CL 325 Biomaterials

• Course Objectives:
• Understanding: to define biocompatibility of
various materials and classify them according to
their suitability for the specific biomedical
application
• Apply: to identify the specific biomaterial to be
used for a specific tissue or organ replacement
• Analyze: to distinguish the advantages and
limitations of specific biomaterials for a specific
biomedical application
 Course Outcome
After completion of the course the student will be able to:
• Give examples of application areas for different types of
biomaterials.
• Apply knowledge from basic material courses to identify
material properties that are critical for metallic, polymer
and ceramic biomaterials, or their combination.
• Explain basic physical, chemical and mechanical processes
that may occur on biomaterials in use.
• Describe corrosion and degradation processes that occur
for different biomaterials and their consequences.
• Select proper type of biomaterial for given applications,
taking into account function, health risk and economic
aspects
Syllabus
MODULE- I
Biomaterials-definition-classification-metal-ceramic-polymers, composites- Source,
application, advantage and limitations [6]
MODULE II:
Metals and alloys-Stainless Steels, CO-based alloys, Ti and Ti based alloys and dental
metals corrosion and remedy, Ceramics-Aluminum oxides, calcium phosphate, glass-
Ceramics, carbon manufacturing and physical properties, deterioration of ceramics [10]
MODULE-III
Polymeric implant materials-polyamides, PE, PP, Polyacrylates, Structure, properties and
application of biological materials-proteins, polysaccharides, Structure and property
relation of Tissues-Mineralized tissues, collagen rich tissues and elastic tissues [8]
MODULE - IV
Soft tissue replacements-Skin implants-sutures, tissue adhesives, percutaneous devices,
artificial skins, maxillofacial implants, ear and eye implants, vascular implants, heart and
lung assist devices, artificial kidney dialysis membranes [8]
MODULE V
Hard tissue replacements-long bone repair-wires, pins, screws, fracture plates, tooth
implants, joint replacement-knee and hip joint-materials of construction, limitations [8]
 Module 1 CL 325
Definition of biomaterials
• A material used to make devices to replace a part
or a function of the body in a safe, reliable,
economic and physiologically acceptable manner
• Do they differ from biological materials?
Yes, biological materials are essentially obtained
from biological (animal or plant) origin e.g. wood,
bone etc.
Biomaterials -may or may not be obtained from
biological source -metals, polymers, ceramics etc.
that are used to make the artificial body parts are
termed as biomaterials.
 Definition of Biomaterials
• A biomaterial is a synthetic material used to
replace part of a living system or to function in
intimate contact with living system.
Or
A systemically and pharmacologically inert
substance designed for implantation within or
incorporation with living systems

contd.
 The success of a biomaterial depends on
(requirement)-
• Biocompatibility of the materials of construction-blood,
tissue etc. -Pharmacological acceptability(nontoxic,
non-allergenic, nonimmunogenic, noncarcinogenic
etc.)
• Time dependent stability at body condition-thermal,
wear, fatigue, chemically inert to body
• Health condition of the recipient
• Competency of the surgeon
Adequate mechanical strength-tensile
• Proper density
• Cost efficiency
• Processability
• Reproducibility
 Biocompatibility
Can be examined by (Definition) Can be described by

• Acute systemic toxicity • How biomaterials interact

• Cytotoxicity
• Hemolysis (rupture of blood cells)
with the human body
• Intravenous toxicity • How those interactions
• Mutagenicity( induction of determine the clinical
permanent transmissible changes
in the amount or structure of the success of a medical device
genetic material of cells or (such as pacemaker, hip
organisms)
• Oral toxicity replacement or stent)
• Pyrogenicity(a fever response)
• Sensitization(the process of
becoming sensitive or
hypersensitive (as to an antigen)
 Definition of biocompatibility
According to ASTM: Comparison of the tissue response produced through the
close association of the implanted candidate material to its implant site within
the host animal to that tissue response recognised and established as suitable
with control materials.

It is the ability of a biomaterial to perform its desired function with respect to a

medical therapy, without eliciting any undesirable local or systemic effects in the
recipient or beneficiary of that therapy, but generating the most appropriate
beneficial cellular or tissue response in that specific situation, and optimising the
clinically relevant performance of that therapy(Williams, David F. (2008). "On the
mechanisms of biocompatibility". Biomaterials. 29 (20)pp-
2941. doi:10.1016/j.biomaterials.2008.04.023. PMID 18440630.)

Biocompatibility is the capability of a prosthesis implanted in the body to exist in

