BMAO Unit 1-1

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RAJIV GANDHI COLLEGE OF ENGINEERING AND TECHNOLOGY, PUCUCHERRY

UNIT-I

2 MARKS:

1) What are biomaterials? (Nov 2018, May 2017)

The Materials which are used for structural applications in the fields of medicine
are known as biomaterials. These materials are used to make devices to replace
damaged or diseased body parts in human and animal bodies. A variety of devices and
materials are used in the treatment of disease or injury. Common place examples
include suture needles, plates, teeth fillings, etc.

2) Define biocompatibility? (Dec 2018, May 2019. May 2017)

Biocompatibility is a general term describing the property of a material being


compatible with living tissue. Biocompatible materials do not produce a toxic or
immunological response when exposed to the body or bodily fluids. Biocompatible
materials are central for use in medical implants and prosthetics to avoid rejection by
the body tissue and to support harmonious biological functioning.

3) Is blood a viscoelastic material? Justify. (Nov 2019)

Viscoelasticity is a property of human blood that is primarily due to the elastic


energy that is stored in the deformation of red blood cells as the heart pumps the blood
through the body. The energy transferred to the blood by the heart is partially stored in
the elastic structure, another part is dissipated by viscosity, and the remaining energy is
stored in the kinetic motion of the blood. When the pulsation of the heart is taken into
account, an elastic regime becomes clearly evident. It has been shown that the previous
concept of blood as a purely viscous fluid was inadequate since blood is not an
ordinary fluid. Blood can more accurately be described as a fluidized suspension of
elastic cells (or a sol).

4) State Wolfe’s law for bone remodelling. (Nov 2019)

Wolfe’s law states that: “Bone in a healthy person is capable of adapting loads that
is placed under. If loading on a particular bone increases, the bone will remodel itself

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over time to become stronger to resist the loading. Conversely, if the loading on a bone
decreases, the bone will become weaker”.

5) How are biomaterials classified? (May 2019)

Based on the application in the medical field biomaterial are classified into:

 Metals and alloys biomaterials


 Ceramics biomaterials
 Polymer biomaterials
 Composite biomaterials
Based on compatibility biomaterials are classified into:
 Biotolerant
 Bioinert
 Bioactive
 Bioresorbable
6) What is the importance of surface properties of biomaterials? (Nov 2016)

The surface properties of an implantable biomaterial play an important role in


biointegration and biocompatibility during a period starting with implantation and for the
whole in-dwelling lifetime of the implant. Upon implantation, several biological events
take place on the biointerface of material and tissue, which are mostly related with the
surface properties of biomaterial.

 Some of the surface properties are:


 The surface region of a material is known to be uniquely reactive.
 The surface of a material is inevitably different from the bulk
 Surface readily contaminate.
 The surface structure of a material is often mobile.
7) What are the factors on which wound healing depends on? (Nov 2016)

Many factors controlling the efficacy, speed, and manner of wound healing fall
under two types: local and systemic factors.

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 Local factors
 Moisture
 Mechanical factors
 Oedema
 Ionizing radiation
 Faculty technique of wound closure
 Ischemia and necrosis
 Foreign bodies.
 Low oxygen tension
 Perfusion
 Systemic factors
 Inflammation
 Diabetes
 Nutrients Metabolic diseases
 Immuno suppression
 Connective tissue disorders
 Smoking
 Age
 Alcohol
8) What are the factors from the choice of material can affect local tissue response
to an implant? (May 2018)
 Local effect of implant on host:
 Blood material interaction
 Toxicity
 Modification of normal healing
 Infection
 Tumorigenesis
 Protein absorption, coagulation, fibrinolysis, platelrt adhesion, complement
activation, leukocyte adhesion, hemolysis
 Encapsulation, foreign body reaction, pannus formation
 Local events following implantation:
 Injury

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 Acute inflammation
 Chronic inflammation
 Granulation tissue
 Foreign body reaction
 Fibrosis
9) Define viscoelasticity. (Nov 2017, May 2018)

Viscoelasticity is the time-dependent and elastic behaviour of materials. This


means that the response to a stimulus is delayed, and there is a loss of energy inside the
material. Viscoelastic behaviour normally occurs at different time scales (relaxation times)
in the same material.

