controlled implanted pump. Testing with various pharmacologic agents is needed to determine its ultimate potential for ophthalmic use. PMID:20126483

  13. Implant interactions with orthodontics.

    PubMed

    Celenza, Frank

    2012-09-01

    Many situations arise in which orthodontic therapy in conjunction with implant modalities is beneficial, relevant or necessary. These situations might entail orthodontic treatment preparatory to the placement of an implant, such as in the site preparation for implant placement. Traditionally, this has been somewhat well understood, but there are certain guidelines that must be adhered to as well as diagnostic steps that must be followed. Provision of adequate space for implant placement is of paramount importance, but there is also the consideration of tissue manipulation and remodeling which orthodontic therapy can achieve very predictably and orthodontists should be well versed in harnessing and employing this modality of site preparation. In this way, hopeless teeth that are slated for extraction can still be utilized by orthodontic extraction to augment tissues, both hard and soft, thereby facilitating site development. On the corollary, and representing a significant shift in treatment sequencing, there are many situations in which orthodontic mechanotherapy can be simplified, expedited, and facilitated by the placement of an implant and utilization as an integral part of the mechanotherapy. Implants have proven to provide excellent anchorage, and have resulted in a new class of anchorage known as "absolute anchorage". Implants can be harnessed as anchors both in a direct and indirect sense, depending upon the dictates of the case. Further, this has led to the development of orthodontic miniscrew systems and techniques, which can have added features such as flexibility in location and placement, as well as ease of use and removal. As orthodontic appliances evolve, the advent of aligner therapy has become mainstream and well accepted, and many of the aforementioned combined treatment modalities can and should be incorporated into this relatively new treatment modality as well. PMID:23040348

  14. 21 CFR 880.6300 - Implantable radiofrequency transponder system for patient identification and health information.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implantable radiofrequency transponder system for patient identification and health information. 880.6300 Section 880.6300 Food and Drugs FOOD AND DRUG... identification code is used to access patient identity and corresponding health information stored in a...

  15. 21 CFR 882.5830 - Implanted diaphragmatic/phrenic nerve stimulator.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted diaphragmatic/phrenic nerve stimulator. 882.5830 Section 882.5830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... which an abnormally low amount of air enters the lungs) caused by brain stem disease, high...

  16. 21 CFR 882.5830 - Implanted diaphragmatic/phrenic nerve stimulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted diaphragmatic/phrenic nerve stimulator. 882.5830 Section 882.5830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... which an abnormally low amount of air enters the lungs) caused by brain stem disease, high...

  17. 21 CFR 882.5830 - Implanted diaphragmatic/phrenic nerve stimulator.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted diaphragmatic/phrenic nerve stimulator. 882.5830 Section 882.5830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... which an abnormally low amount of air enters the lungs) caused by brain stem disease, high...

  18. 21 CFR 880.6300 - Implantable radiofrequency transponder system for patient identification and health information.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implantable radiofrequency transponder system for... radiofrequency transponder system for patient identification and health information. (a) Identification. An implantable radiofrequency transponder system for patient identification and health information is a...

  19. 21 CFR 880.6300 - Implantable radiofrequency transponder system for patient identification and health information.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implantable radiofrequency transponder system for... radiofrequency transponder system for patient identification and health information. (a) Identification. An implantable radiofrequency transponder system for patient identification and health information is a...

  20. 21 CFR 880.6300 - Implantable radiofrequency transponder system for patient identification and health information.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implantable radiofrequency transponder system for... radiofrequency transponder system for patient identification and health information. (a) Identification. An implantable radiofrequency transponder system for patient identification and health information is a...

  1. 21 CFR 880.5970 - Percutaneous, implanted, long-term intravascular catheter.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...: “Guidance on Premarket Notification Submission for Short-Term and Long-Term Intravascular Catheters.” ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Percutaneous, implanted, long-term intravascular... and Personal Use Therapeutic Devices § 880.5970 Percutaneous, implanted, long-term...

  2. 21 CFR 880.5970 - Percutaneous, implanted, long-term intravascular catheter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...: “Guidance on Premarket Notification Submission for Short-Term and Long-Term Intravascular Catheters.” ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Percutaneous, implanted, long-term intravascular... and Personal Use Therapeutic Devices § 880.5970 Percutaneous, implanted, long-term...

  3. 21 CFR 880.5970 - Percutaneous, implanted, long-term intravascular catheter.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...: “Guidance on Premarket Notification Submission for Short-Term and Long-Term Intravascular Catheters.” ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Percutaneous, implanted, long-term intravascular... and Personal Use Therapeutic Devices § 880.5970 Percutaneous, implanted, long-term...

  4. 21 CFR 880.5970 - Percutaneous, implanted, long-term intravascular catheter.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...: “Guidance on Premarket Notification Submission for Short-Term and Long-Term Intravascular Catheters.” ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Percutaneous, implanted, long-term intravascular... and Personal Use Therapeutic Devices § 880.5970 Percutaneous, implanted, long-term...

  5. 21 CFR 880.6300 - Implantable radiofrequency transponder system for patient identification and health information.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... radiofrequency transponder system for patient identification and health information. (a) Identification. An implantable radiofrequency transponder system for patient identification and health information is a device... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implantable radiofrequency transponder system...

  6. 21 CFR 878.3500 - Polytetrafluoroethylene with carbon fibers composite implant material.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Polytetrafluoroethylene with carbon fibers... Prosthetic Devices § 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material. (a) Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous...

  7. 21 CFR 878.3500 - Polytetrafluoroethylene with carbon fibers composite implant material.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Polytetrafluoroethylene with carbon fibers... Prosthetic Devices § 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material. (a) Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous...

  8. 21 CFR 878.3500 - Polytetrafluoroethylene with carbon fibers composite implant material.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Polytetrafluoroethylene with carbon fibers... Prosthetic Devices § 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material. (a) Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous...

  9. 21 CFR 878.3500 - Polytetrafluoroethylene with carbon fibers composite implant material.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Polytetrafluoroethylene with carbon fibers... Prosthetic Devices § 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material. (a) Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous...

  10. Transdermal Photopolymerization for Minimally Invasive Implantation

    NASA Astrophysics Data System (ADS)

    Elisseeff, J.; Anseth, K.; Sims, D.; McIntosh, W.; Randolph, M.; Langer, R.

    1999-03-01

    Photopolymerizations are widely used in medicine to create polymer networks for use in applications such as bone restorations and coatings for artificial implants. These photopolymerizations occur by directly exposing materials to light in "open" environments such as the oral cavity or during invasive procedures such as surgery. We hypothesized that light, which penetrates tissue including skin, could cause a photopolymerization indirectly. Liquid materials then could be injected s.c. and solidified by exposing the exterior surface of the skin to light. To test this hypothesis, the penetration of UVA and visible light through skin was studied. Modeling predicted the feasibility of transdermal polymerization with only 2 min of light exposure required to photopolymerize an implant underneath human skin. To establish the validity of these modeling studies, transdermal photopolymerization first was applied to tissue engineering by using "injectable" cartilage as a model system. Polymer/chondrocyte constructs were injected s.c. and transdermally photopolymerized. Implants harvested at 2, 4, and 7 weeks demonstrated collagen and proteoglycan production and histology with tissue structure comparable to native neocartilage. To further examine this phenomenon and test the applicability of transdermal photopolymerization for drug release devices, albumin, a model protein, was released for 1 week from photopolymerized hydrogels. With further study, transdermal photpolymerization potentially could be used to create a variety of new, minimally invasive surgical procedures in applications ranging from plastic and orthopedic surgery to tissue engineering and drug delivery.

  11. Positron implantation in solids

    SciTech Connect

    Ghosh, V.J.; Lynn, K.G.; Welch, D.O.

    1993-12-31

    The Monte Carlo technique for modeling positron prior to annihilation and electron implantation in semi-infinite metals is described. Particle implantation is modelled as a multistep process, a series of collisions with the atoms of the host material. In elastic collisions with neutral atoms there is no transfer of energy. The particle loses energy by several different channels, excitation of the electron gas, ionization of the ion cores, or, at low energies, by phonon excitation. These competing scattering mechanisms have been incorporated into the Monte Carlo framework and several different models are being used. Brief descriptions of these Monte Carlo schemes, as well as an analytic model for positron implantation are included. Results of the Monte Carlo simulations are presented and compared with expermental data. Problems associated with modeling positron implantation are discuss and the need for more expermental data on energy-loss in different materials is stressed. Positron implantation in multilayers of different metals is briefly described and extensions of this work to include a study of multilayers and heterostructures is suggested.

  12. Imaging for cochlear implants.

    PubMed

    Phelps, P D; Annis, J A; Robinson, P J

    1990-07-01

    Insertion of a sound amplification device into the round window niche (extracochlear implant) or into the coils of the cochlea (intracochlear implant) can give significant benefits to some carefully selected, severely deaf patients. Imaging has an essential role in selective and pre-operative assessment. Severe otosclerosis and post-meningitic labyrinthitis ossificans are common causes of deafness in these patients and can be demonstrated by computed tomography (CT). The most suitable side for operation can be assessed. We describe our experiences with 165 patients, 69 of whom were found suitable for implants. Thin (1 mm) section CT in axial and coronal planes is the best imaging investigation of the petrous temporal bones but the place of magnetic resonance scanning to confirm that the inner ear is fluid-filled and polytomography to show a multichannel implant in the cochlea is discussed. No implants were used for congenital deformities, but some observations are made of this type of structural deformity of the inner ear. PMID:2390686

  13. Enhanced drug delivery capabilities from stents coated with absorbable polymer and crystalline drug

    PubMed Central

    Carlyle, Wenda C.; McClain, James B.; Tzafriri, Abraham R.; Bailey, Lynn; Zani, Brett G.; Markham, Peter M.; Stanley, James R.L.; Edelman, Elazer R.

