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Sample records for acjc prosthesis group

  1. Deformation of facial model for complete denture prosthesis using ARAP group method and elastic properties.

    PubMed

    Cheng, Cheng; Cheng, Xiaosheng; Dai, Ning; Sun, Yuchun; Jiang, Xiaotong; Li, Weiwei

    2017-02-07

    With the development of 3D printing and computer graphics technology, mouth rehabilitation has increasingly adopted digital methods. This research proposes a new method to transform the appearance of facial model after complete denture prosthesis. A feature template with few feature points is first constructed according to the facial muscle anatomy and facial deformation after complete denture prosthesis. Next, the traditional as-rigid-as-possible (ARAP) method is optimised by clustering based on facial muscles. The optimised ARAP method is then used for real-time and interactive simulations. Finally, by classifying the degrees of elasticity in the model with additional weights, the simulation can be customised to the skin of individual patients. Different degrees of elastic deformation and post-operative models are superimposed for match analysis. Compared with our previous study, the error is reduced by 24.05%. Results show that our method can deform facial models accurately and efficiently.

  2. Comparison of gait of persons with partial foot amputation wearing prosthesis to matched control group: observational study.

    PubMed

    Dillon, Michael P; Barker, Timothy M

    2008-01-01

    Our understanding of the gait mechanics of persons with partial foot amputation and the influence of prosthetic intervention has been limited by the reporting of isolated gait parameters in specific amputation levels and limited interpretation and discussion of results. This observational study aimed to more completely describe the gait patterns of persons with partial foot amputation wearing their existing prosthesis and footwear in comparison with a nonamputee control group. Major adaptations occurred once the metatarsal heads were compromised. Persons with transmetatarsal and Lisfranc amputation who were wearing insoles and slipper sockets maintained the center of pressure behind the end of the residuum until after contralateral heel contact. This gait pattern may be a useful adaptation to protect the residuum, moderate the requirement of the calf musculature, or compensate for the compliance of the forefoot. Power generation across the affected ankle was virtually negligible, necessitating increased power generation across the hip joints. The clamshell devices fitted to the persons with Chopart amputation restored their effective foot length and normalized many aspects of gait. These persons' ability to adopt this gait pattern may be the result of the broad anterior shell of the socket, a relatively stiff forefoot, and immobilization of the ankle. The hip joints still contributed significantly to the power generation required to walk.

  3. Prosthesis coupling

    NASA Technical Reports Server (NTRS)

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

    1979-01-01

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

  4. 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. 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.

  7. 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

  8. 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.

  9. Challenges in prosthesis classification.

    PubMed

    Robertsson, Otto; Mendenhall, Stan; Paxton, Elizabeth W; Inacio, Maria C S; Graves, Stephen

    2011-12-21

    Accurate prosthesis classification is critical for total joint arthroplasty surveillance and assessment of comparative effectiveness. Historically, prosthesis classification was based solely on the names of the prosthesis manufacturers. As a result, prosthesis designs changed without corresponding name changes, and other prostheses' names changed over time without substantial design modifications. As the number of prostheses used in total joint arthroplasty on the market increased, catalog and lot numbers associated with prosthesis descriptions were introduced by manufacturers. Currently, these catalog and lot numbers are not standardized, and there is no consensus on categorization of these numbers into brands or subbrands. Classification of the attributes of a prosthesis also varies, limiting comparisons of prostheses across studies and reports. The development of a universal prosthesis classification system would standardize prosthesis classification and enhance total joint arthroplasty research collaboration worldwide. This is a current area of focus for the International Consortium of Orthopaedic Registries (ICOR).

  10. Lower limb prosthesis utilisation by elderly amputees.

    PubMed

    Bilodeau, S; Hébert, R; Desrosiers, J

    2000-08-01

    The goal of prosthetic rehabilitation is to compensate for the loss of a limb by amputation by, in the case of a lower limb, encouraging walking, and to achieve the same level of autonomy as prior to the amputation. However, because of difficulties walking, elderly amputees may use their prosthesis to a greater or lesser degree or simply stop using it during the rehabilitation period. The objective of this research was to study factors such as physical and mental health, rehabilitation, physical independence and satisfaction with the prosthesis to understand why amputees use their prosthesis or not. The sample was composed of 65 unilateral vascular amputees 60 years old or over living at home. The information was collected from medical records, by telephone interview and by mail questionnaire. Prosthesis use was measured by a questionnaire on amputee activities developed by Day (1981). Eighty-one per cent (81%) of the subjects wore their prosthesis every day and 89% of this group wore it 6 hours or more per day. Less use of the prosthesis was significantly related to age, female gender, possession of a wheelchair, level of physical disability, cognitive impairment, poorer self-perceived health and the amputee's dissatisfaction. A multiple regression analysis showed that satisfaction, not possessing a wheelchair and cognitive integrity explained 46% of the variance in prosthesis use.

  11. Visuomotor behaviours when using a myoelectric prosthesis

    PubMed Central

    2014-01-01

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

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

    PubMed

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

    2013-10-03

    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.

  13. A biomechanical study of two postoperative prostheses for transtibial amputees: a custom-molded and a prefabricated adjustable pneumatic prosthesis.

    PubMed

    Boucher, Henry R; Schon, Lew C; Parks, Brent; Kleeman, Jay; Dunn, Warren R; Badekas, Thanos; Noll, Kenneth; Melamed, Eyal

    2002-05-01

    We evaluated an adjustable pneumatic prefabricated prosthesis and a rigid custom-molded prosthesis for immediate postoperative use. Twelve transtibial amputations were performed on cadaver limbs. Differential variable reluctance transducers were placed subcutaneously across the wound edge medially and laterally. The limbs were then placed in either the pneumatic prosthesis (five limbs) or the rigid prosthesis (seven limbs). The specimens underwent static and cyclic loading to simulate weight bearing. The strain readings for static and cyclic loading were greater in the rigid prosthetic group. Only the mean medial strain measurement after cyclic loading was statistically significant. The results demonstrate that the pneumatic prosthesis places less strain across the wound than a rigid prosthesis.

  14. Radiological and clinical effect of prosthesis design in varus knees?

    PubMed Central

    Isyar, Mehmet; Guler, Olcay; Cakmak, Selami; Kara, Adnan; Yalcin, Sercan; Mahirogullari, Mahir

    2015-01-01

    Purpose The aim of the study is to investigate the efficacy of the prosthesis design used in total knee arthroplasty in patients with varus malalignment. Methods After exclusion criteria we classified 90 patients underwent total knee arthroplasty according to prosthesis used into two groups: posterior cruciate ligament substituting and retaining. Mean follow up period was 25–98 months. We evaluated preoperative and postoperative radiological and as well as clinical parameters such as pain, knee function, flexion deformity. Results We found statistically significant difference in both groups in terms of deformity correction (p = 0.000). Conclusion Prosthesis design affects radiological outcomes in varus knees. PMID:26566321

  15. A New Distal Radioulnar Joint Prosthesis

    PubMed Central

    Schuurman, Arnold H.

    2013-01-01

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

  16. A tactile control prosthesis

    NASA Astrophysics Data System (ADS)

    Perry, James Franklin

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

  17. Reading visual braille with a retinal prosthesis.

    PubMed

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

    2012-01-01

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

  18. Novel modification of voice prosthesis.

    PubMed

    Al Kadah, Basel; Papaspyrou, George; Schneider, Mathias; Schick, Bernhard

    2016-03-01

    The undesired dilatation of the tracheooesophageal shunt after surgical implantation of voice prosthesis is a typical complication of this procedure. Temporary removal of the prosthesis and reinsertion after a short period of time is a first-line therapeutical option aiming shrinkage of the shunt. Failure of this measure generally is an indication of revision surgery. We present first experiences treating leakage problems with novel modified voice prosthesis without surgical intervention in specified cases. 11 patients (1 female, 10 male) aging between 51 and 71 years were presented with shunt leakage between 11/2008 and 11/2012 in the ENT-Department of the University Hospital of Homburg/Saar after a custom built voice prosthesis had been used initially successfully. A "Provox 2"(®) voice prosthesis was modified with two discs made of silicone each on the tracheal and oesophageal side and additionally reinforcing the diameter of the prosthesis by a silicone tube. The modified prosthesis was inserted in a retrograde way under general anesthesia, analogical to the approach used with the "Provox 1"(®)-prosthesis. The period of observation ranged between 12 and 48 months. As a measure of control swallowing of methylene blue was used. In all cases leakage suspended. Durability of the modified prosthesis ranged between 2 and 6 months. Neither the patients' complained about, nor did the physicians notice subjectively an impairment of the voice quality. Modifications of "Provox 2"(®)-prosthesis should be regarded in individual cases and constitute a reasonable alternative to revision surgery. A surgical approach is more intricate and costly, more taxing for the patient and susceptible to failure. We regard the necessity of general anesthesia for the insertion of the modified prosthesis as a disadvantage.

  19. Intraocular retinal prosthesis.

    PubMed Central

    Humayun, M S

    2001-01-01

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

  20. The stump and the prosthesis.

    PubMed Central

    Day, H. J.

    1980-01-01

    In performing amputations the surgeon must bear in mind the biomechanical and other constraints of the prosthesis likely to be fitted and, so far as possible, should fashion the stump accordingly. The various types of prosthesis and their features are discussed in relation to amputations of the lower and upper limbs at all levels. PMID:7377694

  1. 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

  2. Conus hip prosthesis.

    PubMed

    Wagner, H; Wagner, M

    2001-01-01

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

  3. 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

  4. Bioelectronic retinal prosthesis

    NASA Astrophysics Data System (ADS)

    Weiland, James D.

    2016-05-01

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

  5. 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.

  6. [Fracture of macroporous hydroxyapatite prosthesis].

    PubMed

    Adetchessi, A T; Pech-Gourg, G; Metellus, P; Fuentes, S

    2012-12-01

    Different prosthesis implants are offered to perform a cranioplasty after a decompressive craniectomy when autologous bone graft cannot be used. The authors report the case of a 25-year-old man who benefited a unilateral decompressive craniectomy after a severe head trauma. Seven months later, a cranioplasty using custom macroporous hydroxyapatite prosthesis was performed. The postoperative course was marked by a generalized seizure leading to a traumatic head injury. The CT-scan showed a comminutive fracture of the prosthesis and an extradural hematoma. The patient underwent a removal of the fractured prosthesis and an evacuation of the extradural clot. The postoperative course was uneventful with a Glasgow outcome scale score at 5. A second cranioplasty using a polyether ether ketone (PEEK) implant was performed. Among cranioplasty prosthesis solutions, hydroxyapatite implants seem to have similar property to the bone. However, its weak mechanic resistance is an actual problem in patients susceptible to present generalized seizures with consecutive head impact. Hence, in patients with decompressive craniectomy who are exposed to potential brain injury, we favor the use of more resistant implant as PEEK prosthesis.

  7. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) 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...

  8. 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 ...

  9. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Testicular prosthesis. 876.3750 Section 876.3750...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis. (a) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled...

  10. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Testicular prosthesis. 876.3750 Section 876.3750...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis. (a) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled...

  11. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Testicular prosthesis. 876.3750 Section 876.3750...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis. (a) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled...

  12. Painful knee prosthesis: surgical approach

    PubMed Central

    Villano, Marco; Carulli, Christian; Puccini, Serena; Soderi, Stefano; Innocenti, Massimo

    2011-01-01

    Summary There are many conditions that may be responsible of a painful knee prosthesis. The possible causes are not always easily diagnosed. Common causes of prosthetic failure, such as aseptic loosening, infection, instability, progressive patellar arthropathy and recurrent synovitis are associated with clearly defined radiographic and/or clinical evidence. Prosthetic infection should always be considered first until any other cause has been demonstrated. In the presence of an infected prosthesis we carry out a two-step revision. Aseptic loosening needs implant revision more often with increasing prosthesis stability. Varus-valgus, anteroposterior, global and patello-femoral instability are failures often due to technical errors; superstabilized or constrained implants are needed depending on the instability entity. In presence of patello-femoral pain it is necessary to evaluate the stability of the patellar component and any alterations in its motion. Patellar progressive arthropathy can often cause late-onset knee pain; in this case patella resurfacing is needed. Altered patellar tracking, may need a lateral release but in some cases is related to misalignment of the components and the revision procedure is mandatory. Nevertheless, the diagnosis and treatment of a painful knee prosthesis can be extremely difficult if there is no clear evidence of any of the most common causes of failure. Referred pain, ligament and tendon dysfunction, cutaneous neuromas, synovitis, a patellar clunk have to be diagnosed and treated. A possible aetiological understimated factor is painful knee prosthesis due to metals sensibilization, in particular to nickel. In this event the quantity of nickel in the revision prosthesis must be minimal. PMID:22461812

  13. Task-Oriented Gaming for Transfer to Prosthesis Use.

    PubMed

    van Dijk, Ludger; van der Sluis, Corry K; van Dijk, Hylke W; Bongers, Raoul M

    2016-12-01

    The aim of this study is to establish the effect of task-oriented video gaming on using a myoelectric prosthesis in a basic activity of daily life (ADL). Forty-one able-bodied right-handed participants were randomly assigned to one of four groups. In three of these groups the participants trained to control a video game using the myosignals of the flexors and extensors of the wrist: in the Adaptive Catching group participants needed to catch falling objects by opening and closing a grabber and received ADL-relevant feedback during performance. The Free Catching group used the same game, but without augmented feedback. The Interceptive Catching group trained a game where the goal was to intercept a falling object by moving a grabber to the left and right. They received no additional feedback. The control group played a regular Mario computer game. All groups trained 20 minutes a day for four consecutive days. Two tests were conducted before and after training: one level of the training game was performed, and participants grasped objects with a prosthesis simulator. Results showed all groups improved their game performance over controls. In the prosthesis-simulator task, after training the Adaptive Catching group outperformed the other groups in their ability to adjust the hand aperture to the size of the objects and the degree of compression of compressible objects. This study is the first to demonstrate transfer effects from a serious game to a myoelectric prosthesis task. The specificity of the learning effects suggests that research into serious gaming will benefit from placing ADL-specific constraints on game development.

  14. [Speech rehabilitation using Provox voice prosthesis].

    PubMed

    Morshed, Kamal; Gołabek, Wiesław; Szymański, Marcin; Olszański, Witold

    2005-01-01

    The first voice prosthesis was described in 1972 by Mozolewski. Eight years later Blom and Singer constructed the first commercial prosthesis. In 1988 another prosthesis was presented as Provox system prosthesis. The aim of the study was to describe the technique of tracheoesophageal puncture (TEP) and to present two years results of the technique performed in 21 patients. Primary TEP with immediate implantation of the Provox 2 prosthesis was applied in 16 (76%) patients. In five patients (24%) secondary TEP was performed. All the patient with primary TEP had cricopharyngeal myotomy. In 7 patients the vocal prosthesis was exchanged. In five because of leakage through the valve and in two patients the vocal prosthesis was extruded. Leakage around the prosthesis occurred in two patients with secondary TEP. The mean device-related lifetime was 216 days and ranged from 30 to 540 days. In non-radiated patients the lifetime of the prosthesis was 255 days and in patients after radiotherapy the lifetime was 150 days. In all the patients the prosthetic voice was more similar to normal voice than in patients with esophageal speech. The implantation of the voice prosthesis is a simple method of restoring of a good quality voice enabling communication.

  15. Indicators of dynamic stability in transtibial prosthesis users.

    PubMed

    Kendell, C; Lemaire, E D; Dudek, N L; Kofman, J

    2010-03-01

    An improved understanding of factors related to dynamic stability in lower-limb prosthesis users is important, given the high occurrence of falls in this population. Current methods of assessing stability are unable to adequately characterize dynamic stability over a variety of walking conditions. F-Scan Mobile has been used to collect plantar pressure data and six extracted parameters were useful measures of dynamic stability. The aim of this study was to investigate dynamic stability in individuals with unilateral transtibial amputation based on these six parameters. Twenty community ambulators with a unilateral transtibial amputation walked over level ground, uneven ground, stairs, and a ramp while plantar pressure data were collected. For each limb (intact and prosthetic) and condition, six stability parameters related to plantar center-of-pressure perturbations and gait temporal parameters, were computed from the plantar pressure data. Parameter values were compared between limbs, walking condition, and groups (unilateral transtibial prosthesis users and able-bodied subjects). Differences in parameters were found between limbs and conditions, and between prosthesis users and able-bodied individuals. Further research could investigate optimizing parameter calculations for unilateral transtibial prosthesis users and define relationships between potential for falls and the dynamic stability measures.

  16. Dosimetry of a silicone breast prosthesis

    SciTech Connect

    McGinley, P.H.; Powell, W.R.; Bostwick, J.

    1980-04-01

    Dose measurements were conducted in a phantom which simulates breast tissue and in another phantom which simulates a breast containing a silicone prosthesis. No detectable difference was found when the irradiations were carried out with tangential beams of /sup 60/Co radiation. The degree of backscatter and absorption of radiation by the prosthesis and phantom were also similar. A slight decrease in dose of approximately 8% was found at the interface between the prosthesis and muscle-equivalent material.

  17. 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…

  18. Tracheostomy cannulas and voice prosthesis.

    PubMed

    Kramp, Burkhard; Dommerich, Steffen

    2009-01-01

    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.

  19. 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

  20. 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.

  1. The Salto Talaris XT Revision Ankle Prosthesis.

    PubMed

    Roukis, Thomas S

    2015-10-01

    The Salto Talaris XT Revision Ankle Prosthesis is an anatomically designed fixed-bearing prosthesis available in the United States based on the design of previous Salto systems. The Salto Talaris XT Revision Ankle Prosthesis design optimizes surface area, cortical contact, and ultrahigh-molecular-weight polyethylene conformity. Two tibial component designs, both with the same base plate dimensions, are available, the standard conical fixation plug affixed to a short keel and a long-stemmed version. The author presents an overview of the Salto Talaris XT Revision Ankle Prosthesis surgical technique and pearls for successful application.

  2. 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.

  3. 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.

  4. Plasticity in the Visual System is Associated with Prosthesis Use in Phantom Limb Pain

    PubMed Central

    Preißler, Sandra; Dietrich, Caroline; Blume, Kathrin R.; Hofmann, Gunther O.; Miltner, Wolfgang H. R.; Weiss, Thomas

    2013-01-01

    The experience of strong phantom limb pain (PLP) in arm amputees was previously shown to be associated with structural neural plasticity in parts of the cortex that belong to dorsal and ventral visual streams. It has been speculated that this plasticity results from the extensive use of a functional prosthesis which is associated with increased visual feedback to control the artificial hand. To test this hypothesis, we reanalyzed data of cortical volumes of 21 upper limb amputees and tested the association between the amount of use of the hand prosthesis and cortical volume plasticity. On the behavioral level, we found no relation between PLP and the amount of prosthesis use for the whole patient group. However, by subdividing the patient group into patients with strong PLP and those with low to medium PLP, stronger pain was significantly associated with less prosthesis use whereas the group with low PLP did not show such an association. Most plasticity of cortical volume was identified within the dorsal stream. The more the patients that suffered from strong PLP used their prosthesis, the smaller was the volume of their posterior parietal cortex. Our data indicate a relationship between prosthesis use and cortical plasticity of the visual stream. This plasticity might present a brain adaptation process to new movement and coordination patterns needed to guide an artificial hand. PMID:23805096

  5. [The use of the vocal prosthesis Provox 2 for speech rehabilitation after total laryngectomy].

