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Sample records for silicone breast prosthesis

  1. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Silicone inflatable breast prosthesis. 878.3530... inflatable breast prosthesis. (a) Identification. A silicone inflatable breast prosthesis is a silicone... intended to be implanted to augment or reconstruct the female breast. (b) Classification. Class III....

  2. 21 CFR 878.3540 - Silicone gel-filled breast prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Silicone gel-filled breast prosthesis. 878.3540...-filled breast prosthesis. (a) Identification—(1) Single-lumen silicone gel-filled breast prosthesis. A single-lumen silicone gel-filled breast prosthesis is a silicone rubber shell made of...

  3. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Silicone inflatable breast prosthesis. 878.3530 Section 878.3530 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3530...

  4. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Silicone inflatable breast prosthesis. 878.3530 Section 878.3530 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3530...

  5. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Silicone inflatable breast prosthesis. 878.3530 Section 878.3530 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3530...

  6. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Silicone inflatable breast prosthesis. 878.3530 Section 878.3530 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3530...

  7. 21 CFR 878.3540 - Silicone gel-filled breast prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Silicone gel-filled breast prosthesis. 878.3540 Section 878.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3540 Silicone...

  8. 21 CFR 878.3540 - Silicone gel-filled breast prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Silicone gel-filled breast prosthesis. 878.3540 Section 878.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3540 Silicone...

  9. 21 CFR 878.3540 - Silicone gel-filled breast prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Silicone gel-filled breast prosthesis. 878.3540 Section 878.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3540 Silicone...

  10. The Misti Gold bio-oncotic gel filled breast prosthesis: an acceptable alternative to silicone?

    PubMed

    Laing, J H; Sanders, R

    1993-04-01

    Concern about the use of silicone gel as a filler for breast prostheses has stimulated interest in other materials. We have evaluated the Misti Gold prosthesis which contains a "bio-oncotic" gel of low molecular weight Polyvinylpyrrolidone (PLASDONE 24AUK). Our experience of its use in breast augmentation is that the aesthetic results obtained with retromammary placement are inferior to those obtained from a silicone gel filled prosthesis. Nonetheless there are theoretical advantages for its use which will need to be considered in the light of recent regulatory decisions.

  11. 21 CFR 878.3540 - Silicone gel-filled breast prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... silicone gel at time of implantation. The device is intended to be implanted to augment or reconstruct the... be implanted to augment or reconstruct the female breast. (3) Polyurethane covered silicone gel... support structure compartmentalizing the silicone gel. The device is intended to be implanted to...

  12. Choosing a Breast Prosthesis: A Survivor's Perspective

    MedlinePlus

    ... shape, depending on a woman's preferences. Q: Why did you decide to wear a breast form/prosthesis ... could wear it with my prosthetic. Q: How did having a mastectomy and then wearing a prosthesis ...

  13. Breast Reconstruction and Prosthesis

    MedlinePlus

    ... feel of the breast after a mastectomy. A plastic surgeon can do it at the same time ... want breast reconstruction. • Have you talked with your plastic surgeon about your options? You may not be ...

  14. Pattern of External Breast Prosthesis Use by Post Mastectomy Breast Cancer Patients in India: Descriptive Study from Tertiary Care Centre.

    PubMed

    Ramu, D; Ramesh, Rakesh S; Manjunath, Suraj; Shivakumar; Goel, Vipin; Hemnath, G N; Alexander, Annie

    2015-12-01

    In India, Breast cancer is now the most common cancer in urban and 2nd most common in rural areas [1]. The incidence is rising, more younger women are getting affected and due to increase in survival rates there is an increase in the total number of women suffering from breast Cancer. So far there are no studies evaluating the pattern of breast prosthesis use in Indian scenario. The aim of this study is to address the patterns of external breast prosthesis used in India and view of Indian women on such prosthesis after mastectomy for breast cancer. This was a descriptive longitudinal study. In this study we interviewed (telephonic) 63 people, after three years of completing treatment under The Department of Surgical Oncology, St. Johns medical college, Bangalore. Among the study group, 27 members (40 %) were using various prosthesis, rest 36 women were not using any type of prosthesis. Among the users of prosthesis, silicon prosthesis was used by 6 women, padded cups by 8 women, cloth or cotton by 12 women and 1 woman used other type of prosthesis. Most women use simple items like cloth and cotton (44 %). Next most commonly used prosthesis are padded cups(). Only 22 % of women were found using silicon prosthesis in this study. Most of the well educated patients used external prosthesis either in the form of silicon prosthesis or padded cups. Most of women below age of 50 used external breast prosthesis. Use of prosthesis was more in urban compared to rural population (48 % vs 25 %). Prosthesis users worried more about the body image than women not using prosthesis. 25 % of women using prosthesis had body image issues where as only 5 % of non prosthesis users had such problems. Prosthesis users need improvement in terms of comfort, size, shape and affordability. Most common reasons for not using prosthesis are age, lack of motivation and awareness. Less than half of the women included in this study used external prosthesis after mastectomy for breast cancer

  15. Women's Satisfaction with Their Breast Prosthesis: What Determines a Quality Prosthesis?

    ERIC Educational Resources Information Center

    Livingston, Patricia M.; White, Victoria M.; Roberts, Susan B.; Pritchard, Emma; Hayman, Jane; Gibbs, Anne; Hill, David J.

    2005-01-01

    The aim of this study is to determine what factors constitute a quality prosthesis and ascertain which factors affect prosthesis satisfaction. Sixty-four women who received full funding for their prosthesis and 38 women who received their hospital's usual funding were recruited. Women rated the information provided about breast prostheses very…

  16. Rehabilitation of amputed thumb with a silicone prosthesis

    PubMed Central

    Asnani, Pooja; Shivalingappa, Chandu Giriyapura; Mishra, Sunil Kumar; Somkuwar, Kirti; Khan, Faisal

    2015-01-01

    Creating prosthesis, having realistic skin surface and seamless visual integration with the surrounding tissues, requires both artistic and technical skill. Anatomical design, thin margins, lifelike fingernails and realistic color/contours are essential for patient satisfaction. Prosthesis is especially useful in case of lost body parts, as reconstructive surgery cannot fully restore aesthetics. This case report describes a simple technique for fabricating silicon finger prosthesis for a patient. PMID:25810684

  17. Stretchable silicon nanoribbon electronics for skin prosthesis.

    PubMed

    Kim, Jaemin; Lee, Mincheol; Shim, Hyung Joon; Ghaffari, Roozbeh; Cho, Hye Rim; Son, Donghee; Jung, Yei Hwan; Soh, Min; Choi, Changsoon; Jung, Sungmook; Chu, Kon; Jeon, Daejong; Lee, Soon-Tae; Kim, Ji Hoon; Choi, Seung Hong; Hyeon, Taeghwan; Kim, Dae-Hyeong

    2014-01-01

    Sensory receptors in human skin transmit a wealth of tactile and thermal signals from external environments to the brain. Despite advances in our understanding of mechano- and thermosensation, replication of these unique sensory characteristics in artificial skin and prosthetics remains challenging. Recent efforts to develop smart prosthetics, which exploit rigid and/or semi-flexible pressure, strain and temperature sensors, provide promising routes for sensor-laden bionic systems, but with limited stretchability, detection range and spatio-temporal resolution. Here we demonstrate smart prosthetic skin instrumented with ultrathin, single crystalline silicon nanoribbon strain, pressure and temperature sensor arrays as well as associated humidity sensors, electroresistive heaters and stretchable multi-electrode arrays for nerve stimulation. This collection of stretchable sensors and actuators facilitate highly localized mechanical and thermal skin-like perception in response to external stimuli, thus providing unique opportunities for emerging classes of prostheses and peripheral nervous system interface technologies. PMID:25490072

  18. Stretchable silicon nanoribbon electronics for skin prosthesis

    NASA Astrophysics Data System (ADS)

    Kim, Jaemin; Lee, Mincheol; Shim, Hyung Joon; Ghaffari, Roozbeh; Cho, Hye Rim; Son, Donghee; Jung, Yei Hwan; Soh, Min; Choi, Changsoon; Jung, Sungmook; Chu, Kon; Jeon, Daejong; Lee, Soon-Tae; Kim, Ji Hoon; Choi, Seung Hong; Hyeon, Taeghwan; Kim, Dae-Hyeong

    2014-12-01

    Sensory receptors in human skin transmit a wealth of tactile and thermal signals from external environments to the brain. Despite advances in our understanding of mechano- and thermosensation, replication of these unique sensory characteristics in artificial skin and prosthetics remains challenging. Recent efforts to develop smart prosthetics, which exploit rigid and/or semi-flexible pressure, strain and temperature sensors, provide promising routes for sensor-laden bionic systems, but with limited stretchability, detection range and spatio-temporal resolution. Here we demonstrate smart prosthetic skin instrumented with ultrathin, single crystalline silicon nanoribbon strain, pressure and temperature sensor arrays as well as associated humidity sensors, electroresistive heaters and stretchable multi-electrode arrays for nerve stimulation. This collection of stretchable sensors and actuators facilitate highly localized mechanical and thermal skin-like perception in response to external stimuli, thus providing unique opportunities for emerging classes of prostheses and peripheral nervous system interface technologies.

  19. Stretchable silicon nanoribbon electronics for skin prosthesis.

    PubMed

    Kim, Jaemin; Lee, Mincheol; Shim, Hyung Joon; Ghaffari, Roozbeh; Cho, Hye Rim; Son, Donghee; Jung, Yei Hwan; Soh, Min; Choi, Changsoon; Jung, Sungmook; Chu, Kon; Jeon, Daejong; Lee, Soon-Tae; Kim, Ji Hoon; Choi, Seung Hong; Hyeon, Taeghwan; Kim, Dae-Hyeong

    2014-12-09

    Sensory receptors in human skin transmit a wealth of tactile and thermal signals from external environments to the brain. Despite advances in our understanding of mechano- and thermosensation, replication of these unique sensory characteristics in artificial skin and prosthetics remains challenging. Recent efforts to develop smart prosthetics, which exploit rigid and/or semi-flexible pressure, strain and temperature sensors, provide promising routes for sensor-laden bionic systems, but with limited stretchability, detection range and spatio-temporal resolution. Here we demonstrate smart prosthetic skin instrumented with ultrathin, single crystalline silicon nanoribbon strain, pressure and temperature sensor arrays as well as associated humidity sensors, electroresistive heaters and stretchable multi-electrode arrays for nerve stimulation. This collection of stretchable sensors and actuators facilitate highly localized mechanical and thermal skin-like perception in response to external stimuli, thus providing unique opportunities for emerging classes of prostheses and peripheral nervous system interface technologies.

  20. Rehabilitation of digital defect with silicone finger prosthesis: a case report.

    PubMed

    Saxena, Deepesh; Jurel, Sunit; Gupta, Ajay; Dhillon, Manu; Tomar, Divya

    2014-08-01

    Patients with acquired defects often had severe trauma which leads to psychological instability, functional loss and poor aesthetics. Digital defects threaten the integrity of one's self esteem and also leads to a reduced and compromised function. A well fitted and colour matched finger prosthesis can make a patient feel a capable person and not a handicap. This article describes a technique for fabrication of custom made finger prosthesis with a silicone elastomer. The customization of the prosthesis leads to a better fit and retention. An excellent shade matching is achieved by the use of intrinsic colours. The other advantages of using silicone as a material of choice for prosthesis fabrication are also discussed.

  1. Prosthetic rehabilitation of large mid-facial defect with magnet-retained silicone prosthesis.

    PubMed

    Shrivastava, Kirti Jajoo; Shrivastava, Saurabh; Agarwal, Surendra; Bhoyar, Anjali

    2015-01-01

    Rehabilitation of maxillofacial defect patients is a challenging task. The most common prosthetic treatment problem with such patients is, getting adequate retention, stability, and support. In cases of large maxillofacial defect, movement of the prosthesis is inevitable. The primary objectives in rehabilitating the maxillofacial defect patients are to restore the function of mastication, deglutition, speech, and to achieve normal orofacial appearance. This clinical report describes maxillofacial prosthetic rehabilitation of large midfacial defect including orbit along with its contents, zygoma and soft tissues including half of the nose, cheeks, upper lip of left side, accompanying postsurgical microstomia and orofacial communication, which resulted from severe fungal infection mucormycosis. The defect in this case was restored with magnet retained two piece maxillofacial prosthesis having hollow acrylic resin framework and an overlying silicone facial prosthesis. The retention of prosthesis was further enhanced with the use of spectacles. This type of combination prosthesis enhanced the cosmesis and functional acceptability of prosthesis. PMID:26929525

  2. Prosthetic rehabilitation of large mid-facial defect with magnet-retained silicone prosthesis

    PubMed Central

    Shrivastava, Kirti Jajoo; Shrivastava, Saurabh; Agarwal, Surendra; Bhoyar, Anjali

    2015-01-01

    Rehabilitation of maxillofacial defect patients is a challenging task. The most common prosthetic treatment problem with such patients is, getting adequate retention, stability, and support. In cases of large maxillofacial defect, movement of the prosthesis is inevitable. The primary objectives in rehabilitating the maxillofacial defect patients are to restore the function of mastication, deglutition, speech, and to achieve normal orofacial appearance. This clinical report describes maxillofacial prosthetic rehabilitation of large midfacial defect including orbit along with its contents, zygoma and soft tissues including half of the nose, cheeks, upper lip of left side, accompanying postsurgical microstomia and orofacial communication, which resulted from severe fungal infection mucormycosis. The defect in this case was restored with magnet retained two piece maxillofacial prosthesis having hollow acrylic resin framework and an overlying silicone facial prosthesis. The retention of prosthesis was further enhanced with the use of spectacles. This type of combination prosthesis enhanced the cosmesis and functional acceptability of prosthesis. PMID:26929525

  3. Silicone-specific blood lymphocyte response in women with silicone breast implants.

    PubMed

    Ojo-Amaize, E A; Conte, V; Lin, H C; Brucker, R F; Agopian, M S; Peter, J B

    1994-11-01

    A blinded cross-sectional study was carried out with 99 women, 44 of whom had silicone breast implants. Group I consisted of 55 healthy volunteer women without breast implants; group II comprised 13 volunteer women with breast implants or explants who felt healthy; group III comprised 21 volunteer women with breast implants who had chronic fatigue, musculoskeletal symptoms, and skin disorders; and group IV comprised 10 women who had their prostheses explanted but still presented with clinical symptoms similar to those of the women in group III. Proliferative responses of peripheral blood mononuclear cells from all 99 women were measured by [3H]thymidine uptake after exposure to SiO2 silicon, or silicone gel. The levels of proliferative responses were expressed as stimulation indices, which were obtained by dividing the counts per minute of stimulated cells by the counts per minute of unstimulated cells. Abnormal responses to SiO2, silicon, or silicone gel were defined as a stimulation index of > 2.8, > 2.1, or > 2.4, respectively. Abnormal responses were observed in 0% of group I, 15% of group II, 29% of group III, and 30% of group IV (P < 0.0005 for group I versus groups II and IV). Thirty-one percent of symptomatic women with silicone gel breast implants had elevated serum silicon levels ( > 0.18 mg/liter); however, there was no significant correlation between abnormal cellular responses and silicon levels in blood serum, type of implant, time since first implantation, prosthesis explantation, number of implants, or report of implant leakage or rupture.(ABSTRACT TRUNCATED AT 250 WORDS)

  4. [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

  5. Do silicone breast implants affect breastfeeding?

    PubMed Central

    Koren, G.; Ito, S.

    1998-01-01

    QUESTION: One of my patients has silicone breast implants. She gave birth to a healthy baby boy but is afraid to breastfeed because she read in a magazine that the baby might be affected by silicone secreted in the milk. How should I advise her? ANSWER: Neither silicone nor its components could be measured in the breast milk of women with silicone implants. Your patient should be able to breastfeed safely. PMID:9870113

  6. Current status of silicone breast implants.

    PubMed

    Cruz, N I

    1991-08-01

    The current status of the silicone breast implants which have recently come under scrutiny by the FDA and received much unfavorable media coverage is reviewed. The gel-filled breast implants which in 1976 were "grandfathered" by the FDA have now been required to provide scientific evidence of safety and effectiveness by July 9, 1991. The possible risks of silicone breast implants include capsular contracture, interference with early tumor detection by routine mammography, development of sarcomas in laboratory animals (no human cases are reported), silicone gel leakage and connective tissue disease. In the less frequently used polyurethane covered implants, the degradation of the polyurethane to diaminotoluene (TDA) has caused liver cancer in laboratory animals, yet at present, this type of implant has been voluntarily removed from the market by the manufacturer. After reviewing the available evidence, the American Society of Plastic Surgery still considers silicone breast implants reliable and safe. PMID:1816782

  7. Silicon and silicone: theoretical and clinical implications of breast implants.

    PubMed

    Yoshida, S H; Chang, C C; Teuber, S S; Gershwin, M E

    1993-02-01

    In the past 10 years, there have been multiple published reports associating silicone breast implants with scleroderma, morphea, SLE, rheumatoid arthritis, CREST syndrome and "human adjuvant disease." The alleged offending material, silicone, is a synthetic polymer containing a silicon-oxygen backbone. Beginning with the heating of SiO2 in the presence of carbon, elemental silicon is produced. Methylchloride is added and the resulting product is hydrolyzed to form low molecular weight prepolymers which are linked to form linear silicone polymers and cross-linked to yield silicone rubbers or elastomers. The polymeric and hydrophobic characteristics of silicone and the presence of electrostatic charges and organic sidegroups make silicone a potentially ideal immunogen, leading to cross-reactivity with autoantigens. Silicon is an essential constituent of proteoglycans which theoretically could result in immunological cross-reactions between silicone and connective tissues. Although the literature contains numerous examples of silicone-associated autoimmune disease, there is no consistent pattern of immunological abnormalities observed. There are, however, some intriguing and interesting observations. Further large-scale studies are needed to determine if a link between silicone exposure and autoimmunity exists. Also, since the inducing events of autoimmune diseases are unknown, studies on silicone could provide a model for autoimmune diseases associated with toxicological factors.

  8. Silicon and silicone: theoretical and clinical implications of breast implants.

    PubMed

    Yoshida, S H; Chang, C C; Teuber, S S; Gershwin, M E

    1993-02-01

    In the past 10 years, there have been multiple published reports associating silicone breast implants with scleroderma, morphea, SLE, rheumatoid arthritis, CREST syndrome and "human adjuvant disease." The alleged offending material, silicone, is a synthetic polymer containing a silicon-oxygen backbone. Beginning with the heating of SiO2 in the presence of carbon, elemental silicon is produced. Methylchloride is added and the resulting product is hydrolyzed to form low molecular weight prepolymers which are linked to form linear silicone polymers and cross-linked to yield silicone rubbers or elastomers. The polymeric and hydrophobic characteristics of silicone and the presence of electrostatic charges and organic sidegroups make silicone a potentially ideal immunogen, leading to cross-reactivity with autoantigens. Silicon is an essential constituent of proteoglycans which theoretically could result in immunological cross-reactions between silicone and connective tissues. Although the literature contains numerous examples of silicone-associated autoimmune disease, there is no consistent pattern of immunological abnormalities observed. There are, however, some intriguing and interesting observations. Further large-scale studies are needed to determine if a link between silicone exposure and autoimmunity exists. Also, since the inducing events of autoimmune diseases are unknown, studies on silicone could provide a model for autoimmune diseases associated with toxicological factors. PMID:8441826

  9. High resolution solid-state 29Si NMR spectroscopy of silicone gels used to fill breast prostheses.

    PubMed

    Dorne, L; Alikacem, N; Guidoin, R; Auger, M

    1995-10-01

    We have used 29Si solid-state nuclear magnetic resonance (NMR) spectroscopy to study the chemical structure of the silicone gels in virgin and explanted breast prostheses. Despite evidences of alteration in the morphological appearance of the silicone gel inside the breast prosthesis, our results do not reveal changes in the chemical nature and structure of the silicone gels after implantation. In addition to the main 29Si resonance peak at -22.26 ppm that corresponds to the resonance frequency of the D repeat unit of the polysiloxane chains, the high sensitivity of our NMR technique allows the detection of very low concentrations of silicone compounds. Within our experimental detection limit of 0.2%, no signal between -90 ppm and -150 ppm are observed. This indicates that no silica products are present inside the gel of the prostheses. Furthermore, our 29Si NMR spectra indicate differences in the chemical compositions of the silicone gels from different manufacturers.

  10. Transaxillary endoscopic silicone gel breast augmentation.

    PubMed

    Strock, Louis L

    2010-09-01

    Following the return of silicone gel breast implants to the US market in 2006, augmentation with these implants has become increasingly popular. Surgeons have an array of refined techniques from which to choose when performing these procedures, many of which offer the advantage of reduced or less-obvious postoperative scarring. For obvious reasons, many patients are requesting placement of the implants through incisions that are removed from the breast area (and thereby hidden). The challenge of these approaches is to provide a level of technical control that matches what is afforded with the traditional inframammary approach. The addition of endoscopic assistance has provided a level of tissue visualization and technical control not previously possible with the transaxillary approach, with results that rival those of an inframammary procedure. In this article, the author presents his current operative technique, which has allowed for the routine placement of silicone gel breast implants through a transaxillary incision using endoscopic assistance.

  11. Breast milk metal ion levels in a young and active patient with a metal-on-metal hip prosthesis.

    PubMed

    Nelis, Raymond; de Waal Malefijt, Jan; Gosens, Taco

    2013-01-01

    Metal-on-metal resurfacing arthroplasty of the hip has been used increasingly over the last 10 years in younger active patients. The dissolution of the metal wear particles results in measurable increases in cobalt and chromium ions in the serum and urine of patients with a metal-on-metal bearing. We measured the cobalt, chromium, and molybdenum ion levels in urine; serum; and breast milk in a young and active patient with a metal-on-metal hip prosthesis after a pathologic fracture of the femoral neck. Metal-on-metal hip prosthesis leads to increasing levels of molybdenum in breast milk in the short-term follow-up. There are no increasing levels of chromium and cobalt ions in breast milk. Besides the already known elevated concentrations in serum of chromium and cobalt after implantation of a metal-on-metal hip prosthesis, we found no increasing levels of chromium and cobalt in urine. PMID:22868068

  12. Capsular Contracture In Silicone Breast Implants: Insights From Rat Models.

    PubMed

    Vieira, Vilberto J; D'Acampora, Armando; Neves, Fernanda S; Mendes, Paulo R; Vasconcellos, Zulmar A DE; Neves, Rodrigo D'Eça; Figueiredo, Claudia P

    2016-09-01

    Breast augmentation with silicone implants is one of the most common procedures performed by plastic surgeons around the world. Capsular contracture is a frequent complication in breast augmentation and reconstructive surgery, that requires invasive intervention. The inflammatory response to implanted mammary prostheses appears to be directly associated to capsular contracture. This review discusses the evidences from rat models studies, on the role of inflammation and fibrosis in capsular contraction and its relation to silicone breast implants surface. PMID:27627068

  13. Breast prosthesis infection and pets: A case report and review of the literature

    PubMed Central

    Lenne, A.; Defourny, L.; Lafosse, A.; Martin, M.; Vandercam, B.; Berlière, M.; Lengelé, B.; Rodriguez-Villalobos, H.

    2016-01-01

    Introduction Pets are not always the human’s best friends, particularly in the presence of comorbidities such as wounds. The following case report describes a Pasteurella multocida infection of a reconstructive breast implant due to a close contact between a cat and its owner. Presentation of case A 33-year-old woman developed a breast implant infection 13 days after an immediate breast reconstruction following a mastectomy for a multifocal ductal carcinoma. The wound was explored surgically and the implant removed. Culture extracted from fluid around the prosthesis evidenced the presence of P. multocida, a Gram-negative coccobacillus which is present in the oral commensal flora of cats and dogs. Conclusion In the case of breast infection, surgical revision – with or without removal of the implant – is required in order to carry out a meticulous intraoperative cleaning. Antibiotherapy is always necessary in such cases. Particularly when patients presenting comorbidities are concerned, the focus must be put on avoiding close contact of the wound with pets. PMID:27084983

  14. Microfabrication of an Implantable silicone Microelectrode array for an epiretinal prosthesis

    SciTech Connect

    Maghribi, M

    2003-06-10

    Millions of people suffering from diseases such as retinitis pigmentosa and macular degeneration are legally blind due to the loss of photoreceptor function. Fortunately a large percentage of the neural cells connected to the photoreceptors remain viable, and electrical stimulation of these cells has been shown to result in visual perception. These findings have generated worldwide efforts to develop a retinal prosthesis device, with the hope of restoring vision. Advances in microfabrication, integrated circuits, and wireless technologies provide the means to reach this challenging goal. This dissertation describes the development of innovative silicone-based microfabrication techniques for producing an implantable microelectrode array. The microelectrode array is a component of an epiretinal prosthesis being developed by a multi-laboratory consortium. This array will serve as the interface between an electronic imaging system and the human eye, directly stimulating retinal neurons via thin film conducting traces. Because the array is intended as a long-term implant, vital biological and physical design requirements must be met. A retinal implant poses difficult engineering challenges due to the size of the intraocular cavity and the delicate retina. Not only does it have to be biocompatible in terms of cytotoxicity and degradation, but it also has to be structurally biocompatible, with regard to smooth edges and high conformability; basically mimicking the biological tissue. This is vital to minimize stress and prevent physical damage to the retina. Also, the device must be robust to withstand the forces imposed on it during fabrication and implantation. In order to meet these biocompatibility needs, the use of non-conventional microfabrication materials such as silicone is required. This mandates the enhancement of currently available polymer-based fabrication techniques and the development of new microfabrication methods. Through an iterative process, devices

  15. [Computer-aided method and rapid prototyping for the personalized fabrication of a silicone bandage digital prosthesis].

    PubMed

    Ventura Ferreira, Nuno; Leal, Nuno; Correia Sá, Inês; Reis, Ana; Marques, Marisa

    2014-01-01

    The fabrication of digital prostheses has acquired growing importance not only for the possibility for the patient to overcome psychosocial trauma but also to promote grip functionality. An application method of three dimensional-computer-aided design technologies for the production of passive prostheses is presented by means of a fifth finger amputee clinical case following bilateral hand replantation.Three-dimensional-computerized tomography was used for the collection of anthropometric images of the hands. Computer-aided design techniques were used to develop the digital file-based prosthesis from the reconstruction images by inversion and superimposing the contra-lateral finger images. The rapid prototyping manufacturing method was used for the production of a silicone bandage prosthesis prototype. This approach replaces the traditional manual method by a virtual method that is basis for the optimization of a high speed, accurate and innovative process.

  16. Polyarteritis Nodosa Presenting as Digital Gangrene and Breast Lesion following Exposure to Silicone Breast Implants

    PubMed Central

    Homsi, Yamen; Carlson, John Andrew; Homsi, Samer

    2015-01-01

    Polyarteritis nodosa (PAN) is a rare systemic necrotizing vasculitis of small and medium sized arteries. We report a case of a 49-year old woman who presented with PAN following exposure to silicone breast implants. Although the relationship between silicone implants and connective tissue diseases has been investigated in the literature, no prior reports were found documenting PAN after silicone mammoplasty. While the pathogenesis of idiopathic PAN is not known yet, responsiveness to immunosuppressive therapy may suggest an immunologic mechanism. More robust research is needed to understand the connection between silicone breast implants and autoimmunity. PMID:26844000

  17. A New Approach to Minimize Acellular Dermal Matrix Use in Prosthesis-based Breast Reconstruction

    PubMed Central

    Hadad, Ivan; Liu, Allen S.

    2015-01-01

    Background: Acellular dermal matrices (ADMs) are often used to improve lower-pole contour, as well as allow for single-stage reconstruction, but numerous studies have shown an increased complication rate using ADM. As such, our group has developed a minimal-ADM-use technique to lower complications while effectively recreating lower-pole contour. Methods: A total of 380 postmastectomy prosthesis-based breast reconstructions were performed in 265 patients by a single surgeon. One hundred eight reconstructions were performed using the traditional ADM technique, with a large piece of ADM along the entire inferior and lateral borders. Two hundred twenty-five reconstructions were performed with the minimal-use technique, patching only the lateral area of the reconstruction. Thirty-five reconstructions were performed without the use of any ADM for high-risk reconstructions, most often in morbidly obese patients. Results: Comparing the traditional technique with the minimal-use technique, the seroma rate dropped from 3% to 0%. The rate of infection and reconstruction loss fell from 9% to 1%. Upon greatly reducing or eliminating the use of ADM use in obese patients, the seroma rate decreased from 15.4% to 5.7%, and the reconstruction loss rate decreased from 38% to 9%. Conclusions: This article describes a new surgical approach to minimize the amount of ADM necessary to create an aesthetically pleasing breast reconstruction. We believe that this approach helps avoid the complications of seroma, infection, and loss of the reconstruction. In certain obese patients, total avoidance of ADM may be the better choice. PMID:26301161

  18. Reconstruction of an ablated breast.

    PubMed

    Scarfì, A; Ordemann, K; Hüter, J

    1986-01-01

    It is the aim of the reconstruction of an ablated breast to repair the woman's integrity. The technique of this operation, according to Bomert, is the sliding of a flap of skin in the case of a horizontal breast scar. For the reconstruction, a silicone prosthesis is implanted which in most cases is prepectoral.

  19. Sjögren’s syndrome after silicone breast implantation

    PubMed Central

    Akyol, Lütfi; Önem, Soner; Özgen, Metin; Sayarlıoğlu, Mehmet

    2015-01-01

    Sjögren’s syndrome, an autoimmune disease characterized by lymphocytic infiltration of the lacrimal and salivary glands, leads to dryness of the mouth and eyes. Herein, we present a case of Sjögren’s syndrome that developed after silicone breast implantation. A cause-effect relationship between breast implantation and Sjögren’s syndrome has not been established. However, the possibility of such an association should be considered when a patient with silicone implants is admitted to the hospital for treatment of Sjögren’s syndrome.

  20. Silicone breast implants: implications for society and surgeons.

    PubMed

    Renwick, S B

    1996-09-16

    In the last two years, scientific studies have confirmed that there is no significant increase in risk of subsequent breast cancer, connective-tissue disease or symptoms in women with silicone gel-filled breast implants. Despite this evidence, a moratorium (in place since 1992) on the use of these prostheses in the United States has been maintained by the pressure of overwhelming litigation. At the same time, Australian authorities also announced a moratorium, restricting the availability of silicone breast implants. Huge damages awarded by United States courts forced Dow Corning, manufacturer of a large percentage of breast prostheses, to file for Chapter 11 bankruptcy in May 1995. This effectively terminated the major source of implantable silicone for medical use. The withdrawal of implantable silicone and other implantable prosthetic material will be a significant loss for surgeons and society. This paper will highlight the consequences if reasoned scientific data are not relied on by Australian courts to assess claims for damages relating to medical devices.

  1. Chemical fingerprinting of silicone-based breast implants.

    PubMed

    Keizers, Peter H J; Vredenbregt, Marjo J; Bakker, Frank; de Kaste, Dries; Venhuis, Bastiaan J

    2015-01-01

    With millions of women worldwide carrying them, silicone-based breast implants represent a large market. Even though silicone breast implants already have a history of use of more than 50 years, the discussion on their safety has not yet come to an end. To improve safety assessment, regulatory authorities should have the availability of a set of tests to be able to determine parameters of implant identity and quality. Therefore, the gels and envelopes of various brands and types of silicone-based breast implants have been subjected to infrared, Raman and NMR spectroscopy. We show that by using a combination of complementary spectroscopic techniques breast implants of various origins can be distinguished on typical chemical hallmarks. It was found that typical silicone-based implants display a surplus of vinyl signals in the gel, cyclosiloxane impurities are tolerable at low levels only and a barrier layer is present in the implant envelope. The techniques presented here and the results obtained offer a good starting point for market surveillance studies. PMID:25459933

  2. Form-stable silicone gel breast implants.

    PubMed

    Jewell, Mark

    2009-01-01

    This article addresses the question of what is the optimal shape for a breast implant. It is oriented toward processes, system engineering, and operational excellence versus being a treatise on the author's personal technique. PMID:19055963

  3. Chemical and physicochemical properties of the high cohesive silicone gel from Poly Implant Prothèse (PIP) breast prostheses after explantation: a preliminary, comparative analytical investigation.

    PubMed

    Beretta, Giangiacomo; Malacco, Matteo

    2013-05-01

    Aim of this work was to gain a deeper insight into the analytical profile of the macromolecular and LMW fractions of polymeric silicones present in breast implants. The study was conducted on silicone gel samples from (i) breast prostheses (Poly Implant Prothèse, PIP) explanted from a patient that needed their therapeutical removal, (ii) from a virgin Mc Ghan 410 MX prosthesis and (iii) from a sample of technical-grade non-cohesive silicone. The gels were analysed using rheological techniques, attenuated total reflectance infrared spectroscopy (ATR-FT-IR), nuclear magnetic resonance ((1)H NMR), gas chromatography coupled to mass spectrometry (GC-MS) and flow injection electrospray mass spectrometry (FI-ESI-MS). Our results demonstrate that, compared to the virgin McGhan gel, the silicone present the PIP prostheses lacks a significant part of the cross-linking sites necessary for the high-cohesive properties of the gel, significant amounts of cholesterol have been absorbed from the breast tissue by the silicone material, demonstrating the lack of impermeability of its elastomer shell. The potential implications and consequences of these analytical results are discussed. PMID:23454600

  4. Silicone Breast Implant and Automatic Implantable Cardioverter Defibrillator: Can They Coexist? A Case Report.

    PubMed

    Or, Friedman; Arik, Zaretski

    2016-08-01

    We present a case of a silicone breast implant rupture after insertion of an automatic implantable cardioverter defibrillator (AICD). A 51-year-old woman presented to our plastic surgery clinic to exchange her silicone breast implants. The patient underwent cosmetic mastopexy and breast augmentation in 2008. Because of recurrent myocardial infarctions and chronic heart failure, she underwent an insertion of an AICD in 2014 in which the left breast implant was hit. In this report, we discuss the first case of an AICD insertion, disrupting a breast implant. This case report illustrates the rare but real possibility of breast implant rupture after even minor surgical manipulation of the breast area. PMID:27622117

  5. Osteomyelitis of sternum and rib after breast prosthesis implantation: A rare or underestimated infection?

    PubMed Central

    Seng, Piseth; Alliez, Antoine; Honnorat, Estelle; Menard, Amelie; Casanova, Dominique; Stein, Andreas

    2014-01-01

    Sternum and rib osteomyelitis complicated from breast implant infection is rare. We report a case of early sternum and rib osteomyelitis occurred during breast implant infection managed in an inter-regional referral center for bone/joint infections in the south of France. PMID:26793446

  6. 21 CFR 878.3590 - Ear prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the...

  7. 21 CFR 878.3590 - Ear prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the...

  8. 21 CFR 878.3590 - Ear prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the...

  9. 21 CFR 878.3590 - Ear prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the...

  10. 21 CFR 878.3590 - Ear prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the...

  11. Investigations of silicone breast implants with the NMR-MOUSE.

    PubMed

    Krüger, Mirko; Schwarz, Annett; Blümich, Bernhard

    2007-02-01

    Silicone breast implants are used for breast augmentation and breast reconstruction. The issues of concern associated with such implants are: (a) the quality control of each implant before implantation, and (b) the detection of implant bleeding after implantation. We have studied the use of the Nuclear Magnetic Resonance-MObile Universal Surface Explorer (NMR-MOUSE) for the nondestructive testing of (a) the quality of implant shells, and (b) changes in implant gel due to leakage of body fluid into the implant. Depth profiles measured nondestructively through implant shells at different positions of each implant by the Profile NMR-MOUSE assured good reproducibility of the quality and thickness of different shell layers. The leakage of implants upon rupture was mimicked by observing changes in the transverse NMR relaxation time of the implant gel upon ingress of physiological saline solution and safflower oil through the rupture. Results demonstrate that nondestructive testing with unilateral NMR is a potential method for use in the quality control of implants and for the screening of implants for rupture after implantation. PMID:17275616

  12. Silicone Breast Implant and Automatic Implantable Cardioverter Defibrillator: Can They Coexist? A Case Report

    PubMed Central

    Arik, Zaretski

    2016-01-01

    Summary: We present a case of a silicone breast implant rupture after insertion of an automatic implantable cardioverter defibrillator (AICD). A 51-year-old woman presented to our plastic surgery clinic to exchange her silicone breast implants. The patient underwent cosmetic mastopexy and breast augmentation in 2008. Because of recurrent myocardial infarctions and chronic heart failure, she underwent an insertion of an AICD in 2014 in which the left breast implant was hit. In this report, we discuss the first case of an AICD insertion, disrupting a breast implant. This case report illustrates the rare but real possibility of breast implant rupture after even minor surgical manipulation of the breast area. PMID:27622117

  13. Lymphocyte response to silica among offspring of silicone breast implant recipients.

    PubMed

    Smalley, D L; Levine, J J; Shanklin, D R; Hall, M F; Stevens, M V

    The current study evaluated immune response to silicon dioxide in children born to women with silicone breast implants. In part one of the study, the T lymphocytes of 21 of 24 such children were significantly stimulated by silicon dioxide (silica). Part two consisted of eleven children, four born preimplantation and seven born postimplantation. None of the preimplant offspring showed T cell responses to silica; five of the seven postimplant children were positive for T cell memory for silica. Part three was a blinded study based on statistically significant differences in T cell stimulation with silicon dioxide between postimplant children and controls. These findings indicate a common immune reaction, that of T cell memory, occurs in mothers and their children born after exposure to silicone mammary implants placed prior to pregnancy. Since not all such children were breast fed the result favors transplacental passage of immunogens such as silicone oligomers or through maternofetal cellular traffic.

  14. 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

  15. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Passive tendon prosthesis. 888.3025 Section 888...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or...

  16. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Passive tendon prosthesis. 888.3025 Section 888...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or...

  17. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Passive tendon prosthesis. 888.3025 Section 888...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or...

  18. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Passive tendon prosthesis. 888.3025 Section 888...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or...

  19. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Passive tendon prosthesis. 888.3025 Section 888...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or...

  20. Regulatory science of new technology: tendency of medical professionals' interests on silicone breast implants.

    PubMed

    Nakazaki, Tomomichi; Ikeda, Koji; Iwasaki, Kiyotaka; Umezu, Mitsuo

    2016-09-01

    New technology related to artificial organs is most attractive for worldwide researchers. We believe they must contribute for the future patients against untreatable diseases. Regulatory science is a new science to establish 'social acceptance' of new technology into the clinical market as soon as possible. In the history of silicone breast implants, we could recognize risks many times; however, we missed such chances to prevent a subsequent crisis. We analyzed the trend of published literature related to silicone breast implants to review the medical professionals' interests on such risks. This trend showed, despite issues of a social acceptance of silicone breast implants in a few countries, other countries' medical professionals had no interest. Our hypothesis is 'medical professionals face the government and do not have contributed to re-establish the social acceptance of new technologies for patients'. Any technology does not have the complete evidence of safety, efficacy and quality, despite regulatory authorities' review and approval with clinical evidences. medical professionals need to conduct subsequently the epidemiological study, to take a meta-analysis periodically and to create/update the guidance for their patients under their professional ethics after the marketing of new technologies. We need to take seriously the 'lesson learned' from the history of silicone breast implants for all kind of new technologies existed in the present.

  1. Effect of fabrication process on the bond strength between silicone elastomer and acrylic resin for maxillofacial prosthesis.

    PubMed

    Hattori, Mariko; Sumita, Yuka I; Muthiah, Lovely; Iwasaki, Naohiko; Takahashi, Hidekazu; Aimaijiang, Yiliyaer; Yoshi, Shigen; Taniguchi, Hisashi

    2014-01-01

    This study evaluated the effects of the fabrication process on tensile bond strength between maxillofacial silicone elastomer and acrylic resin. A common maxillofacial silicone elastomer (VST-50), two primers (Sofreliner primer and R-SI-LINE Plasticbond), and two acrylic resins (Unifast III and Palapress Vario) were selected. Silicone elastomer between primed acrylic resin plates were polymerized using a metal flask mold or a flaskless stone mold. Bond strength of the specimens was measured by a tensile test and analyzed using two-way analysis of variance (ANOVA) with Tukey's honest significant difference test. All fracture surfaces showed interfacial fracture. Both the fabrication process and the primer-acrylic resin combination affected bond strength, and two-way ANOVA indicated a significant interaction. Bond strength was generally greater when silicone elastomer was polymerized using a flaskless stone mold.

  2. Scleroderma renal crisis following silicone breast implant rupture: a case report and review of the literature.

    PubMed

    Al Aranji, G; White, D; Solanki, K

    2014-01-01

    Systemic sclerosis (SSc) is a chronic multisystem autoimmune disorder characterised by progressive functional and structural abnormalities in blood vessels leading to microvascular dysfunction, excessive production and deposition of collagen leading to the fibrosis of skin and internal organs. The aetiology of the disease is unknown. However, exposure to various environmental factors, such as polyvinyl chloride and silica have been thought to play a role in the development of the disease. For this reason, silicone breast implants have been postulated as a cause for a range of autoimmune diseases including systemic sclerosis. This remains as yet unconfirmed. We report the case of a 52-year-old woman who presented with rapid development of skin thickening followed by scleroderma renal crisis (SRC) following rupture of silicone breast implants. This is the first published case of SRC in this setting. The literature on silicone and autoimmunity is reviewed. PMID:24480575

  3. Prosthesis coupling

    NASA Technical Reports Server (NTRS)

    Reswick, J. B.; Mooney, V.; Bright, C. W.; Owens, L. J. (Inventor)

    1979-01-01

    A coupling for use in an apparatus for connecting a prosthesis to the bone of a stump of an amputated limb is described which permits a bio-compatible carbon sleeve forming a part of the prosthesis connector to float so as to prevent disturbing the skin seal around the carbon sleeve. The coupling includes a flexible member interposed between a socket that is inserted within an intermedullary cavity of the bone and the sleeve. A lock pin is carried by the prosthesis and has a stem portion which is adapted to be coaxially disposed and slideably within the tubular female socket for securing the prosthesis to the stump. The skin around the percutaneous carbon sleeve is able to move as a result of the flexing coupling so as to reduce stresses caused by changes in the stump shape and/or movement between the bone and the flesh portion of the stump.

