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

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

• 批准号: 10388466
• 负责人: Daphna Raquel Raz
• 金额: $ 4.06万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 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/10388466
• 关键词: Address; Adopted; Adoption; American; Amputation; Amputees; Area; Artificial Leg; Back Pain; Behavior; Benchmarking; Biological; Certification; Characteristics; 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; Institutes; 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; System; Techniques; Testing; Thigh structure; Torque; Training; Universities; Validation; Volition; Walking; Work; ankle prosthesis; base; career; clinical application; cluster computing; computing resources; design; falls; human subject; improved; insight; kinematics; mathematical algorithm; meetings; novel; patient mobility; powered prosthesis; programs; prosthesis wearer; rehabilitation research; simulation; sound; technology development; time interval; tool

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. Gregg 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.

抽象的 坐姿过渡，个人执行的动议站起来或坐下，是一个重要的确定者 整体流动性和跌倒的共同来源。使用标准的被动假体的单方面截肢者是 由于肌肉和关节不对称而导致的静坐过渡进一步挑战，它们在声音之间暴露 截肢的侧面，通常导致背痛。有动力的膝盖假肢可以产生 足够的扭矩可以在坐姿过渡期间有意义协助，并且可以符合设计标准，例如 在截肢侧产生平稳的运动，与声音侧匹配。这些假肢的控制者 可以设计以允许用户驱动的腿控制。但是，高扭矩的生产不是直接的 用户指挥的风险增加。这是特别关心的，因为这些腿一定是 在受控实验室环境之外采用。那，任何电力假体都必须明显地符合设计 和安全标准。虽然关键的安全医疗设备（例如太空制造商）受到广泛的影响 测试和验证程序，在有能力的假肢领域中没有达成协议的标准 定义和衡量安全性。先前关于坐姿控制器的工作仅重点是测量有限的数量 关于少数受试者的一个设计标准的结果，没有保证 安全。称为正式验证的一组技术提供了强大的工具来推理行为 由相互作用的机械，软件和生物模块组成的系统。给定一个模型 系统，正式验证使我们能够在无限的可能性范围内探究系统的行为 在典型的测试会话中无法在实验室中复制。这些方法然后可以指导现实世界 测试和警报系统设计人员对执行的问题区域。在这个项目中，我建议申请 正式的验证技术，设计具有可证明安全性的静坐过渡的自愿控制器 保证使用基于物理的模型和新型的安全数学公式。 密歇根大学机器人学院是美国同类领域的顶级研究所之一，并提供了 成功完成这项研究的理想环境和基础设施。机器人学院步态 实验室拥有动力假体研究所需的所有必要设备，包括两个最先进的设备 假肢，并获得高级计算资源，例如大湖高性能 计算集群。博士。 Gregg和Ozay已证明与该项目的目标相关的专业知识，并将 提供指导我的研究，培训和实现我的职业目标的精神训练。