    PubMed

    Markowski, Jarosław; Gierek, Tatiana; Paluch, Jarosław; Wardas, Piotr

    2005-01-01

    The authors have presented the application and usage the alloplastic vocal prosthesis Provox 2 to serve for rehabilitation speech after total laryngectomy. Surgical technique of implantation of vocal prosthesis was discussed. The authors estimated in 6 patients following parameters of speech; fundamental frequency, maximum phonation time of vowel "a", maximum intensity and degree of dysphonia. In all 6 cases post-operative course was uncomplicated. Above mentioned parameters of voice were measured in order to comparison quality of oesophageal speech to tracheo - oesophageal speech. The authors assessed speech at 6 patients with voice prosthesis and 6 with good oesophageal speakers as a control group. The results of our investigations showed, that quality of tracheo - esophageal speech obtained with usage vocal prosthesis Provox 2 is more like normal speech than oesophageal speech. Social efficiency and quality of tracheo - oesophageal voice is better than oesophageal voice.

  6. Penile prosthesis implantation: past, present and future.

    PubMed

    Simmons, M; Montague, D K

    2008-01-01

    Penile prosthesis implantation is the oldest effective treatment for erectile dysfunction. This review examines the past, present and future of penile prosthesis implantation. Advances in prosthetic design and implantation techniques have resulted today in devices that produce nearly normal flaccid and erect states, and have remarkable freedom from mechanical failure. The future of prosthetic design holds promises for even more improvements.

  7. 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

  8. 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....

  9. 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....

  10. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Testicular prosthesis. 876.3750 Section 876.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Drug Administration on or before July 5, 1995, for any testicular prosthesis that was in...

  11. 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....

  12. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  13. 21 CFR 878.3590 - 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....

  14. 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....

  15. 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 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....

  16. 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 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 878.3550 - 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....

  18. 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....

  19. 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....

  20. 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....

  1. 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....

  2. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  3. 21 CFR 878.3720 - 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....

  4. 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....

  5. 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 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....

  6. 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....

  7. 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....

  8. 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....

  9. Parametric modelling of a knee joint prosthesis.

    PubMed

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

    1993-01-01

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

  10. Semiconstrained Distal Radioulnar Joint Prosthesis

    PubMed Central

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

    2013-01-01

    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

  11. Therapeutic effects of segmental resection and decompression combined with joint prosthesis on continuous knee osteoarthritis

    PubMed Central

    Xue, Junlai; Wang, Changhong; Liu, Peng; Xie, Xiangchun; Qi, Shan

    2014-01-01

    Objective: To observe the therapeutic effects of segmental resection and decompression combined with joint prosthesis on continuous knee osteoarthritis (OA). Methods: A total of 130 patients with knee OA were selected and randomly divided into an observation group and a control group (n=65). The control group was treated by segmental resection in combination with joint prosthesis, and the observation group was treated by segmental resection and decompression combined with joint prosthesis. They were followed-up for three months. Results: All patients underwent successful surgeries during which no severe complications occurred. During the follow-up period, the overall effective rates of the observation group and the control group were 93.8% and 78.5% respectively, which were not statistically significantly different (p < 0.05). The observation group was significantly less prone to patellar instability, infection and deep vein thrombosis compared with the control group (P < 0.05). On the same day after surgery, the knee joint scores and functional scores of the two groups were similar, which evidently increased three months later, with significant intra-group and inter-group differences (p < 0.05). Conclusion: Combining segmental resection and decompression with joint prosthesis gave rise to satisfactory short-term prognosis by effectively improving the flexion and extension of injured knee and by decreasing complications, thus being worthy of promotion in clinical practice. PMID:25674115

  12. TOTAL ANKLE ARTHROPLASTY: BRAZILIAN EXPERIENCE WITH THE HINTEGRA PROSTHESIS.

    PubMed

    Nery, Caio; Fernandes, Túlio Diniz; Réssio, Cibele; Fuchs, Mauro Luiz; Godoy Santos, Alexandre Leme de; Ortiz, Rafael Trevisan

    2010-01-01

    Ankle arthrosis is becoming more and more common. The search for solutions that preserve joint function has led to a new generation of prosthesis with three components and more degrees of freedom. This paper presents the results achieved for ten patients treated with the HINTEGRA Prosthesis (Integra, New Deal), through collaborative action between the Foot and Ankle Groups of the Orthopedics and Traumatology divisions of Escola Paulista de Medicina, Unifesp, and the School of Medicine of the University of São Paulo (USP). The ten patients (six women and four men, aged between 29 and 66 years), underwent a surgical procedure consisting of Hintermann's technique, between January and June 2005. They were evaluated at prearranged intervals, and the data were subjected to statistical analysis. The surgery led to a significant improvement in ankle mobility. Radiological evaluation showed no signs of loosening or failure in the prosthetic components in any of the patients studied. Although the complication rate in our sample was high, it was equivalent to the rates found by other authors, and directly represents the learning curve associate with this kind of procedure. Four years after the procedure, it was found that the patients pain levels had significantly decreased, and that their functional patterns had significantly improved, with AOFAS and Hintermann scores indicating results that were excellent for 20%, good for 70% and poor for 10%. Treatment of ankle arthritis by means of total arthroplasty using the HINTEGRA prosthesis was capable of providing good results over an average observation period of four years.

  13. Prosthesis

    MedlinePlus

    ... work better. Diseased or missing eyes, arms, hands, legs, or joints are commonly replaced by prosthetic devices. False teeth are known as dental prostheses. An artificial replacement of the jaw bone is called a ...

  14. Automated lower limb prosthesis design

    NASA Astrophysics Data System (ADS)

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

    1994-09-01

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

  15. Finger prosthesis: a boon to handicapped

    PubMed Central

    Gupta, Ridhima; Kumar, Lakshya; Rao, Jitendra; Singh, Kamleshwar

    2013-01-01

    This is a clinical case report of a 52-year-old male patient with four partially missing fingers of the left hand. The article describes the clinical and laboratory procedure of making prosthesis with modern silicone material. A wax pattern was fabricated using the right hand of the patient. A special type of wax was formulated to make the pattern so that it can be easily moulded and carved. Intrinsic and extrinsic staining was also performed to match the adjacent skin colour. The patient was given the finger prosthesis and was asked to use a half glove (sports) to mask the junction between the prosthesis and the normal tissue. It also provides additional retention to the artificial fingers. The patient felt his social acceptance improved after wearing the finger prosthesis. PMID:23988821

  16. Morphological, physical and chemical evaluation of the Vascugraft arterial prosthesis: comparison of a novel polyurethane device with other microporous structures.

    PubMed

    Zhang, Z; King, M W; Guidoin, R; Therrien, M; Pezolet, M; Adnot, A; Ukpabi, P; Vantal, M H

    1994-06-01

    In this study the morphology, physical properties, surface chemical characteristics and microstructure of the Vascugraft arterial prosthesis have been investigated. This is a novel microporous polyurethane device, recently developed by the company Braun-Melsungen AG in Germany for use as a small calibre arterial substitute. This comparative study included two other synthetic grafts: the Mitrathane prosthesis, a hydrophilic prototype polyetherurethane urea graft with closed internal pores, and the commercially successful expanded polytetrafluoroethylene reinforced Goretex prosthesis with an open microporous structure. The Vascugraft prosthesis contains a network of fused microfibres of varying thickness and orientation which provide open and communicating pores similar in size to those in the Goretex material. In addition, they extend from one side of the graft wall to the other. As well as having superior longitudinal and radial compliance to the reinforced Goretex device, the Vascugraft prosthesis has more than adequate bursting and suture retention strengths. Through the use of contact angle measurements, electron spectroscopy for chemical analysis, Fourier transform infrared spectroscopy, differential scanning calorimetry and molecular weight analysis by size exclusion chromatography, the surface of the Vascugraft prosthesis has been shown to be uniquely hydrophobic, as well as containing carbonate groups within an aliphatic polyesterurethane polymer. In addition, variations in micro-phase separation structure of hard and soft segment domains between different sizes and batches of product are marginal. Because of the interesting physical and chemical properties, it is recommended that in vitro biocompatibility and biostability studies be undertaken prior to using the prosthesis in animal or clinical trials.

  17. Intraoral angiosarcoma: treatment with a brachytherapy prosthesis.

    PubMed

    Rosen, Evan B; Ko, Eugene; Wolden, Suzanne; Huryn, Joseph M; Estilo, Cherry L

    2015-03-01

    Angiosarcomas are rare, malignant neoplasms of vascular origin that account for less than 1% of all soft tissue tumors. Angiosarcomas of the oral cavity are especially rare, and brachytherapy may be prescribed as a localized treatment to manage these malignancies. Intraoral brachytherapy requires collaboration between the radiation oncologist and a dental professional for the fabrication of the brachytherapy delivery prosthesis. This clinical report describes an intraoral angiosarcoma and the fabrication of an intraoral brachytherapy prosthesis to manage this malignancy.

  18. [Mechanical complications of total shoulder inverted prosthesis].

    PubMed

    Delloye, C; Joris, D; Colette, A; Eudier, A; Dubuc, J E

    2002-06-01

    Our series of inverted prosthesis included 5 patients with a mean age of 73 +/- 6 years. In 4 cases, the implant was performed as a surgical revision. The follow up was 81 +/- 15 months. Three shoulders were pain free whereas two caused a dull pain after a free interval due to mechanical complications. The mean active elevation was 72 degrees while external rotation was - 2 degrees. The adjusted Constant score passed from 32 to 60. In case of complications, the score dropped to 32. Mechanical complications were important with in one case, an unscrening of the glenosphere and in two cases, a loosening of the glenoid prosthesis. This last and major complication occurred 6 years after surgery and was promoted by the occurrence of a progressive bone erosion in the scapula. This gap represented an attempt to accomodate the medial part of the humeral prosthesis under the scapula when the arm is at rest or in adduction. The concept of an inverted prosthesis is attractive and this implant remains one of the options in cuff-tear arthropathy. Our results were not as good as those reported by others but most of ours patients had been already operated before. The occurrence of an osseous gap on pilar of scapula may lead to failure of this prosthesis. This gap remains a threath as it can progress and as such warrants a design alteration of the prosthesis.

  19. 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

  20. BELOW-ELBOW COSMETIC CONDYLE-SUSPENDED PROSTHESIS

    DTIC Science & Technology

    particular appeal to those amputees who desire a prosthesis for cosmetic reasons. However this type of prosthesis can be so built to provide a means for operating the active mechanical terminal device. (Author)

  1. 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.

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

    NASA Astrophysics Data System (ADS)

    Handford, Matthew L.; Srinivasan, Manoj

    2016-02-01

    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.

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

    PubMed

    Handford, Matthew L; Srinivasan, Manoj

    2016-02-09

    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.

  4. 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

  5. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Glenoid fossa prosthesis. 872.3950 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3950 Glenoid fossa prosthesis. (a) Identification. A glenoid fossa prosthesis is a device that is intended to be implanted in the...

  6. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Mandibular condyle prosthesis. 872.3960 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw...

  7. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mandibular condyle prosthesis. 872.3960 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw...

  8. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  9. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  10. 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... prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to be... and Drug Administration on or before March 30, 1999, for any total temporomandibular joint...

  11. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Glenoid fossa prosthesis. 872.3950 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3950 Glenoid fossa prosthesis. (a) Identification. A glenoid fossa prosthesis is a device that is intended to be implanted in the...

  12. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Glenoid fossa prosthesis. 872.3950 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3950 Glenoid fossa prosthesis. (a) Identification. A glenoid fossa prosthesis is a device that is intended to be implanted in the...

  13. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Mandibular condyle prosthesis. 872.3960 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw...

  14. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  15. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  16. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to... requirement for premarket approval for any mandibular condyle prosthesis intended to be implanted in the...

  17. 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...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  19. 21 CFR 888.3720 - 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 888.3230 - 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  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 888.3780 - 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...

  8. 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...

  9. 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...

  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 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...

  12. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  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..., and to provide vascular access. It is commonly constructed of materials such as...

  14. 21 CFR 884.3650 - Fallopian tube prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  15. 21 CFR 884.3650 - Fallopian tube prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  16. 21 CFR 884.3650 - Fallopian tube prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  17. 21 CFR 884.3650 - Fallopian tube prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  18. 21 CFR 884.3650 - Fallopian tube prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  19. Fabrication of a provisional nasal prosthesis.

    PubMed

    Rosen, Evan B; Golden, Marjorie; Huryn, Joseph M

    2014-11-01

    A technique for making a provisional nasal prosthesis for interim use after the ablation of a midface tumor is described. The technique is especially useful for the re-creation of a nasal form in an expedient and cost-effective manner. A preoperative definitive cast, or moulage, of the patient that includes a nasal form is used to fabricate a vacuum form of the midface. The vacuum form is evaluated on the patient, the extension is adjusted, and an external adhesive knit liner is applied to give the appearance of a contoured nasal bandage. The provisional nasal prosthesis is attached with medical adhesive tape and removed daily by the patient. The prosthesis is easily replaced during the course of treatment and has been found to be functional and esthetically acceptable to those patients receiving care from the Dental Service at Memorial Sloan Kettering Cancer Center.

  20. 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

  1. 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.

  2. Groningen prosthesis for voice rehabilitation after laryngectomy.

    PubMed

    Annyas, A A; Nijdam, H F; Escajadillo, J R; Mahieu, H F; Leever, H

    1984-02-01

    Singer and Blom's endoscopic technique, using a single valved silicone prosthesis, constituted a dramatic advance in speech rehabilitation following total laryngectomy. Since 1980, we have developed a silicone biflanged prosthesis that overcomes some of the inconveniences of previous prostheses. Insertion via the mouth and the oesophagus, or as a primary procedure during total laryngectomy is easily done with the use of specially developed instruments. The success rate in 36 patients in which the voice button was inserted at the time of total laryngectomy was 86.2%.

  3. A running controller for a powered transfemoral prosthesis.

    PubMed

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

    2012-01-01

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

  4. TOTAL ANKLE ARTHROPLASTY: BRAZILIAN EXPERIENCE WITH THE HINTEGRA PROSTHESIS

    PubMed Central

    Nery, Caio; Fernandes, Túlio Diniz; Réssio, Cibele; Fuchs, Mauro Luiz; Godoy Santos, Alexandre Leme de; Ortiz, Rafael Trevisan

    2015-01-01

    Ankle arthrosis is becoming more and more common. The search for solutions that preserve joint function has led to a new generation of prosthesis with three components and more degrees of freedom. This paper presents the results achieved for ten patients treated with the HINTEGRA Prosthesis (Integra, New Deal), through collaborative action between the Foot and Ankle Groups of the Orthopedics and Traumatology divisions of Escola Paulista de Medicina, Unifesp, and the School of Medicine of the University of São Paulo (USP). The ten patients (six women and four men, aged between 29 and 66 years), underwent a surgical procedure consisting of Hintermann's technique, between January and June 2005. They were evaluated at prearranged intervals, and the data were subjected to statistical analysis. The surgery led to a significant improvement in ankle mobility. Radiological evaluation showed no signs of loosening or failure in the prosthetic components in any of the patients studied. Although the complication rate in our sample was high, it was equivalent to the rates found by other authors, and directly represents the learning curve associate with this kind of procedure. Four years after the procedure, it was found that the patients pain levels had significantly decreased, and that their functional patterns had significantly improved, with AOFAS and Hintermann scores indicating results that were excellent for 20%, good for 70% and poor for 10%. Treatment of ankle arthritis by means of total arthroplasty using the HINTEGRA prosthesis was capable of providing good results over an average observation period of four years. PMID:27022527

  5. 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

  6. When to Replace a Prosthesis

    MedlinePlus

    ... en español / Spanish Materials Find Local Facility Members Support Groups & Peer Support How to Find Support Certified Peer Visitor (CPV) Program Support Group Network Support Group Meeting Calendar Hospital/Rehab Facility ...

  7. Catastrophic failure of a monolithic zirconia prosthesis.

    PubMed

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

    2015-02-01

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

  8. Simplified, low cost below-knee prosthesis.

    PubMed

    Kijkusol, D

    1986-08-01

    Problems are encountered in using standard prostheses in developing countries, especially when the prostheses need repair and the amputees cannot come back to the workshop. Very simple, low cost and durable prostheses can solve this problem. The solution described has worked well with villagers in some rural areas of Thailand, where the inexpensive prosthesis permits walking bare-foot and through water and mud.

  9. Evolution of the reverse total shoulder prosthesis.

    PubMed

    Jazayeri, Reza; Kwon, Young W

    2011-01-01

    Over the last decade, reverse total shoulder arthroplasty has gained significant popularity due to its ability to address difficult reconstructive shoulder problems that could not be adequately treated in the past. The concept of the reverse shoulder prosthesis was introduced in the 1970s, but the initial attempts were associated with high complication and implant failure rates. The pioneering work of Paul Grammont (shifting the center of rotation medially and distally) and the development of the DELTA prosthesis have been fundamental to all subsequent reverse shoulder arthroplasty systems. These semiconstrained prostheses utilize the deltoid to improve function and stability of the shoulder joint by coupling a convex glenoid with a concave humeral component. Modern generations of reverse shoulder prosthesis continue to evolve on the fundamentals of Grammont. Though results of these new prosthesis demonstrate promising outcomes, many controversies and challenges continue to be refined. An historical review of the evolution of reverse shoulder arthroplasty is presented, as well as the currently expanding indications for its application.

  10. 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...

  11. 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...

  12. 21 CFR 878.3610 - Esophageal prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  13. 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...

  14. 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...

  15. Role of cytokines in gonarthrosis and knee prosthesis aseptic loosening.

    PubMed

    Loria, Maria Paola; Dambra, Porzia; Moretti, Biagio; Patella, Vittorio; Capuzzimati, Laura; Cavallo, Elsa; Nettis, Eustachio; Pesce, Vito; Dell'Osso, Adriana; Simone, Carmelo; Tursi, Alfredo

    2004-01-01

    Cytokines, which have been demonstrated in synovial fluids during various joint diseases, play an important role in mediating synovial inflammation and in regulating the immune response of many inflammatory processes. We studied synovial fluid, serum, and synovial fragments obtained from 33 patients--10 affected by serious gonarthrosis re-quiring a prosthetic implant, 8 with knee prosthesis aseptic loosening, and (as controls) 15 affected by degenerative meniscopathies--to evaluate the degree of inflammation and level of interleukins (IL-2, IL-4, IL-6, IL-10) and interferon gamma secretion. Histological analysis revealed slightly more infiltration by inflammatory cells in the synovial tissue of patients with gonarthrosis and knee prosthesis aseptic loosening than in that of the control group, with a high prevalence of macrophages. Moreover, we observed enhanced production of the studied cytokines, especially in synovial fluid as compared to serum, indicating that in the pathological conditions examined the inflammatory events are mainly localized. Because the role of these cytokines is to modulate inflammation, better knowledge of the involvement of cells and their soluble mediators in articular damage could guide immunomodulating treatment.

