Biomaterials and Implants

(BMEg3183)

2.1 Metallic biomaterial

Chaltu D.(2019)
Metals
• load bearing implants and internal fixation devices.
• when processed suitably contribute high tensile,
high fatigue and high yield strengths.
• low reactivity.
• properties depend on the processing method and
purity of the metal.

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 Other Uses

Medical Tubing

Stents

Catheters 7
 Physical Properties of Metals:
• Luster (shininess)
• Good conductors of heat and electricity
• High density (heavy for their size)
• High melting point
• Ductile (most metals can be drawn out into thin wires)
• Malleable (most metals can be hammered into thin
sheets)

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 Chemical Properties of Metals:
• Easily lose electrons
• Surface reactive
• Loss of mass (some corrode easily)
• Corrosion is a gradual wearing away
• Change in mechanical properties

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A comparison of general material properties
 Metallic Biomaterials

make up a large part of the biomaterial market – some of the most

common implants are made of metal
 are used as biomaterials due to their excellent electrical and
thermal conductivity and mechanical properties.

The mobile free electrons act as the binding force to hold the
positive metal ions together.
Since the metallic bond is essentially non directional, the position
of the metal ions can be altered without destroying the crystal
structure resulting in a plastically deformable solid.
 Metallic Biomaterials

 Some metals are used as passive substitutes for hard tissue

replacement because of their excellent mechanical properties
and corrosion resistance
e.g. total hip and knee joints, fracture healing aids as bone
plates and screws, spinal fixation devices, and dental
implants.
 Some metallic alloys are used for more active roles in devices
e.g. vascular stents, catheter guide wires, orthodontic
archwires, and cochlea implants.
 Metallic Biomaterials

 vanadium steel -The first metal alloy developed specifically

for human use
– to manufacture bone fracture plates and screws.
 Most metals such as iron (Fe), chromium (Cr), cobalt (Co),
nickel (Ni), titanium (Ti), tantalum (Ta), niobium (Nb),
molybdenum (Mo), and tungsten (W) that were used to make
alloys for manufacturing implants can only be tolerated by the
body in minute amounts.
 Sometimes those metallic elements, in naturally occurring
forms, are essential in red blood cell functions (Fe) or
synthesis of a vitamin B12 (Co), but cannot be tolerated in
large amounts in the body [Black, 1992].
 Metallic Biomaterials

 The biocompatibility of the metallic implant is of considerable

concern because these implants can corrode in an in vivo
environment [Williams, 1982].
 The consequences of corrosion are the disintegration of the
implant material , which will weaken the implant, and the
harmful effect of corrosion products on the surrounding tissues
and organs
 Processing
 Metals exist in the Earth’s
crust in mineral form
(chemically combined
with other elements)
 Must be located, mined,
separated and enriched to
be used for processing
 Eg. Processing history of
a typical metallic implant
(hip implant) 
 Raw Metal to Stock Metal Shapes
 Metal suppliers process bulk raw metals/alloys into
“stock” shapes
e.g. Bars, wire, sheet, rods, plates, tubes, or powders
 Stock shapes sold to implant manufacturers who need
stock metal closer to the final form of the implant
e. g. for screw-shaped dental implants want rods of the
appropriate metal to simplify the machining process
 Can use re-melting and continuous casting, hot rolling,
forging, and cold drawing through dies to reshape metal
 Heat-treating steps can help shape stock and relieve
effects of prior plastic deformation or produce specific
microstructure
 Stock Metal Shapes to Final Metal Devices
1) Specific steps depend on: geometry of the implant,
forming properties of the metal, costs of fabrication
methods
 Not all implant alloys can be feasibly or economically made in
the same way
• 2) May need to add coatings or modify surface roughness
 Many ways to do this (sintering, plasma or flame spraying, ion
implantation, nitriding, and coating with diamond film)
• 3) Finishing steps: chemical cleaning and passivation
(i.e., rendering the metal inactive)
 Very important to biological performance of the implant (affect
the surface properties)
 Processing
• molten metal is cooled to form the solid.
• The solid metal is then mechanically shaped to form a
particular product.
• How these steps are carried out is very important because
heat and plastic deformation can strongly affect the
mechanical properties of a metal.