  4. Preliminary Study on Biosynthesis of Bacterial Nanocellulose Tubes in a Novel Double-Silicone-Tube Bioreactor for Potential Vascular Prosthesis.

    PubMed

    Hong, Feng; Wei, Bin; Chen, Lin

    2015-01-01

    Bacterial nanocellulose (BNC) has demonstrated a tempting prospect for applications in substitute of small blood vessels. However, present technology is inefficient in production and BNC tubes have a layered structure that may bring danger after implanting. Double oxygen-permeable silicone tubes in different diameters were therefore used as a tube-shape mold and also as oxygenated supports to construct a novel bioreactor for production of the tubular BNC materials. Double cannula technology was used to produce tubular BNC via cultivations with Acetobacter xylinum, and Kombucha, a symbiosis of acetic acid bacteria and yeasts. The results indicated that Kombucha gave higher yield and productivity of BNC than A. xylinum. Bacterial nanocellulose was simultaneously synthesized both on the inner surface of the outer silicone tube and on the outer surface of the inner silicone tube. Finally, the nano BNC fibrils from two directions formed a BNC tube with good structural integrity. Scanning electron microscopy inspection showed that the tubular BNC had a multilayer structure in the beginning but finally it disappeared and an intact BNC tube formed. The mechanical properties of BNC tubes were comparable with the reported value in literatures, demonstrating a great potential in vascular implants or in functional substitutes in biomedicine. PMID:26090420

  5. Preliminary Study on Biosynthesis of Bacterial Nanocellulose Tubes in a Novel Double-Silicone-Tube Bioreactor for Potential Vascular Prosthesis

    PubMed Central

    Wei, Bin; Chen, Lin

    2015-01-01

    Bacterial nanocellulose (BNC) has demonstrated a tempting prospect for applications in substitute of small blood vessels. However, present technology is inefficient in production and BNC tubes have a layered structure that may bring danger after implanting. Double oxygen-permeable silicone tubes in different diameters were therefore used as a tube-shape mold and also as oxygenated supports to construct a novel bioreactor for production of the tubular BNC materials. Double cannula technology was used to produce tubular BNC via cultivations with Acetobacter xylinum, and Kombucha, a symbiosis of acetic acid bacteria and yeasts. The results indicated that Kombucha gave higher yield and productivity of BNC than A. xylinum. Bacterial nanocellulose was simultaneously synthesized both on the inner surface of the outer silicone tube and on the outer surface of the inner silicone tube. Finally, the nano BNC fibrils from two directions formed a BNC tube with good structural integrity. Scanning electron microscopy inspection showed that the tubular BNC had a multilayer structure in the beginning but finally it disappeared and an intact BNC tube formed. The mechanical properties of BNC tubes were comparable with the reported value in literatures, demonstrating a great potential in vascular implants or in functional substitutes in biomedicine. PMID:26090420

  6. Assessment of silicone gel breast implant biodurability by NMR and EDS techniques.

    PubMed

    Taylor, R B; Eldred, D E; Kim, G; Curtis, J M; Brandon, H J; Klykken, P C

    2008-06-01

    In a study using explanted gel breast implants and appropriate nonimplanted controls, we examined silicone biodurability after long-term implantation. Using NMR spectroscopy, as well as NMR relaxometry measurements (T(2)), no evidence of hydrolysis or other chemical degradation of the cross-linked silicone matrix was observed in specimens from an early breast implant model (Cronin) explanted after 32 years in vivo or a more recent Silastic II model after 13 years in vivo. In addition, no appreciable differences were seen in T(2) relaxation times comparing explanted breast implants to suitably-matched nonimplanted controls, further underscoring the biostability of the cross-linked silicone shell and gel. Our T(2) data and resultant interpretations differ from a 2004 report by the NMR lab at the University of Münster, highlighting the importance of suitable nonimplanted controls and sample preparation. Energy dispersive spectroscopy (EDS) was also performed, confirming the persistence of a fluorosilicone layer inside the elastomer shells of Silastic II implants.

  7. Investigation of the silicone structure in breast implants using ¹H NMR.

    PubMed

    Formes, Andreas; Diehl, Bernd

    2014-05-01

    Against the background of the scandal about low-grade silicone breast implants of the French manufacturer Poly Implant Prothese (PIP), several types of implants were examined using (1)H NMR spectroscopy. The intention was to classify an implant according to its silicone structure. Therefore, the certificated raw material of the American silicone producer Nusil Technology was analyzed and used as a reference. The list of tested implants consists of implants by PFM medical, PIP, Silimed, Rofil, Eurosilicone, Mentor, Perouse Plastie, Polytech, Nagor, CUI, and McGhan. In the (1)H NMR spectrum the signal of the vinyl group, which is used to cross link silicone rubbers, is visible. It is possible to differentiate between silicones which have a vinyl terminated end group and silicones whose vinyl group is located within the chain of the polymer. The two different types of the vinyl group are one mean to classify the implants. Other categories besides the type of vinyl include the relative amount of the remaining vinyl in the implant and the chemical structure of the material used for the production of the envelope. With these characteristics the examined implants could be grouped into four types. PMID:24342752

  8. Prosthesis Material

    NASA Technical Reports Server (NTRS)

    1995-01-01

    In this photograph, Sandra Rossi user her NASA-developed prosthesis for the first time. Derived from foam insulation technology used to protect the Space Shuttle External Tank from excessive heat, FAB/CAD, a subsidiary of the Harshberger Prosthetic and Orthotic Center, utilized the technology to replace the heavy, fragile plaster they used to produce master molds for prosthetics. The new material was lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the customer.

  9. Prosthesis Material

    NASA Technical Reports Server (NTRS)

    1995-01-01

    In this photograph, James Carden uses a NASA-developed prosthesis to moved planks around his home. Derived from foam insulation technology used to protect the Space Shuttle External Tank from excessive heat, FAB/CAD, a subsidiary of the Harshberger Prosthetic and Orthotic Center, utilized the technology to replace the heavy, fragile plaster they used to produce master molds for prosthetics. The new material was lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the customer.

  10. Prosthesis Material

    NASA Technical Reports Server (NTRS)

    2004-01-01

    In this photograph, Amputee Amie Bradly uses a NASA-developed prosthesis to paint her fingernails. Derived from foam insulation technology used to protect the Space Shuttle External Tank from excessive heat, FAB/CAD, a subsidiary of the Harshberger Prosthetic and Orthotic Center, utilized the technology to replace the heavy, fragile plaster they used to produce master molds for prosthetics. The new material was lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the customer.

  11. Discoidal Porous Silicon Particles: Fabrication and Biodistribution in Breast Cancer Bearing Mice

    PubMed Central

    Chiappini, Ciro; Srinivasan, Srimeenakshi; Alexander, Jenolyn F.; Yokoi, Kenji; Ferrari, Mauro; Decuzzi, Paolo

    2012-01-01

    Porous silicon (pSi) is emerging as a promising material in the development of nanovectors for the systemic delivery of therapeutic and imaging agents. The integration of photolithographic patterning, typical of the semiconductor industry, with electrochemical silicon etching provides a highly flexible strategy to fabricate monodisperse and precisely tailored nanovectors. Here, a microfabrication strategy for direct lithographic patterning of discoidal pSi particles is presented that enables precise and independent control over particle size, shape, and porous structure. Discoidal pSi nanovectors with diameters ranging from 500 to 2600 nm, heights from 200 to 700 nm, pore sizes from 5 to 150 nm, and porosities from 40 to 90% are demonstrated. The degradation in serum, interaction with immune and endothelial cells in vitro, and biodistribution in mice bearing breast tumors are assessed for two discoidal nanovectors with sizes of 600 nm × 400 nm and 1000 nm × 400 nm. It is shown that both particle types are degraded after 24 h of continuous gentle agitation in serum, do not stimulate cytokine release from macrophages or affect endothelial cell viability, and accumulate up to about 10% of the injected dose per gram tissue in orthotopic murine models of breast cancer. The accumulation of the discoidal pSi nanovectors into the breast tumor mass is found to be up to five times higher than for spherical silica beads with similar diameters. PMID:23227000

  12. Radiation therapy after breast augmentation or reconstruction in early or recurrent breast cancer

    SciTech Connect

    Ryu, J.; Yahalom, J.; Shank, B.; Chaglassian, T.A.; McCormick, B. )

    1990-09-01

    Fourteen patients whose augmented or reconstructed breasts were treated with radiation therapy were analyzed. Silicone gel implants were used in 13 patients and free-injected silicone in one patient. The total radiation dose ranged from 4400 to 6200 cGy using tangential photon fields or an en face electron field by megavoltage equipment. In several cases, electron boost radiation was added to the tumor bed. The majority of the patients tolerated therapy well with minimal transient skin reactions; only three patients required a treatment break secondary to moist desquamation. Three patients developed documented implant encapsulation, although the majority retained good to excellent cosmesis. In summary, when breast carcinoma arises in the augmented or reconstructed breast, conservative management (i.e., limited surgery and definitive irradiation) is feasible without compromising the therapy or the cosmetic result. Thus, conservative management should be offered as an option to patients who are interested in breast prosthesis conservation.

  13. [Systemic scleroderma and scleroderma-like disease after silicone implants].

    PubMed

    Zachariae, H; Zachariae, E

    1992-08-01

    Systemic sclerosis or clinical patterns indistinguishable from systemic sclerosis have previously been demonstrated in workers in the polyvinylchloride industry and in mine-workers exposed to silica dust. In recent years, an increasing number of cases of systemic sclerosis, localized scleroderma, and scleroderma-like disease have been diagnosed in women after implantation of silicone gel prosthesis either following operations for breast cancer or cosmetic augmentation mammoplasty. We present two cases of systemic sclerosis or scleroderma-like disease appearing after silicone implants. Together with the already reported cases these results should lead to reduced use of silicone for cosmetic augmentation mammoplasty and a search for another material for patients operated on for breast cancer. The cases described, together with the reports concerning industrially provoked scleroderma, are of interest for the continued efforts to clarify the pathogenesis of scleroderma. Other types of exposure than those described here may also be of interest, i.e. occupational exposure to silicone spray.

  14. Retinal Prosthesis

    PubMed Central

    Weiland, James D.; Humayun, Mark S.

    2015-01-01

    Retinal prosthesis have been translated from the laboratory to the clinical over the past two decades. Currently, two devices have regulatory approval for the treatment of retinitis pigmentosa. These devices provide partial sight restoration and patients use this improved vision in their everyday lives. Improved mobility and object detection are some of the more notable findings from the clinical trials. However, significant vision restoration will require both better technology and improved understanding of the interaction between electrical stimulation and the retina. This paper reviews the recent clinical trials, highlights technology breakthroughs that will contribute to next generation of retinal prostheses. PMID:24710817

  15. Prosthesis Material

    NASA Technical Reports Server (NTRS)

    1995-01-01

    FAB/CAM, a subsidiary of the Harshberger Prosthetic and Orthotic Center, Inc., approached Marshall for help in replacing the heavy, fragile plaster they used to produce master molds for prosthetics. Concurrently, Marshall and Martin Marietta were creating a commercial derivative of the foam insulation used to protect the Space Shuttle External Tank from excessive heat. FAB/CAM found the foam blanks to be lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the consumer. Martin Marietta markets the foam system, MARCORE, for the prosthesis market. The system also has commercial potential in high temperature insulation and structural applications.

  16. A physical study of vibrating membranes in developing a middle ear prosthesis.

    PubMed

    Ledoux, L; Defebvre, A; Pouliquen, J; Vaneecloo, F M

    1991-01-01

    We present a prosthesis meant to replace the tympano-ossicular set as well as the measuring apparatus for developing and characterizing this prosthesis. Such biocompatible materials as silicone elastomer and Teflon are used. Effects due to aging and sterilization have been negligible. Comparisons with anatomic specimens have yielded good results. Furthermore, the first clinical trials with this prosthesis have been promising.

  17. Amine-modified hyaluronic acid-functionalized porous silicon nanoparticles for targeting breast cancer tumors

    NASA Astrophysics Data System (ADS)

    Almeida, Patrick V.; Shahbazi, Mohammad-Ali; Mäkilä, Ermei; Kaasalainen, Martti; Salonen, Jarno; Hirvonen, Jouni; Santos, Hélder A.

    2014-08-01

    Active targeting of nanoparticles to receptor-overexpressing cancer cells has great potential for enhancing the cellular uptake of nanoparticles and for reducing fast clearance of the nanoparticles from the body. Herein, we present a preparation method of a porous silicon (PSi)-based nanodelivery system for breast cancer targeting, by covalently conjugating a synthesized amide-modified hyaluronic acid (HA+) derived polymer on the surface of undecylenic acid-modified thermally hydrocarbonized PSi (UnTHCPSi) nanoparticles. The resulting UnTHCPSi-HA+ nanoparticles showed relatively small size, reduced polydispersibility, high biocompatibility, improved colloidal and human plasma stability, as well as enhanced cellular interactions and internalization. Moreover, we demonstrated that the enhanced cellular association of UnTHCPSi-HA+ relies on the capability of the conjugated HA+ to bind and consequently target CD44 receptors expressed on the surface of breast cancer cells, thus making the HA+-functionalized UnTHCPSi nanoparticles a suitable and promising nanoplatform for the targeting of CD44-overexpressing breast tumors and for drug delivery.Active targeting of nanoparticles to receptor-overexpressing cancer cells has great potential for enhancing the cellular uptake of nanoparticles and for reducing fast clearance of the nanoparticles from the body. Herein, we present a preparation method of a porous silicon (PSi)-based nanodelivery system for breast cancer targeting, by covalently conjugating a synthesized amide-modified hyaluronic acid (HA+) derived polymer on the surface of undecylenic acid-modified thermally hydrocarbonized PSi (UnTHCPSi) nanoparticles. The resulting UnTHCPSi-HA+ nanoparticles showed relatively small size, reduced polydispersibility, high biocompatibility, improved colloidal and human plasma stability, as well as enhanced cellular interactions and internalization. Moreover, we demonstrated that the enhanced cellular association of Un

  18. Natrelle 410 Extra-Full Projection Silicone Breast Implants: 2-Year Results from Two Prospective Studies

    PubMed Central

    McGuire, Patricia; Murphy, Diane K.

    2015-01-01

    Background: The safety and effectiveness of the Natrelle Style 410 highly cohesive silicone gel breast implant (Allergan, Inc., Irvine, Calif.) in full or moderate height and projection have been shown in a 10-year study. Extra-full projection implants may be an appropriate option for some women undergoing breast reconstruction. Methods: A total of 2795 women received at least one Natrelle 410 extra-full projection implant (X-style) for breast reconstruction in two similarly designed, prospective, multicenter studies. Data collected for 2 years after implantation in these studies were pooled to evaluate complication rates and subject and physician satisfaction. Results: Most subjects (76.0 percent) underwent bilateral reconstruction; a total of 4912 devices were implanted. Complication rates at 2 years were low. The most common complications were asymmetry (4.8 percent) and capsular contracture (3.3 percent). The cumulative risk of reoperation was 21.6 percent by subject and 16.6 percent by device; the most common reasons for reoperation were scarring (n = 97), asymmetry (n = 89), implant malposition (n = 78), and infection (n = 71). Subject and physician satisfaction rates exceeded 90 percent. At 2 years, 97 percent of physicians reported that the shape of the breast reflected the shape of the implant, and that the breast implant had maintained its original position. Conclusions: The safety profile of the Natrelle 410 extra-full projection implant mirrors that of its moderate projection and full projection counterparts. Both physicians and subjects were highly satisfied with the implants 2 years after surgery. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV. PMID:26090764

  19. Natrelle Round Silicone Breast Implants: Core Study Results at 10 Years

    PubMed Central

    Murphy, Diane K.

    2014-01-01

    Background: Allergan’s Natrelle round silicone-filled breast implants were approved by the U.S. Food and Drug Administration in 2006 based on interim results from the Core Study; final 10-year study results are now available. Methods: Seven hundred fifteen subjects were implanted with smooth and Biocell textured Natrelle round silicone implants and attended clinic visits at 0 to 4 weeks, 6 months, 1 year, and annually through 10 years. Approximately one-third of subjects underwent magnetic resonance imaging at years 1, 3, 5, 7, and 9 to assess rupture. Results: Complication rates showed modest increases over the previously published 6-year rates. The Kaplan-Meier capsular contracture rate was 18.9 percent for augmentation, 28.7 percent for revision-augmentation, and 24.6 percent for reconstruction. Among augmentation subjects, capsular contracture was significantly lower (p = 0.023) for submuscular (15.7 percent) versus subglandular (26.3 percent) placement. The overall rupture rate in the magnetic resonance imaging cohort was 13.0 percent for subjects and 7.7 percent for implants. By the end of the study, 81.8 percent of augmentation subjects still had an original implant in place. Using a five-point scale, 94.2 percent of augmentation, 83.8 percent of revision-augmentation, and 90.7 percent of reconstruction subjects reported being satisfied or definitely satisfied with their implants. Significant improvement over baseline was also seen in overall breast satisfaction and satisfaction with breast size, shape, feel, and how well they matched. Conclusion: The 10-year data from the Natrelle Core Study, which can guide surgeons and patients in decision-making, demonstrate safety and high levels of patient satisfaction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III. PMID:24867717

  20. Amine-modified hyaluronic acid-functionalized porous silicon nanoparticles for targeting breast cancer tumors.

    PubMed

    Almeida, Patrick V; Shahbazi, Mohammad-Ali; Mäkilä, Ermei; Kaasalainen, Martti; Salonen, Jarno; Hirvonen, Jouni; Santos, Hélder A

    2014-09-01

    Active targeting of nanoparticles to receptor-overexpressing cancer cells has great potential for enhancing the cellular uptake of nanoparticles and for reducing fast clearance of the nanoparticles from the body. Herein, we present a preparation method of a porous silicon (PSi)-based nanodelivery system for breast cancer targeting, by covalently conjugating a synthesized amide-modified hyaluronic acid (HA(+)) derived polymer on the surface of undecylenic acid-modified thermally hydrocarbonized PSi (UnTHCPSi) nanoparticles. The resulting UnTHCPSi-HA(+) nanoparticles showed relatively small size, reduced polydispersibility, high biocompatibility, improved colloidal and human plasma stability, as well as enhanced cellular interactions and internalization. Moreover, we demonstrated that the enhanced cellular association of UnTHCPSi-HA(+) relies on the capability of the conjugated HA(+) to bind and consequently target CD44 receptors expressed on the surface of breast cancer cells, thus making the HA(+)-functionalized UnTHCPSi nanoparticles a suitable and promising nanoplatform for the targeting of CD44-overexpressing breast tumors and for drug delivery.

  1. Late unilateral breast enlargement after insertion of silicone gel implants: A histopathological study

    PubMed Central

    Peters, Walter; Fornasier, Victor

    2007-01-01

    Late unilateral breast enlargement after the insertion of silicone gel breast implants is a very rare phenomenon. The present study reports five women who presented with this finding over the past 20 years. Three of these patients presented with late unilateral hematomas, which developed nine, 12 and 14 years, respectively, after initial breast augmentation, in the absence of any known trauma. These patients presented for treatment one, four and 12 months, respectively, after their breast enlargements initially appeared. Two of these patients had developed chronic expanding hematomas. Extensive histopathological analyses of the capsules of all three patients provided explanations for the etiologies and progressions of the findings in these patients. In each of the three patients, the etiology of the hematoma was consistent with erosion of a capsular artery. Numerous large vessels were seen within the wall of the capsules. In each case, there was a class IV capsular contracture, which could have increased the friction of the intact implant against the capsule, and there was both old (hemosiderin deposits) and new bleeding into the pocket from the capsules. This supports the concept that numerous episodes of bleeding had occurred in each case. Histopathology also demonstrated the progression of the hematomas. After four weeks, only liquefied hematoma was present, while after four months, there were both liquefied hematoma and blood clotting. The hematoma on the surface of the capsule was becoming organized peripherally, but not centrally. After 12 months, the hematoma was becoming very well organized compared with the hematoma at four months. In one of the two remaining cases, late infection was the cause of the breast enlargement. Histopathology of this capsule showed that the involved capsule was six times as thick as the other side. It also showed edema and infiltration by scattered mononuclear cells, polymorphonuclear cells, and irregular crenated and

  2. Cyclic volatile methylsiloxanes in human blood as markers for ruptured silicone gel-filled breast implants.

    PubMed

    Rosendahl, Pia; Hippler, Joerg; Schmitz, Oliver J; Hoffmann, Oliver; Rusch, Peter

    2016-05-01

    The replacement of medical-grade silicone with industrial-grade silicone material in some silicone gel-filled breast implants (SBI) manufactured by Poly Implant Prothèse and Rofil Medical Nederland B.V., reported in 2010, which resulted in a higher rupture tendency of these SBI, demonstrates the need for non-invasive, sensitive monitoring and screening methods. Therefore a sensitive method based on large volume injection-gas chromatography coupled to mass spectrometry (LVI-GC/MS) was developed to determine octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecamethylcyclo-hexasiloxane (D6) in blood samples from women with intact (n = 13) and ruptured SBI (n = 11). With dichloromethane extraction, sample cooling during preparation, and analysis extraction efficiencies up to 100 % and limits of detection of 0.03-0.05 ng D4-D6/g blood were achieved. Blood samples from women with SBI were investigated. In contrast to women with intact SBI, in blood from women with ruptured SBI higher D4 and D6 concentrations up to 0.57 ng D4/g blood and 0.16 ng D6/g blood were detected. With concentrations above 0.18 D4 ng/blood and 0.10 ng D6/g blood as significant criteria for ruptured SBI, this developed analytical preoperative diagnostic method shows a significant increase of the recognition rate. Finally a higher precision (error rate 17%) than the commonly used clinical diagnostic method, mamma sonography (error rate 46%), was achieved. PMID:26968566

  3. Physico-chemical characteristics of coated silicone textured versus smooth breast implants differentially influence breast-derived fibroblast morphology and behaviour.

    PubMed

    Valencia-Lazcano, Anai A; Alonso-Rasgado, Teresa; Bayat, Ardeshir

    2014-12-01

    Capsule formation is an inevitable consequence of silicone breast implantation. Clinically challenging dense fibrocollagenous capsular contractures occur at different rates between smooth compared to textured surfaces. Host response is influenced by several factors including implant surface texture, chemistry and interactions between cells and the extracellular matrix (ECM). Specific coatings can modify the physico-chemical properties of implant surfaces eliciting specific cellular reactions. Therefore, we evaluated the physico-chemical characteristics of coated smooth versus textured silicone breast implants on breast-derived fibroblast morphology and behaviour using (a) confocal laser microscopy, (b) Raman spectroscopy and (c) the effect of four unique protein and glycosaminoglycan (GAG) coatings (aggrecan, collagen I, fibronectin and hyaluronic acid) on breast-derived fibroblast attachment, proliferation, morphology, spreading, cytotoxicity and gene expression. Collagen I, fibronectin and hyaluronic acid coatings exhibited satisfactory fibroblast adhesion (p<0.001) in comparison to uncoated surfaces. Cell adhesion was less on smooth surfaces compared to textured surfaces (p<0.001). Fibroblasts cultured on collagen I, fibronectin and hyaluronic acid coated implants demonstrated improved cell proliferation than uncoated surfaces (p<0.001). LDH assay showed that coating surfaces with collagen I, fibronectin and hyaluronic acid did not induce cytotoxicity. Alpha-actinin expression and fibroblast adhesion to the substrate were upregulated (p<0.001), in textured versus smooth surfaces. FAK, vinculin and paxillin expression were upregulated (p<0.001), in all surfaces coated with fibronectin and collagen I. In conclusion, we present original data for expression of adhesion-related genes, cell morphology and proliferation in breast fibroblasts following the application of specific coatings on breast implant surfaces.

  4. Physico-chemical characteristics of coated silicone textured versus smooth breast implants differentially influence breast-derived fibroblast morphology and behaviour.

    PubMed

    Valencia-Lazcano, Anai A; Alonso-Rasgado, Teresa; Bayat, Ardeshir

    2014-12-01

    Capsule formation is an inevitable consequence of silicone breast implantation. Clinically challenging dense fibrocollagenous capsular contractures occur at different rates between smooth compared to textured surfaces. Host response is influenced by several factors including implant surface texture, chemistry and interactions between cells and the extracellular matrix (ECM). Specific coatings can modify the physico-chemical properties of implant surfaces eliciting specific cellular reactions. Therefore, we evaluated the physico-chemical characteristics of coated smooth versus textured silicone breast implants on breast-derived fibroblast morphology and behaviour using (a) confocal laser microscopy, (b) Raman spectroscopy and (c) the effect of four unique protein and glycosaminoglycan (GAG) coatings (aggrecan, collagen I, fibronectin and hyaluronic acid) on breast-derived fibroblast attachment, proliferation, morphology, spreading, cytotoxicity and gene expression. Collagen I, fibronectin and hyaluronic acid coatings exhibited satisfactory fibroblast adhesion (p<0.001) in comparison to uncoated surfaces. Cell adhesion was less on smooth surfaces compared to textured surfaces (p<0.001). Fibroblasts cultured on collagen I, fibronectin and hyaluronic acid coated implants demonstrated improved cell proliferation than uncoated surfaces (p<0.001). LDH assay showed that coating surfaces with collagen I, fibronectin and hyaluronic acid did not induce cytotoxicity. Alpha-actinin expression and fibroblast adhesion to the substrate were upregulated (p<0.001), in textured versus smooth surfaces. FAK, vinculin and paxillin expression were upregulated (p<0.001), in all surfaces coated with fibronectin and collagen I. In conclusion, we present original data for expression of adhesion-related genes, cell morphology and proliferation in breast fibroblasts following the application of specific coatings on breast implant surfaces. PMID:25238227

  5. Silicate antibodies in women with silicone breast implants: development of an assay for detection of humoral immunity.

    PubMed Central

    Shen, G Q; Ojo-Amaize, E A; Agopian, M S; Peter, J B

    1996-01-01

    Silicon, in the form of sodium silicate (Na2SiO3), adsorbed onto bovine serum albumin (BSA)-precoated plates served as the solid-phase antigen in an enzyme immunoassay to detect silicate-reactive antibodies in the plasma of 40 symptomatic women with silicone breast implants, 91 asymptomatic women with silicone breast implants, 50 healthy control women, and 52 women with rheumatic diseases and without silicone breast implants, Silicate-reactive antibodies of immunoglobulin G (IgG) or IgM isotypes were detected in the plasma of 30% (12 of 40) of the symptomatic women with silicone breast implants; 9% (8 of 91) of the asymptomatic women with silicone breast implants; 5% (1 of 20) of the women without implants who had systemic lupus erythematosus; and 0% (0 of 32) of the women without implants who had either Sjögren syndrome, scleroderma, or rheumatoid arthritis. Only 2% (1 of 50) of the sera from the healthy control women contained silicate-reactive antibodies. Preincubation of sera with silicate and eight other metal compounds (including SiO2) demonstrated that the IgG and IgM antibodies bound specifically to silicate, because preincubation with Na2SiO3 inhibited more than 90% of the activity, whereas CrO3, Li2SO4, MgSO4, NiSO4, HgCl2, ZrOCl2, BeSO4, and SiO2 failed to inhibit the IgG or IgM antibody binding to the silicate-BSA plates. Furthermore, the F(ab')2 portion and not the Fc portion of the silicate-reactive IgG was reactive with BSA-bound silicate in the enzyme immunoassay. The assay for silicate-reactive antibodies was quantified by assigning arbitrary units to a standard curve composed of serial twofold dilutions of high-positive (ten times higher than the cutoff) silicate antibody sera. This novel assay is a useful method for detecting and quantifying humoral immune response to silicate. PMID:8991630

  6. Anatomic asymmetric prostheses: shaping the breast.

    PubMed

    Mira, Juan A

    2003-01-01

    Over more than 50 years the manufacturers of mammary prostheses have offered implants of two basic shapes, sphere or teardrop, and always unilateral (symmetric). In the year 2001 Poly Implants Prothèse invited us to participate in the development of a device that, in our opinion, was going to change the conceptual design for mammary augmentation and reconstruction: the asymmetric anatomical prosthesis (AAP). On December 10, 2001 we performed, via the transareolaris inferior, the first breast augmentation using a prototype of anatomic, asymmetric, cohesive silicone implants. The result was pleasing in all aspects. The prostheses were capable to reproduce faithfully, in all dimensions, the anatomy of the female breasts, including the differences between each side. Since then, we have used the AAP with two different contents, silicone cohesive gel and Hidrogel, this last model in which we are currently experimenting. We utilized either a transareolar or submammary approach, according to the case (atrophy, ptosis, tuberous breast, etc.). We present in this paper the features of this new prosthesis, the procedures used for their implant, and a comparative analysis of our results. PMID:14629058

  7. Should silicone prostheses be considered for specimen banking? A pilot study into their use for human biomonitoring.

    PubMed

    Allan, Ian J; Bæk, Kine; Kringstad, Alfhild; Roald, Helge E; Thomas, Kevin V

    2013-09-01

    Persistent organic pollutant (POP) biomonitoring in humans is challenging and generally carried out using blood, breast milk or adipose tissue, with concentrations normalised to the lipid content of the sample matrix. The goal of this cross-sectional pilot study was to evaluate the validity and feasibility of explanted silicone prostheses as a matrix for persistent organic pollutant biomonitoring in humans. We postulate that pollutant concentrations in silicone prostheses inserted in the body will equilibrate with that in the body over time and provide a measure of the overall body burden. This study included silicone prostheses from 22 female patients of the Colosseum clinic (Oslo, Norway) collected between September 2010 and April 2012. Absorption of chlorinated and brominated POPs into silicone prostheses during implantation was observed. Relative levels of the different contaminants measured in prostheses were in agreement with those from serum and breast milk analyses from the general Norwegian population. The comparison of serum and breast milk-based literature data with prosthesis concentrations transposed into lipid-normalised concentrations supports the validity of the prosthesis measurements. The median of relative percent differences between measurements with replicate silicone prostheses from 11 patients was below 30%. Observed increases in prosthesis concentrations with patients' age were found to be very similar to literature data from studies of the Norwegian population. Silicone prostheses therefore represent a promising matrix for the biomonitoring of nonpolar and non-ionic pollutants in humans. Sample accessibility and body burden representativeness of the silicone prostheses suggest that specimen banking should be initiated. PMID:23955326

  8. Silicon nanowire based biosensing platform for electrochemical sensing of Mebendazole drug activity on breast cancer cells.

    PubMed

    Shashaani, Hani; Faramarzpour, Mahsa; Hassanpour, Morteza; Namdar, Nasser; Alikhani, Alireza; Abdolahad, Mohammad

    2016-11-15

    Electrochemical approaches have played crucial roles in bio sensing because of their Potential in achieving sensitive, specific and low-cost detection of biomolecules and other bio evidences. Engineering the electrochemical sensing interface with nanomaterials tends to new generations of label-free biosensors with improved performances in terms of sensitive area and response signals. Here we applied Silicon Nanowire (SiNW) array electrodes (in an integrated architecture of working, counter and reference electrodes) grown by low pressure chemical vapor deposition (LPCVD) system with VLS procedure to electrochemically diagnose the presence of breast cancer cells as well as their response to anticancer drugs. Mebendazole (MBZ), has been used as antitubulin drug. It perturbs the anodic/cathodic response of the cell covered biosensor by releasing Cytochrome C in cytoplasm. Reduction of cytochrome C would change the ionic state of the cells monitored by SiNW biosensor. By applying well direct bioelectrical contacts with cancer cells, SiNWs can detect minor signal transduction and bio recognition events, resulting in precise biosensing. Our device detected the trace of MBZ drugs (with the concentration of 2nM) on electrochemical activity MCF-7 cells. Also, experimented biological analysis such as confocal and Flowcytometry assays confirmed the electrochemical results.

  9. Changes in photon dose distributions due to breast prostheses

    SciTech Connect

    Klein, E.E. ); Kuske, R.R. )

    1993-02-15

    Subcutaneous prosthetic implants have been routinely used for cosmetic augmentation and for tissue replacement following mastectomy over the last 15 years. The implants come in many forms as the gel filler material and surrounding shell material(s) vary significantly. This study uses a thin window parallel-plate chamber and thermoluminescent dosimeters to quantify any dosimetric changes to surrounding breast tissue due to the presence of the prosthesis. A mammographic phantom was compared to four commercial prostheses, namely two silicon gel fillers within two different shells (silicon or silicon/polyurethane), a tri-glyceride within silicon and a bio-oncotic gel within silicon and a bio-oncotic gel within silicon/polyurethane. The latter two implants were designed with a low-Z fill for diagnostic imaging benefits. Ion chamber results indicate no significant alteration of depth doses away from the implant with only minor canceling (parallel opposed) interface perturbations for all implants. In addition the physical changes to the irradiated prostheses were quantified by tonometry testing and qualified by color change. Each implant exhibited color change following 50 Gy, and the bio-oncotic gel became significantly less formable following irradiation, and even less formable 6 weeks postirradiation. The data indicates that prostheses do not affect the photon beam distribution, but radiation does affect the prosthesis. 9 refs., 10 figs., 5 tabs.

  10. Ten-Year Results From the Natrelle 410 Anatomical Form-Stable Silicone Breast Implant Core Study

    PubMed Central

    Maxwell, G. Patrick; Van Natta, Bruce W.; Bengtson, Bradley P.; Murphy, Diane K.

    2015-01-01

    Background Silicone breast implants have long been used for breast augmentation and reconstruction. During this time, these medical devices have gone through a number of modifications to improve their safety, quality, and clinical outcome performance. Objectives The authors conducted a 10-year study to determine the safety and effectiveness of Natrelle 410 silicone breast implants. Methods This prospective, multicenter study enrolled 941 subjects who were undergoing either augmentation, augmentation revision, reconstruction, or reconstruction revision. Data on complications, reoperations, explantations, and subject satisfaction were collected at annual clinic visits, and one-third of subjects underwent biennial magnetic resonance imaging (MRI) to screen for implant rupture. The authors used the Kaplan-Meier estimator to calculate risk rates for local complications, reoperations, and explantations. Results Capsular contracture rates increased approximately 1% per year from the previously reported 6-year rates. The rates were significantly lower than those from the Natrelle round gel core study. The overall rate of confirmed ruptured implants in subjects who underwent MRI was 5.7%. Eleven late seromas were reported. The most common reason for explantation was a subject requesting a size or style change. Satisfaction rates remained high through 10 years, with most subjects saying they were somewhat or definitely satisfied with their implants. Conclusions This 10-year prospective trial demonstrated the long-term safety and effectiveness of Natrelle 410 anatomical form-stable implants. The complication rates were low and the satisfaction rates were high. Level of Evidence: 1 Therapeutic PMID:25717116

  11. Modified technique to fabricate a hollow light-weight facial prosthesis for lateral midfacial defect: a clinical report

    PubMed Central

    2010-01-01

    Large oro-facial defects result from cancer treatment consequences in serious functional as well as cosmetic deformities. Acceptable cosmetic results usually can be obtained with a facial prosthesis. However, retention of a large facial prosthesis can be challenging because of its size and weight. This article describes prosthetic rehabilitation of a 57-year-old man having a right lateral mid-facial defect with intraoral-extraoral combination prosthesis. A modified technique to fabricate a hollow substructure in heat-polymerizing polymethyl-methacrylate to support silicone facial prosthesis was illustrated. The resultant facial prosthesis was structurally durable and light in weight facilitating the retention with magnets satisfactorily. This technique is advantageous as there is no need to fabricate the whole prosthesis again in case of damage of the silicone layer because the outer silicone layer can be removed and re-packed on the substructure if the gypsum-mold is preserved. PMID:21165271

  12. Liquid- and solid-state high-resolution NMR methods for the investigation of aging processes of silicone breast implants.

    PubMed

    Birkefeld, Anja Britta; Bertermann, Rüdiger; Eckert, Hellmut; Pfleiderer, Bettina

    2003-01-01

    To investigate aging processes of silicone gel breast implants, which may include migration of free unreacted material from the gel and rubber to local (e.g. connective tissue capsule) or distant sites in the body, chemical alteration of the polymer and infiltration of body compounds, various approaches of multinuclear nuclear magnetic resonance (NMR) experiments (29Si, 13C, 1H) were evaluated. While 29Si, 13C, and 1H solid-state magic angle spinning (MAS) NMR techniques performed on virgin and explanted envelopes of silicone prostheses provided only limited information, high-resolution liquid-state NMR techniques of CDCl(3) extracts were highly sensitive analytical tools for the detection of aging related changes in the materials. Using 2D 1H, 1H correlation spectroscopy (COSY) and 29Si, 1H heteronuclear multiple bond coherence (HMBC) experiments with gradient selection, it was possible to detect lipids (mainly phospholipids) as well as silicone oligomer species in explanted envelopes and gels. Silicone oligomers were also found in connective tissue capsules, indicating that cyclic polysiloxanes can migrate from intact implants to adjacent and distant sites. Furthermore, lipids can permeate the implant and modify its chemical composition.

  13. 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 ...

  14. Cyclodextrin-Modified Porous Silicon Nanoparticles for Efficient Sustained Drug Delivery and Proliferation Inhibition of Breast Cancer Cells.

    PubMed

    Correia, Alexandra; Shahbazi, Mohammad-Ali; Mäkilä, Ermei; Almeida, Sérgio; Salonen, Jarno; Hirvonen, Jouni; Santos, Hélder A

    2015-10-21

    Over the past decade, the potential of polymeric structures has been investigated to overcome many limitations related to nanosized drug carriers by modulating their toxicity, cellular interactions, stability, and drug-release kinetics. In this study, we have developed a successful nanocomposite consisting of undecylenic acid modified thermally hydrocarbonized porous silicon nanoparticles (UnTHCPSi NPs) loaded with an anticancer drug, sorafenib, and surface-conjugated with heptakis(6-amino-6-deoxy)-β-cyclodextrin (HABCD) to show the impact of the surface polymeric functionalization on the physical and biological properties of the drug-loaded nanoparticles. Cytocompatibility studies showed that the UnTHCPSi-HABCD NPs were not toxic to breast cancer cells. HABCD also enhanced the suspensibility and both the colloidal and plasma stabilities of the UnTHCPSi NPs. UnTHCPSi-HABCD NPs showed a significantly increased interaction with breast cancer cells compared to bare NPs and also sustained the drug release. Furthermore, the sorafenib-loaded UnTHCPSi-HABCD NPs efficiently inhibited cell proliferation of the breast cancer cells.

  15. Cyclodextrin-Modified Porous Silicon Nanoparticles for Efficient Sustained Drug Delivery and Proliferation Inhibition of Breast Cancer Cells.

    PubMed

    Correia, Alexandra; Shahbazi, Mohammad-Ali; Mäkilä, Ermei; Almeida, Sérgio; Salonen, Jarno; Hirvonen, Jouni; Santos, Hélder A

    2015-10-21

    Over the past decade, the potential of polymeric structures has been investigated to overcome many limitations related to nanosized drug carriers by modulating their toxicity, cellular interactions, stability, and drug-release kinetics. In this study, we have developed a successful nanocomposite consisting of undecylenic acid modified thermally hydrocarbonized porous silicon nanoparticles (UnTHCPSi NPs) loaded with an anticancer drug, sorafenib, and surface-conjugated with heptakis(6-amino-6-deoxy)-β-cyclodextrin (HABCD) to show the impact of the surface polymeric functionalization on the physical and biological properties of the drug-loaded nanoparticles. Cytocompatibility studies showed that the UnTHCPSi-HABCD NPs were not toxic to breast cancer cells. HABCD also enhanced the suspensibility and both the colloidal and plasma stabilities of the UnTHCPSi NPs. UnTHCPSi-HABCD NPs showed a significantly increased interaction with breast cancer cells compared to bare NPs and also sustained the drug release. Furthermore, the sorafenib-loaded UnTHCPSi-HABCD NPs efficiently inhibited cell proliferation of the breast cancer cells. PMID:26440739

  16. Electrochemical approach for monitoring the effect of anti tubulin drugs on breast cancer cells based on silicon nanograss electrodes.

