Modeling of stents exhibiting negative Poisson's ratio effect

Intravascular stents are metallic scaffolding structures deployed in the stenotic arteries to restore the lumen for the blood flow to the down stream tissues. Most stents are balloon expandable and are deployed from its crimped state through a balloon catheter. The efficacy of the stenting procedure mainly depends on the way the stent is deployed. Both numerical and experimental evaluations show that almost all the present day stents undergo the most undesirable effects namely: (i) longitudinal foreshortening: the axial contraction in the length, and (ii) dogboning: flaring of the distal edges, during the radial expansion of the stents. Due to the foreshortening effect, clinicians are forced to select stents longer than the plaque. Still, the final length of the stent depends on the amount of radial expansion, which is subjective during the procedure. This paper introduces a new stent model called "Murugan", which exhibits negative Poisson's ratio effect. That is, the stent may have zero axial contraction or can have extension when under radial expansion. The presence of hyperelastic balloon and the stent-balloon friction is also considered to study their effects in mechanical properties of the stents under consideration. Free expansion analysis is done using finite element method (FEM) to compare the new stent model with the present day stent geometries.     

Mechanical behavior of coronary stents investigated through the finite element method

Intravascular stents are small tube-like structures expanded into stenotic arteries to restore blood flow perfusion to the downstream tissues. The stent is mounted on a balloon catheter and delivered to the site of blockage. When the balloon is inflated, the stent expands and is pressed against the inner wall of the coronary artery. After the balloon is deflated and removed, the stent remains in place, keeping the artery open. Hence, the stent expansion defines the effectiveness of the surgical procedure: it depends on the stent geometry, it includes large displacements and deformations and material non-linearity.In this paper, the finite element method is applied (i) to understand the effects of different geometrical parameters (thickness, metal-to-artery surface ratio, longitudinal and radial cut lengths) of a typical diamond-shaped coronary stent on the device mechanical performance, (ii) to compare the response of different actual stent models when loaded by internal pressure and (iii) to collect suggestions for optimizing the device shape and performance.The stent expansion and partial recoil under balloon inflation and deflation were simulated. Results showed the influence of the geometry on the stent behavior: a stent with a low metal-to-artery surface ratio has a higher radial and longitudinal recoil, but a lower dogboning. The thickness influences the stent performance in terms of foreshortening, longitudinal recoil and dogboning.In conclusion, a finite element analysis similar to the one herewith proposed could help in designing new stents or analyzing actual stents to ensure ideal expansion and structural integrity, substituting in vitro experiments often difficult and unpractical.     

Finite element comparison of performance related characteristics of balloon expandable stents

Cardiovascular stents are commonly made from 316L stainless steel and are deployed within stenosed arterial lesions using balloon expansion. Deployment involves inflating the balloon and plastically deforming the stent until the required diameter is obtained. This plastic deformation induces static stresses in the stent, which will remain for the lifetime of the device. In order to determine these stresses, finite element models of the unit cells of geometrically different, commercially available balloon expandable stents have been created, and deployment and elastic recoil have been simulated. In this work the residual stresses associated with deployment and recoil are compared for the various stent geometries, with a view to establishing appropriate initial stress states for fatigue loading for the stents. The maximum, minimum, and mean stresses induced in the stent due to systolic/diastolic pressure are evaluated, as are performance measures such as radial and longitudinal recoil.     

Geometry parameterization and multidisciplinary constrained optimization of coronary stents

