Introduction

Introduction to Biomaterials : In this section I will discuss

about the following terms……………………
i) Definition of Biomaterials ii) Classification of
Biomaterials
iii) Application’s of Biomaterials

Definition of Biomaterials

***A biomaterial is a nonviable material used in a medical device, intended

to interact with biological systems (Williams, 1987)
***Any material of natural or of synthetic origin that comes in contact with
tissue, blood or biological fluids, and intended for use in prosthetic,
diagnostic, therapeutic or storage application without adversely affecting the
living organism and its components is called biomaterials.

Necessity of biomaterials

Biomaterials are used to make devices to replace a part or a function of the body
in safe, reliably economically, and physiologically acceptable manner. A variety of
devices and materials are used in the treatment of disease or injury. Commonplace
examples include suture needles, plates, teeth fillings, etc.
 Objectives of biomaterials

● To introduce the different biomaterials used in Biomedical Engineering

● To provide some fundamentals properties of these materials,
● To indicate how they are used.

Need for biomaterials

● Millions of patients suffer end stage organ and tissue failure annually.
● Treatment options include transplantation, reconstruction, mechanical
devices.

History of biomaterials
• 3000 B.C.: earliest report of a surgical suture (in acient Egypt).
• 900 A.D.: estimated year (from carbon dating) of the first dental implant found
in Europe, which was found to have properly integrated bone.
• 1829: H.S. Levert studies canine responses to implanted metals – “in vivo” – in
the living body of a plant or animal
• 1870: British surgeon Joseph Lester introduces aseptic surgical techniques –
“asceptic” – free from contamination by harmful bateria, viruses or other
microorganisms
• 1886: German doctor H. Hansmann is the first surgeon to use metal plates for
internal fixation
• 1931: Boston surgeon Smith Peterson develops a metal cup for partial hip
implants
• 1939 – 1945: WWII spurs the development of many new materials and
orthopaedic surgical techniques – Up until ~1950, mostly metals were used
because very few plastics existed
• 1947: first paper on polyethylene as a synthetic implant material
• 1949: paper published about plastics “sweating out” additives, resulting in a
strong (negative) biological reaction.
• After WWII, materials that had been rationed were now available and surgeons
did not collaborate w/ scientists or engineers
• Surgeon hero – dentists/doctors would invent “on the fly” when patients’ lives
or functionality were at stake
• Also, minimal government/regulatory activity was ongoing at this time.
• At the time of the 1962 Drug Amendments and Consumer Bill of Rights passages,
the biomaterials of today did not exist; no companies were making them, nor was there
a formal regulatory approval process – What is now the FDA medical device group
• The “quantum leap” in recent decades, enabled by increasingly better laboratory
technologies (e.g., fluorescence microscopy), is the understanding of biocompatibility
on a cellular and molecular level – Definitions vary, but biocompatibility can be
described as the capacity of a material or device to not induce toxic or injurious effects
on biological systems (i.e., to subvert the wound healing response mentioned earlier) –
Before 1950, this lack of understanding translated to a very low implant success rate
due to rejection by the immune system.

Biomaterials research in the modern era is marked by a high degree of

interdisciplinarity: – Materials science – Chemistry and chemical engineering –
Biology and bioengineering – Physics and biophysics – Biomechanics and mechanical
engin. – Nanotechnology. Example 1 – vascular stents

Generation of biomaterials

There are three different generations seemed to be clearly described as below :

First generation of biomaterials : When synthetic materials were first used in biomedical
applications, the using requirements were a suitable physical properties to match those of
the replaced tissue with a minimal toxic response of the host, so biologically inert or nearly
inert materials were used in order to reduce the corrosion and the releasing ions and
particles after implantation to minimise the immune response and foreign body reaction.
Mechanical properties and toxicity also play a leading role in the selection of materials for
implant manufacture. When inert biomaterials placed inside the body, it would elicit a
foreign fibrous capsule around the material which isolates it from the surrounding tissue.
Examples for the first generation biomaterials: Metals (stainless steel and cobalt–chrome-
based alloys, Ti and Ti alloys). Ceramics (Alumina Al2O3 and Zirconia ZrO2). Polymers
(silicone rubber, acrylic resins).
second generation of biomaterials:
The second generation of biomaterials used bioactive materials ‘ability to interact with the
biological environment to enhance the biological response and the tissue/surface bonding’,
and resorbable biomaterials that have ability to degradation while new tissue regenerates
and heals.
Examples for the second generation biomaterials: Metals (None of the biometallic
materials are bioactive; However, two approaches can be considered to obtain bioactive
metals. The first one consists of coating the surface of the metal with a bioactive ceramic.
The second one is to chemically modify the surface of the metal so as to induce proteins
and cell adhesion and other tissue/material interactions. Ceramics (Bioactive glass, glass–
ceramics and calcium phosphates (CaPs)). Polymers (Biodegradable polymers of synthetic
and natural origin such as polyglycolide (PGA), polylactide (PLA).

