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开发并测试了一种用于在插入过程中振动神经植入物浮动阵列的系统， 减少插入力、凹陷、组织损伤和出血。该方法将允许精确插入 将电极柄插入浅皮质层。本提案是对PAR-15-091 BRAIN倡议的回应： 神经科学研究的新工具和技术的开发，优化和验证。 待解决的问题：穿透电极阵列提供了直接访问中央神经信号的途径。 和周围神经系统的高空间分辨率。复杂的浮动阵列植入物可以 革命性地治疗一系列的医疗条件，包括假肢运动控制和本体感觉 用于截肢者，以及用于截瘫患者的脑机接口。不幸的是，浮动阵列的植入， 其通常由许多高密度电极杆组成， 导致实质上的压缩（凹陷）。这种凹陷通常会阻碍均匀的柄插入， 植入部位的创伤和出血，并可能加重神经胶质瘢痕形成、神经细胞死亡和器械失效。 当前用于高密度浮动阵列的插入过程采用高速和/或气动插入 系统或手动插入，这可能导致严重出血和组织损伤。该项目开发 用于浮动阵列的超声精密插入系统（UPIND-FA），以减少插入力，组织 凹陷和损坏，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）的超声振动将减少凹陷， 便于完全插入所有电极杆，无需推进超过目标深度 （过冲），减少因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，商业气动插入器）。 目的1：开发用于插入FA的UPIND-FA，最大限度地减少凹陷和插入力， release.验收标准。与非振动相比，组织凹陷和插入力降低>70% 插入;提高了所有电极杆在浅深度处的插入精度（目标深度的±100 μm） （<1000 μm）;插入后释放期间FA体扰动<50 μm。目标二： 表明UPIND-FA成功地在体内插入浮动阵列而不损坏电极。验收 标准：与对照插入相比，凹陷减少>70%;所有电极杆完全插入 无目标深度超调;显著提高阵列性能并降低大脑FBR （p<0.05）。目的3：确认UPIND-FA阵列在脑回新皮层中的体内插入显著减少了 组织损伤和大脑FBR超过非振动和商业插入。验收标准：>70% 与对照插入相比，凹陷减少;所有电极杆完全插入，无目标深度 超调，并且与商业气动插入器相比，脑FBR显著（p<0.05）降低。