    2015-01-01

    Current drug eluting stent (DES) technology is not optimized with regard to the pharmacokinetics of drug delivery. A novel, absorbable-coating sirolimus-eluting stent (AC-SES) was evaluated for its capacity to deliver drug more evenly within the intimal area rather than concentrating drug around the stent struts and for its ability to match coating erosion with drug release. The coating consisted of absorbable poly-lactide-co-glycolic acid (PLGA) and crystalline sirolimus deposited by a dry-powder electrostatic process. The AC-SES demonstrated enhanced drug stability under simulated use conditions and consistent drug delivery balanced with coating erosion in a porcine coronary implant model. The initial drug burst was eliminated and drug release was sustained after implantation. The coating was absorbed within 90 days. Following implantation into porcine coronary arteries the AC-SES coating is distributed in the surrounding intimal tissue over the course of several weeks. Computational modeling of drug delivery characteristics demonstrates how distributed coating optimizes the load of drug immediately around each stent strut and extends drug delivery between stent struts. The result was a highly efficient arterial uptake of drug with superior performance to a clinical bare metal stent (BMS). Neointimal thickness (0.17±0.07 mm vs. 0.28±0.11 mm) and area percent stenosis (22±9% vs. 35±12%) were significantly reduced (p<0.05) by the AC-SES compared to the BMS 30 days after stent implantation in an overlap configuration in porcine coronary arteries. Inflammation was significantly reduced in the AC-SES compared to the BMS at both 30 and 90 days after implantation. Biocompatible, rapidly absorbable stent coatings enable the matching of drug release with coating erosion and provide for the controlled migration of coating material into tissue to reduce vicissitudes in drug tissue levels, optimizing efficacy and reducing potential toxicity. PMID:22800575

  14. Adjuvant antiarrhythmic therapy in patients with implantable cardioverter defibrillators.

    PubMed

    Bunch, T Jared; Anderson, Jeffrey L

    2014-04-01

    The risk of sudden cardiac death from ventricular fibrillation or ventricular tachycardia in patients with cardiomyopathy related to structural heart disease has been favorably impacted by the wide adaptation of implantable cardioverter defibrillators (ICDs) for both primary and secondary prevention. Unfortunately, after ICD implantation both appropriate and inappropriate ICD therapies are common. ICD shocks in particular can have significant effects on quality of life and disease-related morbidity and mortality. While not indicated for primary prevention of ICD therapies, beta-blockers and antiarrhythmic drugs are a cornerstone for secondary prevention of them. This review will summarize our current understanding of adjuvant antiarrhythmic drug therapy in ICD patients. The review will also discuss the roles of nonantiarrhythmic drug approaches that are used in isolation and in combination with antiarrhythmic drugs to reduce subsequent risk of ICD shocks. PMID:24288157

  15. Dental devices; reclassification of root-form endosseous dental implants and endosseous dental implant abutments. Final rule.

    PubMed

    2004-05-12

    The Food and Drug Administration (FDA) is reclassifying root-form endosseous dental implants and endosseous dental implant abutments from class III to class II (special controls). Root-form endosseous dental implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are separate components that are attached to the dental implant and intended to aid in prosthetic rehabilitation. FDA is reclassifying these devices on its own initiative on the basis of new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for these devices. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. PMID:15141676

  16. [Anesthesia management in implantation of baroreceptor stimulators].

    PubMed

    Werner, T; Lebar, L; Wittmann, S; Keyser, A; Fischer, M; Schmidli, J; Graf, B M; Zausig, Y A

    2015-09-01

    Baroreceptor stimulators are novel implantable devices that activate the carotid baroreceptor reflex. This results in a decrease in activity of the sympathetic nervous system and inhibition of the renin-angiotensin-aldosterone system. In patients with drug-resistant hypertension, permanent electrical activation of the baroreceptor reflex results in blood pressure reduction and cardiac remodeling. For correct intraoperative electrode placement at the carotid bifurcation, the baroreceptor reflex needs to be activated several times. Many common anesthetic agents, such as inhalation anesthetics and propofol dampen or inhibit the baroreceptor reflex and complicate or even prevent successful placement. Therefore, a specific anesthesia and pharmacological management is necessary to ensure successful implantation of baroreceptor reflex stimulators. PMID:26275386

  17. Implantable Heart Aid

    NASA Technical Reports Server (NTRS)

    1980-01-01

    Medrad utilized NASA's Apollo technology to develop a new device called the AID implantable automatic pulse generator which monitors the heart continuously, recognizes the onset of ventricular fibrillation and delivers a corrective electrical shock. AID pulse generator is, in effect, a miniaturized version of the defibrillator used by emergency squads and hospitals to restore rhythmic heartbeat after fibrillation, but has the unique advantage of being permanently available to the patient at risk. Once implanted, it needs no specially trained personnel or additional equipment. AID system consists of a microcomputer, a power source and two electrodes which sense heart activity.

  18. Hydroxylapatite Otologic Implants

    SciTech Connect

    McMillan, A.D.; Lauf, R.J.; Beale, B.; Johnson, R.

    2000-01-01

    A Cooperative Research and Development Agreement (CRADA) between Lockheed Martin Energy Research Corporation (LMER) and Smith and Nephew Richards Inc. of Bartlett, TN, was initiated in March 1997. The original completion date for the Agreement was March 25, 1998. The purpose of this work is to develop and commercialize net shape forming methods for directly creating dense hydroxylapatite (HA) ceramic otologic implants. The project includes three tasks: (1) modification of existing gelcasting formulations to accommodate HA slurries; (2) demonstration of gelcasting to fabricate green HA ceramic components of a size and shape appropriate to otologic implants: and (3) sintering and evaluation of the HA components.

  19. Ion implantation in silicate glasses

    SciTech Connect

    Arnold, G.W.

    1993-12-01

    This review examines the effects of ion implantation on the physical properties of silicate glasses, the compositional modifications that can be brought about, and the use of metal implants to form colloidal nanosize particles for increasing the nonlinear refractive index.

  20. Current trends in dental implants

    PubMed Central

    Gaviria, Laura; Salcido, John Paul; Guda, Teja

    2014-01-01

    Tooth loss is very a very common problem; therefore, the use of dental implants is also a common practice. Although research on dental implant designs, materials and techniques has increased in the past few years and is expected to expand in the future, there is still a lot of work involved in the use of better biomaterials, implant design, surface modification and functionalization of surfaces to improve the long-term outcomes of the treatment. This paper provides a brief history and evolution of dental implants. It also describes the types of implants that have been developed, and the parameters that are presently used in the design of dental implants. Finally, it describes the trends that are employed to improve dental implant surfaces, and current technologies used for the analysis and design of the implants. PMID:24868501

  1. Tungsten contamination in ion implantation

    NASA Astrophysics Data System (ADS)

    Polignano, M. L.; Barbarossa, F.; Galbiati, A.; Magni, D.; Mica, I.

    2016-06-01

    In this paper the tungsten contamination in ion implantation processes is studied by DLTS analysis both in typical operating conditions and after contamination of the implanter by implantation of wafers with an exposed tungsten layer. Of course the contaminant concentration is orders of magnitude higher after contamination of the implanter, but in addition our data show that different mechanisms are active in a not contaminated and in a contaminated implanter. A moderate tungsten contamination is observed also in a not contaminated implanter, however in that case contamination is completely not energetic and can be effectively screened by a very thin oxide. On the contrary, the contamination due to an implantation in a previously contaminated implanter is reduced but not suppressed even by a relatively thick screen oxide. The comparison with SRIM calculations confirms that the observed deep penetration of the contaminant cannot be explained by a plain sputtering mechanism.

  2. The ruptured PIP breast implant.

    PubMed

    Helyar, V; Burke, C; McWilliams, S

    2013-08-01

    Public concern erupted about the safety of Poly Implant Prothèse (PIP) breast implants when it was revealed in 2011 that they contained an inferior, unlicensed industrial-grade silicone associated with a high rate of rupture. There followed national guidance for UK clinicians, which led to a considerable increase in referrals of asymptomatic women for breast implant assessment. In this review we discuss possible approaches to screening the PIP cohort and the salient characteristics of a ruptured implant. PMID:23622796

  3. Rehabilitation using single stage implants

    PubMed Central

    Mohamed, Jumshad B.; Sudarsan, Sabitha; Arun, K. V.; Shivakumar, B.

    2009-01-01

    Implant related prosthesis has become an integral part of rehabilitation of edentulous areas. Single stage implant placement has become popular because of its ease of use and fairly predictable results. In this paper, we present a series of cases of single stage implants being used to rehabilitate different clinical situations. All the implants placed have been successfully restored and followed up for up to one year. PMID:20376239

  4. Foreign Body Reaction to Subcutaneous Implants.

    PubMed

    Kastellorizios, Michail; Tipnis, Namita; Burgess, Diane J

    2015-01-01

    Subcutaneously implanted materials trigger the host's innate immune system, resulting in the foreign body reaction. This reaction consists of protein adsorption on the implant surface, inflammatory cell infiltration, macrophage fusion into foreign body giant cells, fibroblast activation and ultimately fibrous encapsulation. This series of events may affect the function of subcutaneous implants, such as inhibition of drug diffusion from long-acting drug delivery depots and medical device failure. The foreign body reaction is a complex phenomenon and is not yet fully understood; ongoing research studies aim to elucidate the cellular and molecular dynamics involved. Recent studies have revealed information about the specific role of macrophages and their differential activation towards pro- and anti-inflammatory states, as well as species differences in the timing of collagen deposition and fibrosis. Understanding of the diverse processes involved in the foreign body reaction has led to multiple approaches towards its negation. Delivery of tissue response modifiers, such as corticosteroids, NSAIDs, antifibrotic agents, and siRNAs, has been used to prevent or minimize fibrosis. Of these, delivery of dexamethasone throughout the implantation period is the most common method to prevent inflammation and fibrosis. More recent approaches employ surface modifications to minimize protein adsorption to 'ultra-low' levels and reduce fibrosis. However, the diverse nature of the processes involved in the foreign body reaction favor the use of corticosteroids due to their wide spectrum action compared to other approaches. To date, combination approaches, such as hydrophilic coatings that reduce protein adsorption combined with delivery of dexamethasone are the most effective. PMID:26306445

  5. Prosthetic failure in implant dentistry.

    PubMed

    Sadid-Zadeh, Ramtin; Kutkut, Ahmad; Kim, Hyeongil

    2015-01-01

    Although osseointegrated dental implants have become a predictable and effective modality for the treatment of single or multiple missing teeth, their use is associated with clinical complications. Such complications can be biologic, technical, mechanical, or esthetic and may compromise implant outcomes to various degrees. This article presents prosthetic complications accompanied with implant-supported single and partial fixed dental prostheses. PMID:25434566

  6. Staphylococcal meningitis following Synchromed intrathecal pump implant: a case report.

    PubMed

    Bennett, M I; Tai, Y M; Symonds, J M

    1994-02-01

    Staphylococcal meningitis associated with implantation of an intrathecal drug pump for spasticity was successfully treated by intrathecal vancomycin delivered by the same pump. This produced high CSF antibiotic levels, and the pump and catheter system did not have to be removed. We are unable to identify a similar case reported in the literature to date. PMID:8008414

  7. Club Drugs

    MedlinePlus

    ... Rohypnol, ketamine, as well as MDMA (ecstasy) and methamphetamine ( Drug Facts: Club Drugs , National Institute on Drug ... Club Drugs , National Institute on Drug Abuse, 2010). Methamphetamine is a powerfully addictive stimulant associated with serious ...

  8. Remote actuated valve implant

    DOEpatents

    McKnight, Timothy E; Johnson, Anthony; Moise, Jr., Kenneth J; Ericson, Milton Nance; Baba, Justin S; Wilgen, John B; Evans, III, Boyd McCutchen

    2014-02-25

    Valve implant systems positionable within a flow passage, the systems having an inlet, an outlet, and a remotely activatable valve between the inlet and outlet, with the valves being operable to provide intermittent occlusion of the flow path. A remote field is applied to provide thermal or magnetic activation of the valves.

