An investigation of PLLA hybrid stent design to overcome thick strut problems

Abstract

Biodegradable polymer-based stents simultaneously provide scaffolding, drug release, and biodegradation to eliminate chronic inflammation. The most important factors hindering the wide use of these stents are thick struts, low radial strength, and large footprints formed on the inner wall of the artery as a result of stent expansion. Negative Poisson's Ratio (NPR), also known as the Auxetic design, has shown great potential to provide radial strength with less strut thickness. However, a detailed mechanical evaluation proving improvement in stent performance parameters is not available in the literature. In this study, the performance parameters of two stent designs based on the Auxetic geometry with PLLA were analyzed under in-vivo conditions using an in-silico model consisting of the artery, crimper, and expander FE model. For this purpose, one design utilizes Auxetic unit cell, which is already available in the literature, while the other uses a newly proposed Hybrid design combining Auxetic and Chevron type geometries. Additionally, a specially heated coaxial balloon-catheter system was considered as a deployment tool between glass transition and body temperature, and carried out for thin-strut stent simulations. The Hybrid design is shown to resolve the foreshortening problem of Auxetic design and collapse pressure of commercial PLLA stents. In this present study validates the potential of Hybrid design to overcome problems for polymer-based biodegradable stents.