Validating establishment of functional safety in skin interface with deeply porous transcutaneous pylon for direct skeletal attachment of limb prostheses

验证用于肢体假肢直接骨骼附着的深孔经皮塔皮肤界面功能安全性的建立

• 批准号: 10324937
• 负责人: Mark Pitkin
• 金额: $ 97.64万
• 依托单位: POLY-ORTH INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-24 至 2023-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10324937
• 关键词: Address; American; Amputation; Amputees; Animal Testing; Animals; Anti-Bacterial Agents; Artificial Implants; Bone Tissue; Botulinum Toxins; Cells; Characteristics; Clinical Protocols; Clinical Research; Code; Communication; Country; Data; Development; Devices; Effectiveness; Ensure; Family suidae; Gait; Histopathology; Human; Immobilization; Implant; Infection; Injections; International; Legal patent; Limb Prosthesis; Mechanics; Medical Device; Osseointegration; Outcome; Patients; Permeability; Phase; Porosity; Prosthesis; Prosthesis Failure; Prosthetic rehabilitation; Public Health; Recommendation; Regulation; Reliability of Results; Research; Research Personnel; Residual state; Resistance to infection; Safety; Series; Silver; Skin; Skin Tissue; Structure; System; Technology; Testing; Titanium; Translations; Trauma; War; Work; antimicrobial; bone; botulinum; commercialization; cost; design; efficacy testing; implantable device; implantation; improved; infection rate; infection risk; innovation; limb amputation; manufacturing process; meetings; novel; osseointegrated implant; phase 1 study; phase 2 study; preclinical study; preimplantation; prosthetic socket; risk minimization; safety testing; seal; skeletal

Research efforts of the Poly-Orth International demonstrated feasibility of the novel “Residuum-Integration Prosthetic Technology" to be used in direct skeletal attachment of limb prosthetics. The technology includes a “Skin and Bone Integrated Pylon” (SBIP), which connects the residuum with external limb prosthesis and can be especially beneficial for patients who can not use traditional socket attachment of the prostheses. As histopathology analysis after the study with small and large animals has demonstrated, the SBIP is integrated not only with the residual bone, but also with the residuum’s skin minimizing the risk of infection and secondary trauma. The investigators developed 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 without compromising strength of the implanted device. The technological study on the process of manufacturing of the composite porous structure enforced with a permeable internal frame. Parameters of the SBIP’s specification are protected by the US Patent #8257435. During the proposed translational pre-clinical study, the animal trials will be conducted according to the FDA requirements to ensure smooth translation to the trials in humans. It will include large animals (pigs) and the implantation period up to 22 months.

Poly-Orth International的研究工作证明了小说的可行性 “残体整合修复技术”将用于直接骨骼附着， 假肢该技术包括一个“皮肤和骨骼集成支架”（SBIP）， 其将残肢与外部假肢连接起来，特别是 对于不能使用传统的假体窝附着的患者是有益的。 在对小型和大型动物进行研究后， 已经证明，SBIP不仅与残余骨整合，而且与 残余的皮肤，最大限度地减少感染和二次创伤的风险。调查人员 开发了一种最佳的多孔钛基质和设计的皮肤和骨集成 最大限度地延长胫骨平台骨和皮肤细胞的残余物 而不损害植入装置的强度。技术研究 制造用可渗透性增强的复合多孔结构的方法 内部框架。SBIP规范的参数受美国专利保护 #8257435. 在拟定的转化临床前研究期间，将进行动物试验 根据FDA要求进行，以确保顺利转化为试验 在人类身上。它将包括大型动物（猪）和植入期长达22 个月