Diversity supplement for 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的多样性补充

• 批准号: 10905958
• 负责人: Anna Lisa Somera
• 金额: $ 6.15万
• 依托单位: RHAEOS, INC.
• 依托单位国家: 美国
• 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/10905958
• 关键词: Abdomen; Address; Algorithms; Animal Model; Brain; Catheters; Cerebrospinal Fluid; Cessation of life; Clinical; Coma; Computer Models; Data; Diagnosis; Diagnostic; Distal; Failure; Functional disorder; Human; Hydrocephalus; Image; Implant; Institutional Review Boards; Lethargies; Marketing; Measurement; Measures; Mechanics; Monitor; Nature; Normal Pressure Hydrocephalus; Operative Surgical Procedures; Pain; Patients; Performance; Phase; Radiation exposure; Radioisotopes; Research Personnel; Risk; Seizures; Shunt Device; Site; Skin; Specificity; Symptoms; System; Technology; Testing; Time; United States; Ventricular; aspirate; cerebrospinal fluid flow; commercialization; cost; diagnostic value; implantation; infection risk; nervous system disorder; novel; point-of-care diagnostics; programs; real time monitoring; research clinical testing; sensor; software development; tool; wireless; wireless sensor

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 脑积水是一种因脑脊液积聚过多而引起的神经系统疾病 脑脊液（CSF）进入大脑，并导致嗜睡、癫痫发作、昏迷或死亡。 手术植入导管（称为脑室分流术），将多余的脑脊液转移出去 不幸的是，由于从大脑进入远端吸收部位，例如腹部。 闭塞或错位、分流器的失败率极高 - 2 年内为 51%，98% 超过 10 年 - 通常需要进行矫正手术，即 125,000 次修复。 在美国每年进行一次分流植入或修复手术，费用为 2 美元 十亿。 由于分流故障的非特异性，诊断分流故障极其困难。 尽管 CT 等影像学检查需要长期辐射，但仍经常使用。 暴露风险和侵入性测试（例如脑脊液抽吸和放射性核素追踪）是痛苦的 并且具有显着的感染风险。 低敏感性（~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，这可以说是最重要和最相关的分流性能指标。 连续、无创、实时监测流经植入物的脑脊液流量 分流代表了一个关键的未满足的需求。 诊断，研究人员将使用它们来更好地了解分流故障，并阐明 人们对正常压力脑积水等疾病的病理生理学知之甚少。 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 提供定量的流量数据，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。