Interstitial pressure sensor to detect fluid status

间隙压力传感器检测液体状态

基本信息

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
项目类别：
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

项目摘要

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.

项目摘要 /摘要心力衰竭（HF）仍然是死亡的主要原因，并导致巨大的经济和患者伯恩。尽管针对降低再入院率和改善治疗选择的政策，HF的住院率保持不变。间质液积累与血管内的不成比例更大积累在HF的症状表现和有害结果中起关键作用，包括肺和周围水肿。足够的流体超负荷需要尽早干预HF 症状充血之前的“拥堵级联”。当前用于监视定量的方法体积状态的变化主要限于血管内空间，而针对目标的实验设备地下间隙压力（SCIP）的测量无法提供连续可靠的数据。需要一种非侵入性，易于放置的技术，该技术提供了一个清晰的定量指标医生深入了解何时在HF交通拥堵级联中进行医学干预。解决这个关键未满足的需求，NXT开发了一个IFPX SCIP传感器原型（IFPX），该原型（IFPX）测量了间隙状态的流体状态流体室。我们的长期目标是开发可穿戴的无创设备，以连续监视 SCIP，带有形式因子，例如连续的葡萄糖监测设备。该阶段1应用的目标是在台式实验中测试我们的NXT IFPX SCIP原型传感器，在大型流体动物模型中心力衰竭超负荷以证明传感器的可靠性并以标准证明SCIP信号跟踪，拥塞的入侵指标。初步的原则证明研究表明，SCIP如测量通过历史方法，具有拥塞金标准指标的曲目，包括左心室舒张期在流体超过的HF的猪模型中，压力（LVEDP）和中央静脉压力（CVP）。瞄准中的研究 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，并迭代不同的压力传感翻译设备，以提高IFPX的可靠性和可重复性原型，通过台式测试评估。 AIM 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。然后，台式测试中最有希望的候选人将在 AIM 3中的急性HF动物研究成功定义为SCIP相关的变化（相调节）相关系数R2> 0.7）或LVEDP或CVP成功这些研究的完成将启动II期应用程序，以进一步开发可穿戴技术动物研究并在HF患者中进行试点临床研究。