  9. Cochlear Implantation in Neurobrucellosis

    PubMed Central

    Bajin, Münir Demir; Savaş, Özden; Aslan, Filiz; Sennaroğlu, Levent

    2016-01-01

    Background: Neurobrucellosis is a disease consisting of a wide spectrum of complications such as peripheral neuropathy, cranial nerve involvement, ataxia, meningeal irritation, paraplegia, seizures, coma, and even death. The vestibulocochlear nerve seems to be the most commonly affected cranial nerve (10%). We present a patient with neurobrucellosis whose auditory perception and speech intelligibility skill performances improved after cochlear implantation. Case Report: A 35 year-old woman was admitted to another hospital 2 years ago with the symptoms of headache, nausea, and altered consciousness, who was finally diagnosed with neurobrucellosis. She developed bilateral profound sensorineural hearing loss during the following 6 months. There was no benefit of using hearing aids. After successful treatment of her illness, she was found to be suitable for cochlear implantation. After the operation, her auditory perception skills improved significantly with a Categories of Auditory Performance (CAP) score of 5. According to clinical observations and her family members’ statements, her Speech Intelligibility Rating (SIR) score was 3. Her speech intelligibility skills are still improving. Conclusion: Our case report represents the second case of hearing rehabilitation with cochlear implantation after neurobrucellosis. Cochlear implantation is a cost-effective and time-proven successful intervention in post-lingual adult patients with sensorineural hearing loss. Early timing of the surgery after appropriate treatment of meningitis helps the patient to achieve better postoperative results. PMID:26966626

  10. Implantable electrical device

    NASA Technical Reports Server (NTRS)

    Jhabvala, M. D. (Inventor)

    1982-01-01

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

  11. Remote actuated valve implant

    DOEpatents

    McKnight, Timothy E.; Johnson, Anthony; Moise, Kenneth J.; Ericson, Milton Nance; Baba, Justin S.; Wilgen, John B.; Evans, Boyd Mccutchen

    2016-05-10

    Valve implant systems positionable within a flow passage, the systems having an inlet, an outlet, and a remotely activatable valve between the inlet and outlet, with the valves being operable to provide intermittent occlusion of the flow path. A remote field is applied to provide thermal or magnetic activation of the valves.

  12. Allergy to Surgical Implants.

    PubMed

    Pacheco, Karin A

    2015-01-01

    Surgical implants have a wide array of therapeutic uses, most commonly in joint replacements, but also in repair of pes excavatum and spinal disorders, in cardiac devices (stents, patches, pacers, valves), in gynecological implants, and in dentistry. Many of the metals used are immunologically active, as are the methacrylates and epoxies used in conjunction with several of these devices. Allergic responses to surgical components can present atypically as failure of the device, with nonspecific symptoms of localized pain, swelling, warmth, loosening, instability, itching, or burning; localized rash is infrequent. Identification of the specific metal and cement components used in a particular implant can be difficult, but is crucial to guide testing and interpretation of results. Nickel, cobalt, and chromium remain the most common metals implicated in implant failure due to metal sensitization; methacrylate-based cements are also important contributors. This review will provide a guide on how to assess and interpret the clinical history, identify the components used in surgery, test for sensitization, and provide advice on possible solutions. Data on the pathways of metal-induced immune stimulation are included. In this setting, the allergist, the dermatologist, or both have the potential to significantly improve surgical outcomes and patient care. PMID:26362550

  13. Semiconductor Ion Implanters

    SciTech Connect

    MacKinnon, Barry A.; Ruffell, John P.

    2011-06-01

    In 1953 the Raytheon CK722 transistor was priced at $7.60. Based upon this, an Intel Xeon Quad Core processor containing 820,000,000 transistors should list at $6.2 billion. Particle accelerator technology plays an important part in the remarkable story of why that Intel product can be purchased today for a few hundred dollars. Most people of the mid twentieth century would be astonished at the ubiquity of semiconductors in the products we now buy and use every day. Though relatively expensive in the nineteen fifties they now exist in a wide range of items from high-end multicore microprocessors like the Intel product to disposable items containing 'only' hundreds or thousands like RFID chips and talking greeting cards. This historical development has been fueled by continuous advancement of the several individual technologies involved in the production of semiconductor devices including Ion Implantation and the charged particle beamlines at the heart of implant machines. In the course of its 40 year development, the worldwide implanter industry has reached annual sales levels around $2B, installed thousands of dedicated machines and directly employs thousands of workers. It represents in all these measures, as much and possibly more than any other industrial application of particle accelerator technology. This presentation discusses the history of implanter development. It touches on some of the people involved and on some of the developmental changes and challenges imposed as the requirements of the semiconductor industry evolved.

  14. Semiconductor Ion Implanters

    NASA Astrophysics Data System (ADS)

    MacKinnon, Barry A.; Ruffell, John P.

    2011-06-01

    In 1953 the Raytheon CK722 transistor was priced at 7.60. Based upon this, an Intel Xeon Quad Core processor containing 820,000,000 transistors should list at 6.2 billion! Particle accelerator technology plays an important part in the remarkable story of why that Intel product can be purchased today for a few hundred dollars. Most people of the mid twentieth century would be astonished at the ubiquity of semiconductors in the products we now buy and use every day. Though relatively expensive in the nineteen fifties they now exist in a wide range of items from high-end multicore microprocessors like the Intel product to disposable items containing `only' hundreds or thousands like RFID chips and talking greeting cards. This historical development has been fueled by continuous advancement of the several individual technologies involved in the production of semiconductor devices including Ion Implantation and the charged particle beamlines at the heart of implant machines. In the course of its 40 year development, the worldwide implanter industry has reached annual sales levels around 2B, installed thousands of dedicated machines and directly employs thousands of workers. It represents in all these measures, as much and possibly more than any other industrial application of particle accelerator technology. This presentation discusses the history of implanter development. It touches on some of the people involved and on some of the developmental changes and challenges imposed as the requirements of the semiconductor industry evolved.

  15. The reverse zygomatic implant: a new implant for maxillofacial reconstruction.

    PubMed

    Dawood, Andrew; Collier, Jonathan; Darwood, Alastair; Tanner, Susan

    2015-01-01

    This case report describes the rehabilitation of a patient who had been treated with a hemimaxillectomy, reconstruction with a latissimus dorsi vascularized free flap, and radiotherapy for carcinoma of the sinus some years previously. Limited jaw opening, difficult access through the flap to the bony site, and the very small amount of bone available in which to anchor the implant inspired the development and use of a new "reverse zygomatic" implant. For this treatment, site preparation and implant insertion were accomplished using an extraoral approach. The implant was used along with two other conventional zygomatic implants to provide support for a milled titanium bar and overdenture to rehabilitate the maxilla. Two years later, the patient continues to enjoy a healthy reconstruction. The reverse zygomatic implant appears to show promise as a useful addition to the implant armamentarium for the treatment of the patient undergoing maxillectomy. PMID:26574864

  16. Prosthodontic management of implant therapy.

    PubMed

    Thalji, Ghadeer; Bryington, Matthew; De Kok, Ingeborg J; Cooper, Lyndon F

    2014-01-01

    Implant-supported dental restorations can be screw-retained, cement-retained, or a combination of both, whereby a metal superstructure is screwed to the implants and crowns are individually cemented to the metal frame. Each treatment modality has advantages and disadvantages. The use of computer-aided design/computer-assisted manufacture technologies for the manufacture of implant superstructures has proved to be advantageous in the quality of materials, precision of the milled superstructures, and passive fit. Maintenance and recall evaluations are an essential component of implant therapy. The longevity of implant restorations is limited by their biological and prosthetic maintenance requirements. PMID:24286654

  17. Open Label Trial of Naltrexone Implants: Measuring Blood Serum Levels of Naltrexone

    PubMed Central

    Colquhoun, Ross M.

    2013-01-01

    The usefulness of oral naltrexone has been limited by compliance. Sub-cutaneous implants would seem to offer a solution to this problem and improve long-term outcomes. The aim of the present study was to compare levels of blood serum naltrexone of patients who had received a naltrexone implant after detoxification to a number of dependent variables of interest. These dependent variables included drug use including urine screens of each patient, any adverse response to the implant, subjective evaluation of self-esteem, quality of relationships, and changes in social functioning. Sixty six patients received an implant and were surveyed; urine and blood samples were taken at about 1, 3, and 6 months after implantation. Naltrexone levels were on average above 1 ng/mL at 6 months after insertion and patients showed significant improvements on all dependent variables. The preliminary evidence indicates that implants can improve compliance rates and outcomes. PMID:23761973

  18. MicroRNA-mediated immune modulation as a therapeutic strategy in host-implant integration.

    PubMed

    Ong, Siew-Min; Biswas, Subhra K; Wong, Siew-Cheng

    2015-07-01

    The concept of implanting an artificial device into the human body was once the preserve of science fiction, yet this approach is now often used to replace lost or damaged biological structures in human patients. However, assimilation of medical devices into host tissues is a complex process, and successful implant integration into patients is far from certain. The body's immediate response to a foreign object is immune-mediated reaction, hence there has been extensive research into biomaterials that can reduce or even ablate anti-implant immune responses. There have also been attempts to embed or coat anti-inflammatory drugs and pro-regulatory molecules onto medical devices with the aim of preventing implant rejection by the host. In this review, we summarize the key immune mediators of medical implant reaction, and we evaluate the potential of microRNAs to regulate these processes to promote wound healing, and prolong host-implant integration. PMID:26024977

  19. Additive manufacturing: From implants to organs.

    PubMed

    Douglas, Tania S

    2014-06-01

    Additive manufacturing (AM) constructs 3D objects layer by layer under computer control from 3D models. 3D printing is one example of this kind of technology. AM offers geometric flexibility in its products and therefore allows customisation to suit individual needs. Clinical success has been shown with models for surgical planning, implants, assistive devices and scaffold-based tissue engineering. The use of AM to print tissues and organs that mimic nature in structure and function remains an elusive goal, but has the potential to transform personalised medicine, drug development and scientific understanding of the mechanisms of disease.  PMID:25214247

  20. New approach to orthopedic implant design

    SciTech Connect

    Hollerbach, K; Perfect, S; Martz, H; Ashby, E

    1999-07-03

    This report describes the accomplishments of a three year LDRD project, aimed at developing computational models and methodologies for improving prosthetic joint design. The investigators developed human models as well as prosthetic joint models. Input data came both from high resolution scans performed at Lawrence Livermore National Laboratory (LLNL) and from data provided by collaborators. Results of the approach, in addition to being presented at scientific meetings, are being used to obtain US Food and Drug Administration (FDA) approval in the process of putting new implant designs on the market.

