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Article history: The superelastic, shape memory, biocompatibility, and fatigue properties of Nitinol, a nickel–titanium
Received 22 March 2012 alloy, have made the material attractive for medical devices such as self-expanding cardiovascular stents
Accepted 8 May 2012 (tubular mesh-like structures). Self-expanding stents are used in medical surgery to restore blood flow in
Available online 18 May 2012
a diseased artery segment (narrowing of the blood vessel due to plaque build-up) and keep the artery
open after angioplasty. Finite element analyses (FEAs) of Nitinol devices such as stents reduces testing
and time-to-market by allowing the designer to simulate the stent delivery inside the vessel. In this paper
a FEA has been performed to simulate the deployment and the pulsatile loading of a self-expanding Niti-
nol stent inside an artery. The results of the FEA have been used to assess the impact of the stent on the
artery and to assess the influence of the artery on the deformation field within the stent. Such analyses
will provide valuable information about the stent design and struts dimensions that can be optimized in
order to maximize the effectiveness of the stent during the deployment process. This work was con-
ducted using AbaqusÓ/standard finite element code in conjunction with a user material subroutine
(umat/Nitinol).
Ó 2012 Elsevier Ltd. All rights reserved.
0261-3069/$ - see front matter Ó 2012 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.matdes.2012.05.019
M. Azaouzi et al. / Materials and Design 41 (2012) 410–420 411
Nomenclature
Fig. 2. Self-expanding Nitinol stent (a) and ring and unit-cell model (b).
material is said to be superelastic. When the direct and inverse temperature effects. The material parameters used in the FEA were
transformations take place, the stress remains mainly constant taken from Ref. [12] (see Table 1).
over a large range of deformation respectively at the upper and A user material subroutine (UMAT/Nitinol) implemented in
lower plateau. This unusual behavior above TAf is called pseudo- Abaqus FE code [12] following the model proposed by Auricchio
elasticity. Further loading beyond superelastic limit reveals plastic et al. [13] was used for the present stent simulations. It should
behavior within the martensite phase (3). If a reverse loading is ap- be noted that the superelastic model cannot describe the plasticity
plied (for example, compression instead of tension), a similar of the martensite. The model is based on the loading–unloading
behavior is observed (6), with the exception that the stress levels irreversibility and the concept of generalized plasticity and physi-
required to produce the transformations are higher, while the cal principles [14]. Under the small strain assumption, the theory
transformation strain is lower. The material data required to cali- decomposes strain e into two parts, a purely linear elastic compo-
brate the Abaqus material model can be obtained from the uniaxial nent eEL and a transformation component eL:
behavior in terms of loading, unloading, reverse loading, and
e ¼ eEL þ eL ð1Þ
The austenite to twinned martensite transformation is driven
Table 1 by the resolution of shear forces, and it takes place within a range
Parameters of the Nitinol/UMAT material subroutine.
of stress levels that are characteristic of the material.
Nitinol/UMAT parameters
@F
q 6450 Kg/m3 eL ¼ aDf ; FS 6 F 6 FF ð2Þ
@r
EA 68,000 MPa
mA 0.3 where f is the fraction of martensite phase, a is a material constant
EM 36,000 MPa
which can be calibrated from uniaxial tensile test, and F is a trans-
mM 0.3
eL 0.04
formation potential. The same is true for the reverse transformation
(dr/dT)L 6.5 but at different stress levels. The intensity of the transformation fol-
rSL 520 MPa lows a stress potential law:
rEL 635 MPa
T0 37 °C
Df ¼ f ðr; fÞDF ð3Þ
(dr/dT)U 6.5
Any change in stress direction produces a reorientation of the
rSU 180 MPa
martensite with negligible additional effort. Changes in tempera-
rEU 26 MPa
780 MPa
ture produce a shift in the stress levels at which the transforma-
rSCL
tions take place. This shift is linear in temperature. Because there
M. Azaouzi et al. / Materials and Design 41 (2012) 410–420 413
F¼r
p tan b þ CT ð4Þ
with r being the Mises equivalent stress, p the pressure stress, T the
temperature, b and C are material constants. model cannot describe the plasticity of the martensite phase, there
A rule of mixtures is used to implement the change in linear are some deviations between numerical and experimental results
elasticity from the austenite phase into the martensite phase. In during unloading.
