Abstract

In this work, a strain-based degradation model was implemented and validated to better understand the dynamic interactions between the bioresorbable vascular scaffold (BVS) and the artery during the degradation process. Integrating the strain-modulated degradation equation into commercial finite element codes allows a better control and visualization of local mechanical parameters. Both strut thinning and discontinuity of the stent struts within an artery were captured and visualized. The predicted results in terms of mass loss and fracture locations were validated by the documented experimental observations. In addition, results suggested that the heterogeneous degradation of the stent depends on its strain distribution following deployment. Degradation is faster at the locations with higher strains and resulted in the strut thinning and discontinuity, which contributes to the continuous mass loss, and the reduced contact force between the BVS and artery. A nonlinear relationship between the maximum principal strain of the stent and the fracture time was obtained, which could be transformed to predict the degradation process of the BVS in different mechanical environments. The developed computational model provided more insights into the degradation process, which could complement the discrete experimental data for improving the design and clinical management of the BVS.

Highlights

  • The permanent implantation of stents, with or without carrying drugs, are permanently caging the vessel and preventing physiologic vasomotor function, which have been associated with undesirable outcomes such as restenosis and thrombosis [1]

  • It is clear that the crimping and relaxation of the poly-L-lactide acid (PLLA) stent induced residue stress/strain in the stent

  • We have developed a strain-based degradation framework with focus on the dynamic interactions between the Bioresorbable vascular scaffolds (BVS) and the artery during the degradation process

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Summary

Introduction

The permanent implantation of stents, with or without carrying drugs, are permanently caging the vessel and preventing physiologic vasomotor function, which have been associated with undesirable outcomes such as restenosis and thrombosis [1]. Bioresorbable vascular scaffolds (BVS) were developed to overcome the aforementioned limitations [2]. The BVS, referred to as bioresorbable stent or biodegradable stent, is expected to serve as a temporary scaffold for a period of 6–12 months to allow the artery remodeling and completely reabsorbed within 36 months [3]. The choices of bioresorbable materials as well as structural designs were acknowledged to impact the degradation behavior of BVS [4,5]. Bioresorbable materials of the choice include magnesium-based alloys, pure iron or iron-based alloys, and polymers [6]. Among the several scaffolds developed, the Absorb BVS (Abbott Vascular, Santa Clara, CA), made of poly-L-lactide acid (PLLA), was the first FDA-approved device.

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