Micro-Pumper method for improving the specificity of CSF shunt patency testing

提高脑脊液分流通畅测试特异性的微泵方法

• 批准号: 7802517
• 负责人: Marek Swoboda
• 金额: $ 14.37万
• 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 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7802517
• 关键词: Abbreviations; Abdomen; Accident and Emergency department; Algorithms; Biomedical Engineering; Boston; Brain Injuries; Cerebral Ventricles; Cerebrospinal Fluid; Cerebrospinal fluid shunts procedure; Cessation of life; Chicago; Child; Childhood; Clinic; Clinical; Collaborations; Data; Detection; Development; Device or Instrument Development; Devices; Diagnosis; Diagnostic; Diagnostic Specificity; Emergency Medicine; Event; Exhibits; Exposure to; Failure; Goals; Hand; Headache; Human; Hydrocephalus; Image; Infection; Investigation; Kinetics; Lead; Legal patent; Liquid substance; Magnetic Resonance Imaging; Marketing; Measures; Medical Device; Methods; Modeling; Nausea; Neurosurgeon; Notification; Obstruction; Outcome; Pathology; Pathway interactions; Patients; Pattern; Pediatric Hospitals; Performance; Phase; Philadelphia; Physicians; Physiologic pulse; Pilot Projects; Radiation; Radioisotopes; Reading; Risk; Savings; Series; Shunt Device; Small Business Innovation Research Grant; Specificity; Symptoms; Techniques; Testing; Time; Universities; University Hospitals; Work; X-Ray Computed Tomography; base; clinical care; clinical research site; cost; design; diagnostic accuracy; experience; fluid flow; improved; neurosurgery; programs; prototype; public health relevance; research clinical testing; tool; validation studies; vibration

DESCRIPTION (provided by applicant): This Phase 1 SBIR will develop a portable, non-invasive tool which will improve the diagnostic accuracy of kinetic shunt patency testing, including radionuclide studies or ShuntCheck tests, in pediatric hydrocephalus patients. This will improve clinical care for pediatric hydrocephalus patients with suspect shunt malfunction. Hydrocephalus is a common condition in which CSF accumulates in the brain ventricles, potentially leading to brain damage and death. It is corrected by placing a VP shunt that carries excess CSF away. Although enormously successful, shunts eventually fail, usually by obstruction. However, the clinical symptoms of shunt obstruction, primarily including headache and nausea, are non-specific, making shunt failure challenging to diagnose. Suspected obstruction is typically investigated using static MRI and CT scans which are expensive, and require evidence of fluid accumulation in serial images, precluding prediction of shunt failure. Exposure to radiation is also significant in shunted children, who may require several shunt investigations annually. Radionuclide studies, which provide dynamic measures of shunt CSF flow, are invasive and carry the risk of infection. They also have reduced diagnostic specificity due to intermittent shunt flow - patent shunts do not flow continuously leading to a high level of false positive readings. A new, non-invasive test for shunt flow, ShuntCheck, also suffers from reduced specificity due to intermittent shunt flow. There are currently no tools for differentiating between intermittently flowing patent shunts and occluded shunts. NeuroDx Development (NeuroDx) has recently developed and bench tested a tool which generates a reproducible level of CSF flow through patent shunts. Used in conjunction with radionuclide studies or ShuntCheck testing, this new device can improve diagnostic specificity of both test methods. The NeuroDx "Micro-Pumper" is a small device which is held against the shunt valve during the radionuclide or ShuntCheck test. The device provides specific vibration pulses to the valve, creating a controlled level of CSF flow through the valve. Using a bench model of CSF flow, we have shown that the Micro-Pumper, used in combination with ShuntCheck can differentiate between non-flowing patent shunts and occluded or partially occluded shunts. The goal of this Phase 1 project is to extend these preliminary findings to develop a clinic-ready prototype Micro-Pumper device and to verify its ability to improve ShuntCheck's specificity in our bench model. In Phase 2, we will test the Micro- Pumper/ShuntCheck combination in a series of human studies, beginning with a 30 patient pilot study and concluding with a 300 patient clinical validation study comparing ShuntCheck patency results to clinical outcomes of symptomatic pediatric patients who present at the Emergency Departments of Children's Hospitals. By the end of Phase 2, we anticipate having accumulated sufficient data to enable submission of a pre-market notification (510(k)) to the FDA for the Micro-Pumper (in conjunction with ShuntCheck). The result of this work will be an important change in the diagnostic algorithm currently used to manage symptomatic hydrocephalus patients. Given the need for a non-invasive method to accurately diagnose shunt failure, the potential savings over alternative methods and the potential for improved patient outcomes, the data from this study will support a product which is commercially viable and extremely important. PUBLIC HEALTH RELEVANCE: This proposal supports the development of a portable, non-invasive tool which will improve the diagnostic accuracy of CSF shunt patency testing such as radionuclide studies and ShuntCheck tests. This will improve clinical care for pediatric hydrocephalus patients with suspect shunt malfunction and could lead to an important change in the standard diagnostic pathway currently used to manage symptomatic hydrocephalus patients.

