Bio-Medical

Materials
 Definition

 A biomaterial is a nonviable material used in a

medical device, intended to interact with
biological systems.
 A biomaterial is a synthetic or natural material
suitable for use in constructing artificial organs
and prostheses or to replace bone or tissue.

 Defined by their application NOT chemical

make-up.
“materials of synthetic as well as of natural origin in
contact with tissue, blood, and biological fluids, and
intended for use for prosthetic, diagnostic, therapeutic,
and storage applications without adversely affecting
the living organism and its components” [Bruck, 1980]
 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.
 Biocompatibility is defined as the property of being biologically compatible by not
producing a toxic, injurious, or immunological response in living tissue. The human
body has an extraordinary ability to be able to tell whether an object is foreign or
not. This is part of the bodies protection against invasion from an outside
organism.
 If a substance is placed in the body and the body can tell it is foreign, then an
immune system response will be generated. When an object is incorporated into
the body without any immune responses it is said to be BIOCOMPATIBLE. In order
for a device to be biocompatible, it must follow a very stringent set of demands
from the body.

 The device must be very strong so it does not break inside the body. Depending on
the circumstances, it may need to be either very hard or very flexible. Anything
placed into the body must be able to take a constant physical beating from one's
body. For instance, the valves in a heart open and close about 70 - 80 times a
minute. Over the course of years and years this adds up to millions of pumps. If
the artificial valve cannot meet these standards and fails, the person will die.
 History

 More than 2000 years ago, Romans,

Chinese, and Aztec’s used gold in dentistry.
 Turn of century, synthetic implants become
available.
 1937 Poly(methyl methacrylate) (PMMA)
introduced in dentistry.
 1958, Rob suggests Dacron Fabrics can be
used to fabricate an arterial prosthetic.
 History (Continued)

 1960 Charnley uses PMMA, ultrahigh-

molecular-weight polyethylene, and
stainless steel for total hip replacement.
 Late 1960 – early 1970’s biomaterial field
solidified.
 1975 Society for Biomaterials formed.
 Incision:
a surgical cut made in
skin or flesh
• Intraocular lens (IOL) is a
lens implanted in the eye as
part of a treatment for
cataracts
• The various materials can be used
to manufacture intraocular lens
implants include
polymethylmethacrylate
(PMMA), silicone, hydrophobic
acrylate, hydrophilic acrylate and
collamer.
Prosthetic or Artificial
eye

glass eye
 Bionic eye

A visual prosthesis, often

referred to as a bionic eye,
is an experimental visual
device intended to restore
functional vision in those
suffering from partial or total The implant costs about $100,000 to $150,000
blindness. excluding surgery and maintenance costs.
Since the early 1930’s, scientists have studied and experimented with the use of
electricity to stimulate vision through the visual centers in the brain in the blind.
Because of the advancement of biomaterials, electronics, and retinal surgery
since the 1990’s, the potential of these technologies became a reality. The tests
have shown that visual prostheses were the most probable options to
successfully work in the retinas of blind individuals. The hopes of scientists were
to release a prototype into the public before 2013. This goal was met in May of
2012.
 Material used in bionic eye and its
Biocompatibility

As they Said: in Materials World magazine, 24 Jul 2012

• In order to achieve a very high electrode density, we are using diamond
materials to form the electrode array and seal the implant (the diamond
material is grown synthetically by combining methane and hydrogen
in a microwave-like reactor). Diamond is very biocompatible because it
is an inert material, which means surrounding tissues will not be irritated
by the implant. The implant will be safe to stay in the body for the
patient’s lifetime.
• We are fabricating the electrode array and a box to contain the microchip
entirely out of diamond. All the body will see is carbon, making our implant
biocompatible and reducing the risk of rejection and inflammation in the
surrounding tissue. Furthermore, combining conducting and non-conducting
diamond means we can connect the electrodes to the microchip without using
wires for a fully sealed and isolated design.
 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
Biomaterial Science
Evolution of Biomaterial Science
& Technology
• 1st generation (since 1950s)
Goal: Bioinertness
• 2nd generation (since 1980s)
Goal: Bioactivity
• 3rd generation (since 2000s)
Goal: Regenerate functional tissue
 First Generation
Biomaterials

 Specified by physicians using common

and borrowed materials.
 Most successes were accidental rather
than by design.
 Second Generation
of Biomaterials

 Developed through collaborations of

physicians and engineers.
 Engineered implants using common and
borrowed materials.
 Built on first generation experiences.
 Used advances in materials science
(from other fields).
 Third generation
implants

 Bioengineered implants using bioengineered

materials.
 Few examples on the market.
 Some modified and new polymeric devices.
 Many under development.
 Examples of Biomaterial
Applications
 Heart Valve
 Artificial Tissue
 Dental Implants
 Intraocular Lenses
 Vascular Grafts
 Hip Replacements
 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
 Problems with
Heart Valve’s

 Degeneration of Tissue.
 Mechanical Failure.
 Postoperative infection.
 Induction of blood clots.
 Artificial Tissue

 Biodegradable
 Polymer Result of
Condensation of
Lactic Acid and
Glycolyic Acid
 Dental Implants

 Small titanium fixture that serves as the

replacement for the root portion of a missing
natural tooth.
 Implant is placed in the bone of the upper
or lower jaw and allowed to bond with the
bone.
 Most dental implants are: pure titanium
screw-shaped cylinders that act as roots for
crowns and bridges, or as supports for
dentures.
 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.
Dental Implants
 Intraocular Lenses

 Made of PMM, 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.
Intraocular Lenses
 Vascular Grafts

 Must Be Flexible.
 Designed With Open
Porous Structure.
 Often Recognized By
Body As Foreign.

A vascular bypass (or vascular graft) is a surgical procedure performed to redirect

blood flow from one area to another by reconnecting blood vessels. Often, this is
done to bypass around a diseased artery, from an area of normal blood flow to
another relatively normal area.
vascular bypass
 Vascular Grafts

 Porous.
 Permeable. *refers to the tendency
 Good structure retention. of a material in contact
with the blood to
 Adequate burst strength. produce a thrombus,
 High fatigue resistance. or clot
 Low thrombogenicity*.
 Good handling properties.
 Biostable.
 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.
Hip-Replacements
 Biocompatibility

 The ability of a material to elicit an

appropriate biological response in a
specific application by NOT producing
a toxic, injurious, or immunological
response in living tissue.
 Strongly determined by primary chemical
structure.
 Host Reactions to
Biomaterials
 Thrombosis Hemolysis: breakdown or
destruction of red blood cells so
 Hemolysis
that the contained oxygen -
 Inflammation carrying pigment hemoglobin is
 Infection freed into the surrounding
 Carcinogenesis medium.
the initiation of cancer formation.

 Hypersensitivity
is a set of undesirable reactions produced by the normal immune
system, including allergies and autoimmunity.
 Systemic Effects (means affecting the entire body)
 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

in vitro:
acceptance.
biological processes or reactions happening outside the body in
artificial conditions, often in a test tube
 Biomaterials –
An Emerging Industry

 Next generation of medical implants and

therapeutic modalities.
 Interface of biotechnology and traditional
engineering.
 Significant industrial growth in the next
15 years -- potential of a multi-billion
dollar industry.