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

项目摘要 重度至极重度感音神经性听力损失（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年达到1亿。这种残疾导致生活质量显著降低， 经济负担，估计全世界约为7 500亿美元，来自卫生部门 成本，教育支持和工作场所生产力的损失。对于这个群体， 即使是最复杂的助听器通常也是无效的， 治疗还需要很多年人工耳蜗是目前唯一可行的恢复 “适当”的功能。到2019年，全球仅完成了60万例植入手术， 每年销售5万台设备。这一巨大的差异在那些能够受益于 而那些真正得到植入物的人部分是由他们的成本，可用性和缺乏 训练有素的外科医生和设施。然而，在当前设备中存在几个限制， 导致采用率非常低：（a）高度可见的单位连接到头骨外， 乳突骨，通过电缆连接到声音处理器和放置的可充电电池 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，导致他们拒绝这种选择;（B）通过耳廓进行声音过滤， 由于外部麦克风，耳道被绕过，从而引入不自然的线索;（c） 该设备通常必须在淋浴或游泳时取下（尽管有一些水- 抗性版本现在可用），并且在睡眠期间，增加了损坏的可能性， （d）有一个外部磁铁， 耦合和对齐内部和外部组件会导致皮肤破裂， 植入物挤出;（e）较大的占地面积和放置位置可能会导致器械风险 移位需要翻修手术。全内置人工耳蜗（FICI），没有 任何耳后组件，将解决这一巨大的未满足的医疗需求。 目前没有FDA批准的FICI。由于缺乏自备电源， 这是阻止实现所有FICI的关键障碍。通过电路设计的创新， 信号处理，马萨诸塞州眼耳和马萨诸塞州的合作小组 技术研究所开发，测试和专利的低功耗（1毫瓦）系统上的一个， 芯片（SoC）的FICI，一个关键的进步。目前的可再充电电池具有有机液体 电解质使得它们对于该应用不安全。随着SBIR第一阶段的资金，Audiance，Inc. 已经证明了全固体单堆电池的概念，这是电池的构建块 符合FICI的电化学、安全和占地面积要求。的重点 SBIR第二阶段项目是建立一个多堆栈无线充电电池和集成它 具有电池管理系统，其感测电池的健康状态并控制 充电模式，以提供及时充电和最大的电池寿命。全固态锂离子电池将 为FICI的发展扫除了一个关键的障碍，从而打开了一个机会， 帮助世界各地数百万患有重度至深度SNHL的患者。学习的过程 这种电池的设计和制造将使Audiance能够为一系列 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.