  1. Mesoporous titanium dioxide coating for metallic implants.

    PubMed

    Xia, Wei; Grandfield, Kathryn; Hoess, Andreas; Ballo, Ahmed; Cai, Yanling; Engqvist, Håkan

    2012-01-01

    A bioactive mesoporous titanium dioxide (MT) coating for surface drug delivery has been investigated to develop a multifunctional implant coating, offering quick bone bonding and biological stability. An evaporation induced self-assembly (EISA) method was used to prepare a mesoporous titanium dioxide coating of the anatase phase with BET surface area of 172 m(2)/g and average pore diameter of 4.3 nm. Adhesion tests using the scratch method and an in situ screw-in/screw-out technique confirm that the MT coating bonds tightly with the metallic substrate, even after removal from bone. Because of its high surface area, the bioactivity of the MT coating is much better than that of a dense TiO(2) coating of the same composition. Quick formation of hydroxyapatite (HA) in vitro can be related to enhance bonding with bone. The uptake of antibiotics by the MT coating reached 13.4 mg/cm(3) within a 24 h loading process. A sustained release behavior has been obtained with a weak initial burst. By using Cephalothin as a model drug, drug loaded MT coating exhibits a sufficient antibacterial effect on the material surface, and within millimeters from material surface, against E.coli. Additionally, the coated and drug loaded surfaces showed no cytotoxic effect on cell cultures of the osteoblastic cell line MG-63. In conclusion, this study describes a novel, biocompatiblemesoporous implant coating, which has the ability to induce HA formation and could be used as a surface drug-delivery system. PMID:21954047

  2. 77 FR 31722 - New Animal Drugs; Change of Sponsor; Estradiol; Estradiol Benzoate and Testosterone Propionate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-30

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 522, and 558 New Animal Drugs; Change of... amending the animal drug regulations to reflect a change of sponsor for 17 new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) for various steroid ear implants for...

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

    PubMed Central

    Hirsh, David S.; Goswami, Neela D.

    2016-01-01

    Mycobacterial infections resulting from cardiac implantable electronic devices are rare, but as more devices are implanted, these organisms are increasingly emerging as causes of early-onset infections. We report a patient with an implantable cardioverter-defibrillator pocket and associated bloodstream infection caused by an organism of the Mycobacterium fortuitum group, and we review the literature regarding mycobacterial infections resulting from cardiac device implantations. Thirty-two such infections have been previously described; most (70%) were caused by rapidly growing species, of which M. fortuitum group species were predominant. When managing such infections, clinicians should consider the potential need for extended incubation of routine cultures or dedicated mycobacterial cultures for accurate diagnosis; combination antimicrobial drug therapy, even for isolates that appear to be macrolide susceptible, because of the potential for inducible resistance to this drug class; and the arrhythmogenicity of the antimicrobial drugs traditionally recommended for infections caused by these organisms. PMID:26890060

  4. Drug allergies

    MedlinePlus

    Allergic reaction - drug (medication); Drug hypersensitivity; Medication hypersensitivity ... A drug allergy involves an immune response in the body that produces an allergic reaction to a medicine. The ...

  5. Atypical Case of Three Dental Implants Displaced into the Maxillary Sinus

    PubMed Central

    Bruniera, João Felipe Bonatto; Silva-Sousa, Yara Teresinha Corrêa; Faria, Paulo Esteves Pinto

    2015-01-01

    Oral rehabilitation with dental implants has become a routine treatment in contemporary dentistry. The displacement of dental implants into the sinus membrane, a complication related to the maxillary sinus, is one of the most common accidents reported in the literature. The treatment for this complication is the surgical removal of the implant. A 60-year-old woman with three dental implants displaced into the maxillary sinus (one implant displaced into the left maxillary sinus and two implants displaced into the right maxillary sinus) underwent surgery for removal of the implants. The surgery to remove the implants was performed under local anesthesia through the Caldwell-Luc technique. The patient was subsequently administered antibiotic, anti-inflammatory, and analgesic drugs. The patient returned 7 days after the surgery for suture removal and is being regularly monitored to determine whether future rehabilitation of the edentulous area is necessary. In conclusion, surgical removal of the dental implant displaced into the maxillary sinus is the treatment of choice. This technique is appropriate because it allows the use of local anesthesia and provides direct visualization for the removal of the implants. PMID:26635979

  6. Impact of Dental Implant Surface Modifications on Osseointegration.

    PubMed

    Smeets, Ralf; Stadlinger, Bernd; Schwarz, Frank; Beck-Broichsitter, Benedicta; Jung, Ole; Precht, Clarissa; Kloss, Frank; Gröbe, Alexander; Heiland, Max; Ebker, Tobias

    2016-01-01

    Objective. The aim of this paper is to review different surface modifications of dental implants and their effect on osseointegration. Common marketed as well as experimental surface modifications are discussed. Discussion. The major challenge for contemporary dental implantologists is to provide oral rehabilitation to patients with healthy bone conditions asking for rapid loading protocols or to patients with quantitatively or qualitatively compromised bone. These charging conditions require advances in implant surface design. The elucidation of bone healing physiology has driven investigators to engineer implant surfaces that closely mimic natural bone characteristics. This paper provides a comprehensive overview of surface modifications that beneficially alter the topography, hydrophilicity, and outer coating of dental implants in order to enhance osseointegration in healthy as well as in compromised bone. In the first part, this paper discusses dental implants that have been successfully used for a number of years focusing on sandblasting, acid-etching, and hydrophilic surface textures. Hereafter, new techniques like Discrete Crystalline Deposition, laser ablation, and surface coatings with proteins, drugs, or growth factors are presented. Conclusion. Major advancements have been made in developing novel surfaces of dental implants. These innovations set the stage for rehabilitating patients with high success and predictable survival rates even in challenging conditions. PMID:27478833

  7. Impact of Dental Implant Surface Modifications on Osseointegration

    PubMed Central

    Smeets, Ralf; Stadlinger, Bernd; Schwarz, Frank; Beck-Broichsitter, Benedicta; Jung, Ole; Precht, Clarissa; Kloss, Frank; Gröbe, Alexander; Heiland, Max

    2016-01-01

    Objective. The aim of this paper is to review different surface modifications of dental implants and their effect on osseointegration. Common marketed as well as experimental surface modifications are discussed. Discussion. The major challenge for contemporary dental implantologists is to provide oral rehabilitation to patients with healthy bone conditions asking for rapid loading protocols or to patients with quantitatively or qualitatively compromised bone. These charging conditions require advances in implant surface design. The elucidation of bone healing physiology has driven investigators to engineer implant surfaces that closely mimic natural bone characteristics. This paper provides a comprehensive overview of surface modifications that beneficially alter the topography, hydrophilicity, and outer coating of dental implants in order to enhance osseointegration in healthy as well as in compromised bone. In the first part, this paper discusses dental implants that have been successfully used for a number of years focusing on sandblasting, acid-etching, and hydrophilic surface textures. Hereafter, new techniques like Discrete Crystalline Deposition, laser ablation, and surface coatings with proteins, drugs, or growth factors are presented. Conclusion. Major advancements have been made in developing novel surfaces of dental implants. These innovations set the stage for rehabilitating patients with high success and predictable survival rates even in challenging conditions. PMID:27478833

  8. Asenapine maleate in situ forming biodegradable implant: an approach to enhance bioavailability.

    PubMed

    Avachat, Amelia M; Kapure, Sayali S

    2014-12-30

    Biodegradable injectable in-situ forming implants (ISFI) correspond to an alternative parenteral depot system to microspheres and surgical implants. Objective of present work was to formulate and evaluate long acting implant of asenapine maleate (ASM) using PLGA which would release drug uniformly for 21 days. PLGA 50:50 with different drug: polymer ratios were tried. N-methyl-2-pyrrolidone and dimethyl sulphoxide were used as organic solvents. The influence of various parameters viz. polymer concentration, solvent ratio, viscosity and morphology on formation of implant was investigated. In-vitro dissolution studies indicated that drug: polymer ratio of 1:2 and N-methyl-2-pyrrolidone (0.3ml) gave desired release profile, total cumulative drug released being 97.66% at the end of 21 days. Mathematical models point towards erosion mechanism with zero order kinetics. Ex-vivo studies confirmed the formation of implant in extensor digitorum muscle with desired drug release profile. In-vivo study was performed in Sprague- Dawley rats. Compared to marketed sublingual formulation area under curve of ASM implant was found to increase 2.215 fold. The Cmax was found to be 11ng/ml. Thus long acting ISFI of ASM was successfully formulated showing improved therapeutic results for the treatment of schizophrenia and bipolar disorders which could be a potentialsubstitute to marketed sublingual tablets. PMID:25305379

  9. Pediatric Cochlear Implantation: Why Do Children Receive Implants Late?

    PubMed Central

    Ham, Julia; Whittingham, JoAnne

    2015-01-01

    Objectives: Early cochlear implantation has been widely promoted for children who derive inadequate benefit from conventional acoustic amplification. Universal newborn hearing screening has led to earlier identification and intervention, including cochlear implantation in much of the world. The purpose of this study was to examine age and time to cochlear implantation and to understand the factors that affected late cochlear implantation in children who received cochlear implants. Design: In this population-based study, data were examined for all children who underwent cochlear implant surgery in one region of Canada from 2002 to 2013. Clinical characteristics were collected prospectively as part of a larger project examining outcomes from newborn hearing screening. For this study, audiologic details including age and severity of hearing loss at diagnosis, age at cochlear implant candidacy, and age at cochlear implantation were documented. Additional detailed medical chart information was extracted to identify the factors associated with late implantation for children who received cochlear implants more than 12 months after confirmation of hearing loss. Results: The median age of diagnosis of permanent hearing loss for 187 children was 12.6 (interquartile range: 5.5, 21.7) months, and the age of cochlear implantation over the 12-year period was highly variable with a median age of 36.2 (interquartile range: 21.4, 71.3) months. A total of 118 (63.1%) received their first implant more than 12 months after confirmation of hearing loss. Detailed analysis of clinical profiles for these 118 children revealed that late implantation could be accounted for primarily by progressive hearing loss (52.5%), complex medical conditions (16.9%), family indecision (9.3%), geographical location (5.9%), and other miscellaneous known (6.8%) and unknown factors (8.5%). Conclusions: This study confirms that despite the trend toward earlier implantation, a substantial number of children

  10. Piezosurgery in implant dentistry

    PubMed Central

    Stübinger, Stefan; Stricker, Andres; Berg, Britt-Isabelle

    2015-01-01

    Piezosurgery, or the use of piezoelectric devices, is being applied increasingly in oral and maxillofacial surgery. The main advantages of this technique are precise and selective cuttings, the avoidance of thermal damage, and the preservation of soft-tissue structures. Through the application of piezoelectric surgery, implant-site preparation, bone grafting, sinus-floor elevation, edentulous ridge splitting or the lateralization of the inferior alveolar nerve are very technically feasible. This clinical overview gives a short summary of the current literature and outlines the advantages and disadvantages of piezoelectric bone surgery in implant dentistry. Overall, piezoelectric surgery is superior to other methods that utilize mechanical instruments. Handling of delicate or compromised hard- and soft-tissue conditions can be performed with less risk for the patient. With respect to current and future innovative surgical concepts, piezoelectric surgery offers a wide range of new possibilities to perform customized and minimally invasive osteotomies. PMID:26635486

