STTR Phase II: Development and commercialization of a Wearable Long-term Monitor for Cardiac Arrhythmias

这个小企业技术转让（STTR）第二阶段项目的更广泛的影响/商业潜力在改善美国2000多万人的生活质量和医疗保健的成本/效率方面意义深远。我们需要更好的方法来识别和指导治疗具有危险心脏功能障碍（如间歇性心律失常和心力衰竭）的非卧床患者。例如，心房颤动心律失常折磨着美国近800万患者，每年约有460，000名新患者，并且患者负荷预计到2050年将增长到1210万。疾病及其并发症（中风、充血性心力衰竭、癫痫发作、死亡等）为国家每年的医疗保健成本增加260亿美元。心力衰竭目前困扰着美国近570万人，到2030年将增加到800万人。他们的治疗和频繁住院费用已经达到140亿美元，到2030年将增长到290亿美元。 与减少经济影响一起，创造一种改善诊断并指导对这些患者进行有效治疗的设备，同时他们保持完全走动并在昂贵的医院范围之外进行正常活动，这将对人类健康产生巨大的益处。 拟议的项目具有以下知识价值。在我们的第一阶段STTR计划中，我们专注于开发一种可穿戴式房颤监测仪，以帮助医生诊断阵发性或偶发性房颤。在第二阶段，我们已经转向对阵发性心动过速和最终心力衰竭患者进行动态监测的更迫切需求。目前的动态心电图行业标准不能提供足够的灵敏度或特异性来确定患者是否患有非典型或典型房扑、阵发性室上性心动过速以及各种形式的室性心动过速。准确诊断和监测这些疾病对患者的治疗和结果至关重要。我们的设备将能够对任何类型的心律失常进行动态患者监测，并且我们相信，如果它在一个设备中提供ECG、心脏运动和呼吸频率/模式/容量，则它可以成为所有便携式监测的首选。因此，我们第二阶段工作的总体技术研究目标是开发如上所述的可用于初始临床测试的全功能原型心脏运动传感器。这些功能包括：可穿戴、电池供电、信号存储、雷达心脏运动、一次性天线、机载心电图和呼吸频率。

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project is far-reaching in terms of improving the quality of life and the cost/efficacy of healthcare for more than 20 Million people in the USA. We address the need for better methods for identifying and guiding the treatment of ambulatory patients with dangerous heart dysfunctions such as intermittent arrhythmias and heart failure. For example, atrial fibrillation arrhythmia afflicts nearly 8 Million patients in the USA, approximately 460,000 new patients every year, and the patient load is projected to grow to 12.1 million by 2050. The disease and its complications (stroke, congestive heart failure, seizures, death, etc.) add $26B to the nation's annual healthcare costs. Heart Failure currently afflicts nearly 5.7 Million people in the US growing to 8 Million by 2030. Their treatment and frequent hospitalization costs are already at 14B$ and will grow to 29B$ by 2030. Together with reducing the economic impacts, it would be of an enormous benefit to human health to create a device that improves the diagnosis and guides effective therapy for these patients while they remain fully ambulatory and going about their normal activities outside the expensive confines of the hospital. The proposed project has the following intellectual merits. In our Phase I STTR program we focused on developing a wearable Atrial Fibrillation monitor to assist physicians in the diagnosis of paroxysmal or episodic versions of that disorder. In Phase II we have pivoted towards the even more critical need of ambulatory monitoring of paroxysmal tachycardia and eventually heart failure patients. The current industry standard of ambulatory ECG does not provide enough sensitivity or specificity to determine if the patient has atypical or typical atrial flutter, paroxysmal supraventricular tachycardia as well as various forms of ventricular tachycardia. Accurately diagnosing and monitoring these disorders is critical to patient treatment and outcomes. Our device will be capable of ambulatory patient monitoring for any sort of arrhythmia, and we believe it can be the preferred choice for all portable monitoring if it provides in one device ECG, heart motion and breathing rate/pattern/volume. So, the overarching technical research goal of our Phase II work is to develop a full featured prototype cardiac motion sensor as described above that can be used for initial clinical tests. These features include: wearable, battery powered, signal storage, cardiac motion from radar, disposable antenna, onboard ECG, and breathing rate.