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

该小企业技术转让（STTR）I期项目的更广泛影响/商业潜力将为市场提供一种用于测量充血性心力衰竭（CHF）患者液体状态的新型无创方法。 在心力衰竭症状发作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，CHF在美国的年成本为310亿美元。 其中大部分是住院费用。 近50%的CHF患者出院后会在6个月内再次入院。 CMS认为这些入院治疗大多是可以预防的，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CMS再入院罚款。 非侵入性门诊CHF监测有可能在CHF症状出现之前早期检测到液体超负荷。 如果成功的话，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。拟议的项目将导致一个低成本的，可穿戴的传感器阵列和移动的应用程序的成功开发，用于实时容量状态评估的CHF患者。CHF患者往往有液体积累在组织和肺部由于恶化的心脏功能，医疗依从性差，或饮食。目前的门诊监测仪，如血压和体重，未能在其主要终点，以检测容量超负荷之前，病人有水肿，疲劳和呼吸急促的症状。 目前，流体状态是用侵入性监测模式测量的，例如肺动脉和中心静脉导管压力和波形分析。 在心力衰竭症状和需要住院治疗之前，非常需要对CHF患者的早期血管内液体变化进行准确的非侵入性检测。 外周静脉系统的监测意味着从基于外周动脉的监测器的基本范式转变。 然而，外周静脉在解剖学上连接到CHF患者中有创测量的肺动脉。 因此，外周静脉而不是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.