Continuous Real Time CSF Shunt Flow Monitor ShuntCheck

连续实时脑脊液分流监测仪 ShuntCheck

• 批准号: 8121054
• 负责人: Marek Swoboda
• 金额: $ 25.72万
• 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 2012-07-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8121054
• 关键词: Abbreviations; Abdomen; Address; Affect; American; Animal Model; Behavior; Biological; Boston; Brain Death; Brain Injuries; Businesses; Cerebral Ventricles; Cerebrospinal Fluid; Cerebrospinal fluid shunts procedure; Child; Clinical; Clinical Management; Clinical Research; Complex; Complication; Contracts; Data; Development; Device or Instrument Development; Devices; Diagnosis; Diagnostic; Diagnostic Specificity; Drainage procedure; Electronics; Exposure to; Failure; Family suidae; Generations; Goals; Headache; Health Care Costs; Holter Electrocardiography; Hospitals; Hour; Human; Hydrocephalus; Imaging Techniques; Infection; Legal patent; Manufacturer Name; Marketing; Measurement; Medical Device; Methods; Modeling; Monitor; Nausea; Neurosurgeon; Notification; Obstruction; Outcome; Outpatients; Patient Monitoring; Patients; Performance; Phase; Pilot Projects; Positioning Attribute; Procedures; Radiation; Radioisotopes; Reaction; Reading; Relative (related person); Research; Risk; Running; Sales; Series; Shunt Device; Site; Skin; Small Business Innovation Research Grant; Staging; Symptoms; Technology; Testing; Time; United States; United States National Institutes of Health; Work; X-Ray Computed Tomography; base; commercial application; design; diagnostic accuracy; experience; improved; innovation; neurosurgery; novel diagnostics; programs; prototype; rapid technique; sensor; subcutaneous; tool; validation studies

DESCRIPTION (provided by applicant): This Phase 1 SBIR will develop Continuous Real Time (CRT) ShuntCheck, the first portable, non- invasive device for real time, continuous monitoring of flow in CSF shunts. This device will result in improved clinical management of hydrocephalus by providing a rapid and non-invasive method for detecting CSF shunt obstruction in symptomatic patients, and for monitoring and researching shunt function in asymptomatic patients. 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) and regular, 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). A new, non-invasive thermal dilution test for shunt flow, ShuntCheck, has reduced diagnostic specificity due to intermittent shunt flow - patent shunts do not flow continuously, leading to a high level of false positive readings. There are currently no non-invasive, non-radiologic technologies for assessing shunt function and malfunction. The goal of this Phase 1 project is to develop a prototype device which continuously monitors CSF flow via thermal dilution, and to verify it in a bench and validate it in an animal model of CSF flow. The program is based upon a breakthrough innovation in our thermal dilution technology which allows for long term, continuous CSF flow measurement (like a Holter test for CSF flow). Our Phase 2 goal will be to conduct a full scale clinical study to assess the diagnostic accuracy and utility of our non-invasive test in identifying shunt malfunction in hydrocephalus patients. An important additional outcome of this project will likely be a new tool for better understanding shunt and CSF flow behavior in hydrocephalus patients. Shunt malfunction and management testing constitute approximately 600,000 shunt flow tests annually in the United States alone. 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. 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 proposal is responding. Our proposal directly responds to the request for Diagnostic tools for use in a hospital or outpatient setting that work in real-time to quantitatively determine shunt function. PUBLIC HEALTH RELEVANCE: This proposal addresses the need for diagnostic tools for use in a hospital or outpatient setting that work in real-time to quantitatively determine shunt function by providing the first portable, non-invasive device for continuous monitoring of flow in CSF shunts. Obstruction of CSF shunts, a common complication in hydrocephalus, is currently diagnosed by radiation imaging techniques, such as CT Scan, or by invasive procedures, such as shunt tapping. This new tool will help neurosurgeons differentiate between intermittently flowing and obstructed shunts and will provide a valuable research tool for understanding shunt function.

描述（由申请人提供）： 第一阶段 SBIR 将开发连续实时 (CRT) ShuntCheck，这是第一款便携式、非侵入式设备，用于实时、连续监测 CSF 分流器中的流量。该设备将提供一种快速、非侵入性的方法来检测有症状患者的脑脊液分流阻塞，并监测和研究无症状患者的分流功能，从而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。分流故障的诊断费用昂贵，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），并且对分流患者进行定期、持续的临床管理很复杂（由于缺乏用于调查 CSF 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的工具）。一种新的非侵入性分流热稀释测试 ShuntCheck 由于间歇性分流而降低了诊断特异性 - 专利分流不会连续流动，导致高水平的假阳性读数。目前还没有用于评估分流功能和故障的非侵入性、非放射技术。该第一阶段项目的目标是开发一种原型设备，通过热稀释连续监测脑脊液流量，并在工作台上进行验证，并在脑脊液流量动物模型中进行验证。该计划基于我们热稀释技术的突破性创新，该技术允许长期、连续的脑脊液流量测量（如脑脊液流量的动态心电图测试）。我们第二阶段的目标是进行全面的临床研究，以评估我们的非侵入性测试在识别脑积水患者分流功能障碍方面的诊断准确性和效用。该项目的一个重要的额外成果可能是一个新工具，可以更好地了解脑积水患者的分流和脑脊液流动行为。仅在美国，每年就进行约 600,000 次分流测试，包括分流故障和管理测试。 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。 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，本提案对此作出了回应。我们的提案直接响应了对在医院或门诊环境中使用实时定量确定分流功能的诊断工具的需求。 公共卫生相关性： 该提案满足了对医院或门诊使用的诊断工具的需求，通过提供第一个用于连续监测脑脊液分流中流量的便携式、非侵入性设备，实时定量确定分流功能。脑脊液分流器阻塞是脑积水的常见并发症，目前通过 CT 扫描等放射成像技术或分流器穿刺等侵入性操作进行诊断。这种新工具将帮助神经外科医生区分间歇性分流和阻塞性分流，并为了解分流功能提供有价值的研究工具。