Design Engineering of Nitinol

based Medical Devices.

Applications of Nitinol and role of FEA in designing
Nitinol based medical devices
Abstract
The usage of Shape memory alloy (SMA) has exploded in last
two decades. NiTi SMA Alloy (Nitinol) has been applied in
many industry for example in military, safety, robotics and
aerospace especially in medical industry. Because of unique
properties of Nitinol, it changed the traditional open-surgical
techniques to less-invasive techniques. Nitinol's unique
property is used in designing the medical devices and
instruments for critical applications. Finite Element Analysis
(FEA) approach is used to reduce the design validation time in
product life cycle
of the Medical product. The unique
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properties and applications of Nitinol in medical industry and
role of Finite Element Analysis in designing medical devices
are discussed. This material is worth reading for Medical
device designers, Stress Analyst, Material scientist
and R&D
2
Managers.

TABLE OF CONTENTS
1. Introduction
2. Nitinol Biomechanical Properties
3. Applications Of Nitino
4. Applications Of Nitinol In General Engineering Industry
5. Commercial Development Of Nitinol
6. Impact Of Nitinol In Medical Industry Market
7. Reducing Product Life Cycle Time Through Fea
8. Nitinol In Future Market
9. Conclusion
10. Hcl Mechanical Engineering Practice For Medical Devices
11. Why Hcl Is A Perfect Fit For Outsourcing?
12. References

1. Introduction
Nitinol is one of the shape memory alloys, which stands for Nickel
(Ni), Titanium (Ti) and Naval Ordinance Laboratory (NOL) where
the alloy was discovered in early 1960s. William Buehler and
Frederick Wang discovered its properties during the research about
non-magnetic and non-corroding materials at NOL. The material,
if deformed while cooling below transformation temperature,
returns to its original shape .When heated above transformation
temperature, it is able to recover every curve and angle. When
Nitinol is below its transformation temperature, it has very low yield
strength and can be deformed quite easily into any new shape which
it will retain.
Through FEA many products like Cardiovascular Stent, Guided
wire & Catheters are virtually simulated to minimize the design
cycle. The major advantage of using the FEA is to reduce the
Prototype cost and to reduce the Experimental cost (Testing
facility).
Biochemical and molecular markers have been used in medicine for
disease characterization and diagnosis for centuries. Together,
biomarkers from the past and present provide greater possibilities
to get safer and more effective drugs to market faster. Biomarkers
are factors that are objectively measured and evaluated as indicators
of normal biological processes or pathogenic processes and/or as
indicators of pharmacological responses to therapeutic
intervention. Clinical endpoints are variables that can be used to
measure how patients feel, function, or survive. Surrogate
endpoints are biomarkers that are intended to substitute for a
clinical endpoint.

2. NITINOL BIOMECHANICAL PROPERTIES

Nitinol has unique thermal shape memory property, super elasticity
and high corrosion resistance of a kind not seen in other SMAs.
These properties make it potentially useful in medical devices.
The miniaturization of medical devices has a wide range of
technical and design issues. Nitinol has become a material of
strategic importance as it allows overcoming those issues. Nitinol
allows the increasing trend for less invasive and therefore less
traumatic procedures across medical specialties. The properties of
Nitinol are explained here one by one.

2.1 Shape Memory Effect

The basic mechanism governing the shape-memory effect consists
of martensite formation upon cooling from the austenite phase.
The soft martensite can be easily deformed (up to 8% strain) and
will recover its original shape upon heating to the much stronger
austenite (see Figure 2.1)

Figure 2.1. Atomic structure of SMA (Source: Hand Drawn)

2.2 Superelasticity
Superelasticity refers to the ability to return to its original shape
upon unloading after a substantial deformation. The superelasticity
phenomenon is caused by a stress-induced transformation. By
deforming the austenite, stress-induced martensite is formed. The
martensite reverts to austenite once the stress is removed (see
Figure 2.2). Superelastic Nitinol can be strained 20 times more than
stainless steel without being plastically deformed, and has
tremendous advantages in applications.

