Professional Documents
Culture Documents
2001
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1.
INTRODUCTION
2.
3.
4.
DESIGN EXAMPLE
4.1
Bone and joint replacement
4.2
Cardoivascular devices
4.3
Dental Materials
4.4
Ophthalmology Materials
5.
THE FUTURE
6.
REFERENCES
7.
INTERNET LINKS
1.
INTRODUCTION
The notes are directed towards the materials section of the Bioengineering Focus Module
of the NSW Engineering Studies Stage 6 Syllabus
It is not the aim of these notes to describe every biomedical material nor every
biomedical device.
2.
2.1
Fundamental Considerations
Biomaterials and biomedical devices are used throughout the human body (Figure 1).
Because human life and well being often depends on these devices there are stringent
controls and constraints placed upon the application of devices and the materials that can be
sued. When a prosthetic device is placed into the body, two aspects must be taken into
account:
1)
This concerns the effect of the physiological environment on the material/device The
material must satisfy its design requirements in service. The varied functions of
biomaterials include:
Load transmission and stress distribution eg bone replacement
Articulation to allow movement eg artificial knee joint
Control of blood and fluid flow eg artificial heart
Space filling eg cosmetic surgery
Electrical stimuli eg pacemaker
Light transmission eg implanted lenses
Sound Transmission eg cochlear implant
Biocompatibility
This concerns the effect of the prosthetic device/material (and any degradation product) in
the body. The material must not degrade in its properties within the environment of the body
and must not cause any adverse reactions within the hosts body.
2.2
NaCl aqueous solution (0.9 M) containing organic acids, proteins, enzymes, biological
macromolecules, electrolytes and dissolved oxygen, nitrogen compounds, and soluble
carbonates
pH ~7.4 normal physiological extracellular fluid
Cells (eg. inflammatory cells and fibrotic cells) secrete a whole host of complex
compounds that may significantly affect an implanted biomaterial
Application dependent mechanical environment: static, dynamic, stress, strain, friction
Dependent on:
type of material
static/dynamic stresses
projected device life
interactions with other device components
Mechanisms of
Material Degradation:
corrosion
dissolution
chemical modification
swelling
leaching
wear
Material Properties
Adversely Affected:
strength
fracture toughness
stiffness (elastic modulus)
surface roughness
wear resistance
chemical stability
Materials Selection
Biomedical Devices
Orthopaedic
Dental
Bone Cements
Vascular Devices
Cardiovascular Devices
Drug Delivery
Specialised Devices
Metals:
Ti alloys
CoCr alloys
Stainless Steel
Ceramics:
Composites
Polymers:
soft, hard
3.
3.1 Biometals
Metals are widely used as biomaterials due to their strength and toughness. While the widely
used implant metals (stainless steel, titanium and cobalt alloys) are generally biocompatible,
some people are allergic to ions released from these metals. The major problem with metals
is the generation of fine wear particles in service that can lead to inflammation and implant
loosening.
3.1.1 Biometals CoCrMo Alloys
Similar to Co alloys used for turbine blades in early gas turbine engines (Stellite)
Used in both cast condition and wrought condition. However, the wrought condition
provides superior mechanical and chemical properties due to finer grain sizes and a more
homogenous microstructure
ASTM F 136-98 (as-cast)
y = 430-490 MPa
uts = 720-890 MPa
Elongation = 5-17%
Coherent stable passivation layer (~10 nm) gives excellent corrosion resistance
Excellent wear resistance
Problem: Potentially release harmful Co, Ni and Cr ions into the body
However, titanium has unsatisfactory wear resistance and may produce wear debris
a)
b)
c)
Used in early hip implants for its good strength, ability to work harden, and pitting
corrosion resistance.
However due to potential long term release of Ni2+, Cr3+ and Cr6+ into the body, stainless
steels are restricted to temporary devices
3.2
Bioceramics
Ceramics are stiff, hard and chemically stable and are often used in situations where wear
resistance is vital. Of the large number of ceramics known, only a few are suitably
biocompatible. These ceramics can be grouped according to their relative reactivity in
physiological environment, (Figure 7). The main problem with ceramic components is that
they are brittle and relatively difficult to process.
