International Materials Reviews

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Fatigue and fracture of wires and cables for

biomedical applications

J. L. Gbur & J. J. Lewandowski

To cite this article: J. L. Gbur & J. J. Lewandowski (2016): Fatigue and fracture of
wires and cables for biomedical applications, International Materials Reviews, DOI:
10.1080/09506608.2016.1152347

To link to this article: http://dx.doi.org/10.1080/09506608.2016.1152347

Published online: 11 May 2016.

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 FULL CRITICAL REVIEW

Fatigue and fracture of wires and cables for

biomedical applications
J. L. Gbur and J. J. Lewandowski∗
Fine wires and cables play a critical role in the design of medical devices and subsequent
treatment of a large array of medical diagnoses. Devices such as guide wires, catheters,
pacemakers, stents, staples, functional electrical stimulation systems, eyeglass frames and
orthodontic braces can be comprised of wires with diameters ranging from 10s to 100s of
micrometres. Reliability is paramount as part of either internal or external treatment modalities.
While the incidence of verified fractures in many of these devices is quite low, the criticality of
these components requires a strong understanding of the factors controlling the fracture and
fatigue behaviour.1,2 Additionally, optimisation of the performance and reliability of these devices
Downloaded by [Laurentian University] at 08:38 14 May 2016

necessitates characterisation of the fatigue and fracture properties of its constituent wires. A
review of cable architecture and stress states experienced during testing is followed by an
overview of the effects of changes in material composition, microstructure, processing and test
conditions on fracture and fatigue behaviour of wire and cable systems used in biomedical
applications. The review concludes with recommendations for future work.
Keywords: Biomedical wires/cables, Nitinol, Stainless steel, Wire fatigue, Microstructure, Silver-cored wires/cables, Fatigue modelling

Introduction nor be susceptible to corrosion.20 Reported electrode-

Minimally invasive surgeries coupled with advancing bio-
medical technologies have led to an increased demand for
fine wires and cables in the design of medical devices.
Guide wires, catheters, cardiac leads, stents, staples, func-
tional electrical stimulation (FES) systems, eyeglass frames
and orthodontic braces are just a sampling of the devices
that are manufactured with wire diameters ranging from
10s to 100s of micrometres.2–18 Medical device reliability
and performance is critical to the successful treatment of
the particular pathology as well as patient safety. Further-
more, a firm understanding of the factors controlling the
fatigue and fracture behaviour of the device and its con-
stituents is paramount for the design and optimisation of
these devices.
Implanted devices will necessitate different require-
ments on the wires/strands/cables depending on the
location in the body and function of the device. Neuro-
prosthetic systems can target multiple muscle groups
spanning a large area within the body that may or may
not need to cross joints imposing more severe stress states
than those experienced in cochlear implants or pace-
makers.19 In the case of implantable electrodes, the opti-
mised design would be flexible enough to withstand the
stresses and strains imposed by the surrounding tissues
while possessing suitable strength.20 Furthermore, the
lead wires would not illicit an inflammatory response
Department of Materials Science and Engineering, Case Western Reserve
University, Cleveland, OH 44106, USA
∗
Corresponding author, email JJL3@case.edu
lead mechanical fractures have been attributed to fatigue
of the part (repeated pressure on device),19,21 implan-
tation procedures20 and explantation procedures.20
While much of the fatigue testing and data reported
in the literature focuses on single wires and
strands,2,4,10–12,14,22–70 many biomedical applications
rely on varying assemblies of wires in coiled strands and
cables.7,8,30,71,72 A review of relevant references on cable
architectures and cable mechanics are provided in
order to illustrate the stress states involved with the
more complex geometries found in multi-wire, multi-
strand applications such as pacemaker leads and neurosti-
mulator leads. Expressions for stresses under axial and
bending conditions are presented. References to more
detailed analyses on additional stress states are also
provided.
A variety of test techniques have been developed to
characterise the fatigue properties of wires and cables.
Wire fatigue tests reported in the literature for use in eval-
uating biomedical materials such as alternating bending
testing,29,30,39,62,63 axial fatigue testing,25,33,36,37,42,44,56,72
flex bending fatigue testing,4,10,11,34 pulsatile fatigue
testing,29,39,63,67 rotating bending testing2,7,8,12,14,22–24,26–
32,35,38–41,43,45–55,57–61,63–70
and unidirectional bend
testing71 provide information on the cycle life of these
wires/strands/cables/coils under a variety of stress/strain
conditions. A summary of these techniques as well as
the relative advantages and disadvantages are discussed.
There are additional wire/strand/cable/coil evaluation
techniques that are used in other industrial applications

© 2016 Institute of Materials, Minerals and Mining and ASM International

Published by Taylor & Francis on behalf of the Institute and ASM International
Received 13 September 2014; accepted 5 February 2016
DOI 10.1080/09506608.2016.1152347 International Materials Reviews 2016 1
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications
including double pulley fatigue testing,73 pulley plunger
fatigue testing,74 three-roll fatigue testing,75,76 torsional
fatigue testing77 as well as numerous nondestructive test-
ing methods.78–81
Many of the medical devices under consideration are
implanted in the body with service lives extending into
decades in some applications,82,83 leading to unique
environmental conditions and material demands. Selected
materials need to exhibit high biocompatibility, resistance
to corrosion and provide the necessary balance of
strength, ductility and fatigue resistance for a particular
application. Some common materials used in biomedical
wires and cables include stainless steels,2,7,8,11,14,27,34,40,43,
44,58,60
metal composites2,10,31,58,60,71 and Nitinol
(binary4,22,24–29,32,33,36–39,41,42,44–57,59,61–70,72 and other
alloys26,28,41,44). The review of the literature includes the
aforementioned materials in addition to cobalt–chro-
mium–nickel alloys2,4,8,12,23,30,35,60,71 and titanium
alloys.43,44 As most of these systems are produced via
deformation processing (e.g. wire drawing), a brief review
of the microstructures present in the as-processed wires/
cables is provided, when documented in the literature.
The fatigue data of biomedical wires and cables
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obtained from the literature are arranged according to
material and cable architecture and presented as cyclic
strain vs. life plots or cyclic stress vs. life plots, as reported
in the original references. The data has also been replotted
to provide consistency in the presentation. Effects related
to material processing, material cleanliness, test con-
ditions and cable architecture on the cyclic life of the
wires/strands/coils are provided.
A discussion of available modelling and fitting tech-
niques for conventional cyclic strain/stress life model-
ling/fitting techniques is included. Several examples are
provided where such approaches have been used to
demonstrate the factors contributing to the cyclic life of
such systems. Additionally, brief coverage of the appli-
cation of finite element modelling and analysis of selected
fatigue test methods is discussed. Fractographic obser-
vations on failed wires/cables are provided and discussed
in the light of the material chemistry, cleanliness,
1 Common cable architectures may begin with a DFT or b single solid wire, then combine to form c 1 × 7 strand, d seven-strand
(7 × 7) cable and e IWRC multi-strand cable85
2 International Materials Reviews 2016
processing, microstructure, applied stresses/strains and
cable architectures documented in the literature. The
review closes with a brief discussion of areas that could
benefit from additional work.
Cable architecture
The geometry of a cable, its constituents and their respect-
ive spatial arrangements contribute significantly to the
mechanical behaviour of the system depending on the
stress state experienced in the application.84,85 As such,
cable architectures and terminologies are first reviewed.
A cable or rope consists of strands containing wires,
thereby providing the structure with redundancy and pro-
moting the distribution of damage in individual wires
throughout the strand. However, cable architectures can
predispose the system to internal wear between wires,
related to the layout of the wires and respective contact
points.86–88 The standard specification, ASTM F218089
for implantable strands and cables, outlines the dimen-
sional tolerances, architecture and mechanical require-
ments for these devices.
A strand is typically composed of a particular number
of wires wound about a central, straight wire in helical
fashion producing a cable. The construction of the cable
is described by an M × N designation wherein the M rep-
resents the number of strands present in the cable and the
N is equal to the number of wires in each strand.89
Examples of cable architecture cross-sections are illus-
trated in Fig. 1a–e.
A drawn filled tube (DFT), generally composed of a
softer core material with excellent conductive properties
and a stronger outer shell providing adequate strength
for the composite wire, is shown in Fig. 1a. The DFT
wire (Fig. 1a) or a single, solid wire (Fig. 1b) can serve
as a basis for building strands such as those shown in
Fig. 1c–e. For the example in Fig. 1c, six wires are heli-
cally wrapped around a single, straight, ‘king’ wire produ-
cing a 1 × 7 strand. The 1 × 7 (or other) strands can be
further combined with additional strands to create a
seven-stranded cable with a main core. This configuration
 Gbur and Lewandowski
2 Examples of cable architectures in the a right-handed ordinary lay, b left-handed ordinary lay, c right-handed Lang’s lay, d
left-handed Lang’s lay and e right-handed alternating lay85
results in a single helix for the outer wires in the core
strand and a double helix in the outer strands (Fig. 1d).
In this example, since seven 1 × 7 strands are combined,
the cable architecture is denoted 7 × 7. Additional
strands wrapped around the seven-strand (i.e. 7 × 7)
produces the independent wire rope core (IWRC) shown
in Fig. 1e.85
Layers within the rope can be arranged in a number of
helical configurations, termed the ‘lay’. The lay can affect
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the internal wear of the structure at the wire contact
points and angles where the wires are oriented relative
to each other (Fig. 2). The lay refers to this orientation
and may be right-handed (clockwise, Fig. 2a, c and e)
or left-handed (counter-clockwise, Fig. 2b and d). The
wires may also be ordinary (wires lie in opposite direction
of strands, Fig. 2a and b), Lang’s (wires lie in same direc-
tion as strands, Fig. 2c and d) or alternating in direction
(Fig. 2e) for a distance of one complete rotation denoted
the lay length.85–87,90
The length of the lay or pitch refers to the distance par-
allel to the axis in which a component (wire or strand)
makes one complete revolution about the axis.90 In
addition to the lay, the wires/strands/cables may be coiled.
In Fig 3a, a single wire is helically wound and illustrates a
difference in pitch angles along the length of the coil. The
wires may also be interleaved with each other in the helix
creating a multifilar coil, Fig. 3b.
Lay orientations can have an effect on the perform-
ance of the cable due to the local mechanical interactions
between the wires and strands. Localised bending,
rotation, friction and wear between these members in
addition to the relative contact angles all have a role in
the mechanical performance and fatigue response of
the system and become increasingly important as
damage accumulates (i.e. individual wires fracture)
during tension–tension fatigue.85,87 Costello and
Miller91 provide detailed mathematical treatments for
the static responses of different wire orientations within
the cable while summaries provided in the following sec-
tion have also been used in devising suitable test tech-
niques in evaluating the fracture and fatigue
performance.
3 Helical coils illustrating a different pitches and b a multifilar arrangement
Fatigue and fracture of wires and cables for biomedical applications
Single layer, helically wound wires or strands placed
under tension may become unwound if a torsional
restraint is not placed on the system. This may lead to a
range of problems from simple inconvenience to strand
hockling (i.e. formation of a loop under modest tensile
stress) or kinking.90,92 A significant loss of tensile strength
and fatigue performance can occur following the re-ten-
sioning of strands that have undergone hockling.92 In
standard six and eight strand systems, the torques pro-
duced by the outer stands and IWRC are in the same
direction and therefore additive, while rotation-resistant
systems are manufactured with the outer strands in the
opposing direction to the inner strands, producing oppos-
ing torques.90 Minor to severe loss of mechanical strength
and torsional stiffness91 as well as diminished fatigue per-
formance may result following such effects especially if
the stress is relaxed and then re-applied. The ability of a
cable to resist exterior pressure without distortion in its
respective cross-section, strands, or core is its crush resist-
ance and an ordinary lay possesses higher crush resistance
compared to Lang’s lay.90 Lang’s lay provides greater fati-
gue and abrasion resistance90 however it is contraindi-
cated for applications where the ends are free to rotate
while under tensile stress.91 Chaplin et al.92 compared
right lay-ordinary lay ropes to right lay-Lang’s lay ropes
and found that the ordinary lay ropes performed better
under tensile stress, becoming stiffer as the wires tighten
within the strand. General property/performance trends
include: abrasion resistance improves with fewer, larger
diameter outside wires per strand and fatigue resistance
improves with greater number of smaller diameter outside
wires per strand.90 Work by Lee85 investigated the geo-
metric properties of rope helices and developed math-
ematical modelling techniques to relate the wire
curvature and torsion to the bending stresses of single,
double and triple helical IWRC rope systems in ordinary
lay and Lang’s lay. Some findings from the work indicate
that in a double helix system the location of maximum
curvature and minimum torsion correspond to a mini-
mum helix angle in Lang’s lay configuration85 and a maxi-
mum helix angle in an ordinary lay configuration. The
triple helix system showed a smaller magnitude of
International Materials Reviews 2016 3
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

curvature and subsequent lower bending stresses in the ratio is ν, and the angle of twist per unit length is defined
ordinary lay compared to the Lang’s lay while the tor- by τs.
sional stresses in the Lang’s lay are less varied and sub- Expressions for the total axial force F and total axial
jected to more twisting than the ordinary lay.85 twisting moment Mt acting on the strand can be expressed
as84
F = F1 + F2 (5)
Review of cable mechanics theory
Mt = M 1 + M2 (6)
Many medical devices and other structural systems
require the use of multi-strand cables. This is particularly Stresses caused by these forces and moments can be calcu-
true in implantable electrode applications.1,19,20,71 The lated using the expressions below with the assumption
mechanics of cables are extensively covered in the Theory that the wires are initially stress free84
of Wire Rope by George Costello84 and an overview of the
F1
basic mechanics for a simple strand are noted in the fol- F s1 = (7)
lowing section.84 A full treatment of the static response pR21
of strands and cables along with the development of fric- Axial stress in center, straight wire
tion effects can also be found in Costello’s aforemen-
tioned work.84 Additionally, a complete derivation for 2M1
M s1 = (8)
the behaviour of coiled systems and validation via finite pR31
element analysis can be found in the work by Meagher
and Altman.1 Brief summaries are provided below while Maximum shearing stress on cross section of center,
details can be found elsewhere.40,88,93,94 straight wire
T2
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T s2 = (9)
pR22
Axial response of a strand
The geometry for a simple strand is composed of a centre Axial stress in outer wires due to load T2
wire having a radius R1 large enough that the number of ′
4G2
outer wires m2 with radii R2 do not touch each other. A G ′ s2 = (10)
series of expressions have been developed for a simple pR32
straight strand subjected to an axial force and twisting Maximum normal stress in outer wires due to bending-
moment taking into account the equilibrium equations, moment G′ 2
bending moments and twisting moments detailed
elsewhere.84 2H2
H s2 = (11)
The total axial force F2 and the total axial twisting pR32
moment M2 acting on the outer wires of the strand can
be expressed as84 Maximum shearing stress in outer wires due to twisting

 momentH2
′
F2 T2 N2
= m2 sin a2 + cos a2 (1) Bending response of a strand
ER22 ER22 ER22

Consider an initially straight strand subjected to a bend-
M2 H2
′
G2 ing moment Mb by bending over a radius ρ or cycling
= m 2 sin a 2 + cos a2 through a radius ρ as shown in Fig. 4.
ER32 ER32 ER32
Neglecting friction, the strand can be considered as a
 (2)
′ group of helical springs and therefore the bending stiff-
T 2 r2 N r2
+ 2 R
cos a2 − 22 sin a2 ness of the straight strand A∗ has been approximated
ER2 2 ER2 R2 by the bending stiffness of each wire in the strand
In equations (1) and (2), the following variables are rep- where Mb is the total bending moment applied to the
resented: modulus of elasticity E, radius of m2 helical strand.84
 
wires surrounding the central straight wire R2, tension pE 2m2 sin a2 4 1 A∗
T2, initial helix angle of an outside wire α2, shearing Mb = R 4
+ R = (12)
4 (2 + ncos a2 )
2 2 1
r r
force in y-direction N′, twisting moment H, bending
moment in y-direction G′, and initial radius of the helix Equation (12) is valid if the outer wires of the strand are
of the outside wire r2.84 not touching each other.84
The axial force F1 and the axial twisting moment M1 Maximum stresses in the outer wires of a simple strand
acting on the centre, straight wire within the strand can under bending stresses due to bending moments G2 and
be expressed as84 G2’ and twisting moment H2 are provided by equations
(13)–(15).84
F1
= pj1 (3) 4ms
ER21 G s2 = cos k2 s (13)
pR32
M1 p
= R1 ts (4) Maximum normal bending stress due to G2
ER1 4(1 + n)
3

4ms
where the axial strain in the centre wire is represented by G ′ s2 = sin a2 sin k2 s (14)
j1 , the radius of the centre straight wire is R1, Poisson’s pR32

4 International Materials Reviews 2016

 Gbur and Lewandowski
4 Single strand bent (or cycled) through a radius ρ
Maximum normal bending stress due toG′ 2
2ms
H s2 = cos a2 sin k2 s
pR32
Maximum shearing stress due toH2
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The calculations for k2 and the bending moment in the
outer wires ms are defined in equations (16) and (17),
respectively.84
cos a2
k2 =
r2
p R42 E sin a2
ms =
2r(2 + n cos2 a2 )
Equation (18) is used to determine the maximum nor-
mal stress occurring at a given cross-section.84
4ms
m s2 = Occurs at s = 0, s = p(r2 /cos a2 ), . . . ,
pR32
Most importantly, the centre wire is subjected to pure
bending stresses. The maximum bending stresses on the
centre wire are given by equation (19).84
ER1
m s1 = (19)
r
The maximum bending stress occurs in the centre wire
if it (i.e. core) is larger than the outer wires because the
helix angle associated with the outer wires produces
decreased stiffness and lower stresses in the other wires
compared to the centre wire.84
Contact stresses
Contact stresses may occur between the wires within a
strand, between adjacent strands or between the centre,
core wire and the outer, surrounding wires. The line of
contact between the centre straight (i.e. coil) wire and out-
side wires of a simple strand is a helix. Contact stresses
can be estimated if the contact force per unit length is
known, as shown elsewhere.84,88 Descriptions of how
interwire contact influences the mechanical behaviour
can be found in works by Casey and Lee87 and the US
Navy88 and schematics depicting the types of failure are
discussed in ‘Microstructures and fractography’ section.
Fatigue and fracture of wires and cables for biomedical applications
5 Composite coil (DFT) schematic illustrating loading via
rotating through a radius of curvature ρ
Bending response of a coil
Coiled wires/strands are typically produced by plastic
(15)
deformation of a wire/strand wound around a mandrel,
thereby producing a coil. Coiled systems like that shown
in Fig. 5 provide additional flexibility and can be
stretched axially to elongations that exceed that possible
with a single, straight wire or cable. The calculation of
stress in a helical coil is of particular interest with the
development of composite wire and coil for cardiac and
(16)
neuromuscular applications.1,2,19–21,71
Stress calculations for coiled systems were detailed by
Meagher and Altman1 and Altman et al.2 and full deri-
(17)
vations can be found in their respective works. In the
rotating bending of coil through a radius ρ (or bending
over a mandrel of radius ρ) like that shown in Fig. 5,
the peak stresses σx are given by equation (20).2
Ed
sx = (20)
2r
(18)
In equation (20), the modulus of elasticity E and the
wire diameter d are divided by twice the radius of curva-
ture ρ. Rotation of the bent wire around a radius of curva-
ture leads to the same alternating stress cycle (peak
tension, peak compression) encountered by all regions
about the circumference of the sample.2
Figure 5 details a composite coil (DFT) in a rotating
bending configuration. The DFT coil is composed of
wires consisting of an inner core (e.g. Ag, Au, etc.) sur-
rounded by a biomedically inert alloy (e.g. MP35N, etc.)
outer core that is produced via wire drawing.2 Noted in
Fig. 5 are the inner and outer diameters d1 and d2 of the
DFT coil and the orthogonal components of the applied
bending moment M about a radius ρ. By geometry, the
orthogonal bending components Tθ, MR and MZ are
defined by equations (21)–(23).2
Tu = M sin u cos g (21)
MR = M cos u (22)
MZ = M sin g cos u (23)
In these equations, θ is the angle in the plane perpen-
dicular to the coil axis, γ is the pitch angle, M is the exter-
nally applied moment, Tθ is the torsion normal to the wire
axis, MR is the moment about the axis orthogonal to the
coil axis and MZ is the moment about the coil axis. These
International Materials Reviews 2016 5
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications
bending components lead to a shear stress τ and two nor-
mal stresses σR and σz, respectively.1
Strand/cable fracture
Fracture of strands and cables typically occurs in a pro-
gressive manner and can be traced to the failure of con-
stituent wires. Constituent wires may fracture without
complete strand or cable fracture. However, once a signifi-
cant fraction of constituent wires fracture locally in an
outer strand, fracture of the whole structure can occur
due to tensile overload of neighbouring wires.87 From
the mechanical analyses, degradation of the structure is
influenced by four major factors: mechanical response –
internal forces and moments; mechanical interactions –
secondary bending at the contact points between adjacent
strands to due rotation and friction; geometry of wires
and displacements – instantaneous displacements related
to clamping of neighbouring wires and strands; and the
lay of the wire and cable – contact angles and respective
geometric patterns resulting from mechanical responses
at the contact points.87 In addition to the mechanical con-
tributions to fracture, materials and microstructure selec-
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tion are critical as reviewed later.
As suggested above, cable/rope architecture and mech-
anics affects how such structures may fracture. Verifica-
tion of such concepts for life-cycle analyses and
improving the reliability of such systems requires appro-
priate testing schemes. The following section reviews the
various test techniques that have been developed to docu-
ment the cyclic performance and reliability of such sys-
tems. In some cases, standards95–100 and other guidance
documents83,101 have been developed and/or are under-
going revision that address the specific test techniques
and are provided when appropriate.
Review of test techniques
Medical devices that utilise wires and cables may undergo
complex loading and be subjected to fatigue fracture that
is difficult to predict and test in vivo. Implanted devices
may encounter chronic flexing, bending, buckling, expan-
sion and contraction of the structure or any combination
thereof during the life of the device depending on the ana-
tomical placement.102 Maximising material and device
design and minimising device failure is paramount with
these implanted devices. The FDA has set fatigue require-
ments for regulatory approval for some cardiovascular
devices to a passage of a 10-year equivalent pulsatile fati-
gue/durability test of which many designs target a mini-
mum of 380 × 106 cycles.82,83 Additionally, FDA
guidance documents recommend that for materials such
as Nitinol which can vary considerably depending on
the processing, that physical testing be performed on
post-processed material to best determine relevant mech-
anical properties.83 As such, a variety of test methods have
been developed to better understand the response of the
material and geometry to particular cyclic stress and
strain conditions with the end goal of improving device
and material design and reliability. Most test methods
incorporate some means of alternating tension and com-
pression of the sample, which when repeated over multiple
cycles can lead to an accumulation of microstructural
damage and eventual fatigue failure.22 Fatigue tests con-
ducted under low cycle fatigue (LCF) conditions generally
6 International Materials Reviews 2016
produce failure at less than 103 cycles because this regime is
dominated by plastic strains. High cycle fatigue (HCF) test
conditions are typically dominated by elastic strains and
produce fatigue lifetimes that exceed 104 cycles.103,173
The test methods described in the following section will
provide an overview of each method, test machine, desig-
nated ASTM and/or ISO standard reference when appli-
cable, sample information and a brief summary of some
applications for each method. Data mined from the litera-
ture based on these test methods will be reported in sub-
sequent sections. The fatigue test methods reviewed
include: alternating bending fatigue testing, CENELEC
fatigue testing, flex bending fatigue testing, axial fatigue
testing, rotating bending fatigue testing, unidirectional
bend fatigue testing and pulsatile fatigue testing.
A summary of the test techniques, sample type, test
environment and investigators that have used these
approaches is provided in Table 1.
Alternating bending fatigue testing
(Fig. 6a–d)29,95,103
Alternating bending fatigue testing has been conducted
on individual wires, cables and coils. The process of alter-
nating the wire in tension and compression encompasses a
variety of more specific test methods described in this sec-
tion including a crank-based alternating bending con-
figuration, a ±90° or ±45° alternating bending
CENELEC fatigue configuration and a flex bending fati-
gue test that relies on the use of different diameter man-
drels that move in a vertical fashion creating the
alternating bending fatigue configuration.
Alternating bending (crank-driven) fatigue testing
(Fig. 6a)29
This technique utilises a series of cranks to apply a strain to
the sample and produces fatigue data in a surface strain
range of 0–5% and frequency in a range of 0–1000 cycles
min−1 and is shown in Fig. 6a.29 Cyclic loading is produced
via a rotating motor that cycles the specimen side to side by
means of two cranks. A smooth cycle is maintained by
using eight bearings between the motor and crank assem-
blies. Sample movement is shown in Fig. 6a with the
sample held between two grips and the alternating bending
movement depicted by the dashed lines. The magnitude of
the cyclic strain for a particular diameter wire is controlled
by the length of grips and the setting position of the cranks.
CENELEC fatigue testing (Fig. 6b and c)95
Another variation on alternating bending fatigue testing
is demonstrated in the British Standard, BS EN 45505-
2-2:2008, for Active Implantable Medical Devices95 and
also recommended as a potential method to determine
flexural fatigue in FDA101 guidance documents and ISO
standards for active implantable electrodes.96–98 The
oscillatory test is based on a standard reference coil and
is commonly referred to as the CENELEC standard
coil.30 Performed in dry conditions and at room tempera-
ture, the test fixture (Fig. 6b) is designed to rotate 90° from
the vertical in both directions. The lead body or other
sample form is housed within a fixture having dimensions
no greater than 110% of the sample diameter and a bell
mouth end with a bending radius of curvature of 6 mm.
The small weight attached to the end of the test sample
is sufficient to ensure the sample conforms to the bending
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

Table 1 Test techniques used for wire and cable fatigue

Test method Sample type Test environment Test frequency/speed Investigator(s)

Alternating bending Wire Air 1.67–8.33 Hz Furuichi et al. 29

Fatigue testing Wire Air 3.33–8.33 Hz Matsui et al. 39
Fig. 6d 29 Wire Air 3.33 Hz Takeda et al. 62
Wire Air 8.33 Hz Tobushi et al. 63
Flex bending Wire Air 1 Hz Benini4
Fatigue testing Wire Air 1 Hz Lavvafi34
Fig. 6d 103 Cable Air 1 Hz Lewandowski et al. 11
Cable Air 1 Hz Lewandowski et al. 10
Axial Wire Air 8–15 Hz Dooley et al. 25
Fatigue testing Spring Air/water/NaCl 1–60 mm s−1 Hirmanova et al. 72
Fig. 7 Z-wire Water 20 Hz Launey et al. 33
Z-wire Water 20 Hz Lin et al. 36
Wire Air Mammano et al. 37
Wire Ringer’s 2 Hz Morgan et al. 42
Wire Air 10 Hz Niinomi et al. 44
Wire Air 0.01–35 Hz Sateesh et al. 56
Rotating bending File Air 300 rev min−1 Al-Hadlaq et al. 22
Fatigue testing Wire/coil Air 4000±300 rev min−1 Altman et al. 2
Figs. 8a–c and 92,22,99 Wire Air 3600 rev min−1 Bradley et al. 23
Welded wire Air 200–800 rev min−1 Chan et al. 24
Wire Water 1000 rev min−1 Fasching et al. 26
Downloaded by [Laurentian University] at 08:38 14 May 2016

