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

用于全内置人工耳蜗的全固态无线充电电池

• 批准号: 10369703
• 负责人: Michael Molinski
• 金额: $ 39.33万
• 依托单位: AUDIANCE, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2025-03-01
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10369703
• 关键词: Address; Adoption; Affect; Aging; Anatomy; Anodes; Auditory; Biocompatible Materials; Biological Response Modifier Therapy; Bluetooth; Bypass; Cathodes; Cells; Charge; Cochlear Implants; Coin; Coupled; Couples; Craniocerebral Trauma; Cues; Custom; Cypress; Development; Devices; Disease; Ear; Economic Burden; Electrolytes; Ensure; Eye; FDA approved; Funding; Health; Hearing; Hearing Aids; Heredity; Imides; Implant; Institutes; Iron; Lead; Learning; Legal patent; Life; Liquid substance; Lithium; Massachusetts; Mastoid process; Medical; Medical Device; Monitor; Operative Surgical Procedures; Output; Patients; Performance; Persons; Phase; Polyethylene Glycols; Population; Power Sources; Productivity; Prosthesis; Quality of life; Resistance; Risk; Route; Safety; Sensorineural Hearing Loss; Skin; Sleep; Small Business Innovation Research Grant; Solid; Surgeon; Surveys; Swimming; System; Technology; Temperature; Testing; Time; Training; Water; Work; Workplace; analog; base; bone; cost; cranium; design; disability; external ear auricle; innovation; inorganic phosphate; microphone; migration; ototoxicity; prevent; prototype; radio frequency; remote sensing; seal; sensor; signal processing; social stigma; sound; voltage; wireless; wireless transmission

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.

项目摘要 严重至深刻的感官听力损失（SNHL），是由疾病，衰老，耳毒性引起的 头部创伤和遗产，全世界约6000万，预计将到达 到2050年到2050年。这种残疾导致生活质量大大降低和庞大 经济烧伤，估计全球约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。对于这个人群，放大 即使是最复杂的助听器，通常都是无效的，并且恢复性生物学 疗法已经多年了。目前，人工耳蜗植入物是恢复的唯一可用路线 “足够”功能。截至2019年，全球只完成了60万个直接，大约 每年出售50,000个设备。那些可以受益的人之间的巨大差异 那些实际获得植入物的人部分是由于其成本，可用性和缺乏 训练有素的外科医生和设施。但是，当前设备中有几个限制 有助于采用非常低的采用：（a）在颅骨外的高度可见单元 乳突骨，用电缆连接到声音处理器和可充电电池 在耳朵后面，使残疾非常明显，并造成了不可接受的社会污名 对于许多患者，使他们拒绝此选项； （b）耳膜和 听觉运河由于外部麦克风而被绕开，引入了不自然的提示。 （C） 该设备通常必须在淋浴或游泳时卸下（尽管有几种水 - 现在可以使用抗性版本），在睡觉期间，增加了损坏的可能性， 错位或在这些情况下听到的能力； （d）有一个外部磁铁 夫妻和对齐内部和外部组件可能会导致皮肤分解，并且 植入物扩展； （e）大的足迹和放置叶子打开了设备的风险 需要修改手术的迁移。完全内部人工耳蜗（FICI），没有 耳朵组件后面的任何人都可以解决这种巨大的未满足的医疗需求。 FDA目前没有FICIS批准。缺乏独立电源是 一个关键的障碍，阻止了所有ficis的实现。通过电路设计的创新和 信号处理，马萨诸塞州和马萨诸塞州的合作组 技术研究所已经开发，测试和申请了低功率（1兆瓦）的系统。 芯片（SOC）用于FICI，一个关键的进步。当前可充电电池具有有机液体 电解质使它们在此应用中不安全。与SBIR I期资金，Audiance，Inc。 已经显示了一个全纤维单栈单元的概念证明，该单元是电池的构建块 满足FICI的电化学，安全性和足迹要求。重点 SBIR II期项目是建造一个多堆栈无线可充电电池并将其集成 通过电池管理系统，可以感知电池的健康状况和控制 充电轮廓可及时充电和最大电池寿命。全纤维的解放将 删除用于开发FICI的关键障碍，从而为 帮助世界各地数百万患者严重至深度SNHL。从 该电池的设计和制造将允许听觉自定义一系列电池 其他活跃的植入医疗设备。