    PubMed

    Zanganeh, Somayeh; Khosravi, Safoora; Namdar, Naser; Amiri, Morteza Hassanpour; Gharooni, Milad; Abdolahad, Mohammad

    2016-09-28

    One of the most interested molecular research in the field of cancer detection is the mechanism of drug effect on cancer cells. Translating molecular evidence into electrochemical profiles would open new opportunities in cancer research. In this manner, applying nanostructures with anomalous physical and chemical properties as well as biocompatibility would be a suitable choice for the cell based electrochemical sensing. Silicon based nanostructure are the most interested nanomaterials used in electrochemical biosensors because of their compatibility with electronic fabrication process and well engineering in size and electrical properties. Here we apply silicon nanograss (SiNG) probing electrodes produced by reactive ion etching (RIE) on silicon wafer to electrochemically diagnose the effect of anticancer drugs on breast tumor cells. Paclitaxel (PTX) and mebendazole (MBZ) drugs have been used as polymerizing and depolymerizing agents of microtubules. PTX would perturb the anodic/cathodic responses of the cell-covered biosensor by binding phosphate groups to deformed proteins due to extracellular signal-regulated kinase (ERK(1/2)) pathway. MBZ induces accumulation of Cytochrome C in cytoplasm. Reduction of the mentioned agents in cytosol would change the ionic state of the cells monitored by silicon nanograss working electrodes (SiNGWEs). By extending the contacts with cancer cells, SiNGWEs can detect minor signal transduction and bio recognition events, resulting in precise biosensing. Effects of MBZ and PTX drugs, (with the concentrations of 2 nM and 0.1 nM, respectively) on electrochemical activity of MCF-7 cells are successfully recorded which are corroborated by confocal and flow cytometry assays. PMID:27619088

  17. Electrochemical approach for monitoring the effect of anti tubulin drugs on breast cancer cells based on silicon nanograss electrodes.

    PubMed

    Zanganeh, Somayeh; Khosravi, Safoora; Namdar, Naser; Amiri, Morteza Hassanpour; Gharooni, Milad; Abdolahad, Mohammad

    2016-09-28

    One of the most interested molecular research in the field of cancer detection is the mechanism of drug effect on cancer cells. Translating molecular evidence into electrochemical profiles would open new opportunities in cancer research. In this manner, applying nanostructures with anomalous physical and chemical properties as well as biocompatibility would be a suitable choice for the cell based electrochemical sensing. Silicon based nanostructure are the most interested nanomaterials used in electrochemical biosensors because of their compatibility with electronic fabrication process and well engineering in size and electrical properties. Here we apply silicon nanograss (SiNG) probing electrodes produced by reactive ion etching (RIE) on silicon wafer to electrochemically diagnose the effect of anticancer drugs on breast tumor cells. Paclitaxel (PTX) and mebendazole (MBZ) drugs have been used as polymerizing and depolymerizing agents of microtubules. PTX would perturb the anodic/cathodic responses of the cell-covered biosensor by binding phosphate groups to deformed proteins due to extracellular signal-regulated kinase (ERK(1/2)) pathway. MBZ induces accumulation of Cytochrome C in cytoplasm. Reduction of the mentioned agents in cytosol would change the ionic state of the cells monitored by silicon nanograss working electrodes (SiNGWEs). By extending the contacts with cancer cells, SiNGWEs can detect minor signal transduction and bio recognition events, resulting in precise biosensing. Effects of MBZ and PTX drugs, (with the concentrations of 2 nM and 0.1 nM, respectively) on electrochemical activity of MCF-7 cells are successfully recorded which are corroborated by confocal and flow cytometry assays.

  18. A Simplified Technique for Fabrication of Orbital Prosthesis

    PubMed Central

    Thakral, G.K.; Mohapatra, Abhilash; Seth, Jyotsna; Vashisht, Pallavi

    2014-01-01

    Eye is a vital organ not only for vision, but also an important component of facial expression, and over-all personality of a person. Loss of eye, apart from leading to impaired vision has a crippling effect on the psychology of the patient. Prosthodontic rehabilitation of such cases includes fabrication of prosthesis by acrylic resin, silicone and implants. However, not all patients are willing to use implants for maxillofacial rehabilitation. Therefore, a custom made orbital prosthesis serves as an affordable and satisfactory alternative. PMID:25121068

  19. Chemical modification of silicon nitride microsieves for capture of MCF-7 circulating tumor cells of breast cancer

    NASA Astrophysics Data System (ADS)

    Dien To, Thien; Thoai Le, Huyen; Thi Dinh, Mai Ngoc; Nguyen, Anh Tuan; Doan, Tin Chanh Duc; Mau Dang, Chien

    2015-01-01

    Chemical modification of silicon nitride (SiN) microsieves with glutaraldehyde and 3-glycidoxypropyldimethylethoxysilane (GOPS) for bio-coupling with an antibody to capture MCF-7 circulating tumor cells of breast cancer is reported. In this research, the antibody monoclonal anti-cytokerantin-FITC with fluorescein isothiocyanate label was used due to its good selectivity to MCF-7 circulating tumor cells of breast cancer. Modification efficiency was determined by the variation of contact angle. The increase in contact angle of the microsieves treated with glutaraldehyde and GOPS indicated that the microsieve surface changed from hydrophilic to hydrophobic. These results confirmed the successful immobilization of glutaraldehyde and GOPS onto SiN microsieves. Antibody binding effect was evaluated by fluorescence microscopy. Fluorescent images exhibited that GOPS was more effective than the glutaraldehyde treatment. The GOPS-treated microsieves were then used for capture of MCF-7 cells in phosphate buffered saline (PBS). The fluorescent images proved that the surface modification of SiN microsieves with GOPS helped to increase the efficiency of MCF-7 capture.

  20. Enhancement of Capture Sensitivity for Circulating Tumor Cells in a Breast Cancer Patient's Blood by Silicon Nanowire Platform.

    PubMed

    Kim, Dong-Joo; Choi, Mun-Ki; Jeong, Jin-Tak; Lim, Jung-Taek; Lee, Han-Byoel; Han, Wonshik; Lee, Sang-Kwon

    2016-04-01

    The separation of circulating tumor cells (CTCs) from the blood of cancer patients with high sensitivity is an essential technique for selecting chemotherapeutic agents at a patient-by-patient level. Recently, various research groups have reported a nanostructure-based platform for rare cell capture due to its high surface area and 3D nanotopographic features. However, evaluation of capture sensitivity based on chemical modification of the nanostructure surface has not yet been performed. Here, we evaluated the capture sensitivity for CTCs from the blood of three patients diagnosed with stage IV metastatic breast cancer by using the following three platforms: streptavidin-conjugated silicon nanowire (STR-SiNW), poly-l-lysine-coated silicon nanowire (PLL-SiNW), and poly-l-lysine-coated glass (PLL-glass). The number of evaluated CTCs on STR-SiNW, PLL-SiNW, and PLL-glass were 16.2 ± 5.5 cells, 7.3 ± 2.9 cells, and 4.7 ± 1.5 cells, respectively, per 0.5 ml. Therefore, we suggest that the STR-SiNW platform is highly adaptable for the quantitative evaluation of CTCs from the blood of cancer patients in the clinical setting.

  1. A study of the aging of silicone breast implants using 29Si, 1H relaxation and DSC measurements.

    PubMed

    Birkefeld, Anja Britta; Eckert, Hellmut; Pfleiderer, Bettina

    2004-08-01

    In this study 26 previously implanted silicone breast implants from the same manufacturer (Dow Corning) were investigated with two different analytical methods to characterize potential aging processes such as migration of monomer material from the gel and shell to local and distant sites, chemical alterations of the polymer, and infiltration of body compounds such as lipids. (1)H and (29)Si NMR relaxation measurements (spin-lattice, T1, and spin-spin, T2, relaxation times) were used to study the molecular dynamics of polysiloxane chains, both in gels and in shells. In addition, changes in physical properties were monitored by differential scanning calorimetry (DSC). The results of these measurements indicate that NMR relaxation times are influenced by implant generation, implantation time, shell texture and implant status. (1)H T2 values of shells and gels show a tendency to increase with increasing implantation time, indicating higher mobility and possible disintegration of the polymer network of older implants. Furthermore, the data suggest that aging also involves the migration of low cyclic molecular weight (LMW) silicone and linear chain polymer material from the gels into the shells. The high "bleeding" rate of second-generation (G2) implants (implantation period around 1973-1985), exhibiting thin shells is reflected in reduced relaxation times of these devices, most likely due to a loss of low molecular weight fractions from the gels. Moreover, "gel bleeding" also influences the melting behavior observed in DSC studies. Increased shell rigidity (high Tm and Tg) tends to be correlated with longer (29)Si relaxation times of the corresponding gels, suggesting a reduced transfer of LMW silicones and linear chain polymer from the gel to the shell and to the outside. Remarkably, textured implants seem to be less susceptible to degradation processes than implants with thin shells.

  2. [Vascular graft prosthesis].

    PubMed

    Chakfé, N; Dieval, F; Thaveau, F; Rinckenbach, S; Hassani, O; Camelot, G; Durand, B; Kretz, J-G

    2004-06-01

    Performed since the 1950s, vascular grafting has opened modern era of vascular surgery. Autologous venous grafts are of first choice for revascularisation of small arteries. Synthetic grafts are mainly modelled using microporous polytetrafluoroethylene or terephtalate polyethylene. These prosthesis are mainly used for revascularization of medium and large size arteries. PMID:15220107

  3. Human adjuvant disease: remission of silicone induced autoimmune disease after explanation of breast augmentation.

    PubMed Central

    kaiser, W; Biesenbach, G; Stuby, U; Grafinger, P; Zazgornik, J

    1990-01-01

    Autoimmune diseases following silicone or paraffin implantation are rarely encountered complications of plastic surgery. A 42 year old woman is presented who developed clinical and immunological features of systemic lupus erythematosus 11 years after silicone augmentation. After explanation antinuclear antibody titres decreased from 1/1280 to 1/160, C4 complement fraction and the previously raised angiotensin converting enzyme normalised in step with clinical improvement. It is important that plastic surgeons and rheumatologists should be aware of this possible association. PMID:2256743

  4. Nasal Prosthesis Rehabilitation after Partial Rhinectomy: A Clinical Report

    PubMed Central

    Seçilmiş, Aslı; Öztürk, A. Nilgün

    2007-01-01

    Facial defects resulting from neoplasms, congenital malformations, or trauma can be restorated with facial prostheses using different materials and retention methods to achieve a lifelike look and function. For the successful result, a lot of factors as harmony, texture, color matching, and blending of tissue interface of prosthesis is important. This clinical report describes treatment using a silicone prosthesis with a mechanical - retentined design for a patient who received a partial rhinectomy. Defects resulting from diseases as squamous cell carcinoma can be managed with the prosthetic rehabilitation so that the patient more comfortably and confidently resumed regular daily activity. Mechanical retention alone was sufficient to retain the prosthesis; thus, prosthetic adhesives were not necessary. PMID:19212487

  5. A randomized, double-blind, crossover trial comparing a silicone- versus water-based lubricant for sexual discomfort after breast cancer.

    PubMed

    Hickey, Martha; Marino, Jennifer L; Braat, Sabine; Wong, Swee

    2016-07-01

    Discomfort during sexual activity is common after breast cancer. Vaginal estrogens are effective but commonly avoided due to systemic absorption. Despite the large commercial market for vaginal lubricants, no randomized studies have compared products. We aimed to compare efficacy and acceptability of two major types of lubricant for discomfort during sexual activity in postmenopausal breast cancer patients. In a single-center, randomized, double-blind, AB/BA crossover design, sexually active postmenopausal breast cancer patients used each lubricant for 4 weeks. The primary patient-reported efficacy outcome was total discomfort related to sexual activity (Fallowfield Sexual Activity Questionnaire Discomfort subscale SAQ-D). Acceptability was measured by patient preference and reported intention to continue using the products. Of 38 women analyzed, over 90 % experienced clinically significant sexually related distress at baseline. Water- and silicone-based lubricants did not differ statistically in efficacy based on total sexual discomfort (difference 0.7, 95 % confidence interval (CI) 0-1.4, p = 0.06). In a post hoc analysis, pain/discomfort during penetration improved more during silicone-based lubricant use than during water-based lubricant use (odds ratio 5.4, 95 % CI 1.3-22.1, p = 0.02). All aspects of sexual discomfort measured with diaries were reported more commonly with water- than silicone-based lubricant. Almost twice as many women preferred silicone-based to water-based lubricant than the converse (n = 20, 65 %, vs. n = 11, 35 %). 88 % continued to experience clinically significant sexually related distress despite use of either lubricant. Total sexual discomfort was lower after use of silicone-based lubricant than water-based, but many women continue to experience sexually related distress. PMID:27306420

  6. Desmoid tumor occurring after reconstruction mammaplasty for breast carcinoma.

    PubMed

    Dale, P S; Wardlaw, J C; Wootton, D G; Resnick, J I; Giuliano, A E

    1995-11-01

    We present a case of desmoid tumor associated with prior alloplastic breast reconstruction. Wide local excision that includes chest wall resection, if necessary, is the primary treatment of choice. Patients with extensive nonresectable or recurrent disease may benefit from radiation therapy. Systemic therapy is a possibility in certain cases, but its toxicity generally precludes its use with this nonmetastatic tumor. Although this is the fourth reported case of desmoid tumor arising after implantation of a silicone prosthesis, we cannot claim a causal relationship. Careful follow-up consisting of yearly physical and mammagraphic examinations may facilitate early diagnosis and treatment of locally aggressive desmoid tumors but is not warranted, except in the context of routine screening for breast carcinoma. PMID:8579271

  7. A tactile control prosthesis

    NASA Astrophysics Data System (ADS)

    Perry, James Franklin

    This research involves development and testing of a tactile control prosthesis to aid human operators in control of dynamic vehicles. Specifically, this work includes development and demonstration of a torso mounted tactile drift display that allowed helicopter pilots to hover a Blackhawk helicopter with degraded vision (equivalent to 20/200 acuity), a NASA sponsored pilot-in-the-loop simulator study for a hover display and development and analysis of a tactile control prosthesis to help pilots correctly control an airplane experiencing an engine failure on takeoff. Results of a ten-subject experiment indicate that use of a tactile display in conjunction with a visual display reduces operator delay by 65 msec (SD of 28 msec), (P < 0.001) without a significant increase in error rate. In the pilot-in-the-loop simulation experiment pilots hovered a simulated helicopter better under increased workload conditions with the tactile control prosthesis than without it. The increased workload consisted of an addition drill in which the subject had to agree or disagree with a computer generated sum. Pilots were able to hover more precisely with the tactile display (mean of 5.19, SD of 2.57 feet) than without (mean of 6.39 and SD of 3.31 feet) especially when the secondary task was required (P < 0.001). Although learning effects were exhibited throughout the trials (P < 0.001), the tactile display was of greater benefit in higher workload conditions.

  8. Synthesis of D-mannose capped silicon nanoparticles and their interactions with MCF-7 human breast cancerous cells.

    PubMed

    Ahire, Jayshree H; Chambrier, Isabelle; Mueller, Anja; Bao, Yongping; Chao, Yimin

    2013-08-14

    Silicon nanoparticles (SiNPs) hold prominent interest in various aspects of biomedical applications. For this purpose, surface functionalization of the NPs is essential to stabilize them, target them to specific disease area, and allow them to selectively bind to the cells or the bio-molecules present on the surface of the cells. However, no such functionalization has been explored with Si nanoparticles. Carbohydrates play a critical role in cell recognition. Here, we report the first synthesis of silicon nanoparticles functionalized with carbohydrates. In this study, stable and brightly luminescent d-Mannose (Man) capped SiNPs have been synthesized from amine terminated SiNPs and d-mannopyranoside acid. The surface functionalization is confirmed by Fourier transform infrared spectroscopy (FTIR), nuclear magnetic resonance spectroscopy (NMR), and energy dispersive X-ray spectroscopy (EDX) studies. The mean diameter of the crystal core is 5.5 nm, as measured by transmission electron microscopy (TEM), while the hydrodynamic diameter obtained by dynamic light scattering (DLS) is 16 nm. The quantum yield (QY) of photoluminescence emission is found to be 11.5%, and the nanoparticles exhibit an exceptional stability over two weeks. The Man-capped SiNPs may prove to be valuable tools for further investigating glycobiological, biomedical, and material science fields. Experiments are carried out using Concanavalin A (ConA) as a target protein in order to prove the hypothesis. When Man functionalized SiNPs are treated with ConA, cross-linked aggregates are formed, as shown in TEM images as well as monitored by photoluminescence spectroscopy (PL). Man functionalized SiNPs can target cancerous cells. Visualization imaging of SiNPs in MCF-7 human breast cancer cells shows the fluorescence is distributed throughout the cytoplasm of these cells.

  9. The cytoskeletal organization of breast carcinoma and fibroblast cells inside three dimensional (3-D) isotropic silicon microstructures.

    PubMed

    Nikkhah, Mehdi; Strobl, Jeannine S; De Vita, Raffaella; Agah, Masoud

    2010-06-01

    Studying the cytoskeletal organization as cells interact in their local microenvironment is interest of biological science, tissue engineering and cancer diagnosis applications. Herein, we describe the behavior of cell lines obtained from metastatic breast tumor pleural effusions (MDA-MB-231), normal fibrocystic mammary epithelium (MCF10A), and HS68 normal fibroblasts inside three dimensional (3-D) isotropic silicon microstructures fabricated by a single-mask, single-isotropic-etch process. We report differences in adhesion, mechanism of force balance within the cytoskeleton, and deformability among these cell types inside the 3-D microenvironment. HS68 fibroblasts typically stretched and formed vinculin-rich focal adhesions at anchor sites inside the etched cavities. In contrast, MCF10A and MDA-MB-231 cells adopted the curved surfaces of isotropic microstructures and exhibited more diffuse vinculin cytoplasmic staining in addition to vinculin localized in focal adhesions. The measurement of cells elasticity using atomic force microscopy (AFM) indentation revealed that HS68 cells are significantly stiffer (p < 0.0001) than MCF10A and MDA-MB-231 cells. Upon microtubule disruption with nocodazole, fibroblasts no longer stretched, but adhesion of MCF10A and MDA-MB-231 within the etched features remained unaltered. Our findings are consistent with tensegrity theory. The 3-D microstructures have the potential to probe cytoskeletal-based differences between healthy and diseased cells that can provide biomarkers for diagnostics purposes. PMID:20207413

  10. Conus hip prosthesis.

    PubMed

    Wagner, H; Wagner, M

    2001-01-01

    50 years ago, prosthetic replacement of the hip joint ushered in a new epoch in orthopaedics. Total hip replacement made it possible to remove a severely diseased, painful hip and restore normal function and a normal quality of life to the afflicted patient. The early results of total hip replacement are almost all spectacular and hip replacement has become the most successful type of orthopaedic surgery. These good results using an approach that was technically relatively simple resulted in a temptation to implant prosthetic hip joints with ever increasing frequency in ever younger patients. This led to the emergence of new problems, which were not so clearly recognised at the outset: it emerged that the stability of prosthetic hip joints was of limited duration. This had the following consequence: If a total hip prosthesis is implanted in an elderly person whose remaining life-expectancy is shorter than the longevity of the prosthesis, hip replacement is a life-long solution. We can therefore say that, for a patient who has only 10 to 15 years left to live, their hip problem is solved by total hip replacement. For young people, who still have a long life expectancy in front of them, it is different. They will experience failure of the artificial joint and require further surgery. The commonest and most important type of failure in total hip prostheses is aseptic loosening, which is associated with resorption of bone at the site of the prosthesis. The cause of this phenomenon has only gradually been recognised in the course of the years. Initially, the unanimous opinion was that the methacrylate cement, used to fix the components of the prosthesis in the bone, was the definitive cause of aseptic loosening because fissures and fractures of the cement were almost always found during surgical revision of loosened joints. There was talk of "cement disease" and great efforts were made to improve the quality of the cement and the cementing technique. Moreover, even

  11. The stump and the prosthesis.

    PubMed

    Day, H J

    1980-03-01

    In performing amputations the surgeon must bear in mind the biomechanical and other constraints of the prosthesis likely to be fitted and, so far as possible, should fashion the stump accordingly. The various types of prosthesis and their features are discussed in relation to amputations of the lower and upper limbs at all levels.

  12. Photovoltaic retinal prosthesis with high pixel density

    NASA Astrophysics Data System (ADS)

    Mathieson, Keith; Loudin, James; Goetz, Georges; Huie, Philip; Wang, Lele; Kamins, Theodore I.; Galambos, Ludwig; Smith, Richard; Harris, James S.; Sher, Alexander; Palanker, Daniel

    2012-06-01

    Retinal degenerative diseases lead to blindness due to loss of the `image capturing' photoreceptors, while neurons in the `image-processing' inner retinal layers are relatively well preserved. Electronic retinal prostheses seek to restore sight by electrically stimulating the surviving neurons. Most implants are powered through inductive coils, requiring complex surgical methods to implant the coil-decoder-cable-array systems that deliver energy to stimulating electrodes via intraocular cables. We present a photovoltaic subretinal prosthesis, in which silicon photodiodes in each pixel receive power and data directly through pulsed near-infrared illumination and electrically stimulate neurons. Stimulation is produced in normal and degenerate rat retinas, with pulse durations of 0.5-4 ms, and threshold peak irradiances of 0.2-10 mW mm-2, two orders of magnitude below the ocular safety limit. Neural responses were elicited by illuminating a single 70 µm bipolar pixel, demonstrating the possibility of a fully integrated photovoltaic retinal prosthesis with high pixel density.

  13. Photovoltaic Retinal Prosthesis with High Pixel Density.

    PubMed

    Mathieson, Keith; Loudin, James; Goetz, Georges; Huie, Philip; Wang, Lele; Kamins, Theodore I; Galambos, Ludwig; Smith, Richard; Harris, James S; Sher, Alexander; Palanker, Daniel

    2012-06-01

    Retinal degenerative diseases lead to blindness due to loss of the "image capturing" photoreceptors, while neurons in the "image processing" inner retinal layers are relatively well preserved. Electronic retinal prostheses seek to restore sight by electrically stimulating surviving neurons. Most implants are powered through inductive coils, requiring complex surgical methods to implant the coil-decoder-cable-array systems, which deliver energy to stimulating electrodes via intraocular cables. We present a photovoltaic subretinal prosthesis, in which silicon photodiodes in each pixel receive power and data directly through pulsed near-infrared illumination and electrically stimulate neurons. Stimulation was produced in normal and degenerate rat retinas, with pulse durations from 0.5 to 4 ms, and threshold peak irradiances from 0.2 to 10 mW/mm(2), two orders of magnitude below the ocular safety limit. Neural responses were elicited by illuminating a single 70 μm bipolar pixel, demonstrating the possibility of a fully-integrated photovoltaic retinal prosthesis with high pixel density.

  14. Photovoltaic Retinal Prosthesis with High Pixel Density

    PubMed Central

    Mathieson, Keith; Loudin, James; Goetz, Georges; Huie, Philip; Wang, Lele; Kamins, Theodore I.; Galambos, Ludwig; Smith, Richard; Harris, James S.; Sher, Alexander; Palanker, Daniel

    2012-01-01

    Retinal degenerative diseases lead to blindness due to loss of the “image capturing” photoreceptors, while neurons in the “image processing” inner retinal layers are relatively well preserved. Electronic retinal prostheses seek to restore sight by electrically stimulating surviving neurons. Most implants are powered through inductive coils, requiring complex surgical methods to implant the coil-decoder-cable-array systems, which deliver energy to stimulating electrodes via intraocular cables. We present a photovoltaic subretinal prosthesis, in which silicon photodiodes in each pixel receive power and data directly through pulsed near-infrared illumination and electrically stimulate neurons. Stimulation was produced in normal and degenerate rat retinas, with pulse durations from 0.5 to 4 ms, and threshold peak irradiances from 0.2 to 10 mW/mm2, two orders of magnitude below the ocular safety limit. Neural responses were elicited by illuminating a single 70 μm bipolar pixel, demonstrating the possibility of a fully-integrated photovoltaic retinal prosthesis with high pixel density. PMID:23049619

  15. Rehabilitation of a missing ear with an implant retained auricular prosthesis.

    PubMed

    Guttal, Satyabodh Sheshraj; Shanbhag, Shruti; Kulkarni, Sudhindra S; Thakur, Srinath L

    2015-01-01

    Burns can leave a patient with a severely debilitating disability even after treatment. The objectives of burn rehabilitation are to minimize the adverse effects caused by the injury while rehabilitating the patient's physical and psychological well-being, maximizing social integration. Long-term success of maxillofacial prostheses mainly depends on the retention. Extra oral implant retained prostheses have proved to be a predictable treatment option for maxillofacial rehabilitation. Replacement of a severely deformed external ear with burned tissues may be satisfactorily accomplished by a cosmetic prosthesis anchored by implants integrated in the skull. The use of such implants is now a well-recognized method for creating a stable result in maxillofacial rehabilitation. This case report describes a safe, simple and economical method for the rehabilitation of a patient with missing right auricle using an implant supported silicone prosthesis. The implant was placed in the mastoid region of the temporal bone. Reconstruction of the ear was done with auricular silicone prosthesis, retained using magnets incorporated in an autopolymerizing resin shim to decrease the weight of the prosthesis on a single implant. This method eliminates the need of tedious laboratory procedures and exact casting and fitting requirements of a metal substructure while minimizing the overall weight and cost of the prosthesis while maintaining adequate support, esthetics and retention of the prosthesis. PMID:26929490

  16. Multispectral breast imaging using a ten-wavelength, 64x64 source/detector channels silicon photodiode-based diffuse optical tomography system

    SciTech Connect

    Li Changqing; Zhao Hongzhi; Anderson, Bonnie; Jiang Huabei

    2006-03-15

    We describe a compact diffuse optical tomography system specifically designed for breast imaging. The system consists of 64 silicon photodiode detectors, 64 excitation points, and 10 diode lasers in the near-infrared region, allowing multispectral, three-dimensional optical imaging of breast tissue. We also detail the system performance and optimization through a calibration procedure. The system is evaluated using tissue-like phantom experiments and an in vivo clinic experiment. Quantitative two-dimensional (2D) and three-dimensional (3D) images of absorption and reduced scattering coefficients are obtained from these experiments. The ten-wavelength spectra of the extracted reduced scattering coefficient enable quantitative morphological images to be reconstructed with this system. From the in vivo clinic experiment, functional images including deoxyhemoglobin, oxyhemoglobin, and water concentration are recovered and tumors are detected with correct size and position compared with the mammography.

  17. Implantable imaging system for visual prosthesis.

    PubMed

    Zhou, Chuanqing; Tao, Chen; Chai, Xinyu; Sun, Yong; Ren, Qiushi

    2010-06-01

    In order to propose a method of intraocular imaging system for the visual prosthesis, an implantable microcamera was developed and evaluated in vivo. The microcamera was specially developed and shaped to fit the rabbit's lens capsule and encapsulated with the biocompatible silicone. To evaluate the feasibility of this novel approach, the custom-built device was implanted following the surgical extraction of rabbit's lens. And clinical examinations were performed 1 day, 3 days, 1 week, 2 week, and 1 month postoperatively, including slit-lamp examination, intraocular pressure, wound status, anterior chamber depth, the presence of the iris fibrosi of neovascularization, and the position of the implant. Real-time imaging was performed in vivo 1 month after the operation, and the acquired images were processed with the software and hardware that were specially developed for generating the stimulating pulses. Short-term results showed the novel approach is promising.

  18. A unique method of retaining orbital prosthesis with attachment systems - a clinical report.

    PubMed

    Guttal, Satyabodh S; Akash, N R; Prithviraj, D R; Lekha, K

    2014-06-01

    Diminution of the orbital contents post-surgical removal of a malignant tumor can have a severe psychological impact on the patient in terms of function and esthetics. Therefore, esthetic remedy should be planned subsequently, since tumor obliteration precedes cosmetic concern. A convenient option for successful rehabilitation in such patients is a simple, user-friendly, removable orbital prosthesis. Retention of the prosthesis is one of the key factors for the successful rehabilitation. Spectacle frame, conformers, adhesives, osseointegrated implants, magnets or buttons have been used to impart retention to the prosthesis. The use of semi precision attachments in maxillofacial prostheses is limited to the osseointegrated prostheses. This case report describes a conventional spectacle frame technique, to retain the silicone orbital prosthesis using two different types of stud attachments viz., dalla bona and O-ring attachment systems. PMID:24332358

  19. Bioelectronic retinal prosthesis

    NASA Astrophysics Data System (ADS)

    Weiland, James D.

    2016-05-01

    Retinal prosthesis have been translated to clinical use over the past two decades. Currently, two devices have regulatory approval for the treatment of retinitis pigmentosa and one device is in clinical trials for treatment of age-related macular degeneration. These devices provide partial sight restoration and patients use this improved vision in their everyday lives to navigate and to detect large objects. However, significant vision restoration will require both better technology and improved understanding of the interaction between electrical stimulation and the retina. In particular, current retinal prostheses do not provide peripheral visions due to technical and surgical limitations, thus limiting the effectiveness of the treatment. This paper reviews recent results from human implant patients and presents technical approaches for peripheral vision.

  20. Long-term role of external breast prostheses after total mastectomy.

    PubMed

    Glaus, Simone W; Carlson, Grant W

    2009-01-01

    After total mastectomy, many women choose to wear external breast prosthesis rather than undergo breast reconstruction. The purpose of this study was to evaluate long-term satisfaction among external breast prosthesis wearers and the impact of satisfaction on prosthesis use. A questionnaire was designed to assess demographic information, prosthesis information provision, prosthesis use, and satisfaction with prosthesis. Fifty-nine women who had undergone total mastectomy without breast reconstruction completed the questionnaire. The majority of women (68%) were at least 5 years out from mastectomy. Approximately half (49%) of the women had received information about breast prostheses prior to mastectomy; 29% received information from the surgeon performing the operation. Frequent and prolonged prosthesis use was prevalent with 64% of participants reporting prosthesis use all the time, 6-7 days/week. Participants showed high rates (83%) of overall satisfaction. However, women who wore their prosthesis out in public only were less satisfied than more frequent wearers (50% versus 89%, chi(2) = 8.83, d.f. = 1, alpha = 0.05). Satisfaction increased over time, as women who were greater than 5 years out from mastectomy were more satisfied than women less that 5 years post-mastectomy (90% versus 67%, chi(2) = 4.43, d.f. = 1, alpha = 0.05). The vast majority of women are satisfied with their external breast prosthesis several years after mastectomy. Most women used their prosthesis all the time and overall satisfaction contributed to higher levels of prosthesis use. Given the long-term importance of external breast prostheses for women who have undergone mastectomy, a greater effort to inform patients about external breast prostheses prior to surgery is needed.

  1. Photovoltaic retinal prosthesis

    NASA Astrophysics Data System (ADS)

    Loudin, James; Mathieson, Keith; Kamins, Ted; Wang, Lele; Galambos, Ludwig; Huie, Philip; Sher, Alexander; Harris, James; Palanker, Daniel

    2011-03-01

    Electronic retinal prostheses seek to restore sight to patients suffering from retinal degenerative disorders. Implanted electrode arrays apply patterned electrical stimulation to surviving retinal neurons, producing visual sensations. All current designs employ inductively coupled coils to transmit power and/or data to the implant. We present here the design and initial testing of a photovoltaic retinal prosthesis fabricated with a pixel density of up to 177 pixels/mm2. Photodiodes within each pixel of the subretinal array directly convert light to stimulation current, avoiding the use of bulky coil implants, decoding electronics, and wiring, and thereby reducing surgical complexity. A goggles-mounted camera captures the visual scene and transmits the data stream to a pocket processor. The resulting images are projected into the eyes by video goggles using pulsed, near infrared (~900 nm) light. Prostheses with three pixel densities (15, 55, and 177 pix/mm2) are being fabricated, and tests indicate a charge injection limit of 1.62 mC/cm2 at 25Hz. In vitro tests of the photovoltaic retinal stimulation using a 512-element microelectrode array have recorded stimulated spikes from the ganglion cells, with latencies in the 1-100ms range, and with peak irradiance stimulation thresholds varying from 0.1 to 1 mW/mm2. With 1ms pulses at 25Hz the average irradiance is more than 100 times below the IR retinal safety limit. Elicited retinal response disappeared upon the addition of synaptic blockers, indicating that the inner retina is stimulated rather than the ganglion cells directly, and raising hopes that the prosthesis will preserve some of the retina's natural signal processing.

  2. Updates on the Construction of an Eyeglass-Supported Nasal Prosthesis Using Computer-Aided Design and Rapid Prototyping Technology.

    PubMed

    Ciocca, Leonardo; Tarsitano, Achille; Marchetti, Claudio; Scotti, Roberto

    2016-01-01

    This study was undertaken to design an updated connection system for an eyeglass-supported nasal prosthesis using rapid prototyping techniques. The substructure was developed with two main endpoints in mind: the connection to the silicone and the connection to the eyeglasses. The mold design was also updated; the mold was composed of various parts, each carefully designed to allow for easy release after silicone processing and to facilitate extraction of the prosthesis without any strain. The approach used in this study enabled perfect transfer of the reciprocal position of the prosthesis with respect to the eyeglasses, from the virtual to the clinical environment. Moreover, the reduction in thickness improved the flexibility of the prosthesis and promoted adaptation to the contours of the skin, even during functional movements. The method described here is a simplified and viable alternative to standard construction techniques for nasal prostheses and offers improved esthetic and functional results when no bone is available for implant-supported prostheses.

  3. A blue tooth - auricular prosthesis: a case report.

    PubMed

    H Naveen, Bandlar; R Kashinath, Korapathi; B Shankargouda, Swapnil; Halappa, Mythri

    2014-08-01

    The absence of an ear is a considerable aesthetic problem which affects the patient's psychology and social behaviour. We are describing a case of 25-year-old male reporting to the Department of Prosthodontics, with a chief complaint of deficient left auricular tissue. This can be corrected surgically, prosthetically or through a combination of these approaches; but the choice of treatment depends on patient. The patient chose prosthetic rehabilitation over surgical procedures & retention becomes a critical issue in this approach. Out of many types of retentive methods, we selectively incorporated new materials and used the latest technology to ensure the highest quality prosthesis. Creative approach for each patient with a focus on their individual needs was considered as it gives more satisfaction to the patient. This article describes a new, simple and cost effective technique by embedding Bluetooth-headset device into the silicone elastomer of a mechanically-retained auricular prosthesis. PMID:25302281

  4. Prosthesis for Open Pleurostomy (POP): Management for Chronic Empyemas

    PubMed Central

    Filomeno, Luiz Tarcísio Brito; de Campos, José Ribas Milanez; Machuca, Tiago Noguchi; Neves-Pereira, João Carlos das; Terra, Ricardo Mingarini

    2009-01-01

    OBJECTIVES We developed a prosthesis for open pleurostomy cases where pulmonary decortication is not indicated, or where post-pneumonectomy space infection occurs. The open pleural window procedure not only creates a large hole in the chest wall that is shocking to patients, also results in a permanent deformation of the thorax. prosthesis for open pleurostomy is a self-retained silicone tube that requires the removal of 3 cm of one rib for insertion, and acts as a mature conventional open pleural window. Herein, we report our 13–year experience with this device in the management of different kinds of pleural empyema. METHODS Forty-four consecutive patients with chronic empyema were treated. The etiology of empyema was diverse: pneumonia, 20; lung resections, 12 (pneumonectomies, 7; lobectomies, 4; non-anatomical, 1); mixed-tuberculous, 6; and mixed-malignant pleural effusion, 6. After debridment of both pleural surfaces, the prosthesis for open pleurostomy was inserted and attached to a small recipient plastic bag. RESULTS Infection control was achieved in 20/20 (100%) of the parapneumonic empyemas, in 3/4 (75%) of post-lobectomies, in 6/7 (85%) of post-pneumectomies, in 6/6 (100%) of mixed-tuberculous cases, and in 4/6 (83%) of mixed-malignant cases. Lung re-expansion was also successful in 93%, 75%, 33%, and 40% of the groups, respectively. CONCLUSIONS Prosthesis for open pleurostomy insertion is a minimally invasive procedure that can be as effective as conventional open pleural window for management of chronic empyemas. Thus, we propose that the use of prosthesis for open pleurostomy should replace the conventional method. PMID:19330246

  5. [Central auditory prosthesis].

    PubMed

    Lenarz, T; Lim, H; Joseph, G; Reuter, G; Lenarz, M

    2009-06-01

    Deaf patients with severe sensory hearing loss can benefit from a cochlear implant (CI), which stimulates the auditory nerve fibers. However, patients who do not have an intact auditory nerve cannot benefit from a CI. The majority of these patients are neurofibromatosis type 2 (NF2) patients who developed neural deafness due to growth or surgical removal of a bilateral acoustic neuroma. The only current solution is the auditory brainstem implant (ABI), which stimulates the surface of the cochlear nucleus in the brainstem. Although the ABI provides improvement in environmental awareness and lip-reading capabilities, only a few NF2 patients have achieved some limited open set speech perception. In the search for alternative procedures our research group in collaboration with Cochlear Ltd. (Australia) developed a human prototype auditory midbrain implant (AMI), which is designed to electrically stimulate the inferior colliculus (IC). The IC has the potential as a new target for an auditory prosthesis as it provides access to neural projections necessary for speech perception as well as a systematic map of spectral information. In this paper the present status of research and development in the field of central auditory prostheses is presented with respect to technology, surgical technique and hearing results as well as the background concepts of ABI and AMI. PMID:19517084

  6. Complications of Poly Implant Prothèse breast implants: the current discussion.

    PubMed

    Kolios, Leila; Hirche, Christoph; Spiethoff, Alexander; Daigeler, Adrien; Lehnhardt, Marcus

    2013-03-01

    Against the background of the current discussion about Poly Implant Prothèse (PIP, Seyne-sur-mer, France) breast implants, we want to present a case demonstrating the complications such as implant rupture, silicone dissemination and level III silicone lymphadenopathy. A 29-year-old woman with cosmetic breast augmentation with PIP implants 5 years previously showed a sensitive swelling in her right axilla and neck region. All tests to detect an infectious or lymphomatous lymphadenopathy were negative. After ultrasound and MRI, rupture of the right implant was assumed and multiple pathologically enlarged lymph nodes up to supraclavicular region were shown. An excision biopsy of one axillary lymph node was performed; the histological examination detected a strong silicone lymphadenopathy. Surgical removal of both implants as well as capsulectomy was performed and 14 axillary lymph nodes up to level II were resected. Histologic evaluation confirmed the previous results. Our case underlines the actual discussion concerning increased rupture rate and massive silicone lymphadenopathy by PIP implants. The Agence Francaise de Sécurité Sanitaire des Produits de Santé (AFSSAPS) recommends clinical and ultrasound examination every 6 months for women with PIP implants. Any rupture, suspected rupture or leakage of prosthesis should lead to its explantation as well as that of the contralateral implant. In cases of unusual signs of inflammation, histological and immunohistochemical samples are to be taken. PMID:23480085

  7. Advanced engineering tools for design and fabrication of a custom nasal prosthesis

    NASA Astrophysics Data System (ADS)

    Oliveira, Inês; Leal, Nuno; Silva, Pedro; da Costa Ferreira, A.; Neto, Rui J.; Lino, F. Jorge; Reis, Ana

    2012-09-01

    Unexpected external defects resulting from neoplasms, burns, congenital malformations, trauma or other diseases, particularly when involving partial or total loss of an external organ, can be emotionally devastating. These defects can be restored with prosthesis, obtained by different techniques, materials and methods. The increase of patient numbers and cost constraints lead to the need of exploring new techniques that can increase efficiency. The main goal of this project was to develop a full engineering-based manufacturing process to obtain soft-tissue prosthesis that could provide faster and less expensive options in the manufacturing of customized prosthesis, and at the same time being able to reproduce the highest degree of details, with the maximum comfort for the patient. Design/methodology/approach - This case report describes treatment using silicone prosthesis with an anatomic retention for an 80-years-old woman with a rhinectomy. The proposed methodology integrates non-contact structured light scanning, CT and reverse engineering with CAD/CAM and additive manufacturing technology. Findings - The proposed protocol showed encouraging results since reveals being a better solution for fabricating custom-made facial prostheses for asymmetrical organs than conventional approaches. The process allows the attainment of prosthesis with the minimum contact and discomfort for the patient, disclosing excellent results in terms of aesthetic, prosthesis retention and in terms of time and resources consumed.

  8. Photovoltaic retinal prosthesis: implant fabrication and performance

    NASA Astrophysics Data System (ADS)

    Wang, Lele; Mathieson, K.; Kamins, T. I.; Loudin, J. D.; Galambos, L.; Goetz, G.; Sher, A.; Mandel, Y.; Huie, P.; Lavinsky, D.; Harris, J. S.; Palanker, D. V.

    2012-08-01

    The objective of this work is to develop and test a photovoltaic retinal prosthesis for restoring sight to patients blinded by degenerative retinal diseases. A silicon photodiode array for subretinal stimulation has been fabricated by a silicon-integrated-circuit/MEMS process. Each pixel in the two-dimensional array contains three series-connected photodiodes, which photovoltaically convert pulsed near-infrared light into bi-phasic current to stimulate nearby retinal neurons without wired power connections. The device thickness is chosen to be 30 µm to absorb a significant portion of light while still being thin enough for subretinal implantation. Active and return electrodes confine current near each pixel and are sputter coated with iridium oxide to enhance charge injection levels and provide a stable neural interface. Pixels are separated by 5 µm wide trenches to electrically isolate them and to allow nutrient diffusion through the device. Three sizes of pixels (280, 140 and 70 µm) with active electrodes of 80, 40 and 20 µm diameter were fabricated. The turn-on voltages of the one-diode, two-series-connected diode and three-series-connected diode structures are approximately 0.6, 1.2 and 1.8 V, respectively. The measured photo-responsivity per diode at 880 nm wavelength is ˜0.36 A W-1, at zero voltage bias and scales with the exposed silicon area. For all three pixel sizes, the reverse-bias dark current is sufficiently low (<100 pA) for our application. Pixels of all three sizes reliably elicit retinal responses at safe near-infrared light irradiances, with good acceptance of the photodiode array in the subretinal space. The fabricated device delivers efficient retinal stimulation at safe near-infrared light irradiances without any wired power connections, which greatly simplifies the implantation procedure. Presence of the return electrodes in each pixel helps to localize the current, and thereby improves resolution.

