Development of wireless, wearable flow sensors for continuous, long-term tracking of cerebrospinal fluid dynamics in patients with hydrocephalus

开发无线可穿戴流量传感器，用于连续、长期跟踪脑积水患者的脑脊液动力学

• 批准号: 10728656
• 负责人: Richard Chad Webb
• 金额: $ 24.43万
• 依托单位: RHAEOS, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-18 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10728656
• 关键词: Accident and Emergency department; Activities of Daily Living; Address; Admission activity; Affect; Ambulatory Monitoring; American; Blinded; Brain; Cardiac; Caring; Catheters; Cerebral Ventricles; Cerebrospinal Fluid; Cessation of life; Clinical; Clinical Data; Clinical Research; Clinical Trials Design; Coma; Computer software; Data; Data Set; Development; Development Plans; Device Safety; Devices; Diagnosis; Diagnostic; Distal; Drainage procedure; Emergency department visit; Ensure; Failure; Family; Fatigue; Feasibility Studies; Functional disorder; Goals; Greater sac of peritoneum; Headache; Home; Hospitalization; Hospitals; Hour; Hydrocephalus; Implant; Inpatients; Institutional Review Boards; Intuition; Knowledge; Left; Length; Lethargies; Live Birth; Magnetic Resonance Imaging; Maps; Measurement; Measures; Monitor; Nature; Nausea; Neurologic; Operative Surgical Procedures; Outsourcing; Patient Care; Patients; Performance; Phase; Polysomnography; Procedures; Protocols documentation; Psyche structure; Research; Safety; Second Look Surgery; Seizures; Series; Shunt Device; Site; Skin; Sleep; Spottings; Symptoms; System; Technology; Testing; Tube; United States; Universities; Ventricular; Washington; X-Ray Computed Tomography; accurate diagnosis; arm; cerebrospinal fluid flow; cost estimate; design; diagnostic tool; fluid flow; glymphatic system; implantation; improved; insight; manufacturability; manufacture; manufacturing run; meetings; miniaturize; pressure; product development; remote monitoring; sensor; sleep pattern; software development; subcutaneous; success; tool; usability; user-friendly; wireless; wireless sensor

Hydrocephalus is a common condition caused by the accumulation of cerebrospinal fluid (CSF) in the brain, with symptoms that include headaches, lethargy, seizures, coma, or death, and affects > 1 million patients in the United States. It is usually treated with the surgical implantation of a catheter, known as a ventricular shunt, which diverts the excess CSF in the brain to a distal absorptive site. Overall, 125,000 shunts are implanted or replaced annually in United States, with costs estimated at $2 billion per year. We have identified two unmet needs in hydrocephalus diagnostics: (i) precise, rapid, noninvasive way to monitor shunt function; (ii) a large gap in clinical knowledge of CSF hydrodynamics through shunts owing to a lack of a direct, continuous flow monitoring technology. To address this need, Rhaeos has developed the first wearable, wireless sensor for CSF flow monitoring. Our first platform, Flow Sense, exploits miniaturized thermal sensors and actuators to map thermal transport through the skin as a measure of subdermal fluid flow to make rapid spot checks to address the first challenge outlined above. Expanding these capabilities to include continuous monitoring, 24-hour of CSF flow, particularly during periods of sleep, would benefit the treatment, care and understanding of hydrocephalus. We hypothesize that continuous measurements will provide and allow for robust out-patient monitoring and enhancing in-patient monitoring capabilities, particularly in emergency departments. The resulting technology, if successful, could reduce unnecessary hospital admissions and lower in- patient stay periods by allowing for direct monitoring in patient homes. Additionally, understanding CSF hydrodynamics during sleep will be valuable in enhancing a basic scientific understanding of hydrocephalus and the glymphatic system. To address the goal, we will develop the first sensor capable of continuous, 24-hour CSF flow measurements. In the UG3 phase we will modify our hardware and software platform for safety, comfort, robustness, and usability for continuous, uninterrupted wear at home. Additionally, we will undertake DFMEA and design for manufacturability efforts in compliance with an FDA- and ISO13485 compliant quality management system. The completion and successful outsourced manufacturing run of a sensor capable of continuous use over 1 week will form the core of a set of go/no go milestones to transition to the clinical UH3 phase. In the UH3 phase, we will conduct a 1-week double-arm, single-center, blinded, longitudinal clinical study with historically stable shunt patients and patients with recent shunt revisions.

脑积水是由大脑中脑脊液（CSF）积累引起的常见疾病，其中包括头痛，嗜睡，癫痫发作，昏迷或死亡，并且在美国影响> 100万患者。它通常用导管的手术植入（称为心室分流器）进行治疗，该导管将大脑中过量的CSF转移到远端吸收性部位。总体而言，每年在美国植入或更换125,000个分流器，每年估计成本为20亿美元。我们已经确定了脑积水诊断中的两个未满足的需求：（i）确切，快速，无创的​​方法来监视分流功能； （ii）由于缺乏直接的连续流量监测技术，因此通过分流型CSF流体动力学的临床知识存在很大的差距。为了满足这一需求，Rhaeos开发了第一个用于CSF流量监测的可穿戴无线传感器。我们的第一个平台，流动感，利用了微型热传感器和执行器来绘制通过皮肤的热传输，以衡量下层流体流量，以进行快速检查，以应对上面概述的第一个挑战。扩大这些功能以包括连续监测，CSF流量的24小时，尤其是在睡眠期间，将有益于对脑积水的治疗，护理和理解。我们假设连续测量将提供并允许健壮的门诊监视和增强住院监测能力，尤其是在急诊部门。最终的技术，如果成功的话，可以通过允许在患者家庭中进行直接监控来减少不必要的住院和患者住宿期。此外，在睡眠期间了解CSF流体动力学对于增强对脑积水和淋巴系统的基本科学了解将是有价值的。为了解决目标，我们将开发第一个能够连续24小时CSF流量测量值的传感器。在UG3阶段，我们将修改我们的硬件和软件平台，以确保安全，舒适性，可用性和可用性，以使家里连续，不间断的磨损。此外，我们将在符合FDA-和ISO13485兼容的质量管理系统方面进行DFMEA和设计。能够在1周内连续使用的传感器的完成和成功的外包制造运行将构成一组GO/NO GO里程碑的核心，以过渡到临床UH3阶段。在UH3阶段，我们将进行1周的双臂，单中心，盲目的纵向临床研究，并具有历史稳定的分流患者和最近的分流器修订的患者。