Clinical Demonstration of Implantable Myoelectric Sensors for Prosthesis Control

描述（由申请人提供）：该生物工程研究合作伙伴关系（BRP）的主要目标是在人类截肢者中使用我们的植入式肌电传感器（IMES）系统演示上肢假肢控制。在这个为期五年的项目期结束时，我们计划实现我们的长期愿景，展示假肢手的个人手指控制。限制复杂的手/手臂假肢发展的主要因素仍然是难以定位和隔离足够数量的命令源，利用这些命令源来控制生理上自然的假肢手和/或手臂所需的许多自由度。虽然表面肌电（SEMG）传感已经用于控制临床部署的肌电上肢假肢，使用多个表面EMG信号作为命令源固有地受到表面EMG信号的粗糙性质和缺乏稳定性的限制。我们相信，我们可以通过使用IMES而不是SEMG电极来创建更多的EMG控制部位。我们以前的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，并在动物模型中证明该系统的慢性功能。这些目标已经实现。为了实现我们在人体内植入IMES的新目标并证明增强的假体控制，我们需要对IMES系统进行进一步的技术开发和人体试验。本BRP提案的具体目标是：1）优化IMES系统以与临床可展开假体连接：修改IMES植入物、IMES-TC和多自由度假体控制器，开发临床医生工具以设计患者线圈。2)IMES硬件的鉴定测试和FDA批准：IMES植入物、外部IMES硬件和MDOF控制器的鉴定;在人体临床试验中使用IMES的FDA IDE申请的准备和提交。3)IMES系统在人体中的植入和测试：第1阶段-证明IMES系统可替代经桡截肢者中标准经桡肌电手假体的SEMG控制;第2阶段-证明IMES系统和多自由度控制器可协调经桡截肢者中假肢手的单个手指和拇指的自主运动。

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.