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Medical Device Materials II (#05107G)
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)
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
2.0%
1.8%
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
1.53
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
Recommendations
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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