Effective Use of Nitinol For Medical Devices

Effective Use of Nitinol for Medical Devices
November 2012
Effective Use of Nitinol for Medical Devices | November 2012
TABLE OF CONTENTS
Abstract ............................................................................................. 3
Abbreviations .................................................................................... 4
Market Trends/Challenges ................................................................ 5
Solution ............................................................................................. 5
Best Practices ................................................................................... 7
Common Issues ................................................................................ 8
Conclusion....................................................................................... 10
References ...................................................................................... 11
Author Info ....................................................................................... 11
2012 HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.
Abstract
Nitinol is a shape memory alloy widely used in medical devices in
the form of guide wires and stents. In the early 1960s, a nickel
titanium alloy was developed by W. F. Buehler, a metallurgist
investigating nonmagnetic, salt resisting, waterproof alloys for the
space program at the Naval Ordnance Laboratory in Silver Springs,
Maryland USA. The thermodynamic properties of this intermetallic
alloy were found to be capable of producing a shape memory effect
when specific controlled heat treatment was undertaken. The alloy
was named Nitinol, an acronym for the elements from which the
material was composed, NI for nickel, TI for titanium and NOL from
the Naval Ordnance Laboratory. Nitinol is the name given to a family
of intermetallic alloys of nickel and titanium which have been found
to have unique properties of shape memory and super-elasticity.
Nitinol offers a unique range of characteristics when designing
medical device delivery shafts, including superelastic and shape
memory behavior, good crush resistance, and flexibility. Yet, many
designers are reluctant to specify Nitinol in design due to its high
cost. Instead, more economical material such as stainless steel,
which exhibits good overall trackability, is more often specified. Very
effective cost savings can be achieved if it is possible to replace the
whole or a portion of nitinol wire with some other material such as
stainless steel.
This paper presents an overview of:
o Superiority of nitinol in medical devices
o Constraints in replacing nitinol in medical devices
o Various joining methods of nitinol and stainless steel
The first section describes a few properties of nitinol which are
utilized in medical devices. The primary one is its capability to
exhibit different shapes, known as shape memory behavior, at
different levels of stress and temperature, which is very important
for guides and stents. Due to this property, nitinol is categorized as
a shape memory alloy. Limitations in replacing nitinol totally are also
discussed.
The second section describes different methods to join nitinol and
other materials, and the challenges involved in the joining process.
The metallurgical and mechanical basics of SMA are well developed
and understood. So far, however, their applicability has been limited
due the lack of available fabrication techniques. Included are joining
processes for assembling SMA to themselves, and not at least, to
other materials. The development of such cost efficient and quality
processes will probably be the key to further increase the
engineering applications of SMA. There should be sufficient joint
strength without compromise in essential properties.
Abbreviations
Sl.
No.
Acronyms
Full form
Nitinol
Nickel Titanium Naval Ordinance Laboratory
MRI
Magnetic Resonance Imaging
TiO2
Titanium Dioxide
HAZ
Heat Affected Zone
FEA
Finite Element Analysis
SMA
Shape Memory Alloy
Market Trends/Challenges
Nitinol exhibits shape memory and super-elasticity with good shape
retention, biocompatibility, biomechanical compatibility, MRI
compatibility, flexibility, kink resistance and fatigue resistance.
Shape memory and super elasticity can be triggered thermally or
mechanically.
Nitinol wire is very costly and its machinability is very poor. By using
any alternative material in a device, whether partially or whole,
considerable cost savings can be attained.
The challenge here is that super-elasticity cannot be compromised
in the wire at the distal tip. By using nitinol in the distal section and
using an economical metal like stainless steel for proximal section,
designers can optimize both performance and cost of the overall
design. The challenge here is to join Nitinol and stainless steel
without compromising the beneficial properties.
Solution
Super-elasticity is caused by stress-induced martensite
transformation upon loading and by subsequent reverse
transformation, i.e. austenite, upon unloading. A diagrammatic
representation is shown in Fig. 1. The super-elasticity property of
nitinol is utilized to attain certain shapes at the distal end; upon
removal of stress, it behaves like a super spring.
Fig. 1: Diagrammatic representation of super-elasticity

