Balloon angioplasty with stenting is a well-established interventional procedure to treat stenotic arteries. Despite recent advances such as drug eluting stents, clinical studies suggest that stent design is linked to vascular injury. Additionally, dilation of the medical devices may trigger pathological responses such as growth and migration of vascular smooth cells, and may be a potent stimulus for neointimal hyperplasia. The purpose of this study is to experimentally investigate the mechanical characteristics of the transient expansion of six commercially available balloon-expandable stent systems, and to develop a robust finite element model based on the obtained experimental results. To reproduce the inflation of stent systems as in clinical practice, a pneumatic-hydraulic experimental setup is built, able to record loads and deformations. Characteristic pressure-diameter diagrams for the balloon-expandable stents and the detached balloons are experimentally obtained. Additionally, typical measures such as the burst opening pressure, the maximum dog-boning and foreshortening, and the elastic recoil are determined. The adopted constitutive models account for elastoplastic deformation of the stent, and for the nonlinear and anisotropic behavior of the balloon. The employed contact algorithm, based on a C(2)-continuous surface parametrization, efficiently simulates the interaction of the balloon and stent. The computational model is able to successfully capture the experimentally observed deformation mechanisms. Overall, the numerical results are in satisfactory agreement with experimental data.

A methodology is proposed that identifies optimal stent devices for specific clinical criteria. It enables to predict the effect of stent designs on the mechanical environment of stenotic arteries. In particular, we present a numerical study which is based on the interaction of a vascular stent with a patient-specific, atherosclerotic human iliac lesion of type V. The stress evolution in four different tissue components during and after stenting is investigated. The geometric model of the artery is obtained through MRI, while anisotropic material models are applied to describe the behavior of tissues at finite strains. In order to model the observed fissuring and dissection of the plaque under dilation, the undeformed configuration of the arterial wall incorporates two initial tears. The 3D balloon-stent-artery interaction problem is modeled by means of a contact algorithm, which is based on a C(2)-continuous surface parametrization, hence avoiding numerical instabilities of standard facet-based techniques. In the simulations three different stent designs are studied. The performance of each stent is characterized by scalar quantities relating to stress changes in the artery, contact forces, and changes in lumen area after stenting. The study concludes by suggesting two optimal stent designs for two different clinically relevant parameters.

A lipid core that occupies a high proportion of the plaque volume in addition to a thin fibrous cap is a predominant indicator of plaque vulnerability. Nowadays, noninvasive imaging modalities can identify such structural components, however, morphological criteria alone cannot reliably identify high-risk plaques. Information, such as stresses in the lesion's components, seems to be essential. This work presents a methodology able to analyze the effect of changes in the lipid core and calcification on the wall stresses, in particular, on the fibrous cap vulnerability. Using high-resolution magnetic resonance imaging and histology of an ex vivo human atherosclerotic carotid bifurcation, a patient-specific three-dimensional geometric model, consisting of four tissue components, is generated. The adopted constitutive model accounts for the nonlinear and anisotropic tissue behavior incorporating the collagen fiber orientation by means of a novel and robust algorithm. The material parameters are identified from experimental data. A novel stress-based computational cap vulnerability index is proposed to assess quantitatively the rupture-risk of fibrous caps. Nonlinear finite element analyses identify that the highest stress regions are located at the vicinity of the shoulders of the fibrous cap and in the stiff calcified tissue. A parametric analysis reveals a positive correlation between the increase in lipid core portion and the mechanical stress in the fibrous cap and, hence, the risk for cap rupture. The highest values of the vulnerability index, which correlate to more vulnerable caps, are obtained for morphologies for which the lipid cores were severe; heavily loaded fibrous caps were thus detected. The proposed multidisciplinary methodology is able to investigate quantitatively the mechanical behavior of atherosclerotic plaques in patient-specific stenoses. The introduced vulnerability index may serve as a more quantitative tool for diagnosis, treatment and prevention.

SUMMARYCritical to the simulation of balloon angioplasty is the modeling of the contact between the artery wall and the medical devices. In standard approaches, the 3D contact surfaces are described by means of C 0 -continuous facet-based techniques, which may lead to numerical problems. This work introduces a novel contact algorithm where the target surfaces are described by polynomial expressions with C 2 -continuity. On the basis of uniform cubic B-splines, two different parametrization techniques are presented and compared, while the related implementation of the algorithm into a finite element analysis program is described. Two numerical examples are selected to demonstrate the special merits of the proposed contact formulation. The first example is a benchmark contact problem selected to point out the special features of the proposed strategies. The second example is concerned with the simulation of balloon angioplasty and stenting, where the contact between the balloon, the stent and the artery wall is numerically modeled. A patient-specific 3D model of a stenotic femoral artery serves as a basis. The study concludes by identifying the changes in the mechanical environment of the artery in terms of contact forces and strains by considering two different stent designs.

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