  9. Photovoltaic retinal prosthesis: implant fabrication and performance.

    PubMed

    Wang, Lele; Mathieson, K; Kamins, T I; Loudin, J D; Galambos, L; Goetz, G; Sher, A; Mandel, Y; Huie, P; Lavinsky, D; Harris, J S; Palanker, D V

    2012-08-01

    The objective of this work is to develop and test a photovoltaic retinal prosthesis for restoring sight to patients blinded by degenerative retinal diseases. A silicon photodiode array for subretinal stimulation has been fabricated by a silicon-integrated-circuit/MEMS process. Each pixel in the two-dimensional array contains three series-connected photodiodes, which photovoltaically convert pulsed near-infrared light into bi-phasic current to stimulate nearby retinal neurons without wired power connections. The device thickness is chosen to be 30 µm to absorb a significant portion of light while still being thin enough for subretinal implantation. Active and return electrodes confine current near each pixel and are sputter coated with iridium oxide to enhance charge injection levels and provide a stable neural interface. Pixels are separated by 5 µm wide trenches to electrically isolate them and to allow nutrient diffusion through the device. Three sizes of pixels (280, 140 and 70 µm) with active electrodes of 80, 40 and 20 µm diameter were fabricated. The turn-on voltages of the one-diode, two-series-connected diode and three-series-connected diode structures are approximately 0.6, 1.2 and 1.8 V, respectively. The measured photo-responsivity per diode at 880 nm wavelength is ∼0.36 A W(-1), at zero voltage bias and scales with the exposed silicon area. For all three pixel sizes, the reverse-bias dark current is sufficiently low (<100 pA) for our application. Pixels of all three sizes reliably elicit retinal responses at safe near-infrared light irradiances, with good acceptance of the photodiode array in the subretinal space. The fabricated device delivers efficient retinal stimulation at safe near-infrared light irradiances without any wired power connections, which greatly simplifies the implantation procedure. Presence of the return electrodes in each pixel helps to localize the current, and thereby improves resolution.

  10. Intraocular retinal prosthesis.

    PubMed Central

    Humayun, M S

    2001-01-01

    stimulus duration (P < .05). In all groups, short duration pulses (40, 80, and 120 microseconds) were more efficient in terms of total charge (the product of pulse amplitude and pulse duration) than longer (500 and 1,000 microseconds) pulses (P < .05). In all groups, applying a pulse train did not lead to more efficient charge usage (P < .05). Psychophysical experiments: In high-contrast tests, facial recognition rates of over 75% were achieved for all subjects with dot sizes of up to 31.5 minutes of arc when using a 25 x 25 grid with 4.5 arc minute gaps, a 30% dropout rate, and 6 gray levels. Even with a 4 x 4 array of pixels, some subjects were able to accurately describe 2 of the objects. Subjects who were able to read the 4-pixel letter height sentences (on the 6 x 10 and 16 x 16 array) seemed to have a good scanning technique. Scanning at the proper velocity tends to bring out more contrast in the lettering. The reading speed for the 72-point font is a bit slower than for the next smaller font. This may be due to the limited number of letters (3) visible in the window with this large font. CONCLUSIONS: Specific parameters needed to stimulate the retina were identified. Delineating the optimum parameters will decrease the current requirements. Psychophysical tests show that with limited pixels and image processing, useful vision is possible. Both these findings should greatly simplify the engineering of an electronic retinal prosthesis. PMID:11797315

  11. Designing a prosthesis to simulate the elastic properties of skin.

    PubMed

    Bellamy, K E; Waters, M G J

    2005-01-01

    The materials which are currently used to make maxillofacial prostheses are far from ideal and require considerable improvement with respect to their ability to mimic the properties of skin. To this aim, a novel three-layered maxillofacial prosthesis has been designed consisting of a silicone rubber base layer, an inner gel layer and an outer polymeric coating (to simulate the elastic properties of skin). The aim of the work in this study was to develop the inner silicone gel layer which displays similar properties to facial skin. Through the use of unique linear extensometry testing, in vivo measurements for the Area under the Curve (AUC), Hysteresis (viscoelastic behaviour), Fmax (maximum force), F30 and F60 (force after 30 and 60 seconds) were obtained from the facial skin of 15 volunteers. The results were used as a basis for developing silicone gel formulations for the inner layer, to closely resemble those of facial skin. Gels were made by the addition of both low and high molecular weight unreactive silicone fluids and were further tested for compression, water absorption and dehydration. Testing showed that a gel has been produced that closely simulates the elastic properties of skin when bonded to a base silicone rubber layer. Further testing will need to deduce whether these properties will be affected by the addition of the outer polymeric layer.

  12. Molecular impact surface textured implants (MISTI) alter beneficially breast capsule formation at 36 months.

    PubMed

    Ersek, R A

    1991-01-01

    Since the development of smooth silicone breast implants in 1962, over two million women throughout the world have opted for breast augmentation surgery. While initially successful, smooth implants are prone to developing surrounding scar capsules that may harden and contract--resulting in discomfort, weakening of the shell with rupture, unsightliness, and patient dissatisfaction. This phenomenon has been shown to occur in as much as 70% of implanted patients over time. Our work on the texturing of implantable prosthesis material (published in 1968), and subsequent discoveries, has led us to the development of textured silicone breast implants. Because the host interface is altered by the texture, collagen fibrils select a formation that is multiplanar which results in thinner, more pliable capsules that are more resilient and less likely to contract. At 18 months (August, 1989), with 116 implants, all remain soft, after an additional 18 months follow-up, for a total of 36 months maximum and 18 months minimum. The long-term performance of these implants must await the availability of further clinical data.

  13. Breast implant-associated ALK-negative anaplastic large cell lymphoma: a case report and discussion of possible pathogenesis

    PubMed Central

    George, Eva V; Pharm, John; Houston, Courtney; Al-Quran, Semar; Brian, Grey; Dong, Huijia; Hai, Wang; Reeves, Westley; Yang, Li-Jun

    2013-01-01

    Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is a recently recognized clinical entity, with only 39 well-documented cases reported worldwide, including 3 fatalities. Because of its rarity, the clinical and pathologic features of this malignancy have yet to be fully defined. Moreover, the pathogenesis of ALCL in association with textured silicone gel breast implants is poorly understood. Here we report a case of BIA-ALCL arising in a 67-year-old woman with a mastectomy due to breast cancer followed by implantation of textured silicone gel breast prosthesis. The patient presented with breast enlargement and tenderness 8 years following reconstructive surgery. MRI revealed a fluid collection surrounding the affected breast implant. Pathologic examination confirmed the presence of malignant ALCL T cells that were CD30+, CD8+, CD15+, HLA-DR+, CD25+ ALK- and p53. A diagnosis of indolent BIA-ALCL was made since tumor cells were not found outside of the capsule. Interestingly, an extensive mixed lymphocytic infiltrate and ectopic lymphoid tissue (lymphoid neogenesis) adjacent to the fibrous implant capsule were present. The patient was treated with capsulectomy and implantation of new breast prostheses. Six months later, the patient was found to have BIA-ALCL involvement of an axillary lymph node with cytogenetic evolutionof the tumor. To our knowledge, this is the sixth reported case of aggressive BIA-ALCL. Unique features of this case include the association with lymphoid neogenesis and the in vivo cytogenetic progression of the tumor. This case provides insight into the potential role of chronic inflammation and genetic instability in the pathogenesis of BIA-ALCL. PMID:23923082

  14. Breast implant-associated ALK-negative anaplastic large cell lymphoma: a case report and discussion of possible pathogenesis.

    PubMed

    George, Eva V; Pharm, John; Houston, Courtney; Al-Quran, Semar; Brian, Grey; Dong, Huijia; Hai, Wang; Reeves, Westley; Yang, Li-Jun

    2013-01-01

    Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is a recently recognized clinical entity, with only 39 well-documented cases reported worldwide, including 3 fatalities. Because of its rarity, the clinical and pathologic features of this malignancy have yet to be fully defined. Moreover, the pathogenesis of ALCL in association with textured silicone gel breast implants is poorly understood. Here we report a case of BIA-ALCL arising in a 67-year-old woman with a mastectomy due to breast cancer followed by implantation of textured silicone gel breast prosthesis. The patient presented with breast enlargement and tenderness 8 years following reconstructive surgery. MRI revealed a fluid collection surrounding the affected breast implant. Pathologic examination confirmed the presence of malignant ALCL T cells that were CD30+, CD8+, CD15+, HLA-DR+, CD25+ ALK- and p53. A diagnosis of indolent BIA-ALCL was made since tumor cells were not found outside of the capsule. Interestingly, an extensive mixed lymphocytic infiltrate and ectopic lymphoid tissue (lymphoid neogenesis) adjacent to the fibrous implant capsule were present. The patient was treated with capsulectomy and implantation of new breast prostheses. Six months later, the patient was found to have BIA-ALCL involvement of an axillary lymph node with cytogenetic evolution of the tumor. To our knowledge, this is the sixth reported case of aggressive BIA-ALCL. Unique features of this case include the association with lymphoid neogenesis and the in vivo cytogenetic progression of the tumor. This case provides insight into the potential role of chronic inflammation and genetic instability in the pathogenesis of BIA-ALCL. PMID:23923082

  15. Tracheostomy cannulas and voice prosthesis

    PubMed Central

    Kramp, Burkhard; Dommerich, Steffen

    2011-01-01

    Cannulas and voice prostheses are mechanical aids for patients who had to undergo tracheotomy or laryngectomy for different reasons. For better understanding of the function of those artificial devices, first the indications and particularities of the previous surgical intervention are described in the context of this review. Despite the established procedure of percutaneous dilatation tracheotomy e.g. in intensive care units, the application of epithelised tracheostomas has its own position, especially when airway obstruction is persistent (e.g. caused by traumata, inflammations, or tumors) and a longer artificial ventilation or special care of the patient are required. In order to keep the airways open after tracheotomy, tracheostomy cannulas of different materials with different functions are available. For each patient the most appropriate type of cannula must be found. Voice prostheses are meanwhile the device of choice for rapid and efficient voice rehabilitation after laryngectomy. Individual sizes and materials allow adaptation of the voice prostheses to the individual anatomical situation of the patients. The combined application of voice prostheses with HME (Head and Moisture Exchanger) allows a good vocal as well as pulmonary rehabilitation. Precondition for efficient voice prosthesis is the observation of certain surgical principles during laryngectomy. The duration of the prosthesis mainly depends on material properties and biofilms, mostly consisting of funguses and bacteries. The quality of voice with valve prosthesis is clearly superior to esophagus prosthesis or electro-laryngeal voice. Whenever possible, tracheostoma valves for free-hand speech should be applied. Physicians taking care of patients with speech prostheses after laryngectomy should know exactly what to do in case the device fails or gets lost. PMID:22073098

  16. 21 CFR 878.3800 - External aesthetic restoration prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ....3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with...

  17. High resolution optoelectronic retinal prosthesis

    NASA Astrophysics Data System (ADS)

    Loudin, Jim; Dinyari, Rostam; Huie, Phil; Butterwick, Alex; Peumans, Peter; Palanker, Daniel

    2009-02-01

    Electronic retinal prostheses seek to restore sight in patients with retinal degeneration by delivering pulsed electric currents to retinal neurons via an array of microelectrodes. Most implants use inductive or optical transmission of information and power to an intraocular receiver, with decoded signals subsequently distributed to retinal electrodes through an intraocular cable. Surgical complexity could be minimized by an "integrated" prosthesis, in which both power and data are delivered directly to the stimulating array without any discrete components or cables. We present here an integrated retinal prosthesis system based on a photodiode array implant. Video frames are processed and imaged onto the retinal implant by a video goggle projection system operating at near-infrared wavelengths (~ 900 nm). Photodiodes convert light into pulsed electric current, with charge injection maximized by specially optimized series photodiode circuits. Prostheses of three different pixel densities (16 pix/mm2, 64 pix/mm2, and 256 pix/mm2) have been designed, simulated, and prototyped. Retinal tissue response to subretinal implants made of various materials has been investigated in RCS rats. The resulting prosthesis can provide sufficient charge injection for high resolution retinal stimulation without the need for implantation of any bulky discrete elements such as coils or tethers. In addition, since every pixel functions independently, pixel arrays may be placed separately in the subretinal space, providing visual stimulation to a larger field of view.

  18. 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 ...

  19. Photovoltaic retinal prosthesis: implant fabrication and performance

    PubMed Central

    Wang, Lele; Mathieson, K; Kamins, T I; Loudin, J D; Galambos, L; Goetz, G; Sher, A; Mandel, Y; Huie, P; Lavinsky, D; Harris, J S; Palanker, D V

    2012-01-01

    Objective To develop and test a photovoltaic retinal prosthesis for restoring sight to patients blinded by degenerative retinal diseases. Approach A silicon photodiode array for subretinal stimulation has been fabricated by a silicon-integrated-circuit/MEMS process. Each pixel in the two-dimensional array contains three series-connected photodiodes, which photovoltaically convert pulsed near-infrared light into bi-phasic current to stimulate nearby retinal neurons without wired power connections. The device thickness is chosen to be 30 μm to absorb a significant portion of light while still being thin enough for subretinal implantation. Active and return electrodes confine current near each pixel and are sputter coated with iridium oxide to enhance charge injection levels and provide a stable neural interface. Pixels are separated by 5 μm-wide trenches to electrically isolate them and to allow nutrient diffusion through the device. Three sizes of pixels (280μm, 140 μm, and 70 μm) with active electrodes of 80 μm, 40 μm and 20 μm in diameter were fabricated. Main results The turn-on voltages of one-, two- and three-series-connected photodiode structures are approximately 0.6V, 1.2V and 1.8V, respectively. The measured photo-responsivity per diode at 880 nm wavelength is ~0.36 A/W, at zero voltage bias and scales with the exposed silicon area. For all three pixel sizes, the reverse-bias dark current is sufficiently low (<100 pA) for our application. Pixels of all three sizes reliably elicit retinal responses at safe near-infrared light irradiances, with good acceptance of the photodiode array in the subretinal space. Significance The fabricated device delivers efficient retinal stimulation at safe near-infrared light irradiances without any wired power connections, which greatly simplifies the implantation procedure. Presence of the return electrodes in each pixel helps to localize the current, and thereby improves resolution. PMID:22791690

  20. [A cylinder aneurysm of a penile prosthesis].

    PubMed

    Pannek, J; Bartel, P; Göcking, K

    2011-07-01

    Herniation of a penile prosthesis (cylinder aneurysm) is an extremely rare complication of penile prosthesis surgery. We report the first case of such an aneurysm in a patient with spinal cord injury. The treatment of choice is surgical revision with replacement of the faulty device. Filling of the implanted system with contrast media facilitates preoperative diagnostic workup. PMID:21567276

  1. BIORESORBABLE POLYMERIC MENISCAL PROSTHESIS: STUDY IN RABBITS

    PubMed Central

    Cardoso, Tulio Pereira; de Rezende Duek, Eliana Aparecida; Amatuzzi, Marco Martins; Caetano, Edie Benedito

    2015-01-01

    Objective: To induce growth of a neomeniscus into the pores of a prosthesis in order to protect the knee joint cartilage. Methods: 70 knees of 35 New Zealand rabbits were operated. The rabbits were five to seven months old, weighed 2 to 3.8 kilograms, and 22 were male and 13 were female. Each animal underwent medial meniscectomy in both knees during a single operation. A bioabsorbable polymeric meniscal prosthesis composed of 70% polydioxanone and 30% L-lactic acid polymer was implanted in one side. The animals were sacrificed after different postoperative time intervals. The femoral condyles and neomeniscus were subjected to histological analysis. Histograms were used to measure the degradation and absorption of the prosthesis, the growth of meniscal tissue in the prosthesis and the degree of degradation of the femoral condyle joint cartilage. Results: The data obtained showed that tissue growth histologically resembling a normal meniscus occurred, with gradual absorption of the prosthesis, and the percentages of chondrocytes on the control side and prosthesis side. Conclusion: Tissue growth into the prosthesis pores that histologically resembled the normal rabbit meniscus was observed. The joint cartilage of the femoral condyles on the prosthesis side presented greater numbers of chondrocytes in all its layers. PMID:27022549

  2. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Tracheal prosthesis. 878.3720 Section 878.3720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3720 Tracheal prosthesis....

  3. 21 CFR 878.3680 - Nose prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis....

  4. 21 CFR 878.3550 - Chin prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis....

  5. 21 CFR 878.3550 - Chin prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis....

  6. 21 CFR 878.3550 - Chin prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis....

  7. 21 CFR 878.3680 - Nose prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis....

  8. 21 CFR 878.3680 - Nose prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis....

  9. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Tracheal prosthesis. 878.3720 Section 878.3720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3720 Tracheal prosthesis....

  10. 21 CFR 878.3550 - Chin prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis....

  11. 21 CFR 878.3680 - Nose prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis....

  12. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Tracheal prosthesis. 878.3720 Section 878.3720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3720 Tracheal prosthesis....

  13. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Tracheal prosthesis. 878.3720 Section 878.3720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3720 Tracheal prosthesis....

  14. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Tracheal prosthesis. 878.3720 Section 878.3720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3720 Tracheal prosthesis....

  15. 21 CFR 878.3550 - Chin prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis....

  16. 21 CFR 878.3680 - Nose prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis....

  17. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Testicular prosthesis. 876.3750 Section 876.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis....

  18. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Testicular prosthesis. 876.3750 Section 876.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis....

  19. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Testicular prosthesis. 876.3750 Section 876.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis....

  20. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Testicular prosthesis. 876.3750 Section 876.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis....

  1. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Testicular prosthesis. 876.3750 Section 876.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis....

  2. Reverse Shoulder Arthroplasty Prosthesis Design Classification System.

    PubMed

    Routman, Howard D; Flurin, Pierre-Henri; Wright, Thomas W; Zuckerman, Joseph D; Hamilton, Matthew A; Roche, Christopher P

    2015-12-01

    Multiple different reverse total shoulder arthroplasty (rTSA) prosthesis designs are available in the global marketplace for surgeons to perform this growing procedure. Subtle differences in rTSA prosthesis design parameters have been shown to have significant biomechanical impact and clinical consequences. We propose an rTSA prosthesis design classification system to objectively identify and categorize different designs based upon their specific glenoid and humeral prosthetic characteristics for the purpose of standardizing nomenclature that will help the orthopaedic surgeon determine which combination of design configurations best suit a given clinical scenario. The impact of each prosthesis classification type on shoulder muscle length and deltoid wrapping are also described to illustrate how each prosthesis classification type impacts these biomechanical parameters. PMID:26631189

  3. Parametric modelling of a knee joint prosthesis.

    PubMed

    Khoo, L P; Goh, J C; Chow, S L

    1993-01-01

    This paper presents an approach for the establishment of a parametric model of knee joint prosthesis. Four different sizes of a commercial prosthesis are used as an example in the study. A reverse engineering technique was employed to reconstruct the prosthesis on CATIA, a CAD (computer aided design) system. Parametric models were established as a result of the analysis. Using the parametric model established and the knee data obtained from a clinical study on 21 pairs of cadaveric Asian knees, the development of a prototype prosthesis that suits a patient with a very small knee joint is presented. However, it was found that modification to certain parameters may be inevitable due to the uniqueness of the Asian knee. An avenue for rapid modelling and eventually economical production of a customized knee joint prosthesis for patients is proposed and discussed.

  4. Three-dimensional mapping and comparative analysis of the distal human corpus cavernosum and the inflatable penile prosthesis.

    PubMed

    Hakky, Tariq S; Ferguson, Daniel; Spiess, Philippe E; Bradley, Paul; Lue, Tom F; Carrion, Rafael E

    2013-07-01

    The intricate anatomy of the corpus cavernosum in both the flaccid and tumescent state has not been fully elucidated. We report our experience using a three-dimensional (3D) scanner to reconstruct cadaveric casts and compare them with 3D images of two prototypes of penile prosthesis. Two different models of the Titan Coloplast inflatable penile prosthesis were analyzed using a 3D scanner. The first was the standard model and the second was a newer model with a rounder silicone tip. Two cadaveric phalluses were harvested using Smooth-Cast 300Q polyurethane molding. The molds were excised and scanned along side the penile prosthesis. 3D scans were completed and analyzed using Leios Mesh software, and GOM Inspect software. The 3D scans demonstrated the mean human corporal radii 2 mm from the distal tip to be 36.51 mm (36.01-37.0 mm), which is an obtuse angle. The standard Titan penile prosthesis spherical radius at the same level was 202.52 mm, while the new silicone tip prosthesis had a radius of 139.33 mm. 3D mapping further demonstrated the trajectory of the cavernosa appeared curvilinear and the distal ends appeared blunt. The use of cadaveric cavernosal molds in combination with the 3D scanner allowed us to accurately image the corpus cavernosum for the first time. Our findings suggest that anatomically accurate corporal tips appear to be relatively blunt and that the new Titan silicone tip penile prosthesis more closely resembles the human corporal tip.

  5. [Sport performance with a prosthesis].

    PubMed

    van Keeken, Helco; Bongers, Raoul M; Dekker, Rienk; van der Woude, Luc H V

    2013-01-01

    Technology is a contributory factor to sporting success in many Paralympic sports. This article is about upper and lower limb prostheses that are used in sports. The characteristics of lower limb prosthesis can be modified to respond to predictable leg movements such as with running. Conventional mechanical lower limb prostheses do not respond well to unexpected movements. There are upper limb prostheses that have been adapted for a broad range of sports including fishing, cycling, kayaking, skiing, baseball and even mountain climbing. Techniques are being developed that enable a more natural movement of the prosthesis to occur, such as targeted muscle reinnervation. These techniques are currently still in the experimental stage. The training schedule of the sportsperson must be balanced against his or her tolerance level to avoid mechanical overstrain, not only around the stump but also on the unaffected side. Lower limb prostheses that lead to top sporting successes, such as with running, have resulted in discussions about distorted competition. No upper limb prostheses have led to similar discussions.

  6. Stretch due to Penile Prosthesis Reservoir Migration

    PubMed Central

    Baten, E.; Vandewalle, T.; van Renterghem, K.

    2016-01-01

    A 43-year old patient presented to the emergency department with stretch, due to impossible deflation of the penile prosthesis, 4 years after successful implant. A CT-scan showed migration of the reservoir to the left rectus abdominis muscle. Refilling of the reservoir was inhibited by muscular compression, causing stretch. Removal and replacement of the reservoir was performed, after which the prosthesis was well-functioning again. Migration of the penile prosthesis reservoir is extremely rare but can cause several complications, such as stretch. PMID:26793592

  7. Stretch due to Penile Prosthesis Reservoir Migration.

    PubMed

    Baten, E; Vandewalle, T; van Renterghem, K

    2016-03-01

    A 43-year old patient presented to the emergency department with stretch, due to impossible deflation of the penile prosthesis, 4 years after successful implant. A CT-scan showed migration of the reservoir to the left rectus abdominis muscle. Refilling of the reservoir was inhibited by muscular compression, causing stretch. Removal and replacement of the reservoir was performed, after which the prosthesis was well-functioning again. Migration of the penile prosthesis reservoir is extremely rare but can cause several complications, such as stretch.

  8. Chest wall reconstruction with methacrylate prosthesis in Poland syndrome.

    PubMed

    Arango Tomás, Elisabet; Baamonde Laborda, Carlos; Algar Algar, Javier; Salvatierra Velázquez, Angel

    2013-10-01

    Poland syndrome is a rare congenital malformation. This syndrome was described in 1841 by Alfred Poland at Guy's Hospital in London. It is characterized by hypoplasia of the breast and nipple, subcutaneous tissue shortages, lack of the costosternal portion of the pectoralis major muscle and associated alterations of the fingers on the same side. Corrective treatment of the chest and soft tissue abnormalities in Poland syndrome varies according to different authors. We report the case of a 17-year-old adolescent who underwent chest wall reconstruction with a methyl methacrylate prosthesis. This surgical procedure is recommended for large anterior chest wall defects, and it prevents paradoxical movement. Moreover it provides for individual remodeling of the defect depending on the shape of the patient's chest. PMID:23453291

  9. Chest wall reconstruction with methacrylate prosthesis in Poland syndrome.

    PubMed

    Arango Tomás, Elisabet; Baamonde Laborda, Carlos; Algar Algar, Javier; Salvatierra Velázquez, Angel

    2013-10-01

    Poland syndrome is a rare congenital malformation. This syndrome was described in 1841 by Alfred Poland at Guy's Hospital in London. It is characterized by hypoplasia of the breast and nipple, subcutaneous tissue shortages, lack of the costosternal portion of the pectoralis major muscle and associated alterations of the fingers on the same side. Corrective treatment of the chest and soft tissue abnormalities in Poland syndrome varies according to different authors. We report the case of a 17-year-old adolescent who underwent chest wall reconstruction with a methyl methacrylate prosthesis. This surgical procedure is recommended for large anterior chest wall defects, and it prevents paradoxical movement. Moreover it provides for individual remodeling of the defect depending on the shape of the patient's chest.

  10. External breast prostheses in post-mastectomy care: women's qualitative accounts.

    PubMed

    Gallagher, P; Buckmaster, A; O'Carroll, S; Kiernan, G; Geraghty, J

    2010-01-01

    A good-quality external breast prosthesis and prosthesis-fitting service is an integral part of the recovery process post-mastectomy. However, this is an area of care that has minimal information or research available. The aim of this research was to investigate women's experience of the provision, fitting, supply and use of breast prostheses in Ireland. To ascertain women's own personal and subjective experiences, five focus groups with 47 women recruited through national cancer advocacy/support organizations and four Follow-up Breast Clinics throughout Ireland were conducted. As a result, five main themes emerged: (1) The fitting experience--Fitting? (2) Post-mastectomy products--Having? (3) Cost--Affording? (4) Information--Knowing? and (5) Adaptation--Accepting? The emerging themes pinpointed the impact of the fitting experience, fitting environment and the qualities of a prosthesis fitter on a woman's experience in obtaining a first or replacement breast prosthesis; the importance of the physical characteristics of the prosthesis and mastectomy bras; cost, affordability and entitlements; a lack of and perceived difficulty in getting information; and the myriad of personal and social impacts of a breast prosthesis for the woman. These findings are integral for the development of standards of practice in the fitting and supply of external breast prostheses in post-mastectomy care.

  11. Automated lower limb prosthesis design

    NASA Astrophysics Data System (ADS)

    Bhatia, Gulab H.; Commean, Paul K.; Smith, Kirk E.; Vannier, Michael W.

    1994-09-01

    The design of lower limb prostheses requires definitive geometric data to customize socket shape. Optical surface imaging and spiral x-ray computed tomography were applied to geometric analysis of limb residua in below knee (BK) amputees. Residua (limb remnants after amputation) of BK amputees were digitized and measured. Surface (optical) and volumetric (CT) data of the residuum were used to generate solid models and specify socket shape in (SDRC I-DEAS) CAD software. Volume measurements on the solid models were found to correspond within 2% of surface models and direct determinations made using Archimedean weighing. Anatomic 3D reconstruction of the residuum by optical surface and spiral x-ray computed tomography imaging are feasible modalities for prosthesis design.

  12. [Ocular prosthesis following plastic surgery].

    PubMed

    Morozova, O D; Druianova, Iu S

    1989-01-01

    The shape of the eye prostheses depends on the plastic surgery type. Standard prostheses with thin but not sharp edges are used to recreate the conjunctival cavity, prostheses with a deep retraction or flat ones are employed for a delayed introduction into the stump, prostheses with a 'swelling' at the upper edge are of use in surgery to correct the upper eyelid falling in, prostheses with a flattened lower edge and a 'shelf' at the upper edge are used to fortify the lower eyelid. Individual prostheses are recommended after plastic surgery. The prostheses should not prevent free closing and blinking of the eyelids, retaining the identical opening of the eyes. An inadequately chosen prosthesis brings to nothing the tremendous work made by the surgeon. Ocular prosthetics may be regarded as the final stage stabilizing the results of plastic surgery.

  13. Visuomotor behaviours when using a myoelectric prosthesis

    PubMed Central

    2014-01-01

    Background A recent study showed that the gaze patterns of amputee users of myoelectric prostheses differ markedly from those seen in anatomically intact subjects. Gaze behaviour is a promising outcome measures for prosthesis designers, as it appears to reflect the strategies adopted by amputees to compensate for the absence of proprioceptive feedback and uncertainty/delays in the control system, factors believed to be central to the difficulty in using prostheses. The primary aim of our study was to characterise visuomotor behaviours over learning to use a trans-radial myoelectric prosthesis. Secondly, as there are logistical advantages to using anatomically intact subjects in prosthesis evaluation studies, we investigated similarities in visuomotor behaviours between anatomically intact users of a trans-radial prosthesis simulator and experienced trans-radial myoelectric prosthesis users. Methods In part 1 of the study, we investigated visuomotor behaviours during performance of a functional task (reaching, grasping and manipulating a carton) in a group of seven anatomically intact subjects over learning to use a trans-radial myoelectric prosthesis simulator (Dataset 1). Secondly, we compared their patterns of visuomotor behaviour with those of four experienced trans-radial myoelectric prosthesis users (Dataset 2). We recorded task movement time, performance on the SHAP test of hand function and gaze behaviour. Results Dataset 1 showed that while reaching and grasping the object, anatomically intact subjects using the prosthesis simulator devoted around 90% of their visual attention to either the hand or the area of the object to be grasped. This pattern of behaviour did not change with training, and similar patterns were seen in Dataset 2. Anatomically intact subjects exhibited significant increases in task duration at their first attempts to use the prosthesis simulator. At the end of training, the values had decreased and were similar to those seen in Dataset

  14. Updating upper extremity temporary prosthesis: thermoplastics.

    PubMed

    Fletchall, S; Tran, T; Ungaro, V; Hickerson, W

    1992-01-01

    Since 1989 amputees with upper-extremity burns have been fitted with a temporary prosthesis fabricated from low-temperature thermoplastic. Before 1989 conventional temporary prostheses were fabricated with plaster. The use of the thermoplastic material has produced a lightweight, cost-effective, modular system. No patients exhibited skin breakdown with the thermoplastic material. It appears that thermoplastics may be the next major breakthrough in terms of a design for a temporary upper-extremity prosthesis.

  15. Mechanical analysis of a prototype of small diameter vascular prosthesis: numerical simulations.

    PubMed

    Zidi, M; Cheref, M

    2003-01-01

    This paper concerns a mechanical analysis of a prototype of a small diameter vascular prosthesis made of a fibre reinforcement silicone material. The theoretical approach is carried out for a neoHookean strain energy function augmented with unidirectional reinforcing that is characterized by a single additional constitutive parameter for strength of reinforcement. Numerical simulations based on a finite element model compare the compliance of different grafts and predict the degree of the compliance mismatch in an anastomosis between native artery and vascular prosthesis. Furthermore, specific applied strains on the prototype, viewed as arising surgical manipulation and implying telescopic shear have been simulated. Thus, for different fibre reinforcements, the stress gradient through the wall of the tubular structure is evaluated. PMID:12485630

  16. Techniques for Evaluating the Fit of Removable and Fixed Prosthesis

    PubMed Central

    Shetty, Mallika S.; Shenoy, K. Kamalakanth

    2011-01-01

    The importance of an accurately fitting fixed prosthesis or a removable prosthesis is essential for the success of the restoration. Ill-fitting prosthesis may cause mechanical failures of the prosthesis, implant systems, or biologic complications of the surrounding tissue. There are several causes related to improper seating of the prosthesis. Some of which can be corrected and the others need to be repeated. Hence the clinician must carefully evaluate the adaptation of the prosthesis using the clinical techniques and combination of the available materials and evaluation methods to optimize the fit of prosthesis. This article reviews the various clinical methods that have been suggested for evaluating the fit of the fixed and removable prosthesis. PMID:21991469

  17. Life Estimation of Hip Joint Prosthesis

    NASA Astrophysics Data System (ADS)

    Desai, C.; Hirani, H.; Chawla, A.

    2014-11-01

    Hip joint is one of the largest weight-bearing structures in the human body. In the event of a failure of the natural hip joint, it is replaced with an artificial hip joint, known as hip joint prosthesis. The design of hip joint prosthesis must be such so as to resist fatigue failure of hip joint stem as well as bone cement, and minimize wear caused by sliding present between its head and socket. In the present paper an attempt is made to consider both fatigue and wear effects simultaneously in estimating functional-life of the hip joint prosthesis. The finite element modeling of hip joint prosthesis using HyperMesh™ (version 9) has been reported. The static analysis (load due to the dead weight of the body) and dynamic analysis (load due to walking cycle) have been described. Fatigue life is estimated by using the S-N curve of individual materials. To account for progressive wear of hip joint prosthesis, Archard's wear law, modifications in socket geometry and dynamic analysis have been used in a sequential manner. Using such sequential programming reduction in peak stress has been observed with increase in wear. Finally life is estimated on the basis of socket wear.

  18. Robotic lower limb prosthesis design through simultaneous computer optimizations of human and prosthesis costs

    PubMed Central

    Handford, Matthew L.; Srinivasan, Manoj

    2016-01-01

    Robotic lower limb prostheses can improve the quality of life for amputees. Development of such devices, currently dominated by long prototyping periods, could be sped up by predictive simulations. In contrast to some amputee simulations which track experimentally determined non-amputee walking kinematics, here, we explicitly model the human-prosthesis interaction to produce a prediction of the user’s walking kinematics. We obtain simulations of an amputee using an ankle-foot prosthesis by simultaneously optimizing human movements and prosthesis actuation, minimizing a weighted sum of human metabolic and prosthesis costs. The resulting Pareto optimal solutions predict that increasing prosthesis energy cost, decreasing prosthesis mass, and allowing asymmetric gaits all decrease human metabolic rate for a given speed and alter human kinematics. The metabolic rates increase monotonically with speed. Remarkably, by performing an analogous optimization for a non-amputee human, we predict that an amputee walking with an appropriately optimized robotic prosthesis can have a lower metabolic cost – even lower than assuming that the non-amputee’s ankle torques are cost-free. PMID:26857747

  19. 21 CFR 872.3940 - Total temporomandibular joint prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Total temporomandibular joint prosthesis. 872.3940... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to...

  20. 21 CFR 872.3940 - Total temporomandibular joint prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Total temporomandibular joint prosthesis. 872.3940... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to...

  1. 21 CFR 872.3940 - Total temporomandibular joint prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Total temporomandibular joint prosthesis. 872.3940... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to...

  2. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of...

  3. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device...

  4. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device...

  5. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of...

  6. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made...

  7. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device...

  8. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made...

  9. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made...

  10. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of...

  11. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Vascular graft prosthesis. 870.3450 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3450 Vascular graft prosthesis. (a) Identification. A vascular graft prosthesis is an implanted device intended to...

  12. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Mandibular condyle prosthesis. 872.3960 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw...

  13. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Glenoid fossa prosthesis. 872.3950 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3950 Glenoid fossa prosthesis. (a) Identification. A glenoid fossa prosthesis is a device that is intended to be implanted in the...

  14. 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...

  15. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of...

  16. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device...

  17. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made...

  18. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of...

  19. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device...

  20. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made...

  1. 21 CFR 884.3650 - Fallopian tube prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Fallopian tube prosthesis. 884.3650 Section 884... § 884.3650 Fallopian tube prosthesis. (a) Identification. A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive...

  2. 21 CFR 884.3650 - Fallopian tube prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Fallopian tube prosthesis. 884.3650 Section 884... § 884.3650 Fallopian tube prosthesis. (a) Identification. A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive...

  3. 21 CFR 884.3650 - Fallopian tube prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Fallopian tube prosthesis. 884.3650 Section 884... § 884.3650 Fallopian tube prosthesis. (a) Identification. A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive...

  4. 21 CFR 884.3650 - Fallopian tube prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Fallopian tube prosthesis. 884.3650 Section 884... § 884.3650 Fallopian tube prosthesis. (a) Identification. A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive...

  5. 21 CFR 884.3650 - Fallopian tube prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Fallopian tube prosthesis. 884.3650 Section 884... § 884.3650 Fallopian tube prosthesis. (a) Identification. A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive...

  6. Acrylic Finger Prosthesis: A Case Report

    PubMed Central

    Bandela, Vinod; M, Bharathi; S V, Giridhar Reddy

    2014-01-01

    Hands basic function is to grasp, hold and manipulate items. Hand gesture is perhaps the most blatant example of non-verbal communication. Finger and partial finger amputations are most frequently encountered forms of partial hand loss. Common causes are traumatic injuries, congenital absence or malformations present great clinical challenges. In addition to immediate loss of grasp strength, finger absence may cause marked psychological trauma. Individuals who desire finger replacement usually have high expectation for the appearance of prosthesis. This clinical report portrays simple method to retain acrylic finger prosthesis. PMID:25302271

  7. Production of porous coating on a prosthesis

    DOEpatents

    Sump, Kenneth R.

    1987-01-01

    Preselected surface areas of a prosthesis are covered by a blend of matching primary metallic particles and expendable particles. The particles are compressed and heated to assure that deformation and metallurgical bonding occurs between them and between the primary particles and the surface boundaries of the prosthesis. Porosity is achieved by removal of the expendable material. The result is a coating including discrete bonded particles separated by a network of interconnected voids presenting a homogeneous porous coating about the substrate. It has strength suitable for bone implant usage without intermediate adhesives, and adequate porosity to promote subsequent bone ingrowth.

  8. A running controller for a powered transfemoral prosthesis.

    PubMed

    Huff, Amanda M; Lawson, Brian E; Goldfarb, Michael

    2012-01-01

    This paper describes a running controller for a powered knee and ankle prosthesis. The running controller was implemented on a powered prosthesis prototype and evaluated by a transfemoral amputee subject running on a treadmill at a speed of 2.25 m/s (5.0 mph). The ability of the prosthesis and controller to provide the salient features of a running gait was assessed by comparing the kinematics of running provided by the powered prosthesis to the averaged kinematics of five healthy subjects running at the same speed. This comparison indicates that the powered prosthesis and running controller are able to provide essential features of a healthy running gait.

  9. Ethical considerations for volunteer recruitment of visual prosthesis trials.

    PubMed

    Xia, Yu; Ren, Qiushi

    2013-09-01

    With the development of visual prostheses research from the engineering phase to clinical trials, volunteer recruitment for the early visual prosthesis trials needs to be carefully considered. In this article, we mainly discuss several issues related to volunteer recruitment that had posed serious challenges to the visual prosthesis trials, such as low rates of participants, high expectations and underlying motivations to participate in the visual prosthesis trials as well as the importance of informed consent. When recruiting volunteers for visual prosthesis implants, it is critical that the visual prosthesis researchers should not only take into account the patient's expectations and motivations, but also make the patients fully aware of the possible benefits and risks involved with their participation, and help patients establish realistic expectations for the early phase of visual prosthesis implantation. Based on these considerations to the challenges, eligible volunteers may be recruited in the preliminary stages of visual prosthesis trials.

  10. Rehabilitation of Glossectomy Cases with Tongue Prosthesis: A Literature Review

    PubMed Central

    Balasubramaniam, Muthu Kumar; Shanmugam, Gokul; Tah, Rajdeep

    2016-01-01

    Tongue is the only movable muscular organ without any bone in the human body. It has very important role in perception of taste and sensations like touch, pressure, heat and cold. The purpose of the article is to review various types of tongue prosthesis and their clinical applications. This review helps the clinician to choose the appropriate type of tongue prosthesis for different clinical situations, retention of tongue prosthesis and material selection for each type of prosthesis. A broad search of published literature was performed using the keyword glossectomy, glossal prosthesis and tongue prosthesis from 1980 to 2014 in Medline, Google scholar, internet and text book. This review gives basic knowledge of glossal prosthesis and selection of the same for various clinical conditions. PMID:27042596

  11. Catastrophic failure of a monolithic zirconia prosthesis.

    PubMed

    Chang, Jae-Seung; Ji, Woon; Choi, Chang-Hoon; Kim, Sunjai

    2015-02-01

    Recently, monolithic zirconia restorations have received attention as an alternative to zirconia veneered with feldspathic porcelain to eliminate chipping failures of veneer ceramics. In this clinical report, a patient with mandibular edentulism received 4 dental implants in the interforaminal area, and a screw-retained monolithic zirconia prosthesis was fabricated. The patient also received a maxillary complete removable dental prosthesis over 4 anterior roots. At the 18-month follow-up, all of the zirconia cylinders were seen to be fractured, and the contacting abutment surfaces had lost structural integrity. The damaged abutments were replaced with new abutments, and a new prosthesis was delivered with a computer-assisted design and computer-assisted manufacturing fabricated titanium framework with denture teeth and denture base resins. At the 6-month recall, the patient did not have any problems. Dental zirconia has excellent physical properties; however, care should be taken to prevent excessive stresses on the zirconia cylinders when a screw-retained zirconia restoration is planned as a definitive prosthesis.

