Main Content Report

“FE ANALYSIS NITINOL BASED SHAPE MEMORY ALLOYS FOR MEDICAL APPLICATION”
CHAPTER - 1
1.1 Introduction
A nickel-titanium alloy with near-equiatomic composition called nitinol has shape

memory and superelastic (SE) mechanical capabilities. The mechanical properties are
greatly affected by little changes in the binary alloy composition, and they are also greatly
influenced by the material's heat treatment history and finishing. Super elasticity typically
happens at high temperatures that are close to the material's melting point. Nitinol is made
of nickel and titanium, and the combined qualities of the two metals set it apart from other
superalloys. Well below its melting point, nitinol possesses SE characteristics. These
material characteristics are therefore suitable for a variety of biological and aerospace
applications.
The alloy's shape memory effect, which has the capacity to regain significant
transformations after heating and cooling, is another potent Nitinol mechanism. Nitinol
responds to changes in temperature with a quick and precise shape memory response. Due
to the shear movement of the alloy's particles, the martensitic transition produces a shape
memory effect If the deformations are within recoverable limits (6–10%), nitinol can
recover from significant bending and torsion deformations as well as minor strain.
Excellent corrosion resistance, nonmagnetic nature, low density, and high fatigue strength
are all characteristics of nitinol. These characteristics translate into a variety of applications
for nitinol, including solid-state engines, biomedical devices, and nuclear power
engineering. Elements for tightening and hermetically connecting tubes and electric
conductors, thermomechanical drives and engines, dampers, flow rate controllers, thermo-
detectors, direct-acting emergency devices, and electrical line components are a few further
potential uses for Nitinol.
Due to its mechanical characteristics, biocompatibility, and reduction in size, mass,

complexity, and cost when compared to conventional materials and devices, nitinol is a
great choice for biomedical applications.
While Nitinol stents self-expand due to their superelastic characteristics, stainless

steel stents deploy via balloon expansion. The strain exerted on the vascular wall is
decreased as a result of the stent's ability to expand on its own, which eliminates the
requirement for
K.L.S GIT Departement of mechanical 1

the high stress of plastic deformation caused by balloon inflation during stent deployment.
Nitinol self-expanding stents provide an improved safety profile due to the reduced stress
on the vascular wall. In comparison to conventional stainless steel balloon expanding
stents, the purpose of this paper is to review the biocompatibility and material
characteristics of nitinol and discuss how these characteristics influence its mechanical
attributes, including the circumferential stress on the vessel wall during deployment and
the factor of safety with respect to vessel rupture.
The design validation process for medical products is sped up using the Finite
Element Analysis (FEA) method. Numerous books examine the special qualities and uses
of nitinol in the medical field as well as the function of finite element analysis in the design
of medical devices.
Figure1.1: Stent placement and angioplasty

CHAPTER - 2
2.1. Literature survey
1) C.H. Fu et al.: “Process Mechanics of Low Plasticity Burnishing of Nitinol Alloy”
The use of nitinol alloys in healthcare and aerospace applications has drawn
significant attention. The operation of Nitinol devices depends on the surface integrity
maintained during various production procedures. Due to its unique capacity to affect
material properties down to the deep subsurface on the scale of a few millimetres, low
plasticity burnishing (LPB) is particularly promising to modify surface integrity. To
comprehend how burnishing mechanics affect surface characteristics, this knowledge is
crucial. Burnished surface materials' depth and width are described. The superelastic
mechanical behaviour of Nitinol has been incorporated into a three-dimensional finite
element simulation. The experimental findings support the simulation expectations. To
comprehend burnishing mechanics, the contact stresses, residual stresses, and strain
profiles are examined.
2) P. PONCIN et al.:“Stent Tubing: Understanding the Desired Attributes”
A significant body of evidence backs up the general safety of coronary stents for
cardiovascular disease. However, one cannot ignore their flaws, such as restenosis, which
is why stents continue to change in terms of latticework, materials, and medications. There
aren't many studies describing how titanium gold alloy stents can successfully address
these problems. Methods: For this investigation, we compared two cutting-edge titanium-
gold alloy stents to historical manufacturing records on commonly used stents. The
flexibility, stiffness, and radial forces of each stent type were examined using a 3D CAD
finite element analysis space. Each kind was required to adhere to its own strut shape and
thickness, with the exception of lengths and diameter. Utilizing Von Mises Stress and the
ensuing deformation or expansion was the main focus of our investigation. To determine
the importance of our findings, our analyses were conducted utilising discrete changes and
Pearson's chi-squared statistics. For each kind, three lengths—15mm, 27.5mm, and 40mm
— were examined. Comparisons were made using changes in the mean % of diameter
(3.5mm) or length.

3) K.KOOP et al.:“Determination of Characteristics and Component Simulation Using the

Finite Element Method”
Stents, intravascular scaffolding devices, are used in clinical practise to treat vessel
stenoses. Prior to being extended to its nominal diameter, a stent is first compressed to a
tiny diameter, then delivered to the stenosed area of the vessel using a catheter. Either a
balloon or a material's inherent capacity for self-expansion is used to cause the expansion.
Self- expanding stents are preferred to be made of the shape-memory metal Nitinol, which
is being utilised more frequently in peripheral veins. The first part of this investigation's
objectives is to characterise this material's qualities as they relate to the fabrication of
devices and to suggest potential thermo-mechanical treatments for customising material
properties. These findings are used to define parameters that result in properties that meet
the criteria for a stent material. A material law suitable for use in a Finite Element
programme is inferred from the material data in a second stage. By directly comparing the
results of tension testing to experimental data, this method is proven to work. Finally,
computations of specific loading states for vascular stents are shown as an illustration of
the method's vast potential.
4) S. Dilibal et al.:“Comparison and characterization of NITI and NITICU shape memory

alloys”
Two distinct NickelTitanium (NiTi) shape memory alloys (SMA) compositions are
characterised in this work. The alloys were made up of Ti and 48.64 and 49.9 at. percent
Ni, respectively. The shape memory properties of NiTiCu alloys are examined after the
minor addition of Copper (2.21 percent at. and 3.94 percent at.). These alloys are created
using the vacuum arc remelting (VAR) method. Following sample manufacturing, SMA
samples were characterised using scanning electron microscopy, hardness Vickers testing,
and energy dispersive spectroscopy (EDS) analysis (SEM). NiTiCu SMA becomes harder
after copper adding. The temperatures of Austenite start (As) and Austenite finish (Af)
under stress-free thermal cycling conditions between 0°C and 200°C, however, are
significantly reduced.

