KIB 3004/ KUEU 3147

Materials in BME/
Biomaterials
Introduction and history of
biomaterials

Farina Muhamad
 Course Outcomes

1) Explain the theory of fundamentals of Materials in

Biomedical Engineering
2) Identify the properties of materials (metals,
polymers, ceramics, composites) used as
biomaterials
3) Select the appropriate materials for specific
applications in Biomedical Engineering
 PROGRAMME LEARNING
OUTCOMES (PLO)
PO1- Apply knowledge of mathematics, natural
science, engineering fundamentals and an engineering
specialisation as specified in WK1 to WK4 respectively
to the solution of complex engineering problems
PO7- Understand and evaluate the sustainability and
impact of professional engineering work in the
solutions of complex engineering problems in societal
and environmental contexts.
PO11- Recognize the need to undertake life-long
learning and possess the capacity to do so
independently.
 Rujukan/Bahan
Minggu Topik Kuliah/Tutorial/Tugasan
Pengajaran/Peralatan

Pengenalan kepada Sains Bahan dan Kejuruteraan Buku Rujukan, Nota Kuliah
1 Introduction to Material Science and Enginering

Struktur atom dan ikatan/ Struktur dan ciri umum bahan-bahan Buku Rujukan, Nota Kuliah

Atom Structure and Bond/ General structures and characteristics of

2
materials

Pencirian bahan Buku Rujukan, Nota Kuliah

3 Characterization and mechanical properties of materials

Biobahan logam Buku Rujukan, Nota Kuliah

4 Metal Biomaterials

Biobahan polimer Buku Rujukan, Nota Kuliah

5
Polymeric Biomaterials

Biobahan seramik/komposit Buku Rujukan, Nota Kuliah

6 Ceramic/ Composite Biomaterials

Kesesuaian biologi Buku Rujukan, Nota Kuliah

7 Biocompatibility
Ujian/Test (20%)
Tissue Engineering Buku Rujukan, Nota Kuliah
8 Orthotic materials technology

Testing of Biomaterials Buku Rujukan, Nota Kuliah

9

Hydrogels Buku Rujukan, Nota Kuliah

10 Tugasan (10%)

Pencirian bahan Buku Rujukan, Nota Kuliah

11 Methods and Tools for Material Characterization

Orthotic materials technology Buku Rujukan, Nota Kuliah

12

Hard Tissue Implants Buku Rujukan, Nota Kuliah

13 Tugasan (10%)

Soft Tissue Implants Buku Rujukan, Nota Kuliah

14
 Assessments

Continuous Assessment: 40% (Test, Assignments,

Presentation)
Final Examination: 60%
 Class time

Wednesday 12-1pm
Friday 9-11am

Changes Friday 9-12 noon

What is biomaterials?
 What is biomaterials?
• Biomaterials are rarely used on their own
• Commonly integrated into devices or
implants.
• Cannot be explored without considering
biomedical devices and the biological
response to them.
 What is biomaterials?
• A nonviable material used in a medical device, intended
to interact with biological systems.”
(Attributed to Williams 1987, cited in Biomaterials Science, ed
Ratner, Hoffman, Schoen and Lemons, John Wiley & Sons,
Inc., p2)

• Any material of natural or of synthetic origin that comes in

contact with tissue, blood or biological fluids, and intended for
use in prosthetic, diagnostic, therapeutic or storage
applications without adversely affecting the living organism
and its components
 Definition of biomaterials
Any substance (other than drugs) or combination of
substances, synthetic or natural in origin, which
can be used for any period of time, as a whole or as
a part of a system which treats, augments, or
replaces any tissue, organ, or function of the body
[Williams, 1987]

A systemically and pharmacologically inert

substance designed for implantation within or
incorporation with living systems
[The Clemson University Advisory Board for Biomaterials ]
 What is biological materials?
• Is a natural biocompatible materials produced by a
biological system (that comprise a whole or a part of a
living structure or biomedical device that performs,
augments, or replaces a natural function).

• Present inside living organisms and have the ability

to repair themselves.