Viscoelasticity is the property of materials that both viscous and elastic


characteristics when undergoing deformation.

10) Define creep. (Nov 2017)

Creep (sometimes called cold flow) is the tendency of a solid material to move
slowly or deform permanently under the influence of persistent mechanical stresses. It can
occur as a result of long-term exposure to high levels of stress that are still below the yield
strength of the material.

11 MARKS
1) a. Elaborate in detail about the classification of biomaterials and their biomedical
applications (Nov 2018)
b. Classify the biomaterials giving emphasis on the properties and applications
of each. (Nov 2019)
c. How are biomaterials classified? Mention the merits and demerits of each
category with their application in detail. (May 2018)
The Materials which are used for structural applications in the fields of medicine
are known as biomaterials. These materials are used to make devices to replace damaged
or diseased body parts in human and animal bodies. Common place examples include
suture needles, plates, teeth fillings, etc.

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CLASSIFICATION OF BIOMATERIAL
Based on the application in the medical field biomaterial are classified into following 4
types:
i) METAL AND ALLOYS
 Metals and alloys are used as biomaterials due to their excellent electrical and thermal
conductivity and mechanical properties. Types of Metal and alloys are cobalt based
alloys, titanium, stainless steel, protosal from cast alloy, conducting metals such as
platinum.
Advantages
 High strength
 Fatigue resistance
 Easy to sterilize
Disadvantages
 Corrosion
 Toxicity
 Wetting

Applications of Metal and Alloy


 Metals and alloys biomaterials are used in implant and orthopaedic application
 Stainless steel Predominant implant alloy
 Protosal from cast alloy of Co ,Cr, Mo used for implant hip Endo prosthesis and
advance version of this protosal are widely used in hip joints
ii) CERAMICS

They are used as biomaterials due to their high mechanical strength and
biocompatibility. Types of Bio-ceramic materials are tri calcium phosphate, Metals oxides
such as Al2O3 and SiO2, Apatite ceramics, Porous ceramics, Carbon and Alumina.

Advantage

 High compression strength


 Wear & Corrosion resistance

Disadvantage

 High E modulus

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 Brittle -Low fracture toughness

Applications of Ceramics
 Al2O3 and SiO2 - used to make femoral head
 Apatite ceramics - bio active ceramics-used as synthetic bone
 Carbon good biocompatibility, wide application in heart valves
 Percutaneous carbon – stimulation of cochlea and visual cortex for artificial hearing
and aid the blind respectively.
iii) BIOPOLYMERS
 Biopolymers are macromolecules (protein, nuclei ,acids and polysaccharides) formed
in nature during the growth cycles of all organism
Advantages
 Surface modification
 Biodegradable
Disadvantages
 Surface contamination
 Difficult to sterilize
Application of Biopolymers
 Synthetic polymeric materials have been widely used in medical disposable supplies,
prosthetic materials, dental materials, implants, dressings, extracorporeal devices,
encapsulates, polymeric drug delivery systems, tissue engineered products
iv) COMPOSITE BIOMATERIALS
 The term “composite” is usually reserved for those materials in which the distinct
phases are separated on a scale larger.
Biomaterial applications of composite biomaterials
 Dental filling composites
 Orthopedic implants with porous surfaces
CLASSIFICATION OF BIOMATERIALS BASED ON COMPATIBILITY
1. Biotolerant
Implant separated from the surrounding bone by a layer of soft tissue over the
interface. No contact in the osteogenesis. The layer is induced by the implant release
of monomers, ions, and/or corrosion products. Almost all synthetic polymers and most
metals are this category.

