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Sharon, MA, United States

Pitkin M.,Tufts University | Pilling J.,Michigan Technological University | Raykhtsaum G.,Poly Orth International
Journal of Biomedical Materials Research - Part B Applied Biomaterials | Year: 2012

Composite pylons containing a solid titanium core with drilled holes surrounded by a porous sintered titanium shell have been fabricated and tested in bending along with the raw cores and pylons composed of the porous titanium alone. The new pylons were designed with the concept of enhanced in-growth of bone and skin cells and are intended for direct skeletal attachment of limb prostheses considering requirements for long-lasting anchorage to the residuum bone and a need for a safe skin-implant seal. Load-displacement thresholds were determined after which the integrity of the porous component may be compromised. The composite pylons have a flexural strength and stiffness substantially greater than that of pylons composed of the porous titanium alone. The drilled holes in the solid insert have been shown to have virtually no effect on the flexural strength of the pylon, while meeting a requirement for total permeability of the device for unrestricted cell ingrowth. The predicted strength of the pylons and associated failure modes are in close agreement with those measured. © 2012 WILEY PERIODICALS, INC. Source


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 750.00K | Year: 2009

DESCRIPTION (provided by applicant): The Phase I study Manufacturing technology for skin integrated composite prosthetic pylon demonstrated feasibility of the novel Residuum-Integration Prosthetic Technology to be used in limb prosthetics. The technology includes a Skin and Bone Integrated Pylon (SBIP), which connects the residuum with an external limb prosthesis. As histopathology analysis has demonstrated, the SBIP will be integrated not only with the residual bone, but also with the residuum's skin in order to minimize the risk of infection and secondary trauma. During the proposed Phase II study the investigators will develop an optimal porous titanium matrix and design of the Skin and Bone Integrated Pylon to maximize the ingrowth of bone and skin cells of the residuum to the SBIP. The mathematical modeling and mechanical testing will be followed by a technological study on the process of manufacturing of the composite porous structure enforced with a permeable internal frame. A pre-clinical study with rodent and non-rodent animals will be conducted to verify the scientific hypotheses and to select the optimal design of the SBIP. PUBLIC HEALTH RELEVANCE: Inadequate prosthetic rehabilitation after limb amputation is a serious problem relevant to public health. The public value of solving this serious problem is much more elevated when a country is at war. Providing US Veterans with infection-safe direct skeletal attachment of prostheses will improve the quality of their lives and eliminate the costs associated with the multiple fabrications and adjustments of the prosthetic sockets.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 94.64K | Year: 1999

Not Available The Aeptec Cook/Chill Automated Galley team has significant experience integrating Commercial Off the Shelf (COTS) equipment onto Navy ships. We have assembled a strong team which has expertise in all aspects of the problem to develop our Cook/Chill system concept. Aeptec has just completed the design, installation and testing of the first SHIPWIDE WIRELESS LAN SYSTEM on the USS THE SULLIVANS (DDG-68) and we are processing the PMS400 SHIPALT to add this capability to FFG's, DD's, DDG's, and CG's. Our team includes a commercial food service expert experienced with the implementation of Cook/Chill, a Robotics company, a company that is developing environmentally safe untensils, and engineers that have an extensive background in shipboard integration and the SHIPALT process. Our commercial partner, Hyperport Corporation, will take our Cook/Chill Automated Galley system to a worldwide market through their innovative theme park/commerce center concept that will revolutionize e-commerce. We will examine the current and evolving technology solutions available in industry for their applicability to a shipboard Automated Galley system architecture. Phase I will documents this approach and begin the planning for Phase II when our Cook/Chill Automated Galley recommendations will be implemented into a shipboard system prototype. Our Automated Galley will include a computer front panel that will enable sailors to order their meals remotely or on site. Our design will modify


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 97.30K | Year: 2007

DESCRIPTION (provided by applicant): For centuries, patients with limb amputations have required a prosthetic socket to cover their residuum as a means for attaching the prosthesis to their body. This traditional method constitutes indirect attachment, as an area of soft tissues and skin lies between the prosthesis and the residual bone. In order to eliminate or avoid pain and discomfort associated with indirect attachment, a technology of direct prosthetic attachment called "osseointegration" was introduced in the nineties (Eriksson and Branemark 1994). Despite the relatively successful integration of a titanium implant with the residual bone, the problem of the device-skin interface in the area where the implant goes outside of the residuum remains unsolved. The high risk of infection and secondary trauma precludes the technology of direct skeletal attachment from wide clinical studies and implementation. The proposed study is aimed at developing a new "Residuum-Integration Prosthetic Technology" to be used in limb prosthetics. The technology will include a "Skin and Bone Integrated Pylon" (SBIP), which will connect the residuum with external limb prosthesis. The SBIP will be integrated not only with the residual bone, but also with the residuum's skin in order to minimize the risk of infection and secondary trauma. The investigators will develop an optimal porous titanium matrix and design of the Skin and Bone Integrated Pylon, and also a biological process to maximize the ingrowth of bone and skin cells of the residuum to the SBIP. The mathematical modeling and mechanical testing will be followed by a technological study on the process of manufacturing of the composite porous structure enforced with a permeable internal frame. Inadequate prosthetic rehabilitation after limb amputation is a serious problem relevant to public health. The public value of solving this serious problem is much more elevated when a country is at war. Providing US Veterans with infection-safe direct skeletal attachment of prostheses will improve the quality of their lives and eliminate the costs associated with the multiple fabrications and adjustments of the prosthetic sockets.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 0.00 | Year: 2002

The Phase II project is to complete development of a new Rolling Joint Prosthetic Leg comprising a Rolling Joint (Free-Flow) Foot and Ankle and the Rolling Joint Prosthetic Knee. Original design of both prostheses is based on a Rolling Joint Technology, recently developed by the applicants. The Rolling Joint Foot and Ankle was commercialized in October of 1999. Major efforts during the Phase I of the current study were developed to design, manufacture and testing of the new Rolling Joint Knee. As results of the Phase I study showed, development of Rolling Joint Prosthetic Leg has merit to be continued. Development and testing of the Rolling Joint Knee will be completed during the Phase II proposed. Additional research will be conducted to verify the hypothesis that patients with trans-femoral amputations will benefit from aan assembly of both Rolling Joint Units in a Rolling Joint Leg. New methodology for individual tuning of critical parameters of prostheses will be developed. It will provide more normal, less painful locomotion in a lower limb amputee and increase number of patients to be managed prosthetically. The specific aims of the Phase II project. Complete a development of a new Knee unit prototype with compliant tibial component; conduct a comparative mechanical tests and biomechanical gait study with 20 trans-femoral amputees to verify the hypothesis that a new prosthetic device with the proposed mechanical outcome improves a trans-femoral amputee gait by normalizing "stump-socket" interface during stance phase of gait. Long term objectives of the proposed research are to develop a functional, reliable and economical prosthetic modular system. PROPOSED COMMERCIAL APPLICATIONS: Potential commercial application is the creation of a product line of Rolling Joint Feet and Knees. The RJ Leg will enhance performance of transfemoral amputees without increasing the cost, thus providing a highly competitive product in the field of prosthetic rehabilitation.

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