Microfabricated Cochlear Electrode Array

项目总结/摘要 目前的耳蜗植入物虽然在使用上是有益的，但其能力受到手的限制。 电极阵列的组装。这种繁琐的制造方法非常昂贵，非常劳动- 密集，在实施新技术以改善语音识别方面不足， 音乐欣赏手工组装的一种上级替代方法是微加工，这是一种完全的 自动化、低成本和高产量的制造工艺，其能够实现各种 创新，包括更小的阵列尺寸，用于残余听力保护，药物输送通道， 用于内耳健康和细胞再生，以及用于改善 手术插入。微制造是一种非常有前途的手工组装替代品，但尚未 满足以下商业化要求：（1）基质必须由经证实的， 长期植入材料（USP VI类），（2）电极阵列必须与 标准手术插入技术，（3）基底和电极部位必须能够承受 （4）阵列必须足够长以从尖端延伸 将耳蜗的一部分转移到耳后的位置，在耳后的位置，电子设备被植入皮肤下，以及 (5)该阵列必须具有与 植入式耳蜗刺激器（ICS）。 在第一阶段，MEMStim表明生产微制造耳蜗电极是可行的 由能够满足商业要求（1）-（3）的医用级材料制成的阵列。的目标 第二阶段将生产这样的阵列作为耳蜗的最小可行产品（MVP）。 植入物制造商。MVP将解决要求（4）-（5），并进一步改进 要求（2）的第一阶段结果。为了实现第二阶段的目标， 目的将被实现：（目的1）生产具有微机械特性的全长微制造耳蜗阵列。 集成电缆，可连接到植入式耳蜗刺激器，并符合 中规定的电气、机械耐久性、生物相容性和FDA安全要求 与人工耳蜗制造商进行沟通，并（目标2）制定连接器方案， 将微制造耳蜗电极集成到可植入耳蜗的馈电器 刺激器预期的结果是一个阵列，可以由客户集成到他们的耳蜗 植入系统并通过人工耳蜗制造商将通过的所有操作/使用/安全测试 需要获得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.