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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. Implantable drug-delivery systems.

    PubMed

    Blackshear, P J

    1979-12-01

    Implantable drug-delivery systems are being developed to release drugs to the bloodstream continuously as well as free patients from being hospitalized to receive intravenous infusions or frequent injections. One technique is implantation of a pellet in the subcutaneous tissue so the pellet may be released by erosion. Drugs are also diffused through silicone rubber capsules but only polyacrylamide is able to release large molecules. Contraceptive rings containing progesterone and placed in the uterus or vagina and implanted silicone-rubber capsules use these principles. Disadvantages to the subcutaneous delivery of drugs include: 1) release of the drug in subcutaneous tissue rather than in the bloodstream directly; 2) entry into the circulatory system is controlled by surrounding blood supplies which vary with fat; 3) diffusion may be difficult due to dense layers of fibrous tissue; and 4) drug amounts cannot be readily regulated. The Ommaya reservoir uses a container with a self-sealing membrane implanted in the scalp and connected to a cerebral ventricle to treat forms of leukemia and fungal meningitis. Another development is an implantable disk-shaped infusion pump with 2 compartments, the outer one containing a propellant and the inner chamber containing the drug, holds 45 milliliters and releases about 1 milliliter/day. In the future these systems may release drugs in response to biochemical feedback or deliver a drug to 1 specific area.

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

    PubMed

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

    2010-02-15

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

  6. Drug release mechanisms of compressed lipid implants.

    PubMed

    Kreye, F; Siepmann, F; Siepmann, J

    2011-02-14

    The aim of this study was to elucidate the mass transport mechanisms controlling drug release from compressed lipid implants. The latter steadily gain in importance as parenteral controlled release dosage forms, especially for acid-labile drugs. A variety of lipid powders were blended with theophylline and propranolol hydrochloride as sparingly and freely water-soluble model drugs. Cylindrical implants were prepared by direct compression and thoroughly characterized before and after exposure to phosphate buffer pH 7.4. Based on the experimental results, an appropriate mathematical theory was identified in order to quantitatively describe the resulting drug release patterns. Importantly, broad release spectra and release periods ranging from 1 d to several weeks could easily be achieved by varying the type of lipid, irrespective of the type of drug. Interestingly, diffusion with constant diffusivities was found to be the dominant mass transport mechanism, if the amount of water within the implant was sufficient to dissolve all of the drug. In these cases an analytical solution of Fick's second law could successfully describe the experimentally measured theophylline and propranolol hydrochloride release profiles, even if varying formulation and processing parameters, e.g. the type of lipid, initial drug loading, drug particles size as well as compression force and time. However, based on the available data it was not possible to distinguish between drug diffusion control and water diffusion control. The obtained new knowledge can nevertheless significantly help facilitating the optimization of this type of advanced drug delivery systems, in particular if long release periods are targeted, which require time consuming experimental trials.

  7. Biocompatible polymeric implants for controlled drug delivery produced by MAPLE

    NASA Astrophysics Data System (ADS)

    Paun, Irina Alexandra; Moldovan, Antoniu; Luculescu, Catalin Romeo; Dinescu, Maria

    2011-10-01

    Implants consisting of drug cores coated with polymeric films were developed for delivering drugs in a controlled manner. The polymeric films were produced using matrix assisted pulsed laser evaporation (MAPLE) and consist of poly(lactide-co-glycolide) (PLGA), used individually as well as blended with polyethylene glycol (PEG). Indomethacin (INC) was used as model drug. The implants were tested in vitro (i.e. in conditions similar with those encountered inside the body), for predicting their behavior after implantation at the site of action. To this end, they were immersed in physiological media (i.e. phosphate buffered saline PBS pH 7.4 and blood). At various intervals of PBS immersion (and respectively in blood), the polymeric films coating the drug cores were studied in terms of morphology, chemistry, wettability and blood compatibility. PEG:PLGA film exhibited superior properties as compared to PLGA film, the corresponding implant being thus more suitable for internal use in the human body. In addition, the implant containing PEG:PLGA film provided an efficient and sustained release of the drug. The kinetics of the drug release was consistent with a diffusion mediated mechanism (as revealed by fitting the data with Higuchi's model); the drug was gradually released through the pores formed during PBS immersion. In contrast, the implant containing PLGA film showed poor drug delivery rates and mechanical failure. In this case, fitting the data with Hixson-Crowell model indicated a release mechanism dominated by polymer erosion.

  8. Modified titanium implant as a gateway to the human body: the implant mediated drug delivery system.

    PubMed

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

    2014-01-01

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

  9. 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.

  10. 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.

  11. Evolution of implantable and insertable drug delivery systems.

    PubMed

    Kleiner, Lothar W; Wright, Jeremy C; Wang, Yunbing

    2014-05-10

    The paper describes the development of implantable and insertable drug delivery systems (IDDS) from their early stage in the 1960s until the current stage in the 2010s. It gives a detailed summary of non-degradable and biodegradable systems and their applications in different areas such as vascular disease treatment, birth control, cancer treatment, and eye disease treatment. It also describes the development of various implantable pump systems and some other atypical IDDS, the challenges and the future of IDDS.

  12. 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

  13. Drug delivery implants in the treatment of vitreous inflammation.

    PubMed

    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.

  14. 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

  15. 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.

  16. 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

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

    PubMed

    Bernik, Delia L

    2007-01-01

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

  18. 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. PMID:27446509

  19. Hearing preservation in cochlear implantation and drug treatment.

    PubMed

    Barriat, Sebastien; Poirrier, Annelise; Malgrange, Brigitte; Lefebvre, Philippe

    2010-01-01

    Insertion of an electrode array into the cochlea produces immediate damage to the inner ear, which is responsible for a hearing loss. In addition, a delayed hearing loss can be observed. In order to maximize hearing preservation after insertion of an electrode and to enhance the performance of the cochlear implant, it has been proposed to deliver pharmacological agents to the inner ear. Molecules can be administered locally to the inner ear through a direct perilymphatic perfusion or through the round window membrane. These modalities of treatment have already been successfully applied to some patients with inner ear diseases. In this paper, we will review some basic aspects of drug delivery to the inner ear to prevent the degeneration of the neurosensory hair cells and auditory neurons, and the actual applicability to humans in order to maintain hearing function after the insertion of electrodes of a cochlear implant.

  20. A Wireless Implantable Micropump for Chronic Drug Infusion Against Cancer.

    PubMed

    Cobo, Angelica; Sheybani, Roya; Tu, Heidi; Meng, Ellis

    2016-03-01

    We present an implantable micropump with a miniature form factor and completely wireless operation that enables chronic drug administration intended for evaluation and development of cancer therapies in freely moving small research animals such as rodents. The low power electrolysis actuator avoids the need for heavy implantable batteries. The infusion system features a class E inductive powering system that provides on-demand activation of the pump as well as remote adjustment of the delivery regimen without animal handling. Micropump performance was demonstrated using a model anti-cancer application in which daily doses of 30 μL were supplied for several weeks with less than 6% variation in flow rate within a single pump and less than 8% variation across different pumps. Pumping under different back pressure, viscosity, and temperature conditions were investigated; parameters were chosen so as to mimic in vivo conditions. In benchtop tests under simulated in vivo conditions, micropumps provided consistent and reliable performance over a period of 30 days with less than 4% flow rate variation. The demonstrated prototype has potential to provide a practical solution for remote chronic administration of drugs to ambulatory small animals for research as well as drug discovery and development applications.

  1. A Wireless Implantable Micropump for Chronic Drug Infusion Against Cancer

    PubMed Central

    Cobo, Angelica; Sheybani, Roya; Tu, Heidi; Meng, Ellis

    2016-01-01

    We present an implantable micropump with a miniature form factor and completely wireless operation that enables chronic drug administration intended for evaluation and development of cancer therapies in freely moving small research animals such as rodents. The low power electrolysis actuator avoids the need for heavy implantable batteries. The infusion system features a class E inductive powering system that provides on-demand activation of the pump as well as remote adjustment of the delivery regimen without animal handling. Micropump performance was demonstrated using a model anti-cancer application in which daily doses of 30 μL were supplied for several weeks with less than 6% variation in flow rate within a single pump and less than 8% variation across different pumps. Pumping under different back pressure, viscosity, and temperature conditions were investigated; parameters were chosen so as to mimic in vivo conditions. In benchtop tests under simulated in vivo conditions, micropumps provided consistent and reliable performance over a period of 30 days with less than 4% flow rate variation. The demonstrated prototype has potential to provide a practical solution for remote chronic administration of drugs to ambulatory small animals for research as well as drug discovery and development applications. PMID:26855476

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

    PubMed

    Speed, Joshua S; Hyndman, Kelly A

    2016-05-17

    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.

  3. 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

  4. 76 FR 3488 - Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline and Flunixin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-20

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New... veterinary prescription use of a combination drug injectable solution containing oxytetracycline and flunixin...--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 1. The authority citation for 21 CFR part...

  5. Permeability control of GPC drug delivery by ion implantation

    SciTech Connect

    Zimmerman, R.L. |; Ila, D.; Poker, D.B.; Withrow, S.P.

    1997-02-01

    MeV Ion beams are used to tailor the drug delivery rate of materials with dual usage of prosthesis devices and drug encapsulation. Available surface porosity and diffusivity can be controlled by the choice of specie, fluence and energy of the bombarding ions. Together with appropriate drug concentration gradients within the capsule, the capsule can be made to deliver an initial dose rate either higher or lower than the steady state value for a predetermined time. The exceptional biocompatibility as well as porosity of glassy polymeric carbon (GPC) make it the favored material for drug encapsulation. A wide range of available porosity in the bulk material can be produced by heat treatment. We demonstrate that lithium diffusivity near the surface of GPC can be increased by carbon, oxygen or silicon ion bombardment and can be decreased by gold ion bombardment. In addition enhanced absorption of lithium in a layer near the end of the range of the implanted ions has been observed. {copyright} {ital 1997 American Institute of Physics.}

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

    PubMed

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

    2013-04-15

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

  7. 77 FR 4227 - Implantation or Injectable Dosage Form New Animal Drugs; Gonadotropin Releasing Factor Analog...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-27

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New... gonadotropin releasing factor analog-diphtheria toxoid conjugate injectable solution. DATES: This rule is...: PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 1. The authority citation for...

  8. 75 FR 26647 - Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-12

    ... CFR Part 522 [Docket No. FDA-2010-N-0002] Implantation or Injectable Dosage Form New Animal Drugs... ivermectin injectable solution in cattle and swine for treatment and control of various internal and external...--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 1. The authority citation for 21 CFR part...

  9. 76 FR 57905 - Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New... of an ivermectin injectable solution for treatment and control of various internal and external... as follows: PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 1. The...

  10. A Self-Powered Implantable Drug-Delivery System Using Biokinetic Energy.

    PubMed

    Song, Peiyi; Kuang, Shuangyang; Panwar, Nishtha; Yang, Guang; Tng, Danny Jian Hang; Tjin, Swee Chuan; Ng, Wun Jern; Majid, Maszenan Bin Abdul; Zhu, Guang; Yong, Ken-Tye; Wang, Zhong Lin

    2017-03-01

    The first triboelectric-nanogenerator (TENG)-based self-powered implantable drug-delivery system is presented. Pumping flow rates from 5.3 to 40 µL min(-1) under different rotating speeds of the TENG are realized. The implantable drug-delivery system can be powered with a TENG device rotated by human hand motion. Ex vivo trans-sclera drug delivery in porcine eyes is demonstrated by utilizing the biokinetic energies of human hands.

  11. Modelling chemistry and biology after implantation of a drug-eluting stent. Part I: Drug transport.

    PubMed

    Vo, Tuoi; Lee, William; Peddle, Adam; Meere, Martin

    2017-04-01

    Drug-eluting stents have been used widely to prevent restenosis of arteries following percutaneous balloon angioplasty. Mathematical modelling plays an important role in optimising the design of these stents to maximise their efficiency. When designing a drug-eluting stent system, we expect to have a sufficient amount of drug being released into the artery wall for a sufficient period to prevent restenosis. In this paper, a simple model is considered to provide an elementary description of drug release into artery tissue from an implanted stent. From the model, we identified a parameter regime to optimise the system when preparing the polymer coating. The model provides some useful order of magnitude estimates for the key quantities of interest. From the model, we can identify the time scales over which the drug traverses the artery wall and empties from the polymer coating, as well as obtain approximate formulae for the total amount of drug in the artery tissue and the fraction of drug that has released from the polymer. The model was evaluated by comparing to in-vivo experimental data and good agreement was found.

  12. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

    ... HUMAN SERVICES Food and Drug Administration Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  13. 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

  14. 76 FR 27888 - Implantation or Injectable Dosage Form New Animal Drugs; Gonadotropin Releasing Factor-Diphtheria...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New... for Veterinary Medicine, 21 CFR part 522 is amended as follows: PART 522--IMPLANTATION OR...

  15. 75 FR 1274 - Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol and Flunixin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New... veterinary prescription use of a combination injectable solution containing ] florfenicol and flunixin... RESFLOR GOLD (florfenicol and flunixin meglumine), a combination injectable solution, for treatment...

  16. 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

  17. Intracochlear drug delivery in combination with cochlear implants : Current aspects.

    PubMed

    Plontke, S K; Götze, G; Rahne, T; Liebau, A

    2017-01-01

    Local drug application to the inner ear offers a number of advantages over systemic delivery. Local drug therapy currently encompasses extracochlear administration (i. e., through intratympanic injection), intracochlear administration (particularly for gene and stem cell therapy), as well as various combinations with auditory neurosensory prostheses, either evaluated in preclinical or clinical studies, or off-label. To improve rehabilitation with cochlear implants (CI), one focus is the development of drug-releasing electrode carriers, e. g., for delivery of glucocorticosteroids, antiapoptotic substances, or neurotrophins to the inner ear. The performance of cochlear implants may thus be improved by protecting neuronal structures from insertion trauma, reducing fibrosis in the inner ear, and by stimulating growth of neuronal structures in the direction of the electrodes. Controlled drug release after extracochlear or intracochlear application in conjunction with a CI can also be achieved by use of a biocompatible, resorbable controlled-release drug-delivery system. Two case reports for intracochlear controlled release drug delivery in combination with cochlear implants are presented. In order to treat progressive reduction in speech discrimination and increased impedance, two cochlear implant patients successfully underwent intracochlear placement of a biocompatible, resorbable drug-delivery system for controlled release of dexamethasone. The drug levels reached in inner ear fluids after different types of local drug application strategies can be calculated using a computer model. The intracochlear drug concentrations calculated in this way were compared for different dexamethasone application strategies.

  18. 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.

  19. Development of a multiple-drug delivery implant for intraocular management of proliferative vitreoretinopathy.

    PubMed

    Zhou, T; Lewis, H; Foster, R E; Schwendeman, S P

    1998-11-13

    A prototype multiple-drug delivery implant has been developed for the intraocular management of proliferative vitreoretinopathy (PVR). Because of the recurrent nature of the disease, PVR causes blindness in approximately 7% of patients who have undergone retinal re-attachment surgery. The poly(dl-lactide-co-glycolide) 50/50 (PLGA) implant consists of three cylindrical segments, each of which contains one of the following drugs: 5-fluorouridine (5FUrd, an antimetabolite), triamcinolone (Triam, a corticosteroid), and human recombinant tissue plasminogen activator (t-PA, a thrombolytic agent). The device can be inserted through a 20-gauge syringe needle into the vitreous body of the eye. The implant also possesses a PLGA coating over the t-PA-containing terminal segment, which creates a lag-time to deliver t-PA when most needed and to decrease the risk of postoperative bleeding. Two methods of cylinder fabrication were investigated: heat and solvent extrusion. The release behavior of several drugs was examined as a function of the processing variables including: extrusion method, drug loading, polymer molecular weight, and drug particle size. The presence of either the organic solvent (acetone) during processing or a highly water-soluble drug (5FUrd) in the formulation increased the polymer porosity, which in turn, increased the drug release-rate. Drug loading effects were consistent with percolation concepts, and a low-molecular-weight PLGA (e.g., Mw=42000 for inherent viscosity=0.58 dl/g) was desirable to produce controlled release close to one month. Based on pharmacological and pharmacokinetic data of these compounds and our clinical experience with this disease, several design criteria for a combined implant were devised. Optimal cylindrical segments from the formulation studies were selected and combined in series to form a contiguous implant. After successful combination and coating procedures were developed, prototype implants were prepared. From the 3-drug

  20. 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.

  1. Development of an implantable intrathecal drug infusion pump.

    PubMed

    Hong, S; Lee, J S; Park, J W; Nam, K; Choi, J; Lee, J C; Park, J K; Ko, Y P; Jo, Y H

    2004-01-01

    An intrathecal drug infusion system has been designed, manufactured and tested. The system is composed of a drug reservoir and a pump/controller assembly. The drug reservoir made of SUS316L is a negative pressure gas chamber enclosing a bellows type drug chamber. The pump/controller assembly includes a bacterial filter, a controller circuit board, a battery and a micropump, and is connected to a catheter for intrathecal infusion. The micropump implements a peristaltic pumping of the drug by a sequential motion of three pairs of cam and cam-follower. In vitro performance tests were conducted with prototypes.

  2. Effect of the Subcutaneous Environment on Phase Sensitive In Situ Forming Implant Drug Release, Degradation, and Microstructure

    PubMed Central

    Solorio, Luis; Exner, Agata A.

    2015-01-01

    In situ forming implants are a promising platform used for the release of therapeutic agents. Significant changes in behavior occur when the implants are used in vivo relative to implants formed in vitro. To understand how the injection site effects implant behavior, poly(lactic-co-glycolic acid) implants were examined after injection in the subcutaneous space of a Sprague Dawley rat model to determine how the environment altered implant erosion, degradation, swelling, microstructure and mock drug release. Changes in implant microstructure occurred over time for implants formed in vivo, where it was observed that the porosity was lost over the course of 5 d. Implants formed in vivo had a significantly greater burst release (p<0.05) relative to implants formed in vitro. However during the diffusion period of release, implants formed in vitro had a significantly higher daily release (2.1%/day, p<0.05), which correlated to changes in implant microstructure. Additionally, implants formed in vitro had a 2 fold increase in the first order degradation kinetics relative to the implants formed in vivo. These findings suggest that the changes in implant behavior occur as a result of changes in the implant microstructure induced by the external environment. PMID:26506522

  3. PLA/PEG-PPG-PEG/dexamethasone implant prepared by hot-melt extrusion for controlled release of immunosuppressive drug to implantable medical devices, Part 2: in vivo evaluation.

    PubMed

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

    2013-01-01

    Hot-melt extrusion (HME) plays an important role in preparing implants as local drug delivery systems in pharmaceutical fields. Here, a new PLA/PEG-PPG-PEG/Dexamethasone (PLA/F68/Dex) implant prepared by HME has been developed. Importantly, the implant was successfully achieved to control release of immunosuppressive drug to an implanted device. In particular, this implant has not been reported previously in pharmaceutical fields. FTIR and XRD were adopted to investigate the properties of the samples. The in vivo release study showed that the maximum value of Dex release from the implants was approximately 50% at 1 month. The in vivo degradation behavior was determined by UV spectrophotometer and scanning electron microscopy studies, and the weight loss rate of the implants were up to 25% at 1 month. Furthermore, complete blood count (CBC) test, serum chemistry and major organs were performed, and there is no significant lesion and side effects observed in these results. Therefore, the results elucidated that the new PLA/F68/Dex implant prepared by HME could deliver an immunosuppressive drug to control the inflammatory reaction at the implant site.

  4. 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

  5. An implantable MEMS micropump system for drug delivery in small animals.

    PubMed

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

    2012-06-01

    We present the first implantable drug delivery system for controlled timing and location of dosing in small animals. Current implantable drug delivery devices do not provide control over these factors nor are they 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 μL/min 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.

  6. Drug Delivery: Enabling Technology for Drug Discovery and Development. iPRECIO Micro Infusion Pump: Programmable, Refillable, and Implantable.

    PubMed

    Tan, Tsung; Watts, Stephanie W; Davis, Robert Patrick

    2011-01-01

    Successful drug delivery using implantable pumps may be found in over 12,500 published articles. Their versatility in delivering continuous infusion, intermittent or complex infusion protocols acutely or chronically has made them ubiquitous in drug discovery and basic research. The recent availability of iPRECIO(®), a programmable, refillable, and implantable infusion pump has made it possible to carry out quantitative pharmacology (PKPD) in single animals. When combined with specialized catheters, specific administration sites have been selected. When combined with radiotelemetry, the physiologic gold standard, more sensitive and powerful means of detecting drug induced therapeutic, and/or adverse effects has been possible. Numerous application examples are cited from iPRECIO(®) use in Japan, United States, and Europe with iPRECIO(®) as an enabling drug delivery device where the refillable and programmability functionality were key benefits. The ability to start/stop drug delivery and to have control periods prior dosing made it possible to have equivalent effects at a much lower dose than previously studied. Five different iPRECIO(®) applications are described in detail with references to the original work where the implantable, refillable, and programmable benefits are demonstrated with their different end-points.

  7. Implementation of wireless power transfer and communications for an implantable ocular drug delivery system.

    PubMed

    Tang, T B; Smith, S; Flynn, B W; Stevenson, J T M; Gundlach, A M; Reekie, H M; Murray, A F; Renshaw, D; Dhillon, B; Ohtori, A; Inoue, Y; Terry, J G; Walton, A J

    2008-09-01

    A wireless power transfer and communication system based on near-field inductive coupling has been designed and implemented. The feasibility of using such a system to remotely control drug release from an implantable drug delivery system is addressed. The architecture of the wireless system is described and the signal attenuation over distance in both water and phosphate buffered saline is studied. Additionally, the health risk due to exposure to radio frequency (RF) radiation is examined using a biological model. The experimental results demonstrate that the system can trigger the release of drug within 5 s, and that such short exposure to RF radiation does not produce any significant (implantable system, eliminating the risks associated with battery failure and leakage and also allowing more compact designs for applications such as drug delivery.

  8. 75 FR 54018 - Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol and Flunixin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    ... Administration 21 CFR Part 522 [Docket No. FDA-2010-N-0002] Implantation or Injectable Dosage Form New Animal... Mycoplasma bovis to the bovine respiratory disease (BRD) pathogens for which use of an injectable solution... flunixin meglumine), a combination drug injectable solution. The supplement adds M. bovis to the...

  9. 75 FR 13225 - Implantation or Injectable Dosage Form New Animal Drugs; Flunixin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-19

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New... provides for the use of flunixin meglumine injectable solution in swine. DATES: This rule is effective...) Injectable Solution in swine for control of pyrexia associated with swine respiratory disease. Cross...

  10. 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

  11. 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

  12. Silicone gel breast implant adverse event reports to the Food and Drug Administration, 1984-1995.

    PubMed Central

    Brown, S L; Parmentier, C M; Woo, E K; Vishnuvajjala, R L; Headrick, M L

    1998-01-01

    OBJECTIVES: To characterize the adverse event reports on silicone gel breast implants (SGBIs), including death reports, submitted to the Food and Drug Administration (FDA) from 1984 through 1995 and to analyze changes in the type and complexity of reports following extensive media coverage of breast implants. METHODS: The authors analyzed mandatory and voluntary reports from the adverse events reporting system for medical devices at the FDA. RESULTS: In 1988, adverse event reports related to SGBIs accounted for 2.4% of the 14,473 mandatory reports entered into the FDA database on medical devices. In 1992, SGBI-related reports accounted for 30.3% of the total 66,476 mandatory reports of adverse events. The most frequently reported adverse event in 1988, before the widespread publicity on breast implants, was implant burst or rupture. In contrast, in 1992 the most frequently reported event was reaction, a term used to describe a range of adverse effects. CONCLUSIONS: The numbers of mandatory and voluntary reports of SGBI-related adverse events increased exponentially, as did the complexity of the reports, following publicity over the lack of safety data on breast implants and a short voluntary moratorium on their sale. A significant proportion of reports lacked information on specific medical symptoms or diagnoses. PMID:9847926

  13. [Drug release of coated dental implant neck region to improve tissue integration].

    PubMed

    Wolf, Jens; Sternberg, Katrin; Behrend, Detlef; Schmitz, Klaus-Peter; von Schwanewede, Heinrich

    2009-08-01

    In order to improve tissue integration, the neck region of dental implants was coated with the biodegradable polymer poly (L-lactide) incorporating tetracycline, ibuprofen and the combination of both drugs using a solvent dip-coating process. Metallographic analysis, light microscopy and electron microscopy were used to detect the thickness range and the surface characteristics of the coatings. Cytotoxicity was evaluated using the tetrazolium colorimetric method with the fibroblast cell line L929. The in vitro drug release was measured in isotonic sodium chloride solution by UV spectroscopy. To explore if drug release is concentration-dependent, the total amount of drug was varied in the coating (20% wt, 30% wt and 40% wt). The results showed a continuous release of the embedded drugs in relevant dosage over a period of 6 months. In contrast to high tetracycline concentrations, high ibuprofen concentrations resulted in a decreased metabolic activity of the L929 fibroblasts.

  14. Room-temperature attachment of PLGA microspheres to titanium surfaces for implant-based drug release

    NASA Astrophysics Data System (ADS)

    Xiao, Dongqin; Liu, Qing; Wang, Dongwei; Xie, Tao; Guo, Tailin; Duan, Ke; Weng, Jie

    2014-08-01

    Drug release from implant surfaces is an effective approach to impart biological activities, (e.g., antimicrobial and osteogenic properties) to bone implants. Coatings of polylactide-based polymer are a candidate for this purpose, but a continuous (fully covering) coating may be non-optimal for implant-bone fixation. This study reports a simple room-temperature method for attaching poly (lactide-co-glycolide) (PLGA) microspheres to titanium (Ti) surfaces. Microspheres were prepared with polyvinyl alcohol (PVA) or polyvinylpyrrolidone (PVP) as the emulsifier. Microspheres were attached to Ti discs by pipetting as a suspension onto the surfaces followed by vacuum drying. After immersion in shaking water bath for 14 d, a substantial proportion of the microspheres remained attached to the discs. In contrast, if the vacuum-drying procedure was omitted, only a small fraction of the microspheres remained attached to the discs after immersion for only 5 min. Microspheres containing triclosan (a broad-spectrum antibiotic) were attached by porous-surfaced Ti discs. In vitro experiments showed that the microsphere-carrying discs were able to kill Staphylococcus aureus and Escherichia Coli, and support the adhesion and growth of primary rat osteoblasts. This simple method may offer a flexible technique for bone implant-based drug release.

  15. 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.

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

    PubMed

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

    2010-04-01

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

  17. Bare metal or drug-eluting stent implantation in last remaining vessel PCI? A serious dilemma.

    PubMed

    Zhang, Lei; Zhu, Jianhua; Kiemeneij, Ferdinand

    2009-04-01

    This case report describes the treatment of an old male diabetic patient with last remaining vessel coronary artery disease and poor left ventricular function. In presence of an old occlusion of the left main coronary artery, a subtotal stenosis of a dominant right coronary artery required angioplasty. After ample consideration it was decided to implant a bare metal stent (BMS) instead of a drug-eluting stent (DES). The major reason was the fear for early discontinuation of clopidogrel in case a drug-eluting stent was placed. The procedure and follow-up are described followed by an overview of current literature concerning similar pathology.

  18. Atrioventricular nodal ablation versus antiarrhythmic drugs after permanent pacemaker implantation for bradycardia-tachycardia syndrome.