Wire Air Figueiredo et al. 27

Wire Air/oil 400–3200 rev min−1 Frotscher et al. 28
Wire Air 500 rev min−1 Furuichi et al. 29
Wire/coil Air 120, 3600 rev min−1 Hildebrand et al. 30
Coil Hank’s 1000 rev min−1 Iguchi et al. 7
Coil Air/saline Iguchi et al. 8
Wire Air 3600 rev min−1 Kay et al. 31
Wire Water 6000 rev min−1 Kumar et al. 32
Wire Air 3600 rev min−1 Li et al. 35
Wire Saline 3600 rev min−1 Marrey et al. 12
Wire Water 3600 rev min−1 Martin et al. 38
Wire Air 500 rev min−1 Matsui et al. 39
Wire/cable Air Meyer40
Wire Oil 400 rev min−1 Miyazaki et al. 41
Wire Air/Ringer’s 600 rev min−1 Niinomi43
Cable Lactic acid/Ringer’s 1000 rev min−1 Narushima et al. 14
Wire Water 1000 rev min−1 Norwich et al. 45
Wire Water 500–5000 rev min−1 Norwich46
Wire Water 3600 rev min−1 Patel et al. 47
Wire Water 3600 rev min−1 Patel48
Wire Water 3600 rev min−1 Patel et al. 49
Wire Water 3600 rev min−1 Patel et al. 50
Wire Water/23°C, 60°C 2000 rev min−1 Pelton et al. 51
Wire Methyl alcohol/−25°C 2000 rev min−1 Pelton et al. 51
Wire Water 1000 rev min−1 Polinsky et al. 52
Wire Water 1200 rev min−1 Rahim et al. 53
Wire Water 1200 rev min−1 Rahim et al. 54
Wire Water 3600 rev min−1 Reinoehl et al. 55
Wire Air 100–800 rev min−1 Sawaguchi et al. 57
Wire Air/saline 3600 rev min−1 Schaffer et al. 58
Wire Water 3600 rev min−1 Schaffer et al. 59
Wire/cable Air 3600 rev min−1 Scheiner et al. 60
Wire Water Sheriff et al. 61
Wire Air 500 rev min−1 Tobushi et al. 63
Wire Air/water 100–1000 rev min−1 Tobushi et al. 64
Wire Air/water 100–1000 rev min−1 Tobushi et al. 65
Wire Air/water/oil 100–1000 rev min−1 Tobushi et al. 66
Wire Air 100–500 rev min−1 Tobushi et al. 67
Wire Air/oil 36–800 rev min−1 Wagner et al. 68
Wire Air 300 rev min−1 Ye et al. 69
Wire Air/water 200–2000 rev min−1 Young et al. 70
Unidirectional bend Coil Air 5 Hz Campbell et al. 71
Fatigue testing
Fig. 1071
Pulsatile Wire Air 1.67–8.33 Hz Furuichi et al. 29
Fatigue testing Wire Air 8.33 Hz Matsui et al. 39
Fig. 1071 Wire Air 8.33 Hz Tobushi et al. 63
Wire Air 5 Hz, 8.33 Hz Tobushi et al. 67

International Materials Reviews 2016 7

 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

8 Rotating bending fatigue testing includes a non-guided

6 Alternating bending fatigue testing includes a alternating rotating bending fatigue testing,99 b guided rotating bend-
bending (crank-driven) fatigue testing,29 b CENELEC flex ing fatigue testing99 and c dual bend rotating bending fati-
testing at 90°,95 c CENELEC flex testing at 45°95 and d gue testing2
flex bending fatigue testing103

Flex bending fatigue testing (Fig. 6d )103

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radius. The test proceeds at a rate of 2 Hz for a minimum

Flex bending fatigue testing is a method of alternating
of 47 000 cycles. The standard’s development was based
bending fatigue testing whereby a thin foil is tested in
on the use of a reference test coil manufactured from
accordance with the historical standard ASTM E796.100
MP35N with an individual wire dimension of 0.2286
This technique was developed to evaluate the cyclic per-
mm and coil diameter of 0.9144 mm.95 The minimum rec-
formance of thin electronic components but has been
ommended flexural cycles was determined from a Weibull
adapted to evaluate various wires and strands for biome-
distribution analysis of 224 tested reference coils, with the
dical applications.4,10,11,34,103,104 Figure 6d shows a sche-
notation that conductors composed of other materials
matic representation of the test sample that is
would need to be evaluated for respective acceptance cri-
alternately flexed over a mandrel during the test. This
teria and/or alternative requirements.
test imparts a fully reversed strain cycle at a cyclic fre-
The second test associated with BS EN 45505-2-2:2008
quency from 1–17 Hz to only the wire/cable/ribbon area
targets fatigue testing on the segment of the lead that joins
in contact with the mandrel radius at full extensions of
with the connector body.95 In this instance, the fixture is
the machine stroke. Specimens can be tested in fully
mounted such that it can rotate ±45° from vertical (Fig.
reversed (i.e. R = −1) conditions by placing them between
6c). The lead conductor is fixed in the holder by set screws
the two mandrels or in R = 0 conditions by placing them
while a small weight (100 ± 5 g) is attached to the lead
above or below the mandrels, therby limiting the range of
segment to maintain position without providing a signifi-
motion. A small dead load is applied to the specimen to
cant tensile stress. The fixture is cycled at 2 Hz for 82 000
maintain constant contact with the mandrels during test-
cycles. If asymmetry of the conductor exists, it will have
ing and the resultant applied tension stress should not
an effect on the results depending on the orientation
exceed 10% of the yield strength of the sample.100 Strain
within the fixture. The standard recommends placing
ranges can be varied by the use of different wire and/or
the conductor in the orientation that produces the maxi-
mandrel diameters. Mandrel diameters range from 0.5
mum stress on the part. The cyclic test level, as in the pre-
mm to upwards of 30 mm depending on the machine
vious lead body test, was determined through Weibull
analysis on a specific conductor design and rounding up
to the nearest 1000 cycles.

9 Rotating bending fatigue test schematic for endodontic

7 Schematic of axial fatigue testing machine applications22

8 International Materials Reviews 2016

 Gbur and Lewandowski
10 Unidirectional bend fatigue testing schematics depict a
single end movement and b dual end movement71
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configuration. Tests are often conducted at 1 Hz to mimic
physiological rates and to minimise heat generation while
cycles are recorded with a counter, either mechanical or
light sensor that makes electrical contact with the metallic
specimen. The electrical connection is severed and the
machine stops at catastrophic fracture of the wire/cable/
ribbon. The fatigue performance of 316LVM,11,34,104 var-
ious DFT stranded cables10 and Nitinol dental wires4 was
determined using this technique with mandrel diameters
ranging from 1.15 to 25.4 mm.
The cyclic strain experienced by a flat ribbon can be
determined by approximating the mechanics via beam
theory. As originally developed by Engelmaier,103 and
extended to wires by Meyer,40 the bending moment of a
single wire M, or in the case of the core wire within a
cable, about the mandrels can be approximated by
equation (24) and the moment of inertia I can be calcu-
lated by equation (25).40,103
EIwire
M= (24)
r While most investigations summarised in this review have
p 4
Iwire = d (25)
64
The moment is approximated by the elastic modulus E,
moment of inertia I of the wire and the radius of curvature
of the mandrels ρ. It follows that the normal stress σ due
to bending is given by equation (26) where the maximum
stress occurs at y = d/2.
My Ey
s= = (26)
Iwire r
The cyclic strain, for a fully reversed cycle, can then be
determined by equation (27).
2s d
D1 = = (27)
E r
This relationship is only valid when the wire or cable
diameter is much smaller than the mandrel diameter
and does not take into account any frictional forces
Fatigue and fracture of wires and cables for biomedical applications
incurred by wires within a strand or cable
architecture.10,40
Fatigue ductility of flat (e.g. ribbon, thin sheet) speci-
mens can also be calculated according to ASTM
E796100 using equation (28). The expression is defined
by the fatigue life Nf, fatigue ductility in percent Df, tensile
strength Su, modulus of elasticity E, fracture strength Sf,
minimum core thickness tM where for smooth surfaces tM
= t and for rough surfaces tM is t less the thickness of any
surface roughness, test mandrel diameter 2ρ and thickness
of specimen t.
   0.1785 log(105 /Nf )
Su Sf eDf
Nf−0.6 D0.75
f + 0.9
E Su 0.36
 
2tM
− =0 (28)
2r + t
Samples can be tested in the LCF regime as well as the
HCF regime. Benefits to this test configuration are appli-
cation of a symmetric cyclic strain applied by use of differ-
ent diameter mandrels, constant strain amplitude and the
ability to test in both low and HCF.10,11,103
Axial fatigue testing (Fig. 7)
The utility of axial fatigue testing compared to the many
other forms of fatigue testing described in ‘Review of test
techniques’ section is the ability to test the full volume of
the material rather than just the surface. This technique
typically produces a lower bound to the fatigue data
since it also samples the internal structure of the wire
(i.e. inclusions). The stress ratio R (σmin/σmax) may be var-
ied in these tests with R > 0 to examine the effects on fati-
gue life. Servohydraulic test machines and pneumatic
testers (Fig. 7) are used to provide a sinusoidal stress
application to the part and testing is conducted until frac-
ture or to a predetermined run-out. Negative stress ratios
(i.e. R < 0) are not possible due to the buckling of the wire.
Tension–tension and notched tension–tension tests are
described briefly along with any general test notes from
the respective investigators. Test rates from those papers
included in this review range from 0.01 Hz56 to 35 Hz.56
Notched fatigue testing
tested smooth wires/strands/cables/coils, some appli-
cations involve designs with various stress concentrations
(e.g. welded wires, non-uniform geometry, etc.). The
effects of stress concentrations on the fatigue behaviour
of wires can be determined by carefully placing notches
on the wire surface(s) before fatigue testing. For example,
Niinomi et al. 44 chose notched fatigue tests conducted at
10 Hz and R = 0.1 to analyse the effects of a stress concen-
tration in Ti–29Nb–13Ta–4.6Zr (TNTZ) wires with com-
parisons to Nitinol, pure Ti and SUS316 wires.
Tension–tension fatigue testing
Tension–tension fatigue can be executed under strain con-
trol with an extensometer to evaluate the effect of changes
in mean strain and alternating strain amplitude on fatigue
life of wire. In the case of fine diameter wire, careful exten-
sometry is required due to potential attachment difficul-
ties and therefore data may need to be generated using
other tools such as a non-contact extensometer56 since
International Materials Reviews 2016 9
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications
calculating strain from machine crosshead movement is
not valid for obtaining accurate data. Testing can be con-
ducted with33,36,42,72 or without25,37,44,56,72 the addition of
a chamber to accomodate solution/constant temperature,
while the wire may be held in grips or potted.82 Cyclic ten-
sion tests are also used in Nitinol characterisation to
establish the upper and lower stress plateaus and docu-
ment the changes in hysteresis loops that occur with
increased cycling. Work by Frotscher et al. 28 provided a
cyclic protocol for Nitinol to include a loading and
unloading cycle up to 5% strain while work by Dooley
et al.25 used cyclic axial testing to impart a pre-strain to
wires that subsequently increased the fatigue life.
Rotating bending fatigue testing (Figs. 8a–c
and 9)2,22,99
Rotating bending testing is used extensively for HCF
testing and for accelerated testing, particularly in small
diameter wires.2,7,8,12,14,22–24,26–32,35,38–41,43,45–55,57–61,63–70,
105–107
This method, depending on the nature of the test
machine, permits testing in air or solution under low
and HCF at speeds upwards of 25 000 rev min−1.108 Test-
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ing of this nature becomes important, especially in cardiac
applications, where the implanted device is expected to
withstand hundreds of millions of cycles in its lifetime.2
Early development of this testing apparatus includes the
fatigue testing machine patented by Kenyon106 with vari-
ations of this model emerging in works by Altman et al.,2
Iguchi et al.,7,8 Figueiredo et al.,27 Pelton et al.,51 Schei-
ner et al.,60 Tobushi et al.64 and finally commercially
available systems.108,109
The test was initially developed to evaluate electro-
plated coatings on metallic wires.105 The procedure was
plagued with difficulties in maintaining accurate calibra-
tions for pulsating tension tests and an inability to mini-
mise stress risers induced from gripping of small
diameter specimens.64 The apparatus developed by Ken-
yon105 provides a rotating bending fatigue test method
that minimises lateral vibrations of the wire by immersing
a portion of the wire curvature in low viscosity oil. The
wire sample is held in two inclined bearings with one
end free and the other end fixed to a motor and cycle
counter then run until failure. The stresses in the extreme
fibres are based on the arc formula, equation (29).105,106
EI Ed Ed
Extreme fiber stress = = = sin u (29)
RZ 2R C until failure of the specimen. The failure triggers a break
The variables are defined as modulus of elasticity E,
moment of inertia I, radius of curvature R, section mod-
ulus Z, horizontal chord C and the angle of inclined bear-
ing with the horizontal θ. Various tests using this
experimental procedure explored the drag effect of the
oil immersion, torque due to bearing friction and wire
sag due to self-weight, all of which resulted in minimal
measurable effects on the wire curvature during test or
wire fatigue results leading to a reliable, low cost, reprodu-
cible test method for small diameter wires.106
Wires and cables may be evaluated with this method
and numerous variations in the machine design have
developed since the early model by Kenyon.106 In the
newer art, the sample is still held in a constrained loop
that places the material at the extreme outer fibres of
the loop in alternating tension and compression while
the sample is rotated (Fig. 8a–c).2,22,99 Fatigue cracks
10 International Materials Reviews 2016
typically initiate at the surface followed by fatigue crack
propagation and catastrophic failure in overload.
One variation to the rotating bending apparatus pro-
posed by Kenyon105,106 is a guided rotating bending fati-
gue system (Fig. 8b) used by Pelton et al.51 wherein the
wire is placed in a 90° bend instead of a 180° bend. A
single rotating chuck holds and spins the wire through a
bushing to a variable size mandrel that contains a circular
guide groove, while an idler mandrel present on an adjust-
ment slide supports the wire after exiting the test
mandrel.99
A test rig proposed by Tobushi et al. 64 encloses the
sample to provide a constant temperature environment
for testing in either air or solution. An extensometer is
attached to the sample with the leading end attached to
a rotating motor while the terminal end is free to rotate
in a fixture. Torsional loading is eliminated through the
use of bearings at either end of the sample while an aqu-
eous environment (e.g. water) may be utilised to provide
constant temperature.
In contrast to the previously described test machines,
Fig. 8c employs a dual bend rotating bending configur-
ation developed by Altman et al.2 for use in evaluating
cardiac lead cables at 4000 ± 300 rev min−1 within tracks
situated between two polyethylene blocks and held at a
defined radius. In this apparatus, failure occurs and the
test ceases when the electrical continuity is broken. For
cables, this requires that all conductive paths (i.e. wires)
must fail in order for the test to terminate.
Additional configurations of the rotating bending test
apparatus are commercially available108,109 and also pro-
vide strain-controlled conditions for the determination of
fatigue life with R = −1 and a fully reversed bending con-
dition. The loading scenario can be approximated by
simple bending beam mechanics based on a wire held in
loop geometry with the ends held in parallel and the
loop maintained in a single plane, as shown previously
in Fig. 3. One end of the wire is fixed in a driven chuck
while the other end is either free to rotate in a bushing
or secured in a second driven chuck to provide wire
rotation. The maximum stress occurs at the apex of the
loop, alternates in tension and compression, and elements
at the extreme edges of the wire experience the greatest
surface strains. The testing rate can reach up to 25 000
rev min−1 108 on the commercial systems. The cycle is
counted as the chuck rotates and through a closed elec-
trical circuit the test will continue to run and count cycles
detector and electrically grounds the test sample.110 Other
systems are equipped with an optical break detector
capable of detecting wire breaks greater than 0.102 mm
in diameter in either air or clear liquid environment.
The development of a test bench outfitted with multiple
testers sharing a common water management system is
also available.108 A recent review of the non-guided
method (Fig. 8a) and the guided method (Fig. 8b) com-
pared the test configurations on Nitinol wire.46
With the increased interest in rotating bending fatigue
testing for wires used in biomedical applications, ASTM
recently developed a test method to aid in standardising
the process and reporting of data. ASTM E294899
addresses the test for both non-guided (Fig. 8a) and
guided (Fig. 8b) systems using solid, fine wire. The test
method is intended for wires less than or equal to 1.6
mm and is not meant for evaluation of the internal
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

Table 2 Common materials used for biomedical wires and cables3,5,8,43,113–127

Alloy Designation Applications

302 A313/F899 Stylets, catheters, guidewires, springs

304V A313/F899 Catheters, guidewires, orthodontics
304LV ASTM A580 Stylets, catheters, guidewires, springs
316LVM ASTM F138 Suture wire, orthopaedic cable, catheters
316L ASTM A276 Leads
Custom 455 ASTM A564 Stylets, springs
SUS316L Leads, IVC filters
NAS106N Leads
ASTM F1314 Surgical implants
ASTM F1350 Surgical fixation wire
ASTM F2229 Surgical implants
ASTM F2581 Surgical implants
NAS604PH Leads, dental brush
MP35N ASTM F562 Leads, catheters, orthopaedic cables
35N LT ASTM F562 Leads, catheters, orthopaedic cables
Elgiloy ASTM F1058 Leads, filters, orthopaedic cables
ASTM F1091 Surgical wire
ASTM F90 Sugical implants
Drawn filled tube (DFT) Pacemaker leads
Drawn brazed strand (DBS) Pacemaker leads
Pt-cored Nitinol Wire
Beta III Ti ASTM B863 Archwires, IVC filters
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Pure Ti ASTM B863

Ti–6Al–4V ASTM F136 Surgical implants
Pt–20Ir ASTM B684 Guidewires, leads, microcoils
Nitinol ASTM F2063 Rotary files, stents, archwires, filters
TNTZ Under investigation for dental prostheses

material structure’s effect (i.e. inclusions) on the fatigue
life of the wire.99
An alternate method of rotating bending fatigue testing
is used to evaluate files made of wire for endodontic appli-
cations. In the cleaning and shaping of the root canal, a
rotary file undergoes torsional and flexural loading creat-
ing alternating regions of tension and compression along
the file. Work by Al-Hadlaq et al.22 used a modified test
apparatus, shown with a schematic in Fig. 9, consisting
of a stainless steel test block with a 5 mm radius and 1
mm groove to hold the wire in place during tests conducted
at 300 rev min−1. The handpiece that normally holds the
wire during application was mounted to a stand providing
the previously determined 51° angle of curvature.
Unidirectional bend fatigue testing (Fig. 10)71
With a focus on mimicking the primary in vivo move-
ments of implanted leads, unidirectional bend fatigue test-
ing was developed to aid in determining the fatigue
capacity of lead designs. Campbell and Johnson71 created
custom fixtures to hold and test coils between predeter-
mined end levels of displacement while in a 180° bend.
The applied curvature ratio Rk is constantly maintained
at 0.3 and the coils are cycled at 5 Hz. X-ray images of
the coils held in the 180° bends are digitised in order to
determine the radius of curvature using circle fitting
techniques.
Pulsatile fatigue testing (Fig. 10)71
A specific test apparatus of the aforementioned uni-
directional bend testing was developed by Tobushi
et al. 67 and described as pulsatile bending fatigue. The
wire is secured by grips on both ends and the curvature
of the wire is governed by the proximity of the two grips
to each other creating bending strain. A motor drives the
reciprocating motion of the test through a crank. The
test proceeds with R = 0 and the test rate can be varied
from 100 cpm (i.e. 1.67 Hz) to 1000 cpm (i.e. 16.67 Hz).
Materials
Table 2 provides the most common materials and ASTM
designations used to manufacture fine wires and cables for
use in biomedical devices. Material categories represented
in the table include: stainless steels, cobalt–chromium–
nickel alloys, metal composites, various titanium and
platinum alloys and Nitinol and other NiTi-based ternary
alloys. Table 3 provides the typical composition ranges
provided for these ASTM designations. Emerging
materials being considered include nickel-free alloys.111
Electric-arc and vacuum-arc melting techniques are
often used to produce low inclusion content materials
before extrusion and wire drawing. Fixation pins and
wires for biomedical applications are generally fabricated
from materials with the following ASTM designations:
F67, F75, F90, F136, F138, F562, F563, F1314, F1537
and F1586.112 Multi-strand wire drawing is used to pro-
duce finer diameters with those reported in this review
as small as 0.025 mm.7,8,14,40 Single wires described herein
range from 0.0440 to 1.4 mm.57,68 The following section
provides a description of the more common materials,
ASTM designation, material overview and prospective
applications when available.
Stainless steels
Stainless steels are often utilised in biomedical appli-
cations due to excellent biocompatibility, ease of fabrica-
tion and corrosion resistance.5,123 Austenitic stainless
steels comprise the bulk of those used in medical appli-
cations. Most frequently noted in the review, 316LVM

International Materials Reviews 2016 11

 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

Table 3 Typical compositions for select ASTM materials (avg. wt-%)5,113,115,118–122,127

ASTM
Alloy number C Mn Si P S Cr Ni Mo Fe N Other elements

302 A313 0.12 2.00 1.00 0.045 0.03 17–19 8–10 – Bal. 0.10
304V A313 0.08 2.00 1.00 0.045 0.03 18–20 8.0–10.5 – Bal. 0.10
316LVM F138 0.03 2.00 0.75 0.025 0.01 17–19 13–15 2.25–3.00 Bal. 0.10 Cu 0.50
F1314 0.03 4.0–6.0 0.75 0.025 0.01 20.5–23.5 11.5–13.5 2.0–3.0 Bal. 0.2–0.4 V 0.1–0.3,
Nb 0.1–0.3
Co 0.5,
Cu 0.50
F2229 0.08 21–24 0.75 0.03 0.01 19–23 0.05 0.5–1.5 Bal. 0.85–1.1 Cu 0.25
F2581 0.15–0.25 9.5–12.5 0.2–0.6 0.02 0.01 16.5–18 0.05 2.7–3.7 Bal. 0.45–0.55 Co 0.25
MP35N/ F562 0.025 0.15 0.15 0.015 0.010 19–21 33–37 9.0–10.5 1.0 – Ti 1.0,
35N LT B 0.015
Co Bal.
Elgiloy F1058 0.15 1.5–2.5 1.2 0.015 0.015 19–21 14–16 6.0–8.0 Bal. – Be 0.1,
(1) Co 39–41
F1058 0.15 1.0–2.0 1.2 0.015 0.015 18.5–21.5 15–18 6.5–7.5 Bal. – Be 0.001,
(2) Co 39–42
F90 0.05–0.15 1.0–2.0 0.40 0.04 0.03 19–21 9–11 – 3.0 – W 14–16,
Co Bal.
Nitinol F2063 0.05 – – – – 0.01 54.5–57 – 0.05 0.05 Nb 0.025,
H 0.005,
Cu 0.01,
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Co 0.05
Ti Bal.

typically contains 17–19 wt-% Cr and 13–15 wt-% Ni as
shown in Table 3. Research in material optimisation con-
tinues with a focus on minimising metallic byproducts and
corrosion. Many stainless steel producers are considering
nickel-free options to eliminate the potential for nickel
leaching and related toxicity while levels of chromium,
molybdenum and nitrogen are increased to further protect
the alloy from corrosion and to minimise reactions in
patients that may be sensitised to these liberated
elements.128–130 Stainless steel wires have been used singly
and in multi-strand configurations for a variety of ortho-
dontic128 and implantable cable applications.11,21
Additional ASTM material standards that address wire
specifications not called out in the sections forthcoming
include: ASTM F1314120 nitrogen-strengthened 22Cr–
13Ni–5Mn–2.5Mo and ASTM F1350114 18Cr–14Ni–
2.5Mo. A selection of common stainless steels for use in
biomedical applications is described below while typical
composition limits are provided in Table 3.
302
AISI 302 alloy is a metastable austenitic stainless steel
that can exhibit deformation-induced martensite and
magnetic character.131 Melt practice for AISI 302 follows
ASTM A313 and is an electric-arc melted steel. Strength-
ening is accomplished via grain size control, cold work
and deformation-induced martensite. The phenomenon
of sensitisation whereby precipitation of Cr-rich carbides
at grain boundaries occurs by exposure to 427–816°C for
sufficient times can promote intergranular corrosion and/
or intergranular stress corrosion cracking. Applications
for the 302 stainless steel include stylets, catheters, guide-
wires, springs and needles.5
304V/304LV
Both 304V and 304LV are metastable austenitic stainless
steels that are initially electric-arc melted then vacuum
arc remelted (VAR) for purity and homogeneity.5
Strengthening mechanisms are similar to that used in 302
as is the possibility of sensitisation. The ‘L’ designation
refers to the low carbon version (i.e. C < 0.03 wt-%)132
that is designed to provide additional resistance to sensitis-
ation131 and is particularly recommended for higher temp-
erature applications. Both materials are used in the
production of catheters and guidewires with 304V also
used in stylets, springs, the Bird’s Nest IVC filter and
304LV used in orthodontic applications.5,128–130,133
316L/316LVM
Long used for permanent implants, 316L and 316LVM
are more stable austenitic stainless steels that contain mol-
ybdenum and low carbon content (i.e. C < 0.03 wt-%),132
with the low carbon versions again designed for enhanced
resistance to sensitisation. These alloys are electric-arc
melted followed by VAR to further minimise voids and
impurities.5 Strengthening occurs primarily by grain size
control and cold work. The 316LVM alloy is analogous
to 316LS where S designates a lower limit on the sulphur
content (i.e. %S < 0.01%)132 and follows ASTM F138.121
The 316L alloy differs primarily by the S content (i.e. %S
< 0.03%)132 and follows ASTM A276.132 Both tube and
wire forms of 316L have been used in stent design but
are less used in arterial applications (i.e. carotid and
superficial femoral arteries) that experience significant
forces or dynamic motion that could plastically deform
the device.134 Applications such as suture wire, cables,
skin closure staples, catheters, stents and stylets utilise
wire made from this alloy.5,134 Magnetic character can
exist in heavily deformed wire.
Custom 455
This alloy is a martensitic, age-hardenable stainless steel
that is magnetic. The alloy is double vacuum melted
through a vacuum induction melt (VIM) process and fol-
lowed by VAR.5 Melt practice follows AMS 5617#1. This
alloy exhibits good oxidation resistance and can be heat