(International Endodontic Journal, 33, 297310, 2000)
Due to self passivation, a very stable protective TiO2 layer reduces

the release of nickel a known allergen and possible carcinogen
and protects the base material from corrosion. With proper treating
(electro polishing), excess nickel from the surface is removed and
forms a TiO2 layer enriched in titanium.
In order to optimize the cost, it would be beneficial to join Nitinol with
stainless steel.
Achieving a sound joint is very challenging since it is not limited to

the joint strength, but also comprises the shape memory effect and
super elasticity. Heat involved in the joining processes causes a
reduction of initial properties. While joining nitinol to other metals,
brittle intermetallic compounds will be formed at the joints, which
make the joints brittle, i.e. less strong.
Various joining methods of nitinol and stainless

steel
1) Soldering:
An aggressive flux like aluminum paste flux should be used
to remove the tough oxide layer on nitinol in combination with Sn3.5Ag solder alloy (lead-free) for better results. Use a preheated
O
soldering iron set to 315 C with the solder in place.
2)
Welding
Laser beam welding is promising in welding nitinol to stainless steel.

Diagrammatic representation is shown in Fig. 2. Strong joints have
been made using nickel filler between the nitinol and stainless steel.
The Nickel filler prevents formation of intermetallic compounds and
reduces cracking possibilities to produce strong and more ductile
welds.
Fig. 2: Diagrammatic representation of welding
3) Adhesive bonding
Nitinol can be bonded to other materials using medical grade
epoxies and adhesives.
4) Mechanical joining
Techniques such as crimping and swaging can also be used.
Another technique is to use nitinols shape memory or super
elasticity property for bonding. A nitinol tube connector can be used
as a shrink fit to connect the two mating parts.
Best Practices
When designers choose nitinol wire in medical device, it is typically
in the distal section, that the unique properties of the metal are
employed. But due to lack of proper joining methods, nitinol will be
selected for the entire length.
It is important for clinicians to be aware of the metallurgy of the NiTi
alloy in order that the characteristics of instruments constructed
from this alloy can be appreciated and to encourage research to
maximize their clinical potential.
Welding of SMA to other metals may be challenging due to the
extensive formation of intermetallic compounds. These tend to be
very brittle. In such cases, it may be required to use additives that
prevent such formation.
It is noted that some processes are very promising, but also that
there is more work needed to be able to maintain the initial base
material properties. In fact, it may be wise to include the joining in
the design for certain applications, where shape memory effect, or
superelasticity, is of primary concern. Such conceptual design will
be much more cost effective since it may be possible to integrate
alloy manufacturing and joining operations.
Even though there are comparative advantages for welding with
nickel filler material, joining between nitinol and stainless steel is not
practically used in medical devices due to the risks involved. As
explained in this paper, a number of joining processes have been
applied to SMA. However, to some extent, there is still a lack of
systematic studies on the effects of joining parameters. There is still
a way to go concerning the process and performance optimization.
Common Issues
Joining strength is the main concern. If insufficient, the nitinol distal
end gets detached from the stainless steel and is a deadly situation.
The practice of joining nitinol and stainless steel in medical devices
is not recommended due to this very high risk.
1) Soldering
a) Solder alloy and flux should be biocompatible
b) Post-soldering cleaning of flux residue using detergent,
water or mechanical scrubbing should be performed
2) Welding
a) Formation of brittle intermettalic compound may reduce
properties of nitinol
b) HAZ. Refer to Figs. 3 and 4
Fig. 3: Laser welding (narrow)

(Dong et al, 2006).
Fig. 4: Arc welding (wide)