    PubMed

    Nagamoto, Yasutsugu; Inage, Tomohito; Yoshida, Teruhisa; Takeuchi, Tomohiro; Gondo, Takeki; Fukuda, Yujiro; Takii, Eiichi; Murotani, Kenta; Imaizumi, Tsutomu

    2012-03-01

    Patients often require antiarrhythmic drugs to control tachycardia after permanent pacemaker implantation (PMI) for bradycardia-tachycardia syndrome. We compared atrioventricular nodal ablation (AVNA) to antiarrhythmic drugs after PMI for bradycardia-tachycardia syndrome. Twenty-eight symptomatic patients with bradycardia-tachycardia syndrome, all of which had a long pause after termination of paroxysmal atrial fibrillation, underwent PMI with RV lead placement at the mid-septum site. Among these patients, 14 underwent PMI and AVNA (AVNA group). The remaining 14 patients underwent PMI only, and continued to take anti-arrhythmic drugs (drug group). We compared cardiac function (cardio-thoracic ratio on chest X-ray, left atrial diameter, left ventricular end-diastolic dimension, and left ventricular-ejection fraction by echocardiography), exercise tolerance (6-min walking distance), symptoms, and the number of antiarrhythmic drugs just before and 6 months after PMI. Baseline characteristics were similar between the two groups, except for the number of antiarrhythmic drugs. Six months after PMI, cardiac function, exercise tolerance, and symptoms did not differ significantly between the two groups. Compared to the drug group (p < 0.01), the number of antiarrhythmic drugs was significantly smaller in the AVNA group 6 months after PMI. Patients who underwent AVNA concurrently with PMI with RV lead placement at the mid-septum site for bradycardia-tachycardia syndrome were able to reduce the intake of drugs and improve their tachycardia-related symptoms while maintaining cardiac function and exercise tolerance.

  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. Biological lipid membranes for on-demand, wireless drug delivery from thin, bioresorbable electronic implants

    PubMed Central

    Lee, Chi Hwan; Kim, Hojun; Harburg, Daniel V; Park, Gayoung; Ma, Yinji; Pan, Taisong; Kim, Jae Soon; Lee, Na Yeon; Kim, Bong Hoon; Jang, Kyung-In; Kang, Seung-Kyun; Huang, Yonggang; Kim, Jeongmin; Lee, Kyung-Mi; Leal, Cecilia; Rogers, John A

    2016-01-01

    On-demand, localized release of drugs in precisely controlled, patient-specific time sequences represents an ideal scenario for pharmacological treatment of various forms of hormone imbalances, malignant cancers, osteoporosis, diabetic conditions and others. We present a wirelessly operated, implantable drug delivery system that offers such capabilities in a form that undergoes complete bioresorption after an engineered functional period, thereby obviating the need for surgical extraction. The device architecture combines thermally actuated lipid membranes embedded with multiple types of drugs, configured in spatial arrays and co-located with individually addressable, wireless elements for Joule heating. The result provides the ability for externally triggered, precision dosage of drugs with high levels of control and negligible unwanted leakage, all without the need for surgical removal. In vitro and in vivo investigations reveal all of the underlying operational and materials aspects, as well as the basic efficacy and biocompatibility of these systems. PMID:27175221

  1. 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.

  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. Mathematical modeling of triamcinolone acetonide drug release from the I-vation intravitreal implant (a controlled release platform).

    PubMed

    Barnett, Peter J

    2009-01-01

    In-vitro drug release of triamcinolone acetonide from the I-vation implant can be controlled and tuned by varying its formulation ingredients. These release characteristics can be modeled using a parabolic partial differential equation to describe one dimensional Fickian drug diffusion in a durable polymer matrix.

  4. Controlled drug release from antibiotic-loaded layered double hydroxide coatings on porous titanium implants in a mouse model.

    PubMed

    Badar, Muhammad; Rahim, Muhammad Imran; Kieke, Marc; Ebel, Thomas; Rohde, Manfred; Hauser, Hansjörg; Behrens, Peter; Mueller, Peter P

    2015-06-01

    As an alternative to degradable organic coatings the possibility of using layered double hydroxides (LDHs) to generate implant coatings for controlled drug delivery was evaluated in vivo and in vitro. Coatings prepared from LDH suspensions dissolved slowly and appeared compatible with cultured cells. LDH coatings loaded with an antibiotic resulted in antibacterial effects in vitro. The LDH coating prolonged the drug release period and improved the proliferation of adherent cells in comparison to pure drug coatings. However, during incubation in physiological solutions the LDH coatings became brittle and pieces occasionally detached from the surface. For stress protection porous titanium implants were investigated as a substrate for the coatings. The pores prevented premature detachment of the coatings. To evaluate the coated porous implants in vivo a mouse model was established. To monitor bacterial infection of implants noninvasive in vivo imaging was used to monitor luminescently labeled Pseudomonas aeruginosa. In this model porous implants with antibiotic-loaded LDH coatings could antagonize bacterial infections for over 1 week. The findings provide evidence that delayed drug delivery from LDH coatings could be feasible in combination with structured implant surfaces.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. Intrathecal Drug Delivery Systems (IDDS): The Implantable Systems Performance Registry (ISPR)

    PubMed Central

    Huffman, John M.; Stearns, Lisa M.; Plunkett, Robert J.; Grigsby, Eric J.; Stromberg, E. K.; Roediger, Mollie P.; Wells, Michelle D.; Weaver, Todd W.

    2016-01-01

    Abstract Objectives The ISPR was initially created to monitor the product performance of Medtronic implanted intrathecal drug infusion and spinal cord systems available in the United States. Materials and Methods Data were collected from 50 representative sites implanting and following patients with intrathecal drug delivery systems across the United States between August 7, 2003 and January 31, 2014. Device performance over time was estimated using life table survival methods. Results Of the 6093 patients enrolled in the ISPR, 3405 (55.9%) were female and 2675 (43.9%) were male, and 13 (0.2%) did not provide gender data. The average age at enrollment was 52.9 years (SD =17.6 years) and average follow‐up time was 29.6 months. Currently, the estimates of device survival from pump‐related events exceed 90% for all pump models across the applicable follow‐up time points. The majority of product performance events were catheter‐related. At 5 years of follow‐up, all applicable catheter models, with the exception of revised not as designed or grafted not as designed catheters, had greater than 81% survival from catheter‐related events. Conclusions The ISPR is designed to serve as an ongoing source of system and device‐related information with a focus on “real‐world” safety and product performance. ISPR data continue to be used to guide future product development efforts aimed at improving product reliability and quality. PMID:27730704

  10. 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.

  11. In vitro and in vivo evaluation of novel implantation technology in hydrogel contact lenses for controlled drug delivery.

    PubMed

    Maulvi, Furqan A; Lakdawala, Dhara H; Shaikh, Anjum A; Desai, Ankita R; Choksi, Harsh H; Vaidya, Rutvi J; Ranch, Ketan M; Koli, Akshay R; Vyas, Bhavin A; Shah, Dinesh O

    2016-03-28

    Glaucoma is commonly treated using eye drops, which is highly inefficient due to rapid clearance (low residence time) from ocular surface. Contact lenses are ideally suited for controlled drug delivery to cornea, but incorporation of any drug loaded particulate system (formulation) affect the optical and physical property of contact lenses. The objective of the present work was to implant timolol maleate (TM) loaded ethyl cellulose nanoparticle-laden ring in hydrogel contact lenses that could provide controlled drug delivery at therapeutic rates without compromising critical lens properties. TM-implant lenses were developed, by dispersing TM encapsulated ethyl cellulose nanoparticles in acrylate hydrogel (fabricated as ring implant) and implanted the same in hydrogel contact lenses (sandwich system). The TM-ethyl cellulose nanoparticles were prepared by double emulsion method at different ratios of TM to ethyl cellulose. The X-ray diffraction studies revealed the transformation of TM to amorphous state. In vitro release kinetic data showed sustained drug release within the therapeutic window for 168h (NP 1:3 batch) with 150μg loading. Cytotoxicity and ocular irritation study demonstrated the safety of TM-implant contact lenses. In vivo pharmacokinetic studies in rabbit tear fluid showed significant increase in mean residence time (MRT) and area under curve (AUC), with TM-implant contact lenses in comparison to eye drop therapy. In vivo pharmacodynamic data in rabbit model showed sustained reduction in intra ocular pressure for 192h. The study demonstrated the promising potential of implantation technology to treat glaucoma using contact lenses, and could serve as a platform for other ocular diseases.

  12. Development of an implantable infusion pump for sustained anti-HIV drug administration.

    PubMed

    Baert, Lieven; Schueller, Laurent; Tardy, Yanik; Macbride, Doug; Klooster, Gerben van't; Borghys, Herman; Clessens, Ellen; Van Den Mooter, Guy; Van Gyseghem, Elke; Van Remoortere, Pieter; Wigerinck, Piet; Rosier, Jan

    2008-05-01

    Factors such as insufficient drug potency, non-compliance and restricted tissue penetration contribute to incomplete suppression of Human Immunodeficiency Virus (HIV) and the difficulty to control this infection. Infusion via standard catheters can be a source of infection, which is potentially life threatening in these patients. We developed an implantable infusion pump, allowing to accommodate large volumes (16-50mL) of high viscous solutions (up to 23.96mPas at 39 degrees C) of anti-HIV agents and providing sustained release of medication: a standard Codman 3000 pump, which was initially developed to release aqueous solutions ( approximately 0.7mPas) into the spinal cord such as for pain medication, was transformed for release of viscous solutions up to 40mPas by adapting the diameter of the capillary flow restrictor, the capillary length and way of catheterisation--by placing the indwelling catheter in the vena cava. A pilot study of the pump implanted in 2 dogs showed continuous steady-state release of the protease inhibitor darunavir (25mg/dog/day administered for 25 days), thereby achieving plasma concentration levels of approximately 40ng/mL. Steady-state plasma levels were reproducible after monthly refill of the pumps. In conclusion, the implantable adapted Codman 3000 constant-flow infusion pump customized to anti-HIV therapy allows sustained release of anti-HIV medication and may represent an opportunity to reduce the pill burden and complexity of dosing schemes associated with common anti-HIV therapy.

  13. 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

  14. Clopidogrel Therapy Discontinuation Following Drug Eluting Stent Implantation in Real World Practice in Israel

    PubMed Central

    Blich, Miry; Shwiri, Tawfiq Zeidan; Petcherski, Sirouch; Osherov, Azriel B; Hammerman, Haim

    2012-01-01

    Background Incidence and predictors of clopidogrel discontinuation after drug eluting stent (DES) implantation, in real world practice, are poorly known. Methods Prospective study included all patients who underwent implantation of at least one DES between February 2006 and January 2007. Predictors of clopidogrel discontinuation were assessed by a multivariable analysis. Results In 269 patients, mean period for clopidogrel therapy was 13.2 ± 7.2 month. Twenty eight patients (10.4%) discontinued clolopidogrel prematurely (< 3 months). Early clopidogrel discontinuation was a predictor of late stent thrombosis (P = 0.005) and urgent target vessel revascularization (P = 0.05). There was a trend for higher cardiac mortality among that group (P = 0.07). By 12 months, 173 patients (64.3%) have discontinued clopidogrel therapy. The most frequent circumstance to stop clopidogrel before 12 months was recommendation of family physician. Patients that were followed by cardiologist were more encouraged to longer clopidogrel therapy. In multivariable analysis being non Jew (OR 19.2, 95% CI 2.4 to 142, P = 0.005), not followed by cardiologist (OR 4.7, 95% CI 1 to 23.1, P = 0.05) and lack of information regarding the importance of clopidogrel maintenance at discharge from hospital (OR 10.8, 95% CI 2.7 to 42.9, P = 0.001) were independent predictors of early clopidogrel discontinuation. Conclusions Clopidogrel discontinuation, in real world practice is not unusual and related to poor outcome. Education for general physicians, clear instructions about the importance of antiplatelet maintenance at discharge and follow up by an expert cardiologist are opportunities to improve adherence do antiplatelet therapy following DES implantation.

  15. Implantable and transdermal polymeric drug delivery technologies for the treatment of central nervous system disorders.

    PubMed

    Govender, Thiresen; Choonara, Yahya E; Kumar, Pradeep; Bijukumar, Divya; du Toit, Lisa C; Modi, Girish; Naidoo, Dinesh; Pillay, Viness

    2016-06-07

    The complexity of the brain and the membranous blood-brain barrier (BBB) has proved to be a significant limitation to the systemic delivery of pharmaceuticals to the brain rendering them sub-therapeutic and ineffective in the treatment of neurological diseases. Apart from this, lack of innovation in product development to counteract the problem is also a major contributing factor to a poor therapeutic outcome. Various innovative strategies show potential in treating some of the neurological disorders; however, drug delivery remains the most popular. To attain therapeutic drug levels in the central nervous system, large, intolerable systemic doses are generally administered. The major factors responsible for the success maintenance therapy of neurological diseases included controlled and sustained release of neurotherapeutics, reduced frequency of administration, higher bioavailability, and patient compliances. Conventional oral or injectable formulations cannot satisfy all the requirements in many circumstances. This article reviews the therapeutic implantable polymeric and transdermal devices employed in an attempt to effectively achieve therapeutic quantities of drug across the BBB over a prolonged period, to improve patient disease prognosis.

  16. 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.

  17. 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.

  18. A programmed release multi-drug implant fabricated by three-dimensional printing technology for bone tuberculosis therapy.

    PubMed

    Wu, Weigang; Zheng, Qixin; Guo, Xiaodong; Sun, Jianhua; Liu, Yudong

    2009-12-01

    In the world, bone tuberculosis is still very difficult to treat and presents a challenge to clinicians. In this study, we utilized 3D printing technology to fabricate a programmed release multi-drug implant for bone tuberculosis therapy. The construction of the drug implant was a multi-layered concentric cylinder divided into four layers from the center to the periphery. Isoniazid and rifampicin were distributed individually into the different layers in a specific sequence of isoniazid-rifampicin-isoniazid-rifampicin. The drug release assays in vitro and in vivo showed that isoniazid and rifampicin were released orderly from the outside to the center to form the multi-drug therapeutic alliance, and the peak concentrations of drugs were detected in sequence at 8 to 12 day intervals. In addition, no negative effect on the proliferation of rabbit bone marrow mesenchymal stem cells was detected during the cytocompatibility assay. Due to its ideal pharmacologic action and cytocompatibility, the programmed release multi-drug implant with a complex construction fabricated by 3D printing technology could be of interest in prevention and treatment of bone tuberculosis.

  19. '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

  20. Breast implant surveillance reports to the U.S. Food and Drug Administration: maternal-child health problems.

    PubMed

    Brown, S Lori; Todd, Joan Ferlo; Cope, Judith U; Sachs, Hari Cheryl

    2006-01-01

    There is continuing concern that women who receive breast implants may be at increased risk for adverse reproductive outcomes or experience problems with breastfeeding. It is unknown whether exposure to biomaterials in breast implants may have teratogenic effects or leach into breast milk causing postnatalproblems. We studied the Food and Drug Administration (FDA) experience by analyzing a case series of adverse event reports received and entered into the FDA's Manufacturer and User Facility Device Experience (MAUDE) database or the Device Experience Network (DEN) database by December 31, 2002 regarding women with breast implants. Reports were critically reviewed for lactation difficulties, reproductive problems (spontaneous abortion, delayed conception) and medical conditions among offspring, including neonatal, infant, and childhood diseases and congenital defects that were attributed to implants. We identified 339 reports that described maternal-child adverse events. Nearly half of these reports (46%) described actual problems with breastfeeding or expressed concern that implants would be unsafe or interfere with breastfeeding. Forty-four percent of reports (n=149) described either nonspecific or specific signs, symptoms, or illnesses in children. An additional 3.5% of reports (n=12) detailed a congenital anomaly believed by the reporter to be caused by breast implants.

  1. 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.

  2. 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

  3. 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.

  4. Hepatic arterial perfusion scintigraphy with Tc-99m-MAA: use of a totally implanted drug delivery system

    SciTech Connect

    Ziessman, H.A.; Thrall, J.H.; Yang, P.J.; Walker, S.C.; Cozzi, E.A.; Niederhuber, J.E.; Gyves, J.W.; Ensminger, W.D.; Tuscan, M.C.

    1984-07-01

    Tc-99m-MAA hepatic arterial perfusion scintigraphy (HAPS) using a totally implanted drug delivery system was employed for hepatic arterial chemotherapy in 147 patients (335 studies). Complete perfusion of the involved liver was seen in 88% of patients initially and remained good on follow-up. A significant decrease in hepatic and/or extrahepatic perfusion associated with a hot spot at the tip of the catheter indicated hepatic arterial thrombosis. Extrahepatic perfusion was seen in 14% of cases, usually in the distribution of the stomach, small bowel, and spleen. Significant symptoms of drug toxicity were seen in 70% of patients with extrahepatic perfusion, compared to 19% of those without it.

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

    PubMed

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

    2013-01-30

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

  6. Infections related to breast implants reported to the Food and Drug Administration, 1977-1997.

    PubMed

    Brown, S L; Hefflin, B; Woo, E K; Parmentier, C M

    2001-01-01

    The FDA has a surveillance system for monitoring adverse events related to medical devices. Infection reports submitted to the FDA by breast implant manufacturers between 1977 and 1997 are characterized. Two cases of death caused by toxic shock syndrome after mammoplasty reported to the FDA are presented. Overall, 1,971 reports with a principal adverse event of infection were reported in this time frame. There was a large increase in the number of reports on infections related to breast implants between 1992 and 1995 due to the publicity and litigation surrounding breast implants. When an organism was identified in the report, the most common organism reported was Staphylococcus sp. Information on the time between the implantation and the onset of the infection or the explantation of the implant was not always reported. However, in reports that did contain this information, there were differences between the length of time to infection onset reported for saline breast implants (earlier) compared to silicone gel breast implants (later). More than half of the reports (56.6%) asserted only that there was an infection and that breast implants were explanted as a result; the remaining reports asserted that infection and other signs, symptoms, or diagnoses had afflicted the patient.

  7. Theory of effective drug release from medical implants based on the Higuchi model and physico-chemical hydrodynamics.

    PubMed

    Dukhin, Stanislav S; Labib, Mohamed E

    2012-09-05

    Combining the approach of colloid transport with the generalized Higuchi theory of drug release and with the concept of minimum inhibitory concentration (MIC) known in microbiology, the theory of effective drug release from implants has been developed. Effective release of an antibiotic at a concentration above MIC is a necessary condition to achieve protection against infection from implants such as central catheters. The Higuchi theory in its present form is not predictive of the therapeutic effect from medical implants. The theory of effective release presented in this paper specifies two release modes, namely: one with therapeutic usefulness (effective release) and another without therapeutic effect. Therapeutic usefulness may be achieved when the antibiotic concentration, Cti , on the implant surface kills the organisms of interest and prevents the formation and propagation of biofilm when Cti exceeds the corresponding MIC of the released antibiotic compound. Currently, neither the Higuchi theory nor any other theory can provide such prediction. The present approach requires quantification of the antibiotic transport from the drug-polymer blend implant surface into the tissue and accounts for its coupling with drug diffusion inside the blend, a task that has not been developed in existing theories. Our solution to this task resulted in the derivation of an equation for the time of duration of effective release, Te , which depends on MIC, the Higuchi invariant and the characteristics of convective diffusion within the tissue. The latter characteristics include: diffusivity Dti and diffusion layer thickness δ which is controlled by the velocity of the interstitial fluid in tissue. A smaller Dti is favorable because transport from the catheter surface is weaker, while a thinner diffusion layer is harmful because this transport is stronger. The influence of the tangential component of interstitial velocity in the tissue is especially harmful because the diffusion

  8. Implantable Microimagers

    PubMed Central

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

    2008-01-01

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

  9. 75 FR 9333 - Implantation or Injectable Dosage Form New Animal Drugs; Tilmicosin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-02

    ... Animal Drugs; Tilmicosin 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 Elanco Animal Health, A Division of Eli Lilly &...

  10. 76 FR 22610 - Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-22

    ... Animal Drugs; Enrofloxacin 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 Bayer HealthCare LLC. The supplemental NADA...

  11. 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...

  12. 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.

  13. Phase I trial of an implanted battery-powered, programmable drug delivery system for continuous doxorubicin administration.

    PubMed

    Vogelzang, N J; Ruane, M; DeMeester, T R

    1985-03-01

    A second generation, implantable drug administration device (DAD, Medtronic, Inc, Minneapolis) which contains a 20-mL drug reservoir, a lithium-thionyl-chloride battery, a peristaltic roller pump, a microprocessor circuit, and an acoustic transducer has entered clinical trials. After surgical placement, drug is entered into and removed from the DAD percutaneously through a Silastic "fill port" using a standard gauge needle and syringe. The pump is noninvasively programmed using a hand-held telemetry wand to administer the drug in a continuous infusion, bolus, or bolus-delay mode. Because of the apparent improved therapeutic index of continuous-infusion doxorubicin (CID), a phase I trial of the Medtronic DAD with CID was begun. Thirteen pumps in 13 patients have functioned for a median of 153 days (range, 11 to 395 days) with one pump still functioning. Four pumps ceased function at 170, 278, 331, and 370 days, respectively; there was a catheter-tip clot on one of the pumps that later malfunctioned. All other pumps functioned until the death of the respective patients. In 84 pump refills, without drug extravasation, the median drug delivery error (actual residual volume--calculated residual volume/calculated residual volume X 100%) was 14%. Doxorubicin was compatible with all components of the drug pathway and did not significantly decompose during two weeks in the drug reservoir. The starting dose of CID was 2.0 mg/m2/d and the maximum tolerated dose was 4.1 mg/m2/d (range, 3.5 to 5.5). A median cumulative doxorubicin dose of 244 mg/m2 per patient (range, 10 to 583 mg/m2) has been infused.(ABSTRACT TRUNCATED AT 250 WORDS)

  14. A survey on the applications of implantable micropump systems in drug delivery.

    PubMed

    Mahnama, Ali; Nourbakhsh, Ahmad; Ghorbaniasl, Ghader

    2014-01-01

    Systemic drug delivery is the most prevalent form of the drug administration; but it is not possible to extend this approach to all of diseases. In the traditional approaches of drug delivery, the drug spreads through whole of body and this could cause severe side effects in the healthy parts. In addition, in some parts of our body like the eye, ear and brain, there are biological barriers against drug penetration which made drug delivery to these organs as a challenging work. Micropumps are one of the MEMS based devices with great capabilities in controlled drug administration. The most prevalent application of micropumps in drug delivery is known as continuous subcutaneous insulin infusion (CSII) for diabetic patients; but our study showed that there are some other ongoing investigations to extend application of micropumps in new treatment methods for some incurred diseases.

  15. Drug Release Characteristics and Tissue Distribution of Rifapentine Polylactic Acid Sustained-Release Microspheres in Rabbits after Paravertebral Implantation

    PubMed Central

    Zhang, Zheng; Wu, Linbo; Li, Haijian; Long, Zhicheng; Song, Xinghua

    2016-01-01

    Background Rates of drug-resistant tuberculosis (TB) and TB associated with human immunodeficiency virus (HIV) infection have increased dramatically, intensifying challenges in TB control. New formulations of TB treatment drugs that control drug release and increase local drug concentrations will have a significant impact on mitigating the toxic side effects and increasing the clinical efficacy of anti-TB drugs. Objectives The aim was to observe the sustained release characteristics of rifapentine polylactic acid sustained-release microspheres in vivo and the accumulation of rifapentine in other tissues following paravertebral implantation. Methods This study is a basic animal experimental study that began on July 17, 2014 in the Fifth Affiliated hospital of Xinjiang Medical University. One hundred and eight New Zealand white rabbits (weighing 2.8 - 3.0 kg, male and female, China) were randomly divided into three groups of 36 rabbits each. Blood and tissue samples from the liver, lungs, kidneys, vertebrae, and paravertebral muscle were collected at different time points post-surgery. High performance liquid chromatography (HPLC) analysis with a biological internal standard was used to determine the drug concentrations in samples. Results In group A, no significant differences in rifapentine concentrations in the liver were detected between any two time points (P > 0.05). However, the differences in rifapentine concentrations between day 10 and day 21 were statistically significant (P < 0.05); for days 21, 35, 46, and 60, the differences in rifapentine concentrations between two sequential time points were not statistically significant (P > 0.05). In group B, the differences in rifapentine concentration between days 3 and 10 in vertebral bone and in paravertebral muscles were statistically significant (P < 0.05). Rifapentine was detected in the vertebral bone tissue in the group C animals. The rifapentine concentrations between two sequential time points were

  16. 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.

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

    DTIC Science & Technology

    2009-06-01

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

  18. 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.

  19. 75 FR 1274 - Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... Animal Drugs; Hyaluronate Sodium AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY... NADA provides for a revised human food safety warning for use of hyaluronate sodium injectable solution... for the veterinary prescription use of HYVISC (hyaluronate sodium) Sterile Injection in horses....

  20. 75 FR 62468 - Implantation and Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-12

    ... Animal Drugs; Ceftiofur Crystalline Free Acid AGENCY: Food and Drug Administration, HHS. ACTION: Final... ceftiofur crystalline free acid suspension in swine, by intramuscular injection, for the control of swine... crystalline free acid) for Swine Sterile Suspension. The supplemental NADA provides for the...

  1. 75 FR 4692 - Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-29

    ... Animal Drugs; Ceftiofur Crystalline Free Acid AGENCY: Food and Drug Administration, HHS. ACTION: Final... crystalline free acid injectable suspension for the treatment of lower respiratory tract infections in horses...-209 for EXCEDE (ceftiofur crystalline free acid) Sterile Suspension. The supplemental NADA...

  2. Intracranial Biodegradable Silica-Based Nimodipine Drug Release Implant for Treating Vasospasm in Subarachnoid Hemorrhage in an Experimental Healthy Pig and Dog Model

    PubMed Central

    Koskimäki, Janne; Tarkia, Miikka; Ahtola-Sätilä, Tuula; Saloranta, Lasse; 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

  3. 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

  4. Powering an implantable minipump with a multi-layered printed circuit coil for drug infusion applications in rodents.

    PubMed

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

    2010-03-01

    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 home-cage. 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.

  5. Prevalence and Predictors of Early Discontinuation of Dual-Antiplatelet Therapy After Drug-Eluting Stent Implantation in Korean Population.

    PubMed

    Cho, Mi Hee; Shin, Dong Wook; Yun, Jae Moon; Shin, Joong Hyun; Lee, Seung Pyo; Lee, Hyejin; Lim, Yoo Kyoung; Kim, Eun Ha; Kim, Hyun Kyoung

    2016-11-15

    The administration of antiplatelet drugs for months after a drug-eluting stent implantation is critical in decreasing the risk of complications, and premature discontinuation of antiplatelet therapy before the recommended period is the most important predictor for late complications. Therefore, we investigated the prevalence and associated factors of premature discontinuation of antiplatelet therapy in patients in Korea. This retrospective cohort study was conducted using the Korean National Health Insurance Service-National Sample Cohort data. Patients who were treated with dual-antiplatelet therapy (DAPT) were identified with medication prescription data. The Kaplan-Meier failure time plot was used to illustrate the cumulative probability of treatment discontinuation. Cox regression analysis was conducted to compare predictors of early discontinuation of DAPT. The characteristics of the early discontinuation group were not significantly different from the guideline concordance group, except for a higher prevalence of disability and a lower rate of chronic kidney disease. In a Cox regression model, the presence of hypertension was identified as a negative predictor of early discontinuation, and disability was not a statistically significant predictor. The prevalence of early discontinuation was 31.0% and seems to be significantly higher than those reported from prospective studies, which may more accurately reflect the real-world situation. In conclusion, physicians should make more effort to educate patients on the risk associated with premature discontinuation of antiplatelet therapy after percutaneous coronary intervention with drug-eluting stent, and further studies investigating the reasons for nonadherence of DAPT are needed to improve DAPT compliance.

  6. 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

  7. 77 FR 39390 - Implantation or Injectable Dosage Form New Animal Drugs; Maropitant; Tildipirosin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-03

    ... St., New York, citrate) adding NY 10017. Injectable treatment of Solution. vomiting in cats. \\1\\ The...) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2)...

  8. 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

    ... section. (c) Conditions of use in dogs and cats--(1) Amount. The drug is administered by intravenous... preanesthetic medication reduces propofol dose requirements. (ii) Cats. For induction of general...

