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

这一小型企业技术转让(STTR)第一阶段项目的广泛影响/商业潜力将为市场提供一种新的非侵入性方法，用于测量充血性心力衰竭(CHF)患者的液体状态。在心力衰竭症状出现之前检测容量状态变化的能力具有巨大的患者护理和经济影响。根据美国心脏协会的数据，在美国，慢性心力衰竭的年成本为310亿美元。这笔费用的大部分是住院费用。近50%的CHF患者出院后将在6个月内再次入院。这些住院中的大多数被认为是CMS可以预防的，因此迫使医院承担费用。预计医院系统每年因再次住院而被CMS罚款的费用为2亿美元。非侵入性的门诊心力衰竭监测有可能在心力衰竭症状出现之前更早地发现液体超负荷。如果成功，这项技术的结果将允许护理人员在住院之前对患者进行评估，并在门诊基础上调整药物或饮食。低成本、易用性和低调的设计旨在减少医疗保健的种族和文化障碍，并促进采用。拟议的项目将导致低成本、可穿戴的传感器阵列和移动应用的成功开发，用于实时评估CHF患者的容量状态。由于心功能恶化、医疗依从性差或饮食原因，CHF患者经常会有液体积聚在组织和肺中。目前的门诊监测仪，如血压和体重，在患者出现浮肿、疲劳和呼吸急促症状之前，无法检测到容量超负荷。目前，液体状态是通过有创监测手段测量的，如肺动脉和中心静脉导管压力和波形分析。在CHF患者出现心力衰竭症状和需要住院之前，非常需要对其早期血管内液体变化进行准确的无创性检测。对外周静脉系统的监测标志着从以外周动脉为基础的监测仪的根本范式转变。然而，外周静脉在解剖上与肺动脉相连，这在CHF患者中是侵入性测量的。因此，反映心力衰竭患者肺动脉充血的是外周静脉，而不是动脉，这是合乎逻辑的。

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.