STTR Phase I: Wireless point-of-care sensor for continuous fluid status monitoring of patients with congestive heart failure

这项小型企业技术转移（STTR）一期项目的广泛影响/商业潜力将为市场提供一种新的非侵入性方法来测量充血性心力衰竭（CHF）患者的体液状态。在心力衰竭症状发作之前检测容积状态变化的能力对患者护理和经济影响巨大。根据美国心脏协会的数据，在美国，每年花费310亿瑞士法郎。这笔费用的大部分是住院费。近50%出院的CHF患者将在6个月内再次入院。CMS认为这些病人中的大多数是可以预防的，因此迫使医院承担费用。医院系统的预期成本是每年2亿美元的再入院罚款。非侵入性门诊CHF监测有可能在CHF症状出现之前早期发现液体超载。如果成功，这项技术的结果将允许护理人员在住院前评估患者并调整药物或饮食。低成本、易于使用和不显眼的设计旨在减少医疗保健的种族和文化障碍，并提高采用率。该项目将成功开发一种低成本、可穿戴传感器阵列和移动应用程序，用于实时评估CHF患者的体积状态。由于心功能恶化、医疗依从性差或饮食不良，慢性心力衰竭患者经常在组织和肺部积液。目前的门诊监测，如血压和体重，不能在患者出现水肿、疲劳和呼吸短促症状之前检测出容量过载。目前，液体状态的测量采用有创监测方式，如肺动脉和中心静脉导管压力和波形分析。在心衰症状出现和需要住院治疗之前，非常需要对CHF患者早期血管内液体变化进行准确的无创检测。外周静脉系统的监测标志着一个基本的范式转变，从外周动脉为基础的监测。然而，外周静脉在解剖上与肺动脉相连，在CHF患者中进行有创测量。因此，外周静脉而非动脉反映心力衰竭患者的肺动脉充血是合乎逻辑的。

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project will provide the market with a novel non-invasive method for measuring fluid status in patients with congestive heart failure (CHF). The ability to detect volume status changes prior to the onset of heart failure symptoms has tremendous patient care and economic impact. According to the American Heart Association, the annual cost of CHF is $31B in the US. The majority of this cost is due to hospitalization. Nearly 50% of patients with CHF who are discharged from the hospital will be readmitted within 6 months. Most of these admissions are deemed preventable by CMS, thus forcing the hospitals to absorb the costs. The expected cost to hospital systems is $200M per year in CMS fines for hospital readmissions. Non-invasive outpatient CHF monitoring has the potential for earlier detection of fluid overload prior to CHF symptoms. If successful, the outcome of this technology will allow caregivers to assess the patient and adjust medications or diet on an outpatient bases before hospitalization is warranted. Low-cost, ease of use, and unobtrusive design are aimed to reduce ethnic and cultural barriers to healthcare and enhance adoption. The proposed project will lead to the successful development of a low-cost, wearable sensor array and mobile application for real-time volume status assessment of patients with CHF.Patients with CHF often have fluid accumulating in the tissues and lungs due to worsening cardiac function, poor medical compliance, or diet. Current outpatient monitors such as blood pressure and weight, fail in their primary endpoint to detect volume overload before the patient has symptoms of edema, fatigue, and shortness of breath. Currently, fluid status is measured with invasive monitoring modalities such as pulmonary artery and central venous catheter pressure and waveform analysis. There is a great need for accurate non-invasive detection of early intravascular fluid changes in patients with CHF prior to heart failure symptoms and need for hospitalization. Monitoring of the peripheral venous system signifies a fundamental paradigm shift from peripheral arterial based monitors. However, peripheral veins are anatomically connected to the pulmonary artery that is invasively measured in patients with CHF. It is logical therefore that peripheral veins, not arteries reflect pulmonary arterial congestion seen in patients with heart failure.