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Polymeric Biomaterials
Polymeric Biomaterials
ENT 219
Lecture 10
Polymeric Biomaterials
1.0 Introduction
Application of synthetic polymers
medical disposable supply
prosthetic materials,
dental materials
implants
dressings
extracorporeal devices
encapsulants
polymeric drug delivery systems
tissue engineered products
orthodosis
2
1.0 Introduction
Main Advantages
Ease of manufacturability to produce various shapes
Ease of secondary processability
Reasonable cost
Availability with desired mechanical and physical
properties.
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1.0 Introduction
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2.0 Basic Structure
Polymers have very long chain molecules which are
formed by covalent bonding along the backbone
chain.
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2.0 Basic Structure
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3.0 Crystal & Amorphous
Structure in Biopolymer
Crystallization is easier for polymer with shorter
chain
Branched polymer in which side chains are attached
to the main backbone chain at positions will not
crystallize easily
Linear polymers are much easier to crystallize
Partially crystallized structure (semicrystalline) is
commonly occur in linear polymers
The cross-linked or 3-D network polymers cannot be
crystallized at all & they become amorphous
polymers.
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3.0 Crystal & Amorphous
Structure in Biopolymer
Polymer with small side group are easy to crystallize
Isotactic & syndiotactic polymers usually crystallize
even when the side groups are larger
Copolymerization always disrupts the regularity of
polymer chains thus it is more amorphous
Plasticizers can prevent crystallization by keeping
the chains separated from one another
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3.0 Crystal & Amorphous
Structure in Biopolymer
Thermoplastic Polymers
Usually have linear & branched structures, they
soften when heated & harden when cooled.
The process reversible & can be repeated
The reheating and reforming process did not
have significant change on the polymer
properties
Mostly consist of a very long main chain of
carbon atoms covalently bonded together
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4.0 Biopolymers Properties
Thermoplastic Polymers
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4.0 Biopolymers Properties
Thermosetting Polymers
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4.0 Biopolymers Properties
Thermosetting Polymers
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5.0 Polymeric Biomaterials
Only ten to twenty polymers are mainly
used in medical device fabrications from
disposable to long-term implants
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5.0 Polymeric Biomaterials
Polyethylene (PE)
Available commercially as
high density (HDPE)
low density (LDPE)
linear low density (LLDPE)
very low density (VLDPE)
ultra high molecular weight (UHMWPE)
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5.0 Polymeric Biomaterials
Polyethylene (PE)…(continue)
•Low
density
•High
Density
•Linear low
density
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5.0 Polymeric Biomaterials
Polyethylene (PE)…(continue)
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5.0 Polymeric Biomaterials
Polyethylene (PE)…(continue)
HDPE -pharmaceutical bottles, nonwoven fabrics, &
caps
LDPE - flexible container applications, nonwoven-
disposable & laminated (or coextruded with paper) foil
& polymers for packaging.
LLDPE - pouches & bags due to its excellent puncture
resistance
VLDPE - extruded tubes.
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5.0 Polymeric Biomaterials
Polyethylene (PE)…(continue)
UHMWPE (MW >2×106 g/mol) has been used for orthopedic
implant fabrications.
This orthopedic implant fabrications include load-bearing
applications:
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5.0 Polymeric Biomaterials
Polyvinylchloride (PVC)…continue
PVC tubing-commonly used in intravenous (IV) administration,
dialysis devices, catheters, & cannulae
Specific Properties: Excellent resistance to abrasion, good
dimensional stability, high chemical resistance
Note:
To prevent the thermal degradation of the polymer (HCl could be
released), thermal stabilizers -metallic soaps/salts are
incorporated
Di-2-ethylhexylphthalate (DEHP or DOP) is used in medical PVC
formulation.
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Coronary Stent Implant
Percutaneous transluminal
coronary angioplasty (PTCA or
angioplasty)
PTCA means:
Percutaneous – performed
through the skin
Transluminal – through the
inside opening of a vessel
Coronary – relating to arteries or
veins of the heart
Angioplasty – a procedure to
open blood vessels
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5.0 Polymeric Biomaterials
Polypropylene (PP)
High melting (165-1770C) & heat deflection temperature
Additives for PP such as antioxidants, light stabilizer, nucleating
agents, lubricants, mold release agents, antiblock, & slip agents
are formulated to improve the physical properties &
processability
PP has an exceptionally high flex life & excellent environment
stress-cracking resistance, hence it had been tried for finger
joint prostheses with an integrally molded hinge design [Park,
1984]
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5.0 Polymeric Biomaterials
Polypropylene (PP)…continue
PP is used to make disposable hypothermic syringes, blood
oxygenator membrane, packaging for devices, solutions, and
drugs, suture, artificial vascular grafts, nonwoven fabrics, etc.