addition to the usual stresses and strains, the Nitinol/UMAT rou- For the Nitinol superelastic material model, a small positive
tine tracks variables specific to the model. These variables include slope was provided for the transformation between the austenite
the distribution of the fraction of martensite, transformation and martensite phases, even though in reality the transformation
strains, and equivalent stresses and strains. These are points in zone slope is close to zero or sometimes negative. Due to the differ-
the uniaxial tensile curve into which material points that have a ence between the loading and unloading curves, convergence diffi-
three-dimensional state, specific fraction of martensite, and a culties can arise at the junction of the start or the end of the
specific loading/unloading history are mapped. The material data transformation zone if a large increment is used. To avoid this
required by the model are obtained from straightforward observa- problem during FEA, a maximum increment size of 0.25 was
tions of uniaxial tests in terms of loading, unloading, reverse load- imposed.
ing, and temperature effects. The calibration consists of 14 values
as listed below in Table 1. 3.2. Artery behavior modeling
The mechanical behavior of the Nitinol alloy is illustrated in
Fig. 4 Upon loading, stress first increases linearly with strain up The mechanical behavior of the coronary artery was modeled
using a homogeneous, isotropic and hyper-elastic constitutive
to about 1% (austenite phase). After a first yield point rSL , more
strain can be accumulated with only a little increase of the stress. model based on the work of Holzapfel et al. [16]. The material
The end of this parameters used in (Eq. (5)) are listed in Table 2. The constitutive
almost plateau (loading plateau) is reached at about law is based on a reduced polynomial strain energy density func-
6% strain rEL . After that, there is another linear increase of stress
with strain (martensite phase). During the unloading, the material tion, S, of sixth order:
remains fully martensite till the stress decreases rapidly to the
S ¼ C 1 ðI1 3Þ þ C 2 ðI1 3Þ2 þ C 3 ðI1 3Þ3 þ C 4 ðI1 3Þ4
reverse transformation critical stress rSU . At the lower plateau
(unloading plateau), the strain is recovered with only little þ C 5 ðI1 3Þ5 þ C 6 ðI1 3Þ6 ð5Þ
decrease of stress. When the applied stress is lower than rEU ,
Here I1 is the first invariant of the Cauchy–Green tensor
the stress-induced martensite is completely transformed to be aus-
tenite if no plastic strain occurs during the tensile loading. The last I1 ¼ k21 þ k22 þ k23 ; ki ¼ J 1=3 ki ð6Þ
portion of the deforming strain is finally recovered in a linear fash-
ion again. where ki are the principal stretches and J is the total volume ratio.
Fig. 4 shows the cyclic stress–strain curves at two different tem-
peratures, the stresses increase when the temperature is increased 3.3. FEA procedure
from 20 °C to 37 °C. The unusual feature of Nitinol stents is their
temperature dependent stiffness. Stents with a transition temper- The manufacturing process of Nitinol stents starts from a thin
ature of 30 °C feel quite weak when squeezed or crushed at room tube in which a pattern is micro-machined. The finite element
or lower temperature. In contrast, they feel much stiffer when model is built from this machined tube. Both the deployment
squeezed at temperatures above 30 °C. The material behavior mod- and pulsating load of the stent are considered (Fig. 5). At first,
el has been experimentally validated on the basis of uniaxial ten- the stent is expanded to its nominal dimensions, typically at a
sile test as shown in Fig. 4. The implemented FE model closely diameter much larger than the original tube diameter. The stent
matches experimental measurements obtained from the uniaxial is then annealed to provide its new unloaded configuration. It is
test, where successively large strain loads are applied to the Nitinol then crimped from the outside (Fig. 5a) and inserted into the deliv-
alloy at two different temperatures [15]. Since the superelastic ery system (catheter tube). Once inside the blood vessel, the stent
self-expands out of its containment by removing progressively the include local buckling, slip and stick for frictional contact and, most
catheter tube. After expanding, the stent exerts a Radial Force (RF) frequently, loss of contact between different components. In real-
on the blood vessel (Fig. 5b). ity, in these situations, the stored strain energy will turn into ki-
Numerical simulation and FEA was conducted using Abaqus/im- netic energy. In this analysis, static stabilization coefficient was
plicit Finite Element (FE) code. In this simplified Nitinol stent sim- used carefully to dissipate the local dynamic effect.