harmony with tissue without causing deleterious changes (International
dictionary of medicine and biology, E. L. Becker, S. I. Landau, & A. Manuila, 1986,
New York: Wiley.)
 Important facts
• Immune response and repair functions in the body are
so complicated that it is not adequate to describe the
biocompatibility of a single material in relation to a
single cell type or tissue.
• Sometimes biocompatibility testing are done by in
vitro test that is used in accordance with ISO 10993 (or
other similar standards) to determine if a certain
material (or rather biomedical product) is
biocompatible.
• These tests do not determine the biocompatibility of a
material, but they constitute an important step towards
the animal testing (in vivo) and finally clinical trials that
will determine the biocompatibility of the material in a
given application, and thus medical devices such
as implants or drug delivery devices.
 Guidance on Biocompatibility Assessment
o Data required to assess suitability
• Material characterization-identify the chemical structure of a
material and any potential toxicological hazards, residue levels,
degradation products
• Information on prior use
• Toxicological data
o Supporting documents
• Details of application: size, shape, form, time in contact
• Chemical breakdown of all materials involved
• A review of all toxicity data on those materials in direct contact of
body tissues
• Prior use and details of effects
• Toxicity tests (FDA or ISO)
• Final assessment of all information including toxicological
significance
 Classification of biomaterials
Materials Advantages Disadvantages Examples
Polymers (nylon, PP, Resilient, Easy to Not strong ,deforms Sutures ,blood
Silicone rubber, fabricate with time ,may vessels & other soft
polyester, PTFE etc.) degrade tissues, sutures, hip
socket, Ear, nose
Metals (Ti and its Strong, tough, May corrode, dense, Joint replacements,
alloys, Co-Cr alloys, ductile Difficult to dental root implants,
Au, Ag, stainless fabricate(high pacer and suture
steels) temp.) wires, bone plates
and screws
Ceramics( alumina, Highly Brittle, not resilient, Dental orthopedic
zirconia, calcium biocompatible weak in tension implants
phosphates
including
hydroxyapetite,
carbon)
Composites(carbon- Strong, tailor made Difficult to make Bone cement, dental
carbon, wire or fibre resin
reinforced bone
cement)
 Terms relevant to biomaterials use
Ø Bioabsorbability-a materials capability to be disolved under body
condition with time and be absorbed by the body. These make suitable
materials for prosthetics because they can be engineered to dissolve at the
same rate as new bone growth.
Ø Biodegradability: Materials that decompose due to action of biological
organisms like bacteria. It may be aerobic or anaerobic degradation.
Ø Implant-artificial devices made of synthetic materials to replace the
natural organ or its function
Ø Transplantation-replacement of original body organ by another natural
organ to restore the function
Ø Tissue engineering-refers to the growth of a new tissue using living cells
guided by the structure of a substrate made of a new material and the
substrate is called as scaffold.
Ø Inflammation-
localized protective response elicited by injury or destruction of tissues,
that serves to destroy, dilute, or wall off both
the injurious agent and the injured tissue.
 Inflammation
The classic signs of inflammation are heat, redness, swelling, pain, and loss of function. These
are manifestations of physiologic changes that occur during the inflammatory process.
The three major components of this process are (1)changes in the caliber of blood vessels
and the rate of blood flow through them (hemodynamic changes); (2) increased
capillary permeability; and (3) leukocytic exudation.
Hemodynamic changes -
soon after injury and progress at varying rates, according to the extent of injury. It starts
with dilation of the arterioles and the opening of new capillaries and venular beds in the are
a. This causes an acceleratedflow of blood, accounting for the signs of heat and redness.
Increased permeability of the microcirculation,which permits leakage of protein-
rich fluid out of small blood vessels and into the extravascular fluid compartment,accounting f
or the inflammatory edema.

Leukocytic exudation occurs in the following sequence. First, the LEUKOCYTES move to the endot
helial lining of the small bloodvessels (margination) and line the endothelium in a tightly pack
ed formation (pavementing). Eventually, these leukocytesmove through the endothelial space
s and escape into the extravascular space (emigration). Once they are outside the bloodvessel
s they are free to move and, by CHEMOTAXIS, are drawn to the site of injury. Accumulations of N
EUTROPHILS andMACROPHAGES at the area of inflammation act to neutralize foreign particles by P
HAGOCYTOSIS.
Cellular changes in inflammation.
1, Margination of neutrophils brings these inflammatory cells in close contact with the endo
thelium. 2, Adhesion of plateletsresults in the release of mediators of inflammation and coag
ulation. Fibrin strandsare the first signs of clot formation. 3, Pavementing of leukocytes is me
diated byadhesion molecules activated by the mediators of inflammation released fromplatel
ets and leukocytes. RBC, red blood cells.
 Metals
Advantages:
• High strength-load bearing application
• Bio compatibility-blood, tissue compatibility
• Long term stability in body
• Variety is possible by alloy formation with
different compositions
• Can be processed in very fine structure also
which have flexible nature combined with high
strength
Disadvantages
• Corrosion resistance poor-can give adverse
effects to tissue causing inflammation, tissue
damage (necrosis)
• Passivation occurs
• Failure after a length of time and
rejection/replacement becomes mandatory
• high density
• heavier implant
• processing requires sharp tools and control
over heating
 Examples
• Stainless steel-hip and knee joints
• Co based alloys- Stems of hip prosthesis,
dentistry, plates, screws
• Ti & Ti alloys- All other implants as Co and
Stainless steel except screws, plates etc. (due
to corrosion)
v Sherman vanadium steel-for bone fracture
plates & screws
 Stainless steel
• The first metal developed specifically for human use was
“Sherman Vanadium Steel,” which was used to manufacture
bone fracture plates and screws. Limitation: inadequate
resistance against corrosion
• 18-8sMo stainless steel contains molybdenum to improve
corrosion resistance in salt water. This alloy became known as
type 316 stainless steel.
• In the 1950s the carbon content of 316 stainless steel was
reduced from 0.08 w/o to 0.03 w/o maximum for better
corrosion resistance to chloride solution, and it became
known as 316L.
Compositions of 316L Stainless Steel
Surgical Implants (ASTM, 2000)

40-45%

(60%-55%)
Depending upon the heat treatment (to obtain softer material)and cold
working stainless steel (for greater strength and hardness) wide range of
properties are found.
Type 316L may corrode under certain body conditions e.g. highly stressed
and oxygen depleted region.
So these are suitable for temporary devices e.g. fracture plates, screws and
hip nails.
 •There are few difficulties in handling the Austenitic stainless steel:
•It cannot be cold worked (as it hardens quickly) without intermediate heat treatment
•During heat treatments chromium carbide formation in the grain boundaries may cause
corrosion
•Implants made of austenitic stainless steel cannot be welded
•Possibility of distortion during heat treatment
•Surface oxides formed during heat treatment must be removed by chemical or
mechanical means
•The surface is then cleaned, degreased and passivated in nitric acid (ASTM F86)

