Plug-And-Play Cochlear Electrode Array

即插即用耳蜗电极阵列

• 批准号: 10403757
• 负责人: angelique johnson
• 金额: $ 7.72万
• 依托单位: MEMSTIM, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10403757
• 关键词: 3-Dimensional; 3D Print; Acoustic Nerve; Address; Adoption; Area; Cadaver; Charge; Clinical; Clinical Trials; Cochlea; Cochlear Implants; Devices; Drops; Electrodes; Electronics; Failure; Goals; Grant; Hand; Hearing; Hearing Aids; Human; Individual; Infection; Lasers; Length; Letters; Methods; Microfabrication; Miniaturization; Muscle; Music; Operative Surgical Procedures; Otolaryngology; Output; Phase; Play; Printing; Reaction; Reporting; Residual state; Resolution; Safety; Shapes; Silicones; Site; Slide; Specific qualifier value; Spinal Cord; System; Technology; Temporal bone structure; Testing; Thick; Tissues; Torsion; Welding; Work; biomaterial compatibility; cost; cytotoxicity; deep brain stimulator; electric impedance; genotoxicity; hearing impairment; histological studies; implantation; improved; innovation; interest; millimeter; neuroprosthesis; novel; preservation; response; safety testing; speech recognition; success; two-dimensional

Project Summary/Abstract Worldwide, approximately 466 million people suffer from disabling hearing loss. When conventional hearing aids provide no appreciable benefit, cochlear implants are a solution. Current cochlear implants, while beneficial in their use, are limited in their capabilities by hand-assembly of wire-bundled electrode arrays. Hand assembly is very costly, extremely labor-intensive, and inadequate in implementing new strategies in Otolaryngology for improving speech recognition and music appreciation. Advanced-manufacturing (microfabrication, laser-machining, etc.) has been deemed a superior replacement to the hand-assembly of electrode arrays, and many innovations have been made in this area. However, commercial suppliers have not adopted them. In large part, due to mismatches between the flat 2D bond pads of advanced-manufactured arrays and the 3D feedthrough pins of commercial stimulators. As such, they require additional adapters that not only reintroduce hand-assembly, but also add to the overall manufacturing costs and clinical failures. MEMStim LLC proposes a plug-and-play advanced-manufacturing solution that relies heavily on 3D printing. By printing conductive and nonconductive silicones, biocompatible pluggable arrays can be printed to any size, length, shape or thickness, from several microns to tens of millimeters. Most importantly, the integrated connectors plug readily onto stimulators by way of a novel micro-socket technology. The micro-sockets are compatible and slide right onto the feedthrough pins. The printer resolution can output pluggable connectors that are compatible with pin-to-pin pitches smaller than 100 µm (edge-to-edge), allowing for enhanced miniaturization. In phase I work, high performing stimulating electrode sites and extension cables were demonstrated. Additionally, the feasibility of producing high performing plug-and-play connectors was demonstrated. The goal of this Phase II project is to monolithically integrate all three into the first-ever pluggable cochlear electrode array. The Aims of the Phase II grant are: (1) Produce an integrated 3D printed plug-and-play cochlear array that complies with the functional electrical requirements of cochlear implants; (2) Produce a 3D printed plug- and-play cochlear array that complies with the durability requirements of cochlear implants; and (3) Produce 3D printed plug-and-play cochlear array that complies with the biocompatibility and surgical safety requirements of cochlear implants. The end result will be the first-ever pluggable cochlear electrode array, which is functional and passes all the handling/use/safety tests that are necessary to seek approval from the FDA.

项目概要/摘要 全球约有 4.66 亿人患有常规听力损失。 辅助设备没有提供明显的好处，人工耳蜗是一种解决方案，而目前的人工耳蜗是一种解决方案。 虽然它们的使用是有益的，但其功能受到手工组装线束电极阵列的限制。 组装成本非常高，劳动强度极大，并且不足以实施新的战略 耳鼻喉科可提高语音识别和音乐欣赏能力。 先进制造（微加工、激光加工等）被认为是先进制造的更好替代品 电极阵列的手工组装，并且在该领域已经取得了许多创新。 商业供应商尚未采用它们，很大程度上是由于平面 2D 键合焊盘之间的不匹配。 先进制造的阵列和商业刺激器的 3D 馈通引脚。 需要额外的适配器，不仅重新引入手工组装，而且还增加了整体制造 成本和临床失败。 MEMStim LLC 提出了一种高度依赖 3D 打印的即插即用先进制造解决方案。 通过印刷导电和非导电有机硅，可以将生物相容性可插拔阵列印刷成任何尺寸， 长度、形状或厚度，从几微米到几十毫米，最重要的是集成度。 连接器通过新颖的微插座技术轻松插入刺激器。 兼容并向右滑到馈通引脚上，打印机分辨率可以输出可插拔连接器。 与小于 100 µm（边到边）的引脚到引脚间距兼容，从而可以增强 小型化。 在第一阶段的工作中，展示了高性能刺激电极部位和延长电缆。 此外，还证明了生产高性能即插即用连接器的可行性。 该第二阶段项目的主要目标是将这三者整体集成到有史以来第一个可插式耳蜗电极中 第二阶段资助的目标是：(1) 生产集成的 3D 打印即插即用耳蜗阵列。 (2) 制作3D打印插件 and-play 符合人工耳蜗耐久性要求的人工耳蜗阵列；以及 (3) 生产 3D打印即插即用耳蜗阵列，符合生物相容性和手术安全性 最终结果将是第一个可插式耳蜗电极阵列， 它功能齐全，并通过了寻求批准所需的所有处理/使用/安全测试 FDA