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

通过心脏信号自动非侵入性分析来测量射血分数的移动框架

• 批准号: 9312551
• 负责人: Kaustubh Kale
• 金额: $ 40万
• 依托单位: AVENTUSOFT, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-23 至 2020-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9312551
• 关键词: Accelerometer; Accounting; Address; African American; Algorithms; Area; Auditory; Auscultation; Biological; Blood Pressure; Car Phone; Cardiac; Cardiac health; Cardiology; Cardiomyopathies; Cardiopulmonary; Cardiovascular Diseases; Care Technology Points; Caring; Cause of Death; Cellular Phone; Cessation of life; Chest wall structure; Clinic; Clinical; Cloud Computing; Code; Collaborations; Communities; Complex; Data; Detection; Development; Devices; Diagnosis; Diagnostic; Disease Management; Doctor of Medicine; EFRAC; Early Diagnosis; Echocardiography; Electrocardiogram; Engineering; Event; Florida; Functional disorder; Future; General Practitioners; Guidelines; Health; Health Fairs; Health Insurance Portability and Accountability Act; Health Personnel; Health Professional; Health Services Accessibility; Heart; Heart Auscultation; Heart Diseases; Heart Sounds; Heart failure; Hospitals; Impairment; Improve Access; Institution; Institutional Review Boards; Joints; Label; Lead; Left; Left Ventricular Ejection Fraction; Mass Screening; Master of Public Health; Measurement; Measures; Medical; Medical Device; Methods; Minor; Mississippi; Mitral Valve; Modality; Monitor; Output; Pathologic; Patients; Performance; Phase; Physicians; Population; Prevention; Preventive; Preventive care; Primary Health Care; Public Health; Pulmonary valve structure; Reporting; Research; Resources; Risk Factors; Science; Scientist; Signal Transduction; Small Business Innovation Research Grant; Surgeon; System; Tablet Computer; Tablets; Technology; Therapeutic; Training; Transducers; Triage; Tricuspid valve structure; Underserved Population; United States Dept. of Health and Human Services; Universities; University Hospitals; Validation; Ventricular; Visit; Wireless Technology; Woman; Work; aortic valve; base; biomaterial compatibility; checkup examination; clinical practice; commercialization; cost; cost effective; design; evidence base; health care availability; health care delivery; health care quality; health disparity; heart disease risk; improved; insight; men; minority health; novel; portability; professor; prototype; screening; sensor; signal processing; telehealth; tool

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.

7.项目总结/摘要 该SBIR第二阶段项目将开发一种新的移动的框架来测量左心室射血分数 作为心脏收缩功能障碍的标志，使用心脏信号的自动非侵入性分析。心脏病是 这是男性和女性死亡的主要原因，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， 使其成为国家面临的最昂贵的健康问题。此外，在少数群体中， 和健康差距的人群。例如，心力衰竭相关的死亡率在非洲高出37%， 美国人比白人多。射血分数降低是左心室收缩功能障碍的标志， 最常见的一种心力衰竭通过适当的分流，整体心脏健康可以得到显着改善， 通过测定射血分数而无需2-D超声心动图的初级护理水平。它将 为医疗保健专业人员提供即时技术，以指导诊断、监测和治疗 努力便携式设备的能力使其更容易获得和容易获得，而无需高成本。作为 正在开发的技术不需要熟练的操作员或受过专门训练的医生，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。的战争 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，可以测量 射血分数使用在胸壁处测量的心音信号。科学的范围 该第二阶段项目中提出的是使用我们专门的技术完成诊断框架的开发 工程传感器系统与新算法技术相结合，可通过智能手机访问， 平板电脑，提供便携且经济高效的解决方案。地球仪上资源贫乏的社区无法获得 由于缺乏医疗专业知识和昂贵的医疗服务， 诊断设备。近年来，移动的电话变得越来越先进和普遍。的 通过该项目开发的移动的框架是提供低成本诊断的巨大机会 to under-served服务populations人群.这项开创性工作的好处是开发了一种低成本和便携式 可用于诊断收缩功能障碍的解决方案，从而能够在常规检查期间改善筛查 年度体检，医生访问，社区医疗筛查，课程和健康博览会， 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验证该设备，并寻求FDA 510（k）批准商业化。 其次是商业化在佛罗里达和密西西比地区，基于伙伴关系和联合 建立合作，以帮助创造商业上成功的产品。