Supplement: Design and Model-Based Safety Verification of a Volitional Sit-Stand Controller for a Powered Knee-Ankle Prosthesis

补充：动力膝踝假肢自主坐站控制器的设计和基于模型的安全验证

基本信息

批准号：
10785336
负责人：
Daphna Raquel Raz
金额：
$ 0.25万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-03-01 至 2024-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10785336
关键词：
Address Adopted Adoption Agreement Algorithms American Amputation Amputees Area Artificial Leg Back Pain Behavior Benchmarking Biological Certification Characteristics Child Care Communication Communities Computer Systems Computer software Data Set Development Device Safety Device or Instrument Development Devices Dimensions Ensure Environment Equipment Exhibits Failure Feedback Force of Gravity Formulation Gait Goals High Performance Computing Hip region structure Human Individual Infrastructure Infusion Pumps Joints Knee Leg Link Literature Lower Extremity Mathematical Model Simulation Mathematics Measures Mechanics Medical Device Medical Device Safety Medical center Mentorship Methods Michigan Mission Modeling Motion Movement Muscle National Institute of Biomedical Imaging and Bioengineering National Institute of Child Health and Human Development Outcome Pacemakers Performance Phase Physics Procedures Process Production Program Development Prosthesis Public Health Quality of life Research Residual state Risk Robotics Safety Side Source Specific qualifier value System Techniques Testing Thigh structure Torque Training Universities Validation Walking Work ankle prosthesis career clinical application cluster computing computing resources design falls human subject improved insight kinematics meetings novel patient mobility powered prosthesis programs prosthesis wearer rehabilitation research simulation sound technology development time interval tool

项目摘要

Childcare supplement request for 1-F31-EB-032745-01. The information below is for the original submission. ABSTRACT Sit-stand transitions, the motions executed by individuals to stand up or sit down, are an important determinant of overall mobility and a common source of falls. Unilateral amputees using standard passive prostheses are further challenged by sit-stand transitions due to muscle and joint asymmetries they exhibit between the sound and amputated sides, often resulting in debilitating back pain. Powered knee-ankle prostheses can produce enough torque to assist meaningfully during sit-stand transitions and can meet design criteria such as producing smooth motion on the amputated side that matches the sound side. Controllers for these prostheses can be designed to allow user-driven control of the leg. However, the production of high torques not directly commanded by the user comes with increased risks. This is of particular concern because these legs must be adopted outside of controlled lab environments. Thus, any powered prosthesis must demonstrably meet design and safety criteria. While safety-critical medical devices, such as pacemakers, are subjected to extensive testing and validation procedures, there is no agreed- upon standard in the powered prosthetics field for how to define and measure safety. Prior work on sit-stand controllers has focused only on measuring a limited number of outcomes with respect to one design criterion on a small number of subjects, providing no guarantees about safety. The set of techniques known as formal verification provides powerful tools to reason about the behavior of systems that are composed of interacting mechanical, software, and biological modules. Given a model of a system, formal verification allows us to probe the system’s behavior over an infinite range of possibilities that cannot be replicated in the lab during a typical testing session. These methods can then guide real-world testing, and alert system designers to problematic regions of execution. In this project, I propose to apply formal verification techniques to design a volitional controller for sit-stand transitions with provable safety guarantees, using physics-based models and novel mathematical formulations of safety. The University of Michigan Robotics Institute is one of the top institutes of its kind in the US and provides an ideal environment and infrastructure for the successful completion of this research. The Robotics Institute gait lab has all of the necessary equipment needed for powered prosthesis research, including two state-of-the-art prosthetic legs, and access to advanced computational resources such as the Great Lakes high performance computing cluster. Drs. Umberger and Ozay have proven expertise relevant to the aims of this project, and will provide mentorship that will guide my research, my training, and the attainment of my career goals.

1-F31-EB-032745-01 的儿童保育补助金申请以下信息适用于 1-F31-EB-032745-01。原始提交。抽象的坐站转换，即个人站起来或坐下的动作，是一个重要的使用标准的整体活动能力的决定因素和单侧截肢者跌倒的常见原因。由于肌肉和关节的原因，被动假肢还受到坐站转换的进一步挑战它们在健全侧和截肢侧之间表现出不对称，常常导致衰弱动力膝踝假肢可以产生足够的扭矩来提供有意义的帮助。在坐站转换过程中，可以满足设计标准，例如在座椅上产生平滑的运动可以设计与这些假肢的健全侧相匹配的截肢侧。允许用户对腿部进行驱动控制，但不能直接产生高扭矩。用户命令会带来更大的风险，这是特别值得关注的。因此，任何动力假肢都必须在受控实验室环境之外使用。明显符合设计和安全标准，而安全关键的医疗设备，例如起搏器经过广泛的测试和验证程序，没有商定的- 根据动力假肢领域的标准来定义和衡量先前的工作。坐站控制器仅侧重于测量有限数量的结果针对少数受试者的一种设计标准，不提供安全保证。称为形式验证的一组技术提供了强大的工具来推理由相互作用的机械、软件和生物组成的系统的行为给定一个系统模型，形式化验证使我们能够探究系统的行为。在典型测试期间无法在实验室中复制的无限范围的可能性这些方法可以指导实际测试，并提醒系统设计人员注意。在这个项目中，我建议应用形式验证技术。设计一个用于坐站转换的意志控制器，并具有可证明的安全保证，使用基于物理的模型和新颖的安全数学公式。密歇根大学机器人研究所是美国同类顶尖研究所之一为本研究的成功完成提供了理想的环境和基础设施。机器人研究所步态实验室拥有动力假肢所需的所有必要设备研究，包括两条最先进的假肢，以及先进的计算能力 Umberger 和 Ozay 等资源。拥有与该项目目标相关的经过验证的专业知识，并将提供指导指导我的研究、培训和职业目标的实现。