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Sample records for drug implants

  1. Implantable Drug Dispenser

    NASA Technical Reports Server (NTRS)

    Collins, E. R. J.

    1983-01-01

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

  2. Drug-eluting medical implants.

    PubMed

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

    2010-01-01

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

  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. Magnetizable implants for targeted drug delivery

    NASA Astrophysics Data System (ADS)

    Forbes, Zachary Graham

    The capability to deliver high effective dosages to specific sites in the human body has become the holy grail of drug delivery research. Drugs with proven effectiveness under in vitro investigation often reach a major roadblock under in vivo testing due to a lack of an effective delivery strategy. In addition, many clinical scenarios require delivery of agents that are therapeutic at the desired delivery point, but otherwise systemically toxic. This project proposes a method for targeted drug delivery by applying high magnetic field gradients within the body to an injected superparamagnetic colloidal fluid carrying a drug, with the aid of modest uniform magnetic field. The design involves patterning of endovascular implants, such as coronary stents, with soft magnetic coatings capable of applying high local magnetic field gradients within the body. Examination of the feasibility of the design has been focused around the treatment of coronary restenosis following angioplasty. Drug-eluting stents, which have debuted in hospitals over the past two years, have thus far reduced restenosis rates to below 10%. Our local drug delivery system is a viable alternative or enhancement to drug-eluting stents, offering increased clinician control of dose size, the ability to treat a site repeatedly, and a wide array of applications for treatment of other pathologies. The theoretical models, parallel plate and pipe flow analysis, and cell culture models presented give insight into the use of micron and sub-micron scale magnetic particles for site-specific delivery of pharmaceuticals and magnetically labeled cells.

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

    PubMed Central

    Meng, Ellis; Hoang, Tuan

    2013-01-01

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

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

    PubMed

    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.

  8. MEMS fabricated chip for an implantable drug delivery device.

    PubMed

    Sbiaa, Z

    2006-01-01

    We present a silicon-based implantable drug delivery system (IDDS) for the administration of compounds in vivo. The implanted device contains the drug-filled silicon microchip, control circuitry, telemetry capability, and a battery. At the heart of the IDDS is the drug-containing microchip, a MEMS (MicroElectroMechanical Systems)-based device. A process was developed for the fabrication of the silicon chip. MicroCHIPS' drug release technology has been successfully demonstrated in vitro and in vivo using the therapeutic peptide leuprolide as a model compound.

  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. 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

  12. 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.

  13. Drug loading of polymer implants by supercritical CO2 assisted impregnation: A review.

    PubMed

    Champeau, M; Thomassin, J-M; Tassaing, T; Jérôme, C

    2015-07-10

    Drug loaded implants also called drug-eluting implants have proven their benefits over simple implants. Among the developed manufacturing processes, the supercritical CO2 (scCO2) assisted impregnation has attracted growing attention to load Active Pharmaceutical Ingredients into polymer implants since it enables to recover a final implant free of any solvent residue and to operate under mild temperature which is suitable for processing with thermosensitive drugs. This paper is a review of the state-of-the-art and the application of the scCO2 assisted impregnation process to prepare drug-eluting implants. It introduces the process and presents its advantages for biomedical applications. The influences of the characteristics of the implied binary systems and of the experimental conditions on the drug loading are described. Then, the various current applications of this process for manufacturing drug-eluting implants are reviewed. Finally, the new emerging variations of this process are described.

  14. 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

  15. 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.

  16. Antiarrhythmic Drug Therapy to Avoid Implantable Cardioverter Defibrillator Shocks

    PubMed Central

    Abboud, Jaber

    2016-01-01

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

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

    PubMed

    Abboud, Jaber; R Ehrlich, Joachim

    2016-08-01

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

  18. Antiarrhythmic Drug Therapy to Avoid Implantable Cardioverter Defibrillator Shocks

    PubMed Central

    Abboud, Jaber

    2016-01-01

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

  19. 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

  20. Pain relief mediated by implantable drug delivery devices.

    PubMed

    Hoekstra, A

    1994-03-01

    Various totally implantable drug delivery systems from single access ports to micropumps are now available for administration of repeated boluses, and continuous or programmable infusions. In this respect, emphasis is given to a relatively cheap, totally implantable system for self-administering intraspinal opiates in the treatment of cancer pain. The SECOR pump system, developed by Cordis, consists of a dual pump with refill port and safety valve. The volume of the pliable reservoir is 12 ml and refill is accomplished with a 25-G needle. The bolus delivered with each transcutaneous activation of the pumps is 0.1 ml. Clinical results demonstrated that this patient-controlled drug delivery system is safe and provides excellent pain relief associated with terminal cancer. A possible advantage of this drug delivery system over continuous infusion pumps is that patients can elect to have the morphine delivered only when they feel pain. Thus pain relief would be maximized and tolerance build-up would be minimized.

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

    NASA Astrophysics Data System (ADS)

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

    2011-07-01

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

  2. 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.

  3. 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... availability of the draft guidance entitled ``Implanted Blood Access Devices for Hemodialysis.'' This guidance was developed to support the reclassification of the Implanted Blood Access Devices for...

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

    PubMed Central

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

    2013-01-01

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

  5. 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

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

    PubMed Central

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

    2012-01-01

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

  7. 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

  8. 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.

  9. Solvent induced phase inversion-based in situ forming controlled release drug delivery implants.

    PubMed

    Thakur, Raghu Raj Singh; McMillan, Hannah L; Jones, David S

    2014-02-28

    In situ forming (ISF) drug delivery implants have gained tremendous levels of interest over the last few decades. This is due to their wide range of biomedical applications such as in tissue engineering, cell encapsulation, microfluidics, bioengineering and drug delivery. Drug delivery implants forming upon injection has shown a range of advantages which include localized drug delivery, easy and less invasive application, sustained drug action, ability to tailor drug delivery, reduction in side effects associated with systemic delivery and also improved patient compliance and comfort. Different factors such as temperature, pH, ions, and exchange of solvents are involved in in situ implant formation. This review especially focuses on ISF implants that are formed through solvent induced phase inversion (SPI) technique. The article critically reviews and compares a wide range of polymers, solvents, and co-solvents that have been used in SPI implant preparation for control release of a range of drug molecules. Major drawback of SPI systems has been their high burst release. In this regard, the article exhaustively discusses factors that affect the burst release and different modification strategies that has been utilised to reduce the burst effect from these implants. Performance and controversial issues associated with the use of different biocompatible solvents in SPI systems is also discussed. Biodegradation, formulation stability, methods of characterisation and sterilisation techniques of SPI systems is comprehensively reviewed. Furthermore, the review also examines current SPI-based marketed products, their therapeutic application and associated clinical data. It also exemplifies the interest of multi-billion dollar pharma companies worldwide for further developments of SPI systems to a range of therapeutic applications. The authors believe that this will be the first review article that extensively investigate and discusses studies done to date on SPI systems

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

    PubMed

    Solorio, Luis; Exner, Agata A

    2015-12-01

    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 days. 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 two-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.

  11. 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

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

    PubMed

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

    2015-04-22

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

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

    PubMed Central

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

    2012-01-01

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

  14. 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.

  15. Electrothermally activated microchips for implantable drug delivery and biosensing.

    PubMed

    Maloney, John M; Uhland, Scott A; Polito, Benjamin F; Sheppard, Norman F; Pelta, Christina M; Santini, John T

    2005-12-01

    Novel drug delivery and biosensing devices have the potential to increase the efficacy of drug therapy by providing physicians and patients the ability to precisely control key therapy parameters. Such "intelligent" systems can enable control of dose amount and the time, rate, and location of drug delivery. We have developed and demonstrated the operation of an electrothermal mechanism to precisely control the delivery of drugs and exposure of biosensors. These microchip devices contain an array of individually sealed and actuated reservoirs, each capped by a thin metal membrane comprised of either gold or multiple layers of titanium and platinum. The passage of a threshold level of electric current through the membrane causes it to disintegrate, thereby exposing the protected contents (drugs or biosensors) of the reservoir to the surrounding environment. This paper describes the theory and experimental characterization of the electrothermal method and includes in vitro release results for a model compound.

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

    NASA Astrophysics Data System (ADS)

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

    1993-06-01

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

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

    PubMed

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

    2012-10-01

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

  18. Optimal drug release schedule for in-situ radiosensitization of image guided permanent prostate implants

    NASA Astrophysics Data System (ADS)

    Cormack, Robert A.; Nguyen, Paul L.; D'Amico, Anthony V.; Sridhar, Sri; Makrigiorgos, Mike

    2011-03-01

    Planned in-situ radiosensitization may improve the therapeutic ratio of image guided 125I prostate brachytherapy. Spacers used in permanent implants may be manufactured from a radiosensitizer-releasing polymer to deliver protracted localized sensitization of the prostate. Such devices will have a limited drug-loading capacity, and the drug release schedule that optimizes outcome, under such a constraint, is not known. This work determines the optimal elution schedules for 125I prostate brachytherapy. The interaction between brachytherapy dose distributions and drug distribution around drug eluting spacers is modeled using a linear-quadratic (LQ) model of cell kill. Clinical brachytherapy plans were used to calculate the biologic effective dose (BED) for planned radiation dose distributions while adding the spatial distributions of radiosensitizer while varying the temporal release schedule subject to a constraint on the drug capacity of the eluting spacers. Results: The greatest increase in BED is achieved by schedules with the greatest sensitization early in the implant. Making brachytherapy spacers from radiosensitizer eluting polymer transforms inert parts of the implant process into a means of enhancing the effect of the brachytherapy radiation. Such an approach may increase the therapeutic ratio of prostate brachytherapy or offer a means of locally boosting the radiation effect without increasing the radiation dose to surrounding tissues.

  19. 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

  20. Pulsed laser deposition of hydroxyapatite on nanostructured titanium towards drug eluting implants.

    PubMed

    Rajesh P; Mohan, Nimmy; Yokogawa, Y; Varma, Harikrishna

    2013-07-01

    Titania nanotubes grown on titanium substrates by electrochemical anodization in glycerol-ammonium fluoride-water system were used to develop efficient drug carrying implants upon coating hydroxyapatite (HA) ceramic. The nanostructured surfaces achieved by anodization were caped with HA crystallites by pulsed laser deposition. The implant substrates were studied for their drug carrying capacity using gentamicin as a model. The nano-tubular surface with HA coating had better drug loading capacity of about 800 μg/cm(2) gentamicin while the bare anodized substrate carried less than 660 μg/cm(2). The HA coating alone stored as low as 68 μg/cm(2) and released the drug within the initial burst period itself. The ceramic coated anodized substrates were found to be more efficient in controlled delivery for longer than 160 h with a drug release of 0.5 μg/cm(2) even towards the end. The substrate with nanostructuring alone delivered the whole drug within 140 h. This study proposes the application of laser deposition of HA over nanostructured titanium, which proves to be promising towards controlled drug eluting bioceramic coated metallic prostheses.

  1. Pulsed laser deposition of hydroxyapatite on nanostructured titanium towards drug eluting implants.

    PubMed

    Rajesh P; Mohan, Nimmy; Yokogawa, Y; Varma, Harikrishna

    2013-07-01

    Titania nanotubes grown on titanium substrates by electrochemical anodization in glycerol-ammonium fluoride-water system were used to develop efficient drug carrying implants upon coating hydroxyapatite (HA) ceramic. The nanostructured surfaces achieved by anodization were caped with HA crystallites by pulsed laser deposition. The implant substrates were studied for their drug carrying capacity using gentamicin as a model. The nano-tubular surface with HA coating had better drug loading capacity of about 800 μg/cm(2) gentamicin while the bare anodized substrate carried less than 660 μg/cm(2). The HA coating alone stored as low as 68 μg/cm(2) and released the drug within the initial burst period itself. The ceramic coated anodized substrates were found to be more efficient in controlled delivery for longer than 160 h with a drug release of 0.5 μg/cm(2) even towards the end. The substrate with nanostructuring alone delivered the whole drug within 140 h. This study proposes the application of laser deposition of HA over nanostructured titanium, which proves to be promising towards controlled drug eluting bioceramic coated metallic prostheses. PMID:23623112

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  4. 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

  5. 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.

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

    PubMed

    Fong, Jeffrey; Xiao, Zhiming; Takahata, Kenichi

    2015-02-21

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

  7. 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.

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

    PubMed

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

    2015-01-01

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

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

    PubMed

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

    2015-01-01

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

  10. 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

  11. Study of ocular transport of drugs released from an intravitreal implant using magnetic resonance imaging.

    PubMed

    Kim, Hyuncheol; Lizak, Martin J; Tansey, Ginger; Csaky, Karl G; Robinson, Michael R; Yuan, Peng; Wang, Nam Sun; Lutz, Robert J

    2005-02-01

    Ensuring optimum delivery of therapeutic agents in the eye requires detailed information about the transport mechanisms and elimination pathways available. This knowledge can guide the development of new drug delivery devices. In this study, we investigated the movement of a drug surrogate, Gd-DTPA (Magnevist) released from a polymer-based implant in rabbit vitreous using T1-weighted magnetic resonance imaging (MRI). Intensity values in the MRI data were converted to concentration by comparison with calibration samples. Concentration profiles approaching pseudosteady state showed gradients from the implant toward the retinal surface, suggesting that diffusion was occurring into the retinal-choroidal-scleral (RCS) membrane. Gd-DTPA concentration varied from high values near the implant to lower values distal to the implant. Such regional concentration differences throughout the vitreous may have clinical significance when attempting to treat ubiquitous eye diseases using a single positional implant. We developed a finite element mathematical model of the rabbit eye and compared the MRI experimental concentration data with simulation concentration profiles. The model utilized a diffusion coefficient of Gd-DTPA in the vitreous of 2.8 x 10(-6) cm2 s(-1) and yielded a diffusion coefficient for Gd-DTPA through the simulated composite posterior membrane (representing the retina-choroidsclera membrane) of 6.0 x 10(-8) cm2 s(-1). Since the model membrane was 0.03-cm thick, this resulted in an effective membrane permeability of 2.0 x 10(-6) cm s(-1). Convective movement of Gd-DTPA was shown to have minimal effect on the concentration profiles since the Peclet number was 0.09 for this system.

  12. 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

  13. 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.

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

    PubMed

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

    2013-11-28

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

  15. 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.

  16. Cochlear Implants

    MedlinePlus

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

  17. 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.

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

    PubMed

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

    2014-08-01

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

  19. 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

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

    PubMed

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

    2016-01-01

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

  1. Characterization and biocompatibility of organogels based on L-alanine for parenteral drug delivery implants.

    PubMed

    Motulsky, Aude; Lafleur, Michel; Couffin-Hoarau, Anne-Claude; Hoarau, Didier; Boury, Frank; Benoit, Jean-Pierre; Leroux, Jean-Christophe

    2005-11-01

    The development of simple and efficient drug delivery systems for the sustained release of peptides/proteins and low molecular weight hydrophilic molecules is an ongoing challenge. The purpose of this work was to prepare and characterize novel biodegradable in situ-forming implants obtained via the self-assembly of L-alanine derivatives in pharmaceutical oils. Six different amphiphilic organogelators based on L-alanine were synthesized. These derivatives could successfully gel various vegetable and synthetic oils approved for parenteral administration. Gelation was thermoreversible, and phase transition temperatures depended on gelator structure, concentration and solvent. Hydrogen bonds and van der Waals interactions were shown to be the main forces implicated in network formation. Selected formulations were then injected subcutaneously in rats for preliminary assessment of biocompatibility. Histopathological analysis of the surrounding tissues revealed mild, chronic inflammation and an overall good biocompatibility profile of the implants over the 8 wk evaluation period. This study demonstrates that in situ-forming organogels represent a potentially promising platform for sustained drug delivery.

  2. When microchip implants do more than drug delivery: blending, blurring, and bundling of protected health information and patient monitoring.

    PubMed

    Bramstedt, Katrina A

    2005-01-01

    Although currently in the research stage, scientists argue that drug-releasing microchip implants are on the horizon for future patients. This paper presents ethical reflection on these implants and identifies specific areas of concern; namely, patient monitoring and tracking, and patient privacy and confidentiality. It is foreseeable that drug delivery chips could be multifunctional with the overt or covert addition of sensors that monitor more than just the bloodstream concentrations of prescribed drugs (e.g., cotinine and alcohol in non-compliant patients, patient location via radio frequency or global positioning satellite). Similarly, it is foreseeable that these chips could be embedded with a patient's protected health information that could potentially be accessed and used by unauthorized persons. While drug delivery microchips are theoretically convenient and accurate for dosing, and might offer faster drug delivery with fewer side effects, ethical issues loom and should be contemplated now, while the technology is still under development.

  3. Prodigiosin release from an implantable biomedical device: kinetics of localized cancer drug release.

    PubMed

    Danyuo, Y; Obayemi, J D; Dozie-Nwachukwu, S; Ani, C J; Odusanya, O S; Oni, Y; Anuku, N; Malatesta, K; Soboyejo, W O

    2014-09-01

    This paper presents an implantable encapsulated structure that can deliver localized heating (hyperthermia) and controlled concentrations of prodigiosin (a cancer drug) synthesized by bacteria (Serratia marcesce (subsp. marcescens)). Prototypical Poly-di-methyl-siloxane (PDMS) packages, containing well-controlled micro-channels and drug storage compartments, were fabricated along with a drug-storing polymer produced by free radical polymerization of Poly(N-isopropylacrylamide)(PNIPA) co-monomers of Acrylamide (AM) and Butyl-methacrylate (BMA). The mechanisms of drug diffusion of PNIPA-base gels were elucidated. Scanning Electron Microscopy (SEM) was also used to study the heterogeneous porous structure of the PNIPA-based gels. The release exponents, n, of the gels were found to between 0.5 and 0.7. This is in the range expected for Fickian (n=0.5). Deviation from Fickian diffusion was also observed (n>0.5) diffusion. The gel diffusion coefficients were shown to vary between 2.1×10(-12)m(2)/s and 4.8×10(-6)m(2)/s. The implications of the results are then discussed for the localized treatment of cancer via hyperthermia and the controlled delivery of prodigiosin from encapsulated PNIPA-based devices.

  4. 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.

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

    PubMed

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

    2016-12-01

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

  6. 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.

  7. Intravascular ultrasound characterization of the "black hole" phenomenon after drug-eluting stent implantation.

    PubMed

    Costa, Marco A; Sabate, Manel; Angiolillo, Dominick J; Jimenez-Quevedo, Pilar; Teirstein, Paul; Carter, Andrew; Leon, Martin B; Moses, Jeffrey; Zenni, Martin; Yakubov, Steven; Guzman, Luis A; Gilmore, Paul; Macaya, Carlos; Bass, Theodore A

    2006-01-15

    An intraluminal echolucent tissue, dubbed "black hole," has been identified by intravascular ultrasonography after intracoronary brachytherapy. This study reports the characteristics and incidence of the black hole in patients treated with drug-eluting stent implantation using a sirolimus-eluting stent (SES). We included intravascular ultrasound data from the Compassionate Use of Sirolimus-Eluting Stent (SECURE, n = 61 lesions) registry, a study involving patients in whom previous brachytherapy had failed, and the DIABETES trial (n = 165 lesions), a multicenter, randomized study comparing SES versus bare metal stents in diabetic patients. Intravascular ultrasound follow-up was scheduled at 8 months (SECURE trial, post-brachytherapy population) and 9 months (DIABETES trial). In the SECURE population, a black hole was observed in 10 patients (19.6%). Seven black hole segments had significant intimal hyperplasia (> 10%). A black hole accounted for 27% of total intraluminal tissue. In the DIABETES trial, 2 patients (2.5%) in the SES group and none in the bare metal stent group showed echolucent intimal hyperplasia. In conclusion, a black hole occurred frequently after implantation of a SES in patients in whom intracoronary brachytherapy had previously failed. Black holes were also identified in a nonirradiated population, although the incidence was lower than in the post-brachytherapy patients. Bare metal stents were not associated with this phenomenon.

  8. Nonsteroidal anti-inflammatory drugs as adjuncts in the management of periodontal diseases and peri-implantitis.

    PubMed

    Salvi, G E; Williams, R C; Offenbacher, S

    1997-01-01

    For the past three decades, prostaglandin E2 and other arachidonic acid metabolites have been recognized as important proinflammatory mediators in bone resorption and various forms of periodontal disease. Nonsteroidal anti-inflammatory drugs are chemical compounds that selectively inhibit the synthesis of metabolites of the cyclooxygenase pathway, thereby blocking the production of prostaglandins, thromboxane, and prostacyclin. Inhibiting prostaglandin E2 synthesis with nonsteroidal anti-inflammatory drugs has been unequivocally shown in both animal and human studies to be of primary therapeutic efficacy. Recent lines of nonsteroidal anti-inflammatory drugs research have focused on the development of daily topical administration forms such as gels, toothpastes, and rinses. Furthermore, new studies have implicated prostaglandin E2 in the peri-implantitis process, opening the possibility to manage failing implants with topical nonsteroidal anti-inflammatory drug delivery systems.

  9. 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.

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

    NASA Astrophysics Data System (ADS)

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

    1997-05-01

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

  11. '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

  12. Potential use of gelcasting hydroxyapatite porous ceramic as an implantable drug delivery system.

    PubMed

    Netz, D J; Sepulveda, P; Pandolfelli, V C; Spadaro, A C; Alencastre, J B; Bentley, M V; Marchetti, J M

    2001-02-01

    Hydroxyapatite (HA) ceramic in a porous configuration is suggested as a drug release system. A new technique for the production of this material, based on the foaming of suspensions and in situ polymerization (gelcasting method), resulted in a material whose characteristics are likely to make it useful as an implantable drug delivery system. Three batches of HA ceramic with different porosities were characterized by X-ray diffraction and scanning electron microscopy (SEM). Pore size and shape as well as density were determined. In vitro experiments were performed in order to evaluate the dissolution behavior of cisplatin in the system. X-ray diffraction analysis showed that the final product consisted of a single phase, indicating that the sintering process had not affected the structure of the HA. Energy dispersive X-ray analysis (EDX) showed absence of impurities. Pore diameters were in the range 15--34 microm. SEM showed that the material presented a highly interconnected spheroidal porous network with open micropores and closed macropores. In vitro experiments showed significant differences in the release rate of cisplatin between three different porosities.

  13. 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

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

    PubMed

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

    2014-01-01

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

  15. 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.

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

    PubMed

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

    2015-06-01

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

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

    PubMed

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

    2015-02-01

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

  18. 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.

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

    PubMed

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

    2016-10-01

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

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

    PubMed

    Dukhin, Stanislav S; Labib, Mohamed E

    2012-09-01

    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

  1. 75 FR 13225 - Implantation or Injectable Dosage Form New Animal Drugs; Flunixin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-19

    ... Animal Drugs; Flunixin 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 an original abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The...

  2. 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...

  3. 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...

  4. A novel injectable in situ forming poly-DL-lactide and DL-lactide/glycolide implant containing lipospheres for controlled drug delivery.

