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Chapter 1 Edited

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Kidus Yohannes
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Biomaterial and Implants

By Mekdes Gashaw
[BMEg3114]
Biomedical engineering department
Chapter One

Materials For Biomedical Application


Learning out comes
After completing this lecture students should
 Be able to Discuss what Biomaterials and
implants are.
 Explain the different generations of biomaterial
and the progress in each generation.
 Elucidate the type of biomaterials, Principles of
Chemistry and the application of biomaterials.
 Explicate what biocompatibility is and steps
while developing a biomaterial.
BRAINSTORMING: What comes to your mind when
you hear of these ?
 Biomaterials
 Implants
 Transplants
What is it biomaterial?
 A material intended to interface with biological systems to

evaluate, treat, augment, or replace any tissue, organ or


function of the body (Williams, 1999).
 Any substance (other than drugs) or combination of substance ,

synthetic or natural origin, which can be used for any period of


time, as a whole or as a part of a system which treats,
augments, or replace any tissue, organ or function of the body
(Williams, 1987).
What is biomaterial?
 A biomaterial is any material, natural or man-made, that

comprises whole or part of a living structure or biomedical


device which performs, augments, or replaces a natural
function" (Wikipedia).
 “A systemically and pharmacologically inert substance

designed for implantation within or incorporation with


living system” (The Clemson University advisory Board for
Biomaterials).
Implants?
 Any medical device made from one or more biomaterials

that is intentionally placed within the body, either totally or


partially buried beneath surface- it is usually intended to
remain for a significant period of time.
Transplant ?
Organs or tissues taken from the body and grafted into
another area of the same individual or another individual. -
Wikipedia,
Ex: Heart, kidney, lung, pancreas, thymus, liver, etc.
Biomaterials history
 Archaeologists have uncovered remains of humans
containing metal dental implants as early as 200 A.D.
 Linen was used as a suture material by the Egyptians.
 The development of the biomaterials increased after WWII
with the widespread availability of synthetic materials that
were originally developed for use in the war.
Poly(Methylmethacrylate)-aircraft
Nylon-parachute
Biomaterials history
 1st generation (since 1950s)

Goal: Bioinertness, not reactive with the body; decrease the


potential for negative immune response to the implant
Biomaterials history
 2nd generation (since 1980s)

Goal: Bioactive; interacting in a positive manner with the body


to promote localized healing

http://www.totaljoints.info/Hip.jpg
Biomaterials history
 3rd generation (since 2000s)

Goal: Regenerate functional tissue, smart, instructive;


which can help guide the biological response to the implant
area
Current status of the field
 Today, biomaterials represent a significant portion of the
healthcare industry, with an estimated market size of over
$9 billion per year in the United States.
Future Directions
 Development of “smart” material which can help guide the

biological response in the implant area.


 Design of injectable materials that can be applied locally

and with minimal pain to the patient.


 New set of nano-structured biomaterials for nano-scale

objects as reinforcing agents.


Application of biomaterials
Biomaterials that will be used may be considered from the point of
view of the problem area that is to be solved:
Problem area Examples

Replacement of diseased or Artificial hip joint, kidney dialysis


damaged part machine

Assist in healing Sutures, bone plates, and


screws

Improve function Cardiac pacemaker, intraocular


lens, cochlear implant

Correct functional abnormality Cardiac pacemaker

Correct cosmetic problem Breast implant, soft tissue


augmentation, chin
augmentation
Figure1: Biomaterials have made an enormous impact on the treatment of injury and
disease and are used throughout the body (Cooke et al., 1996; Kuhn, 2005; Ratner et
al., 2020).
Classification of biomaterials
Types of biomaterials

biomaterials

inorganic organic

metals ceramics polymers

Types of biomaterials according to their composition


Types of Biomaterial
biomaterials can also be classified into three according to
tissue response
1. Biotolerant – Polymers Fibrous tissue encapsulation at
implant interface
2. Bioinert – Titanium , Ti alloy , Alumina , zirconia Direct
bone apposition at the implant interface
3. Bioactive- CPC ,Glass ceramics Direct chemical bonding
of implant with the surrounding bone
Types of biomaterials
More specifically biomaterials fall into one of three of
materials:
 Metals (inorganic material)

 Ceramics(inorganic material)

 Polymers (organic material)


