Professional Documents
Culture Documents
• Material structure
• How structure dictates properties
• How processing can change structure
• Failure of engineering materials
• Biocompatibility of materials
This course will help you to:
Week 1 : Overview of Biomedical Materials. Introduction and historical developments. Requirements and Classification of
Biomedical Materials.
Week 2 :
Structure of Solids. Atomic bonding. Crystal structure. Imperfections in Crystalline Structures. Long-chain molecular
compound
Week 3 : Biomedical Metals. Stainless Steels & Co-based Alloys. Types and Compositions. Structure & Properties. Manufacturing of
Implants.
Week 4 : Biomedical Metals. Ti & Ti-based Alloys. Types and Compositions. Structure & Properties. Manufacturing of Implants.
Biomedical metals in Hard Tissue and Soft Tissue Replacements. Biomedical metals in Orthopaedic and Dentistry.
Biomedical metals in Cardiovascular and Cardiothoracic.
Week 5 Biomedical Ceramic. Structure-Property Relationship. Aluminium Oxides. Calcium Phosphates. Properties & Production
of Hydroxyapatite. Glass-Ceramics. Formation & Properties of Glass-Ceramics. Carbons – Structure & Properties.
Biomedical ceramics in Hard Tissue and Soft Tissue Replacements. Biomedical ceramics in Orthopaedic, Dentistry,
Cardiovascular and Cardiothoracic.
Week 6 : Biomedical Polymers. Polymerisation. Effect of Structural Modification and Temperature on Properties. Polymeric
Implant Materials - Polyamides (Nylon), Polyethylene, Polypropylene.
Week 7 : Biomedical Polymers. Polymeric Implant Materials – Polyacrylates, Fluorocarbon Polymers, Rubbers. High strength
thermoplastics. Biomedical polymers in Hard Tissue and Soft Tissue Replacements. Biomedical polymers in Orthopaedic,
Dentistry, Cardiovascular and Cardiothoracic.
Week 9 : Mechanical properties and testing of materials. In-vivo and in-vitro testing.
Week 10 : Characterisation of Materials. Electrical and Magnetic Properties of Materials. Optical properties. X-ray Absorption.
Density & Porosity. Acoustic and Ultrasonic properties. Diffusion properties
Week 11 :
Failure of Engineering Materials. Fracture & Fatigue
Week 12 :
Failure of Engineering Materials. Wear & Degradation/Corrosion
Week 13 : Biocompatibility and Biological Tests. Definition. Biocompatibility tests and their rules. Biological
tests – Cytotoxicity, Genotoxicity, Carcinogenicity, Reproductive Toxicity.
Week 14 : Biocompatibility and Biological Tests. Biological tests – Irritation and Sensitisation, Local effects
after implantation, Systemic Toxicity, Hemocompatibility, Degradation. Biofunctionality tests.
Infection and sterilization.
GRADING:
1. PBL 1 5 5 Week5
2. Mid 1 30 30 Week 8
3. Quiz2 2 1 10 Week 11
5. Final Exam 1 40 40
MATERIALS SELECTION!
Why study materials?
• applied scientists or engineers must make material choices
• materials selection
– in-service performance
– deterioration
– economics
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3
0
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2
0
0
6
1
3
Choice of Medium
medium: wood
“Wood is a natural material that ties the
indoors to the outdoors when it is used…A
project is a creative 3 dimensional design
process…You don't need a huge shop space
or heavy duty metal working machine
tools.”
– George J. Haberer
The Materials Selection Process
1. Pick Application Determine required Properties
Properties: mechanical, electrical, thermal,
magnetic, optical, deteriorative.
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Materials Science and Engineering
structure • arrangement of internal components
• subatomic
• atomic
• microscopic
• macroscopic (bulk)
characterization
processing properties
• material characteristic
• method of preparing
• response to external
material
stimulus
• mechanical, electrical,
performance thermal, magnetic,
• behavior in a optical, deteriorative
particular application
Example – Hip Implant
• With age or certain illnesses joints deteriorate.
Particularly those with large loads (such as hip).
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Adapted from Fig. 22.25, Callister 7e.