A Resorbable Ceramics
B Bioactive Ceramics
C Bioinert Ceramics
Relative
Reactivity
Time (days)
a
b
c
d
Mg-PSZ
5.7
50c
600
9
12
200
Y-TZP
6.0
0.5
1200
10
10
200
Al2O3a
3.90
7
400
5-6d
23
380
HAP
3.15
1
100
0.5
4
100
Boneb
1.7-2.0
60-160
2-12
0.2
3-30
alumina (Al2O3)
partially stabilised zirconia (ZrO2)
silicon nitride (Si3N4)
Functional properties:
As mentioned ceramics generally have excellent wear resistance. This is ideal for
biomaterials as problems arising from wear of biomaterials include:
accelerated degradative processes
weakening of the material
production of shape changes that may affect function
production of biologically active particles (eg. may cause aseptic loosening)
wear particles further accelerate wear (3-body wear)
Coefficient of Friction
Wear Index
15
Metal-UHMWPE
10
5
Al2O3-Al2O3
0
1
10
100
1000
10000
0.15
Metal-UHMWPE
0.10
Al2O3-Al2O3
0.05
Natural Joint
0.00
1
10
100
1000
10000
Wear Mechanisms:
adhesive wear
abrasive wear
corrosive wear
surface fracture/fatigue wear
10
11
Biodegradable
Polylactic/glycolic acid sutures
Polyorthoesters
bone plates
Polyorthoesters
bone plates
Cyanoacrylates
wound closure
Polylactic acid
tendon repair
12
Composition
Chemical Composition
Mwt and Mwt Distribution
Chain Structure
Cross-Linking
Additives
Polymerisation
Residual Monomers
Residual Catalyst
Properties
Mechanical Properties
Surface Chemistry/Energy
Crystallinity
Diffusion/Permeability
Morphology
Molecular Orientation
Cleaning/Sterilisation
Autoclaving
Ethylene Oxide
Radation (UV or ionising)
Dry Heat
Performance
adsorption/swelling
surface reactions
oxidation reactions
leaching
wear
biological
The use of polymers as biomaterials started over 2500 years ago with collagen (found in
animal tissue) used as a surgeons thread. In the 1860s polymer dressings were applied to
wounds and in the 1930s experimental implantable polymer membranes were tested. In the
1970s the polymer polyglycolic acid (PGA) was developed as synthetic degradable sutures.
PGA was further developed over the next few decades and was used in implants that would
slowly release desired chemicals into the body and s scaffolding on which replacement
organs could be grown. Over 25 different types of cells have been grown on the polymer
scaffolds, and skin grown on these scaffolds has been successfully transplanted to heal
diabetic skin ulcers. It is hoped that in the future these scaffolds will be used to grow nerve
cells for use in spinal cord repairs, bone or cartilage cells for joint repairs, pancreatic cells to
make insulin for diabetics, and liver cells to make livers for transplantation.
Polymers are also used in many prosthetic devices as outlined in section 4.
13
4.
DESIGN EXAMPLES
Figure 12: A) Hip joint prosthesis components [11], B) Joint Replacement design [12]
The materials used for these applications include metals ceramics and polymers. Metals
dominate the bulk of the implant structure while ceramics and polymers are typically used at
interfaces and articulating surfaces. The metals used include:
Stainless steels: Commonly austenitic 316L stainless steel, used for its good strength,
ability to work harden, and pitting corrosion resistance. However due to potential long
term release of Ni2+, Cr3+ and Cr6+ into the body, stainless steels are restricted to
temporary devices such as plates and screws.
Co-based alloys: High tensile strength, excellent corrosion resistance and excellent
fatigue strength make these alloys ideal for joint construction. They are used in the cast
or wrought condition but the wrought condition provides superior mechanical and
chemical properties due to finer grain sizes and a more homogenous microstructure.