Figure 2.2. Superelasticity Elastic Property (Source: Hand Drawn)

2.3 Biocompatibility and Corrosion Resistance

The implant material needs to have very good biocompatibility and
corrosion resistance to implant in human body. Based on soft tissue
response study through experimental and clinical data, Nitinol has
proved as a very safe biomaterial than stainless steel and pure
titanium. Nitinol is chemically more stable than stainless steel. The
good corrosion resistance of Nitinol is caused by the formation of
a protective titanium oxide layer on its surface. Based on these
features Nitinol is intended to be used in longterm implants. The
bone response to Nitinol implants studied and observed no signs of
adverse tissue reactions (Castleman et al. 1976). The Nitinol foams
are unique among biocompatible porous metals, because of their
high recovery strain and low stiffness facilitating integration with
bone structures.
Nitinol has been widely used in medical industry. But there are some
limitations to use Nitinol in few medical devices. Nitinol stents do
not resist radial compression to the same extent as balloonexpandable stents. There are non-ideal conditions to use Nitinol
where high radial strength is required like stents for calcific or highly
fibrotic lesions. It cannot be considered as an ideal material for
medical applications involving friction & wear or degradability. It
has a very high manufacturing cost and very tough manufacturing
Techniques.

3. APPLICATIONS OF NITINOL
Nitinol has become a key material to design medical devices and
instruments. The special characteristics of Nitinol are emphasized
by describing the following applications of Nitinol in medical
industry. Today, most self-expanding implants such as stents and
filters use the thermal shape-memory of Nitinol to enable
deployment into the body. Various medical applications of Nitinol
are listed here

3.1 Intravascular Stents

One of the current largest applications of Nitinol is for
intravascular stents. Stent is a flexible tubular structure capable of
being folded into small dimensions allowing its passage into the
problematic locations in the body and then being expanded. Stents
are used to treat narrowed or weakened coronary arteries in the
body. The blockage in blood flow is treated by expanding the stent
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to enlarge diameter of the arteries. Self expanding stent uses the

thermal shape memory of Nitinol to enable deployment into the
body. The figure 3.1 shows, stent deployment inside the artery by
balloon expansion.

Figure 3.1. Coronary artery with the stent expansion (Source: Hand Drawn)

Although Stents are used widely in coronary arteries, they are used
in central and peripheral arteries and veins, bile ducts, esophagus,
colon, trachea or large bronchi, ureters and urethra.

3.2 Radiofrequency interstitial Tissue ablation device

Nitinol is also used for radio frequency ablation devices.
Transurethral needle ablation (TUNA) prostrate ablation device
(see figure 3.2) and Radiofrequency Interstitial Tissue Ablation
(RITA) tissue ablation device (see figure 3.3) are two ablation
devices that use Nitinol. The TUNA uses a fine Nitinol needle,
which is inserted through the urethra and then into several sites in
the prostate to deliver the slow heat energy. TUNA provides
significant improvement in urine flow.

Figure 3.2. Schematic view of thermal (heat) ablation procedure using

radiofrequency energy through the needles within the prostate tissue. (Source:
Hand Drawn)
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The Radiofrequency interstitial tissue ablation Nitinol tubes (see

figure 3.4) are shape set into a curved configuration and deployed
through a straight trocar. The Nitinol components can deployed for
the procedure, withdrawn into the cannula, moved to another
location and the process repeated as many times as required. This
elastic deployment of a curved device through a straight needle or
cannula is probably the most common use of Nitinol for medical
instrumentation.

Figure 3.3. Radiofrequency interstitial tissue ablation device

(Source: Hand Drawn)

3.3. Heart Port Access Devices

The port access technique allows surgeons to forgo the traditional
sternotomy (a cut through the breastbone) and operate on the heart
through a number of smaller incisions. The patient is hooked up to
a heart lung machine without opening the chest. The Port-Access
minimally invasive coronary artery bypass grafting (CABG) port
access device uses superelastic Nitinol strip. This device enables
MIS (Minimally Invasive Surgery) techniques for heart surgery by
providing constant force against tissue around the relatively small
incisions. Figure 3.4. Shows the MIS heart port access.

Figure 3.4. Heart port access ((Source: Hand Drawn)

3.4. Atrial septal-defect occlusion system (ASDOS)

The atrial septal defect occlusion system (ASDOS) is one of the
recently developed systems for nonsurgical closure of interatrial
communications. The ASDOS is used to seal holes in the heart wall.
The ASDOS occluder consists of two self-opening umbrellas made
of five nitinol wire loops supporting webs of polyurethane
membrane (see Figure 3.5). The self-opening of the umbrellas
made by superelastic and thermal shape memory properties of
Nitinol.

