Microfabricated Cochlear Electrode Array

项目摘要/摘要 目前的人工耳蜗植入物，虽然在使用上是有益的，但其能力是有限的，手工- 电极阵列的组装。这种繁琐的制造方法非常昂贵，非常耗费人力-- 在实施改进语音识别和语音识别的新技术方面密集和不足 音乐欣赏。替代手工组装的一种更好的选择是微制造，这是一种完全 自动化、低成本、高产量的制造流程，能够实施各种 一系列创新，包括用于保留残余听力的更小阵列大小，药物输送渠道 用于内耳健康和细胞再生，以及用于改善性能的应变计 外科手术植入。微制造是一种非常有前途的替代手工组装的方法，但还没有。 满足以下商业化要求：(1)基材必须由经过验证的、 长期可植入材料(USP VI类)，(2)电极阵列必须与 标准的外科插入技术，(3)衬底和电极部位必须能够承受 长期电刺激身体，(4)阵列必须足够长，以从尖端延伸 耳后电子设备植入皮肤下的位置，以及 (5)阵列必须具有与电馈线引脚兼容的电线 植入式人工耳蜗器(ICS)。 在第一阶段，MEMSTim表明，生产微制造耳蜗电极是可行的 可满足商业要求的医用级材料阵列(1)-(3)。的目标是 第二阶段将生产作为最小可存活产品(MVP)的耳蜗阵列 植入物制造商。MVP将满足要求(4)-(5)，并进一步改进 需求的第一阶段结果(2)。为了实现第二阶段的目标，以下具体工作如下 将实现以下目标：(目标1)制造全长微制造耳蜗阵列阵列具 集成电缆，可连接到植入式耳蜗刺激器，并符合 电气、机械耐用性、生物兼容性和FDA安全要求 与人工耳蜗制造商的沟通和(AIM 2)产生一种连接器方案 将微制造的耳蜗电极集成到植入性耳蜗线上 刺激器。预期的结果是一个可由客户集成到其耳蜗中的阵列 植入系统，并通过所有处理/使用/安全测试，人工耳蜗制造商将 需要寻求FDA的批准。

Project Summary/Abstract Current cochlear implants, while beneficial in their use, are limited in their capabilities by hand- assembly of the electrode arrays. This tedious manufacturing method is very costly, extremely labor- intensive, and inadequate in implementing new technologies for improving speech recognition and music appreciation. A superior alternative to hand assembly is microfabrication, which is a fully automated, low cost, and high yield manufacturing process that is capable of implementing a variety of innovations, including smaller array size for residual hearing preservation, drug delivery channels for inner ear health and cell regeneration, and strain gauges for improved performance during surgical insertion. Microfabrication is a very promising alternative to hand-assembly, but has yet to meet the following requirements for commercialization: (1) substrates must be composed of proven, long-term implantable materials (USP class VI), (2) electrode arrays must be compatible with standard surgical insertion techniques, (3) substrate and electrode sites must be able to withstand long-term electrical stimulation in the body, (4) the array must be long enough to extend from the tip of the cochlea to the location behind the ear where the electronics are implanted under the skin, and (5) the array must have electrical wiring that is compatible with the electrical feedthrough pins of the implantable cochlear stimulator (ICS). During Phase I, MEMStim showed that it is feasible to produce a microfabricated cochlear electrode array out of medical grade materials that can meet the commercial requirements (1) – (3). The goal of Phase II will be to produce just such an array as a minimum viable product (MVP) for cochlear implant manufacturers. The MVP will address requirements (4) – (5) and further improve upon the Phase I results of requirement (2). In order to accomplish the Phase II goal, the following Specific Aims will be accomplished: (Aim 1) produce a full length microfabricated cochlear array with an integrated cable that can be bonded to an implantable cochlear stimulator and complies with electrical, mechanical durability, biocompatibility, and FDA safety requirements specified in communications with cochlear implant manufacturers and (Aim 2) produce a connector scheme for integrating a microfabricated cochlear electrode to the feedthroughs of an implantable cochlear stimulator. The expected outcome is an array that can be integrated by customers into their cochlear implant systems and pass all handling/use/safety tests that cochlear implant manufacturers would need to seek approval from the FDA.