Long Term Implantable ICP Monitor for Hydrocephalus Patients

描述（由申请人提供）：该I期SBIR将开发ICPCheck，这是首个用于脑积水患者的长期可植入、无创可读颅内压（ICP）监测仪。该装置为有症状患者检测脑脊液分流管阻塞引起的颅内压升高提供了一种快速、无创的方法，为无症状患者监测和研究分流管功能提供了一种方法，将改善脑积水的临床管理。脑积水是脑脊液在脑室积聚的一种常见病症，可通过放置VP分流将多余的脑脊液引流至腹部，将ICP维持在正常水平。分流经常发生功能障碍，通常是由于阻塞，导致危及生命的脑室内ICP升高。但分流管衰竭的症状不明确——头痛、恶心。分流管故障的诊断昂贵且存在风险（CT扫描带来的辐射暴露、分流管龙头和放射性核素测试带来的感染风险），而且分流管患者的常规、持续的临床管理很复杂（由于缺乏调查脑脊液过度引流和评估特定分流阀和虹吸控制装置性能的工具）。目前还没有非侵入性、非放射学的技术来检测由分流器功能障碍引起的脑室内ICP升高。可在分流术中放置的长期植入式脑室内ICP监测仪，可以在手术后进行无创检查，可以满足这一需求——识别CT扫描无法识别的功能障碍（裂隙脑室），并与神经外科医生的判断相结合，潜在地排除功能障碍，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设备，并在ICP的实验模型中验证它。该项目将由NeuroDx Development （ShuntCheck的开发商）和Millar Instruments（主要的心脏和神经外科压力传感器制造商）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II期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因分流故障导致的ICP升高方面的诊断准确性和实用性。NIH公告“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，该应用正在对此作出回应。我们的应用程序直接响应请求

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.