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

用于假体感觉反馈的超低功耗无线植入刺激器

• 批准号: 7167163
• 负责人: DAVID J EDELL
• 金额: $ 14.79万
• 依托单位: INNERSEA TECHNOLOGY, INC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7167163
• 关键词: amputation; biomedical equipment development; clinical research; electromyography; functional ability; human subject; implant; limbs; microelectrodes; neuromuscular stimulator; portable biomedical equipment; prosthesis; quality of life; sensory feedback; telemetry

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.

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。该项目旨在开发微型按钮状刺激器模块（OptiStims），可植入皮下，以提供基于皮肤电的感觉反馈。组件的机械特性将与皮肤的机械特性相似，以确保稳定性和舒适性。这些OptiStim将是超低功率（几微瓦）单通道器械，由假体外壳中的发射器单独RF供电和光控传输。刺激器电路基于专有的创新设计，采用InnerSea Technology过去15年开发的植入式EMG遥测技术概念。由于模块化设计，刺激器可以放置在任意位置，以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容易地结合到目前可用的肌电臂中。第1阶段系统将使用分立元件制造。它将由一个刺激器包装组成，该刺激器包装带有一个由薄的柔性硅胶包围的连接同心环电极。在第2阶段，将开发集成电路，以便刺激器电子平台（ca，2x2 mm）可以与电极组件合并，以实现直径约为6 mm、厚度约为2 mm的微小、柔软的圆盘结构。皮下植入将是一个简单的门诊手术。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通信策略的有效性。所设想的反馈系统代表了一种比外周神经的电接口侵入性小得多的方法。同时，皮下刺激提供了优于使用表面电极或振动器的非侵入性皮肤通信策略的几个优点。这些包括更好的刺激定位和更一致的感觉，无论是在感觉的质量和其感知强度。更一致的感觉源自对与表面电极相关联的皮肤表面耦合参数的变化的更大免疫力，所述表面电极包括位置、水合程度、毛孔和接触压力。最初将针对的感觉信息包括：抓握力、物体滑动和手腕。第1阶段的具体目标是开发OptiStims，并在1例配备功能性2通道感觉反馈系统的肘下截肢受试者中证明该方法的可行性。项目简介：在SBIR第二阶段的资助下，正在开发一种植入式EMG遥测仪。与Phase II OptiStim一起，将有可能使用稳定的EMG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。假肢的功能将得到加强，以改善退伍军人和平民截肢者的生活质量和就业机会。