Figure 3.5. Two umbrella shaped patches that are positioned on either side of
the defect (Source: Hand Drawn)

3.5. Inferior Vena Cava (IVC) Filters

The IVC is a large deep vein that returns blood from the lower half
of the body to the heart. A Simon filter placed in the IVC can catch
blood clots coming up from the legs and prevents them from going
to the lungs. The Simon filter is the first cardiovascular device
developed using Nitinol. This device used for blood vessel
interruption in order to prevent pulmonary embolism. The
insertion of this device is done by exploiting the shape memory
effect. The figure 3.6 shows inferior vena cava filter.

Figure 3.6. Inferior vena cava filter (Source: wikipedia )

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3.6. Surgical instruments

The use of Nitinol in Surgical instruments increases due to the
minimally invasive surgical procedures.
The baskets made in Nitinol (see figure 3.7) are used to remove
kidney, bladder and bile duct stones. The basket is inserted into
human body by exploiting the shape memory effect. The opening
basket happens when it heating up.

Figure 3.7. Nitinol basket for Stone retrieval (Source: Hand Drawn)

Nitinol is used to manufacture surgical tools for laparoscopy

procedure to get the actions of grippers, scissors, and tongs.
These devices allow smooth movements tending to mimic the
continuous movement of muscles. Moreover, these devices
facilitate access to intricate regions.

Figure 3.8. Laparoscopy tools (Source: Hand Drawn)

The intra-aortic balloon pump is used to unblock blood vessels during
angioplasty. The device has an SMA tube whose diameter is reduced compared to
polymer materials due to its pseudoelastic effect. Moreover, it also allows greater
flexibility and torsion resistance when compared to the same tube made of
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stainless steel.

4. APPLICATIONS OF NITINOL IN GENERAL

ENGINEERING INDUSTRY
Nitinol appear in wide spectrum of commerce in industrial
application. It has been used for military, medical, safety and
robotics applications. In the early growth of shape memory alloy
technology the most important applications were fasteners and
couplings, mainly in the military sector. The military has been using
Nitinol couplers in fighter planes since the late 1960s.
These couplers join hydraulic lines tightly and easily. Nitinol also
used to produce eyeglass frames. The cellular phone antenna,
formerly of stainless steel, is now universally manufactured from
super elastic NiTi alloys. Nitinol used to propel walking robots.
Micro-electromechanical (MEM) devices fabricated using thin film
Nitinol actuators. European car manufacturers have long been
using SMA actuators for transmission fluid control. Some clothing
designers are also using Nitinol wire in the fabric of nylon shirts.
Body heat returns the Nitinol wire to its original shape within the
fabric, keeping the garment wrinkle-free. Although Nitinol has
many applications in industrial sector, Medical applications of
Nitinol dominate the today.

5. COMMERCIAL DEVELOPMENT OF NITINOL

The commercial development t of the Nitinol over past 20 years is
tremendous in improving its mechanical properties and
applications. While developing this Nitinol there are lots of
challenges in Design & Manufacturing.
During this phase lot of engineers invest their effort to use the
technology in various fields like Aerospace and Medical domain.
Especially in the Medical domain there more scopes were identified
Presence of nickel at Nitinol gives the more corrosive resistant. The
material properties of the Nitinol are verified with the advance
testing methodology. Since the super elastic nature of the
component will not allow do the testing as easy as the other metals.

6. IMPACT OF NITINOL IN MEDICAL INDUSTRY

MARKET
Nitinol's as excellent corrosion behavior together with the
extraordinary properties opens significant market opportunities.
This Super Elastic nature of the metal presence for the past and
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current market extensively in medical product like stent, guide wire

and etc,
In recent years, endovascular aneurysm repair devices, inferior vena
cava filters and embolic protection devices have also developed into
significant commercially successful products. In 20th century,
Nitinol-based devices accounted for more than half million dollars
of the US peripheral vascular device market.
The most dominating Cardio Vascular industries recent growth
shows that, there is huge market potential in the medical
Instruments. In Mid 20th century the market revenue of the cardio
vascular industry is growing very faster Rate.
When we compare with the other medical domain this is 2/3rd of
the US medical devices revenue. Trends in cardio vascular
operations & Procedures followed in the medical industry are many.
One of the most demands on Nitinol Catheter therapy which will
cure very faster rate without much blood loss.

7. REDUCING PRODUCT LIFE CYCLE TIME

THROUGH FEA
7.1 Testing challenges
Testing phase involves lot of time & cost. Jigs and fixtures to be
developed for any new medical product which undergoes testing
phase. This increases the product life cycle time. Nitinol wire is thin
yet very hard and causes numerous problems with gripping. Unless
the correct gripping technique is used, failure of the wire often
occurs within the jaw face. When measuring of strain, the test
system's position transducer is often insufficient to obtain accurate
measurements. Further, contacting extensometry may introduce
errors such as those caused by the slippage of knife-edges or local
deformation at the contact point.