    PubMed

    Yehia, Soad A; Elshafeey, Ahmed H; Elsayed, Ibrahim

    2012-06-01

    One of the greatest challenges in in situ forming implant (ISFI) systems by polymer precipitation is the large burst release during the first 1-24 hours after implant injection. The aim of this study was to decrease the burst-release effect of a water-soluble model drug, donepezil HCl, with a molecular weight of 415.96 Da, from in situ forming implants using a novel in situ implant containing lipospheres (ISILs). In situ implant suspensions were prepared by dispersing cetyl alcohol and glyceryl stearate lipospheres in a solution of poly-DL-lactide (PDL) or DL-lactide/glycolide copolymer (PDLG). Also, in situ implant solutions were prepared using different concentrations of PDL or PDLG solutions in N-methyl-2-pyrrolidone (NMP). Triacetin and Pluronic L121 were used to modify the release pattern of donepezil from the in situ implant solutions. In vitro release, rheological measurement, and injectability measurement were used to evaluate the prepared in situ implant formulae. It was found that ISIL decreased the burst effect as well as the rate and extent of drug release, compared to lipospheres, PDL, and PDLG in situ implant. The amount of drug released in the first day was 37.75, 34.99, 48.57, 76.3, and 84.82% for ISIL in 20% PDL (IL-1), ISIL in 20% PDLG (IL-2), lipospheres (L), 20% PDL ISFI (I5), and 20% PDLG ISFI (I8), respectively. The prepared systems showed Newtonian flow behavior. ISIL (IL-1 and IL-2) had a flow rate of 1.94 and 1.40 mL/min, respectively. This study shows the potential of using in situ implants containing lipospheres in controlling the burst effect of ISFI.

  5. 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.

  6. Injectable chitosan-based hydrogel for implantable drug delivery: body response and induced variations of structure and composition.

    PubMed

    Sun, Jiali; Jiang, Guoqiang; Qiu, Tingting; Wang, Yujie; Zhang, Kuo; Ding, Fuxin

    2010-12-15

    Thermosensitive hydrogel composed of chitosan and glycerophosphate (CS/GP) is proposed to be the potential candidate of in situ gel-forming implant for long-term drug delivery. The present study was focused on the body response and induced structural and componential variations of the hydrogel, which were considered to impact on the drug delivery significantly but were scarcely reported. The body response was investigated by histological examination. It showed that the hydrogel caused an inflammatory response immediately after being implanted into Sprague-Dawley (SD) rats. The inflammatory response was mainly exhibited as inflammatory cell surrounding and infiltrating, tissue encapsulating, and vascularization in tissue. The effects of the inflammatory response on the structure and component of the CS/GP hydrogel were extensively explored through analyzing the hydrogel samples taken by surgery. The tissue encapsulation and osmotic pressure caused the water loss of the hydrogel and the compaction of the hydrogel network, and resulted in the porosity decreasing. The cell surrounding and infiltrating spawned big pores in the network and generated the subdivision of the network. All these structural and componential variations of the hydrogel in vivo were quite different from those in vitro and were supposed to exert significantly effects on drug release kinetics.

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

    PubMed

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

    2015-08-01

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

  8. 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.

  9. The Tradeoff Between Shorter and Longer Courses of Dual Antiplatelet Therapy After Implantation of Newer Generation Drug-Eluting Stents.

    PubMed

    Bittl, John A

    2016-01-01

    The benefit of prolonged dual antiplatelet therapy (DAPT) after implantation of drug-eluting stents (DESs) remains uncertain. In 10 randomized controlled trials (RCTs) of 31,666 predominantly low-risk patients undergoing DES implantation, shorter courses (3-12 months) of DAPT resulted in lower mortality (odds ratio [OR] 0.83, 95 % confidence interval [CI] 0.69-0.98) and major hemorrhage (OR 0.60, 95 % CI 0.48-0.75) but increased myocardial infarction (MI, OR 1.34, 95 % CI 1.04-1.73) and stent thrombosis (ST, OR 1.75, 95 % CI 1.08-2.82) than did longer courses (12-36 months) of DAPT. A risk-benefit analysis identified 3 fewer deaths and 5 fewer bleeds but 4 more MIs and 3 more STs annually for every 1000 patients treated with the shorter courses. In the predominantly low-risk population enrolled in RCTs, limiting DAPT to 3 to 12 months after DES implantation saved lives and prevented bleeding at the expense of increased ST and MI. PMID:26732901

  10. Cardiac Valve Noise Reduction by Non-Drug Interventions Improves the Sleep Quality of Patients after Mechanical Cardiac Valve Implantation

    PubMed Central

    Xu, Le; Huang, Xizhen; Jiang, Fei; Lin, Fen; Ye, Qingyang; Lin, Jianling

    2016-01-01

    Purpose: To investigate the effects of non-drug interventions on the sleep quality of patients after mechanical cardiac valve implantation. Methods: In this prospective, randomized, controlled trial, 64 patients scheduled for mechanical mitral valve replacement were recruited. Patients underwent cognitive behavioral therapy and wore noise cancelling earplugs and eye mask. Sleep quality was evaluated on the 4th after admission and the 5th days after operation. The primary outcome was the total sleep quality score differences between the 4th day after admission and the 5th day after operation. Results: All patients had been suffering from poor sleep quality for a month before admission. There was no difference between both groups on the 4th day after admission. Overall sleep quality in the intervention group was better than in the control group on the 5th day after operation. The subjective sleep quality of the patients in each group was significantly lower on the 5th day after the operation than on the 4th day after admission (P <0.05). Conclusion: Non-drug intervention could improve the sleep quality of patients after mechanical cardiac valve implantation and help the postoperative recovery of the patients. (Trial registration: ChiCTR-TRC-14004405, 21 March 2014.) PMID:26853244

  11. 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.

  12. 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.

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

    PubMed

    Ordikhani, Farideh; Dehghani, Mehdi; Simchi, Arash

    2015-12-01

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

  14. 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...

  15. 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...

  16. 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

    ... drug regulations to reflect approval of a new animal drug application (NADA) filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of gonadotropin releasing factor-diphtheria toxoid...-5755, filed NADA 141-322 that provides for the veterinary prescription use of IMPROVEST...

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

    PubMed

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

    2015-01-01

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

  18. 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

  19. 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

  20. 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

  1. 76 FR 3488 - Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline and Flunixin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-20

    ... approval of a new animal drug application (NADA) filed by Norbrook Laboratories, Ltd. The NADA provides for... INFORMATION: Norbrook Laboratories, Ltd., Station Works, Newry, BT35 6JP, Northern Ireland, filed NADA...

  2. Drug release behavior of electrospun twisted yarns as implantable medical devices.

    PubMed

    Maleki, H; Gharehaghaji, A A; Toliyat, T; Dijkstra, P J

    2016-01-01

    In this study, twisted drug-loaded poly(L-lactide) (PLLA) and hybrid poly(L-lactide)/poly(vinyl alcohol) (PLLA/PVA) yarns were produced using an electrospinning technique based on two oppositely charged nozzles. Cefazolin, an antibiotic drug was incorporated in the yarn fibers by addition to the PLLA electrospinning solution. Morphological studies showed that independent of the twist rate, uniform and smooth fibers were formed. The diameter of the electrospun fibers in the yarns decreased at higher twist rates but produced yarns with larger diameters. At increasing twist rates the crystallinity of the fibers in the yarns increased. In the presence of cefazolin the fiber diameter, yarn diameter and crystallinity were always lower than in the non-drug loaded yarns. In addition the yarn mechanical properties revealed a slightly lower strength, modulus and elongation at break upon drug loading. The effect of the twist rate on the cefazolin in vitro release behavior from both PLLA and hybrid yarns revealed similar profiles for both types of drug-loaded yarns. However, the total amount of drug released from the hybrid PLLA/PVA yarns was significantly higher. The release kinetics over a period of 30 d were fitted to different mathematical models. Cefazolin release from electrospun PLLA yarns was governed by a diffusion mechanism and could best be fitted by Peppas and Higuchi models. The models that were found best to describe the drug release mechanism from the hybrid PLLA/PVA yarns were a first-order model and the Higuchi model. PMID:27634914

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

    PubMed

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

    2013-05-01

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

  4. 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... as follows: Sec. 522.1315 Maropitant. * * * * * (c) Conditions of use--(1) Dogs--(i) Amount...) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2)...

  5. 75 FR 54018 - Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol and Flunixin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    ... approval of a supplemental new animal drug application (NADA) filed by Intervet, Inc. The supplemental NADA...., Roseland, NJ 07068, filed a supplement to NADA 141-299 that provides for use of RESFLOR GOLD (florfenicol... BRD pathogens for which the use of this product is approved. The supplemental NADA is approved as...

  6. 75 FR 9333 - Implantation or Injectable Dosage Form New Animal Drugs; Tilmicosin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-02

    ... supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides a dose range for use of an injectable solution of tilmicosin phosphate... to NADA 140-929 for MICOTIL 300 (tilmicosin injection, USP) Injection, available by...

  7. 75 FR 1274 - Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol and Flunixin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for... INFORMATION: Intervet, Inc., 56 Livingston Ave., Roseland, NJ 07068, filed NADA 141-299 that provides for use... Histophilus somni, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle. The NADA...

  8. A robust nanofluidic membrane with tunable zero-order release for implantable dose specific drug delivery.

    PubMed

    Fine, Daniel; Grattoni, Alessandro; Hosali, Sharath; Ziemys, Arturas; De Rosa, Enrica; Gill, Jaskaran; Medema, Ryan; Hudson, Lee; Kojic, Milos; Milosevic, Miljan; Brousseau Iii, Louis; Goodall, Randy; Ferrari, Mauro; Liu, Xuewu

    2010-11-21

    This manuscript demonstrates a mechanically robust implantable nanofluidic membrane capable of tunable long-term zero-order release of therapeutic agents in ranges relevant for clinical applications. The membrane, with nanochannels as small as 5 nm, allows for the independent control of both dosage and mechanical strength through the integration of high-density short nanochannels parallel to the membrane surface with perpendicular micro- and macrochannels for interfacing with the ambient solutions. These nanofluidic membranes are created using precision silicon fabrication techniques on silicon-on-insulator substrates enabling exquisite control over the monodispersed nanochannel dimensions and surface roughness. Zero-order release of analytes is achieved by exploiting molecule to surface interactions which dominate diffusive transport when fluids are confined to the nanoscale. In this study we investigate the nanofluidic membrane performance using custom diffusion and gas testing apparatuses to quantify molecular release rate and process uniformity as well as mechanical strength using a gas based burst test. The kinetics of the constrained zero-order release is probed with molecules presenting a range of sizes, charge states, and structural conformations. Finally, an optimal ratio of the molecular hydrodynamic diameter to the nanochannel dimension is determined to assure zero-order release for each tested molecule.

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

    PubMed Central

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

    2016-01-01

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

  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. 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.

  13. 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

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

    PubMed

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

    2016-01-01

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

  15. 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.

  16. 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

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

    PubMed

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

    2016-06-01

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

  18. 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…

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

    PubMed

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

    2015-10-01

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

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

    PubMed

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

    2015-10-01

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

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

    PubMed

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

    2013-08-01

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

  2. First report on the efficacy of l-alanine-based in situ-forming implants for the long-term parenteral delivery of drugs.

    PubMed

    Plourde, François; Motulsky, Aude; Couffin-Hoarau, Anne-Claude; Hoarau, Didier; Ong, Huy; Leroux, Jean-Christophe

    2005-11-28

    The recent advent of biotechnologies has led to the development of labile macromolecular therapeutic agents that require complex formulations for their efficient administration. This work reports a novel concept for the systemic, sustained delivery of such agents. The proposed approach is based on the spontaneous self-assembly of low-molecular weight amphiphilic amino acid derivatives in a hydrophobic pharmaceutical vehicle. The injectable, in situ-forming organogels were obtained by mixing N-stearoyl l-alanine (m)ethyl esters with a vegetable oil and a biocompatible hydrophilic solvent. The gels' in vivo-delivering properties were evaluated in rats with leuprolide, a luteinizing hormone-releasing hormone agonist used in prostate cancer, endometriosis and precocious puberty treatment. Following subcutaneous injection, the gels degraded and gradually released leuprolide for 14 to 25 days. Drug release was accompanied by sustained castration lasting up to 50 days, as assessed by testosterone levels. This study demonstrates that in situ-forming implants based on l-alanine derivatives represent a novel injectable platform for the controlled delivery of hydrophilic compounds, which is simpler than currently available implant and microsphere technologies.

  3. Dental Implants

    MedlinePlus

    ... Procedures Dental Implants Dentures Direct Bonding Implants versus Bridges Orthodontics and Aligners Periodontal Plastic Surgery Porcelain Crowns Porcelain Fixed Bridges Porcelain Veneers Repairing Chipped Teeth Teeth Whitening Tooth- ...

  4. 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

  5. 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

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

    PubMed

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

    2014-11-01

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

  7. 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....

  8. 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....

  9. 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....

  10. 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....

  11. 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....

  12. 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....

  13. 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....

  14. 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....

  15. 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....

  16. 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....

  17. 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

  18. 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

  19. Oxygen plasma functionalization of parylene C coating for implants surface: nanotopography and active sites for drug anchoring.

    PubMed

    Gołda, M; Brzychczy-Włoch, M; Faryna, M; Engvall, K; Kotarba, A

    2013-10-01

    The effect of oxygen plasma treatment (t=0.1-60 min, pO2=0.2 mbar, P=50 W) of parylene C implant surface coating was investigated in order to check its influence on morphology (SEM, AFM observations), chemical composition (XPS analysis), hydrophilicity (contact angle measurements) and biocompatibility (MG-63 cell line and Staphylococcus aureus 24167 DSM adhesion screening). The modification procedure leads to oxygen insertion (up to 20 at.%) into the polymer matrix and together with surface topography changes has a dramatic impact on wettability (change of contact angle from θ=78±2 to θ=33±1.9 for unmodified and 60 min treated sample, respectively). As a result, the hydrophilic surface of modified parylene C promotes MG-63 cells growth and at the same time does not influence S. aureus adhesion. The obtained results clearly show that the plasma treatment of parylene C surface provides suitable polar groups (C=O, C-O, O-C=O, C-O-O and O-C(O)-O) for further development of the coating functionality.

  20. A randomised determination of the Effect of Fluvastatin and Atorvastatin on top of dual antiplatelet treatment on platelet aggregation after implantation of coronary drug-eluting stents. The EFA-Trial.

    PubMed

    Wenaweser, Peter; Eshtehardi, Parham; Abrecht, Linda; Zwahlen, Marcel; Schmidlin, Kurt; Windecker, Stephan; Meier, Bernhard; Haeberli, Andre; Hess, Otto M

    2010-09-01

    Drug-drug interaction between statins metabolised by cytochrome P450 3A4 and clopidogrel have been claimed to attenuate the inhibitory effect of clopidogrel. However, published data regarding this drug-drug interaction are controversial. We aimed to determine the effect of fluvastatin and atorvastatin on the inhibitory effect of dual antiplatelet therapy with acetylsalicylic acid (ASA) and clopidogrel. One hundred one patients with symptomatic stable coronary artery disease undergoing percutaneous coronary intervention and drug-eluting stent implantation were enrolled in this prospective randomised study. After an interval of two weeks under dual antiplatelet therapy with ASA and clopidogrel, without any lipid-lowering drug, 87 patients were randomised to receive a treatment with either fluvastatin 80 mg daily or atorvastatin 40 mg daily in addition to the dual antiplatelet therapy for one month. Platelet aggregation was assessed using light transmission aggregometry and whole blood impedance platelet aggregometry prior to randomisation and after one month of receiving assigned statin and dual antiplatelet treatment. Platelet function assessment after one month of statin and dual antiplatelet therapy did not show a significant change in platelet aggregation from 1st to 2nd assessment for either statin group. There was also no difference between atorvastatin and fluvastatin treatment arms. In conclusion, neither atorvastatin 40 mg daily nor fluvastatin 80 mg daily administered in combination with standard dual antiplatelet therapy following coronary drug-eluting stent implantation significantly interfere with the antiaggregatory effect of ASA and clopidogrel.

  1. 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.

  2. 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.…

  3. [Hearing implants].

    PubMed

    Stokroos, Robert J; George, Erwin L J

    2013-01-01

    In the Netherlands, more than 1.5 million people suffer from sensorineural hearing loss or deafness. However, fitting conventional hearing aids does not provide a solution for everyone. In recent decades, developments in medical technology have produced implantable and other devices that restore both sensorineural and conductive hearing losses. These hearing devices can be categorized into bone conductive devices, implantable middle ear prostheses, cochlear implants and auditory brainstem implants. Furthermore, new implants aimed at treating tinnitus and loss of vestibular function have recently been developed.

  4. Dexamethasone: intravitreal implant.

    PubMed

    2011-01-01

    Macular oedema is one of the complications of retinal vein occlusion. About half of the patients recover spontaneously within 3 to 6 months. There is currently no drug that improves outcome. An intravitreal implant delivering 0.7 mg of dexamethasone has been authorised for the treatment of macular oedema in this setting. Clinical assessment is based on two double-blind randomised trials including a total of 1267 patients, comparing treatment with intravitreal implants delivering about 0.7 mg or 0.35 mg of dexamethasone, versus a sham procedure. Despite a more rapid initial improvement with dexamethasone, the number of patients whose reading ability improved at 6 months did not significantly differ between the groups. A retrospective subgroup analysis raised the possibility that dexamethasone implants may be beneficial in patients with central retinal vein occlusion. The adverse effects of dexamethasone intravitreal implants are the same as those of intraocular steroid injections, including elevated intraocular pressure (25% of patients), cataracts (27%), conjunctival haemorrhage (20%), and ocular pain. In practice, dexamethasone intravitreal implants do not have a positive harm-benefit balance in most patients with macular oedema following retinal vein occlusion. More rapid recovery after central vein occlusion remains to be confirmed. Pending such studies, it is better to avoid using dexamethasone implants. Patients should instead receive ophthalmologic monitoring to detect and manage possible complications, and any risk factors should be treated.

  5. Histrelin Implant

    MedlinePlus

    ... response to histrelin implant. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly.Ask your pharmacist any questions you have about histrelin implant.It is important for you to keep a written list of all of the prescription and ...

  6. 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

  7. Cochlear implant

    MedlinePlus

    ... implant. These specialists may include: Audiologists Speech therapists Ear, nose, and throat doctors (otolaryngologists) This is a very important part of the process. You will need to work closely with your team of specialists to get ...

  8. Cochlear Implants

    MedlinePlus

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

  9. 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.

  10. 21 CFR 886.3320 - Eye sphere implant.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Eye sphere implant. 886.3320 Section 886.3320 Food 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 21 CFR 882.4545 - Shunt system implantation instrument.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  16. 21 CFR 876.3630 - Penile rigidity implant.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Penile rigidity implant. 876.3630 Section 876.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3630 Penile rigidity implant....

  17. 21 CFR 876.3630 - Penile rigidity implant.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Penile rigidity implant. 876.3630 Section 876.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3630 Penile rigidity implant....

  18. 21 CFR 876.3630 - Penile rigidity implant.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Penile rigidity implant. 876.3630 Section 876.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3630 Penile rigidity implant....

  19. 21 CFR 876.3630 - Penile rigidity implant.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Penile rigidity implant. 876.3630 Section 876.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3630 Penile rigidity implant....

  20. 21 CFR 876.3630 - Penile rigidity implant.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  1. Plasma pentraxin 3 may be a more sensitive marker of inflammatory response than high-sensitivity C-reactive protein after bare-metal stent compared to drug-eluting stent implantation.

    PubMed

    Hudzik, Bartosz; Szkodzinski, Janusz; Pietka-Rzycka, Anna; Danikiewicz, Aleksander; Wojnar, Rafal; Lekston, Andrzej; Polonski, Lech; Zubelewicz-Szkodzinska, Barbara

    2013-05-01

    C-reactive protein (CRP) and pentraxin 3 (PTX3) are members of a highly conserved pentraxin superfamily. CRP is synthesized in the liver and may represent a systemic response to local inflammation. PTX3 is synthesized locally at the inflammatory sites and may represent a marker for local inflammation at sites of vessel injury. We compared plasma high-sensitivity CRP (hsCRP) and PTX3 concentrations after bare-metal stent (BMS) and drug-eluting stent (DES) implantation. Fifty-three patients with stable coronary artery disease who underwent percutaneous coronary intervention were divided into 2 groups: 1-24 patients (BMS group) and 2-29 patients (DES group). Patients were scheduled for an elective, 6-month clinical follow-up. Major adverse cardiovascular events (MACEs) (death, myocardial infarction, target vessel revascularization) were assessed. Baseline clinical characteristics were similar in both groups. Patients after BMS implantation had a higher median PTX3 concentration 1.02 ng/mL compared to patients after DES implantation 0.80 ng/mL, P=0.045. Median hsCRP concentrations were similar in both groups: 0.9 mg/L versus 0.89 mg/L, respectively. Six-month follow-up was available in 33 patients. Four out of 33 patients had MACEs during follow-up. The cut-off value to predict MACEs for PTX3 was >1.16 ng/mL (P=0.004) and for hsCRP was >0.95 mg/L (P<0.001). Patients after DES implantation showed significantly lower plasma PTX3 levels compared with patients after BMS implantation. hsCRP showed no difference between the study groups. PTX3 may be a more sensitive marker of local inflammatory response due to vessel injury by BMS than hsCRP. DES implantation may attenuate the early inflammatory response. Lower PTX3 levels may reflect potent anti-inflammatory properties of DES.

  2. 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

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

    PubMed Central

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

    2016-01-01

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

  4. 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.

  5. 21 CFR 882.5225 - Implanted malleable clip.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  6. 21 CFR 882.5225 - 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...

  7. 21 CFR 872.3645 - Subperiosteal implant material.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (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 2014-04-01 2014-04-01 false Subperiosteal implant material. 872.3645...

  8. 21 CFR 872.3645 - Subperiosteal implant material.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (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 2012-04-01 2012-04-01 false Subperiosteal implant material. 872.3645...

  9. 21 CFR 872.3645 - Subperiosteal implant material.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (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 2013-04-01 2013-04-01 false Subperiosteal implant material. 872.3645...

  10. 21 CFR 872.3640 - Endosseous dental implant.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) 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, that... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Endosseous dental implant. 872.3640 Section...

  11. 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...

  12. 21 CFR 872.3630 - Endosseous dental implant abutment.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  13. 21 CFR 872.3980 - Endosseous dental implant accessories.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  14. 21 CFR 872.3630 - Endosseous dental implant abutment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  15. 21 CFR 872.3980 - Endosseous dental implant accessories.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  16. 21 CFR 872.3980 - Endosseous dental implant accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  17. 21 CFR 872.3980 - Endosseous dental implant accessories.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  18. 21 CFR 872.3630 - Endosseous dental implant abutment.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  19. 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...

  20. 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

  1. Facial implants.

    PubMed

    Arcuri, M R; Rubenstein, J T

    1998-01-01

    The application of endosseous dental implants for the retention and stabilization of extraoral prostheses and hearing aids has been shown to be effective functionally and aesthetically. Implants have reduced the need for adhesive use, simplifying cleaning procedures and thus extending the life of the prosthesis. Implant-retained prostheses have provided patients the opportunity to participate in routine activities such as work, shopping, swimming, and jogging with less fear of losing their prosthesis. The implants' impact on patients has resulted in their ability to function in society with confidence that their defects will be less noticeable and their ability to respond to the environment enhanced. The culmination of these effects have without doubt improved the overall quality of life for patients. As with any new technology, its application will encounter unanticipated problems and some limitations in use. As the art and science of this technique evolve, however, it is anticipated that it will result in the ability to provide improved health care for patients.