  11. Implants as absolute anchorage.

    PubMed

    Rungcharassaeng, Kitichai; Kan, Joseph Y K; Caruso, Joseph M

    2005-11-01

    Anchorage control is essential for successful orthodontic treatment. Each tooth has its own anchorage potential as well as propensity to move when force is applied. When teeth are used as anchorage, the untoward movements of the anchoring units may result in the prolonged treatment time, and unpredictable or less-than-ideal outcome. To maximize tooth-related anchorage, techniques such as differential torque, placing roots into the cortex of the bone, the use of various intraoral devices and/or extraoral appliances have been implemented. Implants, as they are in direct contact with bone, do not possess a periodontal ligament. As a result, they do not move when orthodontic/orthopedic force is applied, and therefore can be used as "absolute anchorage." This article describes different types of implants that have been used as orthodontic anchorage. Their clinical applications and limitations are also discussed. PMID:16463910

  12. Hormonal control of implantation.

    PubMed

    Sandra, Olivier

    2016-06-01

    In mammals, implantation represents a key step of pregnancy and its progression conditions not only the success of pregnancy but health of the offspring. Implantation requires a complex and specific uterine tissue, the endometrium, whose biological functions are tightly regulated by numerous signals, including steroids and polypeptide hormones. Endometrial tissue is endowed with dynamic properties that associate its ability to control the developmental trajectory of the embryo (driver property) and its ability to react to embryos displaying distinct capacities to develop to term (sensor property). Since dynamical properties of the endometrium can be affected by pre- and post-conceptional environment, determining how maternal hormonal signals and their biological actions are affected by environmental factors (e.g. nutrition, stress, infections) is mandatory to reduce or even to prevent their detrimental effects on endometrial physiology in order to preserve the optimal functionality of this tissue. PMID:27172870

  13. Sterilisation of implantable devices.

    PubMed

    Matthews, I P; Gibson, C; Samuel, A H

    1994-01-01

    The pathogenesis and rates of infection associated with the use of a wide variety of implantable devices are described. The multi-factorial nature of post-operative periprosthetic infection is outlined and the role of sterilisation of devices is explained. The resistance of bacterial spores is highlighted as a problem and a full description is given of the processes of sterilisation by heat, steam, ethylene oxide, low temperature steam and formaldehyde, ionising radiation and liquid glutaraldehyde. Sterility assurance and validation are discussed in the context of biological indicators and physical/chemical indicators. Adverse effects upon the material composition of devices and problems of process control are listed. Finally, possible optimisations of the ethylene oxide process and their potential significance to the field of sterilisation of implants is explored. PMID:10172076

  14. Miniature implantable ultrasonic echosonometer

    NASA Technical Reports Server (NTRS)

    Kojima, G. K. (Inventor)

    1978-01-01

    A miniature echosonometer adapted for implantation in the interior of an animal for imaging the internal structure of a organ, tissue or vessel is presented. The echosonometer includes a receiver/transmitter circuit which is coupled to an ultrasonic transducer. Power is coupled to the echosonometer by electromagnetic induction through the animal's skin. Imaging signals from the echosonometer are electromagnetically transmitted through the animal's skin to an external readout apparatus.

  15. Hip Resurfacing Implants.

    PubMed

    Cadossi, Matteo; Tedesco, Giuseppe; Sambri, Andrea; Mazzotti, Antonio; Giannini, Sandro

    2015-08-01

    EDUCATIONAL OBJECTIVES As a result of reading this article, physicians should be able to: 1. Describe the advantages of hip resurfacing. 2. Describe the disadvantages of hip resurfacing. 3. Identify the population in which hip resurfacing is most often indicated. 4. Demonstrate how to properly postoperatively manage patients with metal-on-metal prostheses. Hip resurfacing offers a suitable solution for young patients affected by hip disease who have high function demands and good bone quality. Bone stock preservation, restoration of the normal proximal femur anatomy, the lack of stress shielding, and the possibility of resuming sporting activity are proven advantages of hip resurfacing. However, there are some disadvantages, such as fracture of the femoral neck, onset of neck narrowing, and possible complications due to the metal-on-metal bearings, including pseudotumors, peri-implant osteolysis, and chronic elevation of metal ions in serum levels. Recent data suggest that the ideal candidate for hip resurfacing is an active male, younger than 65 years, with primary or posttraumatic osteoarthritis, and with a femoral head diameter larger than 50 to 54 mm. Based on these selection criteria, the literature reports implant survival to be similar to that of total hip arthroplasty. The current authors' experience confirms a low failure rate and excellent functional outcomes, with metal ion serum levels becoming stable over time in well-functioning implants. Proper surgical technique, correct patient selection, and the right choice of a well-established prosthetic model are essential elements for the long-term success of these implants. PMID:26270748

  16. [Neurotology and cochlear implants].

    PubMed

    Merchán, Miguel A

    2015-05-01

    In this review we analyse cochlear implantation in terms of the fundamental aspects of the functioning of the auditory system. Concepts concerning neuronal plasticity applied to electrical stimulation in perinatal and adult deep hypoacusis are reviewed, and the latest scientific bases that justify early implantation following screening for congenital deafness are discussed. Finally, this review aims to serve as an example of the importance of fostering the sub-specialty of neurotology in our milieu, with the aim of bridging some of the gaps between specialties and thus improving both the knowledge in the field of research on auditory pathologies and in the screening of patients. The objectives of this review, targeted above all towards specialists in the field of otorhinolaryngology, are to analyse some significant neurological foundations in order to reach a better understanding of the clinical events that condition the indications and the rehabilitation of patients with cochlear implants, as well as to use this means to foster the growth of the sub-specialty of neurotology. PMID:25912703

  17. The first cardioverter defibrillator implanted in Central Africa

    PubMed Central

    Cabral, Tantchou Tchoumi Jacques; Budzee, Appolonia; Butera, Gianfranco

    2016-01-01

    Sudden cardiac deaths, which account for approximately 350 000 deaths each year, is a major health care problem. Antiarrhythmic drugs have not been reliable in preventing sudden cardiac death. Although β-blockers, angiotensin-converting enzyme inhibitors, and revascularization play a role in prevention of sudden cardiac death, the development and subsequent refinement of the implantable cardioverter-defibrillator has made the most important contribution to its management. We report the first documented implantation of a cardioverter defibrillator in central, eastern and western Africa. PMID:27279942

  18. Implantation of Vascular Grafts Lined with Genetically Modified Endothelial Cells

    NASA Astrophysics Data System (ADS)

    Wilson, James M.; Birinyi, Louis K.; Salomon, Robert N.; Libby, Peter; Callow, Allan D.; Mulligan, Richard C.

    1989-06-01

    The possibility of using the vascular endothelial cell as a target for gene replacement therapy was explored. Recombinant retroviruses were used to transduce the lacZ gene into endothelial cells harvested from mongrel dogs. Prosthetic vascular grafts seeded with the genetically modified cells were implanted as carotid interposition grafts into the dogs from which the original cells were harvested. Analysis of the graft 5 weeks after implantation revealed genetically modified endothelial cells lining the luminal surface of the graft. This technology could be used in the treatment of atherosclerosis disease and the design of new drug delivery systems.

  19. Comparative Study of Bio-implantable Acoustic Generator Architectures

    NASA Astrophysics Data System (ADS)

    Christensen, D.; Roundy, S.

    2013-12-01

    This paper is a comparative study of the design spaces of two bio-implantable acoustically excited generator architectures: the thickness-stretch-mode circular piezoelectric plate and the bending-mode unimorph piezoelectric diaphragm. The generators are part of an acoustic power transfer system for implanted sensors and medical devices such as glucose monitors, metabolic monitors, drug delivery systems, etc. Our studies indicate that at small sizes the diaphragm architecture outperforms the plate architecture. This paper will present the results of simulation studies and initial experiments that explore the characteristics of the two architectures and compare their performance.

  20. Drug allergies

    MedlinePlus

    Allergic reaction - drug (medication); Drug hypersensitivity; Medication hypersensitivity ... Adverse reactions to drugs are common. (adverse means unwanted or unexpected.) Almost any drug can cause an adverse reaction. Reactions range from irritating ...

  1. Drug Safety

    MedlinePlus

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  2. Club Drugs

    MedlinePlus

    ... uses. Other uses of these drugs are abuse. Club drugs are also sometimes used as "date rape" drugs, to make someone unable to say no to or fight back against sexual assault. Abusing these drugs can ...

  3. Foreign body response to subcutaneous biomaterial implants in a mast cell-deficient Kit(w-Sh) murine model.

    PubMed

    Avula, M N; Rao, A N; McGill, L D; Grainger, D W; Solzbacher, F

    2014-05-01

    Mast cells (MCs)_are recognized for their functional role in wound-healing and allergic and inflammatory responses - host responses that are frequently detrimental to implanted biomaterials if extended beyond acute reactivity. These tissue reactions impact especially on the performance of sensing implants such as continuous glucose monitoring (CGM) devices. Our hypothesis that effective blockade of MC activity around implants could alter the host foreign body response (FBR) and enhance the in vivo lifetime of these implantable devices motivated this study. Stem cell factor and its ligand c-KIT receptor are critically important for MC survival, differentiation and degranulation. Therefore, an MC-deficient sash mouse model was used to assess MC relationships to the in vivo performance of CGM implants. Additionally, local delivery of a tyrosine kinase inhibitor (TKI) that inhibits c-KIT activity was also used to evaluate the role of MCs in modulating the FBR. Model sensor implants comprising polyester fibers coated with a rapidly dissolving polymer coating containing drug-releasing degradable microspheres were implanted subcutaneously in sash mice for various time points, and the FBR was evaluated for chronic inflammation and fibrous capsule formation around the implants. No significant differences were observed in the foreign body capsule formation between control and drug-releasing implant groups in MC-deficient mice. However, fibrous encapsulation was significantly greater around the drug-releasing implants in sash mice compared to drug-releasing implants in wild-type (e.g. MC-competent) mice. These results provide insights into the role of MCs in the FBR, suggesting that MC deficiency provides alternative pathways for host inflammatory responses to implanted biomaterials. PMID:24406200

  4. Short implants: are they a viable option in implant dentistry?

    PubMed

    Schwartz, Steven Richard

    2015-04-01

    Short-length implants (<10 mm) can be used effectively in atrophic maxillae or mandibles even with crown/implant ratios that previously would have been considered excessive. Short implants can support either single or multiple units and can be used for fixed prostheses or overdentures. The use of short-length implants may avoid the need for complicated bone augmentation procedures, thus allowing patients who were either unwilling or unable for financial or medical reasons to undergo these advanced grafting techniques to be adequately treated. PMID:25835796

  5. [Actuality with the breast implants].