12 International Materials Reviews 2016

 Gbur and Lewandowski
treated to much higher ultimate tensile strengths (UTSs).
Medical applications include stylets and springs.5
SUS316L and NAS106N
These chromium–nickel stainless steel alloys contain high
manganese and nitrogen.8 They are more resistant to
deformation-induced martensite and thus are typically
non-magnetic. They are twice electroslag remelted
(ESR) to remove impurities, giving them similar drawabil-
ity and elongation for processing. The nitrogen-contain-
ing NAS106N was designed for improved corrosion
resistance and mechanical properties including less
elution of iron and nickel compared to the SUS316L.
These alloys have been used to make leads for electrical
stimulation.7,8 SUS316 is the only austenitic stainless
steel found in current biomedical applications.129 316L
stainless steels have also been a reliable choice for inferior
vena cava (IVF) filters such as the Greenfield IVC filter
which was introduced in 1973 and the subsequent Over-
the-Wire Greenfield IVC filter.133
Ni-free and low Ni stainless steels
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These are emerging austenitic alloys for use in the biome-
dical industry and are an alternative to nickel-containing
stainless steels. The latter can produce health issues in
patients with nickel sensitivity if corrosion in the body
environment releases ion products to the body tis-
sues.111,130 Work by Maruyama et al. 111 investigated the
role of nitrogen as a substitute for nickel using solid-
phase adsorption and N2-gas pressurised electroslag
remelting. Compositions investigated by Maruyama
et al. 111 include Fe–24Cr–2Mo–1N and Fe–23Cr–1Mo–
1N while other investigated systems include Fe–Cr–N
and Fe–Cr–Mn–Mo–N.130 The high nitrogen content
produces an increase in strength and corrosion resistance
in addition to better fatigue resistance.130 ASTM
F2581119 provides a specification for a low nickel, nitro-
gen-strengthened stainless steel (11Mn–17Cr–3Mo) for
bar and wire products that consists of a fine-grained aus-
tenitic structure. ASTM F2229118 is a low-nickel stainless
steel that has also been nitrogen-strengthened (23Mn–
21Cr–1Mo) and is used in bar and wire products for sur-
gical implants. The two alloys also differ in the carbon
content (ASTM F2581 C = 0.15–0.25% and ASTM
F2229 C = 0.08% max) and silicon content (ASTM
F2581 Si = 0.2–0.6% and ASTM F2229 Si = 0.75%
max). The mechanical strength in the annealed and
cold-worked conditions for ASTM F2581 range from
847 and 1103 MPa for UTS and 482 and 827 MPa for
yield strength accompanied by 40 and 12% elongation,
respectively.119 This compares to ASTM F2229 where
the annealed and cold worked values are 827 MPa and
1034/1379 MPa (the specification provides for two differ-
ent cold worked conditions and are designated with a
slash between the values) for the UTS and 517 and 827/
1241 MPa for yield strength with an elongation of 30
and 20/12%, respectively.118
Cobalt–chromium–nickel alloys
Cobalt–chromium alloys are commonly found in ortho-
paedic implants and have also had success as pacemaker
leads, catheters, cardiovascular stents and surgical wire.
The addition of nickel improves plasticity and fatigue
crack growth resistance, but just as with the stainless
Fatigue and fracture of wires and cables for biomedical applications
steels, options are being investigated to provide nickel-
free alloys due to nickel toxicity.123,129 Additional
material standards in ASTM that address wire specifica-
tions, not called out in the sections forthcoming include:
ASTM F90115 Co–20Cr–15W–10Ni (except surgical fix-
ation wire), ASTM F562122 35Co–35Ni–20Cr–10Mo,
ASTM F1091116 Co–20Cr–15W–10Ni surgical fixation
wire and ASTM F1537135 Co–28Cr–6Mo.
MP35N
MP35N is a multiphase nickel–cobalt–chromium–molyb-
denum alloy with 35% nickel.5 This superalloy is initially
melted using VIM, followed by ESR and VAR to remove
impurities. The typical MP35N composition is 35Co–
35Ni–20Cr–10Mo (wt-%) and can be cold worked and
aged for higher strength. It offers excellent combinations
of strength and corrosion resistance with tensile strengths
comparable to 316 stainless steels. MP35N is widely used
for pacemaker leads, stylets, catheters and orthopaedic
cables.2,30,35,60,71
35N LT
Analogous to MP35N, 35N LT is considered a superalloy
composed of primarily nickel, cobalt, chromium and a
lesser amount of molybdenum. It was developed to reduce
the number of TiN particles present in MP35N in order to
improve the fatigue life of fine medical wire.136 The alloy
differs from MP35N in the amount of titanium present
(Ti = 0.70 wt-%MP35N vs. Ti = 0.01 wt-%35N LT).
Magnesium replaces the titanium in 35N LT reducing
the transverse inclusion sizes (from 10 to 20 µm to <3
µm) and generating more spherical (MgO) rather than
cubic (TiN) morphologies.136 Alloy development follows
ASTM F562 (35Co–35Ni–20Cr–10Mo) and is further
enhanced by a double melt process resulting in a lower
inclusion count.5 Medical applications include pacing
leads, stylets, catheters and orthopaedic cables.4,5,23
Elgiloy
Multiple trademarks represent this cobalt–chromium–
nickel–molybdenum–iron alloy including, Elgiloy, FWM
1058, Conichrome and Phynox5 and ASTM F1058 pro-
vides the specification for the (40Co–20Cr–16Fe–15Ni–
7Mo) wire alloy.113 Alloys of this type are processed
through VIM and undergo subsequent electroslag remelt-
ing thereby further refining the melt and minimising
impurities. According to ASTM F1058, there are two
Grades of this material: Grade 1 (commonly referred to
as Elgiloy) and Grade 2 (commonly referred to as Phy-
nox) which differ slightly by the allowable ranges of
manganese, cobalt, chromium, nickel, molybdenum and
beryllium.113 Elgiloy is typically age hardened to impart
high strength and fatigue resistance. The orthodontic
community notes four different tempers of Elgiloy used
in archwires depending on treatment needs ranging
from a blue Elgiloy (soft, easily bent with pliers) then an
increase in resilience with the yellow and green tempers
to the most resilient, red Elgiloy (high spring qualities).128
Elgiloy wires in orthodontic applications provide greater
fatigue resistance and function as a more resilient spring
than what is obtained with stainless steel wires.128 Braided
Elgiloy wires were used in early stent design and continue
to be used today in the WallstentTM despite complicated
placement related to substantial length differences in the
International Materials Reviews 2016 13
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

expanded and constrained conditions.134 Elgiloy is also

non-magnetic and therefore implants constructed of this
alloy can be safely imaged using magnetic resonance ima-
ging. It is a preferred material for balloon-expanding
stents,134 pacemaker leads, IVC filters and orthopaedic
cables.5,128,133

NAS604PH
This cobalt–nickel alloy is produced in Japan for biomedi-
cal applications and is similar to ASTM F90/INS605PH
with the following composition specifications (mass-%):
0.10–0.15 C, ≤0.05 Si, 0.90–1.50 Mn, 15.50–17.50 Ni,
20.50–22.50 Cr, 5.80–6.80 Mo, ≥40.0 Co and balance
Fe.124,126 The addition of molybdenum provides increased
corrosion resistance compared to other similar materials
used in interdental brush systems.126 Iguchi et al.8 investi-
gated this material system for use in coiled implantable
electrode systems. 11 SEM image of a 1 × 7 strand of DFT10,138

Composites
With the increased demand placed on implanted leads to
support higher current carrying capacities, the develop-
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good fatigue life and solderability.5 This palate of proper-
ties is useful for those applications requiring greater stres-
ses on the individual strands and can be found in

ment of composite wires has blossomed.2 Composite
wires take advantage of properties provided by two differ-
ent materials, a conductive and usually softer core and a
stronger exterior sheath providing structural strength
and biocompatibility. The ability to provide strength
enhancements and offer protection from materials that
would potentially be toxic when implanted into the
body are two key advantages for using a metal
composite.137
Drawn filled tube
Among the most commonly used composite wires is DFT
wire wherein extreme compressive forces during wire
drawing are imparted during the processing of the dissim-
ilar metals to create a metal-to-metal bond.5 Microstruc-
ture images of the core/sheath interface have been
examined by transmission electron microscopy (TEM)
and are provided in ‘Microstructures and fractography’
section. The composite’s properties can be tailored by
varying the compositions of the core and sheath. Com-
monly used sheath materials are MP35N, 35N LT,
316LVM, Nitinol, FWM 1058 and titanium alloys.
Core materials may include: gold, silver, platinum, tanta-
lum, Nitinol, tungsten and titanium alloys. The DFT for-
mulation is found in many pacemaker leads, commonly a
silver core with 35N LT or MP35N exterior. A low mag-
nification view of a 1 × 7 strand is shown in Fig. 11.10,138
Recent work10 has investigated DFT cables with
MP35N (21Cr–35Ni–10Mo–25Co) and a silver core com-
prising 41% of the total cross sectional area of the cable.
These are currently being used for Networked Implanta-
ble Neuroprostheses Systems (NNPS).138 NiTi–DFT–Pt
has also been investigated where the percent platinum
has been varied to determine the optimum volume percen-
tage for enhancement in radiographic performance.139
Drawn brazed strand
Another variation of composite wire is available as a
drawn brazed strand (DBS). In this system the alloy
wires are stranded about a softer, conductive core
material. The grouping of wires is then brazed and
drawn creating a composite wire with high conductivity,
pacemaker leads and high fatigue applications.60
Pt-cored Nitinol
In addition, there is a unique composite wire that was cre-
ated to achieve improved radiopacity necessary for x-ray
and other fluoroscopic imaging. A Nitinol superelastic
(SE) wire is cored with platinum and exhibits a plateau
stress of 600 MPa and SE plateau that extends from 1.5
to 4%.140
Other materials
A sampling of other unique metallic alloys found in bio-
medical devices and implantable products is provided
below. Titanium-based alloys and platinum-based alloys
fulfil particular niches in medical treatments ranging
from dental appliances to conductive leads, respectively.
Bioabsorbable materials are also mentioned as they
have been used for soft tissue fixation techniques in the
form of suture anchors141 and are under consideration
for development in self-expandable stents.58
Platinum alloys
The development of platinum-based alloys for implanta-
ble leads takes advantage of the material’s biocompatibil-
ity, radiopacity, low corrosivity, good formability and
perhaps of most interest the high charge density capabili-
ties.35,125 A Pt–20Ir alloy, cold drawn into wire, has been
used for conductors to highly sensitive tissues such as the
brain, nerve tissues and cochlear implants.35,125 The
addition of the iridium provides solid-solution strengthen-
ing and wires may be annealed, stress relieved or cold
worked depending on the application needs. Platinum
alloy wire products range in diameter from 0.0254 to
3.175 mm and are primarily found in guidewires (Pt–W
and Pt–Ni for balloon catheter placement), microcoils
(brain aneurysm treatment) and feedthrough or connector
wires (pacemaker constituents).142
Tantalum alloys
Wire dimensions for ASTM F560 unalloyed tantalum
range from 0.254 to 3.15 mm in diameter and cover

14 International Materials Reviews 2016

 Gbur and Lewandowski
material that is produced from vacuum-arc melting or
electron-beam melting of ingots or powder-metallurgy.143
Early stent design included rings fabricated from tanta-
lum wire such as those in the Wiktor stent.134
Titanium alloys
Titanium is used for orthopaedic implants and in con-
junction with other elements to form biocompatible
alloys, such as Ti–6Al–4V and Nitinol. Alloys of titanium
have a wide range of applications due to high strength,
low density, corrosion resistance and biocompatibility.
Of the four types of titanium alloys (α, near α, α + β and
β), the β phase meets the requirements of most orthopae-
dic implants.129 As mentioned in the section on stainless
steels and Nitinol, concerns over toxicity of leachable
components are at the forefront of material development
for implants. Aluminium and vanadium in Ti–6Al–4V
alloys are at the centre of the concern and vanadium-
free alloys have been investigated.123,129 Beta III titanium,
manufactured as by 3M Unitek, is an example of an alloy
used for archwires in orthodontia whose properties fall
between that of stainless steel and Nitinol.3 The alloy is
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composed primarily of titanium with added molyb-
denum. The lack of nickel in this alloy provides benefit
for patients with nickel sensitivities. The spring back qual-
ity of the beta titanium archwire is greater than the stain-
less steel archwire with approximately half of the force,
providing an advantage for beta titanium in situations
where less stiff materials (i.e. Nitinol) are not adequate.128
The alloy is also used in IVC filters such as the Titanium
Greenfield Filter.133 Interest in evaluating the effects of
modulus and transformation temperatures as a result of
alloying with beta stabilising elements (i.e. Nb, Ta, Zr
and Hf) is developing and work using theoretical methods
based on molecular orbital information has led to the
development of three new alloys: Ti–16.2Hf–24.8Nb–
1Zr, Ti–5.2Hf–31.2Nb–0.4Zr and Ti–16Hf–36.2Nb–
1Zr.144 Research in developing low-modulus beta tita-
nium alloys that also minimise metallic sensitivities in
the body have focussed on some of the following alloy sys-
tems: Ti–Nb–Al,145–147 Ti–Nb–O,148 Ti–Fe–Ta, Ti–Zr–
Nb–Ta, Ti–Ta and Ti–Hf.123 ASTM specifications for
titanium alloys include: ASTM F67149 unalloyed Ti,
ASTM F136127 Ti–6Al–4V ELI, ASTM F1295150 Ti–
6Al–7Nb, ASTM F1472151 Ti–6Al–4V, ASTM
F1713152 Ti–13Nb–13Zr, ASTM F1813153 Ti–12Mo–
6Zr–2Fe and ASTM F2066154 Ti–15Mo.
Bioabsorbable materials
Interest in bioabsorbable materials stems from several
important clinical advantages including gradual stress
transfer to soft tissue, decreased need for removal of hard-
ware and radiolucency.141 Existing bioabsorbable
materials are available for soft tissue fixation techniques
and are generally composed of combinations of poly
(alpha-hydroxy) acids141 and investigations into the use
of ferrous-based bioabsorbable materials are under inves-
tigation for potential use in self-expanding stents.58 In
addition to the typical properties important to implanta-
ble metallic materials (i.e. biocompatibility, corrosion
resistance, adequate strength for the application, etc.),
bioabsorbable alloys must also produce degradation pro-
ducts that are tolerated by the host without any associated
immunogenic or mutagenic tendency, degrade at a rate
Fatigue and fracture of wires and cables for biomedical applications
that supports the healing process and possess enough
strength to perform the required function throughout
the implantation/degradation process.141 Materials such
as cold-worked iron, Fe–Mg DFT, Fe35Mn and
Fe35Mn–Mg DFT have been investigated in wire form
to determine the efficacy of these materials for use as a
biodegradable platform.58
Nitinol and other shape memory (SM) and
superelastic (SE) alloys
The Nitinol family of alloys contain equiatomic or near
equiatomic percentages of nickel and titanium.5,155 A
small amount of a third or fourth element (e.g. Cu, Cr,
Fe, V, Co or Nb)25 may be added to alter properties of
interest such as increased torqueability, stiffness and
strength not accomplished with the binary alloy.28 Nitinol
exhibits a characteristic thermoelastic martensitic trans-
formation which is responsible for the SM and superelas-
ticity exhibited by this alloy. Metal of this type may be
deformed and return to original shape after applied
strains are relaxed and heat is applied. Nitinol is widely
used for biomedical applications. Some of the appli-
cations include guidewires, staples, stents, stylets, form-
ing mandrels, stone retrieval baskets, IVC filters,
eyeglass bridges and orthodontic files and arch-
wires.5,9,25,28,107,128,133,155–158 M-Wire, found in endodon-
tic applications, is also a marketed version of the nickel–
titanium alloy that has undergone thermal processing to
improve flexibility and resistance to cyclic fatigue.22 Niti-
nol alloys provide several advantages over copper-based
alloys in biomedical applications including greater cor-
rosion resistance, larger elastic strains and longer fatigue
lives.159
An overview of SE and SM systems are provided herein
with additional details given elsewhere.28,102,155,160–165
Nitinol’s unique properties are due to the solid–solid-
phase transformation between austenite and martensite
and defined by four different transformation tempera-
tures: As, Af, Ms and Mf, which are the austenite start,
austenite finish, martensite start and martensite finish,
respectively.160 The SE condition presents a high-temp-
erature B2 (Strukturbericht) or 221 (International Tables
for Crystallography, space group Pm-3m) austenitic crys-
tal structure with Ni-rich precipitates and is a thermody-
namically metastable structure.102,155,162,164 The
austenitic structure will transform to a stress-induced
martensite (SIM) when stressed at a temperature greater
than the Af and will subsequently return to the austenitic
(parent phase) upon unloading.163 The Af value is defined
as the transformation of the last volume of martensite
into austenite of a stress-free sample upon heating.102
This value can be experimentally determined via differen-
tial scanning calorimetry (DSC) in addition to the Ms, Mf
and As.160 Alternatively, for those samples with an Af in
the range of −25°C to +90°C, the bend and free recovery
test can also determine transformation temperatures not-
ing that these values may differ from the DSC method due
to the effects of strain and stress on the material.165 Figure
12a illustrates the SE and SM effects schematically.
In reference to a typical Nitinol stress–strain curve, the
end of the upper plateau (approximately 6% strain) rep-
resents the fully formed, stress-oriented martensite, Fig.
12.155,161–163 A small amount of permanent strain
(0.5%) may reside in the parent lattice as a result of the
International Materials Reviews 2016 15
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications
12 Schematics representing a the superelastic effect and b the shape memory effect161,163
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concurrent slip, and a hysteresis is observed due to the
differences between the stresses required for the nuclea-
tion and reversion of the martensite.102,164 This forward
transformation is exothermic and is represented by the
upper plateau shown in Fig. 12.56,161,163 Unloading of
the sample leads to the reverse transformation from mar-
tensite to austenite which is an endothermic process and is
represented by the lower plateau.56
Upon unloading, a decrease in the stress necessary to
trigger re-nucleation of the martensite would be required
and is attributed to preferred variants present during the
initial loading.102 Stress-assisted transformation occurs
with increasing strain until the parent lattice achieves
complete saturation then the deformation of martensite
occurs with traditional slip mechanisms via power-law
hardening mechanisms.102 Increasing defect density will
strengthen the austenitic structure and impact the stress-
assisted martensitic transformation by decreasing the
stress necessary to nucleate the martensite, creating higher
monotonic work-hardening rates, while the resulting
higher strength promotes increased reversible mechan-
isms which all culminate in a decrease in the hysteresis
as the cycling continues.102
In the case of the SM effect, the austenite will transform
from the previously cubic structure into a low temperature
monoclinic B19′ or 11 (International Tables for Crystallo-
graphy, space group P21/m) form upon a decrease in
temperature as a result of the martensitic transformation
as shown in Fig. 12b.28,102,155,162,164 Some transform-
ations may also include a rhombohedral R phase follow-
ing the B2 and before the B19′ phase in some worked and
aged NiTi and NiTiCr alloys denoted as B19. The temp-
erature at which the martensitic transformation occurs
can be raised by the application of stress, and the stress
rate observed in uniaxial tension testing of Nitinol follows
a modified Clausius–Clapeyron relationship as shown
equation (30).
ds −DH
= (30)
dT T1
16 International Materials Reviews 2016
The change in stress σ divided by the change in temp-
erature T is equated to the enthalpy change ΔH, divided
by the temperature multiplied by the resolved uniaxial
strain ε. Because the stress–strain behaviour is strongly
temperature dependent, an increase in the difference
between the operating environment and the austenite fin-
ish temperature Af can shift the hysteresis up, while a
decrease in the difference will shift the hysteresis
down.155 Elastic deformation cannot be recovered if the
temperature is reduced below the martensite finish temp-
erature Mf, although recovery can be accomplished with
added thermal stress.155
Processing Nitinol wires presents unique challenges in
maintaining a desired microstructure due to the mechan-
ical and thermal treatments associated with homogenis-
ation, solution treating, hot/cold working and heat
setting.162 Phase precipitation and phase homogeneity
occurs with solution treatment and homogenisation con-
tributing to the SE behaviour while hot working can coun-
ter strain hardening and dendritic microstructure.162
NiTi binary alloys
SE properties of Nitinol are favoured for self-expanding
stent designs which require recovery from crushing155
and other large deformations134 and in orthodontic
applications where large deflections are necessary with
low forces.107,166 The SM property of Nitinol is also
important in the design of micro-electro-mechanical sys-
tems, actuators for robotics and is also used in orthodon-
tic archwires.24,107,167 More recently, with the concerns
of nickel sensitivity in the body, research has grown in
developing nickel-free SM and SE alloys. Standard
specifications for Nitinol include ASTM F2063117
which outlines the mechanical and metallurgical require-
ments in bar, flat rolled product and tube. Cold-worked
finished tube is described in ASTM F2633.168 Noted
binary alloys under investigation for medical devices
that eliminate nickel due to sensitivity include: Ti–Ta
and Ti–Nb.123
 Gbur and Lewandowski
NiTi ternary alloys
A variety of alloys are commercially available with SM
properties (Ni–Ti–Fe,140 Ni–Ti–Cu140 and Ni–Ti140)
and with SE properties (Ni–Ti,140 Ni–Ti–Fe140 and Ni–
Ti–Cr140). The additional alloying elements aid in tuning
the material for specific applications. The addition of cop-
per can raise or lower the transition temperature range to
austenite thereby modifying the clinical activity for ortho-
dontic archwires in situ.107 An increase in the yield
strength can be achieved with the addition of cobalt as
well as increases in modulus, loading plateau and unload-
ing plateau when compared to the binary NiTi.26 NiTiCu
has been heavily investigated for SM actuator appli-
cations due to the low functional fatigue, high defor-
mation recovery, high transformation temperature
stability and low hysteresis range.169 Alloy systems that
have been under investigation include: Ni–Ti–Cu,169
Ni–Ti–Co,26 Ni–Ti–Nb,170 Ti–Nb–Sn, Ti–Mo–Ga, Ti–
Nb–Al, Ti–Mo–Al, Ti–Sc–Mo, Ti–Mo–Ag and Ti–Mo-
–Sn.24,43,107,123,167 In addition to wire form, ternary alloys
have been investigated in ribbon form and evaluated with
copper and tungsten alloying elements to ascertain effects
on the microstructure and mechanical properties.171
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TNTZ
TNTZ alloys centre on the Ti–Nb–Ta–Zr system.44 The
microstructure in the transverse direction reveals
equiaxed single β with similar results in the longitudinal
section.44 Tension data from evaluation of 1.0 and 0.3
mm diameter wires revealed UTS and 0.2% proof stress
as 740 and 490 MPa for the 1.0 mm wire and 800 and
410 MPa for the 0.3 mm wire, respectively, with
elongations approximately 5% for both wire diameters.44
These developing alloys can also experience varying
degrees of superelasticity and/or SM.
Mechanical property data
Tension data
Mechanical properties for the materials described in ‘Fati-
gue data’ section are listed in Table 4 noting the alloy,
elastic modulus E, yield strength σy, ultimate tensile
strength UTS, percent elongation El %, percent reduction
in area RA% and wire diameter when provided by the
investigator(s). Included in column 2 of Table 4 is the fati-
gue test method used, discussed in ‘Review of test tech-
niques’ section.
Fatigue data
The available fatigue data on individual materials systems
will first be summarised for individual wire and/or cable
systems. When possible, the information will be replotted
from data summaries provided in the original paper(s),
although reproduction of data summaries provided by
others will be used in situations where this is not appropri-
ate. There is a longstanding successful use of stainless
steels in such applications along with their historical data-
base and understanding. Because of this, the data sum-
maries will begin with these materials processed via
conventional wire drawing processes and will transition
to more recent work that has examined the effects of
laser machining/treatment on the microstructure and fati-
gue properties. This will be followed with other recent
work that has explored the effects of producing composite
Fatigue and fracture of wires and cables for biomedical applications
DFT wires on the fatigue performance. General obser-
vations will be summarised on the effects of changes in
wire diameter, cable architecture, material condition (i.e.
as-drawn, annealed, etc.), laser processing and cyclic
stress/strain on the fatigue performance.
Fatigue data is generally presented in cyclic stress vs.
cyclic life or cyclic strain vs. cyclic life using log or semi-
log plots. Tests conducted at high stress/strain typically
fail in LCF and tend to exhibit less scatter than that
obtained in the low stress/strain regime, where HCF con-
ditions dominate.2 The fatigue curves often display a clear
region of LCF followed by a knee in the curve to a region
of HCF. Table 4 provides a summary of typical tensile
properties in some of the systems described.
A listing of data collected is first arranged in Table 4
providing the test method (i.e. from ‘Review of test tech-
niques’ section), investigator(s), material and sample
form. Subsequent sections provide fatigue data for each
major material classification. This review focuses on the
fatigue testing of wire and cable using strain/life and/or
stress/life plots. Readers interested in fatigue crack growth
testing and analysis on bulk materials used in biomedical
applications, including Nitinol and ASTM F562, are
referred to an earlier review by Robertson et al.172 and
work by Schaffer,136 respectively.
Stainless steels
Figure 13 summarises cyclic strain vs. cycles to failure Nf
data for 316L/316 LVM/SUS316,2,11,14,34,40,43,44,58,60
NAS106N,8 austenitic stainless steel7,14 and 308L.27 The
data presented were obtained on single wires, strands or
coiled strands containing wires with diameters ranging
from 0.025 mm7,8,14,40 to 1.0 mm.27,43,44 Data were gener-
ated in air,2,8,11,27,34,40,43,44,58,60 or in solution7,8,14,43,58
using notched tension,44 flex bending (Fig. 6d),11,34 dual
bend rotating bending (Fig. 8c)2 or single bend rotating
bending (Fig. 8a and b)7,8,14,27,40,43,58 fatigue configur-
ations. Data points where the test was stopped at a prede-
termined level are considered run-outs and identified with
an arrow to the right of the data point in this graph and all
subsequent graphs in the review. The values for cyclic
strain range were obtained by assuming linear elastic
material properties and applying classic beam theory as
discussed previously in ‘Review of test techniques’ section.
The majority of the rotary bend tests reported were per-
formed without any groove or guide pin while some others
were performed using groove or guide pin. Altman et al.2
made use of a grooved polyethylene block to guide the wire.
Scheiner et al.60 and Meyer40 used guide pins on a Teflon
block to guide the wire. The use of a groove or guide
pin introduces additional frictional forces on the wire and
this may reduce the fatigue life. Reported test rates ranged
from 60043 to 4000 rev min−1 2 for rotating bending fatigue
and 1 Hz2,11,34 for flex bending fatigue while rates used by
Iguchi et al.,8 Meyer40 and Niinomi44 were not reported.
As indicated in Fig. 13, the 316LVM was tested in both
the annealed (i.e. low strength, high ductility) and hard
(i.e. high strength, lower ductility conditions).
More recent work by Lewandowski et al.11 and Lav-
vafi34 on 316LVM wires were conducted using the flex
bending fatigue technique shown in Fig. 6d. In all of
these cases, the flex fatigue tests were performed at 1 Hz
with less than 86 g load to keep the specimen in place
while testing. This small load produces a very small stress
International Materials Reviews 2016 17
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

Table 4 Data reported for a variety of wires used in biomedical applications

Test Material E σy UTS El RA Wire size

Alloy method form GPa MPa MPa % % mm Source

308L RBT Wire 1.0 Figueiredo et al. 27

316LVM RBT Wire 199 1628 2.6 0.178 Altman et al. 2
316LVM Flex Cable 193 1135 1239 1.9 89 0.034 Lewandowski et al.11
316L RBT Wire 599 896 21 90 0.04 Meyer40
316L RBT Wire 2254 2585 2 40 0.04 Meyer40
316L RBT Cable 1034 1206 80 0.045 Meyer40
316L RBT Cable 482 758 95 0.025 Meyer40
316L RBT Cable 2040 0.025 Narushima et al. 14
316L RBT Wire 173 1801 0.127 Schaffer et al. 58
316LVM RBT Wire 710 0.046 Scheiner et al. 60
316LVM RBT Wire 1896 0.046 Scheiner et al. 60
316LVM RBT Cable 1034 0.034 Scheiner et al. 60
316LVM RBT Cable 1199 0.034 Scheiner et al. 60
316LVM RBT Cable 0.026 Scheiner et al. 60
316LVM RBT Cable 0.046 Scheiner et al. 60
316LVM-A Flex Wire 681 0.254 Lavvafi34
LP Nd:YAG Flex Wire 726 0.245 Lavvafi34
HP Nd:YAG Flex Wire 687 0.204 Lavvafi34
Femtosecond Flex Wire 712 0.230 Lavvafi34
316LVM-H Flex Wire 1200 0.254 Lavvafi34
LP Nd:YAG Flex Wire 1280 0.245 Lavvafi34
Lavvafi34
Downloaded by [Laurentian University] at 08:38 14 May 2016

HP Nd:YAG Flex Wire 815 0.204

Femtosecond Flex Wire 1320 0.230 Lavvafi34
Austenitic SS RBT Coil 0.025 Iguchi et al. 7
Austenitic SS RBT Cable 2600 0.025 Narushima et al. 14
SUS316L Notched Wire 187 320 660 29 47 1.0 Niinomi et al. 44
SUS316L RBT Wire 1.0 Niinomi43
SUS316L RBT Coil 0.025 Iguchi et al. 8
NAS106N RBT Coil 0.025 Iguchi et al. 8
35N LT Flex Wire 1651 2069 77 0.0508 Benini4
35N LT RBT Wire 2847 3132 3.1 0.1765 Bradley et al. 23
ASTM F562 RBT Wire 2876 3076 2.9 0.1765 Bradley et al. 23
L-605 RBT Wire 243 547 1449 0.125 Marrey et al. 12
MP35N RBT Wire, coil 236 2021 3.1 0.127 Altman et al. 2
MP35N RBT Wire 236 1904 2.5 0.102 Altman et al. 2
MP35N RBT Coil 236 2028 3.8 0.178 Altman et al. 2
MP35N UNI Coil 0.1016 Campbell et al. 71
MP35N UNI Coil 0.1143 Campbell et al. 71
MP35N UNI Coil 0.1397 Campbell et al. 71
MP35N RBT Wire 1968 0.1270 Hildebrand et al. 30
MP35N RBT Wire 1985 0.1778 Hildebrand et al. 30
MP35N RBT Wire 1703 0.2286 Hildebrand et al. 30
MP35N RBT Coil 0.2286 Hildebrand et al. 30
MP35N RBT Wire 0.102 Li et al. 35
MP35N RBT Wire 1771 0.046 Scheiner et al. 60
MP35N RBT Wire 2164 0.046 Scheiner et al. 60
MP35N RBT Cable 0.046 Scheiner et al. 60
NAS604PH RBT Coil 0.025 Iguchi et al. 8
Syntacoben RBT Wire 0.045 Scheiner et al. 60
DFT-35N LT Flex Wire 809 1358 60 0.0635 Benini4
DFT-35N LT RBT Wire 1372 1503 2.3 0.1778 Kay et al. 31
DFT-MP35N RBT Wire, coil 1462 2.2 0.127 Altman et al. 2
DFT-MP35N RBT Wire, coil 1462 2.4 0.152 Altman et al. 2
DFT-MP35N RBT Wire, coil 1414 2.0 0.102 Altman et al. 2
DFT-MP35N RBT Coil 1566 2.3 0.178 Altman et al. 2
DFT-MP35N UNI Coil 0.0889 Campbell et al. 71
DFT-MP35N RBT Wire 1351 1503 2.7 0.1778 Kay et al. 31
DFT-MP35N RBT Wire 1289 1523 2.8 0.1778 Kay et al. 31
DFT-MP35N Flex Cable 194 1109 1148 1.5 29 0.038 Lewandowski et al.10
DFT-MP35N Flex Cable 194 0.064 Lewandowski et al.10
DFT-MP35N Flex Cable 194 1051 1068 3.3 29 0.046 Lewandowski et al.10
DFT-MP35N Flex Cable 194 1062 1226 3.3 24 0.058 Lewandowski et al.10
DFT-MP35N Flex Cable 194 808 1111 4.6 18 0.036 Lewandowski et al.10
DFT-Fe25%Mg RBT Wire 161 1665 0.127 Schaffer et al. 58
DFT-Fe57%Mg RBT Wire 109 1100 0.127 Schaffer et al. 58
DFT-Fe35Mn25Mg RBT Wire 129 1439 0.127 Schaffer et al. 58
DBS-316LVM RBT Wire, cable 0.043 Scheiner et al. 60
DBS-316LVM RBT Wire, cable 703 0.046 Scheiner et al. 60

(Continued)

18 International Materials Reviews 2016

 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

Table 4 Continued.