Example: An Orthopedic hip implant exhibiting the use of all three
classes of biomaterials
An orthopedic hip implant exhibiting the use of all three classes of
Biomaterials
In this case the stem, which is implanted in the femur (upper bone of the
leg), is made with a metallic biomaterial.
The implant may be coated with a ceramic to improve attachment to the
bone, or a polymeric cement can be used to hold the stem in place.
Polymeric cement to hold the stem in place.
At the top of the hip stem is a ball(metal or ceramic) that works in
conjunction with the corresponding cement to facilitate motion in the
joint.
The corresponding inner socket is made out of either polymer (for a
metallic ball) or ceramic (for a ceramic ball) and attached to the
pelvis by a metallic socket.
Types of biomaterials
Materials Advantages Disadvanta Examples
ges
Polymers
Nylon, Resilient, Not Strong, Sutures,
Polyethylene, Easy to fabricate Deforms with vascular graft,
Silicone, time, hip socket,
Teflon, may degrade intraocular
Dacron, lenses
Acrylates,
PGA, PLA
Metals
(Titanium and its Strong, May corrode, Joint
alloys, Tough, Dense, replacement,
Co-Cr alloys, Ductile Difficult to make Bone plates and
stainless steel, screws,
Gold) Dental root
implant
Types of biomaterials
Materials Advantages Disadvantages Examples
Ceramics
Aluminum oxide, Very Brittle, Dental implant,
Calcium biocompatible, Not resilient, Femoral head of
phosphates Inert, Difficult to make hip replacement,
Strong in Coating of dental
compression and orthopedic
implants
Composites
Carbon-carbon Strong, Difficult to Joint implants
Ceramic-polymer less stiff than make, Dental fillings
metals, Weak in tension
Strong in
compression
Important properties of
biomaterials
Performance of biomaterials
The ultimate goal of biomaterials in medicine is to treat,
improve, or substitute tissue organs (e.g., bone, muscle,
skin) or body function. The biomaterial application method
must combine the chemical and mechanical features of the
biological system in order to achieve the required
functional results .The success of biomaterials in the body
depends on factors such as:
1. Material properties
 Bulk properties
 Surface properties

26
2. Biocompatibility of the materials
3. Host response
4. Non-toxicity , Corrosion, wear, and fatigue properties
5. Design of the implants and manufacturability
6. Technique used by the surgeon
7. Health and condition of the patient
8. Patient activities
Biomaterial properties
Bulk properties
The bulk of a material presents physical and
chemical properties of the material that
remain during the lifetime of the implant.
 Surface properties is defined by chemical,
microstructure and it interacts with the
host tissue directly.
Biocompatibility
Definition of biocompatibility:
“Biocompatibility is the ability of a
material to perform with an appropriate
host response in a specific application”
(William, 1987).

29
The Concept of Biocompatibility
Biocompatibility characteristic:
Biocompatibility involves the
acceptance of an artificial implant by
the surrounding tissues and by the
body as a whole.
Biocompatible materials
Do not irritate the surrounding structures
Do not provoke an abnormal inflammatory
response
Do not incite allergic or immunologic
reactions
30
The Concept of Biocompatibility
Biocompatible materials have adequate
mechanical properties.
Biocompatible materials have
appropriate optical properties (eye).
Biocompatible materials have
appropriate density.

