Development of a Micro-Mechanical Insertion Tool with Intraoperative Real-Time Electrophysiological Sensing Control for Cochlear Implantation

开发具有术中实时电生理传感控制的人工耳蜗植入微机械插入工具

• 批准号: 10082146
• 负责人: Allan Henslee
• 金额: $ 73.47万
• 依托单位: IOTAMOTION, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10082146
• 关键词: 3-Dimensional; Acoustic Stimulation; Acute; Address; Algorithms; Animals; Clinical Research; Clinical Trials; Clinical Trials Design; Cochlea; Cochlear Implants; Cochlear implant procedure; Computer software; Couples; Data; Data Security; Development; Devices; Electrocochleographies; Electrodes; Electrophysiology (science); Environment; Feedback; Floor; Fracture; Funding; Goals; Gold; Hearing; Human; Implant; Implanted Electrodes; Incidence; Investments; Labyrinth; Letters; Manuals; Measurement; Mechanics; Modeling; Monitor; Motion; Motor; Noise; Operative Surgical Procedures; Patient-Focused Outcomes; Patients; Performance; Phase; Procedures; Production; Quality Control; Quality of life; Reading; Recording of previous events; Residual state; Safety; Secure; Sheep; Signal Transduction; Small Business Innovation Research Grant; Sterility; Structure; Surgeon; System; Tablets; Techniques; Technology; Testing; Time; Tissues; Trauma; Validation; Wireless Technology; Work; X ray microscopy; base; biomaterial compatibility; cell injury; commercialization; design; electric impedance; experience; first-in-human; hearing impairment; hearing preservation; improved; in vivo; in vivo Model; manufacturability; microphone; novel; preclinical study; preservation; prospective; prototype; response; tool; usability

Project Summary/Abstract. One of the more recent goals of cochlear implant (CI) surgery is the preservation of residual hearing to improve overall patient outcomes. Unfortunately, up to 50% of patients experience delayed residual hearing loss following cochlear implant surgery, resulting in a diminished quality of life. To address this issue, iotaMotion is developing an insertion system to assist surgeons in performing controlled and consistent CI electrode insertions as well as to monitor the electrocochleography (ECochG) readings taken from the cochlea during CI electrode insertion, which have been shown to indicate cellular damage and residual hearing loss. The system controls the rate of electrode array insertion and responds in real time to ECochG feedback received from the cochlear tissues via a feedback loop. In Phase I, a working benchtop prototype was developed and the system response to ECochG signals was demonstrated in both benchtop and large animal in vivo proof-of-concept studies. Control algorithms were also developed as part of the feedback loop to the insertion system’s motor unit. Continuing with these results, the goals of this proposed Phase II SBIR project are to: 1) Improve System Usability and Enhance Use Features. With the goal of continuing to improve the prototype developed in Phase I, Aim 1 work will improve system fidelity, incorporate real-time impedance checks, integrate the system into an easy-to-use tablet for use in the OR, and evaluate usability. 2) Establish Manufacturing and Quality Controls. The supply chain and manufacturing and quality procedures to verify/validate system safety and reliability will be implemented using relevant standards and FDA guidance to define testing procedures. The electrical safety, sterility, biocompatibility, functionality, and data security testing of production-level devices that will be used for pre-clinical studies and commercialization will be performed. 3) Evaluate In Vivo Efficacy of the Combined System. The system will be evaluated in an acute in vivo model of cochlear implantation. By comparing usage of the system to the current gold standard of manual CI electrode insertions, iotaMotion will evaluate the system’s ability to monitor ECochG signals from the cochlea and will confirm that the system induces no increases in scalar translocations or OSL fractures when compared to manual insertions as assessed by 3D X-ray microscopy. 4) Perform Observational Clinical Study. As part of the regulatory strategy, the ability of the ECochG monitoring system to collect reliable and significant ECochG signals in an observational clinical study will be evaluated. Completion of these Phase II Aims will set the stage for the development and production of the system in a GMP environment and execution of a prospective clinical trial designed to establish safety and efficacy in humans. We envision the data collected to comprise the basis for the Device History Record that will be used to prepare for first-in-man studies. This Phase II funding will help secure additional company investment and will move us much closer to commercializing this much-needed treatment for people suffering from disabling hearing loss.

项目摘要/摘要。人工耳蜗(CI)手术的近期目标之一是保存 提高残余听力以改善患者的整体预后。不幸的是，多达50%的患者经历了 人工耳蜗术后迟发性残留听力损失，导致生活质量下降。至 为了解决这个问题，iotaMotion正在开发一种插入系统，以帮助外科医生进行受控 和一致的CI电极插入，以及监测所取的耳蜗电(ECochG)读数 在CI电极插入过程中从耳蜗处发出的信号，这已被证明表明细胞损伤和 残留听力损失。该系统控制电极阵列的插入速度，并实时响应 通过反馈环从耳蜗组织接收到的ECochG反馈。在第一阶段，工作台式机 开发了样机，并在两个实验台上演示了系统对ECochG信号的响应 和大型动物体内的概念验证研究。控制算法也被开发为 将反馈回路连接到插入系统的电机单元。继续这些成果，这项提议的目标是 第二阶段SBIR项目是：1)提高系统可用性，增强使用特性。目标是 继续改进在第一阶段开发的原型，目标1的工作将提高系统保真度，包括 实时阻抗检查，将系统集成到易于使用的平板电脑中，供手术室使用，并进行评估 可用性。2)建立制造和质量控制。供应链、制造和质量 验证/验证系统安全性和可靠性的程序将使用相关标准和 FDA关于定义测试程序的指南。电气安全、无菌、生物兼容性、功能性和 将用于临床前研究和商业化的生产级设备的数据安全测试 将会被执行。3)联合系统的体内疗效评价。该系统将在一个 急性体内人工耳蜗术模型的建立。通过将该系统的使用与当前的黄金标准进行比较 手动CI电极插入，iotaMotion将评估系统从 并将确认该系统不会导致标量易位增加或OSL骨折 当与3D X射线显微镜评估的手动插入相比较时。4)进行观察 临床研究。作为监管战略的一部分，ECochG监测系统收集 将对观察性临床研究中可靠和重要的ECochG信号进行评估。完成这些工作 第二阶段AIMS将为在GMP环境中开发和生产该系统奠定基础，并 执行一项旨在确定人体安全性和有效性的前瞻性临床试验。我们展望了 收集的数据构成设备历史记录的基础，该记录将用于准备首次面对面 学习。这笔第二阶段的资金将有助于获得额外的公司投资，并将使我们更接近 将这种亟需的治疗方法商业化，以帮助患有失聪的人。