An All-Solid Wirelessly Rechargeable Battery for a Fully Internal Cochlear Implant

项目总结 严重到严重的感音神经性聋(SNHL)，由疾病、衰老、耳毒性、 头部创伤和遗传，影响全球约6000万人，预计将达到约 到2050年将达到1亿。这种残疾会导致生活质量显著下降，并导致大量 全球经济负担估计约为7500亿美元，来自卫生部门 成本、教育支持和工作场所生产力的损失。对于这一群体来说，放大 即使是最精密的助听器通常也是无效的，而且具有恢复能力 治疗方法还需要数年时间。人工耳蜗术是目前唯一可行的修复方法 “足够”的功能。到2019年，全球只做了60万例植入物，大约 每年售出5万台设备。在那些可以受益的人之间存在巨大的差异 而那些真正接受植入的人，部分原因是他们的成本、可获得性和缺乏 训练有素的外科医生和设施。然而，在当前的设备中有几个限制 有助于极低的采用率：(A)高度可见的单位附着在颅骨外面 乳突骨，通过电缆连接到声音处理器，并放置充电电池 在耳朵后面，使残疾非常明显，并造成不可接受的社会耻辱 对于许多患者，导致他们拒绝这一选择；(B)耳廓和 由于外置麦克风而绕过了耳道，引入了不自然的提示；(C) 在洗澡或游泳时，通常必须取下该设备(尽管有少量水- 现在有了抗性版本)，在睡眠期间，增加了损坏的可能性， 错位，或在这些情况下的听力能力；(D)有外部磁铁， 对接和调整内部和外部组件会导致皮肤破裂和 种植体挤压；(E)较大的占地面积和放置位置为设备留下了风险 需要翻修手术的移植物。一种完全内部人工耳蜗术(FICI)，它没有 耳后的任何部件，都将解决这一巨大的未得到满足的医疗需求。 目前还没有FDA批准的FICI。缺乏自给自足的电源是 阻碍实现所有FICI的关键障碍。通过电路设计和技术创新 信号处理，马萨诸塞州眼耳科和马萨诸塞州合作小组 理工学院已经开发、测试和申请了一种低功耗(1 MW)的系统-on-a-a FICI的芯片(SoC)，这是一个关键的进步。目前的充电电池有有机液体 电解液使它们在这种应用中不安全。在SBIR第一阶段的资助下，Audiance，Inc. 已经展示了全固态单堆电池的概念证明，它是电池的构建块 这符合FICI的电化学、安全性和占地面积要求。这件事的重点是 SBIR第二阶段项目是建造一个多堆无线充电电池并将其集成 具有电池管理系统，该电池管理系统感测电池的健康状态并控制 充电配置文件可提供及时充电和最长电池寿命。完全坚定的自由党将 消除发展FICI的关键障碍，从而打开一个机会 帮助世界各地数百万患有严重到严重SNHL的患者。从中国的经验教训 这种电池的设计和制造将允许Audiance为一系列 其他有源植入式医疗器械。

PROJECT SUMMARY Severe to profound sensorineural hearing loss (SNHL), caused by disease, aging, ototoxicity, head trauma and heredity, affects about 60 million worldwide, and is expected to reach around 100 million by 2050. This disability leads to a significantly lowered quality of life and a large economic burden, estimated to be around $750 billion worldwide, coming from health sector costs, educational support, and loss of workplace productivity. For this population, amplification with even the most sophisticated hearing aids is usually ineffective, and restorative biological therapies are years away. A cochlear implant is currently the only available route for restoring ‘adequate’ functionality. Only 600,000 implants have been done worldwide till 2019, and about 50,000 devices are being sold annually. This large discrepancy between those that can benefit and those that actually get the implant is driven partly by their cost, availability and the lack of trained surgeons and facilities. However, there are several limitations in the current devices that contribute to very low adoption: (a) The highly visible unit attached to the skull outside the mastoid bone, connected by a cable to the sound processor and rechargeable battery placed behind the ears, makes the disability very obvious, and creates an unacceptable social stigma for many patients, causing them to refuse this option; (b) Sound filtering by the auricle and auditory canal is bypassed because of the external microphone, introducing unnatural cues; (c) The device typically must be taken off during showering or swimming (although a few water- resistant versions are now available), and during sleeping, increasing the likelihood of damage, misplacement, or the ability to hear in these situations; (d) Having an external magnet that couples and aligns the internal and external components can lead to skin breakdown and implant extrusion; (e) The large footprint and placement leaves open the risk for device migration requiring revision surgery. A fully internal cochlear implant (FICI), that does not have any behind the ear components, would address this large unmet medical need. There are no FICIs currently approved by the FDA. The lack of a self-contained power supply is a key roadblock preventing realization of all FICIs. Through innovations in circuit design and signal processing, collaborating groups at Massachusetts Eye and Ear and Massachusetts Institute of Technology have developed, tested and patented a low power (1 mW) system-on-a- chip (SoC) for a FICI, a critical advance. Current rechargeable batteries have organic liquid electrolytes making them unsafe for this application. With SBIR Phase I funding, Audiance, Inc. has shown proof of concept of an all-solid single-stack cell that is the building block for a battery that meets the electrochemical, safety and footprint requirements for a FICI. The focus of this SBIR Phase II project is to build a multi-stack wirelessly rechargeable battery and integrate it with a battery management system that senses the state of health of the battery and controls the charge profile to provide timely charging and maximum battery life. The all-solid LIB will remove a critical roadblock for the development of a FICI, and thus open up an opportunity to help millions of patients around the world with severe to profound SNHL. The learning from the design and fabrication of this battery will allow Audiance to customize batteries for a range of other active implantable medical devices.