  9. Implant-assisted magnetic drug targeting in permeable microvessels: Comparison of two-fluid statistical transport model with experiment

    NASA Astrophysics Data System (ADS)

    ChiBin, Zhang; XiaoHui, Lin; ZhaoMin, Wang; ChangBao, Wang

    2017-03-01

    In experiments and theoretical analyses, this study examines the capture efficiency (CE) of magnetic drug carrier particles (MDCPs) for implant-assisted magnetic drug targeting (IA-MDT) in microvessels. It also proposes a three-dimensional statistical transport model of MDCPs for IA-MDT in permeable microvessels, which describes blood flow by the two-fluid (Casson and Newtonian) model. The model accounts for the permeable effect of the microvessel wall and the coupling effect between the blood flow and tissue fluid flow. The MDCPs move randomly through the microvessel, and their transport state is described by the Boltzmann equation. The regulated changes and factors affecting the CE of the MDCPs in the assisted magnetic targeting were obtained by solving the theoretical model and by experimental testing. The CE was negatively correlated with the blood flow velocity, and positively correlated with the external magnetic field intensity and microvessel permeability. The predicted CEs of the MDCPs were consistent with the experimental results. Additionally, under the same external magnetic field, the predicted CE was 5-8% higher in the IA-MDT model than in the model ignoring the permeability effect of the microvessel wall.

  10. 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

  11. 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.

  12. 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.

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

    PubMed Central

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

    2014-01-01

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

  14. Patient profile and periprocedural outcomes of bioresorbable vascular scaffold implantation in comparison with drug-eluting and bare-metal stent implantation. Experience from ORPKI Polish National Registry 2014–2015

    PubMed Central

    Rzeszutko, Łukasz; Tokarek, Tomasz; Siudak, Zbigniew; Dziewierz, Artur; Żmudka, Krzysztof

    2016-01-01

    Introduction There are limited data on the comparison of bioresorbable vascular scaffold (BVS) and drug-eluting stent (DES)/bare-metal stent (BMS) implantation in an unselected population of patients with coronary artery disease. Aim To compare the periprocedural outcomes and patient profile of BVS and DES/BMS implantation in an all-comer population from the ORPKI Polish National Registry. Material and methods A total of 141,324 consecutive patients from 151 invasive cardiology centers in Poland were included in this prospective registry between January 2014 and June 2015. Periprocedural data on patients with at least one BVS (Absorb, Abbott Vascular, Santa Clara, CA, USA), DES or BMS (all available types) implantation in de novo lesions during index percutaneous coronary intervention for stable angina (SA) or acute coronary syndrome were collected. Results Bioresorbable vascular scaffold was the most often used in patients with SA, in single-vessel disease and in younger male patients. Bioresorbable vascular scaffold implantation was significantly more often associated with periprocedural administration of ticagrelor/prasugrel (6.8% vs. 3.6%; p = 0.001) and use of intravascular ultrasound and optical coherence tomography in comparison with the DES/BMS group (2.8% vs. 0.6% and 1.8% vs. 0.1%, respectively; p = 0.001 for both). The incidence of periprocedural death was significantly lower in the BVS group than the DES/BMS group (0.04% vs. 0.32%; p = 0.02), but this difference was no longer significant after adjustment for covariates. On the other hand, coronary artery perforation occurred significantly more often during BVS delivery (0.31% vs. 0.12%; p = 0.01), and BVS implantation was identified as an independent predictor of coronary artery perforation in multivariate logistic regression analysis (OR = 6.728, 95% CI: 2.394–18.906; p = 0.001). Conclusions Patients treated with BVS implantation presented an acceptable safety and efficacy profile in comparison with

  15. 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

  16. 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

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

    PubMed

    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.

  18. Atherosclerotic plaque behind the stent changes after bare-metal and drug-eluting stent implantation in humans: implications for late stent failure?

    PubMed Central

    Andreou, Ioannis; Takahashi, Saeko; Tsuda, Masaya; Shishido, Koki; Antoniadis, Antonios P.; Papafaklis, Michail I.; Mizuno, Shingo; Coskun, Ahmet U.; Saito, Shigeru; Feldman, Charles L.; Edelman, Elazer R.; Stone, Peter H.

    2016-01-01

    Background and aims The natural history and the role of atherosclerotic plaque located behind the stent (PBS) are still poorly understood. We evaluated the serial changes in PBS following bare-metal (BMS) compared to first-generation drug-eluting stent (DES) implantation and the impact of these changes on in-stent neointimal hyperplasia (NIH). Methods Three-dimensional coronary reconstruction by angiography and intravascular ultrasound was performed after intervention and at 6–10-month follow-up in 157 patients with 188 lesions treated with BMS (n=89) and DES (n=99). Results There was a significant decrease in PBS area (−7.2%; p<0.001) and vessel area (−1.7%; p<0.001) after BMS and a respective increase in both areas after DES implantation (6.1%; p<0.001 and 4.1%; p<0.001, respectively). The decrease in PBS area significantly predicted neointimal area at follow-up after BMS (β: 0.15; 95% confidence interval [CI]: 0.10–0.20, p<0.001) and DES (β: 0.09; 95% CI: 0.07–0.11; p<0.001) implantation. The decrease in PBS area was the most powerful predictor of significant NIH after BMS implantation (odds ratio: 1.13; 95% CI: 1.02–1.26; p=0.02). Conclusions The decrease in PBS area after stent implantation is significantly associated with the magnitude of NIH development at follow-up. This finding raises the possibility of a communication between the lesion within the stent and the underlying native atherosclerotic plaque, and may have important implications regarding the pathobiology of in-stent restenosis and late/very late stent thrombosis. PMID:27494445

  19. 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

  20. 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…

  1. The active modulation of drug release by an ionic field effect transistor for an ultra-low power implantable nanofluidic system.

    PubMed

    Bruno, Giacomo; Canavese, Giancarlo; Liu, Xuewu; Filgueira, Carly S; Sacco, Adriano; Demarchi, Danilo; Ferrari, Mauro; Grattoni, Alessandro

    2016-11-10

    We report an electro-nanofluidic membrane for tunable, ultra-low power drug delivery employing an ionic field effect transistor. Therapeutic release from a drug reservoir was successfully modulated, with high energy efficiency, by actively adjusting the surface charge of slit-nanochannels 50, 110, and 160 nm in size, by the polarization of a buried gate electrode and the consequent variation of the electrical double layer in the nanochannel. We demonstrated control over the transport of ionic species, including two relevant hypertension drugs, atenolol and perindopril, that could benefit from such modulation. By leveraging concentration-driven diffusion, we achieve a 2 to 3 order of magnitude reduction in power consumption as compared to other electrokinetic phenomena. The application of a small gate potential (±5 V) in close proximity (150 nm) of 50 nm nanochannels generated a sufficiently strong electric field, which doubled or blocked the ionic flux depending on the polarity of the voltage applied. These compelling findings can lead to next generation, more reliable, smaller, and longer lasting drug delivery implants with ultra-low power consumption.

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

    PubMed

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

    2013-12-01

    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.

  3. 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

  4. 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 milligrams of melatonin. (b) Sponsor. See No. 053923 in § 510.600(c) of this chapter. (c) Conditions of...

  5. 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...

  6. 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 milligrams of melatonin. (b) Sponsor. See No. 053923 in § 510.600(c) of this chapter. (c) Conditions of...

  7. 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 milligrams of melatonin. (b) Sponsor. See No. 053923 in § 510.600(c) of this chapter. (c) Conditions of...

  8. 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 milligrams of melatonin. (b) Sponsor. See No. 053923 in § 510.600(c) of this chapter. (c) Conditions of...

  9. 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

  10. 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

  11. 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....

  12. 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....

  13. 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....

  14. 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....

  15. 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....

  16. 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....

  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 878.4300 - 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....

  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 878.4750 - 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....

  1. 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

  2. Meta-analysis of randomized controlled trials on efficacy and safety of extended thienopyridine therapy after drug-eluting stent implantation

    PubMed Central

    Tang, Wenyi; Yeh, James; Chen, Jian; Liu, Mao; Ke, Jianting; Tan, Guangyi; Lin, Xiufang

    2016-01-01

    Background The potential benefits and risks of extended thienopyridine therapy beyond 12 months after drug-eluting stent (DES) implantation remain unclear. Methods Randomized controlled trials (RCTs) were searched in PubMed, EMBASE, the Cochrane Library and China National Knowledge Infrastructure databases. The adverse clinical endpoints were compared between 12 months group (aspirin alone) and >12 months group (additional thienopyridine plus aspirin after 12-month dual antiplatelet therapy). Odds ratios (ORs) with 95% confidence intervals (95% CIs) were used as summary statistics. A random-effect model was used in the meta-analysis process. Results Finally, three RCTs incorporating 16,265 participants were included in this meta-analysis. The results indicated that the incidences of myocardial infarction (1.55% vs. 2.90%; OR =0.58; 95% CI, 0.40–0.84; P=0.004) and stent thrombosis (0.32% vs. 0.98%; OR =0.35; 95% CI, 0.20–0.62; P<0.001) in the >12 months group were significantly lower than the 12 months group. However, compared to the 12 months group, the extended thienopyridine therapy markedly increased the risk of bleeding events (2.09% vs. 1.28%; OR =1.64; 95% CI, 1.23–2.17; P<0.001). The risks of stroke (0.78% vs. 0.84%; P=0.67) and cardiac death (0.94% vs. 0.89%; P=0.61) were similar between the two groups. Conclusions The synthesis of available evidence indicates that a regimen of extended thienopyridine therapy beyond 12 months may significantly reduce the risks of myocardial infarction and stent thrombosis but increase the risk of bleeding events in the patients who have received DESs implantation. PMID:27747163

  3. Dental Implants.

    PubMed

    Zohrabian, Vahe M; Sonick, Michael; Hwang, Debby; Abrahams, James J

    2015-10-01

    Dental implants restore function to near normal in partially or completely edentulous patients. A root-form implant is the most frequently used type of dental implant today. The basis for dental implants is osseointegration, in which osteoblasts grow and directly integrate with the surface of titanium posts surgically embedded into the jaw. Radiologic assessment is critical in the preoperative evaluation of the dental implant patient, as the exact height, width, and contour of the alveolar ridge must be determined. Moreover, the precise locations of the maxillary sinuses and mandibular canals, as well as their relationships to the site of implant surgery must be ascertained. As such, radiologists must be familiar with implant design and surgical placement, as well as augmentation procedures utilized in those patients with insufficient bone in the maxilla and mandible to support dental implants.

  4. Cochlear Implants

    MedlinePlus

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

  5. 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 ...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted electrical urinary continence device... Implanted electrical urinary continence device. (a) Identification. An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted...

  7. 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...) 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...

  8. 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...

  9. 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... 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...

  10. Outcomes of ≤6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation

    PubMed Central

    Villablanca, Pedro A.; Massera, Daniele; Mathew, Verghese; Bangalore, Sripal; Christia, Panagiota; Perez, Irving; Wan, Ningxin; Schulz-Schüpke, Stefanie; Briceno, David F.; Bortnick, Anna E.; Garcia, Mario J.; Lucariello, Richard; Menegus, Mark; Pyo, Robert; Wiley, Jose; Ramakrishna, Harish

    2016-01-01

    Abstract Background: The benefit of ≤6-month compared with 12-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) placement remains controversial. We performed a meta-analysis and meta-regression of ≤6-month versus 12-month DAPT in patients undergoing PCI with DES placement. Methods: We conducted electronic database searches of randomized controlled trials (RCTs) comparing DAPT durations after DES placement. For studies with longer follow-up, outcomes at 12 months were identified. Odds ratios and 95% confidence intervals were computed with the Mantel–Haenszel method. Fixed-effect models were used; if heterogeneity (I2) > 40 was identified, effects were obtained with random models. Results: Nine RCTs were included with total n = 19,224 patients. No significant differences were observed between ≤6-month compared with 12-month DAPT in all-cause mortality (OR 0.87; 95% confidence interval (CI): 0.69–1.11), cardiovascular (CV) mortality (OR 0.89; 95% CI: 0.66–1.21), non-CV mortality (OR 0.85; 95% 0.58–1.24), myocardial infarction (OR 1.10; 95% CI: 0.89–1.37), stroke (OR 0.97; 95% CI: 0.67–1.42), stent thrombosis (ST) (OR 1.37; 95% CI: 0.89–2.10), and target vessel revascularization (OR 0.95; 95% CI: 0.77–1.18). No significant difference in major bleeding (OR 0.72; 95% CI: 0.49–1.05) was observed, though the all-bleeding event rate was significantly lower in the ≤6-month DAPT group (OR 0.76; 95% CI: 0.59–0.96). In the meta-regression analysis, a significant association between bleeding events and non-CV mortality with 12-month DAPT was found, as well as between ST and mortality in addition to MI with ≤6-month DAPT. Conclusion: DAPT for ≤6 months is associated with similar mortality and ischemic outcomes but less bleeding events compared with 12-month DAPT after PCI with DES. PMID:28033306

  11. Endodontic implants

    PubMed Central

    Yadav, Rakesh K.; Tikku, A. P.; Chandra, Anil; Wadhwani, K. K.; Ashutosh kr; Singh, Mayank

    2014-01-01

    Endodontic implants were introduced back in 1960. Endodontic implants enjoyed few successes and many failures. Various reasons for failures include improper case selection, improper use of materials and sealers and poor preparation for implants. Proper case selection had given remarkable long-term success. Two different cases are being presented here, which have been treated successfully with endodontic implants and mineral trioxide aggregate Fillapex (Andreaus, Brazil), an MTA based sealer. We suggest that carefully selected cases can give a higher success rate and this method should be considered as one of the treatment modalities. PMID:25298723

  12. Drugs.

    ERIC Educational Resources Information Center

    Hurst, Hunter, Ed.; And Others

    1984-01-01

    This document contains the third volume of "Today's Delinquent," an annual publication of the National Center for Juvenile Justice. This volume deals with the issue of drugs and includes articles by leading authorities in delinquency and substance abuse who share their views on causes and cures for the drug problem among youth in this country.…

  13. Shorter- versus Longer-duration Dual Antiplatelet Therapy in Patients with Diabetes Mellitus Undergoing Drug-eluting Stents Implantation: A Meta-analysis of Randomized Controlled Trials

    PubMed Central

    Huang, He; Li, Ya; Chen, Yu; Fu, Guo-Sheng

    2016-01-01

    Background: Patients with diabetes mellitus (DM) have a higher risk of thromboembolic events; however, the optimal duration of dual antiplatelet therapy (DAPT) remains unclear. The goal of this study was to assess the efficacy and safety of various DAPT durations in patients with DM undergoing drug-eluting stent implantation. Methods: We conducted a literature search for randomized controlled trials (RCTs). We searched databases including EMBASE, PubMed, Cochrane Library, and Scopus up to June 2016. Investigators extracted data independently, including outcomes, characteristics, and study quality. A random-effect model was used to pool odds ratios (ORs) with 95% confidence intervals (CIs) of the clinical outcomes. Results: Six RCTs totaling 6040 patients with DM were included in the study. Shorter-duration DAPT resulted in an increased rate of stent thrombosis (ST) (OR, 1.83, 95% CI: 1.03–3.26, P = 0.04), but did not increase the risk of myocardial infarction (OR, 1.33, 95% CI: 0.71–2.47, P = 0.37), stroke (OR, 0.96, 95% CI: 0.52–1.77, P = 0.90), target vessel revascularization (OR, 1.19, 95% CI: 0.46–3.07, P = 0.71), all-cause death (OR: 0.72, 95% CI: 0.48–1.09, P = 0.12), or cardiac death (OR, 0.82, 95% CI: 0.49–1.36, P = 0.44) significantly. Shorter-duration DAPT was associated with a decreased risk of major bleeding (OR, 0.60, 95% CI: 0.38–0.94, P = 0.02). Conclusion: In patients with DM, longer-duration DAPT had a lower risk of ST, but was associated with an increased bleeding risk. PMID:27901002

  14. Breast Implants

    MedlinePlus

    ... sale in the United States: saline-filled and silicone gel-filled. Both types have a silicone outer shell. They vary in size, shell thickness, ... implant them. Provide information on saline-filled and silicone gel-filled breast implants, including data supporting a ...

  15. Progestin implants for female contraception.

    PubMed

    Croxatt, Horacio B

    2002-01-01

    Four different implants, in the form of capsules or covered rods, that release one of the synthetic progestins levonorgestrel, etonogestrel, Nestorone, or Elcometrine and nomegestrol acetate were reviewed. Biocompatible polymers or copolymers of polydimethyl/polymethylvinyl-siloxanes or ethylvinylacetate are used to hold the steroid crystals and to control the rate of release. Once inserted under the skin, these implants release the corresponding steroid continuously over prolonged periods, a process that can be readily interrupted by implant removal. During long-term use of the implant, the released steroid circulates in blood at a fairly stable level. The physical characteristics of the implants, including drug contents and rate of release, serum levels of the progestin during use, and the duration of their effective life are described. Total steroid loads vary in the range of 50 mg to 216 mg; average release rates are in the range of 30-100 ug/day, and effective lives from 6 months to 7 years.

  16. 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

  17. The Control of Drug Release and Vascular Endothelialization after Hyaluronic Acid-Coated Paclitaxel Multi-Layer Coating Stent Implantation in Porcine Coronary Restenosis Model

    PubMed Central

    Bae, In-Ho; Jeong, Myung Ho; Park, Yong Hwan; Lim, Kyung Seob; Park, Dae Sung; Shim, Jae Won; Kim, Jung Ha; Ahn, Youngkeun; Hong, Young Joon; Sim, Doo Sun

    2017-01-01

    Background and Objectives Hyaluronic acid (HA) is highly biocompatible with cells and the extracellular matrix. In contrast to degradation products of a synthetic polymer, degradation products of HA do not acidify the local environment. The aim of this study was to fabricate an HA-coated paclitaxel (PTX)-eluting stent via simple ionic interactions and to evaluate its effects in vitro and in vivo. Materials and Methods HA and catechol were conjugated by means of an activation agent, and then the stent was immersed in this solution (resulting in a HA-coated stent). After that, PTX was immobilized on the HA-coated stent (resulting in a hyaluronic acid-coated paclitaxel-eluting stent [H-PTX stent]). Study groups were divided into 4 groups: bare metal stent (BMS), HA, H-PTX, and poly (L-lactide)-coated paclitaxel-eluting stent (P-PTX). Stents were randomly implanted in a porcine coronary artery. After 4 weeks, vessels surrounding the stents were isolated and subjected to various analyses. Results Smoothness of the surface was maintained after expansion of the stent. In contrast to a previous study on a PTX-eluting stent, in this study, the PTX was effectively released up to 14 days (a half amount of PTX in 4 days). The proliferation of smooth muscle cells was successfully inhibited (by 80.5±12.11% at 7 days of culture as compared to the control) by PTX released from the stent. Animal experiments showed that the H-PTX stent does not induce an obvious inflammatory response. Nevertheless, restenosis was clearly decreased in the H-PTX stent group (9.8±3.25%) compared to the bare-metal stent group (29.7±8.11%). Conclusion A stent was stably coated with PTX via simple ionic interactions with HA. Restenosis was decreased in the H-PTX group. These results suggest that HA, a natural polymer, is suitable for fabrication of drug-eluting stents (without inflammation) as an alternative to a synthetic polymer. PMID:28154600

  18. Histrelin Implant

    MedlinePlus

    ... implant (Supprelin LA) is used to treat central precocious puberty (CPP; a condition causing children to enter puberty too soon, resulting in faster than normal bone growth and development of sexual characteristics) in girls ...

  19. Penile Implants

    MedlinePlus

    ... placed inside the penis to allow men with erectile dysfunction (ED) to get an erection. Penile implants are ... complications and follow-up care. For most men, erectile dysfunction can be successfully treated with medications or use ...

  20. Cochlear implants.

    PubMed

    Connell, Sarah S; Balkany, Thomas J

    2006-08-01

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

  1. Levonorgestrel subdermal implants. Contraception on trial.

    PubMed

    Frank, M L; DiMaria, C

    1997-12-01

    When they were introduced to the world market in the 1980s, levonorgestrel subdermal implants offered the promise of an exciting alternative to traditional hormonal contraception. They provide highly effective, long-acting protection from pregnancy, without the need for user compliance. Broad acceptability of the drug has been reported throughout the world. Recently, however, the implants have met with opposition. The drug is associated with a variety of adverse effects, and removal of implants can be problematic. Serious events have been reported in women using levonorgestrel subdermal implants, although causal relationships have not been demonstrated. Additionally, concerns have been raised over the potential for coercive use of the drug. Numerous law suits have been filed alleging serious problems with implants. As a result, the drug has received considerable negative media attention. Before the controversy over levonorgestrel subdermal implants erupted, contraceptive development had declined, resulting from limitations to profits and funding, legal threats, and changes in the insurance industry. The levonorgestrel subdermal implant experience may serve to accelerate this trend. While the introduction of levonorgestrel subdermal implants offered an alternative to the current array of medical contraception, its experience may serve to dampen future contraceptive development efforts. Costly litigation and much controversy involving the implants have acted to create disincentives to further research and development of new methods of medical contraception.

  2. Contraceptive implants.

    PubMed

    McDonald-Mosley, Raegan; Burke, Anne E

    2010-03-01

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

  3. Epidemiology of silicone-gel breast implants.

    PubMed

    Brown, S Lori

    2002-05-01

    Silicone breast implants have been marketed in the United States since 1963. Questions remain unanswered on the safety of these medical devices despite their popularity and availability. In 1992, the Food and Drug Administration restricted the availability of silicone-gel breast implants to women requiring them for reconstruction after breast cancer or for other medical indications. Inflatable saline breast implants have remained available for either reconstruction or for cosmetic augmentation while manufacturers completed studies addressing issues of safety and effectiveness. The Food and Drug Administration (FDA) has less concern today regarding a putative association between breast implants and autoimmune disease because of epidemiologic studies that have indicated that there is not a large increase in risk for connective tissue disease in women with breast implants. These studies have not ruled out a small increase in risk of connective tissue disease to these women nor have they addressed the issue of an atypical syndrome related to silicone. The FDA has continuing concerns over local complications that are related to breast implants. The current review provides a brief discussion of the regulatory history of silicone implants and of FDA concerns over breast implants, implant prevalence, studies of systemic and local complications related to breast implants, and a brief description of the FDA study of silicone-gel breast implant rupture.

  4. 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 Section 870.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... asynchronous modes and is implanted in the human body. (b) Classification. Class III (premarket approval)....

  5. 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 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...

  6. 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 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...

  7. 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 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...

  8. 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...

  9. 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...

  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 882.5225 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5225 Implanted malleable...

  11. 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 882.5225 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5225 Implanted malleable...

  12. 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 882.5225 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5225 Implanted malleable...

  13. 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). 886.3300 Section 886.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (scleral buckling method). (a) Identification. An absorbable implant (scleral buckling method) is a...

  14. 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). 886.3300 Section 886.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (scleral buckling method). (a) Identification. An absorbable implant (scleral buckling method) is a...

  15. 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...

  16. 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...

  17. 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.

  18. 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

  19. 21 CFR 522.2444 - Sodium thiopental implantation or injectable dosage forms.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 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....

  20. 21 CFR 522.960 - Flumethasone implantation or injectable dosage forms.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 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....

  1. 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....

  2. 21 CFR 522.960 - Flumethasone implantation or injectable dosage forms.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 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....

  3. 21 CFR 522.2444 - Sodium thiopental implantation or injectable dosage forms.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 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....

  4. 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....

  5. 21 CFR 522.2444 - Sodium thiopental implantation or injectable dosage forms.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 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....

  6. 21 CFR 522.960 - Flumethasone implantation or injectable dosage forms.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 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....

  7. 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.

  8. 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

  9. 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...

  10. 21 CFR 882.5820 - Implanted cerebellar stimulator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 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...

  11. 21 CFR 882.5860 - Implanted neuromuscular stimulator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 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...

  12. 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...

  13. 21 CFR 872.3640 - Endosseous dental implant.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 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,...

  14. 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...

  15. 21 CFR 872.3645 - Subperiosteal implant material.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (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 molybdenum... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Subperiosteal implant material. 872.3645...

  16. 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...

  17. 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...

  18. 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).

  19. Short Implants: New Horizon in Implant Dentistry.

    PubMed

    Jain, Neha; Gulati, Manisha; Garg, Meenu; Pathak, Chetan

    2016-09-01

    The choice of implant length is an essential factor in deciding the survival rates of these implants and the overall success of the prosthesis. Placing an implant in the posterior part of the maxilla and mandible has always been very critical due to poor bone quality and quantity. Long implants can be placed in association with complex surgical procedures such as sinus lift and bone augmentation. These techniques are associated with higher cost, increased treatment time and greater morbidity. Hence, there is need for a less invasive treatment option in areas of poor bone quantity and quality. Data related to survival rates of short implants, their design and prosthetic considerations has been compiled and structured in this manuscript with emphasis on the indications, advantages of short implants and critical biomechanical factors to be taken into consideration when choosing to place them. Studies have shown that comparable success rates can be achieved with short implants as those with long implants by decreasing the lateral forces to the prosthesis, eliminating cantilevers, increasing implant surface area and improving implant to abutment connection. Short implants can be considered as an effective treatment alternative in resorbed ridges. Short implants can be considered as a viable treatment option in atrophic ridge cases in order to avoid complex surgical procedures required to place long implants. With improvement in the implant surface geometry and surface texture, there is an increase in the bone implant contact area which provides a good primary stability during osseo-integration.

  20. Short Implants: New Horizon in Implant Dentistry

    PubMed Central

    Gulati, Manisha; Garg, Meenu; Pathak, Chetan

    2016-01-01

    The choice of implant length is an essential factor in deciding the survival rates of these implants and the overall success of the prosthesis. Placing an implant in the posterior part of the maxilla and mandible has always been very critical due to poor bone quality and quantity. Long implants can be placed in association with complex surgical procedures such as sinus lift and bone augmentation. These techniques are associated with higher cost, increased treatment time and greater morbidity. Hence, there is need for a less invasive treatment option in areas of poor bone quantity and quality. Data related to survival rates of short implants, their design and prosthetic considerations has been compiled and structured in this manuscript with emphasis on the indications, advantages of short implants and critical biomechanical factors to be taken into consideration when choosing to place them. Studies have shown that comparable success rates can be achieved with short implants as those with long implants by decreasing the lateral forces to the prosthesis, eliminating cantilevers, increasing implant surface area and improving implant to abutment connection. Short implants can be considered as an effective treatment alternative in resorbed ridges. Short implants can be considered as a viable treatment option in atrophic ridge cases in order to avoid complex surgical procedures required to place long implants. With improvement in the implant surface geometry and surface texture, there is an increase in the bone implant contact area which provides a good primary stability during osseo-integration. PMID:27790598

  1. 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

  2. Modulation of the Foreign Body Reaction for Implants in the Subcutaneous Space: Microdialysis Probes as Localized Drug Delivery/Sampling Devices

    PubMed Central

    Mou, Xiaodun; Lennartz, Michelle R; Loegering, Daniel J; Stenken, Julie A

    2011-01-01

    Modulation of the foreign body reaction is considered to be an important step toward creation of implanted sensors with reliable long-term performance. In this work, microdialysis probes were implanted into the subcutaneous space of Sprague-Dawley rats. The probe performance was evaluated by comparing collected endogenous glucose concentrations with internal standard calibration (2-deoxyglucose, antipyrine, and vitamin B12). Probes were tested until failure, which for this work was defined as loss of fluid flow. In order to determine the effect of fibrous capsule formation on probe function, monocyte chemoattractant protein-1/CC chemokine ligand 2 (MCP-1/CCL2) was delivered locally via the probe to increase capsule thickness and dexamethasone 21-phosphate was delivered to reduce capsule thickness. Probes delivering MCP-1 had a capsule that was twice the thickness (500–600 μm) of control probes (200–225 μm) and typically failed 2 days earlier than control probes. Probes delivering dexamethasone 21-phosphate had more fragile capsules and the probes typically failed 2 days later than controls. Unexpectedly, extraction efficiency and collected glucose concentrations exhibited minor differences between groups. This is an interesting result in that the foreign body capsule formation was related to the duration of probe function but did not consistently relate to probe calibration. PMID:21722577

  3. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... implant). 872.3970 Section 872.3970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3970 Interarticular disc prosthesis (interpositional implant). (a) Identification. An interarticular disc...