Test Material E σy UTS El RA Wire size

Alloy method form GPa MPa MPa % % mm Source

Pure Ti Notched Wire 90 210 360 9 47 1.0 Niinomi et al. 44

Ti–4V6Al equiaxed RBT Wire 1.0 Niinomi43
Ti–4V6Al Windm. RBT Wire 1.0 Niinomi43
Pt–20Ir RBT Wire 230 1178 1231 2.2 0.102 Li et al. 35
Silver RBT Wire, coil 73.4 1145 1.8 0.178 Altman et al. 2
Fe–50%CW RBT Wire 177 813 0.127 Schaffer et al. 58
Fe–90%CW RBT Wire 192 1032 0.127 Schaffer et al. 58
Fe-99%CW RBT Wire 202 1728 0.127 Schaffer et al. 58
Fe35Mn RBT Wire 178 1893 0.127 Schaffer et al. 58
NiTi RBT M-wire file ISO size 30 Al-Hadlaq et al. 22
NiTi Flex Wire 300 1392 64 0.3556 Benini4
NiTi Flex Wire 291 1398 64 0.4064 Benini4
NiTi Flex Wire 313 1345 62 0.4572 Benini4
NiTi Flex Wire 283 1179 67 0.508 Benini4
NiTi Flex Wire 447 1679 57 0.3556 Benini4
NiTi Flex Wire 462 1685 53 0.4064 Benini4
NiTi Flex Wire 429 1489 57 0.4572 Benini4
NiTi Flex Wire 381 1507 62 0.508 Benini4
NiTi RBT Wire 0.5 Chan et al. 24
NiTi RBT Welded wire 0.5 Chan et al. 24
NiTi Axial Wire 0.300 Dooley et al. 25
Fasching et al. 26
Downloaded by [Laurentian University] at 08:38 14 May 2016

NiTi (Af 7°C) RBT Wire 1320 0.381

NiTi (Af 17.9°C) RBT Wire 1.0 Figueiredo et al. 27
NiTi (Af 4°C) RBT Wire 1.0 Figueiredo et al. 27
NiTi (Af 48°C) RBT Wire 1.0 Figueiredo et al. 27
NiTi (Af 57.3°C) RBT Wire 1.0 Figueiredo et al. 27
NiTi RBT Wire 0.8 Frotscher et al. 28
NiTi (Af 50°C) ALT, RBT, UNI Wire 0.75 Furuichi et al. 29
NiTi Axial Spring 0.2 Hirmanova et al. 72
NiTi (As −20.1°C) RBT Wire 0.32 Kumar et al.32
NiTi (As −16°C) RBT Wire 0.32 Kumar et al. 32
NiTi (As −18°C) RBT Wire 0.32 Kumar et al. 32
NiTi (As −14°C) RBT Wire 0.32 Kumar et al. 32
NiTi (As −18.2°C) RBT Wire 0.32 Kumar et al. 32
NiTi (Af 13°C) Axial Z-wire 0.50 Launey et al. 33
NiTi (Af 13°C) Axial Z-wire 0.508 Lin et al. 36
NiTi (Af 94°C) Axial Wire 0.150 Mammano et al. 37
NiTi (Af 32°C) RBT Wire 0.3302 Martin et al. 38
NiTi ALT, RBT, UNI Wire 0.5 Matsui et al. 39
NiTi ALT, RBT, UNI Wire 0.75 Matsui et al. 39
NiTi (Af 77°C) RBT Wire 1.0 Miyazaki et al. 41
NiTi (Af 12°C) Axial Wire 0.65 Morgan et al. 42
NiTi Notched Wire 72 880 1300 14 47 1.0 Niinomi et al. 44
NiTi RBT Wire 0.53 Norwich46
NiTi (Af 11°C) RBT Wire 0.2286 Norwich et al. 45
NiTi (Af 11°C) RBT Wire 0.6096 Norwich et al. 45
NiTi (Af 3.2°C) RBT Wire 0.323 Patel et al. 47
NiTi (Af 12°C) RBT Wire 0.323 Patel et al. 47
NiTi (Af 20.8°C) RBT Wire 0.323 Patel et al. 47
NiTi (Af 9°C) RBT Wire 0.267 Patel48
NiTi (Af 13°C) RBT Wire 0.267 Patel48
NiTi (Af 24°C) RBT Wire 0.323 Patel et al. 49
NiTi (Af 22°C) RBT Wire 0.323 Patel et al. 49
NiTi (Af 18°C) RBT Wire 0.323 Patel et al. 49
NiTi (Af 23°C) RBT Wire 0.323 Patel et al. 49
NiTi (Af 13°C) RBT Wire 1543 14.7 0.127 Patel et al. 50
NiTi (Af 21°C) RBT Wire 1551 14.2 0.127 Patel et al. 50
NiTi (Af 9°C) RBT Wire 1475 14.2 0.267 Patel et al. 50
NiTi (Af 14°C) RBT Wire 1496 14.2 0.267 Patel et al. 50
NiTi (Af 2°C) RBT Wire 0.6 Pelton et al. 51
NiTi (Af 4°C) RBT Wire 0.6 Pelton et al. 51
NiTi (Af 7°C) RBT Wire 0.6 Pelton et al. 51
NiTi (Af 64°C) RBT Wire 0.6 Pelton et al. 51
NiTi (Af 12°C) RBT Wire Polinsky et al. 52
NiTi (Af 30°C) RBT Wire 0.75 Rahim et al. 53
NiTi (Af 30°C) RBT Wire 0.75 Rahim et al. 54
NiTi (Af 9.3°C) RBT Wire 1475 14.2 0.267 Reinoehl et al. 55
NiTi (Af 13.6°C) RBT Wire 1498 14.2 0.267 Reinoehl et al. 55

(Continued)

International Materials Reviews 2016 19

 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

Table 4 Continued.

Test Material E σy UTS El RA Wire size

Alloy method form GPa MPa MPa % % mm Source

NiTi (Af 17.7°C) Axial Wire 0.6 Sateesh et al. 56

NiTi RBT Wire 1.0 Sawaguchi et al. 57
NiTi RBT Wire 1.2 Sawaguchi et al. 57
NiTi RBT Wire 1.4 Sawaguchi et al. 57
NiTi RBT Wire 0.32 Schaffer et al. 59
NiTi (Af 13°C) RBT Wire 0.8 Sheriff et al. 61
NiTi (Af 18.9°C) ALT Wire 0.5 Takeda et al. 62
NiTi (Af 37.9°C) ALT Wire 0.5 Takeda et al. 62
NiTi (Af 43.9°C) ALT Wire 0.5 Takeda et al. 62
NiTi ALT, RBT, UNI Wire 0.5 Tobushi et al. 63
NiTi (Af 49.9°C) RBT Wire 0.75 Tobushi et al. 64
NiTi (Af 49.9°C) RBT Wire 0.75 Tobushi et al. 65
NiTi (Af 49.9°C) RBT Wire 0.75 Tobushi et al.66
NiTi RBT, UNI Wire 0.75 Tobushi et al. 67
NiTi RBT Wire 1.0 Wagner et al. 68
NiTi RBT Wire 1.2 Wagner et al. 68
NiTi RBT Wire 1.4 Wagner et al. 68
NiTi RBT Wire 1.0 Ye et al. 69
NiTi RBT Wire 0.20 Young et al. 70
NiTi RBT Wire 0.32 Young et al. 70
NiTi RBT Wire 0.45 Young et al. 70
Benini4
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NiTi 1018 Flex Wire 933 1499 69 0.2

NiTi 1045 Flex Wire 534 1489 60 0.2 Benini4
NiTiCo (Af 67°C) RBT Wire 1320 0.381 Fasching et al. 26
NiTiCr Axial, RBT Wire 0.8 Frotscher et al. 28
NiTiCr Axial, RBT Wire 1300 1.2 Frotscher et al. 28
NiTiCu (Af 57°C) RBT Wire 1.0 Miyazaki et al. 41
TNTZ Notched Wire 50 490 740 5 47 1.0 Niinomi et al. 44
TNTZ Notched Wire 55 410 800 5 28 0.3 Niinomi et al. 44
LP, low power; HP, high power; A, annealed; H, hard; CW, cold worked; ALT, alternating bending fatigue; Flex, flex bending fatigue; axial,
axial fatigue; notched, notched axial fatigue; RBT, rotating bending fatigue test; UNI, unidirectional bend fatigue.

on stranded wires and cables, particularly for larger diam-
eter wires and is used solely for the purpose of keeping the
wire sample on the mandrels during testing. While the low
test frequency was used to simulate physiological test con-
ditions, it also minimises any sample heating due to the
cyclic strains imposed combined with the low thermal
conductivity of this material. In the flex bending fatigue
tests, high cyclic strain values (e.g. above 5% strain
range) were achieved by using mandrels of smaller diam-
eters (< 2 mm). Figure 14 summarises the flex bending
fatigue work from these authors in addition to other
single strand wire data obtained using other techniques.
The cyclic strain range in all of these experiments was cal-
culated according to equation (27) shown earlier as the
wire diameter/mandrel radius. 316LVM wires were
obtained and tested in both the annealed and hard con-
ditions, while the tensile properties obtained in these con-
ditions are summarised elsewhere.11,34
In addition to examining the fatigue performance of as-
received annealed and hard wires, Lavvafi34 further eval-
uated the effects of laser machining on the subsequent
strength and flex bending fatigue performance (Figs. 15
and 16).
In that work, nano-second (i.e. LP, HP) and femtose-
cond (i.e. FS) laser treatments were performed on both
annealed and hard 316LVM wires before microstructure
examination, microhardness testing, tension testing and
flex bending fatigue experimentation. Metallographic
cross-sections of the annealed and hard materials, covered
in ‘Microstructures and fractography’ section, revealed
the creation of a re-cast layer corresponding to each
pass of the laser leaving a different microstructure com-
pared to the parent material. Significant microstructural
changes were observed on the laser-treated wires depend-
ing on their starting (i.e. annealed vs. hard) condition and
laser intensity employed. In particular, high laser power
(i.e. HP) input produced significant melting on the wire
surface, followed by significant surface roughness and
microcracking, thereby reducing the tension and fatigue
behaviour significantly. However, lower laser power (i.e.
LP) input appeared to produce much less damage on
the wire surfaces and was shown to improve the flex bend-
ing fatigue behaviour of the annealed 316LVM (Fig. 15).
Focussed ion beam (FIB) sectioned regions of the LP-
treated wires revealed refinement of the microstructure,
as seen later in Fig. 75, while microhardness testing
revealed hardness increases near the laser-treated sur-
faces. While the tensile properties of such laser-treated
wires was not significantly affected due to the small
regions affected near the surfaces of the wires, the flex
bending fatigue performance was significantly affected
(Figs. 15 and 77). This likely is due to the microstructure
refinement shown in Fig. 75 and strength increase near
the wire surfaces, although such low power laser treat-
ments may also provide beneficial residual stresses similar
to that commercially obtained in laser shock peening.
More work is warranted in this area due to the widespread
use of various laser machining processes in the manufac-
ture of biomedical (and other) devices.
Additional wire investigations (Fig. 14) utilising rotat-
ing bending fatigue were performed by Altman et al.,2
Figueiredo et al.,27 Meyer,40 Niinomi,43 Schaffer et al.58

20 International Materials Reviews 2016

 Gbur and Lewandowski
and Scheiner et al.60 Altman et al.2 tested an average of 10
samples of 316LVM, 178 µm diameter, 1628 MPa UTS
wire at three different test radii using the dual bend rotat-
ing bending test configuration (Fig. 8b). Due to the test
configuration, each sample could fail in one of two poss-
ible locations. Single bend rotating bending tests of var-
ious configurations were used to evaluate the fatigue life
of 1.0 mm diameter 308L,27 0.127 mm diameter 316L,58
0.04 mm diameter 316LVM40,49 and notched tension
was performed on 1.0 mm diameter SUS316L44 wires.
The wires displayed typical fatigue properties; a decrease
in cyclic strain leads to an increase in fatigue life as well as
an increase in the scatter for a particular cyclic strain in
the HCF regime. Comparisons of the same materials
and wire diameters but with different UTS (e.g.
316LVM-710 MPa vs. 316LVM-1896 MPa) revealed
that the stronger material exhibited a greater fatigue life
in HCF, while the weaker material displayed increased
fatigue life in LCF.60 A similar comparison of hard and
annealed 316LVM wires40 showed that the annealed
wires performed better in LCF and the hard wires per-
formed slightly better in HCF. Schaffer et al.58 investi-
gated fatigue performance as a function of test
Downloaded by [Laurentian University] at 08:38 14 May 2016
environment for 0.127 mm diameter wires of 316L tested
in either phosphate-buffered saline (PBS) or air. The wires
in air exhibited better performance everywhere except
near 4% strain where the wire in PBS had a longer fatigue
life for the same strain.
As shown above and discussed elsewhere,11 the fatigue
life of annealed vs. hard 316LVM is significantly different
in the LCF vs. HCF regime. The high strength (but lower
ductility) 316LVM wires in the hard condition possess
much better fatigue behaviour in the HCF regime (i.e.
low cyclic strain regime) compared to the lower strength
(but higher ductility) annealed 316LVM. However, the
lower ductility exhibited by the hard 316LVM produces
inferior fatigue behaviour in the LCF regime (i.e. high
cyclic strain regime) compared to the higher ductility in
the annealed 316LVM. This is clearly evident in the sum-
mary plot in Fig. 14 and was also pointed out in early
work by Meyer.40 This behaviour is generally consistent
with the behaviour of structural materials where
the HCF performance is improved by increasing the
strength, while the LCF behaviour is improved by
increasing the ductility. The unique improvement to
both the LCF and HCF regimes exhibited by some of
the laser-treated wires observed by Lavvafi34 warrants
additional work to examine the source(s) and generality
of such observations.
While Fig. 14 summarised the behaviour of individual
316LVM wires, Fig. 17 summarises the fatigue life of
316LVM wire strands. The authors in these cases used
flex bending fatigue (Fig. 6d ) as well as the rotary tech-
nique (Fig. 8a) described previously while again examin-
ing the effects of changes in strength level as well as
wire diameter and architecture on the fatigue life. More
than an order of magnitude variation in the HCF life
and nearly an order of magnitude variation in the LCF
life is reported and may be attributed to the differences
in test conditions and wire strength/ductility values.
Moreover, the data plotted in Fig. 17 are often not the
average values of multiple tests conducted at a particular
strain value, but represent a single test.
In order to complete the documentation, the behaviour
of coiled stainless steel strands is summarised in Fig. 18.
Fatigue and fracture of wires and cables for biomedical applications
The tests conducted by Iguchi et al.7,8 were performed
on 1 × 19 coiled strands and tested at 1000 rev min−1 7
in either air or solution under rotating bending fatigue
with the test apparatus similar to Fig. 8a. As shown in
Fig. 18, the levels of cyclic strain imposed on the strands
was generally less than 1.5% due to the limitations
imposed by the test technique and sample geometry.
The additional chromium and manganese, decreased
nickel content and addition of nitrogen showed an
improved fatigue life for the NAS106N (6.02Mn–10Ni–
22Cr–2Mo–0.41N)8 and austenitic stainless steel coils
(6Mn–10Ni–23Cr–0.5N)7 compared to SUS316L coils
(0.79Mn–12.21Ni–17.46Cr–2.09Mo).8
Cobalt–chromium alloys
Figure 19 summarises data obtained by Altman et al.,2
Benini,4 Bradley et al.,23 Campbell and Johnson,71 Hil-
debrand et al.,30 Iguchi et al.,8 Li et al.,35 Marrey
et al.12 and Scheiner et al.60 on various cobalt–chromium
alloys. The wire diameters tested range from 0.04560 to
0.254 mm8 and the majority of the data was generated
in air2,4,8,23,30,35,60,71 and varied in test methods between
a dual bend (Fig. 8c)2 or single bend (Fig.
8a)8,12,23,30,35,60 rotating bending fatigue configuration,
flex bending fatigue (Fig. 6d)4 or unidirectional bending
fatigue (Fig. 10).71 Iguchi et al.8 and Marrey et al.12 tested
in solution. Hildebrand et al.30 evaluated the CENELEC
standard coil according to the CENELEC test conditions
described in ‘CENELEC fatigue testing’ section in rotat-
ing bending fatigue and is listed separately in the coil data
section. The cyclic strain range was obtained by assuming
linear elastic material properties and applying classic
beam theory as discussed previously. The rotary bend
tests were performed by using a groove,2 guide pin60 or
combination of collets and bushings.8,12,23,30,35 Altman
et al.2 evaluated wires at 4000 rev min−1 while Bradley
et al.,23 Hildebrand et al.,30 Li et al.,35 Marrey et al.12
and Scheiner et al.60 tested at 3600 rev min−1. Hildebrand
et al.30 also tested at a slower rotational rate (120 rev
min−1) to simulate the CENELEC test conditions.
Benini4 tested at 1 Hz in flex bending fatigue, while Iguchi
et al.8 did not report the test speed. Tests conducted under
unidirectional bending varied the radius of curvature of
coils under displacement control and maintained a con-
stant applied curvature ratio of 0.3 between the minimum
and maximum curvatures.71
The data reported by Altman et al.,2 Bradley et al.23
and Scheiner et al.60 are averages of multiple tests while
data reported by Benini,4 Campbell and Johnson,71 Hil-
debrand et al.,30 Iguchi et al.,8 Li et al.35 and Marrey
et al.12 represent individual tests. MP35N wire tested by
Altman et al.2 also included wire with a fine coating of
ethylene tetrafluorethylene (ETFE) to minimise the
potential of fixture-induced surface defects during testing.
As illustrated in Fig. 20, no significant difference was
found between the ETFE coated and uncoated wires. In
these tests, the coating had remained intact throughout
the testing and it was concluded that any abrasion during
testing would not likely result in crack initiation.2 Bradley
et al.23 compared 35N LT wire optimised for microclean-
liness to ASTM F562 and documented improvements in
the HCF regime, also evident in Fig. 20.
Data obtained on cobalt–chromium strands is sum-
marised in Fig. 21. The work by Scheiner et al.60 was
International Materials Reviews 2016 21
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications
Downloaded by [Laurentian University] at 08:38 14 May 2016
13 Fatigue life data for stainless steel alloys
collected from a guided rotating bending fatigue test and
displays data averages from multiple tests, noting again
that a decrease in cyclic strain promotes wire longevity,
consistent with previous discussions.
The behaviour of cobalt–chromium coils is summarised
in Fig. 22. The data represents work by Altman et al.,2
Campbell and Johnson71 and Iguchi et al.8 The data
reported by Altman et al.2 in Fig. 22 are averaged data
from multiple tests and does not include the range bars
that illustrates the large scatter in the HCF regime com-
pared to the smaller scatter in LCF. Tests by Altman
et al.2 and Iguchi et al.8 were performed at a R = −1,
22 International Materials Reviews 2016
while an applied curvature ratio of 0.3 between the mini-
mum and maximum curvatures was performed by Camp-
bell and Johnson.71 The respective coil curvature
amplitude ratio was determined by equation (30) located
in the composite coil data section. Data representing the
passive electrode fixation coil design with an individual
wire diameter of 0.1016 mm exhibited greater fatigue
strength compared to the active electrode coil designs
with individual wire diameters of 0.1143 and 0.1397
mm.71 Work by Iguchi et al.8 compared the test environ-
ment conditions, air vs. 0.9% NaCl for NAS604PH and
found little difference in fatigue performance.
 Gbur and Lewandowski
Downloaded by [Laurentian University] at 08:38 14 May 2016
14 Fatigue life data for stainless steel wires
Hildebrand et al.30 performed rotating bending fatigue
tests (Fig. 8a) with the standard CENELEC coil composed
of MP35N. Ten coils were tested at a bend radius of 6 mm
and rate of 120 rev min−1 to mimic the CENELEC test
conditions and an additional ten coils were rotated at
3600 rev min−1, both at a cyclic strain of 0.004715. The
reported average cycles to failure (and respective
standard of deviation) was 21 625 (2907) cycles for 3600
rev min−1 and 83 005 (12 830) cycles for 120 rev min−1.
Composites
Works by Altman et al.,2 Benini,4 Campbell and John-
son,71 Kay and Bradley,31 Lewandowski et al.,10 Schaffer
et al.58 and Scheiner et al.60 evaluated the performance of
single wires, cables, coated cables and coils typically used
in cardiac lead design and FES systems. The strain/life
graph summarising each DFT form (wire, EFTE coated
wire, strand and coil) is shown in Fig. 23. Most authors
tested in air2,4,10,31,60,71 while Schaffer et al.58 also tested
Fatigue and fracture of wires and cables for biomedical applications
in solution. The DFT wires were evaluated under dual
bend (Fig. 8c)2 and single bend rotating bending fati-
gue,31,58,60 flex bending fatigue4,10 and unidirectional
bend fatigue.71 Individual wire diameters ranged from
0.038 mm10 to 0.178 mm.2 Data by Kay and Bradley31
and Schaffer et al.58 are presented individually in Figs.
2531 and 32.58
Figure 24 shows data for DFT and DBS from Altman
et al.,2 Benini4 and Scheiner et al.60 Data from Altman
et al.2 and Scheiner et al. 60 represent an average of mul-
tiple tested samples while data from Benini4 represents
single tests. ETFE coated wires were tested, statistically
compared and determined to behave similarly to
uncoated samples in the work by Altman et al.2 in order
to verify that the dual bend test fixture did not induce
damage to the samples.
Kay and Bradley31 performed unguided rotating bend-
ing fatigue on monofilament wire for 35N LT DFT and
MP35N DFT from two different suppliers (Fig. 25).
Seven wires at each stress level were tested in air with a
International Materials Reviews 2016 23
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications
Downloaded by [Laurentian University] at 08:38 14 May 2016
15 Fatigue life data for 316LVM annealed wires following laser treatment34
run-out defined as 54 million cycles. Weibull analyses of
the data revealed that the optimised 35N LT DFT exhib-
ited a 519% improvement over the MP35N DFT wires.
Details on the microcleanliness evaluation of the individ-
ual materials can be found in ‘Cobalt–chromium–nickel
alloys’ section.
Lewandowski et al.10 examined the effects of changes in
wire diameter and cable configuration on the fully
reversed flex bending fatigue (Fig. 6d ) of DFT. The indi-
vidual wire diameters ranged from 0.038 to 0.064 mm in
1 × 7, 7 × 7 and 7 × 19 architectures with overall cable
diameters ranging from 0.103 to 0.533 mm. A summary
of the results along with rotating bending fatigue data
from Scheiner et al. 60 is shown in Fig. 26. As expected,
in the flex bending fatigue tests, an increase in the mandrel
diameter improves the fatigue life of the cable due to the
lower applied cyclic strain on the specimen. Minimal
effects of changing the wire diameter were obtained on
the fatigue behaviour for a given cyclic strain for tests con-
ducted on both 1 × 7 and 7 × 7 cables. More significant
effects in fatigue behaviour were attributed to the vari-
ation in architecture of the cables.
To complete the discussion of composite alloys, a sum-
mary of the behaviour of coiled strands is presented in
Fig. 27. The data represents work by Altman et al.2 and
Campbell and Johnson.71 As mentioned previously, the
R = −1 data from Altman et al.2 is reported as average
data and does not include range bars. Data from Camp-
bell and Johnson71 represents single data points that
24 International Materials Reviews 2016
were converted to cyclic strain through given values of
applied curvature amplitude Ka represented by equation
(31) and the applied curvature ratio Rk (rmin/rmax) of 0.3
between the minimum and maximum curvatures.
 
