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Sample records for acjc prosthesis group

  1. Prosthesis

    MedlinePlus

    ... by prosthetic devices. False teeth are known as dental prostheses. An artificial replacement of the jaw bone is called a maxillofacial prosthesis. Penis implants are also known as penile prostheses.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. [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

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

    PubMed

    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

  10. 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

  11. Thalamic Visual Prosthesis.

    PubMed

    Nguyen, Hieu T; Tangutooru, Siva M; Rountree, Corey M; Kantzos, Andrew J Kantzos; Tarlochan, Faris; Yoon, W Jong; Troy, John B

    2016-08-01

    Glaucoma is a neurological disorder leading to blindness initially through the loss of retinal ganglion cells, followed by loss of neurons higher in the visual system. Some work has been undertaken to develop prostheses for glaucoma patients targeting tissues along the visual pathway, including the lateral geniculate nucleus (LGN) of the thalamus, but especially the visual cortex. This review makes the case for a visual prosthesis that targets the LGN. The compact nature and orderly structure of this nucleus make it a potentially better target to restore vision than the visual cortex. Existing research for the development of a thalamic visual prosthesis will be discussed along with the gaps that need to be addressed before such a technology could be applied clinically, as well as the challenge posed by the loss of LGN neurons as glaucoma progresses. PMID:27214884

  12. Reading Visual Braille with a Retinal Prosthesis

    PubMed Central

    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. PMID:23189036

  13. 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

  14. 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

  15. Biomechanical Analysis of a Novel Prosthesis Based on the Physiological Curvature of Endplate for Cervical Disc Replacement

    PubMed Central

    Yu, Cheng-Cheng; Hao, Ding-Jun; Huang, Da-Geng; Qian, Li-Xiong; Feng, Hang; Li, Hou-Kun; Zhao, Song-Chuan

    2016-01-01

    Study Design Biomechanical analysis of a novel prosthesis based on the physiological curvature of endplate was performed. Objective To compare the biomechanical differences between a novel prosthesis based on the physiological curvature of the endplate and the Prestige LP prosthesis after cervical disc replacement (CDR). Summary of Background Data Artificial disc prostheses have been widely used to preserve the physiological function of treated and adjacent motion segments in CDR, while most of those present a flat surface instead of an arcuate surface which approximately similar to anatomic structures in vivo. We first reported a well-designed artificial disc prosthesis based on the physiological curvature of the endplate. Methods Three motion segments of 24 ovine cervical spines (C2-5) were evaluated in a robotic spine system with axial compressive loads of 50N. Testing conditions were as follows: 1) intact, 2) C3–4 CDR with artificial disc prosthesis based on the physiological curvature of the endplate, and 3) C3–4 CDR with the Prestige LP prosthesis. The range of motion (ROM) and the pressures on the inferior surface of the two prostheses were recorded and analyzed. Results As compared to the intact state, the ROM of all three segments had no significant difference in the replacement group. Additionally, there was no significant difference in ROM between the two prostheses. The mean pressure on the novel prosthesis was significantly less than the Prestige LP prosthesis. Conclusion ROM in 3 groups (intact group, CDR group with novel prosthesis and CDR group with Prestige LP) showed no significant difference. The mean pressure on the inferior surface of the novel prosthesis was significantly lower than the Prestige LP prosthesis. Therefore, the novel artificial disc prosthesis is feasible and effective, and can reduce the implant-bone interface pressure on the endplate, which may be one possible reason of prosthesis subsidence. PMID:27355319

  16. [Design and study of carbon fiber tracheal prosthesis].

    PubMed

    Qi, L; Liu, D; Han, Z; Wang, F

    1998-12-01

    32 healty adult dogs were selected for this experiment. 10 of them were subjected to the tracheal biomechanics test using indices including the relation between stretcher ratio (lambda) and stress (T), the squeeze stress (delta jy) of medical silk thread on trachea, the side stress (Ts) inducing the tracheal collapse, the functional maximum angle (psi max) of tracheal, and the sever area torsion angle (theta max) of tracheal functional maximum curved. According to the indices measured, two types of tracheal prosthesis were designed, and were made of carbon fiber and silicon. They were the straight tube type tracheal prosthesis and the bifurcate type tracheal prosthesis. The straight tube type tracheal prosthesis was studied with a design of two groups comprising a total of 11 dogs. In the experiment group (n = 6), the outer surface of the tube was not coated with silicon, the average survival period was 379.8 days. In the control group (n = 5), the outer surface of the tube was coated with silicon, the average survival period was 90.4 days. The bifurcate type tracheal prosthesis was studied in 11 dogs, the average survival period was 4.32 days. The main causes of death in the experiment were infection and anastomotic dehiscent. PMID:12552773

  17. 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.

  18. 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

  19. Rapid fabrication of a digital prosthesis.

    PubMed

    Rokaya, Dinesh; Amornvit, Pokpong; Shrestha, Binit

    2015-12-01

    Finger prosthesis often needs refabrication due to its discoloration following use. This article presents a novel, economical, and cost-effective technique to duplicate the patient׳s existing prosthesis to obtain a new wax replica, which is then clinically tried and processed to obtain new silicone finger prosthesis. This technique requires comparatively less clinical and laboratory steps as to fabricate an entirely new prosthesis. The newly fabricated silicone finger prosthesis has the fit and marginal adaptation of the patient׳s existing prosthesis but the esthetics is improved. PMID:26684496

  20. 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 ...

  1. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle. (b) Classification. Class...

  2. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle. (b) Classification. Class...

  3. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle. (b) Classification. Class...

  4. 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...

  5. 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...

  6. 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...

  7. Knee joint replacement prosthesis (image)

    MedlinePlus

    A prosthesis is a device designed to replace a missing part of the body, or to make a part of the body work better. The metal prosthetic device in knee joint replacement surgery replaces cartilage and bone which is damaged from disease or aging.

  8. Obturator prosthesis for hemimaxillectomy patients

    PubMed Central

    Singh, Mayank; Bhushan, Akshay; Kumar, Narendra; Chand, Sharad

    2013-01-01

    Rehabilitation of hemimaxillectomy patients can be challenging. The most common problem with prosthetic treatment in such patients is in getting adequate retention, stability, and support. The size and location of the defect usually influences the amount of impairment and difficulty in prosthetic rehabilitation. The obturator prosthesis is commonly used as an effective means for rehabilitating hemimaxillectomy cases. In cases of large maxillary defects, movement of the obturator prosthesis is inevitable and requires a form of indirect retention to limit the rotation of the prosthesis. The goal of prosthodontics is rehabilitation of missing oral and extraoral structures along with restoration of the normal functions of mastication, speech, swallowing, appearance, and so on. Malignancies are common in the oral region, which are treated through surgical intervention. Surgical intervention creates communication between the oral cavity, nasal cavity, and maxillary sinus. In such cases, it is very difficult for the patient to perform various normal functions like mastication, swallowing, speaking, and so on. Prosthodontic rehabilitation with obturator prosthesis restores the missing structures and acts as a barrier between the communication among the various cavities. PMID:24163568

  9. 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…

  10. 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

  11. Magnetically retained silicone facial prosthesis.

    PubMed

    Venugopalan, S; Ariga, P; Aggarwal, P; Viswanath, A

    2014-01-01

    Patients with orocutaneous fistulas suffer from discomfort in terms of facial esthetics, food spill over and lack of psychological confidence to present them socially. Prosthetic camouflaging of facial defects and use of silicone maxillofacial material are the alternatives to the surgical retreatment. Silicone elastomers provide more options to clinician for customization of the facial prosthesis which is simple, esthetically good when coupled with bio magnets for retention. PMID:24553044

  12. 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.

  13. Contact dermatitis from a prosthesis.

    PubMed

    Munoz, Carla A; Gaspari, Anthony; Goldner, Ronald

    2008-01-01

    Patients wearing a prosthesis face a wide variety of medical problems. Skin complications have long been recognized, but their prevalence is still unknown. The most frequently reported disorders are allergic contact dermatitis (ACD), acroangiodermatitis, epidermoid cysts, epidermal hyperplasia, follicular hyperkeratosis, verrucous hyperplasia, bullous diseases, hyperhidrosis, infections, malignancies, and ulcerations. Contact dermatitis represents one-third of the dermatoses in amputees wearing prostheses. All patients who are suspected of having ACD should be patch tested with standard allergen series as well as materials from the patient's own prosthesis, topical medicaments, moisturizers, and cosmetics. We report a patient with an ACD to mixed dialkyl thiourea present in the rubber parts of his below-the-knee prosthesis. Thiourea derivates are used as accelerators in the manufacture of chloroprene rubber and as fixatives in photography and photocopy paper. Allergy to thiourea is relatively uncommon; different studies have shown a prevalence of 0.7% up to 2.4% in patch-tested patients. Thiourea derivates are often the allergic sources in ACD involving high-grade rubber products made of neoprene such as diving suits, protective goggles, knee braces, and continuous positive airway pressure masks. They are also present in the rubber material of prostheses, as in the case of our patient. PMID:18413115

  14. 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

  15. 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

  16. 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 Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification....

  17. 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....

  18. 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....

  19. 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 Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification....

  20. 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....

  1. 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....

  2. 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....

  3. 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....

  4. 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....

  5. 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....

  6. 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....

  7. 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....

  8. 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....

  9. 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....

  10. 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....

  11. 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....

  12. 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....

  13. Semiconstrained distal radioulnar joint prosthesis.

    PubMed

    Savvidou, Christiana; Murphy, Erin; Mailhot, Emilie; Jacob, Shushan; Scheker, Luis R

    2013-02-01

    Distal radioulnar joint (DRUJ) problems can occur as a result of joint instability, abutment, or incongruity. The DRUJ is a weight-bearing joint; the ulnar head is frequently excised either totally or partially, and in some cases it is fused, because of degenerative, rheumatoid, or posttraumatic arthritis. Articles about these procedures report the ability to pronate and supinate, but they rarely discuss grip strength, and even less do they address lifting capacity. We report the long term results of the first 35 patients who underwent total DRUJ arthroplasty with the Aptis DRUJ prosthesis after 5 years follow-up. Surgical indications were all causes of dysfunctional DRUJ (degenerative, posttraumatic, autoimmune, congenital). We recorded data for patient demographics, range of motion (ROM), strength, and lifting capacity of the operated and of the nonoperated extremity. Pain and functional assessments were also recorded. The Aptis DRUJ prosthesis, a bipolar self-stabilizing DRUJ endoprosthesis that restores forearm function, consists of a semiconstained and modular implant designed to replace the function of the ulnar head, the sigmoid notch of the radius, and the triangular fibrocartilage ligaments. The surgical technique is presented in detail. The majority of the patients regained adequate ROM and improved their strength and lifting capacity to the operated side. Pain and activities of daily living were improved. Twelve patients experienced complications, most commonly being extensor carpi ulnaris (ECU) tendinitis, ectopic bone formation, bone resorption with stem loosening, low-grade infection, and need for ball replacement. The Aptis total DRUJ replacement prosthesis is an alternative to salvage procedures that enables a full range of motion as well as the ability to grip and lift weights encountered in daily living activities. PMID:24436788

  14. Prosthesis infection: prevention and treatment.

    PubMed

    de Donato, G; Setacci, F; Galzerano, G; Ruzzi, U; Borrelli, M P; Mazzitelli, G; Setacci, C

    2014-12-01

    Implantation of a vascular prosthesis increases surgical site infection risk by producing a microenvironment conducive to bacterial attachment and biofilm formation, which sustains bacterial colonization and protects encased organisms from host defenses and antimicrobial therapy. Many maneuvers are used in an attempt to reduce infection in arterial reconstructions, but there are no clear guidelines on the most appropriate or effective. As well, there is no good evidence to guide management. A general principle is that indication for removal of the entire infected graft is mandatory when a suture line is involved in the infectious process, an infected anastomotic aneurism and a suture-line hemorrhage is evident, or when a graft-enteric fistula is diagnosed. Conservative, non-resectional management of graft infection is still a respectable solution for selected patients, as those with significant comorbidities, or those where the implanted aortic graft is in a location that precludes excision without causing a high likelihood of morbidity and/or mortality. Anyway, definitive management depends on the patient's condition and a tailored approach should be always offered. Surgical techniques favor in terms of mortality, patency and reinfection rate the in situ reconstruction. Currently, the choice of the technique used relies on center and operator's experience. This article summarizes the incidence of graft infection, analyze the predisponding factors to graft infection, and review current strategies for prevention and treatment of prosthesis and endograft infection. PMID:25017788

  15. 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

  16. 21 CFR 878.3610 - Esophageal prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis... of a plastic, metal, or polymeric material that is intended to be implanted to restore the...

  17. Custom Ocular Prosthesis: A Palliative Approach

    PubMed Central

    Thakkar, Prachi; Patel, JR; Sethuraman, Rajesh; Nirmal, Narendra

    2012-01-01

    The goal of palliative care is the achievement of the best quality of life for patients and their families. Eyes are generally the first features of the face to be noticed. Loss of an eye is a traumatic event which has a crippling effect on the psychology of the patient. Several ocular and orbital disorders require surgical intervention that may result in ocular defects. An ocular prosthesis is fabricated to restore the structure, function, and cosmetics of the defects created by such conditions. Although an implant eye prosthesis has a superior outcome, due to economic factors it may not be a feasible option for all patients. Therefore, a custom-made ocular prosthesis is a good alternative. This case report presents a palliative treatment for a patient with an enucleated eye by fabricating a custom ocular prosthesis which improved his psychological, physical, social, functional, emotional and spiritual needs. PMID:22837616

  18. Aesthetic finger prosthesis with silicone biomaterial

    PubMed Central

    Raghu, K M; Gururaju, C R; Sundaresh, K J; Mallikarjuna, Rachappa

    2013-01-01

    The fabrication of finger prosthesis is as much an art as it is science. The ideally constructed prosthesis must duplicate the missing structures so precisely that patients can appear in public without fear of attracting unwanted attraction. A 65-years-old patient reported with loss of his right index finger up to the second phalanx and wanted to get it replaced. An impression of the amputated finger and donor were made. A wax pattern of the prosthesis was fabricated using the donor impression; a trial was performed and flasked. Medical grade silicone was intrinsically stained to match the skin tone, following which it was packed, processed and finished. This clinical report describes a method of attaining retention by selective scoring of the master cast of partially amputated finger to enhance the vacuum effect at par with the proportional distribution of the positive forces on the tissues exerted by the prosthesis. PMID:23975917

  19. Computational reverse shoulder prosthesis model: Experimental data and verification.

    PubMed

    Martins, A; Quental, C; Folgado, J; Ambrósio, J; Monteiro, J; Sarmento, M

    2015-09-18

    The reverse shoulder prosthesis aims to restore the stability and function of pathological shoulders, but the biomechanical aspects of the geometrical changes induced by the implant are yet to be fully understood. Considering a large-scale musculoskeletal model of the upper limb, the aim of this study is to evaluate how the Delta reverse shoulder prosthesis influences the biomechanical behavior of the shoulder joint. In this study, the kinematic data of an unloaded abduction in the frontal plane and an unloaded forward flexion in the sagittal plane were experimentally acquired through video-imaging for a control group, composed of 10 healthy shoulders, and a reverse shoulder group, composed of 3 reverse shoulders. Synchronously, the EMG data of 7 superficial muscles were also collected. The muscle force sharing problem was solved through the minimization of the metabolic energy consumption. The evaluation of the shoulder kinematics shows an increase in the lateral rotation of the scapula in the reverse shoulder group, and an increase in the contribution of the scapulothoracic joint to the shoulder joint. Regarding the muscle force sharing problem, the musculoskeletal model estimates an increased activity of the deltoid, teres minor, clavicular fibers of the pectoralis major, and coracobrachialis muscles in the reverse shoulder group. The comparison between the muscle forces predicted and the EMG data acquired revealed a good correlation, which provides further confidence in the model. Overall, the shoulder joint reaction force was lower in the reverse shoulder group than in the control group. PMID:26206550

  20. Incidence and Impact of Patient-Prosthesis Mismatch in Isolated Aortic Valve Surgery

    PubMed Central

    Dumani, Selman; Likaj, Ermal; Kacani, Andi; Dibra, Laureta; Petrela, Elizana; Beca, Vera; Refatllari, Ali

    2015-01-01

    AIM: The mains topics of this work are the incidence of patient-prosthesis mismatch and the influence in the early results of isolated aortic valve surgery. METHODS: In 193 patients isolated aortic valve surgery was performed. The study population was divided in three subgroups: 20 patients with severe, 131 patients with moderate and 42 patients without patient-prosthesis mismatch. The indexed effective orifice area was used to define the subgroups. Operative mortality and perioperative complications were considered the indicators of the early results of aortic valve surgery. RESULTS: The incidence of severe and moderate patient-prosthesis mismatch was respectively 10.3% and 67.8%. Hospital mortality and perioperative complications were: mortality 5% vs. 3.1% vs. 2.4% (p = 0.855), low cardiac output 5% vs. 6.9% vs. 4.8% (p = 0.861); pulmonary complications 5% vs. 3.1 vs. 0.0% (p = 0.430); exploration for bleeding 5% vs. 0.8% vs. 2.4% (p = 0.319); atrial fibrillation 30% vs. 19.8% vs. 11.9% (p = 0.225); wound infection 5% vs. 0.8% vs. 0.00% (p = 0.165), respectively for the group with severe, moderate and without patient-prosthesis mismatch. CONCLUSIONS: Patient-prosthesis mismatch is a common occurrence in aortic valve surgery. This phenomenon does not affect the early results of aortic valve surgery.

  1. Relationship between squamous cell carcinoma of the tongue and the position of dental prosthesis

    PubMed Central

    Yoon, Ki-Yong; Kim, Soung-Min; Lee, Jong-Ho

    2015-01-01

    PURPOSE Squamous cell carcinoma (SCC) of the tongue has a relatively high incidence of all oral cancers. Some studies have reported a relationship between intraoral dental prosthesis and SCC of the tongue; however, this relationship remains controversial. The purpose of this study was to investigate the relationship between SCC of the tongue and the positional aspects of dental prosthesis using a retrospective analysis. MATERIALS AND METHODS A total of 439 patients with SCC of the tongue were diagnosed and treated in the Department of Oral and Maxillofacial Surgery, Seoul National University Dental Hospital. Patients were treated over a 12.5-year period ranging from January 1, 2001 to June 30, 2013. Statistical analysis was performed to examine potential differences between the groups. RESULTS The number of patients with a crown and/or a bridge (134, 63.5%) was significantly different than the number of patients without a prosthesis (77, 36.5%). Even after accounting for different types of prostheses such as crowns, bridges, and dentures, no significant differences were observed between the position of the prosthesis and the location of the SCC of the tongue, with significance defined as a P-value less than .05 by the Pearson-Chi square test. CONCLUSION Patients with crowns and/or bridges exhibited more frequent SCC of the tongue compared with patients without these prosthesis. These data support the hypothesis that mechanical trauma and galvanic phenomena play a role in the etiology of SCC of the tongue. PMID:25932311

  2. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to... requirement for premarket approval for any mandibular condyle prosthesis intended to be implanted in the...

  3. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to... requirement for premarket approval for any mandibular condyle prosthesis intended to be implanted in the...

  4. 21 CFR 878.3800 - External aesthetic restoration prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... external prosthesis adhesive. The device is not intended to be implanted. (b) Classification. Class I... an external prosthesis adhesive to fasten it to the body, the device is exempt from the current...

  5. [Penile prosthesis in case of impotence: 12 years of clinical experience].

    PubMed

    Andrianne, R; Balde, S; de Leval, J; Kempeners, P; Mormont, C

    1995-03-01

    Among 95 patients who have received a penile prosthesis between 1982 and 1993 (mean follow up of 46 months), 21 (22%) presented complications requiring one or more reintervention(s). Only for two patients the problem was mechanical, in the majority, they were non mechanical. Five of those subjects (5.5%) presented such complications that definitive explanation of the device was necessary. The problems presented by the 9 remaining patients were fully satisfactorily managed. Presently 94.5 per cent of the patients are using the device. Follow-up study of our interdisciplinary group demonstrates the efficacity of the prosthesis for revitalisation of the couples. The definitive parameters of implantation acceptance are essentially the partner influence and the treatment cost. This clinical study shows that the implantation of a penile prosthesis is an effective therapy in the treatment of impotence in a selected population. Presently, the mechanical reliability of different device has been good to date. PMID:7725996

  6. 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.

  7. Total hip arthroplasty for failed aseptic Austin Moore prosthesis

    PubMed Central

    Bhosale, Pradeep; Suryawanshi, Ashish; Mittal, Amber

    2012-01-01

    Background: Though Austin Moore (AM) replacement prosthesis has fairly good short term results for intracapsular femoral neck fractures in the elderly, it still is a compromised option and has a high failure rate in the long run. The objective of the present retrospective study is to analyze the functional outcome, assess survivorship of revision total hip arthroplasty (THA) at mid to long term followup, and evaluate intraoperative difficulties faced during conversion of failed aseptic AM prosthesis to cemented THA. Materials and Methods: Eighty-nine cemented THA surgeries for failed AM prosthesis were performed between 1986 and 2005. AM failures were classified into seven groups on the basis of mode of failure. Infected failures were excluded from the study. There were 35 men and 54 women in the study group. The mean age was 68 years (range 57–91 years). Mean followup was 8 years (range 5–13 years). Results: Average Harris Hip Score improved from 65 preoperatively (range 42–73) to 87 (range 76–90) at 1 year postoperatively and to 86 (range 75–89) at the last followup. The overall complication rate was 4.5%. Conclusion: Conversion THA is an excellent treatment strategy for symptomatic failed AM hemiarthroplasty in terms of pain relief and restoration of function and mobility as near as possible to the preinjury level. Also, hemiarthroplasty should not be used in physically active patients, even in elderly individuals. Careful patient selection for hemiarthroplasty versus THA is vital and may decrease the incidence of complications and ameliorate the outcomes in the treatment of intracapsular femoral neck fractures. PMID:22719116

  8. 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

  9. 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...

  10. 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...

  11. 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 884.3650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... § 884.3650 Fallopian tube prosthesis. (a) Identification. A fallopian tube prosthesis is a...

  12. 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...

  13. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vascular graft prosthesis. 870.3450 Section 870... prosthesis. (a) Identification. A vascular graft prosthesis is an implanted device intended to repair... Prostheses 510(k) Submissions.”...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 21 CFR 872.3940 - Total temporomandibular joint prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  6. 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...

  7. 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...

  8. 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...

  9. Fabrication of a Custom Ocular Prosthesis

    PubMed Central

    Sethi, Tania; Kheur, Mohit; Haylock, Colin; Harianawala, Husain

    2014-01-01

    Defects of the eye may follow removal of a part of or the entire orbit. This results in the patient becoming visually, esthetically and psychologically handicapped. Restoring the defect with a silicone- or acrylic-based prosthesis not only restores esthetics but also gives back the lost confidence to the patient. This is a case report of a patient with a ‘pthisical eye’ and details the steps in fabrication of an ocular prosthesis. Particular attention has been given to the laboratory process in this technique to minimize the residual monomer content in the artificial eye. PMID:25100916

  10. [Infections of penile prosthesis: treatment and prevention].

    PubMed

    Olivo, V; Ramírez-Ronda, C H

    1994-01-01

    To date, there are 10,000,000 men with impotence in the United States and it is estimated that at least 17,000 penile prosthesis are implanted annually. The most fearsome complication is the infection of the prosthesis which is usually caused by Staphylococcus epidermidis (in 40-80% of the cases). In general, the incidence of infection is actually 0.8-8.3%, but it can increase to 37% in patients with tertiary implants. The initial empiric treatment is usually with vancomycin and aminoglycosides and prophylaxis is recommended with a penicillinase-resistant synthetic penicillins, first generation cephalosporins, or vancomycin in case of penicillin allergy. PMID:7857483

  11. 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.

  12. Crural Bypass for Critical Lower Limb Ischemia with Omniflow II Prosthesis.

    PubMed

    Dünschede, Friedrich; Stabrauskaite, Justina; Weisser, Gerhard; Espinola-Klein, Christine; Dorweiler, Bernhard; Vahl, Christian-Friedrich

    2016-06-01

    Background Reports about the use of the Omniflow II prosthesis (Bio Nova International, Victoria, Australia) in a crural position in patients with critical lower limb ischemia are rare. Methods All crural bypass operations were registered in a database. Primary end points of the study were amputation-free survival, limb salvage, and long-term patency. Results From January 2007 to December 2012, we implanted 27 Omniflow II prostheses in the crural position for critical lower limb ischemia. Of these, 12 crural bypasses were conducted with adjuvant distal arteriovenous fistula as a means to increase bypass flow in the presence of severely impaired intraoperative runoff or revision for early failure. Fifteen Omniflow II prosthesis bypasses were performed in the crural position without fistula. Overall, two patients died postoperatively. The limb salvage rate was 92% in the fistula group compared with 60% in the nonfistula group after a median observation time of 19 months in patients getting Omniflow prosthesis bypasses. Conclusion Omniflow II prosthesis in patients with critical lower limb ischemia and absence of sufficient autologous vein is durable. Moreover, the use of adjuvant distal arteriovenous fistula may increase the chance of limb salvage in this group of patients. PMID:26291743

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

    PubMed

    Balasubramaniam, Muthu Kumar; Chidambaranathan, Ahila Singaravel; Shanmugam, Gokul; Tah, Rajdeep

    2016-02-01

    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

  14. 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

  15. 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

  16. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (premarket approval). (c) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and... testicular prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed...

  17. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (premarket approval). (c) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and... testicular prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. Comparison between Constrained and Semiconstrained Knee Allograft-Prosthesis Composite Reconstructions

    PubMed Central

    Farfalli, German L.; Aponte-Tinao, Luis A.; Ayerza, Miguel A.; Muscolo, D. Luis; Boland, Patrick J.; Morris, Carol D.; Athanasian, Edward A.; Healey, John H.