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 Metals Manufacturing

•machining" and "metal fabrication" are

synonymous and refers to the activities and
processes that change the shape of a metal
workpiece by deforming it or removing metal
from it. 16
 Microstructure of metals
• Basic atomic architecture
is a crystal structure
• Different elements have Iron
different crystalline
architectures and can
combine with different
partners.

Gold

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 Solidification in Casting
Processes: Formation of Crystals
• Contained nucleation
starts at edges (where
coolest) and grows
inward

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 Formation of Crystals
• Nucleation - The first unit
cell solidifies
• Growth - New unit cells
attach to existing unit
cells.
• Where crystals meet
grain boundaries are
created.

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Solidification of Metals
(Grain formation)
• Crystal will grow naturally
(along axes) until they
begin to interfere.
• The interference point
where crystal structures
meet is called the grain
boundary.

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Grains and Grain Boundaries

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 1. Stainless Steels
 The first stainless steel utilized for implant fabrication was the
18-8 (type 302 in modern classification), which is stronger and
more resistant to corrosion than the vanadium steel.
 Vanadium steel is no longer used in implants since its
corrosion resistance is inadequate in vivo

 Later 18-8sMo stainless steel was introduced which contains

a small percentage of molybdenum to improve the corrosion
resistance in chloride solution (salt water).
 This alloy became known as type 316 stainless steel
 Stainless Steels
 In the 1950s the carbon content of 316 stainless steel was
reduced from 0.08 to a maximum amount of 0.03%
 for better corrosion resistance to chloride solution and
 to minimize the sensitization, and
 hence became known as type 316L stainless steel
 The minimum effective concentration of chromium is 11% to
impart corrosion resistance in stainless steels.

 The chromium is a reactive element, but it and its alloys can

be passivated by 30% nitric acid to give excellent corrosion
resistance.
 Stainless Steels
• The austenitic stainless steels, especially types 316 and 316L,
are most widely used for implant fabrication.
• These cannot be hardened by heat treatment but can be
hardened by cold-working.
• This group of stainless steels is nonmagnetic and possesses
better corrosion resistance than any others.
• The inclusion of molybdenum enhances resistance to pitting
corrosion in salt water.
• The American Society for Testing and Materials (ASTM)
recommends type 316L rather than 316 for implant
fabrication.
TABLE Compositions of 316L Stainless Steel
[American Society for Testing and Materials, F139–86, p.61,
1992]
Element Composition (%)
Carbon 0.03 max
Manganese 2.00 max
Phosphorus 0.03 max
Sulphur 0.03 max
Silicon 0.75 max
Chromium 17.00–20.00
Nickel 12.00–14.00
Molybdenum 2.00–4.00
 Stainless Steels
• The specifications for 316L stainless steel are given in Table
above.
• The only difference in composition between the 316L and 316
stainless steel is the maximum content of carbon, i.e., 0.03%
and 0.08%, respectively, as noted earlier.
• The nickel stabilizes the austenitic at room temperature and
enhances corrosion resistance.
• The austenitic phase formation can be influenced by both the Ni
and Cr contents for 0.10% carbon stainless steels.
• The minimum amount of Ni for maintaining austenitic phase is
approximately 10%.
 Stainless Steels
• A wide range of properties exists depending on the
heat treatment (annealing to obtain softer materials)
or cold working (for greater strength and hardness).
• The engineer must consequently be careful when
selecting materials of this type.
• Even the 316L stainless steels may corrode inside the
body under certain circumstances in a highly stressed
and oxygen depleted region, such as the contacts
under the screws of the bone fracture plate.
 Stainless Steels
• Thus, these stainless steels are suitable for use only in
temporary implant devices such as fracture plates,
screws, and hip nails.
• Surface modification methods such as anodization,
passivation, and glow-discharge nitrogen
implantation are widely used in order to improve
corrosion resistance, wear resistance, and fatigue
strength of 316L stainless steel [Bordiji et al., 1996].
 Stainless Steels

