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IMMEDIATE FIT USING INNOVATIVE TECHNOLOGY TRANSTIBIAL PROSTHESIS

使用创新技术的胫骨假体立即贴合

基本信息

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
项目类别：
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

项目摘要

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.