Continuous Real Time CSF Shunt Flow Monitor ShuntCheck

描述(由申请人提供)：该二期SBIR将开发连续实时(CRT)分流检查，这是第一个便携式、非侵入性设备，用于实时、连续监测脑脊液分流中的流量变化。该装置将为监测和研究分流功能提供一种非侵入性方法，从而改善脑积水的临床治疗。脑积水是一种常见的脑脊液积聚在脑室的情况，可通过放置VP分流术将多余的脑脊液排入腹部来纠正。分流管经常出现故障，通常是由于阻塞，但分流管故障的症状是非特异性的-头痛、恶心。分流功能故障的诊断费用昂贵，而且存在风险(暴露于CT扫描的辐射，放射性核素测试的感染风险)。此外，正在进行的分流患者的临床管理是复杂的(因为缺乏工具来调查脑脊液过度引流，评估特定分流阀和虹吸控制装置的性能，以及简化可编程分流阀的调整)。NeuroDx的现有设备ShuntCheck-Micro-Pumper是一种分流障碍物检测器，可满足对分流故障进行非侵入性测试的需求。虽然这使其成为急诊科的宝贵工具，但测试持续时间较短，限制了其在调整分流阀、调查疑似分流过度引流等方面的应用。一种可以跟踪脑脊液流速变化的非侵入性、非放射学设备将满足许多持续的临床管理需求，并成为神经外科诊所的宝贵工具。在我们的第一阶段研究中，我们开发了基于我们的热稀释技术的突破性创新的实验室CRT原型，并在实验台和动物实验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，并可以跟踪分流速度在延长的时间段内的变化。该第二阶段项目的目标是将CRT ShuntCheck从实验室原型改进为可生产的设备，在工作台和动物测试中验证其安全性和准确性，并完成510k提交以获得FDA批准。第二阶段后的临床研究将证明CRT ShuntCheck在儿童和成人NPH患者中简化瓣膜调节的临床实用性和成本效益。NeuroDx这种产品的商业模式主要是通过持续销售用于这些测试的一次性传感器来产生收入。仅在美国，分流管理测试就构成了每年约105,000次分流测试。NIH的公告“脑脊液分流的先进工具和技术”(PA-09-206)强调了对管理脑积水患者的新诊断工具的需求，本申请正在对此做出回应。我们的应用程序直接响应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SHUN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.