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Fatigue Testing of The Stent
Fatigue Testing of The Stent
Fatigue Testing of The Stent
Biomaterials
journal homepage: www.elsevier.com/locate/biomaterials
Mechanical Engineering, College of Engineering and Informatics, National University of Ireland Galway, Ireland
Biomedical Engineering, College of Engineering and Informatics, National University of Ireland Galway, Ireland
a r t i c l e i n f o
a b s t r a c t
Article history:
Received 22 August 2013
Accepted 24 September 2013
Available online 10 October 2013
Fatigue of CoCr alloy stents has become a major concern in recent times, owing to cases of premature
fracture, often driven by microstructural phenomena. This work presents the development of a micromechanical framework for fatigue design, based on experimental characterisation of a biomedical grade
CoCr alloy, including both microscopy and mechanical testing. Fatigue indicator parameters (FIPs) within
the micromechanical framework are calibrated for the prediction of microstructure-sensitive fatigue
crack initiation (FCI). A multi-scale CoCr stent model is developed, including a 3D global J2 continuum
stent-artery model and a 2D micromechanical sub-model. Several microstructure realizations for the
stent sub-model allow assessment of the effect of crystallographic orientations on stent fatigue crack
initiation predictions. Predictions of FCI are compared with traditional Basquin-Goodman total life
predictions, revealing more realistic scatter of data for the microstructure-based FIP approach. Comparison of stent predictions with performance of a 316L stent for the same generic design exposes the
design as over-conservative for the CoCr alloy. In response, the micromechanical framework is used to
modify the stent design for the CoCr alloy, improving design efciency.
2013 Elsevier Ltd. All rights reserved.
Keywords:
Fatigue
Cobalt alloy
Stent
Microstructure
Modelling
1. Introduction
The L605 CoCr alloy is a popular material used in a broad range
of applications with fatigue loading, including biomedical implants
[1], gas turbine components and bearings [2]. In such applications,
the development of reliable and accurate methods for fatigue life
prediction is a necessary design requirement. L605 fatigue life data
and cyclic stress-strain behaviour are essential inputs for development of successful fatigue assessment techniques. This allows
the capture of energy dissipation and stresses and strains reached
cyclically in the material, which has direct impact on the life of a
component. Microstructural characteristics, such as grain size and
precipitates, can have a signicant role in the fatigue performance
of L605 and, hence, must also be included in predictive modelling
techniques. A limited number of experimental characterisation
studies have been reported for this alloy. Stress-life data has been
published for notched L605 specimens in a study on the use of
ultrasonic methods for detecting cracks in fatigued specimens [3];
however, no information on the cyclic behaviour of the material is
provided. Other studies provide high cycle fatigue (HCF) stress-life
* Corresponding author. Tel.: 353 (0)91 493020; fax: 353 (0)91 563991.
E-mail address: c.sweeney4@nuigalway.ie (C.A. Sweeney).
0142-9612/$ e see front matter 2013 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.biomaterials.2013.09.087
data and crack growth data for the L605 alloy [4,5], but again, do
not report cyclic stress-strain data. Microstructural studies on L605
primarily focus on microstructural evolution under applied heat
treatments. Teague et al. [6] carried out a series of aging treatments
to look at the effects of resulting precipitation on tensile behaviour,
reporting that aging above 800 C produced incoherent precipitates,
decreasing yield strength, while aging below 800 C resulted in
precipitation of coherent precipitates, strengthening the material.
Other studies focused on L605 in stent applications, looking at the
effect of annealing temperatures on precipitation [7], changes in
grain size and tensile properties under different combinations of
cold working and annealing [8] and stent surface enhancement via
an electrochemical process [9].
The primary objective of this study is the development of a
micromechanical approach to L605 fatigue assessment. The L605
stent is an ideal application for this approach, as stent struts can be
80 mm in thickness [1,10], compared to a grain size on the order of
10 mm [11]. Consequently, with often less than ten grains through the
strut thickness, the performance of the stent is highly dependent on
the inhomogeneous microstructure. This has been veried in previous
studies for monotonic behaviour of stent struts, using crystal plasticity
(CP) constitutive modelling, which describes deformation due to
plastic slip on individual slip systems in crystallographic grains [11e
15]. However, this microstructure-sensitive method demands
37
Fig. 1. Optical microscopy images of the L605 alloy, showing (a) longitudinal and (b) transverse views of the bar and (c) grain area distributions for the two views.