31
Host response
 Host response is defined as the “response of the host
organism (local and systemic) to the implanted material or
device”. Most of the materials are never inert, and a
biomaterial’s clinical success depends significantly on the
host tissue’s reaction with the foreign material. For material
establishment-host tissue interaction, these reactions
depend heavily on the
1. time length,
2. purpose, and
3. site of implantation.
Non-toxicity
 Toxicity of biomaterials deals with elements that migrate
out of the biomaterials. A carefully designed biomaterial
should serve its purpose in the living body’s environment
without negatively influencing other cells, organs, or the
whole organism. It is logical to assume that, unless
specifically designed to do so, a biomaterial should not
release or generate anything from its bulk.
Corrosion, wear, and fatigue properties
 Wear is often considered as one of the leading causes of
implant failure. In some cases, wear has also been shown to
accelerate the corrosion of biomedical devices and
implants. The fatigue resistance is related to the material’s
reaction to repeated cyclic loads.
Design and manufacturability
 Manufacturability
is the ability to manufacture
the item with relative ease that is ideal for
its intended use at minimal cost and high
reliability. Concerning biomaterials, the
manufacturability, in a broader sense,
incorporates the potential of the material to
be sterilized by a validated sterilization
technique which is deemed appropriate for
biomedical applications.
Current application of
biomaterials
The human biomaterials
body systems
Cardiovascular Catheters,pacemaker,heart valves,vascular
system graft,LVAD,
Circulatory Artificial blood/ blood substitute ,Bio engineered
system blood vessels ,Balloon Angioplasty ,Stents ,Tubes for
Hemodialysis ,Surgical injection needle
Musculoskeletal Artificial joint replacements , IVDs (Inter vertebral
system disc) ,Artificial muscle
Internal and external bone fixations ,Bone
scaffolds ,Orthopedics
Integumentary Artificial skin / burn dressing., Sutures , Suture
and vestibular needle ,Nail implant
system Intraocular lens , Cochlear implant , Auricle implant
Digestive system Dental Implants , Gastrointestinal tissue
engineering ,3D Liver Mimetic Architecture
Urinary system Fully implantable Artificial alloplastic urinary ,
bladder , Artificial sphincter ,Artificial kidney ,
Hemodialysis
Reproductive Breast implant , Craniofacial reconstruction ,
system Replacement of sex organs
application of biomaterials
Heart valve prosthesis
 Heart valves open and close over 40 million times a year
and they can accumulate damage sufficient to require
replacement in many individuals.
 There are many types of heart valve prostheses and they
are fabricated from carbons, metals, elastomers, plastics,
fabrics and animal or human tissues
Heart valve prosthesis
 Generally, almost as soon as the valve is implanted, cardiac
function is restored to near normal levels and the patient
shows rapid improvement.
 More than 80,000 replacement valves are implanted each
year in the United States .
 In spite of the overall success seen with replacement heart
valves, there are problems that may differ with different
types of valves; they include induction of blood clots,
degeneration of tissue, mechanical failure, and infection.
Artificial hip joints
Artificial hip joints
 After 50 or more years of cyclic mechanical stress, or
because of degenerative or rheumatological disease, the
natural joint wears out, leading to considerable loss of
mobility and often confinement to a wheel chair.
 Hip-joint prostheses are fabricated from titanium, stainless
steel, special high-strength alloys, ceramics, composites,
and ultra high-molecular-weight polyethylene.
Artificial hip joints
 With some types of replacement hip joints and surgical
procedures that use polymeric cement, ambulatory function
is restored within days after surgery.
 For other types, a healing period is required for integration
between bone and the implant before the joint can bear the
full weight of the body.
 After 10-15 years, the implant may loosen, necessitating
another operation.
Dental implants
 The widespread introduction of titanium implants has
revolutionized dental implantology .
 These devices form an implanted artificial tooth anchor
upon which a crown is affixed.
 One of the primary advantages originally cited for the
titanium implant was its osseous integration with the
bone
of the jaw.

Loss of tissue support leading to loosening along with
infection remains an issue in the topic of Dental implants
.
Dental implants
Intraocular lenses
 A variety of intraocular lenses (IOLs) have been fabricated of
poly methyl methacrylate, Silicone elastomer, soft acrylic
polymers, or hydro gels and are used to replace a natural lens
when it becomes cloudy due to cataract formation.
 Good vision is generally restored almost immediately after the
lens is inserted and the success rate with this device is high.
 IOL surgical procedures are well developed and implantation is
often performed on an outpatient basis.
Steps involved in biomaterials
development
The various steps involved in the development of biomaterial
devices are
 Identifying a need
 Device design
 Material Synthesis
 Material Testing
 Fabrication
 Sterilization and Packaging
 Device Testing
 Clinical Use
General Criteria for materials selection
 Mechanical and chemicals properties
 No undersirable biological effects
carcinogenic, toxic, allergenic or immunogenic
 Possible to process, fabricate and sterilize with a good
reproducibility
 Acceptable cost/benefit ratio
summary
 A material intended to interface with biological systems to
evaluate, treat, augment, or replace any tissue, organ or
function of the body (Williams, 1999).
 Biomaterials that will be used may be considered from the
point of view of the problem area that is to be solved:
 More specifically biomaterials fall into one of three group of
materials:
Metals (inorganic material)

Ceramics(inorganic material)

Polymers (organic material)


summary
 The ultimate goal of biomaterials in medicine is to treat,
improve, or substitute tissue organs (e.g., bone, muscle,
skin) or body function. The biomaterial application method
must combine the chemical and mechanical features of the
biological system in order to achieve the required
functional results .
Thank you

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