Immediate fit using innovative technology, transtibial prosthesis

采用创新技术的即时贴合，经胫骨假体

基本信息

批准号：
8551681
负责人：
TIMOTHY R DILLINGHAM
金额：
$ 30.81万
依托单位：
IFIT PROSTHETICS, LLC
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-04-01 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8551681
关键词：
Address Amputation Amputees Biomechanics Businesses Childhood Collaborations Country Development Device Designs Devices Educational Materials Engineering Funding Future Gait Goals Heart Diseases Hour Industry Injection of therapeutic agent International Kidney Diseases Lead Licensing Limb structure Manufacturer Name Marketing Mechanics Metals Molds Monitor Online Systems Patient Self-Report Pattern Pennsylvania Phase Production Property Prosthesis Prosthetic rehabilitation Quality of life Rehabilitation Centers Relative (related person)Research Research Personnel Residual state Safety Sales Sampling Shapes Site Skiing System Techniques Testing United States Universities Vision Walking Wisconsin Work commercialization cost cost effective design experience innovation innovative technologies insight interest limb amputation medical schools meetings novel prosthesis fitting prototype tool

项目摘要

DESCRIPTION (provided by applicant): Our companys' goal is to create and commercialize a modular, immediate fit, transtibial prosthesis system at a fraction of the cost of conventionally manufactured devices. Our product will be mass produced using the latest injection molding techniques with advanced materials that duplicate the strength of metal at a fraction of the cost. This system will be immediately fit on the residual limb and aligned for optimal gait without specialized tools or facilities. The advanced prototype incorporates a new socket that uses a buckle system ? similar to a ski boot ? with a rear entry panel that allows for fine adjustments to optimize fit and comfort. Our new design has been well received by subjects to date and biomechanical testing revealed gait patterns similar to those with their conventional devices. The goals and aims for Phase I were fully met and we demonstrated the feasibility of immediate fit prosthetics. Phase II funding is now necessary to fully test, develop, and commercialize our novel device ?a self-contained transtibial prosthesis system that is immediately fit and provides a high level of comfort and functionality. Our collaboration with Advanced Design Concepts (ADC) and their engineering team has been highly successful in developing our current product. The principal business interest in this study "iFIT Prosthetics, LLC" is well poised to carry out te aims of this Phase II project under the direction of the primary investigator (Dr. Dillingham). Thi proposed two year project will bring our prototype product to the point of, marketing, sales, and commercialization. The specific aims of this Phase II project are threefold. First we will test 30 unilateral transtibial amputees at more intense levels of ambulation, assessing comfort, ease of use and stability with our device. Second, ADC Engineering will fabricate metal templates for injection molding our prototypes and then produce 50 transtibial prostheses. Third, ADC Engineering will conduct International standards testing on our devices to insure they exceed international standards for strength and durability. Concurrent with this testing and manufacture, iFIT Prosthetics will develop web-based sales capabilities and educational materials for prosthetists that will use our product as part of a commercialization plan. The market for this device is quite large internationally and in the United States. Our future customers are many and include; i) amputees from impoverished countries for whom conventional manufacture and prosthesis fitting are cost prohibitive, ii) amputees who experience volume changes in their residual limb shortly after amputation or because of heart and renal diseases, and iii) pediatric amputees who are growing and need an adjustable, comfortable prosthesis. Currently, there are no commercially available devices such as ours on the market. Our product will be introduced at a considerable cost advantage relative to standard prostheses, yet is equally as comfortable and functional. The concept iFIT Prosthetics is advancing?immediate fit devices? could well lead to changes within the prosthetics industry.

描述（由申请人提供）：我们公司的目标是以传统制造设备成本的一小部分来创建和商业化模块化、即时贴合、经胫骨假肢系统。我们的产品将采用最新的注塑技术和先进材料进行批量生产，这些材料可以以极低的成本复制金属的强度。该系统将立即安装在残肢上并对齐以实现最佳步态，无需专门的工具或设施。先进的原型采用了一个使用带扣系统的新插座？类似于滑雪靴？带有后入口面板，可进行微调以优化贴合度和舒适度。迄今为止，我们的新设计已受到受试者的好评，生物力学测试显示其步态模式与传统设备相似。第一阶段的目标和目的已完全实现，我们证明了即刻安装假肢的可行性。现在需要第二阶段的资金来全面测试、开发和商业化我们的新型设备——一种独立的经胫骨假肢系统，可以立即贴合并提供高水平的舒适度和功能。我们与 Advanced Design Concepts (ADC) 及其工程团队的合作在开发当前产品方面取得了巨大成功。本研究的主要商业利益“iFIT Prosthetics, LLC”已准备好在主要研究者（Dillingham 博士）的指导下实现第二阶段项目的目标。这个拟议的为期两年的项目将使我们的原型产品达到营销、销售和商业化的目的。该第二阶段项目的具体目标有三个。首先，我们将对 30 名单侧经胫骨截肢者进行更高强度的步行测试，评估我们设备的舒适度、易用性和稳定性。其次，ADC Engineering 将制造用于注射成型我们的原型的金属模板，然后生产 50 个经胫骨假体。第三，ADC Engineering 将对我们的设备进行国际标准测试，以确保它们在强度和耐用性方面超过国际标准。在进行测试和制造的同时，iFIT Prosthetics 将为假肢师开发基于网络的销售能力和教育材料，这些假肢师将使用我们的产品作为商业化计划的一部分。该设备的市场在国际上和美国都相当大。我们未来的客户有很多，包括： i) 来自贫困国家的截肢者，其传统制造和假肢装配的成本过高，ii) 截肢后不久或由于心脏和肾脏疾病而导致残肢体积变化的截肢者，以及 iii) 正在成长并需要假肢的儿童截肢者可调节、舒适的假肢。目前，市场上还没有像我们这样的商用设备。相对于标准假肢，我们的产品将以相当大的成本优势推出，但同样舒适且功能齐全。 iFIT Prosthetics 正在推进概念？即刻贴合装置？很可能会导致假肢行业发生变化。