Finite element analysis for fatigue behaviour of a self-expanding Nitinol peripheral stent under physiological biomechanical conditions

Self-expanding Nitinol stents are increasingly used to treat femoropopliteal artery (FPA) occlusions, but the risk of stent fatigue failure exists due to complex artery deformation during daily activities. Finite element analysis (FEA) has been widely applied to study the stent fatigue behaviours, but physiological deformation and atherosclerotic plaque were not considered simultaneously in previous studies. In this work, to show the necessity and feasibility of considering both factors in evaluation of the stent fatigue behaviours, a comprehensive FEA framework considering both factors is established, and an easy loading method for the complex boundary condition is proposed. Four comparative simulations are successfully conducted, and the stent fatigue behaviours are analysed based on the distributions and maximum values of the self-defined mean and alternating strains. Results show that both the physiological deformation and atherosclerotic plaque significantly contribute to the stent fatigue life. The case with the complex boundary condition and atherosclerotic plaque is the most critical of the four cases, and the minimum safety factor is 0.62. In conclusion, it is necessary to consider both physiological deformation and atherosclerotic plaque in the evaluation of stent fatigue behaviours, and ignoring any of them would lead to overestimation of the stent fatigue life. The work in this paper offers a solid foundation for accurate evaluation of the stent fatigue lifetime in patient-specific surgery plans via FEA.

[1]  A. Kamenskiy,et al.  Comparison of femoropopliteal artery stents under axial and radial compression, axial tension, bending, and torsion deformations. , 2017, Journal of the mechanical behavior of biomedical materials.

[2]  M. G. Taylor,et al.  Alterations with Age in the Viscoelastic Properties of Human Arterial Walls , 1966, Circulation research.

[3]  Gabriele Dubini,et al.  Modelling of the provisional side-branch stenting approach for the treatment of atherosclerotic coronary bifurcations: effects of stent positioning , 2010, Biomechanics and modeling in mechanobiology.

[4]  E. Romagnoli,et al.  Drug-eluting stenting: the case for post-dilation. , 2008, JACC. Cardiovascular interventions.

[5]  Claire Conway,et al.  A Computational Test-Bed to Assess Coronary Stent Implantation Mechanics Using a Population-Specific Approach , 2012 .

[6]  S. W. Robertson,et al.  Mechanical fatigue and fracture of Nitinol , 2012 .

[7]  S. W. Robertson,et al.  Fatigue and durability of Nitinol stents. , 2008, Journal of the mechanical behavior of biomedical materials.

[8]  C Di Mario,et al.  Coronary stenting after rotational atherectomy in calcified and complex lesions. Angiographic and clinical follow-up results. , 1997, Circulation.

[9]  M. Moulton,et al.  Three-dimensional bending, torsion and axial compression of the femoropopliteal artery during limb flexion. , 2014, Journal of biomechanics.

[10]  Aleksandra Fortier,et al.  Review of biomechanical studies of arteries and their effect on stent performance , 2014 .

[11]  Mark Bruzzi,et al.  A computational analysis of the deformation of the femoropopliteal artery with stenting. , 2014, Journal of biomechanical engineering.

[12]  A. Pelton,et al.  Nitinol Fatigue: A Review of Microstructures and Mechanisms , 2011, Journal of Materials Engineering and Performance.

[13]  Giancarlo Pennati,et al.  A Computational Approach for the Prediction of Fatigue Behaviour in Peripheral Stents: Application to a Clinical Case , 2015, Annals of Biomedical Engineering.

[14]  Ashutosh Kumar Singh,et al.  Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015 , 2016, Lancet.

[15]  Rebecca Fahrig,et al.  In-vivo imaging of femoral artery nitinol stents for deformation analysis. , 2011, Journal of vascular and interventional radiology : JVIR.

[16]  Ferdinando Auricchio,et al.  Shape-memory alloys: macromodelling and numerical simulations of the superelastic behavior , 1997 .

[17]  E. Edelman,et al.  Numerical Simulation of Stent Angioplasty with Predilation: An Investigation into Lesion Constitutive Representation and Calcification Influence , 2017, Annals of Biomedical Engineering.

[18]  N. Simha,et al.  Mean stress effects on fatigue of NiTi , 1999 .

[19]  R. M. Hicks,et al.  Wing Design by Numerical Optimization , 1977 .

