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

I-Corps：Cool Stride：改善截肢者假肢佩戴的新技术

• 批准号: 1640984
• 负责人: Robert Allen
• 金额: $ 5万
• 依托单位: Johns Hopkins University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-05-15 至 2016-10-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1640984&HistoricalAwards=false
• 关键词: Corps; Cool; Stride; Novel; Technology

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.

该项目旨在开发约翰霍普金斯大学（JHU）的技术，以解决截肢者面临的一个普遍而严重的问题：假肢下的热量和汗水积聚。截肢者通常在残肢上和义肢下佩戴由硅胶或类似材料制成的柔性衬垫，以提供填充物，提高舒适度和贴合度。衬垫的主要缺点是它使肢体隔绝，造成一个非常温暖的环境，导致出汗过多。过热和出汗过多往往会导致皮疹、起泡和假体从肢体上滑落。活跃的截肢者必须定期取下义肢和衬垫，以清除积存的汗液。这些因素会限制截肢者运动的动机，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面磨损的衬垫。冷却内衬内嵌了一根管子，通过管子泵送冰水来冷却肢体，减少汗水。如果研发成功，该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，同时减少因假肢下的过热和出汗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，为截肢者的热量和出汗问题开发解决方案。这促使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，这样冷却液就可以在肢体周围循环，降低皮肤温度和出汗量。冷却剂是冰水，储存在储存器（例如，腰包）中，储存器也包含循环泵。这种内衬在沃尔特里德的美国陆军截肢老兵的初步测试中被发现是有效的。最初的产品针对的是最常见的胫骨截肢。在美国，大约有35万截肢者拥有假肢，据估计，在这个市场上，冷却假肢衬垫的销售额有可能达到2500万美元/年或更高。Cool Stride最近从马里兰创新计划获得了10万美元的资金，用于继续原型开发。该团队认为，I-Corps项目将使团队能够从截肢者、义肢医生、报销和监管顾问那里获得反馈，以及关于拟议产品的未知问题。答案应该帮助团队理解a)商业潜力；B)需要进行微小或彻底的设计更改；C)定价结构；D)开发和商业化计划，e)可能需要转向一种截然不同的产品来解决截肢者的热/汗问题。