Equilibrium Socket System - ESS

描述（由申请人提供）：假肢的配合度在很大程度上决定了使用者的功能。在极端情况下，疼痛的契合会导致假体无法使用。体重的昼夜、月经和其他波动会导致假肢的舒适度和功能发生明显变化。因此，在肢体丧失者的日常生活中，由关节窝体积决定的关节窝配合的相对质量是最重要的。本研究的目标是建立在第一阶段成功的基础上，开发一种用于下肢假体的平衡关节窝系统（ESS）。Orthocare Innovations团队进行的第一阶段工作已经成功地验证了一种方法，该方法可以发展成为临床相关的、商业上可行的动态调整假体插槽系统。虽然之前已经开发了套孔容积和真空悬浮系统，但所采用的方法通常是相互矛盾的，有时会违背正常的生理变化。ESS的独特之处在于，它结合了自主和用户可调的动态音量调节水平，使用一个简单的机制，再加上一个安静的，动态调节的真空悬挂系统。该系统将允许假体医生和患者以一种适应正常体积波动的方式控制窝体积的变化和悬浮。这项技术将使患者能够根据自己的感受直接控制调整，从而更充分地参与其中。在拟议的工作中，我们将根据第一阶段的经验教训设计和构建最终的系统，评估人体受试者的性能和可行性，与临床假肢的受试者和同事一起审查结果，并将最终设计过渡到制造。

DESCRIPTION (provided by applicant): The fit of a prosthesis determines the function of the user to a great degree. In the extreme, a painful fit will result in non-use of the prosthesis. Diurnal, menstrual and other fluctuations in body weight lead to noticeable changes in comfort and function of a prosthesis. As a consequence, the relative quality of socket fit determined by socket volume is of paramount concern in the daily lives of persons with limb loss The objective of the proposed work is to build on the demonstrably successful Phase I effort to develop an Equilibrium Socket System (ESS) for Lower Limb Prostheses. The Phase I work undertaken by the Orthocare Innovations team has resulted in identification successful demonstration of an approach that can be developed into a clinically relevant, commercially viable system for dynamically adjusting prosthesis sockets. While both socket volume, and vacuum suspension systems have been developed previously, the approaches taken often work against each other and sometimes against normal physiological change. The unique feature of the ESS is that combines both autonomous and user adjustable level of dynamic volume accommodation using a simple mechanism, coupled with a silent, dynamically adjusting vacuum suspension system. The system will allow both the prosthetist and the patient to control socket volume changes and suspension in a way that accommodates normal volume fluctuation. The technology will enable the patient to participate more fully by directly controlling adjustments based on what they feel. In the proposed work, we will design and build the definitive system from the lessons learned in Phase I, evaluate performance and feasibility with human subjects, review the results with the subjects and colleagues in clinical prosthetics, and transition the final design to manufacture. PUBLIC HEALTH RELEVANCE: This project will improve the fit and function of prostheses by creating a dynamically and automatically adjusting socket interface with the amputated limb. The technology will allow the prosthesis user to adjust the firmness of the fit of their prosthesis quickly, easily, and in a more precisely controlled manner than is currently possible.