5) Z.H.Dughaish et al.:“Effect of Proton Irradiation on Some Physical Properties of Nitinol

(NiTi) Shape Memory Alloy”
Shape memory alloys (SMAs) are a special type of metal alloys that, after
significant deformation, can regain their original shape when heated. Many researchers,
engineers, and designers were drawn to it because of its nonlinear behaviour and heat
sensitivity, leading them to select the ideal material for suitable applications in numerous
industrial domains. Nitinol is the most often utilised substance (NiTi). Nitinol is being used
more frequently in a wide range of nuclear engineering, actuator, aerospace, biomedical,
and medical device applications. When used in nuclear reactors, nitinol is subjected to a
variety of radiations that could have an impact on its structure and properties. People
working in this sector will find a thorough overview of irradiating Nitinol with intense
protons in this article to be very helpful. Proton irradiation results in amorphization.
Following proton irradiation, the hysteresis, austenite transformation temperatures, and the
size and number of vacancy clusters all increased. The transformation temperatures in NiTi
SMAs are significantly impacted by proton irradiation; for example, when the proton beam
energy is higher than 1.875 MeV, the martensitic transformation temperature of the Nitinol
alloy decreases. The proton irradiation-induced flaws are transient, and the alloy can be
returned to its original state by ageing the sample at ambient temperature for roughly 76
days or annealing it for roughly 30 minutes at 520 K. Materials with nanocrystal structure
may be more radiation resistant.
6) K.L.Ng et al.:“Stress-induced phase transformation and detwinningin NiTi

polycrystalline shapememory alloy tubes”
Tensile testing at various temperatures was used to examine the deformation

behaviour associated with the initial austenite (A), rhombohedral (R), and martensite (M)
phase structures in polycrystalline NiTi shape memory alloy tubes. From room temperature
(23 °C) to 70 °C, the tubes' nominal stress-strain curves were noted. While NiTi tubes with
an initial structure of the M-phase underwent martensitic detwinning, those with an initial
structure of the R-phase underwent martensitic transformation. In contrast to the
macroscopically homogenous detwinning process of the tube, it was discovered that the R
to M martensitic type transformation was effected at the macroscopic level by the
nucleation and growth of an inclined cylindrical band. Additionally, in a specific testing
temperature

range, two-stage yielding, which is connected to austenite to rhombohedral (A R) and R M

phase transitions, was seen in the stress-strain curves of NiTi tubes. The nucleated band
continued to have a cylindrical shape as the temperature rose until it reached 60 °C (>Af),
at which point it abruptly changed to a helical shape that could be clearly seen in the
superelastic microtubing.
7) F J Gil1 et al. :“Shape memory alloys for medical applications”
The shape memory alloys display a number of exceptional qualities that open up
new avenues for engineering, particularly biomedical engineering. NiTi is the most
significant alloy utilised in biomedical applications. This alloy has outstanding corrosion
resistance, wear characteristics, mechanical properties, and a good biocompatibility in
addition to the shape memory effect and superelasticity. These characteristics make it the
ideal biological engineering material, particularly for use in orthodontics and orthopaedic
surgery. In this work, the thermoelastic martensitic transition of the materials exhibiting
such a feature serves as the foundation for the memory effect. It is required to examine
certain fundamental concepts of the creation and properties of the martensitic phase in
order to comprehend even the most fundamental engineering aspects of the shape memory
effect. Review of the many characteristics of shape memory, superelasticity, two-way
shape memory, rubbery behaviour, and high damping capacity. Recent applications are
explained and categorised according to various medical specialties.
8) A Schiavone et al. :“A study of balloon type, system constraint and artery Mechanics of
Advanced Materials and Modern Processes
An intuitive understanding of the biomechanical behaviour of the entire stent-artery

system during the process is provided by the use of finite element simulation to model stent
expansion inside stenotic arteries. In the finite element simulation of stent deployment, the
choice of balloon type, system constraint, and artery constitutive model is crucial.

9) Azadeh Farnoush et al.:“Three Dimensional Nonlinear Finite Element Analysis of the

Newly Designed Cardiovascular Stent”
This study used three-dimensional nonlinear finite element analysis to model and
assess a newly developed cardiovascular stent with the goal of creating a computational
framework for analysis and optimization of futuristic design. This unique design offers
advantages over currently available conventional stents on the market, including the
capacity to control stiffness, extend fatigue life, enhance manufacturability, and lessen
tissue injury by reducing geometric sharpness. In order to analyse how the artery reacts to
the deployment of the stent, hyperelastic and soft materials are taken into consideration. To
further explore the impact of stent material on artery reaction, NiTi and 316L stainless steel
material qualities are included to this newly constructed stent.
10) Shabalovskaya SA et al.:“Critical overview of Nitinol surfaces and their modifications

for medical applications”
The analysis shows that the currently created surfaces range in thickness from a few
nanometers to micrometres, and that they are capable of efficiently preventing Ni release
provided that the surface integrity is preserved under strain and that there are no sub-layers
that are enriched in nickel. It is also considered whether different low temperature pre-
treatment techniques ( or = 160 degrees C) created initially for pure titanium are
appropriate to apply for Nitinol surface modifications and coatings. The significance of
choosing original Nitinol surfaces is underlined with relation to the effectiveness of
coatings and the comparative effectiveness of controls in the investigations. Details of their
preparation are also provided in light of the clear benefits of bare Nitinol surfaces for
superelastic implants.

