Therapeutic Intermittent Compression Socket

描述(申请人提供)：为血管功能障碍截肢者提供快速间歇按压(IC)治疗应减少通过增加残肢血流量而进行的再截肢次数。增加肢体的灌注量既可以限制溃疡的形成，又可以促进溃疡的愈合。患者的依从性已被证明对IC治疗的成功结果很重要。因此，该项目的长期目标是开发一种可以集成到假肢插座中的快速IC设备。将压缩装置集成到插座中将使用户能够接受IC治疗，而不需要一天六个小时坐在椅子上，从而提高患者的依从性，并使治疗能够以预防性的方式进行。减少截肢次数将阻止进一步的肢体丧失，从而保持患者的生活质量，这对一些功能和心理社会变量有负面影响。此外，在一半的主要截肢手术中，术后并发症是由基础疾病引起的，据报道，手术死亡率高达17%。最后，据计算，每年花费17亿美元用于经胫骨和经股骨截肢者的截肢手术。通过IC治疗减少截肢的发生率，我们希望提高患者的生活质量，并通过生物医学研究满足NIH改善人类健康的使命。该项目的目标是确定开发一种既能模仿当前商业设备又能集成到假肢插座中的致动器的可行性。该项目的一个目标是开发一种执行器，它能够产生与当前商业设备中产生的压力类似的压力，同时遵守重量和功耗要求。为了实现这一目标，我们计划研究电活性聚合物(EAP)的使用，因为它们重量轻、反应灵敏、耗电少、能量密度高。另一个目标是开发一种装有压力传感器的人造残肢。模拟残肢将使我们能够量化目前的商业系统以及根据这一努力将开发的装置施加到残肢上的压力。这种带仪器的肢体可能会使用商用现成的传感器技术，以实现快速设计迭代，而不会在开发过程中将人类受试者置于危险之中。最终目标是与本地假肢合作，将执行器集成到假肢插座中，并使用仪表化假肢来确保我们达到压力、重量和功耗目标。 与公共卫生相关：该项目的目的是开发一种设备，为肢体血流不佳的截肢者的残肢提供快速间歇按压。该设备将被内置到假肢插座中，为用户提供全天的便携式治疗，这将使用户从每天长达六个小时的椅子上接受建议的治疗量中解放出来。这种装置将减少形成的溃疡的数量，帮助形成的溃疡愈合，并将通过增加肢体的血液流动来减少需要进行的断肢手术的数量，这不仅将有助于减少美国每年在与截肢者相关的费用上花费的17亿美元，而且还将通过保持截肢者的功能状态而不要求他们接受进一步手术来提高他们的生活质量。

DESCRIPTION (provided by applicant): Providing rapid intermittent compression (IC) therapy to persons with dysvascular amputation should reduce the number of reamputations that are performed by increasing blood flow to the residual limb. Increasing perfusion of the limb will both limit ulcer formation and promote ulcer healing. Patient compliance has been shown to be important to successful outcomes with IC therapy. Therefore, this project's long-term objective is to develop a rapid IC device that can be integrated into a prosthetic socket. Integrating the compression device into the socket will allow users to receive IC therapy without being confined to a chair for six hours a day and will thus increase patient compliance and enable the therapy to be performed in a preventative manner. Reducing the number of reamputations would maintain the quality of life of the patient by halting further limb loss, which has a negative impact on a number of functional and psychosocial variables. In addition, postoperative morbidities are caused by the underlying disease in half of major amputations and operative mortality rates as high as 17% have been reported. Finally, it has been calculated that $1.7 billion is spent annually on reamputation procedures performed on trans-tibial and trans-femoral amputees. By reducing the prevalence of reamputation though IC therapy we hope to improve the patient's quality of life and meet NIH's mission of improving human health through biomedical research. The objective of this project is to determine the feasibility of developing an actuator that can both mimic current commercial devices and be integrated into a prosthetic socket. One aim of the project is to develop an actuator that is capable of producing pressures similar to those that are created in current commercial devices while adhering to weight and power consumption requirements. To meet this goal we plan to investigate the use of electro-active polymers (EAPs) as they are light in weight, responsive, use little power and have a high energy density. Another aim is to develop an artificial residual limb that is instrumented with pressure sensors. The mock residual limb will allow us to quantify the pressures that are applied to the residual limb by both current commercial systems as well as the device that will be developed under this effort. This instrumented limb will likely use commercial-off the- shelf sensor technology to enable rapid design iterations without placing human subjects at risk during the development process. The final aim is to work with local prosthetics to integrate the actuator into a prosthetic socket and use the instrumented artificial limb to ensure that we meet our pressure, weight and power consumption goals. PUBLIC HEALTH RELEVANCE: The purpose of this project is to develop a device that provides rapid intermittent compression to the residual limb of amputees that do not have good blood flow in their limbs. The device will be built into the prosthetic socket to provide the user with portable therapy throughout the day, which will free the user from being confined to a chair for up to six hours each day to receive suggested amount of therapy. This device will reduce the number of ulcers that form, help those ulcers that do form to heal and will reduce the number of reamputation surgeries that need to occur by increasing blood flow in the limb, which will not only help to reduce the $1.7 billion that is spent each year in the United States related to but also improve the quality of life of amputees by maintaining their functional status and not requiring them to undergo further surgery.