  16. Biologic Prosthesis Reduces Recurrence After Laparoscopic Paraesophageal Hernia Repair

    PubMed Central

    Oelschlager, Brant K.; Pellegrini, Carlos A.; Hunter, John; Soper, Nathaniel; Brunt, Michael; Sheppard, Brett; Jobe, Blair; Polissar, Nayak; Mitsumori, Lee; Nelson, James; Swanstrom, L

    2006-01-01

    Objective: Laparoscopic paraesophageal hernia repair (LPEHR) is associated with a high recurrence rate. Repair with synthetic mesh lowers recurrence but can cause dysphagia and visceral erosions. This trial was designed to study the value of a biologic prosthesis, small intestinal submucosa (SIS), in LPEHR. Methods: Patients undergoing LPEHR (n = 108) at 4 institutions were randomized to primary repair −1° (n = 57) or primary repair buttressed with SIS (n = 51) using a standardized technique. The primary outcome measure was evidence of recurrent hernia (≥2 cm) on UGI, read by a study radiologist blinded to the randomization status, 6 months after operation. Results: At 6 months, 99 (93%) patients completed clinical symptomatic follow-up and 95 (90%) patients had an UGI. The groups had similar clinical presentations (symptom profile, quality of life, type and size of hernia, esophageal length, and BMI). Operative times (SIS 202 minutes vs. 1° 183 minutes, P = 0.15) and perioperative complications did not differ. There were no operations for recurrent hernia nor mesh-related complications. At 6 months, 4 patients (9%) developed a recurrent hernia >2 cm in the SIS group and 12 patients (24%) in the 1° group (P = 0.04). Both groups experienced a significant reduction in all measured symptoms (heartburn, regurgitation, dysphagia, chest pain, early satiety, and postprandial pain) and improved QOL (SF-36) after operation. There was no difference between groups in either pre or postoperative symptom severity. Patients with a recurrent hernia had more chest pain (2.7 vs. 1.0, P = 0.03) and early satiety (2.8 vs. 1.3, P = 0.02) and worse physical functioning (63 vs. 72, P = 0.03 per SF-36). Conclusions: Adding a biologic prosthesis during LPEHR reduces the likelihood of recurrence at 6 months, without mesh-related complications or side effects. PMID:16998356

  17. Grammont reverse prosthesis: design, rationale, and biomechanics.

    PubMed

    Boileau, Pascal; Watkinson, Duncan J; Hatzidakis, Armodios M; Balg, Frederic

    2005-01-01

    Combined destruction of the rotator cuff and the glenohumeral joint may lead to a painful and pseudo-paralyzed shoulder. In this situation a nonconstrained shoulder prosthesis yields a limited functional result or may even be contraindicated. Previous constrained prostheses (ball-and-socket or reverse ball-and-socket designs) have failed because their center of rotation remained lateral to the scapula, which limited motion and produced excessive torque on the glenoid component, leading to early loosening. The reverse prosthesis designed by Paul Grammont, unlike any previous reverse ball-and-socket design, has introduced 2 major innovations that have led to its success: (1) a large glenoid hemisphere with no neck and (2) a small humeral cup almost horizontally oriented with a nonanatomic inclination of 155 degrees, covering less than half of the glenosphere. This design medializes and stabilizes the center of rotation, minimizes torque on the glenoid component, and helps in recruiting more fibers of the anterior and posterior deltoid to act as abductors. Furthermore, the humerus is lowered relative to the acromion, restoring and even increasing deltoid tension. The Grammont reverse prosthesis imposes a new biomechanical environment for the deltoid muscle to act, thus allowing it to compensate for the deficient rotator cuff muscles. The clinical experience does live up to the biomechanical concept: the reverse prosthesis restores active elevation above 90 degrees in patients with a cuff-deficient shoulder. However, external rotation often remains limited, particularly in patients with an absent or fat-infiltrated teres minor. Internal rotation is also rarely restored after a reverse prosthesis. Failure to restore sufficient tension in the deltoid may result in prosthetic instability. The design does appear to protect against early loosening of the glenoid component, but impingement of the humeral cup on the scapular neck can lead to scapular notching and polyethylene

  18. 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

  19. Design and Control of a Powered Transfemoral Prosthesis.

    PubMed

    Sup, Frank; Bohara, Amit; Goldfarb, Michael

    2008-02-01

    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.

  20. 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

  1. The effects of prosthesis mass on metabolic cost of ambulation in non-vascular trans-tibial amputees.

    PubMed

    Gailey, R S; Nash, M S; Atchley, T A; Zilmer, R M; Moline-Little, G R; Morris-Cresswell, N; Siebert, L I

    1997-04-01

    The effect of prosthesis mass on the metabolic cost of steady-state walking was studied in ten male non-vascular trans-tibial amputees (TTAs) and ten non-amputee controls. The subjects underwent four trials of treadmill ambulation, with each trial performed for nine minutes at level grade and 76 m/min. Twenty minutes of seated rest followed each trial. During trials numbers one and two, TTAs ambulated without mass added to their prosthesis. During the third and fourth trials, either 454 or 907 grammes mass (1 or 2lbs mass respectively) were randomly assigned and added to either the prosthesis or the leg of the non-amputee control. Subjects were blinded to the amount of mass added to their limb. Within-group comparisons across the four trials showed significant differences in oxygen consumption (VO2) and heart rate (HR) between the two non "mass added" trials, but no effect for addition of mass. The VO2 of TTAs was only 0.6 ml/kg/min (4.7 percent) greater during walking following the addition of 907 grammes to the prosthesis than without mass addition at all, while HR averaged only 1.4 beats/min. higher under the same testing condition. Pearson-product moment correlations echoed these findings, as moderate, but in all cases, negative correlations were observed for associations among the factors of subject age, stump length, and prosthesis-shoe weight, and both VO2 and HR. It was concluded that adding up to 907 grammes mass to a non-vascular TTA's prosthesis will not significantly increase the energy expenditure or HR at a normal walking speed, and that elevated energy cost of ambulation in repeated measures testing without mass added may reflect task familiarization and not an added burden of prosthesis mass.

  2. Multigrasp Myoelectric Control for a Transradial Prosthesis

    PubMed Central

    Dalley, Skyler A.; Varol, Huseyin Atakan; Goldfarb, Michael

    2012-01-01

    This paper presents the design and preliminary experimental verification of a multigrasp myoelectric controller. The controller enables the direct and proportional control of a multigrasp transradial prosthesis through a set of nine postures using two surface EMG electrodes. Five healthy subjects utilized the multigrasp controller to manipulate a virtual prosthesis to experimentally quantify the performance of the controller in terms of real time performance metrics. For comparison, the performance of the native hand was also characterized using a dataglove. The average overall transition times for the multigrasp myoelectric controller and the native hand with the dataglove were found to be 1.49 and 0.81 seconds, respectively. The transition rates for both were found to be the same (99.2%). PMID:22275677

  3. Control of dental prosthesis system with microcontroller.

    PubMed

    Kapidere, M; Müldür, S; Güler, I

    2000-04-01

    In this study, a microcontroller-based electronic circuit was designed and implemented for dental prosthesis curing system. Heater, compressor and valve were controlled by 8-bit PIC16C64 microcontroller which is programmed using MPASM package. The temperature and time were controlled automatically by preset values which were inputted from keyboard while the pressure was kept constant. Calibration was controlled and the working range was tested. The test results showed that the system provided a good performance.

  4. Longitudinal performance of an implantable vestibular prosthesis.

    PubMed

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

    2015-04-01

    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. This article is part of a Special Issue entitled .

  5. Improved comfort and function of arm prosthesis after implantation of a Humerus-T-Prosthesis in trans-humeral amputees.

    PubMed

    Witsø, Eivind; Kristensen, Tomm; Benum, Pål; Sivertsen, Svein; Persen, Leif; Funderud, Are; Magne, Tordis; Aursand, Hans Petter; Aamodt, Arild

    2006-12-01

    The use of arm prosthesis in trans-humeral amputees is limited; due to the cone form of the amputation stump. A Humerus-T-Prosthesis was implanted in three patients to create artificial humerus condyles. Two of the patients were successfully rehabilitated with the application of a new type trans-humeral arm prosthesis. This arm prosthesis had a socket which is suspended and stabilized by the humerus and implant only. Traction and rotational stability were secured by adjustable pressure adaptation around the artificial condyles. The third patient developed a pressure wound over the lateral part of the artificial condyle that later healed. He also was subject to a new trauma with a fracture of the ipsilateral scapula and until now has had limited the use of his new arm prosthesis. It was concluded that this new concept for prosthesis fitting of trans-humeral amputees looks promising, but alternative designs of the implant should be tested.

  6. 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

  7. 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

  8. 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

  9. Novel knee joint mechanism of transfemoral prosthesis for stair ascent.

    PubMed

    Inoue, Koh; Wada, Takahiro; Harada, Ryuchi; Tachiwana, Shinichi

    2013-06-01

    The stability of a transfemoral prosthesis when walking on flat ground has been established by recent advances in knee joint mechanisms and their control methods. It is, however, difficult for users of a transfemoral prosthesis to ascend stairs. This difficulty is mainly due to insufficient generation of extension moment around the knee joint of the prosthesis to lift the body to the next step on the staircase and prevent any unexpected flexion of the knee joint in the stance phase. Only a prosthesis with an actuator has facilitated stair ascent using a step-over-step gait (1 foot is placed per step). However, its use has issues associated with the durability, cost, maintenance, and usage environment. Therefore, the purpose of this research is to develop a novel knee joint mechanism for a prosthesis that generates an extension moment around the knee joint in the stance phase during stair ascent, without the use of any actuators. The proposed mechanism is based on the knowledge that the ground reaction force increases during the stance phase when the knee flexion occurs. Stair ascent experiments with the prosthesis showed that the proposed prosthesis can realize stair ascent without any undesirable knee flexion. In addition, the prosthesis is able to generate a positive knee joint moment power in the stance phase even without any power source.

  10. Prosthesis Socket Pressure Tools v. 1.0

    SciTech Connect

    Janik, Gregory

    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 on 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.

  11. 21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  12. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  13. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  15. [Aortoenteric fistula secondary to aortobifemoral prosthesis infection].

    PubMed

    Gabriel Botella, F; Labiós Gómez, M; Ibáñez Gadea, L; Fácila Rubio, L; Carbonell Cantí, C

    2002-05-01

    We present the case of a 76 year-old man, intervened of an obstruction bilateral iliac by means of placement of a prosthesis aortobifemoral that presented pain in the grave left iliac and fever in needles of 39 degrees C to the five years of the intervention. In the physical exploration it highlighted a painful abdomen in the grave left iliac with signs of peritoneal irritation. In the laboratory tests a leukocytosis was detected with neutrophilia and negative culture. The computed thomography (CT) show the presence of gas bubbles around the prosthesis, as well as a liquid collection with areas necrotics in their interior that affected to the psoas and iliac muscles. In the same exploration the aspirative puncture with drainage of the absces demonstrated in the cultivations carried out in aerobic means the presence of Enterococcus faecalis and Enterobacter cloacae. When presenting a high gastrointestinal hemorrhage abruptly, he was practiced and gastroduodenal endoscope in which a aortoduodenal fistula was evidenced with having bled active. When a bypass extra-anatomic, the sick person will practice it died when presenting a shock abrupt hipovolemic that he didn't respond to the pertinent treatment. We analyze the approaches current diagnoses of infection of the vascular prosthesis and their more serious complication, the aortoenteric fistula (AEF) that either appears in the 0.3-5.9% of the patients who undergo prosthetic reconstruction of the abdominal aorta, for occlusive or aneurismal disease. We highlight the importance of carrying out a precocious diagnosis of the infection of the portion retroperitoneal of the vascular graft that, often, it is manifested with subtle and not specific clinical signs, with the techniques at the moment available as: the CT, fine needle aspiration guided by her, and to diminish the rates of mortality, from the current of 43%, until the most optimistic estimated in 19%.

  16. 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

  17. Auricular Prosthesis-A Case Report

    PubMed Central

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

    2014-01-01

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

  18. Belgian experience with the Vibrant Soundbridge prosthesis.

    PubMed

    Thill, M P; Gérard, J M; Garin, P; Offeciers, E

    2002-01-01

    The Belgian Experience with the Vibrant Soundbridge Prosthesis. The authors present the first results obtained with 13 patients implanted with the Vibrant Soundbridge, a semi-implantable electromagnetic hearing device. The first patient was implanted in October 1998. The results show that there were no significant modifications of the hearing thresholds after implantation. The average functional gain was 30 dB in tonal audiometry and 25.6 dB in vocal audiometry. All the patients are satisfied with the device and wear it daily.

  19. 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

  20. Photovoltaic Retinal Prosthesis with High Pixel Density

    PubMed Central

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

    2012-01-01

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

  1. Photovoltaic retinal prosthesis with high pixel density

    NASA Astrophysics Data System (ADS)

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

    2012-06-01

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

  2. [The evaluation of early and late results of using Codubix cranial prosthesis].

    PubMed

    Czepko, Ryszard; Kwinta, Borys

    2005-01-01

    The filling of the cranial defect is an essential problem in neurosurgery on account of the necessity of brain protection as well as for cosmetic reasons. The aim of this study was to evaluate the direct and distant outcome after polypropylene-polyester Codubix prosthesis implantation. This research was based on the analysis of 41 patients treated surgically in the Department of Neurosurgery at the Jagiellonian University in Cracow between 1995-2004. All patients had the Codubix prosthesis implanted. The implantation was performed either synchronously or after the surgery which caused the cranial defect. Directly after the surgery proper healing of the prosthesis could be observed in all patients. The exception was one patient who died directly after the surgery but the cause of his death was not connected with the prosthesis implantation. Seven patients (17,1%) had the temperature temporarily elevated. Three had haematoma collection in the subgaleal space, one (2,4%) developed meningitis which was successfully treated with antibiotics, one (2,4%) suffered from temporary circulation disturbances of the scalp. The late evaluation was performed with help of a questionnaire to which 30 patients (73,2%) responded. The answer ranged 73,2% (30 patients). In this group 16 patients (53,4%) described the cosmetic effect as very good, 10 patients (33%) as good and 4 (13,3%) as unsatisfactory. The commonest reason for the critical note was the depression of the plate which happened to 3 patients. The other 3 patients complained about inappropriate profile of the plate causing the asymmetry of the cranial vault. Seven patients felt temporary pain in the postoperative scar, in one case the pain was took as the friction between the prosthesis and bone margin. Properly performed implantation of accurate bone prosthesis Codubix is safe and usually brings a good cosmetic effect. Direct complications are transitional and occur in the small percent of cases. Distant examinations show

  3. The bionic eye (electronic visual prosthesis): a review.

    PubMed

    Suaning, G J; Lovell, N H; Schindhelm, K; Coroneo, M T

    1998-08-01

    The concept of a visual prosthesis for the blind or partially sighted is not a new one. Indeed, for more than three decades this technology based treatment for blindness has appeared imminent. Despite the concerted efforts of numerous physicians, scientists and engineers, the successful application of a useful visual prosthesis remains elusive. The present review will endeavour to describe past efforts, investigate the present state of the art and indicate the obstacles that must be overcome in order to bring an electronic visual prosthesis to fruition.

  4. Within-subject comparisons of implant-supported mandibular prostheses: choice of prosthesis.

    PubMed

    Feine, J S; de Grandmont, P; Boudrias, P; Brien, N; LaMarche, C; Taché, R; Lund, J P

    1994-05-01

    Although previous studies have demonstrated that implant-supported prostheses are more satisfactory and efficient for edentulous patients than are conventional prostheses, until now no investigation has directly compared different types of implant-supported prostheses. We carried out a within-subject cross-over clinical trial with fixed and long-bar removable implant-supported mandibular prostheses. Fifteen subjects were randomly divided into two groups. One group received the fixed prosthesis first, while the other first received the removable. After a two-month adaptation period, psychometric measurements of various aspects of the prostheses and physiological tests of masticatory efficiency were carried out. The prostheses were then changed, and the procedures repeated. At the end of the study, subjects chose the prosthesis they wished to keep. In this paper, we report on the data gathered at this last appointment. Eight subjects chose the fixed (F group), and seven chose the removable (R group). Both groups rated stability and ability to chew with the fixed as significantly better than with the removable. However, the R group rated ease of cleaning as the most important factor governing their decision, followed by esthetics and stability. The F group considered stability to be the most important factor in their decision, followed by chewing ability and ability to clean. There was a tendency for the removable to be chosen by older subjects (+50 years). These results suggest that patients choose fixed or removable implant-supported prostheses for specific reasons, and that patient attitudes should be considered when the design of a prosthesis is being planned for an individual patient.

  5. Long-acting liposomal bupivacaine decreases inpatient narcotic requirements in men undergoing penile prosthesis implantation

    PubMed Central

    Cotta, Brittney H.; Welliver, Charles; Brahmamdam, Anand; Bednarchik, Cynthia L.; Dynda, Danuta; Köhler, Tobias S.

    2016-01-01

    Objective A new extended-release bupivacaine suspension bupivacaine (ERSB) delivers 3 days of local anesthetic and has been shown to reduce pain and narcotic usage in some patient groups but this issue is largely unstudied in urologic surgery. Material and methods We performed a single-surgeon retrospective chart review of the patients who underwent penile prosthesis implantation. Pain scores and standardized morphine equivalent (ME) dose data were collected during 23 hour- observation period. Subjects who received ERSB were compared with those who received standard bupivacaine or no local anesthesia. Results In a study population of 37 patients, those who received (n=13), and did not receive (n=24) ERSB were grouped, respectively. The groups were comparable demographically. ME was used 3.2 fold more frequently in the non-ERSB group (18.0, and 5.6 for non-ERSB, and ESRB groups, respectively (p=0.04). Mean overall pain scores were 3.8/10 for ERSB and 3.9/10 for non-ERSB group, respectively. Per patient medication cost for the control, and ERSB groups were $5.16 and $285.54, respectively. Conclusion The use of a new ERSB in penile prosthesis implants did lead to reduced narcotic consumption with comparable postoperative pain control to the non-ERSB group. However, the cost of the ERSB ($285/dose) may be prohibitive for its use. PMID:27909614

  6. The effects of aneurysm repair using an aortic prosthesis on the electrical parameters of the muscular layer of the abdominal aorta.

    PubMed

    Hauzer, W; Czerski, A; Zawadzki, W; Gnus, J; Ratajczak, K; Nowak, M; Janeczek, M; Witkiewicz, W; Niespielak, P

    2014-12-01

    The study was carried out on 10 swine of 20-30 kg body weight. Five animals were assigned to each of 2 groups. An aneurysm of the abdominal aorta was created experimentally in animals from the first and second study group. After 4 weeks, animals from the second group were subject to aneurysm repair using an aortic prosthesis. During the experiment, we measured the myoelectric activity of the muscular layer of the abdominal aorta and aneurysmal lesion with the ultrasonographic technique. Measurements of the aorta and aneurysmal lesion and histopathological analyses were carried out post-mortem. We found a statistically significant decrease in the myoelectric activity of the aorta on the aorta-straight prosthesis interface and a significant decrease in the thickness of the muscular layer of the aorta on the aorta-prosthesis interface. No similar changes were found for experimentally induced aneurysms of the abdominal aorta. A straight prosthesis graft may not be the perfect option in the treatment of abdominal aortic aneurysm, as it contributes to the remodelling of the tissue on the prosthesis-aorta interface. This may result in the relapse of an aneurysm and post-operative complications.

  7. [Transcutaneous osseointegrated prosthesis (TOP) after limb amputation : Status quo and perspectives].