11) R. Venugopalan et al.:“Assessing the corrosion behaviour of Nitinol for minimally-

invasive device design”
Nitinol's corrosion behaviour is not appreciably changed by its combination with

SS, titanium, or tantalum. Nitinol can enhance the rate of corrosion by an order of
magnitude when combined with gold, platinum, and platinum-iridium alloys. In the initial
days after immersion in a physiological media, nickel release from nitinol declines from
levels substantially below dietary levels to virtually undetectable levels. The released
nickel concentration in the tissues or organs around the implant is comparable to that
released by 316L stainless steel, according to in vivo tests that show negligible corrosion
of Nitinol following implantation.
12) S. W. Robertson et al.: “Mechanical fatigue and fracture of Nitinol”
Endovascular stents, vena cava filters, and other self-expanding implanted devices
as well as equipment like endodontic files have all been made using the stress induced
transformation (also known as "superelasticity"). The majority of these applications
involve biomechanical loads or strains that vary cyclically, necessitating a thorough
understanding of this alloy's fatigue and fracture resistance. Here, we evaluate the body of
research that has been done on the fatigue of nitinol, looking at its fracture toughness,
damage tolerance, and stress or strain life (total life) behaviours. The use of such data in
fatigue design and life prediction approaches for Nitinol implant devices used in the
medical sector is also covered in this discussion.
13) Shabalovskaya SA :“Surface, corrosion and biocompatibility aspects of Nitinol as an

implant material”
The goal of the current review is to gain a knowledge of the position of this
material among the implant alloys already in use by examining studies on the physical-
chemical properties and biological response of living tissues to NiTi (Nitinol) that have
recently been conducted. The benefits of shape memory and superelasticity are examined
in relation to how well implants work inside the body. Analyzed are various methods for
treating surfaces, sterilising processes, and the surface conditions that arise. Additionally, a
review of corrosion experiments using potentiodynamic and potentiostatic methods on

alloys that have

been wrought and as-cast in various corrosive media as well as in genuine body fluids is
provided. Galvanic and localised corrosion's parameters are presented. In order to compare
amined in relation to the alloy composition, phase state, surface treatment, and strain. the
corrosion behaviour to that of standard implant alloys, the corrosion behaviour is
exAnalysis of the porous Nitinol's biocompatibility, Ni release, and impact on living cells
is based on knowledge of the surface dynamics and corrosion behaviour. The report also
provides a brief summary of the relative toxicities of the metals that make up frequently
used medical alloys, demonstrating that Nitinol's biocompatibility profile is favourable for
current in vivo applications.
14) B. Thierry eta al. "Nitinol versus stainless steel stents: acute thrombogenicity study in
an ex vivo procine model,"
Major issues with coronary stenting continue to be acute and subacute stent
thrombosis and thrombus mediating neointimal growth within the stent struts. There is
currently a clear dearth of information regarding the thrombogenicity of stent materials
under physiological settings. This research compared the relative thrombogenicity of
stainless steel and nitinol stents. Nitinol stents were tested in a regulated ex vivo AV shunt
porcine model after being laser cut to replicate the precise shape of the stainless steel
Palmaz stents. While Palmaz stents obviously showed more thrombus, Nitinol stents only
showed little amounts of white and/or red thrombus, mostly concentrated at the strut
intersections. This led to significantly reduced 125I-fibrin(ogen) adsorption and (111)I-
platelet adhesion on nitinol than on stainless steel devices (36%, p = 0.03 for fibrin(ogen)
and 63%, p = 0.01 for platelet). Scanning electron studies demonstrating various thrombus
shapes for nitinol and stainless steel validated these findings. Nitinol has special
mechanical qualities, and our study's favourable results on its hemocompatibility may
encourage its usage in more treatments for peripheral and coronary revascularization.
15) M. S. Cabrera et al.: "Understanding the requirements of self-expandable stents for

heart valve replacement: Radial force, hoop force and equilibrium,"
For a better understanding of the prerequisites for a successful heart valve

replacement, a precise interpretation of the forces created during stent crimping and
deployment is of utmost importance. The performance of a nitinol stent for tissue-
engineered heart valve implantation is being evaluated in the current study using a

combination of

experimental and computational methodologies. Experimental evaluation of the

mechanical response to parallel plate compression and radial crimping served to validate
the stent model. The experimental results and finite element simulations agreed well. The
radial force on a rigid tool during crimping and self-expansion as well as the hoop force on
the stent were also calculated using computer models. Additionally, stent deployment
against human and ovine pulmonary arteries was simulated to estimate the equilibrium
diameter for various levels of oversizing and the hoop force on the stent-artery system.

2.2 Methedology
1. To conduct research by determining the gaps in the literature review.

2. Getting the Analysis's Objective.
3. Modelling of different-composition nitinol stents.Modeling of stent .
4. Applying Loads and Boundary Conditions.
5. To do the stent analysis and get the data.
6. Contrasting the stainless steel stent currently in use with the nitinol-based stent
7. Finally, finding the optimal composition for the shape memory alloy stent based on
nitinol.
Modelling of different- Finally, finding the

To conduct research To do the stent
composition nitinol optimal composition
by determining the analysis and get the
stents.Modeling of for the shape memory
gaps in the literature data.
stent alloy stent based on
review.
nitinol.
Contrasting the
Getting the Analysis's Applying Loads and stainless steel stent
Objective. Boundary Conditions. currently in use with
the nitinol-based stent
Figure2.2.1: Diagram showing the steps in methology
Figure2.2.2: A biliary stent example Figure2.2.3: Model of nitinol mesh stent

2.3. Objectives
1. To investigate how nitinol stent mechanical performance is affected by material

attributes.
2. To examine the nitinol stent's biocompatibility
3. To research and analyse how stresses manifest in nitinol stent material
4. To examine the pressure required to inflate the stent and clear the plaque-caused
obstruction (blocking substance inside the artery)
5. To research the pressure required for the stent to expand and work properly.
6. To research stressed areas and the stress acting on stent inflation.

CHAPTER – 3
3.1. Nitinol's microstructural phases
Nitinol (NiTi) is a material with a nearly equal atomic ratio of nickel and titanium,
as well as superelastic and shape memory properties. Nitinol's ability to display a
reversible solid-state transition between an austenitic and martensitic microstructure is due
to its unusual atomic structure, which forms a three-dimensional symmetric grid. The
parent phase, austenite, has a straightforward cubic B2(CsCl) crystal structure. Monoclinic
B19 crystal structure describes the martensite, the daughter phase. Once enough energy is
provided, either thermally or by creating stress, the transition between austenite and
martensite occurs instantly. When austenitic Nitinol is cooled to the martensite initiation
temperature, Ms, or when under stress, stress-induced martensite results, the nitinol's
martensite phase transitions (SIM).
Figure3.1.1: Nitinol undergoes a shape memory thermally driven change.
Figure3.1.2: Nitinol's stress-induced martensite (SIM) transition

