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，肢体截肢的患者需要假肢插座才能覆盖其残留物，以作为将假体固定在其身体上的手段。这种传统方法构成间接附着，作为软组织和皮肤的区域，位于假体和残留骨之间。为了消除或避免与间接依恋相关的疼痛和不适，在90年代引入了一种称为“ Ossecletration”的直接假体依恋技术（Eriksson and Branemark 1994）。尽管钛植入物与残留骨相对成功的整合，但植入物移至残基外部的区域中的设备皮肤界面的问题仍然无法解决。感染和继发性创伤的高风险排除了广泛的临床研究和实施的直接骨骼依恋技术。拟议的研究旨在开发一种新的“残留融合假体技术”，用于肢体假体。该技术将包括一个“皮肤和骨骼整合塔”（SBIP），该塔将与外部肢体假体连接在一起。 SBIP不仅将与残留的骨骼整合在一起，还将与残留物的皮肤整合在一起，以最大程度地减少感染和继发性创伤的风险。研究人员将开发出最佳的多孔钛基质和皮肤和骨骼整合塔的设计，也将开发一个生物学过程，以使残基的骨骼和皮肤细胞向SBIP最大化。数学建模和机械测试将进行一项技术研究，该技术研究对使用可渗透的内部框架强制实施的复合多孔结构的制造过程。肢体截肢后的假肢康复不足是与公共卫生有关的严重问题。当一个国家在战争中，解决这个严重问题的公共价值会更高。为美国退伍军人提供感染的直接骨骼固定，将提高其生活质量，并消除与假肢插座的多种制造和调整相关的成本。