Table 2.2 Mechanical Properties of 316L Stainless Steel for

Implants [adapted ASTM, F139–86, p.61, 1992]

Condition UTS ,(MPa) Yield

strength(MPa)
Annealed 485 171

Cold-worked 860 690

 Stainless Steels

stainless steel water pipes

Stainless steel
(alloy of Ni, Fe, Cr, Mn)
(316L grade –
better corrosion resistance)

FOR YEAR 4 BME STUDENTS 29

 Stainless Steels summary
 Several types of stainless steels used for implants
 Most common is 316L, grade 2
 Has less than 0.030% (wt.%) carbon to reduce possibility of
in vivo corrosion (‘L’ in 316L = low carbon)
 Made from:
 Iron (60–65%)
 Chromium (17–20%) - prevents corrosion via strongly adherent
surface oxide (Cr2O3)
 Nickel (12–14%) forms stronger phase (FCC= face-centered cubic)
 Want small and uniform grain size  higher yield stresses
 Can be controlled through manufacturing
 2. Cobalt-Chromium Alloys

• There are basically two types of cobalt-chromium

alloys:
(1) the castable CoCrMo alloy and
(2) the CoNiCrMo alloy which is usually Wrought by (hot)
forging
• The castable CoCrMo alloy has been used for many decades in
dentistry and, relatively recently, in making artificial joints.
• The wrought CoNiCrMo alloy is relatively new, now used for
making the stems of prostheses for heavily loaded joints such
as the knee and hip.
 2. Cobalt-Chromium Alloys

• The ASTM lists four types of CoCr alloys which are

recommended for surgical implant applications:
(1) cast CoCrMo alloy (F75),
(2) wrought CoCrWNi alloy (F90),
(3) wrought CoNiCrMo alloy (F562), and
(4) wrought CoNiCrMoWFe alloy (F563).
• The composition of these are quit different from each
others.
 2. Cobalt-Chromium Alloys

• The molybdenum is added to produce finer grains which

results in higher strengths after casting or forging.
• The chromium enhances corrosion resistance as well as solid
solution strengthening of the alloy.
• The CoNiCrMo alloy originally called MP35N (Standard
Pressed Steel Co.) contains approximately 35% Co and Ni
each.
 Cobalt-Chromium Alloys

Cobalt-chromium- molybdenum
(“COCRMO” or “CMM”)

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 3. Titanium Alloys
• Titanium(Ti) is light metal of density 4.505 g/cm3 at 25 C
• Pure Ti is very important so do its alloys
• Ti is very reactive metal and need surface modifications:
– Anodizing (suitable oxidizing treatment)
– Diffusion of interstitial atoms
– Flame spraying of metals (e.g. Mo)
– Electroplating other metals
 3. Titanium Alloys

 Two most common titanium-based implant

biomaterials:
 Commercially pure (CP) titanium
 98.9–99.6% Ti
 Slightly higher oxygen content increases its yield,
Moderately cold-worked
tensile and fatigue strengths
Commercially pure (CP) titanium
 Used for dental implants
 Extra-low interstitial (ELI) Ti–6Al–4V alloy
 Different microstructures are possible depending
upon heat treating and mechanical working
 Have same tensile strengths but different fatigue
levels
 Difficult to successfully attach coatings
while maintaining other properties

Cast Extra-low interstitial (ELI) Ti–

6Al–4V alloy
 Titanium Alloys
• Ti exists in two allotropic forms
– The low temperature, alpha-form (has CPH crystal structure) at room temp.
– Beta-form (having BCC crystal structure) above 882.5oC temp is stable
• Ti-6Al-4V alloy is used in one of the three conditions:
– Wrought alloy, forged alloy or cast alloy