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5.0 Polymeric Biomaterials
Polymethylmetacrylate (PMMA)
Commercial PMMA-amorphous material with good
resistance to dilute alkalis & other inorganic solutions
Best known for exceptional light transparency (92%
transmission), high refractive index (1.49), good
weathering properties & as one of the most
biocompatible polymers
Used broadly in medical applications:
blood pump & reservoir,
IV system,
membranes for blood dialyzer
in vitro diagnostics.
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5.0 Biomedical Applications of
Polymeric Biomaterials
Polymethylmetacrylate (PMMA )…continue
It is also found in contact lenses & implantable ocular lenses due
to excellent optical properties
Dentures, & maxillofacial prostheses due to good physical &
coloring properties
Bone cement for joint prostheses fixation
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5.0 Biomedical Applications of
Polymeric Biomaterials
Polystyrene (PS) and Its Copolymers
PS has good transparency, lack of color, ease of
fabrication, thermal stability, low specific gravity &
relatively high modulus
Commonly used in tissue culture flasks, roller bottles,
vacuum canisters & filterware
Acrylonitrile–butadiene–styrene (ABS) copolymers
are produced by 3 monomers: acrylonitrile, butadiene
& styrene
Resistant to common inorganic solutions, have good
surface properties, and dimensional stability
For IV sets, clamps, blood dialyzers, diagnostic test
kits
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5.0 Polymeric Biomaterials
Polyesters
Frequently found in medical applications due to their
unique chemical & physical properties
PET (polyethyleneterephthalate) is so far the most
important
Biomedical applications-as artificial vascular graft,
sutures & meshes.
It is highly crystalline with high melting temperature,
hydrophobic & resistant to hydrolysis in dilute acids
Polycaprolactone is crystalline & has a low melting
temperature.
Soft matrix or coating for conventional polyester
fibers. Tissue engineering 30
Polyamides (Nylon)
Flexibility of carbon chain contributes to molecular flexibility, low
melt viscosity and high lubricity
Nylons are hygroscopic and lose their strength in vivo when
implanted
Poly (p-phenylene terephthalate) commonly known as Kevlar®
Very good mechanical properties, good thermal properties, good
chemical resistance, permeable to gases
Tubes for intracardiac catheters,surgical sutures, dialysis devices
components,heart mitral valves, sutures
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Polytetrafluoroethylene
(PTFE)
Commonly known as Teflon®
The polymer is highly crystalline, high density, low modulus of
elasticity & tensile strength
It also has a very low surface tension & friction coefficient (0.1)
Specific Properties: Chemical inertness, exceptional weathering
& heat resistance, nonadhesive, very low coefficient of friction
Application: Vascular & auditory prostheses, catheters, tubes
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5.0 Polymeric Biomaterials
Rubbers
Rubbers have been used for the fabrication of
implants
Natural rubber is compatible with blood in pure form
Crosslinking by x-ray & organic peroxides produces
rubber with superior blood compatibility
Silicone rubber developed for medical use
Good thermal stability, resistance to atmospheric &
oxidative agents, physiological inertness
Burn treatment, shunt, mammary prostheses,
maxillofacial implants
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5.0 Polymeric Biomaterials
Polyurethanes
Polyurethanes are usually thermosetting polymers: they are
widely used to coat implants
polyurethane rubber is quite strong and has good resistance to
oil and chemicals
Exceptional resistance to abrasion, resistance to breaking, very
high elasticity modulus at compression traction & sheering
remarkable
Adhesives, dental materials, blood pumps, artificial heart & skin
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5.0 Polymeric Biomaterials
Polyacetal, Polysulfone & Polycarbonate
Polyacetals & polysulfones are being tested as implant
materials
Polycarbonates have found their applications in the
heart/lung assist devices & food packaging
Polyacetals have reasonably high molecular weight &
excellent mechanical properties
Excellent resistance to most chemicals & to water
over wide temperature ranges
Hard tissue replacement
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5.0 Polymeric Biomaterials
Polyacetal, Polysulfone & Polycarbonate
Polysulfones have a high thermal stability due to the
bulky side groups (therefore, they are amorphous) &
rigid main backbone chains
Polycarbonates are tough, amorphous, & transparent
polymers
Excellent mechanical & thermal properties,
hydrophobicity & antioxidative properties
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5.0 Polymeric Biomaterials
Biodegradable Polymers
Hydrolysis of PLA yields lactic acid which is a normal
byproduct of anaerobic metabolism in the human body
& is incorporated in the tricarboxylic acid (TCA) cycle to
