Fully implanted system for upper limb myoelectric prosthesis control

用于上肢肌电假肢控制的全植入系统

• 批准号: 8976762
• 负责人: Robert F. Kirsch
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-10-01 至 2017-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8976762
• 关键词: Acute; Afghanistan; Algorithms; Amplifiers; Amputation; Amputees; Biological Neural Networks; Boxing; Classification; Clinical assessments; Communication; Complement; Development; Devices; Elbow; Electrodes; Evaluation; FPS-FES Oncogene; Family; Forearm; Future; Hand; Human; Hybrids; Implant; Implantation procedure; Individual; Industry; Injury; Institutional Review Boards; Intervention; Intramuscular; Iraq; Joints; Limb Prosthesis; Limb structure; Lower Extremity; Manufacturer Name; Mechanics; Medical center; Methods; Motion; Movement; Muscle; Myoelectric prosthesis; Operative Surgical Procedures; Paired Comparison; Participant; Pattern Recognition; Performance; Population; Prosthesis; Protocols documentation; Quality Control; Radial; Recruitment Activity; Rehabilitation Research; Rehabilitation therapy; Research; Research Personnel; Research Project Grants; Services; Shoulder; Signal Transduction; Soldier; Strategic Planning; Surface; Surgical Disarticulation; System; Techniques; Telemetry; Testing; Time; Training; United States Food and Drug Administration; Upper Extremity; Upper arm; Veterans; Work; Wrist; advanced system; analog; arm; base; design; digital; experience; implantable device; myoelectric control; neuroprosthesis; novel; novel strategies; operation; powered prosthesis; prosthesis control; prosthesis wearer; prosthetic hand; reinnervation; research and development; research study; standard of care; virtual; virtual reality

DESCRIPTION (provided by applicant): This project will result in the deployment of a fully implanted myoelectric signal (MES) acquisition system in 3 veterans that is used to control advanced dexterous prosthetic hands and wrists for individuals with transradial (below elbow) amputations. A novel MES controller algorithm based on a time-delayed neural network and a probabilistic adaptive filter that selectively suppresses unintended movement commands will allow simultaneous and continuous control of the multiple motions provided by the advanced prosthesis. The implanted MES acquisition system will use a new family of devices that include an implanted battery, implanted amplifiers and analog-to-digital converters, and an implanted telemetry system. This implanted MES acquisition system will provide highly selective and highly repeatable MES recordings from any remaining muscle in the limb, even those located deep within the limb or not located directly underneath the socket. The implanted intramuscular electrodes can be sized for any muscle, will be firmly anchored within the muscles, and do not require any donning by the user. The implanted MES acquisition system will communicate wirelessly with a small external "hub" that is mounted inconspicuously on the prosthetic limb using the industry standard MedRadio protocol. The external hub receives the MES signals, implements the new MES controller algorithm, and then interfaces with the control bus of the prosthesis to command its various joint motions. The controller algorithm will be initially developed using temporary fine-wire EMG electrode recordings and a virtual prosthesis simulator in which 10 amputee participants will perform simulated functional tasks. The muscle signals used in these experiments will be varied to determine which muscles provide the best MES signals for control, how many muscles will be needed in the final system, and to estimate the expected performance of the final system. In parallel, the external hub will be realized using a small commercial device with built-in MedRadio telemetry and a microcontroller for implementing the advanced controller algorithm, and regulatory approvals (Investigational Device Exemption from the Food and Drug Administration and local Institutional Review Board) will be obtained. The permanent system (implanted MES system, external hub with advanced control algorithm, dexterous commercial upper limb myoelectric prosthesis) will then be integrated and realized in 3 individuals with transradial amputations. Extensive technical assessments will demonstrate the performance of the system components. An extensive battery of clinical assessments will compare the functional performance of the user's "standard of care" prosthesis control system (typically surface EMG-based recordings with a state controller) to that of the new implanted MES - advanced controller algorithm approach developed under this project. The proposed work is directly aligned with the strategic plan of the VA Rehabilitation Research and Development Service and is an excellent complement to the recent development of sophisticated and dexterous upper limb prostheses by the Defense Advanced Research Projects Agency (DARPA) and by several commercial prosthesis manufacturers. The proposed fully-implanted MES acquisition system and advanced controller algorithm will provide the much richer command information needed to realize the potential of these advanced upper limb prostheses. Although initially targeted to individuals with transradial amputations, this same basic approach (i.e., implanted MES with advanced controller) is broadly applicable to other veteran amputee populations in the future, including transhumeral, partial hand, shoulder disarticulation, and lower extremity amputees. Targeted muscle reinnervation (TMR), another advanced prosthesis control approach, could also be greatly enhanced by the use of the techniques proposed here. The proposed system thus has the potential to truly revolutionize the way that prosthetists and prosthesis users think about myoelectric control!

描述（由申请人提供）： 该项目将导致在3名退伍军人中部署完全植入的肌电信号（MES）的采集系统，用于控制跨性别（肘部）截肢的人的高级灵性假肢手和手腕。一种基于时间删除的神经网络和概率自适应过滤器的新型MES控制器算法，该算法有选择地抑制意外运动命令，将允许同时且连续控制高级假体提供的多个动作。植入的MES采集系统将使用新的设备系列，其中包括植入电池，植入的放大器和模数转换器以及植入的遥测系统。这种植入的MES采集系统将提供高度选择性且高度可重复的MES记录，这些记录来自肢体中的任何剩余肌肉，甚至在肢体内部或不直接位于插座下方的肌肉中。植入的肌内电极可以针对任何肌肉进行尺寸，将牢固地固定在肌肉中，并且不需要用户戴任何肌肉。植入的MES采集系统将使用行业标准Medradio协议在假肢上无关的小型外部“集线器”进行无线通信。外部枢纽接收MES信号，实现新的MES控制器算法，然后与假体的控制总线接口以指挥其各种关节运动。 控制器算法最初将使用临时的Fine-Wire EMG电极记录和虚拟假体模拟器开发，其中10位截肢者将执行模拟的功能任务。这些实验中使用的肌肉信号将变化，以确定哪些肌肉为控制提供了最佳的MES信号，最终系统中需要多少肌肉以及估计最终系统的预期性能。同时，将使用带有内置MEDRADIO遥测的小型商业设备来实现外部枢纽，以及用于实施高级控制器算法的微控制器，并获得监管批准（研究性设备免除食品药物管理局和地方机构审查委员会的豁免）。永久系统（植入的MES系统，具有高级控制算法的外部枢纽，灵巧的商业上肢肌电假体）将在3个具有跨性别截肢的人中进行集成和实现。广泛的技术评估将证明系统组件的性能。大量的临床评估将比较用户“护理标准”假体控制系统（通常是基于EMG的录音与状态控制器）的功能性能与本项目开发的新植入的MES -Advanted MES-高级控制器算法方法的功能性能。 拟议的工作直接与VA康复研究与开发服务的战略计划保持一致，并且是国防高级研究项目局（DARPA）以及几家商业假体制造商的最新发展和灵敏的上肢假体的最新发展。拟议的完全植入的MES采集系统和高级控制器算法将提供更丰富的命令信息，以实现这些高级上肢假体的潜力。尽管最初针对具有跨性截肢的个体，但这种基本方法（即带有高级控制器的植入MES）将来广泛适用于其他资深截肢者种群，包括经性的，部分手，肩膀，肩膀脱落和下肢截肢者。另一种先进的假体控制方法的靶向肌肉重新支配（TMR）也可以通过此处提出的技术大大增强。因此，拟议的系统有可能真正彻底改变假肢和假肢用户对肌电控制的方式！