Coronary stents are tubular type scaffolds that are deployed, using an inflatable balloon on a catheter, most commonly to recover the lumen size of narrowed (diseased) arterial segments. A common differentiating factor between the numerous stents used in clinical practice today is their geometric design. An ideal stent should have high radial strength to provide good arterial support post-expansion, have high flexibility for easy manoeuvrability during deployment, cause minimal injury to the artery when being expanded and, for drug eluting stents, should provide adequate drug in the arterial tissue. Often, with any stent design, these objectives are in competition such that improvement in one objective is a result of trade-off in others. This study proposes a technique to parameterize stent geometry, by varying the shape of circumferential rings and the links, and assess performance by modelling the processes of balloon expansion and drug diffusion. Finite element analysis is used to expand each stent (through balloon inflation) into contact with a representative diseased coronary artery model, followed by a drug release simulation. Also, a separate model is constructed to measure stent flexibility. Since the computational simulation time for each design is very high (approximately 24?h), a Gaussian process modelling approach is used to analyse the design space corresponding to the proposed parameterization. Four objectives to assess recoil, stress distribution, drug distribution and flexibility are set up to perform optimization studies. In particular, single objective constrained optimization problems are set up to improve the design relative to the baseline geometry—i.e. to improve one objective without compromising the others. Improvements of 8, 6 and 15% are obtained individually for stress, drug and flexibility metrics, respectively. The relative influence of the design features on each objective is quantified in terms of main effects, thereby suggesting the design features which could be altered to improve stent performance. In particular, it is shown that large values of strut width combined with smaller axial lengths of circumferential rings are optimal in terms of minimizing average stresses and maximizing drug delivery. Furthermore, it is shown that a larger amplitude of the links with minimum curved regions is desirable for improved flexibility, average stresses and drug delivery.     

On the effects of different strategies in modelling balloon-expandable stenting by means of finite element method

In recent years, computational structural analyses have emerged as important tools to investigate the mechanical response of stent placement into arterial walls. Although most coronary stents are expanded by inflating a polymeric balloon, realistic computational balloon models have been introduced only recently. In the present study, the finite element method is applied to simulate three different approaches to evaluate stent-free expansion and stent expansion inside an artery. Three different stent expansion modelling techniques were analysed by: (i) imposing a uniform pressure on the stent internal surface, (ii) a rigid cylindrical surface expanded with displacement control and (iii) modelling a polymeric deformable balloon. The computational results showed differences in the free and confined-stent expansions due to different expansion techniques. The modelling technique of the balloon seems essential to estimate the level of injury caused on arterial walls during stent expansion.     

Simulation of a balloon expandable stent in a realistic coronary artery—Determination of the optimum modelling strategy

Computational models of stent deployment in arteries have been widely used to shed light on various aspects of stent design and optimisation. In this context, modelling of balloon expandable stents has proved challenging due to the complex mechanics of balloon–stent interaction and the difficulties involved in creating folded balloon geometries. In this study, a method to create a folded balloon model is presented and utilised to numerically model the accurate deployment of a stent in a realistic geometry of an atherosclerotic human coronary artery. Stent deployment is, however, commonly modelled by applying an increasing pressure to the stent, thereby neglecting the balloon. This method is compared to the realistic balloon expansion simulation to fully elucidate the limitations of this procedure. The results illustrate that inclusion of a realistic balloon model is essential for accurate modelling of stent deformation and stent stresses. An alternative balloon simulation procedure is presented however, which overcomes many of the limitations of the applied pressure approach by using elements which restrain the stent as the desired diameter is achieved. This study shows that direct application of pressure to the stent inner surface may be used as an optimal modelling strategy to estimate the stresses in the vessel wall using these restraining elements and hence offer a very efficient alternative approach to numerically modelling stent deployment within complex arterial geometries. The method is limited however, in that it can only predict final stresses in the stented vessel and not those occurring during stent expansion, in which case the balloon expansion model is required.     

Coronary stent implantation without balloon predilatation: a single-center experience