• Wrought alloy- available at standard shape and size and is

annealed at 730 oC for 1-4 hrs.
• Forged alloy- hot forging temp is b/n 900oC and 980oC
• Casting alloy –to provide a metallurgical stable homogenous
structure castings are annealed at 840oC
Titanium (Ti) or Ti alloys (Ti6Al4V is a very common variant)
•Titanium has good reputation of biocompatibility.
•Titanium and its alloys are non-carcinogenic in experimental
animals or humans

FOR YEAR 4 BME STUDENTS 38

 Nitinol
• Nitinol- an alloy of Ni and Ti
• Has high unusual properties for an engineering alloy and is
designated as ‘shape memory alloy’.
• Nitinol has been used extensively in dentistry because of its
resilience and shape memory property
• Device made from nitinol includes:
– flexible wire flasks
– Prestretched wire and band or double wedge materials for rapid
wedging or separating of teeth.
 Other metals

• Tantalum (Ta)- highly biocompatible, and restricted due to its

high density (16.6 g/cm3) and poor mechanical properties
– Used wire sutures for plastic and neurosurgery and radioisotope for
bladder tumours.
• Platinum and PGM are extremely corrosion resistant but have
poor mechanical properties
– Used mainly for electrodes in neuromuscular stimulation devices such
as cardiac pace makers
 Applications of Metals and Alloys
• Bone and Joint Replacement
• Dental Implants
• Maxilla and Cranio/facial reconstruction
• Cardiovascular devices
Titanium is regularly used for pacemaker cases and
defibrillators, as the carrier structure for replacement heart valves,
and for intra-vascular stents.
• External Prostheses
• Surgical instruments
• Metallic biomaterials have essentially three fields
of use:
– artificial hip joints,
– screw, plates and nails for internal fixation of
fractures, and
– dental implants.
• must support high mechanical load and resistance of material
against breakage is essential.
• High mechanical properties are needed for structural
efficiency of surgical and dental implants.
• But their volume is restricted by anatomic realities what
require good yield and fatigue strengths of metal
 Complications related with metals implants
• in orthopaedic applications is the phenomenon of stress
shielding.
• in TKR or hip replacement, the high strength of the metal in
the implant induces it to assume more than its share of
responsibility for the load in that region.
• This decreases the load born by the surrounding tissue and
therefore shields it from experiencing stress.
• Lack of stress causes bone density to decrease(Wolff’s Law)
as bone tissue resorbs, and causing complications in the
implant/tissue interface.

FOR YEAR 4 BME STUDENTS 43

 Design Considerations
• Should have to match mechanical properties of tissue
with mechanical properties of metal

• have to consider how the metal may fail in vivo

• corrosion
• wear
• Fatigue
• need to consider cost

FOR YEAR 4 BME STUDENTS 44

 Corrosion of metallic implants

• Corrosion is unwanted chemical reaction of metal with its

environment.
– Continued degradation of oxides, hydroxides, other

• Human body is very aggressive to metals used for implants

– Aqueous
– Contains chlorides, Proteins
• Corrosion resistance of a metallic implant is important aspects
of its biocompatibility
 Mechanisms of Corrosion
•Crevice Corrosion -narrow
opening or fissure occur
in the implant

•Pitting Corrosion (large hole)

•Intergranular Corrosion

FOR YEAR 4 BME STUDENTS 46

 Mechanisms of Corrosion

•Fretting Corrosion Stress Corrosion

Cracking

FOR YEAR 4 BME STUDENTS 47

 Mechanisms of Corrosion
Contribution of biological environment

From: S.H. Teoh, International Journal of Fatigue 22 (2000) 825–837

FOR YEAR 4 BME STUDENTS 48

 Wear
•The effects of wear are most predominant in joint prostheses.

•There are two types of wear :

•Interfacial Wear: Occurs when bearing surfaces come into
contact with no lubricant fluid between them.

•Fatigue Wear: Progressive failure due to application of cyclical

stresses.

FOR YEAR 4 BME STUDENTS 49

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