A mobile framework to measure ejection fraction by automated non-invasive analysi

描述(由申请人提供)：这个SBIR第一阶段项目将开发一种新的移动框架，使用心脏信号的自动非侵入性分析来测量左心室射血分数，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，占美国死亡人数的三分之一以上(33.6%)。2010年，美国与心血管疾病相关的总成本估计为4440亿美元，使其成为美国面临的最昂贵的健康问题。此外，它的发生不成比例 在少数群体和健康差距人群中。例如，非裔美国人与心力衰竭相关的死亡率比白人高37%。射血分数降低是最常见的心力衰竭--左心室收缩功能障碍的标志。通过在初级保健水平进行适当的分诊，在不需要二维超声心动图的情况下测定射血分数，可以显著改善总体心脏健康状况。它将为卫生保健专业人员提供医疗保健点技术，以指导诊断、监测和治疗工作。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。由于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的医疗培训中测量射血分数。我们通过国防部-国防部高级研究计划局(DARPA)为期两年的第二阶段工作开发了一项革命性的新技术，该技术能够使用在胸壁测量的四个心脏瓣膜中的每个心脏瓣膜的心音信号来测量射血分数。它基于分离和定位声音的技术，称为听觉场景分析，以从心音中提取信息。SBIR项目中提出的科学范围是开发一种新的诊断框架，使用我们专门设计的加速度计和心电传感器系统，结合新的算法技术，在智能手机或平板电脑上运行，以实现便携且经济高效的解决方案。由于医疗专业知识短缺和医疗诊断设备供应不足，全球各地资源匮乏的社区无法获得高质量的医疗保健。近年来，手机变得越来越先进和无处不在。通过该项目开发的移动框架是向服务不足的人群提供低成本诊断的巨大机会。这项开创性工作的好处是开发了一种低成本和便携的解决方案，可用于诊断收缩功能障碍，从而能够在例行年度体检、医生就诊、社区医疗筛查、课程和健康博览会期间改进筛查，从而实现更健康的社区。这将使测量射血分数成为常规 比如测量血压。在第一阶段，我们将通过用户试验来评估临床相关性。随后在密西西比三角洲地区和佛罗里达地区进行了临床试验，建立了必要的合作伙伴关系和联合合作，以帮助创造出商业上成功的产品。

DESCRIPTION (provided by applicant): This SBIR Phase I 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 2010, total costs associated with cardiovascular disease in the U.S. were estimated to be $444 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. We have developed a revolutionary new technology through a Department of Defense-Defense Advanced Research Projects Agency (DARPA) two- year Phase II effort that enables measurement of ejection fraction using the cardiac sound signals from each of the four heart valves measured at the chest wall. It is based on the technique of separating and localizing sounds, known as auditory scene analysis, to extract information from the cardiac sounds. The scope of the science proposed in this SBIR project is to develop a novel diagnostic framework using our specially engineered accelerometer and electrocardiogram transducer system combined with the novel algorithm technology to run on 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 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 will be as routine as measuring blood pressure. In Phase I, we will evaluate the clinical relevance through user-trials. Followed by clinical trials in the Mississippi delta region and the Florida region, buildin the required partnerships and joint collaborations to help create a commercially successful product.