ShuntCheck Clinical Validation and ShuntCheck-Micro-Pumper Assessment of CSF Shun

ShuntCheck 临床验证和 ShuntCheck-微泵评估 CSF Shun

• 批准号: 8071595
• 负责人: Marek Swoboda
• 金额: $ 35万
• 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: 2010-05-11 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8071595
• 关键词: Address; Algorithms; Biosensor; Boston; Brain Death; Brain Injuries; Brain imaging; Cardiac; Cerebral Ventricles; Cerebrospinal Fluid; Cerebrospinal fluid shunts procedure; Child; Childhood; Clinical; Collaborations; Communities; Complication; Data; Development; Device or Instrument Development; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic Specificity; Exposure to; Failure; Fright; Goals; Headache; Hospitals; Hydrocephalus; Image; Imaging Techniques; Individual; Infection; Investigation; Label; Legal patent; Life; Liquid substance; MRI Scans; Magnetic Resonance Imaging; Marketing; Measures; Medical Device; Methods; Modality; Nature; Nausea; Notification; Obstruction; Operative Surgical Procedures; Outcome; Outpatients; Patients; Pediatric Hospitals; Performance; Phase; Physiologic pulse; Pilot Projects; Procedures; Program Development; Pump; Radiation; Radioisotopes; Reading; Research; Research Design; Risk; Safety; Sample Size; Savings; Shunt Device; Skin Temperature; Small Business Innovation Research Grant; Specificity; Symptoms; Techniques; Technology; Temperature; Testing; Time; Uncertainty; Validation; Work; X-Ray Computed Tomography; base; cerebrospinal fluid flow; clinical decision-making; experience; fluid flow; improved; innovation; mathematical algorithm; meetings; operation; public health relevance; repaired; research clinical testing; tool; vibration

DESCRIPTION (provided by applicant): The goal of this SBIR is to create the first comprehensive set of clinical tools and noninvasive methods for diagnosing cerebrospinal fluid (CSF) shunt obstruction and to validate them to convince clinicians of their clinical value. 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, leading to questions about the device's accuracy. There are currently no tools for differentiating between intermittently flowing patent shunts and occluded shunts. NeuroDx Development (NeuroDx) has recently developed and bench tested "Micro-Pumper", a small device which is held against the shunt valve during the ShuntCheck test. The device provides specific vibration pulses to the valve, creating a controlled level of CSF flow through the valve. 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 validate the accuracy of the ShuntCheck flow/no-flow determination via comparison to MRI flow testing and to test the Micro-Pumper/ShuntCheck combination in a pilot study or pediatric hydrocephalus patients at Children's Hospital Boston. 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 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 diagnostic procedure which is commercially viable and extremely important. 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 creating the first comprehensive set of clinical tools and noninvasive methods for diagnosing cerebrospinal fluid (CSF) shunt obstruction and validating them to convince clinicians of the valuable information available from ShuntCheck(R) (SC) and Micro-Pumper. Obstruction of CSF shunts, a common complication, is currently diagnosed by radiation imaging techniques, such as CT Scan, or by invasive procedures, such as shunt tapping. These new tools will enable shunt obstruction to be diagnosed and will provide a research tool for understanding shunt function.

描述（由申请人提供）： 该SBIR的目标是创建第一套用于诊断脑脊液（CSF）分流阻塞的全面的临床工具和无创方法，并对其进行验证，以使临床医生相信其临床价值。脑积水是一种常见的疾病，其中CSF积聚在脑室中，可能导致脑损伤和死亡。通过放置VP分流管将多余的CSF带走来纠正。尽管分流术取得了巨大的成功，但最终还是失败了，通常是由于阻塞。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，使得分流失败的诊断具有挑战性。通常使用静态MRI和CT扫描来研究疑似阻塞，这是昂贵的，并且需要在连续图像中有液体积聚的证据，从而排除了分流失败的预测。接受分流术的儿童暴露于辐射的情况也很严重，他们每年可能需要接受几次分流术检查。放射性核素检查提供了分流CSF流量的动态测量，但具有侵入性，并有感染的风险。由于间歇性分流，它们也降低了诊断特异性-专利分流不连续流动，导致高水平的假阳性读数。一种新的、无创的分流流量测试，ShuntCheck，也由于间歇性分流而降低了特异性，导致了对该设备准确性的质疑。目前还没有区分间歇性流动的通畅分流和闭塞分流的工具。NeuroDx开发部（NeuroDx）最近开发并台架测试了“微型泵”，这是一种小型器械，在分流检查测试期间抵靠分流阀固定。该设备向阀门提供特定的振动脉冲，从而产生通过阀门的受控水平的CSF流量。我们已经证明，与ShuntCheck联合使用的微型泵可以区分非流动通畅分流管和闭塞或部分闭塞分流管。该第1阶段项目的目标是通过与MRI流量测试进行比较来确认ShuntCheck流量/无流量确定的准确性，并在波士顿儿童医院的儿童脑积水患者的试点研究中测试微型泵/ShuntCheck组合。到第2阶段结束时，我们预计已经积累了足够的数据，可以向FDA提交微型泵（与ShuntCheck一起）的上市前通知（510（k））。这项工作的结果将是目前用于管理脑积水患者的诊断算法的重要变化。考虑到需要一种非侵入性方法来准确诊断分流失败、替代方法的潜在节省以及改善患者结局的潜力，本研究的数据将支持一种商业上可行且极其重要的诊断程序。 公共卫生关系： 该提案通过创建第一套用于诊断脑脊液（CSF）分流阻塞的全面临床工具和无创方法，并对其进行验证，以使临床医生相信ShuntCheck（R）（SC）和Micro-Pumper提供的有价值信息，满足了医院或门诊患者对实时工作的诊断工具的需求，以定量确定分流功能。脑脊液分流管阻塞是一种常见的并发症，目前通过放射成像技术（如CT扫描）或侵入性手术（如分流管穿刺）进行诊断。这些新的工具将使分流阻塞被诊断，并将提供一个研究工具，了解分流功能。