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.

摘要 植入式高通道电子设备与中央和 周围神经系统已经持续了几十年的努力，涵盖了广泛的范围， 应用.可靠且经过临床验证的高通道解决方案， 适合于在耳蜗或听觉神经中使用的电子器件迄今为止还没有 被证明。 该项目旨在开发和翻译一种新型的临床高（60-128）通道植入式 可编程刺激器（IPS），用于耳蜗（CI）和听神经（ANI）植入物， 扩展可用参数空间（电极数量、音调范围、较低刺激阈值） 远远超过目前的限制。在本项目中，我们将评估性能、生物相容性和安全性 一种新的长期植入式can和可编程刺激器，具有高通道馈通 以及用于高通道耳蜗和听觉神经植入物的组件， 高密度犹他州倾斜电极阵列（HD-USEA）。HD-USEA用于穿透 新型颅内听觉假体中的听觉神经电极， 神经途中的脑干，以大大提高听力性能超过 当前标准治疗，人工耳蜗植入体（CI）（NIH 1UG 3 NS 107688 -01）。临床可行性 在人类受试者中的价值将在一种新的高通道听觉假体中得到证明， 根据现有的UG 3/UH 3资助开发用于人类受试者。目前的做法是 然而在使用潜在的高得多的电极通道数的能力方面受到限制， 由于传统的有限的信道计数（12）， （MED-EL同步）CI刺激器。虽然这种方法是UG 3/UH 3项目的优势， 将现有临床验证产品整合到一个新系统中，速度最快，风险最低 在人类演示的第一条道路上，它在使用HD的独特能力方面存在福尔斯不足， USEA架构或其他更高通道Cl电极。