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2. Bioinert
Implants in direct contact with bone tissue, occurring involvement in the
osteogenesis. However, there is no chemical reaction between the tissue and the implant.
There is not, at least in amounts detectable by cells, the release of any component.
Examples of bioinert biomaterials are: alumina, zirconia, titanium, tantalum, niobium, and
carbon.
3. Bioactive
There is the interaction between the implant and the bone tissue, interfering
directly in the osteogenesis. By chemical similarity, the mineral part of bone tissue binds
to the implant, promoting osteoconduction. The main materials of this class are: Ca-
phosphate, vitro-ceramic, and hydroxyapatite.
4. Bioresorbable
Materials that, after a certain period of time in contact with the tissues, end up by being
degraded, solubilized, or phagocytosed by the body. They are of interest in clinical
applications where it is inadvisable the reoperation to remove the implant. Representative
of this class are tricalcium phosphate (TCP) and PLLA (poly-L-lactic acid).
2. List and discuss the sequence of steps occurring during wound healing and
examine the tissue response to body implants. (Nov 2019)
Wound healing refers to a living organism's replacement of destroyed or damaged
tissue by newly produced tissue.

Phase 1: Hemostasis Phase (Stop the bleeding)


Hemostasis, the first phase of healing, begins at the onset of injury, and the objective is
to stop the bleeding. In this phase, the body activates its emergency repair system, the
blood clotting system, and forms a dam to block the drainage. During this process,
platelets come into contact with collagen, resulting in activation and aggregation. An
enzyme called thrombin is at the center, and it initiates the formation of a fibrin mesh,
which strengthens the platelet clumps into a stable clot.

Phase 2: Defensive/Inflammatory Phase (Clotting)

If Phase 1 is primarily about coagulation, the second phase, called the


Defensive/Inflammatory Phase, focuses on destroying bacteria and removing debris—
essentially preparing the wound bed for the growth of new tissue.

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During Phase 2, a type of white blood cells called neutrophils enter the wound to destroy
bacteria and remove debris. These cells often reach their peak population between 24 and
48 hours after injury, reducing greatly in number after three days. As the white blood
cells leave, specialized cells called macrophages arrive to continue clearing debris. These
cells also secrete growth factors and proteins that attract immune system cells to the
wound to facilitate tissue repair. This phase often lasts four to six days and is often
associated with edema, erythema (reddening of the skin), heat and pain.

Phase 3: Proliferative Phase (New cell growth)

Once the wound is cleaned out, the wound enters Phase 3, the Proliferative Phase,
where the focus is to fill and cover the wound.The Proliferative phase features three
distinct stages: 1) filling the wound; 2) contraction of the wound margins; and 3) covering
the wound (epithelialization). During the first stage, shiny, deep red granulation tissue fills
the wound bed with connective tissue, and new blood vessels are formed. During
contraction, the wound margins contract and pull toward the center of the wound. In the
third stage, epithelial cells arise from the wound bed or margins and begin to migrate

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across the wound bed in leapfrog fashion until the wound is covered with epithelium. The
Proliferative phase often lasts anywhere from four to 24 days.

Phase 4: Maturation Phase (Strengthening)

During the Maturation phase, the new tissue slowly gains strength and flexibility. Here,
collagen fibers reorganize, the tissue remodels and matures and there is an overall increase
in tensile strength (though maximum strength is limited to 80% of the pre-injured
strength). The Maturation phase varies greatly from wound to wound, often lasting
anywhere from 21 days to two years. The healing process is remarkable and complex, and
it is also susceptible to interruption due to local and systemic factors, including moisture,
infection, and maceration (local); and age, nutritional status, body type (systemic). When
the right healing environment is established, the body works in wondrous ways to heal and
replace devitalized tissue.

TISSUE RESPONSE TO BODY IMPLANTS


 All implants interact with the biological environment around them. Effects go both
ways “Effects of tissue on the implant and Effects of implant on the tissue”.
 All materials intended for application in humans as biomaterials, medical devices,
or prostheses undergo tissue responses when implanted into living tissue.
 These actions involve fundamental aspects of tissue responses including injury,
inflammatory and wound healing responses, foreign body reactions, and fibrous
encapsulation. Secondly the in vivo evaluation of tissue responses to these
materials is important for performance, safety, and regulatory reasons.
MECHANICAL EFFECTS OF HOST ON IMPLANTS
1. Abrasive wear
2. Fatigue
3. Stress-corrosion
4. Cracking
5. Corrosion
6. Degeneration and dissolution
BIOLOGICAL EFFECTS OF HOST ON IMPLANTS
1. Absorption of substances from tissue
2. Enzymatic degradation