Practice problem-1
 Co-BASED ALLOYS
• These materials are usually referred to as cobalt-
chromium alloys.
• There are basically two types:
• one is the CoCrMo alloy, which is usually used to
cast a product, and the other is CoNiCrMo alloy,
which is usually wrought by (hot) forging.
• The castable CoCrMo alloy has been in use for
many decades in dentistry and in making artificial
joints.
• The wrought CoNiCrMo alloy has been used for
making the stems of prostheses for heavily
loaded joints (such as the knee and hip).
 Properties of Co-Based Alloys
• One of the most promising wrought Co-based alloys is the CoNiCrMo alloy
originally called MP35N (Standard Pressed Steel Co.), which contains
approximately 35 w/o Co and Ni each. The alloy has a high degree of
corrosion resistance to seawater (containing chloride ions) under stress.
Cold-working can increase the strength of the alloy considerably.
• However, there is a considerable difficulty of cold-working, especially
when making large devices such as hip joint stems. Only hot-forging can be
used to fabricate an implant with the alloy.
• The abrasive wear properties of the wrought CoNiCrMo alloy is similar to
the cast Co-CrMo alloy (about 0.14 mm/year in a joint simulation test).
• The superior fatigue and ultimate tensile strength of the wrought
CoNiCrMo alloy make it very suitable for applications that require a long
service life without fracture or stress fatigue. Such is the case for the stems
of the hip joint prostheses.
• The modulus of elasticity for the cobalt-based alloys ranges from 220 to
234 GPa. These values are higher than the moduli of other materials such
as stainless steels.
 Manufacturing Implants Using Co-Based Alloys
• The CoCrMo alloy is particularly susceptible to the work-hardening so that
the normal fabrication procedure used with other metals cannot be
employed.
• Lost wax method is employed as below:
1. A wax pattern of the desired component is made.
2. The pattern is coated with a refractory material, first by a thin coating with
a slurry (suspension of silica in ethyl silicate solution) followed by complete
investing after drying.
3. The wax is melted out in a furnace (100–150oC).
4. The mold is heated to a high temperature, burning out any traces of wax or
gas-forming materials.
5. Molten alloy is poured with gravitational or centrifugal force. The mold
temperature is about 800–1000oC and the alloy is at 1350–1400oC.
• Controlling the mold temperature will have an effect on the grain size of
the final cast; coarse ones are formed at higher temperatures, which will
decrease the strength. However, high processing temperatures will result
in larger carbide precipitates with greater distances between them,
resulting in a less brittle material.
 How to calculate the Co atoms release rate?
• Experimental determination of the rate of nickel release from
the CoNiCrMo alloy and 316L stainless steel in 37oC Ringer's
solution is carried out generally.
• Problem 2:
• Calculate the number of Co atoms released during a year from the femoral head of
a hip joint prosthesis made of CoCrMo alloy. Assume that the wear rate is 0.14
mm/yr and that all of the atoms become ionized.
• Assume a nominal diameter of the prosthetic femoral head of 28 mm. The surface
area is A = 4π(1.4 cm)2 = 24.63 cm2.
• Half of this area is in contact with the socket portion of the joint. Therefore, the
volume of wear material is ½ x24.63 cm2x 0.014 cm/yr = 0.172 cm3/yr
(Atoms/year) =[0.65 0.172( cm3 /yr)x 8.83 (g/cm3 )6.02 x1023 (atoms/mol)]/[58.93 (g/mol)]
Since the density of Co is 8.83 g/cm3, and the atomic weight is 58.93, and the alloy is about
65% cobalt,
atoms/yr= 1.0 x 1022 atoms/yr, or 3.2 x 1014 atoms per second
 Ti AND Ti-BASED ALLOYS
• Ti was tolerated in cat femurs, as was stainless steel and Vitallium®
(CoCrMo alloy). The lightness of titanium (4.5 g/cm3 compared to 7.9
g/cm3 for 316 stainless steel, 8.3 g/cm3 for cast CoCrMo, and 9.2 g/cm3
for wrought CoNiCrMo alloys) and good mechanochemical properties are
salient features for implant application.
Compositions of Ti and Ti-Based Alloys
• There are four grades of unalloyed titanium for implant applications
• The impurity contents distinguish them; oxygen, iron and nitrogen should
be controlled carefully.
• Oxygen in particular has a great influence on ductility and strength.
• Ti6Al4V- The main alloying elements of the alloy are aluminum(5.5–6.5
w/o) and vanadium (3.5–4.5 w/o).
Chemical Compositions of Ti6Al4V Alloys (ASTM, 2000)
 Structure and properties of Ti And its alloys
• Titanium is an allotropic material that exists as a hexagonal close-packed
structure (α-Ti) up to 882oC and a body-centered cubic structure (β-Ti)
above that temperature. The addition of alloying elements to titanium
enables it to have a wide range of properties:
• 1.Aluminum tends to stabilize the α phase, that is, increase the
transformation temperature from α to β phase
• 2. Vanadium stabilizes the β phase by lowering the temperature of the
transformation from α to β.
• The α alloys have single-phase microstructure which promotes good
weldability.
• The stabilizing effect of the high aluminum content of these groups of
alloys makes for excellent strength characteristics and oxidation resistance
at high temperature (300–600oC).
• These alloys cannot be heat-treated for strengthening since they are single
phased since the precipitation of the second or third phase increases the
strength by precipitation hardening Process.
 The mechanical properties of the commercially pure
titanium &Ti6Al4V
• The mechanical properties of the commercially pure titanium,
Ti6Al4V, are given in next page. The modulus of elasticity of these
materials is about 110 GPa, which is half the value of Co-based
alloys.
• The higher impurity content leads to higher strength and reduced
ductility.
• The strength of the Ti alloys is similar to 316 stainless steel or the
Co-based alloys. When compared by specific strength (strength per
density), the titanium alloy excels any other implant materials.
• Titanium, nevertheless, has poor shear strength, making it less
desirable for bone screws, plates, and similar applications.
• Titanium derives its resistance to corrosion by the formation of a
solid oxide layer. Under in vivo conditions the oxide (TiO2) is the
only stable reaction product. The oxide layer forms a thin adherent
film and passivates the material.
Mechanical Properties of Ti6Al4V (ASTM, 2000)
 Manufacture of Implants

• Titanium is very reactive at high temperature and burns

readily in the presence of oxygen.
• It therefore requires an inert atmosphere for high-
temperature processing or is processed by vacuum melting.
• Oxygen diffuses readily in titanium, and the dissolved
oxygen embrittles the metal. As a result any hot-working or
forging operation should be carried out below 925oC.
• Machining at room temperature is not the solution to all
the problems since the material also tends to gall or seize
the cutting tools. Very sharp tools with slow speeds and
large feeds are used to minimize this effect.
Electrochemical machining is an attractive means.
 DENTAL METALS