    2013-01-01

    Allograft-prosthesis composite (APC) can restore capsular and ligamentous tissues of the knee sacrificed in a tumor extirpation. We asked if performing APC would restore knee stability and allow the use of nonconstrained arthroplasty while preventing aseptic loosening. We retrospectively compared 50 knee APCs performed with non-constrained revision knee prosthesis (Group 1) with 36 matched APCs performed with a constrained prosthesis (Group 2). In Group 1, the survival rate was 69% at five and 62% at ten years. Sixteen reconstructions were removed due to complications: eight deep infections, three fractures, two instabilities, one aseptic loosening, one local recurrence, and one nonunion. In Group 2, the survival rate was 80% at five and 53% at ten years. Nine reconstructions were removed: 3 due to deep infections, 3 to fractures, and 3 to aseptic loosening. In both groups, we observed more allograft fractures when the prosthetic stem does not bypass the host-donor osteotomy (P > 0.05). Both groups had mainly good or excellent MSTS functional results. Survival rate and functional scores and aseptic loosening were similar in both groups. A rotating-hinge APC is recommended when host-donor soft tissue reconstruction fails to restore knee instability. The use of a short prosthetic stem has a statistical relationship with APC fractures. PMID:23476114

  3. The effect of a biphasic injectable bone substitute on the interface strength in a rabbit knee prosthesis model

    PubMed Central

    2013-01-01

    Background In joint prosthetic surgery, various methods are used to provide implant stability. We used an injectable bone substitute, composed of calcium sulfate/hydroxyapatite, as bone defect filler to stabilize a tibia prosthesis in an experimental rabbit model. The aim of the study was to investigate and compare the stability of prosthetic fixation with and without the use of an injectable bone substitute. Methods Sixteen rabbits were used and the tibia prostheses were implanted bilaterally, one side with the prosthesis alone and the other side with the prosthesis and calcium sulfate/hydroxyapatite (Cerament™). The rabbits were randomly divided into two groups and euthanized after 6 and 12 weeks, respectively. The prosthesis was extracted measuring the pull-out force in an Instron tester, and the bone surrounding the former prosthesis site was analyzed by histology, histomorphometry, and micro-computed tomography. Results At 6 weeks no difference in maximum pull-out force was found between the prostheses fixed with or without Cerament™. At 12 weeks the maximum pull-out force for the prostheses with Cerament™ was significantly higher than that for the prostheses without Cerament™ (p = 0.04). The maximum pull-out force at 12 weeks was significantly higher than that at 6 weeks for the prostheses fixed with Cerament™ (p = 0.03) but not for the prostheses without. Conclusion We conclude that early prosthesis-bone interface strength is not influenced by a bone substitute. However, during remodeling, the bone substitute might provide improved mechanical support for the prosthesis. The results support further studies of the use of injectable calcium sulfate/hydroxyapatite in fixation of prosthetic joint implants. PMID:23899023

  4. 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

  5. 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

  6. Monomelic hypertrophic osteoarthropathy secondary to aortic prosthesis infection.

    PubMed

    Hernández, M V; Antonio del Olmo, J; Orellana, C; Mestres, C A; Mũnoz-Gómez, J

    1995-01-01

    We describe a case of hypertrophic osteoarthropathy (HOA), exclusively located in the left lower leg and secondary to vascular prosthesis infection. Four years before, the patient underwent aortofemoral bifurcation grafting because of a ruptured aortic aneurysm. The investigations revealed prosthesis infection by Pseudomona aeruginosa and Bacteroides thetaiotamicron. The onset of HOA in a patient with a vascular prosthesis can help to achieve an early diagnosis of graft infection. The literature on this uncommon association is reviewed. PMID:7699670

  7. Orbital prosthesis: a novel reconstructive approach.

    PubMed

    Soni, Bhavita Wadhwa; Soni, Nitin; Bansal, Mohit

    2014-09-01

    Rehabilitation of facial defects is a daunting task, requiring an individualized design of the technique for each patient. The disfigurement associated with the loss of an eye may result in significant physical and emotional problems. Various treatment modalities are available, one of which is the use of implants. Although implant-supported orbital prosthesis has a superior outcome, it may not be advisable in all the patients due to economic factors. The present article describes a reconstructive approach for a patient with exenterated right eye using silicone orbital prosthesis which improved his psychological, physical, social, functional, emotional and spiritual needs. Multidisciplinary management and team approach are essential in providing accurate and effective rehabilitation. PMID:25284538

  8. Inflatable penile prosthesis (IPP): diagnosis of complications.

    PubMed

    Hartman, Robert P; Kawashima, Akira; Takahashi, Naoki; LeRoy, Andrew J; King, Bernard F

    2016-06-01

    Inflatable penile prostheses are a common treatment for erectile dysfunction that is unresponsive to less-invasive measures. Complications can arise at the time of the placement of the prosthesis or at a later date. Complications may be related to infection and/or mechanical failure of one or more of the prosthesis components including cylinder, reservoir, pump, and tubing. Mechanical failure includes kinking, migration, and aneurysmal dilation of the cylinder, erosion of the tunica albuginea of the corpora cavernosum by the cylinder, disconnection of the tubing, and migration of the reservoir. MRI of the entire components with the cylinders in both flaccid and inflated states is the best imaging modality available to image patients with suspected implant complications. PMID:26907716

  9. Innovative Approach for Interim Facial Prosthesis Using Digital Technology.

    PubMed

    Yoshioka, Fumi; Ozawa, Shogo; Hyodo, Ikuo; Tanaka, Yoshinobu

    2016-08-01

    Despite the important role of facial prosthetic treatment in the rehabilitation of head and neck cancer patients, delay in its implementation can be unavoidable, preventing patients from receiving a prompt facial prosthesis and resuming a normal social life. Here, we introduce an innovative method for the fabrication of an interim facial prosthesis. Using a 3D modeling system, we simplified the fabrication method and used a titanium reconstruction plate for facial prosthesis retention. The patient received the facial prosthesis immediately after surgery and resumed a normal social life earlier than is typically observed with conventional facial prosthetic treatment. PMID:26295755

  10. Moderate Patient-Prosthesis Mismatch Has No Negative Effect on Patients’ Functional Status After Aortic Valve Replacement With CarboMedics Prosthesis

    PubMed Central

    Alizadeh-Ghavidel, Alireza; Azarfarin, Rasoul; Alizadehasl, Azin; Sadeghpour-Tabaei, Ali; Totonchi, Ziae

    2016-01-01

    Background: Patient-prosthesis mismatch (PPM) after aortic valve replacement (AVR) is the subject of continuing debate in the cardiac surgery field. Objectives: The aim of this study was to evaluate the frequency and severity of patient-prosthesis mismatch (PPM) and the functional status of patients undergoing aortic valve replacement (AVR) using a CarboMedics prosthesis in the mid-term follow up. Patients and Methods: We retrospectively studied 66 consecutive patients who were referred to AVR with a CarboMedics prosthesis at the Rajaie cardiovascular medical and research center, a university referral hospital in Tehran, Iran. The severity of PPM as well as clinical and echocardiographic parameters and the patients’ New York heat association (NYHA) functional classification status, operative data and postoperative complications, and mortality in a mid-term (4 - 5 months) follow up period was assessed. Severe PPM was defined as the effective orifice area (EOA) indexed to the patient’s body surface area (BSA) < 0.65 cm2/m2 and moderate PPM was defined as the indexed effective orifice area (IEOA) between 0.65 and 0.85 cm2/m2. Results: Of the 66 studied patients, 39 were male and 27 were female. The mean age of the patients was 43 ± 17 with a range of 6 - 76 years. Implanted sizes of the CarboMedics AV prosthesis in 22 patients were 19 and 21 mm, and in 44 patients were 23 and 25 mm. Eleven patients had moderate PPM (IEOA < 0.85 cm2/m2) and 55 of them did not have PPM (IEOA ≥ 0.85 cm2/m2). There were no statistically significant differences between the two groups in the echocardiographic trans-aortic pressure gradients (35.6 ± 19 vs. 23.2 ± 16 mmHg; P = 0.061) and the mean NYHA functional classification (1.10 ± 0.3 vs. 1.01 ± 0.10; P = 0.074) after AVR in the mid-term follow up. Conclusions: Moderate PPM has no negative effect on echocardiographic trans-aortic pressure gradients or the patients’ NYHA functional status after AVR with a Carbo

  11. 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

  12. 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

  13. 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

  14. The functional performance of the Argus II retinal prosthesis

    PubMed Central

    Stronks, H Christiaan; Dagnelie, Gislin

    2014-01-01

    Summary Visual prostheses are devices to treat profound vision loss by stimulating secondary nerve cells anywhere along the visual pathway, typically with electrical pulses. The Argus® II implant, developed by Second Sight Medical Products (SSMP, Sylmar, CA, USA), targets the retina and features 60 electrodes that electrically stimulate the surviving retinal neurons. Of the approximately 20 research groups that are actively developing visual prostheses, SSMP has the longest track record. The Argus II was the first visual prosthesis to become commercially available: It received the CE mark in Europe in 2011 and FDA approval was granted in early 2013 for humanitarian use in the USA. Meanwhile, the Argus II safety/benefit study has been extended for research purposes, and is ongoing. In this review we will discuss the performance of the Argus II in restoring sight to the blind, and we will shed light on its expected developments in the coming years. PMID:24308734

  15. The Evolution of Dental Materials for Hybrid Prosthesis

    PubMed Central

    Gonzalez, Jorge

    2014-01-01

    Since the immemorial, the replacement of missing teeth has been a medical and cosmetic necessity for human kind. Nowadays, middle-aged population groups have experienced improved oral health, as compared to previous generations, and the percentage of edentulous adults can be expected to further decline. However, with the continued increase in the number of older adult population, it is anticipated that the need for some form of full-mouth restoration might increase from 53.8 million in 1991 to 61 million in 2020 [1]. Denture prosthetics has undergone many development stages since the first dentures were fabricated. The introduction of computer-aided design/computer aided manufacturing (CAD/CAM) has resulted in a more accurate manufacturing of prosthetic frameworks, greater accuracy of dental restorations, and in particular, implant supported prosthesis. PMID:24893781

  16. The evolution of dental materials for hybrid prosthesis.

    PubMed

    Gonzalez, Jorge

    2014-01-01

    Since the immemorial, the replacement of missing teeth has been a medical and cosmetic necessity for human kind. Nowadays, middle-aged population groups have experienced improved oral health, as compared to previous generations, and the percentage of edentulous adults can be expected to further decline. However, with the continued increase in the number of older adult population, it is anticipated that the need for some form of full-mouth restoration might increase from 53.8 million in 1991 to 61 million in 2020 [1]. Denture prosthetics has undergone many development stages since the first dentures were fabricated. The introduction of computer-aided design/computer aided manufacturing (CAD/CAM) has resulted in a more accurate manufacturing of prosthetic frameworks, greater accuracy of dental restorations, and in particular, implant supported prosthesis. PMID:24893781

  17. Conversion prosthesis: a transitional fixed implant-supported prosthesis for an edentulous arch--a technical note.

    PubMed

    Balshi, T J; Wolfinger, G J

    1996-01-01

    A technique for fabricating a provisional fixed prosthesis for an edentulous arch immediately following abutment connection, termed conversion prosthesis, is described in detail. Advantages of the restoration include the following: it provides a fixed prosthesis immediately following stage 2 surgery with improved function, stability, and distribution of load; it protects the sutured mucosa; it serves as a prototype for the final prosthesis; it can be used as a verification jig; it preserves the original vertical dimension of occlusion; it aids in obtaining and transferring the interocclusal record; it assists long-term patient maintenance; and it reduces treatment visits. The advantages of its use clearly outweigh the disadvantages. PMID:8820130

  18. Effect of cement washout on loosening of abutment screws and vice versa in screw- and cement- retained implant-supported dental prosthesis

    PubMed Central

    Kim, Seok-Gyu; Son, Mee-Kyoung

    2015-01-01

    PURPOSE The purpose of this study was to examine the abutment screw stability of screw- and cement-retained implant-supported dental prosthesis (SCP) after simulated cement washout as well as the stability of SCP cements after complete loosening of abutment screws. MATERIALS AND METHODS Thirty-six titanium CAD/CAM-made implant prostheses were fabricated on two implants placed in the resin models. Each prosthesis is a two-unit SCP: one screw-retained and the other cemented. After evaluating the passive fit of each prosthesis, all implant prostheses were randomly divided into 3 groups: screwed and cemented SCP (Control), screwed and noncemented SCP (Group 1), unscrewed and cemented SCP (Group 2). Each prosthesis in Control and Group 1 was screwed and/or cemented, and the preloading reverse torque value (RTV) was evaluated. SCP in Group 2 was screwed and cemented, and then unscrewed (RTV=0) after the cement was set. After cyclic loading was applied, the postloading RTV was measured. RTV loss and decementation ratios were calculated for statistical analysis. RESULTS There was no significant difference in RTV loss ratio between Control and Group 1 (P=.16). No decemented prosthesis was found among Control and Group 2. CONCLUSION Within the limits of this in vitro study, the stabilities of SCP abutment screws and cement were not significantly changed after simulated cement washout or screw loosening. PMID:26140172

  19. The effect of extracorporeal shock wave lithotripsy on the prosthesis interface in cementless arthroplasty. Evaluation in a rabbit model.

    PubMed

    Stranne, S K; Callaghan, J J; Fyda, T M; Fulghum, C S; Glisson, R R; Weinerth, J L; Seaber, A V

    1992-06-01

    The effect of extracorporeal shock wave lithotripsy on interfacial strength between prosthesis and bone in cementless arthroplasty was examined using a rabbit model. Paired femora, each implanted with fiber mesh porous coated titanium implants, were harvested from rabbits 15 weeks after implantation. In group I, one femur from each pair was exposed to lithotripsy treatment consisting of 2,000 shocks at 20 kV. In group II, one femur from each pair was exposed to 2,000 shocks at 26 kV. Contralateral femora from each pair served as controls in both groups. Mechanical pushout tests were conducted on the implants using a 1321 Instron testing machine at a constant rate of 1 mm/minute. Shock waves generated at 20 kV were found to have no significant decrease on either the prosthesis/bone interfacial strength or energy to failure of cementless implants. Shock waves generated at 26 kV produced a mean 17.45% decrease in the prosthesis/bone interfacial strength, which approached statistical significance (P = .062), and a 7.84% mean decrease in the energy to failure (P = .268). However, in four of the seven group II specimens, cortical fractures occurred. These findings suggest that lithotripsy will not aid in the removal of uncemented porous coated devices and lithotripsy inadvertently focused at an uncemented device will not disrupt significantly the prosthesis-bone interface. PMID:1613525

  20. 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

  1. 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...

  2. 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. 888.3230 Section 888.3230 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification....

  3. A direct bonded fixed partial dental prosthesis: a clinical report.

    PubMed

    Tanoue, Naomi; Tanaka, Takuo

    2015-01-01

    A direct bonded fixed partial dental prosthesis, with a composite resin denture tooth as a pontic, a tri-n-butylborane initiated adhesive resin, and screw posts for reinforcement, was still functioning after an observation period of 20 years. The prosthesis was found to be reliable for long-term clinical use when chemically and mechanically reinforced. PMID:25277033

  4. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  7. 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

  8. 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... adhesive. (a) Identification. An external prosthesis adhesive is a silicone-type adhesive intended to...

  9. 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... adhesive. (a) Identification. An external prosthesis adhesive is a silicone-type adhesive intended to...

  10. 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

  11. 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

  12. Experimental study of sutureless vascular anastomosis with use of glued prosthesis in rabbits

    PubMed Central

    Vokrri, Lulzim; Qavdarbasha, Arsim; Rudari, Hajriz; Ahmetaj, Halil; Manxhuka-Kërliu, Suzana; Hyseni, Nexhmi; Porcu, Paolo; Cinquin, Philippe; Sessa, Carmine

    2015-01-01

    Objective The objective of this study is to explore the feasibility and efficacy of a new technique for sutureless vascular anastomosis, using glued prosthesis, as a sole anastomosis fixation method in rabbits. Methods Ten rabbits were randomly selected to conduct the experiment. Five rabbits underwent direct anastomosis of infrarenal abdominal aorta, with glued prosthesis. In five other rabbits, reconstruction was done by sutured anastomosis. All animals were immediately examined by echo-Doppler for patency of anastomosis. The burst pressure of the glued anastomosis was measured and compared with that of a sutured artery. The animals were euthanized, and tissue samples were taken for histological examination immediately after the experiment. Results Compared to conventional anastomoses, sutureless vascular anastomoses required shorter time of creation and significantly reduced blood loss (P<5%). There was no significant difference on the average blood flow through the anastomosis between two groups at the end of surgery. All anastomoses with glued prosthesis, examined by echo-Doppler, were patent at the anastomotic site, except one, which was stenosed immediately after surgery. In the control group, except one with stenosis, all conventional anastomoses were patent. Mean burst pressure at the anastomotic site for sutureless anastomoses was lower than in control group. Macroscopically, the BioGlue did not demonstrate any adhesion to the surrounding tissue as it was covered by the vascular prosthesis. Histological examination showed low-grade inflammatory reaction in glued anastomoses versus no inflammatory reaction at the sutured anastomoses. Conclusion This technique may provide a feasible and successful alternative in vascular surgery. However, further long-term studies are necessary to elucidate the break pressure and degree of inflammation at the anastomotic site. PMID:25848302

  13. Site development interim removable dental prosthesis.

    PubMed

    Pasquinelli, Kirk L; Sze, Alexander J; Matosian, Alex J

    2016-07-01

    Transitioning a patient with partial edentulism through hard and soft tissue grafting to an implant restoration with an interim removable dental prosthesis (IRDP) presents a challenge to the restorative dentist. The management of grafted sites requires care, and without the appropriate design, an IRDP may impede surgical outcomes and place the graft at risk for displacement or necrosis. A site development IRDP (SDIRDP) for a grafted site must fulfill restorative goals and promote the surgical objectives for site development. A technique is described for fabricating an SDIRDP that facilitates surgical procedures and maintains prosthetic goals. PMID:26831920

  14. [Radio-carpal amputation and prosthesis].

    PubMed

    Cauquil, C; Thaury, M N; de Godebout, J; Ster, J; Ster, F; Bouzigues, B; Ducros, P

    1992-01-01

    Radio-carpal amputation was rejected for a long time because of the difficulties of fitting both myoelectrical and mechanical prostheses, only allowing a purely aesthetic prosthesis. As a result of miniaturization of control systems and the progress in computers, we believe that this now constitutes the best site for amputation whenever it is possible. Preservation of the antero-posterior bony contours of the radius allows the use of short sockets attached by a system of clips. In this way, flexion-extension of the elbow is left free and the movements of pronation and supination can be used. Liberation of the proximal joints facilitates integration of the prosthetic hand. PMID:1375500

  15. 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...

  16. The role of the rotating hinge prosthesis in the salvage arthroplasty setting.

    PubMed

    Deehan, David John; Murray, James; Birdsall, Paul D; Holland, James P; Pinder, Ian M

    2008-08-01

    We have studied a consecutive series of 72 salvage knee procedures using a Kinematic rotating hinge prosthesis performed in a single arthroplasty unit between 1983 and 1997. Clinical and radiographic assessment of the survivorship of the Kinematic rotating hinge total knee arthroplasty (Howmedica, Rutherford, NJ) were analyzed. Survival analysis revealed a best-case 10-year implant survival of 90%. Concurrently, this group of patients exhibited a significant and sustained improvement in Knee Society Score and pain relief after implantation of a rotating hinge component. There were 10 deaths due to unrelated causes during the study period. This constrained hinged prosthesis remains a viable option in the face of gross deformity, bone loss, and failed multiple previous surgical procedures. PMID:18534529

  17. Changes in performance over time while learning to use a myoelectric prosthesis

    PubMed Central

    2014-01-01

    Background Training increases the functional use of an upper limb prosthesis, but little is known about how people learn to use their prosthesis. The aim of this study was to describe the changes in performance with an upper limb myoelectric prosthesis during practice. The results provide a basis to develop an evidence-based training program. Methods Thirty-one able-bodied participants took part in an experiment as well as thirty-one age- and gender-matched controls. Participants in the experimental condition, randomly assigned to one of four groups, practiced with a myoelectric simulator for five sessions in a two-weeks period. Group 1 practiced direct grasping, Group 2 practiced indirect grasping, Group 3 practiced fixating, and Group 4 practiced a combination of all three tasks. The Southampton Hand Assessment Procedure (SHAP) was assessed in a pretest, posttest, and two retention tests. Participants in the control condition performed SHAP two times, two weeks apart with no practice in between. Compressible objects were used in the grasping tasks. Changes in end-point kinematics, joint angles, and grip force control, the latter measured by magnitude of object compression, were examined. Results The experimental groups improved more on SHAP than the control group. Interestingly, the fixation group improved comparable to the other training groups on the SHAP. Improvement in global position of the prosthesis leveled off after three practice sessions, whereas learning to control grip force required more time. The indirect grasping group had the smallest object compression in the beginning and this did not change over time, whereas the direct grasping and the combination group had a decrease in compression over time. Moreover, the indirect grasping group had the smallest grasping time that did not vary over object rigidity, while for the other two groups the grasping time decreased with an increase in object rigidity. Conclusions A training program should spend more

  18. A model for intracortical visual prosthesis research.

    PubMed

    Troyk, Philip; Bak, Martin; Berg, Joshua; Bradley, David; Cogan, Stuart; Erickson, Robert; Kufta, Conrad; McCreery, Douglas; Schmidt, Edward; Towle, Vernon

    2003-11-01

    In the field of visual prosthesis research, it has generally been held that animal models are limited to testing the safety of implantable hardware due to the inability of the animal to provide a linguistic report of perceptions. In contrast, vision scientists make extensive use of trained animal models to investigate the links between visual stimuli, neural activities, and perception. We describe an animal model for cortical visual prosthesis research in which novel animal psychophysical testing has been employed to compensate for the lack of a linguistic report. One hundred and fifty-two intracortical microelectrodes were chronically implanted in area V1 of a male macaque. Receptive field mapping was combined with eye-tracking to develop a reward-based training procedure. The animal was trained to use electrically induced point-flash percepts, called phosphenes, in performing a memory saccade task. It is our long-term goal to use this animal model to investigate stimulation strategies in developing a multichannel sensory cortical interface. PMID:14616519

  19. 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

  20. 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

  1. The evaluation of various bioabsorbable materials on the titanium fiber metal tracheal prosthesis.

    PubMed

    Mendak, S H; Jensik, R J; Haklin, M F; Roseman, D L

    1984-11-01

    A new type of tracheal prosthesis was studied. It consists of a rigid, porous cylinder of titanium fiber metal coated with a polymer that provides an initial air seal and then is absorbed to permit subsequent fibrous tissue ingrowth and reepithelialization. Fifteen such cylinders measuring 50 mm by 26 mm were coated with one of the following polymers: polycaprolactone 700 (3 coated internally and 3 externally); a copolymer of 75% poly-L-lactic acid and 25% polyglycolic acid (3 coated internally and 3 externally); and polyglactin 910 (3 coated externally). Fifteen kennel-conditioned mongrel dogs, each randomly assigned to one of these five groups, underwent implantation of the prosthesis through a right thoracotomy into a 5-cm defect in the distal intrathoracic trachea. There were no immediate postoperative deaths, and no instances of major air leak from the prosthesis. One animal died after two weeks secondary to a lower respiratory tract infection. Bronchoscopic evaluation revealed varying degrees of tissue ingrowth into the prostheses, with no evidence of infection or distal accumulation of secretions. Histological evaluation showed superior tissue ingrowth and reepithelialization with internally coated prostheses; two out of three polymers gave good results. PMID:6497477

  2. Erectile dysfunction patients are more satisfied with penile prosthesis implantation compared with tadalafil and intracavernosal injection treatments.

    PubMed

    Kucuk, E V; Tahra, A; Bindayi, A; Onol, F F

    2016-09-01

    There are various treatment modalities for erectile dysfunction with different success and satisfaction rates. We aim to compare patient satisfaction with tadalafil, intracavernosal injection, and penile prosthesis implantation in patients with erectile dysfunction. The records of 3448 men with erectile dysfunction were evaluated retrospectively. A total of 356 men with organic erectile dysfunction were enrolled into this study. Of these patients, 132 (37%) received tadalafil 20 mg twice a week for 12 weeks, 106 (30%) patients received tadalafil 5 mg once-daily for 12 weeks, 96 (27%) patients used intracavernosal injection therapy (Bi-mix; papaverine and phentolamine). Moreover, 22 patients underwent penile prosthesis implantation. Patient and partner satisfaction were assessed with International Index of Erectile Function (IIEF) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. Patients' mean age was 52.4 ± 25.76 (32-71). The etiology of erectile dysfunction was chronic systemic diseases in 133 (44%) and radical prostatectomy in 121 patients (40%). The mean IIEF-5 scores improvement after the treatment was higher in penile prosthesis implantation group (12.4 ± 1.3) compared with tadalafil 5 mg (6.7 ± 1.5) (p < 0.01), tadalafil 20 mg (6.2 ± 1.5) (p < 0.01), and intracavernosal injection group (8.4 ± 3.2) (p < 0.05). The EDITS score was significantly higher in penile prosthesis implantation group (78.2 ± 11.3) compared with intracavernosal injection (60.3 ± 6.3), tadalafil 5 mg (72.5 ± 4.5), and tadalafil 20 mg 70.7 ± 3.4 groups (p < 0.05). Partners' EDITS scores were 70.1 ± 10 in penile prosthesis implantation group, 50.2 ± 1.5 in intracavernosal injection group, 62.9 ± 7.8 in tadalafil 5 mg, and 61.3 ± 5.3 in tadalafil 20 mg group (p < 0.05). Erectile dysfunction patients who underwent penile prosthesis implantation seem to be more satisfied compared with tadalafil

  3. Sex therapy for the penile prosthesis recipient.

    PubMed

    Schover, L R

    1989-02-01

    In conclusion, the evidence for technical success of the penile prosthesis is clear, but more detailed follow-up studies suggest that a large minority of patients and partners fail to achieve sexual satisfaction. If the goal of surgery is to restore sexual frequency, variety, and pleasure to optimal levels, an integrated treatment program that incorporates sex therapy may be more successful than implantation alone. The type of sex therapy required depends on the risk factors present for postsurgery sexual dissatisfaction. A majority of patients can benefit from several sessions of brief sexual counseling preoperatively, with routine follow-up at 3 and 6 months after surgery to identify problems in resuming sex successfully. I also would point out that an integrated treatment approach is just as applicable to home intracavernosal injection programs. Including sex therapy in the package might reduce the large drop-out rates currently being seen and might decrease the risk of misuse of these medications. PMID:2916282

  4. DSP based image processing for retinal prosthesis.

    PubMed

    Parikh, Neha J; Weiland, James D; Humayun, Mark S; Shah, Saloni S; Mohile, Gaurav S

    2004-01-01

    The real-time image processing in retinal prosthesis consists of the implementation of various image processing algorithms like edge detection, edge enhancement, decimation etc. The algorithmic computations in real-time may have high level of computational complexity and hence the use of digital signal processors (DSPs) for the implementation of such algorithms is proposed here. This application desires that the DSPs be highly computationally efficient while working on low power. DSPs have computational capabilities of hundreds of millions of instructions per second (MIPS) or millions of floating point operations per second (MFLOPS) along with certain processor configurations having low power. The various image processing algorithms, the DSP requirements and capabilities of different platforms would be discussed in this paper. PMID:17271974

  5. 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.

  6. 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

  7. 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...

  8. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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...

  9. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is... prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in...

  10. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is... prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in...

  11. Metabolics of stair ascent with a powered transfemoral prosthesis.

    PubMed

    Ledoux, E D; Lawson, B E; Shultz, A H; Bartlett, H L; Goldfarb, M

    2015-01-01

    This paper evaluates the effectiveness of a powered knee and ankle prosthesis for stair ascent through a metabolic assessment comparing energy expenditure of a single transfemoral amputee subject while ascending stairs with the powered prosthesis relative to his passive daily use device, as well as comparing the kinematics and kinetics obtained with the passive prosthesis to healthy biomechanics. The subject wore a portable system that measured pulmonary gaseous exchange rates of oxygen and carbon dioxide while he ascended stairs with each of the prostheses in alternating tests. The results indicated that the amputee's energy expenditure decreased by 32 percent while climbing with the powered prosthesis as compared to his passive one, and the kinematics and kinetics achieved were representative of healthy biomechanics. PMID:26737489

  12. A comparative study of internal fixation and prosthesis replacement for radial head fractures of Mason type III

    PubMed Central

    Ruan, Hong-Jiang; Liu, Jun-Jian; Zeng, Bing-fang

    2007-01-01

    Although several treatment options for radial head fractures are available, no clear solutions exist. In this study we therefore compare open reduction and internal fixation (ORIF) with bipolar radial head prosthesis replacement in treatment of radial head fractures of Mason type III. Cement stem and bipolar radial prosthesis were used to treat 12 fresh cases and two old cases of Mason type III radial head fracture. As a control group, another eight cases of radial head type III fracture were treated with ORIF with cannulated screws and Kirschner (K) wires. The 14 patients who received radial head prosthesis replacement were followed-up for 15.9 months (range 10–27 months). According to elbow functional evaluation criteria by Broberg and Morrey, we found excellent results in nine cases, good in four, and fair in one. Mean follow-up of the eight cases in the ORIF group was 14 months (range 10–21 months), with good results in one case, fair in four, and poor in three. The result was good or excellent in 92.9% of prosthesis replacement patients and in 12.5% of ORIF patients. This difference is statistically significant (P = 0.0004; Fisher’s exact test). We concluded that bipolar radial head prosthesis replacement is better than ORIF in treatment of Mason type III radial head fracture. Electronic Supplementary Material The online version of this article (doi:10.1007/s00264-007-0453-3) contains supplementary material, which is available to authorized users. PMID:17938924

  13. 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

  14. Kinematic Analysis of a Posterior-stabilized Knee Prosthesis

    PubMed Central

    Zhao, Zhi-Xin; Wen, Liang; Qu, Tie-Bing; Hou, Li-Li; Xiang, Dong; Bin, Jia

    2015-01-01

    Background: The goal of total knee arthroplasty (TKA) is to restore knee kinematics. Knee prosthesis design plays a very important role in successful restoration. Here, kinematics models of normal and prosthetic knees were created and validated using previously published data. Methods: Computed tomography and magnetic resonance imaging scans of a healthy, anticorrosive female cadaver were used to establish a model of the entire lower limbs, including the femur, tibia, patella, fibula, distal femur cartilage, and medial and lateral menisci, as well as the anterior cruciate, posterior cruciate, medial collateral, and lateral collateral ligaments. The data from the three-dimensional models of the normal knee joint and a posterior-stabilized (PS) knee prosthesis were imported into finite element analysis software to create the final kinematic model of the TKA prosthesis, which was then validated by comparison with a previous study. The displacement of the medial/lateral femur and the internal rotation angle of the tibia were analyzed during 0–135° flexion. Results: Both the output data trends and the measured values derived from the normal knee's kinematics model were very close to the results reported in a previous in vivo study, suggesting that this model can be used for further analyses. The PS knee prosthesis underwent an abnormal forward displacement compared with the normal knee and has insufficient, or insufficiently aggressive, “rollback” compared with the lateral femur of the normal knee. In addition, a certain degree of reverse rotation occurs during flexion of the PS knee prosthesis. Conclusions: There were still several differences between the kinematics of the PS knee prosthesis and a normal knee, suggesting room for improving the design of the PS knee prosthesis. The abnormal kinematics during early flexion shows that the design of the articular surface played a vital role in improving the kinematics of the PS knee prosthesis. PMID:25591565

  15. Ischemic Gangrene of the Glans following Penile Prosthesis Implantation

    PubMed Central

    García Gómez, Borja; Romero Otero, Javier; Díez Sicilia, Laura; Jiménez Alcaide, Estibaliz; García-Cruz, Eduardo; Rodríguez Antolín, Alfredo

    2013-01-01

    The development of ischemic gangrene of the penis following implantation of prosthesis is unusual, and very few cases are available in the literature. As a result, no established treatment protocol is available. We report our experience within a case of gangrene of the glans following implantation of a three-component prosthesis. We present a 53-year-old male, smoker with diabetes and hypercholesterolemia, who underwent surgery for the insertion of a penile prosthesis with 3 components to correct his erectile dysfunction and severe Peyronie's disease. The procedure was carried out without incidents. During the postoperative period, the patient began to complain from penile and perineal pain. He developed avascular necrosis of the glans. The necrosed area was excised. Four weeks later, he developed fever and perineal pain arriving to the emergency room with the prosthesis extruding through the glans. He had emergency surgery to remove the prosthesis plus surgical lavage and was prescribed broad-spectrum antibiotic therapy. Four weeks later, the penis was completely revascularized and reepithelialized. Ischemic gangrene following penile prosthesis implantation takes place in patients with poor peripheral vascularisation. Diabetes mellitus has been the common denominator to all of the reported cases. PMID:23956919

  16. Mastication Improvement After Partial Implant-supported Prosthesis Use

    PubMed Central

    Gonçalves, T.M.S.V.; Campos, C.H.; Gonçalves, G.M.; de Moraes, M.; Rodrigues Garcia, R.C.M.

