A computational approach based on a multiaxial fatigue criterion combining phase transformation and shakedown response for the fatigue life assessment of Nitinol stents

Abstract

Self-expanding stents made of Nitinol, a Nickel–Titanium shape memory alloy, are used in standard medical implants for the treatment of cardiovascular diseases. Despite the increasing success, clinical studies have reported stent failure after the deployment in the human body, thus undermining patient’s safety and life. This study aims to fill the gap of reliable assessment of the fatigue life of Nitinol stents. We propose a global computational design method for preclinical validation of Nitinol stents, which can be extended to patient-specific computations. The proposed methodology is composed of a mechanical finite element analysis and a fatigue analysis. The latter analysis is based on a novel multiaxial fatigue criterion of the Dang Van type, combining the shakedown response of the stent and the complexity of phase transformation taking place within the material. The method is implemented in the case of a carotid artery stent. The implant configuration as well as the applied cyclic loading are shown to affect material phase evolution as well as stent lifetime. The comparison with the results obtained by applying a strain-based constant-life diagram approach allows to critically discuss both fatigue criteria and to provide useful recommendations about their applicability.

Keywords

Shape memory alloys computational fatigue approach cardiovascular stents finite element analysis Dang Van criterion constant-life diagram

Get full access to this article

View all access options for this article.

References

Ackermann

Capek

(2012) Numerical durability evaluation of Nitinol stent. Computer Methods in Biomechanics and Biomedical Engineering 15(suppl 1): 99–101.

Alarcon

Heller

Chirani

et al . (2017) Fatigue performance of superelastic NiTi near stress-induced martensitic transformation. International Journal of Fatigue 95: 76–89.

Allegretti

Berti

Migliavacca

et al . (2018) Fatigue assessment of Nickel–Titanium peripheral stents: comparison of multi-axial fatigue models. Shape Memory and Superelasticity 4: 186–196.

Auricchio

Constantinescu

Scalet

(2014) Fatigue of 316L stainless steel notched m-size components. International Journal of Fatigue 68: 231–247.

Auricchio

Constantinescu

Conti

et al . (2016a) Fatigue of metallic stents: from clinical evidence to computational analysis. Annals of Biomedical Engineering 44(2): 287–301.

Auricchio

Constantinescu

Menna

et al . (2016b) A shakedown analysis of high cycle fatigue of shape memory alloys. International Journal of Fatigue 87: 112–123.

Auricchio

Conti

Morganti

et al . (2010) Shape memory alloy: from constitutive modeling to finite element analysis of stent deployment. Computer Modeling in Engineering and Sciences 57(3): 225–243.

Bonsignore

(2017) Present and future approaches to lifetime prediction of superelastic Nitinol. Theoretical and Applied Fracture Mechanics 92: 298–305.

Chang

Huded

Nolan

et al . (2011) Prevalence and clinical significance of stent fracture and deformation following carotid artery stenting. Journal of Vascular Surgery 54(3): 685–690.

10.

Dordoni

Meoli

et al . (2014) Fatigue behaviour of Nitinol peripheral stents: the role of plaque shape studied with computational structural analyses. Medical Engineering & Physics 36: 842–849.

11.

Everett

Conway

Desany

et al . (2016) Structural mechanics predictions relating to clinical coronary stent fracture in a 5 year period in FDA MAUDE database. Annals of Biomedical Engineering 44(2): 391–403.

12.

Feng

Sun

(2007) Shakedown analysis of shape memory alloy structures. International Journal of Plasticity 23: 183–206.

13.

Garcia-Toca

Rodriguez

Naughton

et al . (2012) Are carotid stent fractures clinically significant?CardioVascular and Interventional Radiology 35(2): 263–267.

14.

Gomez-Lara

Brugaletta

Farooq

et al . (2011) Angiographic geometric changes of the lumen arterial wall after bioresorbable vascular scaffolds and metallic platform stents at 1-year follow-up. JACC: Cardiovascular Interventions 4(7): 789–799.

15.

Gomez-Lara

Garcia-Garcia

Onuma

et al . (2010) A comparison of the conformability of everolimus-eluting bioresorbable vascular scaffolds to metal platform coronary stents. JACC: Cardiovascular Interventions 3(11): 1190–1198.

16.

Moumni

Zaki

et al . (2016) Shakedown based model for high-cycle fatigue of shape memory alloys. Smart Materials and Structures 25: 115012.

17.

Hesami

Pino

Saint-Sulpice

et al . (2018) Rotary bending fatigue analysis of shape memory alloys. Journal of Intelligent Material Systems and Structures 29: 1183–1195.

18.

ISO 25539-2:2012 (2012) Cardiovascular implants—endovascular devices—part 2: vascular stents.

19.