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3. Calcification
LOCAL EFFECT OF IMPLANT ON HOST
1. Blood material interaction
2. Toxicity
3. Modification of normal healing
4. Infection
5. Tumorigenesis
6. Protein absorption, coagulation, fibrinolysis, platelet adhesion, complement
activation, leukocyte adhesion, hemolysis
7. Encapsulation, foreign body reaction, pannus formation

SYSTEMATIC EFFECT OF IMPLANT ON HOST


1. Embolization
2. Hypersensitivity
3. Elevation of implant elements in blood
4. Lymphatic particle transport

3. Explain the surface properties of biomaterials. (May 2019)


Biomaterial Surface
 Biomaterial surfaces exhibit remarkable heterogeneity in physical structure:
 Material dependant: Metals vs. Polymers vs. Ceramics vs. Gels
 Chemistry: Polar vs. Apolar, Charge, Reactivity
 Morphology: Smooth, Rough, Stepped, Patterned, Diffuse
 Order: Crystalline, Amorphous, Semi-Crystalline, Phasic
 Environment: Hydration, Solvent Quality
SURFACE PROPERTIES
 The surface region of a material is known to be uniquely reactive
 The surface of a material is inevitably different from the bulk
 Surfaces readily contaminate
 The surface structure of a material is often mobile.
SURFACE INTERACTION WITH MOLECULES
 Nonspecific interaction
 Specific bonding

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 Surface topology
1. NON-SPECIFIC INTERACTION
 Dipole‐dipole type interactions;
 Electrostatic forces resulting from charged molecules
 Hydration or solvation force that results from expulsion of water between the two
surfaces
 Hydrophobic effects that non‐polar molecules tend to form intermolecular
aggregates in an aqueous medium
 Repulsive steric forces that arise due to proteins on both surfaces forming spikes of
up to 10 nm.
2. SPECIFIC BONDING
 The electronic and atomic structures, and almost all the physical properties, of
solids depend on the nature and strength of the inter‐atomic bonds:
1. Ionic Bonding
2. Covalent Bonding
3. Metallic Bonding
4. Weak Bonding – Vander Waals and hydrogen bonding
3. SURFACE TOPOLOGY
 Topological features occur at different length scales:
1. Sub‐cellular level (< 10 μm)
2. Cellular level (10‐100 μm)
3. Multi‐cellular level (>100 μm)
 Modulate protein adsorption
 Constrain receptor binding and related signaling pathways – cell attachment,
spreading, migration, and function
 Porosity
SURFACE CHARACTERISATION
 Contact Angle Methods
 Electron Spectroscopy for Chemical Analysis (ESCA)
 X‐ray Photoelectron Spectroscopy (XPS)
 Secondary Ion Mass Spectrometry (SIMS)
 Infrared Spectroscopy (IRS)
 Scanning Electron Microscopy (SEM)
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 Scanning Tunneling Microscopy (STM)


 Atomic Force Microscopy (AFM)
SUPERHYDROPHOBICITY
 Ultrahydrophobic (or superhydrophobic) surfaces are highly hydrophobic, i.e.,
extremely difficult to wet.
 The contact angles of a water droplet on an ultrahydrophobic material exceed
150°.
 This is also referred to as the lotus effect, after the superhydrophobic leaves of
the lotus plant. A droplet striking these kinds of surfaces can fully rebound like an
elastic ball.
 In the biomedical arena this property is used as substrates to control protein
adsorption, cellular interaction, and bacterial growth, as well as platforms for drug
delivery devices and for diagnostic tools.
 SURFACE ADSORPTION
 SURFACE ENERGY
 SURFACE HYDROPHOBICITY
 SURFACE CHARGE
1. SURFACE ENERGY
 Surface energy is a term used to describe the surface of a given substrate; surface
energies range from high to low.
 The molecular force of attraction between unlike materials determines their
adhesion.
 The strength of attraction is depends on the surface energy of the substrate. High
surface energy means a strong molecular attraction, while low surface energy means
weaker attractive forces.
2. SURFACE HYDROPHOBICITY
 Hydrophobic surface is a surface that has the ability to repel water.
Surface hydrophobicity is a structure-related function, dependent on the size and shape
of protein molecule, amino acid composition, and sequence, as well as any
intramolecular or intermolecular cross-links.

