IMMEDIATE FIT USING INNOVATIVE TECHNOLOGY TRANSTIBIAL PROSTHESIS

使用创新技术的胫骨假体立即贴合

• 批准号: 9134601
• 负责人: TIMOTHY R DILLINGHAM
• 金额: $ 48.67万
• 依托单位: IFIT PROSTHETICS, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9134601
• 关键词: Address; American; Amputation; Amputees; Biomechanics; Businesses; Collaborations; Devices; Durable Medical Equipment; Engineering; Ensure; Funding; Gait; Goals; Hand; Health; Health system; Industry; Injection of therapeutic agent; Insurance; Insurance Coverage; International; Kinetics; Knee; Knee Prosthesis; Knee joint; Laboratories; Legal patent; Light; Lower Extremity; Marketing; Measurement; Measures; Medicare/Medicaid; Molds; Notification; Outcome; Parents; Patients; Pennsylvania; Persons; Phase; Polymers; Procedures; Production; Prosthesis; Qualifying; Quality of life; Recruitment Activity; Regulation; Resources; Sales; Shapes; Silicones; Small Business Technology Transfer Research; Suspension substance; Suspensions; System; Testing; Time; United States Food and Drug Administration; Universities; Veterans; Weight; Work; commercialization; comparative effectiveness; cost; cost effective; design; effectiveness trial; improved; innovation; innovative technologies; interest; kinematics; manufacturing process; meetings; orthotics; product development; prosthesis fitting; prosthetic foot; residual limb; satisfaction; tool

 DESCRIPTION (provided by applicant): The goal of iFIT Prosthetics, LLC(r) and its founder was to create and commercialize a modular, immediate fit, fully adjustable, transtibial prosthesis system suitable for mass production using high strength polymer materials that are injection molded at a fraction of the cost of conventionally made prostheses. This goal was achieved and now the aims of this Phase IIB competitive renewal are to; i) complete injection mold manufacture for the remaining sizes of transtibial sockets to make a full line of transtibial prostheses to fit most amputees, ii) develop processes and manufacturing procedures to comply with federal CMS Durable Medical Equipment regulations and FDA Device regulations, iii) complete international standards (ISO 10328) durability testing for all components, iv) develop similar devices for transfemoral amputees, and v) conduct a more rigorous comparative effectiveness study between our devices and conventionally manufactured prostheses. The final design can be fit onto the amputee's residual limb using only a few hand-held tools. Our device is comfortable, light in weight, highly functional, and can be aligned while remaining on the patient. This system is compatible with a large number of commercially available prosthetic feet and silicone pin suspension systems. Our collaboration with Advanced Design Concepts (ADC) and their engineering team has been highly successful in developing this product. The principal business interest in this study iFIT Prosthetics, LLC(r) is well poised to carry out the aims of ths Phase IIB two-year competitive renewal. Commercialization of this American-made, innovative, consumer-centered, cost-effective alternative to the current state of prosthetic fabrication holds great promise to increase access to prosthetic devices and to improve the quality of life for the large and growing number of persons with transtibial and transfemoral amputations domestically and internationally.

 描述（由申请人提供）：iFIT Prosthetics, LLC(r) 及其创始人的目标是创建模块化、即时贴合、完全可调、经胫骨假肢系统并使其商业化，该系统适合使用注塑成型的高强度聚合物材料进行大规模生产以传统制造假体成本的一小部分实现了这一目标，现在第二阶段竞争性更新的目标是： i) 完成剩余尺寸的胫骨接受腔的注塑模具制造。制造适合大多数截肢者的全系列经胫骨假体，ii) 开发工艺和制造程序以符合联邦 CMS 耐用医疗设备法规和 FDA 设备法规，iii) 对所有组件完成国际标准 (ISO 10328) 耐久性测试，iv)为经股截肢者开发类似的装置，并且 v) 在我们的装置和传统制造的假肢之间进行更严格的比较有效性研究，最终设计只需使用少量的材料即可安装到截肢者的残肢上。我们的设备舒适、重量轻、功能强大，并且可以在患者身上进行对齐，该系统与我们与 Advanced 合作的大量市售假脚和硅胶销悬挂系统兼容。 Design Concepts (ADC) 及其工程团队在开发该产品方面取得了巨大成功。 iFIT Prosthetics, LLC(r) 的主要商业利益已做好准备，能够实现 IIB 期两年竞争性更新的目标。商业化这种美国制造的、创新的、以消费者为中心的、具有成本效益的替代当前假肢制造状态的产品，有望增加假肢装置的使用机会，并提高大量且不断增加的经胫骨和经股骨患者的生活质量。国内和国际截肢。

项目成果

Pain Outcomes with an Elliptical Regimen (POWER) Study: Identifying the Proper Dosage of Exercise for Therapeutic Effect in Persons with Chronic Back Pain.

椭圆疗法 (POWER) 研究的疼痛结果：确定对慢性背痛患者产生治疗效果的适当运动剂量。

• 发表时间: 2020
• 作者: Dillingham, Timothy;Kenia, Jessica;Popescu, Adrian;Plastaras, Christopher;Becker, Scott;Shofer, Frances
• 通讯作者: Shofer, Frances