  2. POLYMERIC IMPLANTS FOR DELIVERY OF GREEN TEA POLYPHENOLS

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  4. 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

  5. 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

  6. 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

  7. Implantable, multifunctional, bioresorbable optics.

    PubMed

    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

    2012-11-27

    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

  8. 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....

  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, 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....

  11. 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....

  12. 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.

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

    PubMed

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

    2015-12-01

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

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

    PubMed

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

    2016-09-01

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

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

    PubMed

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

    2016-09-01

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

  16. Historical development of active middle ear implants.

    PubMed

    Carlson, Matthew L; Pelosi, Stanley; Haynes, David S

    2014-12-01

    Active middle ear implants (AMEIs) are sophisticated technologies designed to overcome many of the shortcomings of conventional hearing aids, including feedback, distortion, and occlusion effect. Three AMEIs are currently approved by the US Food and Drug Administration for implantation in patients with sensorineural hearing loss. In this article, the history of AMEI technologies is reviewed, individual component development is outlined, past and current implant systems are described, and design and implementation successes and dead ends are highlighted. Past and ongoing challenges facing AMEI development are reviewed.

  17. Biofilm and dental implant: The microbial link

    PubMed Central

    Dhir, Sangeeta

    2013-01-01

    Mouth provides a congenial environment for the growth of the microorganisms as compared to any other part of the human body by exhibiting an ideal nonshedding surface. Dental plaque happens to be a diverse community of the microorganisms found on the tooth surface. Periodontal disease and the peri-implant disease are specific infections that are originating from these resident microbial species when the balance between the host and the microbial pathogenicity gets disrupted. This review discusses the biofilms in relation to the peri-implant region, factors affecting its presence, and the associated treatment to manage this complex microbial colony. Search Methodology: Electronic search of the medline was done with the search words: Implants and biofilms/dental biofilm formation/microbiology at implant abutment interface/surface free energy/roughness and implant, periimplantitis/local drug delivery and dental implant. Hand search across the journals – clinical oral implant research, implant dentistry, journal of dental research, international journal of oral implantology, journal of prosthetic dentistry, perioodntology 2000, journal of periodontology were performed. The articles included in the review comprised of in vivo studies, in vivo (animal and human) studies, abstracts, review articles. PMID:23633764

  18. 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.

  19. Advances in ophthalmic drug delivery.

    PubMed

    Morrison, Peter W J; Khutoryanskiy, Vitaliy V

    2014-12-01

    Various strategies for ocular drug delivery are considered; from basic formulation techniques for improving availability of drugs; viscosity enhancers and mucoadhesives aid drug retention and penetration enhancers promote drug transport into the eye. The use of drug-loaded contact lenses and ocular inserts allows drugs to be better placed where they are needed for more direct delivery. Developments in ocular implants gives a means to overcome the physical barriers that traditionally prevented effective treatment. Implant technologies are under development allowing long-term drug delivery from a single procedure, these devices allow posterior chamber diseases to be effectively treated. Future developments could bring artificial corneas to eliminate the need for donor tissue and one-off implantable drug depots lasting the patient's lifetime.

  20. 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)...

  1. 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)...

  2. 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)...

  3. 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)...

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

    PubMed

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

    2009-07-01

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

  5. Development of novel risperidone implants using blends of polycaprolactones and in vitro in vivo correlation studies.

    PubMed

    Navitha, Aerrolla; Jogala, Satheesh; Krishnamohan, Chinnala; Aukunuru, Jithan

    2014-04-01

    The objective of this study was to develop a novel implant containing risperidone intended for long-term treatment in Schizophrenia utilizing in vitro in vivo correlation (IVIVC) studies. Different implants (F1-F8) containing an antipsychotic drug, risperidone, were prepared using a hot melt extrusion technique by taking polycaprolactones of different molecular weights (Mwt. 15000, 45000, 80000) either alone or as their blends, and PLGA (75:25). The implants contained 40% of the drug. After fabrication, the implants were characterized for various in vitro properties such as drug release and physical strength. Prior to conducting drug release studies, optimum drug release method was developed based on IVIVC studies. An optimized formulation based on drug release and physical strength at the end of fabrication was selected from the various implants fabricated. The bioactivity, reversibility, and IVIVC of optimized formulation were determined using pharmacokinetic studies in rats. Short-term stability studies were conducted with optimized formulation. Drug release depended on polymer molecular weight. Implant fabricated using 50:50 polycaprolactone 45,000 and polycaprolactone 80,000 was considered optimized implant. Optimized formulation selected released the drug for 3-months in vitro and was physically rigid. The optimized implant was able to release the drug in vivo for a period of 3 months, the implants are reversible throughout the delivery interval and, a 100% IVIVC was achieved with optimized implant, suggesting the development of 3-month drug-releasing implant for risperidone. The optimized implant was stable for 6 months at room temperature (25°C) and 45°C. A novel implant for risperidone was successfully prepared and evaluated. PMID:24959417

  6. Implant success!!!.....simplified.

    PubMed

    Luthra, Kaushal K

    2009-01-01

    The endeavor towards life-like restoration has helped nurture new vistas in the art and science of implant dentistry. The protocol of "restoration-driven implant placement" ensures that the implant is an apical extension of the ideal future restoration and not the opposite. Meticulous pre-implant evaluation of soft and hard tissues, diagnostic cast and use of aesthetic wax-up and radiographic template combined with surgical template can simplify the intricate roadmap for appropriate implant treatment.By applying the harmony of artistic skill, scientific knowledge and clinical expertise, we can simply master the outstanding implant success in requisites of aesthetics, phonetics and function.

  7. Chronic, programmed polypeptide delivery from an implanted, multireservoir microchip device.

    PubMed

    Prescott, James H; Lipka, Sara; Baldwin, Samuel; Sheppard, Norman F; Maloney, John M; Coppeta, Jonathan; Yomtov, Barry; Staples, Mark A; Santini, John T

    2006-04-01

    Implanted drug delivery systems are being increasingly used to realize the therapeutic potential of peptides and proteins. Here we describe the controlled pulsatile release of the polypeptide leuprolide from microchip implants over 6 months in dogs. Each microchip contains an array of discrete reservoirs from which dose delivery can be controlled by telemetry.

  8. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  9. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 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 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) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3350 Penile inflatable...

  12. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted electrical urinary continence device. 876.5270 Section 876.5270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Therapeutic Devices §...

  13. 21 CFR 876.3350 - Penile inflatable implant.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Penile inflatable implant. 876.3350 Section 876.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3350 Penile inflatable...

  14. 21 CFR 876.3350 - Penile inflatable implant.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Penile inflatable implant. 876.3350 Section 876.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3350 Penile inflatable...

  15. 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 SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Therapeutic Devices §...

  16. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted electrical urinary continence device. 876.5270 Section 876.5270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Therapeutic Devices §...

  17. 21 CFR 876.3350 - Penile inflatable implant.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Penile inflatable implant. 876.3350 Section 876.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3350 Penile inflatable...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  20. 21 CFR 876.3350 - Penile inflatable implant.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Penile inflatable implant. 876.3350 Section 876.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3350 Penile inflatable...

  1. [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.

  2. Therapies targeting inflammation after stent implantation.

    PubMed

    Okura, Hiroyuki; Takagi, Tsutomu; Yoshida, Kiyoshi

    2013-07-01

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

  3. 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.

  4. 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

  5. Breast reconstruction - implants

    MedlinePlus

    ... visits, your surgeon injects a small amount of saline (salt water) through the valve into the expander. ... breast implants. Implants may be filled with either saline or a silicone gel. You may have another ...

  6. [Pathology of implants].

    PubMed

    Mittermayer, C; Eblenkamp, M; Richter, H A; Zwadlo-Klarwasser, G; Bhardwaj, R S; Klosterhalfen, B

    2002-01-01

    Progress in the surgery of implants and biomaterials can be accomplished by: 1. Painstakingly analysing and registering of defaulting implants after explantation within a "National Registry of Implant Pathology". 2. Development of a DNA-microarray named "Implantat/Chronic Wound" in order to discover the differential transcriptional activities of cells brought into contact with different foreign surfaces. 3. Predictive cell-engineering combined with custom-made implant surfaces with the aim of optimal patient care.

  7. 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...

  8. 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...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

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

    Code of Federal Regulations, 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 21 CFR 876.5280 - Implanted mechanical/hydraulic urinary continence device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  20. 21 CFR 876.5280 - Implanted mechanical/hydraulic urinary continence device.

    Code of Federal Regulations, 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...

  1. 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...

  2. 21 CFR 876.5280 - Implanted mechanical/hydraulic urinary continence device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  3. 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,…

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 21 CFR 1308.25 - Exclusion of a veterinary anabolic steroid implant product; application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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.

  20. 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.

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

    PubMed

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

    2016-08-01

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

  2. Implantation in IVF.

    PubMed

    Busso, Cristiano E; Melo, Marco A B; Fernandez, Manuel; Pellicer, Antonio; Simon, Carlos

    2006-01-01

    The recent advances in assisted reproduction have made it possible to study and interfere in almost every step of the human reproductive process except for implantation. The most complex and important step remains in great part unknown. Implantation in human has proven to be less efficient compared with other species. However, in in vitro fertilization (IVF) patients, it has been evaluated to be even poorer. This paper highlights the factors related to infertile patients and IVF treatments that can affect implantation and implantation's clinical aspects related to these treatments: implantation failure and early pregnancy loss.

  3. 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

  4. Breast implants. A review.

    PubMed

    Van Zele, D; Heymans, O

    2004-04-01

    Breast implants have been used for about four decades for both reconstructive and aesthetic purposes. In 1963, the quality of the artificial implants was revolutionized by the introduction of the silicone gel-filled implant. Since, this modern prosthesis has gone through an evolution of change and improvement with several types of devices with many variations and styles within each class. Actually, for the last three decades, approximately one million women have received silicone breast implants in the USA. But, in 1992, the American FDA banned silicone from the market, leaving saline implants as the only product generally available as an alternative until now. Other filler materials were introduced, but have never progressed beyond the experimental stage in the USA (in contrast with Europe). The evolution of the different implants through time, with their advantages and disadvantages will be discussed, but also the controversy on silicone implants in the USA and their suspected association with systemic diseases. PMID:15154572

  5. Strontium in the bone-implant interface.

    PubMed

    Vestermark, Marianne Toft

    2011-05-01

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

  6. 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.

  7. Nanotechnology and dental implants.

    PubMed

    Lavenus, Sandrine; Louarn, Guy; Layrolle, Pierre

    2010-01-01

    The long-term clinical success of dental implants is related to their early osseointegration. This paper reviews the different steps of the interactions between biological fluids, cells, tissues, and surfaces of implants. Immediately following implantation, implants are in contact with proteins and platelets from blood. The differentiation of mesenchymal stem cells will then condition the peri-implant tissue healing. Direct bone-to-implant contact is desired for a biomechanical anchoring of implants to bone rather than fibrous tissue encapsulation. Surfaces properties such as chemistry and roughness play a determinant role in these biological interactions. Physicochemical features in the nanometer range may ultimately control the adsorption of proteins as well as the adhesion and differentiation of cells. Nanotechnologies are increasingly used for surface modifications of dental implants. Another approach to enhance osseointegration is the application of thin calcium phosphate (CaP) coatings. Bioactive CaP nanocrystals deposited on titanium implants are resorbable and stimulate bone apposition and healing. Future nanometer-controlled surfaces may ultimately direct the nature of peri-implant tissues and improve their clinical success rate.

  8. Nanotechnology and Dental Implants

    PubMed Central

    Lavenus, Sandrine; Louarn, Guy; Layrolle, Pierre

    2010-01-01

    The long-term clinical success of dental implants is related to their early osseointegration. This paper reviews the different steps of the interactions between biological fluids, cells, tissues, and surfaces of implants. Immediately following implantation, implants are in contact with proteins and platelets from blood. The differentiation of mesenchymal stem cells will then condition the peri-implant tissue healing. Direct bone-to-implant contact is desired for a biomechanical anchoring of implants to bone rather than fibrous tissue encapsulation. Surfaces properties such as chemistry and roughness play a determinant role in these biological interactions. Physicochemical features in the nanometer range may ultimately control the adsorption of proteins as well as the adhesion and differentiation of cells. Nanotechnologies are increasingly used for surface modifications of dental implants. Another approach to enhance osseointegration is the application of thin calcium phosphate (CaP) coatings. Bioactive CaP nanocrystals deposited on titanium implants are resorbable and stimulate bone apposition and healing. Future nanometer-controlled surfaces may ultimately direct the nature of peri-implant tissues and improve their clinical success rate. PMID:21253543

  9. 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...

  10. 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...

  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, 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...

  13. 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...

  14. 21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable...

  15. 21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable...

  16. 21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable...

  17. 21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable...

  18. 21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable...

  19. Implants in adolescents

    PubMed Central

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

    2013-01-01

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

  20. Paclitaxel loaded carrier based biodegradable polymeric implants: Preparation and in vitro characterization

    PubMed Central

    Hiremath, Jagadeesh G.; Khamar, Nirav S.; Palavalli, Subhash G.; Rudani, Chetan G.; Aitha, Rajeshkumar; Mura, Prasanthkumar

    2012-01-01

    The objective of this study was to develop paclitaxel (PTX) loaded poly(ε-caprolactone) (PCL) based tiny implants. β-Cyclodextrin (β-CD) and polyethylene glycol (PEG 6000) were used to enhance solubility and release of the drug in the phosphate buffer saline pH 7.4. Implants were evaluated in terms of color, shape, thickness, surface area, weight, drug content. Developed implants were characterized for their surface morphology (SEM analysis), drug physical state by thermal analysis (DSC studies), crystalline nature (XRD studies) and drug excipients compatibility (FT-IR spectroscopy). Macroscopically all the tiny implants were white in color and cylindrical in shape with smooth surfaces. PTX was entrapped within implants in the polymeric amorphous form. In vitro drug release studies showed prolonged and controlled release of PTX with zero order and Korsmeyer–Peppas model being exhibited. Excipients and method of preparation did not affect chemical stability of PTX. PMID:23960822

  1. [MR implant labelling and its use in clinical MRI practice].

    PubMed

    Mühlenweg, M; Schaefers, G

    2015-08-01

    Before a magnetic resonance imaging (MRI) examination, implants in patients must be cleared for MR safety in order to exclude the risk of possible severe injuries and implant malfunction in an MR environment. The general contraindication for measurements of patients with implants still applies; however, in the recent past a way has been found to legally circumvent this contraindication. For this purpose special conditions are required: explicit implant identification and the original manufacturer's labelling are necessary, the required conditions for conditionally MR safe implants must be assured and a risk-benefit analysis with appropriate explanation to the patient has to be performed. This process can be very complex as the implants are often poorly documented and detailed information on the implant MR labelling is also often outdated or not easy to interpret. This article provides information about legal and normative principles of MR measurement of patients with implants. The possible physical interactions with implants will be briefly dealt with as well as possible strategies for better identification and investigation of implants and MR labelling. General approaches for minimizing the risk will be discussed using some examples. The second part deals with the content of MR implant labelling and the current test standards. Furthermore, the additional information from the operating instructions of the MR scanner that are necessary for the interpretation of the MR implant labelling, will be explained. The article concludes with an explanation of the current pattern for MR labelling of implants from the U.S. Food and Drug Administration (FDA) and an exemplary application. PMID:26296804

  2. Implant healing in experimental animal models of diabetes.

    PubMed

    Le, Nga N; Rose, Michael B; Levinson, Howard; Klitzman, Bruce

    2011-05-01

    Diabetes mellitus is becoming increasingly prevalent worldwide. Additionally, there is an increasing number of patients receiving implantable devices such as glucose sensors and orthopedic implants. Thus, it is likely that the number of diabetic patients receiving these devices will also increase. Even though implantable medical devices are considered biocompatible by the Food and Drug Administration, the adverse tissue healing that occurs adjacent to these foreign objects is a leading cause of their failure. This foreign body response leads to fibrosis, encapsulation of the device, and a reduction or cessation of device performance. A second adverse event is microbial infection of implanted devices, which can lead to persistent local and systemic infections and also exacerbates the fibrotic response. Nearly half of all nosocomial infections are associated with the presence of an indwelling medical device. Events associated with both the foreign body response and implant infection can necessitate device removal and may lead to amputation, which is associated with significant morbidity and cost. Diabetes mellitus is generally indicated as a risk factor for the infection of a variety of implants such as prosthetic joints, pacemakers, implantable cardioverter defibrillators, penile implants, and urinary catheters. Implant infection rates in diabetic patients vary depending upon the implant and the microorganism, however, for example, diabetes was found to be a significant variable associated with a nearly 7.2% infection rate for implantable cardioverter defibrillators by the microorganism Candida albicans. While research has elucidated many of the altered mechanisms of diabetic cutaneous wound healing, the internal healing adjacent to indwelling medical devices in a diabetic model has rarely been studied. Understanding this healing process is crucial to facilitating improved device design. The purpose of this article is to summarize the physiologic factors that

  3. Implantable cardioverter defibrillator - discharge

    MedlinePlus

    Baddour LM, Epstein AE, Erickson CC, et al. Update on cardiovascular implantable electronic device infections and their management: a scientific statement from the American Heart Association. Circulation . ...

  4. 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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 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 870.3610 - Implantable pacemaker pulse generator.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... asynchronous modes and is implanted in the human body. (b) Classification. Class III (premarket approval). (c... 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...

  7. 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...

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

    PubMed

    Aizawa, Yoshifusa; Chinushi, Masaomi; Washizuka, Takashi

    2004-05-01

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

  9. 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

  10. 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.

  11. 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.

  12. 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.

  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. Cefoperazone sodium impregnated polycaprolactone composite implant for osteomyelitis.

    PubMed

    Anand, A; Pundir, R; Pandian, C S; Saraf, S; Gupta, H

    2009-07-01

    The use of local antibiotics from a biodegradable implant for chronic osteomyelitis is an attractive alternative. The implant delivers high antibiotic concentration at tissue levels, obliterates dead space, aids bone repair and does not need to be removed. The purpose of this paper is to develop and evaluate a calcium sulphate and polycaprolactone based composite biodegradable implantable delivery system of cefoperazone sodium. Implants were prepared by modified fabrication technique to avoid solvent use. Interaction studies were carried out to check any incompatibility between ingredients. Prepared implants were evaluated for various in vitro parameters like dimensions, hardness, tensile strength, drug release profile and sterility. Morphological changes in pellet before and after drug release were evaluated by scanning electron microscopy. The pellet were also tested for microbiological efficacy and compared with plain drug solution in different concentrations. Developed pellets are regular in shape and size with good tensile strength. The release profile displayed drug levels above MIC continuously up to 2 months. Wide zone of inhibition by pellet against Staph. aureus as compared to drug solution proves its efficacy in treatment of osteomyelitis.

  15. 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

  16. Mobility implants: a review.

    PubMed

    Danz, W

    1990-01-01

    We present a brief review of mobility implants, their contribution, and the experiences derived after almost 40 years since the new concepts of full mobility implants were introduced. In early 1940, experiments with a new material for the making of plastic artificial eyes was also being considered for the making of orbital implants. Methyl-methacrylate (MMA) had proven inert and satisfactory for dental products. The Surgeon Generals office of the Armed Services encouraged further research and experimental work in the development of plastic eyes. The success of the new material sponsored the beginning of great expansion with new concepts for orbital implants. Through a period of more than a decade, the design and types of implants went through three stages. First, the buried implant was introduced, then the exposed integrated followed, and the buried integrated subsequently followed. The path of progress was not smooth. Theoretically correct designs and surgical procedures met unexpected practical difficulties for the ophthalmic surgeon, the patient, and the eye maker. Surgical and technical efforts were carefully reviewed to eliminate the problems encountered, only to have further unforeseen complications arise. Infections, extrusions, and migration of the implant were not uncommon. The exposed integrated implant was eventually abandoned. However, there were some extraordinary successes of mobility. A new era introduced fully buried mobility implants that were more successful. However, this procedure also produced some problems, causing infection (or allergy), extrusion, and migration. Tantalum mesh and gauze gave great promise with the inception of their use. Orbital tissue grew into the material in an astonishing way, making it possible to secure the extraocular muscles and tenons.(ABSTRACT TRUNCATED AT 250 WORDS)

  17. 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.

  18. Development of implants for sustained release of 5-fluorouracil using low molecular weight biodegradable polymers.

    PubMed

    Hanafy, A Fh; El-Egaky, A M; Mortada, S A; Molokhia, A M

    2009-12-01

    Anticancer drugs have poor efficacy especially against solid tumors that hinder drug penetration into the tumor. Thus, the dose has to be increased, but toxicity is a limiting factor. Local administration of a polymeric biodegradable poly-L-lactic acid (PLA) and poly(L-lactic acid-co-glycolic acid) copolymer (PLGA) implant containing an anticancer drug may be an acceptable method of concentrating the drug near the tumor site. This work sought to synthesize low molecular weight PLA and PLGA by polycondensation to yield polymers with good physical properties to make them suitable for use in implantable therapy. The synthesized polymers were characterized by determining their molecular weight, melting point, and percentage crystallinity using DSC. Fourier transformationinfra red spectrum (FT-IR), nuclear magnetic resonance (NMR) and specific optical rotation measurement were also used to characterize the synthesized polymers. Morphological characteristics were assessed using scanning electron microscopy (SEM). Implants were manufactured using compression (C) and injection molding (IM) and were loaded with 12 mg 5-fluorouracil (5-FU) per 120 mg implant. In vitro release patterns of all implants were assessed in phosphate buffered saline pH 7.4 (PBS 7.4) at 37°C. Factors affecting the release of 5-FU from implants were the polymer species, manufacturing technique, drug particle size, drug concentration, implant dimensions, and coating of the implant. Implants prepared with PLGA had significantly faster release of 5-FU than those prepared with PLA. Those manufactured using compression had significantly faster drug release than those prepared by injection molding. A PLA implant that contained 12 mg 5-FU/120 mg with a diameter of 0.3 cm and that was loaded with a drug particle size smaller than 150 μm and prepared by injection molding and then subsequently coated with PLA had the longest release period of 45 days.

  19. Reflections on Rodent Implantation.

    PubMed

    Cha, Jeeyeon M; Dey, Sudhansu K

    2015-01-01

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

  20. Spectroscopy of implants

    NASA Astrophysics Data System (ADS)

    Afanasyeva, Natalia I.

    1994-01-01

    The spectral criteria of selection of soft intraocular lens (IOL) implants of long service in an organism have been defined for ophthalmology. The analysis of Fourier Transform Infrared (FTIR) spectra provides the required and sufficient level of material polymerization for manufacturing non-toxic lenses for the eye. The spectral limits for determining the biocompatibility of samples can be related to the intensity ratio of two bands only in the FTIR spectra of siloxane. Siloxane-poly(urethane) block copolymers and other materials for implants have been studied. Passivated surfaces of implants have been obtained and registered by methods of Fourier Transform Spectroscopy.