1 1 1
Ka = − (31)
rmin rmax 2
Other materials
In addition to the previously discussed stainless steel
alloys, cobalt–chromium alloys and metallic composites,
a variety of other alloys are also found in current biome-
dical devices and others are under development for
implantable devices.
Li et al.35 investigated the fatigue behaviour and micro-
structure of cold drawn Pt–20Ir wire used in implantable
neurostimulators. Wires were tested at 3600 rev min−1 in
rotating bending fatigue (Fig. 8a) and produced run-
outs at 1 × 107 cycles at approximately 0.18% cyclic strain
(Fig. 28).
A comparison of titanium alloys, Ti–6Al–4V (equiaxed
α) and Ti–6Al–4V (Windmanstatten α) to SUS316L is
reproduced from Niinomi in Fig. 29.43 Rotating bending
tests were performed at 600 rev min−1 in air and Ringer’s
solution. The comparison highlights the reduction in fati-
gue life due to corrosion fatigue obtained in SUS316L
tested in a simulated body environment in contrast to
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16 Fatigue life data for 316LVM hard wires following laser treatment34
the Ti–6Al–4V alloys which exhibited similar fatigue life
in both air and solution.
Niinomi et al.44 analysed 1.0 mm diameter wires of Ti–
29Nb–13Ta–4.6Zr (TNTZ) as an alternative to hard-tissue
replacement materials and compared them with the more
common Nitinol, pure Ti and SUS316 wires. Using a
notched fatigue approach, wires were first cut to a length
of 80 mm, then wet polished and notched to a 0.2 mm
depth with a notch radius of 0.15 mm to produce a stress
concentration factor of 2.15. Tests were conducted in air
at 600 rev min−1 with a stress ratio of 0.1, while run-out
was considered at 107 cycles. Figure 30 shows that
SUS316L exhibited the best fatigue life between the mid-
range cyclic stresses, attributed to its inherent ductility
and subsequent resistance to fatigue crack propagation.
TNTZ performed better than Nitinol in the LCF regime
while reductions in the cyclic stress produced similar fati-
gue lives for both the Nitinol and TNTZ, and somewhat
exceeding the performance of pure Ti.
Schaffer et al.58 examined 0.127 mm diameter wires of
cold-worked iron, Fe–Mg DFT, Fe35Mn and Fe35Mn–
Mg DFT in rotating bending fatigue to evaluate their via-
bility as a biodegradable platform for use in self-expand-
ing bioabsorbable stents. Four monolithic wires
(Fe35Mn, Fe–50%CW, Fe–90%CW and Fe–99%CW
where CW = % cold work) and three DFT wires
(Fe35Mn–DFT–25%ZM21, Fe–DFT–25%Mg and Fe–
Fatigue and fracture of wires and cables for biomedical applications
DFT–57%Mg) were tested in air and saline at 3600 rev
min−1 and compared to 316L wire, with a predetermined
run-out of 107 cycles. The Fe35Mn and Fe35Mn–DFT–
25%ZM21 exceeded the performance of the 316L wire
in the LCF regime, while the 316L wire outperformed
all materials in the HCF regime (Fig. 31). The run-out
values in percent alternating strain for 316L was 0.38%,
while that for the highest performing biodegradable
alloy, Fe35Mn, was 0.30%.
Figure 32 compares the effects of test environment on
the fatigue lives of Fe 99CW, Fe35Mn, 316L, Fe35Mn–
DFT–25% ZM21, Fe–DFT–25% Mg and Fe–DFT–
57% Mg. The improvement in LCF behaviour obtained
with the saline environment was attributed to convective
cooling. The authors opined that in the LCF regime, an
increased production of heat during cycling would pro-
duce cyclic softening and decrease the LCF performance.
In contrast, in the HCF regime, a significant decrease in
fatigue life was observed in all bioabsorbable wires tested
in saline with none achieving the run-out of 107 cycles,
attributed to corrosion fatigue. Included in Fig. 32 is a
fit of the LCF data according to the Coffin-Manson173
approach captured in equation (32).
D1p ′
= 1f (2Nf )c (32)
2
International Materials Reviews 2016 25
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17 Fatigue life data for stainless steel strands
Nitinol and other SM and SE alloys
The section on Nitinol alloys is somewhat larger than the
other sections due to its rapidly expanding use in various
biomedical applications. The majority of the work
and interest is in the behaviour of SE Nitinol and will
be the main focus of subsequent sections referring to
Nitinol. However, a basic review of the SE and SM effects
is presented first.
The schematic of the SE effect depicted in Fig. 12a
demonstrates the recoverable stress and strains for a
finite range of temperatures (T > Af, where Af is the
austenite finish temperature). Beginning in an austenitic
state, the applied stress induces a transformation to
martensite, known as stress-induced martensite
(SIM).25,163 This transformation begins with a Hoo-
kean linear elastic deformation until reaching a critical
stress wherein additional stress causes a nonlinear
stress–strain response25 and stress plateau that may per-
sist for approximately 4-6% strain, followed by work
hardening. Additional transformation to martensite,
accompanied by twinning will occur, eventually
exceeding the SE limit. The SIM is in a metastable
state and will revert back to austenite when the stress
is removed, creating the SE effect. Strain recovery
can range from 6 to 8%25 depending on the
26 International Materials Reviews 2016
composition, heat treatment and stress–strain charac-
teristics of the Nitinol.
The SM condition is illustrated in Fig. 12b. The
material in this instance is shape set in the high-temp-
erature austenitic phase wherein the parent phase con-
sists of a cubic crystal structure.25,163 By cooling the
material below the martensite start temperature, another
shape can be formed in the martensitic state. Heating
this structure by heating above the austenite transition
temperature will then return the material to its original
shape,25 and up to 8% strain can be recovered by the
SM effect.25 While in the martensitic phase, deformation
strains are accomodated by a twinning process that can-
not be accommodated in the austenitic phase, leading to
the return of the deformation (i.e. removing the twin
boundaries) upon heating back to austenite.159 This
may occur in one direction where the shape is retained
in one phase or it may occur in two directions wherein
the shape is retained in both phases.163
The series of references by Churchill, Shaw and Iadi-
cola (Series 1–4)163,174–177 and Reedlunn et al. (Series
5)178 provide an excellent overview of SM and SE behav-
iour, along with useful information on a variety of testing
options and common pitfalls. In relation to this section on
fatigue testing conditions and results, included in those
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18 Fatigue life data for stainless steel coiled strands8
papers is advice on characterising those alloy systems.
Some information regarding fatigue testing will be
provided within this review, but the remaining
characterisation information from this series is left for
the reader. Articles on designing with SM
alloys,134,155,159,163,167,178,179 fatigue and fracture (includ-
ing crack growth),15,43,54,123,136,172,180–183 along with
studies addressing multi-axis testing,82,184–186 wire-size
alternate sample forms (i.e. diamond, folded strut, dog
bone, etc.)36,187–192 processing techniques,162,193 laser
machining,194–197 surface conditions,198–200 biocompat-
ibility123,201 and corrosion72,123,166,202–205 also provide
valuable background information for these alloys. Effects
of composition, processing, surface condition, joining
techniques, wire diameter, test environment, rotational
speed/frequency, test configuration, applied mean strain
and material cleanliness will be discussed. Additionally,
a brief treatment noting some fatigue testing of dental
materials including archwires,4 endodontic wires and
files22 will occur at the end of this section.
Figures 33 and 34 present accumulated data on Nitinol-
based alloys. The legacy data includes Nitinol and other
NiTi-based alloys in the single wire form only and is domi-
nated by rotating bending (Fig. 8a–c) fatigue test tech-
niques22,24,26–29,31,32,38,39,41,45–55,57,59,61,63–70 with a few
additional investigations on alternate fatigue methods
including alternating bending (Fig. 8a),29,39,62,63
axial,25,33,36,37,42,56,72 pulsatile (Fig. 10),29,33,36,37,39,63,67,72
Fatigue and fracture of wires and cables for biomedical applications
notched44 and flex bending (Fig. 6d)4 fatigue. Test environ-
ment conditions varied from air4,22,24,25,27–
29,32,37,39,44,56,57,62–70,72 28,41,66,68
to oil to numerous sol-
ution-based environments.26,33,36,38,42,45–55,59,61,64–66,70,72
Unless otherwise stated, all tests utilised a stress ratio of
R = −1 with the exception of pulsatile testing (R = 0, 0.1,
0.2, 0.3),29,39,63,67 axial25,33,36,37,42,56 and notched (R =
0.1).43 Test rates for rotating bending fatigue range from
3668 to 6000 rev min−1 32 and only Figueiredo et al.27 did
not report a test rate. Wire diameters tested ranged from
0.12750 to 1.4 mm.57,68 Additional Nitinol data, not
shown in Figs. 33 and 34, is presented separately by author
in subsequent graphs to illustrate particular effects in Niti-
nol wire fatigue. The following sections summarise some of
the key factors that have been identified as critical to the
fatigue performance of Nitinol alloys.
Effect of material properties/composition
Miyazaki et al. 41 studied the effect of copper additions to
Nitinol as this is known to decrease the stress hysteresis
and transformation strain. Ti-50% Ni and Ti-(50–37)%
Ni-(0–13)%Cu (at.-%) were evaluated and the maximum
recovery strain decreased with an increase in copper con-
tent. For Ti-50%Ni alloy maximum recovery strain was
6.4%, while that for the Ti–40Ni–10Cu was only 5.2%.
Copper content sensitivity was evident in the stress hyster-
esis curves with the curves exhibiting a decrease with
International Materials Reviews 2016 27
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19 Fatigue life data for cobalt–chromium alloys
increased amounts of copper. The ternary alloy exhibited
worse fatigue life compared to the binary Nitinol alloy at
test temperatures less than 95°C. However, no difference
in fatigue lives was observed at test temperatures above
95°C.
Evaluation of Nitinol wire with nitrogen-ion additions
was performed by Takeda et al.62 Wires with a 0.5 mm
diameter tested in air using an alternating bending test
machine (Fig. 6a) at 3.33 Hz indicated that an increase
in the ion dosage produced an increase in the reverse
transformation temperature. Increasing the alternating
strain decreased the fatigue life while both the N-ion trea-
ted and Nitinol performed similarly at 4% strain ampli-
tude. Decreasing the strain amplitude led to larger
HCF improvements in the N-ion implanted samples
(Fig. 35).
Cobalt additions to Nitinol were investigated by Fas-
ching et al. 26 Tensile properties, bending modulus and
guided rotating bending fatigue were compared for
0.381 mm diameter NiTi and NiTiCo wires. An average
of ten samples was reported for tension data noting that
28 International Materials Reviews 2016
the unloading plateau and loading plateau increased
with the addition of cobalt (NiTi unloading 226 MPa
vs. NiTiCo 439 MPa and NiTi loading 492 MPa vs.
NiTiCo 710 MPa measured at 3% strain) while the
UTS was reported as 1320 MPa for both alloys. An
increase in the bending modulus was also observed
(NiTi 414 MPa vs. NiTiCo 586 MPa). Guided rotating
bending fatigue data was generated for three samples
at five different strain levels (2.34%, 1.77%, 1.00%,
0.80% and 0.65%) for both wires and tested to failure
or run-out at 1 × 107 cycles. NiTi performed better
than the NiTiCo in the LCF regime and was attributed
to the higher NiTiCo upper plateau. Both alloys per-
formed similarly in HCF and exhibited an endurance
limit.
Sheriff et al. 61 investigated the influence of varying con-
centrations of hydrogen on the fatigue properties of Niti-
nol. Hydrogen totals as low as 50 wppm caused a
statistically significant decrease in fatigue life in the low
cycle, high strain regime (> 1.4% strain). However,
increasing the hydrogen concentration up to 80 wppm
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20 Fatigue life data for cobalt–chromium wires
did not appear to affect the fatigue life in the low cycle,
high strain regime (> 1.4% strain).
Matsui et al.39 investigated the effects of martensite
transformation by comparing SE wires and SM wires in
pulsatile bending fatigue in air at 5.33 Hz. Longer fatigue
life was exhibited by the SM alloy compared to the SE
alloy at all same strain amplitudes, Fig. 36. The martensi-
tic transformation stress, obtained from the stress plateau,
was reported as 300 MPa for the SM wires and 450
MPa for the SE wires. The authors opined that the
increase in stress in the SE wires led to greater fatigue
damage and therefore shorter fatigue lives in the low
strain amplitudes.
Effect of material processing
Tobushi et al.66 studied the effect of shape memory pro-
cessing (SMP) temperature on the fatigue life of 0.75
mm diameter Ti-55.4 wt-%Ni wire. Fatigue properties
were investigated in water at 60°C and rotating bending
(Fig. 8a) at 500 rev min−1 for specimens at SMP tempera-
tures 350°C, 400°C and 450°C. No distinct difference in
fatigue life was observed between specimens with different
SMP temperatures.
Fatigue and fracture of wires and cables for biomedical applications
The effects of the Af temperature on rotating bending
fatigue was investigated by Patel et al.47 Wires with a
diameter of 0.323 mm were prepared with one of three
Af temperatures (3.2°C, 12.0°C and 20.8°C) and tested
to failure or 100 million cycles in a constant temperature
water bath at either 22°C or 37°C. The fatigue life was
better at 22°C while the material with the smallest differ-
ence between the test temperature and Af had a longer
fatigue life. The temperature difference ΔT was calculated
by equation (33) where Ttest is the test temperature and
Active Af is the austenitic finish temperature.
DT = |Ttest − Active Af | (33)
Pelton et al.51 also compared the effects of Af tempera-
ture on Nitinol wire in rotating bending fatigue. The test
method used was guided rotating bending fatigue (Fig.
8b) and test temperatures were maintained by a constant
bath of either methyl alcohol (−25°C) or distilled water
(23°C and 60°C). The 0.6 mm diameter wires were treated
to obtain the following conditions: Af = 2°C with a bright
finish, Af = 4°C with a black finish, Af = 7°C with a black
finish, Af = 64°C with a black finish. The black finish rep-
resents the native oxide layer and the bright finish was
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21 Fatigue life data for cobalt–chromium alloy strands60
obtained by mechanical polishing techniques. Five wires
for each strain level were tested at 2000 rev min−1 and
run until fracture or 107 cycles. Data comparing the bright
surface wire across the three test temperatures is shown in
Fig. 37a. The bright finished wire performed optimally at
−25°C. Figure 37b–d shows the behaviour of all four wire
treatments obtained at the same test temperatures. At
−25°C (Fig. 37b), all of the wires showed similar behav-
iour. Three compositions at this temperature contained
the R-phase while the fourth was fully martensitic. The
wires with an Af of 64°C exhibited longer life and a greater
fatigue strain limit at the two remaining temperatures.
Lowering the test temperature and ΔT (equation (33))
produced longer wire fatigue life while the bright and
black finishes had minimal effects. Detailed analysis
regarding the distinct regions observed within the fatigue
data and its correlation to the tensile data and transform-
ations are found elsewhere.51
Figueiredo et al.27 compared the LCF life of Nitinol
wires (SE, stabilised martensite, SM, stabilised austenite
SA and dual phase martensite/austenite DP) in a custo-
mised rotating bending fatigue apparatus using a 60°
angle as opposed to the 90° or 180° typically used in simi-
lar tests. The 1 mm wires were also compared with 308L
austenitic steel. The temperature of the wires was moni-
tored with a 0.2 mm thermocouple and maintained by
adjusting the speed of the test. The temperature was
kept between the Af and Md (martensitic deformation
30 International Materials Reviews 2016
temperature) for SE1 and SE2, between As and Af for
the DP wire and below As for the SM wire. Figure 38
shows the unique ‘Z’ shape in the alternating strain–life
plots for SE1, SE2 and DP whereby alternating strain
amplitudes between 4 and 8% produced an increase in
fatigue life with increasing strain. The unique ‘Z’ behav-
iour was attributed to the phase transformation and its
effects on fatigue crack initiation and propagation.27
The Coffin-Manson173 equation (34)
D1 = C(2Nf )b (34)
was used to fit the data below 4% strain for the SM, SA
and 308L wires, with β = −0.3 and −0.5 for the SM and
SA Nitinol wires, respectively.
Recently, Schaffer and Plumley59 studied the effect of
cold work on the fatigue life of 0.32 mm diameter Ti–
50.8 at.-%Ni wire. Ranges of cold work varying from 20
to 55% at 5% increments were produced in wire samples
that were subsequently tested at 3600 rev min−1 in rotat-
ing bending fatigue (Fig. 8a) in a continuously flowing
water bath maintained at 36.85°C. Specimens with 20–
35% cold work exhibited the best fatigue life when the
strain exceeded 1%.
Martin et al.38 evaluated as-received and heat treated
0.3302 mm diameter Nitinol wire for use in a cardiac har-
ness that surrounds the ventricles of the heart and pro-
vides pressure on the muscle tissue while serving as an
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22 Fatigue life data for cobalt–chromium alloy coiled strands
elastic support. The wires were tested in rotating bending
fatigue and comparisons were made for upper plateau
stress, UTS and percent elongation versus cycles to fail-
ure. Increases in the plateau stress and UTS reduced the
mean cycles to failure, while increases in the percent
elongation decreased the mean cycles to failure.
Effect of surface conditions
As discussed previously, surface treatments can have a
strong influence on the cyclic life of a material and are
magnified in fatigue tests that target the outer sample sur-
faces. These treatments can produce variations in the
microstructure and/or topology of the wire leading to a
variety of surface roughnesses that can contribute to vari-
ations in performance, cell surface interactions and adher-
ence of polymer coatings.206 Attention to surface
treatment and the respective characterisation is particu-
larly important with Nitinol as vital material properties
can be affected by the type of finish (i.e. corrosion, Ni-
ion release) that could have adverse effects when
implanted into the body.83 Effects of a variety of oxide
finishes, mechanical and chemical treatments and notch-
ing the wire are discussed in this section.
Fatigue and fracture of wires and cables for biomedical applications
Patel and Gordon49 investigated the effects of varying
the surface finish on Nitinol wire. Light oxide, dark
oxide, black oxide, etched, pickled, mechanically
polished and electropolished Nitinol wires with a
0.323 mm diameter were tested under rotating bending
conditions (Fig. 8a) with applied strains of 0.7–2.5%
at constant temperature. Seven samples of each con-
dition were evaluated in rotating bending fatigue at
3600 rev min−1 with test completion defined as either
wire fracture or achieving a run-out at 100 million
cycles. The results showed that little or no martensite
exists for strains less than 0.9%, with the start of SIM
between 0.9 and 1.5% strain. Stress-induced martensite
is prevalent beyond 1.5% strain and constitutes their
definition of the elastic limit. The etched samples per-
formed best in all three regions while also exhibiting
the lowest initial plateau stress, determined from tension
tests performed before the first cycle. The remaining sur-
face finishes examined in their work produced minor
influences on the fatigue life.
Rahim et al.53 evaluated the effect of surface prep-
aration (electropolishing) on Nitinol wire under rotat-
ing bending fatigue (Fig. 8a). The 0.75 mm diameter
wires were tested in a constant temperature water
bath (37°C) at 1200 rev min−1 and compared to
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23 Fatigue life data for DFT and DBS alloys
literature values from a wire process with a more
inferior surface preparation. The electropolished wires
exhibited longer fatigue lives which were attributed to
the ability of the processing to remove critical surface
defects.
Polinsky et al.52 studied the effects of surface modifi-
cations to Nitinol wire, specifically electropolishing,
chemical etching and mechanical polishing. The samples
were cold-worked Ti–55.8/55.9 wt-%Ni with an initial
light oxide, straw coloured finish maintaining the same
heat treatment, tooling and temperatures. Rotating bend-
ing fatigue tests (Fig. 8a) were performed in a constant
temperature water bath (37°C) and run at a rate of 100
rev min−1. Averaged survival rates for each treatment
were compared to a standard population that was cycled
to 90 000 cycles at 0.8% strain. The electropolish and
chemical etch techniques produced a 290% improvement
in fatigue performance over the non-processed wire while
the mechanical polish provided an exceptional 820%
improvement over the non-processed wire. The improve-
ments were attributed to the ability of the techniques to
32 International Materials Reviews 2016
remove surface defects and smooth processing defects pre-
sent on the surfaces of the wires. The mechanical polish-
ing further improved the surface by creating residual
compressive surface stresses which in turn created a
crack-resistant surface layer.
Matsui et al.39 studied fatigue crack growth of 0.5 mm
diameter Nitinol SMA wire using alternating plane
bending, tension and electrical resistance techniques.
Based on the premise that electrical resistance R
increases during crack growth and that the position of
crack nucleation and direction can be defined, an artifi-
cial notch was introduced into the wire with a diamond
cutter (0.5 mm notch width, knife edge circle of 157 mm)
and crack growth and resistance was monitored at pre-
scribed intervals. An additional test evaluated the effect
of the notch on the fatigue life, but tested at a reduced
test frequency compared to a smooth, unnotched
sample. In this work the notch depth was 0.1 mm in
the 0.75 mm diameter SE wire. The notched sample
experienced a significant decrease in life in the LCF
regime.
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24 Fatigue life data for DFT and DBS wires
Effect of joining
Chan et al.24 examined the rotating bending fatigue (Fig.
8a) behaviour of laser-welded Nitinol wire focussing
specifically on the fatigue fracture mechanisms including
crack initiation, crack propagation, fracture location in
the weld, mode of failure and the effect of bending fre-
quency on the fatigue life of the welded wire. Figure 39
shows that decreases in cyclic strain produce increased
cycles to failure, consistent with other work, while laser-
treated wire exhibited a reduced fatigue life at all strain
levels. Microstructure examination of the welded zone
revealed that the stress to induce martensite was lower
than in the base metal because of thermal-induced defects
from welding. Kinks in the tensile loading curves were
interpreted as due to the need to achieve a greater stress
in order to overcome the SIM transformation barrier.
Effect of wire diameter
Sawaguchi et al. 57 studied Ti50.9 wt-%Ni wires of 1.0, 1.2
and 1.4 mm diameters at rotational bending (Fig. 8a)
speeds 100–800 rev min−1 in room temperature air.
Figure 40 shows that fatigue life slightly decreased with
an increase in wire diameter, even though the data was
normalised using cyclic strain. However, for the same
wire diameters, Wagner et al.68 showed that the depen-
dence of fatigue life on wire diameter was no longer
Fatigue and fracture of wires and cables for biomedical applications
observed when the experiments are conducted in a silicon
oil bath at constant temperature.
Guided rotating bending fatigue was used by Nor-
wich and Fasching45 to evaluate 0.2286 and 0.6096
mm diameter Nitinol wire (Fig. 41). The wires were
etched and electropolished to the sizes listed above
and run to failure or 10 × 106 cycles at 1000 rev min−1
in a 37°C water bath. Tensile tests that included several
other wire diameters exhibited only small variations in
the lower and upper plateau strengths and UTS. A
slight increase in fatigue life was obtained for the smal-
ler diameter wires.
Effect of test environment
Sensitivity of Nitinol fatigue to test environment has been
studied by a variety of investigators.28,64–66,176 The differ-
ence in response to test media has been attributed to
thermo-mechanical coupling.176 Tobushi et al. 64,65 studied
the effect of both air and water at 29.85°C, 59.85°C, 79.85°
C in rotating bending fatigue (Fig. 8h) using 0.75 mm
diameter Ti–55.3 wt-%Ni wire. At 500 rev min−1, LCF
data was fit to the Coffin-Manson173 equation (35)
1a = aNf−b (35)
where β = 0.47 for wire tested in water and β = 0.235 for
wire tested in air. Wires tested in constant temperature
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25 S–N curve for 35N LT DFT and MP35N DFT wire alloys in rotating bending fatigue31
water produced better LCF behaviour (Fig. 42). However,
the cyclic life was shorter in water in the HCF regime,
attributed to possible corrosion fatigue. Tobushi et al.66
also showed no effect of testing the same wire in water
and silicone oil on the fatigue life in rotating bending
(Fig. 8a) at 29.85°C (Fig. 43).
Frotscher et al.28 also studied the effects of test medium
on 0.8 mm wires in rotating bending fatigue (Fig. 8a).
Binary NiTi and ternary NiTiCr were evaluated at 20°C
in air and in oil with the number of cycles for run-out
selected at 106 cycles. Figure 44 shows no significant differ-
ence between the LCF behaviour of NiTi and NiTCr in air
at 400 rev min−1, although the NiTiCr failed before 105
cycles while NiTi tests were stopped at the predetermined
run-out. Both alloys behaved similarly in oil. The NiTi
and NiTiCr fatigue life curves separated after an increase
in cyclic rate to 1600 rev min−1 for tests conducted in air,
with the NiTiCr exhibiting the longer fatigue life at a
given strain amplitude. Finally, when the cyclic rate was
increased to 3200 rev min−1 with an oil medium, the
NiTiCr again displayed a longer life and achieved run-
out while the NiTi failed at 65 977 cycles. The authors
suggested that the higher stiffness of the NiTiCr may be
causative, but recommended further investigation.
Effect of test temperature
Tobushi et al.65 studied the effect of testing at 29.85, 59.85
and 79.85°C in air and water using rotating bending
34 International Materials Reviews 2016
fatigue (Fig. 8a) on 0.75 mm diameter Ti55.3 wt-%Ni
wire. Figure 42, in the previous section, shows a decrease
in fatigue life with an increase in test temperature in both
air and water.
Miyazaki et al.41 also studied the effect of test tempera-
ture on a binary Ti50%Ni alloy and a ternary Ti–Ni–Cu
alloy with up to 10% Cu (Fig. 45). Fatigue life for both
binary and ternary alloys decreased with increasing test
temperatures in an intermediate temperature region,
while no appreciable effect of temperature was observed
in the lower and higher temperature regions for tests con-
ducted in rotating bending fatigue.
Morgan et al.42 suggested that an increase in test temp-
erature equates to an increase in the stress necessary for
SIM transformation. In their evaluation of effects of
mean and alternating strains on Nitinol wire in axial fati-
gue, they postulated that high alternating strains should
decrease the fatigue life with increasing test temperature.
Samples tested at alternating strains below 1.0% at higher
temperatures exhibited longer fatigue lives.
Effect of rotational speed and frequency
Chan et al.24 evaluated the effect of rotational speed on
Nitinol, laser-welded wire by varying the rotating bending
fatigue (Fig. 8a) speed from 200 to 800 rev min−1 at a con-
stant strain of 0.625% (Fig. 39). The reduction of fatigue
life obtained at higher frequencies was rationalised as due
to the additional heat generated in the rapidly rotating
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26 Fatigue life data for DFT and DBS cables
wire, producing more frequent transformations from aus-
tenite to martensite. Additional temperature increases due
to the phase transformation increases the stress required
to initiate the martensite transformation increases. In
this scenario, a test conducted at constant strain ampli-
tude with varying rotational speeds would be subjected
to a decreased stress relaxation in the sample, producing
decreased fatigue life.
Tobushi et al.65 studied the effect of rotational speed
using 0.75 mm diameter Ti55.3 wt-%Ni wire. Tests con-
ducted from 100 to 1000 rev min−1 in rotating bending fati-
gue (Fig. 8a) air and water environment at 59.85°C showed
no difference in fatigue life for tests conducted at different
rotational speeds in water. However, higher rotational
speeds produced a shorter fatigue life in air. It was also
rationalised that large rotational speeds can produce a
large temperature rise in the wire thereby increasing the
stress and producing a shorter fatigue life. In water contain-
ing environments, the wire temperature remains constant
and therefore the fatigue life is not affected by changes in
rotational speed. The authors related this concept to the
area surrounded by the hysteresis loop which represents
strain energy per unit volume. In each cycle, the tempera-
ture rises and the strain energy per unit volume is the pro-
duct of stress and strain (i.e. strain energy increases
Fatigue and fracture of wires and cables for biomedical applications
proportionally to strain amplitude) and is balanced by
heat conduction and radiant heat wherein the temperature
rise also increases proportionally to strain amplitude.
Increases in strain rate greater than 10% min−1 increase
the yield stress due to martensitic transformation in pro-
portion to the strain rate.
Sawaguchi et al. 57 also tested 1.2 and 1.4 mm diameter
Ti–50.9 wt-%Ni wires at rotational speeds of 100 and 800
rev min−1 in rotating bending (Fig. 8a) at room tempera-
ture in air and observed that the fatigue life decreased
with an increase in rotational speed (Fig. 46). Wagner
et al.68 confirmed the results of Tobushi et al.65 showing
the dependence of fatigue life on the rotational speed
was no longer present when tested in oil as the fatigue
life of 1.2 mm diameter wires tested at 100 and 800 rev
min−1 were similar when tested in oil.
Sateesh et al. 56 demonstrated the effects of test fre-
quency in tension–tension cycling of 0.6 mm SE Nitinol
wire held at a constant 22°C. Nine different test rates
were considered (0.01, 0.05, 0.1, 1, 5, 10, 20, 30 and 35
Hz) with a constant strain amplitude range (1.5–6%).
Figure 47 also shows a reduction in cyclic life with an
increase in test frequency, attributed to the amount of
fully transformed martensite in the material. It was
opined that high test frequencies can lead to partial
International Materials Reviews 2016 35
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27 Fatigue life data for DFT coiled strands
martensitic transformations, leaving the remaining
untransformed material to promote slip-driven dislo-
cations (martensitic variants trapped in austenitic phase
that cannot contribute to a reverse transformation) that
create high stress regions leading to crack propagation
and decreased fatigue life.
Effect of test configuration
An investigation of the relationship between the tempera-
ture rise of the sample and time within alternating bend-
ing fatigue (Fig. 8a) cycle and pulsatile bending (Fig. 10)
was performed by Furuichi et al.29 and rationalised by
examining the area within the hysteresis curves in the
stress–strain curves pictured in Fig. 48.
The data comparing various test configurations is
shown in Fig. 49a–d. In all cases, temperatures rose within
the first 20 s of the test regardless of the test frequency and
were attributed to the SIM transformation and respective
heat production during cyclic testing. Increased frequen-
cies resulted in larger rises in temperature due to increased
martensitic transformation stresses and subsequent
increases in dissipated work. When compared to
pulsatile bending fatigue (R = 0), a much lower rise in
temperature was observed than in alternating bending
36 International Materials Reviews 2016
fatigue (R = −1). The almost doubling of the temperature
increase exhibited in alternating bending was explained as
a result of the proportionality of the dissipated work to the
product of the martensitic stress and strain amplitude
leading ultimately to increased fatigue damage and a
shorter fatigue life. An equation illustrating the relation-
ship of the martensitic transition stress σM to the marten-
sitic start temperature under zero stress Ms and
temperature T is shown in equation (36) where the coeffi-
cient CM was reported as 6 MPa K−1.207
sM = CM (T − Ms ) (36)
The fatigue life behaviour was rationalised by the
observations of area within the hysteresis curves in the
stress–strain curves pictured in Fig. 48.
When compared to the rotating bending fatigue (Fig.
8a) test configuration, the alternating bending test data
exhibited a steeper slope in LCF (Fig. 49b). Two
reasons were attributed to the difference in behaviour,
both related to the temperature rise in the specimen
during fatigue. The amount of transformed area in
alternating bending occurred in the surface area along
the lines of bending in the sample where the transform-
ation amount in the rotating bending sample occurred
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28 Fatigue life data for Pt–20Ir wires35
throughout the surface area resulting in a larger volume
of transformed material and therefore a larger tempera-
ture rise. Second, the rotating bending test maintains the
sample in a constant bend configuration with rotation
as the only motion available to aid in heat transfer to
the surrounding air minimising the amount of sample
cooling. In contrast, the alternating bending test con-
figuration, which bends and unbends the sample, allows
for a larger amount of heat to leave the sample to the
air providing increased sample cooling. The temperature
rise was greatest for rotating bending, followed by alter-
nating bending and then pulsatile and noted correlation
to the fatigue life which decreased with the increase in
temperature rise.
Tobushi et al. 67 also compared rotating bending fati-
gue and pulsatile bending fatigue tests for Nitinol wire
at two different test frequencies (300 and 500 rev
min−1 for rotating bending, 5 and 8.33 Hz pulsatile) at
a test temperature of 29.9°C. In the low cycle regime
(εa < 1%), the pulsatile-tested wire possessed a longer
fatigue life than the rotating bending-tested wire, how-
ever in the high cycle regime the opposite was observed
(Fig. 49c). Following this study, Tobushi et al.63 evalu-
ated high-elastic, thin wire (0.5 mm diameter) in all
three aforementioned test methods at a test frequency
of 8.33 Hz/500 rev min−1 (Fig. 49d). Differences
Fatigue and fracture of wires and cables for biomedical applications
observed between methods were attributed to the
amount of material undergoing fatigue as described
above by Furuichi et al. 29
The effects of varying the strain ratio in pulsatile bend-
ing fatigue was investigated by Matsui et al.39 Nitinol
wires were tested in ambient air at 8.33 Hz according to
Fig. 10. Strain ratios that were applied to the samples
included: −1, 0, 0.1, 0.2 and 0.3. Following the rationale
provided above, the best performing wire in LCF was the
greatest strain ratio, Sr = 0.3 and decreasing to Sr = −1
which exhibited the lowest survival for a given maximum
strain (Fig. 50).
Norwich46 performed an evaluation of the unguided
(Fig. 8a) and guided rotating bending fatigue configur-
ations (similar to Fig. 8b) on 0.53 mm diameter Nitinol
wire. Both test methods kept the samples at constant
temperature via water bath and five samples were tested
for each strain level for three different test frequencies.
The data plotted did not show a significant difference
in test technique below 1% strain, but did have variation
above 1% strain. Between 1 and 2% strain an increase in
the fatigue life was observed for the guided method. A
difference between the application of the plateau strain
between the two methods (i.e. unguided occurs at apex,
guided occurs across the whole 90° arc length) and
potential for vibration in the apex of the unguided
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29 Comparison of Ti–6Al–4V (equiaxed α), Ti–6Al–4V (Windmanstatten α) and SUS316L in air and Ringer’s solution43
method to induce non-homogeneous SIM distributions
was cited as the explanation for the behaviour.
Effect of mean strain
Morgan et al.42 explored the effect of mean strain on Niti-
nol wires by axially loading them to 2, 4 and 6% mean
strain in a 38°C Ringers solution. The annealed Ti–
55.9 wt-%Ni wire had a pickled surface finish and an Af
of 12°C. Strain control was monitored by an extensometer
and the test was conducted at 2 Hz for the three mean
strains at 38°C and at a mean strain of 6% at 20°C. For
comparison, wires were also tested at seven different alter-
nating strain amplitudes at both temperatures.
The preliminary data (Fig. 51) demonstrated that
increased mean strain produces a significant increase in
fatigue life at low strain amplitudes (< 1%). At higher
strains, mean strain was found to have little effect upon
the fatigue life. The authors42 proposed that the higher
alternating strains contain large volumes of transforming
material (i.e. between martensite and the parent austenite
phases) that could generate dislocations in the structure
leading to potentially shorter fatigue lives. Additionally,
38 International Materials Reviews 2016
they postulated that at those same high alternating strains
defects may be created due to inclusions or other discon-
tinuities within the microstructure. Conversely, low alter-
nating strains exhibited a much smaller volume of
transforming material decreasing the mismatch between
strain in the Nitinol and inclusions. Microcracking
observed at low alternating strains increased with an
increase in mean strain (i.e. the higher the mean strain,
the more stabilised martensite). The increase in fatigue
life with increasing mean strain was attributed to
increased amounts of SIM and blunting of microcracks
due to localised martensite. Examination of fracture sur-
faces from samples tested with alternating strains exceed-
ing 1.5% mean strain showed that failure was dictated by
surface conditions and high nominal alternating strains.
Fracture surfaces of samples tested under conditions pro-
ducing mean strains below 1.5% followed classic crack
initiation and propagation.
Effect of material cleanliness/inclusions
ASTM F2063117 outlines the specifications for micro-
cleanliness in Nitinol product depending on the austenite
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30 Stress-life diagram of TNTZ alloy compared to pure Ti, Nitinol and SUS316L following notched fatigue44