However, with these alloys there is risk of release of Cr, Ni and Co ions into the body
during wear, corrosion and repassivation events.
14
Figure 13: A) Forces at the hip joint, B) Knee joint prosthesis [13]
4.2 Cardiovascular devices
These are devices use to replace or supplement part of the cardiovascular system. The most
important aspect of these devices is Haemocompatibility the ability to maintain contact
with flowing blood without adverse reaction. It requires:
1) No leaching of toxic products
2) No generation of wear particles
Biomedical Materials Teacher Reference
2001 Materials Science and Engineering - UNSW
15
3) Chemical inertness
4) No chronic inflammatory response
Cardiovascular devices include:
4.2.1. Kidney dialysis machines
These machines use a semi-permeable membrane to purify the blood against artificial
liquids. Blood is fed via silicone or polyurethane elastomer catheters and into the dialyzer.
Inside the dialyzer PVC tubing holds the membranes (which can be cellulosic, Derivated
Cellulose or Synthetic) which is in contact with blood on one side and a non-toxic watery
solution on the other.
16
bioprosthetic. The mechanical valves consist of a supporting skeleton for the valve with a
sutureable sewing ring to allow attachment and a valve occluder which may be a disc,
shutter or ball. Mechanical valves are extremely reliable over the long term but require the
recipient to maintain anticoagulent therapy to avoid clotting. The metal frame for the device,
and the disc shaped occluders are usually a Ti-alloy or CoCrMo. To avoid mechanical
failures at the welds, current devices are machined from a single block of metal. The
common ball shaped occluder is a silicone elastomer developed to be resistant to swelling.
However, titanium balls have been used with densities designed to match blood. The knitted
fabric on the sewing ring is often PET or PTFE. Coatings of carbon are often used on the
valve prothesis due to carbons excellent hemocompatibility, fatigue resistance, wear
resistance and high fracture strength. Bioprosthesic valves also have a sewing ring and rigid
skeleton but the valves themselves are manufactured from xenograft tissue of bovine or
porcine origin. These have the advantages of reduced coagulation but their mechanical
properties can deteriorate with time.
17
Within the artificial heart, polyurethanes are typically used for pump bladders as they can be
used to make durable flexible membranes, critical for such a component. They are
occasionally laminated with reinforcing carbon fibres. Butyl rubbers are often layered inside
polyurethane to create an impermeable layer. PET is used to form the blood contacting inlet
and outlet connectors due to its excellent bio and haemocompatibility. Machined and cast
epoxies, amides (Kevlar), polycarbonate, polyurethane and titanium have all been used for
the housings for the devices.
18
the criteria are based on gold, gold palladium, silver palladium, copper palladium and nickel
chromium alloy systems.
19
SELECTED REFERENCES
Hill, D., Design Engineering of Biomaterials for Medical Devices, John Wiley and
Sons, Chichester, 1998
Cochlear Website: http://www.cochlear.com
Queen Mary University of London Webpage: http://www.materials.qmw.ac.uk/implant/
CO-MO Alooy see OWEN
Polmear, I.J., Light Alloys: Metallurgy of the Lighrt Metals: Third Edition, Arnold
London, 1995
Schlenker, B.R., Introduction to Materials Science: SI Edition, John Wiley & Sons,
Milton, 1974
Ceramic - owen
Ceramic - Owen
PSZ Owen
Almath Crucibles Ltd Website: http://www.almath.vispa.co.uk/zirconia.htm
Witkin, K.B. ed., Clinical Evaluation of Medical Devices: Principles and Case
Studies, Humana Press, Totowa, 1998
20
12.
13.
14.
15.