    PubMed

    Duchateau, J

    2013-09-01

    The author presents the history of breast implants, and the modern evolution where breast implants are largely used in both cosmetic and reconstructive surgery. Breast augmentation is one of the most performed cosmetic procedures, with a high satisfaction rate. However, one needs to remind that breast implants have a limited duration of life. The estimated rate of breast implant rupture after 10 years is of 10% in the current literature, This rate will probably become lower with the new more cohesive implants recently available on the market. It is therefore essential to propose a regular follow-up to all patients having breast implants. This follow-up is performed using a combination of physical examination, mammograms, ultrasound and MRI. The more specific therapeutic approach for patients having a PIP prosthesis will also be discussed. PMID:24195240

  6. Positron Implantation Profile in Kapton

    NASA Astrophysics Data System (ADS)

    Dryzek, J.; Dryzek, E.

    2006-11-01

    The discussion presented in the paper focuses on processes accompanying positron implantation in condensed matter. They finally constitute the positron implantation profile which generally does not exhibit the exponential behavior as it is concluded from the Monte Carlo simulation made using the EGSnrc 4.0 code. The simulation was performed for the kapton and two commonly used positron sources 22Na and 68Ge\\68Ga. New formula for the implantation profile was proposed.

  7. [Pre-implant esthetic study].

    PubMed

    Missika, P; Khayat, P

    1990-09-01

    The first dental prostheses used on Branemark implants were aesthetically disappointing both for the dentists and their patients. Therefore the authors will consider the various aesthetic problems encountered when treating loss of teeth with implant systems. The problems related to resorption are numerous: large bone losses are resolved by adapting removable acrylic, carrying out bone transplants immediately fixed by the implants, using filling materials, or complete dentures fixed with attachments supported by the implants. Periodontal surgery often provides a solution to the problem of gum visibility at the level of the maxillary anterior teeth. The problems related to the site where implants emerge can often be avoided by consultation between the surgeon and the prosthodontist and by flexing a surgical guide compiled from a pre-prosthetic analysis of the clinical situation. The aesthetic problems related to the actual implant systems are dependent on three factors: When the prosthesis is directly screwed onto the implant, the axis of the implant determines the axis of the dental prosthesis and can lead to the emergence of the screw on the buccal surface; With angulated cores, orientated screws provide the required solution. The implant material, when metallic leads to an unsightly border at the gingival level. Ceramic implants, or the "ceraming" of titanium, provide a solution to this problem. In case of diastema the use of an implant system gives the best choice in comparison to the more conventional treatments. In conclusion, the authors point out the importance of pre-implant analysis which must give an evaluation of the aesthetic result. The fragility of the aesthetic evaluation should encourage dentists to obtain the "clear and written consent" of their patients, accepting the risks run by treatment of this kind. PMID:2268774

  8. International Classification of Reliability for Implanted Cochlear Implant Receiver Stimulators

    PubMed Central

    Battmer, Rolf-Dieter; Backous, Douglas D.; Balkany, Thomas J.; Briggs, Robert J. S.; Gantz, Bruce J.; van Hasselt, Andrew; Kim, Chong Sun; Kubo, Takeshi; Lenarz, Thomas; Pillsbury, Harold C.; O’Donoghue, Gerard M.

    2016-01-01

    Objective To design an international standard to be used when reporting reliability of the implanted components of cochlear implant systems to appropriate governmental authorities, cochlear implant (CI) centers, and for journal editors in evaluating manuscripts involving cochlear implant reliability. Study Design The International Consensus Group for Cochlear Implant Reliability Reporting was assembled to unify ongoing efforts in the United States, Europe, Asia, and Australia to create a consistent and comprehensive classification system for the implanted components of CI systems across manufacturers. Setting All members of the consensus group are from tertiary referral cochlear implant centers. Interventions None. Main Outcome Measure A clinically relevant classification scheme adapted from principles of ISO standard 5841-2:2000 (1) originally designed for reporting reliability of cardiac pacemakers, pulse generators, or leads. Results Standard definitions for device failure, survival time, clinical benefit, reduced clinical benefit, and specification were generated. Time intervals for reporting back to implant centers for devices tested to be “out of specification,” categorization of explanted devices, the method of cumulative survival reporting, and content of reliability reports to be issued by manufacturers was agreed upon by all members. The methodology for calculating Cumulative survival was adapted from ISO standard 5841-2:2000 (1). Conclusion The International Consensus Group on Cochlear Implant Device Reliability Reporting recommends compliance to this new standard in reporting reliability of implanted CI components by all manufacturers of CIs and the adoption of this standard as a minimal reporting guideline for editors of journals publishing cochlear implant research results. PMID:20864879

  9. Implant biomaterials: A comprehensive review

    PubMed Central

    Saini, Monika; Singh, Yashpal; Arora, Pooja; Arora, Vipin; Jain, Krati

    2015-01-01

    Appropriate selection of the implant biomaterial is a key factor for long term success of implants. The biologic environment does not accept completely any material so to optimize biologic performance, implants should be selected to reduce the negative biologic response while maintaining adequate function. Every clinician should always gain a thorough knowledge about the different biomaterials used for the dental implants. This article makes an effort to summarize various dental bio-materials which were used in the past and as well as the latest material used now. PMID:25610850

  10. Graphene synthesis by ion implantation

    NASA Astrophysics Data System (ADS)

    Garaj, Slaven; Hubbard, William; Golovchenko, J. A.

    2010-11-01

    We demonstrate an ion implantation method for large-scale synthesis of high quality graphene films with controllable thickness. Thermally annealing polycrystalline nickel substrates that have been ion implanted with carbon atoms results in the surface growth of graphene films whose average thickness is controlled by implantation dose. The graphene film quality, as probed with Raman and electrical measurements, is comparable to previously reported synthesis methods. The implantation synthesis method can be generalized to a variety of metallic substrates and growth temperatures, since it does not require a decomposition of chemical precursors or a solvation of carbon into the substrate.

  11. Graphene synthesis by ion implantation.

    PubMed

    Garaj, Slaven; Hubbard, William; Golovchenko, J A

    2010-11-01

    We demonstrate an ion implantation method for large-scale synthesis of high quality graphene films with controllable thickness. Thermally annealing polycrystalline nickel substrates that have been ion implanted with carbon atoms results in the surface growth of graphene films whose average thickness is controlled by implantation dose. The graphene film quality, as probed with Raman and electrical measurements, is comparable to previously reported synthesis methods. The implantation synthesis method can be generalized to a variety of metallic substrates and growth temperatures, since it does not require a decomposition of chemical precursors or a solvation of carbon into the substrate. PMID:21124725

  12. Implantable medical devices MRI safe.

    PubMed

    Dal Molin, Renzo; Hecker, Bertrand

    2013-01-01

    Pacemakers, ICDs, neurostimulators like deep brain stimulator electrodes, spiral cord stimulators, insulin pumps, cochlear implants, retinal implants, hearing aids, electro cardio gram (ECG) leads, or devices in interventional MRI such as vascular guide wires or catheters are affected by MRI magnetic and electromagnetic fields. Design of MRI Safe medical devices requires computer modeling, bench testing, phantom testing, and animal studies. Implanted medical devices can be MRI unsafe, MRI conditional or MRI safe (see glossary). In the following paragraphs we will investigate how to design implanted medical devices MRI safe. PMID:23739365

  13. Graphene synthesis by ion implantation

    PubMed Central

    Garaj, Slaven; Hubbard, William; Golovchenko, J. A.

    2010-01-01

    We demonstrate an ion implantation method for large-scale synthesis of high quality graphene films with controllable thickness. Thermally annealing polycrystalline nickel substrates that have been ion implanted with carbon atoms results in the surface growth of graphene films whose average thickness is controlled by implantation dose. The graphene film quality, as probed with Raman and electrical measurements, is comparable to previously reported synthesis methods. The implantation synthesis method can be generalized to a variety of metallic substrates and growth temperatures, since it does not require a decomposition of chemical precursors or a solvation of carbon into the substrate. PMID:21124725

  14. Drugs, drugs--who has the drugs?

    PubMed

    Blair, James

    2012-01-01

    Drug diversion, although on the increase, is not the only problem involving drugs that hospital security officials should be concerned with. Growing drug shortages, offshore production, counterfeiting, and weaknesses in the drug supply chain in case of a world-wide pandemic, are even greater causes for concern, the author claims. PMID:22423518

  15. Implantable medical sensor system

    DOEpatents

    Darrow, Christopher B.; Satcher, Jr., Joe H.; Lane, Stephen M.; Lee, Abraham P.; Wang, Amy W.

    2001-01-01

    An implantable chemical sensor system for medical applications is described which permits selective recognition of an analyte using an expandable biocompatible sensor, such as a polymer, that undergoes a dimensional change in the presence of the analyte. The expandable polymer is incorporated into an electronic circuit component that changes its properties (e.g., frequency) when the polymer changes dimension. As the circuit changes its characteristics, an external interrogator transmits a signal transdermally to the transducer, and the concentration of the analyte is determined from the measured changes in the circuit. This invention may be used for minimally invasive monitoring of blood glucose levels in diabetic patients.

  16. Broad beam ion implanter

    DOEpatents

    Leung, Ka-Ngo

    1996-01-01

    An ion implantation device for creating a large diameter, homogeneous, ion beam is described, as well as a method for creating same, wherein the device is characterized by extraction of a diverging ion beam and its conversion by ion beam optics to an essentially parallel ion beam. The device comprises a plasma or ion source, an anode and exit aperture, an extraction electrode, a divergence-limiting electrode and an acceleration electrode, as well as the means for connecting a voltage supply to the electrodes.

  17. Broad beam ion implanter

    DOEpatents

    Leung, K.N.

    1996-10-08

    An ion implantation device for creating a large diameter, homogeneous, ion beam is described, as well as a method for creating same, wherein the device is characterized by extraction of a diverging ion beam and its conversion by ion beam optics to an essentially parallel ion beam. The device comprises a plasma or ion source, an anode and exit aperture, an extraction electrode, a divergence-limiting electrode and an acceleration electrode, as well as the means for connecting a voltage supply to the electrodes. 6 figs.

  18. [Implantation of the zygote].

    PubMed

    Hicks Gómez, J J

    1990-01-01

    In order for implantation to occur, the endometrium must be adequately differentiated, a estate which results from the sequential interaction of progesterone and estrogens, and the local effects of prostaglandins and histamine. Nevertheless, the exact mechanism through which these hormones affect the uterus is not clearly understood. Recently it has been proposed the role of second messengers (cAMP.cGMP, inositol triphosphate and diacylglycerol) in this process. All these messengers are related with the intracellular mechanisms of proteic and steroid hormones action. PMID:2177440

  19. Bone regeneration associated with nontherapeutic and therapeutic surface coatings for dental implants in osteoporosis.