ulation, only a fraction of the stent is modeled and the expansion is
constrained by the artery when the tool is released. As the FEA is 3.4. Boundaries conditions and FE mesh
highly nonlinear (nonlinear geometry and material behavior),
unsymmetric matrix storage has been turned on in Abaqus/implicit Nitinol stents are commonly used in various vascular beds,
in order to aid convergence of the FEA since the stent surface is including the carotid, femoral, renal, and iliac arteries. Each of
highly curved (radius of curvature = 0.1 mm) which will give rise these anatomic locations, and even the individual lesions, presents
to unsymmetric terms in the stiffness matrix. different mechanical challenges. The loading conditions corre-
To solve for static equilibrium, the static procedure in Abaqus/ sponding to the clinical stent deployment should be carefully con-
Standard was used for stent analysis (Newton–Raphson algo- sidered when modeling and designing the Nitinol stent. The
rithm). Instabilities are one of the main convergence difficulties oversizing of the stent to the arterial wall and the worst-case
for stent analysis using a static procedure. Sources of instabilities strains with respect to fatigue life should be considered in the
M. Azaouzi et al. / Materials and Design 41 (2012) 410–420 415
FEA. While more complete modeling of loading conditions is one internal diameter of the artery (dstrut = 2.5 mm). The unusual elastic
way to obtain a more accurate estimate of the fatigue life of a stent, hysteresis of Nitinol allows the continuing opening force of the
frequently these loading conditions are not definitively known, stent acting on the vessel wall (COF), to remain very low even
especially for relatively complex stenting indications. through large deflections and oversizing of the stent. Meanwhile
Since the pattern repeats itself symmetrically, only specific part the forces generated by the stent to resist compression (Radial
of the stent (Unit-cell model) with appropriate symmetry bound- Resistance Force, RRF), increase rapidly with deflection until the
ary conditions was considered (Fig. 6). The tool used to crimp the plateau stress is reached (Fig. 3). The amount of the RRF reached
stent ‘‘strut’’ is considered rigid and cylindrical. A radial displace- at the end of crimping is 6 N. Fig. 8 shows the evolution of the Ra-
ment Ur = + 3.75 mm was imposed on the external surface of the dial Force (RF) as a function of the stent diameter. After crimping,
cylinder (Fig. 6b) for the crimping simulation. Then, the same ra- the strut is allowed to expand progressively by its own stored
dial displacement is imposed on the cylinder (Ur = 3.75 mm) in strain energy inside the artery. The strut expands until its external
the opposite direction for the self-expansion simulation. A diameter matches the initial internal diameter of the artery. When
smooth-step amplitude curve was defined to ramp up the radial the contact between the strut and artery is activated, the strut ex-
displacement from zero at the beginning of the crimping and ramp erts a RF and the artery expands. When the contact is activated, the
the displacement down to zero at the end of the step. RF value becomes 4.85N and 4.3N respectively for an artery diam-
Two symmetrical (axial and circumferential) boundaries condi- eter of 6 mm and 8 mm.
