Microelectrode Array Insertion System using Ultrasonic Vibration to Improve Insertion Mechanics, Reduce Tissue Dimpling and Trauma, and Improve Placement Precision in the Neocortex

使用超声波振动的微电极阵列插入系统改善插入力学，减少组织凹陷和创伤，并提高新皮质的放置精度

• 批准号: 10021212
• 负责人: Maureen L. Mulvihill
• 金额: $ 149.6万
• 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 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10021212
• 关键词: Amputees; Animal Model; BRAIN initiative; Brain; Caliber; Cell Death; Chronic; Cicatrix; Clinical; Collaborations; Communication; Communities; Complex; Coupling; Data; Development; Devices; Dura Mater; Electrodes; Engineering; Equipment Malfunction; Exhibits; Feedback; Foreign Bodies; Frequencies; Goals; Hemorrhage; Human; Image; Implant; Implantation procedure; Implanted Electrodes; Incidence; Individual; Inflammation; Location; Magnetic Resonance Imaging; Manuals; Marketing; Mechanics; Medical; Medical Research; Methods; Microelectrodes; Motion; Neocortex; Neurologic; Neurons; Neurosciences Research; Operative Surgical Procedures; Outcome; Paraplegia; Patient Care; Penetration; Peripheral Nervous System; Phase; Polymers; Property; Proprioception; Prosthesis; Rattus; Resolution; Risk; Sales; Sensory; Shapes; Silicon; Site; Small Business Innovation Research Grant; Speed; Structure; Surface; System; Technology; Testing; Tissues; Trauma; Tungsten; Ultrafine; Ultrasonics; Validation; Work; base; brain machine interface; carbon fiber; commercialization; cranium; density; design; extracellular; flexibility; grasp; implantation; improved; improved outcome; in vivo; innovation; millimeter; minimally invasive; motor control; neural implant; neurotransmission; nonhuman primate; novel; pre-clinical; preservation; prosthesis control; relating to nervous system; response; success; tissue trauma; tool; two-photon; verification and validation; vibration

This Phase II SBIR further develops and tests a system that employs ultrasonic vibration to improve the insertion mechanics for multichannel penetrating electrode arrays. This proposal is in response to PA-18-871 BRAIN Initiative: Development, Optimization, and Validation of Novel Tools and Technologies for Neuroscience Research – including ‘Iterative refinement of such tools and technologies with the end-user community’. The long-term goal of Actuated Medical, Inc. is to develop technology enabling accurate placement of penetrating neural electrode arrays at target locations with minimal tissue trauma and displacement, ultimately paving the way for clinical use of neural implants. Penetrating neural implants provide direct access to extracellular neural signals across the central and peripheral nervous systems with both high temporal and spatial resolution. Unfortunately, the implantation of neural electrode arrays, commonly comprised of numerous closely spaced shanks, applies forces to neural tissue resulting in significant compression (dimpling), prohibiting uniform shank insertion, and increasing the risk of trauma, bleeding and inflammation at the implant site. These issues can increase the chronic foreign body response (FBR) leading to neural cell death, glial scaring, and device failure. Phase I demonstrated the ability to releasably grip and deliver ultrasonic vibration to a range of commercially available implant types, including floating-style arrays, resulting in reductions of insertion force and surface dimpling in bench studies of up to 80-90% for most implants tested. In vivo, ultrasonic vibration significantly reduced brain surface dimpling (~50%, p<0.01) and exhibited evidence of reduced bleeding, while preserving device function as evidenced by post implant neural recordings. Furthermore, preliminary work suggests significant potential for the ultrasonic vibration to improve insertion of ultrafine (8-15 µm) microwire arrays, as well as NeuroNexus’ Matrix platform arrays, one of the most delicate and complicated commercially-available implants. This Phase II SBIR expands use of the NeuralGlider inserter for inserting complex, fragile, and flexible penetrating neural electrode arrays using ultrasonic vibration to reduce insertion force, brain surface dimpling, tissue damage, and bleeding. The project uses a unique multi-institutional collaboration to obtain scientific data, supporting the benefits of the NeuralGlider insertion technology. Phase II hypothesis: Ultrasonic micro-vibration improves insertion accuracy and success, reduces insertion trauma, and improves recording outcomes for penetrating neural electrode arrays. Specific Aims: Aim 1 - Evaluate implantation trauma and inflammation response through 2-photon imaging and magnetic resonance imaging. Aim 2 - Demonstrate efficacy of NeuralGlider insertion approach for ultra-fine, ultra-high-density electrode array designs. Aim 3 - Integrate end user feedback, design upgrades for coupling options, and conduct Verification and Validation. Aim 4 - Demonstrate improved outcomes with micro-vibrated insertion.

第二阶段SBIR进一步开发和测试了一种采用超声波振动的系统