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3. SURFACE CHARGE
 It is the electrical potential difference between the inner and outer surface of a
material.
 Surface charge on biomaterials is emerging as a crucial determinant of regulating
cells responses impacting cells signaling in tissue treatment.
 Charges allocated at the surface determine cells adhesion and later tissue
development.
4. a. Discuss about viscoelastic property of biomaterials. (May 2019)
b. With an example explain and describe the components of stress strain curve of
a ductile metal. (Nov 2016)
 Viscoelasticity is the time-dependent and elastic behaviour of materials. This
means that the response to a stimulus is delayed, and there is a loss of energy inside the
material.
 Viscoelastic behaviour normally occurs at different time scales (relaxation times)
in the same material.

 Viscoelasticity is the property of materials that both viscous and elastic


characteristics when undergoing deformation.

 Viscous materials, like water, resist shear flow and strain linearly with time when
a stress is applied.

 Elastic materials strain when stretched and immediately return to their original
state once the stress is removed.
 Viscoelastic materials have elements of both of these properties and, as such,
exhibit time-dependent strain.
 Whereas elasticity is usually the result of bond stretching along crystallographic
planes in an ordered solid, viscosity is the result of the diffusion of atoms or molecules
inside an amorphous material.

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 Depending on the change of strain rate versus stress inside a material the viscosity
can be categorized as having a linear, non-linear, or plastic response.

 When a material exhibits a linear response it is categorized as a Newtonian


material. In this case the stress is linearly proportional to the strain rate. If the material
exhibits a non-linear response to the strain rate, it is categorized as Non-Newtonian fluid.
 There is also an interesting case where the viscosity decreases as the shear/strain
rate remains constant. A material which exhibits this type of behavior is known
as thixotropic.
 In addition, when the stress is independent of this strain rate, the material exhibits
plastic deformation. Many viscoelastic materials exhibit rubber like behavior explained by
the thermodynamic theory of polymer elasticity.
 Some examples of viscoelastic materials include amorphous polymers,
semicrystalline polymers, biopolymers, metals at very high temperatures, and bitumen
materials.
 Cracking occurs when the strain is applied quickly and outside of the elastic limit.
 Ligaments and tendons are viscoelastic, so the extent of the potential damage to
them depends both on the rate of the change of their length as well as on the force applied.

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 A viscoelastic material has the following properties:


 hysteresis is seen in the stress–strain curve
 stress relaxation occurs: step constant strain causes decreasing stress
 creep occurs: step constant stress causes increasing strain
TYPES OF VISCOELASTICITY

 Linear viscoelasticity is when the function is separable in both creep response and
load. All linear viscoelastic models can be represented by
a Volterra equation connecting stress and strain:Linear viscoelasticity is usually
applicable only for small deformations.
 Nonlinear viscoelasticity is when the function is not separable. It usually happens
when the deformations are large or if the material changes its properties under
deformations.
DYNAMIC MODULUS

 Viscoelasticity is studied using dynamic mechanical analysis, applying a small


oscillatory stress and measuring the resulting strain.
 Purely elastic materials have stress and strain in phase, so that the response of one
caused by the other is immediate.
 In purely viscous materials, strain lags stress by a 90 degree phase.
 Viscoelastic materials exhibit behavior somewhere in the middle of these two types
of material, exhibiting some lag in strain.

EFFECT OF TEMPERATURE ON VISCOELASTIC BEHAVIOUR

 The secondary bonds of a polymer constantly break and reform due to thermal
motion. Application of a stress favors some conformations over others, so the molecules
of the polymer will gradually "flow" into the favored conformations over time.

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 Because thermal motion is one factor contributing to the deformation of polymers,


viscoelastic properties change with increasing or decreasing temperature.
 In most cases, the creep modulus, defined as the ratio of applied stress to the time-
dependent strain, decreases with increasing temperature. Generally speaking, an increase
in temperature correlates to a logarithmic decrease in the time required to impart equal
strain under a constant stress.
 In other words, it takes less work to stretch a viscoelastic material an equal
distance at a higher temperature than it does at a lower temperature.
 More detailed effect of temperature on the viscoelastic behavior of polymer can be
plotted as shown.

