Computational Materials Science 79 (2013) 326335

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Computational Materials Science

journal homepage: www.elsevier.com/locate/commatsci

On the numerical investigation of cardiovascular balloon-expandable

stent using nite element method
M. Azaouzi a, A. Makradi a,, J. Petit b, S. Belouettar a, O. Polit b
a
b

Advanced Material and Structure Department, Centre de Recherche Public Henri Tudor, 66 rue de Luxembourg, L-4002 Esch-sur-Alzette, Luxembourg
Laboratoire Energetique Mcanique Electromagetisme (LEME), Universit Paris Ouest, 50 Rue de svres, F-92410 Ville dAvray, France

a r t i c l e

i n f o

Article history:
Received 21 January 2013
Received in revised form 10 April 2013
Accepted 27 May 2013

Keywords:
Cardiovascular stent
Finite element analysis
Numerical simulation
Fatigue life prediction
Goodman diagram

a b s t r a c t
The present paper shows an effective methodology which is based on Finite Element Analysis (FEA) for
the fatigue life prediction (FLP) of a Balloon-Expandable (BE) stent made of stainless steel material
(AISI316L). BE stent is a tubular, often mesh-like, structure which is expanded inside a diseased (stenosed) artery segment to restore blood ow and keep the vessel open following angioplasty. With design
lives of 1015 years, fatigue life prediction of these devices is critical for the designer, as fatigue failure
may occur after deployment inside the blood vessel due to the heart beating (typically 4  107 cycles/
year). Therefore, it is crucial to study the effect of stenting conditions and stent design on the fatigue life
of BE stents. The objective of this paper is to provide quantitative measures of the stents stress amplitude
and mean stress which are generated by the cardiac pulse pressure. This allows prediction of the devices
life and optimization of stent designs. In this paper, numerical investigations were conducted using an
effective approach based on the well-known stress-based Goodman Diagram (GD) for the FLP of a given
stent design. It has been demonstrated that the percentage of arterys expansion as well as the dimensions of the struts (the fundamental structural unit that forms the stent), have both an impact on the fatigue behavior after stent deployment.
2013 Elsevier B.V. All rights reserved.

1. Introduction
Cardiovascular BE stents are tiny mesh-like devices placed into
an artery, blood vessel, or other duct to hold the structure open.
They are commonly used to treat conditions that result from
blocked or damaged blood vessels in the body. BE stents are made
from materials (AISI316L) that can be plastically deformed through
the ination of a balloon, which upon deployment can undergo as
much as 2030% plastic strain. After the balloon is deated the
stent remains in its expanded shape, except for slight recoil caused
by the elastic portion of the deformation. Numerous stents design
are used in clinical practice today [1], including cylindrical braided
wire meshes, coiled strip, laser-cut metal tubes or etched sheet.
The majority of BE stents are made from laser cut tubing. In any
case, all stents contain stress-concentration features at which the
local stress is high, and it is at these locations that failure may
potentially occur. Two different failure scenarios should be taken
into account when designing the stent. Firstly, failure may occur
during the initial deployment of the stent, which involves large
amounts of plastic deformation as the device is expanded using a
balloon catheter inside the stenosed artery. Secondly, fatigue

Corresponding author. Tel.: +352 42 59 91 1; fax: +352 42 59 91 555.

E-mail address: ahmed.makradi@tudor.lu (A. Makradi).
0927-0256/$ - see front matter 2013 Elsevier B.V. All rights reserved.
http://dx.doi.org/10.1016/j.commatsci.2013.05.043