CoCr alloy stents, for which a clear need has been explicitly
expressed in past work [4]. The L605 CoCr alloy, commonly used in
current generation cardiovascular stents [1], is experimentally
characterised both microstructurally and mechanically, via microscopy, and tensile and low cycle fatigue (LCF) testing, respectively.
The experimental data is used in the development of the L605
micromechanical modelling framework, including realistic geometries, based on measured microstructures, and a CP model, calibrated for both monotonic and cyclic behaviour. This framework is
then used to assess the fatigue performance of an L605 model for a
generic stent design, which is compared to previous work for a 316L
stent [26]. A multi-scale approach is adopted whereby boundary
conditions for the CP sub-model are extracted from a J2 continuum
global stent-artery model. In order to assess the design of the stent
and the potential for premature failure, microstructure-sensitive
fatigue indicator parameters (FIPs) [27,28] are implemented for
the prediction of number of cycles to fatigue crack initiation. Use of
the methodology as a design tool is demonstrated, where the
chosen L605 stent design is modied to improve design efciency.
2. Experimental studies
This section outlines experimental work carried out on the L605 CoCr alloy,
trade-named HAYNES 25 alloy [2], used in the as-received condition: a hot-rolled
bar, solution-annealed at 1230 C, with chemical composition of 20 wt% chromium, 15 wt% tungsten, 10 wt% nickel, 3 wt% iron, 1.5 wt% manganese, 0.4 wt%
silicon, 0.1 wt% carbon and the balance consisting of cobalt. The experimental
programme covers both the microstructural and mechanical characterization of the
L605 alloy via microscopy, and fatigue and tensile testing, respectively.
2.1. Microscopy
Optical microscopy was used to measure the crystallographic grain morphology
in the L605 microstructure. The L605 material was supplied in cylindrical bar form.
Therefore, microscopy was carried out on both transverse cross-sections (parallel to
the cylindrical axis) and longitudinal cross-sections (perpendicular to the cylindrical
axis). The microscopy samples were mounted in an epoxy resin. Surface preparation
was achieved via manual grinding, across a range of grit sizes, automated polishing,
with a range of diamond pastes, nishing with a 0.02 mm polishing suspension, and
cleansing in an ultrasonic bath. An etching solution of 100 ml HCl and 5 ml 30% H2O2
was used [29].
Sample optical micrographs of the L605 microstructure from both longitudinal
and transverse cross-sections can be seen in Fig. 1(a) and Fig. 1(b), respectively.
Individual crystallographic grains are highlighted for illustrative purposes. A Matlab
program was developed to extract information on grain area distributions from
several optical micrographs for both the longitudinal and transverse views, the results shown in Fig. 1(c). An average distribution is also included in Fig. 1(c). There is
clearly a high correlation between the two orientations, indicating an equiaxed
microstructure. Assuming a hexagonal 2D grain shape, the average grain size was
found from these distributions to be 32 mm. An ASTM grain size of 5 was observed for
the microstructure.
SEM imaging was also applied to the etched samples. A scanning electron
micrograph of the L605 microstructure can be seen in Fig. 2(a); precipitates appear
38
Table 1
EDX readings for chemical composition in a particle and within the L605 matrix.
Element
Weight (%)
Co
Cr
W
Ni
C
% Change in weight %
Matrix
Particle
46.31
20.74
17.21
11.13
4.61
15.22
10.9
63.04
3.46
7.37
67
47
226
222
60
surface are observed in Fig. 5(b) and (c), corresponding to fatigue cracking and a nal
tensile overload, respectively. The plastic strain-life curve corresponding to these
L605 fatigue tests is shown in Fig. 6, including identication of the CofneManson
relationship for total life, Nf, as a function of plastic strain range, Dp:
Nf
Dp
g1
(1)
C1
and the identied values of the C1 and g1 constants are given in Table 2.
