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(申请人提供)：这一阶段的SBIR将开发一种便携式、非侵入性工具，将提高动态分流通畅测试的诊断准确性，包括放射性核素研究或ShuntCheck测试，用于儿童脑积水患者。这将改善疑似分流功能障碍的儿童脑积水患者的临床护理。脑积水是一种常见的脑脊液积聚在脑室的情况，有可能导致脑损伤和死亡。可通过放置VP分流术将多余的脑脊液带走来纠正。虽然分流非常成功，但分流最终会失败，通常是因为阻塞。然而，分流梗阻的临床症状，主要包括头痛和恶心，是非特异性的，这使得分流失败的诊断具有挑战性。可疑的梗阻通常使用静态MRI和CT扫描进行调查，这两种检查都很昂贵，而且需要在序列图像中发现液体积聚的证据，从而排除了分流失败的预测。辐射暴露在接受分流手术的儿童中也很重要，他们每年可能需要进行几次分流检查。放射性核素研究提供了脑脊液分流的动态测量，具有侵入性，并带有感染的风险。由于间歇性分流--分流不连续导致高水平的假阳性读数，它们也降低了诊断的特异度。一种新的非侵入性分流检测，ShuntCheck，也由于间歇性分流而降低了特异性。目前还没有区分间歇性分流和闭塞分流的工具。NeuroDx开发公司(NeuroDx)最近开发了一种工具并进行了台架测试，该工具可以通过专利分流产生可重复水平的脑脊液流量。这种新设备与放射性核素研究或ShuntCheck测试结合使用，可以提高这两种测试方法的诊断特异性。NeuroDx“Micro-Pumper”是一种小型装置，在进行放射性核素或分流检查试验时将其紧贴在分流阀上。该装置向瓣膜提供特定的振动脉冲，产生流过瓣膜的受控水平的脑脊液。使用脑脊液流动的台式模型，我们已经证明，微泵与分流检查结合使用可以区分非流动的分流和闭塞或部分闭塞的分流。这个第一阶段项目的目标是扩展这些初步发现，以开发一种可用于临床的微泵装置原型，并在我们的工作台模型中验证其提高ShuntCheck特异性的能力。在第二阶段，我们将在一系列人体研究中测试Micro-Pumper/ShuntCheck的组合，首先是30名患者的试点研究，最后是300名患者的临床验证研究，将ShuntCheck的通畅结果与儿童医院急诊科有症状的儿科患者的临床结果进行比较。到第二阶段结束时，我们预计已经积累了足够的数据，能够向FDA提交Micro-Pumper的上市前通知(510(K))(与ShuntCheck一起)。这项工作的结果将是对目前用于管理症状性脑积水患者的诊断算法的重要改变。考虑到对准确诊断分流故障的非侵入性方法的需求、与替代方法相比的潜在节省以及改善患者预后的可能性，这项研究的数据将支持一种商业上可行且极其重要的产品。 公共卫生相关性：这项提案支持开发一种便携式、非侵入性工具，该工具将提高脑脊液分流通畅性测试(如放射性核素研究和分流检查测试)的诊断准确性。这将改善疑似分流功能障碍的儿童脑积水患者的临床护理，并可能导致目前用于管理症状性脑积水患者的标准诊断路径发生重要变化。