failures may occur in the long term owing to the large number of
arterial dilation caused by cardiac pulse pressure (typically
4  107 cycles/year). With design lives of 1015 years, fatigue life
prediction of these devices is critical for the designer, as fatigue
failure can contribute to clinical complications. The fatigue life
requirement can be evaluated through physical tests which can
be very costly and time consuming. A 10 year device fatigue life
under the heart rate of 75 beats per minute projects a 400 million
cyclic pulsatile loading on the stent. Even with an accelerated fatigue test, a 400 million-cycle fatigue test can last months. FEA is an
extremely useful tool that has proven to be effective and capable of
providing a better and a more detailed understanding of fatigue
and design [24].
Mechanical and fatigue behavior of cardiovascular BE stents
have been investigated by few researchers such as Sweeney et al.
[5], Santos et al. [6] and Barrera et al. [7]. However, more extensive
work needs to be conducted in order to evaluate the fatigue behavior and characterize the long-term structural integrity of cardiovascular implants. The present paper discusses the FLP of a given
BE stents using FEA. Numerical simulations of the deployment
and pulsatile loading of the stent inside the vessel were performed
using Abaqus Finite Element (FE) code. The objective is to perform
numerical investigations that will provide quantitative data of
stresses which are generated during stent deployment and by the
blood pressure. These numerical data could be used to show how

M. Azaouzi et al. / Computational Materials Science 79 (2013) 326335

the stent behaves within the artery and to study the factors that
have an inuence on the fatigue life of the cardiovascular BE stent.
At rst, the experimental methodology used to determine the fatigue limit of the stainless steel material (AISI316L) is presented in
Section 2. Then, some details regarding the FE Modeling methodology of the stent deployment are presented in Section 3. Then, some
results obtained by numerical simulations are provided in Section 4, followed by a discussion about FLP of the BE stent in Section 5. Finally, some concluding remarks are presented in Section 6.

2. High cycle fatigue limit

To determine the High Cycle Fatigue (HCF) limit of AISI316L
material, a specic piezoelectric fatigue testing machines was used
[8]. Thanks to an ultrasonic mechanical vibration frequency, this
machine allows to perform more than 109 cycles per day, for a high
range of stress levels. Stair Case (SC) method [9] was adopted in order to determine the fatigue endurance limit at 109 cycles. The SC
method is based on a statistical approach by choosing carefully a
limited number of experiments to perform. The SC method assumes that the results scattering follows a Gaussian distribution.
In this method, the maximum number of tests is xed at the beginning, and a spacing of the stress amplitude is imposed which is dened with a constant step. It is important that the stress level of
the rst test has to be very close to the sought mean value that will
constitute the fatigue limit of the material. The stair case method
give an estimation of the fatigue limit rN about 287 MPa with a
standard deviation of 3 MPa. The dynamic fatigue system used
for evaluating life span is depicted in Fig. 1 [8]. The main elements
are:
A 2 kW Branson power generator that transforms 50 or 60 Hz
voltage signal into ultrasonic 20 kHz (500 Hz) electrical sinusoidal signals.
A converter (or piezoelectric transducer) excited by the power
generator, which transforms the electrical signal into longitudinal ultrasonic waves and mechanical vibration of the same
frequency.
An ultrasonic horn, constituted by a cylindrical part extended
by a section with a conic prole, that amplies the vibration
coming from the converter in order to achieve the required