    2013-01-01

    Partially edentulous patients may be rehabilitated by the placement of removable dental prostheses, implant-supported removable dental prostheses, or partial implant fixed dental prostheses. However, it is unclear the impact of each prosthesis type over the masticatory aspects, which represents the objective of this paired clinical trial. Twelve patients sequentially received and used each of these 3 prosthesis types for 2 months, after which maximum bite force was assessed by a strain sensor and food comminution index was determined with the sieving method. Masseter and temporal muscle thicknesses during rest and maximal clenching were also evaluated by ultrasonography. Each maxillary arch received a new complete denture that was used throughout the study. Data were analyzed by analysis of variance for repeated measures, followed by the Tukey test (p < .05). Maximum bite force and food comminution index increased (p < .0001) after implant-supported dental prosthesis and implant fixed dental prosthesis use, with the higher improvement found after the latter’s use. Regardless of implant-retained prosthesis type, masseter muscle thickness during maximal clenching also increased (p < .05) after implant insertion. Partial implant-supported prostheses significantly improved masseter muscle thickness and mastication, and the magnitude of this effect was related to prosthesis type (International Clinical Trial Registration RBR-9J26XD). PMID:24158344

  17. Minimally invasive infrapubic inflatable penile prosthesis implant for erectile dysfunction: evaluation of efficacy, satisfaction profile and complications

    PubMed Central

    Antonini, G; Busetto, G M; De Berardinis, E; Giovannone, R; Vicini, P; Del Giudice, F; Conti, S L; Gentile, V; Perito, P E

    2016-01-01

    Erectile dysfunction (ED), the second most common male sexual disorder, has an important impact on man sexuality and quality of life affecting also female partner's sexual life. ED is usually related to cardiovascular disease or is an iatrogenic cause of pelvic surgery. Many non-surgical treatments have been developed with results that are controversial, while surgical treatment has reached high levels of satisfaction. The aim is to evaluate outcomes and complications related to prosthesis implant in patients suffering from ED not responding to conventional medical therapy or reporting side effects with such a therapy. One hundred eighty Caucasian male suffering from ED were selected. The patient population were divided into two groups: 84 patients with diabetes and metabolic syndrome (group A) and 96 patients with dysfunction following laparoscopic radical prostatectomy for prostate cancer (group B). All subjects underwent primary inflatable penile prosthesis implant with an infrapubic minimally invasive approach. During 12 months of follow-up, we reported 3 (1.67%) explants for infection, 1 (0.56%) urethral erosion, 1 (0.56%) prosthesis extrusion while no intraoperative complications were reported. Mean International Index of Erectile Function-5 (IIEF-5) was 8.2±4.0 and after the surgery (12 months later) was 20.6±2.7. The improvement after the implant is significant in both groups without a statistically significant difference between the two groups (P-value 0.65). Mean Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) score 1 year after the implant is 72.2±20.7, and there was no statistically significant difference between groups A and B (P-value 0.55). Implantation of an inflatable prosthesis, for treatment of ED, is a safe and efficacious approach; and the patient and partner satisfaction is very high. Surgical technique should be minimally invasive and latest technology equipment should be implanted in order to decrease after surgery common

  18. Lessons from the past: twenty-five years experience with the Cross-Jones caged disc prosthesis.

    PubMed

    Kovacs, G S; Felkai, B; Toszegi, A M

    1993-11-01

    One hundred and twenty-one patients who received 145 Cross-Jones prostheses between 1967 and 1973 were followed for over 20 years. Thirty-six patients had undergone single aortic valve replacement, receiving an uncovered prosthesis (Group A), while 83 of the 85 patients in Group B undergoing isolated mitral or combined mitral and aortic and/or tricuspid replacements received a cloth-covered prosthesis in the mitral and/or tricuspid position. There were no mechanical failures in Group A, and three patients are alive 24 years after their operations. The seat was smooth in all prostheses inspected at autopsy and the disc was not worn even 15-18 years after surgery. The overall incidence of thromboembolism in this group was 3.56%/pty, of which 2.13%/pty were fatal. All operative offvivors with cloth-covered valves developed mechanical dysfunction leading to death or requiring reoperation within ten years. The cloth cover was invariably disrupted and the disc hitting this rough surface had become worn, with significant diminution in their diameters in all valves recovered during reoperation or at autopsy. In seven patients, the disc escaped from a mitral prosthesis causing immediate death, while one patient survived a tricuspid disc escape for over one month and was then successfully reoperated. The overall incidence of thromboembolism in Group B was 23.4%/pty, of which 11.7%/pty were fatal. PMID:7719509

  19. Comparison of the microbial composition of voice prosthesis biofilms from patients requiring frequent versus infrequent replacement.

    PubMed

    Elving, G Jolanda; van der Mei, Henny C; Busscher, Henk J; van Weissenbruch, Ranny; Albers, Frans W J

    2002-03-01

    This study was performed to establish a possible difference in biofilm composition in patients who require frequent versus infrequent prosthesis replacement. Only Groningen button voice prostheses that were removed because of increased airflow resistance or leakage of food or liquids through the prosthesis were considered for this study. These prostheses were selected from a total of 692 failed voice prostheses over a 2-year evaluation period. The failed voice prostheses were subdivided into a short-lifetime group, corresponding to an implantation period of less than 4 months (20 voice prostheses), and an extended-lifetime group, corresponding to an implantation period of greater than 9 months (18 voice prostheses). The biofilm was removed from the valve sides of the prostheses. The bacterial strain Rothia dentocariosa and the yeast strains Candida albicans I and Candida tropicalis were the predominant strains isolated from the biofilms on the voice prostheses in the short-lifetime group, whereas in the extended-lifetime group, R dentocariosa was found with a fourfold lower isolation frequency and C albicans I was found with a twofold lower isolation frequency. Candida tropicalis was absent from the extended-lifetime group. PMID:11915880

  20. Automated estimation of hip prosthesis migration: a feasibility study

    NASA Astrophysics Data System (ADS)

    Vandemeulebroucke, Jef; Deklerck, Rudi; Temmermans, Frederik; Van Gompel, Gert; Buls, Nico; Scheerlinck, Thierry; de Mey, Johan

    2013-09-01

    A common complication associated with hip arthoplasty is prosthesis migration, and for most cemented components a migration greater than 0.85 mm within the first six months after surgery, are an indicator for prosthesis failure. Currently, prosthesis migration is evaluated using X-ray images, which can only reliably estimate migrations larger than 5 mm. We propose an automated method for estimating prosthesis migration more accurately, using CT images and image registration techniques. We report on the results obtained using an experimental set-up, in which a metal prosthesis can be translated and rotated with respect to a cadaver femur, over distances and angles applied using a combination of positioning stages. Images are first preprocessed to reduce artefacts. Bone and prosthesis are extracted using consecutive thresholding and morphological operations. Two registrations are performed, one aligning the bones and the other aligning the prostheses. The migration is estimated as the difference between the found transformations. We use a robust, multi-resolution, stochastic optimization approach, and compare the mean squared intensity differences (MS) to mutual information (MI). 30 high-resolution helical CT scans were acquired for prosthesis translations ranging from 0.05 mm to 4 mm, and rotations ranging from 0.3° to 3° . For the translations, the mean 3D registration error was found to be 0.22 mm for MS, and 0.15 mm for MI. For the rotations, the standard deviation of the estimation error was 0.18° for MS, and 0.08° for MI. The results show that the proposed approach is feasible and that clinically acceptable accuracies can be obtained. Clinical validation studies on patient images will now be undertaken.

  1. Deterioration of the Provox silicone tracheoesophageal voice prosthesis: microbial aspects and structural changes.

    PubMed

    van Weissenbruch, R; Albers, F W; Bouckaert, S; Nelis, H J; Criel, G; Remon, J P; Sulter, A M

    1997-05-01

    Device life of tracheoesophageal voice prostheses is limited due to deterioration of the polymers. A group of 55 postlaryngectomy patients fitted with a Provox voice prosthesis have been studied prospectively during 6 months. Thirty-seven prostheses were replaced due to a dysfunctional valve mechanism. Although colonization with Candida species was highly associated with destruction of the silicone material, other upper respiratory tract commensals, e.g. Staphylococcus aureus, were also demonstrated. Electron microscopy of the contaminated devices showed colonization and disruption of the silicone material by penetrating yeast hyphae. During the study a remarkable increase of intratracheal phonatory pressures was assessed with progressive colonization of the prostheses. PMID:9199534

  2. [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

  3. Optoelectronic retinal prosthesis: system design and performance

    NASA Astrophysics Data System (ADS)

    Loudin, J. D.; Simanovskii, D. M.; Vijayraghavan, K.; Sramek, C. K.; Butterwick, A. F.; Huie, P.; McLean, G. Y.; Palanker, D. V.

    2007-03-01

    The design of high-resolution retinal prostheses presents many unique engineering and biological challenges. Ever smaller electrodes must inject enough charge to stimulate nerve cells, within electrochemically safe voltage limits. Stimulation sites should be placed within an electrode diameter from the target cells to prevent 'blurring' and minimize current. Signals must be delivered wirelessly from an external source to a large number of electrodes, and visual information should, ideally, maintain its natural link to eye movements. Finally, a good system must have a wide range of stimulation currents, external control of image processing and the option of either anodic-first or cathodic-first pulses. This paper discusses these challenges and presents solutions to them for a system based on a photodiode array implant. Video frames are processed and imaged onto the retinal implant by a head-mounted near-to-eye projection system operating at near-infrared wavelengths. Photodiodes convert light into pulsed electric current, with charge injection maximized by applying a common biphasic bias waveform. The resulting prosthesis will provide stimulation with a frame rate of up to 50 Hz in a central 10° visual field, with a full 30° field accessible via eye movements. Pixel sizes are scalable from 100 to 25 µm, corresponding to 640-10 000 pixels on an implant 3 mm in diameter.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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. PMID:26285201

  11. 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

  12. 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

  13. 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

  14. A new tracheal prosthesis made from collagen grafted mesh.

    PubMed

    Okumura, N; Nakamura, T; Takimoto, Y; Natsume, T; Teramachi, M; Tomihata, K; Ikada, Y; Shimizu, Y

    1993-01-01

    The authors studied the efficacy of a new tracheal prosthesis made from mesh. The prosthesis, 50 mm long and 18-22 mm in diameter, is made from a Marlex mesh cylinder reinforced with a continuous polypropylene spiral that is grafted and coated with porcine collagen to increase its biocompatibility and provide an airtight seal during the initial implantation stage. Circumferential surgical resection and replacement of a seven to nine ring segment of the cervical trachea was performed in 20 adult mongrel dogs. At the time of surgery, a silicone tube was inserted into the tracheal prosthetic lumen to promote secretory transportation until the prosthesis was covered with host tissue. The silicone tube was removed during fiber bronchoscopy 1 month after surgery. With the exception of the prostheses in 3 dogs that died of unrelated causes, all were infiltrated by connective tissue and incorporated completely by the host. One of these 17 dogs died of suffocation caused by luminal stenosis 2.5 months after surgery, but the others survived until they were killed at more than 6 months. The luminal surfaces of the reconstructed tracheae were covered with respiratory epithelium to varying degrees, and in one dog killed at 22 months after surgery, confluent epithelization throughout the length of the prosthesis was confirmed histologically. In eight dogs, prosthetic luminal stenosis occurred because of overgrowth of granulation tissue, which generally was mild in all but three dogs. The authors conclude that this tracheal prosthesis is highly biocompatible and shows promise for clinical application. PMID:8268582

  15. 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

  16. 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

  17. 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...

  18. 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...

  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 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... cemented prosthesis. 888.3680 Section 888.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket)...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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. 888.3750 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...

  11. 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. 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...

  12. 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. 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...

  13. 21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... uncemented prosthesis. 888.3360 Section 888.3360 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... 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 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... uncemented prosthesis. 888.3360 Section 888.3360 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... 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...

  15. 21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... uncemented prosthesis. 888.3690 Section 888.3690 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as...

  16. 21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... uncemented prosthesis. 888.3690 Section 888.3690 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as...

  17. 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...

  18. 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...

  19. 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...

  20. Preliminary Functional Assessment of a Multigrasp Myoelectric Prosthesis

    PubMed Central

    Dalley, Skyler A.; Bennett, Daniel A.; Goldfarb, Michael

    2015-01-01

    The authors have previously described a multigrasp hand prosthesis prototype, and a two-site surface EMG based multigrasp control interface for its control. In this paper, the authors present a preliminary assessment of the efficacy of the prosthesis and multigrasp controller in performing tasks requiring interaction and manipulation. The authors use as a performance measure the Southampton Hand Assessment Procedure (SHAP), which entails manipulation of various objects designed to emulate activities of daily living, and provides a set of scores that indicate level of functionality in various types of hand function. In this preliminary assessment, a single non-amputee subject performed the SHAP while wearing the multigrasp prosthesis via an able-bodied adaptor. The results from this testing are presented, and compared to recently published SHAP results obtained with commercially available single-grasp and multigrasp prosthetic hands. PMID:23366847

  1. 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.

  2. 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.

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

    PubMed

    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

  4. 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

  5. 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

  6. 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

  7. 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

  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. 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. PMID:26491482

  10. 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.

  11. Combination lower lip prosthesis retained by an intraoral component.

    PubMed

    Zeno, Helios A; Sternberger, Sidney S; Tuminelli, Frank J; Billotte, Michael; Kurtz, Kenneth S

    2013-07-01

    Patients who have had a partial or full surgical resection of the maxillary or mandibular lip experience difficulties with articulation of speech, swallowing, and salivary control. This is further complicated by significant alterations in facial esthetics and lowered self-esteem. This clinical treatment will describe the fabrication of a two-piece tooth-retained maxillofacial prosthesis. An intraoral retentive portion and an extraoral section restoring lip anatomy were attached by retentive elements. This prosthesis restored the patient's esthetics, oral function, and self-esteem. PMID:23387560

  12. 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

  13. Aspiration of tracheoesophageal prosthesis in a laryngectomized patient

    PubMed Central

    2012-01-01

    Background The voice prosthesis inserted into a tracheoesophageal fistula has become the most widely used device for voice rehabilitation in patients with total laryngectomy. Case presentation We describe a case of tracheoesophageal prosthesis’ (TEP) aspiration in a laryngectomized patient, with permanent tracheal stoma, that appeared during standard cleaning procedure, despite a programme of training for the safe management of patients with voice prosthesis. Conclusions The definitive diagnosis and treatment were performed by flexible bronchoscopy, that may be considered the procedure of choice in these cases, also on the basis of the literature. PMID:22958961

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

    PubMed

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

    2015-04-01

    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

  15. Percutaneous Revision of a Testicular Prosthesis is Safe, Cost-effective, and Provides Good Patient Satisfaction.

    PubMed

    Cone, Eugene B; Lentz, Aaron C

    2015-09-01

    Office-based percutaneous revision of a testicular prosthesis has never been reported. A patient received a testicular prosthesis but was dissatisfied with the firmness of the implant. In an office setting, the prosthesis was inflated with additional fluid via a percutaneous approach. Evaluated outcomes included patient satisfaction, prosthesis size, recovery time, and cost savings. The patient was satisfied, with no infection, leak, or complication after more than 1 year of follow-up, at significantly less cost than revision surgery. Percutaneous adjustment of testicular prosthesis fill-volume can be safe, inexpensive, and result in good patient satisfaction. PMID:26793527

  16. Rehabilitation of orbital defect with silicone orbital prosthesis retained by dental implants

    PubMed Central

    Guttal, Satyabodh Shesharaj; Desai, Jhanvi; Kudva, Adarsh; Patil, Basavaraj R

    2016-01-01

    Orbital defects can result from cancer, birth anomalies, or trauma leading to an onslaught of problems in the function and psyche of the patient. These defects are restored by surgical reconstruction and followed by placement of orbital prosthesis for cosmetic makeup. The use of dental implants in retaining orbital prosthesis improves patient acceptance of the prosthesis owing to better retention and stability than conventional adhesive retained prosthesis. This case report describes a custom-made magnetic retentive assembly anchored by a dental implant which offers the orbital prosthesis the simplicity of self-alignment and ease of use. PMID:26953033

  17. Chemical stimulation of rat retinal neurons: feasibility of an epiretinal neurotransmitter-based prosthesis

    NASA Astrophysics Data System (ADS)

    Inayat, Samsoon; Rountree, Corey M.; Troy, John B.; Saggere, Laxman

    2015-02-01

    Objective. No cure currently exists for photoreceptor degenerative diseases, which cause partial or total blindness in millions of people worldwide. Electrical retinal prostheses have been developed by several groups with the goal of restoring vision lost to these diseases, but electrical stimulation has limitations. It excites both somas and axons, activating retinal pathways nonphysiologically, and limits spatial resolution because of current spread. Chemical stimulation of retinal ganglion cells (RGCs) using the neurotransmitter glutamate has been suggested as an alternative to electrical stimulation with some significant advantages. However, sufficient scientific data to support developing a chemical-based retinal prosthesis is lacking. The goal of this study was to investigate the feasibility of a neurotransmitter-based retinal prosthesis and determine therapeutic stimulation parameters. Approach. We injected controlled amounts of glutamate into rat retinas from the epiretinal side ex vivo via micropipettes using a pressure injection system and recorded RGC responses with a multielectrode array. Responsive units were identified using a spike rate threshold of 3 Hz. Main results. We recorded both somal and axonal units and demonstrated successful glutamatergic stimulation across different RGC subtypes. Analyses show that exogenous glutamate acts on RGC synapses similar to endogenous glutamate and, unlike electrical prostheses, stimulates only RGC somata. The spatial spread of glutamate stimulation was ˜ 290 μm from the injection site, comparable to current electrical prostheses. Further, the glutamate injections produced spatially differential responses in OFF, ON, and ON-OFF RGC subtypes, suggesting that differential stimulation of the OFF and ON systems may be possible. A temporal resolution of 3.2 Hz was obtained, which is a rate suitable for spatial vision. Significance. We provide strong support for the feasibility of an epiretinal neurotransmitter

  18. Clinical results of posterior cruciate ligament retaining TKA with alumina ceramic condylar prosthesis: comparison to Co-Cr alloy prosthesis.

    PubMed

    Majima, Tokifumi; Yasuda, Kazunori; Tago, Hidenobu; Aoki, Yoshimitu; Minami, Akio

    2008-02-01

    In a prospective study, 194 knees undergoing total knee arthroplasty (110 knees with alumina ceramic prostheses; 84 knees with Co-Cr alloy prostheses) were clinically and radiologically evaluated. Average follow-up period was 66 months (36-124 months). Average age at the time of surgery was 66 years. In the ceramic prostheses, two revision surgeries were performed because of breakage of the tibial tray and late infection, whereas two revisions of the Co-Cr alloy prostheses were carried out due to loosening and late infection. In the other patients, there were no significant differences in clinical parameters (HSS knee score and range of motion) between the two prostheses. In radiological evaluation, we could not find any radiolucent lines around the femoral ceramic component while radiolucency was present in three knees (3.6%) around the Co-Cr femoral component. Beneath the tibial tray, three knees (2.7%) showed a radiolucent line around the former prosthesis while eight knees (9.5%) demonstrated a radiolucent line around the latter prosthesis. Chi-square tests showed a significant difference in the occurrence of radiolucent line around both of the femoral and tibial prosthesis. This study demonstrated that clinical results of the alumina ceramic PCL retaining total knee prosthesis are comparable to the standard Co-Cr alloy PCL retaining total knee prosthesis. Although we could not draw any conclusions regarding the superiority of the ceramic prosthesis with respect to UHMWPE wear and long-term survivorship, this report encouraged a long-term follow-up study on ceramic prostheses. PMID:17982743

  19. The effects of 21 and 23 milimeter aortic valve prosthesis on hemodynamic performance and functional capacity in young adults

    PubMed Central

    Umit Yener, Ali; Ozcan, Sedat; Baran Budak, Ali; Bahadir Genc, Serhat; Ozkan, Turgut; Faruk Cicek, Omer

    2014-01-01

    Objective: Early and medium-term improvement of functional capacity and regression of left ventricular hypertrophy was evaluated in the young adult patient group following application of 21 mm or 23 mm bileaflet aortic mechanical valve prosthesis due to aortic stenosis. Methods : Twenty two patients (10 male, 12 female; mean age 27+-8.2 (19-43)) who underwent isolated aortic valve replacement due to rheumatic aortic stenosis, were included in the study. 21 mm and 23 mm bileaflet mechanical prosthesis was used respectively in eight and fourteen patients. The mean body surface area was 1.86 m2 and 1.68 m2 respectively in 23 mm and 21 mm prosthesis while 1.73 ±0.25 m2 for the whole group. Functional capacity was New York Heart Association (NYHA) class II in 9 patients and class III in thirteen patients. Implantation was performed without enlarging the aortic root in all except four patients. In all patients transvalvular gradients, effective orifice area and the diameter of left ventricle were measured with transthoracic echocardiography during rest and after maximal exercise. Mean follow-up was 34±12 months (range 11-57 months). Results: There were no postoperative complications or deaths. All the patients were assessed as NYHA class I with regards to functional capacity (p=0.01). Significant improvements were determined in postoperative mean transvalvular gradient (p=0.005) and left ventricular mass index (p=0.01) when compared with preoperative values. Conclusion: Our findings show that replacement with 21 mm and 23 mm mechanical prosthesis provides a significant improvement in regression of symptoms and increase of functional capacity in young adults in early and mid-period without increasing mortality and morbidity. PMID:24772143

  20. The Argus(®) II Retinal Prosthesis System.

    PubMed

    Luo, Yvonne Hsu-Lin; da Cruz, Lyndon

    2016-01-01

    The Argus(®) II Retinal Prosthesis System (Second Sight Medical Products) is the first prosthetic vision device to obtain regulatory approval in both Europe and the USA. As such it has entered the commercial market as a treatment for patients with profound vision loss from end-stage outer retinal disease, predominantly retinitis pigmentosa. To date, over 100 devices have been implanted worldwide, representing the largest group of patients currently treated with visual prostheses. The system works by direct stimulation of the relatively preserved inner retina via epiretinal microelectrodes, thereby replacing the function of the degenerated photoreceptors. Visual information from a glasses-mounted video camera is converted to a pixelated image by an external processor, before being transmitted to the microelectrode array at the macula. Elicited retinal responses are then relayed via the normal optic nerve to the cortex for interpretation. We reviewed the animal and human studies that led to the development of the Argus(®) II device. A sufficiently robust safety profile was demonstrated in the phase I/II clinical trial of 30 patients. Improvement of function in terms of orientation and mobility, target localisation, shape and object recognition, and reading of letters and short unrehearsed words have also been shown. There remains a wide variability in the functional outcomes amongst the patients and the factors contributing to these performance differences are still unclear. Future developments in terms of both software and hardware aimed at improving visual function have been proposed. Further experience in clinical outcomes is being acquired due to increasing implantation. PMID:26404104

  1. Role of loads and prosthesis material properties on the mechanics of the proximal femur after total hip arthroplasty.

    PubMed

    Cheal, E J; Spector, M; Hayes, W C

    1992-05-01

    The objective of this study was to establish the role of loads and prosthesis material properties on the mechanics of the proximal femur after total hip arthroplasty. We developed a three-dimensional finite element model of an intact human femur and the same femur with a conventional collared straight-stem femoral component. Using published data, we defined two sets of loading conditions: one that represented three phases of gait, and one that represented four different extreme loads. The four extreme loads were based on the peak joint contact forces that occur during stair ascent and isometric contraction of various muscle groups. The model was analyzed with three different material properties for the prosthesis, including cobalt-chromium alloy, titanium alloy, and a carbon fiber-reinforced polymer (CFRP) laminate. We assumed that the implant was stable, with rigid bonding, collar contact, and no cement. To address femoral component loosening, we examined the shear stresses at the implant-bone interface; to address adaptive bone remodeling, we examined the principal stresses in the supporting cortical bone relative to those in the intact femur. Our analyses of the various loading conditions demonstrated large out-of-plane bending movements and torsional moments, especially for the load representing stair ascent. Based on stepwise multiple regressions, the maximum shear stresses at the implant-bone interface in the distal region were dependent on the total applied axial force and torsion; the maximum shear stresses in the proximal region were dependent on the axial component of the joint contact force alone. Reduction in the prosthesis stiffness, by substitution of the CFRP material properties, resulted in lower interface shear stresses at the distal end of the stem and higher interface shear stresses at the more proximal sections, consistent with the findings of others. We fit equations, based on composite beam theory, to the maximum implant-bone interface shear

  2. 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

  3. 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 §...

  4. 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 §...

  5. 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 §...

  6. 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 §...

  7. 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...

  8. 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...

  9. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  10. 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...

  11. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  12. 21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  13. 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...

  14. 21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  15. 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...

  16. 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...

  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 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a... flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for...

  19. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a... flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for...

  20. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a... flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for...

  1. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a... flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for...

  2. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) 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...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  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. 21 CFR 874.3495 - Total ossicular replacement prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  10. 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...

  11. 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...

  12. 21 CFR 874.3450 - Partial ossicular replacement prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  13. 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...

  14. 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...

  15. 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...

  16. Penile prosthesis surgery in the management of erectile dysfunction

    PubMed Central

    Sadeghi-Nejad, Hossein; Fam, Mina

    2013-01-01

    Introduction We reviewed retrospectively the use of penile prostheses, including the indications and complications of penile prosthesis surgery. Methods We identified publications and the reported advances in penile prosthesis surgery between 1987 and 2012 in Pub-Med, and published information from American Medical Systems, Inc. (Minnetonka, MN, USA) and Coloplast Corporation (Humlebaek, Denmark), using the keywords ‘penile prosthesis’, ‘erectile dysfunction’, ‘mechanical reliability’, ‘complications’ and ‘infection’. Results We describe the novel indications for the use of penile prostheses, the significant advances in implant designs with improved mechanical reliability, the changing landscape of device infection, and the current management of complications. Sixty-eight publications with a grade A, B and C level of evidence are cited. Conclusion The clinical indications to implant a penile prosthesis have expanded beyond organic erectile dysfunction. With the many different devices currently available, the choice of which device to implant can be tailored based on an individual’s unique medical conditions, manual dexterity and expectations, and surgeon preference. There must be a conscious effort to prevent device infection, in the light of the development of increasingly virulent organisms. Penile prosthesis surgery is an integral part of the treatment of erectile dysfunction when non-surgical options fail or are contraindicated. PMID:26558089

  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. Referral of sensation to an advanced humanoid robotic hand prosthesis.

    PubMed

    Rosén, Birgitta; Ehrsson, H Henrik; Antfolk, Christian; Cipriani, Christian; Sebelius, Fredrik; Lundborg, Göran

    2009-01-01

    Hand prostheses that are currently available on the market are used by amputees to only a limited extent, partly because of lack of sensory feedback from the artificial hand. We report a pilot study that showed how amputees can experience a robot-like advanced hand prosthesis as part of their own body. We induced a perceptual illusion by which touch applied to the stump of the arm was experienced from the artificial hand. This illusion was elicited by applying synchronous tactile stimulation to the hidden amputation stump and the robotic hand prosthesis in full view. In five people who had had upper limb amputations this stimulation caused referral touch sensation from the stump to the artificial hand, and the prosthesis was experienced more like a real hand. We also showed that this illusion can work when the amputee controls the movements of the artificial hand by recordings of the arm muscle activity with electromyograms. These observations indicate that the previously described "rubber hand illusion" is also valid for an advanced hand prosthesis, even when it has a robotic-like appearance. PMID:19863429

  19. 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...

  20. Enhanced Neurobehavioral Outcomes of Action Observation Prosthesis Training.

    PubMed

    Cusack, William F; Thach, Scott; Patterson, Rebecca; Acker, Dan; Kistenberg, Robert S; Wheaton, Lewis A

    2016-07-01

    Background Previous studies have demonstrated improved neurobehavioral outcomes when prosthesis users learn task-specific behaviors by imitating movements of prosthesis users (matched limb) compared with intact limbs (mismatched limb). Objective This study is the first to use a unique combination of neurophysiological and task performance methods to investigate prosthetic device training strategies from a cognitive motor control perspective. Intact nonamputated prosthesis users (NAPUs) donned specially adapted prosthetic devices to simulate the wrist and forearm movement that persons with transradial limb loss experience. The hypothesis is that NAPUs trained with matched limb imitation would show greater engagement of parietofrontal regions and reduced movement variability compared with their counterparts trained with a mismatched limb. Methods Training elapsed over 3 days comprised alternating periods of video demonstration observation followed by action imitation. At the beginning and end of the training protocol, participants performed a cued movement paradigm while electroencephalography and electrogoniometry data were collected to track changes in cortical activity and movement variability, respectively. Results Matched limb participants showed greater engagement of motor-related areas while mismatched limb participants showed greater engagement of the parietooccipital system. Matched limb participants also showed lower movement variability. Conclusions These results indicate that the type of limb imitated influences neural and behavioral strategies for novel prosthetic device usage. This finding is important, as customary prosthetic rehabilitation with intact therapists involves mismatched limb imitation that may exacerbate challenges in adapting to new motor patterns demanded by prosthesis use. PMID:26438442

  1. 21 CFR 878.3800 - External aesthetic restoration prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 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 §...

