Immediate fit using innovative technology transtibial prosthesis

使用创新技术的小腿假体立即贴合

• 批准号: 8393054
• 负责人: TIMOTHY R DILLINGHAM
• 金额: $ 35.95万
• 依托单位: IFIT PROSTHETICS, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8393054
• 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; medical schools; meetings; novel; prosthesis fitting; prototype; tool

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. PUBLIC HEALTH RELEVANCE: iFIT Prosthetics Our company's 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. Our prototype for this Phase II project utilies a rear-entry buckle system that easily adjusts to different residual limb shapes and sizes. Such a system will benefit amputees in impoverished countries where conventional devices are not readily available due to high costs, as well as amputees in economically advanced nations who require socket adjustments to accommodate changes in shape and volume. This innovative, highly-functional alternative to the current state of prosthetic fabrication holds great potential o advance the quality of life for amputees worldwide and change the field of prosthetic rehabilitation.

描述（由申请人提供）：我们的公司的目标是在传统制造设备的成本的一小部分中创建和商业化模块化，立即拟合的thranstibial假体系统。我们的产品将使用最新的注射成型技术和高级材料生产，这些技术以成本的一小部分复制金属强度。该系统将立即适合残留的肢体，并在没有专门工具或设施的情况下对准最佳步态。高级原型包含了使用带扣系统的新套接字？类似于滑雪靴？带有后入口面板，可以进行精细的调整以优化拟合和舒适性。迄今为止，我们的新设计受到了受试者的好评，生物力学测试揭示了与传统设备相似的步态模式。第一阶段的目标和目标得到了充分实现，我们证明了立即拟合假肢的可行性。现在，需要全面测试，开发和商业化我们的新型设备？一种自包含的transpibial假体系统，它立即适合并提供高水平的舒适性和功能。我们与高级设计概念（ADC）及其工程团队的合作在开发当前产品方面非常成功。这项研究的主要业务兴趣“ IFIT ProSthetics，LLC”有望在主要研究者（Dillingham博士）的指导下实现这一II期项目的目标。 Thi提议的两年项目将使我们的原型产品达到营销，销售和商业化。该第二阶段项目的具体目标是三倍。首先，我们将在更强烈的移动水平上测试30个单方面的单方面截肢术，评估舒适性，易用性和对设备的稳定性。其次，ADC工程将制造金属模板，以用于模制我们的原型，然后产生50个transibial假体。第三，ADC工程将对我们的设备进行国际标准测试，以确保它们超过国际强度和耐用性。同时，IFIT假肢将与该测试和制造一起开发基于Web的销售能力和教育材料，以将我们的产品用作商业化计划的一部分。该设备的市场在国际和美国都非常大。我们的未来客户很多，包括： i）来自贫困国家的截肢者的常规制造和假体配件是成本率高的，ii）截肢后不久或由于心脏和肾脏疾病的残留肢体变化的截肢者，以及iiii）生长且需要可调节，舒适的假言。目前，市场上没有商业上可用的设备。相对于标准假体，我们的产品将以可观的成本优势引入，但同样舒适且功能齐全。 IFIT假肢的概念正在前进吗？立即适合设备？很可能会导致假肢行业的变化。 公共卫生相关性：IFIT假肢我们公司的目标是以传统制造设备的成本的一小部分创建和商业化模块化，立即拟合的跨义假体系统。我们的产品将使用最新的注射成型技术和高级材料生产，这些技术以成本的一小部分复制金属强度。该系统将立即适合残留的肢体，并在没有专门工具或设施的情况下对准最佳步态。我们针对此II阶段项目的原型采用后输入扣系统，该系统可以轻松适应不同的残留肢体形状和尺寸。这样的系统将使由于成本高而无法容易获得的贫困国家中的截肢者以及经济高级国家的截肢者需要插座调整以适应形状和体积变化。这种创新的，高度功能的替代方案是当前假肢制造状态的巨大潜力o推动了全球截肢者的生活质量，并改变了假肢康复领域。