327

stress amplitude in the middle section of the specimen. The

horn is cooled down by air circulation. The specimen is put
together on the horn head with a tightening screw.
A numerical system to monitor the test machine consisted of a
PC computer and a conversion card.
The computer monitors, the ultrasound generator and the converter are used in order to generate constant stress amplitude on
the specimen. In the same time, vibration frequency and vibration
amplitude of the head horn are controlled, and number of cycles is
stored. To complete the setup, samples are cooled down by water
ow, because the 316L stainless steel, with a weak thermal conductivity, evacuates very slowly the heat generated inside the
specimen during test. For the tests, resonance of the sample is required to get the needed stress amplitude. So, cylindrical specimens are drawn to vibrate on their rst longitudinal eigenmode.
Samples are alternatively in traction and compression states, leading to a fatigue loading ratio R = 1; i.e. the solicitation mode is
alternative symmetric with a mean stress equal to zero. Note that
the useful part of the specimen should represent a volume element
of the material. So, its geometry has to be both compact enough to
avoid buckling in compression and slender enough to spread uniformly stresses and strains along the specimen and avoid rupture
near the toe weld. Fig. 1 shows the retained geometry, it is an axisymmetric specimen whose the rst longitudinal eigenmode is
about 19, 840 Hz.
From all the fatigue tests done on the 316L stainless steel until
the specimens were broken, SN (StressNumber of cycles) diagram for loading ratio R = 1 can be plotted. Fig. 2 shows the results of the experimental fatigue tests, recording the number of
cycles to failure as a function of the applied stress range (i.e. the
difference between the maximum and minimum stress in the cycle). Symbols on the graphs represent individual test specimens
that were performed by considering the sample shown in Fig. 1.
The fatigue limit (rN = 278 MPa) of the material is obtained after
19 fatigue test. In studying the fatigue behavior, we concentrated
on large numbers of cycles to failure (109), since this material must
function for many years at a cyclic loading frequency of the order
of 1 Hz. To predict the number of cycles when fracture occurs for
whatever given stress amplitude, models proposed in literature
were tted on experimental data. The ve models [10] used are
rather similar, the main difference lies in the number of

Fig. 1. Sample dimensions in mm and the gigacyclic fatigue system.

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M. Azaouzi et al. / Computational Materials Science 79 (2013) 326335

Fig. 2. Whler curve models of AISI316L material (Loading ratio R = 1).

parameters to adjust and it is obvious that the more parameters

are available in the model, better is the tting. Between 106 and
1010 cycles, these ve models give close enough results (more or
less 10 MPa). Although experiment is often more reliable, it can
be interesting to use these models in order to determine fatigue
limit beyond 109 cycles.
Wiersma et al. [11] carried out experimental fatigue tests on
specimens of 316L stainless steel, with and without stress concentrations. The authors found a signicant size effect, in which the
behavior of microscopic specimens was different from larger, macroscopic specimens. The measured mechanical properties of a
material are often affected by the size of the test specimen used.
In particular, properties often change if the size of the specimen
(or of particular features in the specimen such as notches and
cracks) is reduced to the same order of magnitude as microstructural features such as grains. Size effects often arise in those properties which characterize the strength and fracture of a material,
whether failure occurs rapidly under monotonic loading or gradually by under cyclic loading. Therefore data obtained from typical,
macroscopic specimens is not relevant if the material is to be used
to make microscopic components such as the cardiovascular stent.
Wiersma et al. used the Theory of Critical Distance (TCD) [12] in order to predict the fatigue limit of microscopic and macroscopic
specimens. For the worst case, the authors predicted a fatigue limit
of macroscopic specimens about 2.5 times more important than
the fatigue limit of microscopic specimens. In the following paragraph, the estimated fatigue limit rN = 287 MPa obtained using
the SC method will be divided by a coefcient C = 2.5 in order to
predict more accurately the fatigue life of the stent using GD and
FEA. The reduced fatigue limit (rN /C  115 MPa) is very close to
the experimental fatigue limit obtained by Wiersma et al. [11] corresponding to the worst case.
3. Numerical modeling
3.1. Stent design and boundary conditions
The stent CAD (Computer Aided Design) and the reduced
numerical model of the BE stent used in the present study are illustrated in Fig. 3. Most BE stent designs have two fundamental constituents: expandable ring elements, and connecting elements
(bridges) which connect adjacent rings together. Expandable rings
are typically comprised of some number of struts arranged in a zigzag pattern (Fig. 3a and b). The mechanical properties of BE stents
such as: exibility, radial strength and fatigue resistance depend

