SBIR-STTR Award

Efforts to establish MRA as clinically practical are hampered by lack of realistic beating heart flow phantoms. We propose to develop an enhanced Coronary Artery Disease (eCAD) phantom for use by MR researchers and developers. eCAD combines features from existing technologies with advanced design, materials and processing to create a controlled environment which reproduces clinical conditions. This will be accomplished by: 1) developing functional cardiac structures based on image data, 2) combining structures with advanced materials and processing to reproduce cardiac functionality and 3) establishing proof- of-concept by verifying that eCAD is anatomically accurate with proper flow patterns and motion under pulsatile conditions. Innovative aspects include designs based on clinical image information, tissue mimicking materials compatible with MRI characteristics, realistic motion of cardiac wall and coronary arteries, and reliability exceeding one year. Technology developed in Phase I will support the additional cardiac structures and variable wall elasticity. In Phase II, we focus on optimizing component materials and procedures in anticipation of constructing advanced flow phantoms for Phase III clinical trials. A commercially available eCAD will be critical for the development, validation and training of medical personnel on using state of the art MRA diagnostic protocols for coronary artery disease. PROPOSED COMMERCIAL APPLICATIONS: The magnitude of the clinical need for a non invasive means to identify patients at risk and stage coronary artery surgery is so large and the commercial availability of adequate MRI tools so limited as to create a lucrative market niche for highly advanced anthropomorphic flow phantoms targeted at coronary artery disease. Products developed from this project will address current and future needs in clinical research, QA, and personnel training applications.

Efforts to establish MRA as clinically practical are hampered by lack of realistic beating heart flow phantom. We propose to develop an enhanced Coronary Artery Disease (eCAD) phantom for use by MR researchers, developers and medical equipment manufacturers, eCAD combines advanced features from previously introduced technology with innovative design, materials and processing to create a controlled environment which reproduces clinical conditions. This will be accomplished by: 1) developing functional cardiac structures based on clinical data, 2) combining structures with advanced materials, processing and modular infrastructure to reproduce cardiac functionality, 3) verifying eCAD is anatomically accurate with proper flow patterns and motion under pulsatile flow conditions and 4) demonstrating prototype reproducibility, stability and commercial potential during extended evaluations in academic and industrial environments. Design optimization and manufacturing technologies are significantly improved through the introduction of powerful computer based, finite element analysis and CAD/CAM integration with in house CNC prototype hardware. Process technology improvements will assist Phase Ill commercialization. A commercially available eCAD will be critical for the development, validation and training of medical personnel on using state of the art MRA diagnostic protocols for coronary artery disease.

Thesaurus Terms:
angiography, coronary disorder, model design /development, phantom model, structural model, technology /technique development computer program /software, computer system design /evaluation, computer system hardware, digital imaging, hemodynamics, morphology, myocardium, pulmonary respiration bioimaging /biomedical imaging, clinical research, human data, magnetic resonance imaging