MME 297: Lecture 01

Introduction
[1] Introduction to Biomaterials:

Reference: 1. JB park, page 6-9

2. Ratner, introduction

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 WHAT ARE BIOMATERIALS ?

❑ A biomaterial is “any material designed to interact in some fashion

with a biological system.”

❑ A biomaterial is a material used in a medical device, intended to

interact with biological systems.

❑ A biomaterial can be defined as any material used to make devices

to replace a part or a function of the body in a safe, reliable, economic,
and physiologically acceptable manner.

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❑ 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.

❑ Thus, a biomaterial is a synthetic material used to replace part of

a living system or to function in intimate contact with living tissue.
• Examples: sutures, tooth fillings, needles, catheters, bone plates.

❑ ..... a systematically and pharmacologically inert substance

designed for implantation within or incorporation with living systems.

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❑ In true sense, natural materials of biological origin, such as bone,
skin, or artery, are not biomaterials. We shall refer them as
“biological materials.”

❑ Artificial materials, on the other hand, are simply in contact with

the skin, such as hearing aids and wearable artificial limbs, are not
biomaterial since the skin acts as a barrier with the external world.

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❑ Since the ultimate goal of using biomaterials is to improve human
health by restoring the function of natural living tissues and organs
in the body, it is also essential to understand relationships among the properties,
functions, and structures of biomaterials.

❑ “Biomaterials science” is the study (from the physical and/or

biological perspective) of materials with special reference to their
interaction with the biological environment.

❑ It encompasses three key areas:

1. Basic sciences (biology, chemistry, physics)
2. Engineering
3. Medicine

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 ❑ The translation of biomaterials science to clinically important
medical devices is dependent on:

1. sound engineering design;

2. testing in vitro, in animals and in humans;
3. clinical realities; and
4. the involvement of industry permitting product development and
commercialization.

FIGURE 1 The path from the basic science of biomaterials, to a medical device, to clinical application.
Ref: Ratner
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❑ Three aspects of study on the subject of biomaterials:
1. Biological materials
2. Implant materials
3. Interaction between the two in the body

❑ So, traditionally, emphasis in the biomaterials field has been on

synthesis, characterization, and host–material interactions biology.

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❑ The success of a biomaterial or an implant
is highly dependent on three major factors:

1. properties and biocompatibility of the implant

2. health condition of the recipient, and

3. competency of the surgeon

who implants and monitors its progress.

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SO, what are the property requirements for an implant?

Consider the case of a bone plate

that is used to stabilize a fractured femur after an accident.

1. Acceptance of the plate to the tissue surface i.e., biocompatibility

(this is a broad term and includes point 2 and 3)

2. Pharmacological acceptability
(non-toxic, non-allergenic, non-immunogenic, non-carcinogenic, etc.)

3. Chemically inert and stable (no time-dependent degradation)

4. Adequate mechanical strength
5. Adequate fatigue life
6. Sound engineering design
7. Proper weight and density
8. Relatively inexpensive, reproducible, and easy to fabricate and process
for large-scale production
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 Class of (synthetic) materials used in the body

Materials Advantages Disadvantages Examples

Polymers (nylons, silicone, • Resilient • Not strong Sutures, blood vessels,
rubber, polyester, • Easy to fabricate • Deforms with time other soft tissues, hip
polytetrafluroethylene, etc.) socket, ear, nose
• May degrade

Metals (Ti and its alloys, • Strong, tough • May corrode Joint replacements,
Co-Cr alloys, Au, Ag, stainless • Ductile • Dense dental root implants,
steels, etc.) pacer and suture wires,
• Difficult to make bone plate and screws

Ceramics (alumina, zirconia, • Very bio-compatible • Brittle Dental and orthopedic

calcium phosphates including • Not resilient implants
hydroxyapatite, carbon)
• Weak in tension

Composites (carbon-carbon, • Strong • Difficult to make Bone cement, dental

wire- or fibre-reinforced bone • Tailor-made resin
cement)

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Key applications of synthetic and modified natural materials in medical field

type of materials
• metals
• glasses & ceramics
• polymers
• composites

form of materials
• molded
• machined parts
• coatings
• fibers
• films
• membranes
• foams
• fabrics
• nanoparticles

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Reference: Ratner
 PERFORMANCE OF BIOMATERIALS
❑ The performance of an implant after insertion can be considered
in terms of reliability.

❑ If the probability of failure of a given system is assumed to be 𝑓,

then the reliability, 𝑟, can be expressed as
𝑟 = 1 −𝑓

❑ If the failure of the implant is contributed by a number of factors,

the total reliability 𝑟𝑡 , can be expressed in terms of the reliabilities
of each contributing factor for failure:

𝑟𝑡 = 𝑟1 , 𝑟2 , … , 𝑟𝑛 Product of each contributing reliabilities

where 𝑟1 = 1 − 𝑓1 , 𝑟2 = 1 − 𝑓2, etc.

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Ref: J B Park page 9
For example, there are four major factors contributing to the failure
of hip joint replacements:

[1] fracture This implies that, even though an implant

[2] wear has a perfect reliability (i.e., r =1) of one
factor, if an infection occurs every time it
[3] infection, and is planted, then the total reliability of the
[4] loosening of implants operation is zero.

Probability
loosening
of Failure infection
fracture

wear

0 5 10 15
Implant Period (Year)

Schematic illustration showing probability of failure of hip joint

at different implant period
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❑ The study of the relationships between the structure and
physical properties of biological materials is also as important
as that of biomaterials.

❑ In many cases, one can study biological materials while ignoring

the fact that they contain and are made with living cells.
• For example, in teeth the function is largely mechanical, so that one can focus
on the mechanical properties of the natural material and try to replace them
with biomaterial.
• In other cases, such as spinal cord or brain, the functionality of tissues or
organs is so dynamic that it is meaningless to replace them with biomaterials.

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 THE EVOLUTION OF THE
BIOMATERIALS FIELD

The development of biomaterials for medical and dental applications has

evolved through three generations, each with a distinct objective.

• The goal of early biomaterials (first generation) was to achieve a

suitable combination of functional properties to adequately
match those of the replaced tissue without deleterious response
by the host.

• They were selected because of the desirable combination of physical

properties specific to the intended clinical use, and because they were
bioinert (i.e., they elicited minimal response from the host tissues), and
therefore
they were considered biocompatible.

Ref: Ratner 15
E.g. elastomeric polymer, silicone rubber, Pyrolytic carbon, originally
developed in the 1960s used as a coating material for nuclear fuel
particles, and now widely used in modified compositions to coat
components of mechanical heart valves

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• Second generation biomaterials evolved from those early biomaterials,
and were intended to elicit a controlled reaction with the tissues into
which they were implanted in order to induce a desired therapeutic effect.

• The second generation of biomaterials also included the development

of resorbable biomaterials, with rates of degradation that could be
tailored to the requirements of a desired application

• Thus, the discrete interface between the implant site and the host
tissue could be eliminated in the long-term, because the foreign
material would ultimately be degraded to soluble, non-toxic
products by the host.

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• The third generation of biomaterials, the logical extension of the
rapidly progressing state-of-the-art, has the goal of supporting and
stimulating the regeneration of functional tissue.

• Tissue engineering use living cells to aid tissue formation or

regeneration, and thereby produce therapeutic or diagnostic
benefit.

• Tissue engineering has led to the replacement in humans of

damaged bladders, trachea, skin, corneal epithelium, and
cartilage.

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