描述（由申请人提供）：此第1阶段SBIR将开发一种便携式，非侵入性工具，该工具将提高小儿脑积水患者中动力分流通气测试的诊断准确性，包括放射性核素研究或shuntcheck测试。这将改善可疑分流器故障的小儿脑积水患者的临床护理。脑积水是CSF在脑室中积聚的常见疾病，可能导致脑损伤和死亡。通过放置将多余CSF携带的VP分流器纠正。尽管取得了巨大成功，但分流器最终通常会因障碍物而失败。然而，分流阻塞的临床症状，主要包括头痛和恶心，是非特异性的，使分流失败挑战诊断。通常，使用静态MRI和CT扫描来研究可疑的障碍，这些静态MRI和CT扫描需要串行图像中流体积累的证据，从而排除了分流故障的预测。流失的儿童也可能需要每年进行几次分流调查。放射性核素研究提供了分流CSF流动的动态度量，具有侵入性，并承受感染的风险。由于间歇性分流的流动，它们还降低了诊断特异性 - 专利并不会连续流动导致高水平的假阳性读数。对分流流的新的，无创的测试，并因间歇性分流流而导致的特异性降低。当前，没有任何工具可区分间歇性流动的专利分流和遮挡分流。 NeuroDX开发（NeuroDX）最近开发并测试了一种工具，该工具生成了可再现的CSF流通过专利分流器。该新设备与放射性核素研究或简历测试结合使用，可以提高两种测试方法的诊断特异性。 NeuroDx“微泵”是一种小型设备，在放射性核素或简核测试期间固定在分流阀上。该设备为阀门提供了特定的振动脉冲，从而形成了通过阀门的控制水平的CSF流量。使用CSF流量的基准模型，我们表明，与Shuntcheck结合使用的微型驾驶器可以区分非流动的专利分流器和闭塞或部分遮挡的分流器。该第1阶段项目的目的是扩展这些初步发现，以开发诊所就绪的原型微型Pumper设备，并验证其在我们的基准模型中提高Shuntcheck特异性的能力。在第2阶段中，我们将在一系列人类研究中测试微型/平滑肌的组合，从30例患者试验研究开始，并与300例患者临床验证研究结束，将Shuntcheck的通知结果与在儿童医院急诊室急诊病人出现的有症状的儿科患者的临床结果进行比较。到第2阶段结束时，我们预计已经累积了足够的数据，可以使MicroPumper的FDA提交前市场通知（510（k））（与Shuntcheck结合使用）。这项工作的结果将是目前用于管理有症状性脑积水患者的诊断算法的重要变化。鉴于需要一种非侵入性方法来准确诊断分流故障，对替代方法的潜在节省以及改善患者预后的潜力，这项研究的数据将支持一种在商业上可行且极为重要的产品。 公共卫生相关性：该提案支持便携式无创工具的开发，该工具将提高CSF分流通畅测试的诊断准确性，例如放射性核素研究和Shuntcheck测试。这将改善可疑分流器故障的小儿脑积水患者的临床护理，并可能导致目前用于管理有症状性脑积水患者的标准诊断途径的重要变化。