Interstitial pressure sensor to detect fluid status

间隙压力传感器检测液体状态

• 批准号: 10603623
• 负责人: Robert Schwartz
• 金额: $ 63.49万
• 依托单位: NXT BIOMEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-11 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10603623
• 关键词: Accelerometer; Acute; Acute Kidney Failure; Address; Admission activity; Animal Model; Animals; Ascites; Atmospheric Pressure; Blood capillaries; Cause of Death; Central venous pressure; Cessation of life; Chronic; Clinical; Clinical Research; Compensation; Congestive Heart Failure; Consumption; Continuous Glucose Monitor; Data; Death Rate; Detection; Development; Devices; Diastolic blood pressure; Early Intervention; Economics; Edema; Engineering; Event; Family suidae; Fluid overload; Functional disorder; Generations; Goals; Heart failure; Hepatic; Hospitalization; Hospitals; Hour; Hydrostatic Pressure; Individual; Infection; Inpatients; Intercellular Fluid; Kidney Failure; Lead; Left; Leg; Liquid substance; Literature; Lower Extremity; Lung; Measurement; Measures; Medical; Methods; Monitor; Morbidity - disease rate; Myocardial Ischemia; Noise; Outcome; Outpatients; Patients; Performance; Peripheral; Phase; Physical Examination; Physicians; Physiological; Physiology; Play; Policies; Pulmonary Edema; Quality of life; Research; Residual state; Role; Sampling; Signal Transduction; Signs and Symptoms; Small Business Innovation Research Grant; Sodium Chloride; Stream; Sturnus vulgaris; Symptoms; System; Technology; Temperature; Testing; Therapeutic Intervention; Time; Tissues; Upper Extremity; Variant; Ventricular; Work; animal data; base; battery life; data exchange; design; design verification; digital; experimental study; hemodynamics; hospital readmission; hospitalization rates; improved; innovation; insight; interstitial; monitoring device; mortality; phase 1 study; porcine model; pre-clinical; pressure; pressure sensor; prototype; pulmonary arterial pressure; readmission rates; remote health care; response; sensor; standard of care; subcutaneous; success; transmission process; vasoconstriction; wearable device

Project Summary / Abstract Heart failure (HF) remains a leading cause of death and results in huge economic and patient burden. Despite policies targeted at reducing readmission rates and improved treatment options, hospitalization rates for HF have remained largely the same. Disproportionally greater interstitial fluid accumulation versus intravascular accumulation plays a pivotal role in the symptomatic manifestation and detrimental outcomes of HF, including pulmonary and peripheral edema. Adequate management of fluid overload requires early intervention in the HF “congestion cascade” prior to the onset of symptomatic congestion. Current methods used to monitor quantitative changes in volume status are mostly limited to the intravascular space, and experimental devices targeting the measurement of subcutaneous interstitial pressure (SCIP) have unable to provide continuous, reliable data. There is a need for a non-invasive, easily placed technology that provides a clear quantitative metric that gives physicians insight into when to medically intervene earlier in the HF congestion cascade. To address this critical unmet need, NXT developed a IFPx SCIP sensor prototype (IFPx) that measures fluid status in the interstitial fluid compartment. Our long-term goal is to develop a wearable, non-invasive device to continuously monitor SCIP, with a form-factor like continuous glucose monitoring devices. The objective for this Phase 1 application is to test our NXT IFPx SCIP prototype sensor in benchtop experiments and in a large animal model of fluid- overloaded heart failure to demonstrate sensor reliability and to demonstrate SCIP signal tracking with standard, invasive metrics of congestion. Preliminary proof-of-principle studies demonstrated that the SCIP, as measured by historic methods, tracks with gold standard metrics of congestion, including left ventricular end diastolic pressure (LVEDP) and central venous pressure (CVP) in a porcine model of fluid-overloaded HF. Studies in Aim 1 are designed to improve the reliability and repeatability of the NXT IFPx SCIP prototype. We will design, test, and iterate different pressure sensing transduction devices to improve reliability and repeatability of the IFPx prototype, as assessed by benchtop testing. Studies in Aim 2 will mainly confirm that the NXT IFPx SCIP sensor can transmit and store data reliably. The most promising candidate from bench tests will then be validated in acute HF animal studies in Aim 3 with success defined as changes in SCIP correlates (Phase-adjusted correlation coefficient r2 > 0.7) or associates (Bland-Altman average±2SD) with LVEDP or CVP Successful completion of these studies will initiate a Phase II application to develop wearable technology further in chronic animal studies and to perform pilot clinical studies in patients with HF.

项目总结/摘要 心力衰竭（HF）仍然是导致死亡的主要原因，并造成巨大的经济和患者负担。尽管 旨在降低再入院率和改善治疗选择的政策， 基本保持不变。与血管内相比，间质液蓄积不成比例地更大 蓄积在HF的症状表现和有害结果中起着关键作用，包括 肺和外周水肿。充分管理液体超负荷需要对HF进行早期干预 在有症状的充血发作之前的“充血级联”。目前用于定量监测的方法 容量状态的变化主要限于血管内空间，并且靶向血管内空间的实验装置 皮下间质压（SCIP）的测量不能提供连续、可靠的数据。 需要一种非侵入性的、容易放置的技术，其提供明确的定量度量， 医生了解何时在HF充血级联中进行早期医学干预。处理这个关键 为了满足未满足的需求，NXT开发了一种IFPx SCIP传感器原型（IFPx），用于测量组织间质中的液体状态 液体室我们的长期目标是开发一种可穿戴的、非侵入性的设备， SCIP，具有类似于连续葡萄糖监测设备的外形。第一阶段申请的目的 是在台式实验和大型动物流体模型中测试我们的NXT IFPx SCIP原型传感器， 超负荷心力衰竭，以证明传感器的可靠性，并证明SCIP信号跟踪与标准， 拥塞的侵入性度量。初步的原理验证研究表明， 通过历史方法，跟踪充血的金标准指标，包括左心室舒张末期 在液体过载HF的猪模型中，测量LVEDP和中心静脉压（CVP）。研究目的 1旨在提高NXT IFPx SCIP原型的可靠性和可重复性。我们将设计，测试， 并采用不同的压力传感换能装置，以提高IFPx的可靠性和可重复性 原型，通过台式测试进行评估。目标2中的研究将主要确认NXT IFPx SCIP传感器 可以可靠地传输和存储数据。最有希望的候选人从台架测试，然后将验证， 目标3中的急性HF动物研究，成功定义为SCIP相关性的变化（相位调整 相关系数r2 > 0.7）或与LVEDP或CVP相关（Bland-Altman平均值±2SD）成功 这些研究的完成将启动第二阶段的应用，以进一步开发可穿戴技术， 动物研究，并在HF患者中进行初步临床研究。