31 Strain–life plots of bioabsorbable materials tested in rotating bending fatigue depicting wire compositions of a Fe–50%CW,
Fe–90%CW, Fe–99%CW, 316L and Mg and b 316L, Fe35Mn, Fe35Mn–DFT–25%ZM21, Fe–DFT–25%Mg, Fe–DFT–57%Mg58

International Materials Reviews 2016 39

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32 Strain–life plots comparing bioabsorbable materials tested in air and saline (PBS) in rotating bending fatigue and data fit
with equation (32)58

start temperature. The maximum allowable dimensions
for porosity and nonmetallic inclusions (i.e. TiC and Ti4-
Ni2Ox) when Af is less than or equal to 30°C shall be less
than 39 µm and should not constitute more than 2.8%
(area percent) while viewed at 400–500×. For Af greater
than 30°C, ASTM F2063 indicates that the maximum
allowable dimensions are agreed to by the purchaser
and supplier. This can become a major concern for pro-
duct stability and reliability when many of the fine wires
and struts within stents are of the same order of

33 Fatigue life data for Nitinol and NiTi-based alloys

40 International Materials Reviews 2016

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33 Continued
magnitude as the allowable inclusion size.208 Martin
et al.38 discussed the effects the size and amount of
inclusions on the microstructure and ultimately the fati-
gue life. Numerous small inclusions create a hetero-
geneous microstructure which corresponds to a more
homogeneous strain in the region under loading and
therefore improved fatigue resistance compared a few
large inclusions that become the source for crack
initiation and earlier fatigue failure.38 It was further stated
that controlling the fracture initiation mechanism (i.e. size
of inclusions) can allow for the design of optimal mean
stretch configurations.
Fracture as a result of nonmetallic inclusions were
reported in axial fatigue,42 rotating bending fatigue32 and
flex bending fatigue.4 Chemical compositions of the
Fatigue and fracture of wires and cables for biomedical applications
inclusions include TiC. A summary of inclusion character-
isation is located in the metallography section in Table 5.
Kumar and Lasley32 investigated the effect of
inclusions on rotating bending fatigue (Fig. 8a) and com-
pared inclusion size and distribution between different
suppliers with different melt processes. Figure 52 depicts
two different methods of plotting the fatigue data, cyclic
strain–life (Fig. 52a) and strain amplitude–life (Fig.
52b), for a variety of vendors with different melt processes.
The quantification of inclusion size, volume fraction and
distribution was performed on 2.06 mm diameter wire
with standard metallographic techniques taking samples
in the longitudinal and transverse directions with further
analysis by SEM and backscattered electron imaging
(BEI). The 2.06 mm wires were redrawn into 0.32 mm
International Materials Reviews 2016 41
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications
34 Trendlines and individual data points taken from Fig. 33 for a alternating bending fatigue, b rotating bending fatigue and c
unidirectional bend fatigue. Individual data points are also seen in subsequent plots
wires and provided the same surface finish and heat treat-
ment for fatigue analysis. Wires were tested in a 37°C
water bath at 6000 rev min−1 and strain amplitudes were
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varied from 0.5 to 1.3% with a predetermined run-out
set at 5 × 106 cycles.
Material A outperformed all other vendor samples and
also contained the largest number of inclusions. Perform-
ance decreased in order with samples B, C, D and
E. Notably, the trend in decreased fatigue life was
matched to an increase in the maximum inclusion size
from A to E. The authors reported that the observed
trends showed that the size of the inclusion played a pro-
minent role in the fatigue life (i.e. a few large inclusions
have a greater impact on the fatigue life than many
small inclusions).
An evaluation of 0.267 mm diameter Nitinol wire from
two different suppliers was performed in rotating bending
fatigue (Fig. 8a) by Patel.48 Tests performed at 3600 rev
min−1 in a constant temperature water bath are shown
in Fig. 53 and reveal similar results from different suppli-
ers. Descriptions of the resulting metallography can be
found in ‘Superelastic Nitinol’ section.
An additional study50 utilised the same configuration
to evaluate 0.127 mm Nitinol wire. The primary differ-
ence in material between the two suppliers stemmed
from the chemical composition of the initial ingots
which differed in the weight percent of carbon (supplier
A = 0.0033 wt-%, supplier B = 0.0365 wt-%). Inclusion
analysis was performed on the starting material in the
longitudinal direction and revealed values for total
inclusions (A = 17 180, B = 33 700), largest defect size
(A = 10 µm, B = 5 µm), number of inclusions greater
than 2 µm (A = 1205, B = 359), and average stringer
length (A = 3451 µm, B = 384 µm). Evaluation of the lar-
gest and smallest inclusions following processing and test-
ing is noted in ‘Superelastic Nitinol’ section. The
inclusions found in material from supplier A exhibited a
lower net nickel percentage. The starting material’s Af
temperatures were determined (A = −7°C, B = −14°C)
and then evaluated again following heat treatment and
subsequent thermo-mechanical treatments necessary to
obtain medical grade wire (A = 13°C, B = 21°C). Average
data from seven samples at each strain level from the
rotating bending fatigue tests is shown in Fig. 54. Samples
were tested to failure or 100 × 106 cycles at 3600 rev
42 International Materials Reviews 2016
min−1. Significant differences in fatigue life were observed
between 0.9 and 1.0% alternating elastic strain. The
authors suggested that the Ni-rich compounds in material
from supplier B may contribute to the increased transition
temperature, while the presence of nickel atoms in the Ni–
Ti matrix acted as defects.
Data reported by Reinoehl et al. 55 include similar
inclusion analyses and mechanical properties for testing
on 0.267 mm diameter Nitinol wire, also under rotating
bending fatigue (Fig. 8a) in a constant temperature
water bath. The material, again representative of two
different suppliers, demonstrated similar fatigue behav-
iour above the Af temperature regardless of other material
parameters (carbon content, inclusion content, lower pla-
teau strength and Af). It was suggested that additional
studies should consider smaller diameter wires to deter-
mine if a threshold exists wherein the inclusion content
impacts fatigue performance.
An extensive evaluation of the effects of impurities on
the fatigue life of SE Nitinol was investigated by Rahim
et al.54 The 0.75 mm diameter wires were either of ultra-
high purity or contained the maximum accepted level of
carbon or oxygen and tested at 1200 rev min−1 in rotat-
ing bending fatigue (Fig. 8a) in a constant temperature
water bath (37°C). Strain–life diagrams representing all
tested samples are shown in Fig. 55a, while samples
which failed due to an inclusion site are shown in
Fig. 55b, and 30 high strain tests are shown in Fig.
55c. Analysis of the fracture surfaces revealed initiation
related to particle/void assemblies, a remnant of the pro-
cessing and other less prominent crack initiators such
as microcracks. The high oxygen content material exhib-
ited the shortest fatigue life in both LCF and HCF
regimes and may be a result of the larger oxides present
in the material. The high purity material contained a
smaller amount of inclusions and crack initiation was
generally associated with particle/void assemblies, leading
the authors to suggest that clean processing can decrease
the probability of crack initiation but not eliminate it.
Dental materials testing
Fatigue testing data of endodontic materials is generally
presented in a slightly different manner than those
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35 Effect of N-ion implantation on Nitinol wire evaluated in alternating bending fatigue62
found in typical materials engineering literature. The
endodontic community typically reports the time-to-fail-
ure and/or rotations-to-failure. The test material may be
in the form of straight wire or tapered files that are used
to clean and shape the root canal. While the Nitinol alloys
provide the capability to follow the contours of the dental
canal better than other available alloys due to its elastic
qualities, the propensity to fracture under flexion/rotation
is a significant concern.209 Multiple investigators have
studied bending and rotating fatigue in endodontic files
and wires reporting effects related to file geometry,209 pro-
cessing,22,61 composition,210,211 radius of curvature,212
torsional loading213,214 and rate.70 A few studies on
wires and files are briefly discussed in this section in
addition to fatigue testing on archwires.4 Additional
information regarding DSC analysis,107 corrosion203 and
mechanical properties6,69,128 for dental wire-form
materials is left for the reader.
Al-Hadlaq et al. 22 evaluated the difference between
thermally processed M-wire (GT series X) and standard
Nitinol wires (GT and Profile) via rotating bending
(Fig. 9) of an endodontic file. Fifteen files of each type
with the same tip diameter (ISO size 30) and taper
(0.04) were tested to fracture at 300 rev min−1 according
to the test method in Fig. 9. Time and cycles to failure
were recorded. The GT series X showed greater resistance
to cyclic fatigue failing at 762 ± 123 cycles compared to
the profile and GT wires that failed at 638 ± 169 and
609 ± 56, respectively.
Fatigue and fracture of wires and cables for biomedical applications
Ye and Gao69 also evaluated M-wire under rotating
bending fatigue conditions and investigated the micro-
structural evolution at four different stages of the fatigue
cycle using DSC, Vicker’s hardness measurements (VHN)
and TEM. The as-received material measured an Af of
50.38 ± 0.82°C and VHN of 384.6 ± 6.5. Measurements
were taken again at 30% (Af 51.16 ± 1.23°C and VHN
382.4 ± 5.7), 60% (Af 50.59 ± 0.53°C and VHN 390.6 ±
5.5) and 90% (Af 50.66 ± 0.83°C and VHN 392.4 ± 7.7)
of the average fatigue life for the wire. TEM evaluation
showed that the composition of the as-received material
was a mixture of austenite and martensite while at 60%
of the fatigue life evidence of martensitic grain growth
and twinning appeared followed by high dislocation den-
sities in the martensite at 90%.
Work by Young and VanVliet70 investigated rate effects
in rotating bending fatigue (similar to Fig. 9) of SE Niti-
nol wire and discovered a notable difference in the
reported effects found in endodontic versus materials
engineering literature. Negligible effects of changes in cyc-
lic rate were reported in the publications of those in the
endodontic community while significant effects were
noted in publications by the materials community. Wire
diameters of 0.20, 0.32 and 0.45 mm were rotated in a cus-
tom fixture with 2, 4 or 8 mm radii of curvature at a rate
of 200, 950 or 2000 rev min−1 in air or water. Effects of
frequency, specific heat of the test medium and volume
of material under strain were considered. Results
suggested that test frequency did have an effect on the
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36 Effect of martensitic transformation (i.e. wire type, SE vs. SM) following pulsatile bending fatigue39

37 Effect of Af temperature on Nitinol wire in guided rotating bending fatigue comparing a bright finish wire at all three test
temperatures, b bright and black wires at −25°C, c bright and black wires at 23°C and d bright and black wires at 60°C51

44 International Materials Reviews 2016

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38 Evaluation of various amounts of austenite and martensite present in Nitinol wire compared to 308L steel in 60° arc rotating
bending fatigue27
fatigue life for clinically relevant strain amplitudes and
frequencies, particularly for small values of each par-
ameter. A study evaluating the heat capacity of the test
medium (water 1.00 cal/g°C and air 0.24 cal/g°C) demon-
strated the effect on wire (Nitinol 0.20 cal/g°C) lifetime
leading to the development of empirical relationships
that illustrate how the ability of the medium to absorb
heat generated during cycling will impact the fatigue
life. Finally, sample volume under strain was found to
have a strong effect on the wire lifetime with noting that
the lifetime varied inversely with sample volume that
also showed some dependence on the stain amplitude.
Benini4 studied the behaviour of commercially available
archwires (GAC Sentalloy and 3M Unitek SE Orthoform
II) under flex bending fatigue at 1 Hz in ambient air. The
archwires, in general, exhibited an increase in fatigue life
if the mandrel diameter was increased. As described in
‘Flex bending fatigue testing’ section, the cyclic strain
depends on the wire diameter and mandrel diameter, so
for a fixed mandrel size an increase in the wire diameter
resulted in a large cyclic strain and therefore shorter fati-
gue life (Fig. 56).
Cyclic tension
Frotscher et al.28 compared as-received NiTiCr 1.2 mm
diameter wire cycled in tension at 30°C to material that
Fatigue and fracture of wires and cables for biomedical applications
was heat treated at 36°C/60 minutes under an argon
atmosphere and 850°C/60 minutes with water quenching.
The upper plateau stress exhibited in static tension
decreased from 500 to 470 MPa in the 20th cycle of cyclic
tension and the lower plateau at the same cycle was 310
MPa. Compared to the heat treated sample, a decrease
of similar magnitude occurred in the upper plateau stress,
while the solution treated sample after 20 cycles failed to
exhibit a stress plateau. Changes in the material behav-
iour during cycling occurred as a result of the decreased
stress level required to form martensite. In addition, the
small grains are less inclined to transform back when
the material is unloaded, and there is an increase in the
dislocation density during cycling which links to the stress
fields surrounding the individual dislocations.
Sateesh et al. 56 evaluated the effects of test frequency in
the cyclic tension behaviour of Nitinol wire at constant
temperature. As the frequency increased, the area of the
hysteresis loop decreased. In addition, the slope of the
martensitic transformation (upper) plateau increased
with the increase in test frequency. It was proposed that
this occurred due to the amount of energy dissipated in
the wire as a function of the increase in temperature
and respective increase in transformation stresses. The
hysteresis loop represents the energy dissipation in a
given cycle and at higher test frequencies the time avail-
able for heat transfer from the wire is reduced causing a
International Materials Reviews 2016 45
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39 Effect of laser-welding on the fatigue life of Nitinol wire in rotating bending fatigue24
buildup of heat and respective increase in transformation
temperature. This increase also increases the slope of the
upper plateau. Similar behaviour was observed in the
reverse transformation, lower plateau. In very high test
frequencies, there is little to no distinction between the
reverse transformation and martensitic unloading.
Dooley et al.25 used cyclic tension to evaluate the effect of
pre-straining (a process described in three
U. S. patents)25,156,157 on the fatigue life of wire. The pre-
straining method introduced a controlled amount of non-
recoverable tensile strain (greater than 0.20%) at specific
regions of interest on the surface while the subsurface
remained within the SE material limit. These pre-strains
could be induced via bending or torsional forces. Their
removal and subsequent material recovery produces residual
compression in the local surface. The evaluated wires had a
nominal diameter of 0.305 mm, were electropolished to
0.300 mm, heat treated in air to impact superelasticity (Af
< 37°C) and possessed a permanent set less than 0.20%
when loaded to 6% strain and unloaded at 37°C. Wires
were then pulled to 4% mean strain and 0.5% alternating
strain in all cases, followed by varying the amount of applied
pre-strain (0, 6 and 8%) and test rate (8, 12 and 15 Hz).
Improvements in the fatigue life were observed with increas-
ing amounts of pre-strain as noted in the Weibull analysis.
Lin et al.36 used a ‘Z’ wire shape form to investigate the
effects of variable amplitude testing of 0.508 mm diam-
eter Nitinol wire. The test frequency was 20 Hz and
46 International Materials Reviews 2016
samples were maintained at a constant temperature in a
water bath and tested until fracture or the predetermined
run-out of 106 cycles. The variable strain test was created
by fatiguing at a large strain amplitude (greater than the
fatigue limit) for prescribed number of cycles then at a
small strain amplitude (equal to or less than the fatigue
limit) for a prescribed number of cycles. The mean strain
was 3% and the tested large strain amplitude and small
strain amplitude combinations were 0.75% for 10 cycles
followed by 0.10% for 50 cycles and 1.00% for 10 cycles
followed by 0.25% for 50 cycles. The results indicated
that more damage is incurred when small strain cycles
(i.e. less than the constant amplitude fatigue limit) are
repeated within a sequence of large and small cycles,
thereby reducing the fatigue life.
A comparison of standard grade and high purity Nitinol
wire was performed by Launey et al.33 Differences in
chemistry were quantified to the amount nickel (55.6 wt-
% standard, 56.0 wt-% high purity), oxygen + nitrogen
(0.0252 wt-% standard, < 0.0060 wt-% high purity), alu-
minium (< 0.0057 wt-% standard, < 0.0050 wt-% high
purity) and hydrogen (0.0015 wt-% standard, 0.0012 wt-
% high purity) with some balance difference in titanium.
Inclusions in these materials generally possessed an area
fraction of 1.01% for standard Nitinol and 0.28% for
high purity Nitinol with longitudinal lengths for nonmetal-
lic inclusions of 35 µm in the standard and 17 µm in the
high purity. Using wire set in a ‘Z’ form (Fig. 57 inset),
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40 Effect of wire diameter on the fatigue life of Nitinol wire in rotating bending fatigue57
axial fatigue tests were performed at 20 Hz in a constant
temperature water bath at a mean strain of 3% with five
samples tested at each alternating strain (0.5–3.0% in
0.5% intervals). A predetermined run-out was set for 107
cycles. Figure 57 reveals that the high purity material per-
formed superior to the standard form and upon metallo-
graphic examination it was observed that the inclusions
(of the form Ti4Ni2Ox) were 5–10 times smaller than the
standard material with a lower area fraction.
A variety of methods to evaluate functional loading
conditions of SM Nitinol wires was investigated by
Mammano et al.37 and included constant stress, constant
strain, constant stress with limited maximum strain and
linear stress–strain with limited maximum strain. The
0.150 mm diameter wires were tested to failure or
stopped at 5 × 105 cycles. Figure 58a plots the constant
stress and constant stress with 3 or 4% strain. The results
indicated that the addition of a limited amount of strain
to a constant stress test led to an improvement in the fati-
gue life compared with the constant stress only test. The
linear stress–strain test data is shown in Fig. 58b and
compared to constant stress with 4% limited strain test
data.
Hirmanova et al.72 designed cyclic tension studies to
evaluate corrosion effects on Nitinol springs in air,
water and simulated body fluid. The helical springs were
created from 0.2 mm Nitinol wire and tested at rates
Fatigue and fracture of wires and cables for biomedical applications
ranging from 1 to 60 mm s−1. Tests performed in air
experienced longer lifetimes indicating that corrosion
affected fatigue life. The authors proposed that the fatigue
limit was correlated to the cracking of the surface oxide
layer (TiO2) which occurred at the beginning of the fati-
gue cycle and through the opening and closing of these
cracks, localised corrosion facilitated early damage and
eventual failure.
Modelling of fatigue life
A number of modelling methods have been used to ana-
lyse the experimental data in addition to computer simu-
lations via finite element modelling and analysis. Coffin–
Manson–Basquin,173 the Universal Slopes method173 and
the finite element method are first reviewed for analyses of
fatigue data, followed by attempts to use this approach on
the materials covered in this review. Though not explored
in this paper, some may find the analytical models from
Baragetti215 which predict the effects of nonlinear bend-
ing in wires also of interest for investigating links between
the bending moment and radius of curvature.
Coffin–Manson–Basquin method
The Coffin–Manson–Basquin (CMB) model attempts to
use uniaxial tension data to predict the total strain–life
International Materials Reviews 2016 47
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41 Effect of wire diameter on the fatigue life of Nitinol wire in rotating bending fatigue45

42 Effect of test environment on the fatigue life in rotating bending fatigue at 500 rev min−1 at 29.85, 59.85 and 79.85°C64,65

48 International Materials Reviews 2016

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43 Effect of test environment (water and silicone oil) on the fatigue life at 29.85°C, 1000 rev min−1 in rotating bending fatigue66
behaviour. The equation relates the strain amplitude pro-
vided by Δε/2 (half the total strain range) to fatigue life
through the fatigue strength coefficient σf′ , fatigue duct-
ility coefficient εf′ , fatigue strength exponent b, fatigue
ductility coefficient c and the elastic modulus E as
shown by equation (37). These values are defined when
considering fully reversed, strain-controlled tests, plotted
as strain amplitude vs. reversals to failure (2Nf)
 ′
D1 sf
= (2Nf )b + 1′f (2Nf )c (37)
2 E
In this equation, σ′ f is essentially the true fracture stress
obtained from a tension test while εf′ has been shown to be
closely represented by εf in tension. This approach has
been used in the aerospace community on a range of
industrially relevant metallic alloys.173 The fatigue
strength exponent b and fatigue ductility exponent c lie
in the range b = −0.057 to −.150 and c = −0.39 to −0.84
for a range of commercial structural materials.173
The essence of the Coffin–Manson–Basquin Model has
been represented by Fig. 59 where the cyclic strain ampli-
tude vs. cycles to failure is plotted on a log–log scale.
When plotted in this manner, the strain–life plots for a
range of commercially available structural materials all
show a similar shape.
In reference to equation (37), it was reasoned that for
complex loading the loading reversals would be easier
to discern than the cycles, therefore the life term was
Fatigue and fracture of wires and cables for biomedical applications
described relative to reversals rather than cycles.173
Applying the terms of equation (37) to Fig. 59, it can be
seen that the strain intercepts are represented by εf′ and
σf′ /E at 2Nf = 1.0 while exponents b and c are the slopes
of the plastic and elastic strains, respectively. The tran-
sition point (i.e. intersect of the plastic and elastic lines)
is defined by the points ΔεT/2 and 2NT and the total strain
amplitude Δε/2 at the transition is denoted as ΔεT/2.
Key guidelines that arise from this approach relate to
the different material parameters that appear to be par-
ticularly important for LCF and HCF. Figure 59 also
shows that the LCF regime appears to be dominated
by εf′ , while the HCF regime appears to be dominated
by σf′ /E. This provides useful starting guidelines for
choosing materials for resistance to strain cycling, and
indicates that materials with high εf′ (i.e. εf) should exhi-
bit better resistance to LCF, while those with high σf′ /E
(i.e. σf /E) should exhibit better resistance to HCF.
Since most high strength materials (i.e. high σf) typically
have lower ductility (i.e. low εf) than low strength
materials (i.e. low σf) which typically possess higher
ductility (i.e. high εf), the relationship indicates that
higher strength materials should exhibit better HCF
behaviour than lower strength materials, while lower
strength materials (that possess higher εf) should exhibit
better LCF behaviour than higher strength materials
(that possess lower εf). This general behaviour has been
documented for a number of commercial structural
materials,173 although subtleties related to test
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44 Effect of test environment on NiTi and NiTiCr on the fatigue life at 32°C, 3200 rev min−1 in rotating bending fatigue (Fig. 8a)28
technique, material cleanliness/inclusions and residual
stresses may skew the behaviour. Nonetheless, this
approach provides a useful start for the presentation of
the fracture and strain–life fatigue behaviour of wires
used in the biomedical industry.
Lewandowski et al.11 have evaluated the strain–life
behaviour of 316LVM 1 × 7 cables in flex bending fatigue
(Fig. 6d ) while also comparing that data to the behaviour
of both as-drawn (i.e. high strength, low εf) 316LVM and
annealed (i.e. low strength, high εf) 316LVM wires as well
as other 316LVM cables and wires in different strength/
ductility combinations. The data is summarised in Fig.
60 and also demonstrates that higher strength 316LVM
wires/cables (e.g. as-drawn wires, high strength 1 × 7
316LVM cables) perform better in the HCF regime but
worse in the LCF regime in comparison to annealed
(i.e. lower strength) 316LVM wires.
In contrast, the lower strength (and higher ductility)
annealed 316LVM wires perform better in LCF but not
as well in HCF, as shown in Fig. 61. This behaviour is
entirely consistent with the predictions made by the
CMB equation as shown in Fig. 61, where the tension
data from the annealed and as-drawn 316LVM40 were
used to successfully capture the differences in LCF and
HCF behaviour of these materials.
50 International Materials Reviews 2016
While the CMB approach appears to nicely capture the
behaviour of monolithic alloys, initial attempts have also
been used on some DFT composite wires/strands.10,71 The
DFT wires/strands are interesting in this regard since the
very soft inner core (e.g. Ag) that provides excellent elec-
trical conductivity for various biomedical stimulation/
sensing applications5 is surrounded by much harder
MP35N. The harder (and biomedically inert) MP35N
provides appreciable strength to the composite in tension,
while bending (and cyclic bending) experiments take
direct advantage of the high strength outer sheath to
impart elevated HCF resistance. Tension tests have
shown that the DFT wires/strands can possess very high
strength (e.g. yield strength > 1 GPa, UTS > 1.4–1.6
GPa) with acceptable ductility (e.g. εf range 0.2–0.35).
Coiling of such strands provides much higher levels of
flexibility and resistance to cyclic fatigue.
Lewandowski et al.10 used the CMB approach to fit
data from flex bending fatigue tests (Fig. 6d ) of DFT
wires and strands that have been used in coiled form for
NNPS as previously described. Uniaxial tension data
obtained from tensile tests (Fig. 62a–c) and from the man-
ufacturer were utilised in equation (37) to perform the fits.
Values that were determined for the fatigue strength and
ductility exponents (i.e. b and c) in the CMB equation
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45 Effect of test temperature on the rotating bending fatigue life for Ti–50Ni and Ti–40Ni–10Cu (at.-%)41

were consistent with those exhibited by conventional met-
allic alloys.173
A number of other investigators4,27,37,58 have used the
CMB relationship or a modified method71,216 to fit fatigue
data for materials such as stainless steels, cobalt–chromium
alloys,4,71 composite alloys,71 bioabsorbable58 and Nitinol
alloys.4,27,72,216 Benini4 found good correlation to 35N
LT and 35NLT-DFT-Ag data but poor correlation with
Nitinol which was attributed to the unique flow character-
istics of SE Nitinol. Figueiredo et al. 27 also experienced
difficulty in fitting CMB to the SE wires between the 4
and 8% alternating strains which were denoted as the ‘Z’
portion of the fatigue curve (Fig. 38).
Though not based on wire data, Maletta et al. 216 pro-
posed some important considerations when applying
CMB to Nitinol alloys and also suggested a modification
that may better capture the pseudoelastic behaviour not
observed in typical structural materials which serve as the
basis for the CMB modelling approach. Tensile and cyclic
axial fatigue data for Nitinol dog bone samples was
obtained for material that remained within the SIM trans-
formation regime during testing. A schematic of the stress–
strain response is shown (Fig. 63a) and the mechanical par-
ameters are listing on the diagram accordingly.
The total strain range Δε (equation (38)) was defined by
the sum of the elastic Δεe and inelastic strain Δεi ranges
where the amplitude of the elastic strain range Δεe. The
stress range Δσ (turning point of the stabilised stress–
strain hysteresis curve) and effective modulus of elasticity
E(ξM) (a function of the volume fraction of martensite)
defined the cyclic elastic strain as shown in equation
(39).216
D1 = D1e + D1i (38)
Ds
D1e = (39)
E(jM )
The effective modulus E(ξM) was expressed by equation
(40), the Reuss formula, which related the effective moduli
of the austenite EA and martensite EM.216
 
jM 1 − jM −1
E(jM ) = + (40)
EM EA
A linear function of the strain in the transformation
plateau was assumed for the volume fraction of marten-
site that occurred during loading and was described by
equations (41) and (42) where εL is the uniaxial