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

    PubMed

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

    2013-06-01

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

  2. The evolution of embryo implantation.

    PubMed

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

    2014-01-01

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

  3. Mometasone implant for chronic rhinosinusitis.

    PubMed

    Wei, Calvin C; Kennedy, David W

    2012-01-01

    The Propel mometasone-eluting stent (Intersect ENT, Palo Alto, CA) is the first Food and Drug Administration-approved device for delivering steroid medication into the ethmoid cavity following surgery. The implant is composed of a biodegradable polymer in a lattice pattern that expands in a spring-like fashion to conform to the walls of a dissected ethmoid cavity and contains a total of 370 μg of mometasone furoate designed for gradual release over 30 days. The purpose of this article is to review the mode of action and the evidence supporting the efficacy of this novel technology. Three recently published clinical trials have demonstrated that the mometasone-eluting stent produced statistically significant reductions in inflammation, polyp formation, and postoperative adhesions. In addition, the implant has been found to significantly reduce the need for postoperative administration of oral steroids and to decrease the frequency of postoperative lysis of adhesions. Minimal adverse effects were reported in these trials and included infection, crusting, and granulation tissue formation. Although the placement of steroid-impregnated packing, stents, sponges, and gels has previously been used in the postoperative sinus cavities, the Propel mometasone-eluting stent introduces a new mechanism for localized and controlled delivery of topical therapy directly to the nasal mucosa for chronic rhinosinusitis.

  4. Peri-Implant Diseases

    MedlinePlus

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

  5. 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.

  6. Risks of Breast Implants

    MedlinePlus

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

  7. Ion implantation at elevated temperatures

    SciTech Connect

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

    1985-11-01

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

  8. Implant treatment planning: endodontic considerations.

    PubMed

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

    2014-12-01

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

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

    PubMed Central

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

    2014-01-01

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

  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. Simple Implant Augmentation Rhinoplasty.

    PubMed

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

    2015-11-01

    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

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

    PubMed Central

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

    2014-01-01

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

  13. Nanobiotechnology Perspectives on Prevention and Treatment of Ortho-paedic Implant Associated Infection.

    PubMed

    Borse, Vivek; Pawar, Vaishali; Shetty, Gautam; Mullaji, Arun; Srivastava, Rohit

    2016-01-01

    Implants are an inevitable part of orthopaedic surgery. However, implant associated infection remains a major challenge for orthopaedic surgeons and researchers. This review focuses on current options available for prevention of implant associated infection, their drawbacks and future promising applications of nanotechnology-based approaches. Nanobiotechnology has shown remarkable progress in recent years especially in biomaterials, diagnostics, and drug delivery system. Although several applications of nanobiotechnology in orthopaedics have been described, few have elaborated their role in the prevention of implant related infection in orthopaedics. Novel "smart" drug delivery systems that release antibiotics locally in response to stimuli such as pH, temperature, enzymes or antigens; implant surface modification on a nanoscale to inhibit bacterial adhesion and propagation at the surgical site and biological approaches such as gene therapy to neutralize bacterial virulence and biomolecules to inhibit the quorum sensing adhesion of bacteria and disruption of biofilms can be used effectively to prevent orthopaedic implant related bacterial infection. PMID:26263909

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

    PubMed Central

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

    2006-01-01

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

  15. 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. PMID:22408779

  16. [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.

  17. Implant interactions with orthodontics.

    PubMed

    Celenza, Frank

    2012-09-01

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

  18. Scuba diving with cochlear implants.

    PubMed

    Kompis, Martin; Vibert, Dominique; Senn, Pascal; Vischer, Mattheus W; Häusler, Rudolf

    2003-05-01

    We report on a patient with bilateral cochlear implants (a Med-El Combi40 and a Med-El Combi40+), as well as considerable experience in scuba diving with both of his implants. After having been exposed to 68 and 89 dives, respectively, in depths of up to 43 m, both cochlear implants are in working order and the patient continues to receive excellent speech recognition scores with both cochlear implant systems. The presented data show that scuba diving after cochlear implantation is possible over a considerable number of dives without any major negative impact on the implants.

  19. Saquinavir-mediated inhibition of human immunodeficiency virus (HIV) infection in SCID mice implanted with human fetal thymus and liver tissue: an in vivo model for evaluating the effect of drug therapy on HIV infection in lymphoid tissues.

    PubMed Central

    Pettoello-Mantovani, M; Kollmann, T R; Raker, C; Kim, A; Yurasov, S; Tudor, R; Wiltshire, H; Goldstein, H

    1997-01-01

    Treatment with protease inhibitors alone or in combination with inhibitors of reverse transcriptase potently suppresses levels of human immunodeficiency virus (HIV) RNA in plasma and thereby may significantly delay the progression of HIV-mediated disease. To investigate the effect of treatment with the protease inhibitor saquinavir on HIV replication in the lymphoid tissues, we used a SCID-hu mouse model that we developed, in which human thymic and liver tissues (hu-thy/liv) were implanted under both kidney capsules in SCID mice (thy/liv-SCID-hu mice). These mice are populated in the periphery with large numbers of human T cells and develop disseminated HIV infection after intraimplant injection. thy/liv-SCID-hu mice with established HIV infection that were treated for 1 month with saquinavir had a significantly lower viral load present in the implanted hu-thy/liv and mouse spleen than did the untreated HIV-infected thy/liv-SCID-hu mice. To examine the capacity of acute treatment with saquinavir to prevent HIV infection, some thy/liv-SCID-hu mice were inoculated with HIV and then immediately started on saquinavir. Although treated mice had markedly lower viral loads in the thy/liv implants and spleens, HIV infection was not completely prevented. Thus, the effect of antiviral therapy on HIV infection in the major site of HIV replication, the lymphoid tissues, can be readily evaluated in our thy/liv-SCID-hu mice. These mice should prove to be a useful model for determining the in vivo effectiveness of different therapeutic interventions on acute and chronic HIV infection. PMID:9303378

  20. [Subretinal visual implants].

    PubMed

    Stingl, K; Greppmaier, U; Wilhelm, B; Zrenner, E

    2010-12-01

    Visual implants are medical technologies that replace parts of the visual neuronal pathway. The subretinal implant developed by our group is being used in a human trials since 2005 and replaces the function of degenerated photoreceptors by an electronic device in blind patients. The subretinal implant consists of a 70-µm thin microchip with 1500 microphotodiodes each with an amplifier and an electrode with area of 3 mm × 3 mm. The power supply is provided by a subdermal power supply cable. The microchip is implanted under the macula and transforms the light signal into an electrical one, which is referred directly to the bipolar cells. Requirements for a good function of the implant are a preserved function of the inner retina, as well as clear optic media and a good visual acuity in the earlier life. The current technology can mediate a visual field of 10 - 12° and a computed resolution of up to 0.25° visual angle (corresponding to a visual acuity of 63 / 1000 - 80 / 1000) in blind patients. The so far best results from our studies reached a visual acuity of 21 / 1000 in blind retinitis pigmentosa patients. This overview is intended to inform the ophthalmologist about the current state of the technology and help him/her to advise interested patients.

  1. Effect and treatment of lactobacillus on inflammation around the implant.

    PubMed

    Zhao, Bing; Wu, Feng; Tian, Guobing

    2015-09-01

    Ultrasonic scaling and antibiotic therapy are traditional therapeutic methods for inflammation around the implant but therapeutic effect is not ideal. In view of maintaining flora balance around the implant and implant long-term solid holdup, this experiment observes impact and clinical effect of lactobacillus metabolite on inflammation around the impact to explore a new kind of ecological drug. This drug has little or no side effect, good curative effect and low recurrence rate, which can be applied for broad groups of people. 16 cases with inflammation around the impact were divided into experimental group and control group, 8 cases for each group. Lactobacillus metabolites gargle was offered to experimental group; purified water was offered to control group. Gargle way is 3 times/day, 20 ml/time, 3 min/time and for 7 days. Two groups of cases were clinical and microbiological tested before gargle, 3 days, 7 days and 30 days after gargle. Based on clinical and microbiological test of 8 cases of health implant, we observe sub gingival flora variation trend and clinical effects of infectors with inflammation around implant. Lactobacillus metabolite can improve clinical index of inflammation around the impact including MPLI, GI, MBI and PD. Lactobacillus metabolite has a strong treatment effect on inflammation around the implant and has no side effect.

  2. Cavotricuspid isthmus ablation and subcutaneous monitoring device implantation in a 2-year-old baby with 2 SCN5A mutations, sinus node dysfunction, atrial flutter recurrences, and drug induced long-QT syndrome: a tricky case of pediatric overlap syndrome?

    PubMed

    De Filippo, Paolo; Ferrari, Paola; Iascone, Maria; Racheli, Marco; Senni, Michele

    2015-03-01

    We describe the case of 2-year-old baby with compound heterozygosity for paternal and maternal alleles mutation of α-subunit of the cardiac sodium channel (SCN5A), sinus node dysfunction, atrial flutter recurrences, and drug induced long-QT syndrome. In this setting, we chose at first to perform linear ablation of cavotricuspid isthmus resulting in a bidirectional isthmus block. As a second step, we decided to implant a miniaturized loop recorder that, with a minimally invasive procedure, permits us to follow the development of the disease in order to define the future strategy. After 8 months follow-up, automatic daily loop-recorder transmissions disclose the complete absence of any arrhythmia along with asymptomatic ventricular pauses due to sinus node dysfunction. Echocardiography shows normal findings, in particular no left ventricular dysfunction.

  3. Immunological aspects of implantation and implantation failure.

    PubMed

    Johnson, P M; Christmas, S E; Vince, G S

    1999-12-01

    The human endometrium contains a significant proportion of leukocytes (8-35% of all cells), the absolute numbers and proportions varying during both the menstrual cycle and early in pregnancy. T cells, macrophages and a population of phenotypically unusual large granular lymphocytes (LGL) are commonly present, although B cells are absent. Relative T cell numbers decrease significantly in first trimester decidua, and hence are unlikely to play an important role in maintenance of human pregnancy, but T cells could be important in implantation where their relative numbers are greater. In addition to producing cytokines, local tissue macrophages may provide an immediate antigen non-specific host defence to infection. Most attention has, nevertheless, focused on a role for LGL in implantation and maintenance of pregnancy since, at the time of implantation, LGL comprise 70-80% of the total endometrial leukocyte population. Although endometrial LGL have been shown to express natural killer (NK) cell-type cytotoxicity against classical NK cell targets, such cytotoxicity against trophoblast is induced only after activation by interleukin (IL)-2. Selective expression of the unusual class I human leukocyte antigen (HLA) molecule, HLA-G, by extravillous cytotrophoblast may assist in protecting invasive cytotrophoblast from potential maternal NK cell attack, probably via interactions with killer inhibitory receptor molecules on LGL. Many cytokines have been demonstrated to be expressed at the maternal-fetal interface although, currently, in mice only two (IL-11 and leukaemia inhibitory factor) appear to be absolutely essential for successful pregnancy outcome. Immune effector cells and cytokines may also play a role in human pregnancy pathologies, such as recurrent early pregnancy loss.

  4. 21 CFR 880.6300 - Implantable radiofrequency transponder system for patient identification and health information.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... entitled “Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implantable radiofrequency transponder system for... radiofrequency transponder system for patient identification and health information. (a) Identification....

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... entitled “Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implantable radiofrequency transponder system for... radiofrequency transponder system for patient identification and health information. (a) Identification....

  6. 21 CFR 880.5970 - Percutaneous, implanted, long-term intravascular catheter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  7. 21 CFR 880.5970 - Percutaneous, implanted, long-term intravascular catheter.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  8. 21 CFR 880.5970 - Percutaneous, implanted, long-term intravascular catheter.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  9. Synergistic effects of bisphosphonate and calcium phosphate nanoparticles on peri-implant bone responses in osteoporotic rats.

    PubMed

    Alghamdi, Hamdan S; Bosco, Ruggero; Both, Sanne K; Iafisco, Michele; Leeuwenburgh, Sander C G; Jansen, John A; van den Beucken, Jeroen J J P

    2014-07-01

    The prevalence of osteoporosis will increase within the next decades due to the aging world population, which can affect the bone healing response to dental and orthopedic implants. Consequently, local drug targeting of peri-implant bone has been proposed as a strategy for the enhancement of bone-implant integration in osteoporotic conditions. In the present study, an established in-vivo femoral condyle implantation model in osteoporotic and healthy bone is used to analyze the osteogenic capacity of titanium implants coated with bisphosphonate (BP)-loaded calcium phosphate nanoparticles (nCaP) under compromised medical conditions. After 4 weeks of implantation, peri-implant bone volume (%BV; by μCT) and bone area (%BA; by histomorphometry) were significantly increased within a distance of 500 μm from implant surfaces functionalized with BP compared to control implants in osteoporotic and healthy conditions. Interestingly, the deposition of nCaP/BP coatings onto implant surfaces increased both peri-implant bone contact (%BIC) and volume (%BV) compared to the deposition of nCaP or BP coatings individually, in osteoporotic and healthy conditions. The results of real-time PCR revealed similar osteogenic gene expression levels to all implant surfaces at 4-weeks post-implantation. In conclusion, simultaneous targeting of bone formation (by nCaP) and bone resorption (by BP) using nCaP/BP surface coatings represents an effective strategy for synergistically improvement of bone-implant integration, especially in osteoporotic conditions.

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Classification of implants, life-supporting or life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... reclassification will be accompanied by a full statement of the reasons for so doing. A statement of the...

  11. 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...

  12. 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...

  13. 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...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implantable radiofrequency transponder system for patient identification and health information. 880.6300 Section 880.6300 Food and Drugs FOOD AND DRUG... identification code is used to access patient identity and corresponding health information stored in a...

  15. 21 CFR 880.6300 - Implantable radiofrequency transponder system for patient identification and health information.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implantable radiofrequency transponder system for patient identification and health information. 880.6300 Section 880.6300 Food and Drugs FOOD AND DRUG... identification code is used to access patient identity and corresponding health information stored in a...

  16. 21 CFR 880.6300 - Implantable radiofrequency transponder system for patient identification and health information.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implantable radiofrequency transponder system for patient identification and health information. 880.6300 Section 880.6300 Food and Drugs FOOD AND DRUG... identification code is used to access patient identity and corresponding health information stored in a...

  17. Dental Implant Complications.

    PubMed

    Liaw, Kevin; Delfini, Ronald H; Abrahams, James J

    2015-10-01

    Dental implants have increased in the last few decades thus increasing the number of complications. Since many of these complications are easily diagnosed on postsurgical images, it is important for radiologists to be familiar with them and to be able to recognize and diagnose them. Radiologists should also have a basic understanding of their treatment. In a pictorial fashion, this article will present the basic complications of dental implants which we have divided into three general categories: biomechanical overload, infection or inflammation, and other causes. Examples of implant fracture, loosening, infection, inflammation from subgingival cement, failure of bone and soft tissue preservation, injury to surround structures, and other complications will be discussed as well as their common imaging appearances and treatment. Lastly, we will review pertinent dental anatomy and important structures that are vital for radiologists to evaluate in postoperative oral cavity imaging.

  18. 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.

  19. 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.

  20. Multichannel extracochlear implant.

    PubMed

    Pulec, J L; Smith, J C; Lewis, M L; Hortmann, G

    1989-03-01

    The transcutaneous eight-channel extracochlear implant has undergone continuous revision to simplify the surgical technique, to minimize patient morbidity, and to improve performance. The extracochlear electrode array has been miniaturized so that it can be inserted through the facial recess without disturbing the external auditory canal, tympanic membrane, or malleus. The use of the remote antenna placed around the external auditory canal has greatly increased battery life and patient comfort. With its simplified incisions, the surgical procedure can be performed as out-patient surgery. Preoperative cochlear nerve testing and use of evoked response cochlear nerve testing allow preadjustment of the speech processor. Current features and performance of the implant are discussed.

  1. 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

  2. Current trends in dental implants.

    PubMed

    Gaviria, Laura; Salcido, John Paul; Guda, Teja; Ong, Joo L

    2014-04-01

    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.

  3. Ion implantation in silicate glasses

    SciTech Connect

    Arnold, G.W.

    1993-12-01

    This review examines the effects of ion implantation on the physical properties of silicate glasses, the compositional modifications that can be brought about, and the use of metal implants to form colloidal nanosize particles for increasing the nonlinear refractive index.

  4. The ruptured PIP breast implant.

    PubMed

    Helyar, V; Burke, C; McWilliams, S

    2013-08-01

    Public concern erupted about the safety of Poly Implant Prothèse (PIP) breast implants when it was revealed in 2011 that they contained an inferior, unlicensed industrial-grade silicone associated with a high rate of rupture. There followed national guidance for UK clinicians, which led to a considerable increase in referrals of asymptomatic women for breast implant assessment. In this review we discuss possible approaches to screening the PIP cohort and the salient characteristics of a ruptured implant. PMID:23622796

  5. 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

  6. Electroforming of implantable tubular magnetic microrobots for wireless ophthalmologic applications.

    PubMed

    Chatzipirpiridis, George; Ergeneman, Olgaç; Pokki, Juho; Ullrich, Franziska; Fusco, Stefano; Ortega, José A; Sivaraman, Kartik M; Nelson, Bradley J; Pané, Salvador

    2015-01-28

    Magnetic tubular implantable micro-robots are batch fabricated by electroforming. These microdevices can be used in targeted drug delivery and minimally invasive surgery for ophthalmologic applications. These tubular shapes are fitted into a 23-gauge needle enabling sutureless injections. Using a 5-degree-of-freedom magnetic manipulation system, the microimplants are conveniently maneuvered in biological environments. To increase their functionality, the tubes are coated with biocompatible films and can be successfully filled with drugs.

  7. 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.

  8. Elementary Implantable Force Sensor

    PubMed Central

    Wachs, Rebecca A.; Ellstein, David; Drazan, John; Healey, Colleen P.; Uhl, Richard L.; Connor, Kenneth A.

    2014-01-01

    Implementing implantable sensors which are robust enough to maintain long term functionality inside the body remains a significant challenge. The ideal implantable sensing system is one which is simple and robust; free from batteries, telemetry, and complex electronics. We have developed an elementary implantable sensor for orthopaedic smart implants. The sensor requires no telemetry and no batteries to communicate wirelessly. It has no on-board signal conditioning electronics. The sensor itself has no electrical connections and thus does not require a hermetic package. The sensor is an elementary L-C resonator which can function as a simple force transducer by using a solid dielectric material of known stiffness between two parallel Archimedean coils. The operating characteristics of the sensors are predicted using a simplified, lumped circuit model. We have demonstrated sensor functionality both in air and in saline. Our preliminary data indicate that the sensor can be reasonably well modeled as a lumped circuit to predict its response to loading. PMID:24883335

  9. 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.

  10. Remote actuated valve implant

    DOEpatents

    McKnight, Timothy E.; Johnson, Anthony; Moise, Kenneth J.; Ericson, Milton Nance; Baba, Justin S.; Wilgen, John B.; Evans, Boyd Mccutchen

    2016-05-10

    Valve implant systems positionable within a flow passage, the systems having an inlet, an outlet, and a remotely activatable valve between the inlet and outlet, with the valves being operable to provide intermittent occlusion of the flow path. A remote field is applied to provide thermal or magnetic activation of the valves.

  11. Ion implantation in polymers

    NASA Astrophysics Data System (ADS)

    Wintersgill, M. C.

    1984-02-01

    An introductory overview will be given of the effects of ion implantation on polymers, and certain areas will be examined in more detail. Radiation effects in general and ion implantation in particular, in the field of polymers, present a number of contrasts with those in ionic crystals, the most obvious difference being that the chemical effects of both the implanted species and the energy transfer to the host may profoundly change the nature of the target material. Common effects include crosslinking and scission of polymer chains, gas evolution, double bond formation and the formation of additional free radicals. Research has spanned the chemical processes involved, including polymerization reactions achievable only with the use of radiation, to applied research dealing both with the effects of radiation on polymers already in commercial use and the tailoring of new materials to specific applications. Polymers are commonly divided into two groups, in describing their behavior under irradiation. Group I includes materials which form crosslinks between molecules, whereas Group II materials tend to degrade. In basic research, interest has centered on Group I materials and of these polyethylene has been studied most intensively. Applied materials research has investigated a variety of polymers, particularly those used in cable insulation, and those utilized in ion beam lithography of etch masks. Currently there is also great interest in enhancing the conducting properties of polymers, and these uses would tend to involve the doping capabilities of ion implantation, rather than the energy deposition.

  12. Peritoneal trophoblastic implant.

    PubMed

    Rachagan, S P; Kutty, K; Govindan, K S

    1997-09-01

    A case of persistent trophoblastic tissue on the pelvic peritoneum is presented. While most cases are secondary to conservative surgery for tubal ectopic pregnancy, primary implantation can also occur as highlighted by this case. A brief pathophysiology of the condition is presented. The importance of monitoring the serum for beta subunit human chorionic gonadotrophin (HCG) is emphasised.

  13. 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.

  14. Implantable electrical device

    NASA Technical Reports Server (NTRS)

    Jhabvala, M. D. (Inventor)

    1982-01-01

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

  15. Implantable Impedance Plethysmography

    PubMed Central

    Theodor, Michael; Ruh, Dominic; Ocker, Martin; Spether, Dominik; Förster, Katharina; Heilmann, Claudia; Beyersdorf, Friedhelm; Manoli, Yiannos; Zappe, Hans; Seifert, Andreas

    2014-01-01

    We demonstrate by theory, as well as by ex vivo and in vivo measurements that impedance plethysmography, applied extravascularly directly on large arteries, is a viable method for monitoring various cardiovascular parameters, such as blood pressure, with high accuracy. The sensor is designed as an implant to monitor cardiac events and arteriosclerotic progression over the long term. PMID:25123467

  16. 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.

  17. The reverse zygomatic implant: a new implant for maxillofacial reconstruction.

    PubMed

    Dawood, Andrew; Collier, Jonathan; Darwood, Alastair; Tanner, Susan

    2015-01-01

    This case report describes the rehabilitation of a patient who had been treated with a hemimaxillectomy, reconstruction with a latissimus dorsi vascularized free flap, and radiotherapy for carcinoma of the sinus some years previously. Limited jaw opening, difficult access through the flap to the bony site, and the very small amount of bone available in which to anchor the implant inspired the development and use of a new "reverse zygomatic" implant. For this treatment, site preparation and implant insertion were accomplished using an extraoral approach. The implant was used along with two other conventional zygomatic implants to provide support for a milled titanium bar and overdenture to rehabilitate the maxilla. Two years later, the patient continues to enjoy a healthy reconstruction. The reverse zygomatic implant appears to show promise as a useful addition to the implant armamentarium for the treatment of the patient undergoing maxillectomy. PMID:26574864

  18. Bioceramic in dental implants: A review.

    PubMed

    Jayaswal, Gaurav P; Dange, S P; Khalikar, A N

    2010-03-01

    Biomaterials are non-drug substance suitable for inclusion in system which augment or replace the function of bodily tissue or organ. Orthopedic and dental applications represent approximately 55% of the total biomaterials market. Changes in biologic responses and device design have been the direct result of advances in material science. Bioceramics fulfill a unique function as biomedical materials. Bioceramics are non-toxic and bioinert, bioactive or bioresorbable. Bioceramics continue to be vital for bone repair and uncemented implant fixation with recent advances in its composition and coating technology.

  19. 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.

