Manufacturing technology for skin integrated composite prosthetic pylon

皮肤一体复合假肢支架制造技术

• 批准号: 7897722
• 负责人: Mark Pitkin
• 金额: $ 40.12万
• 依托单位: POLY-ORTH INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-15 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7897722
• 关键词: Afghanistan; American; Amputation; Amputees; Animals; Cells; Characteristics; Clinical Protocols; Country; Development; Devices; Fatigue; Finite Element Analysis; Histopathology; Infection; Inflammation; Iraq; Life; Limb Prosthesis; Limb structure; Mechanics; Medical Device; Modeling; Phase; Porosity; Progress Reports; Prosthesis; Prosthetic rehabilitation; Public Health; Research Personnel; Residual state; Resistance; Risk; Rodent; Safety; Skin; Structure; Techniques; Technology; Testing; Titanium; Trauma; Veterans; War; animal efficacy; bone; bone cell; cost; design; improved; innovation; manufacturing process; mathematical model; meetings; novel; particle; phase 1 study; phase 2 study; preclinical safety; preclinical study; prototype; public health relevance; secondary infection; skeletal; sound

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.

描述（由申请人提供）：I期研究“皮肤整合复合材料假肢支架的制造技术”证明了新型“残留物整合假肢技术”用于肢体假肢的可行性。该技术包括一个“皮肤和骨骼集成的假肢”（SBIP），它将残肢与外部假肢连接起来。正如组织病理学分析所证明的，SBIP不仅与残余骨结合，而且与残余皮肤结合，以最大限度地减少感染和继发性创伤的风险。在拟定的II期研究期间，研究者将开发最佳多孔钛基质和皮肤和骨集成式支架设计，以最大限度地促进残留物的骨和皮肤细胞长入SBIP。数学建模和力学测试之后，将对具有可渗透内部框架的复合多孔结构的制造过程进行技术研究。将对啮齿类和非啮齿类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无感染的假肢直接骨骼附着将提高他们的生活质量，并消除与多次制造和调整假肢接受腔相关的成本。

项目成果

Subperiosteal transmission of intra-articular pressure between articulated and stationary joints.

• DOI: 10.1038/srep08103
• 发表时间: 2015-01-29
• 期刊: Scientific reports
• 影响因子: 4.6
• 作者: Pitkin M;Muppavarapu R;Cassidy C;Pitkin E
• 通讯作者: Pitkin E

Mechanical properties of totally permeable titanium composite pylon for direct skeletal attachment.

完全渗透的钛合金塔的机械性能，用于直接骨骼附着。

• DOI: 10.1002/jbm.b.32663
• 发表时间: 2012-05
• 期刊: JOURNAL OF BIOMEDICAL MATERIALS RESEARCH PART B-APPLIED BIOMATERIALS
• 影响因子: 3.4
• 作者: Pitkin, M.;Pilling, J.;Raykhtsaum, G.
• 通讯作者: Raykhtsaum, G.

Recording of electric signal passing through a pylon in direct skeletal attachment of leg prostheses with neuromuscular control.

记录通过神经肌肉控制的腿部假肢直接骨骼附着中的塔架的电信号。

• DOI: 10.1109/tbme.2012.2187784
• 发表时间: 2012
• 期刊: IEEE transactions on bio-medical engineering
• 作者: Pitkin,M;Cassidy,C;Muppavarapu,R;Edell,D
• 通讯作者: Edell,D

Application of the skin and bone integrated pylon with titanium oxide nanotubes and seeded with dermal fibroblasts.

• DOI: 10.1177/0309364614550261
• 发表时间: 2015-12
• 期刊: Prosthetics and orthotics international
• 影响因子: 1.5
• 作者: Shevtsov MA;Yudintceva N;Blinova M;Pinaev G;Galibin O;Potokin I;Popat KC;Pitkin M
• 通讯作者: Pitkin M

Distraction Implantation. A New Technique in Total Joint Arthroplasty and Direct Skeletal Attachment.

分心植入。

• 发表时间: 2018
• 期刊: EC orthopaedics
• 作者: Pitkin,Mark