Immediate fit using innovative technology, transtibial prosthesis

描述（由申请人提供）：我们公司的目标是以传统制造设备的一小部分成本创建并商业化模块化，即时适配的跨骨假体系统。我们的产品将大量生产使用最新的注射成型技术与先进的材料，复制金属的强度在成本的一小部分。该系统将立即安装在残肢上，并在没有专门工具或设施的情况下对齐最佳步态。这款先进的原型机采用了一个使用扣环系统的新插座。类似于滑雪靴？有一个后入口面板，允许微调，以优化适合和舒适。到目前为止，我们的新设计得到了受试者的好评，生物力学测试显示步态模式与使用传统设备的人相似。第一阶段的目标和目的已经完全实现，我们展示了立即适配义肢的可行性。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设备。一个独立的经胫骨假体系统，立即适合并提供高水平的舒适性和功能性。我们与高级设计概念（ADC）及其工程团队的合作在开发我们当前的产品方面非常成功。这项研究的主要商业利益“iFIT假肢有限责任公司”在主要研究者（Dillingham博士）的指导下，已经做好了实施第二阶段项目目标的准备。这个提议的两年项目将把我们的原型产品推向市场、销售和商业化的阶段。这个第二期项目的具体目标有三个方面。首先，我们将测试30位单侧经胫截肢者在更高强度的活动水平下，评估我们设备的舒适度、易用性和稳定性。其次，ADC工程将制作金属模板，用于注塑我们的原型，然后生产50个胫骨假体。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将开发基于网络的销售能力，并为使用我们产品作为商业化计划一部分的义肢专家提供教育材料。这种设备在国际和美国的市场相当大。我们未来的客户有很多，包括；1)来自贫困国家的截肢者，对他们来说，传统的制造和假肢装配成本过高；2)截肢后不久或因心脏和肾脏疾病而残肢体积发生变化的截肢者；3)正在成长并需要可调节、舒适的假肢的儿童截肢者。目前，市场上还没有像我们这样的商用设备。我们的产品将以相对于标准假肢的相当大的成本优势推出，但同样舒适和功能。iFIT假肢的概念正在进步？即时适配设备？很可能会导致义肢行业的变革。

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.