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Biomaterials

Module 4 PLO-2/CLO-3/C-4

Testing of Biomaterials

Dr. Saima Shabbir, MS&E, IST


Fundamental Biological
Requirements of Biomaterials
Biocompatibility
In-vitro Tests for Biocompatibility
In-vivo Tests for Biocompatibility
Standards to Assess Biocompatibility

Dr. Saima Shabbir, MS&E, IST


Evolution of Biomaterials

1st generation (since 1950s)


Goal: Bioinertness
2nd generation (since 1980s)
Goal: Bioactivity
3rd generation (since 2000s)
Goal: Regenerate functional tissue

Dr. Saima Shabbir, MS&E, IST


Some Application of Biomaterials
Application Types of Materials
Skeletel system
Joint replacement (knee) Titanium , Stainless steel, PE
Bone plate Stainless steel, Co-Cr alloy
Bone cement PMMA
Artificial tendon and ligment Hydroxylapatie Teflon, Dacron
Dental implant Titanium, alumina, calcium phosphate
Cardiovascalar sysem
Blood vessel prosthesis Dacron, Teflon, Polyurethane
Heart valve Reprocessed tissue, Stainless steel, Carbon
Catheter Silicone rubber, Teflon, polyurethane
Organs
Artificial heart Polyurethane
Skin repair template Silicone-collagen composite
Artificial kidney Cellulose, polyacrylonitrile
Heart-lung machine Silicone rubber
Senses
Platium electrodes
Cochlear replacement
PMMA, Silicone rubber, Hydrogel
Intraocular lens
Silicone-acrylate, Hydrogel
Contact lens
Collagen, Hydrogel
Corneal bandage

Dr. Saima Shabbir, MS&E, IST


Biomaterials Types
Polymeric biomaterials
Bioceramics
Metallic biomaterials
Biocomposite
Biologically based (derived) biomaterials

Dr. Saima Shabbir, MS&E, IST


Polymeric Biomaterials

Advantages Disadvantages
Easy to make complicated Leachable compounds
items Absorb water and
Tailorable physical and proteins etc.
mechanical properties Surface contamination
Surface modification Wear and breakdown
Immobilize cell etc. Biodegradation
Biodegradable Difficult to sterilize

Dr. Saima Shabbir, MS&E, IST


Polymeric Biomaterials
PMMA
PVC
PLA/PGA
PE
PP
PA
PTFE
PET
PUR
Silicones

Dr. Saima Shabbir, MS&E, IST


Bioceramic

Advantages Disadvantages

High compression High modulus


strength (mismatched with
Wear and corrosion bone)
resistance Low strength in tension
Can be highly polished Low fracture toughness
Bioactive/inert Difficult to fabricate

Dr. Saima Shabbir, MS&E, IST


Bioceramics
Alumina
Zirconia (partially stabilized)
Silicate glass
Calcium phosphate (Apatite)
Calcium carbonate

Dr. Saima Shabbir, MS&E, IST


Metallic Biomaterials

Advantages Disadvantages

High strength High moduls


Fatigue resistance Corrosion
Wear resistance Metal ion sensitivity
Easy fabrication and toxicity
Easy to sterilize Metallic looking
Shape memory

Dr. Saima Shabbir, MS&E, IST


Metallic Biomaterials
Stainless steel (316L)
Co-Cr alloys
Ti6Al4V
Au-Ag-Cu-Pd alloys
Amalgam (AgSnCuZnHg)
Ni-Ti
Titanium

Dr. Saima Shabbir, MS&E, IST


Deterioration of Biomaterials

Corrossion
Degradation (oxidative, thermal, hygroscopic)
Calcification
Mechanical loading
Combined

Dr. Saima Shabbir, MS&E, IST


General Criteria for Materials
Selection
Mechanical and chemicals properties
No undersirable biological effects
carcinogenic, toxic, allergenic or immunogenic
Possible to process, fabricate and sterilize with
a good reproducibility
Acceptable cost/benefit ratio

Dr. Saima Shabbir, MS&E, IST


Material Properties

Compresssive strength Surface tension


Tensile strength Hardness and density
Bending strength Hydrophobic/philic
E-Modulus Water
Coefficient of thermal sorption/solubility
expansion Surface friction
Coefficient of thermal Creep
coductivity Bonding properties

Dr. Saima Shabbir, MS&E, IST


The Biological Milieu
Atomic scale
Molecular scale
Cellular level
Tissue
Organ
System
Organism

Dr. Saima Shabbir, MS&E, IST


pH in Humans

Gastric content 1.0


Urine 4.5-6.0
Intracellular 6.8
Interstitial 7.0
Blood 7.17-7.35

Dr. Saima Shabbir, MS&E, IST


Sequence of Local Events
following Implantation in Soft
Tissue
Injury
Acute inflammation
Granulation tissue
Foreign body reaction
Fibrosis

Dr. Saima Shabbir, MS&E, IST


Soft Tissue Response to an Implant
Acute (mins to hrs)
Cell type: Leukocytes (white blood cells)
Function: Recognition, engulfment and degradation (killing)
Chronic (days to months)
Cell types: Macrophages, monocytes and lymphocytes.
Granulation tissue formation (3-5 days)
Cell types: Endothelial cells (forming blood vesssels), fibroblasts
(forming connnective tissue)
Foreign body reaction (days to life time)
Cell types: Foreign body giant cells, Macrophages, fibroblasts
Fibrosis and Fibrous encapsulation
Cell type: Fibroblasts

Dr. Saima Shabbir, MS&E, IST


Biocompatibility

Biocompatibility: The ability of a material to


perform with an appropriate host response in
a specific application.
Host response: the reaction of a living system
to the presence of a material

Dr. Saima Shabbir, MS&E, IST


Biocompatibility
When lacking biocompatiblity

long-lasting chronic inflammation


cytotoxic chemicals
disruption of cells at interface
micron-sized materials
irritation
corrosion of metals
restenosis/thrombosis
Dr. Saima Shabbir, MS&E, IST
Test Hierarchies (for blood-contacting device)
Cell culture, cytotoxicity (Mouse L929 cell line)
Hemolysis (rabbit or human blood)
Mutagenicity (Ames test)
Systemic injection, acute toxicity (Mouse)
Sensitization (Guinea pig)
Pyrogenicity (Rabbit)
Intramuscular implnatation (Rat, rabbit)
Hemocompatibility
Long-term implatation.

Dr. Saima Shabbir, MS&E, IST


Introduction to Testing Biomaterials
How can biomaterials be evaluated to
determine if they are biocompatible and will
function in a biologically appropriate manner
in the in vivo environment?

Dr. Saima Shabbir, MS&E, IST


Introduction to Testing Biomaterials
Evaluation under in vitro (literally "in glass")
conditions: rapid and inexpensive data on
biological interaction.
The question: will the in vitro test measure
parameters relevant to what will occur in vivo
environment?

Dr. Saima Shabbir, MS&E, IST

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