  2. 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...

  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 878.3750 - 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...

  6. 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...

  7. 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 §...

  8. 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 §...

  9. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 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 (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3450 Vascular...

  10. 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 870.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3450 Vascular...

  11. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 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 (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3450 Vascular...

  12. Vocal rehabilitation after total laryngectomy using the Provox voice prosthesis.

    PubMed

    Van Weissenbruch, R; Albers, F W

    1993-10-01

    Vocal rehabilitation in laryngectomized patients can be attained by surgical (tracheoesophageal speech) or conservative methods (oesophageal speech or artificial larynx). We prospectively studied voice restoration in 37 patients who underwent total laryngectomy in the period from February 1991 to February 1993. The patients were given the opportunity to assess both non-shunt oesophageal speech and shunt oesophageal speech using the Provox voice prosthesis. The Provox low resistance, self-retaining voice prosthesis is a biflanged device made of silicon rubber. A primary tracheoesophageal puncture was made in 28 patients, while a secondary puncture was performed in another nine patients. The results were assessed according to criteria established at the 'Third International Congress on Voice Prosthesis' in Groningen (1988). Functional tracheoesophageal speech after primary puncture was achieved in 95% of patients 12 months after puncture, while oesophageal voice was acquired by 55%. Only minor surgical and prosthesis-related complications were encountered during this follow-up period in 29% of the patients. The device lifetime varied from 3 months to at least 2 years (mean 5.4 months). PMID:8877200

  13. 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.

  14. [Scorpio TS prosthesis in severe deformity and revision knee arthroplasty--preliminary report].

    PubMed

    Kowalczewski, Jacek; Marczak, Dariusz; Wielopolski, Aleksander; Milecki, Marcin; Okoń, Tomasz

    2009-01-01

    Authors present early results of Scorpio TS prosthesis in primary and revision total knee arthoplasty due to aseptic and septic loosening. 26 arthroplasties were performed on 25 patients. There were 19 women and 6 men of age from 37 to 80 (average 68.4 years). 11 patients from this group were operated because of septic loosening. The follow up from 2 to 22 months (average 11 months). Early results were access according to Clinical Rating System of The Knee Society: 19 patients had very good and good (73%) including primaries, 1 satisfactory (4%) and 6 poor (23%) results. The satisfactory and poor results were obtained in 7 cases with septic loosening who had had four or more previous operations on the knee. Four of them had instability of prosthesis and we changed it for MRH type. In one case due to reinfection and sepsis amputation above the knee was performed. In another patient tibia fracture below stem and loosening of tibial component occurs after 6 months of revision. ORIF gave fracture union after 8 months and exchange Scorpio TS to MRH was performed. In two cases the wound problems occurred and was solved. There were no reinfection and aseptic loosening in another cases. We didn't notice any thrombosis complications. PMID:20201329

  15. Bone Mineral Density and Fracture Risk Assessment to Optimize Prosthesis Selection in Total Hip Replacement

    PubMed Central

    Pétursson, Þröstur; Edmunds, Kyle Joseph; Gíslason, Magnús Kjartan; Magnússon, Benedikt; Magnúsdóttir, Gígja; Halldórsson, Grétar; Jónsson, Halldór; Gargiulo, Paolo

    2015-01-01

    The variability in patient outcome and propensity for surgical complications in total hip replacement (THR) necessitates the development of a comprehensive, quantitative methodology for prescribing the optimal type of prosthetic stem: cemented or cementless. The objective of the research presented herein was to describe a novel approach to this problem as a first step towards creating a patient-specific, presurgical application for determining the optimal prosthesis procedure. Finite element analysis (FEA) and bone mineral density (BMD) calculations were performed with ten voluntary primary THR patients to estimate the status of their operative femurs before surgery. A compilation model of the press-fitting procedure was generated to define a fracture risk index (FRI) from incurred forces on the periprosthetic femoral head. Comparing these values to patient age, sex, and gender elicited a high degree of variability between patients grouped by implant procedure, reinforcing the notion that age and gender alone are poor indicators for prescribing prosthesis type. Additionally, correlating FRI and BMD measurements indicated that at least two of the ten patients may have received nonideal implants. This investigation highlights the utility of our model as a foundation for presurgical software applications to assist orthopedic surgeons with selecting THR prostheses. PMID:26417376

  16. Bone Mineral Density and Fracture Risk Assessment to Optimize Prosthesis Selection in Total Hip Replacement.

    PubMed

    Pétursson, Þröstur; Edmunds, Kyle Joseph; Gíslason, Magnús Kjartan; Magnússon, Benedikt; Magnúsdóttir, Gígja; Halldórsson, Grétar; Jónsson, Halldór; Gargiulo, Paolo

    2015-01-01

    The variability in patient outcome and propensity for surgical complications in total hip replacement (THR) necessitates the development of a comprehensive, quantitative methodology for prescribing the optimal type of prosthetic stem: cemented or cementless. The objective of the research presented herein was to describe a novel approach to this problem as a first step towards creating a patient-specific, presurgical application for determining the optimal prosthesis procedure. Finite element analysis (FEA) and bone mineral density (BMD) calculations were performed with ten voluntary primary THR patients to estimate the status of their operative femurs before surgery. A compilation model of the press-fitting procedure was generated to define a fracture risk index (FRI) from incurred forces on the periprosthetic femoral head. Comparing these values to patient age, sex, and gender elicited a high degree of variability between patients grouped by implant procedure, reinforcing the notion that age and gender alone are poor indicators for prescribing prosthesis type. Additionally, correlating FRI and BMD measurements indicated that at least two of the ten patients may have received nonideal implants. This investigation highlights the utility of our model as a foundation for presurgical software applications to assist orthopedic surgeons with selecting THR prostheses. PMID:26417376

  17. The heat-activated stapes prosthesis 'SMart' Piston: technique and preliminary results.

    PubMed

    Babighian, Gregorio; Fontana, Marco; Caltran, Silvia; Ciccolella, Michele; Amadori, Maurizio; De Zen, Michela

    2007-01-01

    Since 2003 we are using in our stapedotomies the Nitinol 'Smart' Piston. This prosthesis has a Teflon 'vestibular' end and a wire shaft made by Nitinol, with a heat activated self-crimping loop. Nitinol is an alloy of Nickel + Titanium, belonging to the class of the so-called smart materials, i.e. materials with shape-memory and superelastic properties. Nitinol is lightweight and highly biocompatible thanks to the thin layer of Titanium oxide covering the Nickel surface. The special advantage of this piston is that the loop grips by itself very uniformly and quite tightly around the incudal process or the malleus handle when a minimal heating (about 60 degrees C) is applied using a disposable heater ('Thermal Tip'). This piston was successfully used in our Department between 2003 and 2004 in a first group of 42 cases of stapedotomy and in 7 cases of malleostapedotomy. The shape and the uniformity of the loop grip was controlled by examining fresh temporal bone specimens by S.E.M. (x21 / 166) and in all specimens the loop was uniformly surrounding the ossicle, without 'dead' spaces. It is our feeling that this prosthesis is very useful in stapes surgery for at least two reasons: 1. because it improves the quality of the interface 'piston loop/long process of incus'; 2. because the duration of the procedure is reduced. PMID:17245045

  18. Powered ankle-foot prosthesis for the improvement of amputee ambulation.

    PubMed

    Au, Samuel K; Herr, Hugh; Weber, Jeff; Martinez-Villalpando, Ernesto C

    2007-01-01

    This paper presents the mechanical design, control scheme, and clinical evaluation of a novel, motorized ankle-foot prosthesis, called MIT Powered Ankle-Foot Prosthesis. Unlike a conventional passive-elastic ankle-foot prosthesis, this prosthesis can provide active mechanical power during the stance period of walking. The basic architecture of the prosthesis is a unidirectional spring, configured in parallel with a force-controllable actuator with series elasticity. With this architecture, the anklefoot prosthesis matches the size and weight of the human ankle, and is also capable of delivering high mechanical power and torque observed in normal human walking. We also propose a biomimetic control scheme that allows the prosthesis to mimic the normal human ankle behavior during walking. To evaluate the performance of the prosthesis, we measured the rate of oxygen consumption of three unilateral transtibial amputees walking at self-selected speeds to estimate the metabolic walking economy. We find that the powered prosthesis improves amputee metabolic economy from 7% to 20% compared to the conventional passive-elastic prostheses (Flex-Foot Ceterus and Freedom Innovations Sierra), even though the powered system is twofold heavier than the conventional devices. This result highlights the benefit of performing net positive work at the ankle joint to amputee ambulation and also suggests a new direction for further advancement of an ankle-foot prosthesis. PMID:18002631

  19. Impact of obesity on long-term survival after aortic valve replacement with a small prosthesis

    PubMed Central

    Wang, Biao; Yang, Hongyang; Wang, Tao; Zhang, Xiquan; Zhu, Wenjie; Cao, Guangqing; Wu, Shuming

    2013-01-01

    OBJECTIVES Although many studies have evaluated the impact of obesity on various medical treatments, it is not known whether obesity is related to late mortality with implantation of small aortic prostheses. This study evaluated the effect of obesity on the late survival of patients after aortic valve replacement (AVR) with implantation of a small aortic prosthesis (size ≤21 mm). METHODS From January 1998 to December 2008, 307 patients in our institution who underwent primary AVR with smaller prostheses survived 30 days after surgery. Patients were categorized as normal weight if body mass index (BMI) was <24 kg/m2, overweight if BMI 24–27.9 kg/m2 and obese if BMI ≥28 kg/m2. Data of the New York Heart Association (NYHA) functional classification, left ventricular ejection fraction (LVEF), effective orifice area index (EOAI) and left ventricular mass index of the patients were collected at the third month, sixth month, first year, third year, fifth year and eighth year after operation. RESULTS By multivariable analysis, obesity was a significant independent factor of late mortality (hazard ratio: 1.62; P = 0.01). The obese and overweight groups of patients exhibited lower survival (P < 0.001) and a higher proportion in NYHA Class III/IV (P < 0.01) compared with the normal group. A lower EOAI and higher left ventricular mass index were found in the obese and overweight groups, but we saw no significant variance in LVEF among the three groups. CONCLUSIONS Obesity is associated with increased late mortality of patients after AVR with implantation of small aortic prosthesis. Obesity or/and overweight may also affect the NYHA classification, even in the longer term. EOAI should be improved where possible, as it may reduce late mortality and improve quality of life in obese or overweight patients. PMID:23529754

  20. Achieved Anticoagulation vs Prosthesis Selection for Mitral Mechanical Valve Replacement

    PubMed Central

    Le Tourneau, Thierry; Lim, Vanessa; Inamo, Jocelyn; Miller, Fletcher A.; Mahoney, Douglas W.; Schaff, Hartzell V.; Enriquez-Sarano, Maurice

    2009-01-01

    Background: Thromboembolic events (TEs) are frequent after mechanical mitral valve replacement (MVR), but their association to anticoagulation quality is unclear and has never been studied in a population-based setting with patients who have a complete anticoagulation record. Methods: We compiled a complete record of all residents of Olmsted County, MN, who underwent mechanical MVR between 1981 and 2004, for all TE, bleeding episodes, and international normalized ratios (INRs) measured from prosthesis implantation. Results: In the 112 residents (mean [± SD] age, 57 ± 16 years; 60% female residents) who underwent mechanical MVR, 19,647 INR samples were obtained. While INR averaged 3.02 ± 0.57, almost 40% of INRs were < 2 or > 4.5. Thirty-four TEs and 28 bleeding episodes occurred during a mean duration of 8.2 ± 6.1 years of follow-up. There was no trend of association of INR (average, SD, growth variance rate, or intensity-specific incidence of events) with TE. Previous cardiac surgery (p = 0.014) and ball prosthesis (hazard ratio [HR], 2.92; 95% CI, 1.43 to 5.94; p = 0.003) independently determined TE. With MVR using a ball prosthesis, despite higher anticoagulation intensity (p = 0.002), the 8-year rate of freedom from TE was considerably lower (50 ± 9% vs 81 ± 5%, respectively; p < 0.0001). Compared with expected stroke rates in the population, stroke risk was elevated with non-ball prosthesis MVR (HR 2.6; 95% CI, 1.3 to 5.2; p = 0.007) but was considerable with ball prosthesis MVR (HR 11.7; 95% CI, 7.5 to 18.4; p < 0.0001). INR variability (SD) was higher with a higher mean INR value (p < 0.0001). INR variability (HR 2.485; 95% CI, 1.11 to 5.55; p = 0.027) and cancer history (p < 0.0001) independently determined bleeding rates. Conclusion: This population-based comprehensive study of anticoagulation and TE post-MVR shows that, in these closely anticoagulated patients, anticoagulation intensity was highly variable and not associated with TE incidence post

  1. [Maxillary prosthesis for better QOL--early setting and faster construction of maxillary prosthesis].

    PubMed

    Usui, H; Sakakura, Y; Shimozato, K

    1992-12-01

    The maxillofacial prosthesis (MFP) is well accepted as one of the modalities to ameliolate the postsurgical crippling in the patients with maxillary malignancy. In this report, we analyzed 55 primary cases of MFP out of 100, from July, 1981 to July, 1987 in terms of the time of start after operation, and the duration and procedure of the MFP-making. MFP-making set about within 4 weeks in 35% of patients, 8 weeks in 25%, 12 weeks in 22%, and more than 12 weeks in 18%. The completion of MFP-making averaged 10 days. As a result of simplifying of MFP-making, we shortened a period requiring MFP-making within 3 days in recent 10 cases. There were no adverse effects of early wear of MFP after operation. We believe that early wear of MFP after operation improve the quality of life of patients with maxillary malignancy and considered that wear of MFP is not the completion of treatment, but is one of the procedures of treatment for the patients undergone maxillectomy. PMID:1491275

  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. 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

  4. 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.

  5. A fiber-reinforced composite prosthesis restoring a lateral midfacial defect: a clinical report.

    PubMed

    Kurunmäki, Hemmo; Kantola, Rosita; Hatamleh, Muhanad M; Watts, David C; Vallittu, Pekka K

    2008-11-01

    This clinical report describes the use of a glass fiber-reinforced composite (FRC) substructure to reinforce the silicone elastomer of a large facial prosthesis. The FRC substructure was shaped into a framework and embedded into the silicone elastomer to form a reinforced facial prosthesis. The prosthesis is designed to overcome the disadvantages associated with traditionally fabricated prostheses; namely, delamination of the silicone of the acrylic base, poor marginal adaptation over time, and poor simulation of facial expressions. PMID:18992568

  6. 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.

  7. 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.

  8. An organized start to implant-supported prosthesis

    PubMed Central

    Karthigeyan, Suma; Ali, Seyed Ashraff; Mohan, Kalarani; Deivanai, Mangala

    2013-01-01

    Various treatment options are available for rehabilitating the complete edentulous patients with implants. However, due consideration for the prosthesis is not given prior to implant surgery. This can result in implant being placed in locations that do not provide the best esthetic and functional result. Incorrect implant localization and angle are the primary cause of non-axial loading and may contribute to loss of Osseo-integration. For predictable outcome, the treatment should begin with visualizing the end result. A step-wise pre-implant surgery evaluation is necessary to achieve the objectives. This is a case report of a completely edentulous patient who was treated with fixed implant prosthesis following various steps in the pre-implant surgery evaluation. PMID:23853462

  9. [Effect of prosthesis cleansing agent on the prosthetic base fungi].

    PubMed

    Temmer, K; Stipetić, D; Cekić-Arambasin, A; Kraljević, K

    1991-01-01

    Candida albicans and other fungi are frequently found in subjects wearing prostheses, especially in prostheses with poor hygiene, i.e. with accumulations of food, plaques and calculi. The aim of this study was to assess the efficacy of Corega extradent relative to fungi adhering to the prosthetic base. Results of the study showed the prosthesis hygiene to be substantially related to inflammation of palatal mucosa. The mean number of fungi per sq.cm of prosthetic base was 64 x 10(5). The number of fungi was redetermined after a two-day treatment with Corega extradent, with unchanged other habits of the prosthesis wearing and cleansing. The number of fungi decreased in all study subjects, the mean value of individual differences being 2238 times. In prostheses with a great number of fungi and extremely poor hygiene, the effect of Corega extradent was poorer, indicating the need of additional mechanical cleansing with a brush. PMID:1819938

  10. Replacement of a Dislocated Aortic Prosthesis After Transcatheter Valve Implantation.

    PubMed

    Mandegar, Mohammad Hossein; Moradi, Bahieh; Roshanali, Farideh

    2016-06-01

    A 77-year-old woman who had severe symptomatic aortic stenosis and was a high risk for conventional surgery underwent transcatheter aortic valve implantation by means of the transfemoral approach. The prosthesis migrated and became embolized in the left ventricle after inflation, causing interference with the mitral valve and also partial outflow tract obstruction. The patient was emergently transferred to the operating room. Vertical aortotomy was performed under cardiopulmonary bypass, and the calcified native leaflets were removed. The migrated Edwards SAPIEN XT valve was extracted and subsequently successfully sewn into the annulus after examination for leaflet and stent competence. The hemodynamic performance of the implanted valve was surprisingly more favorable than that of the conventional tissue prosthesis. PMID:27211978

  11. Modified prosthesis for the treatment of malignant esophagotracheal fistula

    SciTech Connect

    Buess, G.; Schellong, H.; Kometz, B.; Gruessner, R.J.; Junginger, T.

    1988-04-15

    Esophagotracheal fistula is usually a sequela of irradiation or laser treatment of advanced carcinoma of the esophagus or the tracheobronchial tree. Resection of the tumor in these cases is not possible, and palliative bypass surgery is highly risky. The peroral placement of a prosthesis is less invasive, but conventional prostheses often fail to occlude the fistula. The authors regularly use an endoscopic multiple-diameter bougie for dilation. After dilation, a specially designed prosthesis is pushed through the tumor stenosis to block the fistula. This procedure can be done without general anesthesia. The funnels of conventional prostheses cannot cover the fistula when there is either a wide, proximal esophagus above the fistula or a high fistula. To cope with this particular situation, a special fistula funnel was developed. It perfectly occludes the fistulas in all patients. Of 21 patients, 19 were discharged without further aspiration.

  12. 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.

  13. Biomechanical Evaluation of a Prototype Foot/Ankle Prosthesis

    PubMed Central

    Quesada, P. M.; Pitkin, M.; Colvin, J.

    2016-01-01

    In this paper, we report on our pilot evaluation of a prototype foot/ankle prosthesis. This prototype has been designed and fabricated with the intention of providing decreased ankle joint stiffness during the middle portion of the stance phase of gait, and increased (i.e., more normal) knee range of motion during stance. Our evaluation involved fitting the existing prototype foot/ankle prosthesis, as well as a traditional solid ankle cushioned heel (SACH) foot, to an otherwise healthy volunteer with a below-knee (BK) amputation. We measured this individual’s lower extremity joint kinematics and kinetics during walking using a video motion analysis system and force platform. These measurements permitted direct comparison of prosthetic ankle joint stiffness and involved side knee joint motion, as well as prosthetic ankle joint moment and power. PMID:10779119

  14. Balloon-dilatable arterial banding prosthesis: experimental study.

    PubMed

    Vince, D J; Culham, J A; Taylor, G P

    1987-07-01

    Two arterial banding prostheses were developed that could be dilated by an intraluminal balloon dilator. One prosthesis consisted of radiopaque umbilical tape with a pleat secured by four 8-0 silk sutures thinly coated with silicone type A medical adhesive. This design was used to band the main pulmonary artery in five dogs, the subclavian artery in five, and the aorta in one. The second prosthesis, a stainless steel fatigued helix encased in a siliconized shield, was used to band the main pulmonary artery in two dogs and the descending aorta in two. After a mean duration of 89 days the bands were dilated with an intraluminal balloon dilator at 6 atm (608 kPa) of pressure for 30 seconds. In all 15 experiments the bands dilated and the gradient at the band was reduced. The stainless steel helix was more successful and has technical advantages for clinical application. PMID:2954182

  15. Characterization of a light switchable microelectrode array for retinal prosthesis

    NASA Astrophysics Data System (ADS)

    Zhang, Xinyi; Xiong, Tao; Chiou, Pei-Yu; Li, Zhihong

    2011-12-01

    A light switchable microelectrode array for retinal prosthesis, which is performed with the photosensitive conductivity of hydrogenated amorphous silicon (a-Si:H) and of more advantages over the two major current retinal prosthetic categories, is characterized. Sensitivity to different visible wavelengths and light intensities are verified as well. Preliminary impedance test invitro shows appropriate impedance for neuron stimulation applications. It is indicated that such device provides a promising potential to restore a certain degree of visual function.

  16. Penile Enhancement Procedures with Simultaneous Penile Prosthesis Placement

    PubMed Central

    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

  17. Femoral prosthesis subsidence in asymptomatic patients. A stereophotogrammetric assessment.

    PubMed

    Chafetz, N; Baumrind, S; Murray, W R; Genant, H K

    1984-01-01

    A radiographic stereophotogrammetric technique (SPG) was used to evaluate quantitatively the presence of early femoral prosthesis subsidence after total hip arthroplasty (THA). This paper focuses on the measurement of subsidence in 12 patients who remained asymptomatic during the first two years after surgery. Only one of these had SPG estimated subsidence in excess of one millimeter at any timepoint. These findings are consistent with the conclusion that early postoperative subsidence is not a common finding among asymptomatic THA patients. PMID:6469528

  18. 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

  19. 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

  20. Magnet retained intraoral-extra oral combination prosthesis: a case report

    PubMed Central

    Kumar, Surender; Bera, Amit; Gupta, Tapas; Banerjee, Ardhendu

    2012-01-01

    Facial prosthesis is generally considered over surgical reconstruction to restore function and appearance in patients with facial defects that resulted from cancer resection. Retention of the prosthesis is challenging due to its size and weight. Retention can be achieved by using medical grade adhesives, resilient attachments, clips and osseointegrated implants. It can also be connected to obturator by magnets. This clinical report highlights the rehabilitation of a lateral midfacial defect with a two piece prosthesis that included an extra oral facial prosthesis and an intraoral obturator with the use of magnets. PMID:23236576

  1. A cortical neural prosthesis for restoring and enhancing memory

    PubMed Central

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

    2011-01-01

    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

  2. [Total hip replacement with isoelastic prosthesis in animals (author's transl)].

    PubMed

    Muhr, O; Stockhusen, H; Müller, O

    1976-10-01

    Uncemented fixation and low-fraction materials are the basis of this experiment. Plastics with an elasticity similar to the bone ("isoelasticity") show very propitious material qualities. The direct cementless incorporation of test bodies must be checked. In 63 sheep isoelastic total hip joints were implanted. After 2 till 51 weeks the animals were sacrificed and 44 specimen of hips and organs were explored macroscopically, radiologically, spherimetrically and histologically. The result was: 1. Plastic hip prosthesis are incorporated in the bone, but the boundary layer is built by a collagenous fiber tissue. 2. Loosening brings resoption of the bone and expansion of the structural changed soft tissue. 3. The transformation of the femoral cortex to osteoporosis is considered possibly as the consequence of an insufficient biological transfer of the weight. 4. Fractures of the femoral prosthesis-stem could not be observed. 5. The radiology allows at the pelvis prosthesis a concret statement concerning stability, on the femoral part a probable one. 6. The abrasion is minimal, the tissue reaction to abrasion products is unessential. 7. Small abrasion particles are carried of by the lymph tract and stored in the first regional gland. A more distant spreading is not demonstrable. PMID:985179

  3. Three-dimensional printed calcaneal prosthesis following total calcanectomy☆

    PubMed Central

    Imanishi, Jungo; Choong, Peter F.M.

    2015-01-01

    Introduction The majority of patients with extremity sarcoma can be surgically treated without amputation. However, limb-salvage surgery for foot sarcomas including the calcaneus remains challenging. Presentation of case A 71-year-old man presented with a 5-year history of right heel persistent pain. Imaging studies revealed an osteolytic, destructive and highly metabolic lesion in the right calcaneus. Computed tomography guided core needle biopsy confirmed the diagnosis of grade 2 chondrosarcoma. A total calcanectomy was performed, and the defect was reconstructed with a patient matched three-dimensional printed titanium calcaneal prosthesis. Intra-operatively, ligaments including the Achilles tendon, and plantar fascia were reattached. The post-operative course was uneventful, and at the 5-month clinical follow-up, the patient was fully weightbearing, with a mobile ankle without pain. Discussion This case is the first to use additive manufacturing to create a prosthetic calcaneus. The complex peri-calcaneal articular surfaces and reattachment of tendinous structures facilitate efforts to stabilize the prosthesis in situ. Conclusion Three-dimensional-printed prosthesis of the calcaneus is a viable alternative to amputation. PMID:25827294

  4. 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.

  5. Restoration of function after brain damage using a neural prosthesis

    PubMed Central

    Guggenmos, David J.; Azin, Meysam; Barbay, Scott; Mahnken, Jonathan D.; Dunham, Caleb; Mohseni, Pedram; Nudo, Randolph J.

    2013-01-01

    Neural interface systems are becoming increasingly more feasible for brain repair strategies. This paper tests the hypothesis that recovery after brain injury can be facilitated by a neural prosthesis serving as a communication link between distant locations in the cerebral cortex. The primary motor area in the cerebral cortex was injured in a rat model of focal brain injury, disrupting communication between motor and somatosensory areas and resulting in impaired reaching and grasping abilities. After implantation of microelectrodes in cerebral cortex, a neural prosthesis discriminated action potentials (spikes) in premotor cortex that triggered electrical stimulation in somatosensory cortex continuously over subsequent weeks. Within 1 wk, while receiving spike-triggered stimulation, rats showed substantially improved reaching and grasping functions that were indistinguishable from prelesion levels by 2 wk. Post hoc analysis of the spikes evoked by the stimulation provides compelling evidence that the neural prosthesis enhanced functional connectivity between the two target areas. This proof-of-concept study demonstrates that neural interface systems can be used effectively to bridge damaged neural pathways functionally and promote recovery after brain injury. PMID:24324155

  6. 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

  7. 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

  8. Urinary Incontinence Could Be Controlled by an Inflatable Penile Prosthesis

    PubMed Central

    Choi, Hyung Ki; Lee, Hye-Yeon

    2016-01-01

    Purpose Due to the increasing numbers of radical prostatectomies (RP) performed for prostate cancer, a substantial and increasing number of patients suffer from postoperative urinary incontinence and erectile dysfunction (ED). The objective of our study was to see whether an inflatable penile prosthesis implantation could control urinary incontinence for patients with the dual problems of ED and incontinence. Materials and Methods From March 2010 through May 2015, 25 post-RP patients were referred to our clinic with ED or incontinence. The degree of incontinence was classified according to the International Consultation on Incontinence Questionnaire-Short Form. Inflatable penile prostheses were implanted in all 25 patients. Results For one month after implantation, partial or full inflation was performed progressively to control urine leakage. Of 18 patients, 13 patients were categorized with mild or moderate stress incontinence. All 13 patients obtained control of incontinence with partial inflation (30% to 60%) and all reported satisfactory outcomes. Five out of the 18 patients were categorized with severe total incontinence. Three of the 5 patients could tolerate incontinence with full inflation on and off. Thirteen patients out of the total of 18 (72.2%) had their incontinence controlled by an inflating penile prosthesis. Conclusions An inflatable penile prosthesis is highly recommended as an initial procedure, especially in patients with the dual problems of ED and incontinence. PMID:27169127

  9. Retinal Prosthesis System for Advanced Retinitis Pigmentosa: A Health Technology Assessment

    PubMed Central

    2016-01-01

    Background Retinitis pigmentosa is a group of genetic disorders that involves the breakdown and loss of photoreceptors in the retina, resulting in progressive retinal degeneration and eventual blindness. The Argus II Retinal Prosthesis System is the only currently available surgical implantable device approved by Health Canada. It has been shown to improve visual function in patients with severe visual loss from advanced retinitis pigmentosa. The objective of this analysis was to examine the clinical effectiveness, cost-effectiveness, budget impact, and safety of the Argus II system in improving visual function, as well as exploring patient experiences with the system. Methods We performed a systematic search of the literature for studies examining the effects of the Argus II retinal prosthesis system in patients with advanced retinitis pigmentosa, and appraised the evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria, focusing on visual function, functional outcomes, quality of life, and adverse events. We developed a Markov decision-analytic model to assess the cost-effectiveness of the Argus II system compared with standard care over a 10-year time horizon. We also conducted a 5-year budget impact analysis. We used a qualitative design and an interview methodology to examine patients’ lived experience, and we used a modified grounded theory methodology to analyze information from interviews. Transcripts were coded, and themes were compared against one another. Results One multicentre international study and one single-centre study were included in the clinical review. In both studies, patients showed improved visual function with the Argus II system. However, the sight-threatening surgical complication rate was substantial. In the base-case analysis, the Argus II system was cost-effective compared with standard care only if willingness-to-pay was more than $207,616 per quality-adjusted life

  10. Intrathoracic tracheal reconstruction with a collagen-conjugated prosthesis: evaluation of the efficacy of omental wrapping.