  12. Argus II retinal prosthesis system: An update.

    PubMed

    Rachitskaya, Aleksandra V; Yuan, Alex

    2016-09-01

    This review focuses on a description of the Argus II retinal prosthesis system (Argus II; Second Sight Medical Products, Sylmar, CA) that was approved for humanitarian use by the FDA in 2013 in patients with retinitis pigmentosa with bare or no light perception vision. The article describes the components of Argus II, the studies on the implant, and future directions. PMID:26855177

  13. 21 CFR 878.3610 - Esophageal prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal...

  14. 21 CFR 878.3610 - Esophageal prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal...

  15. 21 CFR 878.3610 - Esophageal prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal...

  16. 21 CFR 878.3610 - Esophageal prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal...

  17. 21 CFR 878.3610 - Esophageal prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal...

  18. Baseball adaptation for below-elbow prosthesis.

    PubMed

    Truong, X T; Erickson, R; Galbreath, R

    1986-06-01

    A baseball bat adaptation to improve the handling with below-elbow prosthesis is described. The adaptation consists of a ball and socket joint unit interposed between wrist and hand prostheses. A patient who had forearm amputation successfully used the adaptation to play softball.

  19. Immediate reconstruction after removal of nasal prosthesis using diced cartilage wrapped with temporal fascia.

    PubMed

    Takeda, Akira; Akimoto, Minekatsu; Ishikawa, Shinsuke; Sugimoto, Takayuki; Himi, Kazumi; Shimakura, Yasuhito; Furuyama, Nobutaka; Nakakita, Nobuaki

    2014-03-01

    Various materials are used for nasal augmentations. Silicone is the most prevalent because it is durable and facilitates sculpturing. However, the unfortunate patient who presents with complication of the nasal implants and wants to remove them is vexed with a significant resultant cosmetic defect if the implant is removed. However, the patients who have some troubles after augmentation by the implants tend to hate the use of the prosthesis again. Ideally, immediate reconstruction would be offered to the patient, sparing him/her the deformity left by removal of the implant. We treated 16 patients who had undergone immediate nasal reconstruction after removal of foreign body. We reconstructed nasal deformity by diced cartilage wrapped with temporal fascia. The cartilage harvested from the ear concha was finally diced into 1- to 2-mm cubes. A bag was made from deep or superficial temporal fascia, and diced cartilage cubes were placed in the bag, which was grafted onto the nasal dorsum. This procedure had several advantages including getting natural contouring and enough volume and absence of foreign body reaction. It was also soft to the touch compared with prosthesis. The fascia could support the thin dorsum skin. The nasal augmentation effect of this procedure was comparable with that of prosthesis methods. It had lower risks for infection and exposure and provided more psychologic comfort. The nasal deformities were successfully reconstructed using diced cartilage wrapped with temporal fascia. We believe that this is the good method for the immediate nasal reconstruction after the removal of foreign body.

  20. Breast Cancer

    MedlinePlus

    ... version of this page please turn Javascript on. Breast Cancer What is Breast Cancer? How Tumors Form The body is made up ... tumors form in the breast tissue. Who Gets Breast Cancer? Breast cancer is one of the most common ...

  1. Reading visual braille with a retinal prosthesis.

    PubMed

    Lauritzen, Thomas Z; Harris, Jordan; Mohand-Said, Saddek; Sahel, Jose A; Dorn, Jessy D; McClure, Kelly; Greenberg, Robert J

    2012-01-01

    Retinal prostheses, which restore partial vision to patients blinded by outer retinal degeneration, are currently in clinical trial. The Argus II retinal prosthesis system was recently awarded CE approval for commercial use in Europe. While retinal prosthesis users have achieved remarkable visual improvement to the point of reading letters and short sentences, the reading process is still fairly cumbersome. This study investigates the possibility of using an epiretinal prosthesis to stimulate visual braille as a sensory substitution for reading written letters and words. The Argus II retinal prosthesis system, used in this study, includes a 10 × 6 electrode array implanted epiretinally, a tiny video camera mounted on a pair of glasses, and a wearable computer that processes the video and determines the stimulation current of each electrode in real time. In the braille reading system, individual letters are created by a subset of dots from a 3 by 2 array of six dots. For the visual braille experiment, a grid of six electrodes was chosen out of the 10 × 6 Argus II array. Groups of these electrodes were then directly stimulated (bypassing the camera) to create visual percepts of individual braille letters. Experiments were performed in a single subject. Single letters were stimulated in an alternative forced choice (AFC) paradigm, and short 2-4-letter words were stimulated (one letter at a time) in an open-choice reading paradigm. The subject correctly identified 89% of single letters, 80% of 2-letter, 60% of 3-letter, and 70% of 4-letter words. This work suggests that text can successfully be stimulated and read as visual braille in retinal prosthesis patients.

  2. Scleroderma, primary biliary cirrhosis, and Sjögren's syndrome after cosmetic breast augmentation with silicone injection: a case report of possible human adjuvant disease.

    PubMed Central

    Okano, Y; Nishikai, M; Sato, A

    1984-01-01

    A 52-year-old woman developed scleroderma, primary biliary cirrhosis, and Sjögren's syndrome after cosmetic silicone injections. These conditions may possibly represent 'human adjuvant disease'. Images PMID:6742917

  3. Silicone metalization

    DOEpatents

    Maghribi, Mariam N.; Krulevitch, Peter; Hamilton, Julie

    2008-12-09

    A system for providing metal features on silicone comprising providing a silicone layer on a matrix and providing a metal layer on the silicone layer. An electronic apparatus can be produced by the system. The electronic apparatus comprises a silicone body and metal features on the silicone body that provide an electronic device.

  4. Silicone metalization

    DOEpatents

    Maghribi, Mariam N.; Krulevitch, Peter; Hamilton, Julie

    2006-12-05

    A system for providing metal features on silicone comprising providing a silicone layer on a matrix and providing a metal layer on the silicone layer. An electronic apparatus can be produced by the system. The electronic apparatus comprises a silicone body and metal features on the silicone body that provide an electronic device.

  5. The Poly Implant Prothèse breast prostheses scandal: Embodied risk and social suffering.

    PubMed

    Greco, Cinzia

    2015-12-01

    This article examines the 2010 scandal surrounding the use and subsequent recall of adulterated Poly Implant Prothèse (PIP) silicone breast prostheses in France. It uses a mixed method approach that includes 12 interviews with French PIP prosthesis recipients, analyses of medical literature, policy documents of French and EU regulatory agencies, and an online forum for PIP recipients. These data are used to explain how the definition of "acceptable risk" in the silicone implants controversy of the 1990s in the US influenced the PIP scandal later on in France. Additionally, PIP recipients had an embodied experience of risk that clashed with the definition of risk used by authorities and some surgeons. The coverage of re-implantation was also defined at different policy levels, leading to variation in patients' suffering. The combination of fraud and lack of recognition from part of the medical system constitutes an example of social suffering for the patients involved. The PIP scandal is a useful case for analyzing the interconnection of embodied experience and professional and public policy definitions of medical risk through the concepts of moral economy and biological citizenship.

  6. The Poly Implant Prothèse breast prostheses scandal: Embodied risk and social suffering.

    PubMed

    Greco, Cinzia

    2015-12-01

    This article examines the 2010 scandal surrounding the use and subsequent recall of adulterated Poly Implant Prothèse (PIP) silicone breast prostheses in France. It uses a mixed method approach that includes 12 interviews with French PIP prosthesis recipients, analyses of medical literature, policy documents of French and EU regulatory agencies, and an online forum for PIP recipients. These data are used to explain how the definition of "acceptable risk" in the silicone implants controversy of the 1990s in the US influenced the PIP scandal later on in France. Additionally, PIP recipients had an embodied experience of risk that clashed with the definition of risk used by authorities and some surgeons. The coverage of re-implantation was also defined at different policy levels, leading to variation in patients' suffering. The combination of fraud and lack of recognition from part of the medical system constitutes an example of social suffering for the patients involved. The PIP scandal is a useful case for analyzing the interconnection of embodied experience and professional and public policy definitions of medical risk through the concepts of moral economy and biological citizenship. PMID:26584233

  7. Development and functional evaluation of biomimetic silicone surfaces with hierarchical micro/nano-topographical features demonstrates favourable in vitro foreign body response of breast-derived fibroblasts.

    PubMed

    Kyle, Daniel J T; Oikonomou, Antonios; Hill, Ernie; Bayat, Ardeshir

    2015-06-01

    Reproducing extracellular matrix topographical cues, such as those present within acellular dermal matrix (ADM), in synthetic implant surfaces, may augment cellular responses, independent of surface chemistry. This could lead to enhanced implant integration and performance while reducing complications. In this work, the hierarchical micro and nanoscale features of ADM were accurately and reproducibly replicated in polydimethylsiloxane (PDMS), using an innovative maskless 3D grayscale fabrication process not previously reported. Human breast derived fibroblasts (n=5) were cultured on PDMS surfaces and compared to commercially available smooth and textured silicone implant surfaces, for up to one week. Cell attachment, proliferation and cytotoxicity, in addition to immunofluorescence staining, SEM imaging, qRT-PCR and cytokine array were performed. ADM PDMS surfaces promoted cell adhesion, proliferation and survival (p=<0.05), in addition to increased focal contact formation and spread fibroblast morphology when compared to commercially available implant surfaces. PCNA, vinculin and collagen 1 were up-regulated in fibroblasts on biomimetic surfaces while IL8, TNFα, TGFβ1 and HSP60 were down-regulated (p=<0.05). A reduced inflammatory cytokine response was also observed (p=<0.05). This study represents a novel approach to the development of functionalised biomimetic prosthetic implant surfaces which were demonstrated to significantly attenuate the acute in vitro foreign body reaction to silicone. PMID:25818416

  8. Design and Control of a Powered Transfemoral Prosthesis

    PubMed Central

    Sup, Frank; Bohara, Amit; Goldfarb, Michael

    2009-01-01

    The paper describes the design and control of a transfemoral prosthesis with powered knee and ankle joints. The initial prototype is a pneumatically actuated powered-tethered device, which is intended to serve as a laboratory test bed for a subsequent self-powered version. The prosthesis design is described, including its kinematic optimization and the design of a three-axis socket load cell that measures the forces and moments of interaction between the socket and prosthesis. A gait controller is proposed based on the use of passive impedance functions that coordinates the motion of the prosthesis with the user during level walking. The control approach is implemented on the prosthesis prototype and experimental results are shown that demonstrate the promise of the active prosthesis and control approach in restoring fully powered level walking to the user. PMID:19898683

  9. Patient satisfaction with Mentor inflatable penile prosthesis.

    PubMed

    Whalen, R K; Merrill, D C

    1991-06-01

    Patient satisfaction with the Mentor inflatable penile prosthesis was assessed by sending a thirty-six-item questionnaire to 251 patients who had undergone implantation of the device by the senior author (D.C.M.). A total of 152 (61%) of the patients responded. Recovery time, satisfaction, reasons for dissatisfaction, perceptions of erection quality, and psychosexual parameters were evaluated. Eight-eight percent of the patients were engaging in regular sexual activity. Depending on the definition of satisfaction, 81-89 percent of the respondents reported that they were satisfied with the prosthesis. Sixty-eight percent of the survey group were satisfied with the length, width, and firmness of their prosthetic-induced erection. The majority of patients reported improvement in psychosexual functioning after implantation. Reasons for dissatisfaction included inadequate penile length, insufficient firmness, and difficulty with inflation and deflation of the penile cylinders. PMID:2038786

  10. Access to Breast Prostheses via a Government-Funded Service in Victoria, Australia: Experience of Women and Service Providers

    ERIC Educational Resources Information Center

    Livingston, Patricia M.; White, Victoria; Roberts, Susan; Pritchard, Emma; Gibbs, Anne; Hill, David J.

    2003-01-01

    For many women, the only alternative to breast reconstruction following a mastectomy is to use external prostheses, which need replacing regularly at a cost of up to $395 per prosthesis. Commonwealth and state governments across Australia have responded to this need by providing subsidies to assist in the purchase of breast prostheses. However,…

  11. Fabrication of a Cranial Prosthesis Combined with an Ocular Prosthesis Using Rapid Prototyping: A Case Report.

    PubMed

    Shankaran, Gayatri; Deogade, Suryakant Chhagan; Dhirawani, Rajesh

    2016-01-01

    Rapid prototyping (RP) is a technique of manufacturing parts by the additive layer manufacturing technology; where, a three-dimensional (3D) model created in a computer aided design (CAD) system is sectioned into 2D profiles, which are further constructed by RP layer by layer. Its use is not limited to industrial or engineering fields and has extended to the medical field for the manufacturing of custom implants and prostheses, the study of anatomy and surgical planning. Nowadays, dentists are more frequently encountered with the individuals affected with craniofacial defects due to trauma. In such cases, the craniomaxillofacial rehabilitation is a real challenge to bring the patients back to society and promote their well-being. The conventional impression technique for facial prosthesis fabrication has the disadvantage of deforming the soft tissue and causing discomfort for the patient. Herein, we describe the fabrication of a cranial prosthesis combined with an ocular prosthesis with RP and stereolithography.

  12. Fabrication of a Cranial Prosthesis Combined with an Ocular Prosthesis Using Rapid Prototyping: A Case Report

    PubMed Central

    Shankaran, Gayatri; Dhirawani, Rajesh

    2016-01-01

    Rapid prototyping (RP) is a technique of manufacturing parts by the additive layer manufacturing technology; where, a three-dimensional (3D) model created in a computer aided design (CAD) system is sectioned into 2D profiles, which are further constructed by RP layer by layer. Its use is not limited to industrial or engineering fields and has extended to the medical field for the manufacturing of custom implants and prostheses, the study of anatomy and surgical planning. Nowadays, dentists are more frequently encountered with the individuals affected with craniofacial defects due to trauma. In such cases, the craniomaxillofacial rehabilitation is a real challenge to bring the patients back to society and promote their well-being. The conventional impression technique for facial prosthesis fabrication has the disadvantage of deforming the soft tissue and causing discomfort for the patient. Herein, we describe the fabrication of a cranial prosthesis combined with an ocular prosthesis with RP and stereolithography. PMID:27536331

  13. Fabrication of a Cranial Prosthesis Combined with an Ocular Prosthesis Using Rapid Prototyping: A Case Report.

    PubMed

    Shankaran, Gayatri; Deogade, Suryakant Chhagan; Dhirawani, Rajesh

    2016-01-01

    Rapid prototyping (RP) is a technique of manufacturing parts by the additive layer manufacturing technology; where, a three-dimensional (3D) model created in a computer aided design (CAD) system is sectioned into 2D profiles, which are further constructed by RP layer by layer. Its use is not limited to industrial or engineering fields and has extended to the medical field for the manufacturing of custom implants and prostheses, the study of anatomy and surgical planning. Nowadays, dentists are more frequently encountered with the individuals affected with craniofacial defects due to trauma. In such cases, the craniomaxillofacial rehabilitation is a real challenge to bring the patients back to society and promote their well-being. The conventional impression technique for facial prosthesis fabrication has the disadvantage of deforming the soft tissue and causing discomfort for the patient. Herein, we describe the fabrication of a cranial prosthesis combined with an ocular prosthesis with RP and stereolithography. PMID:27536331

  14. Longitudinal performance of an implantable vestibular prosthesis

    PubMed Central

    Phillips, Christopher; Ling, Leo; Oxford, Trey; Nowack, Amy; Nie, Kaibao; Rubinstein, Jay T.; Phillips, James O.

    2014-01-01

    Loss of vestibular function may be treatable with an implantable vestibular prosthesis that stimulates semicircular canal afferents with biphasic pulse trains. Several studies have demonstrated short-term activation of the vestibulo-ocular reflex (VOR) with electrical stimulation. Fewer long-term studies have been restricted to small numbers of animals and stimulation designed to produce adaptive changes in the electrically elicited response. This study is the first large consecutive series of implanted rhesus macaque to be studied longitudinally using brief stimuli designed to limit adaptive changes in response, so that the efficacy of electrical activation can be studied over time, across surgeries, canals and animals. The implantation of a vestibular prosthesis in animals with intact vestibular end organs produces variable responses to electrical stimulation across canals and animals, which change in threshold for electrical activation of eye movements and in elicited slow phase velocities over time. These thresholds are consistently lower, and the slow phase velocities higher, than those obtained in human subjects. The changes do not appear to be correlated with changes in electrode impedance. The variability in response suggests that empirically derived transfer functions may be required to optimize the response of individual canals to a vestibular prosthesis, and that this function may need to be remapped over time. PMID:25245586

  15. A New Distal Radioulnar Joint Prosthesis

    PubMed Central

    Schuurman, Arnold H.

    2013-01-01

    Pain and instability of the distal radioulnar joint (DRUJ) are common sequelae following a fracture of the distal radius. Many soft tissue procedures have been described, not all of which are successful. Ulnar head replacement prostheses are available but do not always provide stability. We designed a two-part, easy to implant, distal radioulnar prosthesis and implanted it in 19 patients. The first prototype was inserted in 2002 and is still in place. During the study, the design was changed twice, resulting in three groups with four patients in group A, five in group B, and ten in group C. Unfortunately all five prostheses in group B had to be removed because of loosening, while only two prostheses in group C had to be removed, for nonprosthetic reasons. For the 12 patients who retained their prosthesis, forearm function increased while grip strength increased significantly. Pain scores decreased and the Disabilities of the Arm, Shoulder, and Hand (DASH) score improved but remained high. We conclude that the prosthesis offers a new treatment option for ulnar instability following distal ulnar resection. PMID:24436843

  16. Ultrasound - Breast

    MedlinePlus

    ... discharge) and to characterize potential abnormalities seen on mammography or breast magnetic resonance imaging (MRI). Ultrasound imaging ... supply in breast lesions . Supplemental Breast Cancer Screening Mammography is the only screening tool for breast cancer ...

  17. Breast pain

    MedlinePlus

    Pain - breast; Mastalgia; Mastodynia; Breast tenderness ... There are many possible causes for breast pain. For example, hormone level changes from menstruation or pregnancy often cause breast tenderness. Some swelling and tenderness just before your period ...

  18. Prosthesis Socket Pressure Tools v. 1.0

    2010-04-28

    Renders, saves, and analyzes pressure from several sensors in a prosthesis™ socket. The program receives pressure data from 64 manometers and parses the pressure for each individual sensor. The program can then display those pressures as number in a table. The program also interpolates pressures between manometers to create a larger set of data. This larger set of data is displayed as a simple contour plot. That same contour plot can also be placed onmore » a three-dimensional surface in the shape of a prosthesis.This program allows for easy identification of high pressure areas in a prosthesis to reduce the user™s discomfort. The program parses the sensor pressures into a human-readable numeric format. The data may also be used to actively adjust bladders within the prosthesis to spread out pressure in real time, according to changing demands placed on the prosthesis. Interpolation of the pressures to create a larger data set makes it even easier for a human to identify particular areas of the prosthesis that are under high pressure. After identifying pressure points, a prosthetician can then redesign the prosthesis and/or command the bladders in the prosthesis to attempt to maintain constant pressures.« less

  19. 21 CFR 878.3800 - External aesthetic restoration prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External aesthetic restoration prosthesis. 878.3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... External aesthetic restoration prosthesis. (a) Identification. An external aesthetic restoration...

  20. 21 CFR 878.3800 - External aesthetic restoration prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External aesthetic restoration prosthesis. 878.3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... External aesthetic restoration prosthesis. (a) Identification. An external aesthetic restoration...

  1. 21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3730 Laryngeal prosthesis (Taub design). (a) Identification. A laryngeal prosthesis (Taub design) is a device intended to direct... device is interposed between openings in the trachea and the esophagus and may be removed and...

  2. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3695 Mandibular implant facial prosthesis. (a) Identification. A mandibular implant facial prosthesis is a device that is intended to be implanted for use in the functional reconstruction of mandibular deficits. The device...

  3. 21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3730 Laryngeal prosthesis (Taub design). (a) Identification. A laryngeal prosthesis (Taub design) is a device intended to direct... device is interposed between openings in the trachea and the esophagus and may be removed and...

  4. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3695 Mandibular implant facial prosthesis. (a) Identification. A mandibular implant facial prosthesis is a device that is intended to be implanted for use in the functional reconstruction of mandibular deficits. The device...

  5. Magnet-Retained Facial Prosthesis Combined with Maxillary Obturator

    PubMed Central

    Hatami, Mahnaz; Badrian, Hamid; Samanipoor, Siamak; Goiato, Marcelo Coelho

    2013-01-01

    Prosthetic rehabilitation of the midfacial defects has always perplexed prosthodontists. These defects lead to functional and esthetic deficiencies. The purpose of this clinical case report was the presentation of the prosthetic rehabilitation of an extraoral-intraoral defect using two-piece prosthesis magnetically connected. This prosthesis has dramatically improved the patient's speech, mastication, swallowing, and esthetic. PMID:23738151

  6. Comparison of the Explantation Rate of Poly Implant Prothèse, Allergan, and Pérouse Silicone Breast Implants within the First Four Years after Reconstructive Surgery before the Poly Implant Prothèse Alert by the French Regulatory Authority

    PubMed Central

    Leduey, Alexandre; Mazouni, Chafika; Leymarie, Nicolas; Alkhashnam, Heba; Sarfati, Benjamin; Garbay, Jean-Rémi; Gaudin, Amélie; Kolb, Frédéric; Rimareix, Françoise

    2015-01-01

    Background. In March 2010, ANSM (Agence Nationale de Sécurité du Medicament), the French Medical Regulatory Authority, withdrew Poly Implant Prothèse (PIP) breast implants from the market due to the use of non-medical-grade silicone gel. The aim of this study was to compare the removal rate (and reasons thereof) of breast implants produced by different manufacturers before the ANSM alert. Materials and Methods. From October 2006 to January 2010, 652 women received 944 implants after breast cancer surgery at the Gustave Roussy Comprehensive Cancer Center, Paris (France). The complications and removal rates of the different implant brands used (PIP, Allergan, and Pérouse) were evaluated and compared. Results. PIP implants represented 50.6% of the used implants, Allergan 33.4%, and Pérouse 16%. The main reasons for implant removal were patient dissatisfaction due to aesthetic problems (43.2%), infection (22.2%), and capsular contracture (13.6%). Two years after implantation, 82% of Pérouse implants, 79% of PIP, and 79% of Allergan were still in situ. There was no difference in removal rate among implant brands. Conclusion. Before the ANSM alert concerning the higher rupture rate of PIP breast implants, our implant removal rate did not predict PIP implant failure related to the use of nonapproved silicone gel. PMID:26543648

  7. Comparison of the Explantation Rate of Poly Implant Prothèse, Allergan, and Pérouse Silicone Breast Implants within the First Four Years after Reconstructive Surgery before the Poly Implant Prothèse Alert by the French Regulatory Authority.

    PubMed

    Leduey, Alexandre; Mazouni, Chafika; Leymarie, Nicolas; Alkhashnam, Heba; Sarfati, Benjamin; Garbay, Jean-Rémi; Gaudin, Amélie; Kolb, Frédéric; Rimareix, Françoise

    2015-01-01

    Background. In March 2010, ANSM (Agence Nationale de Sécurité du Medicament), the French Medical Regulatory Authority, withdrew Poly Implant Prothèse (PIP) breast implants from the market due to the use of non-medical-grade silicone gel. The aim of this study was to compare the removal rate (and reasons thereof) of breast implants produced by different manufacturers before the ANSM alert. Materials and Methods. From October 2006 to January 2010, 652 women received 944 implants after breast cancer surgery at the Gustave Roussy Comprehensive Cancer Center, Paris (France). The complications and removal rates of the different implant brands used (PIP, Allergan, and Pérouse) were evaluated and compared. Results. PIP implants represented 50.6% of the used implants, Allergan 33.4%, and Pérouse 16%. The main reasons for implant removal were patient dissatisfaction due to aesthetic problems (43.2%), infection (22.2%), and capsular contracture (13.6%). Two years after implantation, 82% of Pérouse implants, 79% of PIP, and 79% of Allergan were still in situ. There was no difference in removal rate among implant brands. Conclusion. Before the ANSM alert concerning the higher rupture rate of PIP breast implants, our implant removal rate did not predict PIP implant failure related to the use of nonapproved silicone gel. PMID:26543648

  8. Biodegradation and biocompatibility of a degradable chitosan vascular prosthesis

    PubMed Central

    Kong, Xiaoying; Xu, Wenhua

    2015-01-01

    An instrument made by ourselves was used to fabricate biodegradable chitosan-heparin artificial vascular prosthesis with small internal diameter (2 mm) and different crosslinking degree from biodegradable chitosan, chitosan derivates and heparin. In vivo and in vitro degradation studies, inflammatory analysis and electron microscope scanning of this artificial vascular prosthesis were performed. It was observed that 50% of the prosthesis decomposed in vivo and was replaced by natural tissues. The degradation process of the chitosan-heparin artificial vascular prosthesis of small diameter could be controlled by changing the crosslinking degree. This kind of artificial vascular prosthesis shows good biocompatibility that can be controllability designed to achieve desirable in vascular replacement application. PMID:26064241

  9. Three-piece Inflatable Penile Prosthesis: Surgical Techniques and Pitfalls

    PubMed Central

    Al-Enezi, Ahmad; Al-Khadhari, Sulaiman; Al-Shaiji, Tariq F.

    2011-01-01

    Penile prosthesis surgery plays a vital role in the treatment of erectile dysfunction (ED). As far as outcome is concerned, it is one of the most rewarding procedures for both patients and surgeons. We describe our surgical technique for implantation of the three-piece inflatable penile prosthesis and point out the major surgical pitfalls accompanying this procedure and their specific management. The psychological outcome of penile prosthesis surgery is also discussed. Different surgical approaches are available when performing the procedure. A number of procedure-related problems can be encountered and a thorough knowledge of these is of paramount importance. Penile prosthesis surgery has a favorable psychological outcome. Surgery for implantation of an inflatable penile prosthesis is a rewarding procedure, with a high yield of patient satisfaction. Urologists should have thorough understanding of the surgical pitfalls peculiar to this procedure and their management. PMID:22413049

  10. Amputation and prosthesis implantation shape body and peripersonal space representations

    PubMed Central

    Canzoneri, Elisa; Marzolla, Marilena; Amoresano, Amedeo; Verni, Gennaro; Serino, Andrea

    2013-01-01

    Little is known about whether and how multimodal representations of the body (BRs) and of the space around the body (Peripersonal Space, PPS) adapt to amputation and prosthesis implantation. In order to investigate this issue, we tested BR in a group of upper limb amputees by means of a tactile distance perception task and PPS by means of an audio-tactile interaction task. Subjects performed the tasks with stimulation either on the healthy limb or the stump of the amputated limb, while wearing or not wearing their prosthesis. When patients performed the tasks on the amputated limb, without the prosthesis, the perception of arm length shrank, with a concurrent shift of PPS boundaries towards the stump. Conversely, wearing the prosthesis increased the perceived length of the stump and extended the PPS boundaries so as to include the prosthetic hand, such that the prosthesis partially replaced the missing limb. PMID:24088746

  11. 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.

  12. 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

  13. Satisfaction and problems experienced with wrist movements: comparison between a common body-powered prosthesis and a new biomechatronics prosthesis.

    PubMed

    Abd Razak, N A; Abu Osman, N A; Kamyab, M; Wan Abas, W A B; Gholizadeh, H

    2014-05-01

    This report compares wrist supination and pronation and flexion and extension movements with the common body-powered prosthesis and a new biomechatronics prosthesis with regard to patient satisfaction and problems experienced with the prosthesis. Fifteen subjects with traumatic transradial amputation who used both prosthetic systems participated in this study. Each subject completed two questionnaires to evaluate their satisfaction and problems experienced with the two prosthetic systems. Satisfaction and problems with the prosthetic's wrist movements were analyzed in terms of the following: supination and pronation; flexion and extension; appearance; sweating; wounds; pain; irritation; pistoning; smell; sound; durability; and the abilities to open a door, hold a cup, and pick up or place objects. This study revealed that the respondents were more satisfied with the biomechatronics wrist prosthesis with regard to supination and pronation, flexion and extension, pain, and the ability to open a door. However, satisfaction with the prosthesis showed no significant differences in terms of sweating, wounds, irritation, pistoning, smell, sound, and durability. The abilities to hold a cup and pick up or place an object were significantly better with the body-powered prosthesis. The results of the survey suggest that satisfaction and problems with wrist movements in persons with transradial amputation can be improved with a biomechatronics wrist prosthesis compared with the common body-powered prosthesis.

  14. Auricular Prosthesis-A Case Report

    PubMed Central

    Ravuri, Rajyalakshmi; Bheemalingeshwarrao; Tella, Suchita; Thota, Kiran

    2014-01-01

    Loss of facial organs in an individual may be developmental anomalies or acquired. The missing parts of the face ear, eyes and nose are considered as maxillofacial defects which can be rehabilitated by the prosthesis and/or cosmetic surgeries. This art of science has developed into a more reliable and predictable process due to ever increasing development of materials and equipments used in the procedure. This article describes a simple technique to rehabilitate patients with auricular defects which are both aesthetically acceptable and economical for the individual. PMID:24596801

  15. What Is Breast Cancer?

    MedlinePlus

    ... Next Topic Types of breast cancers What is breast cancer? Breast cancer starts when cells in the breast ... breast cancer? ” and Non-cancerous Breast Conditions . How Breast Cancer Spreads Breast cancer can spread through the lymph ...

  16. Delayed two-stage breast reconstruction with implants: The authors’ recent experience

    PubMed Central

    Rykała, Jan; Szychta, Paweł; Kruk-Jeromin, Julia

    2011-01-01

    BACKGROUND: Presently, breast cancer detection is delayed in Poland and, thus, the only other option for patients is amputation and breast reconstruction (immediate or delayed). Reconstructive methods are based on using the patient’s own tissue (pedicled or free myocutaneous flaps) or implants (a tissue expander, which is later exchanged for a prosthesis or an expandable implant). OBJECTIVE: To evaluate the aesthetic results of a delayed two-stage breast reconstruction with the use of implants (expander and prosthesis) in patients who have previously undergone cancer-related mastectomy. METHODS: From 2006 to 2009, 54 patients (34 to 65 years of age) underwent reconstruction at least one year after their mastectomy and adjuvant chemotherapy; three women also received x-ray therapy. All women underwent a two-stage treatment with a tissue expander, which was later exchanged for a prosthesis. RESULTS: Outcomes of the surgery (evaluated by the physician and the patient at least six months after all stages of reconstruction) were found to be very good in 42 patients and good in 12 patients. After amputation and x-ray therapy in two cases, a fistula developed, which necessitated implant removal. CONCLUSIONS: After amputation, breast reconstruction with implants (expander and prosthesis) provides good aesthetic results. The method is mildly burdening to the patient and does not cause severe scarring. Symmetrization of the second breast is often recommended; however, the cost is not covered by the national health system. In principle, earlier x-ray therapy disqualifies the application of implants. Dividing reconstruction into two stages (expander and prosthesis) allows for possible correction of prosthesis placement. PMID:22942657

  17. Active upper limb prosthesis based on natural movement trajectories.

    PubMed

    Ramírez-García, Alfredo; Leija, Lorenzo; Muñoz, Roberto

    2010-03-01

    The motion of the current prostheses is sequential and does not allow natural movements. In this work, complex natural motion patterns from a healthy upper limb were characterized in order to be emulated for a trans-humeral prosthesis with three degrees of freedom at the elbow. Firstly, it was necessary to define the prosthesis workspace, which means to establish a relationship using an artificial neural network (ANN), between the arm-forearm (3-D) angles allowed by the prosthesis, and its actuators length. The 3-D angles were measured between the forearm and each axis of the reference system attached at the elbow. Secondly, five activities of daily living (ADLs) were analyzed by means of the elbow flexion (EF), the forearm prono-supination (FPS) and the 3-D angles, from healthy subjects, by using a video-based motion analysis system. The 3-D angles were fed to the prosthesis model (ANN) in order to analyze which ADLs could be emulated by the prosthesis. As a result, a prosthesis kinematics approximation was obtained. In conclusion, in spite of the innovative mechanical configuration of the actuators, it was possible to carry out only three of the five ADLs considered. Future work will include improvement of the mechanical configuration of the prosthesis to have greater range of motion. PMID:20196688

  18. Thoracic outlet syndrome following breast implant rupture.

    PubMed

    Mistry, Raakhi; Caplash, Yugesh; Giri, Pratyush; Kearney, Daniel; Wagstaff, Marcus

    2015-03-01

    We present a patient with bilateral breast implant rupture who developed severe locoregional silicone granulomatous lymphadenopathy. Poly Implant Prothese silicone implants had been used for bilateral breast augmentation 5 years prior. Extracapsular implant rupture and bilateral axillary lymphadenopathy indicated explantation, capsulectomy, and selective lymph node excision. Histology demonstrated silicone lymphadenopathy with no evidence of malignancy. Over the subsequent 12 months, she developed progressive locoregional lymphadenopathy involving bilateral cervical, axillary, and internal mammary groups, resulting in bilateral thoracic outlet syndrome. We report the unusual presentation, progression, and the ultimate surgical management of this patient. PMID:25878942

  19. Thoracic Outlet Syndrome Following Breast Implant Rupture

    PubMed Central

    Caplash, Yugesh; Giri, Pratyush; Kearney, Daniel; Wagstaff, Marcus

    2015-01-01

    Summary: We present a patient with bilateral breast implant rupture who developed severe locoregional silicone granulomatous lymphadenopathy. Poly Implant Prothese silicone implants had been used for bilateral breast augmentation 5 years prior. Extracapsular implant rupture and bilateral axillary lymphadenopathy indicated explantation, capsulectomy, and selective lymph node excision. Histology demonstrated silicone lymphadenopathy with no evidence of malignancy. Over the subsequent 12 months, she developed progressive locoregional lymphadenopathy involving bilateral cervical, axillary, and internal mammary groups, resulting in bilateral thoracic outlet syndrome. We report the unusual presentation, progression, and the ultimate surgical management of this patient. PMID:25878942

  20. Optimal circumference reduction of finger models for good prosthetic fit of a thimble-type prosthesis for distal finger amputations.

    PubMed

    Leow, M E; Prosthetist, C; Pho, R W

    2001-01-01

    The prosthetic fit of a thimble-type esthetic silicone prosthesis was retrospectively reviewed in 29 patients who were fitted following distal finger amputations. The aim was to correlate prosthetic fit with the magnitudes of circumference reduction in the finger models used to produce the prostheses and to identify the optimum reduction for the best outcome. A good fit is achieved primarily by making the prosthesis circumferentially smaller than the segment of the residual finger (residuum) over which it "cups". The percentage reduction in circumference of the finger model against the residuum model was calculated by dividing the difference in circumference between the residuum model and the finger model by the residuum model circumference and multiplying the result by 100. The computed percentage circumference reduction in the finger models ranged from small (1-3), moderate (5-7), to large (8-9). Twelve of 15 patients whose finger models had between one to three circumference reductions had a loose prosthetic fit. Only two of 14 patients who had a larger model circumference reduction of between five to nine had loose-fitting prostheses. Two of five patients who had eight to nine model circumference reduction had an uncomfortably tight prosthetic fit. A 5-7% circumference reduction in the finger model was shown in this study to best translate into good fit of a thimble-type prosthesis for distal finger amputations.

  1. Attenuation of sound due to bio-encapsulants in an electronic laryngeal prosthesis.

    PubMed

    Young, K A; Bailey, B J; Devanathan, T

    1980-01-01

    Following total laryngectomy, a person is without voice communication. An electronic laryngeal prosthesis, fully implantable in the neck, would be a desirable means of supplying artificial voice. Such a device must provide a powerful acoustic signal of the correct fundamental frequency for males and females and be rich in harmonic energy. Sound energy must be available to permit a listener to pick up intelligible speech. Such a device places severe demands on any bio-encapsulant: these include provision for an 18 mil displacement of a diaphragm moving at 100 to 200 Hz, excellent fatigue characteristics, hydrolytic and thermal stability, and minimum permeation for water and ionic solutions. This paper describes the application of a polyvinylidene chloride, a segmented copolyether polyurethane, a silicone rubber, and a semi-rigid epoxy--by solvent cast methods--to such a prosthesis. The ability of these materials to pass the sound energy with minimal attenuation was evaluated. Results indicated that the polyurethane coating provided the best compromise between minimum water penetration, maximum flexibility at the implant site, and minimum sound attenuation. PMID:7407286

  2. Current status of breast reconstruction in China: an experience of 951 breast reconstructions from a single institute

    PubMed Central

    Huang, Nai-Si; Quan, Chen-Lian; Ma, Lin-Xiao-Xi; Si, Jing; Chen, Jia-Jian; Yang, Ben-Long; Huang, Xiao-Yan; Liu, Guang-Yu; Shen, Zhen-Zhou; Shao, Zhi-Min

    2016-01-01

    Background Since mastectomy remained the primary strategy for treating breast cancer in China, post-mastectomy reconstruction is of great importance in the Chinese population. The current study aimed to assess the current status of breast reconstruction in China. Methods We reviewed all patients who received breast reconstruction from August 2000 to July 2015 in the Department of Breast Surgery in our institute. Patients’ baseline characteristics, reconstruction strategy, final pathology and loco-regional recurrence (LRR) information were collected. Results A total of 951 breast reconstructions were conducted during the past 15 years, among which 247 (27.0%) were abdominal flap reconstruction; 471 (51.5%) were latissimus dorsi myocutaneous ± implant; and 233 (25.5%) were prosthesis-based reconstruction. The majority of cases (78.1%) were invasive breast cancer and up to 894 cases (94.0%) were immediate reconstruction. Prosthesis-based reconstruction rapidly increased in recent years, and was associated with bilateral reconstruction, contralateral augmentation and higher complications. 18 patients (2.0%) developed local-regional recurrence at the median follow-up time of 26.6 months (range, 3.7–62.0 months). A total of 66 nipple-areolar complex-sparing mastectomies (NSMs) (6.9%) were performed, none of which developed recurrence. Conclusions Breast reconstruction cases increased over the 15 years with the change of paradigm. Most strikingly, prosthesis-based reconstruction rapidly gained its prevalence and became the most common strategy. NSM was only performed for highly selected patients. Patients with breast reconstruction were able to achieve satisfactory loco-regional control in our cohort. PMID:27294034

  3. Secondary reconstruction of the mandible with an aluminum oxide prosthesis.

    PubMed

    Nagamine, T; Yakata, H; Nakajima, T

    1987-02-01

    A case is presented where secondary mandibular reconstruction with an aluminum oxide ceramic prosthesis was performed for a patient who had had an earlier hemimandibulectomy and primary bone graft for management of an ameloblastoma. Various factors that were considered in the construction of the prosthesis and problems encountered during operation are discussed. Although the prosthesis was found to be quite useful for the restoration of facial contour, the results of a long-term follow-up are needed to obtain a final evaluation of the reconstruction.

  4. Ethical issues in the development of a vestibular prosthesis.

    PubMed

    Poppendieck, Wigand; Hoffmann, Klaus-Peter; Merfeld, Daniel; Guyot, Jean-Philippe; Micera, Silvestro

    2011-01-01

    During the development of a neural prosthesis, various ethical aspects have to be considered. These range from the basic design of the prosthesis and manufacturing of the various components and the system using biocompatible materials to extensive in vitro and in vivo testing and investigations in the animal model, before taking the final step and going to human trials. As medical systems, neural prostheses have to be proven absolutely safe before considering any clinical study. In this work, the various steps accompanying the development are described taking the example of a vestibular prosthesis currently developed within the European project CLONS. PMID:22254792

  5. Implantable multilayer microstrip antenna for retinal prosthesis: antenna testing.

    PubMed

    Permana, Hans; Fang, Qiang; Rowe, Wayne S T

    2012-01-01

    Retinal prosthesis has come to a more mature stage and become a very strategic answer to Retinitis Pigmentosa (RP) and Age-related Macular Degeneration (AMD) diseases. In a retinal prosthesis system, wireless link holds a great importance for the continuity of the system. In this paper, an implantable multilayer microstrip antenna was proposed for the retinal prosthesis system. Simulations were performed in High Frequency Structure Simulator (HFSS) with the surrounding material of air and Vitreous Humor fluid. The fabricated antenna was measured for characteristic validation in free space. The results showed that the real antenna possessed similar return loss and radiation pattern, while there was discrepancy with the gain values. PMID:23366231

  6. Ground adaptive standing controller for a powered transfemoral prosthesis.

    PubMed

    Lawson, Brian E; Varol, Huseyin Atakan; Goldfarb, Michael

    2011-01-01

    The scope of this work is the design and verification of a new standing controller for a powered knee and ankle prosthesis. The controller is based upon a finite-state impedance control approach previously developed by the authors. The controller provides a comprehensive standing behavior that incorporates ground adaptation for unlevel terrain. An amputee subject tested the controller with a powered prosthesis for a variety of standing conditions. Results indicate that the powered prosthesis can estimate the ground slope within ±1 degree over a range of ±15 degrees, and that it can provide appropriate joint impedances for standing on slopes within this range.

