Continuous Real Time CSF Shunt Flow Monitor ShuntCheck

描述（由申请人提供）：本II期SBIR将开发连续真实的时间（CRT）分流检查，这是第一种用于真实的时间连续监测CSF分流中流量变化的便携式无创器械。该装置将通过提供监测和研究分流功能的非侵入性方法来改善脑积水的临床管理。脑积水是一种常见的CSF积聚在脑室中的疾病，通过放置VP分流管将多余的CSF引流到腹部来纠正。分流器经常发生故障，通常是由于阻塞，但分流器故障的症状是不特异的-头痛，恶心。分流器故障的诊断是昂贵的并且存在风险（暴露于来自CT扫描的辐射、来自放射性核素测试的感染风险）。此外，分流患者的持续临床管理非常复杂（由于缺乏用于研究CSF过度引流、评估特定分流阀和虹吸控制器械性能以及简化可程控分流阀调整的工具）。NeuroDx的现有设备ShuntCheck-Micro-Pumper是一种分流阻塞检测器，可满足分流故障的非侵入性测试需求。虽然这使其成为急诊科的一个有价值的工具，但测试持续时间短限制了其在分流阀调整、调查疑似分流过度引流等方面的实用性。一种可跟踪CSF流速变化的无创、非放射性器械将满足许多正在进行的临床管理需求，并成为神经外科临床的一个有价值的工具。在我们的第一阶段研究中，我们基于热稀释技术的突破性创新开发了一种实验室原型CRT，并在实验室和动物研究中验证了其安全性和准确性。CRT可以可靠地区分无分流、低分流和强分流，并且可以在延长的时间段内跟踪分流流速的变化。该第二阶段项目的目标是将CRT ShuntCheck从实验室原型改进为生产就绪设备，在实验室和动物试验中验证其安全性和准确性，并完成510 k申报以获得FDA批准。II期后临床研究将证明CRT ShuntCheck在儿科和成人NPH患者中简化瓣膜调节的临床效用和成本效益。NeuroDx针对该产品的商业模式涉及主要通过持续销售用于这些测试的一次性传感器来产生收入。分流管理测试仅在美国每年就进行约105，000次分流流量测试。NIH公告“用于脑脊液分流的先进工具和技术”（PA-09-206）强调了对用于管理脑积水患者的新诊断工具的需求，本申请对此做出了响应。我们的应用程序直接响应在医院或门诊环境中使用的诊断工具的请求，这些工具实时工作以定量确定分流功能。

DESCRIPTION (provided by applicant): This Phase II SBIR will develop Continuous Real Time (CRT) ShuntCheck, the first portable, non- invasive device for real time, continuous monitoring of changes in flow in CSF shunts. This device will result in improved clinical management of hydrocephalus by providing a non-invasive method for monitoring and researching shunt function. Hydrocephalus, a common condition in which CSF accumulates in the brain ventricles, is corrected by placing a VP shunt that drains excess CSF to the abdomen. Shunts frequently malfunction, usually by obstruction, but the symptoms of shunt failure are unspecific - headache, nausea. Diagnosis of shunt malfunction is expensive and presents risks (exposure to radiation from CT Scans, risk of infection from radionuclide testing). Additionally, ongoing clinical management of shunted patients is complex (due to a lack of tools for investigating CSF over drainage, for assessing the performance of specific shunt valves and siphon control devices and for streamlining the adjustment of programmable shunt valves). NeuroDx's existing device, ShuntCheck-Micro-Pumper, is a shunt obstruction detector and addresses the need for a non-invasive test for shunt malfunction. While this makes it a valuable tool for the Emergency Dept, the short duration of the test limits its utility for shunt valve adjustment, investigating suspected shunt over drainage, etc. A non-invasive, non-radiologic device which can track changes in CSF flow rate would address many ongoing clinical management needs and become a valuable tool for the neurosurgery clinic. In our Phase I studies, we developed a laboratory prototype CRT based upon a breakthrough innovation in our thermal dilution technology and validated its safety and accuracy in bench and animal studies. CRT can reliably differentiate between no, low and robust shunt flow and can track changes in shunt flow rates over extended time periods. The goal of this Phase II project is to refine CRT ShuntCheck from a laboratory prototype to a production-ready device, validate its safety and accuracy in bench and animal testing, and complete a 510k submission for FDA clearance. Post-Phase II clinical studies will demonstrate the clinical utility and cost effectiveness of CRT ShuntCheck for streamlining valve adjustment in pediatric and in adult NPH patients. NeuroDx's business model for this product involves the generation of revenue primarily from the ongoing sale of single-use, disposable sensors for these tests. Shunt management testing constitutes approximately 105,000 shunt flow tests annually in the United States alone. The need for new diagnostic tools for managing hydrocephalus patients is highlighted by the NIH announcement "Advanced Tools and Technologies for Cerebrospinal Fluid Shunts" (PA-09-206), to which this application is responding. Our application directly responds to the request for Diagnostic tools for use in a hospital or outpatient setting that work in real-time to quantitatively determine shun function.