3. Computational framework
3.1. Constitutive models
3.1.1. Crystal plasticity model
A key novelty of the present work is the development and
identication of a micromechanical, crystal plasticity constitutive
model for the monotonic and cyclic plastic response of L605. Crystal
plasticity (CP) [34e38] describes deformation in the crystal lattice
via dislocation motion through the use of a deformation gradient F
which is decomposed into elastic and plastic components:
F F e $F p
(2)
Lp F_ p $F 1
X
a
g_ a sa mTa
(3)
where sa and ma are the slip direction and normal to the slip plane,
respectively, on a given slip system. The L605 matrix has a facecentred cubic (fcc) crystal structure [6] and, therefore, has 12
{111}h110i slip systems. The resolved shear stress on a slip system is
calculated by:
Fig. 2. (a) SEM image of the L605 alloy microstructure and (b) particle area distribution within the L605 microstructure; the inset histogram continues the distribution for grain
areas above 1 mm2.
39
Fig. 3. (a) Tensile curve for the L605 alloy compared with a biomedical grade 316 LVM [15] and (b) the fractured tensile specimen.
sa ma 5sa : s
(4)
(5)
s x a n
_
g_ a asgn
sa xa a
ga
(6)
where xa is a kinematic back-stress, ga is an isotropic strain hardening parameter, a_ is a reference strain rate and n is a rate sensitivity exponent. In the present model, in order to effect greater
exibility for simulation of the complex non-linear monotonic and
cyclic micro-plasticity response, the kinematic hardening parameter is a linear combination of two individual evolving backstresses, both described by an Armstrong-Frederick evolution rule:
xa x1a x2a
(7)
x_ ia Ci g_ a Di xia jg_ a j
(8)
where i 1,2, Ci/Di is the saturation value for xi and Di controls the
rate of decay leading to saturation. Ci and Di are material constants
calibrated via comparison with the measured cyclic response of the
material. The evolution of the hardening function of Asaro and coworkers is used:
ho ga
gga g0 gN g0 tanh
gN g0
(9)
g_ a
X
b
hab g_ b
(10)
Fig. 4. (a) Cyclic stress range evolution corresponding to LCF total strain ranges and (b) experimental stress-strain hysteresis loops after various number of cycles for the 1% strain
range.
40
1.49
1.77
g1
f
3 0
s x0 : s0 x0
2
1=2
k rp
(13)
x x1 x2 x3
Fig. 5. (a) Post-test LCF specimen for the 1.2% strain range, (b) fatigue striations in
location of initial crack and (c) static fracture surface.
h g
haa hab hga h0 sech2 0 a
gN g0
(11)
ga
XZ
a
dxi
2
c dp gi xi dp
3 i
jg_ a jdt
(12)
(16)
where Q is the saturation value of the isotropic hardening parameter and b controls the rate of decay leading to saturation; both Q
and b are constitutive constants calibrated as described below.
3.2. Finite element microstructure model
A micromechanical nite element model of the measured
microstructure is developed for the identication of the microscale behaviour of the L605 material under cyclic and tensile
loading. A customized Matlab code is developed for generation of
the 3D microstructure via superposition of a 3D Voronoi tessellation on a voxel mesh. In order to ensure that the grain volume
distribution of the resulting polycrystal accurately simulates the
experimental distribution, 2D grains were idealised as hexagons
and 3D grains as rhombic-dodecahedrons (as seen in
supplementary Fig. S3). The resulting relationship between grain
volume (3D) and grain area (2D) is then given as follows:
3
1 2A 2
V p p
2
3
(15)
drp bQ rdp
(14)
(17)
41
Fig. 8. Comparison of the J2 continuum and CP tensile curves with the L605 experimental data; the large-strain range is calibrated using the additional back-stress terms
and the small-strain range (before dotted line) is calibrated using initial back-stress
terms.
