Long Term Implantable ICP Monitor for Hydrocephalus Patients

描述（由申请人提供）：本I期SBIR将开发ICPCheck，这是首款用于脑积水患者的长期植入式、无创可读颅内压（ICP）监测仪。该器械将通过提供一种快速、无创的方法来检测有症状患者因CSF分流阻塞导致的ICP升高，并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管理。脑积水是一种常见的CSF积聚在脑室的疾病，通过放置VP分流管将多余的CSF引流到腹部来纠正，将ICP维持在正常水平。分流管经常发生故障，通常是由于阻塞，导致危及生命的脑室内ICP升高。但分流失败的症状没有特异性头痛恶心。分流器故障的诊断费用昂贵且存在风险（暴露于CT扫描的辐射、分流器分接头和放射性核素检测的感染风险），分流患者的定期、持续临床管理复杂（由于缺乏研究CSF过度引流和评估特定分流阀和虹吸管控制装置性能的工具）。目前没有无创、非放射学技术检测分流故障引起的脑室内ICP升高。可在分流手术期间放置并可在其后进行无创询问的长期植入式脑室内ICP监测器将满足这一需求-识别CT扫描无法（切开脑室）的故障，并结合神经外科医生的判断，可能排除故障并避免不必要的CT扫描。第一阶段项目的目标是开发一个原型设备，并在ICP的台架模型中对其进行验证。该计划将是NeuroDx Development（ShuntCheck的开发商）和Millar Instruments（首屈一指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-Millar开发的长期漂移控制技术和NeuroDx开发的重新校准技术。我们的第二阶段目标是将我们的概念验证原型转换为MEMS设备，并进行全面的临床前和临床研究，以评估该设备在识别脑积水患者分流故障导致的ICP升高方面的诊断准确性和实用性。NIH公告“用于脑脊液分流的先进工具和技术”（PA-09-206）强调了对用于管理脑积水患者的新诊断工具的需求，本申请对此做出了响应。我们的应用程序直接响应 用于医院或门诊环境的诊断工具，可实时工作以定量确定分流功能。

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.