S.

Kanagaraj
kanagaraj@iitg.ernet.in
http://www.iitg.ernet.in/kanagaraj

31-12-2010
Studies on nonviable materials used in a
medical device intended to interact with
biological systems where the materials are
expected to perform with an appropriate host
response in a specific application

It is expected to give good exposure

pertaining to the field of biomaterials and
have broad understanding biomaterials
research.
 Biologist

Biomaterials

Physician Engineer
Introduction

Classes of materials used in medicine:

metals, polymers, FRPs, fabrics, nanocomposites, bioresorbable and bioerodable
materials, ceramics, glasses

Host reactions to biomaterials:

biocompatibility, implant associated infection

Testing of biomaterials:
in vitro assessment, in vivo assessment, blood materials interactions

Design of materials for biomedical application:

Cardiovascular, dental implants, orthopedic application, skin, ophthalmologic
applications, wound healing, sutures, biomedical and biosensors

Implantation techniques for soft tissue and hard tissue replacements

Problems and possible solutions in implant fixation

Failure analysis of medical devices and implants.

Buddy D. Ratner, Allan S. Hoffman, Frederick J. Schoen, Jack E. Lemons. Biomaterials Science:
An Introduction to Materials in Medicine, Academic Press, 2004, USA
J.B. Park and J.D. Bronzino. Biomaterials: Principles and Applications. CRC Press. 2002. ISBN:
0849314917

Reference Books
T. M. Wright, and S. B. Goodman. Implant Wear in Total Joint Replacement: Clinical and Biologic
Issues, Material and Design Considerations. American Academy of Orthopaedic Surgeons, 2001.
T.S. Hin (Ed.) Engineering Materials for Biomedical Applications. World Scientific. 2004. ISBN
981-256-061-0
B. Rolando (Ed.) Integrated Biomaterials Science. Springer. 2002. ISBN: 0-306-46678-3
D.Shi, Introduction to Biomaterials, Tsinghua University press, 2005
DL. Wise, DJ. Trantolo, K Lewandrowski, JD. Gresser, M Cattaneo, MJ Yaszemski, Biomaterials
Engineering and Devices , Humana Press, New Jercy, 2000
JY Wong and JD Bronzion, Biomaterials, CRC press, 2007
R Barbucci , Integrated Biomaterials Science, Kluwer Academic Publishers, New York, 2002
G S Sawhney, Fundamentals of Biomedical Engineering, New Age International private Limited,
New Delhi, 2007
Attendance – 5%
Mini project – 15%
Mid semester- 30%
End semester-50%
 !"

To select a material for a given use based on

considerations of cost and performance.

To understand the limits of materials and the

change of their properties with use.

To be able to create a new material that will have

desirable properties.

To be able to use the material for different

application.
 " # $ %
USA market for biomaterials (2000) $ 9000 million
Cardiovascular devices (2002) $ 6000 million
Orthopedic musculoskeletal surgery $ 4700 million
Wound care $ 3700 million
In vitro diagnosis $ 10 000 million
Number of devices
Intraocular lenses (2003) 2, 500, 000
Contact lenses (2000) 30, 000, 000
Vascular grafts 300,000
Heart valves 100,000
Pacemakers 400,000
Breast prosthesis 250, 000
Catheters 200, 000, 000
Heat-lungs 300, 000
Hip prosthesis (2002) 250, 000
Knee prosthesis (2002) 250, 000
Dental prosthesis (2000) 910, 000
Global figures are 2-3 times the USA number
! !
SWCNT
MWCNT
 Ramakrishna et al. (2001), Composite Science and
Technology, 61, 1189

Various applications of different

polymer composite biomaterials
 Shoulder joints

&
Elbow

Spine disc

Finger joints

Knee joints
Hip joints

Ankle
 "
'( !) *+,-..+/' ++01
Factors Description
Chemical/Biological Physical Mechanical characteristics
characteristics characteristics
1st level material -chemical composition (bulk -density -Young’s modulus,
properties and surface) Poisson's ratio, Yield
strength, Tensile strength,
Compressive strength
2nd level material -Adhesion -Surface topology -Hardness, Shear modulus,
properties (Texture and Shear strength, Flexural
Roughness) modulus, Flexural strength
Specific functional -Biofunctionality, Bioinert, -Form (solid, porous, -Stiffness, Fracture
requirements Bioactive, Biostability, coating, film, fibre, etc) toughness, Fatigue
(based on Biodegradation behaviour -Geometry, Coefficient strength, Creep resistance,
application) of thermal expansion Friction and wear
-Electrical conductivity resistance, Adhesion
-Colour, aesthetics strength, Impact strength,
-Refractive index Proof stress, Abrasion
-Opacity resistance
Processing and -Reproducibility, quality, sterilizability, packaging, secondary processability
Fabrication
Characteristics of Tissue, Organ, species, age, sex, race, health condition, activity and systemic
host response
Medical or surgical procedure, period of applications and usage
Cost
 %! 2 # 3 4

S.M. Kurtz. The UHMWPE Lexicon, School of Biomedical Engineering

Science and Health Systems, Drexel University, and Exponent, Inc.,
1997----170,280 THR
1998----173,501 THR
----144,133 primary arthroplasties (5% increase over 1994)
No. of revisions --- 28,794 in 1997
--- 29,368 in 1998,
representing 17% of total hip replacements and a 7% increase from
the revisions reported in 1994.

4% of the patients were under the age of 40,

6% of the revision patients were under 40, higher risk of revision for
the younger patients
In-vivo studies of nanocomposites with Goat at University of Evora, Portugal
 5

Approximately 250,000 knee and 250,000 Hip replacements are done annually in
USA, and it is expected to grow rapidly as the population ages. The orthopedics
industry alone has been growing steadily at 10% annually
6

AbioCor™ Implantable Replacement Heart

Blood vessel skin
5 !

Contact lens
 (

About 50,000 substitute heart valves are implanted annually in USA,

and this number is also growing. The prosthetics industry exceeds $10B annually
and is expected to grow rapidly in the next few decades
Replacement Heart valve Dental implant

Metallic hip joint

• 7
• 8 !
8 ! !
7
•# 8 ! 9
2 2 7# 8
8 7
•# 8 8
! 7
•

' 8 ! 9
7