Long Term Implantable ICP Monitor for Hydrocephalus Patients

用于脑积水患者的长期植入式 ICP 监测仪

• 批准号: 8393087
• 负责人: Marek Swoboda
• 金额: $ 34.77万
• 依托单位: NEURODX DEVELOPMENT, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-15 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8393087
• 关键词: Abbreviations; Abdomen; Address; Affect; Algorithms; American; Animal Model; Animals; Brain Death; Brain Injuries; Calibration; Cardiac; Cerebral Ventricles; Cerebrospinal Fluid; Cerebrospinal fluid shunts procedure; Clinical; Clinical Management; Clinical Research; Collaborations; Complex; Complication; Data; Development; Devices; Diagnosis; Diagnostic; Drainage procedure; Exposure to; Failure; Family suidae; Financial compensation; Funding; Goals; Headache; Health Care Costs; Hospitals; Hydrocephalus; Imaging Techniques; Implant; Infection; International; Intracranial Hypertension; Intracranial Pressure; Intraventricular; Judgment; Life; Manufacturer Name; Marketing; Measurement; Medical Device; Membrane; Methods; Modeling; Monitor; Nausea; Neurosurgeon; Notification; Obstruction; Operative Surgical Procedures; Outpatients; Patient Monitoring; Patients; Performance; Phase; Pressure Transducers; Procedures; Radiation; Radioisotopes; Reading; Research; Risk; Shunt Device; Side; Signal Transduction; Site; Small Business Innovation Research Grant; Speed; Staging; Symptoms; System; Technology; Testing; Time; United States National Institutes of Health; Work; X-Ray Computed Tomography; base; commercial application; design; diagnostic accuracy; human study; improved; innovation; instrument; miniaturize; novel diagnostics; pre-clinical; preclinical study; pressure; programs; prototype; rapid technique; research study; response; sensor; tool

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.

描述（由申请人提供）：此I阶段SBIR将开发ICPCHECK，这是第一个长期植入，不可侵入的颅内压（ICP）监测室，用于脑积水患者。该设备将通过提供一种快速且非侵入性的方法来改善脑积水的临床管理，以检测有症状的患者CSF分流器引起的ICP升高，并用于监测无症状患者的分流功能。脑积水是CSF积聚在脑室中的常见状况，通过将副总裁分流器放置在腹部到腹部，并将ICP保持在正常水平的水平上，从而纠正了脑电图。通常通过障碍物经常出现故障，导致脑室室内ICP的生命升高。但是，分流衰竭的症状是不明确的 - 头痛，恶心。分流功能故障的诊断很昂贵，并且会出现风险（受到CT扫描的辐射，分流taps和放射性核素测试感染的风险），并且对脱离患者进行的常规临床管理是复杂的（由于缺乏用于调查CSF过度的工具，并评估特定的Shunt Valves Valves和Siphon Contracthon Contracthon Contracteces的性能）。目前尚无用于检测分流功能出现引起的脑室室内ICP升高的非侵入性的非辐射技术。可以在分流手术期间放置的长期植入室内ICP监测器，此后可以非侵入性地进行询问，这将满足这种需求 - 确定CT扫描无法（狭缝心室）以及Neurosurgeon与Neurosurgeon的判断相结合的故障，与潜在的判断，潜在地进行了判断，并避免了不必要的can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can can。该阶段I项目的目标是开发原型设备并在ICP的基准模型中验证它。该计划将是Neurodx开发（Shuntcheck的开发人员）与Millar Instruments（主要心脏和神经外科压力传感器制造商）之间的合作，并且基于两项突破性创新 - Millar开发的长期漂移控制技术，以及由Neurodx开发的一种用于重新校准的技术。我们的II期目标是将我们的概念验证原型转换为MEMS设备，并进行全尺度的临床前和临床研究，以评估由于脑积水患者分流功能导致的ICP升高的诊断准确性和效用。 NIH公告“用于脑脊液分流器的高级工具和技术”（PA-09-206）强调了对管理脑积水患者的新诊断工具的需求。我们的申请直接响应 用于实时工作以定量的医院或门诊环境中使用的诊断工具确定分流功能。 公共卫生相关性：该应用程序解决了在医院或门诊环境中使用的诊断工具的需求，这些工具可实时使用，以定量确定分流功能，通过为脑力头药患者提供第一长期可植入的，不可侵入性的颅内压（室内ICP）监测器。目前，通过辐射成像技术（例如CT扫描）或通过侵入性手术（例如分流式攻击）诊断出CSF分流器的阻塞是一种常见的脑积水并发症。该设备可以在分流手术期间植入，此后可以进行非侵入性的询问，它将有助于神经外科医生检测到由于分流功能出现而导致的脑室内ICP升高，并将提供有价值的研究工具来理解分流功能。