Over the last few decades, cardiovascular stents have emerged as crucial biomedical devices. Stents undergo cyclic physiological loading, which can lead to progressive accumulation of structural damage over time eventually resulting in a stent fracture. Considering the critical role of stents, it is necessary to assess their fatigue endurance and predict a potential premature failure due to fatigue loading. This paper presents a comprehensive analysis of coronary stent design based on both fatigue failure and damage-tolerant approaches. Employing the fatigue failure approach, S-N analysis was conducted to pinpoint the critical zones of the stent. Initial resistance to fatigue was evaluated using Goodman's and Soderberg's criteria. These criteria were applied to principal and effective stresses obtained using the Finite Element Method. Susceptibility to fatigue damage was performed by simulating the initial crack growth, and it was assessed through the Paris power law. The damage-tolerant approach yields more conservative fatigue stress ranges compared to fatigue failure criteria, ensuring safety under standard physiological loading conditions. The presented approach offers reliable insights into stent durability, with potential for further enhancement.
Santos HAF, Auricchio F, Conti M. Fatigue life assessment of cardiovascular balloon-expandable stents: A two-scale plasticity–damage model approach. *Journal of the Mechanical Behavior of Biomedical Materials*. 2012;15:78–92.
2.
F2063-18 ASTM. *Standard specification for wrought nickel-titanium shape memory alloys for medical devices and surgical implants*. ASTM Book of Standards. 2006;13(01).
3.
F2477-06 ASTM. *Standard test methods for in vitro pulsatile durability testing of vascular stents*. ASTM Book of Standards. 2017;13(01).
4.
Campbell FC. *Fatigue and fracture: Understanding the basics*. 2012.
5.
Beule M, Mortier P, Carlier SG, Verhegghe B, Impe R, Verdonck P. Realistic finite element-based stent design: The impact of balloon folding. *Journal of Biomechanics*. 2008;41(2):383–9.
6.
Donnelly EW, Bruzzi MS, Connolley T, McHugh PE. Finite element comparison of performance related characteristics of balloon expandable stents. *Computer Methods in Biomechanics and Biomedical Engineering*. 2007;10(2):103–10.
7.
Elber W. Fatigue crack closure under cyclic tension. *Engineering Fracture Mechanics*. 1970;2(1):37–45.
8.
Gervaso F, Capelli C, Petrini L, Lattanzio S, Virgilio L, Migliavacca F. On the effects of different strategies in modelling balloon-expandable stenting by means of finite element method. *Journal of Biomechanics*. 2008;41(6):1206–12.
9.
Gong XY, Chwirut DJ, Mitchell MR, Choules BD, Cavanaugh K. Fatigue to fracture: An informative, fast, and reliable approach for assessing medical implant durability. *Journal of ASTM International*. 2009;6(7):102412.
10.
Harewood FJ, McHugh PE. Modeling of size dependent failure in cardiovascular stent struts under tension and bending. *Annals of Biomedical Engineering*. 2007;35:1539–53.
11.
Jovicic GR, Vukicevic AM, Filipovic ND. Computational assessment of stent durability using fatigue to fracture approach. *Journal of Medical Devices*. 2014;8(4):041002.
12.
Kojic M, Slavkovic R, Zivkovic M, Grujovic N, Jovicic G, Vulovic S. *PAK-FM&F—Software for fracture mechanics and fatigue based on the FEM and X-FEM*. 2005.
13.
Lally C, Dolan F, Prendergast PJ. Cardiovascular stent design and vessel stresses: A finite element analysis. *Journal of Biomechanics*. 2005;38(8):1574–81.
14.
Lally C, Dolan F, Prendergast PJ. Erratum to “Cardiovascular stent design and vessel stresses: A finite element analysis.” *Journal of Biomechanics*. 2006;39(9).
15.
Marrey RV, Burgermeister R, Grishaber RB, Ritchie RO. Fatigue and life prediction for cobalt-chromium stent: A fracture mechanics analysis. *Biomaterials*. 2006;27:1988–2000.
16.
Marrey RV, Almeida LH, Lobosco M. Damage-tolerant assessment of the durability of a cardiovascular stent using the Paris power law. *Journal of Biomedical Materials Research Part B: Applied Biomaterials*. 2006;79(1):209–18.
17.
Migliavacca F, Petrini L, Colombo M, Auricchio F, Pietrabissa R. Mechanical behavior of coronary stents investigated through the finite element method. *Journal of Biomechanics*. 2002;35(6):803–11.
18.
Nalla RK, Imbeni V, Kinney JH, Staninec M, Marshall SJ, Ritchie RO. In vitro fatigue behavior of human dentin with implications for life prediction. *Journal of Biomedical Materials Research Part A*. 2003;66(1):10–20.
19.
Pelton AR, Schroeder V, Mitchell MR, Gong XY, Barney M, Robertson SW. Fatigue and durability of Nitinol stents. *Journal of the Mechanical Behavior of Biomedical Materials*. 2008;1(2):153–64.
20.
Ritchie RO. Mechanisms of fatigue-crack propagation in ductile and brittle solids. *International Journal of Fracture*. 1999;100:55–83.
21.
Ritchie RO, Kinney JH, Kruzic JJ, Nalla RK. Cortical bone fracture. In: *Wiley Encyclopedia of Biomedical Engineering*. 2006. p. 32–45.
22.
Robertson SW, Ritchie RO. A fracture-mechanics-based approach to fracture control in biomedical devices manufactured from superelastic Nitinol tube. *Journal of Biomedical Materials Research Part B: Applied Biomaterials*. 2008;84(1):26–33.
23.
Sadananda K, Sarkar S, Kujawski D, Vasudevan AK. A two-parameter analysis of S–N fatigue life using Δσ and σmax. *International Journal of Fatigue*. 2009;31(11–12):1648–59.
24.
Schijve J. Some formulas for the crack opening stress level. *Engineering Fracture Mechanics*. 1981;14(3):461–5.
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