• Dental Amalgam
• An amalgam is an alloy in which one of the component metals is mercury.
• The rationale for using amalgam as a tooth filling material is that since
mercury is a liquid at room temperature it can react with other metals
such as silver and tin and form a plastic mass that can be packed into the
cavity, and which hardens (sets) with time.
• To fill a cavity the dentist mixes solid alloy, supplied in particulate form,
with mercury in a mechanical triturator. The resulting material is readily
deformable and is then packed into the prepared cavity.
• The reaction during setting is thought to be:
γ +Hg γ+γ1+γ2
in which the γ phase is Ag3Sn, the γ1 phase is Ag2Hg3, and the γ2 phase is
Sn7Hg,
Dental amalgams typically contain 45 to 55% mercury, 35 to 45% silver, and
about 15% tin, when fully set
• The strength of the restoration increases during the setting process, so
that the amalgam has attained one quarter of its final strength after one
hour, and almost all of its final strength after one day.
 Gold
• Gold and gold alloys are useful metals in dentistry as a result of their
durability, stability, and corrosion resistance
• Gold fillings are introduced by two methods: casting and malleting.
Gold- Cast restorations
• Cast restorations are made by taking a wax impression of the prepared
cavity, making a mold from this impression in a material such as gypsum
silica, which tolerates high temperature, and casting molten gold in the
mold.
• Gold alloys are used for cast restorations, since they have mechanical
properties superior to those of pure gold
• Copper, alloyed with gold, significantly increases its strength. Platinum also
improves strength, but no more than about 4% can be added, or the
melting point of the alloy is elevated excessively. Silver compensates for
the color of copper.
• A small amount of zinc may be added to lower the melting point and to
scavenge oxides formed during melting. Gold alloys of different
composition are available. Softer alloys containing more than 83% gold are
used for inlays, which are not subjected to much stress.
• Harder alloys containing less gold are chosen for crowns and cusps, which
are more heavily stressed.
 Gold- Malleted restorations
• Malleted restorations are built up in the cavity from layers of
pure gold foil.
• The foils are degassed before use, and the layers are welded
together by pressure at room temperature
• The pure gold is relatively soft, so this type of restoration is
limited to areas not subjected to much stress.
• In this type of welding the metal layers are joined by thermal
diffusion of atoms from one layer to another. Since intimate
contact is required in this procedure, it is particularly
important to avoid contamination.
 Nickel-Titanium Alloys
The SME can be generally related to a diffusionless martensitic phase
transformation that is also thermoelastic in nature, the thermoelasticity
being attributed to ordering in the parent and martensitic phases.
The nickel-titanium alloys show an unusual property in that after the metal is
deformed they can snap back to their previous shape following heating.
This phenomenon is called the shape memory effect. The shape memory
effect (SME) of Ni-Ti alloy was first observed by Buehler and Wiley at the
U.S. Naval Ordnance Laboratory (NOL).
• The equiatomic Ni-Ti alloy (Nitinol R) exhibits an exceptional SME near
room temperature: if it is plastically deformed below the transformation
temperature, it reverts back to its original shape as the temperature is
raised.
• Shape memory alloys are used in orthodontic dental arch wires. They also
are used in arterial blood vessel stents, and may be used in vena cava
filters, intracranial aneurysm clips, and orthopedic implants. On a more
speculative level, they might find use in contractile artificial muscles for an
artificial heart.
 Salient Features
The thermoelastic martensitic transformation exhibits the
following general characteristics:
1. Martensite formation can be initiated by cooling the
material below Ms, defined as the temperature at
which the martensitic transformation begins.
Martensite formation can also be initiated by applying
a mechanical stress at a temperature above Ms.
2. Ms and As (temperature at which the reverse austenitic
transformation begins upon heating) temperatures can
be increased by applying stresses below the yield
point; the increase is proportional to the applied stress.
3. The material is more resilient than most metals.
4. The transformation is reversible.
 Properties of Ni-Ti Alloys
• A widely known Ni-Ti alloy is 55-Nitinol (55 weight % (w/o) or 50 atomic %
(a/o) Ni), which has a single phase and “mechanical memory” plus other
properties — for example, high acoustic damping, direct conversion of heat
energy into mechanical energy, good fatigue properties, and low temperature
ductility.
• Deviation from the 55-Nitinol (near stoichiometric Ni-Ti) in the Ni-rich
direction yields a second group of alloys that are also completely nonmagnetic
but differ from 55- Nitinol in their capability of being thermally hardened to
higher hardness levels. Shape recovery capability decreases and heat-
treatability increases rapidly as Ni content approaches 60w/o.
• The efficiency of 55-Nitinol shape recovery can be controlled by changing the
final annealing temperatures during preparation of the alloy device. For the
most efficient recovery,the shape is fixed by constraining the specimen in a
desired configuration and heating to between 482 and 510oC.
• Both 55- and 60-Nitinols have relatively low moduli of elasticity and can be
tougher and more resilient than stainless steel, Ni-Cr, or Co-Cr based alloys.
• The Ni-Ti alloys also exhibit good biocompatibility and corrosion resistance in
vivo.
 Corrosion in metal implants
• If two dissimilar metals are present in the same
environment, the one that is most negative in the
galvanic series will become the anode.
• Galvanic corrosion can be more rapid than the
corrosion of a single metal.
• Implantation with alloys is therefore to be avoided.
• Galvanic corrosion can be possible in single metal if
there is inhomogeneity in the metal or its
environment
 Corrosion Vs. Biocompatibility
• Corrosion is the unwanted chemical reaction of a metal with its
environment, resulting in continued degradation to oxides,
hydroxides, or other compounds.
• Tissue fluid in the human body contains water, dissolved oxygen,
proteins, and various ions such as chloride and hydroxide.
• A s a re s u l t , t h e h u m a n b o d y p re s e nt s a ve r y a g g re s s i ve
environment to metals used for implantation.
• Corrosion resistance of a metallic implant material is consequently
an important aspect of its biocompatibility
• The lowest free energy state of many metals in an oxygenated
and hydrated environment is that of the oxide.
• Corrosion occurs when metal atoms become ionized and go
into solution, or combine with oxygen or other species in
solution to form a compound that flakes off or dissolves.
 Micro-corrosion Cells in single metals

grains
(Cathode)

Grain boundary
(Anode)
Factors responsible are
• Repetitive deformation in metals in corrosive environment e.g. salts, ions etc. in body
fluid, fatigue testing, rubbing off passive layer, pitting cause local corrosion,
• Grain boundaries and crevices in the area of contact of a screw with bone plates.
 Chemical reactions during corrosion in metal implants
• In the body an external electrical driving source may be present in the
form of a cardiac pacemaker, or an electrode used to stimulate bone
growth. At the anode, or positive electrode, the metal oxidizes. The
following reactions involving a metal M may occur:

At Cathode following reactions occur:

If two dissimilar metals are present in the same environment, the one that is
most negative in the galvanic series will become the anode, and bimetallic (or
galvanic) corrosion will occur.
Galvanic corrosion can be much more rapid than the corrosion of a single
metal. Consequently, implantation of dissimilar metals (mixed metals) is to be
avoided.
 Ceramics
• Alumina-
• Zirconia-
• Calcium phosphate
• Titanium oxide
• Porous Calcium Aluminate
• Tri-calcium phosphate
• Glass- ceramics
 Comparison of properties of metals with ceramics

Metals Ceramics
• Mechanical strength • Mechanical strength(Modulus
(Modulus of elasticity GPa) of elasticityGPa)–CP(40-117),
–steel(230GPa),Co- ZrO2(210), Al2 O3(380)
alloys(220-234), Ti
alloys(110) and
Tantalum(27550)
• Use-cementing for bone
• Use-hard tissue replacement,
implant fixation
total hip replacement
 CALCIUM PHOSPHATE
• Calcium phosphate has been used to make artificial bone.
• Recently, this material has been synthesized and used for
manufacturing various forms of implant as well as for solid
or porous coatings on other implants.
• There are mono-, di-, tri-, and tetra-calcium phosphates, in
addition to the hydroxyapatite and β-whitlockite, which
have ratios of 5/3 and 3/2 for calcium and phosphorus
(Ca/P), respectively.
• Hydroxyapatite acts as a reinforcement in hard tissues and
is responsible for the stiffness of bone, dentin, and enamel
• The mineral part of bone and teeth is made of a crystalline
form of calcium phosphate similar to hydroxyapatite
[Ca10(PO4)6(OH)2]
• The ideal Ca/P ratio of hydroxyapatite is 10/6 and the
calculated density is 3.219 g/cm3.
Properties of Calcium Phosphates (Hydroxyapatite) in
comparison to enamel
• Hard tissues such as bone, dentin, and dental
enamel are natural composites that contain
hydroxyapatite (or a similar mineral) as well as
protein, other organic materials, and water.
Enamel is the stiffest hard tissue with an elastic
modulus of 74 GPa, and it contains the most
mineral. Dentin (E = 21GPa) and compact bone (E
= 12~18 GPa) contain comparatively less mineral.
• The Poisson's ratio for the mineral or synthetic
hydroxyapatite is about 0.27, which is close to
that of bone (≈ 0.3).
Synthetic Polycrystalline hydroxyapatite has a high elastic
modulus (40–117 GPa) which is close to that of enamel.
Hydroxyapatite is excellent biocompatible material.
It appears to form a direct chemical bond with hard tissues.
 Manufacture of Calcium Phosphates (Hydroxyapatite)

• Mainly it is obtained from precipitate of

aqueous solution of Ca(NO3)2 and NaH2PO4.
Precipitates are filtered and dried to form a
fine particle powder.
• After calcination for about 3 hours at 900ºC to
promote crystallization, the powder is pressed
into final form and sintered at about
1050–1200ºC for 3 hours.
• Above 1250ºC the hydroxyapatite shows a
second phase precipitation along the grain
boundaries.
 GLASS-CERAMICS
• Glass-ceramics are polycrystalline ceramics made
by controlled crystallization of glasses.
• They were originally developed by S.D. Stookey of
Corning Glass Works in the early 1960s.
• They were first utilized in photosensitive glasses
in which small amounts of copper, silver and gold
are precipitated by ultraviolet light irradiation.
• These metallic precipitates help to nucleate and
crystallize the glass into a fine grained ceramic
which possess excellent mechanical and thermal
properties.
• Bioglass® and Ceravital® are two glass-ceramics
developed for implants.
 Properties and application of glass ceramics
• The glass-ceramics developed for implantation are SiO2–CaO–Na2O–P2O5
and Li2O–ZnO–SiO2 systems.
• Glass-ceramics have several desirable properties compared to glasses and
ceramics.
• The thermal coefficient of expansion is very low, typically 10–7 to 10–5 per
degree C, and in some cases it can be made even negative.
• Due to the controlled grain size and improved resistance to surface damage,
the tensile strength of these materials can be increased by at least a factor
of two, from about 100 to 200 MPa.
• The resistance to scratching and abrasion are close to that of sapphire.
• The main drawback of the glass-ceramic is its brittleness, as is the case with
other glasses and ceramics.
• Additionally, due to restrictions on the composition for biocompatibility (or
osteogenicity),mechanical strength cannot be substantially improved as for
other glass-ceramics.
• Therefore, they cannot be used for making major load-bearing implants
such as joint implants.
• However, they can be used as fillers for bone cement, dental restorative
composites, and coating material.
 Aluminum oxides
• Alpha-alumina (α-Al2O3) has a hexagonal close-
packed structure (a = 0.4758 nm and c =1.2991
nm).
• Natural alumina is known as sapphire or ruby
(depending on the types of impurities that give
rise to color).
• The single-crystal form of alumina has been used
successfully to make implants.
• The high hardness is accompanied by low friction
and wear; these are major advantages of using
the alumina as joint replacement material in spite
of its brittleness.
 Zirconia
• Zirconia has many salient features in comparison with
alumina.
• The biocompatibility of zirconia is about the same as
alumina ceramic, but its tribological properties are
quite different.
• The friction coefficient also showed a lower value for
the zirconia (0.028–0.082) than alumina (0.044–0.115)
or 316L stainless steel (0.061–0.156).
• One reason for the excellent wear and friction
characteristic of the zirconia is attributed to the fact
that zirconia has less porosity.
• Some researchers evaluated the use of zirconia for a
hemiarthroplasty femoral head implant and found it
suitable due to its low friction with articular cartilage
and its excellent biocompatibility.
 CARBONS
• Pyrolytic carbon is widely utilized for implant fabrication; it is
normally used as a surface coating on such medical devices as
surgical knives, scissors, and articulating surfaces of joint
implants
• The mechanical properties of carbon, especially pyrolytic
carbon, are largely dependent on density.
• The increased mechanical properties are directly related to
the increased density, which indicates the properties depend
mainly on the aggregate structure of the material
 Composites
• The word ""composite"" refers to the combination, on a
macroscopic scale, of two or more materials, different for
composition, morphology and general physical properties.
• Most human tissues such as bones, tendons, skin, ligaments, teeth, etc.,
are composites, made up of single constituents whose amount,
distribution, morphology and properties determine the final behavior of
the resulting tissue or organ.
• Man-made composites can, to some extent, be used to make prostheses
able to mimic these biological tissues, to match their mechanical behavior
and to restore the mechanical functions of the damaged tissue.
• Biocomposite (latin for 'grown by sun') is a composite material formed by
a matrix (resin) and a reinforcement of natural fibers. These kind of
materials often mimic the structure of the living materials involved in the
process keeping the strengthening properties of the matrix that was used,
but always providing biocompatibility.
 Why do we require composites?
• Failure of orthopedic surgery-allergic reaction , wear and loss
of material, Bone weakening due to stress on metal only,
revision surgery costlier by 41% than first, more complicated
than the first and patient has to stay longer at hospital, 30%
patients require revision after 15 yrs
• Bone is porous-Composite biomaterial preserve the strength
of bone in contrast to metal implant.
 Composite to bone
Metal Implant to bone adhesion adhesion through tissue
through cement ingrowth
 Application of composites
• Acrylic resin & silicate used for anterior teeth
–cosmetic reason-
poor mechanical strength-short life & clinical
failure