tions were used to constrain the translational (U) and rotational The expanded diameter of the artery depends on the RF and the
(UR) degree of freedom of the Unit-cell model (Fig. 6c and d). The stent oversizing (defined as the difference between the initial stent
contact interactions between the cylinder and the strut as well as diameter and the initial artery diameter, Dstrut Dartery). The artery
the artery and strut were modeled with the penalty method and a expansion is 42% and 23.75% in the case of an artery of 6 mm and
pure master–slave formulation for both contact interactions. The 8 mm respectively. Fig. 9 shows the equivalent transformation
penalty method was used because it prevents the chattering behav- strain (eL) of the strut’s crimped (a) and expanded (b, c) configura-
ior that might occur due to the differences in mass densities between tions. The maximum strain is located in the curved zone of the
the stent and the artery materials during strut–artery contact. A Cou- strut. It was observed also that eL decreases when the stent oversiz-
lomb friction coefficient of 0.1 was used to model the contact inter- ing decreases (Fig. 9b and c), which means more strain is recovered
action. A self contact interaction was activated to prevent the mesh after expansion of the strut. Fig. 10 shows the contours plots of the
overlapping of the strut at the end of crimping. Once, the numerical circumferential stresses generated in the arterial wall upon stent
simulation of expansion is finished, a pulsating load corresponding deployment. While there is a base level of stress generated by
to the diastolic/systolic cyclic blood pressure (Fig. 7) is exerted on the bulk expansion of the artery, the stresses that arise near the
the inner surface of the strut and artery. Both, stent and artery are contact interface dominate the interaction. Within the contact re-
meshed with solid linear hexahedron Finite Element (FE) in order gions, local stress concentrations arise where the stent exhibits
to capture the local peak stress and strain. The FE mesh size of the the largest radial deformation. The circumferential stress magni-
strut and artery are respectively 0.025 0.025 0.05 and tudes obtained by numerical simulation are in good agreement
0.1 0.2 0.15. This FE is the best candidate for the FEA of stent with those of experimental data published in [17]. It was also no-
models because it provides good balance between accuracy and effi- ticed that the amount of stress in the wall artery depends on the
ciency. As stents are loaded dominantly in bending, the fully-inte- stent oversizing (Fig. 10).
grated linear hexahedron element with incompatible mode C3D8I
has been used. This FE does not suffer from hourglassing and has
integration points closer to the surface. The only concern while using 4.2. Effect of the strut dimensions
the C3D8I element is that care must be taken to make the initial ele-
ment shape as close to a perfect cube as possible. As mentioned before, the strut design is crucial in the treatment
of stenosed artery [18]. The stiffness and flexibility are two main
4. FEA of the stent deployment characteristics of the stent. Stiffness is necessary to maintain the
blood vessel open and at the same time the stent should be as flex-
4.1. Strut–artery interaction ible as possible during its delivery into the specified location of the
stenosed artery. Those two characteristics are dependent on the
As mentioned previously, the initial diameter of the stent is strut design and dimensions [10]. In order to study the effect of
10 mm. The stent is crimped up to a diameter smaller than the the dimensions and number of struts on the RF and artery
Fig. 7. Pulsating load in kPa (one cycle). Fig. 8. Radial force (N) of the stent.
416 M. Azaouzi et al. / Materials and Design 41 (2012) 410–420
Fig. 9. Equivalent transformation strain eL of the strut, (a) end of crimping, (b) end of expansion Dartery = 6 mm, (c) end of expansion Dartery = 8 mm.