7.2 How FEA Can Address

We can make any critical design decisions entirely or primarily on
FEA results. Finite element analysis (FEA) is an important aid in the
design of any Structures, Kinematics and Fluid. Simulation gives us
sufficient design behavior without going to historical way of
prototype and testing.
Two examples of Stent & Guided wire are discussed below.
In the stent design, the role of FEA is predicting the stent's fatigue
life in terms of stress & Tissue damage. Various design iteration on
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stent shape is studied and optimized design is arrived. A better

profile of stent gives benefit of safer deployment with minimal
damage to tissue. FEA technique helps in predicting experimental
and theoretical results to give confidence to designer and Analyst
during design optimization phase.
In guided wire application, UMAT is able to predict the uniaxial
material response at various Transition Temperature (Af) by
comparing with the test data. This gives the idea of Optimization of
the Af to achieve the most suitable design. It also indicates that the
material properties at different Af or application temperature are
predictive. The stress analysis on the device is straight forward as
the hook wire is constrained very tightly inside the needle. The peak
stress and strain values can be estimated from pure geometry
change.
Overall FEA gives the designers advantage of validating miniature
implants to stents avoiding complex test setups.

7.3 Single Element Material Validation

The static single element analysis is conducted to calibrate the
Nitinol anchor material properties. During this process
experimental test data is used as input to find the behavioral pattern
of the Material model. Validation of the Realistic Material curve
with the analysis material curve is observed and ensured.

7.4 Abaqus with Special material capability

Abaqus has enhanced facility to accommodate the behavior of the
material to be modeled. In Abaqus/Standard and Abaqus/explicit
user-defined material model is implemented in user subroutines
UMAT and VUMAT respectively. These interfaces (UMAT and
VUMAT) allow defining any constitutive model of complexity. The
mechanical behavior of Nitinol is implemented in Abaqus both as
UMAT and VUMAT. It can be used with any Abaqus continuum
and structural element type. Simulation of the behavior of parts
made in Nitinol and beyond superelastic material is also possible
nowadays. The results are in good agreement with experiments and
computations.
Abaqus has advanced capabilities to model contact with rigid
bodies and deformable bodies, large deformations, localized
buckling, material removal, complex loading sequences and
synchronization. This helps the designer to quickly iterate over
various available materials.
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8. NITINOL IN FUTURE MARKET

The forecast for the future market shows that there is very high
potential market in some of the areas like Cardio Vascular, Urinary
system, Orthopedic & Cerbral systems.Because of the
Biocompatibility nature it can be set it in any part of our Body.
Availability of various new methodologies will allow the Nitinol
product easily into our body.
Advanced material technology required for many new applications
in booming areas such as porous Nitinol, thin film Nitinol and new
alloys with better physical and mechanical properties. Overall, in
coming years application Nitinol will be applied in numerous areas.
Self-expanding Nitinol stents are expected to play a large role in the
combined peripheral stent and stent graft market, which is forecast
to reach very higher at end of the 20th Century.

9. CONCLUSION
Application of Nitinol in medical devices is very successful because
of its excellent mechanical and thermal properties. Nitinol made
tremendous changes in filed of minimally invasive surgery. The
shape memory property, super elasticity of Nitinol made a big
impact in medical devices to cure cardiovascular diseases. The
Nitinol made devices/instruments are in use to enlarge the fat
deposited arteries, to treat cardiac arrhythmia, to collect the blood
clots, to seal the heart holes, in orthopedic surgery.
This paper gives an overview of how FEA is beneficial to the
NITINOL based products to improve their design and
optimization. Also it gives the technological changes that happened
in the past and future products of Nitinol and their future business
needs in the Market.

Author
Venkatesan Gopal, M.E.
Venkatesan Gopal received his ME in Production Engineering
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from the Madras Institute of technology (MIT) Anna University,

India in 1998. He has been working in Gas turbine, Industrial
application & Life science in R&D organization. He is extensively
working with Ansys & Abaqus software in his career. He is currently
working with HCL Technologies on nonlinear Finite Element
Analysis on Nitinol, Stent creep Research. For more than 5 years he
is involved with FE analysis of medical devices and lot of research
work.

