Mechanical properties of open-cell, self-expandable shape memory alloy carotid stents.

Mechanical properties of carotid stents are important for the selection of the implantable device. The efficacy of cell design is usually investigated on the basis of clinical follow-ups; however, for the specific carotid application the relative importance of the cell design on the stenting outcome is debated. Ideally, a carotid stent should have at the same time low bending stiffness (i.e., high flexibility) to correctly conform to the vessel curvatures in the stenotic region and high stiffness to sustain the vessel wall in the radial direction. In this study, experimental tests on six carotid open-cell design self-expandable stents were carried out to assess bending and radial stiffness. A four-point bending test was adopted to measure the bending stiffness. Radial stiffness was obtained by measuring the stent resistance to local compression in a V-shaped support. Geometrical features, such as the link positioning and their length, were examined as a possible determinant of the mechanical properties of the tested stents. The tested stents showed very different geometrical features and mechanical properties despite similar material and a common open-cell structure consisting in rings connected by roughly straight links. In particular, different strategies are evident regarding the link position. Three distinct behaviors were observed: stents with both low radial and bending stiffness, moderate bending and high radial stiffness, and high bending and moderate radial stiffness. In general, a large link length allows the stent to be more flexible under bending condition, whereas the mutual links positioning plays a key role in the radial stiffness of these devices. Furthermore, for a fixed strut layout, a correlation was found between the strut cross area, as well as metal-to-artery ratio and the resultant radial and bending stiffness.

Trends in biomedical engineering: focus on Smart Bio-Materials and Drug Delivery.

The present article reviews on different research lines, namely: drug and gene delivery, surface modification/modeling, design of advanced materials (shape memory polymers and biodegradable stents), presently developed at Politecnico di Milano, Italy. For gene delivery, non-viral polycationic-branched polyethylenimine (b-PEI) polyplexes are coated with pectin, an anionic polysaccharide, to enhance the polyplex stability and decrease b-PEI cytotoxicity. Perfluorinated materials, specifically perfluoroether, and perfluoro-polyether fluids are proposed as ultrasound contrast agents and smart agents for drug delivery. Non-fouling, self-assembled PEG-based monolayers are developed on titanium surfaces with the aim of drastically reducing cariogenic bacteria adhesion on dental implants. Femtosecond laser microfabrication is used for selectively and spatially tuning the wettability of polymeric biomaterials and the effects of femtosecond laser ablation on the surface properties of polymethylmethacrylate are studied. Innovative functionally graded Alumina-Ti coatings for wear resistant articulating surfaces are deposited with PLD and characterized by means of a combined experimental and computational approach. Protein adsorption on biomaterials surfaces with an unlike wettability and surface-modification induced by pre-adsorbed proteins are studied by atomistic computer simulations. A study was performed on the fabrication of porous Shape Memory Polymeric structures and on the assessment of their potential application in minimally invasive surgical procedures. A model of magnesium (alloys) degradation, in a finite element framework analysis, and a bottom-up multiscale analysis for modeling the degradation mechanism of PLA matrices was developed, with the aim of providing valuable tools for the design of bioresorbable stents.

3D modelling of drug-coated balloons for the treatment of calcified superficial femoral arteries.

BACKGROUND/OBJECTIVES: Drug-coated balloon therapy for diseased superficial femoral arteries remains controversial. Despite its clinical relevance, only a few computational studies based on simplistic two-dimensional models have been proposed to investigate this endovascular therapy to date. This work addresses the aforementioned limitation by analyzing the drug transport and kinetics occurring during drug-coated balloon deployment in a three-dimensional geometry. METHODS: An idealized three-dimensional model of a superficial femoral artery presenting with a calcific plaque and treated with a drug-coated balloon was created to perform transient mass transport simulations. To account for the transport of drug (i.e. paclitaxel) released by the device, a diffusion-reaction equation was implemented by describing the drug bound to specific intracellular receptors through a non-linear, reversible reaction. The following features concerning procedural aspects, pathologies and modelling assumptions were investigated: (i) balloon application time (60-180 seconds); (ii) vessel wall composition (healthy vs. calcified wall); (iii) sequential balloon application; and (iv) drug wash-out by the blood stream vs. coating retention, modeled as exponential decay. RESULTS: The balloon inflation time impacted both the free and specifically-bound drug concentrations in the vessel wall. The vessel wall composition highly affected the drug concentrations. In particular, the specifically-bound drug concentration was four orders of magnitude lower in the calcific compared with healthy vessel wall portions, primarily as a result of reduced drug diffusion. The sequential application of two drug-coated balloons led to modest differences (~15%) in drug concentration immediately after inflation, which became negligible within 10 minutes. The retention of the balloon coating increased the drug concentration in the vessel wall fourfold. CONCLUSIONS: The overall findings suggest that paclitaxel kinetics may be affected not only by the geometrical and compositional features of the vessel treated with the drug-coated balloon, but also by balloon design characteristics and procedural aspects that should be carefully considered.

