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Medical Device Materials II (#05107G)

High Strain Accelerated Fatigue Failure Testing of NiTi Implantable Devices


B. Shuman, C. Finger
Spiration Inc, Redmond, WA
Ken Perry
EchoBio, Bainbridge Island WA

Abstract Introduction

Accelerated testing, using frequencies higher than clinically Medical device implants experience cyclic strains resulting
observed, has been used to reduce time and cost of fatigue from the in-vivo conditions in which they are implanted.
testing. Unfortunately, changes in a device design or Accelerated fatigue testing is commonly used to determine the
manufacturing process may require repeating fatigue testing to fatigue resistance of a medical device design and, by
show that the change does not adversely affect the specified definition, utilizes frequencies higher than clinically observed.
device lifetime. These tests usually subject the test samples to clinically
OBJECTIVE: There were three main objectives of this study: equivalent strains and take weeks to complete. The results
To test implantable Nitinol (NiTi) devices in an accelerated typically show if a design “passes” the specified fatigue life
fatigue failure test at frequencies and strains higher than seen rather than showing what the fatigue life of the design actually
clinically; To investigate the use of this testing to decrease is or how it compares to fatigue life of other designs. The
fatigue testing time; To investigate the use of higher strains as objective of this study is to investigate the use of accelerated
a screening tool for design or processes that may affect fatigue fatigue testing in combination with strains higher than
lifetime. clinically observed. The study includes the investigation of
METHODS: Different groups of NiTi devices were built with optimal mean and alternating fatigue strains for use in
different processing parameters. Quality of electropolish, generating fatigue data used to discern the difference between
radius of curvature and pre-test strain were varied and tested different designs or processes. Fatigue life curves are
against a control group to obtain fatigue lifetime or Strain- generated for samples from the different designs and processes
Number of cycles to failure (S-N) curves. The resulting S-N and compared to determine if the groups have different fatigue
curves were generated for each group of data. The S-N curves lifetimes.
were overlaid to determine the relative difference in fatigue
life between a test group and its control group. Methods:
RESULTS: The divergence of the two fatigue lifetime (S-N)
curves reveals which processes or designs produce devices Testing was performed on NiTi anchors of the Spiration®
with longer fatigue life. For certain testing groups, optimal Intra-Bronchial Valve (IBV™) Device shown in Fig. 1
fatigue testing strain values can highlight the differences (www.spirationinc.com). These devices are intended to be
between groups better than other fatigue testing strain values. used in human airways to block the flow of air to diseased
Accelerated high strain testing produced results in 1 day of areas of the lung tissue.
testing while clinically equivalent strain testing took 28 days. The samples tested were processed with different properties.
CONCLUSIONS: High strain fatigue testing can produce Quality of electropolish (EP), radius of curvature and pre-test
relevant fatigue data much faster than testing at clinically strain were varied to obtain different testing groups. Each
equivalent strains. Optimal strains for determining the group was fatigue tested along with a control group to obtain a
difference in fatigue life between processes or designs can be fatigue lifetime curve.
determined by overlaying the S-N curves for two or more
groups of samples. Future design and process changes or
improvements can be tested using an optimal alternating strain
based on the divergence of the S-N curves. The results of the
testing could be used to determine if the new design or process
has compromised the fatigue lifetime of the device.
© 2005 ASM International. All Rights Reserved. www.asminternational.org
Medical Device Materials II (#05107G)

Fatigue Testing the IBV devices:

Testing was performed using a high frequency linear motor


and custom data acquisition software. The samples were
fixtured such that the anchor tip aligned with and was parallel
to the axis of movement. Each anchor rested against one of
ten actuator pads that were fixed to the motor. Electrical
current was run through the anchor and actively monitored to
determine when the sample had failed. Figure 3 shows how
the devices were fixtured against the actuator.

Figure 1: The Spiration® Intra-Bronchial Valve (IBV™). The Figure 3: Test setup showing 10 different devices being tested
arrow points to one anchor
Preliminary testing was performed to determine the optimal
Range of deflection and strain test frequency, mean strain and alternating strain. Tests were
The mean fatigue strains were chosen to mimic in-vivo mean run at different frequencies while contact between the part and
strain as closely as possible. Figure 2 below shows a section actuator was monitored. The contact between the sample and
of the force-deflection curve of the IBV Device that was the actuators was verified in two ways. First the voltage
chosen for the operating range of fatigue testing. across the part was monitored. If the voltage was erratic, then
the sample was jumping off of the actuator pad. Second, a
strobe light was used to confirm that the samples were actually
moving at the designated frequency. If the anchor was not
Force-Displacement Curve contacting the actuator, the frequency was faster than the
response frequency of the sample, and was reduced.
0.0006 Fatigue testing was then performed by cycling samples at
various mean and alternating deflections in 37 ºC air at 40 Hz.
0.0005
Relative Force

