A mobile framework to measure ejection fraction by automated non-invasive analysis of cardiac signals

7.项目摘要/摘要 这个SBIR第二阶段项目将开发一种新的移动框架来测量左心室射血分数 使用心脏信号的自动非侵入性分析作为收缩功能障碍的标志。心脏病是 男性和女性的主要死因占美国所有死亡人数的三分之一以上(33.6%)。 2011年，美国与心血管疾病相关的总成本估计为3200亿美元， 这使其成为美国面临的最昂贵的健康问题。此外，它在少数群体中发生的比例不成比例 和健康差距人口。例如，与心力衰竭相关的死亡率在非洲人中高出37%- 美国人比白人多。射血分数降低是左心室收缩功能不全的标志， 最常见的心力衰竭类型。通过适当的分诊可以显著改善整体心脏健康状况 通过测定射血分数而不需要二维超声心动图来达到初级保健水平。会的 为医疗保健专业人员提供医疗保健点技术，以指导诊断、监测和治疗 努力。便携设备的功能使其更容易访问和随时可用，而不需要高昂的成本。AS 正在开发的技术不需要熟练的操作员或受过专门培训的医生，它将允许 医疗保健提供者在其正常医疗培训中测量射血分数。在…的过程中 在为期两年的第一阶段工作中，我们开发了一种革命性的医疗设备，能够测量 使用在胸壁测量的心音信号计算射血分数。这门科学的范围 在此第二阶段项目中提出的是使用我们的专门技术完成诊断框架的开发 设计的传感器系统与新的算法技术相结合，可通过智能手机或 平板电脑，提供便携且经济实惠的解决方案。全球资源贫乏的社区无法获得 由于医疗专业知识短缺和昂贵医疗服务供应不足而产生的高质量医疗保健 诊断设备。近年来，手机变得越来越先进和无处不在。这个 通过该项目开发的移动框架是提供低成本诊断的巨大机会 对服务不足的人群。这一开创性工作的好处是开发了一种低成本和便携的 可用于诊断收缩功能障碍的解决方案，从而能够在常规过程中改进筛查 一年一度的体检、看医生、社区医疗筛查、课程和健康博览会，这些都能让你更健康 社区。它将使测量射血分数成为测量血压的常规方法。在第二阶段，我们 将继续通过用户试验对该设备进行验证，并寻求FDA 510(K)批准进行商业化。 然后是佛罗里达和密西西比地区的商业化，基于合作伙伴关系和联合 为帮助创造商业上成功的产品而建立的合作。

7. PROJECT SUMMARY/ABSTRACT This SBIR Phase II project will develop a novel mobile framework to measure left ventricular ejection fraction as a marker for systolic dysfunction using automated non-invasive analysis of cardiac signals. Heart disease is the leading cause of death for men and women accounting for more than one-third (33.6%) of all U.S. deaths. In 2011, total costs associated with cardiovascular disease in the U.S. were estimated to be $320 billion, making it the costliest health problem facing the nation. In addition, it occurs disproportionately among minority and health disparity populations. For example, heart failure related deaths are 37% higher among African- Americans than among whites. Decreased ejection fraction is a marker of left ventricular systolic dysfunction, the most common type of heart failure. Overall cardiac health can be significantly improved by proper triage at the primary care level by determination of the ejection fraction without requiring a 2-D echo-cardiogram. It will provide health care professionals with point-of-care technology to guide diagnostic, monitoring, and therapeutic efforts. Portable device capability makes it even more accessible and readily available without high costs. As the technology being developed does not require skilled operators or specially trained physicians, it will allow healthcare providers to measure ejection fraction within their normal medical training. Through the course of the two-year Phase I work we have developed a revolutionary medical device that enables measurement of ejection fraction using the cardiac sound signals measured at the chest wall. The scope of the science proposed in this Phase II project is to complete development of the diagnostic framework using our specially engineered sensor system combined with the novel algorithm technology to be accessed via a smartphone or tablet for a portable and cost-effective solution. Resource-poor communities across the globe lack access to quality healthcare arising from shortages in medical expertise and poor availability of expensive medical diagnostic devices. In recent years, mobile phones have become increasingly advanced and ubiquitous. The mobile framework developed through this project is a tremendous opportunity to provide low-cost diagnostics to under-served populations. The benefit of this pioneering work is the development of a low-cost and portable solution that can be used to diagnose systolic dysfunction, and thus enable improved screening during routine annual checkups, doctor visits, at community medical screenings, classes, and health fairs leading to healthier communities. It will make measuring ejection fraction as routine as measuring blood pressure. In Phase II, we will continue validation of the device through user-trials and seek FDA 510(k) clearance for commercialization. Followed by commercialization in the Florida and Mississippi region, based on the partnerships and joint collaborations established to help create a commercially successful product.