A computational optimization study of a self-expandable transcatheter aortic valve.

Developing an efficient stent frame for transcatheter aortic valves (TAV) needs thorough investigation in different design and functional aspects. In recent years, most TAV studies have focused on their clinical performance, leaflet design, and durability. Although several optimization studies on peripheral stents exist, the TAV stents have different functional requirements and need to be explicitly studied. The aim of this study is to develop a cost-effective optimization framework to find the optimal TAV stent design made of Ni-Ti alloy. The proposed framework focuses on minimizing the maximum strain occurring in the stent during crimping, making use of a simplified model of the stent to reduce computational cost. The effect of the strut cross-section of the stent, i.e., width and thickness, and the number and geometry of the repeating units of the stent (both influencing the cell size) on the maximum strain is investigated. Three-dimensional simulations of the crimping process are used to verify the validity of the simplified representation of the stent, and the radial force has been calculated for further evaluation. The results suggest the key role of the number of cells (repeating units) and strut width on the maximum strain and, consequently, on the stent design. The difference in terms of the maximum strain between the simplified and the 3D model was less than 5%, confirming the validity of the adopted modeling strategy and the robustness of the framework to improve the TAV stent designs through a simple, cost-effective, and reliable procedure.

Multimodal Loading Environment Predicts Bioresorbable Vascular Scaffolds' Durability.

Bioresorbable vascular scaffolds were considered the fourth generation of endovascular implants deemed to revolutionize cardiovascular interventions. Yet, unexpected high risk of scaffold thrombosis and post-procedural myocardial infractions quenched the early enthusiasm and highlighted the gap between benchtop predictions and clinical observations. To better understand scaffold behavior in the mechanical environment of vessels, animal, and benchtop tests with multimodal loading environment were conducted using industrial standard scaffolds. Finite element analysis was also performed to study the relationship among structural failure, scaffold design, and load types. We identified that applying the combination of bending, axial compression, and torsion better reflects incidence observed in-vivo, far more than tranditional single mode loads. Predication of fracture locations is also more accurate when at least bending and axial compression are applied during benchtop tests (>60% fractures at connected peak). These structural failures may be initiated by implantation-induced microstructural damages and worsened by cyclic loads from the beating heart. Ignoring the multi-modal loading environment in benchtop fatigue tests and computational platforms can lead to undetected potential design defects, calling for redefining consensus evaluation strategies for scaffold performance. With the robust evaluation strategy presented herein, which exploits the results of in-vivo, in-vitro and in-silico investigations, we may be able to compare alternative designs of prototypes at the early stages of device development and optimize the performance of endovascular implants according to patients-specific vessel dynamics and lesion configurations in the future.

Biomechanical interpretation of observed fatigue fractures of peripheral Nitinol stents in the superficial femoral arteries through in silico modelling.

PURPOSE: To suggest an in silico modelling approach to estimate the fatigue failure on peripheral Nitinol stents implanted in the superficial femoral artery (SFA) and interpret the clinically observed stent fractures of a retrospective series of patients. MATERIALS AND METHODS: Preoperative data of 27 patients who underwent SFA Nitinol stenting were retrospectively analyzed. Data about preoperative features of the SFA and the lesion were collected. Follow-up data were also collected about the occurrence of restenosis/occlusion and stent fracture. RESULTS: After a lengthening of the entire vessel, the occluded region was slightly stretched due to its high stiffness, whereas the healthy regions accommodated the artery length variation. The stent fatigue was predicted to be higher in the regions of low stiffness and higher shortening. In 7 out of 27 patients a stent fracture was clinically recorded. The model resulted to be accurate in 90% of the cases. CONCLUSIONS: The clinical outcomes in terms of biomechanical fatigue behavior of peripheral Nitinol stents of the SFA could be interpreted by our new approach.

In vivo and in vitro evaluation of a biodegradable magnesium vascular stent designed by shape optimization strategy.