International Materials Reviews 2016 51

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46 Evaluation of wire diameter and test rate in rotating bending fatigue57

transformation strain (for complete stress-induced phase data from unidirectional bend fatigue tests for MP35N
transformation) and the elastic strain (onset of transform- and MP35N–Ag implantable electrode coils is shown in
ation stress) was noted as εAM
s .216 equation (47). The applied coil curvature amplitude was
defined in equation (31) and was used to develop a curva-
0 if D1 ≤ 1AM
s ture-life relationship analogous to equation (37).71
jM = (D1 − 1AM −1
s )1L if 1AM
s , D1 , 1AMs + 1L (41)
1 if D1 ≥ 1AM
s + 1 L Ka = A1 (Nf )b + A2 (Nf )c (47)
The generated curve illustrated that a decrease in cur-
sAM
1AM
s = s
(42) vature led to an increase in fatigue life and that the
EA slope of the curve decreases with increasing cycles
The strain amplitude εa was defined as the sum of the (Fig. 64).71
elastic εae and inelastic εai strains shown in equation
(43).216 Universal slopes method
1a = 1ae + 1ai (43) The universal slopes equation was modified initially to
incorporate findings from fatigue tests of 29 different
Finally the modified CMB approach (equation (44)) materials, shown in the equation (48) and again after
was determined from the data plotted in Fig. 62b where evaluation of 50 different materials, shown in equation
εae and εai were defined by equations (45) and (46) with (48).173,217,218
exponents C, D, c and d obtained from Fig. 62b.216  
3.5Su
1a = 1ae + 1ai = C(2Nf )c + D(2Nf )d (44) D1 = (Nf )−0.12 + D0.6 (Nf )−0.6 (48)
E
1ae = C(2Nf )c (45)  0.832
Su
D1 = 1.17 (Nf )−0.09
E
1ai = D(2Nf )d (46)  −0.53
Su
Another modification to the CMB approach was devel- + 0.0266D0.155 (Nf )−0.56 (49)
E
oped by Campbell and Johnson71 to address the fitting of

52 International Materials Reviews 2016

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47 Test frequency vs. cyclic life of Nitinol wires in tension–tension fatigue56

48 Stress vs. strain curves for Nitinol representing a alternating bending fatigue and b and c pulsatile bending fatigue56

International Materials Reviews 2016 53

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49 Nitinol strain–life curves comparing alternating bending fatigue, rotating bending fatigue and pulsatile bending
fatigue29,63,67
In equations (48) and (49) the ultimate tensile stress is
noted by Su and the ductility D is given by equation
(50) where %RA is the percent reduction of area.
 
100
D = ln (50)
100 − %RA
Exponents for both the fatigue strength b and fatigue
ductility c are available for a variety of structural metals
and can range from −0.14 to −0.05 and −0.8 and −0.5,
respectively.11,173
This approach was also used to model the strain–life
behaviour of 316LVM 1 × 7 cable (Fig. 65).11 The tensile
data used to develop the modified universal slopes model
in Fig. 65, equation (49) under-predicted in the LCF while
equation (48) modelled the LCF data well but under-pre-
dicted the HCF.
Finite element method
Finite element (FE) modelling can be a powerful tool in
test simulations and material modelling by providing a
means to reduce the cost and time necessary for tra-
ditional laboratory testing leading to shorter development
54 International Materials Reviews 2016
times to bring products to market. For FE models to be
beneficial, both verification and validation are necessary
to instill confidence in the program’s ability to appropri-
ately represent the material or system conditions. Verifica-
tion of a FE solution requires the comparison to a known
solution while validation aims to ensure the physical accu-
racy of the solution to experimental data.75 A thorough
understanding of the limitations of the FE software and
assumptions made in the model development will have a
significant impact on how the FE results can be inter-
preted and applied to real world materials and testing.
Applying FE methods to SE Nitinol is particularly chal-
lenging due to the complicated material response in rotat-
ing bending fatigue. A variety of researchers have
investigated the use of FE for modelling fatigue test-
ing51,75,76,191 and while the recent developments of FE
applied to fatigue could command its own review, only
a highlight of the efforts are presented here.
Meagher and Altman,1 while not performing FE on the
fatigue process, considered flexure of composite wire typi-
cally found in biomedical applications. A model of an
MP35N coil and a DFT composite (i.e. MP35N tube
with a 25% silver core by volume) were developed and
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50 Fatigue life curves illustrating the difference between various applied strain ratios in Nitinol wire39
compared to the theoretical maximum and minimum
principal stresses and von Mises stresses, yielding negli-
gible differences. A brief summary of the theoretical
development can be found in the ‘Review of test tech-
niques’ section of this paper and the full derivation in
the authors’ work.1 The magnitude of the von Mises stres-
ses was compared to the theoretical model derived for the
MP35N coil and DFT and differences were considered
negligible. Furthermore, the models agree with previous
findings that a small curvature, smaller wire diameter,
smaller helix angle and larger coil diameter contribute
to an increased fatigue resistance.
Pelton et al.51 applied nonlinear FE methods to evalu-
ate the behaviour of Nitinol wire under rotating bending
fatigue conditions. The model examined a bright wire in
cross-section for the following strain amplitudes: 1, 2, 5
and 10%. Stress–strain curves (FE and experimental)
reflected the differences in compression and tension
found in Nitinol rotating bending fatigue conditions and
indicated that for a given strain amplitude, compression
exhibits a larger stress amplitude and subsequent accumu-
lation of damage.
Microstructures and fractography
Although this review has documented an extensive
amount of strain–life fatigue data that has been generated
on different materials used for biomedically relevant
wires/cables, fewer works have documented the wire/
Fatigue and fracture of wires and cables for biomedical applications
cable microstructures. While the effects of surface rough-
ness, presence of surface defects (e.g. scratches, pits, die
marks, etc.) and characteristics of the surface oxide have
been reported in some works49,52,53,57,71 less detailed
work has been conducted to characterise the microstruc-
tures present in such wires/cables. One of the reasons for
this lack of detailed microstructure quantification relates
to the typical heavily cold-worked structure present in
many of the wires/cables. The very high dislocation den-
sity in such heavily drawn wires complicates detailed ana-
lyses via TEM and electron backscatter diffraction
(EBSD), while the very fine grain size and heavily
deformed grains present in such small diameter wires
also complicates metallographic analyses.
As indicated earlier in the review, many of the
materials systems utilised in biomedical grade wires
are processed using special techniques (e.g. VAR, etc.)
to produce materials with controlled chemistry and
reduced inclusion content. Inclusions can be potential
sites for fatigue crack nucleation, and a few studies
have specifically investigated the effects of chemistry
control on the strain–life behaviour as documented ear-
lier in this review and covered again in this section.
Controlled inclusion contents may also be helpful in
the wire drawing process as large inclusions can cause
fracture during wire drawing as well as locally deform/
scratch the dies and subsequently affect the surface con-
dition of wires drawn through those regions. This review
continues by covering the microstructural details, where
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51 Mean strain effects on the axial fatigue behaviour of Nitinol wire in Ringers solution42

available, in addition to reviewing the more extensive
fractographic examinations of a number of different
materials that have been performed on fractured wires/
cables.
Stainless steels
The metallographic cross-section of annealed 316LVM
wire34 provided in Fig. 66 demonstrates the relatively
fine grain size (e.g. 5 µm) in this wire. Annealed
316LVM wires/cables, as shown earlier in Figs. 13–15
and 60 exhibit better LCF resistance due to their high
ductility (e.g. εf > 2), but inferior HCF resistance due to
their lower strength (e.g. 592 MPa) in comparison to as-
drawn 316LVM wires/cables which are much stronger
(e.g. yield strength > 2 GPa) but less ductile (e.g. εf = 0.5).
Figure 67 shows the very high tensile reduction in area
(i.e. 86%) in the annealed 316LVM, while tension tests on
1 × 7 316LVM cable shown in Fig. 68 similarly show
roughly 90% reduction in area for each wire in the
cable. Yield strength/UTS of the annealed 316LVM was
1135/1239 MPa, while 1 × 7 cables of as-drawn
316LVM40 exhibited yield/UTS of 2224/2550 MPa and
reduction in area of 40% (εf = 0.5).
Flex bending fatigue tests (Fig. 6d) of 1 × 7 cables of
316LVM produced the data shown in Fig. 69 and were
successfully fit using the CMB equation by using tension
data obtained on identical material.

Table 5 Summary of inclusions reported from various Nitinol alloy wire failure

Test method Inclusion size Wire diameter Morphology Chemistry Investigator(s)

Axial fatigue 2 µm 0.65 mm TiC Morgan et al. 42

Axial fatigue 17–35 µm 0.52 mm Ti4Ni2Ox Launey et al. 33
Tension 3 mm Plate Ti3Ni4 Filip et al. 244
Tension 1–2 µm 1.2 mm Block TiC Frotscher et al. 28
Tension 200–300 nm 1.2 mm Globular TiC Frotscher et al. 28
RBT 3, 8–10 µm 0.32 mm Kumar et al. 32
RBT 0.1–54.9 µm 2.06 mm Kumar et al. 32
RBT 3.2, 4.4 µm 0.267 mm Angular Patel48
RBT 1.2, 3.7 µm 0.127 mm Angular Patel et al. 50

56 International Materials Reviews 2016

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52 Strain–life curves of Nitinol wires in rotating bending fatigue representative of five different vendors plotted as a cyclic strain
vs. cyclic life and b percent strain amplitude vs. cyclic life32

53 Comparison of suppliers and microcleanliness effects on rotating bending fatigue of Nitinol wire48

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54 Comparison of suppliers and microcleanliness effects on rotating bending fatigue of Nitinol wire50
Typical SEM fractography of failed 1 × 7 316LVM
cables, Fig. 70a reveals similar characteristics for each
of the individual wires in the cable, one of which is
shown at higher magnification in Fig. 70b. Since the test
is conducted in fully reversed flex bending, fatigue frac-
ture is expected to start at opposite sides of the wire, con-
sistent with that shown in Fig. 70b, followed by fatigue
crack propagation toward the centre of the wire. This
eventually produces ductile overload near the wire centre-
line as shown in Fig. 70b.
Tests conducted on similar materials in rotating bend-
ing fatigue (Fig. 8a–c) produce a different fracture
appearance (Fig. 71) since the whole circumference of
the wire alternately experiences tension and compression.
Cracking nucleates around the wire circumference and
grows toward the centre of the wire.
In general, the amount of fatigue fracture present on
the fracture surface in comparison to overload failure is
also consistent with classic representations of fatigue fail-
ure and typical effects of loading conditions, stress levels
and stress concentrations summarised in Fig. 72. Samples
fatigued to failure under low cyclic stresses generally exhi-
bit large regions of fatigue and small overload region,
while the opposite is exhibited in samples tested under
higher cyclic stresses, as summarised in Fig. 72. Examples
of other similar observations that have been made for
wires/cables tested using the variety of test techniques
summarised in Figs. 6–10 will also be shown in the
remainder of this section.
58 International Materials Reviews 2016
Laser processed 316LVM
In addition to examining the strain–life behaviour of
316LVM wires/cables, very recent work has started to
examine the effects of various laser processing/machining
treatments applied to wire surfaces on the subsequent ten-
sion and flex bending fatigue (Fig. 6d) behaviour in com-
parison to the original wires.34 This type of information
may be important to the performance of products that
are laser machined/processed, whether this is with nano-
second, femtosecond or other laser systems. One advantage
of conducting such studies on individual wires relates to the
potentially large effects that can be demonstrated due to
the small size of sample and large surface area affected.
As reviewed in a number of publications16,220–241 var-
ious laser-material interactions occur depending upon
the input energy, pulse length and width and details of
the material being processed/machined, among other par-
ameters. The readers can review the various references for
background on the different laser-based machining tech-
niques while the following reviews the effects of femtose-
cond (FS: laser power = 12 µJ, frequency = 100 kHz,
marking speed = 20 mm s−1 and number of passes = 1)
laser treatment of 316LVM wires in comparison to
nano-second laser treatment of wires using either high
power (HP: lamp current = 28 A, frequency = 15 kHz,
marking speed = 50 mm s−1, and number of passes = 10)
or low power (LP: lamp current = 20 A, frequency = 15
kHz, marking speed = 50 mm s−1, and number of passes
= 10).
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55 Effects of inclusions on rotating bending fatigue of Nitinol wire showing a all data, b failures that were initiated at an
inclusion and c fracture data from 30 high strain tests54
Figure 73a is a 3D surface reconstruction along the
length of an as-received 316LVM wire obtained via scan-
ning laser confocal microscopy, demonstrating a surface
roughness Ra = 0.27 µm. Figure 73b–d shows similar
images taken after laser processing the circumference of
a similar 316LVM wire with a nano-second Nd:YAG
laser at low power (Fig. 73b, Ra = 0.5 μm), high power
(Fig. 73c, Ra = 2.8 μm) and using the femtosecond laser
(Fig. 73d, Ra = 0.98 μm). While there are clear differences
in the surface roughness, focused-ion beam (FIB) section-
ing of the laser-treated surfaces of such samples further
reveals some microstructural changes.
The surface of the HP nano-second treated sample
reveals a significant recast layer (Fig. 74a), while higher
magnification views of the recast layer in Fig. 74b and
FIB-sections perpendicular to the surface in Fig. 74c
show a much finer grain size as well as cracks in the
recast layer in comparison to the underlying
microstructure.
In contrast, a much smaller and contiguous (i.e. no
cracks present) recast layer is obtained in the LP nano-
second laser-treated samples shown in Fig. 75a–c. Femto-
second laser treatment produced even less microstructural
changes.
Figure 76 summarises the effects of laser treatments of
various types on the annealed 316LVM wires. While such
treatments did not drastically affect the tensile strength
and ductility since the annealed 316LVM is so ductile, it
is clear that the LP nano-second laser surface treatment
Fatigue and fracture of wires and cables for biomedical applications
improves both the LCF and HCF behaviour, while HP
treatments decrease both LCF and HCF when testing is
conducted in flex bending fatigue (Fig. 6d ). Similar
improvements in flex bending fatigue behaviour are
noted for the femtosecond treated annealed 316LVM
despite minimal effects on the tension properties.
A typical fractographic image taken from the FS laser-
treated wires tested in flex bending fatigue (Fig. 6d) is pro-
vided in Fig. 77 and illustrates the same global features
noted on as-received annealed 316LVM wires shown in
Fig. 70b above with fatigue fracture starting and then pro-
pagating from opposite sides of the wire, followed by cat-
astrophic overload near the centreline of the wire. The
improved fatigue performance in properly laser-treated
samples appears to occur due to the delay of fatigue
nucleation, although the detailed mechanisms of improve-
ments await further analyses. HP treatments that produce
a large and cracked recast layer clearly degrade the fatigue
performance due to the easy growth of such pre-existing
cracks during fatigue. Future work should also examine
electropolishing of laser-treated wires to remove some of
the stress concentrations (Fig. 73b–d ) that may also affect
the results.
Cobalt–chromium–nickel alloys
As demonstrated in stainless steel systems, fatigue frac-
ture of cobalt–chromium alloys in rotating bending
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56 Fatigue life data for archwires tested in flex bending fatigue4
fatigue is dominated by surface conditions. In the case of
the work by Bradley et al.,23 it was shown that processes
optimised for microcleanliness led to improved surface
finish and increased fatigue life. A comparison of the
ASTM F562 with an optimised 35N LT was evaluated
for inclusion feature size, chemistry and quantity, as
well as grain size, visual and Eddy current analysis of
the surface. BEI was used to analyse features lighter or
darker than the background and processed with image
analysis software categorising inclusions by size. The
mean total inclusions found in the ASTM F562 was
1623 (Std. Dev. 435) with the largest mean inclusion
measuring 31.98 µm (Std. Dev. 18.83 µm). In contrast,
the mean total inclusions in the optimised 35N LT was
668 (Std. Dev. 279) with the largest mean inclusion
measuring 4.20 µm (Std. Dev. 0.71 µm). Dark features
in 35N LT exhibited rounded morphology and included
large concentrations of magnesium and oxide while bright
features occurred more randomly and in the form of
stringers with noted increases of molybdenum and
boron. The largest occurring inclusions were typically
present as stringers for ASTM F562, while sub-μm
inclusions were randomly located. ASTM F562 inclusions
exhibited either a core of magnesium, aluminium and
oxygen with titanium and nitrogen surrounding it or a
core of oxygen with high concentrations of aluminium
and/or magnesium.
60 International Materials Reviews 2016
Grain size measurements were taken following typical
metallographic techniques and respective grain size
measured 14.6 in ASTM F562 and 14.3 in 35N LT
while the transverse grain size measured 14.5 and 14.4,
respectively.
Composites
Composite wires – DFT
The composite-like nature of the laser-treated wires
clearly affects the strain–life fatigue behaviour since the
surface of the wire dominates under rotating bending fati-
gue and flex bending fatigue. Examination of actual com-
posite wires (e.g. DFT, Fig. 1a) demonstrates similar
characteristics. Figure 78a and b provides a metallo-
graphic cross-section of a DFT cable while microhardness
indents indicate that the relatively soft silver core is sur-
rounded by a much stronger MP35N outer sheath.
TEM analyses10 revealed a very large grain size and low
dislocation density in the silver core, consistent with its
low strength and a heavily deformed MP35N outer
sheath, indicative of retention of some of the cold worked
structure imparted during wire drawing and consistent
with its much higher strength/hardness. As shown in
Fig. 78c and d, the Ag/MP35N interface is absent of
inclusions/particles and appears to be metallurgically
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57 Comparison of standard grade and high purity Nitinol ‘Z-set’ wire (see inset for shape setting) in axial fatigue33

bonded. Details of the MP35N were not obtained due to
the heavily deformed sub-structure.
Tension tests conducted on individual DFT wires and a
variety of different DFT cable architectures (e.g. 1 × 7,
7 × 7, 7 × 19, etc.) revealed yield strengths ranging from
808 to 1109 MPa, with UTS ranging from 1111 to 1226
MPa, and εf ranging from 0.2 to 0.35.10 Tensile fracture
surface analyses revealed that the soft silver core typically
failed in a ductile manner and was surrounded by a less
ductile sheath of MP35N (Fig. 79). The Ag/MP35N

58 Cyclic tension fatigue behaviour in Nitinol at various test scenarios including a constant stress and constant stress with a
limited maximum strain of either 3 or 4% and b linear stress–strain and constant stress of 4%37

International Materials Reviews 2016 61

 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications
59 Coffin–Manson–Basquin model173
interface remained intact despite the high stresses and
strains sustained during tensile deformation and fracture,
consistent with the TEM examinations of this interface
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shown in Fig. 78c and d.
The flex bending fatigue performance of these DFT
wires and cables was reviewed earlier in Fig. 6d and was
successfully modelled using the CMB relationship. The
60 Selected 316LVM data for wires and cables11
62 International Materials Reviews 2016
strong outer MP35N sheath appears to be beneficial to
the fatigue performance in flex bending fatigue since the
highest stresses are located at the surface(s) of the wire
(s) during such testing. Figure 80a shows one of the 1 ×
7 strands of a 7 × 7 DFT cable that has been tested to fail-
ure in flex bending fatigue. A higher magnification view of
a single wire (Fig. 80a) is provided in Fig. 80b. Fatigue
failure again appears to initiate from opposite sides of
the wire, although the contact points between other
wires often served as initiation sites. Fatigue crack growth
propagated through the MP35N/Ag interface without any
debonding, again consistent with the strong interface
revealed in the TEM and tension tests.
Altman et al.2 reported similar fractographic features in
MP35N and DFT wires and coils with surface-generated
crack initiation in rotating bending fatigue (Fig. 8c). Figure
81a shows the DFT wire, tested at a 25.4 mm radius in
rotating bending with failure at 150 000 cycles. The point
of initiation and region of final fracture are noted in Fig.
81a and b with crack propagation through the MP35N/
Ag interface and through the centre of the sample. The
DFT samples regularly displayed some amount of ductile
pitting of the MP35N near the silver core and metal smear-
ing was observed in the silver core. In the higher stress
interior region of single filar samples, multiple initiation
sites emerged in the MP35N (Fig. 81b), however final fail-
ure occurred at the lower stress exterior of the coil. The
 Gbur and Lewandowski
multifilar coils are more difficult to evaluate as the individ-
ual wires experience particularly complex interactions with
each other at contact points leading to abrasion, galling,
localised fretting and in some cases lips of extruded
material bent over and onto the fracture site (Fig. 81c).
Smearing in some coils was reported in conjunction with
the classic dimples found in classical ductile failure under
tension. The latter were attributed to a possible torsional
component to the failure which may have been a result of
the complex stress state present in the coils tested in rotat-
ing bending.
Optimisation of processing as discussed in ‘Cobalt–
chromium–nickel alloys’ section was investigated in
DFT wire form for 35N LT and MP35N by Kay and
Bouthot.242 Nonmetallic titanium nitride inclusions
were observed at all fracture initiation points for
MP35N DFT and the size of inclusions for the 12 samples
ranged from 2.4 to 5.2 µm. In contrast, the 35N LT DFT
possessed numerous fracture initiation sites and lacked
evidence of inclusions at the points of fracture initiation.
The lack of inclusions was attributed to the cleaner melt
process and produced the corresponding increase in fati-
gue life for 35N LT DFT composites.
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Other materials
Work by Casey and Lee87 investigated the factors influ-
encing rope degradation and described types of wire
61 316LVM wire data fitted with Coffin–Manson–Basquin relationships11,40
Fatigue and fracture of wires and cables for biomedical applications
failure based on testing six-strand, zinc-coated, steel
wire rope subjected to constant amplitude tension–ten-
sion fatigue. Qualitative analysis showed grooving pat-
terns that travel helically along the wire length that
are the result of contact between adjacent wires and
layers. Following testing, the grooves were not consist-
ent in appearance, some regions displaying heavier
grooving than others, due to the changes in radial forces
along the helix and respective mechanical responses.
Additionally, contact patches were visible in both
‘short’ (interwire contact between multi-layer strands)
and ‘long’ (contact with two double helical wires of
outer strands of IWRC) patterns as illustrated in Fig. 82.
The contact points or pairs can act as clamps or pivots and
may serve as sites for fatigue crack initiation in conjunction
with grooving by providing secondary bending and torsion
to the structure.
Based on the fracture responses of the six-strand
ropes, Casey and Lee87 catalogued the types of failure
associated with the constant amplitude, tension–tension
testing. Six types of wire failures were observed and are
illustrated in Fig. 83. The fracture surfaces are related
to the loading conditions in the rope and are influenced
by the rope geometry. Type 1 failures (Fig. 83a) occur
in the IWRC with the cracks propagating transversely
and longitudinally due to the additional localised tor-
sional stresses. Type 2 varies from Type 1 by the inter-
rupted crack growth related to imposed shear stresses
International Materials Reviews 2016 63
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

62 Strain–life behaviour with CMB relationships illustrating a effect of mandrel diameter in flex bending fatigue for various DFT
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cables in comparison to 316LVM 1 × 7 cables, b effect of wire diameter in DFT 1 × 7 cables and c effect of wire diameter in DFT
7 × 7 cables10

developed from localised bending. In Type 2 failures
(Fig. 83b), the crack reinitiates further down the wire
leading to a stepped fracture appearance. Secondary
bending between adjacent layers in the IWRC leads
to a Type 3 failure (Fig. 83c) occurring only between
contact pairs from a double helical wire of Lang’s lay
IWRC and two single helical wires from the straight
core strand. Type 4 failures (Fig. 83d ) display trans-
verse crack propagation and a shear lip on final
rapid fracture. This is the most common failure type
which is dominated by tension stresses, and occurs in
regions of low mechanical interactions. A combination
of tension and torsion produce Type 5 failures
(Fig. 83e) along the IWRC. Finally, Type 6 failures
(Fig. 83f ) are from the result of tensile overload and
stem from localised failures in the multi-layer outer
strands producing the characteristic cup and cone
geometry.
Nitinol and other SM and SE alloys
A general overview of Nitinol microstructures is given to
provide a fundamental understanding of the uniqueness of
this alloy before describing its behaviour following fatigue
testing. Multiple sources address more in-depth nuances of
the material’s structure including martensitic

63 Nitinol modelling showing a stress–strain curve schematic and b tension fatigue data fit with modified CMB
approach216

