Computational modeling can play an important role in the analysis, design, and development of complex medical devices such as biodegradable coronary stents. In this study, experimental mechanical and corrosion testing is conducted to characterize the mechanical and corrosion behavior of magnesium WE43 alloy, a candidate base material for biodegradable magnesium alloy stents. Previously developed uniform and pitting corrosion models are calibrated based on in vitro mechanical and corrosion testing of magnesium WE43 alloy specimens. The calibrated pitting corrosion model can capture the mechanical and corrosion behavior of magnesium WE43, including the experimentally observed non‐linear reduction in failure strength with mass loss, whereas the uniform corrosion model is incapable of capturing this trend. The calibrated corrosion models will be used in future research on magnesium alloy stents.
The field of percutaneous coronary intervention has witnessed many progressions over the last few decades, more recently with the advancement of fully degradable bioabsorbable stents. Bioabsorbable materials, such as metallic alloys and aliphatic polyesters, have the potential to yield stents which provide temporary support to the blood vessel and allow native healing of the tissue to occur. Many chemical and physical reactions are reported to play a part in the degradation of such bioabsorbable materials, including, but not limited to, corrosion mechanisms for metals and the hydrolysis and crystallization of the backbone chains in polymers. In the design and analysis of bioabsorbable stents it is important to consider the effect of each aspect of the degradation on the material's in vivo performance. The development of robust computational modelling techniques which fully capture the degradation behaviour of these bioabsorbable materials is a key factor in the design of bioabsorable stents. A critical review of the current computational modelling techniques used in the design and analysis of these next generation devices is presented here, with the main accomplishments and limitations of each technique highlighted.
Coronary stents made from degradable biomaterials such as magnesium alloy are an emerging technology in the treatment of coronary artery disease. Biodegradable stents provide mechanical support to the artery during the initial scaffolding period after which the artery will have remodeled. The subsequent resorption of the stent biomaterial by the body has potential to reduce the risk associated with long-term placement of these devices, such as in-stent restenosis, late stent thrombosis, and fatigue fracture. Computational modeling such as finite-element analysis has proven to be an extremely useful tool in the continued design and development of these medical devices. What is lacking in computational modeling literature is the representation of the active response of the arterial tissue in the weeks and months following stent implantation, i.e., neointimal remodeling. The phenomenon of neointimal remodeling is particularly interesting and significant in the case of biodegradable stents, when both stent degradation and neointimal remodeling can occur simultaneously, presenting the possibility of a mechanical interaction and transfer of load between the degrading stent and the remodeling artery. In this paper, a computational modeling framework is developed that combines magnesium alloy degradation and neointimal remodeling, which is capable of simulating both uniform (best case) and localized pitting (realistic) stent corrosion in a remodeling artery. The framework is used to evaluate the effects of the neointima on the mechanics of the stent, when the stent is undergoing uniform or pitting corrosion, and to assess the effects of the neointimal formation rate relative to the overall stent degradation rate (for both uniform and pitting conditions).
Significant research has been conducted in the area of coronary stents/scaffolds made from resorbable metallic and polymeric biomaterials. These next‐generation bioabsorbable stents have the potential to completely revolutionise the treatment of coronary artery disease. The primary advantage of resorbable devices over permanent stents is their temporary presence which, from a theoretical point of view, means only a healed coronary artery will be left behind following degradation of the stent potentially eliminating long‐term clinical problems associated with permanent stents. The healing of the artery following coronary stent/scaffold implantation is crucial for the long‐term safety of these devices. Computational modelling can be used to evaluate the performance of complex stent devices in silico and assist in the design and development and understanding of the next‐generation resorbable stents. What is lacking in computational modelling literature is the representation of the active response of the arterial tissue in the weeks and months following stent implantation, ie, neointimal remodelling, in particular for the case of biodegradable stents. In this paper, a computational modelling framework is developed, which accounts for two major physiological stimuli responsible for neointimal remodelling and combined with a magnesium corrosion model that is capable of simulating localised pitting (realistic) stent corrosion. The framework is used to simulate different neointimal growth patterns and to explore the effects the neointimal remodelling has on the mechanical performance (scaffolding support) of the bioabsorbable magnesium stent.
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