I-Corps: Intracranial Phonocatheter to Enable Diagnosis of Pulsatile Tinnitus

I-Corps项目的更广泛影响/商业潜力是开发一种能够通过测量脑静脉流出道内血流动力学变化来诊断脉动性耳鸣（PT）的医疗设备。目前，PT评估需要4 - 6小时，包括诊断性脑血管造影、诊断性脑静脉造影、静脉测压和球囊闭塞测试，所有这些基本上都是在没有任何镇静的情况下进行的，以便为操作员提供声音来源的最佳猜测。与其依赖病人向医生传达他们的经验，该设备被设计成直接测量引起声音的压力波动，并提供覆盖病人血管系统的声音图，医生将对其进行解释。建议的技术可以避免痛苦的球囊阻塞测试和静脉测压，并将手术时间缩短到更合理的30分钟。据估计，超过300万美国人患有PT，其中65%的人患有抑郁症、焦虑症，或者两者兼而有之。一个可靠的诊断可以让神经介入医生治疗他们的症状并改善结果。这个I-Corps项目是基于一种诊断性微导管医疗设备的开发来诊断脉动性耳鸣（PT）。该装置设计了一个或多个嵌入式传感器，可以将血管中产生的声音的压力波动转换为电信号，并通过视觉和听觉反馈直接实时向神经血管内外科医生提供声音生成图。类似于心脏的电生理测绘，该技术为医生提供了脉管系统内压力波（与声音产生相关）的客观地图，并使诊断成为可能。概念验证已经通过一个原型系统进行了评估，该原型系统的远端嵌入了一个现成的麦克风芯片，该系统能够直接检测PT声音，使用来自患者特异性磁共振成像（MRI）数据的台式流动模型在治疗前后进行检测。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is the development of a medical device capable of diagnosing Pulsatile Tinnitus (PT) by measuring hemodynamic changes within the brain’s venous outflow tract. Currently, PT evaluation takes 4 - 6 hours and consists of diagnostic cerebral angiography, diagnostic cerebral venography, venous manometry, and balloon occlusion tests all performed essentially without any sedation to provide operators with the best guess of where the sound is originating. Rather than relying on patients to relay to the physician their experience, the proposed device is designed to directly measure pressure fluctuations causing sound and provide a map of sound overlying the patient’s vasculature that physicians will interpret. The proposed technology may obviate painful balloon occlusion tests and venous manometry and shorten procedural time to a more reasonable 30 minutes. Over 3 million Americans are estimated to have PT, and 65% of them suffer from debilitating depression, anxiety, or both. A reliable diagnosis may allow neurointerventional physicians to treat their symptoms and improve outcomes. This I-Corps project is based on the development of a diagnostic microcatheter medical device to diagnose Pulsatile Tinnitus (PT). The proposed device is designed with one or more embedded transducers that can convert the pressure fluctuations of sound generated in blood vessels into electrical signals and provide a map of sound generation directly to the neuroendovascular surgeon in real-time with both visual and audible feedback. Analogous to electrophysiology mapping of the heart, the proposed technology provides physicians with an objective map of pressure waves (correlating to sound production) within the vasculature and enables the diagnosis. Proof of concept has been evaluated using a prototype system with an off-the-shelf microphone chip embedded at its distal tip that is able to directly detect PT sounds using benchtop flow models derived from patient-specific magnetic resonance imaging (MRI) data before and after treatments.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.