SBIR Phase I: Multi-dimensional Cardiogram Device for Diagnosing Valvular Heart Diseases

This Small Business Innovation Research (SBIR) Phase I project will develop a novel device for the non-invasive assessment of valvular 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. The device uses a novel multi-transducer framework combined with biologically-inspired auditory scene analysis based signal processing for a portable and cost-effective solution. The Phase I will consist of development of prototype 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 and close outpatient follow up. Physicians rely on auscultation and evaluation of risk factors since access to cardiologists and certain diagnostic modalities are not always available or practical. The goal is to meet this important need for a device that can enable non-cardiologist physicians and healthcare professionals to perform examinations for heart disease thath are more detailed than possible with stethoscope auscultation. The proposed technology improves the diagnostic accuracy for valvular heart disease. The broader impact/commercial potential of this project includes development of a patented device to facilitate early detection and to improve diagnostic accuracy of valvular heart disease. Valvular 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. Valvular heart disease is associated with significant morbidity and mortality, and treatment, particularly by valve surgery, is expensive. Furthermore, research concerning the epidemiology, pathophysiology and clinical management of heart disease is limited. 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 diagnosis of valvular heart disease. The societal impact of the proposed technology is significant as a new diagnostic modality will be made available. It is a step up from current technology that does not exist today, and opens the door to numerous commercial possibilities.