16.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
Materials Science and Technology Volume 14, Medical and Dental Materials. Edited
by D.F. Williams. VCH Publishers Inc., New York, 1992
Skalak, R & Chien, S., Handbook of Bioengineering, McGraw-Hill Book Company,
New York, 1987
Kidney Dialysis Foundation Website: http://kdf.org.sg/aboutkidney.html
Abiomed Website: http://www.abiomed.com
Old Dominion Eye Foundation Website: http://www.odeb.org/html/cornealtransplant.htm
J. Black and G. Hastings, Handbook of Biomaterial Properties. Chapman and Hall,
U.K., 1998.
MRS Bulletin, Volume XVI, Biomedical Materials. Materials Research Society,
Pittsburgh, 1991.
L.L. Hench and E.C. Ethridge, Biomaterials: An Interfacial Approach. Academic
Press, New York, 1982.
Biocompatibility of Clinical Implant Materials. Edited by D.F. Williams. CRC Press,
Boca Raton, 1981.
S.F. Hulbert, J.C. Bokros, L.L. Hench, J. Wilson, and G. Heimke, Ceramics in
Clinical Applications: Past Present and Future: pp.189 - 213 in High Tech Ceramics.
Edited by P. Vincenzini. Elsevier, Amsterdam, 1987.
L.L. Hench, Bioceramics: From Concept to Clinic, J. Am. Ceram. Soc., 74 [7] 1487
- 510 (1991).
L.L. Hench, Bioceramics, J. Am. Ceram. Soc., 81 [7] 1705-27 (1998).
S.F. Hulbert, L.L. Hench, D. Forbers, and L.S. Bowman, History of Bioceramics,
Ceram. Int., 8, 131-140 (1982).
Bioceramics of Calcium Phosphate. Edited by K. de Groot. CRC Press, Boca Raton,
1983.
CRC Handbook of Bioactive Ceramics, Volume 2: Calcium Phosphate and
Hydroxylapatite Ceramics. Edited by T. Yamamuro, L.L. Hench, and J. Wilson.
CRC Press, Boca Raton, 1991.
M.N. Rahaman, Ceramic Processing and Sintering. Marcel Dekker Inc., New York,
1995.
Wise, D.L., Trantolo, D.J., Lewandrowski, K-U, Gresser, J.D., Cattaneo, M.V. &
Yaszemski, M.J. eds., Biomaterials Engineering and Devices: Human Applications:
Volume 1, Humana Press, Totowa 2000, pp. 137-142
27.. Williams,D.F. & Roaf, R., Implants in Surgery, W.B. Saunders Company Ltd,
London, 1973, pp 303-356
28.
21
7. Internet Links
Useful Biomaterial Link Pages
http://www.surrey.ac.uk/MME/Research/BioMed/links.html
http://www.bmes.alfred.edu/links.html
http://www.ems.psu.edu/MATSE/faculty/vogler.html
http://www.umist.ac.uk/MatSci/useful/matsites.htm
http://www.bmen.tulane.edu/BMEFAQ/#s4
http://books.nap.edu/books/0309039282/html/103.html
http://www.bae.ncsu.edu/bae/research/blanchard/www/465/textbook/otherprojects/artificial/i
ndex.html
http://enuxsa.eas.asu.edu/~btowe/courses/bme201/study.html
http://www.salspolymer.com/history/polymers8.htm
http://www.beyonddiscovery.org/beyond/beyonddiscovery.nsf/web/polymers?OpenDocume
nt
Cochlear Implants
http://www.cochlear.com/rcs/cochlear/publisher/web/home_static/index.jsp
http://www.zak.co.il/deaf-info/old/ci-faq.html
http://www.listen-up.org/implant.htm#manu
http://www.houstonent.com/index02.htm
Hip Prosthesis
http://www.materials.qmw.ac.uk/implant
Heart Prosthesis
http://school.discovery.com/homeworkhelp/worldbook/atozpictures/lr000617.html
http://www.tmc.edu/thi/tah.html
Ophthalmology Materials
http://www.odeb.org/html/cornealtransplant.htm
Kidney replacement
http://kdf.org.sg/aboutkidney.html
22