50% by volume filler: barium

glass and colloidal silica.
 Hip Replacements
• A damaged hip joint is surgically replaced with
an artificial implant.
• Patients require differing degrees of
replacements, such as total or partial implants,
and new hips are made from plastic, ceramic
and metal materials.
1. Total Hip Replacement (THR)
2. Partial Hip Replacement
3. Hip Resurfacing
When do we require hip joint replacement?
Osteoarthritis in the hip is a condition where the surface(cartilage) of the joint of the hip
gradually wear away resulting in inflammation. This may happen because of a specific
previous injury and due to over repetitive forces on the hip, which goes beyond the
tolerance limit of the hip after a certain period of time.
Traumatic Hip
Fracture (Broken Hip)
with Surgical Fixation
and Total Joint
Replacement
(Arthroplasty).
 UHMHDPE

Metal

Metal

• Marius Smith-Petersen, an American surgeon made the first arthroplasty mold in

1925, and went on to create the first total hip replacement (THR), made with stainless
steel.
• In 2015, U.S. surgeons performed an estimated 378,000 total hip replacements, and
by 2020, that number will grow to more than 510,000, according to Medscape.
• The average cost of a total hip replacement is about $30,000
• The surgery takes about 1-2 hours, plus another 1-2 hours of prep time before hand.
The patient's size and overall health may also influence these estimates. After the
surgery patients will stay a few days in the hospital and have to take blood thinners to
prevent blood clots.
Dr. D. Charnley used bone cement for fixation.
 Salient Features of Total Hip replacement
• The diseased femoral head is cut off and the
medullary canal of the femur is drilled and reamed to
prepare it for the stem of the prosthesis.
• The cartilage of the acetabulum is also reamed.
• PMMA bone cement is prepared from polymer
powder and monomer liquid till the correct dough
consistency is reached-it is packed into the medullary
canal of the femur and the femoral stem is inserted.
• Replace the head of the femur with a ball and
replace the socket with an artificial cup.
 Procedure of hip joint replacement

Biomaterials-an Introduction by J.B. PARK

 Salient features of hip replacement
• Special bone cement usually holds hip implants in place
• Cementless fixation technique-specially textured surface
that encourages the bone to grow onto the implant and
secure it in place.
• A hybrid total hip replacement uses a combination of
both, implanting the cup without cement and setting the
stem in place with cement.
• Traditional Charnley type hip replacement used
UHMWHDPE acetabular cup and metallic (stainless steel
316L, Co-Cr and Ti based alloys ) femoral head and stem
• In original Charnley prosthesis PTFE was used in place of
PE
 Partial hip replacement & resurfacing
• Either acetabulum or femoral head can be
replaced or hip fracture in the neck of femor can
be rectified by the same procedure as earlier.
Hip resurfacing is done to avoid bone loss due to
errosion.
It replaces the socket with an artificial cup and
resurfaces the head of femur by cementing process.
• This component has a short stem inserted into
the neck of the femur.
• Hip resurfacing often improves symptoms of
arthritis.
 Hip Implant Devices
• Metal –on –metal
• Metal on Plastic
• Ceramics-on -metal
• Ceramics on Plastic
• Ceramics on Ceramics
Charnley Hip Prosthesis-
Polymeric cup and
femoral stem with small
diameter head claimed
to be low friction with
less contact surface
 Difficulties
• Fixation of implants-due to the fact that the
implant has an interface with the cancellous
bone which is much weaker than compact
bone.
 Coating surfaces of head and cup with compact diamond

Pre-coating all-poly acetabular cup

outer surface with bone cement layer
combined with X-linked UHMWPE
Stresses on the surface of the femoral stem by a
load of 4000N.
Wear rate Vs. Degree of X-links(radiation dose)
knee joint replacement

• Damage from arthritis is the

most common reason for knee
joint replacement. This includes
both osteoarthritis and
rheumatoid arthritis.
• The prosthesis is made of metal
alloys and polymers
The ends of the bone are covered with a
smooth, glistening layer called articular
cartilage. The articular cartilage is what allows
the bones to glide smoothly with less
resistance than ice sliding on ice. The articular
cartilage can be seen on x-ray as the space in
between the bones.
 Incidence of Joint Degeneration

Development and acceptance of knee joint prostheses –slower

than that of hip joint
Reason:
• Knee ‘s complicated geometry and biomechanics of
movement-it rolls and glides simultaneously
• Lesser stability
 a)Freeman-Swanson
b)Spherocentric

Types of artificial
knee joints

c) Walldius
e) Bechtol
 Classification of replacements

• Hinged
• Non-hinged
-uni-compartmental
-bi-compartmental
The knee can be thought of as having 3
compartments - the medial, the lateral, and
the patellofemoral. In addition, there are 2
special cartilages within the knee joint called
the lateral and medial meniscus, which act as
shock absorbers within the knee joint. There
are also 2 ligaments within the knee, called the
anterior cruciate ligament and the posterior
cruciate ligament, which contribute to knee
stability.
Damaged knee
After replacement
Steps of Knee Replacement

