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，以解决截肢者普遍存在的一个严重问题：假肢下的热量和汗水积累。截肢者通常会在残肢上方和假体下方佩戴由硅胶或类似材料制成的柔性衬垫，以提供填充并改善舒适性。衬垫的主要缺点是它隔绝了肢体，创造了一个非常温暖的环境，导致出汗过多。过热和过多的汗水通常会导致皮疹、起泡和假肢滑脱。活动截肢者必须定期摘除假体和衬垫，以清除累积的汗水。这些因素会限制截肢者的运动动机，从而对康复产生负面影响。JHU技术包括一个冷却衬垫，它取代了目前在假体下穿戴的衬垫。冷却衬里嵌入了管子，通过管子抽出冰水来冷却肢体并减少汗水。如果开发成功，这种产品将有可能显著改善截肢者的生活，使他们更容易使用假肢和进行运动，同时减少由于假体下过热和汗水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学中心与JHU接洽，为截肢者的高温和汗水问题开发解决方案。这使得JHU机械工程系的学生创造了一种制造方法，将冷却液管嵌入硅胶衬里，使冷却液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，储存在储液器(如腰包)中，储液器中也有循环泵。这种班轮在沃尔特里德对美国陆军老兵截肢者的初步测试中被发现是有效的。最初的产品以经胫骨截肢为目标，这是最常见的形式。在美国，大约有35万名经胫骨截肢者安装了假肢，据估计，在最大渗透率下，冷却假肢衬垫在这个市场的销售额有可能达到2500万美元/年或更高。Cool Stede最近从马里兰州创新倡议获得了10万美元的资金，用于继续原型开发。该团队相信，i-Corps计划将使团队能够从截肢者、假肢修复者、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。答案应该帮助团队了解a)商业潜力；b)微小或彻底的设计更改的必要性；c)定价结构；d)开发和商业化计划；e)可能需要转向截肢者的不同产品，以解决发热/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.