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Medical Biomaterials:

From Polymer Implants to Engineered Tissues

Sujata K. Bhatia
Harvard University

Why get involved with medical biomaterials?


The incidence of major chronic diseases, including
diabetes, heart disease, and cancer, is rising
The United States has a graying population: in 2030,
over 20% of the U.S. population will be over age 65
(battling degenerative diseases - arthritis, Alzheimers)
These diseases will require innovative medical device
solutions; drugs and lifestyle changes are not enough
Medical devices are extremely beneficial - every $1
spent on healthcare returns $3 worth of health gains
Medical devices are valuable a $150 billion industry

OK, but why should I get involved?


Medical biomaterials is a fascinating field,
integrating principles of engineering,
biology, chemistry, and medicine
Working in this field allows you to improve
the practice of medicine, and directly
impact peoples lives
We can be heroeswhat dyou say? -David Bowie, 1977

A person is,
among all else,
a material thing,
easily torn,
not easily mended.
-Ian McEwan, Atonement, 2001

The Paralytic
Jean-Baptiste Greuze, 1763

What is a biomaterial anyway?


A biomaterial is a nonviable material used
in a medical device, intended to interact
with biological systems
An essential characteristic of biomaterials is
biocompatibility, the ability of the material
to perform its function without causing an
adverse effect

Requirements of Biomaterials
Mechanical performance
Mechanical engineering

Desired characteristics of stability or degradability


Chemistry and biochemistry

Biocompatibility and non-toxicity


Molecular biology

Producible at a large scale


Chemical engineering

Clinically beneficial and cost-effective


Medicine

Clinical Applications of
Biomaterials

Orthopedics
Cardiology and Vascular Medicine
Ophthalmology
Dentistry
Neurology
General Surgery
Organ Replacement

Orthopedic Biomaterials
Hip replacements
Titanium, polyethylene, ceramic

Knee replacements
Titanium, polyethylene

Bone plates (fracture fixation)


Stainless steel

Bone cement
Poly(methyl methacrylate)

Bony defect repair


Hydroxyapatite

Artificial tendons & ligaments


Dacron, Teflon

Cardiovascular Biomaterials
Blood vessel prostheses
Dacron, Teflon, polyurethane

Heart valves
Reprocessed tissue, stainless steel

Intravascular catheters
Polyurethane, Teflon, silicone

Pacemakers
Platinum electrodes,
polyurethane, silicone

Ophthalmic Biomaterials
Intra-ocular lens
Poly(methyl methacrylate)

Contact lens
Silicone-acrylate, hydrogel

Corneal bandage
Collagen, hydrogel

Dental Biomaterials
Dental implants (tooth fixation)
Titanium, alumina, calcium
phosphate

Dental fillings
Ceramic, composites of powdered
glass and plastic resins

Biomaterials in Neurology
Cochlear implants
Platinum electrode

Deep brain stimulation


Pacemaker for the brain
Platinum leads

Biomaterials in General Surgery


Skin repair template
Silicone-collagen composite

Surgical sutures
Silk, nylon, poly(glycolide-colactide)

Adhesives and sealants


Cyanoacrylate, fibrin

Hernia mesh
Polypropylene

Organ Replacement Biomaterials


Heart-lung machine
Silicone rubber

Artificial kidney
(hemodialyzer)
Cellulose, polyacrylonitrile

Artificial heart
Polyurethane

Hollow-fiber
dialyzer

Shortcomings of Current
Biomaterials

Infection
Thrombosis (clotting)
Inflammation
Poor healing, leading to
encapsulation
Limited durability
Limited adaptability to
environment
Limited biological activity

Chronic inflammation around wear


debris of polyethylene elbow
prosthesis (top) and knee prosthesis
(bottom)

The Next Generation of


Biomaterials
Surface-modified biomaterials
Dr. Buddy Ratner (University of Washington)

Smart biomaterials
Dr. Nick Peppas (University of Texas, Austin)

Bioactive biomaterials
Dr. Elazer Edelman (Harvard/MIT)

Tissue engineered materials


Dr. Robert Langer (MIT)

Surface-Modified Biomaterials
Attack on a
biomaterial begins
with deposition of
proteins or cells on
the outer surface of
the biomaterial
Maybe attack can be prevented if biomaterial
surfaces are modified to create stealth
surfaces that resist protein & cell adsorption