  7. A Walking Controller for a Powered Ankle Prosthesis

    PubMed Central

    Shultz, Amanda H.; Mitchell, Jason E.; Truex, Don; Lawson, Brian E.; Ledoux, Elissa; Goldfarb, Michael

    2015-01-01

    This paper describes a walking controller implemented on a powered ankle prosthesis prototype and assessed by a below-knee amputee subject on a treadmill at three speeds. The walking controller is a finite state machine which emulates a series of passive impedance functions at the joint in order to reproduce the behavior of a healthy joint. The assessments performed demonstrate the ability of the powered prosthesis prototype and walking controller to reproduce essential biomechanical aspects (i.e. joint angle, torque, and power profiles) of the healthy joint, especially relative to a passive prosthesis. PMID:25571414

  8. Dense Breasts

    MedlinePlus

    ... woman’s breasts. It is most commonly determined using mammography, a diagnostic test that uses low dose x- ... woman’s breasts, which is most commonly determined through mammography. The breast is made up of glandular, connective, ...

  9. Breast lump

    MedlinePlus

    Breast mass ... males and females of all ages have normal breast tissue. This tissue responds to hormone changes. Because of this, lumps can come and go. Breast lumps may appear at any age: Both male ...

  10. Breast Diseases

    MedlinePlus

    Most women experience breast changes at some time. Your age, hormone levels, and medicines you take may cause lumps, bumps, and discharges (fluids that are not breast milk). If you have a breast lump, pain, ...

  11. Internal mammary silicone lymphadenopathy diagnosed by robotic thoracoscopic lymphadenectomy.

    PubMed

    Schwartz, Gary S; Antoun, David; Klein, Paula; Belsley, Scott J; Connery, Cliff P

    2013-06-01

    Internal mammary lymphadenopathy can be caused by a variety of disease processes and is a difficult diagnostic dilemma. We report a case of internal mammary lymphadenopathy, in a patient with a significant history of malignancy, requiring a tissue diagnosis. Robotic thoracoscopic lymphadenectomy was used to facilitate excisional biopsy. Pathology was significant for silicone granulomatous lymphadenitis secondary to silicone breast implants inserted after mastectomy for breast cancer. PMID:27000915

  12. Practical do-it-yourself device for accurate volume measurement of breast.

    PubMed

    Tezel, E; Numanoğlu, A

    2000-03-01

    A simple and accurate method of measuring differences in breast volume based on Archimedes' principle is described. In this method, a plastic container is placed on the breast of the patient who is lying in supine position. While the breast occupies part of the container, the remaining part is filled with water and the volume is measured. This method allows the measurement of the volume differences of asymmetric breasts and also helps the surgeon to estimate the size of the prosthesis to be used in augmentation mammaplasty. PMID:10724264

  13. Silicone implant incompatibility syndrome (SIIS): a frequent cause of ASIA (Shoenfeld's syndrome).

    PubMed

    Cohen Tervaert, J W; Kappel, R M

    2013-07-01

    Silicon has a molecular mass of 28 daltons. In nature, silicon is found as silicon dioxide (silica) or in a variety of silicates (e.g., in talc or asbestos). Furthermore, silicon is present in silicones, polymerized siloxanes, which are often used as medical silicones in breast implants. Silicon exposure is associated with different systemic autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, progressive systemic sclerosis, and vasculitis. Remarkably, silicon in silicone-filled breast implants is considered to be safe, not increasing the risk of developing autoimmune diseases. We analyzed the impact of silicone-filled breast implants on the immune system in 32 consecutive patients attending a specialized autoimmunity clinic. All 32 patients had silicone implant incompatibility syndrome and complaints fulfilling the diagnostic criteria of ASIA (autoimmune/inflammatory syndrome induced by adjuvants). Furthermore, in 17 of the 32 patients, a systemic autoimmune disease was diagnosed, and 15 of the 32 patients had an impaired humoral immune system. Patients developed symptoms and signs after long-term follow-up, suggesting that these symptoms and signs started after implant aging and/or rupture. We postulate that silicon in silicone-filled breast implants may increase the risk of developing (auto) immune diseases and immune deficiencies.

  14. Natural tooth as an interim prosthesis

    PubMed Central

    Dhariwal, Neha S.; Gokhale, Niraj S.; Patel, Punit; Hugar, Shivayogi M.

    2016-01-01

    A traumatic injury to primary maxillary anterior tooth is one of the common causes for problems with the succedaneous tooth leading to it noneruption. A missing anterior tooth can be psychologically and socially damaging to the patient. Despite a wide range of treatment options available, sometimes, it is inevitable to save the natural tooth. This paper describes the immediate replacement of a right central incisor using a fiber-composite resin splint with the natural tooth crown as a pontic following surgical extraction of the dilacerated impacted permanent maxillary central incisor. The abutment teeth can be conserved with minimal or no preparation, thus keeping the technique reversible and can be completed at chair side thereby avoiding laboratory costs. It can be used as an interim measure until a definitive prosthesis can be fabricated as the growth is still incomplete. PMID:27433074

  15. Development of a micromachined epiretinal vision prosthesis.

    PubMed

    Stieglitz, Thomas

    2009-12-01

    Microsystems engineering offers the tools to develop highly sophisticated miniaturized implants to interface with the nervous system. One challenging application field is the development of neural prostheses to restore vision in persons that have become blind by photoreceptor degeneration due to retinitis pigmentosa. The fundamental work that has been done in one approach is presented here. An epiretinal vision prosthesis has been developed that allows hybrid integration of electronics on one part of a thin and flexible substrate. Polyimide as a substrate material is proven to be non-cytotoxic. Non-hermetic encapsulation with parylene C was stable for at least 3 months in vivo. Chronic animal experiments proved spatially selective cortical activation after epiretinal stimulation with a 25-channel implant. Research results have been transferred successfully to companies that currently work on the medical device approval of these retinal vision prostheses in Europe and in the USA.

  16. Development of a micromachined epiretinal vision prosthesis

    NASA Astrophysics Data System (ADS)

    Stieglitz, Thomas

    2009-12-01

    Microsystems engineering offers the tools to develop highly sophisticated miniaturized implants to interface with the nervous system. One challenging application field is the development of neural prostheses to restore vision in persons that have become blind by photoreceptor degeneration due to retinitis pigmentosa. The fundamental work that has been done in one approach is presented here. An epiretinal vision prosthesis has been developed that allows hybrid integration of electronics on one part of a thin and flexible substrate. Polyimide as a substrate material is proven to be non-cytotoxic. Non-hermetic encapsulation with parylene C was stable for at least 3 months in vivo. Chronic animal experiments proved spatially selective cortical activation after epiretinal stimulation with a 25-channel implant. Research results have been transferred successfully to companies that currently work on the medical device approval of these retinal vision prostheses in Europe and in the USA.

  17. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... condyle. (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP is required. A PMA... prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in...

  18. Biocompatible membrane of PDMS for the new chamber prosthesis stapes.

    PubMed

    Banasik, Katarzyna; Kwacz, Monika

    2016-06-30

    Stapes protheses are designed for patients with otosclerosis resulting immobilization or significant reduction of the stapes mobility. All currently used prostheses are called - piston prosthesis. However, its use to stimulate the cochlea is still imperfect. New chamber stapes prosthesis allows the perilymph excitation more effective than the piston prothesis. Moreover, the chamber prosthesis eliminates the common causes of piston-stapedotomy failures. The most important element of the new prosthesis is a flexible membrane. The membrane stiffness should be close to the stiffness of normal annular ligament. This work presents the process of selection of the membrane's thickness and its manufacturing technology. Method A 3D model of the chamber stapes prosthesis was build using Autodesk Inventor 2015. The model was imported to Abacus 6.13 computing environment. During numerical simulations, displacements corresponding to applied loads were calculated and the membrane thickness was adjusted so that its stiffness was the same as the ligament stiffness (~ 120 N/m). The compliance ratios calculated from the load-displacement curves for the membrane and the annular ligament were verified using linear regression analysis. After determining the thickness, the manufacturing technology of the membrane was developed. Results The best similarity between the membrane's and annular ligament's stiffness was achieved for PDMS membrane with the 0,15- mm thickness (similarity ratio R2=0,997752). In this work, the technological parameters of spin-coating process for membrane manufacture are also presented. Summary The proper functioning of the chamber stapes prosthesis requires the PDMS membrane with a thickness of 0,15 mm. The 0,15-mm membrane has the tiffness close to the stiffness of the normal annular ligament. Therefore, the chamber stapes prosthesis provides the perilymph stimulation at the level comparable to the healthy ear. New prosthesis is currently under pre

  19. Biocompatible membrane of PDMS for the new chamber prosthesis stapes.

    PubMed

    Banasik, Katarzyna; Kwacz, Monika

    2016-06-30

    Stapes protheses are designed for patients with otosclerosis resulting immobilization or significant reduction of the stapes mobility. All currently used prostheses are called - piston prosthesis. However, its use to stimulate the cochlea is still imperfect. New chamber stapes prosthesis allows the perilymph excitation more effective than the piston prothesis. Moreover, the chamber prosthesis eliminates the common causes of piston-stapedotomy failures. The most important element of the new prosthesis is a flexible membrane. The membrane stiffness should be close to the stiffness of normal annular ligament. This work presents the process of selection of the membrane's thickness and its manufacturing technology. Method A 3D model of the chamber stapes prosthesis was build using Autodesk Inventor 2015. The model was imported to Abacus 6.13 computing environment. During numerical simulations, displacements corresponding to applied loads were calculated and the membrane thickness was adjusted so that its stiffness was the same as the ligament stiffness (~ 120 N/m). The compliance ratios calculated from the load-displacement curves for the membrane and the annular ligament were verified using linear regression analysis. After determining the thickness, the manufacturing technology of the membrane was developed. Results The best similarity between the membrane's and annular ligament's stiffness was achieved for PDMS membrane with the 0,15- mm thickness (similarity ratio R2=0,997752). In this work, the technological parameters of spin-coating process for membrane manufacture are also presented. Summary The proper functioning of the chamber stapes prosthesis requires the PDMS membrane with a thickness of 0,15 mm. The 0,15-mm membrane has the tiffness close to the stiffness of the normal annular ligament. Therefore, the chamber stapes prosthesis provides the perilymph stimulation at the level comparable to the healthy ear. New prosthesis is currently under pre

  20. Intraoral-extraoral combination prosthesis: improving retention using interconnecting magnets.

    PubMed

    Engelen, Marloes; van Heumen, Celeste C M; Merkx, Matthias A W; Meijer, Gert J

    2014-01-01

    Osseointegrated implants have been well documented for retaining an obturator prosthesis as well as a facial prosthesis. However, when the defect extends to both the facial area and the maxilla, it is difficult to rehabilitate those defects to the satisfaction of the patient, especially in cases where implants cannot be placed on both sites. This case report describes the use of magnets to connect two prostheses, thereby increasing retention and patient comfort.

  1. Breast MRI scan

    MedlinePlus

    MRI - breast; Magnetic resonance imaging - breast; Breast cancer - MRI; Breast cancer screening - MRI ... the same breast or the other breast after breast cancer has been diagnosed Distinguish between scar tissue and ...

  2. Ideas on the suspension of the below-knee prosthesis.

    PubMed

    Grevsten, S

    1978-04-01

    Comparative studies with the PTB-suction prosthesis and the ordinary PTB prosthesis have provided opportunities to analyze and understand some functional differences in the suspension of below-knee prostheses. In a roentgenological study of the stump-socket contact signficantly less vertical displacement in the PTB-suction prosthesis has been shown. A study of the pressure variations in the suction socket verified the theory of the necessary pressure gradient in the PTB-suction socket. Added negative pressure by muscle action was also observed. An electromyographic study suggested a muscular activity pattern in the suction prosthesis similar to that of a normal leg, as a contrast to the ordinary PTB prosthesis where simultaneous contractions of antagonistic muscles seemed to be the usual pattern. The latter is interpreted as a defence reaction. An optimal prosthesis has been deduced. It shall have a soft prosthetic socket with a perfect fit, a suction, adhesion and friction fixation and a pressure gradient between the skin and the socket wall with minimum compression distally. The plaster casting shall be done in a downward modelling manner making available space for soft tissue without compression.

  3. [Surgery of the breast on transgender persons].

    PubMed

    Karhunen-Enckell, Ulla; Kolehmainen, Maija; Kääriäinen, Minna; Suominen, Sinikka

    2015-01-01

    For a female-to-male transgender person, mastectomy is the most important procedure making the social interaction easier. Along with the size of the breasts, the quantity and quality of skin will influence the selection of surgical technique. Although complications are rare, corrective surgery is performed for as many as 40% of the patients. Of male-to-female transsexual persons, 60 to 70% opt for breast enlargement. Breast enlargement can be carried out by using either silicone implants or fat transplantation. Since the surgical procedures on breasts are irreversible, their implementation requires confirmation of the diagnosis of transsexualism by a multidisciplinary team.

  4. Rehabilitation of post-traumatic total nasal defect using silicone and acrylic resin.

    PubMed

    Aggarwal, Vikas; Datta, Kusum; Kaur, Sukhjit

    2016-01-01

    Facial defects resulting from neoplasms, congenital abnormalities or trauma can affect the patient esthetically, psychologically, and even financially. Surgical reconstruction of large facial defects is sometimes not possible and frequently demands prosthetic rehabilitation. For success of such prosthesis, adequate replication of natural anatomy, color matching and blending with tissue interface are important criteria. Variety of materials and retention methods are advocated to achieve a functionally and esthetically acceptable restoration. Silicones are the most commonly used materials because of flexibility, lifelike appearance and ability to be used in combination with acrylic resin which is hard, provides body and helps in achieving retention to the prosthesis by engaging mechanical undercuts. Furthermore, the acrylic portion can be relined easily, thus helping comfortable wear and removal of the prosthesis by patient without traumatizing nasal mucosa. This case report describes time saving and cost effective prosthetic rehabilitation of a patient with total nasal defect using custom sculpted nasal prosthesis made up of silicone elastomer and acrylic resin, which is retained by engaging mechanical undercut and use of biocompatible silicone adhesive.

  5. Fibroadenoma - breast

    MedlinePlus

    ... provider if you notice: Any new breast lumps A breast lump that your provider has checked before that grows or changes Bruising on your breast for no reason Dimpled or wrinkled skin (like an orange) on your breast Nipple changes or nipple discharge

  6. Endoscopic Breast Surgery in Treating Patients With Breast Cancer

    ClinicalTrials.gov

    2014-02-05

    Male Breast Cancer; Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer

  7. Silicon spintronics.

    PubMed

    Jansen, Ron

    2012-04-23

    Worldwide efforts are underway to integrate semiconductors and magnetic materials, aiming to create a revolutionary and energy-efficient information technology in which digital data are encoded in the spin of electrons. Implementing spin functionality in silicon, the mainstream semiconductor, is vital to establish a spin-based electronics with potential to change information technology beyond imagination. Can silicon spintronics live up to the expectation? Remarkable advances in the creation and control of spin polarization in silicon suggest so. Here, I review the key developments and achievements, and describe the building blocks of silicon spintronics. Unexpected and puzzling results are discussed, and open issues and challenges identified. More surprises lie ahead as silicon spintronics comes of age.

  8. Adherence of Candida albicans to silicone is promoted by the human salivary protein SPLUNC2/PSP/BPIFA2.

    PubMed

    Holmes, A R; Rodrigues, E; van der Wielen, P; Lyons, K M; Haigh, B J; Wheeler, T T; Dawes, P J D; Cannon, R D

    2014-04-01

    Interactions between Candida albicans, saliva and saliva-coated oral surfaces are initial events in the colonization of the oral cavity by this commensal yeast, which can cause oral diseases such as candidiasis and denture stomatitis. Candida albicans also colonizes silicone voice prostheses, and the microbial biofilm formed can impair valve function, necessitating frequent prosthesis replacement. We have previously shown that saliva promoted binding of C. albicans cells to silicone in vitro, and that the selective binding of specific salivary proteins to voice prosthesis silicone mediated attachment of C. albicans cells. The C. albicans cells adhered to a polypeptide (or polypeptides) of ~36 kDa eluted from saliva-treated silicone. We show here that a protein of similar size was identified in replicate blots of the eluate from saliva-treated silicone when the blots were probed with antibodies to human SPLUNC2, a salivary protein with reported microbial agglutination properties. In addition, SPLUNC2 was depleted from saliva that had been incubated with silicone coupons. To determine whether SPLUNC2 is a yeast-binding protein, SPLUNC2 cDNA was expressed in Escherichia coli. Purified recombinant His-tagged protein (SPLUNC2r) bound to silicone as demonstrated by immunoblot analysis of an eluate from SPLUNC2r-treated silicone coupons and (35) S-radiolabelled C. albicans cells adhered in a dose-dependent manner to SPLUNC2r-coated silicone. We conclude that SPLUNC2 binds to silicone and acts as a receptor for C. albicans adherence to, and subsequent colonization of, voice prosthesis silicone. PMID:24506943

  9. [Are the cobalt hip prosthesis dangerous?].

    PubMed

    Mistretta, Virginie; Kurth, William; Charlier, Corinne

    The placement of a hip prosthesis is one of the most common orthopedic surgical procedures. Some implants contain metal and are therefore capable of releasing metal particles like cobalt in patients who wear metal prostheses. Cobalt can be responsible of local toxicity (including metallosis, hypersensitivity reaction, and benign tumor) or systemic toxicity (including cardiomyopathy, polycythemia, hypothyroidism, and neurological disorders). To monitor potential toxicity of metal hip prostheses, an annual monitoring of patients implanted is recommended and includes clinical examination, radiological examination and blood cobalt determination. The cobalt concentration in blood allows to estimate the risk of toxicity and to evaluate the performance of the implant. The currently recommended threshold value is equal to 7 µg of cobalt per liter of blood. Our study, conducted on 251 patients over a period of 4 years, has shown that the cobalt concentration average was 2.51 µg/l in blood, with 51 patients having a cobaltemia higher than the threshold of 7 µg/l. PMID:27615181

  10. UPDATE ON INFECTIONS IN ARTICULAR PROSTHESIS

    PubMed Central

    Lima, Ana Lucia Lei Munhoz; de Oliveira, Priscila Rosalba Domingos

    2015-01-01

    The implantation of joint prostheses, especially for the hip and knee, is becoming increasingly common. This provides a significant reduction in discomfort and an immeasurable improvement in patient mobility. Reviews of the worldwide literature indicate that 1 to 5% of these prostheses become infected, although it is important to remember that as the number of operations performed to implant these prosthesis increases, so will the number of cases of this type of infection. Gram-positive bacteria predominate in contaminations of joint prostheses, in particular Staphylococcus aureus and Staphylococcus epidermidis. Infections caused by gram-negative bacilli and fungi such as Candida sp have been reported with increased frequency throughout the world. Infections of joint prostheses present characteristic signs that can be divided into acute manifestations (severe pain, high fever, toxemia, heat, redness and wound secretions) and chronic manifestations (progressive pain, cutaneous fistula formation and pus drainage, without fever). The definitive diagnosis of the infection should be made through cultures to isolate the microorganism, using material collected from joint fluid puncture, surgical wound secretions, and surgical debridement. It is essential to cover for methicillin-resistant Staphylococcus aureus, given the epidemiological importance of this agent in these infections. The total duration of antibiotic therapy ranges from six weeks to six months, and this treatment should be adjusted as needed, based on the results from culturing. PMID:27026957

  11. Galvanic gold plating for fixed dental prosthesis

    PubMed Central

    Ozcelik, Tuncer Burak; Yilmaz, Burak

    2013-01-01

    Metal ceramic partial fixed dental prostheses have been commonly used for the replacement of missing teeth for many years. Because of an increase in the price of gold, base metal alloys have been the choice of alloy for the fabrication of metal ceramic restorations in many dental clinics. Some major disadvantages of base metals are their corrosion and the dark coloration they may cause at the crown margins. This article describes a galvanic gold-plating technique, which is used to minimize corrosion and improve the esthetics of metal ceramic restorations fabricated with Cr-Co base metal alloys. This technique involves the deposition of a 6 μm to 8 μm 24 K gold layer directly onto the Cr-Co cast prosthesis framework. The technique improves metal surface properties, making them more biocompatible and usable, however, requires additional equipment and experienced laboratory technicians. Clinical studies should be performed to corroborate the long term success of this technique. PMID:24926220

  12. [Are the cobalt hip prosthesis dangerous?].

    PubMed

    Mistretta, Virginie; Kurth, William; Charlier, Corinne

    The placement of a hip prosthesis is one of the most common orthopedic surgical procedures. Some implants contain metal and are therefore capable of releasing metal particles like cobalt in patients who wear metal prostheses. Cobalt can be responsible of local toxicity (including metallosis, hypersensitivity reaction, and benign tumor) or systemic toxicity (including cardiomyopathy, polycythemia, hypothyroidism, and neurological disorders). To monitor potential toxicity of metal hip prostheses, an annual monitoring of patients implanted is recommended and includes clinical examination, radiological examination and blood cobalt determination. The cobalt concentration in blood allows to estimate the risk of toxicity and to evaluate the performance of the implant. The currently recommended threshold value is equal to 7 µg of cobalt per liter of blood. Our study, conducted on 251 patients over a period of 4 years, has shown that the cobalt concentration average was 2.51 µg/l in blood, with 51 patients having a cobaltemia higher than the threshold of 7 µg/l.

  13. Zirconia in fixed prosthesis. A literature review

    PubMed Central

    Román-Rodríguez, Juan L.; Ferreiroa, Alberto; Solá-Ruíz, María F.; Fons-Font, Antonio

    2014-01-01

    Statement of problem: Evidence is limited on the efficacy of zirconia-based fixed dental prostheses. Objective: To carry out a literature review of the behavior of zirconium oxide dental restorations. Material and Methods: This literature review searched the Pubmed, Scopus, Medline and Cochrane Library databases using key search words “zirconium oxide,” “zirconia,” “non-metal restorations,” “ceramic oxides,” “veneering ceramic,” “zirconia-based fixed dental prostheses”. Both in vivo and in vitro studies into zirconia-based prosthodontic restoration behavior were included. Results: Clinical studies have revealed a high rate of fracture for porcelain-veneered zirconia-based restorations that varies between 6% and 15% over a 3- to 5-year period, while for ceramo-metallic restorations the fracture rate ranges between 4 and 10% over ten years. These results provoke uncertainty as to the long-term prognosis for this material in the oral medium. The cause of veneering porcelain fractures is unknown but hypothetically they could be associated with bond failure between the veneer material and the zirconia sub-structure. Key words:Veneering ceramic, zirconia-based ceramic restoration, crown, zirconia, tooth-supported fixed prosthesis. PMID:24596638

  14. Finite element modeling of retinal prosthesis mechanics

    NASA Astrophysics Data System (ADS)

    Basinger, B. C.; Rowley, A. P.; Chen, K.; Humayun, M. S.; Weiland, J. D.

    2009-10-01

    Epiretinal prostheses used to treat degenerative retina diseases apply stimulus via an electrode array fixed to the ganglion cell side of the retina. Mechanical pressure applied by these arrays to the retina, both during initial insertion and throughout chronic use, could cause sufficient retinal damage to reduce the device's effectiveness. In order to understand and minimize potential mechanical damage, we have used finite element analysis to model mechanical interactions between an electrode array and the retina in both acute and chronic loading configurations. Modeling indicates that an acute tacking force distributes stress primarily underneath the tack site and heel edge of the array, while more moderate chronic stresses are distributed more evenly underneath the array. Retinal damage in a canine model chronically implanted with a similar array occurred in correlating locations, and model predictions correlate well with benchtop eyewall compression tests. This model provides retinal prosthesis researchers with a tool to optimize the mechanical electrode array design, but the techniques used here represent a unique effort to combine a modifiable device and soft biological tissues in the same model and those techniques could be extended to other devices that come into mechanical contact with soft neural tissues.

  15. Metabolic Prosthesis for Oxygenation of Ischemic Tissue

    SciTech Connect

    Greenbaum, Elias

    2009-01-01

    This communication discloses new ideas and preliminary results on the development of a "metabolic prosthesis" for local oxygenation of ischemic tissue under physiological neutral conditions. We report for the first time the selective electrolysis of physiological saline by repetitively pulsed charge-limited electrolysis for the production of oxygen and suppression of free chlorine. For example, using 800 A amplitude current pulses and <200 sec pulse durations, we demonstrated prompt oxygen production and delayed chlorine production at the surface of a shiny 0.85 mm diameter spherical platinum electrode. The data, interpreted in terms of the ionic structure of the electric double layer, suggest a strategy for in situ production of metabolic oxygen via a new class of "smart" prosthetic implants for dealing with ischemic disease such as diabetic retinopathy. We also present data indicating that drift of the local pH of the oxygenated environment can be held constant using a feedback-controlled three electrode electrolysis system that chooses anode and cathode pair based on pH data provided by local microsensors. The work is discussed in the context of diabetic retinopathy since surgical techniques for multielectrode prosthetic implants aimed at retinal degenerative diseases have been developed.

  16. Galvanic gold plating for fixed dental prosthesis.

    PubMed

    Ozcelik, Tuncer Burak; Yilmaz, Burak

    2013-07-01

    Metal ceramic partial fixed dental prostheses have been commonly used for the replacement of missing teeth for many years. Because of an increase in the price of gold, base metal alloys have been the choice of alloy for the fabrication of metal ceramic restorations in many dental clinics. Some major disadvantages of base metals are their corrosion and the dark coloration they may cause at the crown margins. This article describes a galvanic gold-plating technique, which is used to minimize corrosion and improve the esthetics of metal ceramic restorations fabricated with Cr-Co base metal alloys. This technique involves the deposition of a 6 μm to 8 μm 24 K gold layer directly onto the Cr-Co cast prosthesis framework. The technique improves metal surface properties, making them more biocompatible and usable, however, requires additional equipment and experienced laboratory technicians. Clinical studies should be performed to corroborate the long term success of this technique. PMID:24926220

  17. A prototype retinal prosthesis for visual stimulation.

    PubMed

    Abu-Faraj, Ziad O; Rjeily, Dany M Abou; Nasreddine, Rayan W; Andari, Majid A; Taok, Habib H

    2007-01-01

    Vision loss has severe impacts on its victims, carrying with it physiological, psychological, social, and economic consequences thereby degrading the quality of life and depriving the individual from performing many of the daily living activities. This article describes the design and development of a prototype retinal prosthesis for visual stimulation. The system consists of a webcam, a notebook computer, and a prototype excitatory circuit. The system is driven by a MATLAB-based custom-built software. Live webcam images are converted to an 8 x 8 mosaic of 256 gray scale shades. Subsequently, electrical impulses are generated by the excitatory circuit in real-time to topographically stimulate the corresponding epiretinal cells. Following their conversion to gray scale, recorded data from the central pixel of the mosaic yielded: 36.24 nC for black, 48.48 nC for red, 55.68 nC for green, 67.68 nC for blue, and 91.92 nC for white. These results correlate well with data reported in the literature. The hallmark of this work is in the potential of partial restoration of sight that would add quality to the life of individuals with vision loss. PMID:18003325

  18. Implications of transaxillary breast augmentation: lifetime probability of breast cancer development and sentinel node mapping interference.

    PubMed

    Prado, Arturo; Andrades, Patricio; Leniz, Patricio

    2007-01-01

    After the "fifth-generation" breast implants with ultracohesive silicone gel technology are introduced, the Food and Drug Administration (FDA) will sooner or later retire the ban on the use of these devices in the United States. When this happens, the plastic surgery community must be prepared to face a massive demand for reoperations to change saline-filled breast implants because cohesive gel devices have the potential to provide a more natural breast shape, to minimize the risk of postoperative rippling, and to provide a greater degree of safety if the implant loses its integrity. Despite these advantages and extensive use throughout the rest of the world during the ban in the United States, silicone implants also have disadvantages. One drawback is that transaxillary breast augmentation with more "rigid" gel-filled implants may produce trauma to the armpit, may interfere with sentinel node mapping for breast cancer treatment, and may have future medicolegal implications. PMID:17549559

  19. Maxillary cement retained implant supported monolithic zirconia prosthesis in a full mouth rehabilitation: a clinical report

    PubMed Central

    Liu, Perng-Ru; Aponte-Wesson, Ruth; O'Neal, Sandra J

    2013-01-01

    This clinical report presents the reconstruction of a maxillary arch with a cement retained implant supported fixed prosthesis using a monolithic zirconia generated by CAD/CAM system on eight osseointegrated implants. The prosthesis was copy milled from an interim prosthesis minimizing occlusal adjustments on the definitive prosthesis at the time of delivery. Monolithic zirconia provides high esthetics and reduces the number of metal alloys used in the oral cavity. PMID:23755349

  20. Maxillary cement retained implant supported monolithic zirconia prosthesis in a full mouth rehabilitation: a clinical report.

    PubMed

    Sadid-Zadeh, Ramtin; Liu, Perng-Ru; Aponte-Wesson, Ruth; O'Neal, Sandra J

    2013-05-01

    This clinical report presents the reconstruction of a maxillary arch with a cement retained implant supported fixed prosthesis using a monolithic zirconia generated by CAD/CAM system on eight osseointegrated implants. The prosthesis was copy milled from an interim prosthesis minimizing occlusal adjustments on the definitive prosthesis at the time of delivery. Monolithic zirconia provides high esthetics and reduces the number of metal alloys used in the oral cavity.

  1. A digital patient for computer-aided prosthesis design

    PubMed Central

    Colombo, Giorgio; Facoetti, Giancarlo; Rizzi, Caterina

    2013-01-01

    This article concerns the design of lower limb prosthesis, both below and above knee. It describes a new computer-based design framework and a digital model of the patient around which the prosthesis is designed and tested in a completely virtual environment. The virtual model of the patient is the backbone of the whole system, and it is based on a biomechanical general-purpose model customized with the patient's characteristics (e.g. anthropometric measures). The software platform adopts computer-aided and knowledge-guided approaches with the goal of replacing the current development process, mainly hand made, with a virtual one. It provides the prosthetics with a set of tools to design, configure and test the prosthesis and comprehends two main environments: the prosthesis modelling laboratory and the virtual testing laboratory. The first permits the three-dimensional model of the prosthesis to be configured and generated, while the second allows the prosthetics to virtually set up the artificial leg and simulate the patient's postures and movements, validating its functionality and configuration. General architecture and modelling/simulation tools for the platform are described as well as main aspects and results of the experimentation. PMID:24427528

  2. Estimation of crank angle for cycling with a powered prosthesis.

    PubMed

    Lawson, B E; Shultz, A; Ledoux, E; Goldfarb, M

    2014-01-01

    In order for a prosthesis to restore power generation during cycling, it must supply torque in a manner that is coordinated with the motion of the bicycle crank. This paper outlines an algorithm for the real time estimation of the angular position of a bicycle crankshaft using only measurements internal to an intelligent knee and ankle prosthesis. The algorithm assumes that the rider/prosthesis/bicycle system can be modeled as a four-bar mechanism. Assuming that a prosthesis can generate two independent angular measurements of the mechanism (in this case the knee angle and the absolute orientation of the shank), Freudenstein's equation can be used to synthesize the mechanism continuously. A recursive least-squares algorithm is implemented to estimate the Freudenstein coefficients, and the resulting link lengths are used to reformulate the equation in terms of input-output relationships mapping both measured angles to the crank angle. Using two independent measurements allows the algorithm to uniquely determine the crank angle from multi-valued functions. In order to validate the algorithm, a bicycle was mounted on a trainer and configured with the prosthesis using an artificial hip joint attached to the seat post. Motion capture was used to monitor the mechanism for forward and backward pedaling and the results are compared to the output of the presented algorithm. Once the parameters have converged, the algorithm is shown to predict the crank angle within 15° of the externally measured value throughout the entire crank cycle during forward rotation.

  3. Design and Testing of a Bionic Dancing Prosthesis.

    PubMed

    Rouse, Elliott J; Villagaray-Carski, Nathan C; Emerson, Robert W; Herr, Hugh M

    2015-01-01

    Traditionally, prosthetic leg research has focused on improving mobility for activities of daily living. Artistic expression such as dance, however, is not a common research topic and consequently prosthetic technology for dance has been severely limited for the disabled. This work focuses on investigating the ankle joint kinetics and kinematics during a Latin-American dance to provide unique motor options for disabled individuals beyond those of daily living. The objective of this study was to develop a control system for a bionic ankle prosthesis that outperforms conventional prostheses when dancing the rumba. The biomechanics of the ankle joint of a non-amputee, professional dancer were acquired for the development of the bionic control system. Subsequently, a professional dancer who received a traumatic transtibial amputation in April 2013 tested the bionic dance prosthesis and a conventional, passive prosthesis for comparison. The ability to provide similar torque-angle behavior of the biological ankle was assessed to quantify the biological realism of the prostheses. The bionic dancing prosthesis overlapped with 37 ± 6% of the non-amputee ankle torque and ankle angle data, compared to 26 ± 2% for the conventional, passive prosthesis, a statistically greater overlap (p = 0.01). This study lays the foundation for quantifying unique, expressive activity modes currently unavailable to individuals with disabilities. Future work will focus on an expansion of the methods and types of dance investigated in this work.

  4. Design and Testing of a Bionic Dancing Prosthesis

    PubMed Central

    Rouse, Elliott J.; Villagaray-Carski, Nathan C.; Emerson, Robert W.; Herr, Hugh M.

    2015-01-01

    Traditionally, prosthetic leg research has focused on improving mobility for activities of daily living. Artistic expression such as dance, however, is not a common research topic and consequently prosthetic technology for dance has been severely limited for the disabled. This work focuses on investigating the ankle joint kinetics and kinematics during a Latin-American dance to provide unique motor options for disabled individuals beyond those of daily living. The objective of this study was to develop a control system for a bionic ankle prosthesis that outperforms conventional prostheses when dancing the rumba. The biomechanics of the ankle joint of a non-amputee, professional dancer were acquired for the development of the bionic control system. Subsequently, a professional dancer who received a traumatic transtibial amputation in April 2013 tested the bionic dance prosthesis and a conventional, passive prosthesis for comparison. The ability to provide similar torque-angle behavior of the biological ankle was assessed to quantify the biological realism of the prostheses. The bionic dancing prosthesis overlapped with 37 ± 6% of the non-amputee ankle torque and ankle angle data, compared to 26 ± 2% for the conventional, passive prosthesis, a statistically greater overlap (p = 0.01). This study lays the foundation for quantifying unique, expressive activity modes currently unavailable to individuals with disabilities. Future work will focus on an expansion of the methods and types of dance investigated in this work. PMID:26285201

  5. Split-Framework in Mandibular Implant-Supported Prosthesis

    PubMed Central

    2015-01-01

    During oral rehabilitation of an edentulous patient with an implant-supported prosthesis, mandibular flexure must be considered an important biomechanical factor when planning the metal framework design, especially if implants are installed posterior to the interforaminal region. When an edentulous mandible is restored with a fixed implant-supported prosthesis connected by a fixed full-arch framework, mandibular flexure may cause needless stress in the overall restorative system and lead to screw loosening, poor fit of prosthesis, loss of the posterior implant, and patient's discomfort due to deformation properties of the mandible during functional movements. The use of a split-framework could decrease the stress with a precise and passive fit on the implants and restore a more natural functional condition of the mandible, helping in the longevity of the prosthesis. Therefore, the present clinical report describes the oral rehabilitation of an edentulous patient by a mandibular fixed implant-supported prosthesis with a split-framework to compensate for mandibular flexure. Clinical Significance. The present clinical report shows that the use of a split-framework reduced the risk of loss of the posterior implants or screws loosening with acceptable patient comfort over the period of a year. The split-framework might have compensated for the mandibular flexure during functional activities. PMID:26770841

  6. Design and Control of a Pneumatically Actuated Transtibial Prosthesis

    PubMed Central

    Zheng, Hao; Shen, Xiangrong

    2015-01-01

    This paper presents the design and control of a pneumatically actuated transtibial prosthesis, which utilizes a pneumatic cylinder-type actuator to power the prosthetic ankle joint to support the user's locomotion. The pneumatic actuator has multiple advantages over the traditional electric motor, such as light weight, low cost, and high power-to-weight ratio. The objective of this work is to develop a compact and lightweight transtibial prosthesis, leveraging the multiple advantages provided by this highly competitive actuator. In this paper, the design details of the prosthesis are described, including the determination of performance specifications, the layout of the actuation mechanism, and the calculation of the torque capacity. Through the authors’ design calculation, the prosthesis is able to provide sufficient range of motion and torque capacity to support the locomotion of a 75 kg individual. The controller design is also described, including the underlying biomechanical analysis and the formulation of the finite-state impedance controller. Finally, the human subject testing results are presented, with the data indicating that the prosthesis is able to generate a natural walking gait and sufficient power output for its amputee user. PMID:26146497

  7. Estimation of crank angle for cycling with a powered prosthesis.

    PubMed

    Lawson, B E; Shultz, A; Ledoux, E; Goldfarb, M

    2014-01-01

    In order for a prosthesis to restore power generation during cycling, it must supply torque in a manner that is coordinated with the motion of the bicycle crank. This paper outlines an algorithm for the real time estimation of the angular position of a bicycle crankshaft using only measurements internal to an intelligent knee and ankle prosthesis. The algorithm assumes that the rider/prosthesis/bicycle system can be modeled as a four-bar mechanism. Assuming that a prosthesis can generate two independent angular measurements of the mechanism (in this case the knee angle and the absolute orientation of the shank), Freudenstein's equation can be used to synthesize the mechanism continuously. A recursive least-squares algorithm is implemented to estimate the Freudenstein coefficients, and the resulting link lengths are used to reformulate the equation in terms of input-output relationships mapping both measured angles to the crank angle. Using two independent measurements allows the algorithm to uniquely determine the crank angle from multi-valued functions. In order to validate the algorithm, a bicycle was mounted on a trainer and configured with the prosthesis using an artificial hip joint attached to the seat post. Motion capture was used to monitor the mechanism for forward and backward pedaling and the results are compared to the output of the presented algorithm. Once the parameters have converged, the algorithm is shown to predict the crank angle within 15° of the externally measured value throughout the entire crank cycle during forward rotation. PMID:25571415

  8. The mechanical properties of breast prostheses.

    PubMed

    Peters, W J

    1981-03-01

    The mechanical properties of inflatable and gel-filled breast prostheses were evaluated using the Instron Universal Testing Machine. Prosthesis strength characteristics were evaluated in terms of compression strength (rather than tensile strength) because of the relationship to closed capsulotomy. The compression breaking strength of prostheses ranged from 0.62 to 10.8 pounds per square inch. There was considerable variation among prostheses. Pressures exceeding these values have been recorded during closed compression capsulotomy. The clinical relevance of these results is discussed.

  9. 21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a...

  10. 21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a...

  11. 21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a...

  12. 21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a...

  13. 21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a...

  14. 21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a...

  15. 21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a...

  16. 21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a...

  17. 21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a...

  18. 21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is...

  19. 21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is...

  20. 21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is...

  1. 21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is...

  2. 21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is...

  3. 21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint carpal lunate polymer prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3750 Wrist joint carpal lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a...

  4. 21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint carpal trapezium polymer prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3770 Wrist joint carpal trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a...

  5. 21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint carpal scaphoid polymer prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3760 Wrist joint carpal scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a...

  6. 21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a...

  7. 21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a...

  8. 21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a...

  9. An electronic prosthesis mimicking the dynamic vestibular function

    NASA Astrophysics Data System (ADS)

    Shkel, Andrei M.

    2006-03-01

    This paper reports our progress toward development of a unilateral vestibular prosthesis. The sensing element of the prosthesis is a custom designed one-axis MEMS gyroscope. Similarly to the natural semicircular canal, the microscopic gyroscope senses angular motion of the head and generates voltages proportional to the corresponding angular accelerations. Then, voltages are sent to the pulse generating unit where angular motion is translated into voltage pulses. The voltage pulses are converted into current pulses and are delivered through specially designed electrodes, conditioned to stimulate the corresponding vestibular nerve branch. Our preliminary experimental evaluations of the prosthesis on a rate table indicate that the device's output matches the average firing rate of vestibular neurons to those in animal models reported in the literature. The proposed design is scalable; the sensing unit, pulse generator, and the current source can be potentially implemented on a single chip using integrated MEMS technology.

  10. Research, design & development project Myoelectric Prosthesis of Upper Limb

    NASA Astrophysics Data System (ADS)

    Galiano, L.; Montaner, E.; Flecha, A.

    2007-11-01

    A Research Design and Development Project was developed of a myoelectric prosthesis for a pediatric patient presenting congenital amputation of the left forearm below the elbow. A multidisciplinary work-team was formed for this goal, in order to solve the several (/various) aspects regarding this project (mechanical, ergonomics, electronics, physical). The prosthesis as an electromechanical device was divided in several blocks, trying to achieve a focused development for each stage, acording to requisites. A mechanical prototype of the prothesis was designed and built along with the circuitry needed for EMG aquisition, control logic and drivers. Having acomplished the previuos stages, the project is now dealing with the definitions of the interface between the prosthesis and the patient, with promising perspectives.