  20. Additive manufacturing: From implants to organs.

    PubMed

    Douglas, Tania S

    2014-06-01

    Additive manufacturing (AM) constructs 3D objects layer by layer under computer control from 3D models. 3D printing is one example of this kind of technology. AM offers geometric flexibility in its products and therefore allows customisation to suit individual needs. Clinical success has been shown with models for surgical planning, implants, assistive devices and scaffold-based tissue engineering. The use of AM to print tissues and organs that mimic nature in structure and function remains an elusive goal, but has the potential to transform personalised medicine, drug development and scientific understanding of the mechanisms of disease.  PMID:25214247

  1. 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. 

  2. Drug/device combinations for local drug therapies and infection prophylaxis.

    PubMed

    Wu, Peng; Grainger, David W

    2006-04-01

    Combination devices-those comprising drug releasing components together with functional prosthetic implants-represent a versatile, emerging clinical technology promising to provide functional improvements to implant devices in several classes. Landmark antimicrobial catheters and the drug-eluting stent have heralded the entrance, and significantly, routes to FDA approval, for these devices into clinical practice. This review describes recent strategies creating implantable combination devices. Most prominent are new combination devices representing current orthopedic and cardiovascular implants with new added capabilities from on-board or directly associated drug delivery systems are now under development. Wound coverings and implantable sensors will also benefit from this combination enhancement. Infection mitigation, a common problem with implantable devices, is a current primary focus. On-going progress in cell-based therapeutics, progenitor cell exploitation, growth factor delivery and advanced formulation strategies will provide a more general and versatile basis for advanced combination device strategies. These seek to improve tissue-device integration and functional tissue regeneration. Future combination devices might best be completely re-designed de novo to deliver multiple bioactive agents over several spatial and temporal scales to enhance prosthetic device function, instead of the current 'add-on' approach to existing implant device designs never originally intending to function in tandem with drug delivery systems.

  3. Pediatric Cochlear Implantation: Why Do Children Receive Implants Late?

    PubMed Central

    Ham, Julia; Whittingham, JoAnne

    2015-01-01

    Objectives: Early cochlear implantation has been widely promoted for children who derive inadequate benefit from conventional acoustic amplification. Universal newborn hearing screening has led to earlier identification and intervention, including cochlear implantation in much of the world. The purpose of this study was to examine age and time to cochlear implantation and to understand the factors that affected late cochlear implantation in children who received cochlear implants. Design: In this population-based study, data were examined for all children who underwent cochlear implant surgery in one region of Canada from 2002 to 2013. Clinical characteristics were collected prospectively as part of a larger project examining outcomes from newborn hearing screening. For this study, audiologic details including age and severity of hearing loss at diagnosis, age at cochlear implant candidacy, and age at cochlear implantation were documented. Additional detailed medical chart information was extracted to identify the factors associated with late implantation for children who received cochlear implants more than 12 months after confirmation of hearing loss. Results: The median age of diagnosis of permanent hearing loss for 187 children was 12.6 (interquartile range: 5.5, 21.7) months, and the age of cochlear implantation over the 12-year period was highly variable with a median age of 36.2 (interquartile range: 21.4, 71.3) months. A total of 118 (63.1%) received their first implant more than 12 months after confirmation of hearing loss. Detailed analysis of clinical profiles for these 118 children revealed that late implantation could be accounted for primarily by progressive hearing loss (52.5%), complex medical conditions (16.9%), family indecision (9.3%), geographical location (5.9%), and other miscellaneous known (6.8%) and unknown factors (8.5%). Conclusions: This study confirms that despite the trend toward earlier implantation, a substantial number of children

  4. 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

  5. Sterilisation of implantable devices.

    PubMed

    Matthews, I P; Gibson, C; Samuel, A H

    1994-01-01

    The pathogenesis and rates of infection associated with the use of a wide variety of implantable devices are described. The multi-factorial nature of post-operative periprosthetic infection is outlined and the role of sterilisation of devices is explained. The resistance of bacterial spores is highlighted as a problem and a full description is given of the processes of sterilisation by heat, steam, ethylene oxide, low temperature steam and formaldehyde, ionising radiation and liquid glutaraldehyde. Sterility assurance and validation are discussed in the context of biological indicators and physical/chemical indicators. Adverse effects upon the material composition of devices and problems of process control are listed. Finally, possible optimisations of the ethylene oxide process and their potential significance to the field of sterilisation of implants is explored. PMID:10172076

  6. Club Drugs

    MedlinePlus

    ... Rohypnol, ketamine, as well as MDMA (ecstasy) and methamphetamine ( Drug Facts: Club Drugs , National Institute on Drug ... Club Drugs , National Institute on Drug Abuse, 2010). Methamphetamine is a powerfully addictive stimulant associated with serious ...

  7. Atypical Case of Three Dental Implants Displaced into the Maxillary Sinus

    PubMed Central

    Bruniera, João Felipe Bonatto; Silva-Sousa, Yara Teresinha Corrêa; Faria, Paulo Esteves Pinto

    2015-01-01

    Oral rehabilitation with dental implants has become a routine treatment in contemporary dentistry. The displacement of dental implants into the sinus membrane, a complication related to the maxillary sinus, is one of the most common accidents reported in the literature. The treatment for this complication is the surgical removal of the implant. A 60-year-old woman with three dental implants displaced into the maxillary sinus (one implant displaced into the left maxillary sinus and two implants displaced into the right maxillary sinus) underwent surgery for removal of the implants. The surgery to remove the implants was performed under local anesthesia through the Caldwell-Luc technique. The patient was subsequently administered antibiotic, anti-inflammatory, and analgesic drugs. The patient returned 7 days after the surgery for suture removal and is being regularly monitored to determine whether future rehabilitation of the edentulous area is necessary. In conclusion, surgical removal of the dental implant displaced into the maxillary sinus is the treatment of choice. This technique is appropriate because it allows the use of local anesthesia and provides direct visualization for the removal of the implants. PMID:26635979

  8. Impact of Dental Implant Surface Modifications on Osseointegration.

    PubMed

    Smeets, Ralf; Stadlinger, Bernd; Schwarz, Frank; Beck-Broichsitter, Benedicta; Jung, Ole; Precht, Clarissa; Kloss, Frank; Gröbe, Alexander; Heiland, Max; Ebker, Tobias

    2016-01-01

    Objective. The aim of this paper is to review different surface modifications of dental implants and their effect on osseointegration. Common marketed as well as experimental surface modifications are discussed. Discussion. The major challenge for contemporary dental implantologists is to provide oral rehabilitation to patients with healthy bone conditions asking for rapid loading protocols or to patients with quantitatively or qualitatively compromised bone. These charging conditions require advances in implant surface design. The elucidation of bone healing physiology has driven investigators to engineer implant surfaces that closely mimic natural bone characteristics. This paper provides a comprehensive overview of surface modifications that beneficially alter the topography, hydrophilicity, and outer coating of dental implants in order to enhance osseointegration in healthy as well as in compromised bone. In the first part, this paper discusses dental implants that have been successfully used for a number of years focusing on sandblasting, acid-etching, and hydrophilic surface textures. Hereafter, new techniques like Discrete Crystalline Deposition, laser ablation, and surface coatings with proteins, drugs, or growth factors are presented. Conclusion. Major advancements have been made in developing novel surfaces of dental implants. These innovations set the stage for rehabilitating patients with high success and predictable survival rates even in challenging conditions.

  9. Impact of Dental Implant Surface Modifications on Osseointegration.

    PubMed

    Smeets, Ralf; Stadlinger, Bernd; Schwarz, Frank; Beck-Broichsitter, Benedicta; Jung, Ole; Precht, Clarissa; Kloss, Frank; Gröbe, Alexander; Heiland, Max; Ebker, Tobias

    2016-01-01

    Objective. The aim of this paper is to review different surface modifications of dental implants and their effect on osseointegration. Common marketed as well as experimental surface modifications are discussed. Discussion. The major challenge for contemporary dental implantologists is to provide oral rehabilitation to patients with healthy bone conditions asking for rapid loading protocols or to patients with quantitatively or qualitatively compromised bone. These charging conditions require advances in implant surface design. The elucidation of bone healing physiology has driven investigators to engineer implant surfaces that closely mimic natural bone characteristics. This paper provides a comprehensive overview of surface modifications that beneficially alter the topography, hydrophilicity, and outer coating of dental implants in order to enhance osseointegration in healthy as well as in compromised bone. In the first part, this paper discusses dental implants that have been successfully used for a number of years focusing on sandblasting, acid-etching, and hydrophilic surface textures. Hereafter, new techniques like Discrete Crystalline Deposition, laser ablation, and surface coatings with proteins, drugs, or growth factors are presented. Conclusion. Major advancements have been made in developing novel surfaces of dental implants. These innovations set the stage for rehabilitating patients with high success and predictable survival rates even in challenging conditions. PMID:27478833

  10. 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

  11. Implants for cranioplasty.

    PubMed

    Gladstone, H B; McDermott, M W; Cooke, D D

    1995-04-01

    As long as there have been skull defects, there has been a recognized need to cover them in some way. Cranioplasty is the surgical correction of skull defects. The two major purposes of performing a cranioplasty are to protect the brain and to provide reasonable cosmesis. The two physical requirements of the implant are strength and malleability. Originally, foreign materials such as precious metals were used. Autogenous bone grafts have also achieved successful results. Over the past quarter-century, the popularization of acrylics and radiolucent metals has favored them over bone because of their ease of use, the absence of need to harvest donor bone, and, particularly, bone's tendency to resorb or scar. Yet foreign materials can cause excessive inflammation, producing a synovial membrane at the interface between the host bone and cranioplasty construct, increasing the risk of infection. Currently, hydroxyapatite-based ceramics, which may induce bone growth into the implant, are increasingly being used. Future applications will include antibiotic-impregnated implants and computer-generated models to improve the precision of cranioplasty fit and cosmesis.

  12. [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.

  13. Sub-meninges implantation reduces immune response to neural implants.

    PubMed

    Markwardt, Neil T; Stokol, Jodi; Rennaker, Robert L

    2013-04-15

    Glial scar formation around neural interfaces inhibits their ability to acquire usable signals from the surrounding neurons. To improve neural recording performance, the inflammatory response and glial scarring must be minimized. Previous work has indicated that meningeally derived cells participate in the immune response, and it is possible that the meninges may grow down around the shank of a neural implant, contributing to the formation of the glial scar. This study examines whether the glial scar can be reduced by placing a neural probe completely below the meninges. Rats were implanted with sets of loose microwire implants placed either completely below the meninges or implanted conventionally with the upper end penetrating the meninges, but not attached to the skull. Histological analysis was performed 4 weeks following surgical implantation to evaluate the glial scar. Our results found that sub-meninges implants showed an average reduction in reactive astrocyte activity of 63% compared to trans-meninges implants. Microglial activity was also reduced for sub-meninges implants. These results suggest that techniques that isolate implants from the meninges offer the potential to reduce the encapsulation response which should improve chronic recording quality and stability.

  14. Sub-meninges Implantation Reduces Immune Response to Neural Implants

    PubMed Central

    Markwardt, Neil T.; Stokol, Jodi; Rennaker, Robert L.

    2013-01-01

    Glial scar formation around neural interfaces inhibits their ability to acquire usable signals from the surrounding neurons. To improve neural recording performance, the inflammatory response and glial scarring must be minimized. Previous work has indicated that meningeally derived cells participate in the immune response, and it is possible that the meninges may grow down around the shank of a neural implant, contributing to the formation of the glial scar. This study examines whether the glial scar can be reduced by placing a neural probe completely below the meninges. Rats were implanted with sets of loose microwire implants placed either completely below the meninges or implanted conventionally with the upper end penetrating the meninges, but not attached to the skull. Histological analysis was performed 4 weeks following surgical implantation to evaluate the glial scar. Our results found that sub-meninges implants showed an average reduction in reactive astrocyte activity of 63% compared to trans-meninges implants. Microglial activity was also reduced for sub-meninges implants. These results suggest that techniques that isolate implants from the meninges offer the potential to reduce the encapsulation response which should improve chronic recording quality and stability. PMID:23370311

  15. Implantation of Vascular Grafts Lined with Genetically Modified Endothelial Cells

    NASA Astrophysics Data System (ADS)

    Wilson, James M.; Birinyi, Louis K.; Salomon, Robert N.; Libby, Peter; Callow, Allan D.; Mulligan, Richard C.

    1989-06-01

    The possibility of using the vascular endothelial cell as a target for gene replacement therapy was explored. Recombinant retroviruses were used to transduce the lacZ gene into endothelial cells harvested from mongrel dogs. Prosthetic vascular grafts seeded with the genetically modified cells were implanted as carotid interposition grafts into the dogs from which the original cells were harvested. Analysis of the graft 5 weeks after implantation revealed genetically modified endothelial cells lining the luminal surface of the graft. This technology could be used in the treatment of atherosclerosis disease and the design of new drug delivery systems.

  16. [Professional occupation after cochlear implantation].

    PubMed

    Kós, Maria-Izabel; Degive, Colette; Boëx, Colette; Maire, Raphaël; Guyot, Jean-Philippe

    2006-10-01

    This study verifies whether cochlear implants helps deaf adults to maintain or develop their professional occupations. Sixty-seven patients received a questionnaire concerning their professional activities before and after implantation. At the time of implantation 34 were professionally active. After the implantation 29 remained active, 4 of them reporting positive developments in their careers. Five patients became inactive. The previously inactive patients remained inactive. There was no difference in auditory performances between professionally active or inactive patients. Cochlear implants enable most implanted adults to maintain and even progress in their professions. However, deafness still represents an obstacle to social integration as inactive patients who searched for a job were rejected after the job interviews. PMID:17076153

  17. 77 FR 31722 - New Animal Drugs; Change of Sponsor; Estradiol; Estradiol Benzoate and Testosterone Propionate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-30

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 522, and 558 New Animal Drugs; Change of... amending the animal drug regulations to reflect a change of sponsor for 17 new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) for various steroid ear implants for...

  18. Foreign body response to subcutaneous biomaterial implants in a mast cell-deficient Kit(w-Sh) murine model.

    PubMed

    Avula, M N; Rao, A N; McGill, L D; Grainger, D W; Solzbacher, F

    2014-05-01

    Mast cells (MCs)_are recognized for their functional role in wound-healing and allergic and inflammatory responses - host responses that are frequently detrimental to implanted biomaterials if extended beyond acute reactivity. These tissue reactions impact especially on the performance of sensing implants such as continuous glucose monitoring (CGM) devices. Our hypothesis that effective blockade of MC activity around implants could alter the host foreign body response (FBR) and enhance the in vivo lifetime of these implantable devices motivated this study. Stem cell factor and its ligand c-KIT receptor are critically important for MC survival, differentiation and degranulation. Therefore, an MC-deficient sash mouse model was used to assess MC relationships to the in vivo performance of CGM implants. Additionally, local delivery of a tyrosine kinase inhibitor (TKI) that inhibits c-KIT activity was also used to evaluate the role of MCs in modulating the FBR. Model sensor implants comprising polyester fibers coated with a rapidly dissolving polymer coating containing drug-releasing degradable microspheres were implanted subcutaneously in sash mice for various time points, and the FBR was evaluated for chronic inflammation and fibrous capsule formation around the implants. No significant differences were observed in the foreign body capsule formation between control and drug-releasing implant groups in MC-deficient mice. However, fibrous encapsulation was significantly greater around the drug-releasing implants in sash mice compared to drug-releasing implants in wild-type (e.g. MC-competent) mice. These results provide insights into the role of MCs in the FBR, suggesting that MC deficiency provides alternative pathways for host inflammatory responses to implanted biomaterials. PMID:24406200

  19. Foreign body response to subcutaneous biomaterial implants in a mast cell-deficient Kit(w-Sh) murine model.

    PubMed

    Avula, M N; Rao, A N; McGill, L D; Grainger, D W; Solzbacher, F

    2014-05-01

    Mast cells (MCs)_are recognized for their functional role in wound-healing and allergic and inflammatory responses - host responses that are frequently detrimental to implanted biomaterials if extended beyond acute reactivity. These tissue reactions impact especially on the performance of sensing implants such as continuous glucose monitoring (CGM) devices. Our hypothesis that effective blockade of MC activity around implants could alter the host foreign body response (FBR) and enhance the in vivo lifetime of these implantable devices motivated this study. Stem cell factor and its ligand c-KIT receptor are critically important for MC survival, differentiation and degranulation. Therefore, an MC-deficient sash mouse model was used to assess MC relationships to the in vivo performance of CGM implants. Additionally, local delivery of a tyrosine kinase inhibitor (TKI) that inhibits c-KIT activity was also used to evaluate the role of MCs in modulating the FBR. Model sensor implants comprising polyester fibers coated with a rapidly dissolving polymer coating containing drug-releasing degradable microspheres were implanted subcutaneously in sash mice for various time points, and the FBR was evaluated for chronic inflammation and fibrous capsule formation around the implants. No significant differences were observed in the foreign body capsule formation between control and drug-releasing implant groups in MC-deficient mice. However, fibrous encapsulation was significantly greater around the drug-releasing implants in sash mice compared to drug-releasing implants in wild-type (e.g. MC-competent) mice. These results provide insights into the role of MCs in the FBR, suggesting that MC deficiency provides alternative pathways for host inflammatory responses to implanted biomaterials.

  20. The Evolution of Breast Implants.

    PubMed

    Gabriel, Allen; Maxwell, G Patrick

    2015-10-01

    Breast augmentation remains one of the most common procedures performed in the United States. However, shape, feel, safety, and longevity of the implants remain important areas of research. The data provided by manufacturers show the safety and efficacy of these medical devices. Clinicians should strive to provide ongoing data and sound science to continue to improve clinical outcomes in the future. This article explores the evolution of breast implants with special emphasis on the advancement of silicone implants.

  1. 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

  2. Professional occupation after cochlear implantation.

    PubMed

    Kos, M-I; Degive, C; Boex, C; Guyot, J-P

    2007-03-01

    The aims of this study were to verify whether cochlear implants helped profoundly deaf adults to maintain or even to develop their professional occupations, and to identify other elements that may contribute to or, on the contrary, impede such patients' professional success. All adult patients received a questionnaire concerning their professional activities before and after implantation. Demographic data, health information, hearing performance and degree of satisfaction with the implant were also considered. Sixty-seven adults had been implanted, with three different devices, since 1985. At the time of implantation, 34 had been professionally active. After implantation, 29 had remained professionally active, four of whom reported positive developments in their careers. Five patients had become professionally inactive. Those patients who had previously been professionally inactive remained so. There had been no difference in performance, either between different types of cochlear implants or between professionally active or inactive patients. The implanted patients had kept their jobs and many of them had developed their professional skills. In spite of this, cochlear implants may still be perceived as proving insufficiently satisfactory hearing to enable professionally inactive patients to reintegrate and to facilitate further learning or career developments. PMID:17052367

  3. Microchip technology in drug delivery.

    PubMed

    Santini, J T; Richards, A C; Scheidt, R A; Cima, M J; Langer, R S

    2000-09-01

    The realization that the therapeutic efficacy of certain drugs can be affected dramatically by the way in which they are delivered has created immense interest in controlled drug delivery systems. Much previous work in drug delivery focused on achieving sustained drug release rates over time, while a more recent trend is to make devices that allow the release rate to be varied over time. Advances in microfabrication technology have made an entirely new type of drug delivery device possible. Proof-of-principle experiments have shown that silicon microchips have the ability to store and release multiple chemicals on demand. Future integration of active control electronics, such as microprocessors, remote control units, or biosensors, could lead to the development of a 'pharmacy on a chip,' ie 'smart' microchip implants or tablets that release drugs into the body automatically when needed.

  4. Drug allergies

    MedlinePlus

    Allergic reaction - drug (medication); Drug hypersensitivity; Medication hypersensitivity ... A drug allergy involves an immune response in the body that produces an allergic reaction to a medicine. The ...

  5. 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.

  6. 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.

  7. 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.

  8. Computer implants and death.

    PubMed

    Gert, Bernard

    2009-01-01

    Although a patient whose whole brain has ceased to function may have his heart, lungs, and other organs continue to function if they are connected to the appropriate machines, the patient is still dead and the machines can be disconnected. In the future, nanotechnology, or other technology, may allow putting implants in the brainstem that can keep a patient's heart, lungs and other organs functioning, even though the whole natural brain has ceased to function. It would be useful to consider how this technology might affect the criterion of death before it is actually available.

  9. Bone cement implantation syndrome.

    PubMed

    Razuin, R; Effat, O; Shahidan, M N; Shama, D V; Miswan, M F M

    2013-06-01

    Bone cement implantation syndrome (BCIS) is characterized by hypoxia, hypotension, cardiac arrhythmias, increased pulmonary vascular resistance and cardiac arrest. It is a known cause of morbidity and mortality in patients undergoing cemented orthopaedic surgeries. The rarity of the condition as well as absence of a proper definition has contributed to under-reporting of cases. We report a 59-year-old woman who sustained fracture of the neck of her left femur and underwent an elective hybrid total hip replacement surgery. She collapsed during surgery and was revived only to succumb to death twelve hours later. Post mortem findings showed multiorgan disseminated microembolization of bone marrow and amorphous cement material. PMID:23817399

  10. 21 CFR 880.5965 - Subcutaneous, implanted, intravascular infusion port and catheter.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... port and catheter. 880.5965 Section 880.5965 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... port and catheter. (a) Identification. A subcutaneous, implanted, intravascular infusion port and... catheter is either preattached to the port or attached to the port at the time of device placement....

  11. [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.

  12. Bone regeneration associated with nontherapeutic and therapeutic surface coatings for dental implants in osteoporosis.

    PubMed

    Alghamdi, Hamdan S; Jansen, John A

    2013-06-01

    Oral implantology is considered as the treatment of choice for replacing missing teeth in elderly people. However, implant complications may occur in patients with osteoporosis. The pathogenesis underlying osteoporosis is due to an alteration in bone cell response to hormonal, nutritional, and aging factors. For such challenging situations, improved bone regeneration has been shown around dental implants for certain surface modifications. These modifications include coatings of titanium implants with calcium phosphate (CaP) ceramics. Surface coating developments also allow for the addition of organic biomolecules, like growth factors, into the inorganic coatings that increase the bone formation process at the bone-implant interface. The application of therapeutic-based coatings is becoming a rapidly growing research field of interest. CaP-coated implants have the ability to incorporate anti-osteoporotic drugs, which then can be locally released over time from an implant surface in a controlled manner. Thus, it can be anticipated that nontherapeutic and/or therapeutic coated implants can significantly increase low bone density as well as improve impaired bone regeneration in osteoporosis. This review aims to provide a thorough understanding of the underlying mechanisms for impaired bone regeneration around dental implants in osteoporosis. Secondly, the review will focus on biological interactions and beneficial role of the surface-coated (i.e., nontherapeutics and therapeutics) bone implants in osteoporotic bone tissue.

  13. 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. PMID

  14. 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.

  15. 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 ...

  16. The Implantable Cardiac Pacemaker

    PubMed Central

    Trimble, A. S.; Heimbecker, R. O.; Bigelow, W. G.

