Research Project
6993850
DESCRIPTION (provided by applicant): This SBIR Phase I project will develop and commercialize a process for applying nanoparticle composite coatings with drugs and polymers to the surfaces of coronary artery stents. The use of performance-enhancing coatings on implantable medical devices, such as coronary artery stents, has begun to transform the device market and holds tremendous potential for improving human health. Drug-eluting stents have created a breakthrough improvement in the non-surgical treatment of coronary artery disease. They represent the first wave in a new opportunity to use surface-modified medical devices for site-specific therapy. Commercial experience gained with the early versions of these stents showed that improvements in coating technique and materials dramatically impact clinical performance. Our preliminary proof-of-principle experiments have shown that electronanospray can be used to apply nanoparticles of both drug and bioactive substances to the small surface of the stent, together with biocompatible and biodegradable polymers that can be used to control release of those substances. Electrospray offers several key advantages: it is several-fold more efficient than standard spray techniques and provides the ability to control deposition, apply complex (two phase) particles, engineer the coating layers, and differentially coat the inner and outer surfaces of the stent. These features provide the potential not only to improve coatings for stents, but also to apply therapeutic and biocompatible coatings to a wide variety of implantable medical devices. The specific aims are to (1) produce novel stent coatings using Nanocopoeia's electronanospray system and characterize their physical properties, and (2) determine the drug-elution performance profiles of coated stent candidates. Coatings will be assessed for coating mass, surface characteristics, quality and consistency, transfer efficiency, non-line-of-site deposition on inner as well as outer surfaces, and adherence qualities. Performance of the coatings will be assessed using fatigue testing in an artificial artery system. Pharmacokinetic profiles will be established for coating variations.