  11. Preliminary Evaluations of a Self-Contained Anthropomorphic Transfemoral Prosthesis

    PubMed Central

    Sup, Frank; Varol, Huseyin Atakan; Mitchell, Jason; Withrow, Thomas J.; Goldfarb, Michael

    2009-01-01

    This paper presents a self-contained powered knee and ankle prosthesis, intended to enhance the mobility of transfemoral amputees. A finite-state based impedance control approach, previously developed by the authors, is used for the control of the prosthesis during walking and standing. Experiments on an amputee subject for level treadmill and overground walking are described. Knee and ankle joint angle, torque, and power data taken during walking experiments at various speeds demonstrate the ability of the prosthesis to provide a functional gait that is representative of normal gait biomechanics. Measurements from the battery during level overground walking indicate that the self-contained device can provide more than 4500 strides, or 9 km, of walking at a speed of 5.1 km/h between battery charges. PMID:20054424

  12. Multimodal sensor controlled three Degree of Freedom transradial prosthesis.

    PubMed

    Ohnishi, Kengo; Morio, Toshiyuki; Takagi, Tomoo; Kajitani, Isamu

    2013-06-01

    This paper describes the basic concept of our multimodal sensor control system for 3-Degree-of-Freedom transradial prosthesis. The target of developing the controller is to reduce the mental effort of planning operating multiple joints in the conventional multifunctional myoelectric controller and reduce the compensating motion of conventional myoelectric prosthesis. An accelerometer is installed in the socket and the angles of the gravitational force are computed to drive the pronation/spination joint and the palmar flexion/dorsifelxion joint of the prosthesis. A threshold On/Off control using the posture information is implemented with the triggering of a co-contraction EMG signal. Through experiment with able-body subjects, we confirmed that this controller has a potential of reducing compensating shoulder movements for pick-raise-place tasks, when compared to the task conducted with conventional locked-wrist prostheses. Yet modification is required for stability. PMID:24187284

  13. Comparison of Titanium vs. Polycel Total Ossicular Replacement Prosthesis

    PubMed Central

    Faramarzi, Mohammad; Jahangiri, Reza; Roosta, Sareh

    2016-01-01

    Introduction: Even though modern technology progresses so rapidly, annals of otology are replete with so many challenging article, which often compare various types of prosthesis. Since there has not been a prospective randomized clinical trial study which compares the hearing result of total ossicular replacement prosthesis made of Titanium with omega connector and Polycel in the literature, we decided to perform a study encompassing this issue. Materials and Methods: 105 patients, who were in the 2nd stage of their operation and who needed total ossicular replacement prosthesis, were included in this prospective single blind randomized clinical trial study. Patients were classified in two groups: titanium Kurz (TTP™ -Vario system, Kurz GmbH, Dusslingen, Germany) with omega connector and Polycel (Sheehy Plastipore Polycel, Medtronic Xomed Inc). The duration of the follow up was 6-12 months. In order to evaluate hearing results, pure tone audiometric in 0.5, 1, 2, and 4 kHz were checked. In addition, speech reception threshold was recorded. A successful surgery was defined as having a postoperative air–bone gap within 20 dB. Results: We accomplished successful hearing in 64.4% of patients with titanium and 65% of patients with a Polycel prosthesis.Improvement in speech reception threshold was 11.5 dB in the titanium group and 13 dB in the Polycel group. In other words, there was no significant difference between the two groups. In addition, air-bone gap improvement after ossiculoplasty was 11.2 dB in the patients with a titanium prosthesis and 12.4 dB in the Polycel group. In fact, the difference was not significant. Conclusion: We found that both the titanium and the Polycel prosthesis improve speech reception threshold and air-bone gap closure in a similar manner. PMID:27280094

  14. System training and assessment in simultaneous proportional myoelectric prosthesis control

    PubMed Central

    2014-01-01

    Background Pattern recognition control of prosthetic hands take inputs from one or more myoelectric sensors and controls one or more degrees of freedom. However, most systems created allow only sequential control of one motion class at a time. Additionally, only recently have researchers demonstrated proportional myoelectric control in such systems, an option that is believed to make fine control easier for the user. Recent developments suggest improved reliability if the user follows a so-called prosthesis guided training (PGT) scheme. Methods In this study, a system for simultaneous proportional myoelectric control has been developed for a hand prosthesis with two motor functions (hand open/close, and wrist pro-/supination). The prosthesis has been used with a prosthesis socket equivalent designed for normally-limbed subjects. An extended version of PGT was developed for use with proportional control. The control system’s performance was tested for two subjects in the Clothespin Relocation Task and the Southampton Hand Assessment Procedure (SHAP). Simultaneous proportional control was compared with three other control strategies implemented on the same prosthesis: mutex proportional control (the same system but with simultaneous control disabled), mutex on-off control, and a more traditional, sequential proportional control system with co-contractions for state switching. Results The practical tests indicate that the simultaneous proportional control strategy and the two mutex-based pattern recognition strategies performed equally well, and superiorly to the more traditional sequential strategy according to the chosen outcome measures. Conclusions This is the first simultaneous proportional myoelectric control system demonstrated on a prosthesis affixed to the forearm of a subject. The study illustrates that PGT is a promising system training method for proportional control. Due to the limited number of subjects in this study, no definite conclusions can be

  15. Interim Results from the International Trial of Second Sight’s Visual Prosthesis

    PubMed Central

    Humayun, Mark S.; Dorn, Jessy D.; Cruz, Lyndon da; Dagnelie, Gislin; Sahel, José-Alain; Stanga, Paulo E.; Cideciyan, Artur V.; Duncan, Jacque L.; Eliott, Dean; Filley, Eugene; Ho, Allen C.; Santos, Arturo; Safran, Avinoam B.; Arditi, Aries; Del Priore, Lucian V.; Greenberg, Robert J.

    2011-01-01

    Purpose This study evaluates the Argus™ II Retinal Prosthesis System in blind subjects with severe outer retinal degeneration. Design The study design is a single arm, prospective, multicenter clinical trial. Participants Thirty subjects were enrolled in the United States and Europe between 6 June 2007 and 11 August 2009. All subjects were followed for a minimum of six months and up to 2.7 years. Methods The electronic stimulator and antenna of the implant was sutured onto the sclera using an encircling silicone band. Next, a pars plana vitrectomy was performed and the electrode array and cable were introduced into the eye via a pars plana sclerotomy. The microelectrode array was then tacked to the epiretinal surface. Main Outcome Measures The primary safety endpoint for the trial was the number, severity, and relation of adverse events. Principal performance endpoints were assessments of visual function as well as performance on orientation and mobility tasks. Results Subjects performed statistically better with system ON vs. OFF in the following tasks: object localization (96% of subjects); motion discrimination (57%); and discrimination of oriented gratings (23%). The best recorded visual acuity to date is 20/1260. Subjects’ mean performance on Orientation and Mobility tasks was significantly better when the System was ON vs. OFF. Seventy percent of the patients did not have any serious adverse events (SAEs). The most common SAE reported was either conjunctival erosion or dehiscence over the extraocular implant and was successfully treated in all subjects except in one which required explantation of the device without further complications. Conclusions The long-term safety results of Second Sight’s retinal prosthesis system are acceptable and the majority of subjects with profound visual loss perform better on visual tasks with system than without. PMID:22244176

  16. Active Bone Conduction Prosthesis: BonebridgeTM

    PubMed Central

    Zernotti, Mario E.; Sarasty, Andrea Bravo

    2015-01-01

    Introduction Bone conduction implants are indicated for patients with conductive and mixed hearing loss, as well as for patients with single-sided deafness (SSD). The transcutaneous technology avoids several complications of the percutaneous bone conduction implants including skin reaction, skin growth over the abutment, and wound infection. The Bonebridge (MED-EL, Austria) prosthesis is a semi-implantable hearing system: the BCI (Bone Conduction Implant) is the implantable part that contains the Bone Conduction-Floating Mass Transducer (BC-FMT), which applies the vibrations directly to the bone; the external component is the audio processor Amadé BB (MED-EL, Austria), which digitally processes the sound and sends the information through the coil to the internal part. Bonebridge may be implanted through three different approaches: the transmastoid, the retrosigmoid, or the middle fossa approach. Objective This systematic review aims to describe the world́s first active bone conduction implant system, Bonebridge, as well as describe the surgical techniques in the three possible approaches, showing results from implant centers in the world in terms of functional gain, speech reception thresholds and word recognition scores. Data Synthesis The authors searched the MEDLINE database using the key term Bonebridge. They selected only five publications to include in this systematic review. The review analyzes 20 patients that received Bonebridge implants with different approaches and pathologies. Conclusion Bonebridge is a solution for patients with conductive/mixed hearing loss and SSD with different surgical approaches, depending on their anatomy. The system imparts fewer complications than percutaneous bone conduction implants and shows proven benefits in speech discrimination and functional gain. PMID:26491482

  17. Active Bone Conduction Prosthesis: Bonebridge(TM).

    PubMed

    Zernotti, Mario E; Sarasty, Andrea Bravo

    2015-10-01

    Introduction Bone conduction implants are indicated for patients with conductive and mixed hearing loss, as well as for patients with single-sided deafness (SSD). The transcutaneous technology avoids several complications of the percutaneous bone conduction implants including skin reaction, skin growth over the abutment, and wound infection. The Bonebridge (MED-EL, Austria) prosthesis is a semi-implantable hearing system: the BCI (Bone Conduction Implant) is the implantable part that contains the Bone Conduction-Floating Mass Transducer (BC-FMT), which applies the vibrations directly to the bone; the external component is the audio processor Amadé BB (MED-EL, Austria), which digitally processes the sound and sends the information through the coil to the internal part. Bonebridge may be implanted through three different approaches: the transmastoid, the retrosigmoid, or the middle fossa approach. Objective This systematic review aims to describe the world́s first active bone conduction implant system, Bonebridge, as well as describe the surgical techniques in the three possible approaches, showing results from implant centers in the world in terms of functional gain, speech reception thresholds and word recognition scores. Data Synthesis The authors searched the MEDLINE database using the key term Bonebridge. They selected only five publications to include in this systematic review. The review analyzes 20 patients that received Bonebridge implants with different approaches and pathologies. Conclusion Bonebridge is a solution for patients with conductive/mixed hearing loss and SSD with different surgical approaches, depending on their anatomy. The system imparts fewer complications than percutaneous bone conduction implants and shows proven benefits in speech discrimination and functional gain.

  18. In vivo performance of photovoltaic subretinal prosthesis

    NASA Astrophysics Data System (ADS)

    Mandel, Yossi; Goetz, George; Lavinsky, Daniel; Huie, Phil; Mathieson, Keith; Wang, Lele; Kamins, Theodore; Manivanh, Richard; Harris, James; Palanker, Daniel

    2013-02-01

    We have developed a photovoltaic retinal prosthesis, in which camera-captured images are projected onto the retina using pulsed near-IR light. Each pixel in the subretinal implant directly converts pulsed light into local electric current to stimulate the nearby inner retinal neurons. 30 μm-thick implants with pixel sizes of 280, 140 and 70 μm were successfully implanted in the subretinal space of wild type (WT, Long-Evans) and degenerate (Royal College of Surgeons, RCS) rats. Optical Coherence Tomography and fluorescein angiography demonstrated normal retinal thickness and healthy vasculature above the implants upon 6 months follow-up. Stimulation with NIR pulses over the implant elicited robust visual evoked potentials (VEP) at safe irradiance levels. Thresholds increased with decreasing pulse duration and pixel size: with 10 ms pulses it went from 0.5 mW/mm2 on 280 μm pixels to 1.1 mW/mm2 on 140 μm pixels, to 2.1 mW/mm2 on 70 μm pixels. Latency of the implant-evoked VEP was at least 30 ms shorter than in response evoked by the visible light, due to lack of phototransduction. Like with the visible light stimulation in normal sighted animals, amplitude of the implant-induced VEP increased logarithmically with peak irradiance and pulse duration. It decreased with increasing frequency similar to the visible light response in the range of 2 - 10 Hz, but decreased slower than the visible light response at 20 - 40 Hz. Modular design of the photovoltaic arrays allows scalability to a large number of pixels, and combined with the ease of implantation, offers a promising approach to restoration of sight in patients blinded by retinal degenerative diseases.

  19. Auditory Prosthesis with a Penetrating Nerve Array

    PubMed Central

    Snyder, Russell L.

    2007-01-01

    Contemporary auditory prostheses (“cochlear implants”) employ arrays of stimulating electrodes implanted in the scala tympani of the cochlea. Such arrays have been implanted in some 100,000 profoundly or severely deaf people worldwide and arguably are the most successful of present-day neural prostheses. Nevertheless, most implant users show poor understanding of speech in noisy backgrounds, poor pitch recognition, and poor spatial hearing, even when using bilateral implants. Many of these limitations can be attributed to the remote location of stimulating electrodes relative to excitable cochlear neural elements. That is, a scala tympani electrode array lies within a bony compartment filled with electrically conductive fluid. Moreover, scala tympani arrays typically do not extend to the apical turn of the cochlea in which low frequencies are represented. In the present study, we have tested in an animal model an alternative to the conventional cochlear implant: a multielectrode array implanted directly into the auditory nerve. We monitored the specificity of stimulation of the auditory pathway by recording extracellular unit activity at 32 sites along the tonotopic axis of the inferior colliculus. The results demonstrate the activation of specific auditory nerve populations throughout essentially the entire frequency range that is represented by characteristic frequencies in the inferior colliculus. Compared to conventional scala tympani stimulation, thresholds for neural excitation are as much as 50-fold lower and interference between electrodes stimulated simultaneously is markedly reduced. The results suggest that if an intraneural stimulating array were incorporated into an auditory prosthesis system for humans, it could offer substantial improvement in hearing replacement compared to contemporary cochlear implants. PMID:17265124

  20. Breast Biopsy System

    NASA Technical Reports Server (NTRS)

    1994-01-01

    Charge Coupled Devices (CCDs) are high technology silicon chips that connect light directly into electronic or digital images, which can be manipulated or enhanced by computers. When Goddard Space Flight Center (GSFC) scientists realized that existing CCD technology could not meet scientific requirements for the Hubble Space Telescope Imagining Spectrograph, GSFC contracted with Scientific Imaging Technologies, Inc. (SITe) to develop an advanced CCD. SITe then applied many of the NASA-driven enhancements to the manufacture of CCDs for digital mammography. The resulting device images breast tissue more clearly and efficiently. The LORAD Stereo Guide Breast Biopsy system incorporates SITe's CCD as part of a digital camera system that is replacing surgical biopsy in many cases. Known as stereotactic needle biopsy, it is performed under local anesthesia with a needle and saves women time, pain, scarring, radiation exposure and money.

  1. [Total Elbow Replacement - Implantation of the Latitude Prosthesis (Tornier)].

    PubMed

    Hackl, M; Wegmann, K; Leschinger, T; Ries, C; Burkhart, K J; Müller, L

    2015-10-01

    Due to technical progress, the indication for total elbow arthroplasty could be expanded in recent years. As a result, the demand regarding functionality and mobility of the replaced joint has risen as well. Elbow arthroplasty has to be considered as technically demanding. Only with detailed knowledge of this surgical procedure and its possible intraoperative pitfalls can one provide the best possible results. In this instructional video we explain the implantation of the Latitude elbow prosthesis (Tornier) putting emphasis on the correct approach as well as implantation of the prosthesis and subsequent wound closure.

  2. [Prosthetic treatment of mandibular pseudarthrosis using an articulated prosthesis].

    PubMed

    Sidibe, C A; Razouk, O; Dichamp, J; Bertrand, J C; Vaillant, J M

    1994-01-01

    Two cases with complete loss of the tooth-bearing portion of the mandible were repaired with a prosthesis. This type of defect can involve the loss of a large number of teeth and aggression to the remaining teeth must be limited as much as possible. A two-part "articulated" prosthesis with two rings appears to be the best adapted system. This method takes into account the requirements of for additional conventional prostheses and thus makes it possible to save the remaining teeth.

  3. Prospective Analysis of Primary Breast Augmentation on Body Image Using the BREAST-Q: Results from a Nationwide Study

    PubMed Central

    Pusic, Andrea; Murphy, Diane K.

    2016-01-01

    Background: The Breast Implant Follow-up Study is a large, ongoing observational study of women who received Natrelle round silicone-filled or saline-filled breast implants. This analysis describes patient-reported outcomes in the cohort who underwent breast augmentation. Methods: Subjects prospectively completed two validated scales of the BREAST-Q (satisfaction with breasts and psychosocial well-being) preoperatively and at 1 and 4 years postoperatively. Effect size and z tests were used to compare differences between preoperative versus postoperative scores; multivariate mixed models were used to compare differences in scores between silicone-filled and saline-filled implants. Results: Of 17,899 subjects completing the BREAST-Q preoperatively, 14,514 (81.1 percent) completed the postoperative questionnaire (12,726 received silicone-filled implants and 1788 received saline-filled implants). Overall, satisfaction with breasts and psychosocial well-being increased significantly at postoperative year 1 (p < 0.0001 for both), and the improvement was sustained at year 4 (p < 0.0001 for both). Large effect sizes were observed for satisfaction with breasts (2.0 at year 1; 1.8 at year 4) and psychosocial well-being (1.2 at year 1; 1.0 at year 4). In the multivariate model, silicone-filled implants were associated with significantly greater improvement compared with saline-filled implants for satisfaction with breasts and psychosocial well-being at year 1 (p < 0.0001 for both) and year 4 (p < 0.0001 and p < 0.0019, respectively). Conclusions: Breast implants are effective in improving women’s quality of life. The authors found significant and sustained improvements in satisfaction and psychosocial well-being in women undergoing breast augmentation with Natrelle silicone-filled or saline-filled implants. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV. PMID:27219264

  4. Silicon nitride/silicon carbide composite powders

    DOEpatents

    Dunmead, Stephen D.; Weimer, Alan W.; Carroll, Daniel F.; Eisman, Glenn A.; Cochran, Gene A.; Susnitzky, David W.; Beaman, Donald R.; Nilsen, Kevin J.

    1996-06-11

    Prepare silicon nitride-silicon carbide composite powders by carbothermal reduction of crystalline silica powder, carbon powder and, optionally, crystalline silicon nitride powder. The crystalline silicon carbide portion of the composite powders has a mean number diameter less than about 700 nanometers and contains nitrogen. The composite powders may be used to prepare sintered ceramic bodies and self-reinforced silicon nitride ceramic bodies.

  5. Management of long span partially edentulous maxilla with fixed removable denture prosthesis

    PubMed Central

    Jeyavalan, Mahilan I.; Narasimman, M.; Venkatakrishnan, C. J.; Philip, Jacob M.

    2012-01-01

    Restoration of a long span partially edentulous maxilla with tooth supported prosthesis is challenging because of inherent anatomic limitations and unfavourable biomechanics present after the loss of teeth. A tooth supported fixed-removable prosthesis is a treatment option for restoration of such long span partially edentulous maxillary arches. This prosthesis meets the requirements for esthetics, phonetics, comfort, and hygiene, as well as favourable biomechanical stress distribution to the remaining natural tooth abutments. This article presents a procedure for fabrication of a fixed-removable prosthesis that has cement-retained custom cast bar metal substructure and a ball attachment retained removable superstructure prosthesis. PMID:23293488

  6. Prosthetic Rehabilitation of a Patient with Ocular Defect using Semi-customized Prosthesis: A Case Report

    PubMed Central

    Putanikar, Nagaraj Y.; Patil, Anandkumar G.; Shetty, Pavithra K.; Nagaral, Suresh; Mithaiwala, Hatimali I.

    2015-01-01

    Severe physical and psychological distress occurs due to disfigurement caused by loss of eye. Ocular prosthesis is the only mode of rehabilitation for the missing eye. There are different materials and techniques used for the fabrication of the same. Resin proved to be the better among the available materials. Either using the stock eye or using customized ocular prosthesis has their own advantages and disadvantages. Through our clinical report, we have fabricated a semi-customized ocular prosthesis with stock iris and customized sclera. This prosthesis had the advantages of both stock and custom ocular prosthesis providing functionally and esthetically satisfactory result. PMID:25954078

  7. [An obturator prosthesis in a patient with perfect dentition. Functional, esthetic approach].

    PubMed

    Razouk, O; Sidibe, C A; Dichamp, J; Bertrand, J C

    1994-01-01

    A prosthesis was implanted immediately after operation for a velo-palatal tissue defect in an active young female patient in order to avoid function, psychological and social complications involved with this mutilation. The three classical steps of the process were performed: immediate implantation of the prosthesis, temporary prosthesis, definitive prosthesis. Anchoring to the teeth maintained the prosthesis in position. A functional print is always needed to obtain perfect closure. A metallic bridge links the retention part and the obstructive part. The device is effective, discrete, functional and well-tolerated by the patient.

  8. Management of long span partially edentulous maxilla with fixed removable denture prosthesis.

    PubMed

    Jeyavalan, Mahilan I; Narasimman, M; Venkatakrishnan, C J; Philip, Jacob M

    2012-07-01

    Restoration of a long span partially edentulous maxilla with tooth supported prosthesis is challenging because of inherent anatomic limitations and unfavourable biomechanics present after the loss of teeth. A tooth supported fixed-removable prosthesis is a treatment option for restoration of such long span partially edentulous maxillary arches. This prosthesis meets the requirements for esthetics, phonetics, comfort, and hygiene, as well as favourable biomechanical stress distribution to the remaining natural tooth abutments. This article presents a procedure for fabrication of a fixed-removable prosthesis that has cement-retained custom cast bar metal substructure and a ball attachment retained removable superstructure prosthesis. PMID:23293488

  9. Breast Cancer

    MedlinePlus

    Breast cancer affects one in eight women during their lives. No one knows why some women get breast cancer, but there are many risk factors. Risks that ... who have family members with breast or ovarian cancer may wish to be tested for the genes. ...

  10. Reasons why women who have mastectomy decide to have or not to have breast reconstruction.

    PubMed

    Reaby, L L

    1998-06-01

    Breast reconstruction after mastectomy is chosen by approximately 10 percent of Australian women. Younger women are more likely to have this surgical procedure. This suggests that there may be many factors determining this choice. Sixty-four women who wore an external postmastectomy breast prosthesis and 31 women who had postmastectomy breast reconstruction participated in the present study. The purpose was to gain a greater understanding through semi-structured interviews of why women who had breast reconstruction chose this alternative and why women who wore the external postmastectomy breast prosthesis elected not to have reconstruction. The study also ascertained how difficult it was for the women in both groups to decide their particular breast restoration alternative. The most frequently endorsed reasons for not having breast reconstruction in the prosthesis group included: (1) not essential for physical well being, (2) not essential for emotional well being, (3) not having enough information about the procedure, and (4) not wanting anything unnatural in the body. When each member of the group was asked to identify a major reason for not having reconstruction, two predominant issues emerged: (1) fearing complications and (2) perceiving themselves as being too old for the procedure. Twelve percent of the prosthesis group experienced difficulty in making the decision not to have reconstruction. Three factors accounted for this difficulty: (1) the lack of family support, (2) the inability to have a specific type of reconstruction, and (3) the perception that friends and acquaintances saw the surgery as cosmetic. The most frequently reported reasons given by the reconstruction group for having reconstruction included: (1) to get rid of the external breast prosthesis, (2) to be able to wear many different types of clothing, (3) to regain femininity, and (4) to feel whole again. The least influential factors were to improve marital and sexual relations. The major

  11. An Alternative Approach to Combine Orbital Prosthesis and Obturator: A Case Report

    PubMed Central

    Soganci, Gokce; Yalug, Suat; Kocacikli, Mustafa

    2011-01-01

    This report describes a different approach for diminishing the movements of orbital prosthesis during mimic movements and chewing function. Mechanical devices such as magnets are used to enhance the retention in case lack of the implants. However rigid fixation of obturator and orbital prosthesis can result in movements of the orbital prosthesis during mastication. In this case obturator and orbital prosthesis are combined by magnets. However this combination is not rigid because of an active part which provides movement. This active part allows movements in a space constructed in the acrylic base of orbital prosthesis. Thus, the movements that may occur on orbital prosthesis during chewing can be diminished by this simple mechanism. Due to the fact that designing such a mechanism that minimizes the movements of the orbital prosthesis contributes patient’s comfort. PMID:21912502

  12. Transfemoral prosthesis suspension systems: a systematic review of the literature.

    PubMed

    Gholizadeh, Hossein; Abu Osman, Noor Azuan; Eshraghi, Arezoo; Ali, Sadeeq

    2014-09-01

    The purpose of this study was to find the scientific evidence pertaining to various transfemoral suspension systems to provide selection criteria for clinicians. To this end, databases of PubMed, Web of Science, and ScienceDirect were explored. The following key words, as well as their combinations and synonyms, were used for the search: transfemoral prosthesis, prosthetic suspension, lower limb prosthesis, above-knee prosthesis, prosthetic liner, transfemoral, and prosthetic socket. The study design, research instrument, sampling method, outcome measures, and protocols of articles were reviewed. On the basis of the selection criteria, 16 articles (11 prospective studies and 5 surveys) were reviewed. The main causes of reluctance to prosthesis, aside from energy expenditure, were socket-related problems such as discomfort, perspiration, and skin problems. Osseointegration was a suspension option, yet it is rarely applied because of several drawbacks, such as extended rehabilitation process, risk for fracture, and infection along with excessive cost. In conclusion, no clinical evidence was found as a "standard" system of suspension and socket design for all transfemoral amputees. However, among various suspension systems for transfemoral amputees, the soft insert or double socket was favored by most users in terms of function and comfort.

  13. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vascular graft prosthesis. 870.3450 Section 870.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  14. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Vascular graft prosthesis. 870.3450 Section 870.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  15. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Vascular graft prosthesis. 870.3450 Section 870.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  16. Wispy Prosthesis: A Novel Method in Denture Weight Reduction

    PubMed Central

    Anne, Gopinadh; Budeti, Sreedevi; Anche, Sampath Kumar; Zakkula, Srujana; Atla, Jyothi; Jyothula, Ravi Rakesh Dev; Peddinti, Vijaya Kumar

    2016-01-01

    Introduction Stability and retention of the denture becomes at stake with the increase in weight of the denture prosthesis. As a consequence, different materials and methods have been introduced to overcome these issues but denture weight reduction still remains to be a cumbersome and strenuous procedure. Aim To introduce a novel technique for the fabrication of denture prosthesis where in the weight of the denture will not affect the retention and stability of the denture. Materials and Methods Four groups with a sample size of 10 each, were included where in one group was control and other three were study groups. The control group samples were made completely solid and the study group samples were packed with materials like bean balls, cellulose balls and polyacrylic fibers. The weight of all the samples of each study group was measured and compared with the control group. The observations were analyzed statistically by paired t-test. Results It was observed that the bean balls group produced a weight reduction of 31.3%, cellulose balls group 27.4% and polyacrylic fibers group 24.5% when compared to that of the control group. Conclusion This novel technique will eliminate the problems that were associated in creating hollowness and at the same time will reduce the weight of the prosthesis and among all the study groups, bean balls group were found to reduce maximum weight of the prosthesis. PMID:27190947

  17. Verge of Collapse: The Pros/thesis of Art Research

    ERIC Educational Resources Information Center

    Garoian, Charles R.

    2008-01-01

    This article explores "prosthesis" as a metaphor of embodiment in art-based research to challenge the utopian myth of wholeness and normality in art and the human body. Bearing in mind the correspondences between amputated bodies and the cultural dislocations of art, I propose "prosthetic epistemology" and "prosthetic ontology" as embodied knowing…

  18. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Vascular graft prosthesis. 870.3450 Section 870.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3450 Vascular...

  19. 21 CFR 872.3940 - Total temporomandibular joint prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Total temporomandibular joint prosthesis. 872.3940 Section 872.3940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular...

  20. 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...

  1. 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...

  2. 21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Laryngeal prosthesis (Taub design). 874.3730 Section 874.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3730 Laryngeal...

  3. 21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Laryngeal prosthesis (Taub design). 874.3730 Section 874.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3730 Laryngeal...

  4. 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...

  5. 21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Laryngeal prosthesis (Taub design). 874.3730 Section 874.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3730 Laryngeal...

  6. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Date PMA or notice of completion of a PDP is required. (1) Except as described in paragraph (c)(2) of this section, a PMA or a notice of completion of a PDP is required to be filed with the Food and Drug... other mandibular condyle prosthesis shall have an approved PMA or a declared completed PDP in...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... of the mandibular condyle and glenoid fossa. (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the... prosthesis (interpositional implant) shall have an approved PMA or a declared completed PDP in effect...

  8. 21 CFR 878.3750 - External prosthesis adhesive.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External...

  9. 21 CFR 878.3750 - External prosthesis adhesive.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External...

  10. 21 CFR 878.3750 - External prosthesis adhesive.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External...

  11. 21 CFR 878.3750 - External prosthesis adhesive.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External...

  12. 21 CFR 878.3750 - External prosthesis adhesive.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External...

  13. 21 CFR 878.3800 - External aesthetic restoration prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External aesthetic restoration prosthesis. 878.3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices §...

  14. 21 CFR 878.3800 - External aesthetic restoration prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false External aesthetic restoration prosthesis. 878.3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices §...

  15. Bacterial biofilm in persistent penile prosthesis-associated infection.

    PubMed

    Nickel, J C; Heaton, J; Morales, A; Costerton, J W

    1986-03-01

    The ultrastructural microbiology of 2 cases of infection associated with rigid penile prostheses was studied. The persistence of these infections appeared to be related to the mode of growth of the bacteria in protected biofilms adherent to the inert surface of the prosthesis.

  16. 21 CFR 890.3500 - External assembled lower limb prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External assembled lower limb prosthesis. 890.3500 Section 890.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  17. 21 CFR 890.3500 - External assembled lower limb prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External assembled lower limb prosthesis. 890.3500 Section 890.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  18. 21 CFR 890.3500 - External assembled lower limb prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false External assembled lower limb prosthesis. 890.3500 Section 890.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  19. 21 CFR 890.3500 - External assembled lower limb prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false External assembled lower limb prosthesis. 890.3500 Section 890.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  20. 21 CFR 890.3500 - External assembled lower limb prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External assembled lower limb prosthesis. 890.3500 Section 890.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  1. 21 CFR 874.3450 - Partial ossicular replacement prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Partial ossicular replacement prosthesis. 874.3450 Section 874.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the functional reconstruction of segments of the ossicular chain and facilitates...

  2. 21 CFR 874.3495 - Total ossicular replacement prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Total ossicular replacement prosthesis. 874.3495 Section 874.3495 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the total functional reconstruction of the ossicular chain and facilitates...

  3. 21 CFR 874.3450 - Partial ossicular replacement prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Partial ossicular replacement prosthesis. 874.3450 Section 874.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the functional reconstruction of segments of the ossicular chain and facilitates...

  4. 21 CFR 874.3495 - Total ossicular replacement prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Total ossicular replacement prosthesis. 874.3495 Section 874.3495 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the total functional reconstruction of the ossicular chain and facilitates...

  5. 21 CFR 874.3495 - Total ossicular replacement prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Total ossicular replacement prosthesis. 874.3495 Section 874.3495 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the total functional reconstruction of the ossicular chain and facilitates...

  6. 21 CFR 874.3450 - Partial ossicular replacement prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Partial ossicular replacement prosthesis. 874.3450 Section 874.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the functional reconstruction of segments of the ossicular chain and facilitates...

  7. 21 CFR 874.3495 - Total ossicular replacement prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Total ossicular replacement prosthesis. 874.3495 Section 874.3495 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the total functional reconstruction of the ossicular chain and facilitates...

  8. 21 CFR 874.3450 - Partial ossicular replacement prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Partial ossicular replacement prosthesis. 874.3450 Section 874.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the functional reconstruction of segments of the ossicular chain and facilitates...

  9. Key Parameters Evaluation for Hip Prosthesis with Finite Element Analysis

    NASA Astrophysics Data System (ADS)

    Guo, Hongqiang; Li, Dichen; Lian, Qin; Li, Xiang; Jin, Zhongmin

    2007-09-01

    Stem length and cross section are two key parameters that influence the stability and longevity of metallic hip prosthesis in the total hip arthroplasty (THA). In order to assess their influence to the stress and fatigue behavior of hip prosthesis, a series model of hip prosthesis with round-shaped or drum-shaped cross section, and with different stem lengths were created. These models were analyzed under both static and dynamic loading conditions with finite element analysis, and dynamic loading represents normal walking was used in the dynamic analysis. The stress on the metallic stem, cement, and adjacent bone were got, micromotion on the cement-metal interface were got too. Safety factors for fatigue life of the hip prothesis were calculated based on data obtained from dynamic analysis. Static analysis shows that drum-shaped cross section can decrease the displacement of the stem, that stress on drum-shaped stem focus on the corner of the femoral neck and the distal part of hip prosthesis, whereas the stress on the round-shaped stem distributes evenly over most part of the stem, and maximum stress on stem prosthesis fluctuates with stem length bottoming out at stem length range from 80 mm to 110 mm, that drum-shaped stems with drum height 8 mm generate more stress at the distal part of stem than drum-shaped stems with drum height 10 mm and round stems do. Dynamic and fatigue analysis shows that drum-shaped stem with drum height 10 mm and stem length 90 mm has the greatest safety factor therefore long fatigue life.

  10. Cranioplasty prosthesis manufacturing based on reverse engineering technology

    PubMed Central

    Chrzan, Robert; Urbanik, Andrzej; Karbowski, Krzysztof; Moskała, Marek; Polak, Jarosław; Pyrich, Marek

    2012-01-01

    Summary Background Most patients with large focal skull bone loss after craniectomy are referred for cranioplasty. Reverse engineering is a technology which creates a computer-aided design (CAD) model of a real structure. Rapid prototyping is a technology which produces physical objects from virtual CAD models. The aim of this study was to assess the clinical usefulness of these technologies in cranioplasty prosthesis manufacturing. Material/Methods CT was performed on 19 patients with focal skull bone loss after craniectomy, using a dedicated protocol. A material model of skull deficit was produced using computer numerical control (CNC) milling, and individually pre-operatively adjusted polypropylene-polyester prosthesis was prepared. In a control group of 20 patients a prosthesis was manually adjusted to each patient by a neurosurgeon during surgery, without using CT-based reverse engineering/rapid prototyping. In each case, the prosthesis was implanted into the patient. The mean operating times in both groups were compared. Results In the group of patients with reverse engineering/rapid prototyping-based cranioplasty, the mean operating time was shorter (120.3 min) compared to that in the control group (136.5 min). The neurosurgeons found the new technology particularly useful in more complicated bone deficits with different curvatures in various planes. Conclusions Reverse engineering and rapid prototyping may reduce the time needed for cranioplasty neurosurgery and improve the prosthesis fitting. Such technologies may utilize data obtained by commonly used spiral CT scanners. The manufacturing of individually adjusted prostheses should be commonly used in patients planned for cranioplasty with synthetic material. PMID:22207125

  11. Breast Cancer Prevention

    MedlinePlus

    ... of Breast & Gynecologic Cancers Breast Cancer Screening Research Breast Cancer Prevention (PDQ®)–Patient Version What is prevention? Go ... to keep cancer from starting. General Information About Breast Cancer Key Points Breast cancer is a disease in ...

  12. Types of Breast Cancers

    MedlinePlus

    ... the key statistics about breast cancer? Types of breast cancers Breast cancer can be separated into different types ... than invasive ductal carcinoma. Less common types of breast cancer Inflammatory breast cancer This uncommon type of invasive ...

  13. Breast self-exam

    MedlinePlus

    Self-examination of the breast; BSE; Breast cancer - BSE; Breast cancer screening - self exam ... American Cancer Society. Recommendations for early breast cancer detection in women without breast symptoms. Revised October 20, ... ...

  14. Breast restoration decision making: enhancing the process.

    PubMed

    Reaby, L L

    1998-06-01

    The purpose of this study was to explore the breast restoration decision-making patterns used by women who opted to have their breast cancer treated by mastectomy. Sixty-four women wearing external breast prostheses and 31 women with breast reconstructions were interviewed. Modified versions of Simon's notion of "bounded rationality" and Janis and Mann's conflict model provided the conceptual scaffolding for the study. Five breast restoration decision-making patterns emerged from the analysis of the interview data: (a) Enlightened (actively seeks information, considers positive and negative aspects, and demonstrates deliberation on the alternatives), (b) Contented (passively accepts minimum information on alternatives because of a preference toward a particular type), (c) Sideliner (uncritically adopts any alternative that is easy and simple to implement), (d) Shifter (gives over the decision to others), and (e) Panic-stricken (can make no rational decision on alternatives). In the prosthesis group, the major pattern used was the Sideliner, and in the reconstruction group it was the Contented. None of the participants used the Enlightened pattern. The data indicated that there was no evidence of active information-seeking behavior or deliberation on the alternatives as part of the women's decision-making process. The findings suggest a need for a registered nurse oncology specialist to be accessible to women during the period when decisions regarding breast restoration are made. This professional has the knowledge to interact effectively with these women and serve as their advocate during the decision-making process. Implications for professional practice and a model for competent breast restoration decision making are presented.

  15. Prosthetic Rehabilitation of Lower Limb with RTV Silicone Using Prosthodontic Clinical and Laboratory Techniques - A Case Report

    PubMed Central

    Kumar, T. Mohan; Ravindran, Smitha; Nair, K. Chandrasekharan; Kumar, Aswini

    2016-01-01

    Amputation of all or part of a limb may be due to systemic disease, vascular disease, infection, local injury or trauma. Partially amputated lower limbs present a variety of unique clinical and prosthetic challenges, because of distinctly different amputation levels of the lower limb. A female patient with history of Partial Foot Amputation (PFA) surgery at metatarsophalangeal joint level, due to crush injury reported for prosthetic rehabilitation. This case was successfully rehabilitated using Room Temperature Vulcanizing (RTV) medical grade silicone for fabrication of foot prosthesis. Though limited in its function, it amply proves that the clinical and laboratory techniques used in fabrication of maxillofacial prosthesis can be effectively adapted for the fabrication of body prosthesis like toes and feet to enhance the quality of life of the patients. The patient was reviewed every year for three years. PMID:27656585

  16. A Custom Made Intrinsic Silicone Shade Guide for Indian Population

    PubMed Central

    Behanam, Mohammed; Ahila, S.C.; Jei, J. Brintha

    2016-01-01

    Introduction Replication of natural skin colour in maxillofacial prosthesis has been traditionally done using trial and error method, as concrete shade guides are unavailable till date. Hence a novel custom made intrinsic silicone shade guide has been attempted for Indian population. Aim Reconstruction of maxillofacial defects is challenging, as achieving an aesthetic result is not always easy. A concoction of a novel intrinsic silicone shade guide was contemplated for the study and its reproducibility in clinical practice was analysed. Materials and Methods Medical grade room temperature vulcanising silicone was used for the fabrication of shade tabs. The shade guide consisted of three main groups I, II and III which were divided based upon the hues yellow, red and blue respectively. Five distinct intrinsic pigments were added in definite proportions to subdivide each group of different values from lighter to darker shades. A total number of 15 circular shade tabs comprised the guide. To validate the usage of the guide, visual assessment of colour matching was done by four investigators to investigate the consent of perfect colour correspondence. Data was statistically analysed using kappa coefficients. Results The kappa values were found to be 0.47 to 0.78 for yellow based group I, 0.13 to 0.65 for red based group II, and 0.07 to 0.36 for blue based group III. This revealed that the shade tabs of yellow and red based hues matched well and showed a statistically good colour matching. Conclusion This intrinsic silicone shade guide can be effectively utilised for fabrication of maxillofacial prosthesis with silicone in Indian population. A transparent colour formula with definite proportioning of intrinsic pigments is provided for obtaining an aesthetic match to skin tone. PMID:27190946

  17. Upslope walking with a powered knee and ankle prosthesis: initial results with an amputee subject.

    PubMed

    Sup, Frank; Varol, Huseyin Atakan; Goldfarb, Michael

    2011-02-01

    This paper extends a previously developed level- ground walking control methodology to enable an above knee amputee to walk up slopes using a powered knee and ankle prosthesis. Experimental results corresponding to walking on level ground and two different slope angles (5 (°) and 10 (°)) with the powered prosthesis using the control method are compared to walking under the same conditions with a passive prosthesis. The data indicate that the powered prosthesis with the upslope walking controller is able to reproduce several kinematic characteristics of healthy upslope walking that the passive prosthesis does not (such as knee flexion after heel strike and a powered ankle plantarflexion during push-off). Finally, results are shown that demonstrate the ability of the prosthesis to generate a slope estimate, which is in turn utilized to adapt the underlying control parameters to the corresponding slope.

  18. Control of stair ascent and descent with a powered transfemoral prosthesis.

    PubMed

    Lawson, Brian Edward; Varol, Huseyin Atakan; Huff, Amanda; Erdemir, Erdem; Goldfarb, Michael

    2013-05-01

    This paper presents a finite state-based control system for a powered transfemoral prosthesis that provides stair ascent and descent capability. The control system was implemented on a powered prosthesis and evaluated by a unilateral, transfemoral amputee subject. The ability of the powered prosthesis to provide stair ascent and descent capability was assessed by comparing the gait kinematics, as recorded by a motion capture system, with the kinematics provided by a passive prosthesis, in addition to those recorded from a set of healthy subjects. The results indicate that the powered prosthesis provides gait kinematics that are considerably more representative of healthy gait, relative to the passive prosthesis, for both stair ascent and descent.

  19. Maxillofacial Prosthetic Materials- An Inclination Towards Silicones

    PubMed Central

    Choudhary, Sunita; Garg, Hemlata; H.G., Jagadeesh

    2014-01-01

    There have been constant searches and researches which are taking place in the field of dental materials to best suit the ideal selection criteria to satisfy the functionality, biocompatibility, aesthetics as well as the durability as a maxillofacial material. Among all the different materials, Silicone is the most popularly used, but still studies are carried out to overcome their weaknesses and to come out with a material which can be labeled as the “ideal maxillofacial prosthetic material”. This article comprises the materials which were and are in use and the reason for their unpopularity. It also gives us a scope to understand the major fields where the materials lack and thus needs improvement to render an individual with the best maxillo-facial prosthesis. PMID:25654054

  20. False-positive indium-111 labeled leukocyte scintigram in a patient with a painful hip prosthesis

    SciTech Connect

    Feldman, N.; Makler, P.T. Jr.; Alavi, A.