64 International Materials Reviews 2016

 Gbur and Lewandowski
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64 Curvature-life behaviour utilising equation (47) for MP35N and MP35N–Ag passive fixation coil electrodes and MP35N active
fixation coil electrodes in unidirectional bending fatigue71
transformations,29,102,107,165,177,243 thermal responses,174
localisation of strain and temperature fields,175,181 precipi-
tation kinetics244–246 and thermo-mechanical
coupling.176,247
Fractography resulting from the aforementioned fati-
gue tests (Figs. 6–8) is described in this section noting gen-
eral locations of crack initiation and propagation,
fracture characteristics and notable microstructure fea-
tures when provided. In most of these fatigue tests, surface
characteristics contribute significantly to failure. Since the
maximum stresses occur at the extreme elements or sur-
face as described previously, any surface abnormality
can act as a stress riser and serve as a site for crack
initiation. It is important to note that the thickness in
some of the very fine wires and struts located within var-
ious stent architectures may approach the grain size of the
material. This could also contribute to scatter in mechan-
ical testing data as polycrystalline deformation requires
5–10 grains being sampled.82
SE Nitinol
In general, Nitinol and its alloys exhibit ductile behaviour
following standard tensile tests and the fracture surface
can be divided into distinct regions. In the work by
Frotscher et al.,28 the surface was described by three
regions following tensile fracture. A flat, gently sloping,
small homogeneous honeycomb patterned architecture
sloping inward followed by a series of larger
Fatigue and fracture of wires and cables for biomedical applications
heterogeneous honeycomb structures and pores measur-
ing 0.5 µm in size concluding with an extremely pro-
nounced honeycomb structure. TiC particles ranging
from 1 to 2 µm were located within the honeycomb struc-
ture and finer particles ranging from 200 to 300 nm
resided on the surface.
Benini4 observed necking and evidence of microvoid
coalescence in GAC Sentalloy and 3M Unitek SE Ortho-
form II Nitinol wires following tensile testing at a rate of
0.5 mm min−1 (Fig. 84a) analogous to the honeycomb
structure described by Frotscher et al.28 Higher magnifi-
cation views of the Benini4 sample in Fig. 84b reveal par-
ticles at the base of many of the microvoids. Work by
James et al. 248 also reported the characteristic cup and
cone fracture following tension testing in Nitinol SE
wire. While it is clear that microvoids form around
inclusions of various types in SE Nitinol, the role of
inclusions in the fatigue performance is less clear and
has only recently become the focus of much work.
As indicated in the previous discussion, inclusions can
contribute to a reduction in the strain–life behaviour of
wires although the magnitude of such effects may depend
on which of the test techniques shown (Figs. 6–10) is used.
It is equally important to understand how various sur-
face treatments and defects affect the topography and
fatigue behaviour as this is also crucial for designers in
order to maximise the longevity of the component or
device.
International Materials Reviews 2016 65
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65 Predicted behaviour utilising equations (49) and (50) in comparison to experimental data for 316LVM 1 × 7 cables11

Numerous investigators have reported nonmetallic (OD = 0.3 mm, wall thickness = 0.1 mm). Micrographs
inclusions as a potential source for crack initiation leading taken in the region of interest (ROI) that depict the
to failure of wires.28,33,42,48,52 Table 5 lists the inclusion inclusion content and distribution revealed an increase
characteristics summarised in those papers while only a number of inclusions during the tube drawing stage.
selected number of those investigations examined the This was rationalised as due to the fractionalisation of
effect of microcleanliness and its relationship to fatigue brittle inclusions from the plastic deformation of the
life, discussed previously in ‘Fatigue data’ section. Typical drawing process.208 The maximum mean diameter of the
inclusions reported in the literature include TiC,28,42 inclusions plotted against the location within the
TiC(O),249 Ti3Ni4,244 Ti2Ni(C,O) and Ti4Ni2Ox.33,249
Table 5 also lists relative sizes of reported inclusions,
wire diameter, inclusion morphology, chemistry and
investigator(s) when information was provided.
The kinetics of Ti3Ni4 precipitation in SM alloys was
investigated by Filip and Mazanec244 by evaluating
aged 3.0 mm diameter Nitinol wire. Aging at 400 and
600°C produced a homogenous distribution of precipi-
tates while the formation of Ti3Ni4 platelets were
focussed at the grain boundaries and in nearby regions
with low defect density when aged at 900°C. Samples
that were aged possessed greater strength than the
non-aged, hot-drawn wire when tested in tension at
room temperature.
Wohlschlogel et al. 208 investigated the effect of
inclusions on the corrosion behaviour of Nitinol tube.
Materials were obtained from different suppliers and cate-
gorised by different melting techniques (VAR, VIM/
VAR). Samples were evaluated from the initial drawing
stage, after hot drawing and following final drawing step 66 Metallographic cross-section of 316LVM annealed wire34

66 International Materials Reviews 2016

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67 SEM image of 316LVM annealed wire illustrating tensile fracture characteristics (i.e. dimples and high reduction of area)104

production process and separated by supplier with noted TiC inclusion located at the onset of crack propagation
melt process is shown in Fig. 85. A comparison of the in a wire that underwent high alternating strain is
initial drawing procedure (stage i) to the final tube pro- shown in Fig. 87a and b. It was reported that at high
duct (stage iii) displayed a decrease in the inclusion size,
but an increase in the number of inclusions.
Coda et al.249 also examined VIM–VAR Nitinol alloys
and characterised inclusions from 6.3 mm diameter rolled
coil in Fig. 86. Nitinol (chemistries provided in at.-%)
with As = −15°C (50.7 Ni) contained dark (53Ti–32C–
15O) and grey (58Ti–27Ni–15O) inclusions in addition
to inclusions with a dark core (57Ti–37C–6O) and grey
shell (58Ti–28Ni–8O–6C). Nitinol with As = + 95°C
(49.6Ni) contained dark (57Ti–37C–6O) and grey
(63Ti–30Ni–7O and 65Ti–35Ni) inclusions in addition
to inclusions with a dark core (58Ti–38C–4O) and grey
shell (60Ti–28Ni–7O–5C). Four different types of
inclusions were categorised from the VIM/VAR process
including: TiC(O) with substituted oxygen, Ti4Ni2O inter-
metallic oxide, Ti2Ni precipitates with or without intersti-
tial oxygen observed at high temperatures and TiC(O)/
Ti2Ni(C,O) core–shell inclusions (Fig. 86).
Morgan et al.42 evaluated wires in axial fatigue in sol-
ution by varying the mean strain and alternating strain.
Upon fractographic examination of the failed wires, TiC
inclusions were noted as a point of potential stress con-
centration and site of crack initiation. An example of a 68 SEM image of tension failure for 316LVM 1 × 7 cable11

International Materials Reviews 2016 67

 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications
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69 Cyclic strain–life plot with CMB fit line for 316LVM 1 × 7 cable11

alternating strains, failure could easily be traced back to
inclusions at the surface. In contrast, it was difficult to
identify a point of initiation in samples tested at low alter-
nating strains.
Norwich and Fasching45 tabulated the five largest
inclusions (transverse and longitudinal) present in a
variety of different wire diameters shown in Fig. 88.
The largest inclusions were reported as most meaningful
to the effect on fatigue life since they are a source for
fatigue crack initiation. Their data showed that a
decrease in wire diameter (i.e. higher reduction) pro-
duced a decrease in transverse inclusion size, while

70 SEM images of flex bending fatigue failure (Nf = 1647 cycles and mandrel diameter = 1.15 mm) for a 316LVM 1 × 7 cable and b
magnified view of a single wire from image 70a11

68 International Materials Reviews 2016

 Gbur and Lewandowski
71 SEM image of rotating bending fatigue failure of 316LVM
annealed wire (Nf = 22 cycles)219
longitudinal inclusions formed stringers in the direction
of wire drawing. Their analysis focussed on the mech-
anics of the drawing process related to the fragmenta-
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tion and elongation of individual inclusions. The
analysis revealed that drawing to smaller diameter
wires also produced fragmentation of the inclusions pre-
sent and a corresponding reduction in size and increase
in number density of inclusions.
Rahim et al.54 evaluated high purity Nitinol wire and
compared the effects of varying the carbon and oxygen
content on rotating bending fatigue (Fig. 8a). An exten-
sive analysis examined the inclusion content and respect-
ive crack sizes related to the fatigue failures. The number
of inclusions and particle/void components were counted
for the O-rich (2410/158, respectively), C-rich (2005/421,
respectively) and high purity (246/203, respectively)
materials. Additionally, fatigue failures were character-
ised by the type of crack initiation (inclusion, drawing
defect, die mark and other locations) and associated
strain level as show in Table 6.
Shaffer and Plumley59 presented a collection of the fre-
quency of either oxide surface defects or inclusions
observed on the fracture surfaces of samples fatigued at
0.9% strain as a function of percentage of cold work in
the wire. The oxides were considered an extrinsic surface
defect while the inclusions, generally TiC, were con-
sidered intrinsic defects.
Patel48 also revealed surface defect-oriented crack
initiation in rotating bending fatigue (Fig. 8a) with fea-
tures similar to that already presented. Figure 89 shows
crack initiation at a 4.4 µm angular inclusion at the wire
surface. EDS analysis reported titanium, carbon, nitrogen
and oxygen present at the initiation site. The presence of
any near-surface defects contribute to the ease of crack
initiation which is magnified by fatigue tests that are sur-
face condition dependent (i.e. rotating bending fatigue).
Microcleanliness and optimised melt practices are then
critical in minimising the potential for premature failure
due to surface conditions and defects.
Additional work by Patel et al.50 examined inclusions
in finer diameter wire (0.127 mm). Analysis showed non-
metallic inclusions comprised of Ni, Ti, and O as well as
Fatigue and fracture of wires and cables for biomedical applications
72 Schematics representing macroscopic appearance of
samples fatigued under a high cyclic stress/strain and
b low cyclic stress/strain
Ti, Ni, O, C and N in angular shapes. The smallest
inclusions noted were 1.2 µm (transversely, supplier A)
and 3.7 µm (supplier B) and the largest were 3.5 µm (sup-
plier A) and 4.4 µm (supplier B) with the largest having
similar chemistries of Ni, Ti, C and O.
An investigation of cracking patterns observed in
different Nitinol wires (superelastic austenite, SE; stable
martensite, SM; stable austenite, SA) was performed by
Figueiredo et al.27 The schematic depicted in Fig. 90 is
representative of data plotted in Fig. 38 and illustrates
how the cracking pattern observed in the SE wires corre-
lates to the SA and SM strain–life curves and respective
cracking patterns. Analysis of the SE wires at 1% alternat-
ing strain showed a small number of single cracks that
nucleated slowly and followed particular features of the
microstructure (e.g. precipitates) until a particular crack
dominated the growth limiting others. At 3% strain the
cracks in the SE wires were more numerous, still following
microstructural features, and illustrated schematically in
Fig. 90a and b. The phenomenon was explained by
rapid, numerous crack nucleation and then slow crack
propagation occurring within the martensitic variants
and twin boundaries in the SE regime. The onset of the
‘Z’ region described in Fig. 38 was observed near 3%
alternating strain.
Work by Frotscher et al.28 characterised the surfaces of
different NiTiCr wire treatments (as-drawn, ground
polished, electropolished) via confocal microscopy and
revealed the average roughness heights (Ra) and mean
waviness heights (Rz) which are important factors to fati-
gue tests wherein the lifetime is driven by surface
International Materials Reviews 2016 69
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

73 3D surface plots for 316LVM wires with calculated surface roughness values for a as-received, b laser-treated with low
power (LP) Nd:YAG laser, c laser-treated with high power (HP) Nd:YAG laser and d laser-treated with femtosecond (FS)
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laser34

conditions of the sample.28 TiC particles were located on
all surfaces including within the depth of scratches indi-
cating some interaction occurred during the drawing
stage which may be related to the fracture of the TiC par-
ticles or the particles tearing from the surface and adher-
ing to the die. Carbides are generally present in the
melting process and are strongly attracted to the titanium.
In the as-drawn condition, a black oxide layer is formed
related to the self-heating in the drawing and annealing
resulting in an average surface roughness height of 368
nm. The ground polished condition removes the oxide
layer exposing scratches parallel to the wire axis as a
result of drawing and produced a Ra = 395 nm longitudin-
ally and 563 nm transversely. The electropolished wire
produces a smooth surface devoid of scratches and pro-
duced a Ra = 83 nm.
Additional work on surface preparation influences on
material behaviour was performed by Carroll et al.206
Their investigation focussed on the variations in surface
topology and the relationship to cell interaction and
polymer coating adhesion. Wire diameters of 0.762 mm
were drawn from a synthetic polycrystalline diamond
die (SyD) or a natural diamond die (ND) and heat
straightened under various levels of an oxygen-rich
atmosphere to produce either a light oxide (LO, gold to
light brown) or heavy oxide (HO, black) finish. Further-
more, some wires were etched (E), pickled (P) or mechani-
cally polished (M) to achieve a particular finish. Surface
roughness values were measured with an atomic force
microscope and plotted in Fig. 91. Etched and pickled
wires exhibited the greatest amounts of surface roughness
which could be countered by the addition of a mechanical
polishing step which produced significantly smoother
results.
Sawaguchi et al.57 conducted rotating bending fatigue
(Fig. 8a) Nitinol wires and reported fractographic fea-
tures generally consistent with the schematics shown ear-
lier. Additional high resolution imaging revealed fatigue
striations near the crack initiation site and early stages
of fatigue crack growth, followed by dimpled fracture.

74 SEM micrographs for 316LVM wires laser-treated with HP Nd:YAG laser illustrating a cross-section, b higher magnification
and c FIB-sectioned view34

70 International Materials Reviews 2016

 Gbur and Lewandowski
75 SEM micrographs for 316LVM wires laser-treated with LP Nd:YAG laser illustrating a cross-section, b higher magnification
and c FIB-sectioned view34
Few striations were observed for samples subjected to
large surface strains and many for small surface strains,
with dimpled fracture representing final rupture. The
schematic (Fig. 92) shows the extent of regions exhibiting
striations as a function of surface strain, followed by over-
load (shown in grey). The spacing of striations
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increased with increasing crack length, transitioning to
dimpled failure in overload. The observations are entirely
consistent with the schematics shown previously in
Fig. 72.
Evaluation of the microstructure from rotating bend-
ing fatigue, laser-welded Nitinol wire was reported by
Chan et al.24 The initial morphology of the welded
wire displayed increased surface roughness in the welded
zone resulting from melting and re-solidification of the
material thereby creating stress concentrations that
could become sites of crack initiation. Assisting crack
initiation is the reduced diameter of the weld zone,
near the weld boundary, due to thermal distortions.
Cracks originating from surface defects were noted in
the crack initiation zone. The mechanism for crack
propagation was proposed to be based on local SIM
transformations at the crack tips in the weld zone. The
stress necessary to generate (SIM) at the crack tips is
lower than what is observed in the bulk metal, which
could lessen the stress intensity at the tips due to stress
relaxation effects related to the phase transformation
from austenite to martensite. During rotating bending
fatigue, crack initiation occurs at local stress concen-
trations (i.e. surface abnormalities) during the tension
portion of the cycle. At the crack tips, SIM develops
resulting in a partial relaxation of the local stresses
76 Summary of observations for laser-treated hard and annealed wires34
Fatigue and fracture of wires and cables for biomedical applications
thereby slowing crack growth. Crack closure and trans-
formation of the majority of the SIM back to austenite
occurs during the compressive portion of the cycle leav-
ing only a small amount of SIM at the crack tips. In the
next tension half cycle, gas inclusions and SIM remnants
at the crack tips produce additional cracking. The cycle
completes with the austenite ahead of the residual SIM
transforming to martensite. Final ductile failure occurs
when a substantial fraction of cracks have propagated
over the surface and in this case in the weld zone, near
the weld boundary. The fatigue behaviour of the weld-
ment exhibited a reduction in fatigue life with increases
in strain and bending frequency. In comparison to the
unwelded material, the weldment exhibited a reduction
fatigue life by a factor of two for all strains and bending
frequencies.
Work by James et al.248 provided SEM images of Niti-
nol wire subjected to tension, torsion, rotating bending
and compression loading schemes and also evaluated
wires for hydrogen embrittlement. The tensile and rotat-
ing bending fractures were characteristic of the mode of
loading and similar to those reported earlier in this sec-
tion. Torsional failure features were described as ‘swirled
candy cane’ lines along the outer surface of the wire and a
flat fracture surface orthogonal to the longitudinal axis.
Hydrogen embrittlement was induced by subjecting the
Nitinol wire to cathodic charging then placing the wire
under bending loads. The resulting fracture surface lacked
evidence of microvoid coalescence at the initiation point
and maintained a transgranular appearance for approxi-
mately 100 µm before microvoids reappeared. A compres-
sively loaded sample displayed surface roughening and
International Materials Reviews 2016 71
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications
77 SEM image of fractured 316LVM annealed wire following
FS laser treatment and flex bending fatigue (Nf = 64 617
cycles)34
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cracking along the compressive side while the tensile side
remained smooth. The damage to the compressive side
appeared as slip lines at approximately 20% strain,
while cracks developed when the strain reached 25–30%.
78 Micrographs depicting a microhardness indentations in Ag core, b microhardness indentations in MP35N, c low magnifi-
cation TEM of Ag/MP35N interface and d high magnification TEM of Ag/MP35N interface10
72 International Materials Reviews 2016
The cracks propagated in shear and following release of
the bend, the cracks extended further into the wire.
Summary and recommendations for
future work
In reviewing the fracture and fatigue of wires/cables used
in the biomedical industry, topics ranging from mechanics
to testing and materials issues were covered. The mech-
anics analyses of individual wires and stranded cables
reveal that thinner wires (i.e. individual or in a strand)
experience a smaller strain when bent or cycled over a
given radius of curvature. In the elastic regime, this pro-
duces a lower maximum stress on the individual wire as
well as those in the strand. While the core wire in a strand
experiences the maximum stress, those twisted around the
core wire experience less stress dependent on the details of
the twist. Various design criteria used for wire rope were
reviewed and included details of various strand/cable
architectures (e.g. 1 × 7, 7 × 7, etc.). Further reduction
in stresses on the wires/strands for a given displacement
is accomplished by coiling the wires/strands while also
providing much more flexibility to the coil. The mech-
anics analyses for coiled systems are more complicated
than strands, followed by individual wires. Contact points
between wires are difficult to model although these may
be preferential sites of deformation and fatigue initiation.
These issues could benefit from additional modelling that
capture the role of different architectures and contact
points on the local stresses and strains that arise in both
 Gbur and Lewandowski
79 SEM micrograph depicting fracture surface of one DFT
wire in a 7 × 7 DFT cable tested in tension10
strands as well as coiled systems subjected to bending and/
or cyclic loading. While finer wires will always experience
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a smaller strain (and stress) during static and/or cyclic (e.
g. flex, rotating, etc.) bending and thereby exhibit
improved fatigue performance in comparison to
larger diameter wires, there are potential difficulties in
joining finer diameter wires to other mechanical/electrical
components. Design of effective strain reliefs and such
connections are also areas that could benefit from
additional modelling and/or mechanical evaluation.
The review of currently available fatigue test tech-
niques reveals a few standardised tests in addition to
industry and/or application-specific testing. While
strain–life data all exhibit similar characteristics in
that higher cyclic strains, (i.e. Δε = d/ρ) produce shorter
fatigue lives, the large differences in test techniques,
volume of material under peak strain/stress, cyclic fre-
quency used and presence of environment can contrib-
ute to differences in results obtained on nominally the
same material. These differences may be particularly
important in some materials systems where inclusion-
initiated failure may dominate, as well as in systems
80 SEM image depicting a one of the 1 × 7 strands of the 7 × 7 DFT cable and b higher magnification of a wire from image a 10
Fatigue and fracture of wires and cables for biomedical applications
(e.g. Nitinol) where phase transformations that occur
during cyclic loading may affect both the local tempera-
ture as well as strain/stress evolution. While environ-
mental effects may be different at different cyclic
frequencies, the presence of the fluid media will also
mitigate any strain/stress-induced temperature rise
during testing. Although the Coffin–Manson–Basquin
approach to total strain–life modelling has successfully
captured the fatigue behaviour of a few wire/strand sys-
tems based on well-characterised materials systems,
model variants will be needed for the more complicated
materials systems (e.g. SE Nitinol) that exhibit unique
stress vs. strain behaviour or those with surface treat-
ments that locally change the properties without signifi-
cant changes to the global tensile properties due to the
small volume of material affected.
The strain–life behaviour of a number of different
materials systems was reviewed. Ultra-clean processing
has been used to create biomedical grade stainless
steels with very low inclusion content, while the differ-
ences between annealed and as-drawn stainless steel in
the LCF and HCF regimes is consistent with much
previous work on bulk structural materials. Preliminary
effects of various laser surface treatments and oxide
coatings on the local microstructure and strain–life behav-
iour of 316LVM wires has been presented. Much more
work may be warranted in this area particularly since
many biomedical components are machined via a variety
of different laser-based techniques. Details of the local
microstructure, residual stresses and resulting strain–life
behaviour are of interest, as well as the effects of sub-
sequent electropolishing. Various composite approaches
are also being considered to accommodate both the elec-
trical and mechanical requirements of implantable elec-
trodes. These will continue to need to be evaluated in
order to develop and optimise these systems. Ni-free
alloys are starting to be investigated in order to address
Ni-sensitivity but more work is needed to characterise
this family of alloys along with the various issues dis-
cussed in this review.
The expanding usage of Nitinol alloys, particularly the
SE versions in a variety of biomedical and other appli-
cations will benefit from detailed studies of microstructure
International Materials Reviews 2016 73
 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

81 SEM fractography illustrating a DFT wire tested in rotating bending under low stress, with failure at 150 000 cycles, b MP35N
tested at high stress, with failure at 2000 cycles and c DFT coil exhibiting extruded lips2
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82 ‘Short’ and ‘long’ contact patterns on outer wires of multi-layer strands87

83 Types of wire failure. a Type 1, b Type 2, c Type 3, d Type 4, e Type 5 and f Type 687

74 International Materials Reviews 2016

 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

84 SEM images of a Nitinol tensile fracture surface of 3M Unitek SE Orthoform II and b higher magnification image displaying
dimple fracture morphology4,104
Downloaded by [Laurentian University] at 08:38 14 May 2016

85 Maximum mean diameter of inclusion plotted against the stage of processing208

and temperature evolution during tensile deformation, in

addition to similar behaviour under cyclic loading con-
ditions. While SE Nitinol can have appreciable recover-
able strain (e.g. up to 8% and beyond), cyclic loading
well within this regime of strains can produce failure at
a relatively low number of cycles. The importance of the
phase transformation(s) and any dislocation-, microstruc-
ture- or surface roughness-debris that remains after
straining/cycling may be particularly important, while
the effects of texture on such behaviour are also worth
investigating. The importance and role of inclusions on
the fracture and fatigue behaviour of such systems also
warrants additional investigation, as early reports suggest
minimal effects while more recent work demonstrates
more significant effects on strain–life behaviour. The 86 SEM of typical inclusions found in Nitinol alloys249

International Materials Reviews 2016 75

 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

87 Axial fatigue fracture surface of Nitinol wire noting a the inclusion location on the full wire cross-section at high alternating
strains and b high magnification of the TiC inclusion from image a 42

evolution of microstructure/phases at/near such flex bending, tension, etc.) and stress states (e.g. fully
Downloaded by [Laurentian University] at 08:38 14 May 2016

inclusions may also be of interest due to the different reversed, tensile mean stress, etc.) may produce very
stress states present locally vs. the bulk, while examination different strain–life behaviour relevant to various appli-
under different testing conditions (e.g. rotating bending, cations. While rate effects on temperature evolution and

88 Comparison of the five largest inclusions in the longitudinal and transverse directions vs. the wire diameter45

76 International Materials Reviews 2016

 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

Table 6 Fatigue crack initiation sites for Nitinol wire54

Alloy ε% Number of tests Inclusion number Drawing defect Die marks Other locations

High purity >1.2 23 18 4 0 0

<1.2 22 6 10 1 6
O-rich >1.2 23 19 2 2 0
<1.2 10 7 1 2 0
C-rich >1.2 21 14 2 2 2
<1.2 142 4 4 2 4

changes in stress–strain behaviour appear to be mitigated
when testing is conducted in the presence of various fluid
media that control temperature, the potential use of such
materials in air continues to demonstrate the usefulness of
such studies. The effects of various processing conditions
(e.g. laser machining) and subsequent surface finishing
(e.g. electropolishing, oxide coating, etc.) are also worth
investigating since most components must be machined
and finished to final shape and there are a number of
potential options.
While the testing of wires, strands and coiled versions
provides useful information on the fracture and fatigue
Downloaded by [Laurentian University] at 08:38 14 May 2016
of various materials and mechanics issues to be resolved,
a better linkage to actual component behaviour is needed
in many cases. As with many structural materials systems,
sub-system and component testing are conducted to ver-
ify material performance in the actual component. In
this regard, the performance of wire attachments to com-
ponents, strain relief mechanisms, and actual components
must also be evaluated. These are being conducted by the
community according to various standards that have been
developed and continue to evolve. In this regard, the LCF
vs. HCF behaviour may be particularly important to
characterise and understand since some sub-sections of

behaviour of such systems and enables the importance
a component may require resistance to LCF while others
require HCF resistance. Characterisation of anisotropy of
material properties and their inclusion into various
models may also be important (and difficult) in such
small dimensions since multi-axial stresses are likely to
exist in some components. Finally, more robust modelling
techniques will need to be developed to accommodate the
unique flow and fracture behaviour of some emerging
materials systems.

89 SEM image of defect-generated crack initiation48
Acknowledgements
The authors appreciate the work of a number of staff, for-
mer students, post-doctoral researchers and visiting scho-
lars that have contributed to our ongoing work in various
areas. They include: Chris Tuma, Mostafa Shazly, Ravi-
kumar Varadarajan, Luciano Ovidiu Vatamanu, Ding-
qiang Li, Josh Caris, Adel B. Shabasy, Hala A. Hassan,
Brian Benini, Mark E. Lewandowski, John
R. Lewandowski and Hossein Lavvafi. One of the authors
(JJL) was introduced to the importance of such work by
the CWRU-Functional Electrical Stimulation (FES)
Group at CWRU under the lead of P. Hunter Peckham,

90 Stable austenite (SA), superelastic austenite (SE) and stable martensite (SM) Nitinol schematics showing a stress–strain
curves with longitudinal section cracking associated with different microstructure features and b strain amplitude–life
plot with SA to SM transition zone27

International Materials Reviews 2016 77

 Gbur and Lewandowski Fatigue and fracture of wires and cables for biomedical applications

91 Surface roughness of Nitinol wire measured by confocal microscopy for heavy oxide wires and b light oxide wires206
Downloaded by [Laurentian University] at 08:38 14 May 2016

92 Schematics showing the relative amount of fracture surface exhibiting striations and overload (grey region) for a large sur-
face strain (2.33%), b intermediate surface strain (1.75%) and c low surface strain (0.88%)57

with significant input from various FES Group members
including Brian Smith, Fred Montague, Alex Campean,
Jim Buckett, Kevin Kilgore and Joe H. Payer. Access to
early fatigue work and discussions with Tom Mortimer
and Tom Kicher are also appreciated. Work on the var-
ious FES-related systems was supported by: NIH-
NINDS Grant NS-041809, NIH-NIBIB Grant EB-
001740 and NIH-NS074149. Other, more recent support
was provided by the Defense Advanced Research Projects
Agency (DARPA) and the Space and Naval Warfare Sys-
tems Command (SPAWAR) under the DARPA Hand
Proprioception and Touch Interfaces (HAPTIX) pro-
gram, contract award number N66001-15-C-4014. Illus-
trations and graphics support were provided courtesy of
Cleveland FES Center. Work on Nitinol and some
316LVM work was supported by Ohio Third Frontier
under the Nitinol Commercialization Accelerator Lab-
oratory (NCAL) at CWRU in conjunction with Cleve-
land Clinic, University of Toledo, NASA Glenn
Research Center and Norman Noble, Inc. Access to fem-
tosecond laser treatments at Cleveland Clinic via Melissa
Young and Dave Dudzinski are much appreciated while
mechanical reliability evaluations at CWRU were con-
ducted in the Advanced Manufacturing and Mechanical
Reliability Center (AMMRC). Surface analysis and frac-
tography of some 316LVM and Nitinol was performed in
the Swagelok Center for Surface Analysis of Materials
(SCSAM) at CWRU. Assistance provided by Kelvin
Smith Library in preparation of this paper is greatly
appreciated. Support for JRL was provided by Tau Beta
Pi, Don Richards Fellowship and the Case Alumni
Association (CAA) at CWRU. Supply of materials for
the various CWRU investigations was provided by Fort
Wayne Metals, Inc., NASA Glenn Research Center and
the CWRU Dental School. Partial funding for one of
the authors (JLG) has been provided by ASTM Inter-
national Project Grant, Leonard Case Jr., Professorship,
Arthur P. Armington Professorship and the AMMRC.
Supply of materials by Fort Wayne Metals, Inc. for testing
at CWRU is also greatly appreciated.
ORCID
J. L. Gbur http://orcid.org/0000-0002-5919-0422
J. J. Lewandowski http:/orcid.org/0000-0002-3389-2637
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