Noninvasive, wireless thermal sensors for the quantitative monitoring of ventricular shunt function in patients with hydrocephalus

用于定量监测脑积水患者心室分流功能的无创无线热传感器

基本信息

批准号：
10684838
负责人：
Anna Lisa Somera
金额：
$ 149.92万
依托单位：
RHAEOS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-15 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10684838
关键词：
Abdomen Address Adult Affect Algorithms Animal Model Animals Brain Catheters Cerebrospinal Fluid Cerebrospinal fluid shunts procedure Cessation of life Child Childhood Clinical Clinical Research Coma Communities Computer Models Computer software Data Development Device Designs Device Safety Devices Diagnosis Diagnostic Diagnostic Equipment Distal Electronics Excision Exhibits Failure Freezing Functional disorder Goals Gold Head Headache Human Human Resources Hydrocephalus Ice Image Implant Institutional Review Boards Journals Laboratories Lethargies Liquid substance Live Birth Magnetic Resonance Imaging Marketing Measurement Measures Mechanics Medical center Modeling Monitor Nature Neurosurgical Procedures Normal Pressure Hydrocephalus Obstruction Operative Surgical Procedures Pain Patients Peer Review Performance Phase Physicians Pilot Projects Program Development Publishing Radiation Radiation exposure Radioisotopes Research Personnel Risk Sampling Seizures Shunt Device Site Skin Specificity Symptoms System Techniques Technology Temperature Testing Thick Time Tracer Translating United States Universities Validation Ventricular Washington Work X-Ray Computed Tomography academic review algorithm development aspirate cerebrospinal fluid flow clinical decision-making clinical diagnostics cost cost estimate design diagnostic tool diagnostic value flexible electronics implantation infection risk interest nervous system disorder novel point-of-care diagnostics porcine model product development programs real time monitoring recruit repaired research clinical testing scientific computing sensor simulation software development standard of care technology validation ventricular system wireless wireless sensor

项目摘要

ABSTRACT Hydrocephalus is a neurological disorder caused by buildup of excess cerebrospinal fluid (CSF) in the brain, and leads to lethargy, seizures, coma, or death. It is treated with the surgical implantation of a catheter, known as a ventricular shunt, that diverts excess CSF away from the brain and into a distal absorptive site, such as the abdomen. Unfortunately, due to occlusion or mispositioning, shunts have extremely high failure rates - 51% in 2 years, and 98% over 10 years - and often require corrective surgical procedures, known as revisions. 125,000 shunt implantations or revisions are performed annually in the United States, at a cost of $2 billion. Diagnosing shunt failure is extremely difficult, due the non-specific nature of its symptoms. Imaging tests such as CT are commonly used despite their long-term radiation exposure risks and invasive tests such as CSF aspiration and radionuclide tracing are painful and carry significant infection risks. All the above tests have poor diagnostic performance, with low sensitivities (~80%) and specificities (~55%), in large part because they do not directly measure flow dynamics, arguably the most important and relevant shunt performance metric. The continuous, non-invasive, real-time monitoring of CSF flow through implanted shunts represents a critical unmet need. Clinicians would use these data for point-of-care diagnostics, and researchers would use them to better understand shunt failure, and elucidate the pathophysiology of poorly-understood conditions such as normal-pressure hydrocephalus. The present proposal addresses this need by capitalizing on existing wireless sensor hardware to develop the first skin mounted wireless product to give quantitative CSF flow data in implanted shunts. Using precise measurements of thermal transport, we will develop novel algorithms to characterize and quantify flow through underlying shunts with high accuracy. Preliminary patient data, benchtop tests, and computer modeling confirm the ability of the sensor to produce high-quality flow data while being mechanically unobtrusive to the patient. Phase I activities will validate the sensor on large animal models, develop algorithms to deliver quantitative flow data, and implement a quality management system to govern software development, ultimately leading to IRB approval for clinical testing. Phase II activities will validate diagnostic value of the sensor’s performance clinically through a human trial, ultimately leading to a marketing submission to the FDA.

抽象的脑积水是一种由过量脑脊液 (CSF) 积聚引起的神经系统疾病大脑中，并导致嗜睡、癫痫发作、昏迷或死亡，可通过手术治疗。植入导管（称为心室分流器），将多余的脑脊液从脑室转移开不幸的是，由于闭塞或进入远端吸收部位，例如腹部。错位、分流器的失败率极高 - 2 年内失败率为 51%，10 年内失败率为 98% 年 - 通常需要进行矫正手术，即 125,000 次分流术。美国每年都会进行植入或修复手术，耗资 20 亿美元。由于分流失败症状的非特异性，诊断分流失败极其困难。尽管存在长期辐射暴露风险，但 CT 等影像检查仍被广泛使用脑脊液抽吸和放射性核素示踪等侵入性检查是痛苦的并且需要进行上述所有测试的诊断性能均较差，且具有较低的感染风险。敏感性（~80%）和特异性（~55%），很大程度上是因为它们不直接测量流动动力学，可以说是最重要和最相关的分流性能指标。通过植入分流器连续、无创、实时监测脑脊液流量临床医生将使用这些数据进行即时诊断，以及研究人员将利用它们更好地了解分流故障，并阐明其原因尚不清楚的疾病的病理生理学，例如正常压力脑积水。本提案通过利用现有的无线传感器硬件来满足这一需求开发第一个皮肤安装无线产品，以提供定量脑脊液流量数据利用热传输的精确测量，我们将开发新型分流器。高精度地表征和量化通过底层分流器的流量的算法。初步的患者数据、台式测试和计算机建模证实了该技术的能力传感器产生高质量的流量数据，同时在机械上对患者不显眼。第一阶段活动将在大型动物模型上验证传感器，开发算法来交付定量流数据，并实施质量管理体系来管理软件开发，最终导致 IRB 批准进行第二阶段的临床测试。最终通过人体试验验证传感器性能的临床诊断价值导致向 FDA 提交营销申请。