    PubMed

    Alghamdi, Hamdan S; Jansen, John A

    2013-06-01

    Oral implantology is considered as the treatment of choice for replacing missing teeth in elderly people. However, implant complications may occur in patients with osteoporosis. The pathogenesis underlying osteoporosis is due to an alteration in bone cell response to hormonal, nutritional, and aging factors. For such challenging situations, improved bone regeneration has been shown around dental implants for certain surface modifications. These modifications include coatings of titanium implants with calcium phosphate (CaP) ceramics. Surface coating developments also allow for the addition of organic biomolecules, like growth factors, into the inorganic coatings that increase the bone formation process at the bone-implant interface. The application of therapeutic-based coatings is becoming a rapidly growing research field of interest. CaP-coated implants have the ability to incorporate anti-osteoporotic drugs, which then can be locally released over time from an implant surface in a controlled manner. Thus, it can be anticipated that nontherapeutic and/or therapeutic coated implants can significantly increase low bone density as well as improve impaired bone regeneration in osteoporosis. This review aims to provide a thorough understanding of the underlying mechanisms for impaired bone regeneration around dental implants in osteoporosis. Secondly, the review will focus on biological interactions and beneficial role of the surface-coated (i.e., nontherapeutics and therapeutics) bone implants in osteoporotic bone tissue. PMID:23088597

  20. Osmotically controlled drug delivery system with associated drugs.

    PubMed

    Gupta, Brahma Prakash; Thakur, Navneet; Jain, Nishi P; Banweer, Jitendra; Jain, Surendra

    2010-01-01

    Conventional drug delivery systems have slight control over their drug release and almost no control over the effective concentration at the target site. This kind of dosing pattern may result in constantly changing, unpredictable plasma concentrations. Drugs can be delivered in a controlled pattern over a long period of time by the controlled or modified release drug delivery systems. They include dosage forms for oral and transdermal administration as well as injectable and implantable systems. For most of drugs, oral route remains as the most acceptable route of administration. Certain molecules may have low oral bioavailability because of solubility or permeability limitations. Development of an extended release dosage form also requires reasonable absorption throughout the gastro-intestinal tract (GIT). Among the available techniques to improve the bioavailability of these drugs fabrication of osmotic drug delivery system is the most appropriate one. Osmotic drug delivery systems release the drug with the zero order kinetics which does not depend on the initial concentration and the physiological factors of GIT. This review brings out new technologies, fabrication and recent clinical research in osmotic drug delivery. PMID:21486532

  1. In-situ forming composite implants for periodontitis treatment: How the formulation determines system performance.

    PubMed

    Do, M P; Neut, C; Metz, H; Delcourt, E; Mäder, K; Siepmann, J; Siepmann, F

    2015-01-01

    Periodontitis is the primary cause of tooth loss in adults and a very wide-spread disease. Recently, composite implants, based on a drug release rate controlling polymer and an adhesive polymer, have been proposed for an efficient local drug treatment. However, the processes involved in implant formation and the control of drug release in these composite systems are complex and the relationships between the systems' composition and the implants' performance are yet unclear. In this study, advanced characterization techniques (e.g., electron paramagnetic resonance, EPR) were applied to better understand the in-situ forming implants based on: (i) different types of poly(lactic-co-glycolic acid) (PLGA) as drug release rate controlling polymers; (ii) hydroxypropyl methylcellulose (HPMC) as adhesive polymer; and (iii) doxycycline or metronidazole as drugs. Interestingly, HPMC addition to shorter chain PLGA slightly slows down drug release, whereas in the case of longer chain PLGA the release rate substantially increases. This opposite impact on drug release was rather surprising, since the only difference in the formulations was the polymer molecular weight of the PLGA. Based on the physico-chemical analyses, the underlying mechanisms could be explained as follows: since longer chain PLGA is more hydrophobic than shorter chain PLGA, the addition of HPMC leads to a much more pronounced facilitation of water penetration into the system (as evidenced by EPR). This and the higher polymer lipophilicity result in more rapid PLGA precipitation and a more porous inner implant structure. Consequently, drug release is accelerated. In contrast, water penetration into formulations based on shorter chain PLGA is rather similar in the presence and absence of HPMC and the resulting implants are much less porous than those based on longer chain PLGA. PMID:25791762

  2. Hernia Surgical Mesh Implants

    MedlinePlus

    ... Surgical Clinics of North America; 83(5):1045-51, v-vi. 2 . http://www.facs.org/public_ ... FDA Contact FDA Browse by Product Area Product Areas back Food Drugs Medical Devices Radiation-Emitting Products ...

  3. Sequential provisional implant prosthodontics therapy.

    PubMed

    Zinner, Ira D; Markovits, Stanley; Jansen, Curtis E; Reid, Patrick E; Schnader, Yale E; Shapiro, Herbert J

    2012-01-01

    The fabrication and long-term use of first- and second-stage provisional implant prostheses is critical to create a favorable prognosis for function and esthetics of a fixed-implant supported prosthesis. The fixed metal and acrylic resin cemented first-stage prosthesis, as reviewed in Part I, is needed for prevention of adjacent and opposing tooth movement, pressure on the implant site as well as protection to avoid micromovement of the freshly placed implant body. The second-stage prosthesis, reviewed in Part II, should be used following implant uncovering and abutment installation. The patient wears this provisional prosthesis until maturation of the bone and healing of soft tissues. The second-stage provisional prosthesis is also a fail-safe mechanism for possible early implant failures and also can be used with late failures and/or for the necessity to repair the definitive prosthesis. In addition, the screw-retained provisional prosthesis is used if and when an implant requires removal or other implants are to be placed as in a sequential approach. The creation and use of both first- and second-stage provisional prostheses involve a restorative dentist, dental technician, surgeon, and patient to work as a team. If the dentist alone cannot do diagnosis and treatment planning, surgery, and laboratory techniques, he or she needs help by employing the expertise of a surgeon and a laboratory technician. This team approach is essential for optimum results. PMID:23220306

  4. [Allergy diagnostics in implant intolerance].

    PubMed

    Thomas, P; Thomsen, M

    2008-02-01

    To clarify a suspected implant allergy, a patch test with implant metals and bone cement components can be used. The (immuno)histology of periimplant tissue may also indicate T-lymphocyte-dominant inflammation. Identification of histological allergy characteristics and evaluation of the lymphocyte transformation test beyond indications of sensitization will be possible only when larger studies are available. PMID:18227997

  5. Implant Maintenance: A Clinical Update

    PubMed Central

    Gulati, Minkle; Govila, Vivek; Anand, Vishal; Anand, Bhargavi

    2014-01-01

    Introduction. The differences in the supporting structure of the implant make them more susceptible to inflammation and bone loss when plaque accumulates as compared to the teeth. Therefore, a comprehensive maintenance protocol should be followed to ensure the longevity of the implant. Material and Method. A research to provide scientific evidence supporting the feasibility of various implant care methods was carried out using various online resources to retrieve relevant studies published since 1985. Results. The electronic search yielded 708 titles, out of which a total of 42 articles were considered appropriate and finally included for the preparation of this review article. Discussion. A typical maintenance visit for patients with dental implants should last 1 hour and should be scheduled every 3 months to evaluate any changes in their oral and general history. It is essential to have a proper instrument selection to prevent damage to the implant surface and trauma to the peri-implant tissues. Conclusion. As the number of patients opting for dental implants is increasing, it becomes increasingly essential to know the differences between natural teeth and implant care and accept the challenges of maintaining these restorations. PMID:27437506

  6. Porous metal for orthopedics implants

    PubMed Central

    Matassi, Fabrizio; Botti, Alessandra; Sirleo, Luigi; Carulli, Christian; Innocenti, Massimo

    2013-01-01

    Summary Porous metal has been introduced to obtain biological fixation and improve longevity of orthopedic implants. The new generation of porous metal has intriguing characteristics that allows bone healing and high osteointegration of the metallic implants. This article gives an overview about biomaterials properties of the contemporary class of highly porous metals and about the clinical use in orthopaedic surgery. PMID:24133527

  7. Regenerative Surgical Treatment of Peri-implantitis

    ClinicalTrials.gov

    2016-08-31

    Failure of Dental Implant Due to Infection; Infection; Inflammation; Peri-implantitis; Bacterial Infections; Bleeding of Subgingival Space; Molecular Sequence Variation; Periodontal Diseases; Mouth Diseases

  8. Curcumin-releasing mechanically adaptive intracortical implants improve the proximal neuronal density and blood-brain barrier stability.

    PubMed

    Potter, Kelsey A; Jorfi, Mehdi; Householder, Kyle T; Foster, E Johan; Weder, Christoph; Capadona, Jeffrey R

    2014-05-01

    The cellular and molecular mechanisms by which neuroinflammatory pathways respond to and propagate the reactive tissue response to intracortical microelectrodes remain active areas of research. We previously demonstrated that both the mechanical mismatch between rigid implants and the much softer brain tissue, as well as oxidative stress, contribute to the neurodegenerative reactive tissue response to intracortical implants. In this study, we utilize physiologically responsive, mechanically adaptive polymer implants based on poly(vinyl alcohol) (PVA), with the capability to also locally administer the antioxidant curcumin. The goal of this study is to investigate if the combination of two independently effective mechanisms - softening of the implant and antioxidant release - leads to synergistic effects in vivo. Over the first 4weeks of the implantation, curcumin-releasing, mechanically adaptive implants were associated with higher neuron survival and a more stable blood-brain barrier at the implant-tissue interface than the neat PVA controls. 12weeks post-implantation, the benefits of the curcumin release were lost, and both sets of compliant materials (with and without curcumin) had no statistically significant differences in neuronal density distribution profiles. Overall, however, the curcumin-releasing softening polymer implants cause minimal implant-mediated neuroinflammation, and embody the new concept of localized drug delivery from mechanically adaptive intracortical implants. PMID:24468582

  9. Anatomic consideration for preventive implantation.

    PubMed

    Denissen, H W; Kalk, W; Veldhuis, H A; van Waas, M A

    1993-01-01

    The aim of preventive implant therapy is to prevent or delay loss of alveolar ridge bone mass. For use in an anatomic study of 60 mandibles, resorption of the alveolar ridge was classified into four preventive stages: (1) after extraction of teeth; (2) after initial resorption; (3) when the ridge has atrophied to a knife-edge shape; and (4) when only basal bone remains. Implantation in stage 3 necessitates removal of the knife-edge ridge to create space for cylindrical implants. Therefore, implantation in stage 2 is advocated to prevent the development of stage 3. The aim of implantation in stage 4 is to prevent total loss of function of the atrophic mandible. PMID:8359876

  10. [Drug-eluting stents: long-term safety].

