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

• 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
• 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

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儿童保育补充申请。下面的信息是为 原件。 摘要 坐-立转换，即个人站立或坐下的动作，是一种重要的 总体机动性的决定因素和跌倒的共同来源。单侧截肢者使用标准 由于肌肉和关节的原因，被动假体进一步受到坐立转换的挑战 它们在健侧和截肢侧之间表现出不对称性，通常导致虚弱 背部疼痛。动力型膝关节-脚踝假体可以产生足够的扭矩来有意义地辅助 在坐-立转换期间，可以满足设计标准，例如在 与声音侧匹配的截肢侧。这些假肢的控制器可以设计成 以允许用户驱动对腿的控制。但是，高扭矩的产生不是直接的 由用户指挥会带来更大的风险。这一点特别值得关注，因为这些 必须在受控的实验室环境之外采用腿。因此，任何动力假体都必须 明显符合设计和安全标准。而对安全至关重要的医疗设备，如 起搏器，要经过广泛的测试和验证程序，没有商定的- 关于如何定义和测量安全性的电动假肢领域的标准。前期工作 只专注于衡量有限数量的结果 在少数几个主题上只有一个设计标准，没有提供安全保证。这个 一组称为形式验证的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 模块。在给定系统模型的情况下，形式化验证允许我们探测系统的行为 在实验室中无法在典型测试中复制的无限可能性 会议。然后，这些方法可以指导实际测试，并提醒系统设计人员 有问题的执行区域。在这个项目中，我建议应用正式的验证技术 为了设计一种具有可证明的安全保证的坐立转换的意志控制器，使用 基于物理的模型和新的安全数学公式。 密歇根大学机器人研究所是美国同类机构中最顶尖的机构之一， 为顺利完成这项研究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电动假肢所需的所有必要设备 研究，包括两个最先进的假肢，以及访问先进的计算 五大湖高性能计算集群等资源。Umberger博士和Ozay博士 具有与此项目目标相关的已被证明的专业知识，并将提供将 指导我的研究，我的训练，以及我的职业目标的实现。