1 Optimal mean and alternating strains were determined based


0.0004 on the differences between the S-N curve of the test groups.
2
0.0003 Using the optimal testing parameters, tests were performed to
3 determine the sensitivity of the test method. Test sensitivity
0.0002
4 was determined by testing groups that were hypothesized to
0.0001 have different fatigue lifetimes, but had no observable
0 difference in surface characteristics under SEM.
0 0.5 1 1.5 Finally, the relative difference in fatigue life between the
sample groups and their control groups was tested.
Displacement (mm)
Results and Discussion
Figure 2 Force deflection curve for the fatigue test, N=4.
Actual force values were removed for proprietary reasons Samples that were EP and samples that were not EP processed
had significant differences in surface characteristics under
An FEA model was used to relate the fatigue testing SEM. However, samples with different pre-test strain could
conditions to the estimated material strains. Based on the FEA not be differentiated under SEM.
and material tensile tests the fatigue test deflections resulted in
strains spanning between the austenite and martensite phase of
the material. Therefore, a non-linear FEA solver, ABAQUS,
was used.
© 2005 ASM International. All Rights Reserved. www.asminternational.org
Medical Device Materials II (#05107G)

The samples from the pre-test strain group were strained to


7% for 5 cycles prior to fatigue testing. The control group was
strained to 7% once prior to fatigue testing. When the pre-test
strained samples were fatigue tested, they lasted longer than
the control group. The differences are more detectable at
higher alternating strains and less detectable at lower
alternating strains as shown in Fig. 7.

2.0%
1.8%

1/2 Amp. Alt. Strain


1.6%
1.4%
Figure 4. SEM image representing all Electropolished 1.2%
sample, both pre-test strained and non-strained samples 1.0%
0.8%
0.6%
0.4% Control
0.2% Pre-Test Strained
0.0%
1E+3 1E+4 1E+5 1E+6 1E+7 1E+8
Cycles to failure

Figure 7. S-N curves for Pre-test strained (strained 5 times)


samples versus control samples (strained once). Open
markers indicate samples that did not fail.

Statistically, the groups were indistinguishable at lower


strains, however, at high ½ amplitude alternating strains
(1.7%), the T-test p-value was 0.03. Thus, the results of the
test sensitivity testing showed that the test was sensitive
enough to show a difference in fatigue life when SEM
Figure 5. SEM image of a sample that was electropolished ½ observation could not. This conclusion was based only on the
the normal time more conservative, low cycle fatigue data. The apparent bi-
modal behavior of this group of data was not investigated.
Testing the Effect of Bend Radius
Testing was performed on samples that had a slightly different
geometry. The geometrical difference was related to the bend
radius of the part at location of the highest strain. It was
hypothesized that the geometry could be correlated to fatigue
resistance due to differences in strain concentrations. The
data, which was acquired at an effective mean strain of 1.4%
and an effective ½ amplitude alternating strain of 1.4%, is
displayed in Fig. 8.

Figure 6. SEM image of sample without electropolish


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Medical Device Materials II (#05107G)

Fatigue life of different radius IBV anchors S-N Curve for EP vs 1/2 Time EP and no
vs. Bend Radius EP
2.0%
2.53

1/2 Amp. Alt. Strain


2.03 1.5%
Radius (mm)