on the stent design characteristics and strut dimensions. The

struts geometry may be characterized using four design variables:
length L, curvature radius R, width W and thickness T of the crosssection (Fig. 3c). These design variables affect the stent performance such as fatigue resistance, elastic recoil, foreshortening
and exibility [13]. Decreasing the strut thickness T will prevent
excessive ow disturbances and reduce the diameter of the catheter system. Decreasing the strut length L will improve the capacity
of an expanded stent to assume the natural curve of a vessel without unnatural straightening. Increasing the strut width W will improve the vessel coverage (scaffolding) and reduce the vessel tissue
prolapse between the struts.
As the pattern repeats itself symmetrically, only a fraction of
the length of the stent is modeled (Fig. 3c) considering only a rings
quarter model. Symmetrical boundary conditions are applied to
the open surfaces to maintain symmetrical axial and circumferential deformation (Fig. 3e). The quarter rings geometry is parameterized and updated by changing the 2D CAD sketch (sketched in
the Cartesian coordinates system) and then wrapping it onto a
cylindrical surface in order to obtain a 3D CAD model (transformed
to a Cylindrical coordinates system) using a python script. The 3D
CAD geometry of each component of the numerical model can be
modied and remeshed automatically using the python script.
The inner radius of the stent or quarter ring Rstent can be expressed
as a function of R, W and the number of struts in the circumferential direction. The radius of the cylinder and the outer radiuses of
the plaque and artery are dened as design variables for the
parameterization:

Rstent N4R 2W=2p

1a

Rcylinder Rstent

1b

Rplaque 2  ERstent Pth

1c

Rartery 2  ERstent P th Ath

1d

where N is the number of struts in the circumferential direction

(N = 12). E is a variable which represents the imposed percentage
of expansion during stent deployment, Pth is the thickness of the
cholesterol plaque (Pth = 0.5 mm) and Ath is the thickness of the wall
artery (Ath = 0.5 mm).
3.2. Analysis procedure
The expansion and elastic recoil of the quarter ring followed by
one cycle pulsating load are modeled and simulated using
Abaqus/standard FE code [14]. To solve for static equilibrium,
the static procedure in Abaqus/Standard was used for stent analysis (NewtonRaphson algorithm). As the FEA is highly nonlinear
(nonlinear geometry and material behavior), unsymmetric matrix
storage has been turned on in order to aid convergence of the algorithm since the stent surface is highly curved (radius of curvature = 0.1 mm) which will give rise to unsymmetric terms in the
stiffness matrix.
The cylinder used to expand the quarter ring is considered rigid.
A radial displacement is imposed to the cylinder for the expansion
simulation (Ur = 2Rstent). Then, the same radial displacement is imposed in the opposite direction (-Ur) for the elastic recoil simulation.
The elastic Radial Recoil (RR) represents the degree of contraction of
the quarter ring after removing the balloon catheter or cylinder, RR
(%) = (Rstent-loadRstent-unload)/Rstent-load (Rstent-load and Rstent-unload are
respectively the radius of stent before and after removing the balloon catheter). As the rst pulse cycle is considered to provide the
worst-case stressstrain condition, a blood arterial pressure
(Fig. 4) is applied to the inner surface of the quarter ring and plaque
in order to simulate the pulsating load due to the heart beating. The

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329

Fig. 3. 2D stent CAD (a), 3D stent CAD (b), rings quarter model (c), struts design variable (d), FE mesh of the quarter model (e).

cyclic change in the artery diameter is dened by the percent

of Compliance C (%) = (Rartery-systolic  Rartery-diastolic)/Rartery-diastolic
(Rartery-systolic and Rartery-diastolic are respectively the artery radius at
the systolic and diastolic pulse pressure). FLP of the quarter ring
model was conducted using the GD [15] which states that fatigue
failure will occur if the stress state satises the following relation:

fatigue strength (in terms of stress amplitude) at a specied number

of cycles and rUTS is the ultimate tensile strength. rN and rUTS are
material-dependent parameters determined by experimental high
cycle fatigue tests (Table 1).

ra rm

P1
rN rUTS

3.3. Finite element mesh

where ra is the amplitude of the applied cyclic stress (ra = |rsystolic

 rdiastolic|/2), rm is the mean of the applied stress (rm = (rsystolic +
rdiastolic)/2), rN is the fully reversed (zero mean stress) bending

To capture the local peak stress or strain, solid elements were

used. Among solid elements, linear hexahedrons are the best
candidates for stent models because they provide good balance
between accuracy and efciency. As the stent is loaded dominantly

