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The most common approach to treat atherosclerosis in coronary bifurcations is the provisional side-branch (PSB) stenting, which consists sequentially of the insertion of a stent in the main branch (MB) of the bifurcation and a dilatation of the side branch (SB) passing through the struts of the stent at the bifurcation. This approach can be followed by a redilatation of the MB only or by a Final Kissing Balloon (FKB) inflation, both strategies leading to a minor stent distortion in the MB. The positioning of the stent struts in the bifurcation and the stresses generated in the stent and vessel wall are worthy of investigation for a better understanding of the mechanobiology of the system. For this purpose, a computer model of an atherosclerotic coronary bifurcation based on the finite element method was developed; the effects of performing the final redilatation with the two strategies utilising one or two balloons and those created by a different stent strut positioning around the SB were investigated. Results correlate well with previous experimental tests regarding the deformation following balloon expansion. Furthermore, results confirm firstly that the re-establishment of an optimal spatial configuration of the stent after the PSB approach is achieved with both strategies; secondly, results show that case of stent positioning with one cell placed centrally (with regard to the SB) should be preferred, avoiding the presence of struts inside the vessel lumen, which may reduce hemodynamic disturbances. The central positioning also resulted in a better solution in terms of lower stresses in the stent struts and, more importantly, in the vascular tissues.

Biodegradable magnesium alloy stents (MAS) are a promising solution for long-term adverse events caused by interactions between vessels and permanent stent platforms of drug eluting stents. However, the existing MAS showed severe lumen loss after a few months: too short degradation time may be the main reason for this drawback. In this study, a new design concept of MAS was proposed and a shape optimization method with finite element analysis was applied on two-dimensional (2D) stent models considering four different magnesium alloys: AZ80, AZ31, ZM21, and WE43. A morphing procedure was utilized to facilitate the optimization. Two experiments were carried out for a preliminary validation of the 2D models with good results. The optimized designs were compared to an existing MAS by means of three-dimensional finite element analysis. The results showed that the final optimized design with alloy WE43, compared to the existing MAS, has an increased strut width by approximately 48%, improved safety properties (decreased the maximum principal stress after recoil with tissue by 29%, and decreased the maximum principal strain during expansion by 14%) and improved scaffolding ability (increased by 24%). Accordingly, the degradation time can be expected to extend. The used methodology provides a convenient and practical way to develop novel MAS designs.

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Despite their success, stenting procedures are still associated to some clinical problems like sub-acute thrombosis and in-stent restenosis. Several clinical studies associate these phenomena to a combination of both structural and hemodynamic alterations caused by stent implantation. Recently, numerical models have been widely used in the literature to investigate stenting procedures but always from either a purely structural or fluid dynamic point of view. The aim of this work is the implementation of sequential structural and fluid dynamic numerical models to provide a better understanding of stenting procedures in coronary bifurcations. In particular, the realistic geometrical configurations obtained with structural simulations were used to create the fluid domains employed within transient fluid dynamic analyses. This sequential approach was applied to investigate the final kissing balloon (FKB) inflation during the provisional side branch technique. Mechanical stresses in the arterial wall and the stent as well as wall shear stresses along the arterial wall were examined before and after the FKB deployment. FKB provoked average mechanical stresses in the arterial wall almost 2.5 times higher with respect to those induced by inflation of the stent in the main branch only. Results also enlightened FKB benefits in terms of improved local blood flow pattern for the side branch access. As a drawback, the FKB generates a larger region of low wall shear stress. In particular, after FKB the percentage of area characterized by wall shear stresses lower than 0.5 Pa was 79.0%, while before the FKB it was 62.3%. For these reasons, a new tapered balloon dedicated to bifurcations was proposed. The inclusion of the modified balloon has reduced the mechanical stresses in the proximal arterial vessel to 40% and the low wall shear stress coverage area to 71.3%. In conclusion, these results show the relevance of the adopted sequential approach to study the wall mechanics and the hemodynamics created by stent deployment.

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This paper presents a constitutive model for predicting the nonlinear viscoelastic behavior of soft biological tissues and in particular of ligaments. The constitutive law is a generalization of the well-known quasi-linear viscoelastic theory (QLV) in which the elastic response of the tissue and the time-dependent properties are independently modeled and combined into a convolution time integral. The elastic behavior, based on the definition of anisotropic strain energy function, is extended to the time-dependent regime by means of a suitably developed time discretization scheme. The time-dependent constitutive law is based on the postulate that a constituent-based relaxation behavior may be defined through two different stress relaxation functions: one for the isotropic matrix and one for the reinforcing (collagen) fibers. The constitutive parameters of the viscoelastic model have been estimated by curve fitting the stress relaxation experiments conducted on medial collateral ligaments (MCLs) taken from the literature, whereas the predictive capability of the model was assessed by simulating experimental tests different from those used for the parameter estimation. In particular, creep tests at different maximum stresses have been successfully simulated. The proposed nonlinear viscoelastic model is able to predict the time-dependent response of ligaments described in experimental works (Bonifasi-Lista et al., 2005, J. Orthopaed. Res., 23, pp. 67-76; Hingorani et al., 2004, Ann. Biomed. Eng., 32, pp. 306-312; Provenzano et al., 2001, Ann. Biomed. Eng., 29, pp. 908-214; Weiss et al., 2002, J. Biomech., 35, pp. 943-950). In particular, the nonlinear viscoelastic response which implies different relaxation rates for different applied strains, as well as different creep rates for different applied stresses and direction-dependent relaxation behavior, can be described.

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