Microfabricated Cochlear Electrode Array

微加工耳蜗电极阵列

• 批准号: 9341202
• 负责人: angelique johnson
• 金额: $ 65.83万
• 依托单位: MEMSTIM, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9341202
• 关键词: Address; Adopted; Adult; Basilar Membrane; Biological Preservation; Cells; Clinical; Clinical Trials; Cochlea; Cochlear Implants; Communication; Corrosion; Deposition; Dimensions; Drops; Drug Delivery Systems; Ear; Electric Stimulation; Electric Wiring; Electrodes; Electronics; Environment; Fracture; Goals; Hand; Health; Hearing; Hearing Aids; Hearing Impaired Persons; Human; Implant; Labyrinth; Length; Ligaments; Location; Manufacturer Name; Mechanics; Medical; Methods; Microfabrication; Music; Natural regeneration; Operative Surgical Procedures; Otolaryngology; Outcome; Performance; Pharmaceutical Preparations; Phase; Physiologic pulse; Positioning Attribute; Prevention; Process; Research; Residual state; Safety; Saline; Scheme; Shapes; Site; Skin; Specific qualifier value; Speech; Spiral Lamina; System; Techniques; Technology; Temporal bone structure; Testing; Time; Toxicity Tests; Work; biomaterial compatibility; commercialization; cost; cytotoxicity; hearing impairment; improved; innovation; manufacturing process; millimeter; nanometer; new technology; novel; prototype; safety testing; speech recognition; success; systemic toxicity; technological innovation; visual feedback

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.

项目概要/摘要 目前的人工耳蜗虽然在使用上有益，但其手动操作的能力受到限制。 这种繁琐的制造方法成本非常高，而且非常费力。 强化语音识别和实施新技术方面力度不够 音乐欣赏的一个更好的选择是微加工，这是一种完全的手工组装。 自动化、低成本、高产量的制造工艺，能够实现多种 创新，包括用于保留残余听力的较小阵列尺寸、药物输送通道 用于内耳健康和细胞再生，以及应变计以提高性能 微加工是手工组装的一种非常有前途的替代方案，但尚未实现。 满足商业化的以下要求：（1）基材必须由经过验证的、 长期植入材料（USP VI 级），(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 体内长期电刺激，（4）阵列必须足够长以从尖端延伸 耳蜗到耳后电子设备植入皮下的位置，以及 (5) 阵列必须具有与阵列的电气馈通引脚兼容的电线。 植入式耳蜗刺激器（ICS）。 在第一阶段，MEMStim 表明可以生产微加工的耳蜗电极 阵列出可以满足商业要求的医疗级材料（1）-（3）的目标。 第二阶段将生产这样一个阵列作为人工耳蜗的最小可行产品（MVP） MVP 将满足要求 (4) – (5) 并进一步改进 要求（2）的第一阶段结果 为了完成第二阶段的目标，具体如下。 将实现的目标：（目标 1）生产带有 集成电缆可以连接到植入式耳蜗刺激器并符合 电气、机械耐久性、生物相容性和 FDA 安全要求 与人工耳蜗制造商沟通并（目标 2）制定连接器方案 将微型耳蜗电极集成到植入式耳蜗的馈通中 预期的结果是一个可以由客户集成到他们的耳蜗中的阵列。 植入系统并通过人工耳蜗制造商要求的所有操作/使用/安全测试 需要寻求 FDA 的批准。