  4. 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

  5. Dental Implant Surgery

    MedlinePlus

    Dental implant surgery Overview By Mayo Clinic Staff Dental implant surgery is a procedure that replaces tooth roots with ... look and function much like real ones. Dental implant surgery can offer a welcome alternative to dentures ...

  6. Hip Implant Systems

    MedlinePlus

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

  7. 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....

  8. 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....

  9. 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....

  10. 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....

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 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. 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 forms. 522.90 Section 522.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS IMPLANTATION OR INJECTABLE DOSAGE FORM...

  13. 21 CFR 522.90 - Ampicillin implantation and injectible dosage forms.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Ampicillin implantation and injectible dosage forms. 522.90 Section 522.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS IMPLANTATION OR INJECTABLE DOSAGE FORM...

  14. 21 CFR 522.1662 - Oxytetracycline hydrochloride implantation or injectable dosage forms.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 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...

  15. 21 CFR 522.90 - Ampicillin implantation and injectible dosage forms.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Ampicillin implantation and injectible dosage forms. 522.90 Section 522.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS IMPLANTATION OR INJECTABLE DOSAGE FORM...

  16. 21 CFR 522.90 - Ampicillin implantation and injectible dosage forms.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Ampicillin implantation and injectible dosage forms. 522.90 Section 522.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS IMPLANTATION OR INJECTABLE DOSAGE FORM...

  17. 21 CFR 522.1662 - Oxytetracycline hydrochloride implantation or injectable dosage forms.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 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...

  18. 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...

  19. 21 CFR 522.1662 - Oxytetracycline hydrochloride implantation or injectable dosage forms.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 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...

  20. 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.

  1. 21 CFR 876.3350 - Penile inflatable implant.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Penile inflatable implant. 876.3350 Section 876.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... required to be filed with the Food and Drug Administration on or before July 11, 2000, for any...

  2. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Interarticular disc prosthesis (interpositional implant). 872.3970 Section 872.3970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Food and Drug Administration on or before March 30, 1999, for any interarticular disc...

  3. 77 FR 5813 - Cardiovascular Metallic Implants: Corrosion, Surface Characterization, and Nickel Leaching...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-06

    ... HUMAN SERVICES Food and Drug Administration Cardiovascular Metallic Implants: Corrosion, Surface... public workshop entitled ``Cardiovascular Metallic Implants: Corrosion, Surface Characterization, and... device manufacturers, test houses, and academia to discuss corrosion, surface characterization,...

  4. 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.

  5. [Bilateral cochlear implantation].

    PubMed

    Kronenberg, Jona; Migirov, Lela; Taitelbaum-Swead, Rikey; Hildesheimer, Minka

    2010-06-01

    Cochlear implant surgery became the standard of care in hearing rehabilitation of patients with severe to profound sensorineural hearing loss. This procedure may alter the lives of children and adults enabling them to integrate with the hearing population. In the past, implantation was performed only in one ear, despite the fact that binaural hearing is superior to unilateral, especially in noisy conditions. Cochlear implantation may be performed sequentially or simultaneously. The "sensitive period" of time between hearing loss and implantation and between the two implantations, when performed sequentially, significantly influences the results. Shorter time spans between implantations improve the hearing results after implantation. Hearing success after implantation is highly dependent on the rehabilitation process which includes mapping, implant adjustments and hearing training. Bilateral cochlear implantation in children is recommended as the proposed procedure in spite of the additional financial burden.

  6. 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.

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  9. 21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  10. 21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  11. [Biomaterials in cochlear implants].

    PubMed

    Stöver, T; Lenarz, T

    2009-05-01

    Cochlear implants (CI) represent the "gold standard" for the treatment of congenitally deaf children and postlingually deafened adults. Thus, cochlear implantation is a success story of new bionic prosthesis development. Owing to routine application of cochlear implants in adults but also in very young children (below the age of one), high demands are placed on the implants. This is especially true for biocompatibility aspects of surface materials of implant parts which are in contact with the human body. In addition, there are various mechanical requirements which certain components of the implants must fulfil, such as flexibility of the electrode array and mechanical resistance of the implant housing. Due to the close contact of the implant to the middle ear mucosa and because the electrode array is positioned in the perilymphatic space via cochleostomy, there is a potential risk of bacterial transferral along the electrode array into the cochlea. Various requirements that have to be fulfilled by cochlear implants, such as biocompatibility, electrode micromechanics, and although a very high level of technical standards has been carried out there is still demand for the improvement of implants as well as of the materials used for manufacturing, ultimately leading to increased implant performance. General considerations of material aspects related to cochlear implants as well as potential future perspectives of implant development will be discussed.

  12. Breast Implants: Saline vs. Silicone

    MedlinePlus

    ... to women of any age for breast reconstruction. Silicone breast implants Silicone implants are pre-filled with ... likely be inserted at the same time. Ruptured silicone implant If a silicone breast implant ruptures, you ...

  13. 21 CFR 882.5860 - Implanted neuromuscular stimulator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... neuromuscular stimulator. (a) Identification. An implanted neuromuscular stimulator is a device that provides electrical stimulation to a patient's peroneal or femoral nerve to cause muscles in the leg to contract, thus... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted neuromuscular stimulator....

  14. Implants for lucky few

    NASA Astrophysics Data System (ADS)

    Brandon, David

    2011-08-01

    In his article "Vision of beauty" (May pp22-27), Richard Taylor points the way to fractal design for retinal implants and makes an enthusiastic case for incorporating such features into the next generation of such implants.

  15. 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.

  16. 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.

  17. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted electrical urinary continence device. 876.5270 Section 876.5270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the pelvic floor, and a battery-powered transmitter outside the body. (b) Classification. Class...

  18. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted electrical urinary continence device. 876.5270 Section 876.5270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the pelvic floor, and a battery-powered transmitter outside the body. (b) Classification. Class...

  19. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted electrical urinary continence device. 876.5270 Section 876.5270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the pelvic floor, and a battery-powered transmitter outside the body. (b) Classification. Class...

  20. 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 Section 882.5860 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5860...

  1. 21 CFR 882.4545 - Shunt system implantation instrument.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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...

  2. 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 882.5820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5820...

  3. 21 CFR 882.4545 - Shunt system implantation instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 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...

  4. 21 CFR 882.5820 - Implanted cerebellar stimulator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted cerebellar stimulator. 882.5820 Section 882.5820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5820...

  5. 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 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...

  6. 21 CFR 882.4545 - Shunt system implantation instrument.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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...

  7. 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 882.5820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5820...

  8. 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 872.3640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function....

  9. 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...

  10. 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...

  11. 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...

  12. 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

  13. 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.

  14. Differences in ward-to-cath lab systolic blood pressure predicts long-term adverse outcomes after drug-eluting stent implantation.

    PubMed

    Her, Ae-Young; Ann, Soe Hee; Lee, Jun Ho; Kim, Jong Min; Kim, Yong Hoon; Garg, Scot; Singh, Gillian Balbir; Shin, Eun-Seok

    2015-11-01

    We sought to investigate the effect of ward-to-cath lab blood pressure (BP) differences on long-term clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES). There are limited data available on the association between PCI with DES and BP differences on long-term clinical outcomes. This study enrolled 994 patients who underwent PCI with DES from March 2003 to August 2007. Resting BP was measured in a ward environment before transfer to the cardiac catheterization lab (cath lab), and again when the patient was laid down on the cath lab table. Patients were divided into two groups according to the difference in ward-to-cath lab systolic BP. Large difference group (n = 383) was defined as the absolute systolic difference of >20 mmHg and small difference group (n = 424) as the absolute systolic difference of ≤20 mmHg. The primary endpoints were all-cause mortality, cardiac death, nonfatal myocardial infarction and stroke. A total of 807 patients (mean age 60 ± 10 years, 522 males) received follow-up for 5.1 ± 2.4 years. The rate of all-cause mortality was significantly higher in the large difference group compared to the small difference group (6.6 vs. 2.8 %; adjusted hazard ratio (HR) 2.43; 95 % confidence interval (CI) 1.22-4.83; p = 0.012). There were higher cardiac deaths seen in the large difference group compared to the small difference group (3.9 vs. 1.4 %; adjusted HR 2.84; 95 % CI 1.1-7.31; p = 0.031). Stroke (2.4 vs. 1.2 %, p = 0.125) and TVR (3.7 vs. 1.7 %, p = 0.051) had higher trends in the large difference group compared to the small difference group. The composite of primary endpoints (all-cause mortality, cardiac death, nonfatal MI and stroke) occurred more frequently in the large difference group compared to the small difference group (10.0 vs. 6.4 %; adjusted HR 1.71; 95 % CI 1.04-2.81; p = 0.033). A difference in ward-to-cath lab systolic BP of >20 mmHg may contribute to increased adverse

  15. 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...

  16. 21 CFR 876.5280 - Implanted mechanical/hydraulic urinary continence device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  17. 21 CFR 876.5280 - Implanted mechanical/hydraulic urinary continence device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  18. 21 CFR 876.5280 - Implanted mechanical/hydraulic urinary continence device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  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 882.5870 - 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...

  12. 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...

  13. 21 CFR 876.5280 - Implanted mechanical/hydraulic urinary continence device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted mechanical/hydraulic urinary continence....5280 Implanted mechanical/hydraulic urinary continence device. (a) Identification. An implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incontinence by...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted mechanical/hydraulic urinary continence....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...

  15. 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,…

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  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 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...

  3. 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...

  4. 78 FR 38867 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

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

  5. 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...

  6. 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...

  7. 21 CFR 882.5850 - Implanted spinal cord stimulator for bladder evacuation.

    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 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...

  8. 21 CFR 882.5850 - Implanted spinal cord stimulator for bladder evacuation.

    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 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 77 FR 37573 - Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-22

    ... Approval for an Implantable Pacemaker Pulse Generator AGENCY: Food and Drug Administration, HHS. ACTION... protocol (PDP) for implantable pacemaker pulse generators. The Agency has summarized its findings regarding... PMA or notice of completion of a PDP for the implantable pacemaker pulse generator. In accordance...

  16. COMMUNICATION: Drug loading of nanoporous TiO2 films

    NASA Astrophysics Data System (ADS)

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

    2006-12-01

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

  17. Electrostatic self-assembly of multilayer copolymeric membranes on the surface of porous tantalum implants for sustained release of doxorubicin.

    PubMed

    Guo, Xinming; Chen, Muwan; Feng, Wenzhou; Liang, Jiabi; Zhao, Huibin; Tian, Lin; Chao, Hui; Zou, Xuenong

    2011-01-01

    Many studies in recent years have focused on surface engineering of implant materials in order to improve their biocompatibility and other performance. Porous tantalum implants have increasingly been used in implant surgeries, due to their biocompatibility, physical stability, and good mechanical strength. In this study we functionalized the porous tantalum implant for sustained drug delivery capability via electrostatic self-assembly of polyelectrolytes of hyaluronic acid, methylated collagen, and terpolymer on the surface of a porous tantalum implant. The anticancer drug doxorubicin was encapsulated into the multilayer copolymer membranes on the porous tantalum implants. Results showed the sustained released of doxorubicin from the functionalized porous tantalum implants for up to 1 month. The drug release solutions in 1 month all had inhibitory effects on the proliferation of chondrosarcoma cell line SW1353. These results suggest that this functionalized implant could be used in reconstructive surgery for the treatment of bone tumor as a local, sustained drug delivery system.

  18. Randomised, double-blind trial on the value of tapered discontinuation of clopidogrel maintenance therapy after drug-eluting stent implantation. Intracoronary Stenting and Antithrombotic Regimen: CAUTION in Discontinuing Clopidogrel Therapy--ISAR-CAUTION.

    PubMed

    Fiedler, K Anette; Mehilli, Julinda; Kufner, Sebastian; Schlichting, Anna; Ibrahim, Tareq; Sibbing, Dirk; Ott, Ilka; Schunkert, Heribert; Laugwitz, Karl-Ludwig; Kastrati, Adnan; Schulz, Stefanie

    2014-06-01

    There is little evidence on the optimal mode of clopidogrel discontinuation. Epidemiological studies observed clustering of thrombotic events after cessation of chronic clopidogrel therapy. The underlying mechanism has been ascribed to transient platelet hyper-reactivity. Gradual tapering of clopidogrel may have the potential to attenuate this phenomenon. The objective of the present study was to assess whether in patients with drug-eluting stents (DES) gradual discontinuation of clopidogrel maintenance therapy is superior to conventional, abrupt discontinuation. Patients with planned discontinuation of chronic clopidogrel therapy after DES implantation were randomised in a double-blinded fashion to either gradual discontinuation (according to a tapering schema over four weeks) or abrupt discontinuation (after continued clopidogrel therapy for additional four weeks). The primary endpoint was the composite of cardiac death, myocardial infarction, stroke, stent thrombosis, major bleeding or rehospitalisation due to an acute coronary syndrome at 90 days. Enrollment of 3,000 patients was planned. The study was stopped prematurely due to slow recruitment after enrollment of 782 patients. At 90 days, nine of 392 patients (2.3%) with tapered cessation reached the primary endpoint compared to five of 390 patients (1.3%) with abrupt cessation (p=0.284). The composite of death or myocardial infarction occurred in three patients with tapered and three patients with abrupt discontinuation (p=0.764). In conclusion, tapered discontinuation of chronic clopidogrel therapy is not superior to abrupt discontinuation regarding the primary endpoint in this study. However, the results must be interpreted in view of the premature termination of the trial and low event rates.

  19. 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.

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

    PubMed

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

    2012-06-01

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

  2. 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.

  3. Tardive Dyskinesia, Oral Parafunction, and Implant-Supported Rehabilitation

    PubMed Central

    Amore, M.

    2016-01-01

    Oral movement disorders may lead to prosthesis and implant failure due to excessive loading. We report on an edentulous patient suffering from drug-induced tardive dyskinesia (TD) and oral parafunction (OP) rehabilitated with implant-supported screw-retained prostheses. The frequency and intensity of the movements were high, and no pharmacological intervention was possible. Moreover, the patient refused night-time splint therapy. A series of implant and prosthetic failures were experienced. Implant failures were all in the maxilla and stopped when a rigid titanium structure was placed to connect implants. Ad hoc designed studies are desirable to elucidate the mutual influence between oral movement disorders and implant-supported rehabilitation. PMID:28050290

  4. Pediatric cochlear implantation: candidacy evaluation, medical and surgical considerations, and expanding criteria.

    PubMed

    Heman-Ackah, Selena E; Roland, J Thomas; Haynes, David S; Waltzman, Susan B

    2012-02-01

    Since the first cochlear implant approved by the US Food and Drug Administration in the early 1980s, great advances have occurred in cochlear implant technology. With these advances, patient selection, preoperative evaluation, and rehabilitation consideration continue to evolve. This article describes the current practice in pediatric candidacy evaluation, reviews the medical and surgical considerations in pediatric cochlear implantation, and explores the expanding criteria for cochlear implantation within the pediatric population.

  5. Localization and Tracking of Implantable Biomedical Sensors.

    PubMed

    Umay, Ilknur; Fidan, Barış; Barshan, Billur

    2017-03-13

    Implantable sensor systems are effective tools for biomedical diagnosis, visualization and treatment of various health conditions, attracting the interest of researchers, as well as healthcare practitioners. These systems efficiently and conveniently provide essential data of the body part being diagnosed, such as gastrointestinal (temperature, pH, pressure) parameter values, blood glucose and pressure levels and electrocardiogram data. Such data are first transmitted from the implantable sensor units to an external receiver node or network and then to a central monitoring and control (computer) unit for analysis, diagnosis and/or treatment. Implantable sensor units are typically in the form of mobile microrobotic capsules or implanted stationary (body-fixed) units. In particular, capsule-based systems have attracted significant research interest recently, with a variety of applications, including endoscopy, microsurgery, drug delivery and biopsy. In such implantable sensor systems, one of the most challenging problems is the accurate localization and tracking of the microrobotic sensor unit (e.g., robotic capsule) inside the human body. This article presents a literature review of the existing localization and tracking techniques for robotic implantable sensor systems with their merits and limitations and possible solutions of the proposed localization methods. The article also provides a brief discussion on the connection and cooperation of such techniques with wearable biomedical sensor systems.

  6. Localization and Tracking of Implantable Biomedical Sensors

    PubMed Central

    Umay, Ilknur; Fidan, Barış; Barshan, Billur

    2017-01-01

    Implantable sensor systems are effective tools for biomedical diagnosis, visualization and treatment of various health conditions, attracting the interest of researchers, as well as healthcare practitioners. These systems efficiently and conveniently provide essential data of the body part being diagnosed, such as gastrointestinal (temperature, pH, pressure) parameter values, blood glucose and pressure levels and electrocardiogram data. Such data are first transmitted from the implantable sensor units to an external receiver node or network and then to a central monitoring and control (computer) unit for analysis, diagnosis and/or treatment. Implantable sensor units are typically in the form of mobile microrobotic capsules or implanted stationary (body-fixed) units. In particular, capsule-based systems have attracted significant research interest recently, with a variety of applications, including endoscopy, microsurgery, drug delivery and biopsy. In such implantable sensor systems, one of the most challenging problems is the accurate localization and tracking of the microrobotic sensor unit (e.g., robotic capsule) inside the human body. This article presents a literature review of the existing localization and tracking techniques for robotic implantable sensor systems with their merits and limitations and possible solutions of the proposed localization methods. The article also provides a brief discussion on the connection and cooperation of such techniques with wearable biomedical sensor systems. PMID:28335384

  7. 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.

  8. Short term versus long term dual antiplatelet therapy after implantation of drug eluting stent in patients with or without diabetes: systematic review and meta-analysis of individual participant data from randomised trials

    PubMed Central

    Gargiulo, Giuseppe; Windecker, Stephan; da Costa, Bruno R; Feres, Fausto; Hong, Myeong-Ki; Gilard, Martine; Kim, Hyo-Soo; Colombo, Antonio; Bhatt, Deepak L; Kim, Byeong-Keuk; Morice, Marie-Claude; Park, Kyung Woo; Chieffo, Alaide; Palmerini, Tullio; Stone, Gregg W

    2016-01-01

    groups. Long term DAPT was associated with higher rates of major or minor bleeding, irrespective of diabetes (P=0.37 for interaction). Conclusions Although the presence of diabetes emerged as an independent predictor of MACE after implantation of a drug eluting stent, compared with short term DAPT, long term DAPT did not reduce the risk of MACE but increased the risk of bleeding among patients with stents with and without diabetes. PMID:27811064

  9. [Cochlear implant in adults].

    PubMed

    Bouccara, D; Mosnier, I; Bernardeschi, D; Ferrary, E; Sterkers, O

    2012-03-01

    Cochlear implant in adults is a procedure, dedicated to rehabilitate severe to profound hearing loss. Because of technological progresses and their applications for signal strategies, new devices can improve hearing, even in noise conditions. Binaural stimulation, cochlear implant and hearing aid or bilateral cochlear implants are the best opportunities to access to better level of comprehension in all conditions and space localisation. By now minimally invasive surgery is possible to preserve residual hearing and use a double stimulation modality for the same ear: electrical for high frequencies and acoustic for low frequencies. In several conditions, cochlear implant is not possible due to cochlear nerve tumour or major malformations of the inner ear. In these cases, a brainstem implantation can be considered. Clinical data demonstrate that improvement in daily communication, for both cochlear and brainstem implants, is correlated with cerebral activation of auditory cortex.

  10. Implant treatment planning considerations.

    PubMed

    Kao, Richard T

    2008-04-01

    As dental implants become a more accepted treatment modality, there is a need for all parties involved with implant dentistry to be familiar with various treatment planning issues. Though the success can be highly rewarding, failure to forecast treatment planning issues can result in an increase of surgical needs, surgical cost, and even case failure. In this issue, the focus is on implant treatment planning considerations.

  11. 21 CFR 882.5840 - Implanted intracerebral/subcortical stimulator for pain relief.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... pain relief. 882.5840 Section 882.5840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Devices § 882.5840 Implanted intracerebral/subcortical stimulator for pain relief. (a) Identification. An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical...

  12. 21 CFR 882.5840 - Implanted intracerebral/subcortical stimulator for pain relief.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... pain relief. 882.5840 Section 882.5840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Devices § 882.5840 Implanted intracerebral/subcortical stimulator for pain relief. (a) Identification. An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical...

  13. 21 CFR 882.5840 - Implanted intracerebral/subcortical stimulator for pain relief.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... pain relief. 882.5840 Section 882.5840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Devices § 882.5840 Implanted intracerebral/subcortical stimulator for pain relief. (a) Identification. An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical...

  14. 21 CFR 882.5840 - Implanted intracerebral/subcortical stimulator for pain relief.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... pain relief. 882.5840 Section 882.5840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Devices § 882.5840 Implanted intracerebral/subcortical stimulator for pain relief. (a) Identification. An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical...

  15. 21 CFR 882.5840 - Implanted intracerebral/subcortical stimulator for pain relief.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... pain relief. 882.5840 Section 882.5840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Devices § 882.5840 Implanted intracerebral/subcortical stimulator for pain relief. (a) Identification. An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical...

  16. Osseointegrated implant prosthodontics.

    PubMed

    Rogoff, G S

    1992-06-01

    This review covers recent literature on prosthodontic aspects of osseointegrated implants. Long-term prognosis, diagnosis and treatment planning, and clinical impression techniques and fabrication technology are discussed.

  17. 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

  18. Teeth and implants.

    PubMed

    Palmer, R

    1999-08-28

    An osseointegrated implant restoration may closely resemble a natural tooth. However, the absence of a periodontal ligament and connective tissue attachment via cementum, results in fundamental differences in the adaptation of the implant to occlusal forces, and the structure of the gingival cuff.

  19. A no bleed implant.

    PubMed

    Ersek, R A; Navarro, J A; Nemeth, D Z; Sas, G

    1993-01-01

    Breast implants have evolved from the original saline-filled, smooth-surfaced silicone rubber bag to silicone gel-filled smooth-walled sacs to a combination of a silicone gel-filled bag within a saline-filled sac, and, most recently, a reversed, double-lumen implant with a saline bag inside of a gel-filled bag. Texture-surfaced implants were first used in 1970 when the standard silicone gel-filled implant was covered with a polyurethane foam. Because of concerns about the degradation products of this foam, they were removed from the market in 1991. In 1975 double-lumen silicone textured implants were developed, followed by silicone gel-filled textured implants. In 1990 a new radiolucent, biocompatible gel was produced that reduced the problem of radioopacity of silicone implants. Because of the gel's sufficiently low coefficient of friction, leakage caused by fold flaw fracture may also be decreased. We present a case where this new biocompatible gel implant was repositioned after four months. The resulting scar capsule in this soft breast was thin [< 0.002 cm (0.008 in.)] and evenly textured as a mirror image of the textured silicone surface. Scanning electron microscopy and x-ray defraction spectrophotometry revealed no silicone bleed.

  20. 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

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Interarticular disc prosthesis (interpositional... disc prosthesis (interpositional implant). (a) Identification. An interarticular disc prosthesis... Food and Drug Administration on or before March 30, 1999, for any interarticular disc...

  6. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Interarticular disc prosthesis (interpositional... disc prosthesis (interpositional implant). (a) Identification. An interarticular disc prosthesis... Food and Drug Administration on or before March 30, 1999, for any interarticular disc...

  7. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Interarticular disc prosthesis (interpositional... disc prosthesis (interpositional implant). (a) Identification. An interarticular disc prosthesis... Food and Drug Administration on or before March 30, 1999, for any interarticular disc...

  8. 21 CFR 870.3610 - Implantable pacemaker pulse generator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... asynchronous devices implanted in the human body. (b) Classification. Class III (premarket approval). (c) Date... Section 870.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... heart. This device is used as a substitute for the heart's intrinsic pacing system to correct...

  9. The relationship between structures and in vitro properties of a polyanhydride implant containing gentamicin sulfate.

    PubMed

    Deng, J S; Li, L; Tian, Y; Meisters, M; Chang, H C; Stephens, D; Chen, S; Robinson, D

    2001-11-01

    Laboratory scale injection-molding equipment was utilized to fabricate an implant consisting of poly(FAD:SA 1:1) and 20% (w/w) gentamicin sulfate. Characterizations were performed to determine the molecular weight and glass transition temperature of poly(FAD:SA 1:1). A study was carried out to investigate the relationships between the in vitro performance, morphology, and micro-structures of the molded implants. It was found that implants produced with different structures exhibited different physical integrities in water, i.e., cracking or non-cracking. For the non-cracking implants, a skin-core structure formed by an oriented skin layer was observed under a polarized light microscope. The same morphology was not seen in the cracking implants. The crystal orientation in the skin layer of the non-cracking implants was further identified using a wide-angle x-ray diffraction method (WAXD). No crystal orientation could be found in the cracking implants by WAXD. Furthermore, studies were carried out to evaluate the in vitro drug release for implants showing different degrees of integrity in water. The in vitro drug release of the cracking implants was markedly faster than that of the non-cracking implants due to the pronounced initial drug-burst effect as a result of crack formation in the implants.

  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. 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.

  12. Osteoporotic rat models for evaluation of osseointegration of bone implants.

    PubMed

    Alghamdi, Hamdan S; van den Beucken, Jeroen J J P; Jansen, John A

    2014-06-01

    Osseointegration of dental and orthopedic bone implants is the important process that leads to mechanical fixation of implants and warrants implant functionality. In view of increasing numbers of osteoporotic patients, bone implant surface optimization strategies with instructive and drug-loading ability have been heavily explored. However, few animal models are available to study the effect of novel implant surface modifications in osteoporotic conditions. Since laboratory rats comply with a number of practical advantages, including the reliability of several methods for rapid induction of osteoporotic conditions, the present work aimed to define the use of the femoral condyle in osteoporotic female and male rats as a suitable implantation model to study osseointegration of bone implants. The method describes the procedures for induction (by hypogonadism) and assessment (by in vivo micro-computed tomography [CT]) of osteoporotic conditions in both female and male rats. The implantation site architecture (femoral condyle bone properties and dimensions) was comparatively evaluated for female and male rats, and the implant installation procedures are described. Finally, the possible analytical techniques to evaluate bone responses via mechanical tests, ex vivo micro-CT, and histological methods are provided.

  13. 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

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

    PubMed Central

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

    2008-01-01

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

  15. Single implant tooth replacement.

    PubMed

    Briley, T F

    1998-01-01

    It has been shown that direct bone anchorage of dental implants will provide long-term predictability for single tooth implants and multi-unit implants. The function of implant-supported restoration is now routinely achieved. The real challenge facing the restorative dentist and laboratory technician is to achieve optimal aesthetics. The learning objective of this article is to review the prosthodontic procedures essential to maximizing natural aesthetics in implant supported restorations. It will provide a review of master impression techniques, prepable titanium abutments and designing the cement on restoration. Particular emphasis is directed to the soft tissue model from which a series of sequenced techniques can be followed to achieve optimal aesthetics. Analysis of the implant alignment with regard to the neighboring teeth will result in having to make a choice of which prepable abutment will maximize the aesthetic result. The following case outlines how to replace a single missing tooth using an externally hexed implant system and a prefabricated titanium abutment on a 26-year-old male patient.

  16. Boron implanted strontium titanate

    NASA Astrophysics Data System (ADS)

    Cooper, C. J. M.

    Single crystals of strontium titanate implanted with boron were found to have highly conductive surface layers. The effects of varying dose from 10 to the 16th power to 10 to the 17th power ions/sq cm, implantation voltage from 50 to 175 keV and annealing conditions on the room temperature surface resistance and Hall mobility are presented. Variation of the implantation voltage did not have a major effect on the sheet resistances obtained by boron implantation of strontium titanate, while dose and annealing conditions have major effects. Doses of 5 x 10 to the 16th power ions/sq cm required annealing on the order of one hour at 500 K for maximum reduction of the room temperature resistance in the implanted layer. Samples implanted with a dose of 1 x 10 to the 17th power ions/sq cm required slightly higher temperatures (approximately 575 K) to obtain a minimum resistance at room temperature. Long term (several weeks) room temperature annealing was found to occur in high dose samples. After one to two months at room temperature followed by an anneal to 575 K, the surface resistances were found to be lower than those produced by the annealing of a freshly implanted sample to 575 K.