    PubMed

    Willy, Christian; Krettek, Christian

    2017-04-10

    The majority of transfemoral and transtibial amputees can be functionally fitted with conventional suspension sockets; however, due to socket problems using conventional stump care, 60% of the patients have limited function and even in younger patients approximately one sixth are unable to wear the prosthesis daily. After the introduction of transcutaneous osseointegrated prostheses (TOP) the inherent problems of socket-stump care can be avoided for these patients. Against this background this article reviews the recent clinical development of TOP in Sweden, Germany, the Netherlands, Australia and USA currently in nine centers. Unanimously, all groups show that TOP enables physiological weight bearing, improved range of motion in the proximal joint, as well as osseoperceptive sensory feedback and better control of the artificial limb. Likewise, there is agreement that as a rule that there is a clinically less relevant superficial contamination of the stoma. Furthermore, TOP is nowadays also used for transhumeral amputees and after thumb amputation and the development of the indications for this technique are increasing. Future aspects include novel treatment options using implanted intramedullary electrodes allowing permanent and unlimited bidirectional communication with the human body (osseointegrated human-machine gateway). This could possibly realize an innovative form of prosthesis control as well as the combination of TOP and targeted muscle reinnervation (TMR) surgery to create more advanced prosthesis systems for upper and lower extremity amputees.

  8. 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

  9. Interim Prosthesis Options for Dental Implants.

    PubMed

    Siadat, Hakimeh; Alikhasi, Marzieh; Beyabanaki, Elaheh

    2016-01-24

    Dental implants have become a popular treatment modality for replacing missing teeth. In this regard, the importance of restoring patients with function during the implant healing period has grown in recent decades. Esthetic concerns, especially in the anterior region of the maxilla, should also be considered until the definitive restoration is delivered. Another indication for such restorations is maintenance of the space required for esthetic and functional definitive restorations in cases where the implant site is surrounded by natural teeth. Numerous articles have described different types of interim prostheses and their fabrication techniques. This article aims to briefly discuss all types of implant-related interim prostheses by different classification including provisional timing (before implant placement, after implant placement in unloading and loading periods), materials, and techniques used for making the restorations, the type of interim prosthesis retention, and definitive restoration. Furthermore, the abutment torque for such restorations and methods for transferring the soft tissue from interim to definitive prostheses are addressed.

  10. Retention and processing methods of nasal prosthesis.

    PubMed

    Goiato, Marcelo Coelho; Mancuso, Daniela Nardi; Zuccolotti, Bruna Carolina Rossati; Murakawa, Ana Cristina; Lima, Daniela Coelho de; Santos, Daniela Micheline dos; Andreotti, Agda Marobo

    2012-11-01

    Patients with congenital malformations, traumatic or pathological mutilation and maxillofacial developmental disorders can be restored aesthetically and emotionally by the production and use of facial prostheses. The aim of this study was to review the literature about the retention and processing methods of facial prostheses, and discuss their characteristics. A literature review on Medline (PubMed) database was performed by using the keywords "maxillofacial prosthesis, silicone, esin, pigment, cosmetic, prosthetic nose", based on articles published from 1956 to 2010. Several methods of retention, from adhesives to the placement of implants, and different processing methods such as laser, CAD/CAM and rapid prototyping technologies have been reported. There are advantages and disadvantages of each procedure, and none can be classified as better compared to others.

  11. Galvanic gold plating for fixed dental prosthesis.

    PubMed

    Ozcelik, Tuncer Burak; Yilmaz, Burak

    2013-07-01

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

  12. Development of a micromachined epiretinal vision prosthesis.

    PubMed

    Stieglitz, Thomas

    2009-12-01

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

  13. 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.

  14. 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 polyester reinforced medical grade silicone elastomer intended for use in the surgical reconstruction of...

  15. 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 polyester reinforced medical grade silicone elastomer intended for use in the surgical reconstruction of...

  16. 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

  17. Microfluidic neurotransmiter-based neural interfaces for retinal prosthesis.

    PubMed

    Iezzi, Raymond; Finlayson, Paul; Xu, Yong; Katragadda, Rakesh

    2009-01-01

    Natural inter-neuronal communication is mediated primarily via neurotransmitter-gated ion channels. While most of the methods for neural interfacing have been based upon electrical stimulation, neurotransmitter-based approaches for the spatially and temporally controlled delivery of neurotransmitters are relatively new. Methods of neurotransmitter stimulation retinal prosthesis may provide new ways to control neural excitation. Experimental results for retinal ganglion cell stimulation demonstrate the feasibility of a neurotransmitter-based retinal prosthesis.

  18. Rehabilitation of single finger amputation with customized silicone prosthesis

    PubMed Central

    Yadav, Niharika; Chand, Pooran; Jurel, Sunit Kumar

    2016-01-01

    Finger amputations are common in accidents at home, work, and play. Apart from trauma, congenital disease and deformity also leads to finger amputation. This results in loss of function, loss of sensation as well as loss of body image. Finger prosthesis offers psychological support and social acceptance in such cases. This clinical report describes a method to fabricate ring retained silicone finger prosthesis in a patient with partial finger loss. PMID:28163487

  19. Towards a Completely Implantable, Light-Sensitive Intraocular Retinal Prosthesis

    DTIC Science & Technology

    2007-11-02

    electronic retinal prosthesis is under development to treat retinitis pigmentosa and age-related macular degeneration, two presently incurable...34Preservation of the inner retina in retinitis pigmentosa . A morphometric analysis," Arch Ophthalmol, vol. 115, no. 4, pp. 511-515, Apr.1997...Towards a completely implantable, light-sensitive intraocular retinal prosthesis. M.S. Humayun, J.D. Weiland, B. Justus1, C. Merrit1, J. Whalen, D

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

    PubMed

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

    2014-01-01

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

  1. 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

  2. Magnet-Retained Orbital Prosthesis Using a Dental Implant.

    PubMed

    Kim, Soung Min

    2016-12-30

    The loss of an eye and the associated facial disharmony has major physical, psychological, and social consequences for patients undergoing orbital exenteration. A magnet-retained prosthesis with an implant has various advantages over both adhesive and spectacle-retained prostheses for reconstruction of the exenterated orbit.The author demonstrates one representative patient with our orbital reconstruction patients with magnetic implants, which will be applied to various maxillofacial prosthesis strategies in the near future.

  3. Penile prosthesis implantation in Chinese patients with severe erectile dysfunction: 10-year experience.

    PubMed

    Song, Wei-Dong; Yuan, Yi-Ming; Cui, Wan-Shou; Wu, Alex K; Zhu, Yi-Chen; Liu, Jing; Wang, Lin; Bai, Guang-Yi; Peng, Jing; Zhang, Zhi-Chao; Gao, Bing; Guo, Ying-Lu; Lue, Tom F; Xin, Zhong-Cheng

    2013-09-01

    We retrospectively evaluated the clinical outcome of penile prosthesis implantation (PPI) in Chinese patients with severe erectile dysfunction (SED). From July 2000 to December 2011, 224 patients (mean age: 35.9±11.8 years, range: 20-75 years) with SED underwent PPI by experienced surgeon according to standard PPI procedure at our centre. A malleable prosthesis (AMS 650) was implanted in 45 cases (20.1%), and a three-piece inflatable prosthesis (AMS 700 CXM or AMS 700 CXR) was implanted in 179 cases (79.9%). Surgical outcomes, including postoperative complications, clinical efficacy and couple satisfaction, were evaluated over than 6 months postoperatively using medical record abstraction, IIEF-5, quality of life (QoL) scores, and the patient/partner sexual satisfaction score proposed by Bhojwani et al. Of the 224 patients eligible for the study, 201 subjects (89.7%) completed follow-up. All of patients could perform sexual intercourse post PPI with the mean postoperative IIEF-5 and QoL scores were 20.02±2.32 and 5.28±0.76, respectively, which were significantly improved compared with the preoperative scores (6.29±1.5 and 2.13±0.84, P<0.01). Of the 201 men, mechanical malfunction occurred in four cases (2.0%) and three cases were re-implanted new device, and two cases (1.0%) developed a mild curvature of the penis. Scrotal erosion with infection occurred in one case with diabetes mellitus (0.5%) and required complete removal of the implanted AMS 700 CXM. Satisfactory sexual intercourse at least twice per month was reported by 178 men (88.6%), and overall satisfaction with the PPI surgery was reported by 89.0% of men and 82.5% of partners. Patient satisfaction in the three-piece inflatable prosthesis group was higher than in the malleable prosthesis group (P<0.05). Satisfaction, however, between the types of prostheses, did not differ in the partner survey. PPI is a safe and effective treatment option for Chinese patients with SED and experienced surgeon

  4. 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

  5. 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

  6. Fifteen years of experience with Integral-Leg-Prosthesis: Cohort study of artificial limb attachment system.

    PubMed

    Juhnke, Dora-Lisa; Beck, James P; Jeyapalina, Sujee; Aschoff, Horst H

    2015-01-01

    Integral-Leg-Prosthesis (ILP) is a comparatively new attachment system that allows direct skeletal docking of artificial limbs. Between January 1999 and December 2013, 69 patients with transfemoral amputation were fitted with ILPs by a single German surgeon. Device design iterations and surgical techniques evolved during these years. For the purposes of comparison, patients receiving the first two designs and procedure iterations were placed in group 1 and the patients fitted with the final design were placed in group 2. Infection rate and planned and unplanned surgical interventions were statistically compared using Fisher exact test. Data demonstrated that the high rate of stoma-associated infections seen in group 1 was dramatically reduced in group 2. Of the 39 patients with 42 implants in group 2, none had operative interventions secondary to infection. All group 2 patients remained infection-free without the use of antibiotics by following a simple but defined wound-hygiene protocol. We concluded that the final iteration of the osseointegrated intramedullary device with a low energy surface at the soft tissue and prosthesis interface allowed a biologically stable skin stoma that remained infection-free without chronic use of antibiotics. The reduction in the infection rate was attributed to the clinically based, empirically driven changes in design and surgical techniques.

  7. Fabrication of an Implant-Supported Fixed Interim Prosthesis Using a Duplicate Denture: An Alternative Technique.

    PubMed

    Al-Thobity, Ahmad M

    2016-06-22

    The fabrication of an implant-supported fixed complete denture prosthesis involves multiple clinical and laboratory steps. One of the main steps is to provide the patient with an interim fixed prosthesis to evaluate the patient's esthetic and functional needs as well as to enhance the patient's psychology before proceeding to the definitive prosthesis. Different techniques for fabricating interim prostheses have been described in the literature. This report describes an alternative technique that uses a duplicate denture made of self-curing acrylic resin to fabricate an implant-supported fixed interim prosthesis. The interim prosthesis was later used as a blueprint for the definitive implant-supported hybrid prosthesis.

  8. 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

  9. 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.

  10. Neer Award 2005: The Grammont reverse shoulder prosthesis: results in cuff tear arthritis, fracture sequelae, and revision arthroplasty.

    PubMed

    Boileau, Pascal; Watkinson, Duncan; Hatzidakis, Armodios M; Hovorka, Istvan

    2006-01-01

    This clinical study was performed to analyze the midterm results and potential complications of the reverse prosthesis in different diagnosis. Forty-five consecutive patients with Grammont prosthesis were evaluated clinically and radiographically with a mean follow-up of 40 months (range, 24-72 months). The indication was a massive and irreparable cuff tear associated with arthrosis (CTA) in 21 cases, fracture sequelae (FS) with arthritis in 5 cases, and failure of a revision arthroplasty (revision) in 19 cases. Fourteen complications occurred in 11 patients. 3 dislocations, 3 deep infections (all 3 in the revision group), 1 case of aseptic humeral loosening, 2 periprosthetic humeral fractures, 1 intraoperative glenoid fracture, 1 wound hematoma, 2 late acromial fractures, and 1 axillary nerve palsy. Of the patients, 10 (22%) required further surgery: 4 reoperations, 4 prosthesis revisions, and 2 prosthesis removals. Complications were higher in revision than in CTA (47% vs. 5%). All 3 groups showed a significant increase in active elevation (from 55 degrees preoperatively to 121 degrees postoperatively) and Constant score (from 17 to 58 points) but no significant change in active external rotation (from 7 degrees to 11 degrees ) or internal rotation (S1 preoperatively and postoperatively). Of the patients, 78% were satisfied or very satisfied with the result and 67% had no or slight pain. However, the postoperative Constant score, adjusted Constant score, and American Shoulder and Elbow Surgeons shoulder score were all significantly higher in the CTA group with as compared with the revision group (P = .01, .004, and .002, respectively). Scapular notching was seen in 24 cases (68%). No glenoid loosening was observed at current follow-up, even when the notch extended beyond the inferior screw (28% of cases). Atrophy of severe fatty infiltration of the teres minor was associated with lower external rotation (15 degrees vs 0 degrees , P = .02) and lower functional

  11. 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

  12. 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.

  13. Fixation of the reversed shoulder prosthesis.

    PubMed

    Hopkins, Andrew R; Hansen, Ulrich N; Bull, Anthony M J; Emery, Roger; Amis, Andrew A

    2008-01-01

    The last decade has seen an increased interest in reversed shoulder prostheses. Success rates with these designs have been varied, with initial performance marred by failures resulting from improper implant alignment and an emerging engineering understanding. Competitor products to the well-documented Grammont design have yielded increasingly high success rates. Understanding the relationships between implant design, surgical procedure, and clinical outcome is important so that current results can be improved upon. This study considers the performance of 3 different reversed shoulder designs from the perspective of osseointegration, with the results broadly validated through comparison with experimental data. Finite element modeling was used to clarify the relationships between lateral offset of the center of rotation, screw insertion angle, screw length, screw diameter, bone material quality, and the potential for interdigitation of the supporting bone onto the reversed prosthesis. The results indicate that screw length, insertion angle, and diameter, when maximized, allow the least relative motion between the implant and underlying bone. When the bone is stiffer, the relative motion of the implant is lower. In almost all scenarios modeled, the interface micromotion was small enough to suggest that the glenoid was stable enough to encourage bone ingrowth across the majority of the bone-implant interfaces.

  14. Optoelectronic retinal prosthesis: system design and performance.

    PubMed

    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 degrees visual field, with a full 30 degrees field accessible via eye movements. Pixel sizes are scalable from 100 to 25 microm, corresponding to 640-10,000 pixels on an implant 3 mm in diameter.

  15. Amputation and prosthesis fitting in paediatric patients.

    PubMed

    Griffet, J

    2016-02-01

    Amputation of a limb is always perceived as a catastrophe. The principles underlying creation of a stump adapted to modern prosthetic fittings must be fully understood and the patient managed by a multidisciplinary team. In paediatric patients, preserving residual limb length is a crucial point that should be assessed according to the expected growth potential. Advances in prosthetic fittings have led to changes in the overall concept of socket design, which seeks to achieve three objectives: to maximise the weight-bearing surface area, to eliminate friction of the skin on the socket, and to eliminate lever-arm effects. The introduction on the market of new materials has contributed substantially to advances in prosthetic fittings. These advances require the use of new criteria for stump quality and optimisation, which exert a considerable influence on prosthesis function. Prosthetic fitting and specific management of psychological and social problems are provided during an inpatient stay in a physical medicine department, by a team of physicians, other healthcare professionals, social workers, and educators. Three-dimensional imaging and gait analysis provide valuable information.

  16. A First Comparative Study of Oesophageal and Voice Prosthesis Speech Production

    NASA Astrophysics Data System (ADS)

    Carello, Massimiliana; Magnano, Mauro

    2009-12-01

    The purpose of this work is to evaluate and to compare the acoustic properties of oesophageal voice and voice prosthesis speech production. A group of 14 Italian laryngectomized patients were considered: 7 with oesophageal voice and 7 with tracheoesophageal voice (with phonatory valve). For each patient the spectrogram obtained with the phonation of vowel /a/ (frequency intensity, jitter, shimmer, noise to harmonic ratio) and the maximum phonation time were recorded and analyzed. For the patients with the valve, the tracheostoma pressure, at the time of phonation, was measured in order to obtain important information about the "in vivo" pressure necessary to open the phonatory valve to enable speech.

  17. Biomechanical evaluation of an adjustable patellar tendon bearing prosthesis.

    PubMed

    Mizrahi, J; Susak, Z; Bahar, A; Seliktar, R; Najenson, T

    1985-01-01

    The purpose of this study was to determine the relation between geometry of the patellar tendon (PT) insertion in the socket and the dynamic load transmitted through the PT, in a patellar tendon bearing (PTB) prosthesis. The dynamic load was measured by a specially constructed two-component load cell, which was mounted on the experimental prosthesis. Geometry of the PT insertion relative to the socket was altered by adjusting the location of the mounting frame-load cell assembly. Evaluation of performance of the prosthesis in the range of geometries investigated was made objectively by gait analysis of the patients. The latter was performed on a 10 m walkpath, including at halfway two forceplates, from which the foot-ground forces were recorded. Simultaneously, the PT forces on the prosthesis, as sensed by the load cell were monitored. Computer processing of the data included full analysis of the force-trace and the determination of criteria for optimization of the PT insertion. The resulting criteria were those which expressed minimization of abnormalities in the foot-ground forces of each patient, such as vertical and braking forces and their timings. The complete optimization procedure, which was undertaken for two below-knee male amputees, indicated the correct positioning of the PT insertion, actually taken in the final fitting procedure of the socket of the prosthesis.

  18. 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.

  19. 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

  20. 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

  1. 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

  2. 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.

  3. 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

  4. 21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 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...

  5. 21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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)...

  6. 21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 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...

  7. 21 CFR 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... uncemented prosthesis. 888.3180 Section 888.3180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. (a) Identification. An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of...

  8. 21 CFR 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... uncemented prosthesis. 888.3180 Section 888.3180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. (a) Identification. An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of...

  9. 21 CFR 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... uncemented prosthesis. 888.3180 Section 888.3180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. (a) Identification. An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of...

  10. 21 CFR 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... uncemented prosthesis. 888.3180 Section 888.3180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. (a) Identification. An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of...

  11. 21 CFR 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... uncemented prosthesis. 888.3180 Section 888.3180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. (a) Identification. An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of...

  12. 21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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...

  13. 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...

  14. 21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 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)...

  15. 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...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  17. 21 CFR 888.3770 - 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...

  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 888.3760 - 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  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 888.3760 - 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...

  10. 21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  11. 21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  12. 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...

  13. 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...

  14. 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...

  15. 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.

  16. An electronic prosthesis mimicking the dynamic vestibular function.

    PubMed

    Shkel, Andrei M; Zeng, Fan-Gang

    2006-01-01

    This paper presents a functional architecture, system level design, and electronic evaluation of a unilateral vestibular prosthesis. The sensing unit of the prosthesis is a custom-designed one-axis micro-electromechanical system (MEMS) gyroscope. Similar to the natural semicircular canal, the MEMS gyroscope senses angular motion of the head and generates voltages proportional to the corresponding angular acceleration. The voltage is then converted into electric current pulses according to the physiological data relating angular acceleration to the spike count in the vestibular nerve. The current pulses can be delivered to stimulate the corresponding vestibular nerve branch. Electronic properties of the vestibular prosthesis prototype have been systematically evaluated and found to meet the design specifications. A unique feature of the present vestibular implant prototype is the scalability: the sensing unit, pulse generator, and the current source can be potentially implemented on a single chip using integrated MEMS technology.