be finally excreted by the body as CO2 & water
PGA biodegrades by a combination of hydrolytic
scission & enzymatic (esterase) action producing
glycolic acid either enter the TCA cycle or is excreted in
urine and can be eliminated as CO2 & water
PLGA can be controlled from weeks to over a year by
varying the ratio of monomers & the processing
conditions
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5.0 Polymeric Biomaterials
Biodegradable Polymers…(continue)
PLA-high tensile strength & low elongation resulting in
a high modulus. Application:bone fracture fixation
PLGA-tissue engineered repair systems where cells are
implanted within PLGA films or scaffolds
PLGA-drug delivery systems in which drugs are loaded
within PLGA microspheres
Other-Poly-p-dioxanon:bioabsorbable polymer which
can be fabricated into flexible monofilament surgical
sutures
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5.0 Polymeric Biomaterials
Summary
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Biopolymers
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Cardiovascular Applications
Heart valves can be stenotic or incompetent
Polymers are used to make artificial heart valves
Leaflets are made from biometals
• Sewing ring made from PTFE or
PET
Connected to heart tissue
• Blood clogging is side effect
• PTFE is used as vascular graft to bypass clogged arteries.
• Blood oxygenators : Hydrophobic polymer membranes
used to oxygenate blood during bypass surgery
Air flows on one side and blood on the other side
and oxygen diffuses into blood.
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Extra: Opthalmic
Applications
Eye glasses, contact lenses and Intraocular implants are
made of polymers.
Hydrogel is used to make soft contact lenses
Absorbs water and allows snug fit
Oxygen permeable
Made of poly-HEMA
• Hard lenses made from PMMA
Not oxygen permeable
Mixed with Siloxanylalkyl
Metacrylate and metacrylic
acid to make permeable and hydrophilic.
• Intraocular implants are made of PMMA
• Poly-HEMA-Poly(hydroxyethyl methacrylic) acid
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Orthopedic Applications
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Tissue Engineering
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Sterilization of
healthcare products
The objective of sterilization is to prevent the
introduction into the body of pathogenic organisms
not normally present.
Sterilization can be defined as ‘the removal or
destruction of all living organisms, including
resistant forms such as bacterial or fungal spores’.
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Sterilization method
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Dry Heat
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Autoclaving
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Autoclaving
used significantly in hospitals for the sterilization of
repeated use articles.
not the predominant method in the commercial
sterilization of medical devices because of the
difficulties involved with autoclaving packaged
products.
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Irradiation
Generated by either gamma rays from a
Cobalt (Co60) source or an electron beam
(E-beam).
The cost of capital equipment is great, but
high throughputs will improve the return on
investment.
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Dosage for either process is measured in Megarad
(Mrad) and
as a general rule a radiation dose of around 2.5
Mrad will sterilize clean articles in air.
very effective for fully packaged and sealed single-
use items (most plastic films are effectively
transparent to radiation) where only one radiation
dose is required.
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lead to changes in the tensile strength, elongation
at break and impact strength (depend both on the
basic polymer and any additives used).
Irradiated devices are completely safe to handle and
can be released and used immediately after
sterilization.
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Ethylene oxide
Ethylene oxide is a powerful alkylating agent and is
regarded by the EPA as a toxic and possibly
carcinogenic gas (exposure to EtO is regulated by
the EPA and OSHA).
When mixed with air, EtO is not only flammable but
can also be explosive.
The effectiveness of EtO sterilization depends on
many variables such as time, gas concentration,
temperature and relative humidity (necessary to
moisten bacteria to insure effective destruction).
monitoring EtO sterilization difficult and time
consuming
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Some plastics are relatively permeable to EtO and
the process can then be used to sterilize fully
packaged articles by using thin packaging films,
such as PE.
EtO gas to enter the package and sterilize the
contents. The packaging film must also be
permeable to water vapor and air to be effective.
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Standards
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