 There are mainly five regions (some denoted four, which combines VI and V
together) included in the typical polymers
 Region I: Glassy state of the polymer is presented in this region. The temperature
in this region for a given polymer is too low to endow molecular motion. Hence the
motion of the molecules is frozen in this area. The mechanical property is hard and brittle
in this region
 Region II: Polymer passes glass transition temperature in this region. Beyond Tg,
the thermal energy provided by the environment is enough to unfreeze the motion of
molecules. The molecules are allowed to have local motion in this region hence leading
to a sharp drop in stiffness compared to Region I.
 Region III: Rubbery plateau region. Materials lie in this region would exist long-
range elasticity driven by entropy. For instance, a rubber band is disordered in the initial
state of this region. When stretching the rubber band, you also align the structure to be
more ordered. Therefore, when releasing the rubber band, it will spontaneously seek
higher entropy state hence goes back to its initial state. This is what we called entropy-
driven elasticity shape recovery.

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 Region IV: The behavior in the rubbery flow region is highly time-dependent.
Polymers in this region would need to use a time-temperature superposition to get more
detailed information to cautiously decide how to use the materials. For instance, if the
material is used to cope with short interaction time purpose, it could present as 'hard'
material. While using for long interaction time purposes, it would act as 'soft' material.
 Region V: Viscous polymer flows easily in this region. Another significant drop in
stiffness.
VISCOELASTIC CREEP

 When subjected to a step constant stress, viscoelastic materials experience a time-


dependent increase in strain. This phenomenon is known as viscoelastic creep.
 Viscoelastic creep data can be presented by plotting the creep modulus (constant
applied stress divided by total strain at a particular time) as a function of time. Below its
critical stress, the viscoelastic creep modulus is independent of stress applied. A family of
curves describing strain versus time response to various applied stress may be represented
by a single viscoelastic creep modulus versus time curve if the applied stresses are below
the material's critical stress value.
5. Write briefly about the various mechanical properties affecting biomaterials.
(Nov 2016, Nov 2017)
1. TENSILE AND SHEAR PROPERTIES
a) Tensile Testing
 Parameters measured: Engineering stress (σ) and Engineering strain (ԑ).
 σ = F/A : Force applied perpendicular to the cross section of sample
 ԑ = (li-l0)/l0: l0 is the length of sample before loading, li is the length during
testing.

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b) Compression Testing
 Performed mainly for biomaterials subjected to compressive forces during
operation. E.g. orthopedic implants.
 Stress and strain equations same as for tensile testing except force is taken negative
and l0 larger than li.
 Negative stress and strain obtained.
c) Shear Testing
 Forces parallel to top and bottom faces
 Shear stress (τ) = F/A0
 Shear strain (γ)=tanθ ; θ is the deformation angle.
d) Torsion Testing
 Torsion is the twisting of an object due to an applied torque.
 The stress is perpendicular to the radius
2. BENDING PROPERTIES:
ELASTICITY:
A temporary shape change that is self-reversing after the force is removed, so that the
object returns to its original shape, is called elastic deformation.
PLASTICITY:
When the stress is sufficient to permanently deform the metal, it is called plastic
deformation
Material 1: Ceramics
 Stress proportional to strain.
 Governed by Hooke’s law: σ = ԑE; τ=Gγ
 E Young’s modulus G: Shear modulus - measure of material stiffness.
 Fracture after applying small values of strain: ceramics are brittle in nature.
Material 2: Metal
 Stress proportional to strain with small strain; elastic deformation.
 At high strain, stress increases very slowly with increased strain followed by
fracture: Plastic deformation.
Material 3: Plastic deformation polymer
 Stress proportional to strain with small strain; elastic deformation.
 At high strain, stress nearly independent of strain, shows slight increase: Plastic
deformation.