The performance of biodegradable magnesium alloy stents (BMgS) requires special attention to non-uniform residual stress distribution and stress concentration, which can accelerate localized degradation after implantation. We now report on a novel concept in stent shape optimization using a finite element method (FEM) toolkit. A Mg-Nd-Zn-Zr alloy with uniform degradation behavior served as the basis of our BMgS. Comprehensive in vitro evaluations drove stent optimization, based on observed crimping and balloon inflation performance, measurement of radial strength, and stress condition validation via microarea-XRD. Moreover, a Rapamycin-eluting polymer coating was sprayed on the prototypical BMgS to improve the corrosion resistance and release anti-hyperplasia drugs. In vivo evaluation of the optimized coated BMgS was conducted in the iliac artery of New Zealand white rabbit with quantitative coronary angiography (QCA), optical coherence tomography (OCT) and micro-CT observation at 1, 3, 5-month follow-ups. Neither thrombus or early restenosis was observed, and the coated BMgS supported the vessel effectively prior to degradation and allowed for arterial healing thereafter. The proposed shape optimization framework based on FEM provides an novel concept in stent design and in-depth understanding of how deformation history affects the biomechanical performance of BMgS. Computational analysis tools can indeed promote the development of biodegradable magnesium stents.

Biomechanical Impact of Wrong Positioning of a Dedicated Stent for Coronary Bifurcations: A Virtual Bench Testing Study.

The treatment of coronary bifurcations is challenging for interventional cardiologists. The Tryton stent (Tryton Medical, Inc., USA) is one of the few devices specifically designed for coronary bifurcations that underwent large clinical trials. Although the manufacturer provides specific recommendations to position the stent in the bifurcation side branch (SB) according to four radio-opaque markers under angiographic guidance, wrong device positioning may accidentally occur. In this study, the virtual bench testing approach was used to investigate the impact of wrong positioning of the Tryton stent in coronary bifurcations in terms of geometrical and biomechanical criteria. A finite element model of the left anterior descending/first diagonal coronary bifurcation was created with a 45° distal angle and realistic lumen diameters. A validated model of the Tryton stent mounted on stepped delivery balloon was used. All steps of the Tryton deployment sequence were simulated. Three Tryton positions, namely 'proximal', 'recommended', and 'distal' positions, obtained by progressively implanting the stent more distally in the SB, were compared. The 'recommended' case exhibited the lowest ostial area stenosis (44.8 vs. 74.3% ('proximal') and 51.5% ('distal')), the highest diameter at the SB ostium (2.81 vs. 2.70 mm ('proximal') and 2.54 mm ('distal')), low stent malapposition (9.9 vs. 16.3% ('proximal') and 8.5% ('distal')), and the lowest peak wall stress (0.37 vs. 2.20 MPa ('proximal') and 0.71 MPa ('distal')). In conclusion, the study shows that a 'recommended' Tryton stent positioning may be required for optimal clinical results.

The role of inelastic deformations in the mechanical response of endovascular shape memory alloy devices.

Nickel-titanium alloys are commonly adopted for producing cardiovascular minimally invasive devices such as self-expandable stents, aortic valves and stent-grafts. These devices are subjected to cyclic loads (due to blood pulsatility, leg or heart movements), that can induce fatigue fracture, and may also be subjected to very large deformations (due to crimping procedure, a tortuous physiological path or overloads), that can induce material yield. Recently, the authors developed a new constitutive model that considers inelastic strains due to not-completed reverse phase transformation (not all the stress-induced martensite turns back to austenite) or/and plasticity and their accumulation during cyclic loads. In this article, the model is implemented in the finite element code ABAQUS/Standard and it is used to investigate the effects of inelastic strain accumulation on endovascular nickel-titanium devices. In particular, the behavior of a transcatheter aortic valve is studied considering the following steps: (1) crimping, (2) expansion in a tube resembling a durability test chamber and (3) cyclic loads due to pressure variation applied on the inner surface of the tube. The analyses are performed twice, activating and not activating that part of the new model which describes the development of irreversible strain. From the results, it is interesting to note that plasticity has a very significant effect on the local material response, inducing stress modification from compression to tension. However, permanent deformations are concentrated in few zones of the stent frame and their presence does not affect the global behavior of the device that maintains its capability of recovering the original shape. In conclusion, this work suggests that at least for cardiovascular devices where the crimping is high (local strain may reach values of 8%-9%), taking into account inelastic effects due to plasticity and not-completed reverse phase transformation can be important, and hence using a suitable constitutive model is recommended.

