Immediate fit using innovative technology transtibial prosthesis

描述(由申请人提供)：我们公司的目标是创造一种模块化的、立即适合的、经胫骨假体系统并将其商业化，成本仅为传统制造设备的一小部分。我们的产品将采用最新的注塑成型技术进行批量生产，采用先进的材料，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，并在没有专门工具或设施的情况下对齐以获得最佳步态。先进的原型结合了一个新的插座，使用了扣子系统？类似于滑雪靴？带有后部进入面板，允许精细调整，以优化贴合和舒适性。到目前为止，我们的新设计受到了受试者的好评，生物力学测试显示了与传统设备相似的步态模式。第一阶段的目标和目的完全实现了，我们证明了即刻适配假体的可行性。现在需要第二阶段的资金来全面测试、开发我们的新型设备并将其商业化--一种立即适合并提供高水平舒适性和功能性的自给式经胫骨假体系统。我们与高级设计概念公司(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极大的成功。这项研究的主要商业利益“iFit Prosthetics，LLC”已经做好准备，在主要研究人员(Dillingham博士)的指导下实现这一第二阶段项目的目标。这个提出的为期两年的项目将使我们的原型产品达到营销、销售和商业化的地步。这一第二阶段项目的具体目标有三个。首先，我们将测试30名单侧经胫骨截肢者，在更剧烈的行走水平下，评估我们的设备的舒适性、易用性和稳定性。其次，ADC工程公司将制造金属模板，用于注塑我们的原型，然后生产50个经胫骨假体。第三，ADC工程公司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将为假肢医生开发基于网络的销售能力和教育材料，这些假肢医生将使用我们的产品作为商业化计划的一部分。这种设备在国际上和美国的市场都很大。我们未来的客户很多，包括：i)来自贫困国家的截肢者，对他们来说，传统的制造和假体装配的成本令人望而却步；ii)截肢者在截肢后不久或由于心脏和肾脏疾病而经历残肢容量变化；iii)儿童截肢者正在成长，需要可调节、舒适的假体。目前，市场上还没有像我们这样的商业设备。与标准假体相比，我们的产品将以相当大的成本优势推出，但同样具有舒适性和功能性。IFit假体的概念正在进步？即刻修复设备？很可能导致假肢行业的变化。 与公共健康相关：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，创造一种模块化的、立即适合的经胫骨假体系统并将其商业化。我们的产品将采用最新的注塑成型技术进行批量生产，采用先进的材料，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，并在没有专门工具或设施的情况下对齐以获得最佳步态。我们的这个第二阶段项目的原型使用了一个后部进入扣系统，可以很容易地调整到不同的残肢形状和大小。这种系统将使贫困国家的截肢者受益，因为贫困国家的传统设备由于成本高而难以获得，以及经济发达国家的截肢者，他们需要插座调整以适应形状和体积的变化。这种创新的、功能强大的假体制造替代方案具有巨大的潜力，可以提高世界各地截肢者的生活质量，并改变假肢康复领域。

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.