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Material 4: Elastic polymer


 Stress increases very slowly with increasing strain.
 Do not fracture at a very high strain values.
3. TIME DEPENDENT PROPERTIES
CREEP: Defined as plastic deformation of sample under constant load over time.
 Creep at 37 deg C a significant concern for biomedical applications.
 Metals: Grain boundary movement, vacancy diffusion
 Ceramics: little or no vacancy diffusion
 Polymers: viscous response in amorphous regions.
 Creep is function of crystallinity: As % crystallinity increases, creep decreases.
Creep curve
3 distinct regions:
 Primary creep: increase in strain with time; creep rate decreases.
 Secondary creep: linear relation between creep strain and time.
 Tertiary creep: Leads to fracture.
4. ELASTIC MODULUS
 Elastic modulus is simply defined as the ratio of stress to strain within the proportional
limit.
 Physically, it represents the stiffness of a material within the elastic range when tensile
or compressive load are applied.
 It is clinically important because it indicates the selected biomaterial has similar
deformable properties with the material it is going to replace.
 These force-bearing materials require high elastic modulus with low deflection. As the
elastic modulus of material increases fracture resistance decreases. It is desirable that
the biomaterial elastic modulus is similar to bone.
 The Elastic modulus of a material is generally calculated by bending test because
deflection can be easily measured in this case as compared to very small elongation in
compressive or tensile load.
 Another method of elastic modulus measurement is non-destructive method. It is also
clinically very good method because of its simplicity and repeatability since materials
are not destroyed.
5. HARDNESS

BIO MEDICAL DEPARTMENT,


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BM T71-BIOMATERIALS AND ARTIFICIAL ORGANS
RAJIV GANDHI COLLEGE OF ENGINEERING AND TECHNOLOGY, PUCUCHERRY

 Hardness is one of the most important parameters for comparing properties of


materials. It is used for finding the suitability of the clinical use of biomaterials.
Biomaterial hardness is desirable as equal to bone hardness.
 If higher than the biomaterial, then it penetrates in the bone. As above said,
biomaterials sample are very small therefore, micro and nano scale hardness test
(Diamond Knoop and Vickers indenters) are used.
6. FRACTURE STRENGTH
 Strength of materials is defined as the maximum stress that can be endured before
fracture occurs.
 Strength of biomaterials (bioceramics) is an important mechanical property because
they are brittle. In brittle materials like bioceramics, cracks easily propagate when the
material is subject to tensile loading, unlike compressive loading.
 A number of methods are available for determining the tensile strength of materials,
such as the bending flexural test, the biaxial flexural strength test and
the weibull approach.
 In bioceramics, flaws influence the reliability and strength of the material during
implantation and fabrication. There are a number of ways that flaws can be produced
in bioceramics such as thermal sintering and heating. The importance is for
bioceramics to have high reliability, rather than high strength.
7. FRACTURE TOUGHNESS
 Fracture toughness is required to alter the crack propagation in ceramics. It is helpful
to evaluate the serviceability, performance and long term clinical success of
biomaterials.
 It is reported that the high fracture toughness material improved clinical performance
and reliability as compare to low fracture toughness.
 It can be measured by many methods e.g. indentation fracture, indentation strength,
single edge notched beam, single edge pre cracked beam and double cantilever beam.
8. FATIGUE
 Fatigue is defined as failure of a material due to repeated/cyclic loading or unloading
(tensile or compressive stresses).
 It is also an important parameter for biomaterial because cyclic load is applied during
their serving life. In this cyclic loading condition, micro crack/flaws may be generated