Surface-Modified Biomaterials
Surface modification can be achieved by
coating with hydrophilic polymer (PEG)
Surface-modified biomaterials should be
resistant to clotting, bacterial colonization,
and the foreign body response
U. Washington
Engineered
Biomaterials

Smart Biomaterials
Smart biomaterials
are materials that
respond to changes
in pH, temperature,
electrical stimuli, or
chemical stimuli
These materials can
be made using pHsensitive or thermosensitive polymers

Smart Biomaterials
Hydrogels with pH-responsive swelling
behavior are made from ionic networks
Poly(methacrylic acid) grafted with
poly(ethylene glycol)

Temperature-responsive hydrogels exist also


Poly(N-isopropylacrylamide)

Smart biomaterials may have powerful


applications in drug delivery
An insulin pill that encapsulates drug at pH 2
in the stomach, and swells to release drug at pH 7

Bioactive Biomaterials
Bioactive biomaterials are implants that are
biologically or pharmacologically active
Biomaterials can be
rendered bioactive by
incorporating smallmolecule drugs, biologic
growth factors, adhesion
receptors, or enzymatic
cleavage sites

Bioactive Biomaterials
Several bioactive biomaterials are already on
the market, with a dramatic clinical impact:
Drug-eluting stents for minimally invasive
treatment of coronary artery disease
Chemotherapeutic(BCNU)-eluting wafers
for local treatment of brain cancer
Lupron-releasing implants for local
treatment of prostate cancer
Bone-morphogenic protein (BMP)releasing implants for spinal surgery and
fracture repair

Tissue Engineering
Tissue engineering is an
approach to organ
regeneration in which live
cells are seeded onto a
degradable polymer scaffold
Following implantation,
the polymer construct
gradually degrades, and
the live cells grow into
organized tissue

Tissue Engineering
Tissue engineering has been investigated for
virtually every organ system:

Dermal fibroblasts + collagen matrix Skin (in clinical use)


Vascular endothelial cells + tubular scaffold Blood vessels
Vascular endothelial cells + leaflet scaffold Heart valves
Urothelial cells + tubular or flat scaffold Ureters, Bladder
Chondrocytes + molded scaffold Cartilage
Periosteal cells + polymer mesh Bone
Hepatocytes + polymer mesh Liver
Enterocytes + tubular scaffold Intestine
Neurons + electrically conducting polymer Nerves

DuPonts Technology Platforms


Wound Closure
and Care:
Sealants and
Adhesives

Open Surgery

Interventional
Devices:
Microspheres
Interventional
Devices

We can rebuild him. We


have the technology. We
have the capability to make
the worlds first bionic man.
Steve Austin will be that
man. Better than he was
before.
Better stronger faster.

Summary
Biomaterials have improved
millions of lives by providing
material solutions to biomedical The Agnew Clinic
Thomas Eakins, 1889
problems
Traditional biomaterials have been
made from polymers, ceramics, and
metals
The next generation of biomaterials
will incorporate biomolecules,
therapeutic drugs, and living cells

So, do biomaterials make a difference?


Suppose your dad has a heart attack:
50 years ago certain death
25 years ago open bypass surgery
Involves cracking open the chest cavity
Infection, graft clotting, graft failure

15 years ago balloon angioplasty


Vascular injury by balloon; incomplete opening

10 years ago bare-metal stent


Risk of re-closure of artery within a few years

Today drug-eluting stent


Combination of drug and device provides lasting solution

How can you get involved in


medical biomaterials?
Basic research & development
PhD in chemistry, biology, engineering
Clinical research & development
MD and specialty training
Translational research - bench to bedside
MD/PhD dual degree
Sales and marketing
Technical undergraduate degree + MBA
Intellectual property law
Technical undergraduate degree + JD

For More Information

Biomedical Engineering Society - www.bmes.org


Society for Biomaterials - www. biomaterials.org
Advanced Medical Technology - www.advamed.org
Science Careers - nextwave.sciencemag.org
Langer, R. and Peppas, N.A. Advances in biomaterials,
drug delivery, and bionanotechnology, AIChE J. 2003;
49:2990-3006.
Langer, R. and Tirrell, D.A. Designing materials for
biology and medicine, Nature 2004 Apr 1; 428:487-492.
Bhatia, S.K. and Bhatia, S.R. Biomaterials,
Encyclopedia of Chemical Processsing 2005.
Bhatia, S.K. and Bhatia, S.R. Bioactive Devices,
Encyclopedia of Chemical Processsing 2009.