A portable device for ambulatory monitoring of heart failure

描述（由申请人提供）：目前在美国约有500万患者患有心力衰竭（HF），每年约有100万人住院，每年的费用超过350亿美元。该项目的长期目标是开发一种创新技术，以协助HF门诊管理。申报器械将由非卧床个体使用，以提醒他们及其医疗保健提供者HF状态恶化（例如，通过无线/蜂窝电话或其它方法）。这将有助于早期治疗干预，从而减少住院、发病率、成本和潜在死亡率。该技术依赖于检测由于心脏、血流和瓣膜的物理运动而引起的低频胸壁振动的变化。这些亚声振动可以用适当的传感器和数字信号处理方法检测和分析。申报的第一代新型器械预期不用于HF患者的初始诊断（即，区分正常与异常受试者）;相反，它旨在用于早期动态检测可能与HF个体的临床变化相关的胸壁振动变化。申报器械是无创、安全的，并且需要较短的测量时间（约60秒）。不需要经常佩戴该装置。相反，患者通常会根据需要每天进行一次自我检测。在第一阶段，将对候选传感器进行测试，并建造第一代原型。将在正常和HF受试者中测试胸壁振动信号的再现性。这些人体研究将有助于描述HF状态变化的胸部振动相关性。如果该项目成功，所提出的新技术将被HF门诊患者用于自我监测，用于自动远程评估（例如通过互联网或电话），或作为医疗保健提供者访问期间的快速评估和监测工具。预期所设想的装置将是紧凑的、使用方便和舒适的、快速的、廉价的和安全的。 公共卫生相关性：该项目建议开发一种设备，通过提醒他们及其提供者疾病恶化来帮助改善对心力衰竭门诊患者的监测和治疗。这将有助于改善早期治疗干预，从而减少住院、疾病、费用和潜在死亡。

DESCRIPTION (provided by applicant): About five million patients currently suffer from heart failure (HF) in the US, resulting in about one million hospitalizations annually and a yearly cost of over 35 billion USD. The long-term objective of this project is to develop an innovative technology to assist HF outpatient management. The proposed device will be used by ambulatory individuals to alert them and their healthcare providers to deterioration of HF status (e.g., via wireless/cell phone or other methods). This will facilitate early therapeutic intervention, which may result in reduced hospitalization, morbidity, cost and potentially mortality. The technology relies on detecting changes in low-frequency chest wall vibrations due to the physical motion of the heart, blood flow and valves. These sub-audible vibrations can be detected and analyzed with appropriate sensors and digital signal processing methods. The proposed first-generation novel device is not intended for initial diagnosis of HF patients (i.e., distinguishing normal from abnormal subjects); rather it is intended for early ambulatory detection of changes in chest wall vibrations that may be associated with clinical changes in HF individuals. The proposed device would be non-invasive, safe, and require brief measurement time (~ 60 sec). There would not be a need to wear the device constantly. Instead, patients would typically test themselves once daily and as needed. During Phase I, candidate sensors will be tested and a first-generation prototype built. Reproducibility of chest wall vibration signals will be tested in normal and HF subjects. These human studies will help delineate chest vibration correlates of HF status changes. If the project is successful, the proposed novel technology would be used by HF outpatients for self monitoring, for automated remote assessment (e.g. via internet or phone), or as a rapid assessment and monitoring tool during healthcare provider visits. It is expected that the envisioned device would be compact, easy and comfortable to use, rapid, inexpensive and safe. PUBLIC HEALTH RELEVANCE: This project proposes to develop a device to help improve monitoring and treatment of out-patients with heart failure by alerting them and their providers to worsening disease. This will allow improved early therapeutic intervention, which should result in reduced hospitalizations, illness, cost and potentially deaths.