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

Abstract

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.

Keywords: Covered stent; Finite element analysis (FEA); Nitinol; Stent testing.