Clinical Demonstration of Implantable Myoelectric Sensors for Prosthesis Control

描述(申请人提供)：生物工程研究伙伴关系(BRP)的主要目标是展示在人类截肢者身上使用我们的植入式肌电传感器(IMES)系统进行上肢假肢控制。到这个五年的项目期结束时，我们计划实现我们的长期愿景，即演示假手的个人手指控制。限制复杂手/臂假体发展的主要因素仍然是定位和隔离足够数量的指令源以控制生理上自然假手和/或手臂所需的多个自由度。虽然表面肌电信号传感已被用于临床部署的肌电上肢假体的控制，但多个表面肌电信号作为指令源的使用固有地受到表面肌电信号的粗略性质和缺乏稳定性的限制。我们相信，通过使用IMES而不是表面肌电信号电极，我们可以创建更多的肌电控制点。我们之前的BRP的主要目标是开发一种基于植入式肌电传感器(IMES)的肌电控制系统，并在动物模型中展示该系统的慢性功能。这些目标已经实现。为了实现IMES植入人体的新目标并展示增强的假体控制，我们的IMES系统和人体试验将需要进一步的技术开发。这项BRP建议的具体目标是：1)优化IMES系统与临床可展开假体的接口：修改IMES植入物、IMES-TC和多自由度假体控制器，开发临床医生工具来为患者设计线圈。2)IMES硬件的资格测试和FDA的批准：IMES植入物、外部IMES硬件和MDOF控制器的资格鉴定；准备和提交FDA在人体临床试验中使用IMES的IDE申请。3)IMES系统在人体上的植入和测试：第一阶段--演示IMES系统作为肌电表面肌电信号的替代物在经尺截肢患者中的应用；第二阶段--IMES系统和多自由度控制器在经尺截肢者中协调假手单个手指和拇指的自愿运动的演示。

DESCRIPTION (provided by applicant): The primary goal of this Bioengineering Research Partnership (BRP) is to demonstrate upper limb prosthesis control using our implantable myoelectric sensor (IMES) system in human amputees. By the end of this five year project period we plan to achieve our long term vision of demonstrating individual finger control of a prosthetic hand. The major factor limiting the development of sophisticated hand/arm prostheses remains the difficulty in locating and isolating sufficient numbers of command sources with which to control the many degrees-of-freedom required for a physiologically natural prosthetic hand and/or arm. While surface myoelectric (SEMG) sensing has been used for control of clinically-deployed myoelectric upper-limb prostheses, the use of multiple surface EMG signals as command sources is inherently limited by the gross nature, and lack of stability, of surface EMG signals. We believe that we can create many more EMG control sites by using IMES rather than SEMG electrodes. The primary goals of our previous BRP were to develop a myoelectric control system based upon implantable myoelectric sensors (IMES) and to demonstrate chronic functioning of this system in an animal model. These goals were accomplished. To achieve our new goal of implantation of IMES in humans and demonstration of enhanced prosthesis control, further technical development of our IMES system and human trials will be required. The specific aims for this BRP proposal are: 1) Optimization of the IMES System to Interface with Clinically Deployable Prostheses: Revise the IMES implant, IMES-TC, and multi-degree-of-freedom prosthesis controller, develop clinician tools to design coils for patients. 2) Qualification Testing of IMES Hardware and FDA Approval: Qualification of IMES Implants, External IMES Hardware, and MDOF Controller; Preparation And Submission Of FDA IDE Application For Use Of IMES In A Human Clinical Trial. 3) Implantation And Testing of The IMES System in Humans: Phase 1 - Demonstration of the IMES System as a Substitute For SEMG Control Of Standard-Of-Care Transradial Myoelectric Hand Prostheses In Transradial Amputees; Phase 2 - Demonstration of the IMES System and MDOF Controller Coordinating Volitional Movements of The Individual Fingers And Thumb of A Prosthetic Hand In Transradial Amputees.