  17. 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

  18. Nanotechnology for dental implants.

    PubMed

    Tomsia, Antoni P; Lee, Janice S; Wegst, Ulrike G K; Saiz, Eduardo

    2013-01-01

    With the advent of nanotechnology, an opportunity exists for the engineering of new dental implant materials. Metallic dental implants have been successfully used for decades, but they have shortcomings related to osseointegration and mechanical properties that do not match those of bone. Absent the development of an entirely new class of materials, faster osseointegration of currently available dental implants can be accomplished by various surface modifications. To date, there is no consensus regarding the preferred method(s) of implant surface modification, and further development will be required before the ideal implant surface can be created, let alone become available for clinical use. Current approaches can generally be categorized into three areas: ceramic coatings, surface functionalization, and patterning on the micro- to nanoscale. The distinctions among these are imprecise, as some or all of these approaches can be combined to improve in vivo implant performance. These surface improvements have resulted in durable implants with a high percentage of success and long-term function. Nanotechnology has provided another set of opportunities for the manipulation of implant surfaces in its capacity to mimic the surface topography formed by extracellular matrix components of natural tissue. The possibilities introduced by nanotechnology now permit the tailoring of implant chemistry and structure with an unprecedented degree of control. For the first time, tools are available that can be used to manipulate the physicochemical environment and monitor key cellular events at the molecular level. These new tools and capabilities will result in faster bone formation, reduced healing time, and rapid recovery to function.

  19. High-efficiency wireless power delivery for medical implants using hybrid coils.

    PubMed

    Artan, N Sertac; Patel, Ramesh C; Ning, Chengzhi; Chao, H Jonathan

    2012-01-01

    With the exciting developments in the implant technology allowing sophisticated signal processing, stimulation, and drug delivery capabilities, there is new hope for many patients of epilepsy, Parkinson's disease, and stroke to improve their quality of life. Such implants require high power to deliver the promised rich functionality. Yet, delivering high power to implants without damaging the tissue due to heating while keeping the implant footprint small is a challenge. In this paper, we propose a hybrid multi-layer coil as the secondary coil to provide a power and space-efficient solution. The proposed coils can deliver power to an implant for long durations without increasing the skin temperature over 1C.

  20. Biomedical implantable microelectronics.

    PubMed

    Meindl, J D

    1980-10-17

    Innovative applications of microelectronics in new biomedical implantable instruments offer a singular opportunity for advances in medical research and practice because of two salient factors: (i) beyond all other types of biomedical instruments, implants exploit fully the inherent technical advantages--complex functional capability, high reliability, lower power drain, small size and weight-of microelectronics, and (ii) implants bring microelectronics into intimate association with biological systems. The combination of these two factors enables otherwise impossible new experiments to be conducted and new paostheses developed that will improve the quality of human life.

  1. Implantable cardioverter-defibrillator

    MedlinePlus

    ... ncbi.nlm.nih.gov/pubmed/23265327 . Swerdlow CD, Wang PJ, Zipes DP. Pacemakers and implantable cardioverter-defibrillators. ... and lifestyle Controlling your high blood pressure Dietary fats explained Fast food tips Heart attack - discharge Heart ...

  2. 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.

  3. Risks of Breast Implants

    MedlinePlus

    ... has traveled to other parts of the body. Connective Tissue Disease The FDA has not detected any association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. In order ...

  4. Breast Reconstruction with Implants

    MedlinePlus

    ... removes your breast to treat or prevent breast cancer. One type of breast reconstruction uses breast implants — silicone devices filled with silicone gel or salt water (saline) — to reshape your breasts. Breast reconstruction ...

  5. Urinary incontinence - injectable implant

    MedlinePlus

    Intrinsic sphincter deficiency repair; ISD repair; Injectable bulking agents for stress urinary incontinence ... Urine leakage that gets worse Pain where the injection was done Allergic reaction to the material Implant ...

  6. Breast reconstruction - implants

    MedlinePlus

    ... cosmetic surgery after breast cancer can improve your sense of well-being and your quality of life. Alternative Names Breast implants surgery References Roehl KR, Wilhelmi BJ, Phillips LG. Breast reconstruction. ...

  7. 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.

  8. Surgical techniques for cochlear implantation in the very young child.

    PubMed

    Parisier, S C; Chute, P M; Popp, A L; Hanson, M B

    1997-09-01

    Early cochlear implantation to treat prelingually deafened children has been shown to improve speech perception and overall performance. The current age limit for implantation is 24 months in accordance with US Food and Drug Administration guidelines, but it is believed that earlier implantation is possible and may result in better performance. Implantation in children younger than 36 months, however, is complicated by the altered anatomy of the temporal bone in this young age group. We have developed specific modifications in the cochlear implantation technique for this young age group. This technique was used in implantation for 17 children younger than 36 months. The ages ranged from 16 to 36 months and averaged 30 months. All patients except one had complete electrode insertion without complication. The technique of cochlear implantation must be modified not only for differences in anatomy in these young children but also for the expected continued growth of the temporal bone and related structures. Cochlear implantation can be safely performed on children as young as 16 months.

  9. Simple Implant Augmentation Rhinoplasty

    PubMed Central

    Nguyen, Anh H.; Bartlett, Erica L.; Kania, Katarzyna; Bae, Sang Mo

    2015-01-01

    Augmentation rhinoplasty among Asian patients is often performed to improve the height of the nasal dorsum. As the use of autogenous tissues poses certain limitations, alloplastic materials are a viable alternative with a long history of use in Asia. The superiority of one implant prosthesis over another for augmentation rhinoplasty is a matter of debate, with each material representing varying strengths and weaknesses, indications for use, and precautions to consider in nasal implant placement. An implant prosthesis should be used on a case-by-case basis. Augmentation rhinoplasty requires the consideration of specific anatomical preoperative factors, including the external nose, nasal length, nasofrontal angle, humps, and facial proportions. It is equally important to consider several operative guidelines to appropriately shape implants to minimize the occurrence of adverse effects and postoperative complications. The most common postoperative complications include infection, nasal height change, movement of implant prosthesis, and silicone implant protrusion. In addition, the surgeon should consider the current standards of Asian beauty aesthetics to better understand the patient's desired outcome. PMID:26648804

  10. 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

  11. Contraceptive implants and lactation.

    PubMed

    Díaz, Soledad

    2002-01-01

    The safety and efficacy of four contraceptive implants, plant, Implanon, Nestorone and Elcometrine, have been evaluated during use in the postpartum period by lactating women. These implants provide highly effective contraceptive protection with no negative effect on breastfeeding or infant growth and development. Breastfeeding women initiating Norplant use in the second postpartum month experience significantly longer periods of amenorrhea than do untreated women or intrauterine device users. After weaning, the bleeding pattern is similar to that observed in non-nursing women. Norplant use does not affect bone turnover and density during lactation. Norplant and Implanon release orally active progestins while Nestorone and Elcometrine implants release an orally inactive progestin, which represents an advantage since the infant should be free of steroidal effects. The infant's daily intake of steroids (estimated from concentrations in maternal milk during the first month of use) range from 90 to 100 ng of levonorgestrel (Norplant), 75-120 ng of etonogestrel (Implanon), and 50 ng and 110 ng of Nestorone (Nestorone and Elcometrine implants, respectively). Nursing women needing contraception may use progestin-only implants when nonhormonal methods are not available or acceptable. Implants that deliver orally active steroids should only be used after 6 weeks postpartum to avoid transferring of steroids to the newborn.

  12. Biocompatible implant surface treatments.

    PubMed

    Pattanaik, Bikash; Pawar, Sudhir; Pattanaik, Seema

    2012-01-01

    Surface plays a crucial role in biological interactions. Surface treatments have been applied to metallic biomaterials in order to improve their wear properties, corrosion resistance, and biocompatibility. A systematic review was performed on studies investigating the effects of implant surface treatments on biocompatibility. We searched the literature using PubMed, electronic databases from 1990 to 2009. Key words such as implant surface topography, surface roughness, surface treatment, surface characteristics, and surface coatings were used. The search was restricted to English language articles published from 1990 to December 2009. Additionally, a manual search in the major dental implant journals was performed. When considering studies, clinical studies were preferred followed by histological human studies, animal studies, and in vitro studies. A total of 115 articles were selected after elimination: clinical studies, 24; human histomorphometric studies, 11; animal histomorphometric studies, 46; in vitro studies, 34. The following observations were made in this review: · The focus has shifted from surface roughness to surface chemistry and a combination of chemical manipulations on the porous structure. More investigations are done regarding surface coatings. · Bone response to almost all the surface treatments was favorable. · Future trend is focused on the development of osteogenic implant surfaces. Limitation of this study is that we tried to give a broader overview related to implant surface treatments. It does not give any conclusion regarding the best biocompatible implant surface treatment investigated till date. Unfortunately, the eventually selected studies were too heterogeneous for inference of data.

  13. [Larynx: implants and stents].

    PubMed

    Sittel, C

    2009-05-01

    There is a wide variety of devices and materials to be implanted into the human larynx. Some are intended to remain only for a period of time, like laryngeal stents. If removal is not intended the device meets the definition for a medical implant. The majority of implants is used for the treatment of unilateral vocal fold immobility. There a 2 types of implants serving this purpose: Implants in a stricter sense are devices of solid material, which are brought into the paraglottic space through a window in the laryngeal framework (medialization thyroplasty). Several different products are presented in this review. In contrast, there are different substances available for endoscopic injection into the paralyzed vocal fold (injection laryngoplasty). Since some of these substances show a corpuscular consistency and a high viscosity they need to be deposited into the lateral paraglottic space. Therefore, the term "injectable implants" has been coined for these materials. The different substances available are discussed in detail in this review. Laryngeal stents are primarily used in the early postoperative phase after open reconstruction of the larynx. The different devices available on the market are described with their specific characteristics and intended use.

  14. 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.

  15. Levofloxacin implants with predefined microstructure fabricated by three-dimensional printing technique.

    PubMed

    Huang, Weidong; Zheng, Qixin; Sun, Wangqiang; Xu, Huibi; Yang, Xiangliang

    2007-07-18

    A novel three-dimensional (3D) printing technique was utilized in the preparation of drug implants that can be designed to have complex drug release profiles. The method we describe is based on a lactic acid polymer matrix with a predefined microstructure that is amenable to rapid prototyping and fabrication. We describe how the process parameters, especially selection of the binder, were optimized. Implants containing levofloxacin (LVFX) with predefined microstructures using an optimized binder solution of ethanol and acetone (20:80, v/v) were prepared by a 3D printing process that achieved a bi-modal profile displaying both pulsatile and steady state LVFX release from a single implant. The pulse release appeared from day 5 to 25, followed by a steady state phase of 25 days. The next pulse release phase then began at the 50th day and ended at the 80th day. To evaluate the drug implants structurally and analytically, the microscopic morphologies and the in vitro release profiles of the implants fabricated by both the 3D printing technique and the conventional lost mold technique were assessed using environmental scanning electron microscopy (ESEM) and UV absorbance spectrophotometry. The results demonstrate that the 3D printing technology can be used to fabricate drug implants with sophisticated micro- and macro-architecture in a single device that may be rapidly prototyped and fabricated. We conclude that drug implants with predefined microstructure fabricated by 3D printing techniques can have clear advantages compared to implants fabricated by conventional compressing methods.

  16. 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

  17. Bone density around endosseous implants in patients taking alendronate: a pilot study.

    PubMed

    Griffiths, Garth R

    2012-06-01

    The purpose of this blind, randomized, controlled pilot investigation was to noninvasively determine bone mineral density (BMD) changes around endosseous implants placed in healthy patients who were administered the oral aminobisphosphonate alendronate. BMD was analyzed using computed tomography (CT) and grayscale imaging. Male patients (62 ± 12 years of age) were selected for placement of implants in a two-stage protocol. Patients requiring implants were initially seen for placement of half the total number of implants unilaterally in the maxilla or mandible, and each patient underwent a baseline CT scan. Six months from baseline, contralateral implants were placed with randomization into groups receiving 70 mg of alendronate weekly or a placebo, and a second CT scan was completed. Alendronate/placebo was discontinued after 6 months, and a CT scan was completed at 12 months. Patients returned for an exit evaluation and CT scan at 18 months. Hounsfield units were measured at implant placement and nonsurgical sites in the maxilla and mandible. Within the limitations of this study, results included: a decreasing trend in BMD surrounding an implant when alendronate was administered for 6 months starting at the time of implant placement, a less evident decreasing trend in BMD surrounding an implant when alendronate was administered for 6 months after the implant had successfully undergone osseointegration, and a trend suggesting BMD "rebound" when alendronate was discontinued for 6 months after initial drug administration starting either at the time of implant placement or after the implant had successfully undergone osseointegration for 6 months.

  18. Polyanhydride implant for antibiotic delivery--from the bench to the clinic.

    PubMed

    Li, Luk Chiu; Deng, John; Stephens, Dennis

    2002-10-16

    A polyanhydride implant (Septacin) containing gentamicin sulfate was developed for sustained local delivery of the drug to the site of infection in the treatment of osteomyelitis. Laboratory-scale injection molding equipment was utilized to fabricate the implant for in vitro characterization. Molding conditions were optimized to produce implants with a skin-core structure which was found to be critical in preventing the initial cracking of the implant during in vitro drug release test in water. A manufacturing process consisting of twin-screw extrusion, pelletizing, and injection molding was developed. Polymer-drug pellets were characterized with respect to copolymer molecular weight and drug content uniformity. The implants were terminally sterilized by gamma-radiation which was found to cause increase in copolymer molecular weight as a result of polymer chain extension. The stability of Septacin was evaluated as a function of storage temperature and time. A marked decline in copolymer molecular weight occurred in samples stored above freezing temperatures and significantly slower drug-release profiles were also exhibited by these samples. In vivo drug release from Septacin in rats showed that the gentamicin plasma levels were extremely low, indicating the low systemic exposure to gentamicin. Furthermore, Septacin samples have demonstrated efficacy in the rat skin-abscess and horse-joint infection models. Results from a human in vivo study also showed high local drug concentrations at implantation sites while systemic exposure to the drug was minimal.

  19. [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.

  20. International Breast Implant Registry: a user report.

    PubMed

    Renner, C; Neuhann-Lorenz, C

    2006-01-01

    The International Breast Implant Registry (IBIR) was founded in 2002 under the auspices of the International Plastic, Reconstructive, and Aesthetic Surgery Foundation (IPRAF), the International Confederation for Plastic, Reconstructive, and Aesthetic Surgery (IPRAS), and the European and International Committee for Quality Assurance, Medical Technologies, and Devices in Plastic (EQUAM) on the basis of continuous discussion about the safety and compatibility of different breast implants. The IBIR aims to integrate and replace the already existing national breast implant registries. It also is assumed that the European Parliament, the Food and Drug Administration, and international organizations of plastic and aesthetic surgeons will postulate obligatory international breast implant registration. Currently, IBIR is in a pilot phase with the goal of understanding data collection issues and concerns in various countries whereby the data entered to date will be completely available in the final version. A well-established global registry represents an important tool of quality assurance. By publishing their experiences in applying the registry, the authors aim to encourage more plastic and aesthetic surgeons to submit their cases to the registry and thus enhance its value as a successful and powerful device.

  1. Extraoral prostheses using extraoral implants.

    PubMed

    Pekkan, G; Tuna, S H; Oghan, F

    2011-04-01

    The aim of this study was to evaluate extraoral prostheses and the use of extraoral implants in patients with facial defects. 10 cases were treated utilizing maxillofacial prostheses employing extraoral implants in five cases. 16 extraoral implants were installed. Seven implants were placed in irradiated sites in the orbital regions. Six implants were placed in mastoid regions and three in a zygoma region that was irradiated. Two implants failed before initial integration was achieved in irradiated areas. Using 14 extraoral implants as anchors, five extraoral prostheses were set. The other five cases were treated with extraoral prostheses without using extraoral implants due to cost and patient-related factors. The data included age, sex, primary disease, implant length, implant failure, prosthetic attachment, radiation therapy, and peri-implant skin reactions. The use of extraoral implants for the retention of extraoral prostheses has simplified the placement, removal, and cleaning of the prosthesis by the patient. The stability of the prostheses was improved by anchors. Clinical and technical problems are presented with the techniques used for their resolution. Using extraoral implants resulted in a high rate of success in retaining facial prostheses and gave good stability and aesthetic satisfaction.

  2. Towards biodegradable wireless implants.

    PubMed

    Boutry, Clémentine M; Chandrahalim, Hengky; Streit, Patrick; Schinhammer, Michael; Hänzi, Anja C; Hierold, Christofer

    2012-05-28

    A new generation of partially or even fully biodegradable implants is emerging. The idea of using temporary devices is to avoid a second surgery to remove the implant after its period of use, thereby improving considerably the patient's comfort and safety. This paper provides a state-of-the-art overview and an experimental section that describes the key technological challenges for making biodegradable devices. The general considerations for the design and synthesis of biodegradable components are illustrated with radiofrequency-driven resistor-inductor-capacitor (RLC) resonators made of biodegradable metals (Mg, Mg alloy, Fe, Fe alloys) and biodegradable conductive polymer composites (polycaprolactone-polypyrrole, polylactide-polypyrrole). Two concepts for partially/fully biodegradable wireless implants are discussed, the ultimate goal being to obtain a fully biodegradable sensor for in vivo sensing.

  3. 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.

  4. 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.

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 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 2014-04-01 2014-04-01 false Implantable radiofrequency transponder system...

  6. 21 CFR 880.6300 - Implantable radiofrequency transponder system for patient identification and health information.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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 2013-04-01 2013-04-01 false Implantable radiofrequency transponder system...

  7. 21 CFR 880.6300 - Implantable radiofrequency transponder system for patient identification and health information.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 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 2012-04-01 2012-04-01 false Implantable radiofrequency transponder system...

  8. 21 CFR 880.6300 - Implantable radiofrequency transponder system for patient identification and health information.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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 2011-04-01 2011-04-01 false Implantable radiofrequency transponder system...

  9. 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...

  10. 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...

  11. 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...

  12. Mycobacterium fortuitum causing infection of a biventricular pacemaker/implantable cardioverter defibrillator.

    PubMed

    Hu, Yuhning L; Bridge, Bronwyn; Wang, Jeffrey; Jovin, Ion S

    2012-12-01

    Increased utilization of cardiovascular implantable electronic devices (CIED) has seen a corresponding rise in related infections. Non-tuberculosis mycobacteria (NTM) are rarely the cause. Treatment involves susceptibilities, antimicrobials, and device removal. This study presents a patient who underwent a biventricular implantable cardioverter defibrillator upgrade with a multi-drug resistant Mycobacterium fortuitum located at the pocket site and a lead infection.

  13. 21 CFR 878.3500 - Polytetrafluoroethylene with carbon fibers composite implant material.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 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...

  14. 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

  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, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 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 882.5830 - Implanted diaphragmatic/phrenic nerve stimulator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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...

  19. 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...

  20. 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 composite implant material. 878.3500 Section 878.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY...

  1. 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 composite implant material. 878.3500 Section 878.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY...

  2. 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 product; application. 1308.25 Section 1308.25 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT...(41)(B)(i) of the Act (21 U.S.C. 802(41)(B)(i)), may apply to the Office of Diversion Control,...

  3. The silicone breast implant controversy.

    PubMed

    Guerette, P H

    1995-02-01

    Feminists call it objectification. Consumer advocates call it victimization. Medical personnel call it augmentation. Women, implantation. Whatever the term, media hype and the increasing number of lawsuits against U.S. manufacturers of silicone breast implants has caused widespread concern among women and raised serious questions about the long term health risks and safety of breast implant devices.

  4. Implant surfaces and interface processes.

    PubMed

    Kasemo, B; Gold, J

    1999-06-01

    The past decades and current R&D of biomaterials and medical implants show some general trends. One major trend is an increased degree of functionalization of the material surface, better to meet the demands of the biological host system. While the biomaterials of the past and those in current use are essentially bulk materials (metals, ceramics, polymers) or special compounds (bioglasses), possibly with some additional coating (e.g., hydroxyapatite), the current R&D on surface modifications points toward much more complex and multifunctional surfaces for the future. Such surface modifications can be divided into three classes, one aiming toward an optimized three-dimensional physical microarchitecture of the surface (pore size distributions, "roughness", etc.), the second one focusing on the (bio) chemical properties of surface coatings and impregnations (ion release, multi-layer coatings, coatings with biomolecules, controlled drug release, etc.), and the third one dealing with the viscoelastic properties (or more generally the micromechanical properties) of material surfaces. These properties are expected to affect the interfacial processes cooperatively, i.e., there are likely synergistic effects between and among them: The surface is "recognized" by the biological system through the combined chemical and topographic pattern of the surface, and the viscoelastic properties. In this presentation, the development indicated above is discussed briefly, and current R&D in this area is illustrated with a number of examples from our own research. The latter include micro- and nanofabrication of surface patterns and topographies by the use of laser machining, photolithographic techniques, and electron beam and colloidal lithographies to produce controlled structures on implant surfaces in the size range 10 nm to 100 microns. Examples of biochemical modifications include mono- or lipid membranes and protein coatings on different surfaces. A new method to evaluate, e

  5. 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.

  6. 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.

  7. 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

  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. Practicing implant dentistry profitably.

    PubMed

    Stump, G; Adams, M; Alwan, M

    1997-03-01

    The success of dental implants has opened up countless treatment possibilities for restorative dentists to offer to their patients. Just as our clinical paradigms have had to change because of this new technology, so too must our paradigms concerning the way we communicate with our patients change if we are to get them to say "yes" to treatment that we know that they need. Success in clinical treatment using implants requires a systematic approach. A systematic approach to communicating with your patients will allow you to have the same high degree of success with treatment acceptance that is possible with dental implants. The key to the systems we have discussed is Relationship Centered Care. A relationship is fostered and enhanced through a Comprehensive Examination Process, a structured Consultation Process utilizing the influencing process and Financial Arrangements that allow the patient to receive what they want while the office maintains the profitability that it needs. A system for calculating rational fees can be utilized that allows the practice to have control over an area that traditionally was controlled by anecdotal factors. The Pride Institute has developed this material and is presenting it to the profession so that restorative dentists can truly practice implant dentistry profitably.

  10. Effect of implant design on initial stability of tapered implants.

    PubMed

    Chong, Linus; Khocht, Ahmed; Suzuki, Jon B; Gaughan, John

    2009-01-01

    Implant design is one of the parameters for achieving successful primary stability. This study aims to examine the effect of a self-tapping blades implant design on initial stability in tapered implants. Polyurethane blocks of different densities were used to simulate different bone densities. The two different implant designs included one with self-tapping blades and one without self-tapping blades. Implants were placed at 3 different depths: apical third, middle third, and fully inserted at 3 different densities of polyurethane blocks. A resonance frequency (RF) analyzer was then used to measure stability of the implants. Repeated-measures analysis of variance was used to examine the effect of implant design, insertion depth, and block density on RF. Analysis of covariance was used to examine the strength of association between RF and the aforementioned factors. In both medium-density (P = .017) and high-density (P = .002) blocks, fully inserted non-self-tapping implants showed higher initial stability than self-tapping implants. No differences were noted between the 2 implant designs that were not fully inserted. The highest strength of association was with insertion depth (standardized beta [std beta] = -0.60, P = .0001), followed by block density (std beta = -0.15, P = .0002). Implant design showed a weak association (std beta = -0.07, P = .09). In conclusion, fully inserted implants without self-tapping blades have higher initial stability than implants with self-tapping blades. However, the association strength between implant design and initial stability is less relevant than other factors, such as insertion depth and block density. Thus, if bone quality and quantity are optimal, they may compensate for design inadequacy.

  11. [Allergic reactions to implant materials].

    PubMed

    Thomas, P

    2003-01-01

    The extent of the immune response upon implantation of metallic devices depends on the individual reactivity and on material characteristics. If specific T-cellular sensitization occurs or an allergy to metal preexists, hypersensitive reactions to implant components may develop. They include eczema, impaired wound healing, and sterile osteomyelitis. The existence of allergy-induced implant loosening is still an open question. Further improvement of clinical allergological diagnostics, better understanding of peri-implantar immune reactions, and interdisciplinary collection of epidemiological data concerning allergy to implants will contribute to a better knowledge about tolerance of implant material in humans.

  12. 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.

  13. Design and testing of polymeric implants for the long-term release of dopamine

    SciTech Connect

    Saltzman, W.M.; Radomsky, M. . Dept. of Chemical Engineering); Freese, A.; Langer, R. )

    1988-01-01

    Hydrophobic, biocompatible polymers can be used for the encapsulation and subsequent controlled release of many water-soluble, bioactive molecules. The authors developed general methods for fabricating biocompatible implants and mathematical models for predicting the rate of drug release from the polymer implant based on measurable microstructural parameters. These models apply equally well for small molecules and macromolecules (e.g. proteins). Since polymeric implants may be useful in the treatment of many diseases-including neurological disorders-they now demonstrate the utility of these transport models for designing implantable devices for use in the brain.

  14. Impression techniques for implant dentistry.

    PubMed

    Chee, W; Jivraj, S

    2006-10-07

    The object of making an impression in implant dentistry is to accurately relate an analogue of the implant or implant abutment to the other structures in the dental arch. This is affected by use of an impression coping which is attached to the implant or implant abutment. This impression coping is incorporated in an impression - much as a metal framework is 'picked up' in a remount impression for fixed prosthodontics. With implant copings the coping is usually attached to the implant or abutment with screws. The impression material used is usually an elastomeric impression material; the two types most widely used and shown to be the most appropriate are polyether and polyvinyl siloxane impression materials.

  15. Engineered porous metals for implants

    NASA Astrophysics Data System (ADS)

    Vamsi Krishna, B.; Xue, Weichang; Bose, Susmita; Bandyopadhyay, Amit

    2008-05-01

    Interest is significant in patient-specific implants with the possibility of guided tissue regeneration, particularly for load-bearing implants. For such implants to succeed, novel design approaches and fabrication technologies that can achieve balanced mechanical and functional performance in the implants are necessary. This article is focused on porous load-bearing implants with tailored micro-as well as macrostructures using laser-engineered net shaping (LENS™), a solid freeform fabrication or rapid prototyping technique that can be used to manufacture patient-specific implants. This review provides an insight into LENS, some properties of porous metals, and the potential applications of this process to fabricate unitized structures which can eliminate longstanding challenges in load-bearing implants to increase their in-vivo lifetime, such as in a total hip prosthesis.

  16. Additive manufacturing: From implants to organs.

    PubMed

    Douglas, Tania S

    2014-05-12

    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. 

  17. 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.

  18. 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

  19. 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.

  20. Electromagnetic irradiation may be a new approach to therapy for peri-implantitis.

    PubMed

    Cao, Zhensheng; Chen, Yijia; Chen, Yuxue; Zhao, Qing; Xu, Xiaomei; Chen, Yangxi

    2012-03-01

    Peri-implantitis can lead to bone destruction around a dental implant through inflammation and immune reactions caused by bacteria adhering to the surface of the implant abutment. Electromagnetic irradiation can inhibit bacterial growth, increase bone formation, decrease bone resorption and reduce the inflammatory response. Our hypothesis is that electromagnetic irradiation may be a new treatment approach for peri-implantitis and may simultaneously maintain bone mass around the dental implant. The results would be more significant when combined with other agents, because the effect of some antibiotics and anti-inflammatory drugs is strengthened by electromagnetic irradiation. This non-invasive therapy is expected to be conducted in a convenient manner, and even by patients at home, thereby facilitating the prevention and treatment of peri-implantitis.

  1. 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

  2. The breast implant controversy.

    PubMed

    Cook, R R; Harrison, M C; LeVier, R R

    1994-02-01

    The breast implant issue is a "bad news/good news" story. For many women with implants, the controversy has caused a fair degree of anxiety which may or may not be resolved as further information becomes available. It has also taken its toll on Dow Corning. Whole lines of medical products have been eliminated or are being phase out. The development of new medical applications has been terminated. As a consequence, employees have lost their jobs. What the effect will be on the biomedical industry as a whole remains to be seen (11). While silicones have been an important component in various medical devices, it is likely that other materials can be used as replacements. However, suppliers of non-silicone materials are also reevaluating their role in this market. For example, Du Pont, the nation's largest chemical company, has determined that the unpredictable and excessive costs of doing business with manufacturers of implantable medical devices no longer justifies the unrestricted sale of standard raw materials into this industry. Other companies are quietly following suit. On the up side, it is possible that the research being driven by this controversy will result in a greater understanding of the immunologic implications of xenobiotics, of the importance of nonbiased observations, of the need for ready access to valid data sets, and of the opportunity for valid scientific information to guide legal decisions. Only time will tell.