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Table 3
Numerical results.
Conguration
1
2
3

E (%)
10
25
50

rm_max

ra_max

(MPa)

(MPa)

330.5
462.3
686.6

5.8
14.9
8.8

RR (%)

C (%)

eeq (%)

7.2
8.75
18.4

7.2
6.3
4.6

8.1
8.4
11.6

low stiffness when penetration is small and high stiffness when

penetration is large was used to slowly nudge the components into
contact and ease convergence difculties.
3.5. Material behavior modeling

Fig. 4. Blood pressure [16].

Table 1
Material parameters of the stent [11].
Youngs modulus E (GPa)
Poisson coefcient
Ultimate tensile strength rUTS (MPa)
Yield strength ry (MPa)
Strain to failure ef (%)
Endurance limit rN (MPa)

210
0.3
580
315
37
115

The mechanical behavior of the stainless steel material

(AISI316L) of the stent is modeled using an elasto-plastic and isotropic constitutive material model. The material parameters were
obtained from experimental tests carried out on microscopic specimens (Table 1).
The hyper-elastic constitutive model used to describe the atherosclerotic plaque behavior in the vessel is based on the
MoonyRivlin hyper-elastic constitutive theory [17]. The constitutive model is based on a third-order strain-energy density function
which has the following form:
2

in bending, the fully-integrated linear hexahedron element with

incompatible mode (denoted in Abaqus by C3D8I) was used for
stent analysis. This FE does not suffer from hourglassing and has
integration points closer to the surface. The C3D8I FE provides
good estimate of the peak stress even with the coarsest mesh.
The quarter ring is meshed with 2  2 FE in the cross-section corresponding to four integration point through the cross-section. The
FE size of quarter rings mesh is 0.05  0.05  0.075 mm. The atherosclerotic plaque and artery are meshed with a hybrid fully-integrated linear hexahedron FE that is denoted in Abaqus by C3D8H.
The cylinder is meshed with quadratic shell FE. Mesh convergence
were performed to strike a balance between solution accuracy and
efciency. The average FE length size of the artery and plaque is
0.15 mm.
3.4. Contact interaction
The contact interactions between the cylinders and stent as
well as the stent and plaque were modeled with the penalty method and a pure masterslave formulation. The penalty method was
used because it prevents the chattering behavior that might occur
due to the differences in mass densities between the stent and the
plaque materials during contact. A Coulomb friction coefcient of
0.1 was used to model the contact interaction. As contact is not
established at the beginning of the FEA, convergence difculties
could arise due to unconstrained rigid body motions before contact
is made. Therefore, contact stabilization was used to ease convergence difculties. In addition, nonlinear penalty stiffness, with

S1 a1 I1  3 a2 I2  3 a3 I1  3 a4 I1  3I2  3
3

a5 I1  3

Here I1 and I2 are the rst and second invariants of the

Cauchy-green tensor.

I1 k21 k22 k23

4a

I2 k21  k22 k22  k23 k21  k23

4b

where ki are the principal stretches.

The mechanical behavior of the artery was modeled using a
homogeneous, isotropic and hyper-elastic constitutive model
material based on the work of Holzapfel et al. [18]. This model
has been found to adequately describe the nonlinear stressstrain
relationship of elastic arterial tissue. The constitutive model is
based on a reduced polynomial strain energy density function of
sixth order:
2

S2 b1 I1  3 b2 I1  3 b3 I1  3 b4 I1  3
5

b5 I1  3 b6 I1  3

Using Eqs. (3) and (5), the stress components can be obtained by
differentiating the strain-energy density function, with respect to
the corresponding strains components. The material parameters
used in (Eqs. (3) and (5)) and listed in Table 2 were taken from
the Refs. [19,20].