Fxk
n X
m h
X
j1 i1
sexp
i
i2
ssim
i
j
(18)
where n and m represent the number of strain ranges and a predetermined number of stress-strain data points throughout the
cyclic loading history, respectively, and sexp
and ssim
are the
i
i
experimentally measured and simulated stresses, respectively, at
pre-determined sample strains. This minimisation function was
used for calibration of both the CP and J2 continuum constants.
For the CP model, the isotropic hardening function ga and the
back-stress x1a are found to be sufcient for accurate calibration of
the cyclic response, or small-strain regime. It was found, however,
that an additional back-stress x2a was required to also achieve
satisfactory calibration of the tensile response, or large-strain
regime, while using one set of parameters for both tensile and cyclic
responses. Similarly for the J2 continuum model, the isotropic
hardening parameter r and the back-stresses x1 and x2 are used to
calibrate for cyclic behaviour, while the third back-stress x3 is used
p_
2
Lp : Lp
3
Zt
_
pdt
(19)
42
Fig. 9. Comparison of J2 continuum and CP stabilised hysteresis loops with the L605 experimental data for different applied strain ranges.
XZ
a
sa g_ a dt
(20)
g1
c2
g2
c3
g3
230 MPa
60 MPa
9
240 GPa
1846
50 GPa
250
2.7 GPa
0.55
"
D 1 1
N
Nf
1
1a
b1
(21)
where a and b are constants, identied to give the best t across all
strain ranges. Fig. 10(a) shows a comparison of damage curves from
Table 4
Calibrated CP constants for the L605 alloy.
g0
gN
h0
C1
D1
C2
D2
100 MPa
130 MPa
100 MPa
80 GPa
750
1.25 GPa
0.001
43
Fig. 10. (a) Comparison of curves for experimental data and the damage evolution relation and (b) predictions of Ni using pcrit and Wcrit in comparison with Ni data back-calculated
from experimental Nf data via use of the damage evolution relation.
44
Fig. 11. (a) 3D global stent-artery model, (b) schematic of change in stent diameter during applied loading history and (c) 2D micromechanical sub-model with 5-element unit
facilitating the inclusion of precipitates.
allowing uniform strain in the third dimension. Different realizations of random crystallographic orientations are used to
generate seven stent sub-model microstructures in order to simulate typical inhomogeneities observed in real stent microstructures.
For comparative purposes a separate sub-model analysis is carried
out using the J2 constitutive model, but without the precipitates, as
the J2 constitutive model was calibrated against the macroscopic
behaviour of the alloy, i.e. including the effects of precipitates.
The loading steps of Fig. 11(b) are applied in the sub-model via
displacement of a master node on the lower strut in Fig. 11(c).
Boundary conditions are applied to maintain periodicity of the submodel in the global stent structure; a more detailed description is
provided in previous work [26].
Two approaches are adopted for the fatigue assessment of the
stent sub-model. The rst is a microstructure-sensitive approach
for the prediction of number of cycles to FCI, Ni, in the CP sub-model
analyses via use of the p and W FIPs of Section 3.4:
Ni
pcrit precoil
;
pcyc
Ni
wcrit wrecoil
wcyc
(22)
where precoil and Wrecoil are values of the FIPs accumulated postrecoil, taking into account initial plastic deformation during the
stent installation process.
The second method, used here for comparative purposes, is the
industry standard approach for predicting the number of cycles to
45
fatigue failure, Nf. This total life approach uses a combination of the
Basquin HCF equation and the Goodman equation for mean stress
effects, typically used in stent design practices under the recommendation of the US Food and Drug Administration (FDA) [17]. The
combined equation is represented as follows:
"
Nf
Ds
#g2
C2 1 ssTSm
(23)
where Ds and sm are the maximum principal stress range and mean
maximum principal stress, respectively, for a stabilised cycle of
loading, sTS is the ultimate tensile strength of the L605 CoCr alloy
and C2 and g2 are Basquin constants calculated from HCF data for
the L605 alloy [4].