The atoms in a twinning lattice structure are simply displaced into the martensite
phase without dissolving their atomic connections or diffusing through the material.
Nitinol becomes fully martensitic and prone to non-plastic deformation once it reaches a
temperature lower than its martensite finish temperature, Mf. The critical stress needed to
transform to the martensite phase is greater than what is needed for atomic structural
dislocation and Nitinol behaves like conventional engineering materials with a linear
elastic and plastic region until failure if temperature exceeds the martensite deformation
temperature Md, the temperature where energy from the SIM equals the energy for plastic
deformation of the austenite phase. Only at temperatures between the austenite initiation
temperature, Af, and Md the martensite phase can stress be applied.
Nitinol can undergo a variety of treatments to improve its functionality or change

the temperatures at which it transforms. However, the treatments could result in the
introduction of micro-structural flaws in the form of precipitates and dislocations, creating
an energy barrier between the austenite and martensite transformations and a transitional
rhombohedral phase (R-phase). Before reaching the martensite state, the R- phase is
reported to have a discontinuity in the stress-strain curve and many transformation peaks
visible in x-ray diffraction (XRD) as a result of minor localised transformations inside the
material's inhomogeneity. Small recoverable strains around 0.5 percent that are undesirable
are produced during the R-phase transformation.
Figure3.1.2: Microstructure phase change in thermal and mechanical systems: Hysteresis

3.2.The shape-memory property of nitinol
Because of the effects of temperature on its martensite and austenite phases, nitinol
has the ability to remember its original shape after deformation. Austenitic Nitinol enters
the twinned martensitic phase when cooled below its Mf temperature. At this stage, the
martensite crystal structure is preserved while the atomic structure can accept deformation
through non-plastic detwinning. When a load is applied during this phase, the twinned
atomic structure adapts into the detwinned martensite structure; when the load is
withdrawn, the change in the detwinned martensite structural arrangement causes a
minimal elastic recovery of around 1%. The material must be heated above its Af
temperature in order to fully recover, reverting it to the initial fixed shape in the austenite
phase. This phenomena in nitinol is completely reversible.
Figure3.2.1: Relationship between temperature, stress, and strain for phase-changed

nitinol

3.3.Superelasticity of nitinol
The term "superelasticity" describes a material's capacity to flex elasto-plastically

under loads that cause larger strains than those experienced by ordinary materials. As
previously mentioned, temperatures below Ms can cause the martensite phase of nitinol to
form. However, stress can cause the martensite phase at temperatures between Af and Md.
When a load is applied to austenitic nitinol, the shear stress at the borders of the detwinned
crystals from the load will cause the martensite phase to form. In a stress-strain diagram,
this transformation is represented as a plateau region with a low Young's modulus that
extends for strains to around 6 percent. The martensite phase is unstable when the load is
removed, and the material reverts to its austenite phase. As long as interatomic bonds are
intact, the recovery of strain in this mechanism is totally reversible up to stresses of over
eleven percent. Only one percent of stains can be recovered elastically by typical
engineering metals.

CHAPTER -4
4.1. Nitinol's resistance to corrosion
Because human tissues include water, dissolved oxygen, proteins, and different
ions, including chloride and hydroxide, which all contribute to corrosion, they can be an
unfavourable environment for metals and alloys. Therefore, once implanted in the body, all
base metals and alloys will corrode. To meet biocompatibility standards, the level of
corrosion and its toxicity to the body must be assessed. Titanium and nickel combine to
form the almost equiatomic alloy known as nitinol. It is vital to recognise the effects of the
separate components because corrosion may liberate nickel and titanium ions, even though
the biocompatibility of Nitinol is not determined by the biocompatibility traits of nickel
and titanium individually. Known for its biocompatibility and resistance to corrosion,
titanium oxidises to form a stable titanium oxide (TiO2) surface layer.
However, nickel has toxic effects at high doses that can cause cellular damage,
allergic reactions, or the growth of malignant neoplasms. Implants made of pure nickel
have been demonstrated to irritate and necrose tissue. Although the precise mechanism by
which nickel causes cancer is unknown, nickel sulphide is thought to be the end product of
this process (Ni3S2). However. The body frequently forms nickel oxide (NiO) and nickel
chloride (NiCl) from nickel-containing implants, while nickel sulfide—a carcinogen—is
not as common. Implanted nickel cobalt-chromium alloys have a higher frequency of
Ni3S2 production than stainless steel, titanium alloys do not form any Ni3S2. The most
frequent trigger for allergic contact dermatitis is nickel. When nickel comes into contact
with skin tissue, nickel ions may escape from the metal and then link to a carrier protein.
This protein then transports the nickel ion to a Langerhans cell, an antigen-presenting cell
in the skin, where it may be recognised as foreign. The Langerhans cell then presents this
nickel ion to a T cell, which then triggers an inflammatory cascade. T suppressor cells,
fortunately, prevent this inflammatory response from occurring. The majority of people can
ingest foods that may contain nickel without experiencing any negative reactions to nickel
because these T suppressor cells are more common in the gut. If given a prosthesis
containing nickel, patients having a history of allergic contact dermatitis to nickel are at a
higher risk of problems. The likelihood of rejection of the protesthes is thought to be
decreased but not entirely eliminated by the presence of suppressor T cells nearby where
nickel-containing

prostethes are positioned. Therefore, there is very little chance of negative effects from the
nickel included in implanted Nitinol stents.
When transplanted into human tissue, biomaterials frequently rely on a passive

oxide layer to protect against corrosion. Nitinol and stainless steel both passively produce
layers of titanium oxide and chromium oxide, respectively. By homogenising the thickness,
texture, and compositions of the surface, surface treatments such as electropolishing or
passivation in acid solution can increase the effectiveness of the oxide layer.
In addition to having poorer static corrosion resistance than Nitinol, stainless steel
also exhibits lower corrosion resistance under strain due to its weaker passive oxide layer
and slower repassivation process. An essential component in the design of stents is
corrosion resistance, which nitinol seems to exhibit as being higher than stainless steel.