  3. [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.

  4. Electronic retinal implant surgery.

    PubMed

    MacLaren, R E

    2017-02-01

    Blindness due to outer retinal degeneration still remains largely untreatable. Photoreceptor loss removes light sensitivity, but the remaining inner retinal layers, the optic nerve, and indeed the physical structure of the eye itself may be unaffected by the degenerative processes. This provides the opportunity to restore some degree of vision with an electronic device in the subretinal space. In this lecture I will provide an overview of our experiences with the first-generation retinal implant Alpha IMS, developed by Retina Implant AG and based on the technology developed by Eberhart Zrenner as part of a multicentre clinical trial (NCT01024803). We are currently in the process of running a second NIHR-funded clinical trial to assess the next-generation device. The positive results from both studies to date indicate that the retinal implant should be included as a potential treatment for patients who are completely blind from retinitis pigmentosa. Evolution of the technology in future may provide further opportunities for earlier intervention or for other diseases.

  5. Tubo-uterine implantation.

    PubMed

    Green-armytage, V G

    1957-02-01

    After characterizing 2 types of patients presenting with tubal infertility (1 that is "as a rule overweight (the uterus is fixed (and there is easily palpable tubo-uterine pathology," and 1 that is "slim, young, intelligent and often beautiful", 12 1-sentence suggestions are made to increase the success of tubo-uterine implantations in the second type of presenting patient (because the first group has, in the author's mind, disappointing prognosis). Figures are the bulk of the document, with 3 figures demonstrating the type of operation, 3 showing the scheme of the operation, 1 figure showing a posterior view of the implanted tube in utero with a polyethylene prosthesis in situ down to the cervix, and 1 figure showing the instruments used in the operation. A few points of experience the author shares are: 1) operate immediately after a menstrual period; 2) give antibiotics prophylactically and after the procedure; 3) use a Bonney Myomectomy Clamp to elevate the uterus; 4) never use a knife or bistoury at the cornua; 5) use polyethylene rods, when available; and 6) caesarean section is the indicated delivery route after tubo-uterine implantation. Out of 38 patients with the requisite history and findings who have been operated on by this author, 14 have gone to full-term, i.e., 36.1%; 2 have aborted, giving a pregnancy rate of 42.2%, and there was 1 ectopic pregnancy.

  6. Bone Substitutes for Peri-Implant Defects of Postextraction Implants

    PubMed Central

    Santos, Pâmela Letícia; Gulinelli, Jéssica Lemos; Telles, Cristino da Silva; Betoni Júnior, Walter; Chiacchio Buchignani, Vivian; Queiroz, Thallita Pereira

    2013-01-01

    Placement of implants in fresh sockets is an alternative to try to reduce physiological resorption of alveolar ridge after tooth extraction. This surgery can be used to preserve the bone architecture and also accelerate the restorative procedure. However, the diastasis observed between bone and implant may influence osseointegration. So, autogenous bone graft and/or biomaterials have been used to fill this gap. Considering the importance of bone repair for treatment with implants placed immediately after tooth extraction, this study aimed to present a literature review about biomaterials surrounding immediate dental implants. The search included 56 articles published from 1969 to 2012. The results were based on data analysis and discussion. It was observed that implant fixation immediately after extraction is a reliable alternative to reduce the treatment length of prosthetic restoration. In general, the biomaterial should be used to increase bone/implant contact and enhance osseointegration. PMID:24454377

  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. SURFACE CHEMISTRY INFLUENCE IMPLANT MEDIATED HOST TISSUE RESPONSES

    PubMed Central

    Kamath, Shwetha; Bhattacharyya, Dhiman; Padukudru, Chandana; Timmons, Richard B.; Tang, Liping

    2011-01-01

    Implant-mediated fibrotic reactions are detrimental to the performance of encapsulated cells, implanted drug release devices and sensors. To improve the implant function and longevity, research has emphasized altering cellular responses. Although material surface functional groups have been shown to be potent in affecting cellular activity in vitro and short term in vivo responses, these groups appear to have little influence on long-term in vivo fibrotic reactions, possibly as a result of insufficient interactions between recruited host cells and functional groups on the implants. To maximize the influence of functionality on cells, and to mimic drug release microspheres, functionalized micron-sized particles were created and tested for their ability in modulating tissue responses to biomaterial implants. In this work, the surfaces of polypropylene particles were controllably coated with four different functional groups, specifically –OH, -NH2, -CFx and –COOH, using a radio frequency glow discharge plasma polymerization technique. The effect of these surface functionalities on host tissue responses were then evaluated using a mice subcutaneous implantation model. Major differences were observed in contrasting tissue response to the different chemistries. Surfaces with –OH and –NH2 surface groups induced the thickest fibrous capsule accompanied with the greatest cellular infiltration into the implants. In contrast, surfaces with –CFx and –COOH exhibited the least inflammatory/fibrotic responses and cellular infiltrations. The present results clearly demonstrate that, by increasing the available functionalized surface area and spatial distribution, the effect of surface chemistry on tissue reactivity can be substantially enhanced. PMID:18022841

  9. 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.

  10. 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.

  11. The anti-implantation action of tamoxifen in mice.

    PubMed

    Pugh, D M; Sumano, H S

    1982-01-01

    The process of implantation of the blastocyst in utero in the mouse is normally triggered by oestradiol-17 beta. It can, however, be prevented by the drug tamoxifen whose actions in other species are classified as anti-oestrogenic, but which the mouse is held to be a weak oestrogen. Results are presented which support the claim that the anti-implantation action of tamoxifen is dose dependent, oestrogenicity dominating at high doses and anti-oestrogenicity being of major importance at lower doses.

  12. 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

  13. 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

  14. 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.

  15. 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.

  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. Age at implantation and auditory memory in cochlear implanted children.

    PubMed

    Mikic, B; Miric, D; Nikolic-Mikic, M; Ostojic, S; Asanovic, M

    2014-05-01

    Early cochlear implantation, before the age of 3 years, provides the best outcome regarding listening, speech, cognition an memory due to maximal central nervous system plasticity. Intensive postoperative training improves not only auditory performance and language, but affects auditory memory as well. The aim of this study was to discover if the age at implantation affects auditory memory function in cochlear implanted children. A total of 50 cochlear implanted children aged 4 to 8 years were enrolled in this study: early implanted (1-3y) n = 27 and late implanted (4-6y) n = 23. Two types of memory tests were used: Immediate Verbal Memory Test and Forward and Backward Digit Span Test. Early implanted children performed better on both verbal and numeric tasks of auditory memory. The difference was statistically significant, especially on the complex tasks. Early cochlear implantation, before the age of 3 years, significantly improve auditory memory and contribute to better cognitive and education outcomes.

  18. [Implant rehabilitation of distal mandibular atrophy using a blade implant].

    PubMed

    Veron, C; Chanavaz, M

    1997-11-01

    After a brief revision of the anatomy of the posterior mandible and its natural resorption pattern, the ramus plate-form implant would be the implant of choice for the rehabilitation of this region. This "site specific" implant is inserted on the top of the crest and superficially impacted within the residual alveolar bone at the distal segment of the horizontal branch and guided to climb parallel to the anterior aspect of the ascending ramus. Its form and specific dimensions are perfectly compatible with the frequently limited quantity of available bone above the nerve canal in patients with advanced atrophy of the posterior mandible. It provides a predictable abutment for the implant-supported or dento-implant-supported prostheses of the posterior mandible.

  19. Theranostic 3-Dimensional nano brain-implant for prolonged and localized treatment of recurrent glioma.

    PubMed

    Ramachandran, Ranjith; Junnuthula, Vijayabhaskar Reddy; Gowd, G Siddaramana; Ashokan, Anusha; Thomas, John; Peethambaran, Reshmi; Thomas, Anoop; Unni, Ayalur Kodakara Kochugovindan; Panikar, Dilip; Nair, Shantikumar V; Koyakutty, Manzoor

    2017-03-06

    Localized and controlled delivery of chemotherapeutics directly in brain-tumor for prolonged periods may radically improve the prognosis of recurrent glioblastoma. Here, we report a unique method of nanofiber by fiber controlled delivery of anti-cancer drug, Temozolomide, in orthotopic brain-tumor for one month using flexible polymeric nano-implant. A library of drug loaded (20 wt%) electrospun nanofiber of PLGA-PLA-PCL blends with distinct in vivo brain-release kinetics (hours to months) were numerically selected and a single nano-implant was formed by co-electrospinning of nano-fiber such that different set of fibres releases the drug for a specific periods from days to months by fiber-by-fiber switching. Orthotopic rat glioma implanted wafers showed constant drug release (116.6 μg/day) with negligible leakage into the peripheral blood (<100 ng) rendering ~1000 fold differential drug dosage in tumor versus peripheral blood. Most importantly, implant with one month release profile resulted in long-term (>4 month) survival of 85.7% animals whereas 07 day releasing implant showed tumor recurrence in 54.6% animals, rendering a median survival of only 74 days. In effect, we show that highly controlled drug delivery is possible for prolonged periods in orthotopic brain-tumor using combinatorial nanofibre libraries of bulk-eroding polymers, thereby controlling glioma recurrence.

  20. Theranostic 3-Dimensional nano brain-implant for prolonged and localized treatment of recurrent glioma

    PubMed Central

    Ramachandran, Ranjith; Junnuthula, Vijayabhaskar Reddy; Gowd, G. Siddaramana; Ashokan, Anusha; Thomas, John; Peethambaran, Reshmi; Thomas, Anoop; Unni, Ayalur Kodakara Kochugovindan; Panikar, Dilip; Nair, Shantikumar V.; Koyakutty, Manzoor

    2017-01-01

    Localized and controlled delivery of chemotherapeutics directly in brain-tumor for prolonged periods may radically improve the prognosis of recurrent glioblastoma. Here, we report a unique method of nanofiber by fiber controlled delivery of anti-cancer drug, Temozolomide, in orthotopic brain-tumor for one month using flexible polymeric nano-implant. A library of drug loaded (20 wt%) electrospun nanofiber of PLGA-PLA-PCL blends with distinct in vivo brain-release kinetics (hours to months) were numerically selected and a single nano-implant was formed by co-electrospinning of nano-fiber such that different set of fibres releases the drug for a specific periods from days to months by fiber-by-fiber switching. Orthotopic rat glioma implanted wafers showed constant drug release (116.6 μg/day) with negligible leakage into the peripheral blood (<100 ng) rendering ~1000 fold differential drug dosage in tumor versus peripheral blood. Most importantly, implant with one month release profile resulted in long-term (>4 month) survival of 85.7% animals whereas 07 day releasing implant showed tumor recurrence in 54.6% animals, rendering a median survival of only 74 days. In effect, we show that highly controlled drug delivery is possible for prolonged periods in orthotopic brain-tumor using combinatorial nanofibre libraries of bulk-eroding polymers, thereby controlling glioma recurrence. PMID:28262735

  1. Theranostic 3-Dimensional nano brain-implant for prolonged and localized treatment of recurrent glioma

    NASA Astrophysics Data System (ADS)

    Ramachandran, Ranjith; Junnuthula, Vijayabhaskar Reddy; Gowd, G. Siddaramana; Ashokan, Anusha; Thomas, John; Peethambaran, Reshmi; Thomas, Anoop; Unni, Ayalur Kodakara Kochugovindan; Panikar, Dilip; Nair, Shantikumar V.; Koyakutty, Manzoor

    2017-03-01

    Localized and controlled delivery of chemotherapeutics directly in brain-tumor for prolonged periods may radically improve the prognosis of recurrent glioblastoma. Here, we report a unique method of nanofiber by fiber controlled delivery of anti-cancer drug, Temozolomide, in orthotopic brain-tumor for one month using flexible polymeric nano-implant. A library of drug loaded (20 wt%) electrospun nanofiber of PLGA-PLA-PCL blends with distinct in vivo brain-release kinetics (hours to months) were numerically selected and a single nano-implant was formed by co-electrospinning of nano-fiber such that different set of fibres releases the drug for a specific periods from days to months by fiber-by-fiber switching. Orthotopic rat glioma implanted wafers showed constant drug release (116.6 μg/day) with negligible leakage into the peripheral blood (<100 ng) rendering ~1000 fold differential drug dosage in tumor versus peripheral blood. Most importantly, implant with one month release profile resulted in long-term (>4 month) survival of 85.7% animals whereas 07 day releasing implant showed tumor recurrence in 54.6% animals, rendering a median survival of only 74 days. In effect, we show that highly controlled drug delivery is possible for prolonged periods in orthotopic brain-tumor using combinatorial nanofibre libraries of bulk-eroding polymers, thereby controlling glioma recurrence.

  2. [Biodegradable synthetic implant materials : clinical applications and immunological aspects].

    PubMed

    Witte, F; Calliess, T; Windhagen, H

    2008-02-01

    In the last decade biodegradable synthetic implant materials have been established for various clinical applications. Ceramic materials such as calcium phosphate, bioglass and polymers are now routinely used as degradable implants in the clinical practice. Additionally these materials are now also used as coating materials or as microspheres for controlled drug release and belong to a series of examples for applications as scaffolds for tissue engineering. Because immense local concentrations of degradation products are produced during biodegradation, this review deals with the question whether allergic immune reactions, which have been reported for classical metallic and organic implant materials, also play a role in the clinical routine for synthetic biodegradable materials. Furthermore, possible explanatory theories will be developed to clarify the lack of clinical reports on allergy or sensitization to biodegradable synthetic materials.

  3. 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

  4. 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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  6. Bimodal fitting or bilateral implantation?

    PubMed

    Ching, Teresa Y C; Massie, Robyn; Van Wanrooy, Emma; Rushbrooke, Emma; Psarros, Colleen

    2009-01-01

    This paper summarises findings from studies that evaluated the benefits of bimodal fitting (combining a hearing aid and a cochlear implant in opposite ears) or bilateral cochlear implantation, relative to unilateral implantation, for children (Ching et al., 2007). On average, the size of binaural speech intelligibility advantages due to redundancy and head shadow was similar for the two bilateral conditions. An added advantage of bimodal fitting was that the low-frequency cues provided by acoustic hearing complemented the high-frequency cues conveyed by electric hearing in perception of voice and music. Some children with bilateral cochlear implants were able to use spatial separation between speech and noise to improve speech perception in noise. This is possibly a combined effect of the directional microphones in their implant systems and their ability to use spatial cues. The evidence to date supports the provision of hearing in two ears as the standard of care.

  7. Cochlear implantation following cerebellar surgery.

    PubMed

    Saeed, Shahad; Mawman, Deborah; Green, Kevin

    2011-08-01

    Cochlear implantation in patients with known central nervous system conditions can result in wide-ranging outcomes. The aim of this study is to report two cases of cochlear implantation outcomes in patients with acquired cerebellar ataxia following cerebellar surgery. The first is a female implanted with the Nucleus 24 implant in September 2000 and the second is a male implanted with a MED-EL Sonata Flexsoft electro-acoustic stimulation in July 2009. Programming these patients resulted in significant non-auditory stimulation which resulted in less than optimum map fittings. The patients did not gain any open set speech perception benefit although both of them gained an awareness of sound with the device. However, patient 2 elected to become a non-user because of the limited benefit.

  8. Influence of gait loads on implant integration in rat tibiae: experimental and numerical analysis.

    PubMed

    Piccinini, Marco; Cugnoni, Joel; Botsis, John; Ammann, Patrick; Wiskott, Anselm

    2014-10-17

    Implanted rat bones play a key role in studies involving fracture healing, bone diseases or drugs delivery among other themes. In most of these studies the implants integration also depends on the animal daily activity and musculoskeletal loads, which affect the implants mechanical environment. However, the tissue adaption to the physiological loads is often filtered through control groups or not inspected. This work aims to investigate experimentally and numerically the effects of the daily activity on the integration of implants inserted in the rat tibia, and to establish a physiological loading condition to analyse the peri-implant bone stresses during gait. Two titanium implants, single and double cortex crossing, are inserted in the rat tibia. The animals are caged under standard conditions and divided in three groups undergoing progressive integration periods. The results highlight a time-dependent increase of bone samples with significant cortical bone loss. The phenomenon is analysed through specimen-specific Finite Element models involving purpose-built musculoskeletal loads. Different boundary conditions replicating the post-surgery bone-implant interaction are adopted. The effects of the gait loads on the implants integration are quantified and agree with the results of the experiments. The observed cortical bone loss can be considered as a transient state of integration due to bone disuse atrophy, initially triggered by a loss of bone-implant adhesion and subsequently by a cyclic opening of the interface.

  9. 75 FR 69591 - Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-15

    ... issue a proposed regulation addressing the Affordable Care Act provisions. Inhalation, Infusion..., infusion, instilled, implanted and injectable drugs that are not generally dispensed through retail... publish a list of drugs that meet the statutory definition of inhalation, infusion, instilled,...

  10. Failure of Urological Implants in Spinal Cord Injury Patients due to Infection, Malfunction, and Implants Becoming Obsolete due to Medical Progress and Age-Related Changes in Human Body Making Implant Futile: Report of Three Cases.

    PubMed

    Vaidyanathan, Subramanian; Soni, Bakul; Singh, Gurpreet; Hughes, Peter; Selmi, Fahed; Mansour, Paul

    2013-01-01

    Any new clinical data, whether positive or negative, generated about a medical device should be published because health professionals should know which devices do not work, as well as those which do. We report three spinal cord injury patients in whom urological implants failed to work. In the first, paraplegic, patient, a sacral anterior root stimulator failed to produce erection, and a drug delivery system for intracavernosal administration of vasoactive drugs was therefore implanted; however, this implant never functioned (and, furthermore, such penile drug delivery systems to produce erection had effectively become obsolete following the advent of phosphodiesterase type 5 inhibitors). Subsequently, the sacral anterior root stimulator developed a malfunction and the patient therefore learned to perform self-catheterisation. In the second patient, also paraplegic, an artificial urinary sphincter was implanted but the patient developed a postoperative sacral pressure sore. Eight months later, a suprapubic cystostomy was performed as urethral catheterisation was very difficult. The pressure sore had not healed completely even after five years. In the third case, a sacral anterior root stimulator was implanted in a tetraplegic patient in whom, after five years, a penile sheath could not be fitted because of penile retraction. This patient was therefore established on urethral catheter drainage. Later, infection with Staphylococcus aureus around the receiver block necessitated its removal. In conclusion, spinal cord injury patients are at risk of developing pressure sores, wound infections, malfunction of implants, and the inability to use implants because of age-related changes, as well as running the risk of their implants becoming obsolete due to advances in medicine. Some surgical procedures such as dorsal rhizotomy are irreversible. Alternative treatments such as intermittent catheterisations may be less damaging than bladder stimulator in the long term.

  11. Hydrogen Implants for Layer Exfoliation

    NASA Astrophysics Data System (ADS)

    Cherekdjian, S.; Couillard, J. G.; Wilcox, C.

    2011-01-01

    Researchers at Corning Incorporated have developed a process whereby single crystal silicon thin films are transferred onto a flat panel display glass substrate using hydrogen ion implantation. The energy of the implant controls the effective exfoliation thickness, agreeing well with SRIM calculations, while the hydrogen ion dose controls the size of the platelets formed. The ion dose was found to influence the final void defect count in exfoliated films. Finally, the ion beam and ion implant end-station cooling characteristics were investigated. These parameters control the effective implant heat load generated during ion beam processing. The temperature at which exfoliation occurs during an exfoliation heat cycle was found to be inversely proportional to the hydrogen ion dose when the temperature during ion implantation is <100 °C. The most sensitive exfoliation temperature to ion dose dependence was observed for cooler implants, i.e. <35 °C. Data indicates that at the minimum exfoliation dose the exfoliation temperature is reduced significantly by increasing the implant heat generated during ion beam processing. Higher hydrogen doses than the minimum required for exfoliation exhibit only a small exfoliation temperature variation with ion dose. By optimizing the implant heat load generated during ion beam processing it is observed that the efficiency of the exfoliation process is also enhanced. Implant temperatures of 150 to 160 °C were found to further reduce the minimum implant dose required for exfoliation by an additional 5%, as verified by calorimetric measurements. These results enable us to further conclude that hydrogen out-diffusion is not significant in this process.

  12. Tribological properties of nitrogen implanted and boron implanted steels

    SciTech Connect

    Kern, K.T.; Walter, K.C.; Griffin, A.J. Jr.; Kung, H.; Lu, Y.; Nastasi, M.; Tesmer, J.R.; Fayeulle, S.

    1996-06-01

    Samples of a steel with high chrome content was implanted separately with 75 keV nitrogen ions and with 75 keV boron ions. Implanted doses of each ion species were 2-, 4-, and 8 {times} 10{sup 17}/cm{sup 2}. Retained doses were measured using resonant non-Rutherford Backscattering Spectrometry. Tribological properties were determined using a pin-on-disk test with a 6-mm diameter ruby pin with a velocity of 0.94 m/min. Testing was done at 10% humidity with a load of 377 g. Wear rate and coefficient of friction were determined from these tests. While reduction in the wear rate for nitrogen implanted materials was observed, greater reduction (more than an order of magnitude) was observed for boron implanted materials. In addition, reduction in the coefficient of friction for high-dose boron implanted materials was observed. Nano-indentation revealed a hardened layer near the surface of the material. Results from grazing incidence x-ray diffraction suggest the formation of Fe{sub 2}N and Fe{sub 3}N in the nitrogen implanted materials and Fe{sub 3}B in the boron implanted materials. Results from transmission electron microscopy will be presented.

  13. Double valve Implantation

    PubMed Central

    Stassano, Paolo; Mannacio, Vito; Musumeci, Antonino; Golino, Alessandro; Maida, Piero; Ferrigno, Vincenzo; Buonocore, Gaetano; Spampinato, Nicola

    1991-01-01

    From January 1976 through December 1987, 194 patients with a mean age of 43.3 ± 13.7 years (range, 11 to 74 years) underwent double (mitral and aortic) replacement of native valves with 8 types of bioprostheses: Carpentier-Edwards, 127 valves; Hancock, 76 valves; Liotta-Bioimplant, 57 valves; Ionescu-Shiley, 53 valves; Vascor, 27 valves; Carpentier-Edwards Pericardial, 22 valves; Angell-Shiley, 20 valves; and Implamedic, 6 valves. Concomitant cardiac procedures were performed in 25 patients (12.8%). There were 18 operative deaths (9.27%). Our retrospective analysis was restricted to 352 bioprostheses implanted in the 176 patients who survived surgery and were considered at risk for valve tissue failure. The overall cumulative duration of follow-up was 1,174.1 patient-years (range, 1 to 13 years). The durations of follow-up for specific valves were: Carpentier-Edwards, 920.2 valve-years; Hancock, 383.8 valve-years; Liotta-Bioimplant, 310.2 valve-years; Ionescu-Shiley, 357.7 valve-years; Vascor, 131.2 valve-years; Carpentier-Edwards Pericardial, 52.0 valve-years; Angell-Shiley, 167.0 valve-years; and Implamedic, 31.0 valve-years. Thirty patients had thromboembolic accidents, for a linearized incidence of 2.5% per patient-year. At 13 years, the actuarial freedom from thromboembolic accidents was 85.8% ± 10.7%. Nine patients had endocarditis, for a linearized incidence of 0.7% per patient-year. At 13 years, the actuarial freedom from endocarditis was 92.0% ± 1.5%. Twenty-four patients had valve tissue failure, for a cumulative linearized incidence of 1.87% per valve-year. The cumulative actuarial probability of freedom from valve tissue failure was 78.6% ± 3.7% at 10 years and 51.2% ± 10.7% at 13 years. The 24 patients with valve tissue failure all underwent reoperation: 20 of these had double valve replacement, 3 had aortic valve replacement alone, and 1 had mitral valve replacement alone. The mean interval between initial valve implantation and reoperation was

  14. 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.

  15. 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

  16. Management of fluocinolone implant dissociation during implant exchange.

    PubMed

    Yeh, Steven; Cebulla, Colleen M; Witherspoon, S Robert; Emerson, Geoffrey G; Emerson, M Vaughn; Suhler, Eric B; Albini, Thomas A; Flaxel, Christina J

    2009-09-01

    Three patients with chronic, noninfectious uveitis requiring immunosuppressive therapy underwent fluocinolone acetonide (FA) implant exchange complicated by dissociation of the medication reservoir from its anchoring strut. In 2 patients, the medication reservoir descended into the vitreous cavity and required pars plana vitrectomy with intraocular foreign body removal techniques for its retrieval. The use of viscoelastic or perfluorocarbon to elevate the device was helpful in the safe removal of the FA implant device. Surgeons performing FA implant exchange should be aware of this potential complication and anticipate the possible need for vitreoretinal instrumentation and personnel. Patients undergoing FA explantation or exchange should be counseled regarding this potential complication prior to surgery.

  17. 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 ...

  18. Patient-Specific Orthopaedic Implants.

    PubMed

    Haglin, Jack M; Eltorai, Adam E M; Gil, Joseph A; Marcaccio, Stephen E; Botero-Hincapie, Juliana; Daniels, Alan H

    2016-11-01

    Patient-specific orthopaedic implants are emerging as a clinically promising treatment option for a growing number of conditions to better match an individual's anatomy. Patient-specific implant (PSI) technology aims to reduce overall procedural costs, minimize surgical time, and maximize patient outcomes by achieving better biomechanical implant fit. With this commercially-available technology, computed tomography or magnetic resonance images can be used in conjunction with specialized computer programs to create preoperative patient-specific surgical plans and to develop custom cutting guides from 3-D reconstructed images of patient anatomy. Surgeons can then place these temporary guides or "jigs" during the procedure, allowing them to better recreate the exact resections of the computer-generated surgical plan. Over the past decade, patient-specific implants have seen increased use in orthopaedics and they have been widely indicated in total knee arthroplasty, total hip arthroplasty, and corrective osteotomies. Patient-specific implants have also been explored for use in total shoulder arthroplasty and spinal surgery. Despite their increasing popularity, significant support for PSI use in orthopaedics has been lacking in the literature and it is currently uncertain whether the theoretical biomechanical advantages of patient-specific orthopaedic implants carry true advantages in surgical outcomes when compared to standard procedures. The purpose of this review was to assess the current status of patient-specific orthopaedic implants, to explore their future direction, and to summarize any comparative published studies that measure definitive surgical characteristics of patient-specific orthopaedic implant use such as patient outcomes, biomechanical implant alignment, surgical cost, patient blood loss, or patient recovery.

  19. Microsystems Technology for Retinal Implants

    NASA Astrophysics Data System (ADS)

    Weiland, James

    2005-03-01

    The retinal prosthesis is targeted to treat age-related macular degeneration, retinitis pigmentosa, and other outer retinal degenerations. Simulations of artificial vision have predicted that 600-1000 individual pixels will be needed if a retinal prosthesis is to restore function such as reading large print and face recognition. An implantable device with this many electrode contacts will require microsystems technology as part of its design. An implantable retinal prosthesis will consist of several subsystems including an electrode array and hermetic packaging. Microsystems and microtechnology approaches are being investigated as possible solutions for these design problems. Flexible polydimethylsiloxane (PDMS) substrate electrode arrays and silicon micromachined electrode arrays are under development. Inactive PDMS electrodes have been implanted in 3 dogs to assess mechanical biocompatibility. 3 dogs were followed for 6 months. The implanted was securely fastened to the retina with a single retinal tack. No post-operative complications were evident. The array remained within 100 microns of the retinal surface. Histological evaluation showed a well preserved retina underneath the electrode array. A silicon device with electrodes suspended on micromachined springs has been implanted in 4 dogs (2 acute implants, 2 chronic implants). The device, though large, could be inserted into the eye and positioned on the retina. Histological analysis of the retina from the spring electrode implants showed that spring mounted posts penetrated the retina, thus the device will be redesigned to reduce the strength of the springs. These initial implants will provide information for the designers to make the next generation silicon device. We conclude that microsystems technology has the potential to make possible a retinal prosthesis with 1000 individual contacts in close proximity to the retina.