• Permanent Implants
• Prosthetic devices manufactured from
synthetic materials (e.g., hip prostheses,
>200,000/yr in U.S., many designs)
Example – Hip Implant
• Requirements
– mechanical
strength (many
cycles)
– good lubricity
– biocompatibility
g. ., orthopedic replacements:
- loss of bone marrow (origin of blood stem cells)
- no regenerative ability
- reduced range of mobility
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5
Resistivity, r
(10-8 Ohm-m)
4
3
2
1
0
-200 -100 0 T (°C)
Thermal Conductivity
photograph, 400
Chapter 19,
Callister 7e.
300
(W/m-K)
(Courtesy of
Lockheed
Missiles and 200
Space
Company, Inc.)
100
0
0 10 20 30 40
Composition (wt% Zinc)
Adapted from
Fig. 19.4W, Callister
6e. (Courtesy of Adapted from Fig. 19.4, Callister 7e.
Lockheed Aerospace (Fig. 19.4 is adapted from Metals Handbook:
Ceramics Systems, Properties and Selection: Nonferrous alloys and
Sunnyvale, CA) Pure Metals, Vol. 2, 9th ed., H. Baker,
(Note: "W" denotes fig. (Managing Editor), American Society for Metals,
is on CD-ROM.) 1979, p. 315.)
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MAGNETIC
• Magnetic Storage: • Magnetic Permeability
--Recording medium vs. Composition:
is magnetized by --Adding 3 atomic % Si
recording head. makes Fe a better
recording medium!
Magnetization
Fe+3%Si
Fe
Magnetic Field
Adapted from C.R. Barrett, W.D. Nix, and
Fig. 20.23, Callister 7e. A.S. Tetelman, The Principles of
(Fig. 20.23 is from J.U. Lemke, MRS Bulletin, Engineering Materials, Fig. 1-7(a), p. 9,
Vol. XV, No. 3, p. 31, 1990.) 1973. Electronically reproduced
by permission of Pearson Education, Inc.,
Upper Saddle River, New Jersey.
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OPTICAL
• Transmittance:
--Aluminum oxide may be transparent, translucent, or
opaque depending on the material structure.
polycrystal: polycrystal:
single crystal low porosity high porosity
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DETERIORATIVE
• Stress & Saltwater... • Heat treatment: slows
--causes cracks! crack speed in salt water!
4 mm
--material:
7150-T651 Al "alloy"
(Zn,Cu,Mg,Zr)
1. Transplantation
• Replacement of tissue or organ from human or animal donor
• Adv:
complete recovery of lost function for patient lifetime
• Disads:
possibility of rejection—attack by immune system
side effects of immunosuppressive drugs (e.g., steroids)
limited donor pool
2. Autograft
• Donor is also recipient
• Examples: skin grafts, nerve grafts, breast reconstructions, saphenous (calf) vein for
coronary or peripheral artery bypass (~300,000/yr in U.S.)
• Adv:
complete recovery of lost function for patient lifetime
virtually no danger of rejection
• Disads:
limited self-donor tissue available
trauma/scarring at removal site
3. Regenerated Tissues/Organs
• Cells grown on a scaffold device (synthetic or collagen-based, often resorbable) provide
restored function (e.g., skin and cartilage)
• Adv:
no donor/self-donor tissue limitations
function restored for patient lifetime (in principle)
• Disads:
biological complexities of complete organ regeneration unsolved
possible immune response, depending on cell source
Institute for Genomics and Bioinformatics
9/17/2022 39
Institute for Genomics and Bioinformatics
Biomaterials
Materials used to safely replace or interact with biological systems
Recommended literature:
“Biomaterials, an introduction” J. Park and R.S. Lakes 2007
Springer Science
and
“Biomaterials Science” BD. Rafner 2004 Elsevier Academic Press
(available from the TUG-Bib in e-version) Allograft material. (A) clinical aspect of a
mandibular bone defect; (B) freeze-dried
demineralized bone allograft; (C) biomaterial
filling the bone defect associated with a non-
absorbable barrier.
A very short history
Institute for Genomics and Bioinformatics
of biomaterials
The Romans, Chinese, and
Aztec used gold in dentistry
more than 2000 years ago.
Biocompatibility
Institute for Genomics and Bioinformatics
engineering
biological engineering medical
engineering
biology medicine
Institute for Genomics and Bioinformatics
orthopaedic
cardiovascular
dental craniofacial
craniofacial
Source: the internet
General Applications of
Biomaterials
• Storage of fluids, tissues, and other biological
products
• Diagnosis
• Monitoring
• Therapy
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Classification of Medical Devices
Based on the duration of the device use, invasiveness and risk to
the user.
