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Manufacturing technology for skin integrated composite prosthetic pylon

皮肤一体复合假肢支架制造技术

基本信息

批准号：
7270800
负责人：
Mark Pitkin
金额：
$ 9.73万
依托单位：
POLY-ORTH INTERNATIONAL
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-08-01 至 2008-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7270800
关键词：
Amputation Animals Area Biological Process Blood Cells Cells Characteristics Clinical Protocols Clinical Research Country Devices Ensure Implant In Vitro Infection Knee Lead Life Limb Prosthesis Limb structure Mechanics Methods Modeling Object Attachment Osseointegration Pain Patients Phase Phase I Clinical Trials Phase II Clinical Trials Porosity Prosthesis Prosthetic rehabilitation Public Health Rattus Research Personnel Residual state Risk Sampling Skeletal system Skin Small Business Funding Mechanisms Small Business Innovation Research Grant Solid Structure Technology Testing Titanium Trauma United States Food and Drug Administration Veterans War Week ankle joint bone commercialization cost design human subject implantation improved in vivo innovation manufacturing process mathematical model particle secondary infection size soft tissue

项目摘要

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.

描述（由申请人提供）：几个世纪以来，截肢患者都需要一个假肢接受腔来覆盖其残端，作为将假肢连接到身体上的一种方式。这种传统的方法构成间接附着，因为软组织和皮肤区域位于假体和残余骨之间。为了消除或避免与间接附着相关的疼痛和不适，在90年代引入了称为“骨整合”的直接假体附着技术（Eriksson和Branemark 1994）。尽管钛植入物与残余骨的整合相对成功，但植入物位于残余骨外的区域中的装置-皮肤界面的问题仍未解决。感染和继发性创伤的高风险使直接骨骼附着技术无法进行广泛的临床研究和实施。这项研究旨在开发一种新的“残体整合修复技术”，用于肢体修复。该技术将包括一个“皮肤和骨骼集成的支架”（SBIP），它将连接残肢与外部假肢。SBIP将不仅与残余骨结合，而且与残余皮肤结合，以最大限度地减少感染和二次创伤的风险。研究人员将开发一种最佳的多孔钛基质和皮骨一体化支架的设计，以及一种生物学过程，以最大限度地促进骨和皮肤细胞向SBIP的长入。数学建模和力学测试之后，将对具有可渗透内部框架的复合多孔结构的制造过程进行技术研究。截肢后的假肢康复不足是一个严重的公共卫生问题。当一个国家处于战争状态时，解决这一严重问题的公共价值要高得多。为美国退伍军人提供无感染的假肢直接骨骼附着将提高他们的生活质量，并消除与多次制造和调整假肢接受腔相关的成本。