    1986-01-01

    A Tronzo hip prosthesis is designed to elicit an inflammatory reaction in order to promote prosthesis stability. A three-phased bone scan and Ga-67 imaging in conjunction with physical examination and laboratory findings failed to demonstrate evidence for osteomyelitis in a patient with a painful hip prosthesis, in whom images obtained with In-111-labeled leukocytes were positive. This observation demonstrated that the interpretation of the latter technique in demonstrating inflammation can cause a false impression of an infectious process.

  1. The method of manufacture of nylon dental partially removable prosthesis using additive technologies

    NASA Astrophysics Data System (ADS)

    Kashapov, R. N.; Korobkina, A. I.; Platonov, E. V.; Saleeva, G. T.

    2014-12-01

    The article is devoted to the topic of creating new methods of dental prosthesis. The aim of this work is to investigate the possibility of using additive technology to create nylon prosthesis. As a result of experimental studies, was made a sample of nylon partially removable prosthesis using 3D printing has allowed to simplify, accelerate and reduce the coat of manufacturing high-precision nylon dentures.

  2. Magnetic resonance imaging compatibility test of a cranial prosthesis with titanium screws

    NASA Astrophysics Data System (ADS)

    Jimenez, R.; Benavides, A.; Flores, D.; Hidalgo, S. S.; Solis, S. E.; Uribe, E.; Rodriguez, A. O.

    2012-10-01

    The follow-up of patients with skull prosthesis is necessary to provide adequate medical care. Skull prostheses for cranioplasty have been developed at the Faculty of Odontology of Universidad Nacional Autonoma de Mexico. We built a skull prosthesis phantom and tested for compatibility with standard magnetic resonance imaging procedures. Results showed full compatibility but susceptibility artefacts occurred due to titanium used to fix the prosthesis to the skull.

  3. A cognitive prosthesis for complex decision-making.

    PubMed

    Tremblay, Sébastien; Gagnon, Jean-François; Lafond, Daniel; Hodgetts, Helen M; Doiron, Maxime; Jeuniaux, Patrick P J M H

    2017-01-01

    While simple heuristics can be ecologically rational and effective in naturalistic decision making contexts, complex situations require analytical decision making strategies, hypothesis-testing and learning. Sub-optimal decision strategies - using simplified as opposed to analytic decision rules - have been reported in domains such as healthcare, military operational planning, and government policy making. We investigate the potential of a computational toolkit called "IMAGE" to improve decision-making by developing structural knowledge and increasing understanding of complex situations. IMAGE is tested within the context of a complex military convoy management task through (a) interactive simulations, and (b) visualization and knowledge representation capabilities. We assess the usefulness of two versions of IMAGE (desktop and immersive) compared to a baseline. Results suggest that the prosthesis helped analysts in making better decisions, but failed to increase their structural knowledge about the situation once the cognitive prosthesis is removed.

  4. A cognitive prosthesis for complex decision-making.

    PubMed

    Tremblay, Sébastien; Gagnon, Jean-François; Lafond, Daniel; Hodgetts, Helen M; Doiron, Maxime; Jeuniaux, Patrick P J M H

    2017-01-01

    While simple heuristics can be ecologically rational and effective in naturalistic decision making contexts, complex situations require analytical decision making strategies, hypothesis-testing and learning. Sub-optimal decision strategies - using simplified as opposed to analytic decision rules - have been reported in domains such as healthcare, military operational planning, and government policy making. We investigate the potential of a computational toolkit called "IMAGE" to improve decision-making by developing structural knowledge and increasing understanding of complex situations. IMAGE is tested within the context of a complex military convoy management task through (a) interactive simulations, and (b) visualization and knowledge representation capabilities. We assess the usefulness of two versions of IMAGE (desktop and immersive) compared to a baseline. Results suggest that the prosthesis helped analysts in making better decisions, but failed to increase their structural knowledge about the situation once the cognitive prosthesis is removed. PMID:27633232

  5. Research and development of a versatile portable speech prosthesis

    NASA Technical Reports Server (NTRS)

    1981-01-01

    The Versatile Portable Speech Prosthesis (VPSP), a synthetic speech output communication aid for non-speaking people is described. It was intended initially for severely physically limited people with cerebral palsy who are in electric wheelchairs. Hence, it was designed to be placed on a wheelchair and powered from a wheelchair battery. It can easily be separated from the wheelchair. The VPSP is versatile because it is designed to accept any means of single switch, multiple switch, or keyboard control which physically limited people have the ability to use. It is portable because it is mounted on and can go with the electric wheelchair. It is a speech prosthesis, obviously, because it speaks with a synthetic voice for people unable to speak with their own voices. Both hardware and software are described.

  6. Running with a powered knee and ankle prosthesis.

    PubMed

    Shultz, Amanda H; Lawson, Brian E; Goldfarb, Michael

    2015-05-01

    This paper presents a running control architecture for a powered knee and ankle prosthesis that enables a transfemoral amputee to run with a biomechanically appropriate running gait and to intentionally transition between a walking and running gait. The control architecture consists firstly of a coordination level controller, which provides gait biomechanics representative of healthy running, and secondly of a gait selection controller that enables the user to intentionally transition between a running and walking gait. The running control architecture was implemented on a transfemoral prosthesis with powered knee and ankle joints, and the efficacy of the controller was assessed in a series of running trials with a transfemoral amputee subject. Specifically, treadmill trials were conducted to assess the extent to which the coordination controller provided a biomechanically appropriate running gait. Separate trials were conducted to assess the ability of the user to consistently and reliably transition between walking and running gaits.

  7. The Scarless Latissimus Dorsi Flap Provides Effective Lower Pole Prosthetic Coverage in Breast Reconstruction

    PubMed Central

    Miteff, Kirstin G.

    2014-01-01

    Background: The evolution of surgical breast cancer treatment has led to the oncologically safe preservation of greater amounts of native skin, yet we are still often using flaps with large skin paddles, thereby resulting in significant donor-site scars. This explains the increasing appeal of acellular dermal matrix reconstructions. Acellular dermal matrices can, however, have significant problems, particularly if there is any vascular compromise of the mastectomy skin flaps. We have developed a method of raising the latissimus dorsi flap through the anterior mastectomy incisions without requiring special instruments or repositioning. This can provide autologous vascularized cover of the prosthesis. Methods: A clear surgical description of the scarless latissimus dorsi flap harvest is provided, and our results of a retrospective cohort review of 20 consecutive patients with 27 traditional latissimus dorsi breast reconstructions were compared with those of 20 consecutive patients with 30 scarless latissimus dorsi breast reconstructions. Results: Operative time, length of stay, and complication rates were reduced in the scarless group. Patients Breast-Q scores were equivalent in each group. The aesthetic assessment was good/excellent in 77% of both groups; however, subscale assessment was better in the scarless group. This was statistically significant (P = 0.0). Conclusions: Breast reconstruction using the scarless latissimus dorsi flap is time effective, requires no patient repositioning, and uses standard breast instrumentation. It is safe and versatile while reducing the risk of exposed prosthesis if native skin necrosis occurs. It is a vascularized alternative to acellular dermal matrices. PMID:25289340

  8. Penile enhancement procedures with simultaneous penile prosthesis placement.

    PubMed

    Hakky, Tariq S; Suber, Jessica; Henry, Gerard; Smith, David; Bradley, Paul; Martinez, Daniel; Carrion, Rafael E

    2012-01-01

    Here we present an overview of various techniques performed concomitantly during penile prosthesis surgery to enhance penile length and girth. We report on the technique of ventral phalloplasty and its outcomes along with augmentation corporoplasty, suprapubic lipectomy, suspensory ligament release, and girth enhancement procedures. For the serious implanter, outcomes can be improved by combining the use of techniques for each scar incision. These adjuvant procedures are a key addition in the armamentarium for the serious implant surgeon. PMID:22811703

  9. 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.

  10. Moulded cement-prosthesis for osteosarcoma of the proximal humerus.

    PubMed

    Pan, K L; Ong, G B; Potukuchi, A P

    2006-12-01

    We report a case of an 11-year-old boy with osteosarcoma of the proximal humerus treated with wide excision and reconstruction with a cement spacer-prosthesis. After seven years of follow-up, the patient is now almost a young adult. We present his current physical and functional status, which seems to defray the initial doubts regarding long-term problems when we chose this method of reconstruction. PMID:17600994

  11. Viscous Flow Structures Downstream of a Model Tracheoesophageal Prosthesis

    NASA Astrophysics Data System (ADS)

    Hemsing, Frank; Erath, Byron

    2013-11-01

    In tracheoesophageal speech (TES), the glottis is replaced by the tissue of the pharyngeoesophageal segment (PES) as the vibrating element of speech production. During TES air is forced from the lungs into the esophagus via a prosthetic tube that connects the trachea with the esophagus. Air moving up the esophagus incites self-sustained oscillations of the surgically created PES, generating sound analogous to voiced speech. Despite the ubiquity with which TES is employed as a method for restoring speech to laryngectomees, the effect of viscous flow structures on voice production in TES is not well understood. Of particular interest is the flow exiting the prosthetic connection between the trachea and esophagus, because of its influence on the total pressure loss (i.e. effort required to produce speech), and the fluid-structure energy exchange that drives the PES. Understanding this flow behavior can inform prosthesis design to enhance beneficial flow structures and mitigate the need for adjustment of prosthesis placement. This study employs a physical model of the tracheoesophageal geometry to investigate the flow structures that arise in TES. The geometry of this region is modeled at three times physiological scale using water as the working fluid to obtain nondimensional numbers matching flow in TES. Modulation of the flow is achieved with a computer controlled gate valve at a scaled frequency of 0.22 Hz to mimic the oscillations of the PES. Particle image velocimetry is used to resolve flow characteristics at the tracheoesophageal prosthesis. Data are acquired for three cases of prosthesis insertion angle.

  12. A Simplified Method to Fabricate a Pneumatic Ocular Prosthesis for Large Ocular Defects.

    PubMed

    Aggarwal, Himanshi; Kumar, Pradeep; Singh, Raghuwar Dayal

    2014-12-01

    When an enucleation or exenteration procedure removes the entire orbital contents but not the eyelids, an abnormally large orbital socket is created that would require an equally sized volume enhancing, flush fitting ocular prosthesis. The solid acrylic prosthesis would rest on or in the lower fornix and owing to its weight, causes distortion of the lower eyelid and/or asymmetrical alignment of the entire palpebral fissure. The aim of this article was to describe a method of fabricating a pneumatic light weight custom ocular prosthesis using lost wax technique to overcome the deteriorating effects of conventional solid ocular prosthesis. PMID:26199499

  13. Management of an Anophthalmic Patient by the Fabrication of Custom Made Ocular Prosthesis

    PubMed Central

    SINGH, Meenakshi; NAYAK, Meghanand; SOLANKI, Jitender; GUPTA, Sarika; SINGH, Anjali

    2015-01-01

    The loss or disfigurement of a body parts specially that pertaining to the face has a deep psychological and social impact on the patient. After enucleation, evisceration or exteneration of the eye, the aim of an ocular prosthesis should be to restore the natural appearance, install confidence and a sense social acceptability in the patient. Custom made prosthesis has several advantages over the stock eye prosthesis. This article illustrates rehabilitation of the enucleated right eye of a patient with a custom made ocular prosthesis. PMID:26715901

  14. Ocular prosthetics: use of a tissue conditioner material to modify a stock ocular prosthesis.

    PubMed

    Ow, R K; Amrith, S

    1997-08-01

    The custom-made ocular prosthesis contributes to enhanced tissue health of the anophthalmic socket. For this purpose, an acrylic resin ocular prosthesis may be modified, by using an appropriate dental impression material and being adapted closely to the anophthalmic socket. The modeling impression material is subsequently replaced by acrylic resin. This article describes the application of a viscoelastic tissue conditioner material, as an impression medium for prosthetic modification of an ocular prosthesis. The tissue conditioner material exhibits favorable tissue compatibility, adhesion to acrylic resin, and detailed surface registration. These advantages facilitate the clinical procedure and evaluation of modifications made to the ocular prosthesis.

  15. Breast Feeding.

    ERIC Educational Resources Information Center

    International Children's Centre, Paris (France).

    This set of documents consists of English, French, and Spanish translations of four pamphlets on breast-feeding. The pamphlets provide information designed for lay persons, academics and professionals, health personnel and educators, and policy-makers. The contents cover health-related differences between breast and bottle milk; patterns of…

  16. A cortical neural prosthesis for restoring and enhancing memory

    NASA Astrophysics Data System (ADS)

    Berger, Theodore W.; Hampson, Robert E.; Song, Dong; Goonawardena, Anushka; Marmarelis, Vasilis Z.; Deadwyler, Sam A.

    2011-08-01

    A primary objective in developing a neural prosthesis is to replace neural circuitry in the brain that no longer functions appropriately. Such a goal requires artificial reconstruction of neuron-to-neuron connections in a way that can be recognized by the remaining normal circuitry, and that promotes appropriate interaction. In this study, the application of a specially designed neural prosthesis using a multi-input/multi-output (MIMO) nonlinear model is demonstrated by using trains of electrical stimulation pulses to substitute for MIMO model derived ensemble firing patterns. Ensembles of CA3 and CA1 hippocampal neurons, recorded from rats performing a delayed-nonmatch-to-sample (DNMS) memory task, exhibited successful encoding of trial-specific sample lever information in the form of different spatiotemporal firing patterns. MIMO patterns, identified online and in real-time, were employed within a closed-loop behavioral paradigm. Results showed that the model was able to predict successful performance on the same trial. Also, MIMO model-derived patterns, delivered as electrical stimulation to the same electrodes, improved performance under normal testing conditions and, more importantly, were capable of recovering performance when delivered to animals with ensemble hippocampal activity compromised by pharmacologic blockade of synaptic transmission. These integrated experimental-modeling studies show for the first time that, with sufficient information about the neural coding of memories, a neural prosthesis capable of real-time diagnosis and manipulation of the encoding process can restore and even enhance cognitive, mnemonic processes.

  17. [Joint prosthesis infection with Staphyococcus lugdunensis: 7 cases].

    PubMed

    Lecuire, F; Gontier, D; Carrere, J; Basso, M; Benareau, I; Rubini, J

    2007-02-01

    Staphylococcus lugdunensis was described in Lyon in 1988. This coagulase-negative staphylococcus is the cause of diverse infections which are often severe, particularly in the field cardiology where numerous publications are available for reference. The severity of S. lugdunensis infection is related to specific virulence factors associated with significant adherence properties despite good sensitivity to antibiotics. Publications dealing with joint prosthesis infections are sparse and the reports available have noted failure of treatment unless the prosthesis is removed. S. lugdunensis can easily be identified with an Api Id 32 Staph battery from BioMerieux. We analyzed seven cases of joint prosthesis infections with S. lugdunensis observed between 1991 and 2005. Four chronic infections were managed using the classical schema of implant removal then reimplantation, using a two-stage procedure for three and a single stage for one. Combined with adequate antibiotic treatment, this method was successful in all four cases. We did however have three cases of failure (two were secondary to a probable hematogenic infection and the other an early postoperative infection); these cases were operated on by early lavage and antibiotic therapy without success. PMID:17389830

  18. Prosthesis-free solution for below-knee amputations.

    PubMed

    Lal, Hitesh; Sharma, Deepak Kumar; Mittal, Deepak

    2012-05-01

    The Ilizarov fixator can be used as a bone regenerator to correct limb-length discrepancies in patients who require limb lengthening.A 17-year-old man presented with 12 cm of left lower-limb shortening and amputation at the left mid-forefoot region, which was the result of severe burns of the left lower limb at 2 years of age. The burns damaged the distal femoral, proximal, and distal tibial physes. Scarring around knee and leg acted as a bowstring and slowed normal longitudinal femoral and tibial bone growth. The patient wished to be prosthesis free. Limb lengthening was performed with the Ilizarov fixator. The patient became prosthesis free and was able to perform activities of daily living wearing normal footwear, which was possible because the patient had a good heel pad. The patient can walk on a normal limb with no prosthesis, the significant advantage being the right proprioceptive feedback it gives the patient during ambulation because it is sensate.This technique can be used in other patients with below-knee amputations in which the tibial amputated end can be given a myoplasty cover or padding nearly as good as a heel. Subsequently, tibiae can be lengthened, and patients can be made to bear weight on artificial heels. PMID:22588425

  19. Literature Review on Needs of Upper Limb Prosthesis Users

    PubMed Central

    Cordella, Francesca; Ciancio, Anna Lisa; Sacchetti, Rinaldo; Davalli, Angelo; Cutti, Andrea Giovanni; Guglielmelli, Eugenio; Zollo, Loredana

    2016-01-01

    The loss of one hand can significantly affect the level of autonomy and the capability of performing daily living, working and social activities. The current prosthetic solutions contribute in a poor way to overcome these problems due to limitations in the interfaces adopted for controlling the prosthesis and to the lack of force or tactile feedback, thus limiting hand grasp capabilities. This paper presents a literature review on needs analysis of upper limb prosthesis users, and points out the main critical aspects of the current prosthetic solutions, in terms of users satisfaction and activities of daily living they would like to perform with the prosthetic device. The ultimate goal is to provide design inputs in the prosthetic field and, contemporary, increase user satisfaction rates and reduce device abandonment. A list of requirements for upper limb prostheses is proposed, grounded on the performed analysis on user needs. It wants to (i) provide guidelines for improving the level of acceptability and usefulness of the prosthesis, by accounting for hand functional and technical aspects; (ii) propose a control architecture of PNS-based prosthetic systems able to satisfy the analyzed user wishes; (iii) provide hints for improving the quality of the methods (e.g., questionnaires) adopted for understanding the user satisfaction with their prostheses. PMID:27242413

  20. Visual prosthesis wireless energy transfer system optimal modeling

    PubMed Central

    2014-01-01

    Background Wireless energy transfer system is an effective way to solve the visual prosthesis energy supply problems, theoretical modeling of the system is the prerequisite to do optimal energy transfer system design. Methods On the basis of the ideal model of the wireless energy transfer system, according to visual prosthesis application condition, the system modeling is optimized. During the optimal modeling, taking planar spiral coils as the coupling devices between energy transmitter and receiver, the effect of the parasitic capacitance of the transfer coil is considered, and especially the concept of biological capacitance is proposed to consider the influence of biological tissue on the energy transfer efficiency, resulting in the optimal modeling’s more accuracy for the actual application. Results The simulation data of the optimal model in this paper is compared with that of the previous ideal model, the results show that under high frequency condition, the parasitic capacitance of inductance and biological capacitance considered in the optimal model could have great impact on the wireless energy transfer system. The further comparison with the experimental data verifies the validity and accuracy of the optimal model proposed in this paper. Conclusions The optimal model proposed in this paper has a higher theoretical guiding significance for the wireless energy transfer system’s further research, and provide a more precise model reference for solving the power supply problem in visual prosthesis clinical application. PMID:24428906

  1. Literature Review on Needs of Upper Limb Prosthesis Users.

    PubMed

    Cordella, Francesca; Ciancio, Anna Lisa; Sacchetti, Rinaldo; Davalli, Angelo; Cutti, Andrea Giovanni; Guglielmelli, Eugenio; Zollo, Loredana

    2016-01-01

    The loss of one hand can significantly affect the level of autonomy and the capability of performing daily living, working and social activities. The current prosthetic solutions contribute in a poor way to overcome these problems due to limitations in the interfaces adopted for controlling the prosthesis and to the lack of force or tactile feedback, thus limiting hand grasp capabilities. This paper presents a literature review on needs analysis of upper limb prosthesis users, and points out the main critical aspects of the current prosthetic solutions, in terms of users satisfaction and activities of daily living they would like to perform with the prosthetic device. The ultimate goal is to provide design inputs in the prosthetic field and, contemporary, increase user satisfaction rates and reduce device abandonment. A list of requirements for upper limb prostheses is proposed, grounded on the performed analysis on user needs. It wants to (i) provide guidelines for improving the level of acceptability and usefulness of the prosthesis, by accounting for hand functional and technical aspects; (ii) propose a control architecture of PNS-based prosthetic systems able to satisfy the analyzed user wishes; (iii) provide hints for improving the quality of the methods (e.g., questionnaires) adopted for understanding the user satisfaction with their prostheses. PMID:27242413

  2. [Infection in Joint Prosthesis. When Should it Be Suspected?].

    PubMed

    Luis Marenco, José; Corzo, Juan

    2008-10-01

    Joint prosthesis constitute one of the major advances of medicine in the treatment of patients with osteoarticular disease. Infections of prosthetic material, though having a low frequency (1%-3% according to the series and type of prosthesis) constitute one of the larger complications of this surgery and a diagnostic challenge for the physician. The concept of prosthesis infection includes colonization due to germs in periprosthetic material that also leads to clinical manifestations. There are diverse classifications of the prosthetic infections, most of which are based in the form of clinical presentation which largely depends on the germ which is responsible for the infection. In this sense, late forms are generally caused by poorly virulent germs (plasma coagulase negative staphilococcus is the most frequent) and are the most difficult to diagnose. Diagnostic suspicion must be established in relation to the clinical manifestations and a series of accompanying clinical signs. In this sense, in the abscense of baseline inflammatory rheumatism, the persistent elevation of CRP (which normalizes 1-2 weeks after the surgery), or the presence of inflammatory joint fluid (with cell counts over 1700 cells/μL and especially with a predominance of PMN>68%) are signs that strenghten the diagnostic suspicion of bacterial infection. The definitive diagnosis is established by the isolation of the causal germ in culture and, in this sense, the biopsy of periprosthetic material and its study by the pathology department as well as its culture, allow for a trustworthy diagnosis in 80%-90% of cases.

  3. A cortical neural prosthesis for restoring and enhancing memory.

    PubMed

    Berger, Theodore W; Hampson, Robert E; Song, Dong; Goonawardena, Anushka; Marmarelis, Vasilis Z; Deadwyler, Sam A

    2011-08-01

    A primary objective in developing a neural prosthesis is to replace neural circuitry in the brain that no longer functions appropriately. Such a goal requires artificial reconstruction of neuron-to-neuron connections in a way that can be recognized by the remaining normal circuitry, and that promotes appropriate interaction. In this study, the application of a specially designed neural prosthesis using a multi-input/multi-output (MIMO) nonlinear model is demonstrated by using trains of electrical stimulation pulses to substitute for MIMO model derived ensemble firing patterns. Ensembles of CA3 and CA1 hippocampal neurons, recorded from rats performing a delayed-nonmatch-to-sample (DNMS) memory task, exhibited successful encoding of trial-specific sample lever information in the form of different spatiotemporal firing patterns. MIMO patterns, identified online and in real-time, were employed within a closed-loop behavioral paradigm. Results showed that the model was able to predict successful performance on the same trial. Also, MIMO model-derived patterns, delivered as electrical stimulation to the same electrodes, improved performance under normal testing conditions and, more importantly, were capable of recovering performance when delivered to animals with ensemble hippocampal activity compromised by pharmacologic blockade of synaptic transmission. These integrated experimental-modeling studies show for the first time that, with sufficient information about the neural coding of memories, a neural prosthesis capable of real-time diagnosis and manipulation of the encoding process can restore and even enhance cognitive, mnemonic processes. PMID:21677369

  4. TOTAL ANKLE ARTHROPLASTY: BRAZILIAN EXPERIENCE WITH THE HINTEGRA PROSTHESIS.

    PubMed

    Nery, Caio; Fernandes, Túlio Diniz; Réssio, Cibele; Fuchs, Mauro Luiz; Godoy Santos, Alexandre Leme de; Ortiz, Rafael Trevisan

    2010-01-01

    Ankle arthrosis is becoming more and more common. The search for solutions that preserve joint function has led to a new generation of prosthesis with three components and more degrees of freedom. This paper presents the results achieved for ten patients treated with the HINTEGRA Prosthesis (Integra, New Deal), through collaborative action between the Foot and Ankle Groups of the Orthopedics and Traumatology divisions of Escola Paulista de Medicina, Unifesp, and the School of Medicine of the University of São Paulo (USP). The ten patients (six women and four men, aged between 29 and 66 years), underwent a surgical procedure consisting of Hintermann's technique, between January and June 2005. They were evaluated at prearranged intervals, and the data were subjected to statistical analysis. The surgery led to a significant improvement in ankle mobility. Radiological evaluation showed no signs of loosening or failure in the prosthetic components in any of the patients studied. Although the complication rate in our sample was high, it was equivalent to the rates found by other authors, and directly represents the learning curve associate with this kind of procedure. Four years after the procedure, it was found that the patients pain levels had significantly decreased, and that their functional patterns had significantly improved, with AOFAS and Hintermann scores indicating results that were excellent for 20%, good for 70% and poor for 10%. Treatment of ankle arthritis by means of total arthroplasty using the HINTEGRA prosthesis was capable of providing good results over an average observation period of four years.

  5. PIP breast implants: rupture rate and correlation with breast cancer

    PubMed Central

    MOSCHETTA, M.; TELEGRAFO, M.; CORNACCHIA, I.; VINCENTI, L.; RANIERI, V.; CIRILLI, A.; RELLA, L.; IANORA, A.A. STABILE; ANGELELLI, G.

    2014-01-01

    Aim To evaluate the incidence of Poly Implant Prosthése (PIP) rupture as assessed by magnetic resonance imaging (MRI), the prevalence of the detected signs and the potential correlation with breast carcinoma. Patients and methods 67 patients with silicone breast implants and clinical indications for breast MRI were evaluated for a total of 125 implants: 40 (32%) PIP in 21 patients and 85 non-PIP in 46 patients (68%), the latest considered as control group. A 1.5-T MR imaging device was used in order to assess implant integrity with dedicated sequences and in 6 cases a dynamic study was performed for characterizing breast lesions. Two radiologists with more than 5 years’ experience in the field of MRI evaluated in consensus all MR images searching for the presence of clear signs of intra or extra-capsular implant rupture. Results 20/40 (50%) PIP implants presented signs of intra-capsular rupture: linguine sign in 20 cases (100%), tear-drop sign in 6 (30%). In 12/20 cases (60%), MRI signs of extra-capsular rupture were detected. In the control group, an intra-capsular rupture was diagnosed in 12/85 cases (14%) associated with extra-capsular one in 5/12 cases (42%). Among the six cases with suspected breast lesions, in 2/21 patients with PIP implants (10%) a breast carcinoma was diagnosed (mucinous carcinoma, n=1; invasive ductal carcinoma, n=1). In 4/46 patients (9%) with non-PIP implants, an invasive ductal carcinoma was diagnosed. Conclusion The rupture rate of PIP breast implants is significantly higher than non-PIP (50% vs 14%). MRI represents the most accurate imaging tool for evaluating breast prostheses and the linguine sign is the most common MRI sign to be searched. The incidence of breast carcinoma does not significantly differ between the PIP and non-PIP implants and a direct correlation with breast cancer can not been demonstrated. PMID:25644728

  6. Utilization of nickel-titanium shape memory alloy for stapes prosthesis.

    PubMed

    Kasano, F; Morimitsu, T

    1997-04-01

    A new type of stapes prosthesis made of nickel-titanium shape memory alloy wire was developed and its biocompatibility was examined in 24 ears of 12 cats. The prosthesis was implanted at the long crus of the incus. The incus was examined 27-355 days after operation. In 23 ears, the prosthesis was found macroscopically well implanted at the aimed position. In one ear the prosthesis was found to be dislocated and in another the prosthesis was slightly loosened. The incudes were removed and five specimens were prepared for scanning electron microscopy and the other specimens were observed under light microscopy. Histological studies revealed severe bone resorption of the long crus in the dislocated case and moderate bone resorption in the slightly loosened case. These bone resorptions were found to be caused by the inadvertent removal of the mucosal membrane during the implant operations. In seven ears under a light microscope and in one ear under a scanning electron microscope, slight bone resorption as bone erosion was seen at the contact area of the prosthesis. This bone resorption was induced by the mechanical pressure of the prosthesis and was not progressive due to fading of the pressure of the prosthesis. With the exception of pressure induced bone erosions, there was no progressive bone resorption which was prosthesis induced. The biocompatibility of the nickel-titanium alloy stapes prosthesis with the long crus of the incus was proved. The prosthesis should be implanted loosely at the long crus of the incus without removal of the mucosal membrane. PMID:9134135

  7. Bond strength between acrylic resin and maxillofacial silicone

    PubMed Central

    HADDAD, Marcela Filié; GOIATO, Marcelo Coelho; dos SANTOS, Daniela Micheline; CREPALDI, Nádia de Marchi; PESQUEIRA, Aldiéris Alves; BANNWART, Lisiane Cristina

    2012-01-01

    The development of implant dentistry improved the possibilities of rehabilitation with maxillofacial prosthesis. However, clinically it is difficult to bond the silicone to the attachment system. Objectives This study aimed to evaluate the effect of an adhesive system on the bond strength between acrylic resin and facial silicone. Material and Methods A total of 120 samples were fabricated with auto-polymerized acrylic resin and MDX 4-4210 facial silicone. Both materials were bonded through mechanical retentions and/or application of primers (DC 1205 primer and Sofreliner primer S) and adhesive (Silastic Medical Adhesive Type A) or not (control group). Samples were divided into 12 groups according to the method used to attach the silicone to the acrylic resin. All samples were subjected to a T-peel test in a universal testing machine. Failures were classified as adhesive, cohesive or mixed. The data were evaluated by the analysis of variance (ANOVA) and the Tukey's HSD test (α=.05). Results The highest bond strength values (5.95 N/mm; 3.07 N/mm; 4.75 N/mm) were recorded for the samples that received a Sofreliner primer application. These values were significantly higher when the samples had no scratches and did not receive the application of Silastic Medical Adhesive Type A. Conclusions The most common type of failure was adhesive. The use of Sofreliner primer increased the bond strength between the auto-polymerized acrylic resin and the Silastic MDX 4-4210 facial silicone. PMID:23329247

  8. Porous silicon advances in drug delivery and immunotherapy

    PubMed Central

    Savage, D; Liu, X; Curley, S; Ferrari, M; Serda, RE

    2013-01-01

    Biomedical applications of porous silicon include drug delivery, imaging, diagnostics and immunotherapy. This review summarizes new silicon particle fabrication techniques, dynamics of cellular transport, advances in the multistage vector approach to drug delivery, and the use of porous silicon as immune adjuvants. Recent findings support superior therapeutic efficacy of the multistage vector approach over single particle drug delivery systems in mouse models of ovarian and breast cancer. With respect to vaccine development, multivalent presentation of pathogen-associated molecular patterns on the particle surface creates powerful platforms for immunotherapy, with the porous matrix able to carry both antigens and immune modulators. PMID:23845260

  9. Silicon Detectors

    NASA Astrophysics Data System (ADS)

    Sadrozinski, Hartmut

    2014-03-01

    The use of silicon detectors has experienced an exponential growth in accelerator and space based experiments, similar to trends in the semiconductor industry as a whole, usually paraphrased as ``Moore's Law.'' Some of the essentials for this phenomenon will be presented, together with examples of the exciting science results which it enabled. With the establishment of a ``semiconductor culture'' in universities and laboratories around the world, an increased understanding of the sensors results in thinner, faster, more radiation-resistant detectors, spawning an amazing wealth of new technologies and applications, which will be the main subject of the presentation.

  10. A Fixed Telescopic Prosthesis Designed to Retrieve and Convert to Fixed-Removable Combination Case: A Clinical Report.

    PubMed

    Zoidis, Panagiotis; Panagiota, Spyropoulou; Polyzois, Gregory

    2015-06-01

    This clinical report describes a fixed maxillary telescopic dental prosthesis (FTDP) employing milled base metal copings and a metal superstructure veneered with composite resin, for the restoration in a periodontally compromised patient with uncontrolled diabetes. The telescopic prosthesis framework design incorporated occlusal rest seats in key positions along the arch in case of future posterior tooth loss, in order to be converted to fixed - removable combination prosthesis. The mandible was restored with a conventional fixed ceramo-metal dental prosthesis.

  11. A Fixed Telescopic Prosthesis Designed to Retrieve and Convert to Fixed-Removable Combination Case: A Clinical Report

    PubMed Central

    Panagiota, Spyropoulou; Polyzois, Gregory

    2015-01-01

    This clinical report describes a fixed maxillary telescopic dental prosthesis (FTDP) employing milled base metal copings and a metal superstructure veneered with composite resin, for the restoration in a periodontally compromised patient with uncontrolled diabetes. The telescopic prosthesis framework design incorporated occlusal rest seats in key positions along the arch in case of future posterior tooth loss, in order to be converted to fixed - removable combination prosthesis. The mandible was restored with a conventional fixed ceramo-metal dental prosthesis.

  12. Breast Cancer Overview

    MedlinePlus

    ... Breast Cancer - Overview Request Permissions Print to PDF Breast Cancer - Overview Approved by the Cancer.Net Editorial Board , ... bean-shaped organs that help fight infection. About breast cancer Cancer begins when healthy cells in the breast ...

  13. Surgery for Breast Cancer

    MedlinePlus

    ... Next Topic Breast-conserving surgery (lumpectomy) Surgery for breast cancer Most women with breast cancer have some type ... Relieve symptoms of advanced cancer Surgery to remove breast cancer There are two main types of surgery to ...

  14. Learning about Breast Cancer

    MedlinePlus

    ... genetic terms used on this page Learning About Breast Cancer What do we know about heredity and breast ... Cancer What do we know about heredity and breast cancer? Breast cancer is a common disease. Each year, ...

  15. Fibrocystic breast disease

    MedlinePlus

    Fibrocystic breast disease; Mammary dysplasia; Diffuse cystic mastopathy; Benign breast disease; Glandular breast changes ... FF, Fort GG, et al, eds. Fibrocystic breast disease. In: Ferri FF, ed. Ferri's Clinical Advisor 2015 . ...

  16. Premenstrual breast changes

    MedlinePlus

    Premenstrual tenderness and swelling of the breasts; Breast tenderness - premenstrual; Breast swelling - premenstrual ... Symptoms of premenstrual breast tenderness may range from mild to ... most severe just before each menstrual period Improve during ...

  17. Breast enlargement in males

    MedlinePlus

    Gynecomastia; Breast enlargement in a male ... The condition may occur in one or both breasts. It begins as a small lump beneath the nipple, which may be tender. One breast may be larger than the other. Enlarged breasts ...

  18. 21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Shoulder joint metal/polymer semi-constrained... Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  19. 21 CFR 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Shoulder joint metal/polymer non-constrained... Shoulder joint metal/polymer non-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace...

  20. 21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint patellofemorotibial metal/polymer... Devices § 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. (a) Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a...

  1. 21 CFR 888.3800 - Wrist joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist...

  2. 21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer...

  3. 21 CFR 888.3810 - Wrist joint ulnar (hemi-wrist) polymer prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint ulnar (hemi-wrist) polymer prosthesis. 888.3810 Section 888.3810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-wrist) polymer prosthesis. (a) Identification. A wrist joint ulnar (hemi-wrist) polymer...

  4. 21 CFR 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Elbow joint radial (hemi-elbow) polymer prosthesis. 888.3170 Section 888.3170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-elbow) polymer prosthesis. (a) Identification. An elbow joint radial (hemi-elbow)...

  5. 21 CFR 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Shoulder joint metal/polymer non-constrained... Shoulder joint metal/polymer non-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace...

  6. 21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shoulder joint metal/polymer semi-constrained... Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  7. 21 CFR 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Elbow joint radial (hemi-elbow) polymer prosthesis. 888.3170 Section 888.3170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-elbow) polymer prosthesis. (a) Identification. An elbow joint radial (hemi-elbow)...

  8. 21 CFR 888.3550 - Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint patellofemorotibial polymer/metal/metal... § 888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis. (a) Identification. A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a...

  9. 21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint femorotibial metal/polymer semi... § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device...

  10. 21 CFR 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Elbow joint radial (hemi-elbow) polymer prosthesis. 888.3170 Section 888.3170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-elbow) polymer prosthesis. (a) Identification. An elbow joint radial (hemi-elbow)...

  11. 21 CFR 888.3110 - Ankle joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ankle joint metal/polymer semi-constrained... Ankle joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an...

  12. 21 CFR 888.3810 - Wrist joint ulnar (hemi-wrist) polymer prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint ulnar (hemi-wrist) polymer prosthesis. 888.3810 Section 888.3810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-wrist) polymer prosthesis. (a) Identification. A wrist joint ulnar (hemi-wrist) polymer...

  13. 21 CFR 888.3110 - Ankle joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ankle joint metal/polymer semi-constrained... Ankle joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an...

  14. 21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint patellofemorotibial metal/polymer... Devices § 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. (a) Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a...

  15. 21 CFR 888.3160 - Elbow joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Elbow joint metal/polymer semi-constrained... Elbow joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an...

  16. 21 CFR 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shoulder joint metal/polymer non-constrained... Shoulder joint metal/polymer non-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace...

  17. 21 CFR 888.3520 - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint femorotibial metal/polymer non... § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended...

  18. 21 CFR 888.3160 - Elbow joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Elbow joint metal/polymer semi-constrained... Elbow joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an...

  19. 21 CFR 888.3110 - Ankle joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ankle joint metal/polymer semi-constrained... Ankle joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an...

  20. 21 CFR 888.3510 - Knee joint femorotibial metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint femorotibial metal/polymer constrained... Knee joint femorotibial metal/polymer constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace...

  1. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Elbow joint metal/polymer constrained cemented prosthesis. 888.3150 Section 888.3150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer constrained cemented prosthesis. (a) Identification. An elbow joint...

  2. 21 CFR 888.3520 - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint femorotibial metal/polymer non... § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended...

  3. 21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint patellofemoral polymer/metal semi... § 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. (a) Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a...

  4. 21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint patellofemorotibial metal/polymer... Devices § 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. (a) Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a...

  5. 21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Shoulder joint metal/polymer semi-constrained... Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  6. 21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in...

  7. 21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in...

  8. 21 CFR 888.3800 - Wrist joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist...

  9. 21 CFR 888.3510 - Knee joint femorotibial metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint femorotibial metal/polymer constrained... Knee joint femorotibial metal/polymer constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace...

  10. 21 CFR 888.3520 - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint femorotibial metal/polymer non... § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended...

  11. 21 CFR 888.3510 - Knee joint femorotibial metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint femorotibial metal/polymer constrained... Knee joint femorotibial metal/polymer constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace...

  12. 21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint femorotibial metal/polymer semi... § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device...

  13. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Elbow joint metal/polymer constrained cemented prosthesis. 888.3150 Section 888.3150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer constrained cemented prosthesis. (a) Identification. An elbow joint...

  14. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Elbow joint metal/polymer constrained cemented prosthesis. 888.3150 Section 888.3150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer constrained cemented prosthesis. (a) Identification. An elbow joint...

  15. 21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in...

  16. 21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint patellofemoral polymer/metal semi... § 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. (a) Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a...

  17. 21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer...

  18. 21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non... December 26, 1996 for any ankle joint metal/polymer non-constrained cemented prosthesis that was...

  19. 21 CFR 888.3810 - Wrist joint ulnar (hemi-wrist) polymer prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint ulnar (hemi-wrist) polymer prosthesis. 888.3810 Section 888.3810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-wrist) polymer prosthesis. (a) Identification. A wrist joint ulnar (hemi-wrist) polymer...

  20. 21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint patellofemoral polymer/metal semi... § 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. (a) Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a...

  1. 21 CFR 888.3800 - Wrist joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist...

  2. 21 CFR 888.3550 - Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint patellofemorotibial polymer/metal/metal... § 888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis. (a) Identification. A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a...

  3. 21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer...

  4. 21 CFR 888.3550 - Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint patellofemorotibial polymer/metal/metal... § 888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis. (a) Identification. A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a...

  5. 21 CFR 888.3160 - Elbow joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Elbow joint metal/polymer semi-constrained... Elbow joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an...

  6. 21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non... December 26, 1996 for any ankle joint metal/polymer non-constrained cemented prosthesis that was...

  7. 21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint femorotibial metal/polymer semi... § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device...

  8. 21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non... December 26, 1996 for any ankle joint metal/polymer non-constrained cemented prosthesis that was...

  9. 21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Hip joint femoral (hemi-hip) metallic cemented or... Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. (a) Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be...

  10. 21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Hip joint femoral (hemi-hip) metallic cemented or... Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. (a) Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be...

  11. 21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Hip joint femoral (hemi-hip) metallic cemented or... Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. (a) Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be...

  12. 21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint femoral (hemi-hip) metallic cemented or... Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. (a) Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be...

  13. 21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hip joint femoral (hemi-hip) metallic cemented or... Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. (a) Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be...

  14. 21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint femorotibial metal/composite semi... § 888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a...

  15. 21 CFR 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint tibial (hemi-knee) metallic resurfacing... Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis. (a) Identification. A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be...

  16. 21 CFR 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint femorotibial metal/composite non... § 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite non-constrained cemented prosthesis is a...

  17. 21 CFR 888.3580 - Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint patellar (hemi-knee) metallic... § 888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis. (a) Identification. A knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis is a device made...

  18. 21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint femorotibial metal/composite semi... § 888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a...

  19. 21 CFR 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint tibial (hemi-knee) metallic resurfacing... Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis. (a) Identification. A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be...

  20. 21 CFR 888.3580 - Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint patellar (hemi-knee) metallic... § 888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis. (a) Identification. A knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis is a device made...