    1964-01-01

    The transistorized implanted pacemaker is proving to be an effective and reliable method for long-term pacing of the heart. All patients suffering from Stokes-Adams seizures were first given a trial period of conservative therapy, including isoproterenol (Isuprel), ephedrine, atropine and steroids. Twenty-four pacemaker implants were performed on 23 patients over a 21-month period. The preoperative insertion of a pacemaker cardiac catheter was a very valuable safety precaution. In this way the heart could be safely and reliably paced during the period of preoperative assessment and during the critical periods of anesthetic induction and thoracotomy. Infection did not occur, probably because of careful gas sterilization of the units. Various models of pacemakers are compared, and the reasons for two pacemaker failures are presented. There were two early deaths and one late death in the series. The relationship of progressive coronary disease to recent infarction is stressed. Patients having intermittent heart block frequently showed the picture of “competing pacemakers” postoperatively, but without deleterious effect. Twenty patients, between 54 and 88 years of age, are alive and well at the time of reporting, with excellent pacemaker response and no further Stokes-Adams attacks. ImagesFig. 1Fig. 2Fig. 3Fig. 4Fig. 5Fig. 6 PMID:14118681

  17. Transcatheter aortic valve implantation.

    PubMed

    Kapadia, Samir R; Tuzcu, E Murat

    2009-12-01

    Aortic stenosis is the most important valvular heart disease affecting the elderly population. Surgical aortic valve replacement is the mainstay of treatment, although a substantial number of patients are considered high risk for surgery. Many of these patients do not undergo surgery and have poor outcomes from medically treated symptomatic, severe aortic stenosis. Transcatheter aortic valve implantation (TAVI) provides a promising treatment option for some of these patients. Several devices are under investigation. The Edwards Sapien valve (Edwards Lifesciences, Irvine, CA) and the CoreValve (Medtronic, Minneapolis, MN) have the largest human experience to date. Initial data suggest that these devices have an acceptable safety profile and provide excellent hemodynamic relief of aortic stenosis. The Edwards Sapien valve is currently under investigation in the United States in the PARTNER (Placement of Aortic Transcatheter Valve) trial in high-risk surgical or inoperable patients; TAVI is available for clinical use in both Canada and Europe. TAVI is not used in low- or intermediate-risk surgical patients; however, future studies may prove its applicability in these subsets. The major complications of TAVI include access site-related problems and device malpositioning/migration. There are several new-generation prosthetic valves and delivery systems designed to be low profile and repositionable. Technical advances and refinement of the implantation methods may make TAVI even safer and ultimately a better treatment option, not only for patients with high surgical risk but also for those with moderate or low risk.

  18. Porous metal for orthopedics implants

    PubMed Central

    Matassi, Fabrizio; Botti, Alessandra; Sirleo, Luigi; Carulli, Christian; Innocenti, Massimo

    2013-01-01

    Summary Porous metal has been introduced to obtain biological fixation and improve longevity of orthopedic implants. The new generation of porous metal has intriguing characteristics that allows bone healing and high osteointegration of the metallic implants. This article gives an overview about biomaterials properties of the contemporary class of highly porous metals and about the clinical use in orthopaedic surgery. PMID:24133527

  19. 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

  20. Awake transapical aortic valve implantation.

    PubMed

    Petridis, Francesco Dimitri; Savini, Carlo; Castelli, Andrea; Di Bartolomeo, Roberto

    2012-05-01

    Transapical aortic valve implantation is being employed as a less invasive alternative to open heart surgery in high-risk patients with severe aortic stenosis. Here we report the case of an awake transapical aortic valve implantation in a patient with severe chronic obstructive pulmonary disease.

  1. Photonic technologies for visual implants

    NASA Astrophysics Data System (ADS)

    Buss, Ruediger; Praemassing, F.; Puettjer, D.; Stawski, N.; Jaeger, Dieter

    2003-02-01

    In this paper two applications of photonic technologies for visual implants in the field of medicine are presented. Both are technical systems working as vision aid for people suffering from blindness due to damages in their visual system. The first system is a retinal implant (RI), the second an intraocular vision aid (IoVA) for people with opaque cornea.

  2. Hernia Surgical Mesh Implants

    MedlinePlus

    ... Surgical Clinics of North America; 83(5):1045-51, v-vi. 2 . http://www.facs.org/public_ ... FDA Contact FDA Browse by Product Area Product Areas back Food Drugs Medical Devices Radiation-Emitting Products ...

  3. 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

  4. [Dental implants in tooth grinders].

    PubMed

    Lobbezoo, F; Brouwers, J E; Cune, M S; Naeije, M

    2004-03-01

    Bruxism (tooth grinding and clenching) is generally considered a contraindication for dental implants, although the evidence is usually based on clinical experience only. So far, studies to the possible cause-and-effect relationship between bruxism and implant failure do not yield consistent and specific outcomes. This is partly due to the large variation in the technical and the biological aspects of the investigations. Although there is still no proof that bruxism causes overload of dental implants and their suprastructures, a careful approach is recommended. Practical advices as to minimize the chance of implant failure are given. Besides the recommendation to reduce or eliminate bruxism itself, these advices concern the number and dimensions of the implants, the design of the occlusion and articulation patterns, and the use of a hard nightguard. PMID:15058243

  5. Curcumin-releasing mechanically adaptive intracortical implants improve the proximal neuronal density and blood-brain barrier stability.

    PubMed

    Potter, Kelsey A; Jorfi, Mehdi; Householder, Kyle T; Foster, E Johan; Weder, Christoph; Capadona, Jeffrey R

    2014-05-01

    The cellular and molecular mechanisms by which neuroinflammatory pathways respond to and propagate the reactive tissue response to intracortical microelectrodes remain active areas of research. We previously demonstrated that both the mechanical mismatch between rigid implants and the much softer brain tissue, as well as oxidative stress, contribute to the neurodegenerative reactive tissue response to intracortical implants. In this study, we utilize physiologically responsive, mechanically adaptive polymer implants based on poly(vinyl alcohol) (PVA), with the capability to also locally administer the antioxidant curcumin. The goal of this study is to investigate if the combination of two independently effective mechanisms - softening of the implant and antioxidant release - leads to synergistic effects in vivo. Over the first 4weeks of the implantation, curcumin-releasing, mechanically adaptive implants were associated with higher neuron survival and a more stable blood-brain barrier at the implant-tissue interface than the neat PVA controls. 12weeks post-implantation, the benefits of the curcumin release were lost, and both sets of compliant materials (with and without curcumin) had no statistically significant differences in neuronal density distribution profiles. Overall, however, the curcumin-releasing softening polymer implants cause minimal implant-mediated neuroinflammation, and embody the new concept of localized drug delivery from mechanically adaptive intracortical implants.

  6. Speech Production Intelligibility of Early Implanted Pediatric Cochlear Implant Users

    PubMed Central

    Habib, Mirette G.; Waltzman, Susan B.; Tajudeen, Bobby; Svirsky, Mario A.

    2010-01-01

    Objectives To investigate the influence of age, and age at implantation, on speech production intelligibility in prelingually deaf pediatric cochlear implant recipients. Methods Forty prelingually, profoundly deaf children who received cochlear implants between 8 and 40 months of age. Their age at testing ranged between 2.5 – 18 years. Children were recorded repeating the ten sentences in the Beginner’s Intelligibility Test. These recordings were played back to normal-hearing listeners who were unfamiliar with deaf speech and who were instructed to write down what they heard. They also rated each subject for the intelligibility of their speech production on a 5-point rating scale. The main outcome measures were the percentage of target words correctly transcribed, and the intelligibility ratings, in both cases averaged across three normal-hearing listeners. Results The data showed a strong effect of age at testing, with older children being more intelligible. This effect was particularly pronounced for children implanted in the first 24 months of life, all of whom had speech production intelligibility scores of 80% or higher when they were tested at age 5.5 years or older. This was true for only five out of nine children implanted at age 25 to 36 months. Conclusions Profoundly deaf children who receive cochlear implants in the first two years of life produce highly intelligible speech before age 6. This is also true for most, but not all children implanted in their third year. PMID:20472308

  7. Dexamethasone intravitreal implant for the treatment of noninfectious uveitis.

    PubMed

    Hunter, Rebecca S; Lobo, Ann-Marie

    2011-01-01

    Uveitis can be a sight-threatening eye disease with significant morbidity. Corticosteroids remain the mainstay of treatment of uveitis and provide an effective treatment against ocular inflammation. However, the various modes available for corticosteroid drug delivery can carry significant ocular and systemic side effects which can limit their use in the treatment of uveitis. In an effort to avoid the damage to ocular structures that can ensue with recurrent episodes of ocular inflammation, the side effects associated with systemic steroids, and the need for repeated administration of both topical and locally injected corticosteroids, sustained-release intraocular corticosteroid implants have been developed. The dexamethasone (DEX) drug delivery system (Ozurdex(®); Allergan Inc, Irvine, CA), is a biodegradable intravitreal implant. This implant has been shown to be effective in the treatment of macular edema and noninfectious posterior uveitis and has been approved by the FDA for these entities. This review will highlight the current methods available for corticosteroid delivery to the eye with a particular emphasis on the DEX intravitreal implant and the evidence currently available for its use in noninfectious uveitis.

  8. Transcatheter aortic valve implantation.

    PubMed

    Nielsen, Hans Henrik Møller

    2012-12-01

    Transcatheter aortic valve implantation (TAVI) was introduced experimentally in 1989, based on a newly developed heart valve prosthesis - the stentvalve. The valve was invented by a Danish cardiologist named Henning Rud Andersen. The new valve was revolutionary. It was foldable and could be inserted via a catheter through an artery in the groin, without the need for heart lung machine. This allowed for a new valve implantation technique, much less invasive than conventional surgical aortic valve replacement (SAVR). Surgical aortic valve replacement is safe and improves symptoms along with survival. However, up to 1/3 of patients with aortic valve stenosis cannot complete the procedure due to frailty. The catheter technique was hoped to provide a new treatment option for these patients. The first human case was in 2002, but more widespread clinical use did not begin until 2006-2010. Today, in 2011, more than 40,000 valves have been implanted worldwide. Initially, because of the experimental character of the procedure, TAVI was reserved for patients who could not undergo SAVR due to high risk. The results in this group of patients were promising. The procedural safety was acceptable, and the patients experienced significant improvements in their symptoms. Three of the papers in this PhD-thesis are based on the outcome of TAVI at Skejby Hospital, in this high-risk population [I, II and IV]. Along with other international publications, they support TAVI as being superior to standard medical treatment, despite a high risk of prosthetic regurgitation. These results only apply to high-risk patients, who cannot undergo SAVR. The main purpose of this PhD study has been to investigate the quality of TAVI compared to SAVR, in order to define the indications for this new procedure. The article attached [V] describes a prospective clinical randomised controlled trial, between TAVI to SAVR in surgically amenable patients over 75 years of age with isolated aortic valve stenosis

  9. Novel glass-like coatings for cardiovascular implant application: Preparation, characterization and cellular interaction.

    PubMed

    Kiefer, Karin; Amlung, Martin; Aktas, Oral Cenk; de Oliveira, Peter W; Abdul-Khaliq, Hashim

    2016-01-01

    Glass coatings are of great interest for biomedical implant application due to their excellent properties. Nowadays they are used in different fields including drug delivery, for bone tissue regeneration or as implant. Nevertheless they can only be applied using high temperatures. Therefore their usage in the field of cardiovascular implant application is still restricted. Accordingly new developments in this field have been carried out to overcome this problem and to coat cardiovascular implants. Here, novel glass-like coatings have been developed and applied using sol-gel technique at moderate temperatures. The biocompatibility and selectivity have been analyzed using human endothelial cells. The obtained results clarify that the developed compositions can either promote or suppress endothelial cell growth only by altering the sintering atmosphere. A later application as thin layer on cardiovascular implants like stents is conceivable.

  10. Bio-Alcamid in drug-induced lipodystrophy.

    PubMed

    Protopapa, Carmelo; Sito, Giuseppe; Caporale, Domenico; Cammarota, Nazzareno

    2003-12-01

    The development of new drugs to counter human immunodeficiency virus (HIV) infection has led to an increase in lipodystrophic syndrome among HIV-infected individuals receiving combination therapy. Bio-Alcamid(TM) is a recently developed polymeric substance that can be implanted to compensate for adipose effects. We have implanted this substance in 73 patients with up to three years' follow-up. The aesthetic results were deemed excellent by both physicians and patients. No implant dislocation, implant migration, granuloma, allergic reaction or intolerance were recorded.

  11. 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).

  12. Percutaneous Pulmonary Valve Implantation

    PubMed Central

    Lee, Hyoung-Doo

    2012-01-01

    Pulmonary regurgitation (PR) is a frequent sequelae after repair of tetralogy of Fallot, pulmonary atresia, truncus arteriosus, Rastelli and Ross operation. Due to patient growth and conduit degeneration, these conduits have to be changed frequently due to regurgitation or stenosis. However, morbidity is significant in these repeated operations. To prolong conduit longevity, bare-metal stenting in the right ventricular outflow tract (RVOT) obstruction has been performed. Stenting the RVOT can reduce the right ventricular pressure and symptomatic improvement, but it causes PR with detrimental effects on the right ventricle function and risks of arrhythmia. Percutaneous pulmonary valve implantation has been shown to be a safe and effective treatment for patients with pulmonary valve insufficiency, or stenotic RVOTs. PMID:23170091

  13. Transcatheter Aortic Valve Implantation.

    PubMed

    Malaisrie, S Chris; Iddriss, Adam; Flaherty, James D; Churyla, Andrei

    2016-05-01

    Severe aortic stenosis (AS) is a life-threatening condition when left untreated. Aortic valve replacement (AVR) is the gold standard treatment for the majority of patients; however, transcatheter aortic valve implantation/replacement (TAVI/TAVR) has emerged as the preferred treatment for high-risk or inoperable patients. The concept of transcatheter heart valves originated in the 1960s and has evolved into the current Edwards Sapien and Medtronic CoreValve platforms available for clinical use. Complications following TAVI, including cerebrovascular events, perivalvular regurgitation, vascular injury, and heart block have decreased with experience and evolving technology, such that ongoing trials studying TAVI in lower risk patients have become tenable. The multidisciplinary team involving the cardiac surgeon and cardiologist plays an essential role in patient selection, procedural conduct, and perioperative care.

  14. 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

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

    PubMed

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

    2015-01-01

    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

  16. 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

  17. 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.

  18. Hardness of ion implanted ceramics

    SciTech Connect

    Oliver, W.C.; McHargue, C.J.; Farlow, G.C.; White, C.W.

    1985-01-01

    It has been established that the wear behavior of ceramic materials can be modified through ion implantation. Studies have been done to characterize the effect of implantation on the structure and composition of ceramic surfaces. To understand how these changes affect the wear properties of the ceramic, other mechanical properties must be measured. To accomplish this, a commercially available ultra low load hardness tester has been used to characterize Al/sub 2/O/sub 3/ with different implanted species and doses. The hardness of the base material is compared with the highly damaged crystalline state as well as the amorphous material.

  19. Rapid implantation of dissolving microneedles on an electrospun pillar array.

    PubMed

    Yang, Huisuk; Kim, Soyoung; Huh, Inyoung; Kim, Suyong; Lahiji, Shayan F; Kim, Miroo; Jung, Hyungil

    2015-09-01

    Dissolving microneedles (DMNs), designed to release drugs and dissolve after skin insertion, have been spotlighted as a novel transdermal delivery system due to their advantages such as minimal pain and tissue damage, ability to self-administer, and no associated hazardous residues. The drug delivery efficacy of DMNs, however, is limited by incomplete insertion and the extended period required for DMN dissolution. Here, we introduce a novel DMN delivery system, DMN on an electrospun pillar array (DEPA), which can rapidly implant DMNs into skin. DMNs were fabricated on a pillar array covered by a fibrous sheet produced by electrospinning PLGA solution (14%, w/v). DMNs were implanted into the skin by manual application (press and vibration for 10 s) by tearing of the fibers hung on the 300-μm pillars. Separation of DMNs from the fibrous sheet was dependent on both pillar height and the properties of the fibrous sheet. After evaluation of the implantation and dissolution of DMNs with diffusion of red dye by taking cross-sectional images of porcine skin, the hypoglycemic effect of insulin loaded DEPA was examined using a healthy mouse model. This DMN array overcomes critical issues associated with the low penetration efficiency of flat patch-based DMNs, and will allow realization of patient convenience with the desired drug efficacy. PMID:26117659

  20. Stability studies of a somatostatin analogue in biodegradable implants.

    PubMed

    Rothen-Weinhold, A; Besseghir, K; Vuaridel, E; Sublet, E; Oudry, N; Gurny, R

    1999-02-15

    In recent years, peptides and proteins have received much attention as drug candidates. For many polypeptides, particularly hormones, it is desirable to release the drug continuously at a controlled rate over a period of weeks or even months, and thus a controlled release system is needed. Polylactic acid (PLA) is a biocompatible and biodegradable material with wide utility for many applications, including the design of controlled release systems for pharmaceutical agents. Pharmaceutical development of these delivery systems presents new problems in the area of stability assessment, especially for peptide drugs. In this study, we aimed to investigate the influence of different steps, during the manufacturing of an implant, on peptide stability in the polymeric matrix. Polylactic acid implants containing vapreotide, a somatostatin analogue, were prepared by extrusion. The effects of time, extrusion and temperature on the peptide stability were studied. The influence of various gamma sterilization doses, as well as the conditions under which the implants were irradiated, were also investigated. Peptide stability in the polymeric matrix was evaluated at various temperatures and at various time intervals up to 9 months. PMID:10205641

  1. Effect of cargo properties on in situ forming implant behavior determined by noninvasive ultrasound imaging

    PubMed Central

    Solorio, Luis; Olear, Alexander M.; Zhou, Haoyan; Beiswenger, Ashlei C.; Exner, Agata A.

    2012-01-01

    Diagnostic ultrasound has been shown to be an effective method for the noninvasive characterization of in situ forming implant behavior both in vivo and in vitro through the evaluation of the echogenic signal that forms as a consequence of the polymer phase transition from liquid to solid. The kinetics of this phase transition have a direct effect on drug release and can be altered through factors that change the mass transfer events of the solvent and aqueous environment, including properties of the entrapped active agent. This study examined the effect of payload properties on implant phase inversion, swelling, drug release, and polymer degradation. Poly(DL-lactide-co-gylcolide) implants were loaded with either: sodium fluorescein, bovine serum albumin (BSA), doxorubicin (Dox), or 1′-dioctadecyl-3,3,3′,3′-tetramethylindocarbocyanine perchlorate (DiI). Fluorescein and Dox were released at near equivalent rates throughout the diffusion phase of release but due to differing drug–matrix interactions, Dox-loaded implants released a lower mass of drug during the degradation phase of release. DiI was not readily released, and due to increased depot hydrophobicity, resulted in significantly lower swelling than the other formulations. The initial echogenicity was higher in Dox-loaded implants than those loaded with fluorescein, but after the initial precipitation, phase inversion and drug release occurred at near equivalent rates for both Dox and fluorescein-loaded implants. Nonlinear mathematical fitting was used to correlate drug release and phase inversion, providing a noninvasive method for evaluating implant release (R2>0.97 for Dox, BSA, and fluorescein; DiI had a correlation coefficient of 0.56). PMID:22712054

  2. 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

  3. [Future of implantable electrical cardiac devices].

    PubMed

    Daubert, Jean-Claude; Behaghel, Albin; Leclercq, Christophe; Mabo, Philippe

    2014-03-01

    Major improvements in implantable electrical cardiac devices have been made during the last two decades, notably with the advent of automatic internal defibrillation (ICD) to prevent sudden arrhythmic death, and cardiac resynchronisation (CRT) to treat the discoordinated failing heart. They now constitute a major therapeutic option and may eventually supersede drug therapy. The coming era will be marked by a technological revolution, with improvements in treatment delivery, safety and efficacy, and an expansion of clinical indications. Leadless technologyfor cardiac pacemakers and defibrillators is already in the pipeline, endovascular leads currently being responsible for most long-term complications (lead failure, infection, vein thrombosis, etc.). Miniaturized pacemakers based on nanotechnology can now be totally implanted inside the right ventricle through the transvenous route, thus eliminating leads, pockets and scarring In the same way, totally subcutaneous ICD systems are now available, although they are currently only capable of delivering shocks, without pacing (including antitachycardia pacing). In CRT optimised delivery is important to improve clinical responses and to reduce the non-response rate (around 30 % with current technology). Endocardial left ventricular pacing could be a solution if it can be achieved at an acceptable risk. Multisite ventricular pacing is an alternative. Besides CRT neuromodulation, especially by vagal stimulation, is another important field of device researchfor heart failure. Preliminary clinical results are encouraging. PMID:26427291

  4. PARP1 during embryo implantation and its upregulation by oestradiol in mice.

    PubMed

    Joshi, Anubha; Mahfooz, Sahil; Maurya, Vineet Kumar; Kumar, Vijay; Basanna, Chadchan Sangappa; Kaur, Gurpreet; Hanif, Kashif; Jha, Rajesh Kumar

    2014-06-01

    Pregnancy requires successful implantation of an embryo, which occurs during a restricted period defined as 'receptivity of the endometrium' and is influenced by the ovarian steroids progesterone and oestradiol. The role of poly(ADP-ribose)polymerase-1 (PARP1) in apoptosis is well established. However, it is also involved in cell differentiation, proliferation and tissue remodelling. Previous studies have described the presence of PARP in the uterus, but its exact role in embryo implantation is not yet elucidated. Hence, in this study, we studied the expression of PARP1 in the uterus during embryo implantation and decidualisation, and its regulation by ovarian steroids. Our results show upregulation of the native form of PARP1 (∼116 kDa) in the cytosolic and nuclear compartments of implantation and non-implantation sites at day 5 (0500 h), followed by downregulation at day 5 (1000 h), during the embryo implantation period. The transcript level of Parp1 was also augmented during day 5 (0500 h). Inhibition of PARP1 activity by the drug EB-47 decreased the number of embryo implantation sites and blastocysts at day 5 (1000 h). Further, cleavage of native PARP1 was due to the activity of caspase-3 during the peri-implantation stage (day 5 (0500 h)), and is also required for embryo implantation, as inhibition of its activity compromised blastocyst implantation. The native (∼116 kDa) and cleaved (∼89 kDa) forms of PARP1 were both elevated during decidualisation of the uterus. Furthermore, the expression level of PARP1 in the uterus was found to be under the control of the hormone oestrogen. Our results clearly demonstrate that PARP1 participates in the process of embryo implantation. PMID:24516177

  5. Modification of inflammatory response to implanted biomedical materials in vivo by surface bound superoxide dismutase mimics.

    PubMed

    Udipi, K; Ornberg, R L; Thurmond, K B; Settle, S L; Forster, D; Riley, D

    2000-09-15

    The healing response to implanted biomedical materials involves varying degrees and stages of inflammation and healing which in some cases leads to device failure. In this article, we describe synthetic methods and in vivo results of a novel surface treatment for biomedical materials involving covalent conjugation of a low molecular weight superoxide dismutase mimic (SODm), which imparts anti-inflammatory character to the material. SODm investigated in this study are a new class of anti-inflammatory drugs consisting of a Mn(II) complex of a macrocyclic polyamine ring that catalyze the dismutation of superoxide at rates equivalent to that of native enzyme. The SODms were covalently linked to small disks of ultra-high molecular weight polyethylene, poly(etherurethane urea), and tantalum metal at two concentrations and implanted in a subcutaneous rat implant model for 3, 7, 14, and 28 days. Histological examination of the implant tissue performed at 3 and 28 days revealed striking anti-inflammatory effects on both acute and chronic inflammatory responses. At 3 days, the formation of a neutrophil-rich acute inflammatory infiltrate seen in control implants was inhibited for all three materials treated with SODm. At 28 days, foreign body giant cell formation (number of FBGCs per field) and fibrous capsule formation (mean thickness of implant capsule) were also significantly inhibited over untreated control implants. A mechanism based on our current understanding of superoxide as an inflammatory mediator at implanted biomedical materials is proposed.