  17. Echocardiographic features of aortic ball valve prosthesis malfunction.

    PubMed

    Weisburst, M R; Singh, A K; Riley, R S

    1982-11-01

    A case of aortic ball valve prosthesis malfunction is described in which the poppet became alternately stuck in the open and closed position. The patient experienced chest pain followed by pulmonary edema and cardiac arrest. Malfunction of prosthetic valve was diagnosed on echocardiogram and cardiopulmonary resuscitation was carried out until a Bjork-Shiley valve could be inserted in place of the faulty prosthesis. At the time of the operation, poppet migration had occurred and the poppet could not be found. Subsequent Bjork-Shiley aortic valve prosthesis dysfunction was suggested by variation in the intensity of the aortic opening sound and in the duration of the systolic ejection period. Fluoroscopy revealed the missing poppet in the left ventricle. Following surgical removal of the poppet, "normal" Bjork-Shiley valve function was restored.

  18. Development of alumina ceramic bipolar hip prosthesis and clinical application.

    PubMed

    Asada, K; Yoshida, K; Shimazu, A; Yunoki, H; Ishida, N

    1987-02-01

    The concept of the bipolar type prosthesis is that the articular motion is observed primarily between the HDP bearing insert and the inner head, thereby avoiding the greater frictional shear force between the prosthetic head and acetabulum found with the traditional one piece endoprosthesis. A newly developed ceramic bipolar hip prosthesis utilizes an outer head composed of bio-inert fine alumina ceramic rather than a metal head. The mechanical strength of this prototype bipolar hip prosthesis was tested with static load and impact force, and the dynamic fatigue strength was also tested with repeated loads. Results were judged to show that the device has strength adequate for clinical use. The hip prostheses has been clinically applied in replacement of the femoral head of a neck fracture, femoral head necrosis and osteoarthritic hip. Finally, using a mathematical model, the so-called self-centering effect due to center offset between outer and inner heads is discussed.

  19. [Tests of hand functionality in upper limb amputation with prosthesis].

    PubMed

    Bazzini, G; Orlandini, D; Moscato, T A; Nicita, D; Panigazzi, M

    2007-01-01

    The need for standardized instruments for clinical measurements has become pressing in the fields of occupational rehabilitation and ergonomics. This is particularly the case for instruments that allow a quantitative evaluation of upper limb function, and especially hand function in patients who have undergone an amputation and then application of an upper limb prosthesis. This study presents a review of the main tests used to evaluate hand function, with a critical analysis of their use in subjects with an upper limb prosthesis. The tests are divided into: tests to evaluate strength, tests to evaluate co-ordination and dexterity, tests of global or overall function, and tests proposed specifically for subjects with an upper limb prosthesis. Of the various tests presented, the authors give their preference to the Bimanual Functional Assessment, Abilhand and/or the ADL Questionnaire, because of the practical usefulness, clinimetric features, simplicity and ease of administration of these tests.

  20. 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

  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. The making of indigenous vascular prosthesis

    PubMed Central

    Unnikrishnan, Madathipat; Viswanathan, Sidharth; Balasubramaniam, K.; Muraleedharan, C.V.; Lal, Arthur Vijayan; Mohanan, P.V.; Mohanty, Meera; Kapilamoorthy, Tirur Raman

    2016-01-01

    Background & objectives: Vascular illnesses are on the rise in India, due to increase in lifestyle diseases and demographic transition, requiring intervention to save life, organ or limbs using vascular prosthesis. The aim of this study was to develop indigenous large diameter vascular graft for treatment of patients with vascular pathologies. Methods: The South India Textile Research Association, at Coimbatore, Tamil Nadu, India, developed seamless woven polyester (Polyethylene terephthalate) graft at its research wing. Further characterization and testing followed by clinical trials were conducted at Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, India. Fifteen in vivo experiments were carried out in 1992-1994 in pigs as animal model. Controlled (phase I) clinical trial in ten patients was performed along with control graft. Thereafter, phase II trial involved 22 patients who underwent multi-centre clinical trial in four centres across India. Results: Laboratory testing showed that polyester graft was non-toxic, non-leeching and non-haemolytic with preserved long-term quality, further confirming in pigs by implanting in thoracic aorta, comparable to control Dacron grafts. Perigraft incorporation and smooth neointima formation which are prime features of excellent healing characteristics, were noted at explantation at planned intervals. Subsequently in the phase I and II clinical trials, all patients had excellent recovery without mortality or device-related adverse events. Patients receiving the test graft were followed up for 10 and 5 years, respectively. Serial clinical, duplex scans and CT angiograms performed periodically confirmed excellent graft performance. Interpretation & conclusions: Indigenously developed Chitra vascular graft was comparable to commercially available Dacron graft, ready for clinical use at affordable cost to patients as against costly imported grafts. PMID:27748302

  3. 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.

  4. Auditory Prosthesis with a Penetrating Nerve Array

    PubMed Central

    Snyder, Russell L.

    2007-01-01

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

  5. [Avoidance of patient-prosthesis mismatch].

    PubMed

    Sakamoto, Y; Hashimoto, K

    2006-04-01

    To minimize the incidence of patient-prosthesis mismatch (PPM), we have routinely adopted aortic root enlargement to avoid PPM for patients with small aortic annulus. The aim of this study was to review our strategy of avoiding PPM. The Carpentier-Edwards Perimount (CEP) valves were implanted in 53 patients who were mostly aged over 65 and the St. Jude Medical (SJM) mechanical valves were used in 128 patients aged under 65. A standard 21-mm SJM valve was used in only 3 patients and no 19-mm valves were employed. However, 19-mm CEP valves were used in 12 patients with a small body surface area (1.43 +/- 0.14 m2). Of these, 26 patients (14.4%) who had a small aortic annulus and 24 patients aged under 65 underwent aortic root enlargement. No patient receiving an SJM valve had an projected indexed effective orifice area (EOAI) < or = 0.85 cm2/m2 because of performing aortic valve replacement (AVR) with annular enlargement and only 2 (3.8%) out of 53 patients receiving CEP valves developed PPM. Consequently, the prevalence of PPM was 1.1% in this series. The prevalence of PPM was low in patients over 65 years old with a relatively small body size who received bioprosthetic valves. A pericardial bioprosthesis was considered to be an appropriate valve in older population with regard to avoiding PPM. In patients under 65 years old with a small annulus, the first choice for avoiding PPM is aortic annular enlargement, which may be avoided by high performance mechanical valves with larger EOA.

  6. [Ankle joint prosthesis for bone defects].

    PubMed

    Lampert, C

    2011-11-01

    Large defects of the talus, i.e. due to tumors, large areas of osteolysis in total ankle replacement (TAR) and posttraumatic talus body necrosis are difficult to manage. The gold standard in these circumstances is still tibiocalcaneal arthrodesis with all the negative aspects of a completely rigid hindfoot. We started 10 years ago to replace the talus by a custom-made, all cobalt-chrome implant (laser sintering). The first patient with a giant cell tumor did very well but the following patients showed all subsidence of the metal talus into the tibia due to missing bony edges. Therefore, we constructed a custom-made talus (mirrored from the healthy side) and combined it with a well functioning total ankle prosthesis (Hintegra). So far we have implanted this custom-made implant into 3 patients: the first had a chondrosarcoma of the talus (1 year follow-up), the second had massive osteolysis/necrosis of unknown origin (6 months follow-up) and the third massive osteolysis following a correct TAR (2 months follow-up). The results are very encouraging as all of the patients are practically pain free and have a good range of movement (ROM): D-P flexion 15°-0-20° but less motion in the lower ankle joint: ROM P-S 5°-0-5°. No subsidence was detected in the tibia or the calcaneus. The custom-made talus combined with the Hintegra total ankle replacement will probably be an interesting alternative to a tibiocalcaneal arthrodesis in selected cases with massive defects of the talus.

  7. 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.

  8. 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

  9. Iliopsoas tendonitis caused by overhang of a collared femoral prosthesis.

    PubMed

    Brew, Christopher J; Stockley, Ian; Grainger, Andrew J; Stone, Martin H

    2011-04-01

    Pain after total hip arthroplasty can be due to a variety of causes, one of the less common being iliopsoas tendonitis. We report an unusual case of iliopsoas tendonitis caused by overhang of the femoral calcar by a collared femoral prosthesis resulting in impingement on the iliopsoas tendon. An ultrasound-guided corticosteroid and local anesthetic diagnostic injection to the site of impingement confirmed the diagnosis with temporary symptom relief. Revision of the femoral stem to a collarless prosthesis resulted in immediate and complete resolution of symptoms.

  10. Prosthesis-preserving aortic root repair after aortic valve replacement.

    PubMed

    Hamamoto, Masaki; Kobayashi, Taira; Kodama, Hiroshi

    2015-07-01

    We describe a new technique of prosthesis-preserving aortic root replacement for patients who have previously undergone aortic valve replacement. With preservation of the mechanical prosthesis, we implant a Gelweave Valsalva graft using double suture lines. The first suture line is made between the sewing cuff of the mechanical valve and the graft, with mattress sutures of 2/0 braided polyester with pledgets. After the first sutures are tied, the second suture line is created between the graft collar and the aortic root remnant with continuous 4/0 polypropylene sutures.

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

    PubMed

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

    2015-10-01

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

  12. Heterotopic ossification associated with myelopathy following cervical disc prosthesis implantation.

    PubMed

    Wenger, Markus; Markwalder, Thomas-Marc

    2016-04-01

    This case report presents a 37-year-old man with clinical signs of myelopathy almost 9 years after implantation of a Bryan disc prosthesis (Medtronic Sofamor Danek, Memphis, TN, USA) for C5/C6 soft disc herniation. As demonstrated on MRI and CT scan, spinal cord compression was caused by bony spurs due to heterotopic ossification posterior to the still moving prosthesis. The device, as well as the ectopic bone deposits, had to be removed because of myelopathy and its imminent aggravation. Conversion to anterior spondylodesis was performed.

  13. Design and characterization of a powered elbow prosthesis.

    PubMed

    Bennett, Daniel A; Mitchell, Jason; Goldfarb, Michael

    2015-01-01

    This paper describes the design of a powered elbow prosthesis, which incorporates a belt and cable drive transmission with a brushless DC motor to achieve an output torque of approximately 18.4 Nm, a backdrive torque of 1.5 Nm, and a speed of up to 360 deg/s while remaining within the anthropomorphic envelope with regard to mass and size. The measured torque and speed of the prosthesis is commensurate with nominal capability of the natural limb (for purposes of performing activities of daily living).

  14. Dynamics of dental implants and orthodontics in today's periodontal prosthesis.

    PubMed

    Cheng, Y M

    2000-03-01

    Periodontal prosthesis refers to multidisciplinary efforts to stop disease progression, correct deformities created by dental diseases, and establish a therapeutic occlusion to restore the form and function of the masticatory system. These efforts are critical for the long-term prognosis and maintenance of the guarded teeth and the overall prosthesis. This article presents a functionally and esthetically challenging case, which illustrates a multidisciplinary approach--specifically implantology and orthodontics--and how they impact on each other during treatment. The role and importance of dental implants and orthodontics in setting up a case is illustrated in this article.

  15. An investigation into vascular prosthesis modified with an electron beam.

    PubMed

    Lowkis, B; Szymonowicz, M; Rutkowski, J

    1997-01-01

    The present paper shows the results of an investigation into the effect of implanted electric charge on blood platelet adhesion to woven surfaces of "Dallon" polyester vascular prosthesis. The electrets were formed using the electron beam method. The assessment of the electret effect on blood platelet adhesion was performed on the basis of microscopic studies. It was shown that an implanted negative electric charge remarkably suppresses thrombocyte adhesion to the prosthesis surface. The electret effect was found to play a significant role in the process of preparing nonthrombogenic surfaces.

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2012-01-01

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

  18. Penile prosthesis implantation in the era of medical treatment for erectile dysfunction.

    PubMed

    Montague, Drogo K

    2011-05-01

    Penile prosthesis implantation, the oldest of the modern treatments for erectile dysfunction (ED), still plays an important role despite the advent of less invasive alternatives. For some men with ED, penile prosthesis implantation is the only effective or acceptable treatment. Penile prosthesis implantation remains a viable option in the contemporary management of ED as evidenced by annual penile prosthesis implantation cases in the United States rising from 17,540 in 2000 to 22,420 in 2009. Improvements in prosthesis design and implantation techniques have resulted in significant increases in device survival and patient satisfaction.

  19. 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

  20. [Carcinoma of the esophagus. Palliative treatment with endoscopic prosthesis].

    PubMed

    Sala, T; Pertejo, V; Linares, M; Del Val, A

    1990-08-01

    The efficacy and safety of endoscopically inserted esophageal prosthesis was evaluated in 33 patients with non-operable carcinoma involving the esophagus. In 30 cases, the origin of the tumor was esophageal, and in 3 cases, bronchopulmonary. Esophago-pulmonary fistula was present in 9 patients. Histologic exam of the tumors revealed 11 adenocarcinomas and 22 epidermoid carcinomas. In every case, Atkinson prosthesis was used and previous esophageal dilatation was needed in 21 patients. Normal oral feeding was achieved in 29 patients. Mean hospital stay after insertion of the prosthesis was 5 days. Survival rate was 84.8% at one month, 63.6% at 4-6 months, 42.4% survived more than 6 months, and 21.2% were still alive one year after the procedure. Complications occurred in 3 patients (9%) -esophageal perforation in two cases, and pneumonia in one case. One patient died. In conclusion, in patients with advanced carcinoma involving the esophagus, palliative therapy with endoscopically inserted esophageal prosthesis is effective, relatively safe and cheap.

  1. 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…

  2. 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...

  3. 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...

  4. 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...

  5. 21 CFR 874.3495 - Total ossicular replacement prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  6. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Passive tendon prosthesis. 888.3025 Section 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a...

  7. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Passive tendon prosthesis. 888.3025 Section 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a...

  8. Transtibial prosthesis suspension failure during skydiving freefall: a case report.

    PubMed

    Gordon, Assaf T; Land, Rebekah M

    2009-01-01

    This report describes the unusual case of an everyday-use prosthesis suspension system failure during the freefall phase of a skydiving jump. The case individual was a 53-year-old male with a left transtibial amputation secondary to trauma. He used his everyday prosthesis, a transtibial endoskeleton with push-button, plunger-releasing, pin-locking silicon liner suction suspension and a neoprene knee suspension sleeve, for a standard recreational tandem skydive. Within seconds of exiting the plane, the suspension systems failed, resulting in the complete prosthesis floating away. Several factors may have led to suspension system failure, including an inadequate seal and material design of the knee suspension sleeve and liner, lack of auxiliary suspension mechanisms, and lack of a safety cover overlying the push-button release mechanism. This is the first report, to our knowledge, to discuss prosthetic issues specifically related to skydiving. While amputees are to be encouraged to participate in this extreme sport, special modifications to everyday components may be necessary to reduce the possibility of prosthesis failure during freefall, parachute deployment, and landing.

  9. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) 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...

  10. 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 §...

  11. 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 §...

  12. 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 §...

  13. 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...

  14. 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...

  15. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  16. 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...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    Code of Federal Regulations, 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 §...

  19. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  20. 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...

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

    PubMed

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

    2014-09-01

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

  2. 21 CFR 872.3940 - Total temporomandibular joint prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Total temporomandibular joint prosthesis. 872.3940 Section 872.3940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... and Drug Administration on or before March 30, 1999, for any total temporomandibular joint...

  3. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Glenoid fossa prosthesis. 872.3950 Section 872.3950 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... or a notice of completion of a PDP is required to be filed with the Food and Drug Administration...

  4. 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 Section 872.3940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... and Drug Administration on or before March 30, 1999, for any total temporomandibular joint...

  5. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Silicone inflatable breast prosthesis. 878.3530 Section 878.3530 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... required to be filed with the Food and Drug Administration on or before November 17, 1999, for any...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  7. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Mandibular condyle prosthesis. 872.3960 Section 872.3960 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... this section, a PMA or a notice of completion of a PDP is required to be filed with the Food and...

  8. Effectiveness and versatility of biological prosthesis in transplanted patients

    PubMed Central

    Vennarecci, Giovanni; Mascianà, Gianluca; De Werra, Edoardo; Sandri, Giovanni Battista Levi; Ferraro, Daniele; Burocchi, Mirco; Tortorelli, Giovanni; Guglielmo, Nicola; Ettorre, Giuseppe Maria

    2017-01-01

    AIM To emphasize the effectiveness and versatility of prosthesis, and good tolerance by patients with incisional hernia (IH). METHODS From December 2001 to February 2016, 270 liver transplantations were performed at San Camillo Hospital. IH occurred in 78 patients (28.8%). IH usually appeared early within the first year post-orthotopic liver transplantation. In the first era, fascial defect was repaired by primary closure for defects smaller than 2.5 cm or with synthetic mesh for greater defects. Recently, we started using biological mesh (Permacol™, Covidien). We present a series of five transplanted patients submitted to surgery for abdominal wall defect correction repaired with biological mesh (Permacol™, Covidien). RESULTS In our cases, the use of biological prosthesis (Permacol™, Covidien) have proven to be effective and versatile in repairing hernia defects of different kinds; patients did not suffer infections of the prosthesis and no recurrence was observed. Furthermore, the prosthesis remains intact even in the years after surgery. CONCLUSION The cases that we presented show that the use of biological mesh (Permacol™, Covidien) in transplanted patients may be safe and effective, being careful in the management of perioperative immunosuppression and renal and graft function, although the cost of the product itself has been the main limiting factor and there is need for prospective studies for further evaluations. PMID:28280694

  9. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  10. 21 CFR 874.3730 - 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Silicone inflatable breast prosthesis. 878.3530 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...

  16. 21 CFR 878.3750 - External prosthesis adhesive.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  17. 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...

  18. 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...

  19. 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 §...

  20. 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...

  1. 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...

  2. 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 SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices §...

  3. 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 §...

  4. 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...

  5. 21 CFR 878.3750 - External prosthesis adhesive.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  6. Development of an internally braced prosthesis for total talus replacement.

    PubMed

    Regauer, Markus; Lange, Mirjam; Soldan, Kevin; Peyerl, Steffen; Baumbach, Sebastian; Böcker, Wolfgang; Polzer, Hans

    2017-03-18

    Total loss of talus due to trauma or avascular necrosis, for example, still remains to be a major challenge in foot and ankle surgery with severely limited treatment options. Implantation of a custom made total talar prosthesis has shown promising results so far. Most important factors for long time success are degree of congruence of articular surfaces and ligamentous stability of the ankle. Therefore, our aim was to develop an optimized custom made prosthesis for total talus replacement providing a high level of primary stability. A custom made hemiprosthesis was developed using computed tomography and magnetic resonance imaging data of the affected and contralateral talus considering the principles and technology for the development of the S.T.A.R. prosthesis (Stryker). Additionally, four eyelets for fixation of artificial ligaments were added at the correspondent footprints of the most important ligaments. Two modifications can be provided according to the clinical requirements: A tri-articular hemiprosthesis or a bi-articular hemiprosthesis combined with the tibial component of the S.T.A.R. total ankle replacement system. A feasibility study was performed using a fresh frozen human cadaver. Maximum range of motion of the ankle was measured and ligamentous stability was evaluated by use of standard X-rays after application of varus, valgus or sagittal stress with 150 N. Correct implantation of the prosthesis was technically possible via an anterior approach to the ankle and using standard instruments. Malleolar osteotomies were not required. Maximum ankle dorsiflexion and plantarflexion were measured as 22-0-28 degrees. Maximum anterior displacement of the talus was 6 mm, maximum varus tilt 3 degrees and maximum valgus tilt 2 degrees. Application of an internally braced prosthesis for total talus replacement in humans is technically feasible and might be a reasonable procedure in carefully selected cases with no better alternatives left.