• A total knee replacement (TKR) is a

complex procedure that requires an
o r t h o p e d i c s u r g e o n t o m a ke
precise measurements and skillfully
remove the diseased portions of
your bone, in order to shape the
remaining bone to accommodate
t h e k n e e i m p l a nt . D u r i n g t h e
procedure, the surgeon builds the
artificial knee inside your leg, one
component at a time, to create a
highly realistic artificial joint.
The surgeon makes an incision across
the front of your knee to gain access to
the patella, more commonly referred to
as the kneecap. In a traditional knee
replacement, the incision is usually
about 8 to 10 inches long. In minimally
invasive knee surgery, the incision is
usually about 4 to 6 inches long.
The first part of your knee that is exposed
is your kneecap, called thepatella. Once
your knee is open, the surgeon rotates the
patella outside the knee area. This allows
the surgeon to view the area needed to
perform the surgical procedure.

The first bone your surgeon will resurface

is your femur, commonly known as the
thighbone. Once the surgeon has opened
up and exposed your knee joint, he or she
will carefully measure your bones and
make precise cuts using special
instruments. The damaged bone and
cartilage from the end of the femur is cut
away. The end of your femur is cut and
resurfaced to fit the first part of the
artificial knee, the femoral component.
 The surgeon attaches the metal
femoral component to the end of
your femur and uses bone cement
to seal it into place.

The next bone your surgeon

resurfaces is your tibia, or
shinbone. The surgeon removes
damaged bone and cartilage from
t h e to p o f t h e t i b i a a n d t h e n
shapes the bone to fit the metal
and plastic tibial components.
The bottom portion of the implant, called the
tibial tray, is fitted to the tibia and secured into
place using bone cement. Once the tray is in
place, the surgeon will snap in a polyethylene
(medical-grade plastic) insert to sit between
the tibial tray and the femoral component, and
act as a kind of buffer. This insert will provide
support for your body as you bend and flex
your knee.

Before returning the patella to its normal

position, the surgeon might need to flatten the
patella and fit it with an additional plastic
component in order to ensure a proper fit with
the rest of your implant. The plastic piece, if
needed, is cemented to underlying bone.
Your surgeon will bend and flex the
knee to ensure that the implant is
w o r k i n g c o r r e c t l y, a n d t h a t
alignment, sizing, and positioning
i s s u i t a b l e . To c o m p l e t e t h e
procedure, the surgeon will close
the incision with stitches or staples,
and then bandage it and prep you
for recovery. You may leave the
operating room with your leg in a
continuous passive motion (CPM)
machine that will gently bend and
flex your new knee for you while
you are lying down.
Total knee replacement
• Total knee replacement surgery was first performed
in 1968, and has evolved over the years into a
reliable and effective way to relieve disabling pain
and allow patients to resume their active lives.
 Posterior-Stabilized Designs

Special bar on
femoral
component

Tibial
Component

The tibial component has a raised surface with an internal

post that fits into a special bar (called a cam) in the femoral
component. These components work together to do what the
PCL does: prevent the thighbone from sliding forward too far
on the shinbone when you bend your knee.
• Cruciate retaining design
• Bicruciate design
• Partial or unicompartmental
• Total or bicompartmental
Polymers in heart implant
 Artificial Heart Valves

Five types of prosthetic heart

valves:
A. Starr-Edwards mitral caged
ball valve. (Courtesy of Baxter
Edwards CVS.)
B. Medtronic Hall tilting disk
valve. (Courtesy of Medtronic
Starr Edwards(Ball & Cage)
Heart Valve Division.)
C. St. Jude bileaflet valve.
(Courtesy of St. Jude Medical,
Inc.)
D. Hancock porcine valve.
(Courtesy of Medtronic Heart
Valve Division.)
E. Carpentier-Edwards bovine
pericardial valve. (Courtesy of
Baxter Edwards CVS.)
PU based Mitral valve
Artificial tricuspid valve
Pyrollitic carbon is used to coat the metal frame
Requirements
Pressure Recovery
Intra Aortic Balloon Pump
 Normal balloon inflation

When balloon-assisted, the diastolic pressure should always be the highest

pressure recorded on the waveform. This will ensure that the coronary arteries
receive the maximum blood flow. The balloon-assisted systolic pressure should
be lower than the patients non-assisted, systolic pressure due to the reduction in
afterload.
Xenograft
Cardiovascular stents
Stent grafts. (a) Configuration of device
showing composite metal and fabric portions

b)well-healed experimental device explanted

from a dog aorta. The lumen is widely patent
and the fabric and metal components are
visible.

c)High-power photomicrograph of stent graft

interaction with the vascular wall,
demonstrating mild intimal thickening.
 Porous vascular implant