Fig. 10. Circumferential stress (MPa) in the artery after stent deployment, (a) Dartery = 6 mm and (b) Dartery = 8 mm.
expansion, four geometrical parameters: L, W, H and N have been influence on strain for given conditions of oversizing and number
varied as illustrated in Table 3. of struts. It has been demonstrated that the amount of strain is
The variation of the radial force and artery expansion as a func- an important factor in the fatigue life prediction of Nitinol stent,
tion of the strut dimensions and number is illustrated in Fig. 11. It which is loaded during in vivo service by a cyclic blood pressure
can be noticed that the effect of L, W and H is remarkable on the RF. due to the heart beating. Pelton et al. [19] demonstrated from
A small variation of W and H generates an important variation of experimental data that there is an increased fatigue life at mean
the artery expansion. However the number N of strut along the cir- strains above about 1.5% compared with the zero-mean conditions.
cumferential direction has not a significant effect. An increase in L The author speculated that this result could be due to strain
or decrease in W and H results in a decrease of the strut stiffness accommodation from stress-induced martensitic transformation.
and thus lead to a decreased artery expansion. On the other hand, From Table 4 it could be expected that the fatigue life of Nitinol
an increase in M results in a moderate decrease of the artery stent is directly related to the oversizing amount, dimensions
expansion. Fig. 11 shows a visible dependency of the artery expan- and number of struts. This result indicates that for an accurate fa-
sion on the stent oversizing and dimensions. An oversizing of tigue life prediction it is crucial to take into account the stent over-
2 mm generates less variation of the artery expansion in compari- sizing as well as the interaction between the stent and artery.
son with a larger over-sizing of 4 mm.
Table 4 shows the amount of residual strain of the strut at the
end of expansion which is obtained for different strut dimensions 5. FEA of the pulsating load
(A, B, C and D). It can be seen that the difference between Dstrut
and Dartery (which has been defined previously as the stent oversiz- 5.1. Evolution of the stress and strut diameter
ing) has an influence on the amount of strain recovery. From
Table 4 it could be noticed that in the case of an artery diameter After deployment of the stent, a cyclic pulsating load (Fig. 7)
Dartery of 6 mm more strain was recovered as L, H and W increase was applied to the inner surface of the strut. The strut responses
(A, B and C) and in contrary less strain is recovered when N in- corresponding to an artery of 6 mm and 8 mm are illustrated in
crease (D). In the other hand, the amount of strain recovery in- Fig. 12. The equivalent stress req of the strut increases with the
creases when W, H and N increase (B, C and D), but it decreases stent over-sizing. During progressive expansion of the strut, req in-
if L increase (A). The effect of strut dimensions on the strain recov- creases up to 350 MPa in the case of an artery diameter of 6 mm.
ery is considerable and it depends at the same time on the strut But it remains constant in the case of an artery diameter of 8 mm.
oversizing. Strut length, width and thickness have the greatest Fig. 13 shows the behavior of the strut which occurs during the
transitory step following the deployment inside the artery. The
stent response to the cyclic pulsating load depends on the stent
Table 3
over-sizing as well as the stent design. In the case of an important
Different strut dimensions.
over-sizing (Dstrut Dartery = 4 mm), the stent continue its progres-
Reference model A B C D sive expansion until stabilization. In the case of an artery diameter
L (mm) 2.25 L/2 2L L L L of 6 mm, more elastic strain has been recovered after stabilization
W (mm) 0.15 W 2W/3 4W/3 W W of the strut response to 125 cyclic pulsating loads. In the other
H (mm) 0.2 H H H/2 2H H
hand, the strain amount remains almost constant over 125 cycles
N 12 N N N 2N/3 4N/3
for an artery diameter of 8 mm.
M. Azaouzi et al. / Materials and Design 41 (2012) 410–420 417
Fig. 11. Effect of the strut dimensions on the radial force and artery expansion.
5.2. Fatigue life analysis often depends on the specifics of the specimens and test environ-
ment. Regarding the material properties of Nitinol and the small
In this paragraph, the fatigue life analysis of the stent is limited cross-section of the stent, it is recommended to conduct fatigue life
to a preliminary scoping assessment. In general, both stress based analysis with strain based approach. From the FEA conducted in
and strain based approaches provide insight into the mechanisms this paper, it has been demonstrated that the equivalent transfor-
of fatigue behavior to predict lifetimes and the appropriate choice mation strain eL (strain recovery) is related to the amount of
418 M. Azaouzi et al. / Materials and Design 41 (2012) 410–420
Table 4
Effect of the strut dimensions on the strain recovery.
