Continuous Real Time CSF Shunt Flow Monitor ShuntCheck

连续实时脑脊液分流监测仪 ShuntCheck

• 批准号: 8520078
• 负责人: Frederick J Fritz
• 金额: $ 47.47万
• 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 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8520078
• 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; Computers; 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; Tablets; 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）：该II期SBIR将开发连续实时（CRT） ShuntCheck，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器的流量变化。该装置通过提供一种非侵入性的方法来监测和研究分流功能，将改善脑积水的临床治疗。脑积水是脑脊液在脑室积聚的一种常见病症，可通过放置VP分流术将多余的脑脊液引流至腹部来纠正。分流管常因梗阻而失灵，但分流管失灵的症状不明确，如头痛、恶心等。分流器故障的诊断是昂贵的，并且存在风险（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是复杂的（由于缺乏工具来调查脑脊液引流，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现有的设备ShuntCheck-Micro-Pumper是一种分流阻塞检测器，满足了对分流故障进行非侵入性测试的需求。虽然这使其成为应急部门的宝贵工具，但测试持续时间短限制了其在分流阀调整，调查可疑分流排水等方面的实用性。一种可以跟踪脑脊液流速变化的非侵入性、非放射性设备将解决许多正在进行的临床管理需求，并成为神经外科临床的宝贵工具。在I期研究中，我们基于热稀释技术的突破性创新开发了实验室CRT原型，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、低分流流量和强劲分流流量，并可以在较长时间内跟踪分流流量的变化。该二期项目的目标是将CRT ShuntCheck从实验室原型改进为可生产的设备，在实验室和动物试验中验证其安全性和准确性，并完成510k的FDA审批。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对该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，每年就进行大约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，该应用正在对此作出回应。我们的应用程序直接响应了在医院或门诊环境中使用的诊断工具的请求，这些工具可以实时定量地确定顺功能。