[20]  Sanjay Shrivastava,et al.  Fracture of self-expanding nitinol stents stressed in vitro under simulated intravascular conditions. , 2008, Journal of vascular surgery.

[21]  W. von Maltzahn,et al.  Experimental measurements of elastic properties of media and adventitia of bovine carotid arteries. , 1984, Journal of biomechanics.

[22]  F. Migliavacca,et al.  Computational Modeling to Predict Fatigue Behavior of NiTi Stents: What Do We Need? , 2015, Journal of functional biomaterials.

[23]  Giancarlo Pennati,et al.  Computational Modelling of In Vitro Set-Ups for Peripheral Self-Expanding Nitinol Stents: The Importance of Stent–Wall Interaction in the Assessment of the Fatigue Resistance , 2013 .

[24]  Sanjay Pant,et al.  Geometry parameterization and multidisciplinary constrained optimization of coronary stents , 2011, Biomechanics and Modeling in Mechanobiology.

[25]  J. Messenger,et al.  Quantitative assessment of the conformational change in the femoropopliteal artery with leg movement , 2009, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[26]  Shijia Zhao,et al.  Performance of self-expanding nitinol stent in a curved artery: impact of stent length and deployment orientation. , 2012, Journal of biomechanical engineering.

[27]  Giancarlo Pennati,et al.  FATIGUE BEHAVIOR CHARACTERIZATION OF NITINOL FOR PERIPHERAL STENTS , 2012 .

[28]  Hiroshi Yagi,et al.  Comparison of Second-Generation Stents for Application in the Superficial Femoral Artery: An In Vitro Evaluation Focusing on Stent Design , 2010, Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists.

[29]  F. Moll,et al.  The incidence of arterial stent fractures with exclusion of coronary, aortic, and non-arterial settings. , 2008, European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery.

[30]  H. Hsiao,et al.  Quintupling fatigue resistance of intravascular stents via a simple design concept , 2014 .

[31]  Lu Wang,et al.  Deformation mechanisms of prototype composite braided stent-grafts in bending fatigue for peripheral artery application. , 2018, Journal of the mechanical behavior of biomedical materials.

[32]  A. Qiao,et al.  Influence of the Realistic Artery Geometry Parameters on a Coronary Stent Fatigue Life , 2019, International Journal of Computational Methods.

[33]  P. Hayes,et al.  Atherectomy for peripheral arterial disease. , 2014, The Cochrane database of systematic reviews.

[34]  M. Walsh,et al.  Simulation of human atherosclerotic femoral plaque tissue: the influence of plaque material model on numerical results , 2015, Biomedical engineering online.

[35]  Daniel J. Kelly,et al.  The consequences of the mechanical environment of peripheral arteries for nitinol stenting , 2011, Medical & Biological Engineering & Computing.

[36]  Giancarlo Pennati,et al.  Fatigue behaviour of Nitinol peripheral stents: the role of plaque shape studied with computational structural analyses. , 2014, Medical engineering & physics.

[37]  Silvia Schievano,et al.  Computational studies of shape memory alloy behavior in biomedical applications. , 2005, Journal of biomechanical engineering.

[38]  Tina M Morrison,et al.  Design considerations for studies of the biomechanical environment of the femoropopliteal arteries. , 2013, Journal of vascular surgery.

[39]  Claire Conway,et al.  Structural Mechanics Predictions Relating to Clinical Coronary Stent Fracture in a 5 Year Period in FDA MAUDE Database , 2015, Annals of Biomedical Engineering.

[40]  Giancarlo Pennati,et al.  Computational Study of Axial Fatigue for Peripheral Nitinol Stents , 2014, Journal of Materials Engineering and Performance.

[41]  Ashutosh Kumar Singh,et al.  Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980–2015: a systematic analysis for the Global Burden of Disease Study 2015 , 2016, The Lancet.

[42]  Maurice Buchbinder,et al.  Nitinol Stent Implantation Versus Balloon Angioplasty for Lesions in the Superficial Femoral Artery and Proximal Popliteal Artery: Twelve-Month Results From the RESILIENT Randomized Trial , 2010, Circulation. Cardiovascular interventions.

[43]  S. M. Harvey,et al.  Nitinol Stent Fatigue in a Peripheral Human Artery Subjected to Pulsatile and Articulation Loading , 2011, Journal of Materials Engineering and Performance.

[44]  Shijia Zhao,et al.  Assessment of shape memory alloy stent deployment in a stenosed artery , 2011 .