    PubMed

    Teramachi, M; Okumura, N; Nakamura, T; Yamamoto, Y; Kiyotani, T; Takimoto, Y; Matsuda, S; Ikada, Y; Shimizu, Y

    1997-04-01

    Reconstructions of the intrathoracic trachea in 24 dogs were done with the use of 50 mm long collagen-conjugated tracheal prostheses. Omental wrapping was also done in 14 of the dogs (omentopexy group) to evaluate the efficacy of this option in comparison with results in the other 10 dogs (control group). All 24 dogs had uneventful postoperative courses and were killed at 4 weeks or 3, 6, or 12 months after the operation. Better epithelialization and fewer complications, such as mesh exposure and luminal stenosis, were observed in the omentopexy group than in the control group. Angiography and analysis of regenerated blood vessels revealed that vessel ingrowth had started within 4 weeks and that vessel formation reached its maximal point within 6 to 12 months in the omentopexy group. In contrast, revascularization of the subepithelial region in the control group was poor even after 3 months, and vessel formation continued for as long as 12 months. The differences between the two groups were considered to be mainly a result of the speed of blood vessel ingrowth into the regenerated mucosa. We conclude that our prosthesis can be used safely for intrathoracic tracheal reconstruction and that omental wrapping is a useful supplementary method that reduces the occurrence of complications. PMID:9104979

  11. Chemoprophylaxis of fungal deterioration of the Provox silicone tracheoesophageal prosthesis in postlaryngectomy patients.

    PubMed

    van Weissenbruch, R; Bouckaert, S; Remon, J P; Nelis, H J; Aerts, R; Albers, F W

    1997-04-01

    A double-blind randomized trial was conducted among 36 laryngectomees to assess the influence of a buccal bioadhesive slow-release tablet containing miconazole nitrate on the lifetime of the Provox voice prosthesis. All patients colonized with Candida spp and treated with miconazole showed a significant decrease of colonization at the end of the study. Intratracheal phonatory pressures were remarkably higher after 2 months of follow-up in the placebo group. No local or systemic adverse reactions to miconazole were observed during this study. Patient compliance was acceptable according to regular miconazole determination in saliva samples. The device lifetime was significantly higher in patients treated with miconazole even after 1 year of follow-up. The use of a buccal bioadhesive slow-release tablet containing an antimycotic agent proves to be an adequate method of preventing fungal colonization and deterioration of silicone voice prostheses. PMID:9109726

  12. 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

  13. Intervertebral prosthesis versus anterior lumbar interbody fusion: one-year results of a prospective non-randomised study.

    PubMed

    Schroven, Ive; Dorofey, Dimitri

    2006-01-01

    The authors conducted a prospective non-randomised study on the ProDisc intervertebral prosthesis versus anterior lumbar interbody fusion (ALIF). The first group included 14 patients, the second group 10 patients. In the ProDisc group the Oswestry Disability Index improved from +/- 38.42 preoperatively (60 being the worst possible condition) to +/- 15.21 after 6 months and to +/- 12.5 after 12 months. This was definitely better than the ALIF group, where the corresponding figures were +/- 38, +/- 25 and +/- 21.4. The ProDisc patients also scored better with respect to duration of hospitalisation, blood loss and operation time. The complications were comparable in both groups. PMID:16570900

  14. [Role of the process of endothelium formation on the wall of the aortic prosthesis in protection against infection. Experimental study in dogs].

    PubMed

    Gaudencio, A M; Netto, B M; Silva, M R; Ferreira, L M; Aguiar, E T; Sato, M K; Aun, R; Langer, B; Puech-Leao, P

    1998-04-01

    An experimental canine model was developed in order to evaluate the role of endothelialization of aortic prostheses for protection against septicemic infection and the utilization of 131I radiolabeled bacteria for vascular experimentation. Two groups of dogs were submitted to insertion of a dacron prosthesis segment in the abdominal aorta with subsequent infusion of inert 131I radiolabeled bacteria. In the first group ("A"), formed by five dogs, the infusion was made 30 minutes after the insertion of the prosthesis and in the second group ("B"), formed by four dogs, in a new surgery performed 12 weeks after. Fragments of the animals' prostheses and aortas were collected after 30 minutes of septicemia and analyzed by scan electron microscopy and submitted to reading of radioactivity uptake by a well-type counter. The microscopy recognized a complete endothelialization of the prostheses of dogs of group "B" 12 weeks after their insertion. Statistical analysis comparing fragments of non-endothelialized prostheses, of endothelialized prostheses and aortas demonstrated that the lower radioactivity uptake of the endothelialized prostheses in relation to non-endothelialized ones was significant (p = 0.0143) and that there was no significant statistical difference in uptake in the aortas and in endothelialized prosthesis (p = 0.3173). It was, therefore, concluded that prosthesis endothelialization fully protected them against septicemic infection; bacteremia contaminated all the non-endothelialized prostheses; there was no bacterial adhesion in the endothelialized prostheses and the use of bacteria labeled with radioisotope 131I is appropriate for the study of infections in vascular prosthetic devices. PMID:9608922

  15. 21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... uncemented acetabular component, prosthesis. 888.3330 Section 888.3330 Food and Drugs FOOD AND DRUG..., prosthesis. (a) Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The...

  16. 21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... uncemented acetabular component, prosthesis. 888.3330 Section 888.3330 Food and Drugs FOOD AND DRUG..., prosthesis. (a) Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The...

  17. 21 CFR 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  18. 21 CFR 888.3590 - Knee joint tibial (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 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...

  19. 21 CFR 888.3490 - Knee joint femorotibial metal/composite 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/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...

  20. 21 CFR 888.3580 - Knee joint patellar (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 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  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 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  10. 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...

  11. 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...

  12. 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...

  13. 21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  14. 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...

  15. 21 CFR 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 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 888.3550 - 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...

  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 888.3590 - 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...

  19. 21 CFR 888.3500 - Knee joint femorotibial metal/composite 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/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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 21 CFR 888.3490 - Knee joint femorotibial metal/composite 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/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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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)...

  17. 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...

  18. 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)...

  19. 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...

  20. 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...

  1. 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)...

  2. 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...

  3. 21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 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 888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hip joint metal/polymer semi-constrained cemented prosthesis. 888.3350 Section 888.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer semi-constrained cemented prosthesis. (a) Identification. A hip joint metal/polymer...

  5. 21 CFR 888.3160 - Elbow joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 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 888.3110 - Ankle joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  7. 21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 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 888.3520 - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  9. 21 CFR 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  10. 21 CFR 888.3310 - Hip joint metal/polymer constrained 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 metal/polymer constrained cemented or... Hip joint metal/polymer constrained cemented or uncemented prosthesis. (a) Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted...

  11. 21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  12. 21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 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 888.3810 - Wrist joint ulnar (hemi-wrist) 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 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...

  14. Split-frame implant prosthesis designed to compensate for mandibular flexure: a clinical report.

    PubMed

    Paez, Carmen Yamily; Barco, Thomas; Roushdy, Sally; Andres, Carl

    2003-04-01

    When an edentulous mandible is restored with 4 or more implants connected by a metal bar and retained with screws, mandibular flexure may cause screw loosening and unnecessary stresses and strains on the prosthesis and implants. Separating the prosthesis at the midline can relieve these stresses and strains. This article describes the separation of a hybrid mandibular denture at the midline. PMID:12690344

  15. 21 CFR 888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Hip joint metal/polymer semi-constrained cemented prosthesis. 888.3350 Section 888.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer semi-constrained cemented prosthesis. (a) Identification. A hip joint metal/polymer...

  16. 21 CFR 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  17. 21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  18. 21 CFR 888.3520 - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  19. 21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  20. 21 CFR 888.3810 - Wrist joint ulnar (hemi-wrist) 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 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...

  1. 21 CFR 888.3310 - Hip joint metal/polymer constrained 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 metal/polymer constrained cemented or... Hip joint metal/polymer constrained cemented or uncemented prosthesis. (a) Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted...

  2. 21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  3. 21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  4. 21 CFR 888.3160 - Elbow joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  5. 21 CFR 888.3110 - Ankle joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  6. Bone-prosthesis composite with rotating hinged-knee prosthesis in limb salvage surgery for high-grade sarcoma around the knee.

    PubMed

    Wang, Chien-Shun; Wu, Po-Kuei; Chen, Cheng-Fong; Chen, Wei-Ming; Liu, Chien-Lin; Chen, Tain-Hsiung

    2015-01-01

    Bone prosthesis composite (BPC) had been widely-used in reconstruction after wide excision of malignant tumors around the knee. However, implant selection for BPC remains a dilemma. Forty-one patients with high-grade malignant bone tumors around the knee who underwent excision and reconstruction with BPC and rotating hinged knee (RHK) prosthesis were included. The mean follow-up time was 54 months (range, 31-78 months). The average Musculoskeletal Tumor Society Rating score was 93.4% (range, 73-100%). The mean range of motion was 125°. Complications included 2 local recurrences, 2 nonunions, and 1 peri-prosthetic fracture. The reconstruction with BPC using the RHK prosthesis provided consistently good functional results with a low complication rate. The RHK prosthesis is a promising choice for BPC reconstruction. PMID:25155237

  7. Prosthesis Infections after Orthopedic Joint Replacement: The Possible Role of Bacterial Biofilms

    PubMed Central

    Song, Zhijun; Borgwardt, Lotte; Høiby, Niels; Wu, Hong; Sørensen, Torben Sandberg; Borgwardt, Arne

    2013-01-01

    Prosthesis-related infection is a serious complication for patients after orthopedic joint replacement, which is currently difficult to treat with antibiotic therapy. Consequently, in most cases, removal of the infected prosthesis is the only solution to cure the infection. It is, therefore, important to understand the comprehensive interaction between the microbiological situation and the host immune responses that lead to prosthesis infections. Evidence indicates that prosthesis infections are actually biofilm-correlated infections that are highly resistant to antibiotic treatment and the host immune responses. The authors reviewed the related literature in the context of their clinical experience, and discussed the possible etiology and mechanism leading to the infections, especially problems related to bacterial biofilm, and prophylaxis and treatment of infection, including both microbiological and surgical measures. Recent progress in research into bacterial biofilm and possible future treatment options of prosthesis-related infections are discussed. PMID:23888204

  8. Rehabilitation of orbital cavity after orbital exenteration using polymethyl methacrylate orbital prosthesis.

    PubMed

    Jain, Sumeet; Jain, Parul

    2016-01-01

    Squamous cell carcinoma of the eyelid is the second most common malignant neoplasm of the eye with the incidence of 0.09 and 2.42 cases/100 000 people. Orbital invasion is a rare complication but, if recognized early, can be treated effectively with exenteration. Although with advancements in technology such as computer-aided design and computer-aided manufacturing, material science, and retentive methods like implants, orbital prosthesis with stock ocular prosthesis made of methyl methacrylate retained by anatomic undercuts is quiet effective and should not be overlooked and forgotten. This clinical report describes prosthetic rehabilitation of two male patients with polymethyl methacrylate resin orbital prosthesis after orbital exenteration, for squamous cell carcinoma of the upper eyelid. The orbital prosthesis was sufficiently retained by hard and soft tissue undercuts without any complications. The patients using the prosthesis are quite satisfied with the cosmetic results and felt comfortable attending the social events. PMID:27134437

  9. Results with the Roseland(®) HAC trapeziometacarpal prosthesis after more than 10 years.

    PubMed

    Semere, A; Vuillerme, N; Corcella, D; Forli, A; Moutet, F

    2015-04-01

    The Roseland(®) hydroxyapatite-coated prosthesis is a total trapeziometacarpal joint prosthesis used for the surgical treatment of thumb basal joint arthritis. The aim of this retrospective study was to evaluate its long-term outcomes. Fifty-one patients (64 thumbs) underwent trapeziometacarpal joint replacement with this prosthesis. The mean follow-up was 12.5 years. Survival rate of the prosthesis was 91%. There was either no pain or only occasional pain in 91% of cases. The mean QuickDASH score was 27.6. Abnormal radiographic findings were present in 70% of cases. Since they were often asymptomatic, no further treatment was carried out. Complications were common (25%) and occurred early on but could often be treated without surgery. The long-term results with the Roseland(®) HAC prosthesis are satisfactory in terms of pain relief and function. However, the high complication rate is a major concern. PMID:25769771

  10. CAD CAM trans-tibial temporary prosthesis: analysis and comparison with an established technique.

    PubMed

    Ruder, G K

    1992-12-01

    The purpose of this study was to evaluate the application of CAD CAM in the production of temporary trans-tibial prostheses. The CAD CAM system was assessed based on the number of socket attempts, number of prosthetic appointments, and temporary prosthesis rehabilitation time. These parameters were considered to be related to the quality of socket fit and were influenced by the entire interdisciplinary team including the patient. A concurrent prospective comparison between the CAD CAM system and an established fiberglass/pelite liner technique was also performed. Patients (n = 30), were fitted with either a conventional or a CAD CAM socket. Records were kept before and after discharge until the interdisciplinary team considered the patient ready for definitive prosthesis casting. After approximately 90 postoperative days, patients were deemed fit to proceed from their initial plaster cast prostheses to their temporary prostheses. The group fitted with conventional sockets had an in-patient rehabilitation phase of 10.5 +/- 15.0 days and required 2.9 +/- 1.1 prosthetic appointments. In-patients fitted with CAD CAM sockets required 5.1 +/- 1.8 appointments and were hospitalised for 23.6 +/- 15.0 days. The significantly increased rehabilitation duration and number of appointments (p = 0.01), were generally due to incorrect socket volume and/or inadequately modified relief/loading areas. In this study 67% of the patients fitted with CAD CAM sockets required at least one additional attempt. The clinical evaluation and modification of the temporary prostheses, including the decision to remake a particular socket, were carried out by the same prosthetist who cast the patients.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:1491953

  11. Evaluation of Palatal Plate Thickness of Maxillary Prosthesis on Phonation- A Comparative Clinical Study

    PubMed Central

    B, Sreedevi; Anne, Gopinadh; Manne, Prakash; Bindu O, Swetha Hima; Atla, Jyothi; Deepthi, Sneha; Chaitanya A, Krishna

    2014-01-01

    Background: Prosthodontic treatment involves clinical procedures which influence speech performance directly or indirectly. Prosthetic rehabilitation of missing teeth with partial or complete maxillary removable dentures influences the individual voice characteristics like Phonation, resonance etc. Aim: To evaluate the effect of Acrylic palatal plate thickness (1mm-3mm) of maxillary prosthesis on phonation. Materials and Methods: Twelve subjects were selected randomly between the age group of 20-25 years who have full complement of teeth and have no speech problems. Speech evaluation was done under four experimental conditions i.e. Without any experimental acrylic palatal plate (control), with experimental acrylic palatal plates of thickness 1 mm, 2 mm and 3 mm respectively. The speech material for phonation test consisted of Vowels sounds /a/, /i/, and /o/. Speech analysis to assess phonation was done using digital acoustic analysis (PRAAT software). The obtained results were statistically analyzed by One-way ANOVA and Tukey’s multiple post-hoc for comparison of four experimental conditions with respect to different vowel sounds. Results: Mean harmonics to noise ratio (HNR) values obtained for all the Experimental conditions did not show significant difference (p>0.05). In conclusion, an increase in the thickness of the acrylic palatal plate of maxillary prosthesis for about 1 mm - 3mm in complete or partial maxillary removable dentures resulted in no significant effect on phonation of vowel sounds /a/, /i/ and /o/. Conclusion: Increasing the thickness of the palatal plate from 1 mm to 3 mm has not shown any significant effect on the phonation. PMID:24959508

  12. A quantitative assessment of results with the Angelchik prosthesis.

    PubMed Central

    Wyllie, J. H.; Edwards, D. A.

    1985-01-01

    The Angelchik antireflux prosthesis was assessed in 15 unpromising patients, 12 of whom had peptic strictures of the oesophagus. Radiological techniques were used to show the effect of the device on gastro-oesophageal reflux, and on the bore and length of strictures. Twelve months later (range 6-24) most patients were well satisfied with the operation, and all considered it had been worthwhile; there was radiological evidence of reduction in reflux and remission of strictures. The device never surrounded the oesophageal sphincter; in all but 1 case it encircled a tube of stomach. Images Fig. 5 Fig. 6 PMID:4037629

  13. A concept for hip prosthesis identification using ultra wideband radar.

    PubMed

    Lui, Hoi-Shun; Shuley, Nicholas; Crozier, Stuart

    2004-01-01

    Ultra wideband (UWB) radar has been extensively investigated both theoretically and practically for the identification buried artifacts. Ground probe radar (GPR) concentrates on the identification of lightly buried land mines, unexploded ordnance (UXO) and archeological targets. The same technology is proposed in a similar context for the rapid identification of in vivo implanted metallic prostheses. The technique is based on resonance based target identification and the paper investigates UWB scattering from a metallic hip prosthesis in free space as a first step in the identification process. PMID:17271965

  14. Seeing the light: a photonic visual prosthesis for the blind

    NASA Astrophysics Data System (ADS)

    Degenaar, Patrick; Grossman, Nir; McGovern, Brian; Neil, Mark; Drakakis, Emmanuel; Nikolic, Konstantin

    2009-02-01

    This paper highlights how the genetic incorporation of artificial opsins into the retina can lead to a new class of retinal prosthesis. We demonstrate the efficacy of incorporating channelrhodopsin into neuron cells in-vitro and show how that can be scaled to in-vivo. We show that we need typically 100mW/cm2 of instantaneous light intensity on the neuron in order to stimulate action potentials which results in 10W/cm2 required from the light source. We thus use GaN LED arrays to provide spatially controlled stimulation which is of sufficient brightness to stimulate the cells.

  15. Load transfer with the Austin Moore cementless hip prosthesis.

    PubMed

    Keaveny, T M; Bartel, D L

    1993-03-01

    More than 1,300 Austin Moore hemiarthroplasties have been reviewed in the literature, with no reports of fracture of the stem. Many patients with these hip implants had good function. The lack of stem fractures in patients with good functions has not been explained and contrasts with stem fractures that have occurred in patients with cemented prostheses of other designs during the same time. We used three-dimensional finite-element analysis and free-body diagrams to explain the lack of fractures for this device by a description of the probable load-transfer mechanisms between the prosthesis and the bone. Results from our finite-element analysis indicate that, with good calcar-collar support, the stresses in the stem are small because the stem portion of the prosthesis and the bone are uncoupled and, consequently, do not share the resultant bending moment of the head and abductor forces. If the stem is coupled to the bone so that the resultant bending moment is shared, high stresses in the stem are predicted; such stresses are inconsistent with the complete absence of fractures of these prostheses. The results of the finite-element analysis further showed that loss of calcar-collar support with proximal fixation through the fenestrations resulted in high stresses in the stem and stress shielding of the proximal medial cortex. The uncoupled prosthesis also may be modeled with a free-body diagram as a three-force member loaded at the head, stem tip, and in the proximal region. With this model, it can be shown that the reaction force of the stem tip, and thus the peak bending stress in the stem, increases as calcar-collar support is decreased. If there is no calcar-collar support, proximal support must be provided by some combination of integration of bone in the fenestrations and wedging due to the lateral-medial taper of the device. Stresses in the stem are largest when there is no wedging, but high stresses develop in the cancellous bone in the fenestrations. When

  16. Potential of an electric prosthesis for dynamic facial reanimation.

    PubMed

    Griffin, Garrett R; Kim, Jennifer C

    2011-09-01

    Chronic facial paralysis is a devastating condition with severe functional and emotional consequences. The current surgical armamentarium permits the predictable reestablishment of a protective blink as well as good resting symmetry. Yet the ultimate goal of symmetric, spontaneous emotional expression remains elusive despite significant progress in the areas of peripheral nerve grafting and free tissue transfer. This commentary explores the possibility of an implantable electrical prosthesis for facial reanimation. It reviews animal studies supporting this concept as well as recent human data suggesting that such an implant could rescue denervated facial musculature, thus overcoming a major hurdle for existing reanimation techniques. PMID:21636836

  17. Acute LVOT Obstruction with a Carbomedics Mechanical Valve Prosthesis.

    PubMed

    Alsidawi, Said; Joyce, David L; Malouf, Joseph F; Nkomo, Vuyisile T

    2016-06-01

    A 62-year-old female with severe symptomatic rheumatic mitral stenosis was referred for mitral valve replacement. A 27-mm Carbomedics mechanical mitral valve was placed using everting sutures. As the patient was weaned off cardiopulmonary bypass, she became hemodynamically unstable. Intraoperative transesophageal echocardiogram revealed a significant drop in left ventricular function along with severe LVOT obstruction. The Carbomedics prosthesis was replaced by a 27-mm St. Jude mechanical valve using noneverting sutures which relieved the LVOT obstruction. doi: 10.1111/jocs.12749 (J Card Surg 2016;31:376-379). PMID:27087635

  18. Texturing polymer surfaces by transfer casting. [cardiovascular prosthesis

    NASA Technical Reports Server (NTRS)

    Banks, B. A.; Weigand, A. J.; Sovey, J. S. (Inventor)

    1982-01-01

    A technique for fabricating textured surfaces on polymers without altering their surface chemistries is described. A surface of a fluorocarbon polymer is exposed to a beam of ions to texture it. The polymer which is to be surface-roughened is then cast over the textured surface of the fluorocarbon polymer. After curing, the cast polymer is peeled off the textured fluorocarbon polymer, and the peeled off surface has negative replica of the textured surface. The microscopic surface texture provides large surface areas for adhesive bonding. In cardiovascular prosthesis applications the surfaces are relied on for the development of a thin adherent well nourished thrombus.

  19. Some examples of image warping for low vision prosthesis

    NASA Technical Reports Server (NTRS)

    Juday, Richard D.; Loshin, David S.

    1988-01-01

    NASA has developed an image processor, the Programmable Remapper, for certain functions in machine vision. The Remapper performs a highly arbitrary geometric warping of an image at video rate. It might ultimately be shrunk to a size and cost that could allow its use in a low-vision prosthesis. Coordinate warpings have been developed for retinitis pigmentosa (tunnel vision) and for maculapathy (loss of central field) that are intended to make best use of the patient's remaining viable retina. The rationales and mathematics are presented for some warpings that we will try in clinical studies using the Remapper's prototype.

  20. [Early rehabilitation of vascular amputees. Value of the multipurpose prosthesis].

    PubMed

    Brenot, R; Grumler, B; Didier, J P; David, M

    1984-01-01

    After a recall of surgical indications and of technical points of the lower limbs amputations in arteriosclerosis disease, the authors report their experience of early rehabilitation. They define the aims of the rehabilitation and the means to reach it. Among these, a multipurpose prosthesis made by them, authorized their patients to an early walk training. The results are analysed with 86 patients rehabilitated in 2 years by this method. They have 49 good results/51 with amputation below the knee, 31 good results/35 with femoral amputation. The mean age of the patients is 72. PMID:6502020

  1. Cochlear implantation: a biomechanical prosthesis for hearing loss

    PubMed Central

    Yawn, Robert; Hunter, Jacob B.; Sweeney, Alex D.

    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. PMID:26097718

  2. A Multigrasp Hand Prosthesis for Providing Precision and Conformal Grasps

    PubMed Central

    Bennett, Daniel A.; Dalley, Skyler A.; Truex, Don; Goldfarb, Michael

    2015-01-01

    This paper presents the design of an anthropomorphic prosthetic hand that incorporates four motor units in a unique configuration to explicitly provide both precision and conformal grasp capability. The paper describes the design of the hand prosthesis, and additionally describes the design of an embedded control system located in the palm of the hand that enables self-contained control of hand movement. Following the design description, the paper provides experimental characterizations of hand performance, including digit force capability, bandwidth of digit movement, physical properties such as size and mass, and electrical power measurements during activities of daily living. PMID:26167111

  3. Hearing results with clothespin ossiculoplasty: preliminary report on the Kraus Modified Schuring Ossicle-Cup Prosthesis (Clothespin Prosthesis).

    PubMed

    Kraus, E M

    1993-07-01

    The clothespin partial ossicular replacement prosthesis (PORP) is designed to increase joint stability during incus replacement ossiculoplasty. Fundamental modifications have been made in the Schuring ossicle-cup, which include a forked well, increased well wall thickness and length, and a flexible tip disk added to the shaft. The forked well functions like a straight clothespin rather than an inverted cup. The forked well enables the clothespin prothesis to slide down over the stapes superstructure, between the facial nerve canal and the promontory, to form a stable, mortise-and-tenon prosthesis-stapedial joint. Joint stability is enhanced because the inferior tine of the forked well is able to lever against the inferior surface of the stapes superstructure, creating a counterforce to gravity. This is in contrast to the more unstable ball-and-socket joint created by most partial ossicular replacement prostheses when they articulate with the stapes capitulum. The addition of a flexible disk to the shaft tip produces a tight, stable union between the prosthesis and the ossicular cap by increasing resistance at the shaft-ossicle interface. Fluoroplastic composition maximizes intraoperative versatility and reliability while the ossicle cap minimizes extrusions. One-year hearing results for twelve chronic ear patients with mobile stapes undergoing clothespin ossiculoplasty during intact canal wall tympanomastoidectomy revealed postoperative air-bone gaps within 20 dB in 92% of cases. The mean postoperative air-bone gap was 8.9 dB, and the mean improvement in air-bone gap was 14.4 dB.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:8336964

  4. Long-term results of the Wagner cone prosthesis

    PubMed Central

    Schraml, Annemarie; Hohenberger, Gerd

    2007-01-01

    The Wagner cone prosthesis is indicated in uncemented total hip replacement of cases with cylinder-shaped femurs, deformed femurs, femurs with increased antetorsion, and in conditions of intramedullary bony scar tissue after previous osteotomies. The objective of this study is to present long-term results. From January 1, 1993 to December 31, 1995, 132 implantations were made with the Wagner cone prosthesis. We report the clinical and radiographic results of 94 cone prostheses with a mean observation period of 11.5 years. The Merle d’Aubigné score improved from a preoperative mean value of 8.8 to a postoperative mean of 16.3. The radiographic evaluation revealed 32 cases with cortical hypertrophy, 73 cases with atrophy of the proximal femur, and 18 cases with complete pedestal formation. Radiolucencies over Gruen zones 1 and 7 occurred in 42 cases; only zone 1 was affected in 24 cases. Complications included three deep infections, three acetabular revisions, five total joint revisions, one recurrent luxation, and three heterotopic ossifications. In spite of the fact that the examined cohort often included patients who had undergone multiple previous operations (a maximum of six) of the proximal femur or the acetabulum, the long-term results of the Wagner cone prostheses were very promising. PMID:17932669

  5. Computer design synthesis of a below knee-Syme prosthesis

    NASA Technical Reports Server (NTRS)

    Elangovan, P. T.; Ghista, D. N.; Alwar, R. S.

    1979-01-01

    A detailed design synthesis analysis of the BK Syme prosthesis is provided, to determine the socket's cutout orientation size and shape, cutout fillet shape, socket wall thickness distribution and the reinforced fiber distribution in the socket wall, for a minimally stressed structurally safe lightweight prosthesis. For analysis purposes, the most adverse socket loading is obtained at the push-off stage of gait; this loading is idealized as an axial in-plane loading on the bottom edge of the circular cylindrical socket shell whose top edge is considered fixed. Finite element stress analysis of the socket shell (with uniform and graded wall thickness) are performed for various orientations of the cutout and for various types of corner fillets. A lateral cutout with a streamline fillet is recommended. The wall material (i.e., thickness) distribution is determined so as to minimize the stresses, while ensuring that the wall material's stress limits are not exceeded. For such a maximally stressed lightweight socket shell, the panels in the neighborhood of the cutout are checked to ensure that they do not buckle under their acquired stresses. A fiber-reinforced laminated composite socket shell is also analyzed in order to recommend optimum variables in orientations and densities of reinforcing fibers.