A Computational Approach for the Prediction of Fatigue Behaviour in Peripheral Stents: Application to a Clinical Case.

Nickel-Titanium (NiTi) peripheral stents are commonly used for the treatment of diseased femoropopliteal arteries (FPA). However, cyclic deformations of the vessel, induced by limb movements affect device performance and fatigue failure may occur. Stent strut fracture has been described in the literature, and is implicated as a potential causative factor in vessel re-occlusion. In this paper, a numerical approach is proposed to predict the fatigue behaviour of peripheral NiTi stents within patient-specific arterial geometries, as additional information to aid clinician intervention planning. The procedure needs some patient-specific vessel features derived from routine clinical images but, when this information is not available, reference data from the literature may be used, obviously increasing the uncertainties of the results. In addition, specific stent material data are required and can be obtained from experimental tests. Several 3D finite element models resembling stented vessel segments are built and used for fatigue analyses. For each model, axial cyclic boundary conditions are obtained from a patient-specific lumped parameter model representing the entire artery as a series of suitable springs. This allows the simplification of stiffness changes along the vessel due to plaque and stent that affect local axial deformations. Imposed local cyclic bending values depend on the stent location along the FPA. The procedure is exemplified by its application to an actual clinical case that showed two strut fractures at 18 months follow-up. Interestingly, despite the lack of some of patient-specific information and the use of data from the literature to inform the model, the numerical approach was able to interpret the in vivo fractures.

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.

The effect of fixture neck design in a realistic model of dental implant: a finite element approach.

The aim of this work is to develop an accurate finite element model able to reproduce a standard experimental set-up for the evaluation of mechanical failure of a dental implant system. The considered system is composed of a fixture, an abutment and a connecting screw. We analysed the behaviour of the implant system considering three different designs of the fixture, in order to establish which one provides the better mechanical behaviour. After the definition of the numerical models, loading conditions were selected in order to reproduce the same stress state found in previous mechanical failure tests. Preloading and functional loading conditions were simulated. The analysis of the numerical results shows that the structure yielding is due to the fixture neck plastic deformation, that increases the load eccentricity and then the bending stress on the connecting screw. Only slight differences were found between the three implant systems in the amount and distribution of stress. The model reproduces properly the implant systems and the experimental set-up. The goodness of the model can be summarised as: realistic geometrical structure, elastoplastic model for the material description, correct definition of the contacts and the existing tolerance among the different system components, reproduction of the preloading stress condition. The present study permitted to define a valid procedure for the realization of numerical models of implant systems.

On the necessity of modelling fluid-structure interaction for stented coronary arteries.

Although stenting is the most commonly performed procedure for the treatment of coronary atherosclerotic lesions, in-stent restenosis (ISR) remains one of the most serious clinical complications. An important stimulus to ISR is the altered hemodynamics with abnormal shear stresses on endothelial cells generated by the stent presence. Computational fluid dynamics is a valid tool for studying the local hemodynamics of stented vessels, allowing the calculation of the wall shear stress (WSS), which is otherwise not directly possible to be measured in vivo. However, in these numerical simulations the arterial wall and the stent are considered rigid and fixed, an assumption that may influence the WSS and flow patterns. Therefore, the aim of this work is to perform fluid-structure interaction (FSI) analyses of a stented coronary artery in order to understand the effects of the wall compliance on the hemodynamic quantities. Two different materials are considered for the stent: cobalt-chromium (CoCr) and poly-l-lactide (PLLA). The results of the FSI and the corresponding rigid-wall models are compared, focusing in particular on the analysis of the WSS distribution. Results showed similar trends in terms of instantaneous and time-averaged WSS between compliant and rigid-wall cases. In particular, the difference of percentage area exposed to TAWSS lower than 0.4Pa between the CoCr FSI and the rigid-wall cases was about 1.5% while between the PLLA cases 1.0%. The results indicate that, for idealized models of a stented coronary artery, the rigid-wall assumption for fluid dynamic simulations appears adequate when the aim of the study is the analysis of near-wall quantities like WSS.

Fatigue behaviour of Nitinol peripheral stents: the role of plaque shape studied with computational structural analyses.

