SBIR-STTR Award

Three million myocardial infarctions are recorded annually in the United States, with an accompanying mortality rate of approximately 15%. The annual medical costs for screening of patients at risk for cardiac diseases using nuclear medicine imaging are estimated at greater than $500,000,000. A reduction in mortality is expected with improved diagnostic imaging procedures. However, it is difficult to develop and evaluate improved cardiac imaging protocols without a realistic beating heart phantom. The long term goal of this project is the development and marketing of a Dynamic Cardiac Ventricular Phantom (DCVP) system for use in clinical protocol evaluation, quality assurance and training. Phase I specific aims are to: (l) determine the average three-dimensional configuration of the beating myocardial ventricles, (2) incorporate this information into the preliminary design of a DCVP and design a test fixture system using computer aided design, (3) construct the test fixture system, and (4) evaluate and determine materials and system components suitable for use in the DCVP. The phantom will be designed primarily for nuclear cardiac imaging using single photon emission computed tomography (SPECT) and positron emission tomography (PET), but could be adapted for other cardiovascular imaging technologies such as ultrasound, magnetic resonance, and computed tomography. PROPOSED COMMERCIAL APPLICATIONS: We expect to manufacture a DCVP system from commercially available components and materials using customized processing equipment. The system will be easy to use and robust with a goal of Mean Time Between Failure (MTBF) of 125 hours. The targeted sales price range is $7,500 to $15,000 per system. Projected first year sales are 250 systems with an expected total sales of 5,000 systems over the expected 10 year life of the product.

Thesaurus Terms:
cardiovascular disorder diagnosis, cardiovascular visualization, computer assisted diagnosis, heart function, model design /development, myocardium, phantom model biomedical equipment development, clinical biomedical equipment, computer processing of clinical data, computer program /software, computer simulation, heart ventricle, heart ventriculography positron emission tomography, single photon emission computed tomographyNational Heart, Lung and Blood Institute (NHLBI)

Coronary artery disease is the number one killer of both men and women in the United States today. Three million myocardial infarctions are recorded annually in the U.S., with an accompanying mortality rate of approximately 15%. The annual costs for screening of patients at risk for cardiac diseases using nuclear medicine imaging procedures alone are greater than 500 million US dollars. A reduction in mortality is expected with improved diagnostic imaging procedures for cardiac diseases. However, it is difficult to develop and evaluate improved cardiac imaging methods and protocols without a realistic heart phantom. The long term goal of this project are the development of a Dynamic Heart Phantom (DHP) system that consists of both the left and right ventricles for use in clinical protocol evaluation, quality assurance and training. Phase II specific aims are to: (1) continue analysis of the size and shape of the ventricles; (2) develop technologies to model normal and ischemic myocardium and cost-effective manufacturing methods for the DHP; (3) development and testing of the control and monitoring system for the DHP; and (4) evaluate the imaging characteristics and performance of the DHP using multimodality clinical imaging equipment at three independent clinical sites. PROPOSED COMMERCIAL APPLICATIONS: We expect to manufacture a DHP system from commercially available components and materials using customized processing equipment. The system will be easy to operate and robust with a goal of Mean Time Between Failure (MTBF) of 125 hours. The targeted sales price range is $7,500 to $15,000 per system. Projected first year sales are 250 systems with an expected total sales of 5,000 systems over the expected 10 year life of the product.

Thesaurus Terms:
biomedical equipment development, cardiovascular visualization, imaging /visualization, model design /development, phantom model heart ventricle, method development, morphology bioimaging /biomedical imaging, computed axial tomography, human data, magnetic resonance imaging, positron emission tomography, single photon emission computed tomographyNATIONAL HEART, LUNG, AND BLOOD INSTITUTE