Innovative, non-invasive, battery-less, disposable cardiac biosensor for hemodynamic monitoring

用于血流动力学监测的创新、非侵入、无电池、一次性心脏生物传感器

• 批准号: 10188673
• 负责人: Kaustubh Kale
• 金额: $ 22.5万
• 依托单位: AVENTUSOFT, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-20 至 2022-03-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10188673
• 关键词: Accelerometer; Address; Adhesives; Adult; Aging; Algorithms; Ambulatory Monitoring; Android; Biosensor; Blood; Blood Pressure; Bradycardia; Caliber; Cardiac; Cardiovascular Diseases; Cardiovascular system; Caring; Cellular Phone; Cessation of life; Chronic; Communication; Companions; Complex; Computer software; Congestive; Congestive Heart Failure; Consultations; Coronary Artery Bypass; Data; Data Store; Development; Devices; Diagnosis; Echocardiography; Economics; Education; Elderly; Electrocardiogram; Ensure; Environment; Etiology; Event; Goals; Gold; Harvest; Health Insurance Portability and Accountability Act; Health Personnel; Healthcare; Heart; Heart Abnormalities; Heart Rate; Heart Valves; Home; Hospitalization; Hospitals; Human; Individual; Intervention; Lead; Left; Legal patent; Lung; Measurement; Measures; Medical; Medical Care Team; Medical Device Designs; Modeling; Monitor; Myocardial Infarction; Operative Surgical Procedures; Outpatients; Patient Education; Patient Monitoring; Patients; Phase; Primary Health Care; Procedures; Public Health; Pulmonary artery structure; Quality of life; Radio communications; Reader; Recovery; Reporting; Scientist; Secure; Signal Transduction; Skin; Small Business Innovation Research Grant; Sternum; Supervision; System; Tachycardia; Technology; Telephone; Testing; Time; Validation; Ventricular; Visit; Weight; Wireless Technology; Work; base; care providers; clinical practice; dashboard; design; detection method; empowered; evidence base; heart function; hemodynamics; high risk; hospital readmission; implantable device; improved; innovation; insight; light weight; mortality; multidisciplinary; new technology; non-compliance; novel; older patient; patient population; portability; pressure; prototype; pulmonary function; radio frequency; smart watch; smartphone Application; time interval; trend; vibration

7. PROJECT SUMMARY/ABSTRACT This SBIR Phase I project will design and develop an innovative, miniature, battery-less, disposable cardiac biosensor, to provide easy home assessment of heart and lung function. The biosensor will deliver comparable hemodynamic measurements to the gold standard assessments. Economic impetus has led to early discharge of complex and elderly patients with cardiovascular disease. Older adults discharged from hospitals following diagnoses of congestive heart failure exacerbation, myocardial infarction, coronary artery bypass grafting surgery or other high-risk cardiac procedures are at higher risk for re-hospitalizations and increased mortality resulting from gaps in care following hospital discharge. The assessment solutions available for patient monitoring at home, namely, blood pressure, weight, electrocardiograms, have not demonstrated reduction in readmission for any reason or death of any causes after discharge. Invasive implant devices, such as CardioMEMS, have demonstrated that hemodynamic measurements allow more effective management leading to fewer hospitalizations and lower deaths. Thus, aging adults are in need of reliable, robust, safe (non-invasive), and simple technologies that can provide hemodynamic assessment post hospitalization. There is need for meaningful interventions through a phone consultation or outpatient primary care visits that reduce re-admissions and mortality. Using this SBIRs technology, it will be possible for a patient to have access to gold standard hemodynamic measurements, through an integrated, wearable, battery-less, cardiac biosensor. The biosensor’s data can be read with a smart phone using secure near field communication, enabling patients and their health care providers to have easy access to their hemodynamic measurements via a smartphone application. Early objective measurements of hemodynamic changes will lead to early and prompt outpatient interventions. This will improve the quality of life for individuals with chronic cardiovascular conditions enabling them to remain at home longer. We have a multidisciplinary team of scientists and practice stakeholders who will work together to develop and test the conceptual model that will be applicable across diverse patient populations. The overall goal of this project it to demonstrate that new technology can meaningfully accommodate the needs of older adults and address their unique problems and challenges. For the first time there will be a biosensor that truly addresses the market need of an un-obstructive, non-invasive, accurate, absolute and actionable system for post-discharge use at home. This will facilitate close self-monitoring and outpatient monitoring of our most vulnerable patients, while maintaining close supervision by the health care teams. This battery-less, disposable biosensor technology for providing in-depth hemodynamics has additional far reaching benefits. Such a device does not exist today thus opening up numerous commercial possibilities.

7.项目摘要/摘要 这个SBIR第一阶段项目将设计和开发一种创新的、微型的、无电池的一次性心脏 生物传感器，提供轻松的家庭心肺功能评估。生物传感器将提供类似的 血流动力学测量以金标准评估。经济推动导致提前出院 患有复杂和老年心血管疾病的患者。下列老年人已出院 充血性心力衰竭加重、心肌梗死、冠状动脉旁路移植术的诊断 手术或其他高危心脏手术再次住院的风险更高，死亡率也更高 这是由于出院后的护理缺口造成的。可供患者使用的评估解决方案 在家中的监测，即血压、体重、心电图，并没有显示出减少 出院后因任何原因再次入院或因任何原因死亡。侵入性植入设备，如 心脏微机械系统，已经证明血流动力学测量允许更有效的管理领导 减少住院和降低死亡率。因此，老年人需要可靠、健壮、安全(非侵入性)、 和简单的技术，可以提供入院后的血流动力学评估。有必要 通过电话咨询或门诊初级保健就诊进行有意义的干预，减少再次入院 和死亡率。使用这种SBIRS技术，患者将有可能获得黄金标准 通过集成的、可穿戴的、无电池的心脏生物传感器进行血流动力学测量。生物传感器的 使用安全的近场通信，可以使用智能手机读取数据，从而使患者和他们的健康 护理人员可以通过智能手机应用程序轻松访问他们的血流动力学测量。早些时候 客观测量血流动力学变化将导致早期和及时的门诊干预。这 将改善慢性心血管疾病患者的生活质量，使他们能够保持在 回家的时间更长。我们有一个由科学家和实践利益相关者组成的多学科团队，他们将共同努力 开发并测试适用于不同患者群体的概念模型。整体而言 这个项目的目标是证明新技术可以有意义地满足旧技术的需求 并解决他们独特的问题和挑战。这将是第一次有一个真正的生物传感器 满足市场对无障碍、非侵入性、准确、绝对和可操作的系统的需求 出院后在家使用。这将有助于密切自我监测和门诊监测我们的大多数 在保持卫生保健团队密切监督的同时，对易受伤害的患者进行监测。这是一款无电池的一次性产品 用于提供深度血流动力学的生物传感器技术还有其他深远的好处。这样的装置 今天已经不存在了，因此打开了无数的商业可能性。