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）：