Table 2
Material parameters of the atherosclerotic plaque and artery [19,20].
Coefcients (MPa)
Plaque

a1
0.49596

a2
0.50661

a3
1.19353

a4
3.6378

a5
4.73725

a6

Artery

b1
0.00652

b2
0.0489

b3
0.00926

b4
0.76

b5
0.43

b6
0.0869

M. Azaouzi et al. / Computational Materials Science 79 (2013) 326335

331

(a) Configuration n1.

(b) Configuration n2.

(c) Configuration n3.

Fig. 5. Goodman diagram (left) and contour plot of the fatigue safety factor (right).

4. Fatigue life prediction based on numerical simulation

4.1. Deployment and pulsating load
Numerical simulation and FEA of a quarter rings model was
conducted considering the following typical strut dimensions:
L = 1.2 mm, W = 0.1 mm, T = 0.1 mm and R = 0.06 mm. Three congurations were adopted by increasing the expansion of the stent
and consequently the artery diameter (see Table 3). The initial ar-

tery diameter is increased by 10%, 25% and 50% for each conguration during the deployment simulation. Then a 1 cycle pulsating
load representing the blood pressure simulation is applied to the
inner surface of the artery. After simulating the deployment and
pulsating load, fatigue life prediction of the quarter rings model
was performed by post processing the numerical results using a
python script [21]. The mean stress and stress amplitude are calculated and then plotted automatically after each numerical
simulation.

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M. Azaouzi et al. / Computational Materials Science 79 (2013) 326335

Fatigue is a phenomenon occurring under loadtime uctuation

at localized areas due to irreversible permanent deformation. Since
BE stents must function for many years at a cyclic loading frequency
of the order of 1 Hz, fatigue failure may occur. Failure of a stent due
to fatigue may result in loss of radial support of the stented vessel,
thrombus formation or focal restenosis, or in perforation of the vessel by the stent struts [22]. Fatigue analysis, combined with stress/
strain analysis and accelerated durability testing, provides an indication of device durability. The fatigue resistance of the stent to
physiologic loading may be determined using FEA in combination
with a stress-based Goodman analysis as shown in Fig. 4.
The diagrams of Fig. 5 represents a plot of the stress amplitude
ra versus mean stress rm. The line shown in the diagram represents the failure line dened by Goodman equation: ra/rN + rm/
rUTC = 1. The stent is deformed far beyond the materials yield
stress during deployment. Data point above or closer to the failure
line on the GD indicate that fatigue failure will occur at a specic
locations as mentioned in Fig. 5. Each point illustrated in the diagram represents the equivalent Von-Mises stress calculated at
the integration point of each FE. From this diagram it can be noticed that rm is much more important than ra and the latter one
is much smaller than rN, whereas rm is much closer to the fatigue
failure line. This result can be explained as follow: Firstly, failure
may occur during the initial deployment of the stent, which involves large amounts of plastic deformation or mean stress rm as
the device is expanded using a balloon catheter inside the stenosed
vessel. Secondly, fatigue failures may occur in the long term owing
to the large number of pulsatile loading dened by ra and to which
blood vessels are subjected due to the heart beating (typically
4  107 cycles/year). The strains obtained when increasing the percentage of expansion E are noticeably different (Fig. 5). The mean
strain increases when E increases, in contrary the strain amplitude
increases before decreasing when E increases. This behavior is due
to the fact that when the stent is over expanded, the stress concentration becomes very high as well as the deformation gradient. And
as the elastic springback amount decreases when the expansion
percentage increases, the radial displacement of the stent becomes
very small and consequently the amplitude strain decreases.
The fatigue Safety Factor (SF) calculated using Goodman equation give an idea about the critical zones susceptible to a fatigue
failure. The fatigue SF is calculated based on materials constant fatigue life diagram in combination with FEA. The risk of failure is
higher in the inner curved zone of the quarter rings model
(Fig. 5). The elastic RR, the artery compliance C and the maximum
equivalent plastic strain eeq obtained by numerical simulation are
depicted in Table 3. The elastic RR increases when the percentage
of arterys expansion increases, this result is due the increase of
the inward radial force which is exerted by the artery on the quarter ring. The recoil behavior of BE stents inuences proper device
selection, sizing, acute post-implant results, and long-term clinical
outcomes. Elastic RR is a function of stent design and material
selection; therefore, knowledge of stent recoil helps to characterize