OBJECTIVE: Assessment of safety and efficacy of coronary stent deployment, without balloon predilatation. BACKGROUND: With newer high-performance balloon-premounted stents it has become more common to attempt coronary stent deployment without balloon pre- or postdilatation. METHODS: During 1998 524 coronary angioplasties were performed in the authors' institute, of which 279 resulted in coronary stenting. Of these 101 (36.2%) were stents without balloon predilatation (SWBP). PTCA was performed according to standard technique using mostly 7 F. guiding catheters, and 'rapid exchange' balloons and pre-mounted stents. RESULTS: Seventy-two patients had acute coronary syndromes (41 acute MI or post-MI angina, 28 unstable angina, 10 rescue PTCA after failed thrombolysis). Mean age was 56.4 3 11.1 years, 84.5% were males. Sixty per cent of the lesions were ACC-AHA type B2 or C. Target arteries were LAD 57.6%, LCX 21.2%, RCA 14.1% and SVG 7.1%. Procedure time was 18.2 3 17.3 minutes. Mean heparin dose was 3850 3 1570 units. Twenty-two patients received abciximab prior to stent deployment. Seven stents were not deployed without previous balloon dilatation and were retrieved safely via the guiding catheters and deployed after balloon dilatation. There was no stent embolization, ectopic suboptimal or partial stent deployment. Immediate angiographic success was obtained in 95 patients (94.1%). Minimal lumin diameter (MLD) increased from 0.27 3 0.15 to 3.23 3 2.1 mm. There were two in-hospital deaths (1.9%) due to cardiogenic shock. An intra-aortic balloon pump was required in eight patients. Two patients (1.9%) experienced subacute stent thrombosis. CONCLUSION: SWBP in selective groups of patients and lesions is feasible and safe. Larger randomized comparative trials are needed to assess the benefits and cost saving of this approach.     

Effects of stent design parameters on normal artery wall mechanics

A stent is a device designed to restore flow through constricted arteries. These tubular scaffold devices are delivered to the afflicted region and deployed using minimally invasive techniques. Stents must have sufficient radial strength to prop the diseased artery open. The presence of a stent can subject the artery to abnormally high stresses that can trigger adverse biologic responses culminating in restenosis. The primary aim of this investigation was to investigate the effects of varying stent "design parameters" on the stress field induced in the normal artery wall and the radial displacement achieved by the stent. The generic stent models were designed to represent a sample of the attributes incorporated in present commercially available stents. Each stent was deployed in a homogeneous, nonlinear hyperelastic artery model and evaluated using commercially available finite element analysis software. Of the designs investigated herein, those employing large axial strut spacing, blunted corners, and higher amplitudes in the ring segments induced high circumferential stresses over smaller areas of the artery's inner surface than all other configurations. Axial strut spacing was the dominant parameter in this study, i.e., all designs employing a small stent strut spacing induced higher stresses over larger areas than designs employing the large strut spacing. Increasing either radius of curvature or strut amplitude generally resulted in smaller areas exposed to high stresses. At larger strut spacing, sensitivity to radius of curvature was increased in comparison to the small strut spacing. With the larger strut spacing designs, the effects of varying amplitude could be offset by varying the radius of curvature and vice versa. The range of minimum radial displacements from the unstented diastolic radius observed among all designs was less than 90 microm. Evidence presented herein suggests that stent designs incorporating large axial strut spacing, blunted corners at bends, and higher amplitudes exposed smaller regions of the artery to high stresses, while maintaining a radial displacement that should be sufficient to restore adequate flow.     

Numerical study of the uniformity of balloon-expandable stent deployment

Stents are small tubelike structures, implanted in coronary and peripheral arteries to reopen narrowed vessel sections. This endovascular intervention remains suboptimal, as the success rate is limited by restenosis. This renarrowing of a stented vessel is related to the arterial injury caused by stent-artery and balloon-artery interactions, and a local subsequent inflammatory process. Therefore, efforts to optimize the stent deployment remain very meaningful. Several authors have studied with finite element modeling the mechanical behavior of balloon-expandable stents, but none of the proposed models incorporates the folding pattern of the balloon. We developed a numerical model in which the CYPHER stent is combined with a realistic trifolded balloon. In this paper, the impact of several parameters such as balloon length, folding pattern, and relative position of the stent with respect to the balloon catheter on the free stent expansion has been investigated. Quantitative validation of the modeling strategy shows excellent agreement with data provided by the manufacturer and, therefore, the model serves as a solid basis for further investigations. The parametric analyses showed that both the balloon length and the folding pattern have a considerable influence on the uniformity and symmetry of the transient stent expansion. Consequently, this approach can be used to select the most appropriate balloon length and folding pattern for a particular stent design in order to optimize the stent deployment. Furthermore, it was demonstrated that small positioning inaccuracies may change the expansion behavior of a stent. Therefore, the placement of the stent on the balloon catheter should be accurately carried out, again in order to decrease the endothelial damage.     