  7. Custom-made silicone hand prosthesis: A case study.

    PubMed

    Nayak, S; Lenka, P K; Equebal, A; Biswas, A

    2016-09-01

    Up to now, a cosmetic glove was the most common method for managing transmetacarpal (TMC) and carpometacarpal (CMC) amputations, but it is devoid of markings and body color. At this amputation level, it is very difficult to fit a functional prosthesis because of the short available length, unsightly shape, grafted skin, contracture and lack of functional prosthetic options. A 30-year-old male came to our clinic with amputation at the 1st to 4th carpometacarpal level and a 5th metacarpal that was projected laterally and fused with the carpal bone. The stump had grafted skin, redness, and an unhealed suture line. He complained of pain projected over the metacarpal and suture area. The clinical team members decided to fabricate a custom-made silicone hand prosthesis to accommodate the stump, protect the grafted skin, improve the hand's appearance and provide some passive function. The custom silicone hand prosthesis was fabricated with modified flexible wires to provide passive interphalangeal movement. Basic training, care and maintenance instructions for the prosthesis were given to the patient. The silicone hand prosthesis was able to restore the appearance of the lost digits and provide some passive function. His pain (VAS score) was reduced. Improvement in activities of daily living was found in the DASH questionnaire and Jebsen-Taylor Hand Function test. A silicone glove is a good option for more distal amputations, as it can accommodate any deformity, protect the skin, enhance the appearance and provide functional assistance. This case study provides a simple method to get passively movable fingers after proximal hand amputation.

  8. Development of an internally braced prosthesis for total talus replacement

    PubMed Central

    Regauer, Markus; Lange, Mirjam; Soldan, Kevin; Peyerl, Steffen; Baumbach, Sebastian; Böcker, Wolfgang; Polzer, Hans

    2017-01-01

    Total loss of talus due to trauma or avascular necrosis, for example, still remains to be a major challenge in foot and ankle surgery with severely limited treatment options. Implantation of a custom made total talar prosthesis has shown promising results so far. Most important factors for long time success are degree of congruence of articular surfaces and ligamentous stability of the ankle. Therefore, our aim was to develop an optimized custom made prosthesis for total talus replacement providing a high level of primary stability. A custom made hemiprosthesis was developed using computed tomography and magnetic resonance imaging data of the affected and contralateral talus considering the principles and technology for the development of the S.T.A.R. prosthesis (Stryker). Additionally, four eyelets for fixation of artificial ligaments were added at the correspondent footprints of the most important ligaments. Two modifications can be provided according to the clinical requirements: A tri-articular hemiprosthesis or a bi-articular hemiprosthesis combined with the tibial component of the S.T.A.R. total ankle replacement system. A feasibility study was performed using a fresh frozen human cadaver. Maximum range of motion of the ankle was measured and ligamentous stability was evaluated by use of standard X-rays after application of varus, valgus or sagittal stress with 150 N. Correct implantation of the prosthesis was technically possible via an anterior approach to the ankle and using standard instruments. Malleolar osteotomies were not required. Maximum ankle dorsiflexion and plantarflexion were measured as 22-0-28 degrees. Maximum anterior displacement of the talus was 6 mm, maximum varus tilt 3 degrees and maximum valgus tilt 2 degrees. Application of an internally braced prosthesis for total talus replacement in humans is technically feasible and might be a reasonable procedure in carefully selected cases with no better alternatives left. PMID:28361015

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

    NASA Astrophysics Data System (ADS)

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

    2007-09-01

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

  10. 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.

  11. [The endo-exo prosthesis for patients with a problematic amputation stump].

    PubMed

    Frölke, Jan Paul M; van de Meent, Henk

    2010-01-01

    Following lower limb amputation, quality of life is highly related to the ability to use a prosthetic limb. The conventional way to attach a prosthetic limb to the body is with a socket. Many patients experience serious discomfort wearing a conventional prosthesis because of pain, instability during walking, pressure sores, bad smell or skin irritation. In addition, sitting is uncomfortable and pelvic and lower back pain due to unstable gait is often seen in these patients. The main disadvantage of the current prosthesis is the attachment of a rigid prosthesis socket to a soft and variable body. The socket must fit tightly for stability during walking but should also be comfortable for sitting. The implantation of an osseointegrated, intramedullary, transcutaneously conducted prosthesis is a new procedure for attaching a limb prosthesis to the human body without the disadvantages of the conventional prosthesis. The intramedullary prosthesis is designed with a rough surface resembling cancellous bone to enable a secure solid integration with the long bone. We treated two patients with this new prosthesis, a 44-year-old man after a transfemoral amputation, and a 32-year-old woman after a lower leg amputation; both amputations were necessary because of trauma. Those two patients are now, more than one year after the operation, showing excellent functional results without infectious complications. We assume that endo-exo prosthesis may be a promising option for selected patients unable to use a conventional prosthesis because of a problematic amputation stump.

  12. Posterior enlargement of the small annulus during aortic valve replacement versus implantation of a small prosthesis.

    PubMed

    Pugliese, P; Bernabei, M; Santi, C; Pasqué, A; Eufrate, S

    1984-07-01

    Twenty-two patients with a small aortic annulus were identified among 196 consecutive patients undergoing aortic valve replacement (AVR). The 11 patients in Group 1 underwent posterior enlargement aortic annuloplasty, and the 11 in Group 2 received a small aortic prosthesis (less than or equal to 21 mm). The two groups were unselected. Core hypothermia, cardioplegia, and local cooling were employed for all operations. Isolated AVR was performed in 3 patients in each group. In Group 1, the mean increase in diameter of the annulus was 4.82 mm, which resulted in a mean area increase of 169.91 mm2 (51.7%). Mean aortic cross-clamp times were 140.4 minutes and 93.5 minutes in Groups 1 and 2, respectively. There were 2 operative deaths in Group 1, and 1 operative and 1 late death in Group 2. Mean follow-up was 26.5 months for Group 1 and 43.4 months for Group 2. No thomboembolic or bleeding episodes have been recorded. Considerations and conclusions are offered from the study of this small series of patients.

  13. [Research on point cloud smoothing in knee joint prosthesis modeling based on reverse engineering].

    PubMed

    Zhang, Guoliang; Yao, Jin; Wei, Xing; Pei, Fuxing; Zhou, Zongke

    2008-10-01

    At present, foreign standard knee joint prosthesis is mostly used in clinical practice; it can well represent the biological characteristic of knee joint on human being. So this paper adopts the reverse engineering technology in that connexion, presents novel positioning method of acquiring the point data on the surface of knee joint prosthesis, puts forward the algorithm of three-point angle method for removing the noise error and correcting the noise error based on the least squares plane to smooth point cloud. And then, the surface of knee joint prosthesis with better accuracy and smoothness can be generated. Finally, the knee joint prosthesis model can be generated. Thus, a basis is provided for the localization of knee joint prosthesis. This new algorithm is mainly used for the surface modeling based on point cloud smoothing, including the surface of knee joint prosthesis, the surface of regular shape, and the surface with gentle change in curvature.

  14. 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

  15. Manufacturer-provided effective orifice area index charts and the prevention of prosthesis-patient mismatch.

    PubMed

    House, Chad M; Nelson, William B; Kroshus, Timothy J; Dahiya, Ranjan; Pibarot, Philippe

    2012-01-01

    Prosthesis-patient mismatch (PPM) occurs when an implanted prosthesis is too small relative to the patient's body surface area (BSA). However, mismatch can often be prevented by indexing the expected effective orifice area (EOA) of a prosthesis to the patient's BSA and then selecting the largest implantable prosthesis to avoid mismatch. Previously, prosthesis manufacturers have attempted to simplify this process by providing charts that include the expected EOA for their prosthesis, already indexed into an array of BSA values. One caveat with these charts is that the expected EOA data must truly be reliable, or the charts will misguide the implanting surgeon. Manufacturer-provided charts could be improved by standardizing the EOA data, with one potential source being the hemodynamic data submitted to the United States Food and Drug Administration. This review discusses PPM, manufacturer-provided EOA charts, and the regulation of EOA data.

  16. Running with a powered knee and ankle prosthesis.

    PubMed

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

    2015-05-01

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

  17. Designing and testing a hybrid lightweight shoulder prosthesis.

    PubMed

    Sekine, Masashi; Tsuchiya, Nobuto; Kita, Kahori; Yu, Wenwei

    2014-01-01

    Lightweight prostheses are preferred in terms of usability in daily living. However, this is not a property easy to realize, especially for shoulder prostheses. High portability, multiple degrees of freedom (DOFs) with an appropriate ROM (range of motion), sufficient end-effector power, and suitable viscoelasticity for the safe use in daily living, usually result in a heavy weight. In this paper, a hybrid shoulder prosthesis that combined servo motors and pneumatic elastic actuators, with a weight distribution scheme, was designed to meet the requirements. The prosthetic system was preliminarily tested by comparing its ADL (activities of daily living) motion data with that of an intact arm. The experiment results showed that the shoulder prosthesis could reproduce the motion of an intact arm, thus demonstrate its usability in daily living.

  18. 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.

  19. A cognitive prosthesis for complex decision-making.

    PubMed

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

    2017-01-01

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

  20. Midterm clinical results of the Autocentric II patellofemoral prosthesis

    PubMed Central

    Speigner, B.; Gosens, T.; de Waal Malefijt, J.

    2009-01-01

    We studied the outcome of patellofemoral arthroplasties using the Autocentric prosthesis implanted in our clinic between 1994 and 2004. New insight on indications and contraindications motivated us to find risk factors in the failure of this prosthesis. Twenty-four patients had surgery for patellofemoral arthritis not responding to exhaustive nonoperative measures. The mean age at the time of patellofemoral arthroplasty (PFA) was 63.4 (SD 11.3, range 38–81) years with a mean follow-up of 4.8 (SD 2.9, range 2–11) years. Additional interventions were necessary in 21 knees during follow-up in our population, and seven knees required total knee arthroplasty (TKA) mainly due to progressive tibiofemoral osteoarthritis and maltracking of the patella. The patient outcomes and quality of life scores showed disappointing results, even after revision to TKA. This retrospective analysis underlines the importance of strict indications for patellofemoral arthroplasty and, in particular, of contraindications. PMID:19224212

  1. AMS 700 inflatable penile prosthesis with InhibiZone.

    PubMed

    McKim, Stephen E; Carson, Culley C

    2010-05-01

    Inflatable penile prostheses are the definitive therapy for erectile dysfunction refractory to medical therapy. For years mechanical malfunction was the most common cause of device failure, but recent advances in design have largely eliminated this, and now infection is the most significant problem with these implants. Antibiotic-coated medical devices, such as central venous and bladder catheters, have proven effective in reducing bacterial colonization and biofilm formation, leading to decreased rates of infection. In 2001, American Medical Systems (AMS) released its AMS 700 series penile prosthesis impregnated with a proprietary combination of the antibiotics rifampin and minocycline, called InhibiZone. Multiple studies have found that this device significantly reduces infection rates in men receiving penile prostheses. In July 2009, the US FDA approved the AMS 700 with InhibiZone as the only inflatable penile prosthesis with clinical evidence showing significant reduction in the rate of revision surgery due to infection.

  2. A case of TURBT after penile prosthesis implantation.

    PubMed

    Senda, Motohiro; Otani, Toshikazu; Ito, Yuichi

    2006-08-01

    The patient was a 66-year-old man who had undergone implantation of a penile prosthesis for organic erectile dysfunction 7 years prior to consulting our hospital with a complaint of gross hematuria. Since a pedunculated, superficial tumor 1 cm in diameter was noted lateral to the left ureteral orifice, transurethral resection of the bladder tumor (TURBT) was performed. In this patient, we were able to insert the sheath with no difficulty, and the surgical procedure was done smoothly, resulting in complete resection of the tumor. However, the location of the tumor in the anterior or posterior wall of the bladder predicted difficulty of the tumor resection. Therefore, we consider it important to sufficiently evaluate the feasibility of complete TURBT before surgery and to thoroughly examine the patient for benign prostatic hyperplasia and bladder cancer, which can cause difficulty with post-implantation ransurethral procedures, and to perform transurethral surgery before implantation, if prosthesis implantation is planned.

  3. 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.

  4. Hip arthroplasty. Part 1: prosthesis terminology and classification.

    PubMed

    Pluot, E; Davis, E T; Revell, M; Davies, A M; James, S L J

    2009-10-01

    Hip arthroplasty is an extremely common orthopaedic procedure and there is a wide array of implants that are in current use in the UK. The follow-up of patients who have undergone insertion of a hip prosthesis is shifting from a consultant-lead hospital service towards primary care. As this change in patient care continues it becomes increasingly important that an accurate description of the radiographic features is communicated to the primary-care practitioner so appropriate specialist input can be triggered. This review focuses on the terminology and classification of hip prostheses. This acts as a precursor for Part 2 of this series, which describes the normal and abnormal radiographic findings following hip prosthesis insertion.

  5. 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.

  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. Molecular Identification of a Dietzia maris Hip Prosthesis Infection Isolate

    PubMed Central

    Pidoux, O.; Argenson, J.-N.; Jacomo, V.; Drancourt, M.

    2001-01-01

    Dietzia maris, an environmental actinomycete, has been implicated only once in human disease. We herein report the first D. maris isolate from a bone biopsy specimen in a patient hospitalized for a total hip prosthesis replacement. Cell wall fatty acid analysis and 16S ribosomal DNA gene sequencing were utilized to achieve its definite identification. This case report illustrates the usefulness of such methods for the accurate identification of actinomycetes. PMID:11427581

  9. 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.

  10. Using a Visible Light-Polymerized Resin to Fabricate an Interim Partial Removable Dental Prosthesis.

    PubMed

    Segal, Aaron; Yu, Hui Wen; Elkassaby, Heba

    2017-02-01

    An interim partial removable dental prosthesis (RDP) is any dental prosthesis that replaces some teeth in a partially dentate arch designed to enhance esthetics, stabilization, and/or function for a limited period of time, after which it is to be replaced by a definitive dental prosthesis. This article describes a technique that uses a visible light-polymerized (VLP) resin as the base material for an interim partial RDP. This technique can be easily accomplished in a dental office or laboratory and results in a predictable dental prosthesis. This technique eliminates the need for laboratory processing.

  11. Penile prosthesis implant: scientific advances and technological innovations over the last four decades

    PubMed Central

    2017-01-01

    Despite introduction of oral phosphodiesterase type 5 inhibitors and intracavernosal vasoactive agents, penile prosthesis implant remains a relevant and desired option with sales of penile prostheses continue to stay high, as many men became refractory to medical therapy and/or seeking a more effective and permanent therapy. There are two types of penile prosthesis implants: inflatable and non-inflatable types, and the inflatable penile implants can be subdivided into single-, two- and three-piece devices. Non-inflatable penile prosthesis (non-IPP) may be referred to as semi-rigid rod or malleable prosthesis. IPP is considered a superior option to malleable prosthesis as it produces penile rigidity and flaccidity that closely replicates a normal penile erectile function. Since the introduction of IPP by Scott in 1973, surgical landscape for penile prosthesis implantation has changed dramatically. Advances in prosthesis design, device technologies and surgical techniques have made penile prosthesis implant a more natural, durable and reliable device. The following article reviews the scientific advances and technological innovation in modern penile prosthesis implants over the last four decades. PMID:28217449

  12. Penile prosthesis implant: scientific advances and technological innovations over the last four decades.

    PubMed

    Chung, Eric

    2017-02-01

    Despite introduction of oral phosphodiesterase type 5 inhibitors and intracavernosal vasoactive agents, penile prosthesis implant remains a relevant and desired option with sales of penile prostheses continue to stay high, as many men became refractory to medical therapy and/or seeking a more effective and permanent therapy. There are two types of penile prosthesis implants: inflatable and non-inflatable types, and the inflatable penile implants can be subdivided into single-, two- and three-piece devices. Non-inflatable penile prosthesis (non-IPP) may be referred to as semi-rigid rod or malleable prosthesis. IPP is considered a superior option to malleable prosthesis as it produces penile rigidity and flaccidity that closely replicates a normal penile erectile function. Since the introduction of IPP by Scott in 1973, surgical landscape for penile prosthesis implantation has changed dramatically. Advances in prosthesis design, device technologies and surgical techniques have made penile prosthesis implant a more natural, durable and reliable device. The following article reviews the scientific advances and technological innovation in modern penile prosthesis implants over the last four decades.

  13. Dental prosthesis aspiration: An uncommon cause of respiratory distress.

    PubMed

    De Wilde, Belphine A L; Malfait, Thomas L; Bonte, Katrien; Malfait, Thomas L A

    2016-12-01

    We present a case of a 66-year-old Caucasian man with acute respiratory distress. The patient had a history of multiple cerebrovascular accidents which resulted in left hemiplegia, swallowing problems, and aphasia. He was tentatively diagnosed with aspiration pneumonia. However, because of clinical deterioration further investigations concluded to the aspiration of a dental prosthesis. After intubation and stabilization, the prosthesis could be manually extracted. However, the patient developed a Staphylococcus epidermidis sepsis and despite adequate antibiotic therapy, he eventually died. Dental prosthesis aspiration is a medical situation associated with a higher morbidity and mortality rate compared to ingested foreign bodies. It requires a high level of suspicion to ensure a timely diagnosis and life-saving treatment. Thorough history taking is of great importance in case of tracheobronchial aspiration, which is in the adult population mostly secondary to an underlying disorder. In impaired adults with missing dental prostheses there should be extra awareness for this problem. This case report illustrates the importance of a detailed history in case of tracheobronchial aspiration and shows the limitations in the diagnostic usefulness of bedside chest radiography.

  14. Abiotrophia defectiva knee prosthesis infection: A case report

    PubMed Central

    2011-01-01

    Background Abiotrophia species have rarely been implicated in osteoarticular infections. We report one case of an A. defectiva knee prosthesis infection. Case presentation A 71-year-old man of Italian origin presented with pain and swelling of the knee four years after the implantation of a total knee replacement prosthesis. While standard culturing of the synovial fluid resulted in no isolation of microorganisms, the direct inoculation of the synovial fluid into a rich culture medium resulted in the identification of A. defectiva by polymerase chain reaction sequencing. Repeated attempts of culturing microorganisms from blood were negative, and echocardiograms and colonoscopies were unremarkable. High-dose amoxicillin for nine months and a two-stage replacement of the knee prosthesis led to full patient recovery by the time of the 12-month follow-up examination. Conclusions Because Abiotrophia spp. are fastidious microorganisms, it is likely that cases of Abiotrophia orthopedic infection are misdiagnosed as culture-negative infections. Direct inoculation of synovial fluids into rich broth medium and further polymerase chain reaction-based detection of culture-negative synovial fluids are key tests for accurate documentation and detection of these infections. PMID:21896178

  15. Visual prosthesis wireless energy transfer system optimal modeling

    PubMed Central

    2014-01-01

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

  16. 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

  17. 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

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

    PubMed Central

    Lee, Christine; Tu, Hong Anh; Weir, Mark; Holubowich, Corinne

    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

  19. Duocentric® reversed shoulder prosthesis and Personal Fit® templates: innovative strategies to optimize prosthesis positioning and prevent scapular notching.