• They do not contain any metal, ceramic, or synthetic

polymer material.
Types of biological materials
• Human Derived
- Antibodies
- Blood & plasma
- DNA
- Enzymes, peptides, proteins,
- RNA

• Natural Materials
- Hydroxyapatite (HA)
- Artificial tissue
- Bone & tissue
- Bio-polymers (starch, cellulose, silk etc)
 What is biocompatibility?
• The ability of material to perform within an
appropriate host response in a specific application.

• The quality of not having toxic or injurious effects on

biological systems.

• Without causing / having:

– a harmful tissue reaction (pain, swelling or
necrosis) that could compromise function;
– a systemic toxic reaction; or
– tumorigenic potential.
What is biocompatibility?
 Biomaterials Science Is An
Interdisciplinary Affair:
• Physical scientists
• Engineers
• Dentists
• Biological scientists
• Surgeons
• Veterinary practitioners in industry
• Government
• Clinical specialties
• Academic settings.
 BIOMATERIALS
SCIENTISTS
• study the interactions of natural and synthetic
substances and implanted devices with living
cells, their components, and complexes such as
tissues and organs.
 BIOMATERIALS
ENGINEERS
• develop and characterize the materials used to
measure, restore and improve physiologic
function, and enhance survival and quality of life.
 THE SOCIETY FOR
BIOMATERIALS

A professional society which promotes advances

in all phases of materials research and
development by encouragement of cooperative
educational programs, clinical applications, and
professional standards in the biomaterials field.
Internationally recognized leaders in the
biomaterials field participate in the Society and
sponsored events. (www.biomaterials.org)
 BIOMATERIALS JOURNALS
• Biomaterials World News
• Materials Today
• Nature
• Journal of Biomedical Materials Research
• Cells and Materials
• Journal of Biomaterials Science
• Artificial Organs
• Materials Engineering C
• Tissue Engineering
• Annals of Biomedical Engineering
• Medical Device Link
• Biomaterials
 Characteristics of Biomaterials
• Physical Requirements
– Hard Materials.
– Flexible Material.
 Chemical Requirements
 Must not react with any tissue in the
body.
 Must be non-toxic to the body.
 Long-term replacement must not be
biodegradable.
WHERE ARE BIOMATERIALS ?
BIOMATERIALS COVER ALL CLASSES OF MATERIALS –
METALS, POLYMERS, CERAMICS, COMPOSITES

18
 Skin/cartilage
Drug Delivery
Devices
Ocular
Polymers implants

Orthopedic Bone
screws/fixation replacements

Heart
valves
Metals Synthetic Ceramics
BIOMATERIALS

Dental Implants Dental Implants

Semiconductor
Materials Biosensors
Implantable
Microelectrodes
Materials for use in the body
Uses of biomaterials
Biomaterials in organ
Biomaterials in body system
Early Biomaterials
Old civilizations: detailed dental work on a mummy from ancient Egypt that
archaeologists have dated to 2000 BCE. The work shows intricate gold work
around the teeth. This mummy was found with two donor teeth that had holes
drilled into them. Wires were strung through the holes and then around the
neighboring teeth

During the Roman period (5th BCE –4th CE),

crowns and bridges were manufactured from
gold strips and were attached to existing teeth
with great precision.

28
 History
• Romans, Chinese, and Aztecs used gold in
dentistry over 2000 years ago
• Ivory & wood teeth
• Aseptic surgery 1860 (Lister)
• Bone plates 1900, joints 1930
• Turn of the century, synthetic plastics came into
use
* WWII, shards of PMMA unintentionally got
lodged into eyes of aviators
* Parachute cloth used for vascular prosthesis
 History (Continued)
• 1960- Polyethylene and stainless steel being
used for hip implants
• 1960- Charnley uses PMMA, ultrahigh-
molecular-weight polyethylene, and stainless
steal for total hip replacement.
• Late 1960 – early 1970’s biomaterial field
solidified.
• 1975 Society for Biomaterials formed.
Evolution of Biomaterials
First Generation Biomaterials
 Intraocular Lens
• Implantation often performed on outpatient basis

