Surface characterization of polymer-drug modified vascular stents and intraocular lenses

Two of the most important medical devices in clinical use today are endoluminal stents and intraocular lenses (IOLs). In both devices, surface and interfacial properties are of basic importance in the development and clinical performance of these devices.;Drug eluting stents have revolutionized the world of interventional cardiology. Research reported here was devoted to the design and development of new drug eluting stents wherein the metallic backbone is completely embedded in a polymeric matrix used also as a drug reservoir. This design, using silicone-drug compositions can lead to higher drug payloads, less tissue damage during angioplasty balloon/stent expansion, and the novel capability of delivering multiple drugs.;The adhesion of the polymeric coating to the metallic stent is essential and has not been adequately reported previously. The adhesion of polydimethylsiloxane (PDMS) coatings to a stainless steel stent substrate was shown to be enhanced by the application of mixtures of tetra-n-propyl silicate, tetrabutyltitanate, tetra-2-methoxyethoxysilane, and 3-(trimethoxysilyl)propyl methacrylate coupling agents. Additionally, the effect of drug loading on the stress/strain properties of the polymeric coating is of basic importance. The tensile strength and percent elongation of dexamethasone loaded PDMS films was shown to remain satisfactory for stent coatings at low concentrations (less than 1%) but decreased as the concentrations of dexamethasone in PDMS was increased to 5%.;The release of multiple therapeutic agents from PDMS coatings to reduce in-stent restenosis has not been previously reported. The release profile of Paclitaxel, dexamethasone 21-acetate, and their combination from PDMS coatings was studied using high precision liquid chromatography (HPLC). Although dexamethasone release was reduced by paclitaxel, paclitaxel release was unaffected by combination with dexamethasone. Paclitaxel release from the polymeric matrices was shown to inhibit human coronary smooth muscle cell growth in vitro whereas dexamethasone exhibited no similar effect.;A second major subject of this research was a series of studies concerning the properties of foldable hydrophobic acrylic intraocular lenses (IOLs) which have not previously been investigated. Most IOLs implanted today in the U.S. and the western world are foldable. The goal of this research was to conduct new surface characterization studies on the surfaces of several different foldable lenses in clinical use. Atomic force microscopy showed that these IOLs have different morphologies and that hydration greatly altered the surface morphology of these implants. Contact angle goniometry studies indicated that water contact angles varied significantly from one lens to the other and that prolonged hydration led to a reduction of the water contact angle. Nanoindentation experiments yielded new information on the surface mechanical properties of IOLs and a new methodology was developed to analyze nanoindent data to determine the surface modulus and hardness of foldable IOLs and low modulus polymers in general. The novel surface properties studies reported here can be important in guiding the design and the development of new ocular implants.