  20. 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).

  1. Male chest enhancement: pectoral implants.

    PubMed

    Benito-Ruiz, J; Raigosa, J M; Manzano-Surroca, M; Salvador, L

    2008-01-01

    The authors present their experience with the pectoral muscle implant for male chest enhancement in 21 patients. The markings and technique are thoroughly described. The implants used were manufactured and custom made. The candidates for implants comprised three groups: group 1 (18 patients seeking chest enhancement), group 2 (1 patient with muscular atrophy), and group 3 (2 patients with muscular injuries). Because of the satisfying results obtained, including significant enhancement of the chest contour and no major complications, this technique is used for an increasing number of male cosmetic surgeries.

  2. [Considerations for optimizing joint implants].

    PubMed

    Tensi, H M; Orloff, S; Gese, H; Hooputra, H

    1994-09-01

    Despite the increasing use of orthopaedic implants, there is still a lack of adequate testing procedures and legal guidelines. Examples of the consequences of this neglect are given. Modern techniques for the calculation of stresses (finite element method [FEM]) and the prediction of life cycle duration are presented. Such methods, applied in the development and manufacturing phases of standard and special implants, may ensure an adequate prosthetic life cycle, with particular emphasis being placed on the biomedical optimization of the implant/bone interface and surrounding bone.

  3. Accidental Implant Screwdriver Ingestion: A Rare Complication during Implant Placement

    PubMed Central

    Jain, Anshul; Baliga, Shridhar D

    2014-01-01

    One of the complications during a routine dental implant placement is accidental ingestion of the implant instruments, which can happen when proper precautions are not taken. Appropriate radiographs should be taken to locate the correct position of foreign body; usually the foreign body passes asymptomatically from gastrointestinal tract but sometimes it may lead to intestinal obstruction, perforations and impactions. The aim of this article is to report accidental ingestion of 19 mm long screw driver by a senile patient. PMID:25628702

  4. 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 ...

  5. Gold-coated pacemaker implantation for a patient with type IV allergy to titanium

    PubMed Central

    Kypta, Alexander; Blessberger, Hermann; Lichtenauer, Michael; Lambert, Thomas; Kammler, Juergen; Steinwender, Clemens

    2016-01-01

    A 65-year-old man was scheduled for pacemaker implantation for symptomatic sick-sinus-syndrome (SSS). He suffered from multiple drug-allergies and allergies to several metals like quicksilver and titanium. Gold-coated pacemaker generators and polyurethane leads are effective in avoiding allergic reactions to pacing system components. Therefore, we decided to implant a custom-made gold-coated DDDR-pacemaker generator and polyurethane leads. PMID:27479204

  6. Occlusion on oral implants: current clinical guidelines.

    PubMed

    Koyano, K; Esaki, D

    2015-02-01

    Proper implant occlusion is essential for adequate oral function and the prevention of adverse consequences, such as implant overloading. Dental implants are thought to be more prone to occlusal overloading than natural teeth because of the loss of the periodontal ligament, which provides shock absorption and periodontal mechanoreceptors, which provide tactile sensitivity and proprioceptive motion feedback. Although many guidelines and theories on implant occlusion have been proposed, few have provided strong supportive evidence. Thus, we performed a narrative literature review to ascertain the influence of implant occlusion on the occurrence of complications of implant treatment and discuss the clinical considerations focused on the overloading factors at present. The search terms were 'dental implant', 'dental implantation', 'dental occlusion' and 'dental prosthesis'. The inclusion criteria were literature published in English up to September 2013. Randomised controlled trials (RCTs), prospective cohort studies and case-control studies with at least 20 cases and 12 months follow-up interval were included. Based on the selected literature, this review explores factors related to the implant prosthesis (cantilever, crown/implant ratio, premature contact, occlusal scheme, implant-abutment connection, splinting implants and tooth-implant connection) and other considerations, such as the number, diameter, length and angulation of implants. Over 700 abstracts were reviewed, from which more than 30 manuscripts were included. We found insufficient evidence to establish firm clinical guidelines for implant occlusion. To discuss the ideal occlusion for implants, further well-designed RCTs are required in the future.

  7. Rehabilitation of malpositioned implants with a CAD/CAM milled implant overdenture: a clinical report.

    PubMed

    Moeller, Mauricio S; Duff, Renee E; Razzoog, Michael E

    2011-03-01

    Dentists may be faced with the challenge of restoring unfavorably placed implants. In some instances, previously integrated implants may be from different manufacturers. This clinical report describes the rehabilitation of a patient with a maxillary CAD/CAM implant bar-supported overdenture that presented with malpositioned implants, from different manufacturers, including one from a discontinued implant system.

  8. Evaluation of the effects of methotrexate released from polymeric implants in solid Ehrlich tumor.

    PubMed

    de Fátima Pereira, Adriana; Mara da Costa, Vivian; Cristina Magalhães Santos, Millene; Maciel de A Ribeiro, Rosy Iara; Gabriela Silva, Ana; Carmo Horta Pinto, Flávia; Vieira Teixeira Vidigal, Paula; Rodrigues Da Silva, Gisele

    2014-04-01

    In this study, the effects of the controlled and sustained release of methotrexate from poly(ɛ-caprolactone) implants were evaluated in the solid Ehrlich tumor. The drug locally leached from the implantable devices was capable of reducing the tumor growth and the necrotic areas of the tumor site. Furthermore, the methotrexate exerted its anti-tumor effect probably by the recruitment of neutrophils at the tumor site, which assisted in modulating the growth of the tumor. The polymeric implants containing methotrexate could be a chemotherapic alternative to treat locally solid tumors with lower systemic side effects.

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

    PubMed Central

    Tom, James

    2016-01-01

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

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

    PubMed

    Tom, James

    2016-01-01

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

  11. Miniscrew implant applications in contemporary orthodontics.

    PubMed

    Chang, Hong-Po; Tseng, Yu-Chuan

    2014-03-01

    The need for orthodontic treatment modalities that provide maximal anchorage control but with minimal patient compliance requirements has led to the development of implant-assisted orthodontics and dentofacial orthopedics. Skeletal anchorage with miniscrew implants has no patient compliance requirements and has been widely incorporated in orthodontic practice. Miniscrew implants are now routinely used as anchorage devices in orthodontic treatment. This review summarizes recent data regarding the interpretation of bone data (i.e., bone quantity and quality) obtained by preoperative diagnostic computed tomography (CT) or by cone-beam computed tomography (CBCT) prior to miniscrew implant placement. Such data are essential when selecting appropriate sites for miniscrew implant placement. Bone characteristics that are indications and contraindications for treatment with miniscrew implants are discussed. Additionally, bicortical orthodontic skeletal anchorage, risks associated with miniscrew implant failure, and miniscrew implants for nonsurgical correction of occlusal cant or vertical excess are reviewed. Finally, implant stability is compared between titanium alloy and stainless steel miniscrew implants.

  12. Advances in lens implant technology

    PubMed Central

    Kampik, Anselm; Dexl, Alois K.; Zimmermann, Nicole; Glasser, Adrian; Baumeister, Martin; Kohnen, Thomas

    2013-01-01

    Cataract surgery is one of the oldest and the most frequent outpatient clinic operations in medicine performed worldwide. The clouded human crystalline lens is replaced by an artificial intraocular lens implanted into the capsular bag. During the last six decades, cataract surgery has undergone rapid development from a traumatic, manual surgical procedure with implantation of a simple lens to a minimally invasive intervention increasingly assisted by high technology and a broad variety of implants customized for each patient’s individual requirements. This review discusses the major advances in this field and focuses on the main challenge remaining – the treatment of presbyopia. The demand for correction of presbyopia is increasing, reflecting the global growth of the ageing population. Pearls and pitfalls of currently applied methods to correct presbyopia and different approaches under investigation, both in lens implant technology and in surgical technology, are discussed. PMID:23413369

  13. Implants for draining neovascular glaucoma.

    PubMed Central

    Molteno, A C; Van Rooyen, M M; Bartholomew, R S

    1977-01-01

    The implant design, surgical technique, and pharmacological methods of controlling bleb fibrosis, used to treat neovascular glaucoma, are described, together with the results of 14 operations performed on 12 eyes. Images PMID:843508

  14. Implantable micropump technologies for murine intracochlear infusions.

    PubMed

    Johnson, D G; Waldron, M J; Frisina, R D; Borkholder, D A

    2010-01-01

    Due to the very small size of the mouse inner ear, 600 nL volume, developing effective, controlled infusion systems is quite challenging. Key technologies have been created to minimize both size and power for an implantable pump for murine intracochlear infusions. A method for coupling fine capillary tubing to microfluidic channels is presented which provides low volume, biocompatible interconnects withstanding pressures as high as 827 kPa (120 psi) and consuming less than 20 nL of volume exiting in-plane with the pump. Surface micromachined resistive bridges integrated into the flow channel for anemometry based flow rate measurement have been optimized for low power operation in the ultra-low flow rate regime. A process for creation of deformable diaphragms over pump chambers with simultaneous coating of the microfluidic channels has been developed allowing integration of a biocompatible fluid flow path. These advances represent enabling capabilities for a drug delivery system suitable for space constrained applications such as subcutaneous implantation in mice.

  15. Implantable Micropump Technologies for Murine Intracochlear Infusions

    PubMed Central

    Johnson, D. G.; Waldron, M. J.; Frisina, R. D.; Borkholder, D. A.

    2011-01-01

    Due to the very small size of the mouse inner ear, 600 nL volume, developing effective, controlled infusion systems is quite challenging. Key technologies have been created to minimize both size and power for an implantable pump for murine intracochlear infusions. A method for coupling fine capillary tubing to microfluidic channels is presented which provides low volume, biocompatible interconnects withstanding pressures as high as 827 kPa (120 psi) and consuming less than 20 nL of volume exiting in-plane with the pump. Surface micromachined resistive bridges integrated into the flow channel for anemometry based flow rate measurement have been optimized for low power operation in the ultra-low flow rate regime. A process for creation of deformable diaphragms over pump chambers with simultaneous coating of the microfluidic channels has been developed allowing integration of a biocompatible fluid flow path. These advances represent enabling capabilities for a drug delivery system suitable for space constrained applications such as subcutaneous implantation in mice. PMID:21096713

  16. Electrodeposited silk coatings for bone implants

    PubMed Central

    Elia, Roberto; Michelson, Courtney D.; Perera, Austin L.; Brunner, Teresa F.; Harsono, Masly; Leisk, Gray G.; Kugel, Gerard; Kaplan, David L.

    2014-01-01

    The aim of this study was to characterize the mechanical properties and drug elution features of silk protein-based electrodeposited dental implant coatings. Silk processing conditions were modified to obtain coatings with a range of mechanical properties on titanium studs. These coatings were assessed for adhesive strength and dissolution, with properties tuned using water vapor annealing or glycerol incorporation to modulate crystalline content. Coating reproducibility was demonstrated over a range of silk concentrations from 1 to 10%. Surface roughness of titanium substrates was altered using industry relevant acid etching and grit blasting, and the effect of surface topography on silk coating adhesion was assessed. Florescent compounds were incorporated into the silk coatings, which were modulated for crystalline content, to achieve four days of sustained release of the compounds. This silk electrogelation technique offers a safe and relatively simple approach to generate mechanically robust, biocompatible and degradable implant coatings that can also be functionalized with bioactive compounds to modulate the local regenerative tissue environment. PMID:25545462

  17. Surgical Tooth Implants, Combat and Field.

    DTIC Science & Technology

    1984-07-15

    and identify by block number) --- This Annual Report summarizes progress to date on a long-term implant study of a serrated ceramic dental implant...upper two parts of the implant, post and core and crown, are conventional metaT materials. A series of graded dental implants have been produced to...throughout the experimental period. Periodic radio- graphic analyses of dental implants verify this observation. Gross and microscopic patho- logic analyses

  18. Surgical Tooth Implants, Combat and Field.

    DTIC Science & Technology

    1985-11-15

    development of dental implantology must not be overlooked. The early stages of this project clearly defined that rigid fixation of an implant device...block number) .-... This report summarizes progress on a long-ter implant study of a serrated ceramic dental implant designed for fresh extraction...implant, post and core and crown, are conventional metal materials, A series of graded dental implants have been produced to provide an interference fit

  19. [Guidelines for nursing methodology implantation].

    PubMed

    Alberdi Castell, Rosamaría; Artigas Lelong, Berta; Cuxart Ainaud, Núria; Agüera Ponce, Ana

    2003-09-01

    The authors introduce three guidelines as part of the process to implant the nursing methodology based on the Virginia Henderson Conceptual Model; they propose to help nurses adopt the aforementioned method in their daily practice. These three guidelines shall be published in successive articles: Guidelines to identify attitudes and aptitudes related to the nursing profession; Guidelines to implant the nursing methodology based on the Virginia Henderson Conceptual Model; and Guidelines to plan areas for improvement.

  20. The bisphosphonate ibandronate improves implant integration in osteopenic ovariectomized rats.

    PubMed

    Kurth, A H A; Eberhardt, C; Müller, S; Steinacker, M; Schwarz, M; Bauss, F

    2005-08-01

    Osteoporosis is known to impair the process of implant osseointegration. Bisphosphonates are drugs that inhibit osteoclast-mediated bone resorption and normalize the high rate of bone turnover that characterizes this disease. Consequently, there is a rationale for using bisphosphonates to enhance the early stabilization of implants in subjects with low bone mass. In this study, 84 rats received titanium-only or hydroxyapatite (HA)-coated titanium femoral implants, 3 months after being ovariectomized (OVX) or sham operated. They were then treated for 4 weeks. The OVX rats were randomly assigned to daily subcutaneous injections of either saline or the bisphosphonate ibandronate (at a dose of 1 microg/kg or 25 microg/kg), while the sham-operated animals received saline throughout. The 1 microg/kg or 25 microg/kg ibandronate doses are considered translatable to doses used to treat osteoporosis and metastatic bone disease (MBD), respectively, in rats, and roughly reflect those used in humans. At the end of the treatment period, bone mineral density (BMD) at the lumbar spine increased in both of the ibandronate-treated groups when compared with the OVX control animals and to a level similar to that of the sham-operated control group. Osseointegration, determined by histomorphometric analysis and expressed as percentage of osseointegration implant surface (OIS), did not differ between groups for the titanium-only implants. For the HA-coated implants, however, OIS was 113.5% and 185% higher in the groups receiving 1 microg/kg or 25 microg/kg ibandronate, respectively, relative to the OVX controls. In turn, the OIS of the HA-coated implants was 56.5% lower in the OVX control group than in the sham control group. These findings clearly demonstrate that OVX-induced osteopenia impairs the osseointegration of HA-coated titanium implants and that ibandronate, administered at doses analogous to those used to clinically treat osteoporosis and MBD, counters this harmful effect

  1. Fungal Biofilms, Drug Resistance, and Recurrent Infection

    PubMed Central

    Desai, Jigar V.; Mitchell, Aaron P.; Andes, David R.

    2014-01-01

    A biofilm is a surface-associated microbial community. Diverse fungi are capable of biofilm growth. The significance of this growth form for infection biology is that biofilm formation on implanted devices is a major cause of recurrent infection. Biofilms also have limited drug susceptibility, making device-associated infection extremely difficult to treat. Biofilm-like growth can occur during many kinds of infection, even when an implanted device is not present. Here we summarize the current understanding of fungal biofilm formation, its genetic control, and the basis for biofilm drug resistance. PMID:25274758

  2. Auditory Midbrain Implant: A Review

    PubMed Central

    Lim, Hubert H.; Lenarz, Minoo; Lenarz, Thomas

    2009-01-01

    The auditory midbrain implant (AMI) is a new hearing prosthesis designed for stimulation of the inferior colliculus in deaf patients who cannot sufficiently benefit from cochlear implants. The authors have begun clinical trials in which five patients have been implanted with a single shank AMI array (20 electrodes). The goal of this review is to summarize the development and research that has led to the translation of the AMI from a concept into the first patients. This study presents the rationale and design concept for the AMI as well a summary of the animal safety and feasibility studies that were required for clinical approval. The authors also present the initial surgical, psychophysical, and speech results from the first three implanted patients. Overall, the results have been encouraging in terms of the safety and functionality of the implant. All patients obtain improvements in hearing capabilities on a daily basis. However, performance varies dramatically across patients depending on the implant location within the midbrain with the best performer still not able to achieve open set speech perception without lip-reading cues. Stimulation of the auditory midbrain provides a wide range of level, spectral, and temporal cues, all of which are important for speech understanding, but they do not appear to sufficiently fuse together to enable open set speech perception with the currently used stimulation strategies. Finally, several issues and hypotheses for why current patients obtain limited speech perception along with several feasible solutions for improving AMI implementation are presented. PMID:19762428

  3. Biomechanics of Corneal Ring Implants

    PubMed Central

    2015-01-01

    Purpose: To evaluate the biomechanics of corneal ring implants by providing a related mathematical theory and biomechanical model for the treatment of myopia and keratoconus. Methods: The spherical dome model considers the inhomogeneity of the tunica of the eye, dimensions of the cornea, lamellar structure of the corneal stroma, and asphericity of the cornea. It is used in this study for calculating a strengthening factor sf for the characterization of different ring-shaped corneal implant designs. The strengthening factor is a measure of the amount of strengthening of the cornea induced by the implant. Results: For ring segments and incomplete rings, sf = 1.0, which indicates that these implants are not able to strengthen the cornea. The intracorneal continuous complete ring (MyoRing) has a strengthening factor of up to sf = 3.2. The MyoRing is, therefore, able to strengthen the cornea significantly. Conclusions: The result of the presented biomechanical analysis of different ring-shaped corneal implant designs can explain the different postoperative clinical results of different implant types in myopia and keratoconus. PMID:26312619

  4. Retinal implants: a systematic review.

    PubMed

    Chuang, Alice T; Margo, Curtis E; Greenberg, Paul B

    2014-07-01

    Retinal implants present an innovative way of restoring sight in degenerative retinal diseases. Previous reviews of research progress were written by groups developing their own devices. This systematic review objectively compares selected models by examining publications describing five representative retinal prostheses: Argus II, Boston Retinal Implant Project, Epi-Ret 3, Intelligent Medical Implants (IMI) and Alpha-IMS (Retina Implant AG). Publications were analysed using three criteria for interim success: clinical availability, vision restoration potential and long-term biocompatibility. Clinical availability: Argus II is the only device with FDA approval. Argus II and Alpha-IMS have both received the European CE Marking. All others are in clinical trials, except the Boston Retinal Implant, which is in animal studies. Vision restoration: resolution theoretically correlates with electrode number. Among devices with external cameras, the Boston Retinal Implant leads with 100 electrodes, followed by Argus II with 60 electrodes and visual acuity of 20/1262. Instead of an external camera, Alpha-IMS uses a photodiode system dependent on natural eye movements and can deliver visual acuity up to 20/546. Long-term compatibility: IMI offers iterative learning; Epi-Ret 3 is a fully intraocular device; Alpha-IMS uses intraocular photosensitive elements. Merging the results of these three criteria, Alpha-IMS is the most likely to achieve long-term success decades later, beyond current clinical availability.

  5. Ion implanted dielectric elastomer circuits

    NASA Astrophysics Data System (ADS)

    O'Brien, Benjamin M.; Rosset, Samuel; Anderson, Iain A.; Shea, Herbert R.

    2013-06-01

    Starfish and octopuses control their infinite degree-of-freedom arms with panache—capabilities typical of nature where the distribution of reflex-like intelligence throughout soft muscular networks greatly outperforms anything hard, heavy, and man-made. Dielectric elastomer actuators show great promise for soft artificial muscle networks. One way to make them smart is with piezo-resistive Dielectric Elastomer Switches (DES) that can be combined with artificial muscles to create arbitrary digital logic circuits. Unfortunately there are currently no reliable materials or fabrication process. Thus devices typically fail within a few thousand cycles. As a first step in the search for better materials we present a preliminary exploration of piezo-resistors made with filtered cathodic vacuum arc metal ion implantation. DES were formed on polydimethylsiloxane silicone membranes out of ion implanted gold nano-clusters. We propose that there are four distinct regimes (high dose, above percolation, on percolation, low dose) in which gold ion implanted piezo-resistors can operate and present experimental results on implanted piezo-resistors switching high voltages as well as a simple artificial muscle inverter. While gold ion implanted DES are limited by high hysteresis and low sensitivity, they already show promise for a range of applications including hysteretic oscillators and soft generators. With improvements to implanter process control the promise of artificial muscle circuitry for soft smart actuator networks could become a reality.

  6. Implantable Wireless MEMS Sensors for Medical Uses

    NASA Technical Reports Server (NTRS)

    Chimbayo, Alexander

    2006-01-01

    Sensors designed and fabricated according to the principles of microelectromechanical systems (MEMS) are being developed for several medical applications in outer space and on Earth. The designs of these sensors are based on a core design family of pressure sensors, small enough to fit into the eye of a needle, that are fabricated by a "dissolved wafer" process. The sensors are expected to be implantable, batteryless, and wireless. They would be both powered and interrogated by hand-held radio transceivers from distances up to about 6 in. (about 15 cm). One type of sensor would be used to measure blood pressure, particularly for congestive heart failure. Another type would be used to monitor fluids in patients who have hydrocephalus (high brain pressure). Still other types would be used to detect errors in delivery of drugs and to help patients having congestive heart failure.

  7. Three-dimensional printing and nanotechnology for enhanced implantable materials

    NASA Astrophysics Data System (ADS)

    Tappa, Karthik Kumar

    Orthopedic and oro-maxillofacial implants have revolutionized treatment of bone diseases and fractures. Currently available metallic implants have been in clinical use for more than 40 years and have proved medically efficacious. However, several drawbacks remain, such as excessive stiffness, accumulation of metal ions in surrounding tissue, growth restriction, required removal/revision surgery, inability to carry drugs, and susceptibility to infection. The need for additional revision surgery increases financial costs and prolongs recovery time for patients. These metallic implants are bulk manufactured and often do not meet patient's requirements. A surgeon must machine (cut, weld, trim or drill holes) them in order to best suit the patient specifications. Over the past few decades, attempts have been made to replace these metallic implants with suitable biodegradable materials to prevent secondary/revision surgery. Recent advances in biomaterials have shown multiple uses for lactic acid polymers in bone implant technology. However, a targeted/localized drug delivery system needs to be incorporated in these polymers, and they need to be customized to treat orthopedic implant-related infections and other bone diseases such as osteomyelitis, osteosarcoma and osteoporosis. Rapid Prototyping (RP) using additive manufacturing (AM) or 3D printing could allow customization of constructs for personalized medicine. The goal of this study was to engineer customizable and biodegradable implant materials that can elute bioactive compounds for personalized medicine and targeted drug delivery. Post-operative infections are the most common complications following dental, orthopedic and bone implant surgeries. Preventing post-surgical infections is therefore a critical need that current polymethylmethacrylate (PMMA) bone cements fail to address. Calcium Phosphate Cements (CPCs) are unique in their ability to crystallize calcium and phosphate salts into hydroxyapatite (HA) and

  8. 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.

  9. Why are mini-implants lost: the value of the implantation technique!

    PubMed

    Romano, Fabio Lourenço; Consolaro, Alberto

    2015-01-01

    The use of mini-implants have made a major contribution to orthodontic treatment. Demand has aroused scientific curiosity about implant placement procedures and techniques. However, the reasons for instability have not yet been made totally clear. The aim of this article is to establish a relationship between implant placement technique and mini-implant success rates by means of examining the following hypotheses: 1) Sites of poor alveolar bone and little space between roots lead to inadequate implant placement; 2) Different sites require mini-implants of different sizes! Implant size should respect alveolar bone diameter; 3) Properly determining mini-implant placement site provides ease for implant placement and contributes to stability; 4) The more precise the lancing procedures, the better the implant placement technique; 5) Self-drilling does not mean higher pressures; 6) Knowing where implant placement should end decreases the risk of complications and mini-implant loss.

  10. Why are mini-implants lost: The value of the implantation technique!

    PubMed Central

    Romano, Fabio Lourenço; Consolaro, Alberto

    2015-01-01

    The use of mini-implants have made a major contribution to orthodontic treatment. Demand has aroused scientific curiosity about implant placement procedures and techniques. However, the reasons for instability have not yet been made totally clear. The aim of this article is to establish a relationship between implant placement technique and mini-implant success rates by means of examining the following hypotheses: 1) Sites of poor alveolar bone and little space between roots lead to inadequate implant placement; 2) Different sites require mini-implants of different sizes! Implant size should respect alveolar bone diameter; 3) Properly determining mini-implant placement site provides ease for implant placement and contributes to stability; 4) The more precise the lancing procedures, the better the implant placement technique; 5) Self-drilling does not mean higher pressures; 6) Knowing where implant placement should end decreases the risk of complications and mini-implant loss. PMID:25741821

  11. Imaging of common breast implants and implant-related complications: A pictorial essay.

    PubMed

    Shah, Amisha T; Jankharia, Bijal B

    2016-01-01

    The number of women undergoing breast implant procedures is increasing exponentially. It is, therefore, imperative for a radiologist to be familiar with the normal and abnormal imaging appearances of common breast implants. Diagnostic imaging studies such as mammography, ultrasonography, and magnetic resonance imaging are used to evaluate implant integrity, detect abnormalities of the implant and its surrounding capsule, and detect breast conditions unrelated to implants. Magnetic resonance imaging of silicone breast implants, with its high sensitivity and specificity for detecting implant rupture, is the most reliable modality to asses implant integrity. Whichever imaging modality is used, the overall aim of imaging breast implants is to provide the pertinent information about implant integrity, detect implant failures, and to detect breast conditions unrelated to the implants, such as cancer.

  12. Reasons for failures of oral implants.

    PubMed

    Chrcanovic, B R; Albrektsson, T; Wennerberg, A

    2014-06-01

    This study reviews the literature regarding the factors contributing to failures of dental implants. An electronic search was undertaken including papers from 2004 onwards. The titles and abstracts from these results were read to identify studies within the selection criteria. All reference lists of the selected studies were then hand-searched, this time without time restrictions. A narrative review discussed some findings from the first two parts where separate data from non-comparative studies may have indicated conclusions different from those possible to draw in the systematic analysis. It may be suggested that the following situations are correlated to increase the implant failure rate: a low insertion torque of implants that are planned to be immediately or early loaded, inexperienced surgeons inserting the implants, implant insertion in the maxilla, implant insertion in the posterior region of the jaws, implants in heavy smokers, implant insertion in bone qualities type III and IV, implant insertion in places with small bone volumes, use of shorter length implants, greater number of implants placed per patient, lack of initial implant stability, use of cylindrical (non-threaded) implants and prosthetic rehabilitation with implant-supported overdentures. Moreover, it may be suggested that the following situations may be correlated with an increase in the implant failure rate: use of the non-submerged technique, immediate loading, implant insertion in fresh extraction sockets, smaller diameter implants. Some recently published studies suggest that modern, moderately rough implants may present with similar results irrespective if placed in maxillas, in smoking patients or using only short implants.