• 3 basic materials – PMMA, Acrylic, silicone

 Intraocular Lenses

• Made of PMMA, silicone elastomer,

and other materials.
• By age 75 more than 50% of population
suffers from cataracts.
• 1.4 million implantations in the United
States yearly.
• Good vision is generally restored almost
immediately after lens is inserted.
 Vascular Grafts
• Must Be Flexible.
• Designed With Open Porous Structure.
• Often Recognized By Body As Foreign.
 Vascular Grafts
• Achieve and maintain homeostasis.
• Porous.
• Permeable.
• Good structure retention.
• Adequate burst strength.
• High fatigue resistance.
• Low thrombogenecity.
• Good handling properties.
• Biostable.
 Vascular Grafts
• Braids, weaves, and knits.
– Porosity
– Permeability
– Thickness
– Burst strength
– Kink resistance
– Suture retention
– Wall thickness
– Tensile properties
– Ravel resistance
Second Generation of Biomaterials
 A dental implant is a "root" device, usually Metallic Biomaterials: Dental Implants
made of titanium, used in dentistry to support
restorations that resemble a tooth or group of
teeth to replace missing teeth.

The majority of dental implants are made out of

commercially pure titanium. More recently grade
5 titanium has increased in use. Grade 5
titanium, Titanium 6AL-4V, (signifying the
Titanium alloy containing 6% Aluminium and 4%
Vanadium alloy). Ti- 6Al-4V alloy offers better
tensile strength and fracture resistance.

40
http://en.wikipedia.org/wiki/Dental_implant
Dental Implants
Procedure Metallic Biomaterials: Dental Implants

Phase 1. Surgical placement of the

implant(s) into the bone. This is usually done
right in the dentist’s office, with a local
anesthetic. After surgery, there is a healing
period of approximately four months. During this
time, the implants fuse to the bone by a process
known as ‘osseointegration’

Phase 2. there is a minor surgical exposure of

the top of the implant, whereby the dentist will
attach the post to the implant. The function of
the post is to become the support for either one
tooth or a set of teeth. This is a short procedure
that usually requires only local anesthesia.

Phase 3. The last phase is the restorative

phase. The dentist will take impressions and
then make a prosthesis that will attach to the
implants. This will require several visits. Once
completed, your mouth will be restored to
natural looking, strong teeth. 42
http://www.dentalimplant.com/topic4.htm
 Dental Implants
• Capable of bonding to bone, a
phenomenon known as "osseointegration”.
• Bio-inert, there is no reaction in tissue and
no rejection or allergic reactions.
 Metallic Biomaterials: Bone Implants
Hip replacement

Hip replacement operations are highly successful in relieving pain and

restoring movement.

Men and patients who weigh more than 165 lb have higher rates of failure. The
chance of a hip replacement lasting 20 years is approximately 80%. 44
Hip-Replacements
 Hip-Replacements
• Most Common Medical Practice Using
Biomaterials.
• Corrosion Resistant high-strength Metal
Alloys.
• Very High Molecular Weight Polymers.
• Thermoset Plastics.
 Hip-Replacements
• Some hip replacements ambulatory function
restored within days after surgery.
• Others require an extensive healing period
for attachment between bone and the
implant.
• Most cases good function restored.
• After 10-15 years, implant loosens requiring
another operation.
 Heart Valve
• Fabricated from carbons, metals,
elastomers, fabrics, and natural valves.

• Must NOT React With Chemicals in Body.

• Attached By Polyester Mesh.

• Tissue Growth Facilitated By Polar Oxygen-

Containing Groups.
 Heart Valve
• Almost as soon as valve implanted cardiac
function is restored to near normal.

• Bileaflet tilting disk heart valve used most

widely.