  6. Development of a dexamethasone intravitreal implant for the treatment of noninfectious posterior segment uveitis.

    PubMed

    Whitcup, Scott M; Robinson, Michael R

    2015-11-01

    Uveitis is a group of ocular inflammatory disorders that can lead to severe vision loss. Despite advances in anti-inflammatory therapy, many patients are resistant to or intolerant of existing treatments. A biodegradable, sustained-release implant, dexamethasone intravitreal implant 0.7 mg (Ozurdex), has been developed to deliver dexamethasone to target tissues in the posterior segment of the eye, minimizing systemic drug exposure and limiting side effects. The implant releases dexamethasone over a period of up to 6 months as the poly(D,L-lactide-co-glycolide) polymer matrix of the implant is metabolized to carbon dioxide and water. The implant is placed in the vitreous of the eye with a single-use applicator in a sutureless, office-based procedure. Treatment with a single dexamethasone intravitreal implant in patients with noninfectious intermediate or posterior uveitis has been shown to produce significant improvements in intraocular inflammation and best-corrected visual acuity with treatment benefit sustained for 6 months. Dexamethasone intravitreal implant has also been shown to reduce central retinal thickness and improve best-corrected visual acuity in patients with macular edema of various etiologies. The implant has been approved for treatment of noninfectious uveitis involving the posterior segment, diabetic macular edema, and macular edema associated with branch and central retinal vein occlusion.

  7. [Imaging in silicone breast implantation].

    PubMed

    Gielens, Maaike P M; Koolen, Pieter G L; Hermens, Roland A E C; Rutten, Matthieu J C M

    2013-01-01

    Recently, there have been concerns regarding the use of breast implants from Poly Implant Prothèse (PIP, Seyne sur Mer, France) for breast augmentation due to their tendency to rupture and the possibility of having toxic contents. MRI using a specific silicone-sensitive sequence has proven to be the most sensitive and specific technique in the detection of intra- and extracapsular implant rupture. However, given its high costs, it is important that this technique is used sparingly. In this clinical lesson, we compare the sensitivity and specificity of mammography, ultrasound, CT and MRI for the detection of breast implant rupture. Based on two cases, a diagnostic approach is given in order to reduce health care costs. PMID:24252405

  8. 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

  9. Dental-Implantate und ihre Werkstoffe

    NASA Astrophysics Data System (ADS)

    Newesely, Heinrich

    1983-07-01

    Some new trends in materials for dental implants, which also effect in the operative techniques and implant design, are described. Advantages and shortcomings of the different material types are exemplified and correlated with their bioinert resp. bioactive functions. The practical interest in metallic implants focussed in titanium resp. oxide ceramics in the ceramic field, whereas the special goal of implant research follows from the improvement of the bioactive principle with loaded calcium phosphate implants.

  10. 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.

  11. Cochlear implants in young children.

    PubMed

    Niparko, John K; Blankenhorn, Rebecca

    2003-01-01

    The cochlear implant is best characterized as a device that provides access to the sound environment. The device enables the hearing pathway to respond to environmental and speech sounds, providing informational cues from the surroundings and from others that may escape visual detection. As the developmental effects of a profound hearing loss are multiple, cochlear implants have been applied to ever younger children in an attempt to promote a more normal level of developmental learning through audition. In deafness, transducer elements of the inner ear fail to trigger auditory nerve afferent nerves in the presence of sound input. However, large reserves of afferent fibers exist even in the auditory nerve of a profoundly deaf patient. Furthermore, these nerve fibers retain the ability to respond to prosthetic activation. Through developmental learning in the early, formative years, auditory centers of the brain appear capable of processing information from the implant to provide speech comprehension and oral language development. Multichannel implants have replaced original single channel designs. multichannel devices enable larger percentages of recipients to recognize the spoken word without visual cues because they provide spectral information in addition to temporal and intensity cues. Testing under conditions of auditory (implant)-only input reveals significant open-set speech understanding capabilities in more than 75% of children after three years of device use. The benefit provided by implants may vary with a number of conditions including: hearing history, age of deafness onset, age at implantation, etiology of deafness, linguistic abilities, and the presence of a motivated system of support of oral language development. Patient variables should be given individual consideration in judging candidacy for a cochlear implant and in planning rehabilitative and education services after surgery and activation of the device.

  12. Drug Resistance

    MedlinePlus

    HIV Treatment Drug Resistance (Last updated 3/1/2016; last reviewed 3/1/2016) Key Points As HIV multiplies in the ... the risk of drug resistance. What is HIV drug resistance? Once a person becomes infected with HIV, ...

  13. 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.

  14. Orbital implants: potential new directions.

    PubMed

    Hicks, Celia R; Morrison, David; Lou, Xia; Crawford, Geoffrey J; Gadjatsy, Adam; Constable, Ian J

    2006-11-01

    This article reviews orbital implants used to replace an eye after enucleation or evisceration. Advantages of implant placement are described, with discussion of implant and wrap material, and design features that affect clinical outcomes. Implants may be porous or nonporous, pegged for linkage with a cosmetic shell or unpegged, and may be wrapped with a covering material or tissue or unwrapped. Device shape, volume and material qualities affect tissue tolerance and the risk of exposure or extrusion. Limitations of currently available devices are discussed, with factors affecting surgeon and patient choice. Ideally, a device should be easy to insert, avoid the need for wrapping or adjunctive tissues, be light, biointegratable, comfortable after implantation and provide satisfactory orbital volume replacement, movement and cosmesis without requiring further surgery or pegging. This review briefly discusses developments in implant design and aspects of design that affect function, but is not a detailed clinical review; rather, it aims to stimulate thought on optimal design and discusses recent developments. Novel technology in the form of a prototype device with a soft, biointegratable anterior surface is described as an example of newer approaches.

  15. Nanostructured Surfaces of Dental Implants

    PubMed Central

    Bressan, Eriberto; Sbricoli, Luca; Guazzo, Riccardo; Tocco, Ilaria; Roman, Marco; Vindigni, Vincenzo; Stellini, Edoardo; Gardin, Chiara; Ferroni, Letizia; Sivolella, Stefano; Zavan, Barbara

    2013-01-01

    The structural and functional fusion of the surface of the dental implant with the surrounding bone (osseointegration) is crucial for the short and long term outcome of the device. In recent years, the enhancement of bone formation at the bone-implant interface has been achieved through the modulation of osteoblasts adhesion and spreading, induced by structural modifications of the implant surface, particularly at the nanoscale level. In this context, traditional chemical and physical processes find new applications to achieve the best dental implant technology. This review provides an overview of the most common manufacture techniques and the related cells-surface interactions and modulation. A Medline and a hand search were conducted to identify studies concerning nanostructuration of implant surface and their related biological interaction. In this paper, we stressed the importance of the modifications on dental implant surfaces at the nanometric level. Nowadays, there is still little evidence of the long-term benefits of nanofeatures, as the promising results achieved in vitro and in animals have still to be confirmed in humans. However, the increasing interest in nanotechnology is undoubted and more research is going to be published in the coming years. PMID:23344062

  16. 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

  17. [Implant-associated infections - Diagnostics].

    PubMed

    Renz, N; Müller, M; Perka, C; Trampuz, A

    2016-10-01

    The diagnosis of implant-associated infections is challenging as chronic low-grade infections often only manifest as subtle clinical symptoms. Clinical evaluation, patient history, imaging, histopathological and microbiological examinations build the cornerstones of the diagnostics for implant-associated infections. New onset of pain at rest, local symptoms at the surgical site and early loosening of the prosthesis or pseudarthrosis should raise suspicion for an infection and prompt further evaluation. Percutaneous sinus tracts, purulent wound secretions and skin erosions with exposure of the implant are certain signs of implant-associated infections. Elevated C‑reactive protein levels in blood support the diagnosis of infection but are neither sufficient sensitive nor specific to confirm or exclude infection. Preoperative antibiotic therapy interferes with the diagnostic evaluation and should be avoided. In periprosthetic joint infections, joint aspiration with determination of the leukocyte count and microbiological examination is a crucial first diagnostic step. Through microbiological and histopathological examinations of intraoperative tissue samples, as well as sonication of explanted implants, the causative pathogen can be identified in most cases. In osteosynthesis-associated infections imaging plays a key role to detect non-union, infection callus, sequester, peri-implant osteolysis and extraosseous and intramedullary pathologies. In prosthetic joint infections imaging provides information about the position and stability of the prosthesis. In case of hematogenic infection seeding from a distant focus, blood cultures should be sampled, followed by a meticulous investigation of potential primary focus of infection, depending on the causative agent.

  18. 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. PMID:24403565

  19. [Implantable hemodynamic monitoring devices].

    PubMed

    Seifert, M; Butter, C

    2015-11-01

    Heart failure is one of the most frequent diagnoses in hospital admissions in Germany. In the majority of these admissions acute decompensation of an already existing chronic heart failure is responsible. New mostly wireless and remote strategies for monitoring, titration, adaptation and optimization are the focus for improvement of the treatment of heart failure patients and the poor prognosis. The implantation of hemodynamic monitoring devices follows the hypothesis that significant changes in hemodynamic parameters occur before the occurrence of acute decompensation requiring readmission. Three different hemodynamic monitoring devices have so far been investigated in clinical trials employing right ventricular pressure, left atrial pressure and pulmonary artery pressure monitoring. Only one of these systems, the CardioMENS™ HF monitoring system, demonstrated a significant reduction of hospitalization due to heart failure over 6 months in the CHAMPION trial. The systematic adaptation of medication in the CHAMPION trial significantly differed from the usual care of the control arm over 6 months. This direct day to day management of diuretics is currently under intensive investigation; however, further studies demonstrating a positive effect on mortality are needed before translation of this approach into guidelines. Without this evidence a further implementation of pressure monitoring into currently used devices and justification of the substantial technical and personnel demands are not warranted.

  20. Formulation and evaluation of PLA and PLGA in situ implants containing secnidazole and/or doxycycline for treatment of periodontitis.

    PubMed

    Gad, Heba A; El-Nabarawi, Mohamed A; Abd El-Hady, Seham S

    2008-01-01

    The purpose of this study is to formulate in situ implants containing doxycycline hydrochloride and/or secnidazole that could be used in the treatment of periodontitis by direct periodontal intrapocket administration. Biodegradable polymers [poly (lactide) (PLA) and poly (lactide-co-glycolide) (PLGA)], each polymer in two concentrations 25%w/w, 35%w/w were used to formulate the in situ implants. The rheological behavior, in vitro drug release and the antimicrobial activity of the prepared implants were evaluated. Increasing the concentration of each polymer increases the viscosity and decreases the percent of the drugs released after 24 h. PLA implants showed a slower drugs release rate than PLGA implants in which the implants composed of 25% PLGA showed the fastest drugs release. The in vitro drug release and antimicrobial activity results were compared with results of Atridox. Results revealed that the pharmaceutical formulation based on 25% PLGA containing secnidazole and doxycycline hydrochloride has promising activity in treating periodontitis in comparison with Atridox. PMID:18654864

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

    PubMed Central

    Shah, Amisha T; Jankharia, Bijal B

    2016-01-01

    The number of women undergoing breast implant procedures is increasing exponentially. It is, therefore, imperative for a radiologist to be familiar with the normal and abnormal imaging appearances of common breast implants. Diagnostic imaging studies such as mammography, ultrasonography, and magnetic resonance imaging are used to evaluate implant integrity, detect abnormalities of the implant and its surrounding capsule, and detect breast conditions unrelated to implants. Magnetic resonance imaging of silicone breast implants, with its high sensitivity and specificity for detecting implant rupture, is the most reliable modality to asses implant integrity. Whichever imaging modality is used, the overall aim of imaging breast implants is to provide the pertinent information about implant integrity, detect implant failures, and to detect breast conditions unrelated to the implants, such as cancer. PMID:27413269

  2. 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

  3. Cochlear implantation: a biomechanical prosthesis for hearing loss.

    PubMed

    Yawn, Robert; Hunter, Jacob B; Sweeney, Alex D; Bennett, Marc L

    2015-01-01

    Cochlear implants are a medical prosthesis used to treat sensorineural deafness, and one of the greatest advances in modern medicine. The following article is an overview of cochlear implant technology. The history of cochlear implantation and the development of modern implant technology will be discussed, as well as current surgical techniques. Research regarding expansion of candidacy, hearing preservation cochlear implantation, and implantation for unilateral deafness are described. Lastly, innovative technology is discussed, including the hybrid cochlear implant and the totally implantable cochlear implant.

  4. Implantable Cardioverter Defibrillators. Prophylactic Use

    PubMed Central

    2005-01-01

    Executive Summary Objective The use of implantable cardiac defibrillators (ICDs) to prevent sudden cardiac death (SCD) in patients resuscitated from cardiac arrest or documented dangerous ventricular arrhythmias (secondary prevention of SCD) is an insured service. In 2003 (before the establishment of the Ontario Health Technology Advisory Committee), the Medical Advisory Secretariat conducted a health technology policy assessment on the prophylactic use (primary prevention of SCD) of ICDs for patients at high risk of SCD. The Medical Advisory Secretariat concluded that ICDs are effective for the primary prevention of SCD. Moreover, it found that a more clearly defined target population at risk for SCD that would be likely to benefit from ICDs is needed, given that the number needed to treat (NNT) from recent studies is 13 to 18, and given that the per-unit cost of ICDs is $32,000, which means that the projected cost to Ontario is $770 million (Cdn). Accordingly, as part of an annual review and publication of more recent articles, the Medical Advisory Secretariat updated its health technology policy assessment of ICDs. Clinical Need Sudden cardiac death is caused by the sudden onset of fatal arrhythmias, or abnormal heart rhythms: ventricular tachycardia (VT), a rhythm abnormality in which the ventricles cause the heart to beat too fast, and ventricular fibrillation (VF), an abnormal, rapid and erratic heart rhythm. About 80% of fatal arrhythmias are associated with ischemic heart disease, which is caused by insufficient blood flow to the heart. Management of VT and VF with antiarrhythmic drugs is not very effective; for this reason, nonpharmacological treatments have been explored. One such treatment is the ICD. The Technology An ICD is a battery-powered device that, once implanted, monitors heart rhythm and can deliver an electric shock to restore normal rhythm when potentially fatal arrhythmias are detected. The use of ICDs to prevent SCD in patients resuscitated

  5. 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

  6. Biomechanical load analysis of cantilevered implant systems.

    PubMed

    Osier, J F

    1991-01-01

    Historically, dental implants have been placed in areas where quality bone exists. The maxillary sinus areas and mandibular canal proximities have been avoided. From these placements, various cantilevered prosthetic applications have emerged. This analysis uses static engineering principles to define the loads (i.e., forces) placed upon the implants. These principles make use of Newton's first and third laws of mechanics by summing the forces and moments to zero. These summations then generate mathematical equations and their algebraic solutions. Three implant systems are analyzed. The first is a two-implant system. The second is a three-implant cross-arch stabilized system usually found in mandibular replacements of lower full dentures. The third is a five-implant system which is identical to the three-implant cantilevered system but which uses implants in the first molar area, thereby negating the cantilevered load magnification of the three-implant design. These analyses demonstrate that, in a cantilevered application, the implant closest to the point of load application (usually the most posterior implant) takes the largest compressive load. Implants opposite the load application (generally the anterior implant) are in tension. These loads on the implants are normally magnified over the biting force and can easily reach 2 1/2 to five times the biting load.

  7. Materials for endosseous dental implants.

    PubMed

    Wataha, J C

    1996-02-01

    The goal of placement of endosseous dental implants is to achieve osseointegration or biointegration of the bone with the implant. A wide variety of materials has been used for these implants, but only a few promote osseointegration and biointegration. Titanium and titanium alloy (Ti6A14V) have been the most widely used of these materials. The surface oxide of titanium appears to be central to the ability of this material to osseointegrate. The oxide limits dissolution of elements and promotes the deposition of biological molecules which allow bone to exist as close as 30 A to the surface of the implant. The details of the ultrastructure of the gap between the implant and bone remain undefined, and the consequences of elements which are released on the interface over time are not known. These areas of investigation are particularly important in defining the differences between commercially pure titanium implants and those made of titanium, aluminium and vanadium. The epithelial interface between the gingiva and titanium appears to contain many of the structural characteristics of the native tooth-gingiva interface, but details are still vague. The connective tissue interface with the titanium appears to be one of tightly fitting tissues rather than adhesion. Ceramic coatings appear to improve the ingrowth of bone and promote chemical integration of the implant with the bone. The characteristics of these coatings are complex and affect the bony response, but the mechanisms remain obscure. The degradation of the coatings is an issue of particular controversy. Progress in dental implantology is likely to continue as the interface between the material and bone is more clearly understood, and biological molecules and artificial tissues are developed.

  8. Drug Abuse

    MedlinePlus

    ... as drugged driving, violence, stress, and child abuse. Drug abuse can lead to homelessness, crime, and missed work or problems with keeping a job. It harms unborn babies and destroys families. There are different types of treatment for drug abuse. But the best is to prevent drug ...

  9. Controlled drugs.

    PubMed

    2016-05-18

    Essential facts Controlled drugs are defined and governed by the Misuse of Drugs Act 1971 and associated regulations. Examples of controlled drugs include morphine, pethidine and methadone. Since 2012, appropriately qualified nurses and midwives can prescribe controlled drugs for medical conditions within their competence. There are some exceptions when treating addiction. PMID:27191427

  10. Noninvasive Characterization of the Effect of Varying PLGA Molecular Weight Blends on In Situ Forming Implant Behavior Using Ultrasound Imaging

    PubMed Central

    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 53kDa), 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 R2 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 53kDa 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 intermediate

  11. Medical implants and methods of making medical implants

    SciTech Connect

    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.

  12. Implantable biomedical devices on bioresorbable substrates

    DOEpatents

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

    2014-03-04

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

  13. Cochlear Implantation in Older Adults

    PubMed Central

    Lin, Frank R.; Chien, Wade W.; Li, Lingsheng; Niparko, John K.; Francis, Howard W.

    2012-01-01

    Cochlear implants allow individuals with severe-to-profound hearing loss access to sound and spoken language. The number of older adults in the United States who are potential candidates for cochlear implantation is approximately 150,000 and will continue to increase with the aging of the population. Should cochlear implantation (CI) be routinely recommended for these older adults, and do these individuals benefit from CI? We reviewed our 12 year experience with cochlear implantation in adults ≥60 years (n = 445) at Johns Hopkins to investigate the impact of CI on speech understanding and to identify factors associated with speech performance. Complete data on speech outcomes at baseline and 1 year post-CI were available for 83 individuals. Our results demonstrate that cochlear implantation in adults ≥60 years consistently improved speech understanding scores with a mean increase of 60. 0% (S. D. 24. 1) on HINT sentences in quiet . The magnitude of the gain in speech scores was negatively associated with age at implantation such that for every increasing year of age at CI the gain in speech scores was 1. 3 percentage points less (95% CI: 0. 6 – 1. 9) after adjusting for age at hearing loss onset. Conversely, individuals with higher pre-CI speech scores (HINT scores between 40–60%) had significantly greater post-CI speech scores by a mean of 10. 0 percentage points (95% CI: 0. 4 – 19. 6) than those with lower pre-CI speech scores (HINT <40%) after adjusting for age at CI and age at hearing loss onset. These results suggest that older adult CI candidates who are younger at implantation and with higher preoperative speech scores obtain the highest speech understanding scores after cochlear implantation with possible implications for current Medicare policy. Finally, we provide an extended discussion of the epidemiology and impact of hearing loss in older adults. Future research of CI in older adults should expand beyond simple speech outcomes to take into

  14. Capacitive Feedthroughs for Medical Implants.

    PubMed

    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.

  15. 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

  16. Capacitive Feedthroughs for Medical Implants.

    PubMed

    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

  17. 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

  18. 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.

  19. PROPERTIES OF DEFECTS AND IMPLANTS IN Mg+ IMPLANTED SILICON CARBIDE

    SciTech Connect

    Jiang, Weilin; Zhu, Zihua; Varga, Tamas; Bowden, Mark E.; Manandhar, Sandeep; Roosendaal, Timothy J.; Hu, Shenyang Y.; Henager, Charles H.; Kurtz, Richard J.; Wang, Yongqiang

    2013-09-25

    As a candidate material for fusion reactor designs, silicon carbide (SiC) under high-energy neutron irradiation undergoes atomic displacement damage and transmutation reactions that create magnesium as one of the major metallic products. The presence of Mg and lattice disorder in SiC is expected to affect structural stability and degrade thermo-mechanical properties that could limit SiC lifetime for service. We have initiated a combined experimental and computational study that uses Mg+ ion implantation and multiscale modeling to investigate the structural and chemical effects in Mg implanted SiC and explore possible property degradation mechanisms.

  20. 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

  1. 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.

  2. Implant rehabilitation in bruxism patient.

    PubMed

    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

  3. 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

  4. [Signal processing in contour implants].

    PubMed

    Ormezzano, Y; Deleurme, C; Vormès, E; Frachet, B

    1990-01-01

    Signal processing by cochlear implants is aimed at transmitting all the acoustic information carried by the human voice, whether in its semantic, esthetic or affective aspects, as an electrical signal. The "translating" approach, which encodes the signal according to the characteristics of the sounds, can only be ideally used in multiple-canal implants. On the contrary, our experience with various single-canal prostheses shows that our patients choose one of these according to the comfort of the signal and to its reliability rather than to the complexity of signal processing: all prostheses produce approximately the same results, whatever the method implemented. The contour implant allows an easy, effective and well-tolerated fitting at low costs.

  5. MRI artefacts after Bonebridge implantation.

    PubMed

    Steinmetz, C; Mader, I; Arndt, S; Aschendorff, A; Laszig, R; Hassepass, F

    2014-07-01

    The new transcutaneous bone conduction implant (BCI) Bonebridge (BB, MED-EL) allows the skin to remain intact and therefore overcomes some issues related to percutaneous systems, such as skin reaction around the external screw and cosmetic complaints. According to manufacturer, BB is MRI conditional up to 1,5 Tesla (T). The artefact of the neurocranium after BB implantation is extensive as shown in the present report. This has to be taken into account when patients suffering conductive, mixed or single-sided hearing loss with candidacy for a BCI are counselled. In patients with comorbid intracranial tumour or other diseases of the brain that require imaging control scans with MRI percutaneous, BCI should be the implant of choice considering the very small artefact of the percutaneous screw in MRI.

