Development of an AMF Orion/Blackrock HD-USEA based 60/128 channel implantable wireless simulator system for human auditory nerve implants

开发基于 AMF Orion/Blackrock HD-USEA 的 60/128 通道植入式无线模拟器系统，用于人类听觉神经植入

• 批准号: 10470963
• 负责人: Robert Jay Greenberg
• 金额: $ 72.82万
• 依托单位: BLACKROCK MICROSYSTEMS
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10470963
• 关键词: Acoustic Nerve; Adoption; Aging; Animal Model; Architecture; Auditory Prosthesis; Brain Stem; Chronic; Clinical; Cochlear Implants; Cochlear Nerve; Communities; Data; Development; Devices; Electrodes; Electronics; Epilepsy; Funding; Grant; Hearing; Human; Implant; Implanted Electrodes; In Vitro; Insurance; Lead; Life Expectancy; Mechanics; Medical Device; Metals; Modeling; Ocular Prosthesis; Operative Surgical Procedures; Orphan; Performance; Peripheral; Peripheral Nerves; Peripheral Nervous System; Phase; Publishing; Reproducibility; Research; Resolution; Retina; Risk; Route; Safety; Sterilization; Study Subject; System; Technology; Testing; Time; Translating; United States National Institutes of Health; Utah; Vision; Visual Cortex; base; biomaterial compatibility; brain computer interface; clinical research site; density; diagnostic strategy; falls; first-in-human; human subject; improved; in vivo; neural implant; neuroregulation; nonhuman primate; novel; phase 2 designs; programs; standard of care; voltage; wireless

Abstract The development of implantable high channel electronics interfacing with the central and peripheral nervous system has been a continuing effort for decades covering a wide range of applications. Reliable and clinically proven high channel solutions with hermetic encapsulation of the electronics that would be suitable for the use in a Cochlear or auditory nerve have so far not been demonstrated. The project aims to develop and translate a novel clinical high (60-128) channel implantable programmable stimulator (IPS) for use in Cochlear (CI) and auditory nerve (ANI) implants to expand the useable parameter space (electrode count, tonal range, lower stimulation threshold) far beyond current limits. In this project we will evaluate performance, biocompatibility and safety of a new chronically implantable can and programmable stimulator with high channel feedthrough and assembly for the use in a high channel cochlear and auditory nerve implant that uses the high-density Utah Slant Electrode Array (HD-USEA). The HD-USEA is used as penetrating auditory nerve electrode in a new type of intracranial auditory prosthesis that targets the auditory nerve en route to the brainstem in order to substantially improve hearing performance over the current standard of care, the cochlear implant (CI) (NIH 1UG3NS107688-01). Clinical feasibility and value in human subjects will be demonstrated in a new high channel auditory prosthesis being developed for use in human subjects under an existing UG3/UH3 grant. The current approach is however limited in the ability to use the potentially far higher electrode channel count and subsequent tonal range and resolution due to the limited channel count (12) of the conventional (MED-EL Synchrony) CI stimulator. While this approach is a strength of the UG3/UH3 project that combines existing clinically proven products into one new system as the fastest and lowest risk path towards first in human demonstration, it falls short in using the unique capabilities of the HD- USEA architecture or other higher channel CI electrodes.

抽象的 植入高通道电子与中央和 几十年来，周围神经系统一直是持续的努力，涵盖了广泛的范围 申请。可靠且临床证明的高通道解决方案，并具有密封封装 适合在人工耳蜗或听觉神经中使用的电子设备迄今没有 被证明了。 该项目旨在开发和翻译新型的临床高（60-128）通道可植入 可编程刺激器（IPS）用于耳蜗（CI）和听觉神经（ANI）植入物 扩展可用的参数空间（电极计数，音调范围，较低的刺激阈值） 超出了当前限制。在这个项目中，我们将评估性能，生物相容性和安全性 具有高通道进料的新的慢性植入罐和可编程刺激器 和用于在高道通道的人工耳蜗和听觉神经植入物中使用的组装 高密度犹他州倾斜电极阵列（HD-USEA）。 HD-USEA用作穿透 一种新型的颅内听觉假体中的听觉神经电极，该假体针对听觉 神经在通往脑干的途中，以实质上提高听力表现 当前的护理标准，人工耳蜗（CI）（NIH 1UG3NS107688-01）。临床可行性 人类受试者的价值将在新的高渠道听觉假体中证明 开发用于在现有的UG3/UH3赠款下用于人类受试者。当前的方法是 但是，使用潜在的较高电极通道计数的能力有限，并且 由于传统的频道计数有限（12），随后的音调范围和分辨率 （MED-EL同步）CI刺激器。虽然这种方法是UG3/UH3项目的优势 将现有的临床验证产品结合到一个最快和最低风险的新系统中 在人类示范中迈出了第一条的道路，它使用了HD-的独特功能，这是不足的 USEA架构或其他高级通道CI电极。