SBIR-STTR Award

Non invasive MR evaluation of the carotid artery wall and lumen is hampered by the lack of a comprehensive and anatomically correct commercially available flow phantom. The objective of this project is to develop an advanced artificial carotid artery flow phantom for use in developing MRI applications to identify patients at risk for transient ischemic attack or strokes due to atherosclerotic carotid artery disease. This phantom combines the best features of existing technologies with: innovative vessel design based on image data (Aim 1), elastic wall and matrix materials and advanced wall layering construction methodology (Aim 2) to produce flexible thin walled branching flow phantoms. Branching vessels are anatomically accurate and will exhibit proper vessel distention and translation under pulsatile flow (Aim 3). Technology developed in Phase I will support variable wall elasticity to properly mimic atherosclerotic lesions. In Phase II, we focus on optimizing component materials and procedures identified in Phase I in anticipation of constructing advanced flow phantoms for Phase III clinical trials. A comprehensive flow phantom will be critical for the development, validation and training of medical personnel on using state of the art MRI screening protocols for atherosclerotic carotid artery disease. PROPOSED COMMERCIAL APPLICATIONS: The magnitude of the clinical need for a non invasive means to identify patients at risk and stage carotid artery surgery is so large and the commercial availability of adequate MR tools so limited as to create a lucrative market niche for highly advanced anthropomorphic flow phantoms targeted at cerebrovascular disease. Products developed from this project will address current and future needs in clinical research, QA, and personnel training applications

Non invasive MRI evaluation of the carotid artery wall lumen and blood flow patterns is hampered by the lack of a comprehensive and anatomically correct commercially available flow phantom. The objective of this project is to develop an advanced artificial carotid artery flow phantom for use in developing MRI applications to identify patients at risk for transient ischemic attack or strokes. In Phase I, proof-of-concept was established. Phase II technical aims are selected to systematically expand the knowledge and experience base of key technologies: 1) lumen design, based on image data, 2) wall mechanics, with regional variation, 3) image morphology, including two distinct layers with fibrous cap lesion and 4) fluid motion with custom pulsatile flow pump and experimental results compared to hemodynamic simulations. Prototypes are constructed and evaluated in: academic, clinical and industrial environments to gauge commercial potential and identify key functional requirements for commercial development. Materials and preparations are optimized to obtain precision and stability of parameters on the order of 20 percent over 18 months. A comprehensive flow phantom will be critical for the development, validation and training of medical personnel on using state of the art MRI screening protocols for atherosclerotic carotid artery disease. PROPOSED COMMERCIAL APPLICATION: The magnitude of the clinical need for a non invasive means to identify patients at risk and stage carotid 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 cerebrovascular disease. Products developed from this project will address current and future needs in clinical research, QA, and personnel training applications. (See Product Development Plan, pages 45-50).

Thesaurus Terms:
blood flow, blood flow measurement, carotid artery, magnetic resonance imaging, model design /development, phantom model angiography, atherosclerosis, blood vessel, disease /disorder model, elasticity, hemodynamics, stroke, transient ischemic attack bioimaging /biomedical imaging, digital imaging, human tissue