Manufacturing technology for skin integrated composite prosthetic pylon

说明(申请人提供)：第一阶段研究“皮肤一体化复合假体支架制造技术”论证了新型“残渣-一体化假体技术”应用于肢体假肢的可行性。这项技术包括一个“皮肤和骨骼一体化塔架”(SBIP)，它将残余物与外部假肢连接起来。正如组织病理学分析所证明的那样，SBIP不仅将与残骨整合，还将与残骨皮肤整合，以将感染和继发性创伤的风险降至最低。在拟议的第二阶段研究中，研究人员将开发一种最佳的多孔钛基质和皮肤与骨骼集成支架的设计，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。将对啮齿动物和非啮齿动物进行临床前研究，以验证科学假设，并选择SBIP的最佳设计。公共卫生相关性：截肢后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): 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.