Manufacturing technology for skin integrated composite prosthetic pylon

描述(申请人提供)：几个世纪以来，肢体截肢患者需要一个假肢插座来覆盖他们的残留物，作为将假体固定到他们身体上的一种手段。这种传统的方法构成了间接附着体，因为假体和残骨之间有一块软组织和皮肤。为了消除或避免与间接附着体相关的疼痛和不适，90年代引入了一种被称为“骨整合”的直接假体附着体技术(Eriksson和Branemark，1994)。尽管钛种植体与残留骨的结合相对成功，但种植体出残留物区域的装置-皮肤界面的问题仍未解决。感染和继发性创伤的高风险阻碍了直接骨骼附着技术的广泛临床研究和实施。这项研究的目的是开发一种新的“残余物-集成假体技术”，用于假肢。这项技术将包括一个“皮肤和骨骼一体化假体”(SBIP)，它将把残余物与外部假肢连接起来。SBIP不仅将与残骨结合，还将与残骨皮肤结合，以最大限度地减少感染和继发创伤的风险。研究人员将开发一种最佳的多孔钛基质和皮肤与骨骼一体化支架的设计，以及一种生物工艺，以最大限度地使残留物的骨和皮肤细胞向SBIP内生长。在数学建模和力学测试之后，将对具有渗透性内框架的复合材料多孔结构的制造过程进行技术研究。截肢术后假肢康复不充分是关系到公众健康的严重问题。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感染安全的直接骨骼附着体将提高他们的生活质量，并消除与假体插座的多次制造和调整相关的成本。

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.