  6. Magnet retained lip prosthesis in a geriatric patient

    PubMed Central

    Rao, Srinivasa B; Gurram, Sunil Kumar; Mishra, Sunil Kumar; Chowdhary, Ramesh

    2015-01-01

    Surgical resection of lips is a relatively rare procedure. A defective lip may cause the patient to feel socially vulnerable as well as functionally handicapped and the defect will influence the patient's self-esteem and body image. Patients with labial defects also experience speech problems along with drying and crusting of the tissues in the area of defect. The lip and cheek provide a valve mechanism for speech. Rehabilitation of patients with this type of surgery creates numerous challenges for both the surgical and the maxillofacial prosthetic teams. The goals of prosthetic treatment include regaining favorable speech and restoration of esthetics. This case report presents a 65-year-old woman who was referred for restoration of her lost lip. This case paper describes a quick and simple method of positioning magnets with lip prosthesis attached to maxillary denture and thus esthetics and speech of the patient is restored. Use of retention magnets simplify the clinical and laboratory phase retains the denture and makes it stable and comfortable for the patient. The advent of magnets has enhanced the dental practitioner's capabilities with a remarkably improved potential for increasing prosthesis stability and preserving tissue. PMID:26929510

  7. Simultaneous penile prosthesis and male sling/artificial urinary sphincter.

    PubMed

    Lee, Dominic; Romero, Claudio; Alba, Frances; Westney, O Lenaine; Wang, Run

    2013-01-01

    Erectile dysfunction (ED) and stress urinary incontinence (SUI) from urethral sphincteric deficiency is not an uncommon problem. The commonest etiology is intervention for localized prostate cancer and/or radical cystoprostatectomy for muscle invasive bladder cancer. Despite advances in surgical technology with robotic assisted laparoscopic prostatectomy and nerve sparing techniques, the rates of ED and SUI remain relatively unchanged. They both impact greatly on quality of life domains and have been associated with poor performance outcomes. Both the artificial urinary sphincter and penile prosthesis are gold standard treatments with proven efficacy, satisfaction and durability for end-stage SUI and ED respectively. Simultaneous prosthesis implantation for concurrent conditions has been well described, mostly in small retrospective series. The uptake of combination surgery has been slow due in part to technical demands of the surgery and to an extent, a heightened anxiety over potential complications. This paper aims to discuss the technical aspect of concurrent surgery for both disease entity and the current published outcomes of the various surgical techniques with this approach. PMID:23202702

  8. Cosmetic effect of knee joint in a knee disarticulation prosthesis.

    PubMed

    de Laat, Fred A; van der Pluijm, Mark J; van Kuijk, Annette A; Geertzen, Jan H; Roorda, Leo D

    2014-01-01

    Despite numerous advantages, knee disarticulations (KDs) are rarely performed because of the anticipated KD prosthesis fitting problems that include the positioning of the knee joint distally from the KD socket. This results in lengthening of the thigh and subsequent shortening of the shank. The objective of this study was to assess the cosmetic effect of the knee joint in a KD prosthesis by determining the extent of the lengthening of the thigh and the shortening of the shank. This lengthening and shortening were measured through an experimental setup using laser techniques. These measurements were made of 18 knee joints used in KD prostheses. Lengthening of the thigh varied between 23 and 92 mm, and shortening of the shank varied between 3 and 50 mm. The polycentric knees Medi KH6 and Medi KHF1 showed the least lengthening of the thigh, and the polycentric knees Teh Lin Prosthetic & Orthotic Co. Ltd Graph-Lite and Medi KP5 showed the least shortening of the shank. PMID:25856500

  9. Prototype neural semicircular canal prosthesis using patterned electrical stimulation.

    PubMed

    Gong, W; Merfeld, D M

    2000-05-01

    The design of a prototype semicircular canal prosthesis is presented along with preliminary results. This device measures angular velocity of the head (+/-500 degrees/s) using a piezoelectric vibrating gyroscope. With a digital filter this velocity is filtered to match the dynamic characteristics of the semicircular canals, which are the physiological rotation sensors of the vestibular system. This digitally filtered signal is used to modulate the pulse rate of electrical stimulation. The pulse rate is varied between 50 and 250 Hz via a sigmoidal lookup table relating pulse rate to angular velocity; the steady-state rate is 150 Hz. A current source utilizes these timing pulses to deliver charge balanced, cathodic-first, biphasic, current pulses to the nerves innervating the semicircular canal via platinum electrodes. Power is supplied via lithium batteries. dc/dc converters are used to generate regulated +/-5 V supplies from the batteries. All of the components are contained in a small, lightweight, Nylon box measuring roughly 43 mm x 31 mm x 25 mm, which can be mounted on the top of an animal's head. This device has been tested in guinea pigs having surgically implanted platinum electrodes, and the results show that the prosthesis can provide a rotational cue to the nervous system. PMID:10925955

  10. Output space tracking control for above-knee prosthesis.

    PubMed

    Popović, D B; Kalanović, V D

    1993-06-01

    The control of a knee joint in an active above-knee prosthesis has been designed using the Lyapunov tracking method. A simulation of locomotion was done to prove that the tracking control in output space is a valuable real time control method for artificial legs. The data used for simulation was collected in able-bodied subjects while they walked on a powered treadmill. Human volunteers were braced with an ankle splint (limiting dorsi- and plantar flexion) and with a knee cage (limiting knee movements to the lateral plane). We studied the achieved tracking of the prescribed knee motion, deviations of the thigh movement from the prescribed trajectory, maximal angular deviations from the desired trajectory and the power consumption as functions of a limited maximal knee torque and a damping constant in the knee actuator. We found that the use of output tracking method is suitable for the design of appropriate hardware of an above-knee prosthesis and for real-time control. PMID:8262536

  11. Optimal control for the active above-knee prosthesis.

    PubMed

    Popović, D; Oğuztöreli, M N; Stein, R B

    1991-01-01

    Control of an active above-knee prosthesis has been simulated for a selected gait activity using a hierarchical closed-loop method. An extension of finite-state control, referred to as artificial reflex control, was adopted at the strategic level of control. At the actuator level of control an optimal tracking method, based on dynamic programming, is applied. This deals mainly with the actuator level of control, but considers the interaction of the leg dynamics and the switching effects of artificial reflex control. Optimal tracking at the actuator level of the above-knee prosthesis reduces the on-off effects of finite-state methods, such as artificial reflex control. The proposed method can also be used for the design of prosthetic elements. Specific attention is paid to the limited torque and power in the prosthetic joint actuator, which are imposed by the principle of self-containment in the artificial leg. The hierarchical structure, integrating artificial reflex control and optimal tracking, can be used in real time, as estimated from the number of computer operations required for the suggested method. PMID:2048773

  12. [Fibrinolytic therapy in thrombosis of a mitral valve prosthesis].

    PubMed

    Viedt, C; Mereles, D; Kübler, W; Kreuzer, J

    2000-08-01

    A 48-year-old woman presented with progressive dyspnea due to thrombosis of a mitral valve prosthesis. The patient had undergone mitral valve replacement (St. Jude Medical) six years prior to admission because of mitral stenosis (Class III); three years later the prosthesis had to be replaced (St. Jude Medical) because of valve thrombosis. At admission, transesophageal echocardiography showed a thrombus on the atrial side of the fixed valve leaflet and a thrombus (2.4 x 1.6 cm) floating from the left atrial roof. Because of the previous thoracotomies, thrombolysis was initiated despite the mobile thrombus with the attendant risk of embolization. Urokinase was infused in a dose to maintain the fibrinogen level around 100 mg/dl. After 24 h, the mean pressure gradient across the prosthetic mitral valve (measured by doppler echocardiography) had decreased from 23 to 11 mmHg. After 13 days of this modified thrombolytic regimen, the clinical symptoms of the patient had resolved and echocardiography showed a normal function of the prosthetic mitral valve without evidence of residual thrombosis. This patient demonstrates that prolonged cautious thrombolysis can be effective for the treatment of prosthetic valve thrombosis in hemodynamically moderately compromised patients. PMID:11013975

  13. Surgical treatment of early acute thrombosis of mechanical mitral prosthesis.

    PubMed

    Jiang, Shengli; Zhang, Tao; Ren, Chonglei; Wang, Yao

    2010-10-01

    Prosthetic valve thrombosis is a rare but life threatening complication of mechanical heart valve prosthesis. A 44-year-old woman diagnosed with rheumatic heart disease with severe mitral valve stenosis, moderate tricuspid valve insufficiency, and atrial fibrillation underwent transseptal mitral valve replacement and tricuspid valvuloplasty in our department. Heparin and warfarin were routinely used postoperatively. Although the international normalized ratio (INR), activated partial thromboplastin time ratio, and platelet count were satisfactory, the patient presented with severe dyspnea suddenly 10 days after discharge; echocardiogram showed that the prosthetic posterior leaflet was immobile. The patient suffered cardiac arrest suddenly during the examination and cardiopulmonary resuscitation was carried out successfully. Emergent surgery was performed, confirming the prosthetic valve thrombosis. The prosthetic valve was replaced with another mechanical prosthesis. The patient recovered smoothly and was discharged 14 days later with atrial fibrillation. During the 12-months follow-up period, her prosthetic valve and heart function were normal with INR around 3.0. This case highlights the need for awareness among clinicians for the possibility of valve thrombosis in the early postoperative period. PMID:20961833

  14. Reconstruction of the mandible by bone graft and metal prosthesis.

    PubMed

    Kummoona, Raja

    2009-07-01

    This clinical research was carried out in the Maxillofacial Unit, Surgical Specialties Hospital, Medical City, Baghdad, and included 188 patients with mandibular defects. The patients' ages ranged from 4 to 70 years (mean, 37 years); 60 of them were female, and 128 were male. One hundred twenty-six patients represent 67.03% of total cases with benign and locally aggressive tumors and malignant tumors of the mandible and oral cavity. Eighty-four cases (44.68%) of these were benign, 42 cases (22.34%) were malignant tumors, and 62 patients constitute about 32.98% with mandibular defect of posttraumatic missile injuries. Reconstruction of the mandible were done by a variety of techniques ranging from immediate reconstruction of the mandible by chrome-cobalt prosthesis, Kirschner wire, rib graft and bone graft from the iliac crest, and other additional technique of reimplanted condyle, secured with bone graft, and Dacron osteomesh tray carrying cancellous bone harvested from iliac crest. Long-term follow-up ranged between 5 and 10 years.The aim of these study was to share experience and to present an interesting pathology and methods of reconstruction of the mandible by metal prosthesis and bone graft; the management of these cases was a difficult task to be approached in some cases and was a surgical challenge to us. PMID:19521256

  15. [The effect of prosthesis-patient mismatchon early myocardial remodeling after aortic valve replacement].

    PubMed

    Belov, Iu V; Katkov, A I; Seslavinskaia, T V; Vinokurov, I A; Salagaev, G I

    2015-01-01

    The reductionofan effective orifice area is associated with the development of the phenomenon of prosthesis-patient mismatch (PPM). The purpose of this study was to evaluate the impact of PPM on the immediate results of surgical treatment in patients with aortic valve stenosis. The study included 50 patients who underwent aortic valve replacement. All patients were divided into 2 groups: with PPM (27 patients) and without it (23 patients). Immediate postoperative results were not statistically different. Analysis of echocardiographic data showed worse results in patients with PPM. It was marked reduction of LV EDV on 23.43 ± 8.93 ml in the group without PPM and on 16.5 ± 1.76 ml in patients with PPM (p<0.05). Also it was noted a greater decrease of pulmonary artery pressure (16.56 ± 12.94 mm Hg) compared with the group with PPM (8.44 ± 7.38 mm Hg), p<0.05. The presence of PPM in patients after aortic valve replacement leads to a slower reverse remodeling of the myocardium. PMID:26031944

  16. The importance of psychosexual counselling in the re-establishment of organic and erotic functions after penile prosthesis implantation.

    PubMed

    Pisano, F; Falcone, M; Abbona, A; Oderda, M; Soria, F; Peraldo, F; Marson, F; Barale, M; Fiorito, C; Gurioli, A; Frea, B; Gontero, P

    2015-01-01

    Although many studies about penile prosthesis implantation (PPI) have been published so far, only a small amount of them take into account patients and partners outcome in terms of satisfaction and erotic function. The aim of this study is to explore the value of psycosexual counselling in and the sexual and erotic function of penile prosthesis recipients. Thirty patients and their partners were randomised into two groups. In arm A (case group) patients and their partners underwent a multistep psychosexual counselling before and after surgery. In arm B (control group) surgery was performed without the specific psychosexual counselling scheme. Specific questionnaires (International Index of Erectile Function (IIEF) and the Sexual Daydreaming Scale (SDS)) were administered before surgery and 12 months afterwards. Twenty-four months postoperatively patients were asked to complete the Global Assessment Questions (GAQ) and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), while their partners were asked to answer to the EDITS partner's section. Between January 2009 and October 2011, we enrolled 30 patients undergoing PPI in our institution (15 in each arm). Twenty-four months postoperative follow-up is available for all of them. No significant differences between the two groups in terms of baseline questionnaires scores were observed. Mean IIEF score was significantly higher in case group (arm A 68.3, arm B 53.4, P-value<0.001). At 12 months after PPI the improvement of erotic function according to SDS was significantly higher in the study group for both patients and their partners. Improvement in satisfaction rates were confirmed at 24 months, with statistically significant scores for EDITS in arm A patients and partners as compared with arm B. PPI with a pre- and postoperative psychosexual counselling scheme resulted in better postoperative sexual activity and erotic function for both patients and partners than PPI alone. PMID:26268774

  17. 3D optical measurement of relative displacement for the tuberosities in the shoulder prosthesis

    NASA Astrophysics Data System (ADS)

    Yao, XueFeng; Meng, LiBo; Yu, LiuPing; Zhu, YiMing; Jiang, ChunYan

    2011-04-01

    In this paper, a binocular 3-D computer vision measurement system is used to measure the relative displacement for the greater and lesser tuberosities in the shoulder prosthesis. The basic principles of binocular optical measurement are introduced in detail, and the loading apparatus is designed for external rotation and anteflexion of the shoulder prosthesis. Both the motion of external rotation and anteflexion of the shoulder are measured, and the corresponding displacement values for the greater and lesser tuberosities are extracted. These results will play an important role in evaluating the stability of humeral tuberosity in the shoulder prosthesis.

  18. Maxillary palatal ramp prosthesis: A prosthodontic solution to manage mandibular deviation following surgery

    PubMed Central

    (Bhattacharya), Sampa Ray; Majumdar, Dibyendu; Singh, Dilip K.; Islam, M. D. Rabiul; Ray, Pradip K.; Saha, Nilanjana

    2015-01-01

    Mandibular resection following surgical treatment for neoplastic lesions of the oral cavity leads to numerous complications including altered mandibular movements, disfigurement, difficult in swallowing, impaired speech and articulation, and deviation of the mandible towards the resected site. Various prosthetic methods are employed to reduce or minimize mandibular deviation and improve and restore the lost functions and esthetic, like maxillomandibular fixation, implant supported prosthesis, removable mandibular guide flange prosthesis, and palatal based guidance restoration. This clinical report describes the rehabilitation of a patient following segmental mandibulectomy using palatal ramp prosthesis. PMID:25821361

  19. An innovative impression technique for fabrication of a custom made ocular prosthesis

    PubMed Central

    Tripuraneni, Sunil Chandra; Vadapalli, Sriharsha Babu; Ravikiran, P; Nirupama, N

    2015-01-01

    Various impression and fitting techniques have been described in the past for restoring ocular defects. The present article describes a new direct impression technique for recording and rehabilitating ocular defects, by custom-made ocular prosthesis. All the techniques described in the history, mainly concentrated in recording the tissue surface of the defect, which made it difficult to contour the palpebral surface resulting in the poor esthetics of the prosthesis. The present impression technique uses heavy bodied polyvinyl siloxane impression material, which facilitates accurate recording of the tissue surface and the palpebral surface of the defect, resulting in the fabrication of functionally and esthetically acceptable prosthesis. PMID:26265651

  20. The reverse shoulder prosthesis (Delta III) in acute shoulder fractures: technical considerations with respect to stability.

    PubMed

    Van Seymortier, Peter; Stoffelen, Daniel; Fortems, Yves; Reynders, Piet

    2006-08-01

    The reverse shoulder prosthesis reverses the relationship between the scapular and humeral component, resulting in a mechanical advantage as the deltoid muscle is able to compensate for the rotator cuff deficiency. Based on this mechanical advantage, the reverse shoulder prosthesis has become an accepted alternative for the treatment of complex proximal humeral fractures. The purpose of this article is to discuss technical considerations related to stability in the use of the reverse shoulder prosthesis in acute shoulder fractures, based on clinical experience. PMID:17009830

  1. Hybrid type anterior fibre-reinforced composite resin prosthesis: a case report.

    PubMed

    Garoushi, Sufyan; Shinya, Akikazu; Shinya, Akiyoshi; Vallittu, Pekka K

    2008-03-01

    A variety of therapeutic modalities, from implant to conventional Maryland prosthesis, can be used for the replacement of a missing anterior tooth. In patients refusing implant treatment, when minimal teeth reduction is preferred, a fibre reinforced composite (FRC) prosthesis can be a good alternative to conventional prosthetic techniques. The purpose of this case report is to describe the clinical procedure for fabricating hybrid type FRC prosthesis with pre-impregnated unidirectional E-glass fibres. Fibre-reinforced composite, in combination with adhesive technology, appears promising treatment option for replacing missing teeth. However, further clinical investigation will be required to provide additional information on this technique. PMID:18468325

  2. Tissue augmentation using Bioplastique as a treatment of leakage around a Provox 2 voice prosthesis.

    PubMed

    Rokade, A V; Mathews, J; Reddy, K T V

    2003-01-01

    Rehabilitation of voice and speech after laryngectomy with valve prosthesis has become a well-established practice in recent years. The formation of tracheo-oesophageal fistula (TOF) and the subsequent management of the patient with a voice prosthesis can be associated with a number of problems and complications. We report a new technique of the use of injectable Bioplastique in the treatment of persistent leakage around Provox 2 voice prosthesis. Our experience in two cases has shown that it is a relatively simple and effective procedure in stopping the leak around the valve immediately and is without any short-term complications. PMID:12590865

  3. Implantable optrode design for optogenetic visual cortical prosthesis

    NASA Astrophysics Data System (ADS)

    Dong, Na; Sun, Xiaohan; Degenaar, Patrick

    2012-02-01

    The rise of optogenetic neural stimulation has opened new opportunities for neuroprosthesis such as visual cortical prosthesis, which necessitates an efficient delivery of light into the cortex. New forms of photosensitizing channelrhodopsin are reducing the required light intensities for stimulation, but implantable systems need to be highly efficient. Such efficiency calls for low loss in the transmission path, high coupling efficiency between the optic delivery system and optical emitter, as well as emitting efficiency from the light emitting diode. In this paper, we perform simulation results based on ray optics and illuminating theory as to the best strategy to attachment of optrode structures to Gallium Nitride-μLED arrays so as to maximize the efficiency of light delivery to the target neural tissue.Our results show that it is feasible to connect optrode elements and GaN-μLEDarrays for cortical stimulation and describe the optimisation requirements.

  4. Cemented total hip prosthesis: Radiographic and scintigraphic evaluation

    SciTech Connect

    Aliabadi, P.; Tumeh, S.S.; Weissman, B.N.; McNeil, B.J. )

    1989-10-01

    Conventional radiographs, technetium-99m bone scans, and gallium-67 scans were reviewed in 44 patients who had undergone cemented total hip joint replacement and were imaged because of suspicion of prosthesis loosening or infection. A complete radiolucent line of 2 mm or wider along the bone-cement interface or metal-cement lucency on conventional radiographs was used as the criterion for prosthetic loosening with or without infection and proved to be 54% sensitive and 96% specific. Scintigraphic criteria for prosthetic loosening were increased focal uptake of the radiopharmaceutical for the femoral component and increased focal or diffuse uptake for the acetabular component. For bone scintigraphy, sensitivity was 73% and specificity was 96%. Combining the results of conventional radiographs and bone scans increased sensitivity to 84% and decreased specificity to 92% for the diagnosis of loosening, infection, or both. The study also showed that Ga-67 scintigraphy has a low sensitivity for the detection of infection.

  5. [Infection of a hip prosthesis after dry needling].

    PubMed

    Steentjes, Koen; de Vries, Lieke M A; Ridwan, Ben U; Wijgman, A J Jurgen

    2016-01-01

    A 57-year-old patient presented to the orthopaedic department with hip pain 7 months after hip replacement and two weeks after dry needling by a physiotherapist. Dry needling is used by physiotherapists to treat pain and stiffness. In the Netherlands, there are no clear guidelines or contra-indications described for this treatment. The surgical scar of our patient showed signs of inflammation for which debridement and irrigation were performed. Tissue samples showed positive bacterial cultures and the patient was treated with antibiotics. One week after completing this treatment, the infection returned. Debridement and irrigation were repeated and antibiotic treatment was recommenced. Three months later, the patient showed no signs of infection with the prosthesis still in situ. Although there is no strong evidence for a causal relationship between dry needling and the infection, dry needling should be used carefully in patients with a joint replacement, due to the increased risk of infection. PMID:26786794

  6. Leaflet escape in a revised Edwards-Duromedics mitral prosthesis.

    PubMed

    Mert, Murat; Ozkara, Ahmet; Hatemi, AliCan

    2003-07-01

    The original Duromedics-Edwards bileaflet valve was withdrawn from the market in 1988 after 12 reports of leaflet escape. The leaflet was modified by the manufacturer, and the revised Edwards-Duromedics and Edwards TEKNA valves were introduced in 1990 and 1993, respectively. However, problems of leaflet escape have now been reported with the new models. A case is reported of sudden leaflet fracture of a revised Duromedics mitral valve 86 months after implantation; this was managed successfully by emergency replacement with a St. Jude Medical mechanical prosthesis. The fracture had occurred transversely, with the two fragments embolizing bilaterally to the right common iliac and left external iliac arteries. In the absence of an exact diagnosis, but with a high index of suspicion, the key to survival of patients with leaflet escape is immediate reoperation. PMID:12918855

  7. Fatal leaflet escape in an Edwards TEKNA aortic prosthesis.

    PubMed

    Pfeiffer, Heidi; Bertolini, Julia; Scheld, Hans Heinrich; Brinkmann, Bernd

    2006-01-01

    The case is reported of a 26-year-old male patient who died eight years after the replacement of an aortic valve with a bileaflet mechanical valve (TEKNA; Edwards, USA). Following prosthesis implantation, the patient had been in a good state of health, and his death occurred unexpectedly. Forensic autopsy revealed a leaflet escape, with two fragments of the leaflet being found bilaterally in the common iliac arteries. Death occurred due to an acute cardiac insufficiency. Immunohistochemical investigations revealed fresh myocardial fiber necroses. Stereomicroscopic and scanning electron microscopic investigations demonstrated surface erosions of the leaflet. Although the valve was withdrawn from the market in June 2000, it had previously been implanted in over 18,000 patients. Thus, from a clinical viewpoint, the question of using a prophylactic replacement in affected patients must be discussed. PMID:16480019

  8. [Limb prosthesis of the 19th and 20th century].

    PubMed

    Knoche, W

    2009-02-01

    Wouldn't the thought of a separate stump-cushioning, as mentioned by Heine, Eichler and others, make sense even today, regarding difficult and badly blood-supplied amputation-stumps? Shouldn't the thought of Hermann and Habermann, to do a knee-saving interference, be updated, especially for the weak and helpless patients? It is safe to say that one has to challenge the question, which objective methods of inspection are under consideration, to check and control the correct fit and construction for every individual patient. It is a credit to the executive of the orthopaedic-supply-center Hamburg-Altona, zur Verth, who challenged that question almost one hundred years ago. Not only zur Verth rated the value of amputation-levels in his amputation-scheme, but Arnsberger invented 1927 a device to objectify the composition of a prosthesis. PMID:19259935

  9. Subsidence of the femoral prosthesis. A stereophotogrammetric evaluation.

    PubMed

    Chafetz, N; Baumrind, S; Murray, W R; Genant, H K; Korn, E L

    1985-12-01

    A quantitative three-dimensional measurement method, radiographic stereophotogrammetry (SPG), was employed to assess the relation between early subsidence of the femoral prosthesis after total hip arthroplasty (THA) and subsequent clinical course. The SPG technique and the authors' error control mechanisms are described in 15 patients in the early postoperative period, and the findings are correlated with those of follow-up clinical examinations. Among the 12 patients who remained clinically asymptomatic with respect to pain, only one had an SPG estimate of subsidence in excess of 1 mm at any point in time. Each of the three patients who later became symptomatic had SPG estimates of subsidence in excess of 1.75 mm within six months of the operation. Thus far, the patient with the largest estimate of subsidence is the only one who required surgical revision. PMID:4064420

  10. Some Examples Of Image Warping For Low Vision Prosthesis

    NASA Astrophysics Data System (ADS)

    Juday, Richard D.; Loshin, David S.

    1988-08-01

    NASA and Texas Instruments have developed an image processor, the Programmable Remapper 1, for certain functions in machine vision. The Remapper performs a highly arbitrary geometric warping of an image at video rate. It might ultimately be shrunk to a size and cost that could allow its use in a low-vision prosthesis. We have developed coordinate warpings for retinitis pigmentosa (tunnel vision) and for maculapathy (loss of central field) that are intended to make best use of the patient's remaining viable retina. The rationales and mathematics are presented for some warpings that we will try in clinical studies using the Remapper's prototype. (Recorded video imagery was shown at the conference for the maculapathy remapping.

  11. Evaluation of Strength in the ``Toronto'' Osseous-Prosthesis System

    NASA Astrophysics Data System (ADS)

    Giacomo, R.; Cicciã¹, M.; Dini, R.; Franceschini, G.; Maiorana, C.

    2010-06-01

    Several surgical techniques like are today available in order to recovery large bone defects of the jaw. Aim of the surgeon is to obtain a good tridimensional volume to place dental implant and to recovery the patient’s aesthetics and function. Several prosthetic solution were considered for prosthetic rehabilitation. However after a bone graft surgery Toronto screwed prosthesis on dental implants, following Branemark intuitions, was considered the better prosthetic rehabilitation solution. According to Wölff, the dental implants osteointegration is related to the strengths directed to mandibular bone. Our investigation’s aim is to underline through FEM analysis the stress over the prosthetic elements and over bone surface in order to help the surgeon choice about the dental implant positioning, and at the same time reducing the bone trauma on the patients.

  12. 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

  13. Promising short-term clinical results of the cementless Oxford phase III medial unicondylar knee prosthesis

    PubMed Central

    van Dorp, Karin B; Breugem, Stefan JM; Bruijn, Daniël J; Driessen, Marcel JM

    2016-01-01

    AIM: To investigate the short-term clinical results of the Oxford phase III cementless medial unicondylar knee prosthesis (UKP) compared to the cemented medial UKP. METHODS: We conducted a cross-sectional study in a tertairy orthopedic centre between the period of May 2010 and September 2012. We included 99 medial UKP in 97 patients and of these UKP, 53 were cemented and 46 were cementless. Clinical outcome was measured using a questionnaire, containing a visual analogue scale (VAS) for pain, Oxford Knee score, Kujala score and SF-12 score. Knee function was tested using the American Knee Society score. Complications, reoperations and revisions were recorded. Statistical significance was defined as a P value < 0.05. RESULTS: In a mean follow-up time of 19.5 mo, three cemented medial UKP were revised to a total knee prosthesis. Reasons for revision were malrotation of the tibial component, aseptic loosening of the tibial component and progression of osteoarthritis in the lateral- and patellofemoral compartment. In five patients a successful reoperation was performed, because of impingement or (sub)luxation of the polyethylene bearing. Patients with a reoperation were significant younger than patients in the primary group (56.7 vs 64.0, P = 0.01) and were more likely to be male (85.7% vs 38.8%, P = 0.015). Overall the cementless medial UKP seems to perform better, but the differences in clinical outcome are not significant; a VAS pain score of 7.4 vs 11.7 (P = 0.22), an Oxford Knee score of 43.3 vs 41.7 (P = 0.27) and a Kujala score of 79.6 vs 78.0 (P = 0.63). The American Knee Society scores were slightly better in the cementless group with 94.5 vs 90.2 (P = 0.055) for the objective score and 91.2 vs 87.8 (P = 0.25) for the subjective score. CONCLUSION: The cementless Oxford phase III medial UKP shows good short-term clinical results, when used in a specialist clinic by an experienced surgeon. PMID:27114932

  14. Fabrication of an integrated cartilage/bone joint prosthesis and its potential application in joint replacement.

    PubMed

    Hou, Yi; Chen, Chen; Zhou, Song; Li, Yubao; Wang, Danqing; Zhang, Li

    2016-06-01

    An integrated cartilage/bone joint prosthesis was designed and fabricated using a two-step molding injection method, in which ethylene-vinyl acetate copolymer (EVA) was used as the upper cartilage layer, and hydroxyapatite/polyamide66 (HA/PA66) composites as the underlying bone layer. Holes punched in the underlying layer improved the interfacial bonding strength between the two layers by means of the mechanical interlocking obviously. Then, the physicochemical properties and in vivo behaviors of the integrated joint prosthesis were investigated. The results showed that the upper layer displayed good bio-tribological properties which were suitable for the articular cartilage replacement, while the underlying layer demonstrated good mechanical performance, excellent biocompatibility and high bioactivity, and could accelerate bone regeneration and the early bio-fixation of the prosthesis. Therefore, the prosthesis prepared here will have a wide prospect to be used in joint replacement. PMID:26889776

  15. 21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... made of alloys, such as cobalt-chromium-molybdenum, or alloys with ultra-high molecular weight... equivalent to a shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis that was in...