the behavior of a particular stent design. It can be also noticed that

the arterys compliance becomes less important when the artery
expands further.
4.2. Effect of the strut dimensions
In order to study the effect of the strut dimensions on the fatigue behavior of the stent, each design variables was changed in a
typical range by25%, which means the effect of L, W, R and T were
studied independently as mentioned in Table 4. These geometrical
parameters do not contribute equally to the mechanical and fatigue behavior of the stent. From Table 4 and Fig. 5, it could be noticed that the strut length and width have the most substantial
impact, followed by wall thickness and radius. The elastic RR is inversely proportional to W and R, but proportional to L and T. The
equivalent plastic strain eeq is proportional to W and T, though it
is inversely proportional to L and R. Strut length and width have
the greatest inuence on elastic RR and eeq. The distribution of ra
as a function of rm is illustrated in Fig. 6. A small variation of L,
W and T generates an important variation of the mean strain rm.
However this design variable does not have the same signicant effect on the strain amplitude ra. An increase in L or decrease in W
and T results in an increase of the fatigue lifetime of BE stent. On
the other hand, an increase in R results in a moderate increase of
the fatigue lifetime. The maximum equivalent plastic strain obtained considering congurations A, B, C and D is much lower than
the strain to failure (37%) of the stainless steel material, thus the
stent may be expanded further without any risk of failure. However, fatigue lifetime of the stent may be reduced because the
residual stresses and consequently rm obtained after deployment
increases when the stent expansion increases. Radial stresses generated by the struts over the arterial wall upon stent deployment
arise near the contact interface and dominate the interaction.
Within the contact regions, local stress concentrations arise where
the stent exhibits the largest radial deformation. The amount of
stresses in the arterial wall depends on the initial stent diameter
and stent oversizing.
5. Discussion
BE stents have unique attributes that inuence the assessment
of their durability. First, the overall size of the stent is very small
and the cross-sectional dimensions of a single strut are on the order of 0.1  0.1 mm. Fatigue of such a small structure is unique and
often not predicted by testing and analysis of larger specimens. The
relative size of the grains 0.01 mm versus strut width and thickness 0.070.12 mm may affect the material properties at this size
scale. There is proven inuence of the size of the grains in AISI 316L
stents on the behavior of individual struts. Murphy et al. [23] successfully modeled the tensile response of stainless steel struts by
explicitly considering these struts to consist of hexagonal grains
with random crystallographic orientations; nite element analysis

Table 4
Effect of the strut dimensions.
Conguration

rm_max (MPa)

ra_max (MPa)

RR (%)

eeq (%)

L (mm)

0.9
1.5

A1
A2

588.8
346.7

14.9
18.2

6.4
10.8

12.8
5.7

W (mm)

0.075
0.125

B1
B2

375.4
485.6

18.3
13.3

11.3
7

5.2
11.3

R (mm)

0.045
0.075

C1
C2

473.1
435.6

12
17.4

9.5
8.4

8.3
8

T (mm)

0.075
0.125

D1
D2

418.5
519.7

19.2
12.4

8.6
9

8
8.7

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333

Fig. 6. Effect of the strut dimensions on the fatigue life using Goodman diagram.

was used to obtain the response of the struts to different types of

mechanical loading. The results showed that using this modeling
approach, a size effect, already seen experimentally was produced

successfully. Previous work [24] also demonstrated that stress

strain and fatigue behavior of the stainless steel material
(AISI316L) used in medical implants are size dependent at the