• Class I devices: crutches, bedpans, tongue depressors,
adhesive bandages etc. –minimal invasiveness, does not
contact the user internally.
• Class II devices: hearing aids, blood pumps, catheters, contact
lens, electrodes etc. –higher degree of invasiveness and risk,
but relatively short duration.
• Class III devices: cardiac pacemakers, intrauterine devices,
intraocular lenses, heart valves, orthopedic implants, etc. -
considerably more invasive and can pose immense risk to the
user-implantables.
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BIOMATERIAL OR MEDICAL
DEVICE?
• It is important to know that the FDA neither approves
materials nor maintains a list of approved materials
• Although FDA recognizes that many of the currently available
biomaterials have vast utility in the fabrication of medical
devices, the properties and safety of these materials must be
carefully assessed with respect to the specific application in
question and its degree of patient contact.
• An important principle in the safety assessment of medical
devices is that a material that was found to be safe for one
intended use in a device might not be safe in a device
intended for a different use.
• Accurate characterization is an essential step in selecting a
material for a medical device, but ultimately the final
assessment must be performed on the finished product,
under actual use conditions.
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Biomaterials Research in Industry
• is dominated as much by the regulatory approval process and
submission requirements as by the physical, mechanical, and
chemical properties of the medical device.
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Manufacture of a Medical Device
• One of the first steps involves the selection of suitable
biocompatible materials.
• This is an essential step because the types of tests required
for evaluation of a device depend on the physical and
chemical nature of its materials in addition to the nature of
the device's exposure to the body.
• A specific material may appear suitable on the basis of its
physical properties, cost, and availability, but might contain
toxic chemical components.
• Therefore, it is advisable to screen the candidate materials at
an early stage to eliminate those that are toxic, and select
those that are sufficiently biocompatible or nontoxic for their
intended use.
• Chemical constituents and potential extractables should be
identified and quantitated for overall safety assessment of the
device.
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Biomaterials Scientists
• study the interactions of natural and synthetic substances and
implanted devices with living cells, their components, and
complexes such as tissues and organs.
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Biomaterials Engineers
• develop and characterize the materials used to measure,
restore and improve physiologic function, and enhance
survival and quality of life.
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The Society For Biomaterials
A professional society which promotes advances in all phases of
materials research and development by encouragement of
cooperative educational programs, clinical applications, and
professional standards in the biomaterials field.
Internationally recognized leaders in the biomaterials field
participate in the Society and sponsored events.
(www.biomaterials.org)
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Relevant Biomaterials Journals
Journal of Biomedical Materials Research
Biomaterials
Journal of Biomaterials Science. Polymer Edition
Journal of Biomaterials Applications
Journal of Materials Science: Materials in Medicine
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Relevant Websites
• Biomaterials Network (www.biomat.net)
• Medical Device Information (www.devicelink.com)
• Medical Materials Engineering reference
(www.engineeringreference.com)
• United States Patents and Trademarks Office (www.uspto.gov)
• General search-Google (www.google.com)
• MEDLINE-(www.ncbi.nih.gov/entrez/query.fcgi)
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Where can I find information about
medical devices?
• www.nlm.nih.gov/services/meddevice.html
Just a few of the sites are:
• - Medical Device Link's Suppliers Page at
http://www.devicelink.com/company/
• Second generation
• Bio active and biodegradable materials
II
• Third generation
• Materials designed to stimulate specific responses at
III molecular level
FIRST GENERATION
• Invented in 1980
• AIM :
Same physical properties to match replaced
tissue
Minimal toxic response to host
Bio inert – minimum immune response and
foreign body reaction
SECOND GENERATION
• Invented between 1980 and 2000
• AIM
Interact with biological environment
Enhance biological response and tissue surface
bonding (BIO ACTIVE)
Undergo progressive degradation with healing and
regeneration of tissues (BIODEGRADABLE)
THIRD GENERATION
• Invented in 2002(Hench and polak)
• AIM
To stimulate specific cellular response at
molecular level
Signal and stimulate specific cellular activity
Classes of Biomaterials:
Metals:
Strong, ductile
high thermal & electrical conductivity
opaque, reflective.
Polymers/plastics: Covalent
bonding sharing of e’s
Soft, ductile, low strength, low density
thermal & electrical insulators
Optically translucent or transparent.
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Please do not blindly follow the
presentation files only, refer it just as
reference material. More concentration
should on class room work, text
book-reference books.