Degradation and adhesive/cohesive strengths of a reservoir-based drug eluting stent.

This paper presents the results of loss of mechanical strengths due to the degradation that occurs in a model reservoir-based coronary stent, the NEVO(™) Sirolimus-eluting Stent (NEVO(™) SES). The adhesion of the formulation to the reservoir and cohesion within the formulation in the time course of hydrolysis were determined using a micro-testing system that was developed specifically for the measurements of the adhesive and cohesive strengths of suspended polymeric films. The strengths were measured after hydration, during degradation with gentle agitation, as well as degradation with pulsatile mechanical loading. The morphology and molecular weight changes in the time course of NEVO(™) SES formulation degradation were also studied using Scanning Electron Microscopy (SEM) and Gel Permeation Chromatography (GPC) techniques. Morphological changes, such as pore formation, lagged behind the decrease in the molecular weight of the formulation. In contrast, the adhesion/cohesion strengths showed that the mechanical integrity of the stents dropped significantly within a few hours of hydration, before reaching a plateau. Despite the significant molecular weight decrease and morphological changes, the plateau mechanical strengths reached were essentially the same during degradation, under both, mechanically unloaded and loaded conditions.

Adhesion and cohesion in structures containing suspended microscopic polymeric films.

This paper presents a novel technique for the characterization of adhesion and cohesion in suspended micro-scale polymeric films. The technique involves push-out testing with probes that are fabricated using focused ion beam techniques. The underlying stresses associated with different probe tip sizes were computed using a finite element model. The critical force for failure of the film substrate interface is used to evaluate adhesion, while the critical force for penetration of the film determines cohesion. When testing a standard material, polycarbonate, a shear strength of approximately 70 MPa was calculated using the Mohr-Coulomb theory. This value was shown to be in agreement with the results in the literature. The technique was also applied to the measurement of adhesion and cohesion in a model drug-eluting stent (the Nevo™ Sirolimus Eluting Coronary Stent) containing suspended microscopic polymeric films in metallic Co-Cr alloy reservoirs. The cohesive strength of the formulation was found to be comparable with that of plastics such as those produced by reaction injection molding and high-density polyethylene.