Immediate fit using innovative technology, transtibial prosthetic system

描述（由申请人提供）：假肢我们的目标是创造一个“套件中的胫骨假体”，可以使用现代技术和先进的聚合物材料廉价制造。该系统将立即安装在残肢上，并在没有专门工具或实验室的情况下调整为最佳步态。这样的系统减轻了许多步骤涉及到传统的假体建设，这是昂贵的和劳动密集型。拟建假肢系统的主要市场是贫困的第三世界国家。这种系统的市场很大，包括外国医疗保健组织和部委、世界卫生组织和经常支持人道主义任务的美国军方。二级市场是在经济较发达的国家，当肢体大小和形状发生变化时，截肢者的早期康复。由于创伤和血管异常疾病引起的胫骨截肢是我国和世界范围内最常见的截肢手术，也是本项目的重点。我们与高级设计概念（ADC）工程公司的四年合作至今在开发我们的初步原型设计方面取得了相当大的成功。与本研究的主要商业利益“iFIT Prosthetics， LLC”的持续合作将使我们能够开发第二代假肢系统。在这个项目中，我们的目标是；i)根据我们的经验设计和制造下一代原型跨胫义肢系统，并使用截肢者焦点小组进行消费者输入，ii)通过生物力学测试和定量调查对10名志愿者进行试点可行性研究，以及iii)导出最终原型并使用有限元分析对其进行重新测试，为ISO测试和商业化做准备。这个STTR项目的结果可能会改变不发达国家提供下肢假体的方式。先进的材料和制造技术使下肢假肢领域受益匪浅。这样的创新对于促进这些个体康复的科学和实践有着相当大的希望。

DESCRIPTION (provided by applicant): Prosthetics Our goal is to create a "transtibial prosthesis in a kit" that can be inexpensively manufactured using modern technology and advanced polymer materials. This system will be immediately fit on the residual limb and aligned for optimal gait without specialized tools or labs. Such a system alleviates the many steps involved with conventional prosthesis construction which is costly and labor intensive. The primary market for the proposed prosthetic system is impoverished third world countries. The market for such a system is large and consists of foreign healthcare organizations and ministries, the World Health Organization, and the U.S. Military which frequently supports humanitarian missions. A secondary market is in the early rehabilitation of amputees when the limb is changing size and shape in more economically advanced nations. Transtibial amputations due to trauma and dysvascular diseases are the most commonly performed levels of amputation in this country and worldwide and are the focus of this project. Our four year collaboration with Advanced Design Concepts (ADC) engineering firm has been quite successful to date in developing our preliminary prototype design. Continued collaboration with the principal business interest in this study, "iFIT Prosthetics, LLC" will enable us to develop the second generation prosthetic system. In this project, our aims are; i) to design and build the next generation prototype transtibial prosthetic system building on our experience and using a focus group of amputees for consumer input, ii) to conduct a pilot feasibility study on 10 volunteer subjects using biomechanics testing and quantitative surveys, and iii) to derive a final prototype and retest it using finite element analyses in preparation for ISO testing and commercialization. The results of this STTR project could change the way in which lower limb prostheses are provided in underdeveloped nations. The field of lower limb prosthetics can benefit greatly from advanced materials and fabrication techniques. Such innovations hold considerable promise to advance the science and practice of rehabilitation for these individuals. PUBLIC HEALTH RELEVANCE: Prosthetics Our company's goal is to create a "transtibial prosthesis in a kit" that can be inexpensively manufactured using modern technology and advanced polymer materials. This system will be immediately fit on the residual limb and aligned for optimal gait without specialized tools or facilities. Such a system will benefit amputees in impoverished countries as well as amputees in economically advanced nations. This innovative, highly-functional alternative to the current state of prosthetic fabrication holds great potential to advance the quality of life for amputees worldwide.