A Computational Framework Examining the Mechanical Behaviour of Bare and Polymer-Covered Self-Expanding Laser-Cut Stents.

PURPOSE Polymer covered stents have demonstrated promising clinical outcomes with improved patency rates compared to traditional bare-metal stents. However, little is known on the mechanical implication of stent covering. This study aims to provide insight into the role of a polymeric cover on the biomechanical performance of self-expanding laser-cut stents through a combined experimental-computational approach. METHODS Experimental bench top tests were conducted on bare and covered versions of a commercial stent to evaluate the radial, axial and bending response. In parallel, a computational framework with a novel covering strategy was developed that accurately predicts stent mechanical performance. Different stent geometries and polymer materials were also considered to further improve understanding on covered stent mechanics. RESULTS Results show that stent covering causes increased initial axial stiffness and up to 60% greater radial resistive force at small crimp diameters as the cover folds and self-contacts. The incorporation of a cover allows stent designs without interconnecting struts, thereby providing improved flexibility without compromising radial force. It was also shown that use of a stiffer PET polymeric covering material caused significant alterations to the radial and axial response, with the initial axial stiffness increasing six-fold and the maximum radial resistive force increasing four-fold compared to a PTFE-PU covered stent. CONCLUSION This study demonstrates that stent covering has a substantial effect on the overall stent mechanical performance and highlights the importance of considering the mechanical properties of the combined cover and stent.