  16. Short-Term Effect of Prosthesis Transforming Sensory Modalities on Walking in Stroke Patients with Hemiparesis.

    PubMed

    Owaki, Dai; Sekiguchi, Yusuke; Honda, Keita; Ishiguro, Akio; Izumi, Shin-Ichi

    2016-01-01

    Sensory impairments caused by neurological or physical disorders hamper kinesthesia, making rehabilitation difficult. In order to overcome this problem, we proposed and developed a novel biofeedback prosthesis called Auditory Foot for transforming sensory modalities, in which the sensor prosthesis transforms plantar sensations to auditory feedback signals. This study investigated the short-term effect of the auditory feedback prosthesis on walking in stroke patients with hemiparesis. To evaluate the effect, we compared four conditions of auditory feedback from plantar sensors at the heel and fifth metatarsal. We found significant differences in the maximum hip extension angle and ankle plantar flexor moment on the affected side during the stance phase, between conditions with and without auditory feedback signals. These results indicate that our sensory prosthesis could enhance walking performance in stroke patients with hemiparesis, resulting in effective short-term rehabilitation. PMID:27547456

  17. Late Reconstruction of a Traumatic Trapeziometacarpal Dislocation with a Semi-constrained Prosthesis: A Case Report.

    PubMed

    Zollinger, Paul E

    2007-12-01

    Traumatic dislocation of the trapeziometacarpal joint is rare. A stable reduction should be accomplished as soon as possible, usually with K-wiring. In this case of persistent instability a semi-constrained prosthesis was applied successfully. PMID:26815093

  18. Rehabilitation of Digital Defect with Silicone Finger Prosthesis: A Case Report

    PubMed Central

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

    2014-01-01

    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. PMID:25302277

  19. Digital capture, design, and manufacturing of a facial prosthesis: Clinical report on a pediatric patient.

    PubMed

    Grant, Gerald T; Aita-Holmes, Cynthia; Liacouras, Peter; Garnes, Johnathan; Wilson, William O

    2015-07-01

    A digitally captured, designed, and fabricated facial prosthesis is presented as an alternative to customary maxillofacial prosthodontics fabrication techniques, where a facial moulage and patient cooperation may be difficult. PMID:25882970

  20. 21 CFR 888.3550 - Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... III. (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a... polymer/metal/metal constrained cemented prosthesis shall have an approved PMA or a declared completed...

  1. 21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  2. 21 CFR 888.3550 - Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... III. (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a... polymer/metal/metal constrained cemented prosthesis shall have an approved PMA or a declared completed...

  3. 21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  4. 21 CFR 878.3540 - Silicone gel-filled breast prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... application (PMA) is required. A PMA is required to be filed with the Food and Drug Administration on or... silicone gel-filled breast prosthesis shall have an approved PMA in effect before being placed...

  5. Enlargement of mitral valve ring in a young woman with severe prosthesis-patient mismatch.

    PubMed

    Attisani, Matteo; Pellegrini, Augusto; Sorrentino, Paolo; Rinaldi, Mauro

    2014-04-01

    Mechanical prosthesis is the first choice for valve replacement at the mitral position in children. Replacement of the original prosthesis because of prosthesis-patient mismatch (PPM) is almost inevitable when prostheses are implanted in small children. The impact of PPM on long-term mortality becomes significant when the effective orifice area (EOA) is severely reduced. In these cases prosthesis replacement can be technically difficult, and it often requires extended enlargement of the mitral valve annulus ring. We report a case of a woman who underwent a mitral valve replacement with a 19-mm St. Jude mechanical prosthetic valve at the age of 3 years. At the age of 33 years, the patient underwent a successful minimally invasive mitral annulus ring enlargement and implantation of a 23-mm St. Jude mechanical prosthetic valve via a right minithoracotomy. PMID:24808442

  6. The influence of textile vascular prosthesis crimping on graft longitudinal elasticity and flexibility.

    PubMed

    Hajjaji, R; Abdessalem, S Ben; Ganghoffer, J F

    2012-12-01

    Textile vascular prostheses are the principal substitute for the replacement of large vascular arteries. These prostheses undergo a thermal treatment of crimping inducing a wavy shape of the graft wall. Today mechanical properties of crimped vascular prostheses are not well known. After implantation, vascular prostheses are exposed to several longitudinal forces due to blood pressure, inducing their deformation during the cardiac cycle. In arteries that undergo large bending deformation, the flexibility is a necessary feature of vascular prostheses. In the present work, a longitudinal tensile model and a bending model of woven vascular prosthesis are numerically simulated. The obtained results provide a better understanding of the impact of the crimping parameters on the longitudinal elasticity and the bending stiffness of the textile vascular prosthesis. Mathematical predictive models of longitudinal elasticity and bending stiffness of the textile prosthesis have been developed, allowing relating the prosthesis elasticity and flexibility with the crimping parameters. PMID:23159512

  7. CT-generated porous hydroxyapatite orbital floor prosthesis as a prototype bioimplant.

    PubMed

    Levy, R A; Chu, T M; Halloran, J W; Feinberg, S E; Hollister, S

    1997-09-01

    Hydroxyapatite bioceramic was used for the manufacture of an orbital floor prosthesis from spiral CT data acquired transaxially at 1-mm beam collimation, pitch of 1, and 0.2-mm reconstruction intervals. CT data were converted to vector file format for subsequent prosthesis manufacture on a stereo-lithography machine. The orbital floor prosthesis was engrafted onto an acrylic model of the orbit as a qualitative indication of its overall accuracy. High anatomic accuracy was achieved, as determined by visual inspection. Cross-hatching of the vector file data allowed a porous internal architecture of the prosthesis. Refinements in chemical structure of the hydroxyapatite bioceramic are expected to enhance mechanical properties. PMID:9296194

  8. Rehabilitation of a Partial Nasal Defect with Facial Prosthesis: A Case Report

    PubMed Central

    Negahdari, Ramin; Pournasrollah, Alireza; Bohlouli, Sepideh; Sighari Deljavan, Alireza

    2014-01-01

    >Malignancies of the midface result in cosmetic deformities that make maxillofacial prosthesis as an integral part of the treatment plan. Facial defects can be devastating in their impact on physical structure and function of the affected individual, leading to potentional compromises in quality of life. Reconstruction of nasal defects is a challenge for the prosthodontist because of esthetic and retention problems associated with the facial prosthesis. This paper reports the rehabilitation of a partial nasal defect caused by basal cell carcinoma treatment using a nasal prosthesis made with silicone elastomers and mechanical and anatomical retentive aids. The patient had no problem with the prosthesis, except for a partial loss of extrinsic coloration in the two-year follow-up. PMID:25587390

  9. Self-Contained Powered Knee and Ankle Prosthesis: Initial Evaluation on a Transfemoral Amputee

    PubMed Central

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

    2009-01-01

    This paper presents an overview of the design and control of a fully self-contained prosthesis, which is intended to improve 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. The prosthesis was tested on an unilateral amputee subject for over-ground walking. Prosthesis sensor data (joint angles and torques) acquired during level ground walking experiments at a self-selected cadence demonstrates the ability of the device to provide a functional gait similar to normal gait biomechanics. Battery measurements during level ground walking experiments show that the self-contained device provides over 4,500 strides (9.0 km of walking at a speed of 5.1 km/h) between battery charges. PMID:20228944

  10. [Fatigue property analysis of prosthesis of hip joint with two different materials].

    PubMed

    Tang, Gang; Wang, Jiange; Luo, Hongxia

    2015-02-01

    Total hip replacement (THR) is replacing the prosthesis stem similar to human bone that takes advantage of the material with both good mechanical properties and biocompatibility to the damaged articular surface. Thus it can not only alleviate or even eliminate the pain but also effectively maintain the joint stability and freedom and restore its normal performance. Finite element analysis was used in this study to establish a 3D model of artificial hip stem, and explore its fatigue properties of different materials to ensure the safety and reliability. The calculating obtained two results of different metal hip prosthesis, including lifetime and deformation. The minimum service life of titanium prosthesis reaches 568 million times, which satisfies ISO standards, while the stainless steel does not suit to be a prosthesis material. PMID:25997269

  11. Short-Term Effect of Prosthesis Transforming Sensory Modalities on Walking in Stroke Patients with Hemiparesis

    PubMed Central

    Sekiguchi, Yusuke; Honda, Keita; Ishiguro, Akio

    2016-01-01

    Sensory impairments caused by neurological or physical disorders hamper kinesthesia, making rehabilitation difficult. In order to overcome this problem, we proposed and developed a novel biofeedback prosthesis called Auditory Foot for transforming sensory modalities, in which the sensor prosthesis transforms plantar sensations to auditory feedback signals. This study investigated the short-term effect of the auditory feedback prosthesis on walking in stroke patients with hemiparesis. To evaluate the effect, we compared four conditions of auditory feedback from plantar sensors at the heel and fifth metatarsal. We found significant differences in the maximum hip extension angle and ankle plantar flexor moment on the affected side during the stance phase, between conditions with and without auditory feedback signals. These results indicate that our sensory prosthesis could enhance walking performance in stroke patients with hemiparesis, resulting in effective short-term rehabilitation. PMID:27547456

  12. [Intermittent diastolic dysfunction of a mechanical aortic prosthesis: a clinical case].

    PubMed

    Pinneri, F; De Felice, F; Gostoli, E; Garzaro, L; Mazza, A; Borello, G

    2000-09-01

    We describe the case of a 48 year-old man whose Sorin bileaflet aortic prosthesis presented persistent systolic and intermittent diastolic failure due to fibrous tissue overgrowth in the left ventricular outflow tract. PMID:11140292

  13. A procedure for design of a posterior resin-bonded prosthesis.

    PubMed

    Bohnenkamp, D M

    1996-06-01

    A procedure is described that uses red and brown crayon-type pencils and graphite pencil lead with a surveyor to draw a color-coded design on a study cast before fabrication of a posterior resin-bonded prosthesis. During diagnosis and treatment planning, abutments on the study cast are analyzed for undercuts and the height of contour on each abutment tooth is marked with a graphite pencil lead. Metal retainers for the prosthesis are indicated with brown lines drawn on the abutments. Enamel surfaces requiring alteration to allow insertion of the prosthesis and provide resistance to displacement are marked in red on the study cast. The surveyed color-coded study cast can be used as a reference guide by both the clinician and the laboratory technician during fabrication of the posterior resin-bonded prosthesis. PMID:8725847

  14. Positron-emission tomography pitfalls related to oral prosthesis.

    PubMed

    More, Yogesh; Dusing, Reginald; Counts, Shaheen; Bond, Justin; Tsue, Terrance; Girod, Douglas

    2013-02-01

    This case report describes false-positive positron-emission tomography/computed tomography (PET/CT) findings related to oral prostheses and its implications in cancer surveillance. In head and neck cancer management, F18-flurodeoxyglucose (FDG) PET/CT is widely accepted for evaluating treatment response and detecting recurrence. Interpretation of FDG PET/CT images in this setting is often challenging due to various prostheses and reconstruction methods. Following surgery for squamous cell carcinoma of the maxillary alveolus, a 61-year-old female had a FDG PET/CT scan on a 7-month follow-up that showed high FDG uptake along the resection site. Clinical examination showed no signs of inflammation or recurrence. Repeat FDG PET/CT without the prosthesis was normal. The PET/CT attenuation-corrected images demonstrated high FDG uptake (standardized uptake value: 11.6) along the resection site corresponding to contrast-enhanced CT images of the lesion. PET/CT nonattenuation-corrected images also confirmed increased activity. Repeat PET/CT without the prosthesis was normal. FDG is not tumor specific; it can accumulate in inflammation, infection, and post-therapy settings. Metallic and high-density prostheses show radial artifacts on CT and falsely elevated FDG uptake on PET/ CT in adjacent areas. Salivary pooling may concentrate FDG. The presence of oral prostheses has not been described as a cause of this high level of activity. PET/CT images that demonstrate intense activity corresponding to dense structures should be viewed with caution. A detailed history and physical exam as well as knowledge of artifacts are pertinent for the managing physician. Laryngoscope, 2012. PMID:22778055

  15. [Socio-psychological aspects of prosthesis in women undergoing mastectomy for breast cancer].

    PubMed

    Gundareva, I D; Chulkova, V A

    1987-01-01

    A relationship between prosthetics, personality features and occupational rehabilitation of mastectomized women is discussed. Questionnaire-based data were obtained on patients' attitude towards prosthetics as well as on certain social and labor characteristics of 65 women under study. Prosthesis users approved of its cosmetic characteristics. Their satisfaction contributed to their adaptation to domestic and industrial environment. A tetrachoric coefficient correlation was established between "use of prosthesis" and "occupation". PMID:3590666

  16. A technique to orient a stone cast in the fabrication of a nasal prosthesis.

    PubMed

    Acharya, Varun; Montgomery, Patricia C

    2014-09-01

    Obtaining the correct orientation of the stone cast in the fabrication of a nasal prosthesis is a challenging task. The current technique involves repeated trials of the waxed nasal prosthesis on the patient's face to establish its correct position. This article proposes a simplified technique to aid in establishing the proper orientation of the stone cast in an effort to decrease the number of error corrections related to midline discrepancies during the wax sculpting stage. PMID:24725614

  17. Titanium ball joint total ossicular replacement prosthesis--experimental evaluation and midterm clinical results.

    PubMed

    Gostian, A O; Pazen, D; Luers, J C; Huttenbrink, K B; Beutner, D

    2013-07-01

    During reconstruction of the ossicular chain, there is a need to address the forces and loads caused by the ambient atmospheric pressure variations and the resulting tympanic membrane movements. It is understood that when a rigid middle ear prosthesis is inserted the malleoincudal joint, a keyfactor in controlling pressure variations in the middle ear space is bypassed. In this paper we describe a modified total titanium ossicular replacement prosthesis with an innovative micro ball joint in the headplate which is designed to compensate for tympanic membrane movements caused by atmospheric pressure variations. The characteristics of this modified prosthesis were examined in temporal bone experiments and compared to the standard titanium total ossicular reconstruction prosthesis. Sound-induced stapes footplate movements were investigated by means of a Laser vibrometer and revealed no significant differences between the two prostheses in vitro. Intraoperatively, the insertion of the modified prosthesis required more delicate handling. The angle between the shaft and the headplate was variable and ranged from 60 to 90° as estimated by the surgeon. Twelve consecutive patients were eligible for clinical evaluation. The pure tone average (PTA) air-bone gap after a mean follow up period of 32 months was 18.8 dB. Furthermore, no extrusion, dislocation or other adverse events were observed. We conclude that the modified total ossicular replacement prosthesis with integrated micro ball joint yields similar volume velocities of the stapes footplate in the laboratory experiments compared to the standard rigid prosthesis. The audiological and morphological results are encouraging and show that the mobile prosthesis headplate adjusting to the level of the tympanic membrane is a further step in the development of a physiological middle ear implant. This article is part of a special issue entitled "MEMRO 2012". PMID:23142147

  18. Fabrication of a new silicone auricular prosthesis without removing the existing metallic framework.

    PubMed

    Goveas, Reiyal; Shrestha, Binit; Srithavaj, M L Theerathavaj; Thaworanunta, Sita

    2014-12-01

    Silicone prostheses require constant repair and refabrication. Auricular prostheses retained with implants have better retention than adhesive-retained prostheses. However, refabrication is complicated if the patient is unwilling to surrender the metallic framework attached to the implants and revert to the use of adhesives. This article describes a technique by which the metal framework of the existing prosthesis need not be removed, thereby improving the patient's quality of life until the new prosthesis is delivered. PMID:24998323

  19. TAVI in the case of preexisting mitral prosthesis: tips & tricks and literature review.

    PubMed

    Vavuranakis, Manolis; Vrachatis, Dimitrios A; Kariori, Maria G; Moldovan, Carmen; Kalogeras, Konstantinos; Lavda, Maria; Aznaouridis, Konstantinos; Stefanadis, Christodoulos

    2014-11-01

    Very limited data exist on transcatheter aortic valve implantation (TAVI) in the setting of a preexisting mitral prosthesis regarding the technique, potential complications, and outcomes. Here, we report two cases of transfemoral TAVI with a self-expanding bioprosthesis (CoreValve; Medtronic, Inc) in patients who had previously undergone mitral valve replacement (one with an Omniscience and one with a St. Jude prosthesis). A brief literature review is also presented. PMID:25364003

  20. A Starr-Edwards mitral prosthesis after 44 years of good performance.

    PubMed

    De Santo, Luca Salvatore; De Feo, Marisa; Della Corte, Alessandro; Cerasuolo, Flavio; Santé, Pasquale; Torella, Michele; Nappi, Gianantonio

    2010-06-01

    The Starr-Edwards caged-ball prosthesis has been widely used to replace cardiac valves. The Model 6120 mitral prosthesis was introduced on the market in 1965 to reduce the high incidence of ball variance and thromboembolism of the previous model. We report the case of a Starr-Edwards Model 6120 which had been in place for 44 years and was still well functioning with no apparent structural damage. PMID:20812436

  1. Design of visual prosthesis image processing system based on SoC

    NASA Astrophysics Data System (ADS)

    Guo, Fei; Yang, Yuan; Gao, Yong; Wu, Chuan Ke

    2014-07-01

    This paper presents a visual prosthesis image processing system based on Leon3 SoC (System on Chip) platform. The system is built through GRLIB system development platform. It integrates the image preprocessing IP core, image encoder IP core and image data modulation IP core we designed. We transplant the system to the FPGA development board and verify the system functions. The results show that the designed system can achieve the functions of visual prosthesis image processing system effectively.

  2. [THE THROMBUS FORMATION IN THE PROSTHESIS AS A REACTION OF ORGANISM ON ITS MATERIAL].

    PubMed

    Alekseyeva, T A; Gupalo, Yu M; Kolomoets, A M; Lazarenko, O N; Lazarenko, G O; Litvin, P M; Lohs, I V; Smorzhevskiy, V J; Stepkin, V I

    2016-04-01

    Abstract Vascular prostheses, excised because of their functional properties loss, were studied. Using different methods there was established, that this complication is caused by the thrombus formation as a reaction of organism on the prosthesis material. The testing procedure on compatibility was proposed, using atomic-power microscope. Components of a patient immunity may identify the prosthesis material and start the rejection mechanisms in case of negative reaction. PMID:27434951

  3. 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

  4. [Mechanical changes in the femur induced by a joint prosthesis. Comparative extensometric studies].

    PubMed

    Delecrin, J; Royer, J; Passuty, N; Bainvel, J V

    1991-01-01

    This study using electrical extensometry is aimed at comparing the relative deformations of the same fresh femur before and after the successive implantation of the following titanium prostheses: a cement-free prosthesis with metaphyseal endocortical support, a cemented prosthesis with, then without collar, and finally a screwed titanium prosthesis. The 56 deformation measurement paths produce an overall exploration of the behavior of the femur. The results applied to the same straight section of the femur are different from those of earlier works. The density of the measurement areas has particularly been increased in the upper metaphysis by the use of bidirectional gages. The loading device ensures the absence of variations of the external stress torsion transmitted to the femur between the individual prostheses. The results recorded with the cement-free prosthesis with metaphyseal endocortical support and with the collar-free cemented prosthesis are very similar. The incidence of the "collar effect" is very low in spite of optimal in vitro implantation conditions ensuring good contact between the collar and the neck of the femur. The screwed prosthesis is the implant that most stiffens the upper end of the femur. The testing procedure chosen has allowed recording the deformations caused by the mere insertion of the implants and the bone. The importance of the upper metaphysea endocortical support of the cement-free, screwless implant contributes in ensuring a better primary anchorage, producing stresses that will then foster the secondary anchorage through endosteal osteogenesis. PMID:1843673

  5. Bionic ankle–foot prosthesis normalizes walking gait for persons with leg amputation

    PubMed Central

    Herr, Hugh M.; Grabowski, Alena M.

    2012-01-01

    Over time, leg prostheses have improved in design, but have been incapable of actively adapting to different walking velocities in a manner comparable to a biological limb. People with a leg amputation using such commercially available passive-elastic prostheses require significantly more metabolic energy to walk at the same velocities, prefer to walk slower and have abnormal biomechanics compared with non-amputees. A bionic prosthesis has been developed that emulates the function of a biological ankle during level-ground walking, specifically providing the net positive work required for a range of walking velocities. We compared metabolic energy costs, preferred velocities and biomechanical patterns of seven people with a unilateral transtibial amputation using the bionic prosthesis and using their own passive-elastic prosthesis to those of seven non-amputees during level-ground walking. Compared with using a passive-elastic prosthesis, using the bionic prosthesis decreased metabolic cost by 8 per cent, increased trailing prosthetic leg mechanical work by 57 per cent and decreased the leading biological leg mechanical work by 10 per cent, on average, across walking velocities of 0.75–1.75 m s−1 and increased preferred walking velocity by 23 per cent. Using the bionic prosthesis resulted in metabolic energy costs, preferred walking velocities and biomechanical patterns that were not significantly different from people without an amputation. PMID:21752817

  6. Bionic ankle-foot prosthesis normalizes walking gait for persons with leg amputation.

    PubMed

    Herr, Hugh M; Grabowski, Alena M

    2012-02-01

    Over time, leg prostheses have improved in design, but have been incapable of actively adapting to different walking velocities in a manner comparable to a biological limb. People with a leg amputation using such commercially available passive-elastic prostheses require significantly more metabolic energy to walk at the same velocities, prefer to walk slower and have abnormal biomechanics compared with non-amputees. A bionic prosthesis has been developed that emulates the function of a biological ankle during level-ground walking, specifically providing the net positive work required for a range of walking velocities. We compared metabolic energy costs, preferred velocities and biomechanical patterns of seven people with a unilateral transtibial amputation using the bionic prosthesis and using their own passive-elastic prosthesis to those of seven non-amputees during level-ground walking. Compared with using a passive-elastic prosthesis, using the bionic prosthesis decreased metabolic cost by 8 per cent, increased trailing prosthetic leg mechanical work by 57 per cent and decreased the leading biological leg mechanical work by 10 per cent, on average, across walking velocities of 0.75-1.75 m s(-1) and increased preferred walking velocity by 23 per cent. Using the bionic prosthesis resulted in metabolic energy costs, preferred walking velocities and biomechanical patterns that were not significantly different from people without an amputation. PMID:21752817

  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. Revision stapes surgery for lysis of the long process of the incus: comparing hydroxyapatite bone cement versus malleovestibulopexy and total ossicular replacement prosthesis.

    PubMed

    Pitiot, Vincent; Hermann, Ruben; Tringali, Stéphane; Dubreuil, Christian; Truy, Eric

    2016-09-01

    The objective of the study was to report audiological results in revision stapes surgery, comparing hydroxyapatite (HAP) bone cement, malleovestibular (MV) prosthesis, and total ossicular replacement prosthesis (TORP). The study is a retrospective case review conducted in a tertiary referral center. Patients treated for revision stapes surgery from 2010 to 2014, where a lysis of the long process of the incus (LPI) was observed with the use of HAP bone cement, MV prosthesis, or a TORP were included in the study. The main outcomes measured were pre- and postoperative bone conduction (BC) and air conduction (AC) pure-tone averages (PTA) (0.5, 1, 2, 3 kHz), including high frequencies BC (HFBC) (1, 2, 3, 4 kHz) and air-bone gap (ABG). 107 revision stapes surgery were performed in 96 ears. Main cause of failure was LPI lysis in 38 cases (39.6 %). 31 patients were analyzed: HAP bone cement was used in 11 patients (Group I), MV prosthesis in ten patients (Group II), and TORP in ten patients (Group III). The mean post-operative ABG was 10.7 dB (±7.4) (p = 0.003), 10.7 dB (±8.8) (p = 0.001), and 16.9 dB (±9.8) (p = 0.001), respectively. There were no significant differences between groups. In Group I, the mean change in HFBC revealed an improvement of 5.6 dB (±7.9) (p = 0.03), while in Group III there was a significant deterioration of the thresholds of 5.8 dB (±7.6) (p = 0.04). There were no cases of post-operative anacusis. In revision stapes surgery when LPI is eroded, we recommend to perform a cement ossiculoplasty for stabilizing a standard Teflon piston when LPI is still usable, the LPI lengthening with cement being not recommended. When LPI is too eroded, we prefer performing a malleovestibulopexy, and reserve TORP for cases with a bad anatomical presentation. PMID:26690574

  9. Toxicity analysis of ocular prosthesis acrylic resin with or without pigment incorporation in human conjunctival cell line.

    PubMed

    da Silva, Emily Vivianne Freitas; Goiato, Marcelo Coelho; Bonatto, Liliane da Rocha; de Medeiros, Rodrigo Antonio; Santos, Daniela Micheline Dos; Rangel, Elidiane Cipriano; Oliveira, Sandra Helena Penha de

    2016-10-01

    The aim of this study was to evaluate the influence of pigment incorporation on the cytotoxicity of ocular prosthesis N1 color acrylic resin. Nine samples were manufactured by heat-polymerization in water bath and divided into 3 groups: acrylic resin without pigment incorporation (group R), acrylic resin with pigment incorporation (group RP), and acrylic pigment (group P). Eluates formed after 72h of sample immersion in medium were incubated with conjunctival cell line (Chang conjunctival cells) for 72h. The negative control group consisted in medium without samples (group C). The cytotoxic effect from the eluates was evaluated using MTT assay (cell proliferation), ELISA assay (quantification of IL1β, IL6, TNF α and CCL3/MIP1α) and RT-PCR assay (mRNA expression of COL IV, TGF β and MMP9). Data were submitted to ANOVA with Bonferroni post-tests (p<0.05). All groups were considered non-cytotoxic based on cell proliferation. However, resin with pigment incorporation showed significant IL6 quantity increase. Resin without pigment incorporation exhibited higher mRNA expression of COL IV, MMP9 and TGF β, however it was also observed for the negative control group. The materials exhibited divergent biological behavior. Despite the pigment incorporation that resulted in an increase of IL6, no cytotoxicity was observed based on cell proliferation. PMID:27521695

  10. The importance of trochanteric lag screws to achieve primary stability in cementless fixation of the RM hip prosthesis.

    PubMed

    Heitemeyer, U; Hierholzer, G; Haines, J

    1987-01-01

    To allow the bony incorporation of a cementless prosthesis it is important to achieve stability at the time of operation. To neutralize tension and torsional stresses the RM-shaft prosthesis is fixed with two lag screws in the trochanteric part of the femur. By measuring the applied torque intraoperatively we could demonstrate that the threads of the screws found a better grip when inserted from the bone to the prosthesis. Thus, the stronger fixation of the screws enhanced the primary stability of the cementless prosthesis. PMID:3566504

  11. Experimental analysis of Model-Based Roentgen Stereophotogrammetric Analysis (MBRSA) on four typical prosthesis components.

    PubMed

    Seehaus, Frank; Emmerich, Judith; Kaptein, Bart L; Windhagen, Henning; Hurschler, Christof

    2009-04-01

    Classical marker-based roentgen stereophotogrammetric analysis (RSA) is an accurate method of measuring in vivo implant migration. A disadvantage of the method is the necessity of placing tantalum markers on the implant, which constitutes additional manufacturing and certification effort. Model-based RSA (MBRSA) is a method by which pose-estimation of geometric surface-models of the implant is used to detect implant migration. The placement of prosthesis markers is thus no longer necessary. The accuracy of the pose-estimation algorithms used depends on the geometry of the prosthesis as well as the accuracy of the surface models used. The goal of this study was thus to evaluate the experimental accuracy and precision of the MBRSA method for four different, but typical prosthesis geometries, that are commonly implanted. Is there a relationship existing between the accuracy of MBRSA and prosthesis geometries? Four different prosthesis geometries were investigated: one femoral and one tibial total knee arthroplasty (TKA) component and two different femoral stem total hip arthroplasty (THA) components. An experimental phantom model was used to simulate two different implant migration protocols, whereby the implant was moved relative to the surrounding bone (relative prosthesis-bone motion (RM)), or, similar to the double-repeated measures performed to assess accuracy clinically, both the prosthesis and the surrounding bone model (zero relative prosthesis-bone motion (ZRM)) were moved. Motions were performed about three translational and three rotational axes, respectively. The maximum 95% confidence interval (CI) for MBRSA of all four prosthesis investigated was better than -0.034 to 0.107 mm for in-plane and -0.217 to 0.069 mm for out-of-plane translation, and from -0.038 deg to 0.162 deg for in-plane and from -1.316 deg to 0.071 deg for out-of-plane rotation, with no clear differences between the ZRM and RM protocols observed. Accuracy in translation was similar

  12. Potential Use of Poly-N-Acetyl-β-(1,6)-Glucosamine as an Antigen for Diagnosis of Staphylococcal Orthopedic-Prosthesis-Related Infections▿

    PubMed Central

    Sadovskaya, Irina; Faure, Stéphanie; Watier, Denis; Leterme, Damien; Chokr, Ali; Girard, Julien; Migaud, Henry; Jabbouri, Saïd

    2007-01-01

    Staphylococcus aureus and coagulase-negative staphylococci are microorganisms most frequently isolated from orthopedic-implant-associated infections. Their capacity to maintain these infections is thought to be related to their ability to form adherent biofilms. Poly-N-acetyl-β-(1,6)-glucosamine (PNAG) is an important constituent of the extracellular biofilm matrix of staphylococci. In the present study, we explored the possibility of using PNAG as an antigen for detecting antibodies in the blood sera of patients with staphylococcal orthopedic-prosthesis-associated infections. First, we tested the presence of anti-PNAG antibodies in an animal model, in the blood sera of guinea pigs that developed an implant-associated infection caused by biofilm-forming, PNAG-producing strains of Staphylococcus epidermidis. Animals infected with S. epidermidis RP62A showed levels of anti-PNAG immunoglobulin G (IgG) significantly higher than those of the control group. The comparative study of healthy individuals and patients with staphylococcal prosthesis-related infections showed that (i) relatively high levels of anti-PNAG IgG were present in the blood sera of the healthy control group, (ii) the corresponding levels in the infected patients were slightly but not significantly higher, and (iii) only 1 of 10 patients had a level of anti-PNAG IgM significantly higher than that of the control group. In conclusion, the encouraging results obtained in the animal study could not be readily applied for the diagnosis of staphylococcal orthopedic-prosthesis-related infections in humans, and PNAG does not seem to be an appropriate antigen for this purpose. Further studies are necessary to determine whether the developed enzyme-linked immunosorbent assay method could serve as a complementary test in the individual follow-up treatment of such infections caused by PNAG-producing staphylococci. PMID:17942607

  13. Twelve Year Outcomes of Oxinium Total Knee Arthroplasty Compared to the Same Cobalt Chrome Prosthesis

    PubMed Central

    Vertullo, Christopher; Lewis, Peter; Graves, Stephen; Kelly, Lan; Myers, Peter

    2016-01-01

    Introduction: Alternative bearings surfaces to Cobalt Chrome (Co-Cr), such as Oxidised have been introduced in an attempt to reduce polyethylene wear and hence decrease TKA loosening and lysis. While non-comparative reports have been described as promising, no short or long term clinical studies exists showing the superiority of Oxinium on a polyethylene bearing surfaces. In this study, we investigate the long-term outcomes of Oxinium and Co-Cr TKR in a “like for like” or matched cohort analysis of the Genesis II design (Smith & Nephew, Memphis, TN, USA). Using data from a large national joint replacement registry we selected cohorts that used only the cruciate retaining design, with the same method of fixation and polyethylene type, differing only in the femoral component bearing surfaces. Our primary hypothesis was that Oxinium TKA would have a lower cumulative percent revision than the same Co-Cr prosthesis at 12 years for all causes of revision. Our secondary hypothesis was that Oxinium TKA would have a lower loosening/ lysis rate and lower rate of non-infective revision than the same Co-Cr prosthesis at 12 years. Methods: Cumulative percent revision and revision diagnosis data were obtained from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from 1 September 1999, until 31 December 2013. Results: At 12 years the cumulative percent revision of the Co-Cr Genesis II of 4.8 % (95%: CI 4.2, 5.4) for all causes was not statistically different to the Oxinium Genesis II CPR of 7.7 % (95%: CI 6.2, 9.5) (For the entire period, Hazard Ratio = 1.09 (95%: CI 0.92, 1.29), p = 0.329). The CPR for all causes was not different in the under 55 years old age group (Figure 3) (HR= 1.06 (0.68, 1.66) p=0.798).). Subgroup analysis of the CPR for loosening /lysis in both groups overall was not different (HR= 0.87 (95%: CI 0.61, 1.26), p = 0.461) Subgroup analysis of all causes of revisions excluding infection in both groups overall was not

  14. Artificial epi-Retinal Prosthesis (AeRP)

    NASA Astrophysics Data System (ADS)

    Doorish, John F.

