Plug-And-Play Cochlear Electrode Array

项目总结/摘要 全世界约有4.66亿人患有听力损失。当传统的听力 艾滋病没有明显的好处，人工耳蜗是一个解决办法。目前的人工耳蜗， 有益于它们的使用，但是由于手工组装成束的电极阵列，它们的能力受到限制。手 组装成本非常高，劳动密集型，不足以实施新的战略， 耳鼻喉科提高语音识别和音乐欣赏。 先进制造（微细加工、激光加工等）被认为是一个上级的替代品， 电极阵列的手工组装，并且在该领域中已经进行了许多创新。然而，在这方面， 商业供应商尚未采用这些标准。在很大程度上，由于平面2D焊盘之间的失配， 先进制造的阵列和商业刺激器的3D馈通引脚。所以他们 需要额外的适配器，不仅重新引入手工组装，而且增加了整体制造 成本和临床失败。 MEMStim LLC提出了一种即插即用的先进制造解决方案，该解决方案严重依赖3D打印。 通过印刷导电和非导电硅树脂，生物相容性可插拔阵列可以印刷成任何尺寸， 长度、形状或厚度，从几微米到几十毫米。最重要的是，综合 连接器通过新颖的微型插座技术容易地插入刺激器。微型插座是 兼容并直接滑到馈通引脚上。打印机分辨率可输出可插拔连接器 与小于100 µm（边到边）的引脚间距兼容， 小型化 在第一阶段的工作中，高性能的刺激电极位点和延长电缆被证明。 此外，生产高性能即插即用连接器的可行性也得到了证明。目标 这个第二阶段的项目是将所有三个集成到有史以来第一个可插拔的耳蜗电极中 阵第二阶段赠款的目的是：（1）生产集成的3D打印即插即用耳蜗阵列 符合人工耳蜗功能性电气要求;（2）生产3D打印插头- 符合人工耳蜗植入体耐久性要求的and-play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 人工耳蜗植入体的要求。最终的结果将是有史以来第一个可插拔的耳蜗电极阵列， 其具有功能性，并通过了所有必要的处理/使用/安全测试，以获得 FDA.

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.