(Dong et al, 2006).
c) Due to excessive thermal stress and strain, cracking may

occur at the joint. Refer to Fig. 5.
Fig. 5: Crack at the joint (van der Eijk,2004b)
3) Adhesive bonding
a) Joining strength is less
b) Adhesive may degrade based on the service environment
4) Mechanical joining
a) Joining strength is comparatively less
b) May cause deformation and crack
c) Requires manufacturing to close tolerance
Conclusion
Different joining methods are discussed in this paper. The joining
methods included are soldering, welding, adhesive bonding, and
mechanical joining. All joining techniques that involve heat to the
base metals tend generally to cause reduction of their initial
properties, but the most severe reduction in shape and
superelasticity recovery is achieved in welding.
In joining SMA to other metals, formation of brittle intermetallic
compounds is difficult to avoid. Each method has its drawbacks in
terms of the joint strength and process. Among these, laser welding
with Nickel filler is the most promising. It results in narrower HAZ
and a strong and ductile weld joint. It should be noticed that,
although degradation of properties occurs in most joining processes
using heat, this deterioration may take place locally.
The joining process involves an in-depth study of the chemical
composition and microstructure of nitinol, stainless steel and filler
metal. In conventional alloys, successful joints are obtained in spite
of differences in the chemical compositions and the microstructure
of weld metal and heat affected zone (HAZ) on one hand, and the
base metal on the other. In welding SMA, this may not be the case,
as the matching of chemical composition and microstructure, as well
as transformation temperature, is very important because this
controls the mechanical properties and the behavior of the joint.
The significance of local strength or ductility changes in a
component is not very clear, and there is a need for finite element
modeling to simulate the impact on the structural integrity of the
component. Moreover, with brittle materials or local brittle
constituents, formation of micro cracks has been observed in
joining, especially when joining NiTi to other materials. The
significance of such micro cracks should be assessed by fracture
mechanics. With proper validation of the weld strength by the FEA
and physical testing, laser welding of nitinol and stainless steel wire
can definitely be introduced into medical devices without the risk of
failure, and considerable cost savings can be attained
10
References
www.medicaldesign.com
www.nitinol.com
www.cregannatactx.com
Thompson SA, An overview of nickeltitanium alloys used in
dentistry. International Endodontic Journal,33, 297310, 2000.
Odd M. Akselsen
SINTEF Materials and Chemistry, Norway
Author Info
Mr. Bibin Kuruvilla K has four
years of experience in the
development of relays and APQP
guidelines and one year of
experience in medical device
design improvement.
11
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Effective Use of Nitinol for Medical Devices | November 2012

Effective Use of Nitinol for Medical Devices | November 2012

Effective Use of Nitinol for Medical Devices | November 2012

Nickel Titanium Naval Ordinance Laboratory

Magnetic Resonance Imaging

Heat Affected Zone

Finite Element Analysis

Shape Memory Alloy

Effective Use of Nitinol for Medical Devices | November 2012

Fig. 1: Diagrammatic representation of super-elasticity

Due to self passivation, a very stable protective TiO2 layer reduces

Effective Use of Nitinol for Medical Devices | November 2012

Achieving a sound joint is very challenging since it is not limited to

Various joining methods of nitinol and stainless

Laser beam welding is promising in welding nitinol to stainless steel.

Fig. 2: Diagrammatic representation of welding

Effective Use of Nitinol for Medical Devices | November 2012

Effective Use of Nitinol for Medical Devices | November 2012

Fig. 3: Laser welding (narrow)

Fig. 4: Arc welding (wide)

c) Due to excessive thermal stress and strain, cracking may

Fig. 5: Crack at the joint (van der Eijk,2004b)

Effective Use of Nitinol for Medical Devices | November 2012

Effective Use of Nitinol for Medical Devices | November 2012

Effective Use of Nitinol for Medical Devices | November 2012

Hello, Im from HCLs Engineering and R&D Services. We enable

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