  13. Implant maintenance treatment and peri-implant health.

    PubMed

    Howe, Mark-Steven

    2017-03-01

    Data sourcesMedline (PubMed), Embase, Cochrane Central Register of Controlled Trials and Cochrane Oral Health Group Trials Register databases and a manual search of the Journal of Dental Research, Journal of Clinical Periodontology, Journal of Periodontology and the International Journal of Periodontics and Restorative Dentistry from January 2014 to February 2015.Study selectionProspective, retrospective, randomised or not, case-controlled or case series trials showing the incidence or recurrence of peri-implant disease plus or minus PIMT over more than six months.Data extraction and synthesisThree reviewers independently selected studies and abstracted data with two reviewers assessing study quality using the Newcastle-Ottawa Scale (NOS). A multivariate binomial regression was used to examine the data.ResultsThirteen studies were included with ten contributing to the meta-analysis. The average quality assessment score (NOS) was 5.3 out of a possible nine, only one paper achieved eight. At patient level mucositis ranged from 18.5-74.2% and peri-implantitis from 8-28%, with significant effects being seen for treatment (z= -14.36, p<0.001). Mucositis was affected by history of periodontitis and mean PIMT at implant and patient levels, respectively. For peri-implantitis there were also significant effects of treatment (z = -16.63, p<0.001). Increased peri-implantitis was observed for patients with a history of periodontal disease. (z=3.76, p<0.001). Implants under PIMT have 0.958 the incident event compared to those with no PIMT.ConclusionsWithin the limitations of the present systematic review it can be concluded that implant therapy must not be limited to placement and restoration of dental implants, but to the implementation of PIMT to potentially prevent biological complications and heighten the long-term success rate. Although it must be tailored to a patients risk profiling, our findings suggest reason to claim a minimum recall PIMT interval of five to six

  14. Deuterium implantation in magnetic garnets

    SciTech Connect

    Wilts, C.H.; Urai, A.

    1988-11-01

    The magnetic effects of deuterium implantation and subsequent annealing were measured in Gd, Tm, and Ga-substituted yttrium iron garnet films for comparison with measurements made earlier with hydrogen implantation. Implantation energy was 60 keV and the dose ranged from 0.5 to 3 x 10/sup 16/ ions/cm/sup 2/ for D/sup +//sub 2/ ions, as compared to an energy of 120 keV and a dose from 0.3 to 4 x 10/sup 16/ ions/cm/sup 2/ for H/sup +//sub 2/ in the earlier study. Measurements made included x-ray rocking curves and ferromagnetic resonance spectra measured at 9.5 GHz. For all doses the implanted layer remained crystalline. Implanted layer thickness was about 4200 A and peak strain occured at a depth of 2600 A. Peak strain increased monotonically, but departed from a linear relation with dose. For the highest dose, the peak strain was 2.5%. Relaxation of strain with annealing was intermediate between that found earlier for hydrogen and neon implantation. As compared to all other implant elements, both deuterium and hydrogen show a large anomalous magnetic anisotropy which can exceed 10 000 Oe for either ion. The absence of this effect for He, Ne, and other ions supports the conjecture that the effect is chemical and related to electronic bonding rather than strain or disorder. The anomalous anisotropy for deuterium decreases and shifts location with annealing. It has largely disappeared at temperatures of 300--350 /sup 0/C. The shape of the profile is consistent with the hypothesis that the shift in anisotropy is associated with diffusion of the deuterium atoms to the surface of the garnet film. At the highest dose, crystalline damage in the region of highest strain is sufficient to radically alter magnetic properties and in particular reduces even the excess anisotropy so that a two-peak profile results until modified by annealing.

  15. Selective serotonin reuptake inhibitors and the risk of osseointegrated implant failure: a cohort study.

    PubMed

    Wu, X; Al-Abedalla, K; Rastikerdar, E; Abi Nader, S; Daniel, N G; Nicolau, B; Tamimi, F

    2014-11-01

    Selective serotonin reuptake inhibitors (SSRIs), the most widely used drugs for the treatment of depression, have been reported to reduce bone formation and increase the risk of bone fracture. Since osseointegration is influenced by bone metabolism, this study aimed to investigate the association between SSRIs and the risk of failures in osseointegrated implants. This retrospective cohort study was conducted on patients treated with dental implants from January 2007 to January 2013. A total of 916 dental implants in 490 patients (94 implants on 51 patients using SSRIs) were used to estimate the risk of failure associated with the use of SSRIs. Data analysis involved Cox proportional hazards, generalized estimating equation models, multilevel mixed effects parametric survival analysis, and Kaplan-Meier analysis. After 3 to 67 mo of follow-up, 38 dental implants failed and 784 succeeded in the nonusers group, while 10 failed and 84 succeeded in the SSRI-users group. The main limitation of this retrospective study was that drug compliance dose and treatment period could not be acquired from the files of the patients. The primary outcome was that compared with nonusers of SSRIs, SSRI usage was associated with an increased risk of dental implants failure (hazard ratio, 6.28; 95% confidence interval, 1.25-31.61; p = .03). The failure rates were 4.6% for SSRI nonusers and 10.6% for SSRI users. The secondary outcomes were that small implant diameters (≤4 mm; p = .02) and smoking habits (p = .01) also seemed to be associated with higher risk of implant failure. Our findings indicate that treatment with SSRIs is associated with an increased failure risk of osseointegrated implants, which might suggest a careful surgical treatment planning for SSRI users.

  16. Selective Serotonin Reuptake Inhibitors and the Risk of Osseointegrated Implant Failure

    PubMed Central

    Wu, X.; Al-Abedalla, K.; Rastikerdar, E.; Abi Nader, S.; Daniel, N.G.; Nicolau, B.; Tamimi, F.

    2014-01-01

    Selective serotonin reuptake inhibitors (SSRIs), the most widely used drugs for the treatment of depression, have been reported to reduce bone formation and increase the risk of bone fracture. Since osseointegration is influenced by bone metabolism, this study aimed to investigate the association between SSRIs and the risk of failures in osseointegrated implants. This retrospective cohort study was conducted on patients treated with dental implants from January 2007 to January 2013. A total of 916 dental implants in 490 patients (94 implants on 51 patients using SSRIs) were used to estimate the risk of failure associated with the use of SSRIs. Data analysis involved Cox proportional hazards, generalized estimating equation models, multilevel mixed effects parametric survival analysis, and Kaplan-Meier analysis. After 3 to 67 mo of follow-up, 38 dental implants failed and 784 succeeded in the nonusers group, while 10 failed and 84 succeeded in the SSRI-users group. The main limitation of this retrospective study was that drug compliance dose and treatment period could not be acquired from the files of the patients. The primary outcome was that compared with nonusers of SSRIs, SSRI usage was associated with an increased risk of dental implants failure (hazard ratio, 6.28; 95% confidence interval, 1.25-31.61; p = .03). The failure rates were 4.6% for SSRI nonusers and 10.6% for SSRI users. The secondary outcomes were that small implant diameters (≤4 mm; p = .02) and smoking habits (p = .01) also seemed to be associated with higher risk of implant failure. Our findings indicate that treatment with SSRIs is associated with an increased failure risk of osseointegrated implants, which might suggest a careful surgical treatment planning for SSRI users. PMID:25186831

  17. Medical implants and methods of making medical implants

    DOEpatents

    Shaw, Wendy J; Yonker, Clement R; Fulton, John L; Tarasevich, Barbara J; McClain, James B; Taylor, Doug

    2014-09-16

    A medical implant device having a substrate with an oxidized surface and a silane derivative coating covalently bonded to the oxidized surface. A bioactive agent is covalently bonded to the silane derivative coating. An implantable stent device including a stent core having an oxidized surface with a layer of silane derivative covalently bonded thereto. A spacer layer comprising polyethylene glycol (PEG) is covalently bonded to the layer of silane derivative and a protein is covalently bonded to the PEG. A method of making a medical implant device including providing a substrate having a surface, oxidizing the surface and reacting with derivitized silane to form a silane coating covalently bonded to the surface. A bioactive agent is then covalently bonded to the silane coating. In particular instances, an additional coating of bio-absorbable polymer and/or pharmaceutical agent is deposited over the bioactive agent.

  18. Feasibility of an implanted microphone for cochlear implant listening.

    PubMed

    Gérard, Jean-Marc; Demanez, Laurent; Salmon, Caroline; Vanpoucke, Filiep; Walraevens, Joris; Plasmans, Anke; De Siati, Daniele; Lefèbvre, Philippe

    2017-03-01

    This study aimed at evaluating the feasibility of an implanted microphone for cochlear implants (CI) by comparison of hearing outcomes, sound quality and patient satisfaction of a subcutaneous microphone to a standard external microphone of a behind-the-ear sound processor. In this prospective feasibility study with a within-subject repeated measures design comparing the microphone modalities, ten experienced adult unilateral CI users received an implantable contralateral subcutaneous microphone attached to a percutaneous plug. The signal was pre-processed and fed into their CI sound processor. Subjects compared listening modes at home for a period of up to 4 months. At the end of the study the microphone was explanted. Aided audiometric thresholds, speech understanding in quiet, and sound quality questionnaires were assessed. On average thresholds (250, 500, 750, 1k, 2k, 3k, 4k and 6 kHz) with the subcutaneous microphone were 44.9 dB, compared to 36.4 dB for the external mode. Speech understanding on sentences in quiet was high, within approximately 90% of performance levels compared to hearing with an external microphone. Body sounds were audible but not annoying to almost all subjects. This feasibility study with a research device shows significantly better results than previous studies with implanted microphones. This is attributed to technology enhancements and careful fitting. Listening effort was somewhat increased with an implanted microphone. Under good sound conditions, speech performance is nearly similar to that of external microphones demonstrating that an implanted microphone is feasible in a range of normal listening conditions.

  19. Implantable biomedical devices on bioresorbable substrates

    SciTech Connect

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

    2014-03-04

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

  20. Nasal dorsal augmentation with silicone implants.

    PubMed

    Erlich, Mark A; Parhiscar, Afshin

    2003-11-01

    Silicone rubber has been used safely and effectively for facial augmentation for nearly 5 decades in eastern Asia. We have used silicone rubber nasal implants in primary ethnic rhinoplasty and have found consistent and long-lasting results with low complication rates. Silicone dorsal nasal augmentation in primary rhinoplasty avoids donor site morbidity and implant resorption as seen with autogenous implants. Silicone nasal implants have a low extrusion and infection rate. In the appropriate patient with proper placement, silicone nasal implant is nearly the ideal implant material.

  1. Capacitive Feedthroughs for Medical Implants

    PubMed Central

    Grob, Sven; Tass, Peter A.; Hauptmann, Christian

    2016-01-01

    Important technological advances in the last decades paved the road to a great success story for electrically stimulating medical implants, including cochlear implants or implants for deep brain stimulation. However, there are still many challenges in reducing side effects and improving functionality and comfort for the patient. Two of the main challenges are the wish for smaller implants on one hand, and the demand for more stimulation channels on the other hand. But these two aims lead to a conflict of interests. This paper presents a novel design for an electrical feedthrough, the so called capacitive feedthrough, which allows both reducing the size, and increasing the number of included channels. Capacitive feedthroughs combine the functionality of a coupling capacitor and an electrical feedthrough within one and the same structure. The paper also discusses the progress and the challenges of the first produced demonstrators. The concept bears a high potential in improving current feedthrough technology, and could be applied on all kinds of electrical medical implants, even if its implementation might be challenging. PMID:27660602

  2. SURFACE CHEMISTRY INFLUENCE IMPLANT BIOCOMPATIBILITY

    PubMed Central

    Thevenot, Paul; Hu, Wenjing; Tang, Liping

    2011-01-01

    Implantable medical devices are increasingly important in the practice of modern medicine. Unfortunately, almost all medical devices suffer to a different extent from adverse reactions, including inflammation, fibrosis, thrombosis and infection. To improve the safety and function of many types of medical implants, a major need exists for development of materials that evoked desired tissue responses. Because implant-associated protein adsorption and conformational changes thereafter have been shown to promote immune reactions, rigorous research efforts have been emphasized on the engineering of surface property (physical and chemical characteristics) to reduce protein adsorption and cell interactions and subsequently improve implant biocompatibility. This brief review is aimed to summarize the past efforts and our recent knowledge about the influence of surface functionality on protein:cell:biomaterial interactions. It is our belief that detailed understandings of bioactivity of surface functionality provide an easy, economic, and specific approach for the future rational design of implantable medical devices with desired tissue reactivity and, hopefully, wound healing capability. PMID:18393890

  3. Factors affecting residual hearing preservation in cochlear implantation.

    PubMed

    Zanetti, D; Nassif, N; Redaelli de Zinis, L O

    2015-12-01

    The likelihood of residual hearing preservation in cochlear implantation (CI) is related to surgical factors such as type of cochleostomy (trans-fenestral vs. promontorial), use of lubricants and protective drugs, and device-related factors such as shape, length and flexibility of the array. We investigated the impact of these factors on the hearing preservation rate in adults and children with conventional audiological indications to CI. Eighty-two children aged 1-9 years and 73 adults (16-79 years) received a CI in the right (59%) or left ear (41%). An anterior-inferior promontorial cochleostomy was performed in 143 ears (92%); a trans-fenestral approach was used in 12 (8%). A perimodiolar electrode was implanted in 144 ears (93%), and a straight electrode in the remaining 11 (7%). Overall, some post-operative hearing was retained in 39% of ears. The rate of preservation was higher at the low than at the high frequencies. When correlated with age, side of implant, implant model and type of cochleostomy, the mean threshold variations did not reach statistical significance for any of these variables. A slight trend in favour of better residual hearing preservation in children vs. adults was seen, especially at lower frequencies.

  4. Developing a wireless implantable body sensor network in MICS band.

    PubMed

    Fang, Qiang; Lee, Shuenn-Yuh; Permana, Hans; Ghorbani, Kamran; Cosic, Irena

    2011-07-01

    Through an integration of wireless communication and sensing technologies, the concept of a body sensor network (BSN) was initially proposed in the early decade with the aim to provide an essential technology for wearable, ambulatory, and pervasive health monitoring for elderly people and chronic patients. It has become a hot research area due to big opportunities as well as great challenges it presents. Though the idea of an implantable BSN was proposed in parallel with the on-body sensor network, the development in this area is relatively slow due to the complexity of human body, safety concerns, and some technological bottlenecks such as the design of ultralow-power implantable RF transceiver. This paper describes a new wireless implantable BSN that operates in medical implant communication service (MICS) frequency band. This system innovatively incorporates both sensing and actuation nodes to form a closed-control loop for physiological monitoring and drug delivery for critically ill patients. The sensing node, which is designed using system-on-chip technologies, takes advantage of the newly available ultralow-power Zarlink MICS transceiver for wireless data transmission. Finally, the specific absorption rate distribution of the proposed system was simulated to determine the in vivo electromagnetic field absorption and the power safety limits.

  5. Drug Resistance

    MedlinePlus

    HIV Treatment Drug Resistance (Last updated 3/2/2017; last reviewed 3/2/2017) Key Points As HIV multiplies in the ... the risk of drug resistance. What is HIV drug resistance? Once a person becomes infected with HIV, ...

  6. Noninvasive characterization of the effect of varying PLGA molecular weight blends on in situ forming implant behavior using ultrasound imaging.

    PubMed

    Solorio, Luis; Olear, Alexander M; Hamilton, Jesse I; Patel, Ravi B; Beiswenger, Ashlei C; Wallace, Jon E; Zhou, Haoyan; Exner, Agata A

    2012-01-01

    In situ forming implants (ISFIs) have shown promise in drug delivery applications due to their simple manufacturing and minimally invasive administration. Precise, reproducible control of drug release from ISFIs is essential to their successful clinical application. This study investigated the effect of varying the molar ratio of different molecular weight (Mw) poly(D,L-lactic-co-glycolic acid) (PLGA) polymers within a single implant on the release of a small Mw mock drug (sodium fluorescein) both in vitro and in vivo. Implants were formulated by dissolving three different PLGA Mw (15, 29, and 53 kDa), as well as three 1:1 molar ratio combinations of each PLGA Mw in 1-methyl-2-pyrrolidinone (NMP) with the mock drug fluorescein. Since implant morphology and microstructure during ISFI formation and degradation is a crucial determinant of implant performance, and the rate of phase inversion has been shown to have an effect on the implant microstructure, diagnostic ultrasound was used to noninvasively quantify the extent of phase inversion and swelling behavior in both environments. Implant erosion, degradation, as well as the in vitro and in vivo release profiles were also measured using standard techniques. A non-linear mathematical model was used to correlate the drug release behavior with polymer phase inversion, with all formulations yielding an R(2) value greater than 0.95. Ultrasound was also used to create a 3D image reconstruction of an implant over a 12 day span. In this study, swelling and phase inversion were shown to be inversely related to the polymer Mw with 53 kDa polymer implants increasing at an average rate of 9.4%/day compared with 18.6%/day in the case of the 15 kDa PLGA. Additionally the onset of erosion, complete phase inversion, and degradation facilitated release required 9 d for 53 kDa implants, while these same processes began 3 d after injection into PBS with the 15 kDa implants. It was also observed that PLGA blends generally had

  7. Implant rehabilitation in bruxism patient

    PubMed Central

    Goiato, Marcelo Coelho; Sonego, Mariana Vilela; dos Santos, Daniela Micheline; da Silva, Emily Vivianne Freitas

    2014-01-01

    A white female patient presented to the university clinic to obtain implant retained prostheses. She had an edentulous maxillary jaw and presented three teeth with poor prognosis (33, 34 and 43). The alveolar bone and the surrounding tissues were healthy. The patient did not report any relevant medical history contraindicating routine dental treatment or implant surgery, but self-reported a dental history of asymptomatic nocturnal bruxism. The treatment plan was set and two Branemark protocols supported by six implants in each arch were installed after a 6-month healing period. A soft occlusal splint was made due to the patient's history of bruxism, and the lack of its use by the patient resulted in an acrylic fracture. The prosthesis was repaired and the importance of using the occlusal splint was restated. In the 4-year follow-up no fractures were reported. PMID:24907215

  8. Implant rehabilitation in bruxism patient.

    PubMed

    Goiato, Marcelo Coelho; Sonego, Mariana Vilela; dos Santos, Daniela Micheline; da Silva, Emily Vivianne Freitas

    2014-06-06

    A white female patient presented to the university clinic to obtain implant retained prostheses. She had an edentulous maxillary jaw and presented three teeth with poor prognosis (33, 34 and 43). The alveolar bone and the surrounding tissues were healthy. The patient did not report any relevant medical history contraindicating routine dental treatment or implant surgery, but self-reported a dental history of asymptomatic nocturnal bruxism. The treatment plan was set and two Branemark protocols supported by six implants in each arch were installed after a 6-month healing period. A soft occlusal splint was made due to the patient's history of bruxism, and the lack of its use by the patient resulted in an acrylic fracture. The prosthesis was repaired and the importance of using the occlusal splint was restated. In the 4-year follow-up no fractures were reported.

  9. Oral Implant Imaging: A Review

    PubMed Central

    GUPTA, Sarika; PATIL, Neelkant; SOLANKI, Jitender; SINGH, Ravinder; LALLER, Sanjeev

    2015-01-01

    Selecting an appropriate implant imaging technique has become a challenging task since the advent of advanced imaging modalities, and many of these are used for implant imaging. On imaging, the modality should not only consider the anatomy but should also provide dimensional accuracy. Many dentists use the conventional method, mostly orthopantograph (OPG), in their routine practice of implant placement. However, because of the drawbacks associated with OPG, higher technologies, such as computed tomography (CT) and cone beam computed tomography (CBCT), are better accepted. These help improve image sharpness and reduce distortion. These techniques are not used widely due to the cost effect. Therefore, to decide on the type of imaging technique, all associated advantages and disadvantages should be considered, which will be broadly discussed in this review. PMID:26715891

  10. MRI in ocular drug delivery

    PubMed Central

    Li, S. Kevin; Lizak, Martin J.; Jeong, Eun-Kee

    2008-01-01

    Conventional pharmacokinetic methods for studying ocular drug delivery are invasive and cannot be conveniently applied to humans. The advancement of MRI technology has provided new opportunities in ocular drug-delivery research. MRI provides a means to non-invasively and continuously monitor ocular drug-delivery systems with a contrast agent or compound labeled with a contrast agent. It is a useful technique in pharmacokinetic studies, evaluation of drug-delivery methods, and drug-delivery device testing. Although the current status of the technology presents some major challenges to pharmaceutical research using MRI, it has a lot of potential. In the past decade, MRI has been used to examine ocular drug delivery via the subconjunctival route, intravitreal injection, intrascleral injection to the suprachoroidal space, episcleral and intravitreal implants, periocular injections, and ocular iontophoresis. In this review, the advantages and limitations of MRI in the study of ocular drug delivery are discussed. Different MR contrast agents and MRI techniques for ocular drug-delivery research are compared. Ocular drug-delivery studies using MRI are reviewed. PMID:18186077

  11. Intraocular Implants for the Treatment of Autoimmune Uveitis

    PubMed Central

    Lee, Darren J.

    2015-01-01

    Uveitis is the third leading cause of blindness in developed countries. Currently, the most widely used treatment of non-infectious uveitis is corticosteroids. Posterior uveitis and macular edema can be treated with intraocular injection of corticosteroids, however, this is problematic in chronic cases because of the need for repeat injections. Another option is systemic immunosuppressive therapies that have their own undesirable side effects. These systemic therapies result in a widespread suppression of the entire immune system, leaving the patient susceptible to infection. Therefore, an effective localized treatment option is preferred. With the recent advances in bioengineering, biodegradable polymers that allow for a slow sustained-release of a medication. These advances have culminated in drug delivery implants that are food and drug administration (FDA) approved for the treatment of non-infectious uveitis. In this review, we discuss the types of ocular implants available and some of the polymers used, implants used for the treatment of non-infectious uveitis, and bioengineered alternatives that are on the horizon. PMID:26264035

  12. Carbon Fiber Biocompatibility for Implants

    PubMed Central

    Petersen, Richard

    2016-01-01

    Carbon fibers have multiple potential advantages in developing high-strength biomaterials with a density close to bone for better stress transfer and electrical properties that enhance tissue formation. As a breakthrough example in biomaterials, a 1.5 mm diameter bisphenol-epoxy/carbon-fiber-reinforced composite rod was compared for two weeks in a rat tibia model with a similar 1.5 mm diameter titanium-6-4 alloy screw manufactured to retain bone implants. Results showed that carbon-fiber-reinforced composite stimulated osseointegration inside the tibia bone marrow measured as percent bone area (PBA) to a great extent when compared to the titanium-6-4 alloy at statistically significant levels. PBA increased significantly with the carbon-fiber composite over the titanium-6-4 alloy for distances from the implant surfaces of 0.1 mm at 77.7% vs. 19.3% (p < 10−8) and 0.8 mm at 41.6% vs. 19.5% (p < 10−4), respectively. The review focuses on carbon fiber properties that increased PBA for enhanced implant osseointegration. Carbon fibers acting as polymer coated electrically conducting micro-biocircuits appear to provide a biocompatible semi-antioxidant property to remove damaging electron free radicals from the surrounding implant surface. Further, carbon fibers by removing excess electrons produced from the cellular mitochondrial electron transport chain during periods of hypoxia perhaps stimulate bone cell recruitment by free-radical chemotactic influences. In addition, well-studied bioorganic cell actin carbon fiber growth would appear to interface in close contact with the carbon-fiber-reinforced composite implant. Resulting subsequent actin carbon fiber/implant carbon fiber contacts then could help in discharging the electron biological overloads through electrochemical gradients to lower negative charges and lower concentration. PMID:26966555

  13. Carbon Fiber Biocompatibility for Implants.

    PubMed

    Petersen, Richard

    Carbon fibers have multiple potential advantages in developing high-strength biomaterials with a density close to bone for better stress transfer and electrical properties that enhance tissue formation. As a breakthrough example in biomaterials, a 1.5 mm diameter bisphenol-epoxy/carbon-fiber-reinforced composite rod was compared for two weeks in a rat tibia model with a similar 1.5 mm diameter titanium-6-4 alloy screw manufactured to retain bone implants. Results showed that carbon-fiber-reinforced composite stimulated osseointegration inside the tibia bone marrow measured as percent bone area (PBA) to a great extent when compared to the titanium-6-4 alloy at statistically significant levels. PBA increased significantly with the carbon-fiber composite over the titanium-6-4 alloy for distances from the implant surfaces of 0.1 mm at 77.7% vs. 19.3% (p < 10(-8)) and 0.8 mm at 41.6% vs. 19.5% (p < 10(-4)), respectively. The review focuses on carbon fiber properties that increased PBA for enhanced implant osseointegration. Carbon fibers acting as polymer coated electrically conducting micro-biocircuits appear to provide a biocompatible semi-antioxidant property to remove damaging electron free radicals from the surrounding implant surface. Further, carbon fibers by removing excess electrons produced from the cellular mitochondrial electron transport chain during periods of hypoxia perhaps stimulate bone cell recruitment by free-radical chemotactic influences. In addition, well-studied bioorganic cell actin carbon fiber growth would appear to interface in close contact with the carbon-fiber-reinforced composite implant. Resulting subsequent actin carbon fiber/implant carbon fiber contacts then could help in discharging the electron biological overloads through electrochemical gradients to lower negative charges and lower concentration.

  14. Mutation breeding by ion implantation

    NASA Astrophysics Data System (ADS)

    Yu, Zengliang; Deng, Jianguo; He, Jianjun; Huo, Yuping; Wu, Yuejin; Wang, Xuedong; Lui, Guifu

    1991-07-01

    Ion implantation as a new mutagenic method has been used in the rice breeding program since 1986, and for mutation breeding of other crops later. It has been shown, in principle and in practice, that this method has many outstanding advantages: lower damage rate; higher mutation rate and wider mutational spectrum. Many new lines of rice with higher yield rate; broader disease resistance; shorter growing period but higher quality have been bred from ion beam induced mutants. Some of these lines have been utilized for the intersubspecies hybridization. Several new lines of cotton, wheat and other crops are now in breeding. Some biophysical effects of ion implantation for crop seeds have been studied.

  15. A Percutaneously Implantable Fetal Pacemaker

    PubMed Central

    Zhou, Li; Vest, Adriana N.; Chmait, Ramen H.; Bar-Cohen, Yaniv; Pruetz, Jay; Silka, Michael; Zheng, Kaihui; Peck, Ray; Loeb, Gerald E.

    2015-01-01

    A miniaturized, self-contained pacemaker that could be implanted with a minimally invasive technique would dramatically improve the survival rate for fetuses that develop hydrops fetalis as a result of congenital heart block. We are currently validating a device that we developed to address this bradyarrhythmia. Preclinical studies in a fetal sheep model are underway to demonstrate that the device can be implanted via a minimally invasive approach, can mechanically withstand the harsh bodily environment, can induce effective contractions of the heart muscle with an adequate safety factor, and can successfully operate for the required device lifetime of three months using the previously-developed closed loop transcutaneous recharging system. PMID:25570982

  16. A reconnectable multiway implantable connector.

    PubMed

    Rushton, D N; Tromans, A M; Donaldson, N de N

    2002-12-01

    A well-tried plug-and-socket connector system designed for connecting multichannel implanted cables was adapted so as to allow disconnection and reconnection during surgery. Five different sealing techniques were tested in vitro, and it was found that only one of them had the required qualities of high leakage path impedance (taken as more than one megaohm for the worst sample) after three months of saline soak, together with demountability under surgical conditions. The system has subsequently been successfully implemented in a patient in whom reconnection was required two years after implantation.

  17. Implants and Ethnocide: Learning from the Cochlear Implant Controversy

    ERIC Educational Resources Information Center

    Sparrow, Robert

    2010-01-01

    This paper uses the fictional case of the "Babel fish" to explore and illustrate the issues involved in the controversy about the use of cochlear implants in prelinguistically deaf children. Analysis of this controversy suggests that the development of genetic tests for deafness poses a serious threat to the continued flourishing of Deaf…

  18. Educational Challenges for Children with Cochlear Implants.

    ERIC Educational Resources Information Center

    Chute, Patricia M.; Nevins, Mary Ellen

    2003-01-01

    This article addresses educational challenges for children with severe to profound hearing loss who receive cochlear implants. Despite the implants, these children face acoustic challenges, academic challenges, attention challenges, associative challenges, and adjustment challenges. (Contains references.) (Author/DB)

  19. Scientists Design Heat-Activated Penis Implant

    MedlinePlus

    ... implant, Le used a heat-activated exoskeleton of nitinol, a metal known for its elasticity. A urologist could do a simplified operation to insert the nitinol implant, which would remain flaccid at body temperature ...

  20. Benefits and Risks of Cochlear Implants

    MedlinePlus

    ... systems Will have to be careful of static electricity. Static electricity may temporarily or permanently damage a cochlear implant. ... more details regarding how to deal with static electricity, contact the manufacturer or implant center. Have less ...