Equilibrium Socket System - ESS

描述（由申请人提供）：假体的适合性在很大程度上决定了使用者的功能。在极端情况下，疼痛的配合将导致不使用假体。体重的昼夜、月经和其他波动会导致假体的舒适度和功能发生明显变化。因此，插座体积确定的插座适合的相对质量是最重要的关注，在日常生活中的人与肢体损失的目标，拟议的工作是建立在证明成功的第一阶段的努力，开发一个平衡插座系统（ESS）下肢假体。Orthocare Innovations团队开展的第一阶段工作已经成功证明了一种方法，该方法可以开发成一种临床相关的、商业上可行的系统，用于动态调整假体承窝。虽然之前已经开发了插座体积和真空悬挂系统，但所采取的方法通常相互对抗，有时甚至对抗正常的生理变化。ESS的独特之处在于，它使用简单的机制结合了自主和用户可调节的动态容积调节水平，再加上安静的动态调节真空悬挂系统。该系统将允许修复师和患者以适应正常体积波动的方式控制接受腔体积变化和悬挂。该技术将使患者能够更充分地参与，根据他们的感受直接控制调整。在拟议的工作中，我们将从第一阶段的经验教训中设计和构建最终的系统，评估人类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。 公共卫生相关性：该项目将通过创建与截肢的动态和自动调节的承窝接口来改善假肢的适合性和功能。该技术将允许假体使用者快速、容易地并且以比目前可能的方式更精确控制的方式来调整其假体的配合的硬度。

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.