Fatigue resistance of Nitinol stents implanted into femoro-popliteal arteries is a critical issue for the particular biomechanical environment of this district. Hip and knee joint movements due to the cyclic daily activity expose the superficial femoral artery (SFA), and therefore the implanted stents, to quite large and cyclic deformations influencing stent fatigue resistance. Objective of this work is to provide a tool based on finite element analysis able to evaluate the biomechanical effect of SFA on stent fatigue resistance. Computer simulations of the treatment of stenotic vessel by angioplasty and stenting and of the subsequent in vivo loading conditions (axial compression and bending) were carried out. Three different stenotic vessel models were defined, by keeping a constant stenosis rate and changing the plaque sharpness and number of stenoses. The fatigue behaviour was analysed comparing the amplitude and mean value distribution of the first principal strain in the whole stent for the different simulated conditions. Results showed that the maximum mean strain is similar in all the models, while the alternating strain is related to both plaque shape and loading conditions. In conclusion, this study confirms the requisite of replicating in vivo loading conditions. It also reveals the importance of taking into account the thickness variation of the vessel in the stenotic zone in the assessment of the stent fatigue resistance.

Experimental data confirm numerical modeling of the degradation process of magnesium alloys stents.

Biodegradable magnesium alloy stents (MAS) could present improved long-term clinical performances over commercial bare metal or drug-eluting stents. However, MAS were found to show limited mechanical support for diseased vessels due to fast degradation. Optimizing stent design through finite element analysis (FEA) is an efficient way to improve such properties. Following previous FEA works on design optimization and degradation modeling of MAS, this work carried out an experimental validation for the developed FEA model, thus proving its practical applicability of simulating MAS degradation. Twelve stent samples of AZ31B were manufactured according to two MAS designs (an optimized one and a conventional one), with six samples of each design. All the samples were balloon expanded and subsequently immersed in D-Hanks' solution for a degradation test lasting 14 days. The experimental results showed that the samples of the optimized design had better corrosion resistance than those of the conventional design. Furthermore, the degradation process of the samples was dominated by uniform and stress corrosion. With the good match between the simulation and the experimental results, the work shows that the FEA numerical modeling constitutes an effective tool for design and thus the improvement of novel biodegradable MAS.

A comparative computational analysis of the mechanical behavior of two nickel-titanium rotary endodontic instruments.

INTRODUCTION: A finite element model of two nickel-titanium (Ni-Ti) rotary endodontic instruments (ProTaper and SystemGT; Dentsply-Maillefer, Ballaigues, Switzerland) was developed to investigate the mechanical behavior of these devices and to identify the benefits/limitations of different geometries during instrumentation in various root canals. METHODS: Instrument shape, curved root canal geometry, and Ni-Ti alloy pseudo-elastic behavior were investigated in this study using computational techniques. Two different operating conditions were simulated: (1) the file insertion-removal cycle which resembles the standard working condition and (2) the file subjected to a torque in the counter-clockwise direction, which mimics the auto-reverse movement of the instrument when the tip is locked in the canal wall. RESULTS: The simulations of standard and auto-reverse conditions produced bending and torsion loading conditions in the files, respectively. In the standard situation in which different canal shapes were considered, the strains in the SystemGT were generally lower than the strains in the ProTaper and always in the pseudo-elastic range; in only 1 case did the ProTaper overcame the pseudo-elastic range limit. In the auto-reverse situation, a better behavior of the ProTaper was detected. CONCLUSIONS: The two simulated conditions highlighted the different mechanical properties of the files; the SystemGT showed slightly better performances under flexural solicitation, whereas the Protaper presented better behavior under torsion solicitations.

Computational studies of shape memory alloy behavior in biomedical applications.

BACKGROUND: Nowadays, shape memory alloys (SMAs) and in particular Ni-Ti alloys are commonly used in bioengineering applications as they join important qualities as resistance to corrosion, biocompatibility, fatigue resistance, MR compatibility, kink resistance with two unique thermo-mechanical behaviors: the shape memory effect and the pseudoelastic effect. They allow Ni-Ti devices to undergo large mechanically induced deformations and then to recover the original shape by thermal loading or simply by mechanical unloading. METHOD OF APPROACH: A numerical model is developed to catch the most significant SMA macroscopic thermo-mechanical properties and is implemented into a commercial finite element code to simulate the behavior of biomedical devices. RESULTS: The comparison between experimental and numerical response of an intravascular coronary stent allows to verify the model suitability to describe pseudo-elasticity. The numerical study of a spinal vertebrae spacer where the effects of different geometries and material characteristic temperatures are investigated, allows to verify the model suitability to describe shape memory effect. CONCLUSION: the results presented show the importance of computational studies in designing and optimizing new biomedical devices.