1.53
1.0%
1.03
0.53 0.5% EP
0.03 1/2 EP
No EP
1000 10000 100000 0.0% Series3
Cycles to failure 1E+3 1E+4 1E+5 1E+6 1E+7 1E+8
Cycles to Failure (n)
Figure 8. Regression analysis of bend radius and cycles to
failure, R2<0.01 Figure 9. S-N curve for EP, ½ time EP and No EP devices.
Open markers indicate samples that did not fail.
The results of this data show no correlation between bend
radius and cycles to failure. Prior work1 2 3 4 has shown Electropolishing has been shown to reduce micro cracking
martensitic phase transformation to increase fatigue resistance thus it was expected that the fatigue life would increase
under certain circumstances. It is possible, however not significantly. Accordingly, Fig. 9 shows the difference in
investigated here, that the decreased bend radii increased fatigue resistance between devices that were electropolished
fatigue resistance by inducing local martensitic phase and devices that were not. The difference in fatigue life is
transformation at the point of highest strain. Strain induced shown at different alternating strains. The difference between
martensite may play a more significant role in increasing the samples that have been electropolished for ½ the amount of
fatigue life of samples with a smaller radius. Samples with a time as the EP group can also be differentiated, however, the
larger radius do not have the martensite advantage, however, results are more ambiguous at higher strains.
they have less strain. Martensite strain transformation could
be “leveling the playing field”. The S-N data shown in Fig. 9 was used to test other groups of
non-EP samples at the optimal ½ amplitude alternating strain
Testing the Affect of Electropolish of 1.1%. Figure 10 shows the relative difference in fatigue life
Preliminary testing was performed to determine the optimal between three groups of samples using an effective ½
mean and alternating strain that would best discern the amplitude alternating strain of 1.1% and a mean strain of
differences between electropolished and non-electropolished 2.7%.
sample groups. High alternating strains and low mean strains
resulted in larger differences between the groups. This is
likely due to the geometry of the IBV device. Therefore, an
effective mean strain of 2.7% was selected for the fatigue 2E+4
Cycles to failure (n)

testing. p=0.004
p=0.006
The next set of testing was run at the selected mean strain 1E+4
while the alternating strain was varied for three groups: EP, ½
time EP and no EP samples. Figure 9 shows the resulting S-N
curve for the three groups of data. 5E+3

0E+0
Non-EP EP Non-EP 2

Figure 10: Summary of fatigue life for electropolished


samples versus two different non-electropolished sample
groups. Error bars represent 1 standard deviation. N=6 each
group
© 2005 ASM International. All Rights Reserved. www.asminternational.org
Medical Device Materials II (#05107G)

Fig. 9 contains more information about the different sample References:


groups than Fig. 10, however, selecting one alternating strain
1
allows testing to be more concentrated and statistically Harrison WJ, Lin Z.C.: The Study of Nitinol Bending
significant. Thus, Fig. 10 shows with statistical significance Fatigue, SMST 2000, 391
that the fatigue life of the IBV device is superior after an EP
2
process. This data took 1 day to acquire while a clinically Pelton A., Gong X, Duerig T.: Fatigue Testing of Diamond-
equivalent strain test would have taken 28 days. Furthermore, Shaped Specimens, SMST 2003, 293
the clinically equivalent strain test would have likely resulted
3
in no failures, making it even more difficult to understand the Morgan N.B., Painter J., Moffat A.: Mean Strain Effects and
differences in fatigue lifetime between the groups. Microstructural Observations During In-vitro Fatigue Testing
of NiTi, SMST 2003, 303
4
Conclusions Tabanli R, Simha H, Berg B,: Mean stress effects on fatigue
of NiTi, Material Science and Engineering A273 (1999) 644
Sensitivity evaluations shows that this testing can more
accurately discern the difference between samples that have a
reduced fatigue life and samples that do not when compared to
SEM surface analysis.
The results of different radius of curvature testing shows that
different radius of curvatures do not correlate to fatigue life
for the range of radii tested.
These results show that samples not electropolished or with
poor electropolish finish have a significantly reduced fatigue
life.
Finally, this work has shown that high strain fatigue testing
can be used as a screening tool to screen designs quickly.
Different geometry or radius of curvature, different amounts
of electropolish or different amounts of pre-test strain are
examples of designs or processes that can be quickly evaluated
for their affect on fatigue life.

Recommendations

These methods were not validated to clinically relevant


conditions, therefore it is recommended that validation of
these methods be completed prior to extrapolating results to
clinically relevant conditions.
It is also recommended that future work include measurement
or control of internal sample heating to understand and
account for this affect on fatigue life or strain. However, the
sample groups in this study were tested at the same boundary
conditions, thus, it is not likely that the high testing frequency
affected the conclusions.
This work shows that applied fatigue testing can be performed
on medical devices without lengthy testing. Using this
method of determining the sensitivity of a test and the
resulting fatigue characteristics of different designs and
processes, the design time can be reduced by ruling out
processes and designs that reduce fatigue life. This method of
testing can also be used as a quality tool to periodically check
the fatigue resistance of manufactured product.

Acknowledgments:
Thanks to the Spiration team including Tim Zilinsky, Seung
Yi, Lyle Jackson, Randy Walls, and Mitch Reynolds for their
support
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applications of metals and materials.

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