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: 10493303
• 负责人: Mark Pitkin
• 金额: $ 73.16万
• 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 2024-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10493303
• 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.

多恩国际的研究工作表明了小说的可行性 用于直接骨骼附件 肢体假肢。该技术包括“皮肤和骨骼整合塔”（SBIP）， 将残留物与外部肢体假体连接起来，尤其是 对无法使用伪造的传统插座附着的患者有益。 作为研究后的组织病理学分析，大小动物具有 证明，SBIP不仅与残留骨相结合，而且还与 残留物的皮肤最大程度地减少了感染和继发性创伤的风险。调查人员 开发了最佳的多孔钛基质和皮肤的设计 塔塔最大化残留物的骨头和皮肤细胞向SBIP 没有植入装置的强度损害。关于 使用可渗透的复合多孔结构的制造过程 内部框架。 SBIP规范的参数受美国专利的保护 ＃8257435。 在拟议的翻译前研究中，动物试验将是 根据FDA要求进行的，以确保平稳翻译为试验 在人类中。它将包括大型动物（猪）和植入周期长达22 月份。

项目成果

Recent Progress in Animal Studies of the Skin- and Bone-integrated Pylon With Deep Porosity for Bone-Anchored Limb Prosthetics With and Without Neural Interface.

用于具有和不具有神经接口的骨锚式肢体假肢的具有深孔隙的皮肤和骨整合塔的动物研究的最新进展。

• DOI: 10.1093/milmed/usaa445
• 发表时间: 2021
• 期刊: Military medicine
• 影响因子: 1.2
• 作者: Pitkin,Mark;Cassidy,Charles;Shevtsov,MaximA;Jarrell,JoshuaR;Park,Hangue;Farrell,BradJ;Dalton,JohnF;Childers,WLee;Kistenberg,RobertS;Oh,Kyunggeune;Klishko,AlexanderN;Prilutsky,BorisI
• 通讯作者: Prilutsky,BorisI

Protecting the skin-implant interface with transcutaneous silver-coated skin-and-bone-integrated pylon in pig and rabbit dorsum models.

• DOI: 10.1002/jbm.b.34725
• 发表时间: 2021-04
• 期刊: JOURNAL OF BIOMEDICAL MATERIALS RESEARCH PART B-APPLIED BIOMATERIALS
• 影响因子: 3.4
• 作者: Shevtsov, Maxim;Gavrilov, Dmitriy;Yudintceva, Natalia;Zemtsova, Elena;Arbenin, Andrei;Smirnov, Vladimir;Voronkina, Irina;Adamova, Polina;Blinova, Miralda;Mikhailova, Nataliya;Galibin, Oleg;Akkaoui, Michael;Pitkin, Mark
• 通讯作者: Pitkin, Mark