• More than 45,000 replacement valves

implanted every year in the United States.
Bileaflet Heart Valves
 Mechanical Valves

• Materials:
– Stainless steel, titanium, cobalt-chromium alloys
– Pyrolytic carbon
– Silicone rubber
– Polyester fabric
• Advantages: long term durability
• Disadvantages: antithrombogenic therapy (potent
drug)
Problems with Heart Valve’s

• Degeneration of Tissue.
• Mechanical Failure.
• Postoperative infection.
• Induction of blood clots.
Third generation implants
 Tissue Engineering
Tissue Engineering is the in vitro development
(growth) of tissues or organs to replace or support
the function of defective or injured body parts.
Research is presently being conducted on
several different types of tissues and organs,
including:

 Skin
 Cartilage
 Blood Vessels
 Bone
 Muscle
 Nerves
 Liver
 Kidney
 etc. etc. etc.
 Bioprosthetic valves
• Materials:
– ”fixed”porcine valve
– ”fixed”bovine pericardium
– Cryopreserved human valve
– polyester fabric-coated SS struts
• Advantages:
– superior hemodynamics
• Disadvantages:
– Limited durability
– Calcification
– mechanical breakdown
– Prone to infection
 Evolution of Biomaterials
Structural

Soft Tissue
Replacements

Functional Tissue
Engineering Constructs
Advances in Biomedical
Technology
 What are some of the
Challenges?
• To more closely replicate complex tissue
architecture and arrangement in vitro.
• To better understand extracellular and
intracellular modulators of cell function.
• To develop novel materials and processing
techniques that are compatible with biological
interfaces.
• To find better strategies for immune
acceptance.
 Classification of Medical Devices
Based on the duration of the device use, invasiveness and
risk to the user.
•Class I devices: crutches, bedpans, tongue depressors,
adhesive bandages etc. –minimal invasiveness, does not
contact the user internally.

•Class II devices: hearing aids, blood pumps, catheters,

contact lens, electrodes etc. –higher degree of
invasiveness and risk, but relatively short duration.

•Class III devices: cardiac pacemakers, intrauterine

devices, intraocular lenses, heart valves, orthopedic
implants, etc. -considerably more invasive and can pose
immense risk to the user-implantables.
International standards for biomaterials engineering

Food and Drug Administration FDA

http://www.fda.gov/

American Society for Testing and Materials Committee ASTM

http://www.astm.org/ABOUT/aboutASTM.html

International Standards Organisation ISO

http://www.iso.org/iso/home/about.htm
- Material requirements
- Testing Conditions
- Controls
- Data interpretation
 Biomaterial Or Medical Device?
• It is important to know that the FDA neither approves materials
nor maintains a list of approved materials

• Although FDA recognizes that many of the currently available

biomaterials have vast utility in the fabrication of medical
devices, the properties and safety of these materials must be
carefully assessed with respect to the specific application in
question and its degree of patient contact.

• An important principle in the safety assessment of medical

devices is that a material that was found to be safe for one
intended use in a device might not be safe in a device intended
for a different use.

• Accurate characterization is an essential step in selecting a

material for a medical device, but ultimately the final
assessment must be performed on the finished product, under
actual use conditions.
Biomaterials Research in Industry

SELECTION OF BIOMATERIALS

• is dominated as much by the regulatory approval

process and submission requirements as by the
physical, mechanical, and chemical properties of
the medical device.
 Manufacture of a Medical Device
• One of the first steps involves the selection of suitable
biocompatible materials.

• This is an essential step because the types of tests required for

evaluation of a device depend on the physical and chemical
nature of its materials in addition to the nature of the device's
exposure to the body.

• A specific material may appear suitable on the basis of its

physical properties, cost, and availability, but might contain toxic
chemical components.

• Therefore, it is advisable to screen the candidate materials at an

early stage to eliminate those that are toxic, and select those that
are sufficiently biocompatible or nontoxic for their intended use.

• Chemical constituents and potential extractables should be

identified and quantified for overall safety assessment of the
device.
 The Road To FDA Approval

Approval Steps:
1.In vitro testing (“in glass”)
2.In vivo testing w/healthy animals
3.In vivo testing w/animal models of disease
4.Controlled clinical trials