Dartery A B C D
L/2 2L 2W/3 4W/3 2H/3 4H/3 2N/3 4N/3
eL (%) 6 mm 3.025 1.5 3.382 2.675 3.612 2.433 3.57 4.19
8 mm 0.036 0.23 0.376 0.032 0.306 0.03 0.083 0.055
Fig. 12. History of the maximum Von-Mises stress req in the strut during pulsating load.
over-sizing of the stent and its strut dimensions (Table 4). The fa- These results are in concordance with the Nitinol behavior that re-
tigue lifetime of Nitinol depend on eL [19]. As a consequence, the flects an elastic response at a large amount of stress, and then a
fatigue lifetime of this medical device will depend on the stent superelastic response at almost constant stress (see plateau stress
over-sizing as well as the strut dimensions. shown in Fig. 3). Fig. 14 shows also a relatively dependence of the
In order to show the stent behavior regarding the cyclic loading, stress amplitude on the stent oversizing.
it is possible also to consider the stress based approach. The result
illustrated in Fig. 14 was obtained using AbaqusÓ finite element
code. The post-processing of the result was performed using a py- 6. Discussion
thonÓ script [20]. The stress amplitude and average stress was cal-
culated after stabilization over the strut. The stabilization of the Nowadays, more than 100 types of stents are available on the
strut response to the pulsating load occurs after 125 cyclic pulsat- market [21,22]. Stents can be categorized according to their expan-
ing loads. Each point in this figure represents the stress which was sion mechanism, geometrical shape, and manufacturing process
calculated at the centroid of the hexahedron finite element. The [21]. In terms of expansion mechanism, stent can be classified as
chattering of stresses results from the variation of the equivalent balloon-expandable where the angioplasty balloon is employed
transformation strain obtained over the strut (Fig. 9b and c). From to both open the blocked artery and expand by plastic deformation
the two diagram illustrated in Fig. 14, it can be noticed that the the stent, or as self-expanding where as the stent is pushed out of
stress amplitude Dr which is determined as a function of the aver- the catheter it immediately opens out to support the already di-
age stress rmean is considerably depending on the stent over-sizing. lated lumen. Balloon-expandable stents have to be overexpanded
M. Azaouzi et al. / Materials and Design 41 (2012) 410–420 419
Fig. 14. Stress amplitude over the strut, (a) Dartery = 8 mm and (b) Dartery = 6 mm.
to achieve a certain diameter due to the elastic springback after Because of the superelastic behavior of Nitinol alloy, it is recom-
deflation. The springback is highly undesirable feature and the mended to use strain-life approach for the fatigue prediction
overexpansion may damage the vessel and cause restenosis. On [19], but we believe that it is relatively acceptable to use stress-life
the other hand, self-expanding stent will continue to gently push approach when we take into account the in vivo interaction be-
outward against the artery wall after deployment and follow artery tween the stent and artery. It is obvious that the numerical results
movements. A classification and comparison of the self-expanding could be investigated deeply for the fatigue life estimation by tak-
stents design and properties can be found in [18,22]. The design ing into account the in vivo interactions between the stent, the
requirements for a stent include: flexibility, trackability, biocom- cholesterol’s plaque and artery.
