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: 8399277
• 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/8399277
• 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; public health relevance; 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! PUBLIC HEALTH RELEVANCE: Reducing the functional consequences of limb loss has long been a major focus of the VA Rehabilitation Research and Development Service. Recently, more than 1000 soldiers have returned from current operations in Iraq and Afghanistan with amputations, and the VA RR&D Service has prioritized research to make prostheses capable of providing function approaching pre-injury levels. Advanced prostheses that nearly match the mechanical performance of natural human arms are beginning to emerge from federal research projects and from commercial manufacturers, but the way that users control these prostheses is still too awkward and unreliable. This project will develop a new approach that will allow amputees to control their prostheses in essentially the same way they would control their natural arm. This new system will be surgically implanted, so nothing other than the prosthesis will have to be put on during use, and the quality of control it provides will always be the same. This system could eventually work with almost any myoelectric or powered prosthesis.

描述(由申请人提供)： 该项目将导致在3名退伍军人中部署一个完全植入的肌电信号(MES)采集系统，该系统用于控制横径(肘下)截肢患者的先进灵巧假手和手腕。基于时延神经网络和概率自适应滤波器的新型MES控制器算法选择性地抑制意外运动命令，将允许对先进假肢提供的多个运动进行同时和连续控制。植入的MES采集系统将使用一系列新的设备，包括植入的电池、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采集系统将从肢体中任何剩余的肌肉提供高度选择性和高度可重复性的MES记录，即使是那些位于肢体深处或不直接位于插口下方的肌肉。植入的肌肉内电极可以为任何肌肉调整大小，将牢固地固定在肌肉内，并且不需要使用者佩戴任何东西。植入的MES采集系统将使用行业标准的MedRadio协议，与安装在假肢上的小型外部“集线器”进行无线通信。外部集线器接收MES信号，执行新的MES控制器算法，然后与假肢的控制总线接口，以命令其各种关节运动。控制器算法最初将使用临时细丝EMG电极记录和一个虚拟假肢模拟器来开发，在该模拟器中，10名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有所不同，以确定哪些肌肉为控制提供最佳的MES信号，最终系统需要多少肌肉，以及估计最终系统的预期性能。同时，外部枢纽将使用内置MedRadio遥测的小型商业设备和用于实施先进控制器算法的微控制器来实现，并将获得监管批准(食品和药物管理局和当地机构审查委员会的调查设备豁免)。永久系统(植入MES系统、具有先进控制算法的外部集线器、灵巧的商用上肢肌电假体)将在3名横断性截肢患者身上集成和实现。广泛的技术评估将展示系统组件的性能。一组广泛的临床评估将比较用户的“标准护理”假肢控制系统(通常是基于表面肌电信号的记录和状态控制器)的功能性能与在该项目下开发的新的植入式MES-高级控制器算法方法的功能性能。拟议的工作与退伍军人康复研究和发展服务的战略计划直接一致，是对美国国防高级研究计划局(DARPA)和几家商业假肢制造商最近开发的复杂和灵活的上肢假体的极好补充。建议的全植入MES采集系统和先进的控制器算法将提供更丰富的命令信息，以实现这些先进的上肢假体的潜力。虽然最初是针对经桡关节截肢的患者，但这种相同的基本方法(即，植入带有先进控制器的MES)在未来也广泛适用于其他退伍军人截肢人群，包括经股骨截肢、部分手截肢、肩关节脱位和下肢截肢患者。靶向肌肉神经重建(TMR)是另一种先进的假体控制方法，也可以通过使用这里提出的技术大大增强。因此，拟议的系统有可能真正革命性地改变假肢医生和假肢使用者对肌电控制的看法！ 公共卫生相关性： 减少肢体丧失的功能后果长期以来一直是退伍军人康复研究和发展服务的主要重点。最近，1000多名士兵从伊拉克和阿富汗的当前行动中带着截肢回来，退伍军人管理局已经优先进行研究，使假肢能够提供接近受伤前水平的功能。联邦研究项目和商业制造商正开始研发出接近自然人类手臂机械性能的先进假肢，但使用者控制这些假肢的方式仍然过于笨拙和不可靠。这个项目将开发一种新的方法，允许截肢者控制他们的假肢，基本上就像他们控制他们的自然手臂一样。这一新系统将通过外科手术植入，因此在使用过程中，除了假体之外，不需要佩戴其他任何东西，而且它提供的控制质量永远是相同的。该系统最终可以用于几乎任何肌电或电动假肢。