BIO MEDICAL DEPARTMENT,


20
BM T71-BIOMATERIALS AND ARTIFICIAL ORGANS
RAJIV GANDHI COLLEGE OF ENGINEERING AND TECHNOLOGY, PUCUCHERRY

at the interface of the matrix and the filler. This micro crack can initiate permanent
plastic deformation which results in large crack propagation or failure.
 During the cyclic load several factor also contribute to microcrack generation such as
frictional sliding of the mating surface, progressive wear, residual stresses at grain
boundaries, stress due to shear.
6. What are the various types of tissue response to implants and what are the
factors affecting the performance of implants? (Nov/Dec 2017)
 All implants interact with the biological environment around them.Effects go both
ways “Effects of tissue on the implant and Effects of implant on the tissue”.
 All materials intended for application in humans as biomaterials, medical devices,
or prostheses undergo tissue responses when implanted into living tissue.
 These actions involve fundamental aspects of tissue responses including injury,
inflammatory and wound healing responses, foreign body reactions, and fibrous
encapsulation.Secondly the in vivo evaluation of tissue responses to these materials
is important for performance, safety, and regulatory reasons.
MECHANICAL EFFECTS OF HOST ON IMPLANTS
1. Abrasive wear
2. Fatigue
3. Stress-corrosion
4. Cracking
5. Corrosion
6. Degeneration and dissolution
BIOLOGICAL EFFECTS OF HOST ON IMPLANTS
1. Absorption of substances from tissue
2. Enzymatic degradation
3. Calcification
LOCAL EFFECT OF IMPLANT ON HOST
1. Blood material interaction
2. Toxicity
3. Modification of normal healing
4. Infection
5. Tumorigenesis

BIO MEDICAL DEPARTMENT,


21
BM T71-BIOMATERIALS AND ARTIFICIAL ORGANS
RAJIV GANDHI COLLEGE OF ENGINEERING AND TECHNOLOGY, PUCUCHERRY

6. Protein absorption, coagulation, fibrinolysis, platelet adhesion, complement


activation, leukocyte adhesion, hemolysis
7. Encapsulation, foreign body reaction, pannus formation
SYSTEMATIC EFFECT OF IMPLANT ON HOST
1. Embolization
2. Hypersensitivity
3. Elevation of implant elements in blood
4. Lymphatic particle transport
LOCAL EVENTS FOLLOWING IMPLANTATIONS
Local events following implantations are as follows
1. INJURY
The reaction of vascularized living tissue to local injury Goals are:
 To reduce the agent or process causing injury
 To start off healing process by regenerating parenchymal cells
 The formation of fibroblastic scar tissue
2. ACUTE INFLAMMATION
 Short duration from minutes to days
 Characterized by the emigration of leukocytes especially neutrophils
 Emigration assisted by adhesion molecules on both WBC and endothelial cells
 The expression of these molecules is affected by the imflammatory response
 WBC migration controlled by chemotaxis
 Specific receptors on the leukocytes detect chemotactic agents, they also control
the activation of leukocytes
 After localization of WBCs phagocytosis and the release of enzymes take place
3. CHRONIC INFLAMMATION
 Characterized by the presence of macrophages, monocytes, and lymphocytes
 Proliferation of blood vessels and connective tissue
 Could be either caused by the nature of the biomaterial or by motion in the implant
 Lymphocytes and plasma are related to the immune reaction
4. GRANULATION TISSUE
 Fibroblasts and vascular endothelial cells in the implant site proliferate and form
granulation tissue “Granulation tissue from the pink soft granular appearance on
the surface of healing tissue”. Seen 3-5 days after implantation
BIO MEDICAL DEPARTMENT,
22
BM T71-BIOMATERIALS AND ARTIFICIAL ORGANS
RAJIV GANDHI COLLEGE OF ENGINEERING AND TECHNOLOGY, PUCUCHERRY

 Angiogenesis small blood vessel formation. Angiogenesis includes proliferation,


maturation, and organization of endothelial cells
 At the beginning of the process proteoglycans dominate then type III collagen
dominates
5. FOREIGN BODY REACTION
 Foreign body giant cells are formed by the fusion of monocytes and macrophages
to phagocytose the material
 Composed of foreign body giant cells and components of granulation tissue.
 Reaction dependent on the form and topography of the implant
 Smooth surfaces have a reaction of one layer of macrophages one to two cells in
thickness
6. FIBROSIS AND FIBROUS ENCAPSULATION
 Last response to biomaterials
 Repair of the implant site can be one of two: Regeneration:
 replacement of the injured tissue with parenchymal cells of the same type
 Replacement with fibrous capsule “Fibrous capsule: connective tissue”
 Dependent on:
 Proliferative capacity of cells in the tissue (labile, stable/expanding,
permanent/static)
 Retention of the framework.

BIO MEDICAL DEPARTMENT,


23
BM T71-BIOMATERIALS AND ARTIFICIAL ORGANS

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