Optimization of a Novel Preferential Covered Stent through Bench Experiments and in Vitro Platelet Activation Studies

Abstract

Bare metal stenting (BMS) does not adequately address the atheroembolic characteristic of carotid artery stenosis. While simple covered stents (CS) may prevent dislodged fragments of the atherosclerotic plaque from entering the blood stream, they also block blood flow into the major branches of the artery alongside the lesion, which is not desirable. Preferential covered stents (PCS) behave as a covered stent in a tubular part of a vessel but maintain side-branch flow over the bifurcation region by means of slits in the membrane. Stent design, membrane material, and slits configuration are the three main components contributing to stent performance. Optimization of PCS designs was conducted and tested. Methods: A newly designed BMS was developed and compared to a commercially available peripheral stent. Two materials (expanded poly(tetrafluoroethylene)) and silicone polyurethane co-polymers (Elast-eon E2A) were used as stent coverings with slits applied using various cutting methods to form the PCS. These PCS samples were tested for physical resilience, flexibility, ability to preserve side-branch flow, slit edge roughness, and platelet activation. Results: Fabrication of E2A-coated stents required pretreatment of the stent with poly(ethylene glycol) to achieve firm attachment. The newly designed BMS with nine crowns design and larger cell size showed higher flexibility than commercially available stents. A combination of a larger stent cell size, E2A membrane coating, and three slits per stent cell unit configuration resulted in preserved side-branch flow similar to physiological conditions in the flow experiment. Slit edge roughness changed with different cutting methods and laser machine cutting parameters. In vitro studies showed platelet activation was minimal with lower slit edge roughness samples. Conclusion: An optimized PCS prototype was developed consisting of a newly designed stent, E2A membrane, and a three-slit pattern created by specific femtosecond laser cutting.