4.2. Nitinol's compatibility with blood(hemocompatibility)
Blood compatibility is essential in the deployment of cardiovascular stents to avoid

thrombosis and restenosis of the stented channel. Blood proteins called fibrinogen and
albumin interact with the surface of stents to determine thrombotic risk. While albumin
reduces platelet adhesion, fibrinogen causes platelet activation, which raises the risk of
possible thrombus development. A surface that does not encourage fibrinogen fixation will
have a lower risk of thrombus development because fibrinogen that fixes to the surface of
the substrate stimulates platelet aggregation. It is hypothesised that amorphous TiO2 will
lessen fibrinogen adherence. The thrombogenic occlusion and/or restenosis rates are
correlated with the hemocompatibility of stents.
Thierry et al. used an ex vivo swine AV shunt model to examine the

thrombogenicity of Nitinol vs. stainless steel stents. The stainless steel stents' geometry
was used as a guide to laser cut the Nitinol stents. Their surface roughness was found to be
equal as well. Although Nitinol stents are self-expanding, stainless steel and Nitinol stents
were both implanted using balloon catheters to guarantee that their interactions with the
vessel walls would be equivalent. The development of thrombus on the stents was
examined using a scanning electron microscope. According to Thierry et al., compared to
stainless steel stents, Nitinol stents greatly reduced the amount of fibrinogen production
and decreased platelet adhesion. After 15 minutes of perfusion, the Nitinol stents showed
36 percent less fibrinogen adsorption and 63 percent less platelet deposition than the
stainless steel stents.
The denaturation of fibrinogen is reduced by the TiO2 on Nitinol's oxidised

surface. Additionally, albumin has an affinity for nickel and reduces thrombus
development. Nickel's presence on Nitinol's surface also helps to prevent thrombi from
forming.Since the stent's surface is initially exposed to blood and at risk of thrombus
development until the lumen has time to epithelialize the stent, nitinol possesses
advantageous surface characteristics that lower thrombus formation risk compared to
stainless steel.

4.3. Nitinol's biomechanical compatibility
The biomedical implants made of stainless steel and other metals are more stiff than
the tissues they are placed next to. Because of its high compliance, nitinol has improved
biomechanical compatibility. It is advantageous for implants because nitinol's stress-strain
hysteresis superimposes with biologic materials because of its comparable stress strain
response to tissue. This reduces stress on the surrounding tissues, reducing discomfort. The
deployment of a rigid stainless steel stent, on the other hand, forces a vessel that is
naturally tortuous into a straight confirmation and produces bending stress on the vessel
wall. This tension causes irritation and inflammation, which may lead to restenosis and
neointimal hyperplasia.
A balloon is inflated for high-pressure dilation to plastically distort a stainless steel

stent into place in order to accomplish full deployment. The study's stainless steel stent was
created with flared ends to reduce internal tension placed on the stent by the balloon during
expansion. The stent's outer edges are designed to pierce the vessel wall and anchor it
there. Non-uniform expansion is caused by any flaws or imperfections within the stent.
The "healing cascade" that causes thrombosis and restenosis is thought to be caused by the
interaction of high-pressure dilatation and vascular damage from the stainless steel stent.
As a result, just a small amount of balloon pressure is needed to inflate the Nitinol
stent into a stable position. If the struts of the stent had any flaws, the applied stress would
not cause the uniform deformation seen in the stainless steel stent since the expanding
stress needed is so low. Additionally, the martensitic nitinol stent's resistance to dislocation
motion is increased by nitinol's distinctively high strain hardening, which also causes
homogeneous plastic deformation.
In comparison to stainless steel stents, the low pressure uniform deployment of

Nitinol stents is thought to lessen vascular damage and thrombus formation.

CHAPTER-5
5.1. Analysis of stent mechanics
The varied loads that a blood artery experiences during stent deployment as well as
physiological stresses must be taken into account while constructing a stent. Hoop or
circumferential loading, measured in the direction perpendicular to the radial and axial
stress, can be used to assess the pressure exerted on a vessel. The interior wall stress often
fluctuates at several places. It is possible to represent a vessel with thick or thin walls when
studying how pressure causes circumferential loading of vessels. The thick-wall models
have a non-uniform stress field because the stress varies significantly between the inside
and outside surfaces, contrary to the thin-walled models that assume the difference in the
radial distribution of the circumferential stress is minimal and can be adequately
represented by the mean value of the stress . If the ratio of wall thickness to internal radius
is less than or equal to 0.1, it is valid to assume having roughly homogeneous stress across
the wall thickness and use the thin-wall model. Otherwise, it is recommended to use the
thick-wall model.
Figure 5.1.1: Radial distribution of circumferential (hoop) stress in a pressure vessel

5.2. Pressure vessel: thin-walled vs. thick-walled
Depending on where they are in the body and whether they are an artery or vein,
vessels can vary in thickness. In comparison to veins, arteries have a thicker tunica media,
smooth muscle layer, and vessel wall, making them the sites of stenosis most frequently.
It's interesting that several sources used a pressure vessel with a thin wall to assess stents
and the strains placed on the blood arteries. When the internal diameter to wall thickness
ratio is less than 0.1, a thin-wall model is typically utilised. When comparing the size of
typical healthy blood arteries with those of commonly stented blood vessels (with Nitinol
and stainless steel stents), a ratio greater than 0.1 is found, indicating the thick-walled
model would be preferable to the thin-walled model . Age, race, and gender will all affect
the size of the vessel. The dimensions that were used in this study are averages derived
from earlier research. If the ratio of the wall thickness to internal radius is less than or
equal to 0.1, it is valid to assume having roughly homogeneous stress across the wall
thickness and use the thin-wall model. Otherwise, it is recommended to use the thick-wall
model. minute and can be adequately represented by the mean value of the stress(rule of
thumb).
Table 5.2.1: Coronary artery dimensions, internal diameter, and wall thickness ratio are
used to evaluate the modelling approach.
Name of artery Inner Thickness of Wall Ratio

diameter(mm) (mm) (THICKNESS/RADIUS)
Coronary 2.2 1.1 1
As per thumb rule for coronary artery
𝑇ℎ𝑖𝑐𝑘𝑛𝑒𝑠𝑠 𝑜𝑓 𝑐𝑜𝑟𝑜𝑛𝑎𝑟𝑦 𝑎𝑟𝑡𝑒𝑟𝑦

𝐼𝑛𝑡𝑒𝑟𝑛𝑎𝑙 𝑟𝑎𝑑𝑖𝑢𝑠 𝑜𝑓 𝑐𝑜𝑟𝑜𝑛𝑎𝑟𝑦 𝑎𝑟𝑡𝑒𝑟𝑦
= 1.1 = 1 > 0.1
1.1
Therefore, a thick-walled model would be preferable to a thin-walled model.

