SBIR Phase I: Nanocomposite Coating on Coronary Stents

This Small Business Innovation Research Phase I Project aims to design and develop a process for applying nanocomposite coatings of multiple components to the surfaces of small parts with intricate geometry using a novel electronanospray process. Electronanospray generates monodisperse streams of highly uniform nanoparticles. The primary objectives of this proposal are to define key process conditions that are needed to coat drug-eluting coronary artery stents. Specifically, it will determine the impact of particle size (nanoscale 20 to 500 nm range) and the composition and number of spray stream components (2 or more) on coating thickness and uniformity, and nanocomposite composition and surface qualities. The process can coat biodegradable polymers, drugs and biotherapeutics on surfaces with intricate geometry. Advantages of this coating technology include a high transfer efficiency uniformity, non-line-of-sight coating, and the ability to combine multiple active agents in a single coating operation. Commercially this technology has application not only for coating medical devices but also modifying the surface of other small intricate parts where the nanocomposite coating enables new functionality. The drug-eluting (coated) stent market is growing rapidly and is predicted to exceed $6 billion by 2008. A novel coating process would capture a significant revenue stream if it could provide higher yield, greater quality and thereby lower costs, while at the same time offering improved therapeutic potential and improved human health by eliminating the need for high risk surgery. For example, improved coatings could enable longer-term activity of the implants with one or more therapeutic agents or diminish late side effects, such as thrombosis or scarring, that are now beginning to appear with current generation implants. The commercial value extends beyond the medical device implant market (e.g. aerospace applications, sensing technologies) if it can be demonstrated that this coating process can be used for applying other nanocomposite, multi-functional coatings to very small surfaces.