Validation of ShuntCheck-Micro-Pumper, a non-invasive diagnostic procedure for de

ShuntCheck-Micro-Pumper 的验证，一种非侵入性诊断程序

• 批准号: 8293077
• 负责人: Frederick J Fritz
• 金额: $ 97.63万
• 依托单位: NEURODX DEVELOPMENT, LLC
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-03-01 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8293077
• 关键词: Abdomen; Address; Adverse effects; Affect; American; Boston; Brain Death; Brain Injuries; Businesses; Cerebral Ventricles; Cerebrospinal fluid shunts procedure; Childhood; Clinic; Clinical; Clinical Management; Clinical Research; Collaborations; Complication; Contracts; Data; Development; Device or Instrument Development; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic Sensitivity; Diagnostic Specificity; Diagnostic tests; Exposure to; FDA approved; Failure; Generations; Goals; Headache; Health Care Costs; Hospitals; Human; Hydrocephalus; Imaging Techniques; Infection; Laboratories; Legal patent; Manufacturer Name; Marketing; Measurement; Medical Device; Methods; Modeling; Nausea; Neurosurgeon; Notification; Obstruction; Outcome; Outpatients; Patients; Pediatric Hospitals; Performance; Phase; Pilot Projects; Procedures; Production; Pump; Radiation; Radioisotopes; Research; Risk; Roentgen Rays; Safety; Sales; Second Look Surgery; Series; Shunt Device; Small Business Innovation Research Grant; Specificity; Symptoms; System; Technology; Testing; Time; United States; United States National Institutes of Health; Validation; Work; X-Ray Computed Tomography; commercialization; design; experience; improved; innovation; neurosurgery; novel diagnostics; phase 1 study; prototype; rapid technique; response; sensor; subcutaneous; tool

DESCRIPTION (provided by applicant): This Phase 2 SBIR will provide and clinically validate the first portable, non-invasive diagnostic test for differentiating intermittently flowing patent shunts from occluded or partially occluded shunts - ShuntCheck- Micro-Pumper. 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, potentially for identifying oncoming occlusion before symptoms emerge. 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 no tools exist for predicting shunt malfunction. There are currently no non-invasive, non-radiologic technologies for assessing shunt function and malfunction. NeuroDx has developed a non-invasive device called ShuntCheck which uses thermal dilution to detect CSF flow in subcutaneous shunts. While clinical studies of ShuntCheck demonstrated the accuracy of flow/no-flow measurements, they showed that "no-flow" does not indicate an occluded shunt (since shunt flow can be intermittent) and "flow" does not indicate a patent shunt (since a partially occluded shunt can cause elevated ICP while allowing CSF flow). To address this problem, NeuroDx developed the Micro-Pumper, a small, handheld device which generates a temporary increase in CSF flow through patent but not occluded shunts. This "micro-pumped" flow can be detected by ShuntCheck as an indication of shunt flow capacity. In our Phase 1 studies, we developed operating parameters and a laboratory prototype Micro-Pumper that reliably generates increased CSF flow in a wide variety of patent, but not partially-obstructed, shunt valves. Repeated micro-pumping did not result in any adverse effects on shunt valve function. A pilot clinical study of the ShuntCheck-Micro-Pumper, currently underway at Children's Hospital Boston, indicates that the procedure is acceptable to pediatric patients and generates detectable flows in patent shunts. In Phase 2, we plan to develop a production ready version of the Micro-Pumper, optimize the ShuntCheck design for use with the Micro-Pumper and validate the accuracy of the combined procedure in human clinical studies. Pediatric shunt malfunction and management testing constitute approximately 310,000 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.

描述（由申请人提供）： 该第2阶段SBIR将提供并在临床上验证第一个便携式，非侵入性诊断测试，以间歇性流动的专利分流与闭塞或部分遮挡的分流器 - Shuntcheck-微型驾驶员。该设备将通过提供一种快速且无创的方法来检测有症状患者的CSF分流阻塞，并有可能在症状出现之前鉴定临界闭塞，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。分流功能故障的诊断很昂贵，并且会出现风险（受到CT扫描的辐射，放射性核素测试感染的风险），并且没有任何用于预测分流功能故障的工具。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。 NeuroDX开发了一种称为Shuntcheck的非侵入性装置，该设备使用热稀释度检测皮下分流器中的CSF流动。虽然对简检查的临床研究证明了流量/无流量测量值的准确性，但他们表明“无流量”并未表明闭塞的分流（因为分流流可以间歇性）和“流动”并不表示专利的分流（因为部分闭塞的ICP会导致ICP较高的ICP，同时允许CSF流动）。为了解决这个问题，NeuroDX开发了微型泵，这是一种小型手持设备，可暂时通过专利的CSF流量增加，但不会阻塞分流。可以通过shuntcheck检测到这种“微泵”流量作为分流流量的指示。在我们的第一阶段研究中，我们开发了工作参数和实验室原型微型驾驶器，可可靠地产生各种专利（但不是部分目标）的分流阀中CSF流量增加。重复的微泵化不会对分流阀函数产生任何不利影响。目前在波士顿儿童医院正在进行的Shuntcheck-Micro-Pumper的试点临床研究表明，该手术是儿科患者可以接受的，并在专利分流器中产生可检测的流量。在第2阶段，我们计划开发微型​​烟工的生产现成版本，优化与微型驾驶员一起使用的Shuntcheck设计，并在人类临床研究中验证合并过程的准确性。仅在美国，小儿分流器故障和管理测试每年就构成大约310,000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一次性，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。