4.3. Results
Table 5 shows the microstructure-sensitive FCI predictions for
the L605 stent for all 7 microstructure realizations and for both pcrit
and Wcrit. The table also shows the Basquin-Goodman predictions
for total life. As the latter is traditionally applied to macroscale
results, which do not account for peaks due to microstructural inhomogeneities, a grain volume-averaging technique, described in
more detail in a previous study [26], is applied to Ds and sm, used in
Eq. (23), for the CP models. For comparative purposes these stress
values are averaged over the average grain volume for the J2 continuum sub-model. An average Basquin-Goodman total life of
6.43 1014 cycles with standard deviation (SD) of 1.58 1015 is
predicted for the CP sub-models, compared with a total life of
2.45 1016 cycles for the J2 sub-model.
The pcrit method predicts an Ni of 2.71 107 cycles
(SD 1.36 107) and the Wcrit method predicts an Ni of 3.48 107
cycles (SD 2.48 107). The predicted locations of microstructuresensitive FCI for both FIPs and all microstructure realizations are
shown in Fig. 12(b). Clearly, FCI is predicted to have a high probability of occurring along the inner radius of the top strut, the same
location at which failure is predicted to occur for the J2 continuum
sub-model, as shown in Fig. 12(a).
5. Discussion
5.1. Experiments
Quite a broad range of particle areas is observed embedded in
the L605 matrix, as seen from Fig. 2(b). Precipitate size can have
signicant inuence on the fatigue performance of a material; ne
precipitates that are coherent with the matrix can strengthen the
material behaviour and cause increased hardening, whereas coarse
precipitates, with incoherent precipitate-matrix interface, can act
as stress concentrators and may offer free surfaces conducive to
crack initiation [51,52]. The effects of both types of precipitates on
1
2
3
4
5
6
7
Ni (pcrit)
3.98
3.95
4.00
2.20
2.19
2.20
4.00
Ni (Wcrit)
7
10
106
107
107
107
107
107
3.90
2.35
7.73
3.12
1.20
3.11
5.10
Nf
7
10
106
107
107
107
107
107
Table 5
Nf and Ni predictions for the CP stent unit cell simulations.
Realization
Fig. 12. (a) Predicted site of fatigue failure for the J2 continuum sub-model and (b)
predicted sites of fatigue crack initiation for the CP sub-models.
1.16
4.07
7.09
6.37
2.73
1.18
4.22
12
10
1012
1011
108
1014
108
1015
46
are critical to the accuracy of the tensile calibration in the largestrain region of Fig. 8 for the micro and macro-scales, respectively. Omission of these terms gives errors of up to 55% in
macroscopic tensile stresses. Such a response would result in gross
underestimation of the amount of strain hardening and, thus, stress
magnitudes achieved during stent deployment. Under-prediction
of deployment stresses would result in reduced elastic recovery
predicted during recoil and, thus, an increase in predicted residual
stresses during stent fatigue.
The damage evolution law of Eq. (21) provides a method for
back-calculation of Ni from experimental Nf data. However, it can be
seen from Fig. 10(b) that using the critical FIP values, pcrit and Wcrit,
identied for the 0.5% strain range, the majority of Ni predictions
for the 1.2% strain range are longer than the experimentally
observed number of cycles to failure. In Fig. 10(a), the least correlation exists between the experimental and calculated damage
evolution curves for the 1.2% strain range, particularly at D Dc. In
fact, the experimental damage curve for the 1.2% strain range
indicates that FCI occurs almost immediately before fatigue failure,
as is predicted using the CP simulations of Fig. 10(b). It should also
be noted that use of the damage evolution law of Eq. (21) to
calculate Ni at a constant critical damage Dc results in a constant
ratio of Ni/Nf across all strain ranges. A previous study, which describes use of an ultrasonic method for detection of cracks between
the range of 30e110 mm in notched L605 fatigue specimens [3],
reported that the Ni/Nf ratio increases with decreasing fatigue life
for the L605 alloy. This supports the CP predictions of Fig. 10(b) for
the higher strain ranges, where Ni is predicted at larger numbers of
cycles than is predicted by the damage evolution law.
5.3. Stent fatigue simulations
The FDA recommends that stents are designed to have a minimum operational life of 10 years or approximately 4 108 cycles.