    PubMed

    Karpov, Iu A; Samko, A N; Buza, V V

    2009-01-01

    The review concerns the problem of late thromboses of drug-eluting stents and their influence on late prognosis of the patients; presents long-term results of the trial of sirolimus-eluting stents implanted to patients with coronary heart disease; analyses mechanisms of development of late stent thrombosis, data from different meta-analyses and registers comparing long-term outcomes in patients with implanted sirolimus-eluting stents and metallic stents; suggests risk factors of late thromboses of drug-eluting stents; presents original evidence on 3.5-year follow-up of patients with implanted sirolimus-eluting stents and metallic stents. PMID:19537584

  11. Dexamethasone intravitreal implant for the treatment of noninfectious uveitis

    PubMed Central

    Hunter, Rebecca S; Lobo, Ann-Marie

    2011-01-01

    Uveitis can be a sight-threatening eye disease with significant morbidity. Corticosteroids remain the mainstay of treatment of uveitis and provide an effective treatment against ocular inflammation. However, the various modes available for corticosteroid drug delivery can carry significant ocular and systemic side effects which can limit their use in the treatment of uveitis. In an effort to avoid the damage to ocular structures that can ensue with recurrent episodes of ocular inflammation, the side effects associated with systemic steroids, and the need for repeated administration of both topical and locally injected corticosteroids, sustained-release intraocular corticosteroid implants have been developed. The dexamethasone (DEX) drug delivery system (Ozurdex®; Allergan Inc, Irvine, CA), is a biodegradable intravitreal implant. This implant has been shown to be effective in the treatment of macular edema and noninfectious posterior uveitis and has been approved by the FDA for these entities. This review will highlight the current methods available for corticosteroid delivery to the eye with a particular emphasis on the DEX intravitreal implant and the evidence currently available for its use in noninfectious uveitis. PMID:22140307

  12. Electromagnetic compatibility of implantable neurostimulators to RFID emitters

    PubMed Central

    2011-01-01

    Background The objective of this study is to investigate electromagnetic compatibility (EMC) of implantable neurostimulators with the emissions from radio frequency identification (RFID) emitters. Methods Six active implantable neurostimulators with lead systems were tested for susceptibility to electromagnetic fields generated by 22 RFID emitters. These medical devices have been approved for marketing in the U.S. for a number of intended uses that include: epilepsy, depression, incontinence, Parkinsonian tremor and pain relief. Each RFID emitter had one of the following carrier frequencies: 125 kHz, 134 kHz, 13.56 MHz, 433 MHz, 915 MHz and 2.45 GHz Results The test results showed the output of one of the implantable neurostimulators was inhibited by 134 kHz RFID emitter at separation distances of 10 cm or less. The output of the same implantable neurostimulator was also inhibited by another 134 kHz RFID emitter at separation distances of 10 cm or less and also showed inconsistent pulsing rate at a separation distance of 15 cm. Both effects occurred during and lasted through out the duration of the exposure. Conclusions The clinical significance of the effects was assessed by a clinician at the U.S. Food and Drug Administration. The effects were determined to be clinically significant only if they occurred for extended period of time. There were no observed effects from the other 5 implantable neurostimulators or during exposures from other RFID emitters. PMID:21658266

  13. New biomaterial as a promising alternative to silicone breast implants.

    PubMed

    Teck Lim, Goy; Valente, Stephanie A; Hart-Spicer, Cherie R; Evancho-Chapman, Mary M; Puskas, Judit E; Horne, Walter I; Schmidt, Steven P

    2013-05-01

    One in eight American women develops breast cancer. Of the many patients requiring mastectomy yearly as a consequence, most elect some form of breast reconstruction. Since 2006, only silicone breast implants have been approved by the FDA for the public use. Unfortunately, over one-third of women with these implants experience complications as a result of tissue-material biocompatibility issues, which may include capsular contracture, calcification, hematoma, necrosis and implant rupture. Our group has been working on developing alternatives to silicone. Linear triblock poly(styrene-b-isobutylene-b-styrene) (SIBS) polymers are self-assembling nanostructured thermoplastic rubbers, already in clinical practice as drug eluting stent coatings. New generations with a branched (arborescent or dendritic) polyisobutylene core show promising potential as a biomaterial alternative to silicone rubber. The purpose of this pre-clinical research was to evaluate the material-tissue interactions of a new arborescent block copolymer (TPE1) in a rabbit implantation model compared to a linear SIBS (SIBSTAR 103T) and silicone rubber. This study is the first to compare the molecular weight and molecular weight distribution, tensile properties and histological evaluation of arborescent SIBS-type materials with silicone rubber before implantation and after explantation. PMID:23466517

  14. Antibiotic use during the intracoelomic implantation of electronic tags into fish

    USGS Publications Warehouse

    Mulcahy, D.M.

    2011-01-01

    The use of antibiotics, in particular, the use of a single dose of antibiotics during electronic tag implantation is of unproven value, and carries with it the potential for the development of antibiotic resistance in bacteria and the alteration of the immune response of the fish. Antibiotic use during electronic tag implantation must conform to relevant drug laws and regulations in the country where work is being done, including the requirements for withdrawal times before human consumption is a possibility. Currently, the choice of antibiotics (most often tetracycline or oxytetracycline) and the use of a single dose of the drug are decisions made without knowledge of the basic need for antibiotic usage and of the bacteria involved in infections that occur following electronic tag implantation. Correct perioperative use of an antibiotic is to apply the drug to the animal before surgery begins, to assure serum and tissue levels of the drug are adequate before the incision is made. However, the most common perioperative application of antibiotics during implantation of an electronic tag is to delay the administration of the drug, injecting it into the coelom after the electronic tag is inserted, just prior to closure of the incision. There is little empirical evidence that the present application of antibiotics in fish being implanted with electronic tags is of value. Improvements should first be made to surgical techniques, especially the use of aseptic techniques and sterilized instruments and electronic tags, before resorting to antibiotics. ?? 2010 Springer Science+Business Media B.V.(outside the USA).

  15. Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation.

    PubMed

    Camenzind, Edoardo; Wijns, William; Mauri, Laura; Boersma, Eric; Parikh, Keyur; Kurowski, Volkhard; Gao, Runlin; Bode, Christoph; Greenwood, John P; Gershlick, Anthony; O'Neill, William; Serruys, Patrick W; Jorissen, Brenda; Steg, P Gabriel

    2009-12-01

    Drug-eluting stents (DES) reduce restenosis rates compared to bare-metal stents. Most trials using DES enrolled selected patient and lesion subtypes, and primary endpoint focused on angiographic metrics or relatively short-term outcomes. When DES are used in broader types of lesions and patients, important differences may emerge in long-term outcomes between stent types, particularly the incidence of late stent thrombosis. PROTECT is a randomized, open-label trial comparing the long-term safety of the zotarolimus-eluting stent and the sirolimus-eluting stent. The trial has enrolled 8,800 patients representative of those seen in routine clinical practice, undergoing elective, unplanned, or emergency procedures in native coronary arteries in 196 centers in 36 countries. Indications for the procedure and selection of target vessel and lesion characteristics were at the operator's discretion. Procedures could be staged, but no more than 4 target lesions could be treated per patient. Duration of dual antiplatelet therapy was prespecified to achieve similar lengths of treatment in both study arms. The shortest predefined duration was 3 months, as per the manufacturer's instructions. The primary outcome measure is the composite rate of definite and probable stent thrombosis at 3 years, centrally adjudicated using Academic Research Consortium definitions. The main secondary end points are 3-year all-cause mortality, cardiac death, large nonfatal myocardial infarction, and all myocardial infarctions. This large, international, randomized, controlled trial will provide important information on comparative rates of stent thrombosis between 2 different DES systems and safety as assessed by patient-relevant long-term clinical outcomes. PMID:19958855

  16. Drug Facts

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  17. Drug Reactions

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    ... problem is interactions, which may occur between Two drugs, such as aspirin and blood thinners Drugs and food, such as statins and grapefruit Drugs and supplements, such as gingko and blood thinners ...

  18. Drug Resistance

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  19. Transcatheter aortic valve implantation.

    PubMed

    Nielsen, Hans Henrik Møller

    2012-12-01

    Transcatheter aortic valve implantation (TAVI) was introduced experimentally in 1989, based on a newly developed heart valve prosthesis - the stentvalve. The valve was invented by a Danish cardiologist named Henning Rud Andersen. The new valve was revolutionary. It was foldable and could be inserted via a catheter through an artery in the groin, without the need for heart lung machine. This allowed for a new valve implantation technique, much less invasive than conventional surgical aortic valve replacement (SAVR). Surgical aortic valve replacement is safe and improves symptoms along with survival. However, up to 1/3 of patients with aortic valve stenosis cannot complete the procedure due to frailty. The catheter technique was hoped to provide a new treatment option for these patients. The first human case was in 2002, but more widespread clinical use did not begin until 2006-2010. Today, in 2011, more than 40,000 valves have been implanted worldwide. Initially, because of the experimental character of the procedure, TAVI was reserved for patients who could not undergo SAVR due to high risk. The results in this group of patients were promising. The procedural safety was acceptable, and the patients experienced significant improvements in their symptoms. Three of the papers in this PhD-thesis are based on the outcome of TAVI at Skejby Hospital, in this high-risk population [I, II and IV]. Along with other international publications, they support TAVI as being superior to standard medical treatment, despite a high risk of prosthetic regurgitation. These results only apply to high-risk patients, who cannot undergo SAVR. The main purpose of this PhD study has been to investigate the quality of TAVI compared to SAVR, in order to define the indications for this new procedure. The article attached [V] describes a prospective clinical randomised controlled trial, between TAVI to SAVR in surgically amenable patients over 75 years of age with isolated aortic valve stenosis

  20. A Retrospective Analysis of Ruptured Breast Implants

    PubMed Central

    Baek, Woo Yeol; Lew, Dae Hyun

    2014-01-01

    Background Rupture is an important complication of breast implants. Before cohesive gel silicone implants, rupture rates of both saline and silicone breast implants were over 10%. Through an analysis of ruptured implants, we can determine the various factors related to ruptured implants. Methods We performed a retrospective review of 72 implants that were removed for implant rupture between 2005 and 2014 at a single institution. The following data were collected: type of implants (saline or silicone), duration of implantation, type of implant shell, degree of capsular contracture, associated symptoms, cause of rupture, diagnostic tools, and management. Results Forty-five Saline implants and 27 silicone implants were used. Rupture was diagnosed at a mean of 5.6 and 12 years after insertion of saline and silicone implants, respectively. There was no association between shell type and risk of rupture. Spontaneous was the most common reason for the rupture. Rupture management was implant change (39 case), microfat graft (2 case), removal only (14 case), and follow-up loss (17 case). Conclusions Saline implants have a shorter average duration of rupture, but diagnosis is easier and safer, leading to fewer complications. Previous-generation silicone implants required frequent follow-up observation, and it is recommended that they be changed to a cohesive gel implant before hidden rupture occurs. PMID:25396188