Therapeutic Intermittent Compression Socket

描述（由申请人提供）：向血管障碍截肢患者提供快速间歇性压迫（IC）治疗，应通过增加流向残肢的血流减少再次截肢的次数。增加肢体的灌注将限制溃疡形成并促进溃疡愈合。患者依从性已被证明是重要的成功结果与IC治疗。因此，本项目的长期目标是开发一种可集成到假肢接受腔中的快速IC器件。将加压装置集成到插座中将允许用户接受IC治疗，而无需每天被限制在椅子上六个小时，并且因此将增加患者的依从性，并且使得能够以预防性方式执行治疗。减少再次截肢的数量将通过阻止进一步的肢体丧失来维持患者的生活质量，肢体丧失对一些功能和心理社会变量产生负面影响。此外，在一半的大截肢手术中，术后发病率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17亿美元用于对经胫骨和经股骨截肢者进行再截肢手术。通过IC治疗减少再截肢的发生率，我们希望改善患者的生活质量，并满足NIH通过生物医学研究改善人类健康的使命。该项目的目的是确定开发一种既能模仿当前商业设备又能集成到假肢接受腔中的致动器的可行性。该项目的一个目标是开发一种致动器，该致动器能够产生类似于当前商业设备中产生的压力，同时符合重量和功耗要求。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，响应快，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工残肢。模拟残肢将使我们能够量化目前的商业系统以及将在此努力下开发的设备施加到残肢的压力。这种仪器化肢体可能会使用商业现成的传感器技术，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风险之中。最终的目标是与当地的假肢合作，将致动器集成到假肢接受腔中，并使用仪器化假肢，以确保我们满足我们的压力，重量和功耗目标。 公共卫生相关性：本项目的目的是开发一种装置，为肢体血流不佳的截肢者的残肢提供快速间歇性压迫。该装置将内置于假肢接受腔中，为使用者提供全天便携式治疗，这将使使用者不必每天被限制在椅子上长达六小时接受建议的治疗量。这种装置将减少形成的溃疡数量，帮助那些形成的溃疡愈合，并通过增加肢体中的血流来减少需要进行的截肢手术的数量，这不仅有助于降低成本，在美国，每年花费17亿美元，通过维持截肢者的功能状态，接受进一步的手术

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.