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The shape memory alloy of the positioned

stent-like member

Fernando Suárez
Aditya Kumar
Soham Anjaria

Materials Science & Engineering Winter Term 2009-2010


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Outline
• Introduction
• Definition of stent
• Requirements in stent’s design
• Materials used in stents
• Form of stents
• Geometry of stents

Materials Science & Engineering Winter Term 2009-2010


Introduction 3

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Introduction

Biomaterials science
“ The study and knowledge of the interactions
between living and non-living materials “

Biomaterial
“ A material intended to interface with biological
systems to evaluate, treat, augment or replace
any tissue, organ or function of the body ”

Materials Science & Engineering Winter Term 2009-2010


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Introduction

Biocompatibility
“ The ability of a material to perform with an appropiate
host response in a sepecific application ”

• Host reactions to the material

• Enviroment’s effects on the material


(degradation of the material)

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Introduction

Groups of materials used for implantations


Materials Advantages Disadvantages Applications

Polymers Resilient, easy Not strong, deforms Sutures, blood


manufacturing with time, may vessels, hip socket,
degrade ear, nose

Metals Strong, tough May corrode, Joint replacements,


ductile dense, difficult to dental, root
make implants, bone
plates and screws

Ceramics High Brittle, not resilient, Dental and


biocompatibility weal in tension orthopedic
implantation

Composites Strong, tailor-made Difficult to make Bone cement,


dental resin

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Introduction

Shape memory alloys (SMA’s)

• 1-Way memory effect


• 2-Way memory effect
• Superelastic effect
(isothermal phase)

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Introduction

“One-way” shape memory effect

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Introduction

Superelastic effect

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Stents

Definition of Stent

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Requirements in stent design


• Biological requirements
• Material requirements

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Stents requirements

Biological requirements
• Acceptance of the material
• Pharmacological acceptability
• Chemically inert and stable
• Mechanical strength
• Fatigue life
• Weight and density
• Radiopacity

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Stents requirements

Material requirements
• Low profile
• Reliable delivery system
• Trackability
• Elasticity
• Flexibility
• Uniform radial strength
• Corrosion resistance
• Availability for various lesions

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The Ideal Stent Material
General requirements:
– Corrosion resistant
– Vascular compatible
– Fatigue resistant
– Visible using X-ray and MRI (density of material)

Considerations specific to either balloon expandable


or self-expanding stents must also be made

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Material requirements for balloon expandable stents
• High elastic modulus
– minimum recoil

• High tensile properties after expansion


– Radial strength with minimal material volume

• Low yield strength


– to make it deformable at manageable balloon pressures

• Steep strain hardening rate


– Rise in strength during expansion

• High ductility
– Needed to withstand deformation during expansion
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Compromise in material selection

• Higher tensile strength materials typically have higher yield


strengths

• Higher tensile strength increasing radial strength


Higher yield strength undesired recoil

• Similarly, small grain size favors fatigue resistance, but usually


raises the yield strength and hence the amount of recoil.

 Require careful compromise

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Self-expanding stents

• manufactured in the expanded


shape, then compressed and
constrained in a delivery
system.

• Upon release from the delivery


system they self-expand
(spring back) to the preset
diameter.

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Materials for Self expanding stents

• Ideally, the material should have a low elastic modulus and a


high yield stress for large elastic strains.

• The shape memory effect of Nitinol can be used.

• Large strains can be achieved either superelastically or


through the thermal memory of the material.

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Relevant Properties to Compare
Density  radiopacity as the denser material typically
improves visibility

The elastic modulus  radial strength, the resistance to


buckling, and recoil.

Ultimate tensile strength (UTS) & 0.2% yield strength 


mechanical strength of the material.

Break elongation  ductility.

The ratio of yield strength to elastic modulus the elastic


range of the materials, which affects acute recoil and radial
strength.

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Stainless Steel

• most stents are built of stainless steel, the least-expensive


stent material available,
• not fully compatible with the human body and a weak
radiopacity
• 316L stainless steel is a reference for successful stent
applications.

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Cobalt Alloys

• L605 may show the best result.

• L605 shows far better result than 316L

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Other Metals and Alloys

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Nitinol for self-expanding stents
• Nitinol (55% nickel and 45% titanium, sometimes called NiTi) - highly
biocompatible, decreases the rate of corrosion, very flexible and excellent
shape memory (when heated to a certain temperature)

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Nitinol for self-expanding stents

Martensitic nitinol - long and low initial stress/strain plateau and


following a very steep work hardening curve.
- the shape memory effect or regular balloon expandable stent
Superelastic nitinol - remarkable recovery.
- use for slotted tube self expanding stents
Cold worked nitinol - excellent Hookian-like elasticity, permitting
large recovery of strains, quite high UTS, with a similar ductility to
superelastic nitinol, and exceptionally temperature independent
properties
- for some creative designs.

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Alternative Materials

• Polymers (biodegradable, bioabsorbable, or bioerodible) - only as


short term.

• For example, biodegradable materials can form an effective stent


coating because they can be mixed with an antirestinotic drug and
will degrade within a few weeks, thus releasing the drug into the
surrounding tissue and reducing the risk of restenosis.

• Shape-memory polymers can be used to produce a device that will


transition from a temporary state to a different permanent state
through the inducement of a stimulus of heat or cold.

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Form of Stents
• Sheet
Gianturco-Roubin stent (Cook GRII)

Formed from stainless steel sheet, featuring an


axial backbone

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Form of Stents
• Wire (round or flat)

SX & BX Stents

SX stent fabricated from cobalt alloy wire

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Geometry of Stents

Good designs depend on mainly two points:


Radial strength
The external pressure that a stent can withstand without a 'clinical significal
damage'

Flexibility
The stent ability to bend in order to accommodate vessel turns or angles during
delivery is flexibilty

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Geometry of Stents
• Coil geometry
Good flexibility but limited strength
Fabricated from Nitinol ribbon

• Helical spiral geometry


Good flexibility but lack of longitudinal support
Cross flex – fabricated from stainless steel wire

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Geometry of Stents

Woven geometry
Strength depnds on axial fixation of ends


Individual ring
'Z' shaped structure used to support grafts

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Geometry of Stents

Sequential ring
Struts – series of 'Z' shaped expandable elements
70% of commercial stents availble in the market

Mainly two types:


Closed cell

Flex connectors


Non-flex connectors


Combined flex/non-fles connectors

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Geometry of Stents

Open cell

Periodic Peak-Peak connection

Flex connection


Non-flex connection


Peak valley connection


Mid strut-mid strut connection

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Coating
• To increase biocompability
• To reduce thrombogenic risk after the deployment of
a stent
• To reduce platelet activation and interaction during
the acute phase of stent re-endotheliazation

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Radio opacity enhancements


To improve X ray visibility, markers are added to the
stent struts

Drug Eluting Stents(DES)


To decrease coronary restenosis rates

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CONCLUSION
In summary, in this paper we have come with classification of
stents, different material available for stents, geometries of stents and
recent development of stents. Due to unique properties of Shape
Memory Alloys, they are used to make SX stents. SX stents are more
benefitial for human beings in many aspects. In these days, stents
made up of SMAs are used widely against various severe diseases
from which any disease can lead human life to death.

Materials Science & Engineering Winter Term 2009-2010

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