    2006-09-01

    There are several research projects going on around the world, which are attempting to develop a prosthetic device to restore sight to the blind. This paper describes the efforts of Second Sight of New York, Inc. The device being developed is called an Artificial epi-Retinal Prosthesis (AeRP), which is basically a small optical computer that fits into the intraocular space of the eye. The AeRP is designed to draw light into the device by specially designed fibre optics. The light is ‘digitized’ by the fibre optic system and then directed to individual photodiode cells making up concentric cylinders thus providing several hundred photodiode cells in the device. The produced electrical stimulation from each cell is then delivered to the retinal ganglion cells by a specially designed delivery system utilizing electrically conducting polymer strands (ECP), which sit on an ‘umbrella’ at the back of the device. The retinal ganglion cells receive the electrical stimulation, which would then be transmitted through the visual system of the brain. There are several innovations in this approach as compared to the other projects. They include, first the design, which will allow for a high number of PC to produce electrical stimulation that will stimulate multiple RGC per PC; the use of the ECP strands has not been used in such an approach before this. Tests have revealed that nerve cells have a good affinity for the material of the ECP. The use of the ECP as well as the fact that the AeRP is completely photovoltaic, with no external power sources, implies that there will not be high heat build-up in the back of the eye, which might damage RGC. A smaller version of the AeRP called the Mini epi-Retinal Prosthesis (MeRP) is the subject of a complimentary paper. It is being built now and will be tested in cell culture studies to determine the efficacy of the design and materials. No actual implants have been performed yet.

  15. Does prosthesis design affect the need for secondary resurfacing in total knee arthroplasty?

    PubMed Central

    Rotigliano, Niccolò; Hirschmann, Michael T.

    2016-01-01

    statistically significant difference between group B and A, D and E as well as between group C and A, D and E (p<0.001). Conclusion: Prosthesis design influences the need for secondary resurfacing of the patella. It was shown that the rate ranges from 1 to 7%. The highest rate for secondary resurfacing was found in the PFC Sigma TKA.

  16. Feasibility of Structural and Functional MRI Acquisition with Unpowered Implants in Argus II Retinal Prosthesis Patients: A Case Study

    PubMed Central

    Cunningham, Samantha I.; Shi, Yonggang; Weiland, James D.; Falabella, Paulo; Olmos de Koo, Lisa C.; Zacks, David N.; Tjan, Bosco S.

    2015-01-01

    Purpose Magnetic resonance imaging (MRI) can measure the effects of vision loss and recovery on brain function and structure. In this case study, we sought to determine the feasibility of acquiring anatomical and functional MRI data in recipients of the Argus II epiretinal prosthesis system. Methods Following successful implantation with the Argus II device, two retinitis pigmentosa (RP) patients completed MRI scans with their implant unpowered to measure primary visual cortex (V1) functional responses to a tactile task, whole-brain morphometry, V1 cortical thickness, and diffusion properties of the optic tract and optic radiation. Measurements in the subjects with the Argus II implant were compared to measurements obtained previously from RP patients and sighted individuals. Results The presence of the Argus II implant resulted in artifacts that were localized around the patient's implanted eye and did not extend into cortical regions or white matter tracts associated with the visual system. Structural data on V1 cortical thickness and the retinofugal tract obtained from the two Argus II subjects fell within the ranges of sighted and RP groups. When compared to the RP and sighted subjects, Argus II patients' tactile-evoked cross-modal functional MRI (fMRI) blood oxygen level-dependent (BOLD) responses in V1 also fell within the range of either sighted or RP groups, apparently depending on time since implantation. Conclusions This study demonstrates that successful acquisition and quantification of structural and functional MR images are feasible in the presence of the inactive implant and provides preliminary information on functional changes in the brain that may follow sight restoration treatments. Transitional Relevance Successful MRI and fMRI acquisition in Argus II recipients demonstrates feasibility of using MRI to study the effect of retinal prosthesis use on brain structure and function. PMID:26693097

  17. A simplified palatal lift prosthesis for neurogenic velopharyngeal incompetence.

    PubMed

    Rilo, Benito; Fernández-Formoso, Noelia; da Silva, Luis; Pinho, Joâo Carlos

    2013-08-01

    Velopharyngeal incompetence is a contributing factor to speech disorders and implies the presence of hypernasality, inappropriate nasal escape, and decreased air pressure during speech. One prosthetic treatment is a rehabilitative procedure employing a palatal lift prosthesis (PLP), which reduces hypernasality by approximating the incompetent soft palate to the posterior pharyngeal wall and consists of two parts, the anterior denture base and the palatal lifting plate, which are connected with steel wires; however, it seems difficult to reproduce the mobility of the soft palate in speaking, and it is therefore likely that the palatal lifting plate stimulates or oppresses the tissue of the soft palate and hinders rather than assists articulatory function. To avoid these disturbances we devised an adjustable PLP with a flexible conjunction between the denture base and the palatal lifting plate to obtain the optimal vertical lifting angle. The palatal plate was adapted to conform in a passive manner to the soft palate with light-cured resin. The designed PLP simplified the procedure and reduced the number of adjustments and visits. PMID:23387878

  18. Simplified Design Equations for Class-E Neural Prosthesis Transmitters

    PubMed Central

    Troyk, Philip; Hu, Zhe

    2013-01-01

    Extreme miniaturization of implantable electronic devices is recognized as essential for the next generation of neural prostheses, owing to the need for minimizing the damage and disruption of the surrounding neural tissue. Transcutaneous power and data transmission via a magnetic link remains the most effective means of powering and controlling implanted neural prostheses. Reduction in the size of the coil, within the neural prosthesis, demands the generation of a high-intensity radio frequency magnetic field from the extracoporeal transmitter. The Class-E power amplifier circuit topology has been recognized as a highly effective means of producing large radio frequency currents within the transmitter coil. Unfortunately, design of a Class-E circuit is most often fraught by the need to solve a complex set of equations so as to implement both the zero-voltage-switching and zero-voltage-derivative-switching conditions that are required for efficient operation. This paper presents simple explicit design equations for designing the Class-E circuit topology. Numerical design examples are presented to illustrate the design procedure. PMID:23292784

  19. PERSPECTIVE: Toward a wide-field retinal prosthesis

    NASA Astrophysics Data System (ADS)

    Ameri, Hossein; Ratanapakorn, Tanapat; Ufer, Stefan; Eckhardt, Helmut; Humayun, Mark S.; Weiland, James D.

    2009-06-01

    The purpose of this paper is to present a wide field electrode array that may increase the field of vision in patients implanted with a retinal prosthesis. Mobility is often impaired in patients with low vision, particularly in those with peripheral visual loss. Studies on low vision patients as well as simulation studies on normally sighted individuals have indicated a strong correlation between the visual field and mobility. In addition, it has been shown that an increased visual field is associated with a significant improvement in visual acuity and object discrimination. Current electrode arrays implanted in animals or human vary in size; however, the retinal area covered by the electrodes has a maximum projected visual field of about 10°. We have designed wide field electrode arrays that could potentially provide a visual field of 34°, which may significantly improve the mobility. Tests performed on a mechanical eye model showed that it was possible to fix 10 mm wide flexible polyimide dummy electrode arrays onto the retina using a single retinal tack. They also showed that the arrays could conform to the inner curvature of the eye. Surgeries on an enucleated porcine eye model demonstrated feasibility of implantation of 10 mm wide arrays through a 5 mm eye wall incision.

  20. Comparison of two impression techniques for auricular prosthesis: pilot study.

    PubMed

    Mohamed, Kasim; Mani, U M; Seenivasan, M K; Vaidhyanathan, A K; Veeravalli, P T

    2013-01-01

    The purpose of this article was to compare the accuracy of a new impression technique, the triple-layer impression technique (TLIT), with the conventional impression technique (CIT) to fabricate an auricular prosthesis. Fifteen male subjects (aged 22-45 yr) were selected. Ten markings were made on the subject's ear (super aurale [sa], sub aurale [sba], pre aurale [pra], post aurale [poa], A, A1, B, B1, C, and C1) and five measurements (sa-sba, pra-poa, A-A1, B-B1, and C-C1) were made. Custom-made trays were used to record impression in CIT and TLIT. Impressions were made using alginate, and models were cast with type IV gypsum product. Markings were transferred on the cast. Measurements were rechecked on the models. Distribution analysis of difference in measurements between the two impression techniques and the subject's actual values was evaluated. Sign test was used to analyze the statistical significance. Statistically significant differences were found in measurements A-A1, B-B1, and C-C1 between the two techniques when compared with the subject's actual dimensions (p < 0.01). TLIT was found to produce accurate models when compared with CIT. The TLIT used in the study was cost effective, less technique sensitive, and tailor made to reduce chairside orientation time during wax try-in appointments for rehabilitating patients, especially those with unilateral auricular defects. PMID:24458893

  1. Medical treatment of joint prosthesis: indication, opportunities and liability profiles.

    PubMed

    Molfetta, L; Trompetto, C; Silvestri, E

    2015-01-01

    Orthopaedic specialists should completely and sequentially manage osteoarthritis, from the onset to the prosthesis, with no attitude of resignation, complying with national and international Guidelines (GLs) and abiding by the criteria of appropriateness of drugs, rehabilitation and orthopaedic device prescription, in line with the ethics of the medical profession. The GLs are a paper that rationalises the quantity of existing information for a disease, without abusing the decision of the doctor; a large volume of scientific knowledge is concentrated in a format that is easily accessible to doctors when carrying out their work. The use of drugs has taken on a connotation of a rational and multifactorial choice, rather than an accidental and incremental choice - inspired only by safety, rather than efficacy criteria. The Notes compiled by the Italian Medicines Agency - a legal instrument to define the reimbursability of medicines and, therefore, an instrument for managing pharmaceutical expenditure – are, in reality, a means to guarantee the appropriateness of the use of medicines, orienting the therapeutic choices according to established Guidelines. In the specific case of osteoarthritis, the knowledge of the GLs is the most appropriate and complete approach towards the disease, in the context of its pathogenetic complexity in its natural history. Moreover, pharmacological treatment of the subchondral osteometabolic damage becomes necessary when documented by magnetic resonance or a scintigraphy; the bone-related pain cannot be challenged through symptomatic analgesic treatment alone. PMID:26753668

  2. PRELIMINARY RESULTS FROM THE METIS-NEWDEAL® TOTAL METATARSOPHALANGEAL PROSTHESIS

    PubMed Central

    Silva, Luís Fernando Nunes Pires; Sousa, Cristina Varino; Pinto, Ricardo Rodrigues; Santos, Claudia; Geada, José Muras

    2015-01-01

    Objective: To evaluate the preliminary results from the METIS-Newdeal® metatarsophalangeal prosthesis for treating hallux rigidus grade III/IV. Methods: This was a prospective study on eight metatarsophalangeal prostheses that were placed in six patients between November 2007 and July 2009. The patients' mean age was 55 years and the mean follow-up after the surgery was 50 weeks. The results were evaluated using the AOFAS-MTP score and x-ray images as controls. Results: The AOFAS-MTP score increased significantly from 42p before the surgery to 82p after the surgery (↑ 1.95x), mainly due to improvement in the functional level. No intercurrences were identified radiologically. Among the five patients who underwent operations, only one expressed dissatisfaction with the surgery: this was expressed after early infection appeared at the surgical site, and it was the only postoperative complication found. Conclusion: Total metatarsophalangeal arthroplasty using METIS-Newdeal® presented promising short-term results. However, evaluations on a larger number of cases with a longer follow-up are needed in order to draw more consistent conclusions. PMID:27027011

  3. Prototype to product—developing a commercially viable neural prosthesis

    NASA Astrophysics Data System (ADS)

    Seligman, Peter

    2009-12-01

    The Cochlear implant or 'Bionic ear' is a device that enables people who do not get sufficient benefit from a hearing aid to communicate with the hearing world. The Cochlear implant is not an amplifier, but a device that electrically stimulates the auditory nerve in a way that crudely mimics normal hearing, thus providing a hearing percept. Many recipients are able to understand running speech without the help of lipreading. Cochlear implants have reached a stage of maturity where there are now 170 000 recipients implanted worldwide. The commercial development of these devices has occurred over the last 30 years. This development has been multidisciplinary, including audiologists, engineers, both mechanical and electrical, histologists, materials scientists, physiologists, surgeons and speech pathologists. This paper will trace the development of the device we have today, from the engineering perspective. The special challenges of designing an active device that will work in the human body for a lifetime will be outlined. These challenges include biocompatibility, extreme reliability, safety, patient fitting and surgical issues. It is emphasized that the successful development of a neural prosthesis requires the partnership of academia and industry.

  4. Adaptive myoelectric pattern recognition toward improved multifunctional prosthesis control.

    PubMed

    Liu, Jie

    2015-04-01

    The non-stationary property of electromyography (EMG) signals in real life settings usually hinders the clinical application of the myoelectric pattern recognition for prosthesis control. The classical EMG pattern recognition approach consists of two separate steps: training and testing, without considering the changes between training and testing data induced by electrode shift, fatigue, impedance changes and psychological factors, and often results in performance degradation. The aim of this study was to develop an adaptive myoelectric pattern recognition system, aiming to retrain the classifier online with the testing data without supervision, providing a self-correction mechanism for suppressing misclassifications. This paper presents an adaptive unsupervised classifier based on support vector machine (SVM) to improve the classification performance. Experimental data from 15 healthy subjects were used to evaluate performance. Preliminary study on intra-session and inter-session EMG data was conducted to verify the performance of the unsupervised adaptive SVM classifier. The unsupervised adaptive SVM classifier outperformed the conventional SVM by 3.3% and 8.0% for the combination of time-domain and autoregressive features in the intra-session and inter-session tests, respectively. The proposed approach is capable of incorporating the useful information in testing data to the classification model by taking into account the overtime changes in the testing data with respect to the training data to retrain the original classifier, therefore providing a self-correction mechanism for suppressing misclassifications. PMID:25749182

  5. ASIC Design and Data Communications for the Boston Retinal Prosthesis

    PubMed Central

    Shire, Douglas B.; Ellersick, William; Kelly, Shawn K.; Doyle, Patrick; Priplata, Attila; Drohan, William; Mendoza, Oscar; Gingerich, Marcus; McKee, Bruce; Wyatt, John L.; Rizzo, Joseph F.

    2016-01-01

    We report on the design and testing of a custom application-specific integrated circuit (ASIC) that has been developed as a key component of the Boston retinal prosthesis. This device has been designed for patients who are blind due to age-related macular degeneration or retinitis pigmentosa. Key safety and communication features of the low-power ASIC are described, as are the highly configurable neural stimulation current waveforms that are delivered to its greater than 256 output electrodes. The ASIC was created using an 0.18 micron Si fabrication process utilizing standard 1.8 volt CMOS transistors as well as 20 volt lightly doped drain FETs. The communication system receives frequency-shift keyed inputs at 6.78 MHz from an implanted secondary coil, and transmits data back to the control unit through a lower-bandwidth channel that employs load-shift keying. The design’s safety is ensured by on-board electrode voltage monitoring, stimulus charge limits, error checking of data transmitted to the implant, and comprehensive self-test and performance monitoring features. Each stimulus cycle is initiated by a transmitted word with a full 32-bit error check code. Taken together, these features allow researchers to safely and wirelessly tailor retinal stimulation and vision recovery for each patient. PMID:23365888

  6. Modelling and gait evaluation of asymmetrical-keel foot prosthesis.

    PubMed

    Allard, P; Trudeau, F; Prince, F; Dansereau, J; Labelle, H; Duhaime, M

    1995-01-01

    The paper documents a new concept in prosthetic foot design. It is based on the capacity of a flexible keel to allow a greater medio-lateral function than previously available. The heel has a complex curvature consisting of a medially concave shape that joins the mid-foot. There a hump acting as a leaf-spring ends at the metatarsal break, with an inwardly curved toe extremity. These curvatures contribute to increased medio-lateral control at heel-strike and propulsion for weight transfer and push-off. Results from finite-element modelling indicate that the asymmetrically shaped keel is at least twice as active in storing energy compared with a completely symmetrical one. A preliminary gait study is carried out for a 24-year-old below-knee amputee fitted with the new design, the SPACE foot and a dynamic elastic response foot with a symmetrical keel. With the SPACE foot, there is a 14% increase in walking speed combined with a reduction in the phasic asymmetries. The absolute difference between the initial and terminal double support is 1.4% for the asymmetrical keel design compared with 4.4% for the symmetrical keel foot prosthesis. The peak ankle power generation burst indicates that the SPACE foot behaves as a dynamic elastic response foot. PMID:7616775

  7. Control aspects of motor neural prosthesis: sensory interface.

    PubMed

    Popović, Dejan B; Dosen, Strahinja; Popović, Mirjana B; Stefanović, Filip; Kojović, Jovana

    2007-01-01

    A neural prosthesis (NP) has two applications: permanent assistance of function, and temporary assistance that contributes to long-term recovery of function. Here, we address control issues for a therapeutic NP which uses surface electrodes. We suggest that the effective NP for therapy needs to implement rule-based control. Rule-based control relies on the triggering of preprogrammed sequences of electrical stimulation by the sensory signals. The sensory system in the therapeutic NP needs to be simple for installation, allow self-calibration, it must be robust, and sufficiently redundant in order to guarantee safe operation. The sensory signals need to generate control signals; hence, sensory fusion is needed. MEMS technology today provides sensors that fulfill the technical requirements (accelerometers, gyroscopes, force sensing resistors). Therefore, the task was to design a sensory signal processing method from the mentioned solid state sensors that would recognize phases during the gait cycle. This is necessary for the control of multi channel electrical stimulation. The sensory fusion consists of the following two phases: 1) estimation of vertical and horizontal components of the ground reaction force, center of pressure, and joint angles from the solid-state sensors, and 2) fusion of the estimated signals into a sequence of command signals. The first phase was realized by the use of artificial neural networks and adaptive neuro-fuzzy inference systems, while the second by the use of inductive learning described in our earlier work [1]. PMID:18002969

  8. Building on residual speech: a portable processing prosthesis for aphasia.

    PubMed

    Linebarger, Marcia C; Romania, John F; Fink, Ruth B; Bartlett, Megan R; Schwartz, Myrna F

    2008-01-01

    This article examines the challenges of developing electronic communication aids for individuals with mild-to-moderate aphasia and introduces a new portable aid designed for this population. People with some residual speech are often reluctant to use communication aids that replace their natural speech with synthesized speech or the recorded utterances of another individual. SentenceShaper (computer software; Psycholinguistic Technologies, Inc; Jenkintown, Pennsylvania; www.sentenceshaper.com), a computerized "processing prosthesis," allows the user to record spoken sentence fragments and hold them in memory long enough to combine them into larger structures. Previous studies have shown that spoken narratives created with SentenceShaper--composed of concatenated, recorded segments in the user's own voice--may show marked superiority to the individual's spontaneous speech and that sustained use may engender treatment effects. However, these findings do not guarantee the program's efficacy to support functional communication or its acceptance by people with aphasia. Here, we examine strengths and weaknesses of SentenceShaper as the basis for a communication aid for individuals with mild-to-moderate aphasia and review factors guiding the design of SentenceShaper To Go, a portable extension to the program. Data from a "proof-of-concept" pilot study with the portable system suggest the viability of providing computer-based support for users' residual speech in composing and delivering spoken messages. PMID:19319763

  9. Bone vibration measurement using ultrasound: application to detection of hip prosthesis loosening.

    PubMed

    Rowlands, A; Duck, F A; Cunningham, J L

    2008-04-01

    Hip prosthesis loosening can be determined in vivo using a vibration-based technique called vibrometry. In this technique, a low frequency (<1000Hz) sinusoidal vibration is applied to the femoral condyles and the resulting vibration is measured at the greater trochanter. If the prosthesis is securely fixed, the output vibration signal matches that of the input vibration, whereas if the prosthesis is loose, the output vibration signal is distorted and shows the marked presence of harmonics of the input frequency. One of the main problems with this application of this technique is in measuring the output vibration where significant amounts of soft tissue cover the measurement site. In order to circumvent this problem, an ultrasound probe, normally used for the measurement of blood flow, has been used to measure the output vibration. This has been evaluated by comparing the results obtained from the ultrasound probe with those from a conventional accelerometer in models representing a tight and loose hip prosthesis under simulated clinical conditions. The ultrasound probe was able to consistently detect the output vibration, for both the loose and secure prostheses. Under the test conditions used (which attempted to simulate a large thickness of soft tissue), the ultrasound probe was able to produce a greatly enhanced output vibration signal compared to the accelerometer. This suggests that the use of an ultrasound probe to detect mechanically induced vibration through significant amounts of soft tissue appears to be viable and could lead to enhanced detection of prosthesis loosening using this technique. PMID:17587635

  10. Rapid development of auricular prosthesis using CAD and rapid prototyping technologies.

    PubMed

    Subburaj, K; Nair, C; Rajesh, S; Meshram, S M; Ravi, B

    2007-10-01

    External ear defects can be corrected by surgery, but this may not be feasible for personal or medical reasons. Reconstructive solutions are a good alternative, but rely on the artistry and availability of the anaplastologist. A semi-automated methodology using computer-aided design (CAD) and rapid prototyping (RP) technologies was developed for auricular prosthesis development, and demonstrated in a real-life case. The correct geometry and position of the prosthesis were ensured by stacking the computed tomography scan images of the contralateral normal ear in reverse order, and joining them using a medical modelling software program. The CAD model of the remnant portion of the defective ear was subtracted from the model of the mirrored contralateral ear, using a haptic CAD system, to obtain the final geometry of the prosthesis. Polymer models were fabricated in RP systems, and used for making a corresponding mould. Medical grade silicone rubber of the appropriate colour was packed into the mould to fabricate the final ear prosthesis and fitted to the deficient side of the patient using medical grade adhesive. The computer-aided methodology gave a high level of accuracy in terms of shape, size and position of the prosthesis, and a significantly shorter lead time compared to the conventional (manual) technique. PMID:17822875

  11. 21 CFR 888.3640 - Shoulder joint metal/metal or 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 Shoulder joint metal/metal or metal/polymer... § 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. (a) Identification. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a...

  12. 21 CFR 888.3640 - Shoulder joint metal/metal or 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 Shoulder joint metal/metal or metal/polymer... § 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. (a) Identification. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a...

  13. 21 CFR 888.3640 - Shoulder joint metal/metal or 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 Shoulder joint metal/metal or metal/polymer... § 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. (a) Identification. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a...

  14. Development and performance of a new prosthesis system using ultrasonic sensor for wrist movements: a preliminary study

    PubMed Central

    2014-01-01

    Background The design and performance of a new development prosthesis system known as biomechatronics wrist prosthesis is presented in this paper. The prosthesis system was implemented by replacing the Bowden tension cable of body powered prosthesis system using two ultrasonic sensors, two servo motors and microcontroller inside the prosthesis hand for transradial user. Methods The system components and hand prototypes involve the anthropometry, CAD design and prototyping, biomechatronics engineering together with the prosthetics. The modeler construction of the system develop allows the ultrasonic sensors that are placed on the shoulder to generate the wrist movement of the prosthesis. The kinematics of wrist movement, which are the pronation/supination and flexion/extension were tested using the motion analysis and general motion of human hand were compared. The study also evaluated the require degree of detection for the input of the ultrasonic sensor to generate the wrist movements. Results The values collected by the vicon motion analysis for biomechatronics prosthesis system were reliable to do the common tasks in daily life. The degree of the head needed to bend to give the full input wave was about 45° - 55° of rotation or about 14 cm – 16 cm. The biomechatronics wrist prosthesis gave higher degree of rotation to do the daily tasks but did not achieve the maximum degree of rotation. Conclusion The new development of using sensor and actuator in generating the wrist movements will be interesting for used list in medicine, robotics technology, rehabilitations, prosthetics and orthotics. PMID:24755242

  15. 21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated 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 metal/polymer/metal semi-constrained... Devices § 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. (a) Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a...

  16. 21 CFR 888.3535 - Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    .../polymer porous-coated uncemented prosthesis. 888.3535 Section 888.3535 Food and Drugs FOOD AND DRUG... Devices § 888.3535 Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis. (a) Identification. A knee joint femorotibial (uni-compartmental) metal/polymer...

  17. 21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated 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 metal/polymer/metal semi-constrained... Devices § 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. (a) Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a...

  18. 21 CFR 888.3535 - Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    .../polymer porous-coated uncemented prosthesis. 888.3535 Section 888.3535 Food and Drugs FOOD AND DRUG... Devices § 888.3535 Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis. (a) Identification. A knee joint femorotibial (uni-compartmental) metal/polymer...

  19. Retrograde Transcatheter Closure of Mitral Paravalvular Leak through a Mechanical Aortic Valve Prosthesis: 2 Successful Cases

    PubMed Central

    Zhou, Daxin; Pan, Wenzhi; Guan, Lihua; Qian, Juying

    2016-01-01

    The presence of a mechanical aortic valve prosthesis has been considered a contraindication to retrograde percutaneous closure of mitral paravalvular leaks, because passing a catheter through the mechanical aortic valve can affect the function of a mechanical valve and thereby lead to severe hemodynamic deterioration. We report what we believe are the first 2 cases of retrograde transcatheter closure of mitral paravalvular leaks through a mechanical aortic valve prosthesis without transseptal or transapical puncture. Our experience shows that retrograde transcatheter closure of mitral paravalvular leaks in this manner can be an optional approach for transcatheter closure of such leaks, especially when a transapical or transseptal puncture approach is not feasible. This technique might also be applied to other transcatheter procedures in which there is a need to pass a catheter through a mechanical aortic valve prosthesis. PMID:27127428

  20. Custom ocular prosthesis in rehabilitation of a child operated for retinoblastoma.

    PubMed

    Shah, Vinit; Yadav, Lakshya; Singh, Mayank; Kharbanda, Smriti

    2015-01-01

    A maxillofacial prosthodontist forms an important link in the interdisciplinary management of a patient with anopthalmosis. Prosthetic management of an anopthalmic defect aims to deliver a well-fitting ocular prosthesis that can mimic the original eye as closely as possible, and thus restoring the patient's self-confidence and thereby rehabilitating them in the society. The fabrication of a custom ocular prosthesis is a demanding art. This case report presents a simplified technique for the fabrication of a custom ocular prosthesis for a child who had lost his eye to enucleation following retinoblastoma. Early and effective rehabilitation of the defect goes a long way in restoring the self-image of a child in its early character building age. PMID:27390504