Overview of Biomaterials

and Their Use in Medical Devices

A BIOMATERIAL, as defined in this hand- shapes, have relatively low cost, and be readily
book, is any synthetic material that is used to available.
replace or restore function to a body tissue and Figure 1 lists the various material require-
is continuously or intermittently in contact ments that must be met for successful total
with body fluids (Ref 1). This definition is joint replacement. The ideal material or
somewhat restrictive, because it excludes material combination should exhibit the
materials used for devices such as surgical or following prop- erties:
dental instru- ments. Although these
instruments are exposed to body fluids, they do • A biocompatible chemical composition to
not replace or augment the function of human avoid adverse tissue reactions
• Excellent resistance to degradation (e.g.,
tissue. It should be noted, however, that cor- rosion resistance for metals or
materials for surgical instru- ments, resistance to
particularly stainless steels, are reviewed biological degradation in polymers)
briefly in Chapter 3, “Metallic Materials,” in • Acceptable strength to sustain cyclic loading
this handbook. Similarly, stainless steels and endured by the joint
shape memory alloys used for dental/endodon- • A low modulus to minimize bone resorption
tic instruments are discussed in Chapter 10, • High wear resistance to minimize wear-
debris generation
“Biomaterials for Dental Applications.”
Also excluded from the aforementioned
defi- Uses for Biomaterials (Ref 3)
nition are materials that are used for external
prostheses, such as artificial limbs or devices One of the primary reasons that biomaterials
such as hearing aids. These materials are not are used is to physically replace hard or soft
exposed to body fluids. tis- sues that have become damaged or
Exposure to body fluids usually implies that destroyed through some pathological process
the biomaterial is placed within the interior of (Ref 3). Although the tissues and structures of
the body, and this places several strict restric- the body perform for an extended period of
tions on materials that can be used as a bioma- time in most people, they do suffer from a
terial (Ref 1). First and foremost, a biomaterial variety of destruc- tive processes, including
must be biocompatible—it should not elicit an fracture, infection, and cancer that cause pain,
adverse response from the body, and vice disfigurement, or loss of function. Under these
versa. Additionally, it should be nontoxic and circumstances, it may be possible to remove
noncar- cinogenic. These requirements the diseased tissue and replace it with some
eliminate many engineering materials that are suitable synthetic material. Orthopedics. One
available. Next, the biomaterial should possess of the most prominent application areas for
adequate physi- cal and mechanical properties biomaterials is for orthope- dic implant
to serve as aug- mentation or replacement of devices. Both osteoarthritis and rheumatoid
body tissues. For practical use, a biomaterial arthritis affect the structure of freely
should be amenable to being formed or
machined into different
movable (synovial) joints, such as the hip, with artificial arteries. As shown in Table 1,
knee, shoulder, ankle, and elbow (Fig. 2). The polymers are the material of choice for
pain in such joints, particularly weight-bearing vascular prostheses (see Chapter 7, “Polymeric
joints such as the hip and knee, can be Materi- als,” in this handbook for further
considerable, and the effects on ambulatory details).
function quite devastating. It has been possible Ophthalmics. The tissues of the eye can
to replace these joints with prostheses since the
suffer from several diseases, leading to
advent of anes- thesia, antisepsis, and reduced vision and eventually, blindness.
antibiotics, and the relief of pain and
Cataracts, for example, cause cloudiness of the
restoration of mobility is well known to lens. This may be replaced with a synthetic
hundreds of thousands of patients.
(polymer) intraoc- ular lens (Table 1).
The use of biomaterials for orthopedic Materials for contact lenses, because they are
implant devices is one of the major focal points
in intimate contact with the tis- sues of the eye,
of this handbook. In fact, Chapters 2 through 7 are also considered biomateri- als. As with
and Chapter 9 (refer to Table of Contents) all
intraocular lenses, they too are used to preserve
deal with the materials and performance and restore vision (see Chapter 7, “Polymeric
associ- ated with orthopedic implants. As
Materials,” in this handbook for details).
shown in Table 1, a variety of metals,
Dental Applications. Within the mouth,
polymers, and ceramics are used for such
both the tooth and supporting gum tissues can
applications.
be readily destroyed by bacterially controlled
Cardiovascular Applications. In the car- diseases. Dental caries (cavities), the
diovascular, or circulatory, system (the heart
demineral- ization and dissolution of teeth
and blood vessels involved in circulating blood associated with the metabolic activity in plaque
throughout the body), problems can arise with
(a film of mucus that traps bacteria on the
heart valves and arteries, both of which can be surface of the teeth), can cause extensive tooth
successfully treated with implants. The heart
loss. Teeth in their entirety and segments of
valves suffer from structural changes that pre- teeth both can be replaced or restored by a
vent the valve from either fully opening or
variety of materials (Table 1). A thorough
fully closing, and the diseased valve can be review of these materials can be found in
replaced with a variety of substitutes. As with
Chapter 10, “Biomaterials for Dental
orthopedic implants, ceramics (carbons, as Applications,” in this handbook.
described in Chapter 6, “Ceramic Materials,”
Wound Healing. One of the oldest uses of
in this hand- book), metals, and polymers are
implantable biomaterials can be traced back to
used as materi- als of construction (Table 1).
the introduction of sutures for wound closure.
Arteries, particularly the coronary arteries
The ancient Egyptians used linen as a suture as
and the vessels of the lower limbs, become
far back as 2000 B.c. Synthetic suture materials
blocked by fatty deposits (atherosclerosis), and
include both polymers (the most widely syn-
it is possible in some cases to replace segments
thetic suture material) and some metals (e.g.,