patibility, low surface area (Scaffolding), minimal foreshortening, In self-expanding Nitinol stents, the COF and RRF are two
high radial strength (kink resistance), radiopacity, and fatigue important factors. As it has been discussed previously, Nitinol
resistance [18,23]. stents exert a low chronic outward force against the wall vessel
The stent design is a major factor which determines its reliabil- but resist deformation with a much higher force. The radial
ity during insertion into the blocked artery and throughout the strength (RRF) or crush recoverability is an important feature for
long term in vivo service. For example, the stent performance could stents in superficial vessels (carotid or femoral artery) that could
be improved by increasing strut thickness (which increases radio- be deformed through outside forces. An increase or decrease of
visibility, radial stiffness and arterial wall support). Nevertheless, the radial strength depends on the stent design and strut
excessive strut thickness may impart more vascular injury, cause dimensions. Experimental analysis of the radial strength and flex-
more intimal hyperplasia, and engender a higher risk for restenosis ibility relevant to the performance of 14 stents can be found in
than thinner strut. A comparative study regarding the relationship [26].
between strut dimensions and arterial wall reaction as well as the The mechanical properties of self-expanding Nitinol stent re-
impact of stent design on clinical outcome are discussed in [24]. In ported in the past include chronic outward force (COF), radial resis-
clinical practice, the sent design and material is very important for tance force (RRF), flexibility, shortening ratio, radiopacity, and
the lesion that is going to be treated. Balloon-expandable stent are trackability [23]. The first 3 properties are related to device behav-
used especially for coronary arteries, though self-expanding stents ior after stent deployment, and the last 3 are important factors
are more appropriate for peripheral arteries such as carotid and during the insertion process. We believe that the first 3 properties,
femoral artery where ballon-expandable stents could become namely, COF, RRF and flexibility have an effect on the clinical per-
crushed and compromise blood flow. formances such as patency and complications. Among these prop-
In the last decade, self-expanding stents comprise the vast erties, the radial stiffness or strength is obviously the most
majority of the endovascular stent market where the SMART Niti- important because in self-expanding stent, radial force maintains
nol stent (manufactured by CordisÓ Corporation) is widely used. A and expands the luminal patency at the stricture once the stent
survey of a popular self-expanding stents design can be found in is deployed. The FEA presented herein focused on the radial force
[21,23]. The success of the SMART stent design was largely due which reflects the stent strength. This FEA is very useful in terms
to its very fine mesh structure that offered exceptional contouring, of the understanding of stent behavior during its deployment,
flexibility, and apposition characteristics. However, as the stent is the interaction with blood vessel and the relationship between
subjected to a long-term cyclic pulsatile (typically 4 107 cycles/ the stent design and the COF as well as the RRF. The FEA was con-
year) and musculoskeletal loading, fatigue fracture may occur. ducted using a pattern similar to the Nitinol SMART stent design
Pelton et al. [19] investigated the in vivo fatigue resistance and [20] in order to demonstrate the effect of strut dimensions on
durability of Nitinol SMART stent, and demonstrated that there is the strain recovery as well as the radial strength. However, due
a significant effect of the equivalent transformation strain eL on to the complexity of the stent deployment process as well as
the fatigue life of stents. Based on the fundamental strain-life ap- in vivo pulsating load, it is necessary to conduct a relatively sophis-
proach, prediction of a stent’s fatigue performance requires a pre- ticated FEA.
cise analysis of the fatigue strains of a stent in vivo and a profound The fatigue resistance is related to the amount of the residual
understanding of Nitinol’s fatigue behavior under the similar strain obtained after deployment, an improvement of the self-
deformation patterns. Several researchers investigated the effects expanding stent reliability in terms of fatigue resistance, may be
of mean and alternating strain on the fatigue behavior of super- performed by combining numerical simulations with optimization
elastic Nitinol stent and observed that the oscillating strain has a strategies. Accordingly, the stent behavior and its interaction with
greater effect on fatigue life than the mean strain [25]. In the other the artery during deployment could be refined by optimizing the
hand, the FEA performed herein is based on the stress-life ap- radial strength (COF and RRF). It should be also mentioned that
proach which demonstrated the dependency of the alternating the transition temperature TAf of the stent can be adjusted to a
stress (Dr) and mean stress (rmean) on the stent oversizing. certain extent during material processing. This gives the designer
420 M. Azaouzi et al. / Materials and Design 41 (2012) 410–420