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M. Azaouzi et al. / Computational Materials Science 79 (2013) 326335

micron scale. This can be explained in terms of the relative importance of the microstructure or grains (Fig. 7). Grains which lie on
the boundaries of the strut can deform more easily than internal
grains because they are less constrained by the grains which surround them.
Murphy et al. [25] incorporated voids in the strut geometries
and showed that the growth and coalescence of voids within these
struts could explain why thinner struts were more prone to failure
under similar loading conditions. These approaches, however,
seem complicated and time consuming from a computational point
of view.
Fatigue failure of BE stent originates from a damage or microcrack due to stress concentrations at surface irregularities or because of high plastic deformations during balloon expansion.
Minute irregularities may produce a high value for the stress due
to stress concentration and serve as the starting point for the
microcrack, which progressively increases until the critical zone
breaks into two parts similar to a brittle fracture. No plastic deformation is observed in the failure surface. The process of fatigue
failure can be divided into two phases: (1) the initiation of a crack
and its growth up to the rst grain boundary, and (2) the subsequent propagation of the crack through the remainder of the struts
cross-section. Conventionally, high-cycle fatigue limit is dened at
a value between 106 and 107 cycles to failure. At very high numbers of cycles (about 107), it is well known that the initiation phase
takes up most of the life. The time spent in the propagation phase
depends on the dimensions of the cross-section. An increased
cross-section implies increased time spent in the propagation
phase, but it engenders large amounts of plastic deformation or
mean stress rm as the stent is expanded using a balloon catheter
inside the stenosed vessel. Therefore, optimization of the strut
dimensions may improve the fatigue resistance of the stent [26].
Systolicdiastolic pulsatile pressure is not the only clinical
force/deformation mode that must be addressed in fatigue analysis. Other cyclic deformation modes, such as arterial bending, axial
tension or compression, and torsion can occur, at various frequencies and phases, due to the anatomical differences between patients. As a result, duty cycles for all possible deformation modes
at body specic locations should be carefully studied and implemented into stent designs and validation testing. Furthermore,
the properties of the stent in vivo can be inuenced signicantly
by handling and processing (laser cutting, polishing, etc.) including
delivery, and deployment into the body. This leads to difculties in
generating representative numerical fatigue data that are necessary for the fatigue lifetime estimation. Similarly, the most advanced technology in assessing metal fatigue, that is, damage
tolerant fatigue life approach, or fracture mechanics, does not apply directly to small structures owing to the lack of small scale

Fig. 7. Grain size through the strut cross-section [23].

yielding conditions as well as the size effects in the crack growth

diagram. In addition, the loading/deformation environment and
duty cycles of stents are not generally known. This is due to the
lack of knowledge of mechanical properties of cardiovascular tissues and how they deform together with surrounding hard/soft
diseased tissue (atherosclerotic plaque). There is also another challenge specic to stent fatigue and durability analysis which is the
material and geometric nonlinearity and anisotropy of the metal,
artery, and stent-tissue interactions. Finally, there is no quantitative experimental validation to verify the analytical fatigue safety
factor calculation from FEA or other operational stress analysis. Fatigue test to success only qualitatively validates the fatigue analysis; the analysis and experiment agree only on no fractures at
400 million cycles. When failure would eventually occur is unknown due to the lack of the testing to fracture.
6. Conclusion
The fatigue analysis presented in this paper provides a qualitative validation of the adequacy of balloon-expandable stents design. Fatigue analysis of a given stent design was conducted
using nite element method in conjunction with a stress-based
Goodman Diagram and considering an isotropic elasto-platsic
material behavior. It has been demonstrated that the dimensions
of the fundamental structural unit that forms the stent (namely
strut) and the percentage of arterys expansion have both a noticeable impact on the fatigue behavior of cardiovascular stents. However, in order to accurately represent the constitutive behavior of
the material at the micron size-scale, a computational micromechanics approach should be taken into account and a crystal plasticity theory need to be used to represent the constitutive behavior
of the individual grains. In addition, in order to predict signicant
effects of material inhomogeneity on microplasticity and microcrack initiation, it is crucial to perform a micromechanical fatigue
analysis by using a FEM based on micromechanical methodology.
Acknowledgment
This work has been supported by the National Research
Funding of Luxembourg (FNR) via the project DeStenEE, C09/MS/
09.
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