5.3. Thick walled coronary artery modeling
The varied loads that a blood artery experiences during stent deployment as well as
physiological stresses must be taken into account while constructing a stent. Hoop or
circumferential loading, measured in the direction perpendicular to the radial and axial
stress, can be used to assess the pressure exerted on a vessel. The interior wall stress often
fluctuates at several places. It is possible to represent a vessel with thick or thin walls when
studying how pressure causes circumferential loading of vessels. The thick-wall models
assume that the stress varies significantly between the inside and outside surfaces, leading
to a non-uniform stress field, in contrast to the thin-walled models that assume that the
difference in the radial distribution of the circumferential stress . If the ratio of the wall
thickness to internal radius is less than or equal to 0.1, it is valid to assume having roughly
homogeneous stress across the wall thickness and use the thin-wall model. Otherwise, it is
recommended to use the thick-wall model. minute and can be adequately represented by
the mean value of the stress.
Figure 5.3.1: Model with thick walls for a coronary artery

Coronary artery internal pressure (blood pressure) :
i. 𝑝𝑠 = (120 𝑚𝑚 − 𝐻𝑔)[1.33𝑥10−4 (𝑁 /𝑚𝑚2 )/𝑚𝑚-𝐻𝑔] = 0.01596 𝑁 /𝑚𝑚2

ii. 𝑝𝐷𝑠= (80 𝑚𝑚 − 𝐻𝑔)[1.33𝑥10−4 (𝑁 /𝑚𝑚2 )/𝑚𝑚-𝐻𝑔] = 0.01064 𝑁 /𝑚𝑚2
The coronary artery's size (nominal) :
i. The coronary artery's internal diameter = 2.2 mm

ii. Coronary artery thickness = 1.1 mm
iii. Coronary artery external diameter = 3.3 mm
For a thick walled cylinder we have :
Radial stresses
𝑟 2𝑝 2 𝑟2
𝜎 = 𝑖 𝑖 0
𝑟
(𝑟 − 𝑟 ) (1 − 𝑟2 )
2 2
0 𝑖
𝑟𝑖2𝑝2𝑑𝑠 𝑟02 1.12∗0.015962 1.652
𝜎𝑟𝑠 = (1 − 𝑟2 )= (1 − ) = -8.9662*e-5 /𝑚 𝑚 2
(𝑟2−𝑟2) (1.652−1.12) 1.3752
0 𝑖
2
𝑟𝑖 𝑝𝑠2 2
𝑟02)= 1.1 ∗0.01064
2
1.652
𝜎𝑟𝑑𝑠 = (1 − (1 − ) = -3.9849*e-5 /𝑚 𝑚 2
(𝑟2−𝑟2) 𝑟2 (1.652−1.12) 1.3752
0 𝑖
Hoop stresses
𝜎 = 𝑟 2𝑝 2 𝑟2
𝑖 𝑖 0
2 (1 + )
𝜃
(𝑟 − 𝑟 )
2
𝑟2
0 𝑖
2 2
2 2
𝑟02 ) = 1.1 ∗0.01596 1.652
𝜎𝜃𝑠 = 𝑟2𝑖 𝑝 𝑑𝑠2 (1 + (1.652−1.12)
(1 + ) = 4.9722*e-4 𝑁 /𝑚 𝑚 2
(𝑟 −𝑟 ) 𝑟2 1.3752
0 𝑖
2 2 2 2
𝑟𝑖 𝑝𝑠 𝑟02) = 1.1 ∗0.01064 1.652
𝜎𝜃𝑑𝑠 (1 + (1 + ) = 2.2098*e-4 𝑁 /𝑚 𝑚 2
=
(𝑟2−𝑟2) 𝑟2 (1.652−1.12) 1.3752
0 𝑖

3. Axial stresses
𝑝𝑖𝑟2 − 𝑝0𝑟2
𝜎 = ( 𝑖2 0
)
𝑟 −𝑟 2
𝑧
0 𝑖
Since there is no external pressure on the coronary artery 𝑝0 = 0
𝜎𝑧𝑠 =( 𝑝𝑠𝑟
2
0.01596∗1.12
𝑟2−𝑟
𝑖 = = 12.768*e-3 /𝑚 𝑚 2
(1.652−1.12)
0 𝑖
𝜎𝑧𝑑𝑠 = ( 𝑝𝑠𝑟
2
0.01064∗1.12
𝑟2−𝑟
𝑖 = = 8.512*e-3 𝑁 /𝑚 𝑚 2
(1.652−1.12)
0 𝑖

CHAPTER-6
6.1. CAD model of a coronary stent
Healthcare equipment must function well in challenging circumstances. The

product must succeed; failure is simply not an option. The medical sector need failsafe
products that deliver with accuracy. Performance and dependability in this area are
essential for a successful product. Pulse oximeters, phacoemulsifiers, scanners,
lithotripters, and orthopaedic implants, to mention a few, are examples of precision
medical equipment and gadgets that improve patients' quality of life. In the design of
medical equipment, precision is paramount. In addition to validation toolkits, SolidWorks
features the ideal balance of usability, productivity, and functionality that enables medical
designers to create complicated items correctly the first time. SolidWorks has become the
de facto standard for medical equipment makers in their design process. SolidWorks has
established a new paradigm in the quality design of medical equipment by continuing to
innovate and improvise.
Table 9.1: showing the stent charactistics
Stent characteristics Dimensions in mm
Length 8 -25
Diametre 2.5 - 4
Strut diameter 0.101 - 0.148
Figure 6.1.1:Front view of coronary stent

Figure 6.1.2:Side view of coronary stent
Figure 6.1.3:Isometric view of coronary stent

6.2. Loads and boundary conditions
Figure6.2.1: Internal Pressure is Applied to the Balloon
An FE mesh should only be subjected to realistic boundary and loading

circumstances that are a good representation of the actual conditions in order to produce
reliable findings. Two load scenarios make up the loading procedure; In the first step, the
balloon was subjected to a constant internal pressure of 0.0156 MPa without taking the
balloon and stent into account. This pressure is equivalent to 120 mm Hg of blood
pressure. The pressure causes the vessel to expand and creates an initial tension while
simulating the internal blood pressure. In the second instance, the inside surface of the
balloon was subjected to a constant pressure by maintaining the initial pressure that was
applied to it. Various values of pressure were used to apply this. When it comes to stents
that are balloon- expandable, stent apposition is created by inflating a balloon. Typically,
the balloon is first positioned inside the stent and is longitudinally longer than the stent.
The balloon is deflated and removed following balloon inflation and stent implantation.
We can infer from data sources that the balloon is a more flexible structural component
than the stent. As a result, it is reasonable to disregard the balloon stiffness in comparison
to the stent stiffness within an acceptable range of approximation. This viewpoint has
significant implications since it enables the option of excluding the balloon from the study
while also taking into account the fact that the internal pressure of the balloon is directly
delivered to the stent. As a result, we apply an internal, consistent radial pressure to the
stent.

