Continuous Real Time CSF Shunt Flow Monitor ShuntCheck

连续实时脑脊液分流监测仪 ShuntCheck

• 批准号: 8639595
• 负责人: Frederick J Fritz
• 金额: $ 51.91万
• 依托单位: NEURODX DEVELOPMENT, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-05-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8639595
• 关键词: Abbreviations; Abdomen; Address; Adult; Affect; American; Animal Model; Animal Testing; Animals; Brain Death; Brain Injuries; Businesses; Cerebral Ventricles; Cerebrospinal Fluid; Cerebrospinal fluid shunts procedure; Childhood; Clinic; Clinical; Clinical Management; Clinical Research; Complex; Contracts; Data Security; Device or Instrument Development; Devices; Diagnosis; Diagnostic; Drainage procedure; Electronics; Emergency Situation; Exposure to; Failure; Foundations; Generations; Goals; Headache; Health Care Costs; Heating; Holter Electrocardiography; Hospitals; Human; Hydrocephalus; Infection; Laboratories; Link; Manufacturer Name; Marketing; Medical Device; Methods; Modeling; Monitor; Nausea; Normal Pressure Hydrocephalus; Obstruction; Outpatients; Patients; Pediatric Hospitals; Performance; Phase; Procedures; Production; Pump; Radiation; Radioisotopes; Reporting; Research; Risk; Running; Safety; Sales; Shunt Device; Small Business Innovation Research Grant; Symptoms; System; Tablet Computer; Technology; Testing; Time; United States; United States National Institutes of Health; Wireless Technology; Work; X-Ray Computed Tomography; base; cost effectiveness; design; detector; digital; ergonomics; exhaust; experience; improved; innovation; journal article; meetings; neurosurgery; novel diagnostics; phase 1 study; prototype; public health relevance; sensor; tool; user friendly software

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.

描述（由申请人提供）：第二阶段 SBIR 将开发连续实时 (CRT) ShuntCheck，这是第一款便携式、非侵入性设备，用于实时、连续监测 CSF 分流中的流量变化。该设备将通过提供一种用于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。脑积水是脑脊液积聚在脑室的一种常见病症，可通过放置 VP 分流器将多余的脑脊液排至腹部来纠正。分流器经常出现故障，通常是由于阻塞，但分流器故障的症状并不具体——头痛、恶心。分流器故障的诊断费用昂贵且存在风险（CT 扫描的辐射暴露、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很复杂（由于缺乏用于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调整的工具）。 NeuroDx 的现有设备 ShuntCheck-Micro-Pumper 是一款分流阻塞检测器，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、调查可疑分流过度引流等方面的实用性。能够跟踪脑脊液流量变化的非侵入性、非放射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，我们基于热稀释技术的突破性创新开发了实验室原型 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流量、低分流流量和强分流流量，并且可以跟踪长时间段内分流流量的变化。该第二阶段项目的目标是将 CRT ShuntCheck 从实验室原型改进为可投入生产的设备，在实验室和动物测试中验证其安全性和准确性，并完成 510k 提交以供 FDA 审批。 II 期后临床研究将证明 CRT ShuntCheck 在简化儿科和成人 NPH 患者瓣膜调整方面的临床实用性和成本效益。 NeuroDx 该产品的商业模式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。仅在美国，每年就进行约 105,000 次分流管理测试。 NIH 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，本应用程序对此做出了回应。我们的应用程序直接响应对在医院或门诊环境中使用的诊断工具的要求，这些工具可以实时工作以定量确定顺流功能。