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）： 该阶段1 SBIR将开发连续实时（CRT）Shuntcheck，这是第一个实时的便携式，非侵入性设备，对CSF分流器中的流量进行连续监视。该设备将通过提供一种快速且非侵入性的方法来检测有症状患者的CSF分流阻塞，以及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CSF在脑室中积累的常见状况，通过将副总裁分流器放置在腹部中，可以纠正脑心室。分流经常出现故障，通常是由于障碍物而出现的，但是分流衰竭的症状是不明确的 - 头痛，恶心。 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).全新的分流器流量的非侵入性热稀释测试Shuntcheck降低了由于间隙流动流的诊断特异性 - 专利分流器不会连续流动，导致高水平的假阳性读数。目前尚无用于评估分流功能和故障的非侵入性，非放射线技术。该阶段1项目的目的是开发一种原型设备，该原型设备通过热稀释来连续监视CSF流量，并在长凳上验证它并在CSF流动的动物模型中对其进行验证。该程序基于我们的热稀释技术中的突破性创新，该创新允许长期连续的CSF流量测量（例如CSF流量的Holter测试）。我们的第二阶段目标是进行全尺度临床研究，以评估我们非侵入性测试在识别脑积水患者分流功能时的诊断准确性和效用。该项目的一个重要额外结果可能是一种新工具，可以更好地了解脑积水患者的分流和CSF流动行为。仅在美国，分流功能故障和管理测试每年大约构成大约600,000个分流流程测试。 Neurodx为该产品的业务模型涉及主要来自持续出售这些测试的单使用，一次性传感器的收入。 NIH公告“用于脑脊液分流器的高级工具和技术”（PA-09-206）强调了对管理脑积水患者的新诊断工具的需求。我们的建议直接响应了用于实时工作以定量确定分流功能的医院或门诊环境中使用的诊断工具的请求。 公共卫生相关性： 该建议解决了用于实时使用的诊断工具，以实时工作，以定量确定分流功能，通过提供第一个便携式，非侵入性设备来连续监视CSF分流中流量的流量。目前，通过辐射成像技术（例如CT扫描）或通过侵入性手术（例如分流式攻击）诊断出CSF分流器的阻塞是一种常见的脑积水并发症。该新工具将有助于神经外科医生间歇性流动和阻塞分流器区分，并为理解分流功能提供宝贵的研究工具。