Ultra-low-power wireless implant stimulator for prosthesis sensory feedback

描述(由申请人提供)：项目摘要/摘要：人们普遍认为，通过提供感觉反馈，假肢的功能和用户接受度将得到改善。该项目旨在开发微小的纽扣式刺激器模块(OptiStims)，它可以植入皮下，提供基于皮肤的感觉反馈。组件的机械特性将与皮肤相似，以确保稳定性和舒适性。这些OptiStims将是超低功率(几微瓦)的单通道设备，由假体外壳中的发射器通过单独的射频供电和光学控制。刺激器电路基于一种专利的创新设计，使用了InnerSea Technology过去15年来为植入式肌电遥测开发的技术概念。由于采用模块化设计，刺激器可以放置在任意位置，形成用于反馈策略的定制空间阵列。控制和人工传感器系统将很容易地整合到目前可用的肌电手臂中。第一阶段系统将使用分立部件制造。它将包括一个刺激器组件和一个连接的同心圆环电极，周围环绕着一层薄薄的柔性硅胶。在第二阶段，将开发一种集成电路，以便刺激器电子平台(ca，2x2 mm)可以与电极组件合并，以获得直径约6 mm、厚度约2 mm的微小、柔软的圆盘结构。皮下植入将是一种简单的门诊手术。在开发用于感觉替代的电触觉系统方面，已经有大量的先前工作证明了这种交流策略的有效性。设想的反馈系统是一种比连接到周围神经的电子接口侵入性小得多的方法。同时，与使用表面电极或振动器的非侵入性皮肤通信策略相比，皮下刺激具有几个优点。这些包括更好的刺激定位和更一致的感觉，无论是感觉的质量还是感知的强度。更一致的感觉源于对皮肤表面耦合参数变化的更大免疫力，这些参数与表面电极相关，包括位置、水化程度、毛孔和接触压力。最初针对的感官信息包括：握力、物体滑动和手腕。第一阶段的具体目标是开发OptiStims，并在1肘下截肢者中展示该方法的可行性，该受试者配备了一个功能性的双通道感觉反馈系统。项目简介：在SBIR第二阶段的资助下，一种植入式肌电遥测仪正在开发中。与第二阶段的OptiSTim一起，截肢者将有可能使用稳定的肌电源进行闭环控制，并通过稳定的皮肤神经刺激进行感觉反馈。假肢的功能将得到增强，以改善退伍军人和平民截肢者的生活质量和就业机会。

DESCRIPTION (provided by applicant): Project Summary/Abstract: It is widely recognized that the functionality and user acceptance of prosthetic limbs would be improved by providing sensory feedback. This project aims to develop tiny button-like stimulator modules (OptiStims) which can be implanted subdermally to provide electrocutaneous based sensory feedback. The mechanical characteristics of the assembly will be similar to that of the skin to ensure stability and comfort. These OptiStims will be ultra-low power (a few microwatts) single channel devices that are individually RF powered and optically controlled transcutaneously from transmitters in the prosthesis shell. The stimulator circuitry is based on a proprietary, innovative design using technology concepts previously developed over the past 15 years at InnerSea Technology for implantable EMG telemetry. Because of the modular design, the stimulators can be placed in arbitrary locations to form customized spatial arrays for feedback strategies. The control and artificial sensor systems will be readily incorporated into presently available myoelectric arms. The Phase 1 system will be fabricated using discrete components. It will consist of a stimulator package with an attached concentric ring electrode surrounded by a thin flexible silicone. During Phase 2, an integrated circuit would be developed so that the stimulator electronics platform (ca, 2x2mm) could be merged with the electrode components to achieve a tiny, soft, disk structure approximately 6 mm diameter and 2mm thick. Subcutaneous implantation will be a simple outpatient procedure. There has been extensive prior work in developing electrotactile systems for sensory substitution that demonstrated the effectiveness of this communication strategy. The envisioned feedback system represents a considerably less invasive approach than electrical interfaces to peripheral nerves. At the same time, subdermal stimulation provides several advantages over non-invasive cutaneous communication strategies that use surface electrodes or vibrotactors. These include better stimulus localization and more consistent sensation both in regard to the quality of the sensation and its perceived intensity. More consistent sensation derives from greater immunity to variations in skin surface coupling parameters associated with surface electrodes including location, degree of hydration, pores, and contact pressure. Sensory information that will initially be targeted include: grasp force, object slippage and wrist. The Specific Aim of PHASE 1 is to develop the OptiStims and show the feasibility of the approach in 1 below elbow amputee subject fitted with a functional 2 channel sensory feedback system. Project Narrative: Under SBIR Phase II funding, an implantable EMG telemeter is being developed. Together with the Phase II OptiStim, it will be possible to fit amputees with closed loop control using stable sources of EMG, and feedback of sensation through stable skin neurostimulation. The functionality of prosthetic limbs will be enhanced to improve quality of life and employment opportunities for veteran and civilian amputees alike.