Analysis of the transient expansion behavior and design optimization of coronary stents by finite element method

The percutaneous transluminal coronary angioplasty (PTCA) assisted with stenting technique has become a primary therapy to coronary heart disease. In practice, the structure conditions of both ends of stent/balloon system influence a stent's instantaneous expansion behavior. The transitory nonuniform expansion, the so-called dogboning, of stent/balloon system is one of the main reasons to induce the acute vascular injury at the two edges of a stent. This kind of vascular injury has a close relationship with the in-stent restenosis. In the present paper, the finite element method (FEM) was applied to simulate the transient expansion process of stent/balloon system with different stent structure and balloon length under the internal pressure. And two types of stent and six collocations of stent and balloon were modeled. Modeling results showed that the dogboning phenomenon can be eliminated by improving geometry of a stent or/and varying the length of balloon over stent. The above modeled results were further confirmed by following in situ observation.     

Finite element analyses for improved design of peripheral stents

Due to the recent increase in the number of stent insertion procedures, the number of studies to evaluate the mechanical behaviors of stents, such as the stress and deformation states, using finite element analysis is also increasing. However, it is still not easy to design stents that are uniformly expanded and show enough radial strength and flexibility. Therefore, in this study, the Taguchi method and finite element analysis were used to determine a set of optimal design variables for unit patterns of stents, and a new design approach was developed to realize uniform expansion, enough radial strength and good flexibility. The stent designed using the new design approach was verified by experiments.     

Fabrication and in vitro deployment of a laser-activated shape memory polymer vascular stent

Background

Vascular stents are small tubular scaffolds used in the treatment of arterial stenosis (narrowing of the vessel). Most vascular stents are metallic and are deployed either by balloon expansion or by self-expansion. A shape memory polymer (SMP) stent may enhance flexibility, compliance, and drug elution compared to its current metallic counterparts. The purpose of this study was to describe the fabrication of a laser-activated SMP stent and demonstrate photothermal expansion of the stent in an in vitro artery model.

Methods

A novel SMP stent was fabricated from thermoplastic polyurethane. A solid SMP tube formed by dip coating a stainless steel pin was laser-etched to create the mesh pattern of the finished stent. The stent was crimped over a fiber-optic cylindrical light diffuser coupled to an infrared diode laser. Photothermal actuation of the stent was performed in a water-filled mock artery.

Results

At a physiological flow rate, the stent did not fully expand at the maximum laser power (8.6 W) due to convective cooling. However, under zero flow, simulating the technique of endovascular flow occlusion, complete laser actuation was achieved in the mock artery at a laser power of ~8 W.

Conclusion

We have shown the design and fabrication of an SMP stent and a means of light delivery for photothermal actuation. Though further studies are required to optimize the device and assess thermal tissue damage, photothermal actuation of the SMP stent was demonstrated.     

Analyses and design of expansion mechanisms of balloon expandable vascular stents

Vascular stents are expanded in blood vessels with lumens larger than their cardiac counterparts. Extreme radial expansion significantly reduces the expanded length of some designs, resulting in insufficient lesion coverage and inaccurate placement. It is hypothesized that expansion mechanisms of a balloon-expandable stent, driven by plastic hinges, are controlled by the cell topology. This hypothesis is first tested for stent expansion using kinematic and kinetic analyses, followed by more detailed finite element (FE) calculations. Three balloon-expandable stent designs are laser micro-machined for experimental verification of the length–diameter relations predicted by the analytical and FE models. It is found that stent designs with positive, negative, or zero foreshortening over expansion phase can be designed by tailoring unit cell geometries and hence obtain desired length–diameter and pressure–diameter characteristics.     

