Neural Implant Insertion System using Ultrasonic Vibration to Reduce Tissue Dimpling and Improve Insertion Precision of Floating Arrays in the Neocortex

使用超声波振动的神经植入物插入系统减少组织凹陷并提高新皮质中浮动阵列的插入精度

• 批准号: 9565293
• 负责人: Maureen L. Mulvihill
• 金额: $ 37.85万
• 依托单位: ACTUATED MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2019-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9565293
• 关键词: Achievement; Amputees; Animal Experimentation; Award; BRAIN initiative; Blood specimen; Brain; Cell Death; Chronic; Cicatrix; Communities; Coupling; Craniotomy; Custom; Development; Devices; Electrodes; Electronics; Engineering; Enteral Feeding; Equipment Malfunction; Foreign Bodies; Goals; Hemorrhage; Human; Implant; Implanted Electrodes; Inflammation; Legal patent; Manuals; Medical; Medical Research; Methods; Microelectrodes; Motion; Neocortex; Neurons; Neurosciences; Neurosciences Research; Paraplegia; Patient-Focused Outcomes; Performance; Peripheral Nervous System; Phase; Primates; Procedures; Proprioception; Prosthesis; Research; Research Personnel; Research Project Grants; Resolution; Risk; Rodent; Sales; Series; Site; Small Business Innovation Research Grant; Societies; Speed; System; Technology; Testing; Tissues; Transducers; Trauma; Ultrasonics; United States National Institutes of Health; Validation; base; brain machine interface; clinical application; commercialization; density; extracellular; implantation; improved; in vivo; innovation; meetings; motor control; neural implant; neurotransmission; nonhuman primate; novel; pre-clinical research; relating to nervous system; response; success; tissue trauma; tool; verification and validation; vibration

This Phase I SBIR develops and tests a system for vibrating neural implant floating arrays during insertion to reduce insertion force, dimpling, tissue damage, and bleeding. The approach will allow precise insertion of electrode shanks into shallow cortical layers. This proposal is in response to PAR-15-091 BRAIN Initiative: Development, Optimization, and Validation of Novel Tools and Technologies for Neuroscience Research. Problem to be solved: Penetrating electrode arrays provide direct access to neural signals across the central and peripheral nervous system with high spatial resolution. Sophisticated floating array implants may revolutionize treatment for a range of medical conditions, including prosthetic motor control and proprioception for amputees, and brain-machine interfacing for paraplegics. Unfortunately, implantation of floating arrays, which are commonly comprised of numerous high-density electrode shanks, applies forces to neural tissue resulting in substantial compression (dimpling). This dimpling often prohibits uniform shank insertion, increases trauma and bleeding at the implant site and may accentuate glial scaring, neural cell death, and device failure. Current insertion procedures for high-density floating arrays employ high-speed and/or pneumatic insertion systems or manual insertion, which can cause significant bleeding and tissue damage. This project develops an Ultrasonic Precision Insertion system for Floating Arrays (UPIND-FA) to reduce insertion force, tissue dimpling and damage, ultimately enhancing electrode placement accuracy and functionality. Hypothesis: Ultrasonic vibration of high-density neural electrode floating arrays (FAs) will reduce dimpling to facilitate complete insertion of all electrode shanks without requiring advancement beyond target depth (overshoot), reduce Foreign Body Response (FBR) due to insertion trauma and improve electrode performance, as compared to non-vibrated and/or high-speed insertion (i.e., Commercial pneumatic inserter). Aim 1: Development of UPIND-FA for insertion of FAs, with minimized dimpling and insertion force, and easy release. Acceptance Criteria. >70% reduction in tissue dimpling and insertion force compared to non-vibrated insertion; improved insertion accuracy (±100 μm of target depth) of all electrode shanks at shallow depths (<1000 μm) over a commercial insertion; <50 μm perturbation of FA body during release post-insertion. Aim 2: Show that UPIND-FA successfully inserts floating arrays in vivo without electrode damage. Acceptance Criteria: >70% reduction in dimpling compared to control insertion; complete insertion of all electrode shanks without target depth overshoot; significant improvement in array performance and reduction in brain FBR (p<0.05). Aim 3: Confirm UPIND-FA array insertion in vivo in a gyrencephalic neocortex significantly reduces tissue damage and brain FBR over non-vibrated and the commercial insertions. Acceptance Criteria: >70% dimpling reduction over control insertion; complete insertion of all electrode shanks without target depth overshoot, and significant (p<0.05) reduction in brain FBR compared to the commercial pneumatic inserter.

第一阶段 SBIR 开发并测试了一种系统，用于在插入神经植入物浮动阵列期间振动神经植入物浮动阵列。 减少插入力、凹陷、组织损伤和出血。该方法将允许精确插入。 该提案是为了响应 PAR-15-091 BRAIN Initiative： 神经科学研究新工具和技术的开发、优化和验证。 待解决的问题：穿透电极阵列可以直接访问中枢神经信号 和具有高空间分辨率的周围神经系统可能。 彻底改变一系列医疗状况的治疗，包括假肢运动控制和本体感觉 不幸的是，植入浮动阵列，用于截肢者和脑机接口。 通常由许多高密度电极柄组成，向神经组织施加力 导致显着的压缩（凹陷），这种凹陷通常会阻碍柄部的均匀插入，并增加。 植入部位的创伤和出血，可能会加剧神经胶质疤痕、神经细胞死亡和装置故障。 当前高密度浮动阵列的插入程序采用高速和/或气动插入 系统或手动插入，这可能会导致严重出血和组织损伤。 用于浮动阵列的超声波精密插入系统 (UPIND-FA)，可减少插入力、组织 凹痕和损坏，最终提高电极放置精度和功能。 假设：高密度神经电极浮动阵列（FA）的超声波振动将减少凹陷 促进所有电极柄的完全插入，无需前进超出目标深度 （过冲），减少由于插入创伤引起的异物反应（FBR）并改善电极 与非振动和/或高速插入（即商用气动插入器）相比。 目标 1：开发用于插入 FA 的 UPIND-FA，具有最小化的凹痕和插入力，并且易于使用 与非振动相比，组织凹陷和插入力减少 >70%。 插入；提高所有电极柄在浅深度的插入精度（目标深度 ±100 μm） (<1000 μm) 超过商业插入；插入后释放期间 FA 体的扰动<50 μm。 表明 UPIND-FA 成功将浮动阵列插入体内，且没有电极损坏。 标准：与所有电极柄完全插入相比，凹痕减少 >70%； 无目标深度超调；显着改善阵列性能并降低大脑 FBR (p<0.05)：确认 UPIND-FA 阵列在脑环新皮质中的体内插入显着。 与非振动和商业插入相比，组织损伤和脑 FBR 验收标准：>70%。 控制插入时的凹痕减少；完全插入所有电极柄而无目标深度 与商用气动插入器相比，大脑 FBR 出现过冲和显着（p<0.05）降低。