I-Corps: Cool Stride : Novel Technology to Improve Amputees Prosthetic Wearing

该项目旨在开发约翰霍普金斯大学（JHU）的技术，以解决截肢者常见的严重问题：假肢下的热量和汗水积聚。截肢者通常在残肢上和假肢下佩戴由硅树脂或类似材料制成的柔性衬里，以提供衬垫并提高舒适度和贴合度。内衬的主要缺点是它使肢体绝缘，创造了一个非常温暖的环境，导致过度出汗。过热和过度出汗通常会导致皮疹、起泡和假体从肢体上滑落。活跃的截肢者必须定期取出假体和内衬，以去除积聚的汗液。 这些因素可能会限制截肢者锻炼的动力，从而对康复产生负面影响。 JHU技术包括一个冷却内衬，它取代了目前在假体下磨损的内衬。 冷却内衬具有嵌入式管道，通过该管道泵送冰水以冷却肢体并减少出汗。 如果研发成功，这款产品有可能显著改善截肢者的生活，使他们更容易使用假肢和锻炼，同时减少因假肢下过热和出汗而导致的皮肤损伤和其他问题的可能性。沃尔特里德国家军事医疗中心与JHU合作，为截肢者的过热和出汗问题开发解决方案。 这使得JHU机械工程系的学生创造了一种制造方法，将冷却剂管嵌入硅胶衬里中，以便冷却剂流体可以在肢体周围循环，降低皮肤温度和汗液产生。 冷却剂是冰水，其储存在还包含循环泵的储液器（例如腰包）中。 这种衬垫在沃尔特里德的美国陆军退伍军人截肢者的初步测试中被发现有效。最初的产品针对经胫骨截肢，这是最常见的形式。美国约有350，000名经胫骨截肢者安装假肢，据估计，该市场的冷却假体内衬销售额在最大渗透率下可能达到2500万美元/年或更高。酷大步最近获得了10万美元的资金，从马里兰州创新计划，以继续原型开发。 该团队认为，I-Corps计划将使该团队能够从截肢者、假肢专家、报销和监管顾问那里获得关于这些以及关于拟议产品的未知问题的反馈。 这些答案应有助于团队了解a）商业潜力; B）微小或根本设计变更的需求; c）定价结构; d）开发和商业化计划;以及e）可能需要转向一种截然不同的产品，以解决截肢者的热量/汗水问题。

This project aims to develop technology from Johns Hopkins University (JHU) to address a common and serious problem for amputees: heat and sweat build-up under their prosthetic limb. Amputees typically wear a flexible liner made of silicone or similar material over the residual limb and under their prosthesis to provide padding and improve comfort and fit. The main drawback of the liner is that it insulates the limb, creating a very warm environment leading to excess sweating. Overheating and excessive sweat often results in rashes, blistering, and the prosthesis sliding off the limb. Active amputees must regularly remove their prosthesis and liner to remove the sweat that has accumulated. These factors can limit the motivation of amputees to exercise, thus negatively impacting rehabilitation. The JHU technology comprises a cooling liner which replaces the current liner worn under the prosthesis. The cooling liner has embedded tubing through which ice water is pumped to cool the limb and reduce sweat. If successfully developed this product has the potential to significantly improve the lives of amputees, making it easier for them to use their prosthesis and to exercise, while reducing the potential for skin damage and other problems that result from excess heat and sweat under the prosthesis.Walter Reed National Military Medical Center approached JHU to develop a solution for amputees' heat and sweat problems. This led students in JHU's Mechanical Engineering Department to create a manufacturing method to embed coolant tubes into a silicone liner, so that coolant fluid can be circulated around the limb, reducing skin temperature and sweat production. The coolant is ice water, which is stored in a reservoir (e.g. a waist pack) which also contains the circulating pump. This liner was found to be effective in preliminary tests on US Army Veteran amputees at Walter Reed. The initial product targets transtibial amputation, the most frequent form. There are approximately 350,000 transtibial amputees in the US who have prosthetic limbs and it is estimated that sales of the cooled prosthetic liner in this market have the potential to reach $25M/year or more at maximum penetration. Cool Stride was recently awarded $100,000 in funding from the Maryland Innovation Initiative to continue prototype development. This team believes that the I-Corps program will allow the team to generate feedback from amputees, prosthetists, reimbursement and regulatory consultants on these, as well as yet unknown issues, regarding the proposed product. The answers should help the team understand a) commercial potential; b) the need for minor or radical design changes; c) pricing structure; d) development and commercialization plan, and e) possible need to pivot towards a distinctly different product to solve amputee heat/sweat issues.