    PubMed

    Trouilloud, P; Gonzalvez, M; Martz, P; Charles, H; Handelberg, F; Nyffeler, R W; Baulot, E

    2014-05-01

    We describe our experience with a new system of patient-specific template called Personal Fit(®), which is unique in shoulder surgery and used in combination with Duocentric(®) prosthesis. The reverse prosthesis's concept is the invention of Paul Grammont, developed with Grammont's team of Dijon University as from 1981, which led to the first reversed total shoulder prosthesis called Trumpet in 1985. The Duocentric(®) prosthesis developed in 2001 is the third-generation prosthesis, coming from the Trumpet and the second-generation prosthesis Delta(®) (DePuy). This prosthesis provides a novel solution to the notching problem with an inferior overhang integrated onto the glenoid baseplate. Personal Fit(®) system is based on reconstructing the shoulder joint bones in three dimensions using CT scan data, placing a landmark on the scapula and locating points on the glenoid and humerus. That will be used as a reference for the patient-specific templates. We study the glenoid position planned with Personal Fit(®) software relative to native glenoid position in 30 cases. On average, the difference between the planned retroversion (or anteversion in one case) and native retroversion was 8.6°.

  20. Ocular prosthesis incorporating IPS e-max press scleral veneer and a literature review on non-integrated ocular prosthesis

    PubMed Central

    Da Costa, Godwin Clovis; Aras, Meena Ajay; Chalakkal, Paul; Da Costa, Michelle Clovis

    2017-01-01

    The article highlights a new method for the fabrication of an ocular prosthesis by the incorporation of a ceramic scleral veneer. The steps of fabrication include impression making, wax try-in, performing a “cut-back” on a selected stock eye, insertion of the IPS e-max press scleral veneer, finishing and insertion. It also includes a detailed review on non-integrated ocular prostheses. PMID:28149792

  1. Ocular prosthesis incorporating IPS e-max press scleral veneer and a literature review on non-integrated ocular prosthesis.

    PubMed

    Da Costa, Godwin Clovis; Aras, Meena Ajay; Chalakkal, Paul; Da Costa, Michelle Clovis

    2017-01-01

    The article highlights a new method for the fabrication of an ocular prosthesis by the incorporation of a ceramic scleral veneer. The steps of fabrication include impression making, wax try-in, performing a "cut-back" on a selected stock eye, insertion of the IPS e-max press scleral veneer, finishing and insertion. It also includes a detailed review on non-integrated ocular prostheses.

  2. Oral hygiene in patients with oral cancer undergoing chemotherapy and/or radiotherapy after prosthesis rehabilitation: protocol proposal

    PubMed Central

    RAPONE, B.; NARDI, G.M.; DI VENERE, D.; PETTINI, F.; GRASSI, F.R.; CORSALINI, M.

    2016-01-01

    SUMMARY Purpose This study was aimed at assessing the effectiveness and the importance of an oral hygiene (OH) protocol in patients undergoing radiation therapy and chemotherapy after prosthesis rehabilitation, in order to reduce or minimize oral complications. Materials and methods This study was carried out at the Department of Dental Science, at the University of Bari-Italy from December 2012 to December 2015 on 34 selected patients with primary oral cancer undergoing chemotherapy and radiotherapy after prosthesis rehabilitation. They were divided into 2 groups according to their age, sex and cancer therapy. Seventeen patients were assigned to the control group and seventeen in the experimental one. In the experimental group (Table 1), patients underwent an oral hygiene protocol whereas in the control group (Table 2) patients received the usual care provided within the clinical setting. All the patients gave written informed consent. It has been asked and obtained the authorisation from the Ethics Committee of the Dental Science and Surgery Department. Results Results show that in patients undergoing the oral hygiene protocol, the complications and the risks of infection and permanent dental problems have been minimized. Indeed, of the seventeen patients undergoing the OH protocol, 70% obtained positive results and were satisfied with the program outcome. Conclusions The role of the health care providers is essential to educate patients to adhere to the prescribed treatments and reinforce their motivation in oral hygiene. The oral hygiene procedures prevent and ameliorate oral complications due to the radiation therapy and chemotherapy. PMID:28280537

  3. A Fixed Telescopic Prosthesis Designed to Retrieve and Convert to Fixed-Removable Combination Case: A Clinical Report

    PubMed Central

    Panagiota, Spyropoulou; Polyzois, Gregory

    2015-01-01

    This clinical report describes a fixed maxillary telescopic dental prosthesis (FTDP) employing milled base metal copings and a metal superstructure veneered with composite resin, for the restoration in a periodontally compromised patient with uncontrolled diabetes. The telescopic prosthesis framework design incorporated occlusal rest seats in key positions along the arch in case of future posterior tooth loss, in order to be converted to fixed - removable combination prosthesis. The mandible was restored with a conventional fixed ceramo-metal dental prosthesis. PMID:27688397

  4. Treatment of an old infection in a total hip replacement with an interim spacer prosthesis.

    PubMed

    Zilkens, K W; Casser, H R; Ohnsorge, J

    1990-01-01

    When treating a septic hip-joint prosthesis with bone loss of the proximal femur secondary to osteomyelitis, we implanted a specially designed prosthesis to act as a local antibiotic and spacer between the acetabulum and femur until the infection abated. Arthroplasty could then be carried out with no trouble and there was no recurrence of infection.

  5. 21 CFR 888.3100 - Ankle joint 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 Ankle joint metal/composite semi-constrained... Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  6. 21 CFR 888.3100 - Ankle joint metal/composite 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/composite semi-constrained... Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  7. 21 CFR 888.3100 - Ankle joint 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 Ankle joint metal/composite semi-constrained... Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  8. 21 CFR 888.3500 - Knee joint femorotibial metal/composite 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/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...

  9. 21 CFR 888.3490 - Knee joint femorotibial metal/composite 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/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 888.3490 - 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...

  11. 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...

  12. 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...

  13. 21 CFR 888.3100 - Ankle joint 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 Ankle joint metal/composite semi-constrained... Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  14. 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...

  15. 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...

  16. 21 CFR 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint femorotibial metal/composite non... § 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite non-constrained cemented prosthesis is a...

  17. "Wrap technique": a new operative procedure using a self-adhesive prosthesis for laparoscopic ventral rectopexy.

    PubMed

    Gravié, J-F; Maigné, C

    2015-06-01

    The aim of the present study was to describe and assess a new method of fixation using a self-adhesive prosthesis (Adhesix(™)) in laparoscopic ventral rectopexy (LVR). The technical principles are based on a very low dissection and the adhesive properties of the prosthesis which can be applied to the rectum without stitches or staples. The prosthesis is made from polypropylene coated with a synthetic hydrogel. The binding of the prosthesis to rectum and vagina takes place in a wet environment after a few minutes and enables the shaping of the mesh on the surface of the rectum (wrap effect). Between March 2010 and March 2013, 41 patients were operated on using LVR with a self-adhesive prosthesis. The effectiveness of prosthesis fixation was evaluated in a subset of 27 patients suffering from complete rectal prolapse. With a median follow-up of 30 months, there were no major complications and no recurrence. In this initial experience, LVR with a self-adhesive prosthesis does not increase the risk of recurrence. No undesirable effects were associated with the prosthesis.

  18. 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...

  19. 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...

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

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. Echocardiographic and phonocardiographic assessment of the St. Jude cardiac valve prosthesis.

    PubMed

    DePace, N L; Kotler, M N; Mintz, G S; Lichtenberg, R; Goel, I P; Segal, B L

    1981-09-01

    Forty-three consecutive patients with a St. Jude mitral, aortic, or combined prosthesis were studied by simultaneous phonocardiography and echocardiography. Twenty-eight patients had a mitral prosthesis, 20 an aortic prosthesis, and five had both. No opening click was recorded in any patient; however, a loud aortic or mitral closing click was recorded in all 43 patients. In patients with St. Jude mitral valve prosthesis, an echo-free space separated the two leaflets during diastole; seven of these also had a mid-diastolic closing and late diastolic reopening motion; two of the seven had an associated closing mid-diastolic click. A mid-diastolic rumble was recorded in six of 28 patients with St. Jude mitral valve prosthesis. In patients with a St. Jude aortic valve prosthesis, left atrium leaflet motion was recorded in 17 of 20 patients and was indistinguishable in appearance from echocardiograms obtained with various eccentric monocusp valves. In addition, we report one case of malfunction of a St. Jude mitral valve and one case of a paravalvular leak diagnosed by echophonocardiography. We concluded that the St. Jude cardiac prosthesis has variable normal phonocardiographic-echocardiographic patterns. Knowledge of these variable patterns is important in assessing patients with suspected malfunction of a St. Jude cardiac prosthesis.

  7. 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...

  8. 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...

  9. 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...

  10. 21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in...

  11. 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...

  12. 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...

  13. 21 CFR 888.3800 - Wrist 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 Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist...

  14. 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...

  15. 21 CFR 888.3350 - Hip 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 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 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint patellofemoral polymer/metal semi... § 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. (a) Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a...

  17. 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...

  18. 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...

  19. 21 CFR 888.3810 - Wrist joint ulnar (hemi-wrist) polymer prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint ulnar (hemi-wrist) polymer prosthesis. 888.3810 Section 888.3810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-wrist) polymer prosthesis. (a) Identification. A wrist joint ulnar (hemi-wrist) polymer...

  20. 21 CFR 888.3810 - 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...

  1. 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...

  2. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Elbow joint metal/polymer constrained cemented prosthesis. 888.3150 Section 888.3150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer constrained cemented prosthesis. (a) Identification. An elbow joint...

  3. 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...

  4. 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...

  5. 21 CFR 888.3650 - Shoulder joint 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 Shoulder joint metal/polymer non-constrained... Shoulder joint metal/polymer non-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace...

  6. 21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non... December 26, 1996 for any ankle joint metal/polymer non-constrained cemented prosthesis that was...

  7. 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...

  8. 21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non... December 26, 1996 for any ankle joint metal/polymer non-constrained cemented prosthesis that was...

  9. 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...

  10. 21 CFR 888.3120 - Ankle joint 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 Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non... December 26, 1996 for any ankle joint metal/polymer non-constrained cemented prosthesis that was...

  11. 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...

  12. 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...

  13. 21 CFR 888.3550 - Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non... December 26, 1996 for any ankle joint metal/polymer non-constrained cemented prosthesis that was...

  16. 21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Shoulder joint metal/polymer semi-constrained... Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  17. 21 CFR 888.3510 - Knee joint femorotibial 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 Knee joint femorotibial metal/polymer constrained... Knee joint femorotibial metal/polymer constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace...

  18. 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)...

  19. 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...

  20. 21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint patellofemoral polymer/metal semi... § 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. (a) Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a...

  1. 21 CFR 888.3800 - Wrist joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist...

  2. 21 CFR 888.3110 - 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...

  3. 21 CFR 888.3800 - Wrist joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist...

  4. 21 CFR 888.3540 - Knee joint patellofemoral polymer/metal 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 patellofemoral polymer/metal semi... § 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. (a) Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a...

  5. 21 CFR 888.3350 - Hip 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 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...

  6. 21 CFR 888.3510 - Knee joint femorotibial 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 Knee joint femorotibial metal/polymer constrained... Knee joint femorotibial metal/polymer constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace...

  7. 21 CFR 888.3310 - Hip joint metal/polymer constrained 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 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...

  8. 21 CFR 888.3800 - Wrist 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 Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist...

  9. 21 CFR 888.3520 - 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...

  10. 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...

  11. 21 CFR 888.3120 - Ankle joint 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 Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non... December 26, 1996 for any ankle joint metal/polymer non-constrained cemented prosthesis that was...

  12. 21 CFR 888.3150 - Elbow 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 Elbow joint metal/polymer constrained cemented prosthesis. 888.3150 Section 888.3150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer constrained cemented prosthesis. (a) Identification. An elbow joint...

  13. 21 CFR 888.3350 - Hip 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 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...

  14. 21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in...

  15. 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...

  16. 21 CFR 888.3650 - Shoulder joint 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 Shoulder joint metal/polymer non-constrained... Shoulder joint metal/polymer non-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace...

  17. 21 CFR 888.3170 - 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)...

  18. 21 CFR 888.3310 - Hip joint metal/polymer constrained 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 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...

  19. 21 CFR 888.3310 - Hip joint metal/polymer constrained 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 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...

  20. 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...

  1. 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...

  2. 21 CFR 888.3660 - Shoulder 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 Shoulder joint metal/polymer semi-constrained... Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  3. 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...

  4. 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...

  5. 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)...

  6. 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...

  7. 21 CFR 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Shoulder joint metal/polymer non-constrained... Shoulder joint metal/polymer non-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace...

  8. 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...

  9. 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...

  10. 21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint patellofemoral polymer/metal semi... § 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. (a) Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a...

  11. 21 CFR 888.3510 - Knee joint femorotibial metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint femorotibial metal/polymer constrained... Knee joint femorotibial metal/polymer constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace...

  12. 21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shoulder joint metal/polymer semi-constrained... Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  13. 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)...

  14. 21 CFR 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Shoulder joint metal/polymer non-constrained... Shoulder joint metal/polymer non-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace...

  15. 21 CFR 888.3800 - Wrist joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist...

  16. 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...

  17. 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...

  18. 21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in...

  19. 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)...

  20. 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...

  1. 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...

  2. 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...

  3. 21 CFR 888.3150 - Elbow 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 Elbow joint metal/polymer constrained cemented prosthesis. 888.3150 Section 888.3150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer constrained cemented prosthesis. (a) Identification. An elbow joint...

  4. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Elbow joint metal/polymer constrained cemented prosthesis. 888.3150 Section 888.3150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer constrained cemented prosthesis. (a) Identification. An elbow joint...

  5. 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...

  6. 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...

  7. 21 CFR 888.3510 - Knee joint femorotibial metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint femorotibial metal/polymer constrained... Knee joint femorotibial metal/polymer constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace...

  8. 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...

  9. 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...

  10. 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...

  11. 21 CFR 888.3510 - Knee joint femorotibial metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint femorotibial metal/polymer constrained... Knee joint femorotibial metal/polymer constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace...

  12. 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...

  13. 21 CFR 888.3540 - Knee joint patellofemoral polymer/metal 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 patellofemoral polymer/metal semi... § 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. (a) Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a...

  14. 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...

  15. 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...

  16. 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...

  17. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Elbow joint metal/polymer constrained cemented prosthesis. 888.3150 Section 888.3150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer constrained cemented prosthesis. (a) Identification. An elbow joint...

  18. 21 CFR 888.3550 - Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  19. 21 CFR 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shoulder joint metal/polymer non-constrained... Shoulder joint metal/polymer non-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace...

  20. 21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Shoulder joint metal/polymer semi-constrained... Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  1. 21 CFR 888.3660 - Shoulder 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 Shoulder joint metal/polymer semi-constrained... Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  2. 21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... 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...

  3. 21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... 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)...

  4. Acute tricuspid valve obstruction following the use of tricuspid ball valve prosthesis

    PubMed Central

    Samaan, H. A.; Murali, R.

    1970-01-01

    A case is presented in which the mitral and tricuspid valves were replaced by a ball-valve prosthesis. The patient was admitted as an emergency 18 months later with the clinical picture of acute venous inflow obstruction to the heart due to tricuspid ball-valve prosthesis obstruction. Successful replacement under emergency open heart surgery, using assisted circulation, is described. Images PMID:5452288

  5. 21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... § 874.3540 Prosthesis modification instrument for ossicular replacement surgery. (a) Identification. A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by...

  6. 21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... § 874.3540 Prosthesis modification instrument for ossicular replacement surgery. (a) Identification. A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by...

  7. 21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... § 874.3540 Prosthesis modification instrument for ossicular replacement surgery. (a) Identification. A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by...

  8. 21 CFR 888.3210 - Finger joint metal/metal constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint metal/metal constrained cemented... metal/metal constrained cemented prosthesis. (a) Identification. A finger joint metal/metal constrained..., 1996 for any finger joint metal/metal constrained cemented prosthesis that was in...

  9. 21 CFR 888.3370 - Hip joint (hemi-hip) acetabular metal 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 (hemi-hip) acetabular metal cemented... (hemi-hip) acetabular metal cemented prosthesis. (a) Identification. A hip joint (hemi-hip) acetabular metal cemented prosthesis is a device intended to be implanted to replace a portion of the hip...

  10. 21 CFR 888.3210 - Finger joint 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 Finger joint metal/metal constrained cemented... metal/metal constrained cemented prosthesis. (a) Identification. A finger joint metal/metal constrained..., 1996 for any finger joint metal/metal constrained cemented prosthesis that was in...

  11. 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...

  12. 21 CFR 888.3210 - Finger joint 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 Finger joint metal/metal constrained cemented... metal/metal constrained cemented prosthesis. (a) Identification. A finger joint metal/metal constrained..., 1996 for any finger joint metal/metal constrained cemented prosthesis that was in...

  13. 21 CFR 888.3210 - Finger joint metal/metal constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint metal/metal constrained cemented... metal/metal constrained cemented prosthesis. (a) Identification. A finger joint metal/metal constrained..., 1996 for any finger joint metal/metal constrained cemented prosthesis that was in...

  14. 21 CFR 888.3100 - Ankle joint 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 Ankle joint metal/composite semi-constrained... Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  15. 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...

  16. 21 CFR 888.3210 - Finger joint 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 Finger joint metal/metal constrained cemented... metal/metal constrained cemented prosthesis. (a) Identification. A finger joint metal/metal constrained..., 1996 for any finger joint metal/metal constrained cemented prosthesis that was in...

  17. 21 CFR 888.3340 - Hip joint 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 Hip joint metal/composite semi-constrained cemented prosthesis. 888.3340 Section 888.3340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Hip joint metal/composite semi-constrained cemented prosthesis. (a) Identification. A hip joint...

  18. Computer-aided design and three-dimensional printing in the manufacturing of an ocular prosthesis.

    PubMed

    Ruiters, Sébastien; Sun, Yi; de Jong, Stéphan; Politis, Constantinus; Mombaerts, Ilse

    2016-04-27

    Restoring the facial appearance in acquired anophthalmos entails precision fitting of a customised ocular prosthesis. The fabrication is an artisanal process, and is primarily based on an impression of the anophthalmic cavity. This is usually achieved by the impression-moulding method, which, however, may introduce errors, resulting in a poorly fitted prosthesis. We developed a new method in the manufacturing of a customised ocular prosthesis based on computer-aided design and computer-aided manufacturing. An ocular prosthesis, based on a three-dimensional (3D) printed impression-free mould of the anophthalmic cavity, was successfully fitted in a 68-year-old male. To the best of our knowledge, this is the first case of a customised ocular prosthesis designed with the aid of 3D printing.

