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结束时，我们计划实现我们的长期愿景，展示假肢手的单个手指控制。限制复杂手/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指令源，以控制生理上自然的假手和/或手臂所需的许多自由度。虽然表面肌电（SEMG）传感已被用于控制临床部署的肌电上肢假肢，但由于表面肌电信号的粗大性质和缺乏稳定性，使用多个表面肌电信号作为命令源本身就受到限制。我们相信，通过使用IMES电极而不是表面肌电信号电极，我们可以创建更多的肌电控制位点。我们之前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。这些目标都实现了。为了实现我们在人体植入IMES和展示增强假体控制的新目标，我们的IMES系统需要进一步的技术发展和人体试验。本BRP提案的具体目标是：1)优化IMES系统与临床可展开假体的接口：修改IMES种植体，IMES- tc和多自由度假体控制器，开发临床医生工具为患者设计线圈。2) IMES硬件的资质测试和FDA批准：IMES植入物、外部IMES硬件、MDOF控制器的资质；3) IMES系统在人体中的植入和测试：第一阶段- IMES系统在经桡骨截肢者中作为标准护理经桡骨肌电假肢表面肌电信号控制的替代品的演示；第二阶段-演示IMES系统和mof控制器协调假肢的单个手指和拇指的意志运动在桡骨截肢者。

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.