Equilibrium Socket System - ESS

描述(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，疼痛的发作将导致不使用假体。体重的昼夜、月经和其他波动会导致假体舒适性和功能的显著变化。因此，由接受腔体积决定的接受腔适合度的相对质量在肢体丧失患者的日常生活中是最受关注的。拟议工作的目标是在第一阶段取得明显成功的基础上，开发一种用于下肢假体的平衡接受腔系统(ESS)。Orthocare创新团队进行的第一阶段工作成功地证明了一种方法，该方法可以开发成临床上相关的、商业上可行的系统，用于动态调整假体插座。虽然插座体积和真空悬浮系统都是以前开发出来的，但所采取的方法往往相互矛盾，有时甚至违背正常的生理变化。ESS的独特之处在于，通过一个简单的机构，结合了自主和用户可调的动态音量调节水平，再加上静音、动态调整的真空悬挂系统。该系统将允许修复师和患者以一种适应正常音量波动的方式来控制插座音量的变化和悬挂。这项技术将使患者能够通过直接控制基于他们感觉的调整来更充分地参与。在拟议的工作中，我们将从第一阶段吸取的经验教训中设计和构建最终系统，评估人体受试者的性能和可行性，与受试者和临床假体同事一起审查结果，并将最终设计过渡到制造。 公共卫生相关性：该项目将通过创建一个动态和自动调整的截肢插座接口来改善假体的适合性和功能。这项技术将允许假体使用者快速、轻松地调整假体适合度，并以比目前可能的方式更精确地控制。

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.