First arterial implant stitching fabrics with Modern arterial implant

hand
 Types
Classification on the basis of materials used:
• Bare metallic stents
• Coated stents
• Drug eluting stents
• Biodegradable stents
 Metallic stents
• Requirements:
Expandable-ability to plastic deformation, sufficient elasticity to
be compressed for delivery and then expanding in the target
area
Radial hoop strength and negligible recoil-should not collapse
after implantation
Low profile-ability to be crimped on the balloon catheter
supported by a guide wire
Adequate radio-opacity/MRI compatibility
Thromboresistivity -blood compatible
Drug delivery capacity
Metals- Stainless steel , Ta, Pt-Ir alloy, Ti, Ni-Ti alloy , Co-Cr
Biodegradable metallic stents-Pure Fe, Mg alloys(+Al+Zr+rare
earth metals)
 Surface Characteristics of stent
• Surface energy-surface chemistry-wettability,
thrombogenicity- PET,PTFE, PU compared-PU least surface
energy,hydrophilic coating on SS stents reduces accumulation
of platelets
• Surface texture-Polishing is essential –rough surface causes
thrombosis
• Surface potential-Metals are electropositive and blood
elements are electronegative-accentuates thrombogenicity-
coating the metal surface by biological / inorganic/ polymeric
materials
• Stability of surface oxide layer-acts as barrier to the release
of ions from the bulk materials underneath the surface.
 Rationale for coatings
• Thrombosis and neo-intimal hyperplasia-major
problem
Effect of coating:
• Surface energy gets reduced
• Surface texture smoothened
• Surface potential neutralized
• Stability of surface oxide layer enhanced
Types of methods of Coating:
• Galvanization
• Sputtering followed by bombarding ions
• Pulsed biased arc ion plating
• Dipping
• spraying
• plasma based depositions
 Materials used in coating
• Inorganic Coating-gold, silicon carbide, Iridium
oxide, diamond like Carbon(ceramic)
• Endothelial cells-(Biological)
• Porous materials-PU films with 30μm pores
• Polymers
 Metallic/Inorganic Coatings(ceramic)
• Gold –preferred on SS to enhance fluoroscopic visibility-
reduced neo-intimal hyperplasia on gold coated (thermally
processed) SS surface-due to smoothness and removal of
embedded impurities in the gold surface for porcine coronary
arteries but in human trials it was not satisfactory.
• Iridium oxide- It reduces inflamamtory reactions of metal by
the conversion of H2O2 to water and oxygen
• S i l i c o n - c a r b i d e – a m o r p h o u s hyd ro g e n ate d S i C i s a
semiconductor and antithrmbogenic
• Carbon- chemically inert, biocompatible
 Polymer coating
• Bio-stable (not biodegradable) polymers
• Biodegradable
• Copolymers
• Biological polymers
Tissue ingrowth and fixation of stents
Schematic diagram of arterial graft life tester
Artificial heart implant devices
Major applications
• Catheters and tubings
• Artificial heart
• Cardiac assist device-Intra aortic
balloon(IAB)
Cardiac
Pacemaker
Brain
Pacemaker
Details of an arterial electrode

Ball-point Screw in

porous
 Porous implant

Structure of porous coating for bony ingrowth.

Details of carbon-
polysulfone composite
femoral stem construction
Knee prostheses with black carbon fiber-reinforced
polyethylene tibial components
 Soft Tissue Replacement
Requirements
• They should achieve a reasonably close approximation of
the physical properties, especially flexibility and texture.
• They should not deteriorate or change properties after
implantation over time.
• If materials are designed for degradation, rate and modes
of degradation should follow the intended pathway.
• They should not cause adverse tissue reaction-They should
be non-carcinogenic, non-toxic, non-allergenic, and non-
immunogenic.
• They should be sterilizable.
• They should be low cost.
• Others-feasibility of mass production and aesthetic
qualities
 Sutures
Types-
• According to the physical integrity
Absorbable (biodegradable) & nonabsorbable.
• According to the source
Natural sutures (catgut, silk, and cotton), and Synthetic sutures
(nylon, polyethylene, polypropylene, stainless steel, and
tantalum).
• According to the physical form
Monofilament & multifilament
Shape Memory effect of Ni-Ti alloy
Absorbable synthetic suture-Vicryl –after
implantation
Comparison of absorbability of sutures with time
 Fate of suture after implantation
Absorbable
• Biological degradation by enzymes-specific
functional groups
• Hydrolysis of synthetic polymers enzymes-
specific functional groups
Non-absorbable
Suture material get encapsulated or walled of by
fibroblasts
 Surgical tapes
Surgical tape or medical tape is a
type of pressure-sensitive adhesive
tape used in medicine and first
aid to hold a bandage or
other dressing onto a wound.
Features:
• hold firmly onto skin, dressing materials, and underlying layers of tape
• Removed easily without damaging the skin
• Surgical tape is often white because it contains zinc oxide, which is added to help
prevent infections
• breathable tapes such as Kinesiology Tape, and other elastic bandages with
adhesive are made of cotton, microporous material, such as 3M Micropore, are
widely used.
• Some types are commonly used in sports to add a non-slip wrapping to things
which must be gripped, such as tennis racquets, and hockey and lacrosse sticks,
because of their rough texture and removability leaving little residue.
 Pressure sensitive adhesive in Surgical tapes
• natural rubber adhesives,
• synthetic rubber adhesives,
• acrylic adhesives
Typical applications;
single-coated tapes in wound care dressings,
surgical tapes and electrodes,
double coated tapes and transfer adhesives
diagnostic test strips, ostomy devices, surgical
drapes, advanced wound care dressings and
other
Skin Trauma due to rubber based adhesive

Paper
backing
PSA

PU backed PSA
Breathable
Comparison of three types of PSA
 Ligament, Cartilage, tendons
• Ligament-connective tissue that joins bone to
bone-strong, elastic, fibrous

• Tendons-connective tissue that joins bone to

muscles-strong, elastic, fibrous

• Cartilage-connective tissue that acts as soft

cushion on bone-strong, elastic, fibrous
Tissue Adhesives
 Main Strength depends on-

• Covalent bonding
• Thickness,
• porosity
• Flexibility
• Rate of degradation
Materials indicate the nature of fillers and other additives(tackifiers, sealants etc.)
Fixation of dental resin
monomers with adhesive
through Ca+2
 Percutaneous Devices
Skin implant
• Problems-
ØAttachment is not permanent
ØDowngrowth and/or overgrowth of epithelium
around the device
ØAny opening may cause bacterial infection
 Factors and variables concerned
End-use factors
• a. Transmission of information: biopotentials, temperature, pressure, blood
• flow rate, etc.
• b. Energy: electrical and electromagnetic stimulation, power for heart assist
• devices, cochlear implants, etc.
• c. Matter: cannula for kidney dialysis and blood infusion or exchange, etc.
Engineering factors
• a. Materials selection: polymers, ceramics, metals, and composites.
• b. Design variations: button, tube with and without skirt, porous or smooth
• surface, etc.
• c. Mechanical stresses: soft and hard interface, porous or smooth interface.
Biological factors
• a. Implant host: man, dog,rabbit, sheep, etc.
• b. Implant location: abdominal, dorsal, forearm, etc.
Human factors
• a. Postsurgical care.
• b. Implantation technique.
• c. Aesthetic outlook.
 Cross-sectional Image of PD-skin interface

Figure 1

Figure 2 Air chamber

Figure3
Artificial Skins and Burn Dressing

Artificial Skins and Burn Dressing

Materials Used for temporary and permanent Skin transplantation
Design requirements and schematic representation of skin
implants
Ear Implant

Figure A
Figure B
PD

Figure C
Figure D