An experimental investigation of the mechanical performance of PLLA wire-braided stents.

Abstract

Much of our current understanding of the performance of self-expanding wire-braided stents is based on mechanical testing of Nitinol-based or polymeric non-bioresorbable (e.g. PET, PP etc.) devices. The small amount of data present for bioresorbable devices characterizes stents with big nominal diameters (D>6mm), with a distinct lack of data describing the mechanical performance of small-diameter wire-braided bioresorbable devices (D≤5mm). This study presents a systematic investigation of the mechanical performance of wire-braided bioresorbable Poly-L-Lactic Acid (PLLA) stents having different braiding angles (α=45° , α=30°, and α=20°), wire diameters (d=100μm, and d=150μm), wire count (n=24 and n=48), braiding patterns (1:1-1, 2:2-1 and 1:1-2) and stent diameters (D=5mm, D=4mm, and D=2.5mm). Mechanical characterisation was carried out by evaluating the radial, longitudinal and bending response of the devices. Our results showed that smaller braid angles, larger wire diameters, higher number of wires and smaller stent diameter led to an increase in the stent mechanical properties across each of the three mechanical tests performed. It was found that geometrical features of a polymeric braided stent could be adapted to achieve a similar performance to the one of a metallic device. In particular, substantial increases in stent mechanical properties were found for a low braiding angle and when the braiding pattern followed a one-over-one-under configuration with two wires in parallel (1:1-2). Finally, it was shown that a mathematical model proposed in literature for metal braided stents can provide reasonable predictions also of polymeric stent performance but just in circumstances where wire friction does not have a dominant role. This study presents a wide range of experimental data that can provide an important reference for further development of wire-braided bioresorbable devices.