A portable device for ambulatory monitoring of heart failure
Department of Health and Human Services
Agency Tracking Number:
Solicitation Topic Code:
Small Business Information
BIOMEDICAL ACOUSTICS RESEARCH COMPANY
4079 Conway Place Circle, Orlando, FL, 32812-7988
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (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 projectis 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 ofthe 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, andrequire 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 beused 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 andcomfortable 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.
* information listed above is at the time of submission.