Development of a Micro-Mechanical Insertion Tool withIntraoperative 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: 9902397
• 负责人: Allan Henslee
• 金额: $ 7.5万
• 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 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9902397
• 关键词: Address; Algorithms; Animal Model; Animals; Clinical Trials; Cochlea; Cochlear Implants; Cochlear implant procedure; Complete Hearing Loss; Computer software; Couples; Development; Devices; Electrocochleographies; Electrodes; Electrophysiology (science); Feedback; Funding; Goals; Gold; Grant; Hearing; Implant; Incidence; Investments; Knowledge; Laboratories; Labyrinth; Manuals; Measurement; Measures; Mechanics; Molecular; Monitor; Motion; Motor; Movement; Operative Surgical Procedures; Outcome; Patients; Performance; Phase; Privatization; Quality of life; Reading; Residual state; Resistance; Secure; Sheep; Signal Transduction; Small Business Innovation Research Grant; Structure; Surgeon; System; Technology; Testing; Time; Trauma; base; cell injury; commercialization; design; experience; hearing impairment; hearing preservation; implantation; improved; in vivo; in vivo Model; in vivo evaluation; interest; novel; preservation; prevent; prototype; robot control; success; tool

Abstract: While the Cochlear Implant (CI) has traditionally been used to treat patients with severe to complete hearing loss, recent advances have now made the CI a treatment option for people with moderate hearing levels who previously did not qualify for a traditional CI. These hearing preservation approaches attempt to preserve the patient's residual hearing following CI surgery. However, studies have suggested that trauma to the cochlea during electrode insertion results in damage to delicate inner ear structures, and up to 50% of patients experience delayed hearing loss following surgery that results in a diminished quality of life.1 Additionally, recent studies suggest that trauma to the cochlea occurring during electrode insertion may be correlated with changes in Electrocochleography (ECochG) readings taken from the cochlea. In this SBIR, iotaMotion aims to develop an insertion tool that couples cochlear implant ECochG measurements to a micromechanical control system that will assist the surgeon to sense, predict, and mitigate cochlear insertion trauma in real-time during electrode insertion. The anticipated impact of this technology will be to improve short and long-term hearing outcomes for CI patients by enhancing “hearing preservation” cochlear implantation. The project will develop a functional prototype with insertion control algorithms for a “smart” insertion tool and then evaluate the system's feasibility in a pilot animal study via the following three aims:1) Develop a Working Benchtop Prototype of a Real-Time Intracochlear Damage Monitoring and Insertion Tool. The first stage of development will comprise the design, fabrication, and testing of the device in a laboratory setting; demonstrating that the insertion tool can be controlled and regulated by the novel hardware and software inputs. 2) Evaluate the control system EcochG feedback sensitivity and reliability with motion control algorithms that utilize real-time feedback to prevent intracochlear damage. Aim 2 will develop several firmware control algorithms that detect ECochG changes with a feedback loop to the control console and motor unit for micromechanical motion adjustments. This will help determine the relationship between ECochG readings and electrode movement within the cochlea. 3) Demonstrate proof of concept capability to assist the surgeon during electrode insertion based on real time ECochG feedback in pilot large animal study. The final specific aim will evaluate the prototype device in vivo with a pilot animal model. The ability of the device to sense and mitigate ECochG changes through motion adjustments will be validated. Ultimately, the success of Phase I will allow development of this insertion system to progress to a second iteration of the design (based on the knowledge gained in Phase I) and further in vivo testing to establish the efficacy of the device as compared to the current gold standard of implantations. SBIR funding will help secure additional outside investment and bring us closer to commercializing this much needed treatment for people suffering from disabling hearing loss.

翻译后摘要：虽然髋关节植入物（CI）传统上被用来治疗严重的患者完成 听力损失，最近的进展现在使CI成为中度听力患者的治疗选择 以前没有资格获得传统CI的级别。这些听力保护方法试图 在CI手术后保留患者的残余听力。然而，研究表明， 电极插入期间的耳蜗导致对脆弱的内耳结构的损伤， 患者在手术后出现延迟性听力损失，导致生活质量下降。1 此外，最近的研究表明，在电极插入过程中发生的耳蜗创伤可能是 与耳蜗电描记术（ECochG）读数的变化相关。在这个SBIR中， iotaMotion旨在开发一种插入工具，将人工耳蜗ECochG测量与 微机械控制系统，将帮助外科医生感知，预测和减轻耳蜗 在电极插入过程中实时检测插入创伤。这项技术的预期影响将是 通过增强“听力保留”人工耳蜗改善CI患者的近远期听力结果 置入该项目将开发一个功能原型与插入控制算法的“智能” 插入工具，然后通过以下三个目的评估系统在试点动物研究中的可行性：1） 实时颅内损伤监测和植入工作台原型的研制 工具.第一阶段的发展将包括设计，制造和测试的设备在一个 实验室设置;证明插入工具可以由新型硬件控制和调节 和软件输入。2)评估控制系统EcochG反馈灵敏度和可靠性， 运动控制算法利用实时反馈来防止脑内损伤。目标2将 开发几种固件控制算法，通过控制反馈回路检测ECochG变化 用于微机械运动调节的控制台和电机单元。这将有助于确定关系 ECochG读数和耳蜗内电极移动之间的关系。3)演示概念证明 能够在电极插入过程中根据试点中的真实的ECochG反馈帮助外科医生 大型动物研究最终的具体目标是用试验动物模型在体内评价原型器械。 将确认器械通过运动调整感知和缓解ECochG变化的能力。 最终，第一阶段的成功将使这种插入系统的开发进展到第二阶段。 设计迭代（基于第I阶段获得的知识）和进一步的体内试验，以确定 与当前的黄金标准相比，该器械的有效性。SBIR资金将有助于确保 额外的外部投资，使我们更接近于将这种急需的治疗方法商业化， 患有听力损失