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

I-Corps：颅内声导管可诊断搏动性耳鸣

• 批准号: 2341954
• 负责人: Matthew Amans
• 金额: $ 5万
• 依托单位: University of California-San Francisco
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-12-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2341954&HistoricalAwards=false
• 关键词: Corps; Intracranial; Phonocatheter; Enable; Diagnosis

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.

该I-Corps项目更广泛的影响/商业潜力是开发一种能够通过测量大脑静脉流出道内的血液动力学变化来诊断脉动性耳鸣（PT）的医疗器械。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，所有这些测试基本上都是在没有任何镇静剂的情况下进行的，以便为操作员提供声音起源的最佳猜测。所提出的设备不是依赖于患者向医生传达他们的经验，而是被设计为直接测量引起声音的压力波动，并提供覆盖患者脉管系统的声音图，医生将对其进行解释。所提出的技术可以减轻疼痛的球囊闭塞试验和静脉测压，并将手术时间缩短至更合理的30分钟。据估计，超过300万美国人患有PT，其中65%患有抑郁症，焦虑症或两者兼而有之。一个可靠的诊断可以让神经介入医生治疗他们的症状和改善结果。本I-Corps项目基于诊断微导管医疗器械的开发，用于诊断搏动性耳鸣（PT）。 申报器械设计有一个或多个嵌入式换能器，可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实时直接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标测，所提出的技术为医生提供了脉管系统内的压力波（与声音产生相关）的客观标测图，并实现了诊断。使用原型系统对概念验证进行了评估，该原型系统的远端尖端嵌入了现成的麦克风芯片，该芯片能够使用源自患者特定磁共振成像（MRI）的台式流动模型直接检测PT声音。该奖项反映了NSF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进行评估，被认为值得支持审查标准。