SBIR Phase II: Multi-dimensional Cardiogram Device for Monitoring of Heart Diseases

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is in developing a first-of-its-kind hemodynamic parameter monitoring device for the early detection of heart disease that will significantly improve the management of patients with compromised heart functions. Heart disease is perhaps the next cardiac epidemic, as over the past 50 years, a steady rise in life expectancy has led to progressively increasing frequency of degeneration. Heart disease is associated with significant morbidity and mortality, and treatment, particularly by surgery, is expensive. Many technologies have emerged to assist the diagnosis such as the electrocardiogram, magnetic resonance imaging, and cardiac catheterization, and the 2-D echocardiogram. Existing 2-D echocardiogram instruments have been inadequate tools for screening as they require significant support staff and infrastructure. Considering the cost, risks, and availability of these diagnostic tools, cardiac auscultation remains an important part of the initial investigative process for heart disease patients. The societal impact of this project is significant as a new modality will be made available. The device is not an improvement over existing technologies but a step up from current technology that does not exist today and opens the door to numerous commercial possibilities. The proposed project will develop a novel device for the non-invasive assessment of heart disease called Multi-Dimensional Cardiogram (MDCG). This technology addresses the market for early detection of heart disease by offering, novel multi-transducer framework, advanced hardware and algorithmic signal processing. The phase II will consist of development of the hardware and software for a portable device. The device will provide physicians with multiple dimensions of information from the heart signal to diagnose heart disease based on the Mitral, Tricuspid, Aortic and Pulmonary valve sounds; enabling earlier detection, close outpatient follow up, and remote home monitoring. Physicians rely on auscultation and evaluation of risk factors since access to cardiologists and certain diagnostic modalities are not always available or practical. We have identified and propose to meet this important need for a device that can enable non-cardiologist physicians and healthcare professionals to perform examinations for heart disease which are more detailed than possible with stethoscope auscultation. The MDCG technology improves the diagnostic accuracy required for monitoring patients with heart disease. The intellectual merits of this device include the development of a high-performance system in a single, low-power compact package that is easy-to-use and has a small transducer array footprint.