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) 手术的最新目标之一是保留人工耳蜗 残余听力，以改善患者的整体治疗效果。不幸的是，多达 50% 的患者经历过 人工耳蜗植入手术后延迟性残余听力损失，导致生活质量下降。到 为了解决这个问题，iotaMotion 正在开发一种插入系统，以协助外科医生执行受控操作 和一致的 CI 电极插入以及监测耳蜗电图 (ECochG) 读数 CI 电极插入期间从耳蜗中流出，这已被证明表明细胞损伤和 残余听力损失。系统控制电极阵列插入速率并实时响应 ECochG 通过反馈回路从耳蜗组织接收反馈。第一阶段，工作台 开发了原型，并在两个台式机上演示了系统对 ECochG 信号的响应 和大型动物体内概念验证研究。控制算法也被开发为 插入系统电机单元的反馈回路。继续这些结果，本提议的目标 第二阶段SBIR项目旨在： 1）提高系统可用性并增强使用功能。目标是 继续改进第一阶段开发的原型，目标 1 工作将提高系统保真度，纳入 实时阻抗检查，将系统集成到易于使用的平板电脑中以供手术室使用，并评估 可用性。 2) 建立制造和质量控制。供应链、制造和质量 将使用相关标准和方法来实施验证/验证系统安全性和可靠性的程序 FDA 定义测试程序的指南。电气安全性、无菌性、生物相容性、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 将被执行。 3) 评估组合系统的体内功效。该系统将在 人工耳蜗植入的急性体内模型。通过将系统的使用情况与当前的黄金标准进行比较 手动 CI 电极插入，iotaMotion 将评估系统监测 ECochG 信号的能力 耳蜗，并将确认该系统不会导致标量易位或 OSL 骨折增加 通过 3D X 射线显微镜评估与手动插入进行比较。 4) 进行观察 临床研究。作为监管策略的一部分，ECochG 监测系统能够收集 将评估观察性临床研究中可靠且显着的 ECochG 信号。完成这些 第二阶段的目标将为在 GMP 环境中开发和生产该系统奠定基础 执行旨在确定人体安全性和有效性的前瞻性临床试验。我们设想 收集的数据构成设备历史记录的基础，该记录将用于为首次人体试验做准备 研究。第二阶段的资金将有助于确保公司的额外投资，并使我们更接近 将这种针对残疾性听力损失患者急需的治疗方法商业化。