  19. Effect of a dental prosthesis on speaker-specific characteristics of voice.

    PubMed

    Hamlet, S L; Geoffrey, V C; Bartlett, D M

    1976-12-01

    Subjects were fitted with an experimental dental appliance which had the effect of lowering and retracting the alveolar-palatal contour. Recordings of subjects speaking without the prosthesis and with the prosthesis at two stages of speech adaptation were analyzed acoustically and by judgmental evaluation for the effect of the appliance in disguising the voice. Individual differences were found in the type and extent of sibilant anf vowel changes produced by wearing the prosthesis. Listeners made more errors on a speaker authentication task involving recordings obtained immediately after the unfamiliar prosthesis was placed in the mouth than on recordings made after a week of accomodation to the appliance, or recordings made a week apart when no prosthesis was worn.

  20. An Underreported Consequence of Obesity in Pregnancy: Patient-Prosthesis Mismatch

    PubMed Central

    Hartman, William R.; Arendt, Katherine W.; Rehfeldt, Kent H.

    2012-01-01

    As the rate of obesity increases in childbearing-aged women, so too will the complications of obesity in pregnancy. An uncommon and likely underreported complication occurs in obese women who have received prepregnancy cardiac valve replacement with a prosthesis that is inadequately sized for body habitus, a condition referred to as patient-prosthesis mismatch (PPM). The physiologic changes of pregnancy as well as the increased weight gain combine to exacerbate PPM. We report a case of PPM that necessitated prosthesis replacement at 16-week gestation. As the incidence of this clinical scenario increases, it is important to understand the implications of prosthesis sizing, as well as the repercussions of having cardiopulmonary surgery to correct the undersized valve prosthesis while pregnant. PMID:22830065

  1. A case study of radiotherapy planning for a bilateral metal hip prosthesis prostate cancer patient

    SciTech Connect

    Su, Andy; Reft, Chester; Rash, Carla; Price, Jennifer; Jani, Ashesh B. . E-mail: jani@rover.uchicago.edu

    2005-09-30

    The purpose of this report is to communicate the observed advantage of intensity-modulated radiotherapy (IMRT) in a patient with bilateral metallic hip prostheses. In this patient with early-stage low-risk disease, a dose of 74 Gy was planned in two phases-an initial 50 Gy to the prostate and seminal vesicles and an additional 24 Gy to the prostate alone. Each coplanar beam avoided the prosthesis in the beam's eye view. Using the same target expansions for each phase, IMRT and 3D-conformal radiotherapy (CRT) plans were compared for target coverage and inhomogeneity as well as dose to the bladder and rectum. The results of the analysis demonstrated that IMRT provided superior target coverage with reduced dose to normal tissues for both individual phases of the treatment plan as well as for the composite treatment plan. The dose to the rectum was significantly reduced with the IMRT technique, with a composite V80 of 35% for the IMRT plan versus 70% for 3D-CRT plan. Similarly, the dose to the bladder was significantly reduced with a V80 of 9% versus 20%. Overall, various dosimetric parameters revealed the corresponding 3D-CRT plan would not have been acceptable. The results indicate significant success with IMRT in a clinical scenario where there were no curative alternatives for local treatment other than external beam radiotherapy. Therefore, definitive external beam radiation of prostate cancer patients with bilateral prosthesis is made feasible with IMRT. The work described herein may also have applicability to other groups of patients, such as those with gynecological or other pelvic malignancies.

  2. Younger age increases the risk of early prosthesis failure following primary total knee replacement for osteoarthritis

    PubMed Central

    2010-01-01

    Background and purpose Total knee replacements (TKRs) are being increasingly performed in patients aged ≤ 65 years who often have high physical demands. We investigated the relation between age of the patient and prosthesis survival following primary TKR using nationwide data collected from the Finnish Arthroplasty Register. Materials From Jan 1, 1997 through Dec 31, 2003, 32,019 TKRs for primary or secondary osteoarthritis were reported to the Finnish Arthroplasty Register. The TKRs were followed until the end of 2004. During the follow-up, 909 TKRs were revised, 205 (23%) due to infection and 704 for other reasons. Results Crude overall implant survival improved with increasing age between the ages of 40 and 80. The 5-year survival rates were 92% and 95% in patients aged ≤ 55 and 56–65 years, respectively, compared to 97% in patients who were > 65 years of age (p < 0.001). The difference was mainly attributable to reasons other than infections. Sex, diagnosis, type of TKR (condylar, constrained, or hinge), use of patellar component, and fixation method were also associated with higher revision rates. However, the differences in prosthesis survival between the age groups ≤ 55, 56–65, and > 65 years remained after adjustment for these factors (p < 0.001). Interpretation Young age impairs the prognosis of TKR and is associated with increased revision rates for non-infectious reasons. Diagnosis, sex, type of TKR, use of patellar component, and fixation method partly explain the differences, but the effects of physical activity, patient demands, and obesity on implant survival in younger patients warrant further research. PMID:20809740

  3. Frozen Autograft-Prosthesis Composite Reconstruction in Malignant Bone Tumors.

    PubMed

    Subhadrabandhu, Saran; Takeuchi, Akihiko; Yamamoto, Norio; Shirai, Toshiharu; Nishida, Hideji; Hayashi, Katsuhiro; Miwa, Shinji; Tsuchiya, Hiroyuki

    2015-10-01

    Several methods are available using an endoprosthesis or biological reconstruction for malignant bone tumors. Methods that use allograft-prosthesis composites have shown promising results. In 1999, the authors developed a method of reconstruction that uses a tumor-bearing autograft treated with liquid nitrogen. This technique was modified to produce a pedicle frozen autograft to maintain anatomical continuity on one side. In this study, the results of bone reconstructions using frozen autograft-prosthesis composites were retrospectively evaluated. The demographic data, histological records, surgical procedures, functional scores, and complications of 22 patients who had bone sarcoma or metastasis and at least 2 years of follow-up were reviewed. There were 19 patients with primary bone sarcoma and 3 with bone metastasis. Average age was 36 years (range, 9-73 years), and mean follow-up was 63 months (range, 24-176 months). Reconstructions were performed on 10 proximal femurs, 5 distal femurs, 4 proximal tibias, 1 proximal humerus, 1 proximal radius, and 1 hemipelvis. There were 12 pedicle-freezing and 10 free-freezing procedures. Union rate was 90% (9/10), and average union time was 9.5 months. Average Musculoskeletal Tumor Society score was 89.3%. Complications included 1 fracture, 2 infections, 3 soft tissue recurrences, and 1 posterior interosseous nerve palsy. The authors concluded that the frozen autograft-prosthesis composite demonstrated excellent Musculoskeletal Tumor Society scores, a low complication rate, and a good union rate and was superior when used with the pedicle-freezing technique.

  4. 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.

  5. 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

  6. 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

  7. 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.

  8. In vivo isocenter dose in two hip prosthesis patients

    SciTech Connect

    Burleson, W.D.; Stutzman, C.D.; Stitt, J.A.; Karlsson, U.L.; Mian, T.A. )

    1991-06-01

    Hip prostheses may cause irradiation dose inhomogeneities in conventional four-field target volumes to the pelvis. Two patients, with bilateral and unilateral prostheses, were subjected to thermoluminescent dosimetry measurements in the prostatic urethra during 24 MV photon portal exposures. The results suggested a 13% decrease in absorbed dose only for conventional four-field beam geometry with bilateral prostheses, as compared to oblique four-field beam geometry or unilateral prosthesis. This supports the suggestion that beam technique modifications may be warranted for patients with hip prostheses.

  9. A New Biologic Prosthesis for Vascular Substitute in Mongrel Dogs

    PubMed Central

    Marquez-Zacarias, Luis A.; Rey, Alejandro R.; Heine, M. Christina; Manrique, Jose J.

    1985-01-01

    New glutaraldehyde-treated vascular prosthesis tubes of bovine pericardium were placed in the abdominal aortas of 29 mongrel dogs and observed for 30 to 540 days. Clinical evaluation was performed during follow-up, and histologic and arteriographic studies were done at the end of the study. Patency was shown by arteriography in 27 of 29 tubes (93.1%). Neoendothelialization was found in all grafts, and there was a mixed effect, characterized by both rejection and foreign body reaction in the prostheses from 180 days onward. Both the handling and consistency of the grafts were excellent for implantation. Graft procoagulation and animal anticoagulation were not necessary. Images PMID:15227017

  10. Game-Based Rehabilitation for Myoelectric Prosthesis Control

    PubMed Central

    Vujaklija, Ivan; Kayali, Fares; Purgathofer, Peter; Aszmann, Oskar C

    2017-01-01

    Background A high number of upper extremity myoelectric prosthesis users abandon their devices due to difficulties in prosthesis control and lack of motivation to train in absence of a physiotherapist. Virtual training systems, in the form of video games, provide patients with an entertaining and intuitive method for improved muscle coordination and improved overall control. Complementary to established rehabilitation protocols, it is highly beneficial for this virtual training process to start even before receiving the final prosthesis, and to be continued at home for as long as needed. Objective The aim of this study is to evaluate (1) the short-term effects of a commercially available electromyographic (EMG) system on controllability after a simple video game-based rehabilitation protocol, and (2) different input methods, control mechanisms, and games. Methods Eleven able-bodied participants with no prior experience in EMG control took part in this study. Participants were asked to perform a surface EMG test evaluating their provisional maximum muscle contraction, fine accuracy and isolation of electrode activation, and endurance control over at least 300 seconds. These assessments were carried out (1) in a Pregaming session before interacting with three EMG-controlled computer games, (2) in a Postgaming session after playing the games, and (3) in a Follow-Up session two days after the gaming protocol to evaluate short-term retention rate. After each game, participants were given a user evaluation survey for the assessment of the games and their input mechanisms. Participants also received a questionnaire regarding their intrinsic motivation (Intrinsic Motivation Inventory) at the end of the last game. Results Results showed a significant improvement in fine accuracy electrode activation (P<.01), electrode separation (P=.02), and endurance control (P<.01) from Pregaming EMG assessments to the Follow-Up measurement. The deviation around the EMG goal value

  11. A comparison of retinal prosthesis electrode array substrate materials.

    PubMed

    Weiland, James D; Humayun, Mark S; Eckhardt, Helmut; Ufer, Stefan; Laude, Lucien; Basinger, Brooke; Tai, Yu-Chong

    2009-01-01

    Simulations of artificial vision suggest that 1000 electrodes may be required to restore vision to individuals with diseases of the outer retina. In order to achieve such an implant, new technology is needed, since the state-of-the-art implantable neural stimulator has at most 22 contacts with neural tissue. A critical component of this system is the multi-channel, stimulating electrode array. This array must meet very challenging, competing requirements for manufacturing, integration, surgical handling, and biocompatibility. Our lab has evaluated 3 polymers as retinal prosthesis substrates: polyimide, parylene, and silicone.

  12. In Vivo Paracoccidioides sp. Biofilm on Vascular Prosthesis.

    PubMed

    Cattana, Maria Emilia; Tracogna, Maria Fernanda; Marques, Isabel; Rojas, Florencia; Fernández, Mariana; de Los Ángeles Sosa, María; Mussin, Javier; Giusiano, Gustavo

    2017-03-23

    Paracoccidioidomycosis is an endemic mycosis caused by Paracoccidioides species limited to Latin America arising with the chronic form in 90% of cases. The capacity of microorganisms to form biofilms is considered of great importance medical since can contribute to the persistence and to the chronic state of the diseases. The ability of Paracoccidioides to form biofilm has been demonstrated in vitro. In our study, for the first time we have observed this capability in vivo on a vascular prosthesis using scanning electron microscope showing a dense network of Paracoccidioides yeasts covered by an extracellular matrix.

  13. Modelling heat transfer in a bone-cement-prosthesis system.

    PubMed

    Hansen, Eskil

    2003-06-01

    The heat transfer in a general bone-cement-prosthesis system was modelled. A quantitative understanding of the heat transfer and the polymerization kinetics in the system is necessary because injury of the bone tissue and the mechanical properties of the cement have been suggested to be effected by the thermal and chemical history of the system. The mathematical model of the heat transfer was based on first principles from polymerization kinetics and heat transfer, rather than certain in vitro observed properties, which has been the common approach. Our model was valid for general three-dimensional geometries and an arbitrary bone cement consisting of an initiator and monomer. The model was simulated for a cross-section of a hip with a potential femoral stem prosthesis and for a cement similar to Palacos R. The simulations were conducted by using the finite element method. These simulations showed that this general model described an auto accelerating heat production and a residual monomer concentration, which are two phenomena suggested to cause bone tissue damage and effect the mechanical properties of the cement.

  14. Implant supported prosthesis in a patient with progeria: case report.

    PubMed

    Ceylan, Gözlem; Yilmaz, Nergiz; Senyurt, Ozgün; Ergün Kunt, Göknil

    2009-08-01

    Prosthodontic rehabilitation can be accomplished with fixed, overdenture, complete, or implant-retained prostheses. Dental treatment overcomes the patient's functional, psychological, esthetic and phonation problems. Remaining healthy teeth may allow the dentist to fabricate a removable partial overdenture, fixed partial prosthesis or implant - supported prosthesis. The retention of a number of abutments helps maintain a positive ridge form with greater height and volume of the alveolar bone, improving masticatory performance, as well as providing a more stable prostheses. Dental patients who have medical problems need many treatment procedures. Multidisciplinary treatment planning is invaluable for patient's dental health. Progeria is a rare genetic condition where symptoms resembling aspects of aging are manifested at an early age. characteristic clinical findings of Progeria disease include abnormalities of the skin and hair in conjunction with characteristic facial features and skeletal abnormalities. The characteristic facies show protruding ears, beaked nose, thin lips with centrofacial cyanosis, prominent eyes, frontal and parietal bossing with pseudohydrocephaly, midface hypoplasia with micrognathia and large anterior fontanel. The other reported anomalies are dystrophic nails, hypertrophic scars and hypoplastic nipples. The findings that are nearly interested in dentistry are delayed dentition, anodontia, hypodontia, or crowding of teeth. This article presents the multidisciplinary dental treatment planning includes surgical, endodontic and prosthetic treatment of a patient with a history of progeria. In this case complete-arch fixed prostheses in both maxilla and mandible, supported by a combination of implants and teeth are reported.

  15. 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

  16. Midterm results of the Salto Total Ankle Prosthesis.

    PubMed

    Bonnin, M; Judet, T; Colombier, J A; Buscayret, F; Graveleau, N; Piriou, P

    2004-07-01

    The Salto Total Ankle Prosthesis is noncemented with mobile bearings and is characterized by an anatomic design and a dual Ti-HA coating. Between 1997 and 2000, 98 consecutive Salto prostheses were implanted. At last followup, two patients were deceased, one patient was lost to followup, and two prostheses were removed in two patients. Ninety-three implants in 91 patients were available with a mean followup of 35 months (range, 24-68 months). Survivorship at 68 months, with the end point implant removal, then was 98% (favorable scenario) to 94.9% (unfavorable scenario). The American Orthopaedic Foot and Ankle Society score was 32.3 points preoperatively and 83.1 points at followup. Seventy-two patients are pain-free, 54 patients walk unlimited distances, and 25 patients have limitation but walk more than 1 km. Sixty-seven patients have no limp but seven need walking aids. Fifty-eight patients can walk on tiptoes, 49 patients can walk on uneven ground, 14 patients can run, 76 patients ascend stairs normally, and 63 patients descend stairs normally. Range of motion as measured on stress radiographs improved from 15.2 degrees preoperatively to 28.3 degrees at followup. Preliminary results of the Salto prosthesis are encouraging and validate the concept of anatomic replacement.

  17. Assessment of Lower Limb Prosthesis through Wearable Sensors and Thermography

    PubMed Central

    Cutti, Andrea Giovanni; Perego, Paolo; Fusca, Marcello C.; Sacchetti, Rinaldo; Andreoni, Giuseppe

    2014-01-01

    This study aimed to explore the application of infrared thermography in combination with ambulatory wearable monitoring of temperature and relative humidity, to assess the residual limb-to-liner interface in lower-limb prosthesis users. Five male traumatic transtibial amputees were involved, who reported no problems or discomfort while wearing the prosthesis. A thermal imaging camera was used to measure superficial thermal distribution maps of the stump. A wearable system for recording the temperature and relative humidity in up to four anatomical points was developed, tested in vitro and integrated with the measurement set. The parallel application of an infrared camera and wearable sensors provided complementary information. Four main Regions of Interest were identified on the stump (inferior patella, lateral/medial epicondyles, tibial tuberosity), with good inter-subject repeatability. An average increase of 20% in hot areas (P < 0.05) is shown after walking compared to resting conditions. The sensors inside the cuff did not provoke any discomfort during recordings and provide an inside of the thermal exchanges while walking and recording the temperature increase (a regime value is ∼+1.1 ± 0.7 °C) and a more significant one (∼+4.1 ± 2.3%) in humidity because of the sweat produced. This study has also begun the development of a reference data set for optimal socket/liner-stump construction. PMID:24618782

  18. Stress analysis of hemispherical ceramic hip prosthesis bearings.

    PubMed

    Anderson, I A; Bowden, M; Wyatt, T P

    2005-03-01

    We present design criteria and test data for ceramic hemispherical 'resurfacing' prosthesis bearings that are attached by placement on the conical trunnion of the prosthesis stem. These large diameter bearings will be subjected to higher torques than conventional 28 mm bearings. Prototypes were fabricated and tested. The pattern of failure and subsequent analysis suggests that fracture initiated on the surface of the bore and that this was preceded by the development of large circumferential hoop stresses. Widening the bore will improve stability under torque loads but this may be at the expense of bearing strength. A finite element analysis has shown that the optimum taper bore to bearing diameter ratio is 0.43 and that designs with large taper bore to bearing diameter ratios (over 0.6) should be avoided due to the development of excessively high hoop stresses on the inner bore surface. High meridional tensile stresses can appear where the internal roof surface joins the conical bore surface as the load is removed. A smooth radius between the conical bore and the roof will help to overcome this. Further improvements include a thinner roof that is smoothly arched internally. Thus, the design of the component can be optimised, making it less susceptible to fracture without compromising the stability of the ceramic head on its trunnion.

  19. Design of a biomimetic polymer-composite hip prosthesis.

    PubMed

    Bougherara, Habiba; Bureau, Martin; Campbell, Melissa; Vadean, Aurelian; Yahia, L'Hocine

    2007-07-01

    A new biomimetic composite hip prosthesis (stem) was designed to obtain properties similar to those of the contiguous bone, in particular stiffness, to allow normal loading of the surrounding femoral bone. This normal loading would reduce excessive stress shielding, known to result in bone loss, and micromotions at the bone-implant interface, leading to aseptic prosthetic loosening. The design proposed is based on a hollow substructure made of hydroxyapatite-coated, continuous carbon fiber (CF) reinforced polyamide 12 (PA12) composite with an internal soft polymer-based core. Different composite configurations were studied to match the properties of host tissue. Nonlinear three-dimensional analysis of the hip prosthesis was carried out using a three-dimensional finite element bone model based on the composite femur. The performance of composite-based hip and titanium alloy-based (Ti-6Al-4V) stems embedded into femoral bone was compared. The effect of core stiffness and ply configuration was also analyzed. Results show that stresses in composite stem are lower than those in Ti stem, and that the femoral bone implanted with composite structure sustains more load than the one implanted with Ti stem. Micromotions in the composite stem are significantly smaller than those in Ti stem over the entire bone-implant surface because of the favorable interfacial stress distribution.

  20. 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.