SBIR-STTR Award

Unstable plaque is well established as producing high risk for sudden myocardial infarction (MI), through plaque rupture and subsequent thrombotic response, or thrombosis generated at the inflamed plaque surface. It cannot be located by angiography, and has been estimated to account for 60-70 percent of fatal MIs and up to 85 percent of all MIs. Accumed Systems, Inc. will develop a Thermal Sensing Catheter (TSC) to identify unstable plaque. Such measurements have been made in research labs, but no such product now exists. Technological innovation to achieve this includes developing new micro-thermistor and specialized manufacturing techniques to embed them in sensing arms, as well as developing new and novel testing techniques. It will measure the surface temperature of the inner wall of coronary arteries at multiple sites and identify sites of unstable plaque. Specific aims: 1) Prove the viability of intra-arterial measurements by making repeated measurements of simulated hot spots in canine arteries with prototype catheters. Demonstrate meeting preliminary spatial, thermal, and temporal specifications. 2) Confirm the functionality of the design and generate prototypes for the next round of tests on atherosclerotic rabbits to take place in Phase II. PROPOSED COMMERCIAL APPLICATION: The Thermal Sensing Catheter (TSC) to be developed will have immediate commercial applications in the large (est. $200 million/year) market for atherosclerotic plaque stability assessment. The underlying technology will also have a wide range of other cardiovascular applications where inflammation is present, e.g. myocarditis, valvulitis, aortis, as well as in those in other areas about to be biopsied, such as skin lesions, gingival lesions and urinary bladder.

The purpose of this study will be to detect the prevalence and prognostic value of plaque temperature heterogeneity in diabetic patients undergoing stent implantation. The objective is to develop and commercialize an intraluminal Thermal Sensing System (TSS) for taking surface temperature measurements of atherosclerotic plaque lesions within the walls of coronary arteries with the goal that current and future means to prevent coronary events can be implemented selectively. The system comprises an invasive catheter and an external instrument. The device has been validated in vitro and in vivo. A pilot human study involving patients undergoing angioplasty for medically indicated reasons was completed successfully. Specific Aims for the proposed SBIR Phase II are: [1] Advance the current intraluminal TSS toward a commercially viable product - change to thermocouples, improve catheter flexibility, reduce sensing element profile, integrate an occlusion feature - followed by revalidation of System safety and performance. [2] Demonstrate in a human clinical trial the predictive value of plaque surface temperature for future ischemic events and validate the performance of the TSS. After this grant we have plans in place to commercialize the technology including design for manufacturability, additional clinical studies, and a market development strategy for this exciting and useful new diagnostic devic

Thesaurus Terms:
atherosclerotic plaque, biomedical equipment development, biosensor, diagnosis quality /standard, diagnostic catheterization, disease /disorder classification, prognosis, temperature biomedical equipment safety, cardiovascular disorder prevention, clinical biomedical equipment, clinical trial, coronary artery, diabetes mellitus, diagnosis design /evaluation, intraluminal angioplasty, longitudinal human study, medical complication, pathologic process bioengineering /biomedical engineering, biotechnology, clinical research, human subject, swine