Co-Author
Ganesan Mani, B.E.
Ganesan Mani received his B.E in Mechanical Engineering from the
Dr.Mahalingam College of Engg & Technology, Anna University,
India in 2005.From the last 2 years he is dedicatedly involved with
research work in thermal areas of the Medical devices.
HCL Mechanical Engineering Practice for Medical Devices
HCL offers advanced mechanical engineering services to medical
device customers that help them in developing complex mechanical
designs and products at an accelerated pace that significantly reduce
their time-to-market and help them penetrate deep early into the
existing and emerging markets.
HCL has domain specific expertise in the various product segments
including of Orthopedic Implants, Surgical Instruments,
Implantable Devices, Surgical Disposables, Capital Equipments,
Diagnostic Devices, Infusion Pumps, Monitoring Devices, Drug
Delivery Devices etc.
We have a proven product development process as per US-FDA as
well as MDD. HCL's capabilities in providing solutions throughout
the product development life cycle from conceptual design,
Industrial and Mechanical Engineering design, Finite Element
analysis, Prototyping Verification and Validation and Sustenance
Engineering and Legacy Services makes it a unique one-stop
solutions provider for mechanical engineering services. At HCL, we
provide end-to-end innovative and customized mechanical
engineering solutions for the medical device customers to cater
their specific requirements.

11. Why HCL is a Perfect Fit for Outsourcing?

Breadth of Expertise: We are a FDA registered design house for
end-to end concurrent design and development of medical devices
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and work across Class I, II and III medical devices and equipments.
Our focused background enables us to understand and rapidly
execute projects.
End to end engineering solutions provider: We offer end to end
mechanical engineering services including Requirement
Specifications, Concept Design, Industrial Design, Detailed
Design, Reliability Engineering, FEA, CAE, Prototyping,
Verification and Validation, Certification and Sustenance
engineering
Significant Reduction in Product Development Cost: We have
proven systems and processes that assure cost benefits; we offer
upto 50 % cost reduction on product development.
Faster time-to-market: Our large pool of experienced engineers
along with matured product development process ensures up to
50% reduction in time to market.
Execution excellence & IP security: World class processes like Six
Sigma, CMMi Level 5, SEI CMM Level 5, PCMM Level 5, ISO
9000, MDD & ISO-13485 ensure quality that's unmatchable while
ISO 27001 ensures that data and IP security.
Experience in medical system documentation Our engineers know
what is important to approving regulatory authorities and design
your device with that in mind ensuring quicker approvals.
Freeing up of Client's Resources: We offer expanded capabilities
and capacity immediately, without the costs of hiring and training a
full-time staff, adding expensive R&D capitalization costs, or
reassigning your valuable personnel from current assignments.
Extensive Investments for Customers: Investments in dedicated
labs and resources for medical devices customers.
Flexibility: Outsourcing your product development and sustenance
needs to HCL gives you the flexibility to assign your valuable
resources where you need them the most.
Selected Medical Devices HCL has worked on.
?
?
?
?
?
?
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Laparoscopic Devices
Hip and Knee Implants
Cardio vascular stents
Blood Glucose Meter
Nerve stimulator
Dialysis Equipment
Patient Monitoring System

? Cardiac Defibrillators
? Breast Biopsy System
? Catheter Connecter
? Needle Holder
? Orthopedic implants
? Surgical Disposables
? Docking Station
? Anesthesia Tray
? Infusion System
? Drug Delivery System
? and many more

12. REFERENCES
? Trends and Developments in Self-expanding Nitinol Stents by
?
?

Philippe Poncet
Scott Russell, Metal with Memory: The Future of Nitinol
dated on 17.09.2007 in http://findarticles.com.
Industrial Applications for Shape Memory Alloys,
Proceedings of the International Conference on Shape Memory
and Superelastic Technologies, Pacific Grove, California, P.171182 (2000).
A.R. Pelton, D. Stckel and T.W. Duerig, Medical Uses of
Nitinol, Materials Science Forum Vols. 327-328 (2000) pp. 6370, Proceedings of the International Symposium on Shape
Memory Materials held in Kanazawa, Japan, May 1999.
L.G. Machado and M.A. Savi, Medical applications of shape
memory alloys, Brazilian Journal of Medical and Biological
Research (2003) 36: 683-691
Duerig TM, Pelton A & Stckel D (1999). An overview of
nitinol medical applications. Materials Science and Engineering
A, 273-275: 149-160.
Andreas Schuessler, Mark Piper, Boundaries for the use of
Nitinol in Medical Applications, Proceedings of the
International Conference on Shape Memory and Superelastic
Technologies.

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