6.3. Analysis and result discussion
Analysis of Nitinol Stent

Table6.3.1:Material properties of nitinol
Density 6450 kg m^-3
Coefficient of Thermal Expansion 1.1e-005 C^-1
Specific Heat 434 J kg^-1 C^-1
Thermal Conductivity 60.5 W m^-1 C^-1
Resistivity 1.7e-007 ohm m
Figure6.3.1: Nitinol stent with von Mises stress
The above figure makes it plain that the Von Misses stress varies from a minimum
of 26.953 to 171.25 MPa along the length of the stent material, and it is also evident that
the von Misses stress is primarily concentrated along the coils of the stent material at the
periphery of stent thickness. According to the tale, the inner bend region of the stent, which
is coloured red, is where the most tension is concentrated. As a result, stent bends are more
important for stress; in the example above, we can see that the inner bend's (less than800
MPa) stress is nearly uniform.

Figure6.3.2: The radial displacement in nitinol stent
We can see a radial displacement of 1.83e-2mm for a balloon stent inflation of 1.0 MPa
from the above figure.
Table6.3.2: Radial displacement and von Mises stress in nitinol stent
SL NO Pressure applied Max Radial Max Von Misses

(MPa) Displacement (mm) Stress (Mpa)
1 0.1 1.83e-3 26.953
2 1 1.83e-2 171.25

Analysis of NiTiCu Stent
Table6.3.3:Material properties of NiTiCu

Figure6.3.3: NiTiCu stent with von Mises stress
The Von Mises stress ranges from 19.66 to 191.66 MPa, as can be seen from the
stress distribution (Fig. 11). Similar to the previous analysis, the accompanying figure
shows that stent bends are particularly important for stress, particularly in the inner
radius/region.
As opposed to Nitinol, we see increased stress on sharp stent bend regions in this
instance, that is, for NiTiCu stents. Therefore, under the same 1.0 MPa pressure load, the
stent made of NiTiCu alloy creates greater stress.

Figure6.3.4: The radial displacement in NiTiCu stent
The radial displacement is 1.8738e-2mm for a balloon inflation of 1.0 MPa, as seen in the
above picture.
Table6.3.4:Radial displacement and von Mises stress in NiTiCu stent
SL NO Pressure applied Max Radial Max Von Misses

1 0.1 1.87e-3 19.166
2 1 1.8738e-2 191.66

Analysis of SS316L Stent
Table6.3.5:Material properties of SS316L

Figure6.3.5: SS316L stent with von Mises stress
The von Misses stress varies from a minimum of 456.47e-6 to a maximum of

188.1MPa over the length of the stent material, and it is evident that around the perimeter
of stent thickness, the von Misses stress is primarily concentrated along the coils of stent
material . According to the tale, the inner bend region of the stent, which is coloured red, is
where the most tension is concentrated. As a result, stent bends are more important for
stress; in the example above, we can see that the inner bend's (less than800 MPa) stress is
nearly uniform.

Figure6.3.6: The radial displacement in SS316L stent
For a balloon inflation of 1.0 MPa, we can see from the preceding figure a radial
displacement of 2.5246e-3mm.
Table6.3.6:Radial displacement and von Mises stress in SS316L stent
SL NO Pressure Load Max Radial Max Von misses

1 0.1 4.1067e-4 18.8
2 1 2.5246e-3 188.1

6.4. Bar charts representing summary of results for various materials
The von Misses stress that developed for the materials under investigation when pressure
loads of 0.1MPa were applied is shown in this graph.
Stress distribution
30 26.953
25
18.8 19.66
20
15
von Mises
10
0 Materials
SS316LNiTiCuNiTi
Figure6.4.1: The distribution of stress in various materials
The von Misses stress that developed for the materials under investigation when pressure
loads of 1MPa were applied is shown in this graph.
Stress distribution
191.66
195
190 188.1
185
180
175
vonMises
171.25
170
165
160
Material
SS316LNiTiCuNiTi
Figure6.4.2: The distribution of stress in various materials

The graph that follows shows the radial displacement caused by applying pressure loads of
0.1 MPa to the materials under consideration
Radial Displacement
2.00E-03 1.87E-03 1.83E-03
1.80E-03
1.60E-03
1.40E-03
1.20E-03
1.00E-03
8.00E-04
6.00E-04
4.00E-04 Radial Displacement(mm)
Radial
2.00E-04 4.11E-04
0.00E+00
SS316L NiTiCu NiTi

Material
Figure6.4.3:Radial displacement in different materials
The graph that follows shows the radial displacement caused by applying pressure loads of
1 MPa to the materials under consideration
Radial Displacement
2.00E-02 1.87E-02 1.83E-02
1.80E-02
1.60E-02
1.40E-02
1.20E-02
1.00E-02
8.00E-03
6.00E-03
4.00E-03 Radial Displacement(mm)
Radial
2.00E-03
0.00E+00 2.52E-03
SS316L NiTiCu NiTi

Material
Figure6.4.4:Radial displacement in different materials

6.5. Comparision of Nitinol with SS316L stent
Following a balloon angioplasty, stents are frequently implanted to lessen vessel

recoil and restenosis. Stents are divided into two categories based on how they expand:
self- expanding or balloon-expanding. Balloon-expanding stents are created in a crimped
state around a balloon, which when inflated, causes the balloon to expand, deforming the
plastic to the desired diameter. Self-expanding stents are made with an outer diameter that
is somewhat bigger than the vessel wall before being compressed into a delivery system
with a tiny diameter. The stent is released when the placement site is reached and expands
on its own against the vessel wall.
Table6.5.1: Comparision between SS316L and nitinol stent
CHARACTERISTICS SS316L NITINOL
Expansion Balloon expanding Both balloon

expanding and self
expanding
Superelasticity Not a superelastic Unique superelasticity

material
Biocompatibility Less compatible than More compatible

nitinol
Hemocompatible Less compatible than More

nitinol compatible(good
surface properties)
Rigidity More rigid (high stress Less

to plastic deformation) rigid(superelasticity
,reducing vessel
injury)