Both the traditional J2 continuum approach and the average CP submodel response predict total stent fatigue life several orders of
magnitude greater than the FDA minimum requirement. In previous work [26], for an identical geometry, CP analyses for a 316L SS
stent predicted an average fatigue life of 7.27 108 cycles,
compared to an average total life of 6.43 1014 cycles for the L605
CP sub-models. The contrast in performance of the two materials
illustrates that, while the generic stent design is suitable for the
316L SS material, it is a highly conservative design for the L605
alloy. Therefore, the stent geometry could be modied, for the L605
alloy, to improve design efciency. To investigate this, additional
L605 analyses were carried out for a modied stent geometry,
where the stent strut cross-section was reduced by 20 mm in each
dimension. The results are compared in Fig. 13 with predictions for
the original stent geometry and with 316L predictions from previous work [26]. The bar chart of Fig. 13 shows the average predictions for CP sub-model analyses, with error bars marking the
range of data and FDA minimum required Nf shown. At 1.28 1012
cycles, the average total life predicted for the L605 thin strut geometry is two orders of magnitude lower than for the original geometry. However, this total life remains several orders of
magnitude higher than the FDA recommended minimum total life,
indicating that the thin strut design remains over-conservative.
Therefore, according to the predictions of Fig. 13, a further reduction in strut cross-sectional area could be adopted for the L605
stent geometry, while still attaining acceptable fatigue performance. Thinner struts are highly desirable in stent geometries due
to increased exibility and reduced restenosis rates [1]. It is
important to note, however, that the analyses carried out in this
study do not investigate strut necking during the installation process, which may also limit the stent design [13e15].
Fig. 13. Averages and scatter in total life and FCI predictions for the L605 thin strut and
normal strut sub-models and for a 316L normal strut sub-model.
the J2 continuum model was calibrated for cyclic behaviour only, i.e.
neglecting the large-strain monotonic hardening, the predicted
location of Nf would be along the outer radius of the lower strut.
Simple beam bending theory indicates that this region experiences
cyclic compression, which is not conducive to cracking. This illustrates the importance of accurate calibration of constitutive models
against both monotonic and cyclic plasticity responses.
Fig. 14 has been constructed to assess the effect of crystallographic orientation on FCI predictions. The maximum Schmid factors with respect to the y-direction (the direction of loading applied
to the lower sub-model strut) are plotted for every grain in the
original L605 stent sub-model, across all seven crystallographic
orientation realizations. Maximum Schmid factors for grains in
which FCI is predicted to occur are clearly marked. The graph
generally shows a trend for FCI to occur in grains with high
maximum Schmid factors. Interestingly, the most noticeable outlier
in this trend (the pcrit prediction for realization 6) is the only case
for which FCI is predicted to occur in a grain along the outer radius
of the lower strut, a region in which x-direction loading is likely to
be signicant, compared with y-direction loading. Therefore, the
maximum Schmid factor relative to the principal loading direction
for this grain may be higher than shown and, consequently, may be
in line with the general trend.
The present paper has employed, for illustrative purposes, a 2D
stent sub-model. Aside from the stiffer response of a 2D model, the
out of plane loading experienced by the stent while installed in a
blood vessel is neglected; this may affect the fatigue lives predicted.
Clearly, an important next step, albeit computationally onerous, is
the development of a 3D micromechanical stent sub-model.
Limited comparisons are provided in the literature between
computational methods for assessing stent performance and
experimental data. Those that do carry out comparisons are
generally concerned with monotonic loading of the stent only
[60,61] or patient-specic cases [20,62]. Therefore, experimental
validation of the micromechanical methodology for assessment of
stent fatigue design is a key future objective.
6. Conclusions
A micromechanical framework for the fatigue behaviour of a
biomedical grade CoCr alloy has been presented, including realistic
microstructure geometries, a crystal plasticity constitutive model
Fig. 14. Maximum Schmid factors relative to the y-direction for each grain in the L605
NIR sub-model, for all seven realizations of crystallographic orientation. Maximum
Schmid factors of grains for which FCI has been predicted using the p and W FIPs are
marked.
47
48
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