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This document provides an introduction to biomaterials and biocompatibility. It defines biocompatibility as a material's ability to perform with an appropriate host response for a specific application. Biocompatibility is determined by four factors: toxicology, reactions to extrinsic organisms, mechanical effects, and cell-biomaterial interactions. Common biomaterial applications discussed include heart valves, hip replacements, dental implants, intraocular lenses, and left ventricular assist devices. Examples of materials used historically and for new biomedical purposes are also presented.

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40 views

02 Lec 2

This document provides an introduction to biomaterials and biocompatibility. It defines biocompatibility as a material's ability to perform with an appropriate host response for a specific application. Biocompatibility is determined by four factors: toxicology, reactions to extrinsic organisms, mechanical effects, and cell-biomaterial interactions. Common biomaterial applications discussed include heart valves, hip replacements, dental implants, intraocular lenses, and left ventricular assist devices. Examples of materials used historically and for new biomedical purposes are also presented.

Uploaded by

Mursalin Sonnet
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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MME 297: Lecture 02

Introduction
[2] Introduction to Biomaterials: Biocompatibility &
Applications
WHAT IS BIOCOMPATIBILITY?
❑ “Biocompatibility” is the ability of a material to perform with an
appropriate host response in a specific application.

Appropriate host responses

• resistance to blood clotting


• resistance to bacterial colonization
• normal, uncomplicated healing

❑ This definition, though accurate and quite useful in design,


development, and application of biomaterials in medicine, nevertheless
offers no insights into the mechanisms of biocompatibility, how to test
the biocompatibility of a material or how to optimize or enhance the
biocompatibility of a material.
❑ Biocompatibility is the cumulative effect of the following
four factors:

1. Toxicology - The measurement and study of the effects of


material leaching from biomaterials.
• Polymeric materials often contain extractable components, such as unreacted
monomer, oligomers, initiator fragments, stabilizers, and other processing
additives.

• Metals, glasses, and ceramics can release ions and other processing
components.

• The type of reaction that will be considered from a toxicology standpoint is if these
substances are released and negatively impact cells (in vitro) or adjacent tissues
(in vivo), or if they affect an organism systemically.
2. Extrinsic organisms - Reactions related to products from
extrinsic microbiologic organisms colonizing the biomaterial
• In the case of implants that are contaminated with fungi, bacteria or bacterial cell-wall
endotoxin, an intense and usually long-term biological reaction is seen, characterized
by large numbers of white cells (called “pus”) in the vicinity of the implant.

• In humans, this reaction would be described by the patient as producing pain,


redness, and heat.

• This response to the contaminated implant can lead to exceptionally thick foreign-
body capsules.

• High concentrations of extravascular white cells and thick, dense foreign-body


capsules are characteristics of poor biocompatibility.
3. Mechanical effects include rubbing, irritation, compression, and
modulus mismatch. Closely related are size- and shape-related
effects.
• If an implant is rubbing, abrading or moving in contact with tissue, or has sharp
corners, undesirable reactions that are superficially classified as “non-biocompatible”
will be observed.

• Mechanical mismatch between a hard biomaterial and a soft tissue can lead to
damage or irritation to the soft tissue. Cell responses to mechanical forces are well-
known and usually quite significant.

• In general, it is the role of the implant designer to ensure that the device does not
excessively rub or irritate tissue (rounded edges are better than sharp edges, for
example).

• It is the role of the surgeon to appropriately place and anchor the device in the
implant site to minimize such rubbing and irritation.
4. Cell–biomaterials interactions
• A broad range of interactions with surrounding proteins, and cells,
induce cell–biomaterials interactions (and tissue–biomaterials interactions) that might
direct longer-term in vivo bioreaction.

• Living cells interact and attach to different materials in different ways,


and the nature of that interaction may have immense influence on cell fate, including
attachment, spreading, proliferation, differentiation, activation, secretion, and
detachment.

• All “biocompatible” materials, be they hydrophilic, hydrophobic, metallic, polymeric or


ceramic, will heal similarly if there are: (1) no leachables; (2) no products from
extrinsic organisms; and (3) no mechanical irritation.
Biocompatibility test requirements[1] :

1. Acute systemic toxicity


2. Cytotoxicity (toxic to living cells)
3. Hemolysis (destruction of red blood cells which leads to the release
of hemoglobin from within the red blood cells into the blood plasma)
4. Intravenous toxicity
5. Mutagenicity (capacity to cause permanent genetic alterations)
6. Oral toxicity
7. Pyrogenicity (capacity to produce fever)
8. Sensitisation (induce primary immune response, develop hypersensitivity)

[1] United States Food and Drug Administration (FDA)


EXAMPLES OF TODAY’S BIOMATERIALS
APPLICATIONS

Heart Valve Prostheses

• The natural heart valve opens and closes over 40 million


times per year, and can require replacement due to disease
or wear.

• There are many types of heart valve prostheses, and they


are fabricated from carbons, metals, elastomers,
plastics, fabrics, and animal or human tissues chemically
pretreated to reduce their immunologic reactivity, and
to enhance durability.

• In spite of the overall success, there are problems, many of


them specific to a specific type of valve;
they include induction of blood clots (sometimes shed into
the bloodstream as emboli), degeneration of valve
tissue leaflets, mechanical failure
Total Hip Replacement Prostheses

• The human hip joint is subjected to high levels of mechanical


stress, and receives considerable abuse in the course of normal
and extraordinary activity.

• after 50 or more years of cyclic mechanical stress the natural joint


wears out, leading to loss of mobility

• Hip joint prostheses are fabricated from a variety of materials,


including titanium, stainless steel, special high-strength
alloys, ceramics, composites, and ultrahigh molecular
weight polyethylene (UHMWPE).

• After 10–15 years, many of these implants fail


by loosening, which usually necessitates another operation
Dental Implants

• These devices form an implanted artificial tooth anchor upon which a crown is affixed

• A special requirement of a material in this application is the ability to form a tight seal against
bacterial invasion where the implant traverses the gingiva (gum).

• One of the primary advantages originally cited for the titanium implant was its osseous integration
with the bone of the jaw.
Intraocular Lenses

• Implants to replace lenses in the eye that have clouded


due to cataracts are called intraocular lenses (IOLs).

• They have been fabricated from a variety of


transparent materials including poly(methyl
methacrylate), silicone elastomer, soft acrylic polymers,
and hydrogels

• Observations of implanted lenses through the cornea


using a microscope to directly study the implants show
that inflammatory cells such as macrophages migrate
to the surface of the lenses after implantation.
Left Ventricular Assist Devices

• They are now used to maintain a patient with a failing heart while the
patient awaits the availability of a transplant heart, and some patients
receive these LVADs as a permanent therapy.

• a patient with an LVAD is always at risk for infection and blood clots
initiated within the device. These could break off (embolize) and possibly
obstruct blood flow to a vital organ.
DESIGNED BIOMATERIALS
Material Earlier used for Designed for
Silicones Sealant, adhesive, lubricants Artificial kidneys, dialysis
membrane
Polyurethanes hard plastics, flexible films heart
valves
Teflon wire insulation synthetic vascular grafts
Polyethylene glycol Gate insulator, lubricant vehicle for intravenously
administering fat-soluble
hormones
Titanium Military artifacts bony tissue implants
Bioglass Bone bonding (silicate-
based glasses and glass-
ceramics containing
critical amounts of Ca and P
ions)
The path from an identified need
to a clinical product

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