CHAPTER - 7
7.1. Conclusion
The initial standard for stent production was 316L stainless steel. In order to meet
the demands of more dynamic, crush-resistant stents that are required for peripheral
vascular and nonvascular systems, stainless steel stents' stiffness is less than ideal. Nitinol
stents that can be self-expand and stainless steel stents that expand using a balloon have
significant differences. The distinctive atomic structure and material characteristics of
nitinol offer an obvious remedy for the drawbacks of stainless steel stents, revolutionising
the accepted standard for vascular stents in use today.
From the displacement analysis NiTi and NiTiCu are found to be more suitable than
SS316L. Because stainless steel is stiff, it takes a lot of tension to for it to expand in
diameter and cause damage to the vessel walls. The superelastic characteristics of nitinol
allow for homogeneous low pressure deployment, considerably decreasing vascular
damage, and lowering irritation problems.
Nitinol's special superelastic and shape-memory qualities can be tuned to exact

specifications for an application's best results.

7.2. Future scope
i. The research has provided us with enough data to support additional investigation
into how radial pressure and Von Mises stresses affect the performance of
biocompatible stents.
ii. The rigidity of stainless steel stents is frequently favoured for boosting the patency
of severely calcified vessels. Nitinol stents, however, can be used because of their
advantageous expansion properties to increase laminal diameter by delivering a
constant outward force to rebuild the artery over time and preserve patency.
iii. In the future, balloon expansion procedures for restoring patency might not be
necessary because to the use of superelastic materials like Nitinol.
iv. Nitinol's adaptable mechanical characteristics and processing-induced
transformation temperatures may make it possible to create pathologic-specific
stents that improve patient outcomes.
v. Nitinol is a potential material for stent and other medical device customisation due
to its adaptability.

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Plasticity Burnishing of Nitinol Alloy”Journal of material engineering and performance
Vol.11 Dec 2012
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Attributes”American Journal of Biomedical Research. 2018, Vol. 6 No. 2, 46-52
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“FE ANALYSIS NITINOL BASED SHAPE MEMORY ALLOYS FOR MEDICAL APPLICATION”

A nickel-titanium alloy with near-equiatomic composition called nitinol has shape

Due to its mechanical characteristics, biocompatibility, and reduction in size, mass,

While Nitinol stents self-expand due to their superelastic characteristics, stainless

K.L.S GIT Departement of mechanical 1

Figure1.1: Stent placement and angioplasty

K.L.S GIT Departement of mechanical 2

2) P. PONCIN et al.:“Stent Tubing: Understanding the Desired Attributes”

K.L.S GIT Departement of mechanical 3

3) K.KOOP et al.:“Determination of Characteristics and Component Simulation Using the

4) S. Dilibal et al.:“Comparison and characterization of NITI and NITICU shape memory

K.L.S GIT Departement of mechanical 4

5) Z.H.Dughaish et al.:“Effect of Proton Irradiation on Some Physical Properties of Nitinol

6) K.L.Ng et al.:“Stress-induced phase transformation and detwinningin NiTi

Tensile testing at various temperatures was used to examine the deformation

K.L.S GIT Departement of mechanical 5

range, two-stage yielding, which is connected to austenite to rhombohedral (A R) and R M

7) F J Gil1 et al. :“Shape memory alloys for medical applications”

An intuitive understanding of the biomechanical behaviour of the entire stent-artery

K.L.S GIT Departement of mechanical 6

9) Azadeh Farnoush et al.:“Three Dimensional Nonlinear Finite Element Analysis of the

10) Shabalovskaya SA et al.:“Critical overview of Nitinol surfaces and their modifications

K.L.S GIT Departement of mechanical 7

11) R. Venugopalan et al.:“Assessing the corrosion behaviour of Nitinol for minimally-

Nitinol's corrosion behaviour is not appreciably changed by its combination with

12) S. W. Robertson et al.: “Mechanical fatigue and fracture of Nitinol”

13) Shabalovskaya SA :“Surface, corrosion and biocompatibility aspects of Nitinol as an

K.L.S GIT Departement of mechanical 8

alloys that have

K.L.S GIT Departement of mechanical 9

15) M. S. Cabrera et al.: "Understanding the requirements of self-expandable stents for

For a better understanding of the prerequisites for a successful heart valve

K.L.S GIT Departement of mechanical 1

K.L.S GIT Departement of mechanical 1

experimental and computational methodologies. Experimental evaluation of the

K.L.S GIT Departement of mechanical 1

1. To conduct research by determining the gaps in the literature review.

Modelling of different- Finally, finding the

Figure2.2.1: Diagram showing the steps in methology

Figure2.2.2: A biliary stent example Figure2.2.3: Model of nitinol mesh stent

K.L.S GIT Departement of mechanical 1

1. To investigate how nitinol stent mechanical performance is affected by material

K.L.S GIT Departement of mechanical 1

Figure3.1.1: Nitinol undergoes a shape memory thermally driven change.

Figure3.1.2: Nitinol's stress-induced martensite (SIM) transition

K.L.S GIT Departement of mechanical 1

Nitinol can undergo a variety of treatments to improve its functionality or change

Figure3.1.2: Microstructure phase change in thermal and mechanical systems: Hysteresis

K.L.S GIT Departement of mechanical 1

3.2.The shape-memory property of nitinol

Figure3.2.1: Relationship between temperature, stress, and strain for phase-changed

K.L.S GIT Departement of mechanical 1

The term "superelasticity" describes a material's capacity to flex elasto-plastically

K.L.S GIT Departement of mechanical 1

K.L.S GIT Departement of mechanical 1

When transplanted into human tissue, biomaterials frequently rely on a passive

K.L.S GIT Departement of mechanical 2

4.2. Nitinol's compatibility with blood(hemocompatibility)

Blood compatibility is essential in the deployment of cardiovascular stents to avoid

Thierry et al. used an ex vivo swine AV shunt model to examine the

The denaturation of fibrinogen is reduced by the TiO2 on Nitinol's oxidised

K.L.S GIT Departement of mechanical 2

4.3. Nitinol's biomechanical compatibility