Numerical investigations of the mechanical properties of a braided non-vascular stent design using finite element method

This paper discusses various issues relating to the mechanical properties of a braided non-vascular stent made of a Ni–Ti alloy. The design of the stent is a major factor which determines its reliability after implantation into a stenosed non-vascular cavity. This paper presents the effect of the main structural parameters on the mechanical properties of braided stents. A parametric analysis of a commercial stent model is developed using the commercial finite element code ANSYS. As a consequence of the analytical results that the pitch of wire has a greater effect than other structural parameters, a new design of a variable pitch stent is presented to improve mechanical properties of these braided stents. The effect of structural parameters on mechanical properties is compared for both stent models: constant and variable pitches. When the pitches of the left and right quarters of the stent are 50% larger and 100% larger than that of the central portion, respectively, the radial stiffness in the central portion increases by 10% and 38.8%, while the radial stiffness at the end portions decreases by 128% and 164.7%, the axial elongation by 25.6% and 56.6% and the bending deflection by 3.96% and 10.15%. It has been demonstrated by finite element analysis that the variable pitch stent can better meet the clinical requirements.     

Influence of overlapping pattern of multiple overlapping uncovered stents on the local mechanical environment: A patient-specific parameter study

BackgroundMultiple overlapping uncovered stents (MOUS) system has shown potentials in managing complex aortic aneurysms with side branches involvement. It promotes the development of thrombus by modulating local flow pattern that reduces the wall tension, while maintaining patency of side branches. However the modulation of local hemodynamic parameters depends on various factors that have not been assessed comprehensively.MethodsAneurysm 3D geometry was reconstructed based on CT images. One-way fluid-structure interaction analysis was performed to quantify structural stress concentration in the wall, and changes of blood velocity, wall shear stress (WSS), oscillatory shear index (OSI), relative residence time (RRT) and pressure in the sac due to the stent deployment.ResultsHigh structural stress concentration due to stent deployment was found in the landing zone and it increased linearly with the number of stents deployed. The wall tension in the sac was unaffected by the stent deployment. Stress within the wall was insensitive to the different overlapping pattern. After one stent was deployed, the mean flow velocity in the sac reduced by 36.4%. The deployment of the 2nd stent further reduced the mean sac velocity by 10%. WSS decreased while both OSI and RRT increased after stent deployment, however pressure in the sac remained nearly unchanged. Except for the cases with complete stents struts alignment, different overlapping pattern had little effect on flow parameters.ConclusionsMechanical parameters modulated by the MOUS are insensitive to different overlapping pattern suggesting that endovascular procedure can be performed with less attention to the overlapping pattern.     

Analysis of prolapse in cardiovascular stents: a constitutive equation for vascular tissue and finite-element modelling

The effectiveness of a cardiovascular stent depends on many factors, such as its ability to sustain the compression applied by the vessel wall, minimal longitudinal contraction when it is expanded, and its ability to flex when navigating tortuous blood vessels. The long-term reaction of the tissue to the stent is also device dependant; in particular some designs provoke in-stent restenosis (i.e., regrowth of the occlusion around the stent). The mechanism of restenosis is thought to involve injury or damage to the vessel wall due to the high stresses generated around the stent when it expands. Because of this, the deflection of the tissue between the struts of the stent (called prolapse or "draping") has been used as a measure of the potential of a stent to cause restenosis. In this paper, uniaxial and biaxial experiments on human femoral artery and porcine aortic vascular tissue are used to develop a hyperelastic constitive model of vascular tissue suitable for implementation in finite-element analysis. To analyze prolapse, four stent designs (BeStent 2, Medtronic AVE; NIROYAL, Boston Scientific; VELOCITY, Cordis; TETRA, Guidant) were expanded in vitro to determine their repeating-unit dimensions. This geometric data was used to generate a finite element model of the vascular tissue supported within a repeating-unit of the stent. Under a pressure of 450 mm Hg (representing the radial compression of the vessel wall), maximum radial deflection of 0.253 mm, 0.279 mm, 0.348 mm and 0.48 mm were calculated for each of the four stents. Stresses in the vascular wall were highest for the VELOCITY stent. The method is proposed as a way to compare stents relative to their potential for restenosis and as a basis for a biomechanical design of a stent repeating-unit that would minimize restenosis.     

