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（由适用提供）：IFIT Prosthetics，LLC（R）及其创始人的目的是创建和商业化模块化，直接拟合，完全可调的，可调节的，适用于大量生产的，适用于使用高强度聚合物材料的大规模生产，这些材料是在常规制作的普通话成本的一小部分中模成的高强度聚合物。实现了这一目标，现在这一阶段IIB竞争续约的目标是； i）完整的注射模具制造，用于剩余尺寸的跨态插座尺寸，以制作完整的跨态假体系列，以适合大多数截肢者，ii）制定过程和制造程序，以符合联邦CMS持久的医疗设备法规和FDA设备法规，以及用于制定所有国际标准的FDA设备法规（III）的所有devere deprem（ISO 10328）deverment，ISO 10328） amputees和v）在我们的设备和常规制造的假体之间进行了更严格的比较有效性研究。最终设计只能使用几个手持工具适合截肢者的残留肢体。我们的设备舒适，重量轻，功能高，并且可以在保留在患者身上的同时对齐。该系统与大量市售的假肢和硅胶销悬架系统兼容。我们与高级设计概念（ADC）及其工程团队的合作在开发该产品方面非常成功。这项研究的主要业务兴趣IFIT ProSthetics，LLC（R）有利，可以实现IIB阶段两年竞争性续约的目标。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方案的商业化，可替代假体制造状态，这有很大的希望，可以增加获得假体设备的获取，并在国内和国际上改善大量且越来越多的跨语言和跨性别截肢的人的生活质量。