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器械的一小部分成本创建并商业化模块化、即时适配、经胫骨假体系统。我们的产品将采用最新的注塑成型技术和先进的材料进行大规模生产，这些材料可以以一小部分的成本复制金属的强度。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进行最佳步态调整。先进的原型结合了一个新的插座，使用扣系统？类似于滑雪靴子吗后部入口面板可进行微调，以优化贴合度和舒适度。到目前为止，我们的新设计受到了受试者的好评，生物力学测试显示步态模式与传统器械相似。第一阶段的目标和目的完全达到了，我们证明了立即适合修复的可行性。第二阶段的资金现在是必要的，以充分测试，开发和商业化我们的新设备？一种独立的经胫骨假体系统，其立即适配并提供高水平的舒适性和功能性。我们与Advanced Design Concepts（ADC）及其工程团队的合作在开发我们当前的产品方面取得了巨大成功。本研究的主要商业利益方“iFIT Prosthetics，LLC”已做好准备，在主要研究者（迪灵厄姆博士）的指导下实现本II期项目的目标。这个为期两年的项目将使我们的原型产品达到市场营销、销售和商业化的程度。第二阶段项目的具体目标有三个方面。首先，我们将测试30名单侧经胫骨截肢者在更激烈的水平amplitude，评估舒适度，易用性和稳定性与我们的设备。其次，ADC工程将制造金属模板，用于注塑成型我们的原型，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。在进行测试和生产的同时，iFIT Prosthetics将开发基于网络的销售功能和教育材料，供将使用我们产品的假肢师作为商业化计划的一部分。该器械在国际和美国的市场相当大。我们未来的客户有很多，包括：i）来自贫困国家的截肢者，他们的传统制造和假肢安装成本过高，ii）截肢后不久或由于心脏和肾脏疾病而经历残肢体积变化的截肢者，以及iii）正在成长并需要可调节的，舒适的假肢的儿科截肢者。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体相当大的成本优势推出，但同样舒适和功能。iFIT Prosthetics的概念正在推进？即时适配设备？很可能会导致假肢行业的变革。 公共卫生相关性：iFIT假体我们公司的目标是以传统制造设备的一小部分成本创造并商业化一种模块化、即时适配的经胫骨假体系统。我们的产品将采用最新的注塑成型技术和先进的材料进行大规模生产，这些材料可以以一小部分的成本复制金属的强度。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进行最佳步态调整。我们的第二阶段项目的原型采用了后入式带扣系统，可以轻松调整以适应不同的残肢形状和大小。这样的系统将使贫困国家的截肢者受益，在这些国家，由于成本高，传统设备不容易获得，以及经济发达国家的截肢者，他们需要调整接受腔以适应形状和体积的变化。这种创新的，高功能的替代目前的假肢制造状态具有巨大的潜力，以提高世界各地截肢者的生活质量和改变假肢康复领域。

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.