  6. Treatment of Infected Facial Implants.

    PubMed

    Mohan, Kriti; Cox, Joshua A; Dickey, Ryan M; Gravina, Paula; Echo, Anthony; Izaddoost, Shayan A; Nguyen, Anh H

    2016-05-01

    Alloplastic facial implants have a wide range of uses to achieve the appropriate facial contour. A variety of materials such as metals, polymers, ceramics and synthetic injectable fillers are available to the reconstructive and aesthetic surgeon. Besides choosing the right surgical technique and the adequate material, the surgeon must be prepared to treat complications. Infection is an uncommon but serious complication that can cause displeasing consequences for the patient. There are few references in literature regarding treatment and management of facial implant-related infections. This study aims to discuss the role of biofilm in predisposing alloplastic materials to infection, to provide a review of literature, to describe our own institutional experience, and to define a patient care pathway for facial implant-associated infection. PMID:27152100

  7. 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

  8. Long-term monitoring for nanomedicine implants and drugs

    NASA Astrophysics Data System (ADS)

    Kendall, Michaela; Lynch, Iseult

    2016-03-01

    Increasing globalization means that traditional occupational epidemiological approaches may no longer apply, suggesting a need for an alternative model to assess the long-term impact of nanomaterial exposure on health.

  9. 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

  10. Substrate-anchored and degradation-sensitive anti-inflammatory coatings for implant materials

    NASA Astrophysics Data System (ADS)

    Wu, Duo; Chen, Xingyu; Chen, Tianchan; Ding, Chunmei; Wu, Wei; Li, Jianshu

    2015-06-01

    Implant materials need to be highly biocompatible to avoid inflammation in clinical practice. Although biodegradable polymeric implants can eliminate the need for a second surgical intervention to remove the implant materials, they may produce acidic degradation products in vivo and cause non-bacterial inflammation. Here we show the strategy of “substrate-anchored and degradation-sensitive coatings” for biodegradable implants. Using poly(lactic acid)/hydroxyapatite as an implant material model, we constructed a layer-by-layer coating using pH-sensitive star polymers and dendrimers loaded with an anti-inflammatory drug, which was immobilised through a hydroxyapatite-anchored layer. The multifunctional coating can effectively suppress the local inflammation caused by the degradation of implant materials for at least 8 weeks in vivo. Moreover, the substrate-anchored coating is able to modulate the degradation of the substrate in a more homogeneous manner. The “substrate-anchored and degradation-sensitive coating” strategy therefore exhibits potential for the design of various self-anti-inflammatory biodegradable implant materials.

  11. Substrate-anchored and degradation-sensitive anti-inflammatory coatings for implant materials

    PubMed Central

    Wu, Duo; Chen, Xingyu; Chen, Tianchan; Ding, Chunmei; Wu, Wei; Li, Jianshu

    2015-01-01

    Implant materials need to be highly biocompatible to avoid inflammation in clinical practice. Although biodegradable polymeric implants can eliminate the need for a second surgical intervention to remove the implant materials, they may produce acidic degradation products in vivo and cause non-bacterial inflammation. Here we show the strategy of “substrate-anchored and degradation-sensitive coatings” for biodegradable implants. Using poly(lactic acid)/hydroxyapatite as an implant material model, we constructed a layer-by-layer coating using pH-sensitive star polymers and dendrimers loaded with an anti-inflammatory drug, which was immobilised through a hydroxyapatite-anchored layer. The multifunctional coating can effectively suppress the local inflammation caused by the degradation of implant materials for at least 8 weeks in vivo. Moreover, the substrate-anchored coating is able to modulate the degradation of the substrate in a more homogeneous manner. The “substrate-anchored and degradation-sensitive coating” strategy therefore exhibits potential for the design of various self-anti-inflammatory biodegradable implant materials. PMID:26077243

  12. Preoperative imaging of sensorineural hearing loss in pediatric candidates for cochlear implantation.

    PubMed

    Young, Joseph Y; Ryan, Maura E; Young, Nancy M

    2014-01-01

    Cochlear implantation is the only U.S. Food and Drug Administration-approved treatment for children with marked bilateral sensorineural hearing loss. It provides auditory benefits that range from simple sound detection to substantial word understanding. Improved hearing through cochlear implantation has been demonstrated to enhance the rate of language acquisition, enable development of spoken language, and advance literacy in deaf children. Magnetic resonance imaging and computed tomography both have roles in the preoperative assessment of inner-ear abnormalities, cochlear nerve deficiency, and variant anatomy that may affect the decision to implant and the prognosis for auditory improvement and increase the risk for complications. Most cochlear abnormalities may be successfully treated with cochlear implantation, but the presence of a cochlear malformation may increase the risk for intraoperative cerebrospinal fluid leakage and postoperative bacterial meningitis. Eighth-nerve deficiency correlates with poor auditory outcomes and may affect eligibility for cochlear implantation. Another important consideration for implantation is the presence of labyrinthitis ossificans in some children with deafness resulting from bacterial meningitis, which may cause obstruction that limits electrode insertion. Anatomic variations of the facial nerve or middle-ear cavity, which are more common in syndromic patients, may also affect the surgical approach and make implantation difficult.

  13. [Needle implantations--clinical report].

    PubMed

    Esswein, W

    1977-04-01

    In the last four years 27 patients with edentulous lower jaw were treated with implantation of rows of tantalum needles; 25 of them were followed up clinically and radiologically. After an average of two years and seven months where the success rate was found to be 72%. Reasons for failure were thought to be mistakes in operative technique, insufficient oral hygiene of the patients and less than optimal aftercare. These needle implants have proved their value also in cases with marked atrophy of the lower jaw where other prosthetic-surgical methods aimed at improving the prosthesis site have failed.

  14. 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

  15. FDA Approves Eye Implant for Aging Boomers

    MedlinePlus

    ... fullstory_159648.html FDA Approves Eye Implant for Aging Boomers Tiny lens reshapes cornea to improve focus ... 2016 (HealthDay News) -- An implant that helps the aging eye focus on small print and nearby objects ...

  16. Elderly Benefit from Using Implantable Defibrillators

    MedlinePlus

    ... org Learn More Elderly benefit from using implantable defibrillators June 17, 2013 Categories: Heart News Study Highlights: Older people may benefit from implantable cardioverter defibrillators (ICDs) as much as younger people. Overall health, ...

  17. Beyond cochlear implants: awakening the deafened brain.

    PubMed

    Moore, David R; Shannon, Robert V

    2009-06-01

    Cochlear implants have provided hearing to more than 120,000 deaf people. Recent surgical developments include direct electrical stimulation of the brain, bilateral implants and implantation in children less than 1 year old. However, research is beginning to refocus on the role of the brain in providing benefits to implant users. The auditory system is able to use the highly impoverished input provided by implants to interpret speech, but this only works well in those who have developed language before their deafness or in those who receive their implant at a very young age. We discuss recent evidence suggesting that developing the ability of the brain to learn how to use an implant may be as important as further improvements of the implant technology. PMID:19471266

  18. How Does an Implantable Cardioverter Defibrillator Work?

    MedlinePlus

    ... on Twitter. How Does an Implantable Cardioverter Defibrillator Work? An implantable cardioverter defibrillator (ICD) has wires with ... tune the programming of your ICD so it works better to correct irregular heartbeats. The type of ...

  19. Physiological and molecular determinants of embryo implantation

    PubMed Central

    Zhang, Shuang; Lin, Haiyan; Kong, Shuangbo; Wang, Shumin; Wang, Hongmei; Wang, Haibin; Armant, D. Randall

    2014-01-01

    Embryo implantation involves the intimate interaction between an implantation-competent blastocyst and a receptive uterus, which occurs in a limited time period known as the window of implantation. Emerging evidence shows that defects originating during embryo implantation induce ripple effects with adverse consequences on later gestation events, highlighting the significance of this event for pregnancy success. Although a multitude of cellular events and molecular pathways involved in embryo-uterine crosstalk during implantation have been identified through gene expression studies and genetically engineered mouse models, a comprehensive understanding of the nature of embryo implantation is still missing. This review focuses on recent progress with particular attention to physiological and molecular determinants of blastocyst activation, uterine receptivity, blastocyst attachment and uterine decidualization. A better understanding of underlying mechanisms governing embryo implantation should generate new strategies to rectify implantation failure and improve pregnancy rates in women. PMID:23290997

  20. 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 culture.…

  1. Psychosocial issues in ventricular assist device implantation and management.

    PubMed

    Petty, Michael; Bauman, Lillian

    2015-12-01

    The primary goal of mechanical circulatory support (MCS) is to increase quantity and quality of life (QOL) in patients with systolic heart failure refractory to medical therapies. A key contributor to the success in MCS therapy is a comprehensive assessment of the candidate for device implantation. A crucial element of that assessment is an evaluation of the individual's psychosocial status, recommended by most current MCS guidelines. By focusing on criteria including drug, alcohol and tobacco abuse, ability to learn and problem solve, history of adherence to medical regimens, and adequate psychosocial support following implant, the team has an opportunity to create an individualized post-discharge plan that addresses identified gaps and optimizes the patient's likelihood for success. Information gathered also provides the team with a setting in which to discuss the patient's personal goals for the therapy and advanced care planning. We explore all of these issues and offer recommendations for approaching psychosocial assessment for MCS patients.

  2. Optimizing pain control through the use of implantable pumps

    PubMed Central

    Ilias, Wilfried; Todoroff, Boris

    2008-01-01

    Intrathecal therapy represents an effective and well established treatment of nonmalignant as well as malignant pain. Devices available include mechanical constant flow pumps as well as electronic variable flow pumps with patient-controlled bolus release. The latter provide faster dose finding, individual pain control, and good acceptance by patients. New technologies such as membrane pumps and rechargeable devices are expected to be developed to clinical perfection. The available drugs for intrathecal therapy are listed according to the polyanalgesic consensus on intrathecal therapy. The integration of remote patient-controlled analgesia into electronic implantable devices, and the peptide analgesic ziconotide, have significantly improved intrathecal therapy. Complications include infections, catheter ruptures or disconnections, catheter granulomas, and technical dysfunctions. Further possibilities for optimizing intrathecal therapy include development of new drugs, drug side effects, catheter and pump technologies, and surgical techniques. PMID:22915907

  3. Environmental standards for intraocular lens implantation.

    PubMed

    Crawford, B A; Kaufman, D V

    1984-02-01

    Successful implantation of prosthetic devices depends upon their freedom from postoperative inflammation and infection. Techniques and lessons learned in orthopaedic and other implant surgery should be applied to intraocular lens implantation. The avoidance of contamination by particles and micro-organisms is one essential principle of the surgical procedure. Practical steps are described to reduce both types of contamination. These measures taken together are recommended for adoption as a standard of environmental safety for lens implantation.

  4. Detailed spectral analysis of decellularized skin implants

    NASA Astrophysics Data System (ADS)

    Timchenko, E. V.; Timchenko, P. E.; Volova, L. T.; Dolgushkin, D. A.; Shalkovsky, P. Y.; Pershutkina, S. V.

    2016-08-01

    The resutls of detailed analysis of donor skin implants using Raman spectroscopy method are presented. Fourier-deconvolution method was used to separate overlapping spectrum lines and to improve its informativeness. Based on the processed spectra were introduced coefficients that represent changes in relative concentration of implant components, which determines the quality of implants. It was established that Raman spectroscopy method can be used in assessment of skin implants.

  5. Augmentation mammaplasty using implants: a review.

    PubMed

    Takayanagi, Susumu

    2012-09-01

    One of the techniques for augmentation mammaplasty is the procedure using implants. Even though this technique has been used for many years, there are still several controversial issues to be discussed and overcome for patient safety. In this review article, capsular contracture, leak or rupture of the implants, possible systemic disease, relation with breast cancer, and recent problems with Poly Implant Prothese implants are described and discussed. PMID:23094237

  6. Augmentation Mammaplasty Using Implants: A Review

    PubMed Central

    2012-01-01

    One of the techniques for augmentation mammaplasty is the procedure using implants. Even though this technique has been used for many years, there are still several controversial issues to be discussed and overcome for patient safety. In this review article, capsular contracture, leak or rupture of the implants, possible systemic disease, relation with breast cancer, and recent problems with Poly Implant Prothese implants are described and discussed. PMID:23094237

  7. Dental implants in the older adult.

    PubMed

    Jones, John D; Partida, M Norma; Turkyilmaz, Ilser

    2012-01-01

    A need for dental implant treatment in the older population is recognized considering the prevalence of partial and complete edentulism and the positive predictability of implant therapy. Even with a number of barriers to overcome for the older adult seeking implant care, dental implants provide stabilizing support for removable dental appliances and have been shown to be successful in that population. In this paper, we describe quality of life, systemic, surgical, and prosthodontic considerations of this prosthetic treatment along with maintenance challenges.

  8. Combined Subpectoral Implantation of Implantable Cardioverter-Defibrillator and Augmentation Mammoplasty in a Young Female Patient

    PubMed Central

    Kim, Dong-Jun; Park, Je Wook; Youn, Jong-Chan; Lee, Dong Won; Koo, Bon-Nyeo; Lee, Moon-Hyoung

    2016-01-01

    Subcutaneous implantation of a cardiac implantable electronic device is the standard method. Occasionally, subpectoral cardiac implantable electronic device (CIED) implantation via axillary incisions is performed in young female patients for cosmetic purposes. Because subpectoral CIED implantation and augmentation mammoplasty involve the same layer, it is feasible to perform both procedures simultaneously. We report a case of combined subpectoral implantation of an implantable cardioverter-defibrillator and augmentation mammoplasty via the axillary approach in a young female patient with dilated cardiomyopathy and small breasts. PMID:27721868

  9. TiO2 nanotube platforms for smart drug delivery: a review

    PubMed Central

    Wang, Qun; Huang, Jian-Ying; Li, Hua-Qiong; Chen, Zhong; Zhao, Allan Zi-Jian; Wang, Yi; Zhang, Ke-Qin; Sun, Hong-Tao; Al-Deyab, Salem S; Lai, Yue-Kun

    2016-01-01

    Titania nanotube (TNT) arrays are recognized as promising materials for localized drug delivery implants because of their excellent properties and facile preparation process. This review highlights the concept of localized drug delivery systems based on TNTs, considering their outstanding biocompatibility in a series of ex vivo and in vivo studies. Considering the safety of TNT implants in the host body, studies of the biocompatibility present significant importance for the clinical application of TNT implants. Toward smart TNT platforms for sustainable drug delivery, several advanced approaches were presented in this review, including controlled release triggered by temperature, light, radiofrequency magnetism, and ultrasonic stimulation. Moreover, TNT implants used in medical therapy have been demonstrated by various examples including dentistry, orthopedic implants, cardiovascular stents, and so on. Finally, a future perspective of TNTs for clinical applications is provided. PMID:27703349

  10. Cochlear implants: a remarkable past and a brilliant future

    PubMed Central

    Wilson, Blake S.; Dorman, Michael F.

    2013-01-01

    The aims of this paper are to (i) provide a brief history of cochlear implants; (ii) present a status report on the current state of implant engineering and the levels of speech understanding enabled by that engineering; (iii) describe limitations of current signal processing strategies and (iv) suggest new directions for research. With current technology the “average” implant patient, when listening to predictable conversations in quiet, is able to communicate with relative ease. However, in an environment typical of a workplace the average patient has a great deal of difficulty. Patients who are “above average” in terms of speech understanding, can achieve 100% correct scores on the most difficult tests of speech understanding in quiet but also have significant difficulty when signals are presented in noise. The major factors in these outcomes appear to be (i) a loss of low-frequency, fine structure information possibly due to the envelope extraction algorithms common to cochlear implant signal processing; (ii) a limitation in the number of effective channels of stimulation due to overlap in electric fields from electrodes, and (iii) central processing deficits, especially for patients with poor speech understanding. Two recent developments, bilateral implants and combined electric and acoustic stimulation, have promise to remediate some of the difficulties experienced by patients in noise and to reinstate low-frequency fine structure information. If other possibilities are realized, e.g., electrodes that emit drugs to inhibit cell death following trauma and to induce the growth of neurites toward electrodes, then the future is very bright indeed. PMID:18616994

  11. Myths about Cochlear Implants: A Family Perspective.

    ERIC Educational Resources Information Center

    Luetke-Stahlman, B.

    1994-01-01

    A parent of two young children who received cochlear implant surgery addresses common myths about this procedure including "deaf people don't support the use of cochlear implants,""if you choose cochlear implant surgery, you are choosing the hearing world,""hearing parents are not qualified to decide," and "the deaf child him/herself should…

  12. An Uncommon Presentation of Breast Implant Rupture

    PubMed Central

    Watson, David I.; Dean, Nicola R.

    2016-01-01

    Summary: Late periprosthetic seroma has lately been concerning for breast implant-associated anaplastic large cell lymphoma. The authors present an uncommon presentation of breast implant rupture with a seroma and skin rash forming 2 years after insertion of the implant. PMID:27579243

  13. The hydroxyapatite orbital implant: a prospective study.

    PubMed

    Ashworth, J L; Rhatigan, M; Sampath, R; Brammar, R; Sunderland, S; Leatherbarrow, B

    1996-01-01

    The hydroxyapatite orbital implant was first released for use as an orbital implant in humans in August 1989. It has been shown to be well tolerated, providing good motility of the artificial eye with a low complication rate when used as a primary implant. This prospective study evaluated the hydroxyapatite orbital implant used as both a primary and a secondary implant. Sixty patients were implanted between October 1992 and November 1994, 28 being implanted as a primary procedure at the time of enucleation or evisceration, and 32 as a secondary procedure. Seven patients underwent second-stage drilling and pegging of the implant. The mean follow-up time was 13 months (range 2-26 months). A standardised operative and post-operative protocol was followed. The patients were evaluated post-operatively for the amount of enophthalmos, degree of upper lid sulcus deformity, motility of the prosthesis, location of the implant in the socket, socket status and the presence or absence of discharge, position of the drill hole and coverage of the implant. Complications and their management were documented. Both patient and surgeon made a subjective assessment of cosmesis and the patient's satisfaction with the overall result was noted. The results of this study show the hydroxyapatite orbital implant to provide excellent motility of the artificial eye and good cosmesis with a low rate of complications when used both as a primary and as a secondary implant.

  14. Design optimization of functionally graded dental implant.

    PubMed

    Hedia, H S; Mahmoud, Nemat-Alla

    2004-01-01

    The continuous increase of man's life span, and the growing confidence in using artificial materials inside the human body necessities introducing more effective prosthesis and implant materials. However, no artificial implant has biomechanical properties equivalent to the original tissue. Recently, titanium and bioceramic materials, such as hydroxyapatite are extensively used as fabrication materials for dental implant due to their high compatibility with hard tissue and living bone. Titanium has reasonable stiffness and strength while hydroxyapatite has low stiffness, low strength and high ability to reach full integration with living bone. In order to obtain good dental implantation of the biomaterial; full integration of the implant with living bone should be satisfied. Minimum stresses in the implant and the bone must be achieved to increase the life of the implant and prevent bone resorption. Therefore, the aim of the current investigation is to design an implant made from functionally graded material (FGM) to achieve the above advantages. The finite element method and optimization technique are used to reach the required implant design. The optimal materials of the FGM dental implant are found to be hydroxyapatite/titanium. The investigations have shown that the maximum stress in the bone for the hydroxyapatite/titanium FGM implant has been reduced by about 22% and 28% compared to currently used titanium and stainless steel dental implants, respectively.

  15. Using Aerospace Technology To Design Orthopedic Implants

    NASA Technical Reports Server (NTRS)

    Saravanos, D. A.; Mraz, P. J.; Davy, D. T.

    1996-01-01

    Technology originally developed to optimize designs of composite-material aerospace structural components used to develop method for optimizing designs of orthopedic implants. Development effort focused on designing knee implants, long-term goal to develop method for optimizing designs of orthopedic implants in general.

  16. Rescuing failed oral implants via Wnt activation

    PubMed Central

    Yin, Xing; Li, Jingtao; Chen, Tao; Mouraret, Sylvain; Dhamdhere, Girija; Brunski, John B.; Zou, Shujuan; Helms, Jill A.

    2016-01-01

    Aim Implant osseointegration is not always guaranteed and once fibrous encapsulation occurs clinicians have few options other than implant removal. Our goal was to test whether a WNT protein therapeutic could rescue such failed implants. Material and Methods Titanium implants were placed in over-sized murine oral osteotomies. A lack of primary stability was verified by mechanical testing. Interfacial strains were estimated by finite element modelling and histology coupled with histomorphometry confirmed the lack of peri-implant bone. After fibrous encapsulation was established peri-implant injections of a liposomal formulation of WNT3A protein (L-WNT3A) or liposomal PBS (L-PBS) were then initiated. Quantitative assays were employed to analyse the effects of L-WNT3A treatment. Results Implants in gap-type interfaces exhibited high interfacial strains and no primary stability. After verification of implant failure, L-WNT3A or L-PBS injections were initiated. L-WNT3A induced a rapid, significant increase in Wnt responsiveness in the peri-implant environment, cell proliferation and osteogenic protein expression. The amount of peri-implant bone and bone in contact with the implant were significantly higher in L-WNT3A cases. Conclusions These data demonstrate L-WNT3A can induce peri-implant bone formation even in cases where fibrous encapsulation predominates. PMID:26718012

  17. An Uncommon Presentation of Breast Implant Rupture.

    PubMed

    Koh, Eugene; Watson, David I; Dean, Nicola R

    2016-05-01

    Late periprosthetic seroma has lately been concerning for breast implant-associated anaplastic large cell lymphoma. The authors present an uncommon presentation of breast implant rupture with a seroma and skin rash forming 2 years after insertion of the implant. PMID:27579243

  18. The development of an injection-molding process for a polyanhydride implant containing gentamicin sulfate.

    PubMed

    Deng, Jone-Shin; Meisters, Marts; Li, Luk; Setesak, Jeff; Claycomb, Lee; Tian, Youqin; Stephens, Dennis; Widman, Matt

    2002-01-01

    A production-scale manufacturing process has been developed for polyanhydride/gentamicin sulfate implants for the treatment of osteomyelitis. Gentamicin sulfate was first dried to an acceptable moisture level by using a tumble vacuum dryer. Dried gentamicin sulfate powder and polyanhydride granules were separately fed into the twin-screw extruder at a pre-determined metering rate using a gravimetric feeding device. The extruded molten mixture was solidified to form strands which were subsequently cut into pellets by using a pelletizer. The pellets were characterized with respect to copolymer molecular weight and drug content uniformity. The pellets were later fed into production-scale injection-molding equipment for implant fabrication. The injection-molding cycle was developed and evaluated in terms of cycle reproducibility. Implants were tested and shown to yield an oriented skin-core structure exhibiting a desirable in-vitro drug release profile.

  19. Drug Debacle.

    PubMed

    Sorrel, Amy Lynn

    2016-01-01

    Medicaid's Vendor Drug Program is under examination by the Texas Legislature. TMA's Physicians Medicaid Congress is seizing the opportunity to call for an administrative overhaul of a drug benefit physicians describe as unnecessarily complicated and confusing. PMID:27441421

  20. Drug Debacle.

    PubMed

    Sorrel, Amy Lynn

    2016-07-01

    Medicaid's Vendor Drug Program is under examination by the Texas Legislature. TMA's Physicians Medicaid Congress is seizing the opportunity to call for an administrative overhaul of a drug benefit physicians describe as unnecessarily complicated and confusing.