Long Term Implantable ICP Monitor for Hydrocephalus Patients

描述(由申请人提供)：这个第一阶段的SBIR将开发ICPCheck，这是第一个用于脑积水患者的长期植入式、非侵入性可读颅内压(ICP)监测器。该装置将通过提供一种快速和非侵入性的方法来检测有症状患者因脑脊液分流阻塞引起的颅内压升高，以及监测和研究无症状患者的分流功能，从而改善脑积水的临床治疗。脑积水是一种常见的脑脊液积聚在脑室的情况，通过放置VP分流术将多余的脑脊液排入腹部，使颅内压保持在正常水平，可以纠正这种情况。分流管经常出现故障，通常是由于梗阻，导致危及生命的脑室内颅内压升高。但分流失败的症状是非特异性的--头痛、恶心。分流功能故障的诊断费用昂贵，而且存在风险(暴露在CT扫描的辐射中，分流龙头感染的风险和核素测试)，以及分流患者常规的、持续的临床管理是复杂的(由于缺乏工具来调查脑脊液过度引流和评估特定分流阀和虹吸控制装置的性能)。目前还没有非侵入性、非放射学的技术来检测分流故障引起的脑室内颅内压升高。可以在分流手术期间放置的长期可植入脑室内ICP监测器将满足这一需求-识别CT扫描无法识别的故障(脑室裂开)，并结合神经外科医生的判断，潜在地排除故障并避免不必要的CT扫描。这个第一阶段项目的目标是开发一个原型装置，并在电感耦合等离子体的台架模型上进行验证。该项目将是NeuroDx开发公司(ShuntCheck的开发商)和米勒仪器公司(领先的心脏和神经外科压力传感器制造商)之间的合作，并基于两项突破性创新--米勒公司开发的长期漂移控制技术和NeuroDx公司开发的再校准技术。我们的第二阶段目标是将我们的概念验证原型转化为MEMS设备，并进行全面的临床前和临床研究，以评估该设备在确定脑积水患者因分流故障而导致的颅内压升高方面的诊断准确性和实用性。NIH的公告“脑脊液分流的先进工具和技术”(PA-09-206)强调了对管理脑积水患者的新诊断工具的需求，本申请正在对此做出回应。我们的应用程序直接响应 在医院或门诊环境中使用的实时工作以定量确定分流功能的诊断工具。 公共卫生相关性：这一应用解决了医院或门诊环境中使用的诊断工具的需求，通过为脑积水患者提供第一个长期植入式、非侵入性可读脑室内压(ICP)监测仪，实时工作以定量确定分流功能。脑脊液分流阻塞是脑积水的常见并发症，目前通过放射成像技术(如CT扫描)或侵入性检查(如分流手术)进行诊断。这种装置可以在分流手术中植入，之后可以无创询问，将有助于神经外科医生检测由于分流故障引起的脑室内颅内压升高，并将为了解分流功能提供有价值的研究工具。

DESCRIPTION (provided by applicant): This Phase I SBIR will develop ICPCheck, the first long term implantable, non-invasively readable intracranial pressure (ICP) monitor for hydrocephalus patients. This device will result in improved clinical management of hydrocephalus by providing a rapid and non-invasive method for detecting elevated ICP due to 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, maintaining ICP within normal levels. Shunts frequently malfunction, usually by obstruction, leading to a life-threatening elevation of intraventricular ICP. 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 shunt taps and radionuclide testing) and regular, ongoing clinical management of shunted patients is complex (due to a lack of tools for investigating CSF over-drainage and for assessing the performance of specific shunt valves and siphon control devices). There are currently no non-invasive, non-radiologic technologies for detecting elevated intraventricular ICP caused by shunt malfunction. A long-term implantable intraventricular ICP monitor which can be placed during shunt surgery and which can be interrogated non-invasively thereafter would address this need - identifying malfunction where CT scan cannot (slit ventricles) and, in conjunction with the neurosurgeon's judgment, potentially ruling out malfunction and avoiding an unnecessary CT scan. The goal of this Phase I project is to develop a prototype device and to validate it in a bench model of ICP. The program will be a collaboration between NeuroDx Development (developer of ShuntCheck) and Millar Instruments (the premier cardiac and neurosurgical pressure transducer manufacturer) and is based upon two breakthrough innovations - a technology for long term drift control developed by Millar and a technology for recalibration developed by NeuroDx. Our Phase II goal will be to convert our proof-of-concept prototype into a MEMS device and to conduct full scale preclinical and clinical studies to assess the diagnostic accuracy and utility o the device in identifying elevated ICP due to shunt malfunction in hydrocephalus patients. 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 application is responding. Our application directly responds to the request for Diagnostic tools for use in a hospital or outpatient setting that work in real-time to quantitativey determine shunt function. PUBLIC HEALTH RELEVANCE: This application 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 long term implantable, non- invasively readable intracranial pressure (intraventricular ICP) monitor for hydrocephalus patients. 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 device, which can be implanted during shunt surgery and which can be interrogated non-invasively thereafter, will help neurosurgeons detect elevated intraventricular ICP due to shunt malfunction and will provide a valuable research tool for understanding shunt function.