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。项目摘要/摘要 这个SBIR II期项目将开发一个新型的移动框架，以测量左心室射血分数 使用自动化的心脏信号的非侵入性分析作为收缩功能障碍的标记。心脏病是 男女死亡的主要原因，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，它发生在少数群体中 和健康差异人群。例如，非洲与心力衰竭相关的死亡增长37％ 美国人比白人。减少的射血分数是左心室收缩功能障碍的标记， 最常见的心力衰竭类型。通过适当的分类可以显着改善整体心脏健康 通过确定射血分数的初级保健水平，而无需2-D回声电脑图。会 为医疗保健专业人员提供服务点技术，以指导诊断，监测和治疗 努力。便携式设备功能使其更容易访问，并且可以随时使用高昂的成本。作为 正在开发的技术不需要熟练的操作员或经过特殊培训的医生，它将允许 医疗保健提供者在其正常的医学培训中衡量射血分数。通过 我们开发了一项革命性的医疗设备的两年阶段工作，可以测量 使用在胸壁上测得的心脏声音信号的射血分数。科学范围 在此第二阶段项目中提出的是使用我们的专门为完成诊断框架的开发 工程传感器系统与将通过智能手机或 平板电脑用于便携式且具有成本效益的解决方案。全球资源贫乏的社区无法获得 质量医疗保健是由于医疗专业知识短缺和昂贵医疗的可用性不佳而产生的 诊断设备。近年来，手机变得越来越先进和无处不在。这 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 到服务不足的人群。这项开创性工作的好处是开发低成本和便携式 可用于诊断收缩功能障碍的解决方案，从而在常规过程中改善筛选 在社区医疗筛查，课程和健康展览会上，年度检查，探视医生访问，导致更健康的 社区。它将使测量射血分数与测量血压一样常规。在第二阶段，我们 将继续通过用户审判对设备进行验证，并寻求FDA 510（k）清算以进行商业化。 然后根据合作伙伴关系和联合在佛罗里达和密西西比地区进行商业化 建立的合作旨在帮助创建商业上成功的产品。