Regulatory clearance of the Glide Control Strategy for Upper Limb Prostheses

上肢假肢滑动控制策略的监管许可

基本信息

批准号：
10603007
负责人：
Rahul Reddy Kaliki
金额：
$ 87.33万
依托单位：
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-05-17 至 2026-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10603007
关键词：
Affect Amputees Architecture Artificial Arm Calibration Caring Clinical Clinical Research Data Development Devices Documentation Electrodes Engineering Ensure Experimental Designs Goals Healthcare Individual Intuition Joystick Limb Prosthesis Location Marketing Measurement Measures Medical Medical Device Methods Motion Movement Myoelectric prosthesis Occupational Therapist Outcome Participant Patients Pattern Recognition Performance Phase Positioning Attribute Production Productivity Prosthesis Prosthetic rehabilitation Provider Quality of life Questionnaires Radial Rehabilitation Outcome Rehabilitation therapy Research Specific qualifier value System Technology Testing United States Food and Drug Administration Upper Extremity Validation Work clinical care clinically relevant commercialization design evidence base experience fabrication functional outcomes grasp home test improved individual patient innovation limb loss myoelectric control novel prosthesis control prosthetic hand rehabilitative care residual limb satisfaction usability vector verification and validation

项目摘要

Regulatory clearance of the Glide Control Strategy for Upper Limb Prostheses ABSTRACT There is a pressing need to improve control of myoelectric prostheses for individuals with upper limb loss (ULL). To date, only two fundamental control methods have been made commercially available – Direct Control (DC, introduced in 1960) and Pattern Recognition (PR, introduced in 2016). Both have significant limitations, as outlined within the proposal. Thus, we propose a new control method called Glide. The Glide architecture does not use ‘triggers’ to switch between different grasps like DC systems, nor does it require frequent ‘recalibration’ like PR systems. Instead, it combines the simplicity of DC with the functionality of PR. It is based on effecting joystick-style motions of the residual limb to move a “Glide cursor” to specific locations within a circular region called the “Glide domain.” The Glide cursor position is determined by the resultant of the vector summation of two to eight EMG channels (depending on individual patient’s needs), where each of the electrode channels are spaced at equal angular distances apart from each other on the Glide domain. To date, we have 1) developed the controller hardware; 2) iteratively developed the control strategy and user interface with direct involvement of clinicians and individuals with ULL; and 3) evaluated a total of nine individuals with trans-radial ULL including seven who completed long-term in-home testing. Of note, our experience now includes one individual who has been using the system for two and half years and counting. We now propose to commercialize the novel Glide control strategy and enable accessibility to the widest group of patients possible. We propose two aims to accomplish these goals. The first aim is a regulatory aim, where we will complete the Verification and Validation of the system and submit a 510(k) for regulatory approval. The second aim is a scientific aim, where we will evaluate the hypothesis that use of Glide results in improved functional, satisfaction and usage metrics as compared to use of a standard DC prosthesis. An important benefit of this aim, presuming the results are favorable, is that it will provide strong support for reimbursement. If we are successful, we will have met our dual mandate – to improve usability of upper limb prostheses, while simultaneously increasing real-world access to advanced prosthetic technologies.

上肢假肢滑动控制策略的监管许可抽象的迫切需要改善上肢丧失（ULL）患者对肌电假肢的控制。迄今为止，只有两种基本控制方法已实现商业化——直接控制（DC、（1960 年推出）和模式识别（PR，2016 年推出）都有很大的局限性，因为提案中概述。因此，我们提出了一种新的控制方法，称为 Glide。Glide 架构不使用“触发器”来进行切换。它不像 DC 系统那样在不同的抓握之间进行切换，也不像 PR 系统那样需要频繁的“重新校准”。它结合了 DC 的简单性和 PR 的功能。它基于实现操纵杆式运动。残肢将“滑动光标”移动到称为“滑动域”的圆形区域内的特定位置。滑动光标位置由 2 至 8 个 EMG 通道矢量求和的结果确定（取决于个别患者的需求），其中每个电极通道以相等的角度间隔滑翔域上彼此相距的距离。迄今为止，我们已经1）开发了控制器硬件；2）迭代开发了控制策略和用户。超级巨星和 ULL 个人的直接参与；3) 总共评估了 9 个人经径向 ULL 包括七名完成长期家庭测试的人，我们现在的经验。其中包括一名已经使用该系统两年半并且还在继续增加的人。我们现在建议将新颖的 Glide 控制策略商业化，并让最广泛的群体能够使用我们提出了两个目标来实现这些目标，其中第一个目标是监管目标。我们将完成系统的验证和确认，并提交 510(k) 供监管部门批准。第二个目标是科学目标，我们将评估使用 Glide 可以改善结果的假设与使用标准 DC 假体相比，功能、满意度和使用指标是一个重要的优势。假设结果良好，这一目标的目的是为报销提供强有力的支持。如果我们成功了，我们将完成我们的双重使命——提高上肢假肢的可用性，同时同时增加现实世界获得先进假肢技术的机会。