Kapnisis

Halwani

Brott

et al . (2013) Stent overlapping and geometric curvature influence the structural integrity and surface characteristics of coronary Nitinol stents. Journal of the Mechanical Behavior of Biomedical Materials 20: 227–236.

20.

Kumar

Cui

Danpinid

et al . (2013) Design and finite element-based fatigue prediction of a new self-expandable percutaneous mitral valve stent. Computer-Aided Design 45: 1153–1158.

21.

Lally

Dolan

Prendergast

(2005) Cardiovascular stent design and vessel stresses: a finite element analysis. Journal of Biomechanics 38: 1574–1581.

22.

Lim

McDowell

(1995) Path dependence of shape memory alloys during cyclic loading. Journal of Intelligent Material Systems and Structures 6(6): 817–830.

23.

Mahtabi

Shamsaei

Mitchell

(2015) Fatigue of Nitinol: the state-of-the-art and ongoing challenges. Journal of the Mechanical Behavior of Biomedical Materials 50: 228–254.

24.

Meoli

Dordoni

Petrini

et al . (2014) Computational study of axial fatigue for peripheral Nitinol stents. Journal of Materials Engineering and Performance 23: 2606–2613.

25.

Muller-Hulsbeck

Schafer

Charalambous

et al . (2010) Comparison of second generation stents for application in the superficial femoral artery: an in vitro evaluation focusing on stent design. Journal of Endovascular Therapy 17(6): 767–776.

26.

Nikanorov

Smouse

Osman

et al . (2008) Fracture of self-expanding Nitinol stents stressed in vitro under simulated intravascular conditions. Journal of Vascular Surgery 48(2): 435–440.

27.

Paul

Paranjape

Amin-Ahmadi

et al . (2017) Effect of machined feature size relative to the microstructural size on the superelastic performance in polycrystalline NiTi shape memory alloys. Materials Science & Engineering A 706: 227–235.

28.

Peigney

(2010) Shakedown theorems and asymptotic behaviour of solids in non-smooth mechanics. European Journal of Mechanics—A/Solids 29(5): 784–793.

29.

Pelton

(2011) Nitinol fatigue: a review of microstructures and mechanisms. Journal of Materials Engineering and Performance 20(4–5): 613–617.

30.

Pelton

Schroeder

Mitchell

et al . (2008) Fatigue and durability of Nitinol stents. Journal of the Mechanical Behavior of Biomedical Materials 1: 153–164.

31.

Petrini

Trotta

Dordoni

et al . (2016) A computational approach for the prediction of fatigue behaviour in peripheral stents: application to a clinical case. Annals of Biomedical Engineering 44(2): 536–547.

32.

Racek

Stora

Sittner

et al . (2015) Monitoring tensile fatigue of superelastic NiTi wire in liquids by electrochemical potential. Shape Memory and Superelasticity 1: 204–230.

33.

Robertson

Pelton

Ritchie

(2012) Mechanical fatigue and fracture of Nitinol. International Materials Reviews 57(1): 1–37.

34.

Runciman

Pelton

et al . (2011) An equivalent strain/Coffin-Manson approach to multiaxial fatigue and life prediction in superelastic Nitinol medical devices. Biomaterials 32: 4987–4993.

35.

Scalet

(2018) An efficient algorithm for the solution of min-max problems in multiaxial fatigue. International Journal of Fatigue 112: 117–129.

36.

Sfyroeras

Koutsiaris

Karathanos

et al . (2010) Clinical relevance and treatment of carotid stent fractures. Journal of Vascular Surgery 51(5): 1280–1285.

37.

Souza

Mamiya

Zouain

(1998) Three-dimensional model for solids undergoing stress-induced phase transformations. European Journal of Mechanics—A/Solids 17: 789–806.

38.

U.S. Food and Drug Administration (2010) Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems: Guidance for Industry and FDA Staff. Silver Spring, MD: U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Centre for Devices and Radiological, Health.

39.

Valibhoy

Mwipatayi

Sieunarine

(2007) Fracture of a carotid stent: an unexpected complication. Journal of Vascular Surgery 45(3): 603–606.

40.

Wang

Zuo

Yang

et al . (2017) Finite element simulation and optimization of radial resistive force for shape memory alloy vertebral body stent. Journal of Intelligent Material Systems and Structures 28(15): 2140–2150.

41.

Weafer

Bruzzi

(2017) Micromechanical investigation into the effect of texture on the fatigue behaviour of superelastic Nitinol. International Journal of Fatigue 93: 148–155.

42.

Zheng

Moumni

(2017) Investigation on fatigue behaviors of NiTi polycrystalline strips under stress-controlled tension via in-situ macro-band observation. International Journal of Plasticity 90: 116–145.