a.
b.
c.

Fig. 1 Implant material requirements in orthopedic applications. Source: Ref 2

 Chapter 1: Overview of Biomaterials and Their Use in Medical Devices / 3

stainless steels and tantalum). Chapter 7, Another important wound-healing category

“Poly- meric Materials,” in this handbook is that of fracture fixation devices. These inc-
discusses the characteristics and properties of lude bone plates, screws, nails, rods, wires, and
synthetic suture materials. other devices used for fracture treatment.
Although some nonmetallic materials (e.g.,
car- bon-carbon composite bone plates) have
been investigated, almost all fracture fixation
Table 1 Examples of medical and dental devices used for orthopedic applications are
materials and their applications made from metals, most notably stainless
steels (see Chap- ter 3, “Metallic Materials,” in
Material Principal applications
this handbook for details).
Metals and alloys Drug-Delivery Systems. One of the fastest
316L stainless steel Fracture fixation, stents, surgical growing areas for implant applications is for
instruments devices for controlled and targeted delivery of
drugs. Many attempts have been made to incor-
CP-Ti, Ti-Al-V, Ti-Al-Nb, Bone and joint
Ti- replacement, porate drug reservoirs into implantable devices
13Nb-13Zr, Ti-Mo-Zr-Fe fracture fixation, dental for a sustained and preferably controlled re-
implants, pacemaker
encapsulation
lease. Some of these technologies use new
poly-
Co-Cr-Mo, Cr-Ni-Cr-Mo Bone and joint replacement,
dental implants, dental meric materials as vehicles for drug delivery.
restorations, heart valves Chapters 7, “Polymeric Materials,” and 9,
Ni-Ti Bone plates, stents,
orthodontic wires “Coatings,” in this handbook describe these
Gold alloys Dental restorations materials.
Silver products Antibacterial agents
Platinum and Pt-Ir Electrodes
Hg-Ag-Sn amalgam Dental restorations
Types of Biomaterials (Ref 1)
Ceramics and glasses

Alumina Joint replacement, dental Most synthetic biomaterials used for

implants
Zirconia Joint replacement implants are common materials familiar to the
Calcium phosphates Bone repair and augmentation, average materials engineer or scientist (Table
surface coatings on metals 1). In gen- eral, these materials can be divided
Bioactive glasses Bone replacement
Porcelain Dental restorations into the fol- lowing categories: metals,
Carbons Heart valves, percutaneous polymers, ceramics, and composites.
devices, dental implants
Polymers
Polyethylene Joint replacement
Polypropylene Sutures
PET Sutures, vascular prosthesis
Polyamides Sutures
PTFE Soft-tissue augmentation,
vascular prostheses
Polyesters Vascular prostheses, drug-
delivery systems
Polyurethanes Blood-contacting devices
PVC Tubing
PMMA Dental restorations, intraocular
lenses, joint replacement
(bone cements)
Silicones Soft-tissue replacement,
ophthalmology
Hydrogels Ophthalmology, drug-delivery
systems
Composites

BIS-GMA-quartz/silica filler Dental restorations

PMMA-glass fillers Dental restorations (dental
cements)

