Non-invasive hemodynamic sensor patch for remote, early detection and prevention of heart failure with left bundle branch block

无创血流动力学传感器贴片，用于远程、早期检测和预防左束支传导阻滞心力衰竭

• 批准号: 10250749
• 负责人: Brennan Torstrick
• 金额: $ 25.62万
• 依托单位: HUXLEY MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10250749
• 关键词: Accelerometer; Adult; Algorithmic Analysis; American; Blood Pressure; Body Composition; Body mass index; Bundle-Branch Block; Cardiac; Cardiovascular Diseases; Cardiovascular system; Chest; Chronic; Chronic Care; Clinical; Collection; Contracts; Data; Data Collection; Defibrillators; Detection; Devices; Diagnosis; Diagnostic; Disease; Disease Progression; Drops; EFRAC; Early Diagnosis; Early Intervention; Early treatment; Echocardiography; Electrocardiogram; Electrodes; Electrophysiology (science); Epidemiology; Etiology; Exhibits; Failure; Functional disorder; Future; Goals; Gold; Health; Heart; Heart failure; Home; Hospitalization; Intervention; Knowledge; Left; Location; M-Mode Echocardiography; Measurement; Measures; Mechanics; Methods; Monitor; Motion; Outcome; Pacemakers; Patients; Phase; Photoplethysmography; Physiologic pulse; Physiological; Positioning Attribute; Prevention; Prevention strategy; Resolution; Resources; Risk; Science; Signal Transduction; Skin; Sleep; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Symptoms; System; Techniques; Technology; Telemedicine; Testing; Time; Treatment Failure; United States; Ventricular; Ventricular Function; Ventricular Remodeling; Wireless Technology; Work; automated analysis; cardiac resynchronization therapy; care delivery; cost effective; experience; flexibility; flexible electronics; heart function; hemodynamics; human old age (65+); implantation; improved; innovation; mortality; multimodality; prevent; remote monitoring; remote patient monitoring; remote sensor; sensor; stem; treatment guidelines; usability; wearable sensor technology

1 Project Abstract 2 The long-term goal of this SBIR is to develop a remote, non-invasive early-warning system for heart 3 failure progression in presymptomatic patients at elevated risk of developing heart failure. The early-warning 4 system consists of a wireless sensor patch worn periodically by patients at home that diagnoses cardiac 5 hemodynamics and electrophysiology to notify cardiologists of patients whose ventricular function is worsening 6 and may benefit from early intervention. Currently there are no validated remote monitoring approaches for early 7 detection of heart failure. Consequently, treatment guidelines restrict most invasive heart failure interventions 8 (e.g. implantation of a pacemaker or defibrillator) to patients suffering from later-stage heart failure where some 9 degree of symptoms may be irreversible. The need for early detection in heart failure is critical, as heart failure 10 is the leading cause of hospitalizations in adults over 65 years old and among the leading causes of mortality. 11 The proposed technology will aid early detection, prevention, and treatment of heart failure patients so 12 they can live longer, more fulfilling lives. Specific hemodynamic changes are known to be predictive of heart 13 failure outcomes, but current technologies used to diagnose cardiac hemodynamics are resource intensive 14 clinical methods like echocardiography or non-specific remote sensors like scales which only measure symptoms 15 of heart failure and not the underlying function of the heart. This SBIR will develop an unobtrusive hemodynamic 16 patch and automated analysis algorithm to monitor signals specific to the etiology of heart failure that are 17 predictive of disease progression. The proposed solution changes the diagnostic paradigm in 3 specific ways: 18 passive measurement of multiple hemodynamic-specific variables, direct integration into remote monitoring 19 workflows, and ease of use to support more efficient chronic care delivery (e.g. telemedicine). 20 Aim 1 will evaluate the accuracy and precision of the patch versus clinical standard devices like 21 echocardiography, electrocardiography, and blood pressure cuffs. This Aim will validate that the sensor can 22 reliably measure hemodynamic and electrophysiological signals at clinical grade accuracy. It will also investigate 23 the sensitivity of the data collected to patch placement and body composition variability. Aim 2 will investigate 24 cardiac physiological changes associated with heart failure progression in patients with left bundle branch block 25 (LBBB), a cardiac conduction disorder associated with increased risk of developing heart failure. To achieve this, 26 LBBB patients at various disease stages will sleep while wearing the wireless patch. Then, physiological signal 27 changes associated with disease stage will be identified. Successful completion of Phase I will validate technical 28 feasibility of a non-invasive sensor capable of identifying upstream physiological changes predictive of heart 29 failure. The work also has broader applications to improve health and gain fundamental knowledge by elucidating 30 specific progressive hemodynamic changes associated with LBBB-driven dysfunction and by introducing a non- 31 invasive hemodynamic remote monitoring platform to empower future longitudinal cardiovascular studies.

1个项目摘要 2这个SBIR的长期目标是为心脏开发一个遥远的，无创的早期训练系统 3预症状患者的失败进展，患心力衰竭的风险升高。早期的 4系统由患者在家定期穿着的无线传感器贴片诊断心脏 5个血液动力学和电生理学，以通知心脏病的心脏病学家的心室功能恶化恶化 6，可能会受益于早期干预。目前尚无早期验证的远程监视方法 7检测心力衰竭。因此，治疗指南限制了大多数侵入性心力衰竭干预措施 8（例如，对起搏器或除颤器的植入）患有晚期心力衰竭的患者 9症状可能是不可逆的。由于心力衰竭 10是65岁以上的成年人住院的主要原因，也是死亡的主要原因之一。 11所提出的技术将有助于早期检测，预防和治疗心力衰竭患者，因此 12他们可以生活更长，更充实的生活。已知特定的血液动力学变化可以预测心脏 13个失败结果，但是用于诊断心脏血液动力学的当前技术是资源密集型 14种临床方法，例如超声心动图或非特异性遥控传感器，例如量表，仅测量症状 15是心力衰竭，而不是心脏的基本功能。该SBIR将发展出一种不引人注目的血液动力学 16个贴片和自动分析算法，以监测特定于心力衰竭病因的信号 17疾病进展的预测。提出的解决方案以3种特定方式更改诊断范式： 18多种血流动力学特异性变量的被动测量，直接集成到远程监控中 19个工作流程，易用性，以支持更有效的慢性护理提供（例如远程医疗）。 20 AIM 1将评估贴片与临床标准设备（如临床标准设备）的准确性和精度 21超声心动图，心电图和血压袖口。这个目标将验证传感器可以 22可靠地测量临床等级准确性下的血液动力学和电生理信号。它也会调查 23收集到斑块放置和身体组成变异性的数据的敏感性。 AIM 2将调查 24与左束分支患者心力衰竭进展相关的心脏生理变化 25（LBBB），一种与增加心力衰竭风险有关的心脏传导障碍。为此， 穿着无线贴剂时，在各种疾病阶段处于各种疾病阶段的26名LBBB患者。然后，生理信号 将确定与疾病阶段相关的27个变化。成功完成第一阶段将验证技术 28非侵入性传感器的可行性 29失败。这项工作还具有更广泛的应用程序，可以通过阐明来改善健康和获得基本知识 30特定的与LBBB驱动功能障碍相关的特定进行性血流动力学变化，并通过引入非 - 31侵入性血液动力学远程监测平台，以赋予未来的纵向心血管研究。