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: 10011251
• 负责人: Robert Jay Greenberg
• 金额: $ 22.12万
• 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 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10011251
• 关键词: Acoustic Nerve; Adoption; Aging; Animal Model; Architecture; Auditory Prosthesis; Brain Stem; Chronic; Clinical; Cochlear Implants; Cochlear Nerve; Communities; Data; Development; Devices; Diagnostic; 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; Wireless Technology; base; biomaterial compatibility; brain computer interface; clinical research site; density; falls; first-in-human; human subject; improved; in vivo; neural implant; neuroregulation; nonhuman primate; novel; phase 2 designs; programs; standard of care; voltage

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 与中枢神经系统接口的植入式高通道电子器件的开发 周围神经系统是几十年来不断努力的领域，涵盖了广泛的领域 应用程序。可靠且经过临床验证的高通道解决方案，采用气密封装 迄今为止，还没有适用于耳蜗或听觉神经的电子设备 已被证明。 该项目旨在开发并转化一种新型临床高（60-128）通道植入式 可编程刺激器 (IPS)，用于耳蜗 (CI) 和听觉神经 (ANI) 植入物 扩展可用参数空间（电极数量、音调范围、较低刺激阈值） 远远超出目前的限制。在这个项目中，我们将评估性能、生物相容性和安全性 具有高通道馈通的新型长期植入罐和可编程刺激器 以及用于高通道耳蜗和听觉神经植入物的组件，该植入物使用 高密度犹他倾斜电极阵列 (HD-USEA)。 HD-USEA 用作穿透 一种新型颅内听觉假体中的听神经电极，以听觉为目标 通往脑干的神经，以显着提高听力表现 目前的护理标准是人工耳蜗 (CI) (NIH 1UG3NS107688-01)。临床可行性 人类受试者的价值将在新型高通道听觉假体中得到体现 根据现有的 UG3/UH3 拨款开发用于人类受试者。目前的做法是 然而，使用可能更高的电极通道数的能力受到限制，并且 由于传统的通道数（12）有限，随后的色调范围和分辨率 （MED-EL 同步）CI 刺激器。虽然这种方法是 UG3/UH3 项目的优势， 将现有经过临床验证的产品整合到一个新系统中，作为最快且风险最低的系统 在迈向人类演示第一的道路上，它在使用 HD-的独特功能方面存在不足。 USEA 架构或其他更高通道 CI 电极。