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

STTR 第二阶段：可穿戴式心律失常长期监测仪的开发和商业化

• 批准号: 1660253
• 负责人: Dennis Matthews
• 金额: $ 75万
• 依托单位: Cardiac Motion, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-01 至 2020-02-29
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1660253&HistoricalAwards=false
• 关键词: STTR; Phase; II; Development; commercialization

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.

这项小型企业技术转让（STTR）第二阶段项目的更广泛影响/商业潜力是深远的，它将改善美国2000多万人的生活质量和医疗保健的成本/功效。我们解决需要更好的方法来识别和指导治疗危险的心脏功能障碍的门诊患者，如间歇性心律失常和心力衰竭。例如，心房纤颤性心律失常在美国折磨着近800万患者，每年约有46万新患者，预计到2050年患者负荷将增长到1210万。这种疾病及其并发症（中风、充血性心力衰竭、癫痫发作、死亡等）使美国每年的医疗费用增加了260亿美元。目前美国有近570万人患有心力衰竭，到2030年这一数字将增至800万。他们的治疗和频繁住院费用已经达到140亿美元，到2030年将增加到290亿美元。在减少经济影响的同时，创造一种设备，可以提高诊断水平，指导对这些患者的有效治疗，同时他们可以完全走动，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好处。提议的项目有以下智力上的优点。在我们的一期STTR项目中，我们专注于开发一种可穿戴式心房颤动监测器，以帮助医生诊断发作性或发作性心房颤动。在第二阶段，我们已经转向更关键的需求，即对阵发性心动过速和最终心力衰竭患者进行动态监测。现行的动态心电图行业标准没有提供足够的灵敏度和特异性来判断患者是否有不典型或典型的心房扑动、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门诊患者监测，我们相信如果它在一个设备中提供ECG，心脏运动和呼吸速率/模式/体积，它可以成为所有便携式监测的首选。因此，我们二期工作的总体技术研究目标是开发一个功能齐全的心脏运动传感器原型，如上述所述，可用于初步临床试验。这些功能包括：可穿戴、电池供电、信号存储、来自雷达的心脏运动、一次性天线、机载ECG和呼吸频率。

项目成果

Measurement of the Complex Human Atrial-Ventricular Motions using Contact-Based Doppler Radar

• DOI: 10.1109/wamicon.2019.8765441
• 发表时间: 2019-04
• 期刊: 2019 IEEE 20th Wireless and Microwave Technology Conference (WAMICON)
• 作者: Xiaomeng Gao;Xiaonan Jiang;Songjie Bi;D. Matthews;S. Schaefer;X. Liu

Coupling-Cancellation-Antenna for Improving Doppler Radar Motion Measurement Accuracy

用于提高多普勒雷达运动测量精度的耦合消除天线

• DOI: 10.1109/wamicon.2019.8765442
• 发表时间: 2019
• 期刊: 2019 IEEE 20th Wireless and Microwave Technology Conference (WAMICON
• 作者: Bi, Songjie;Jiang, Xiaonan;Gao, Xiaomeng;Liu, Xiaoguang
• 通讯作者: Liu, Xiaoguang

A Multi-Arc Method for Improving Doppler RadarMotion Measurement Accuracy

提高多普勒雷达运动测量精度的多弧法

• DOI: 10.1109/mwsym.2018.8439687
• 发表时间: 2018
• 期刊: 2018 IEEE/MTT-S International Microwave Symposium - IMS
• 作者: Bi, Songjie;Gao, Xiaomeng;Lubecke, Victor M.;Lubecke, Olga Boric-;Matthews, Dennis;Liu, Xiaoguang Leo
• 通讯作者: Liu, Xiaoguang Leo