Abbreviations: CP-Ti, commercially pure titanium; PET, polyethylene tereph-

thalates (Dacron, E.I. DuPont de Nemours & Co.); PTFE, polytetra fluoroeth-
Fig. 2 Schematic showing key components of a natural syn-
ovial joint. It consists of layers of bearing material
ylenes (Teflon, E.I. DuPont de Nemours & Co.); PVC, polyvinyl chlorides; (articular cartilage) mounted on relatively hard bones forming
PMMA, polymethyl methacrylate; BIS-GMA, bisphenol A-glycidyl. Source: the skeletal frame. The synovial fluid acts as a lubricant. In
Adapted from Ref 3
an artificial joint, lubrication is supplied by low-friction
polymeric bearing materials. Source: Ref 4
4 / Handbook of Materials for Medical Devices

Metals. As a class of materials, metals are the most widely used for load-bearing implants. For instance,
some of the most common ortho- pedic surgeries involve the implantation of metallic implants. These range
from simple wires and screws to fracture fixation plates and total joint prostheses (artificial joints) for hips,
knees, shoulders, ankles, and so on. In addition to orthopedics, metallic implants are used in maxillofacial
surgery, cardiovascular surgery, and as dental materials. Although many metals and alloys are used for
medical device applica- tions, the most commonly employed are stain- less steels, commercially pure
titanium and tita- nium alloys, and cobalt-base alloys (Table 1). The use of metals for implants is reviewed
in Chapter 3, “Metallic Materials,” in this hand- book. Dental alloys are discussed in Chapters 10,
“Biomaterials for Dental Applications,” and 11, “Tarnish and Corrosion of Dental Alloys.”
Polymers. A wide variety of polymers are
used in medicine as biomaterials. Their applica- tions range from facial prostheses to tracheal tubes, from
kidney and liver parts to heart com- ponents, and from dentures to hip and knee joints (Tables 1, 2).
Chapters 7, “Polymeric Materials,” and 10, “Biomaterials for Dental Applications,” in this handbook review
the use of polymers for these applications.
Polymeric materials are also used for medical adhesives and sealants and for coatings that serve a variety
of functions (see Chapters 8, “Adhesives,” and 9, “Coatings,” in this hand- book for details).
Ceramics. Traditionally, ceramics have seen widescale use as restorative materials in

Table 2 Examples of polymers used as biomaterials

Application Polymer

Knee, hip, shoulder joints Ultrahigh molecular weight

polyethylene
Finger joints Silicone
Sutures Polylactic and polyglycolic acid, nylon
Tracheal tubes Silicone, acrylic, nylon
Heart pacemaker Acetal, polyethylene, polyurethane
Blood vessels Polyester, polytetrafluoro- ethylene, PVC
Gastrointestinal segments Nylon, PVC, silicones Facial prostheses Polydimethyl siloxane,
polyurethane, PVC
Bone cement Polymethyl methacrylate

PVC, polyvinyl chloride. Source: Ref 1

dentistry. These include materials for crowns, cements, and dentures (see Chapter 10, “Bioma-
terials for Dental Applications,” in this hand- book for details). However, their use in other fields of
biomedicine has not been as extensive, compared to metals and polymers. For example, the poor
fracture toughness of ceramics se- verely limits their use for load-bearing applica- tions. As shown
in Table 1, some ceramic mate- rials are used for joint replacement and bone repair and
augmentation. Chapters 6, “Ceramic Materials,” and 9, “Coatings,” in this handbook review the
uses of ceramics for nondental bio- medical applications.
Composites. As shown in Table 1, the most successful composite biomaterials are used in the
field of dentistry as restorative materials or dental cements (see Chapter 10, “Biomaterials for
Dental Applications,” in this handbook for details). Although carbon-carbon and carbon- reinforced
polymer composites are of great interest for bone repair and joint replacement because of their low
elastic modulus levels, these materials have not displayed a combina- tion of mechanical and
biological properties appropriate to these applications. Composite materials are, however, used
extensively for prosthetic limbs, where their combination of low density/weight and high strength
make them ideal materials for such applications.
Natural Biomaterials. Although the bio-
materials discussed in this handbook are syn- thetic materials, there are several materials derived
from the animal or plant world being considered for use as biomaterials that deserve brief mention.
One of the advantages of using natural materials for implants is that they are similar to materials
familiar to the body. In this regard, the field of biomimetics (or mimicking nature) is growing.
Natural materials do not usually offer the problems of toxicity often faced by synthetic materials.
Also, they may carry specific protein binding sites and other biochemical signals that may assist in
tissue healing or integration. However, natural materi- als can be subject to problems of
immunogenic- ity. Another problem faced by these materials, especially natural polymers, is their
tendency to denature or decompose at temperatures below their melting points. This severely limits
their fabrication into implants of different sizes and shapes.