Mechanistic evaluation of long-term in-stent restenosis based on models of tissue damage and growth

Development and application of advanced mechanical models of soft tissues and their growth represent one of the main directions in modern mechanics of solids. Such models are increasingly used to deal with complex biomedical problems. Prediction of in-stent restenosis for patients treated with coronary stents remains a highly challenging task. Using a finite element method, this paper presents a mechanistic approach to evaluate the development of in-stent restenosis in an artery following stent implantation. Hyperelastic models with damage, verified with experimental results, are used to describe the level of tissue damage in arterial layers and plaque caused by such intervention. A tissue-growth model, associated with vessel damage, is adopted to describe the growth behaviour of a media layer after stent implantation. Narrowing of lumen diameter with time is used to quantify the development of in-stent restenosis in the vessel after stenting. It is demonstrated that stent designs and materials strongly affect the stenting-induced damage in the media layer and the subsequent development of in-stent restenosis. The larger the artery expansion achieved during balloon inflation, the higher the damage introduced to the media layer, leading to an increased level of in-stent restenosis. In addition, the development of in-stent restenosis is directly correlated with the artery expansion during the stent deployment. The correlation is further used to predict the effect of a complex clinical procedure, such as stent overlapping, on the level of in-stent restenosis developed after percutaneous coronary intervention.

     

Finite element analysis of the biomechanical interaction between coronary sinus and proximal anchoring stent in coronary sinus annuloplasty

Recent clinical studies of the percutaneous transvenous mitral annuloplasty (PTMA) devices have shown a short-term reduction of mitral regurgitation after implantation. However, adverse events associated with the devices such as compression and perforation of vessel branches, device migration and fracture were reported. In this study, a finite element analysis was carried out to investigate the biomechanical interaction between the proximal anchor stent of a PTMA device and the coronary sinus (CS) vessel in three steps including: (i) the stent release and contact with the CS wall, (ii) the axial pull t the stent connector and (iii) the pressure inflation of the vessel wall. To investigate the impact of the material properties of tissues and stents on the interactive responses, the CS vessel was modelled with human and porcine material properties, and the proximal stent was modelled with two different Nitinol materials with one being stiffer than the other. The results indicated that the vessel wall stresses and contact forces imposed by the stents were much higher in the human model than the porcine model. However, the mechanical differences induced by the two stent types were relatively small. The softer stent exhibited a better fatigue safety factor when deployed in the human model than in the porcine model. These results underscored the importance of the CS tissue mechanical properties. Vessel wall stress and stent radial force obtained in the human model were higher than those obtained in the porcine model, which also brought up questions as to the validity of using the porcine model to assess device mechanical function. The quantification of these biomechanical interactions can offer scientific insight into the development and optimisation of the PTMA device design.     

Stainless and shape memory alloy coronary stents: a computational study on the interaction with the vascular wall

Balloon-expandable and self-expandable stents are the two types of coronary stents available. Basically, they differ in the modality of expansion.The present study analyses the stress state induced on the vascular wall, by the expansion of balloon- and self-expandable stents, using the finite element method. Indeed, modified mechanical stress state is in part responsible in the restenosis process. The balloon-expandable stents herein investigated are assumed to be made of stainless steel, while the self-expandable stents are made of a shape memory alloy. The effects of the severity of the coronary stenosis, the atherosclerotic plaque stiffness and the stent design are investigated. Comparing the self-expandable stent with the balloon-expandable one, the former induces fewer stresses and lower damage to the vessel, but, on the other hand, its lower stiffness induces a lower capability to restore vasal lumen and to contrast arterial elastic recoil.     

Realistic finite element-based stent design: the impact of balloon folding

At present, the deployment of an intravascular stent has become a common and widely used minimally invasive treatment for coronary heart disease. To improve these coronary revascularization procedures (e.g. reduce in-stent restenosis rates) the optimal strategy lies in the further development of stent design, material and coatings. In the context of optimizing the stent design, computational models can provide an excellent research tool. In this study, the hypothesis that the free expansion of a stent is determined by the unfolding and expansion of the balloon is examined. Different expansion modeling strategies are studied and compared for a new generation balloon-expandable coronary stent. The trifolded balloon methodology presented in this paper shows very good qualitative and quantitative agreement with both manufacturer's data and experiments. Therefore, the proposed numerical expansion strategy appears to be a very promising optimization methodology in stent design.