Chapter 1 Edited
Chapter 1 Edited
By Mekdes Gashaw
[BMEg3114]
Biomedical engineering department
Chapter One
http://www.totaljoints.info/Hip.jpg
Biomaterials history
3rd generation (since 2000s)
biomaterials
inorganic organic
Ceramics(inorganic material)
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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).
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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
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The Concept of Biocompatibility
Biocompatible materials have adequate
mechanical properties.
Biocompatible materials have
appropriate optical properties (eye).
Biocompatible materials have
appropriate density.
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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)