Third-generation of biomaterials:
The third-generation biomaterials used bioactive and bioresorbable materials as temporary
three-dimensional porous structures which are able to activate genes that stimulate
regeneration of living tissue. For these biomaterials, the bioactivity and biodegradability
concepts are combined, so the combination of bioactivity and biodegradability is the most
characteristics of the third-generation biomaterials. Metals have been used in the
development of porous structures that focused on titanium and titanium alloys
 Design and Selection factors of a
biomaterials
The characteristics to be taken into consideration when it is meant a biomaterial used for
implant including
 Biocompatibility  Surface modifications
 Biofunctionality,  sterilizibility.

 Chemical Stability

 Mechanical
stability

Biocompatibility :
Biocompatibility of a biomaterial is related to the organism accepting the body, until then a
foreign matter, and admitting it as part of the whole, as well as not exhibiting signs of harmful
effects at its locus of operation. The expression biocompatibility comprehends different
properties of materials, such as toxicity, tissues compatibility, blood compatibility
(hemocompatibility).
Biofunctionality :
Biofunctionality is essential for the material to perform the functions to which it has been
designed for, at the required period of time and effectively. For materials of long-lasting
biofunctionality the material should not degrade by contact with the tissue; since thus it would
partly lose its functionality, it should also keep its chemical and mechanical stability
throughout the whole process to which it has been enabled. For metals, degradation is related
to corrosion which causes harmful effects to the body if these are not of a tolerable degree.

Biotolerablity :
Biotolerable is the way by which are designed materials that are tolerated by the body, being
separated from the host tissue by the formation of a housing of fibrous tissue. This layer is
induced by the release of chemical compounds, ions, corrosion products, and other ones
resulting from the implanted material. Among the biotolerable materials are highlighted the
synthetic polymer materials and most of the metals.

Surface modifications :

surface modifications keeps the characteristics of internal properties of the material with a
suitable surface in order to better meet the specification of the locus of application.
 Bioactive :
Materials have been developed to incorporate bioactivity through biological recognition,
including incorporation of adhesion factors, polyanionic sites that mimic the electrostatics of
biological regulatory polysaccharides, and cleavage sites for enzymes involved in cell
migration.
Bioinert :
Biologically inert, or Bioinert materials are ones which do not initiate a response or interact
when introduced to biological tissue. In other words, introducing the material to the body will
not cause a reaction with the host .

Chemical
Stability
Tendency of a material to resist change or decomposition due to internal reaction, or due to the
action of air, heat, light, pressure, etc.

Sterilizable
Sterilizable means to make a materila free from bacteria or other microorganisms.

Define the following

terms :
 Bioactive materials  Bioinert materials Biodegradable materials
Bioactive
materials
Bioactive :
are materials that can make chemical bonds with the bone tissue, characterized as an
osseointegration process. Through this process the bone tissue connects to the implanted material
promoting the coating by bone cells. Materials employed as bioactive are the calcium phosphate,
hydroxyapatite, and calcium phosphate compound-based glasses and vitroceramics.

Bioinert materials :
Bioinert are materials which are also tolerated by the body, but where there is no chemical reaction
between the material and the tissue. The material either does not release components in any
significant amount or does not release components and the formation of fibrous housing is
minimal. Common examples of bioinert materials are alumina, zirconia, titanium and alloys and
carbon.
Biodegradable materials :
Biodegradable are materials which degrade, solubilize, or are absorbed when in contact with the
body for a certain period of time. Their application is of deep interest since there is no need of a
further surgery for the withdrawal of the implant. Within this class most important are the
biopolymers.

Properties of Biomaterials

Biomaterials has the following properties………………

Physical Properties :
The physical properties of the biomaterial are fundamental for the response of cell adhesion.
When cells adhere to the biomaterial surface physical chemical reactions between cell and
biomaterial occur, such reactions being influenced by factors such as cell behavior, biomaterial
surface properties, and environmental factors. The biomaterial surface properties include
wettability, filler, roughness, softness, and chemical composition.

Chemical Properties :
chemical properties also influence the kind of cell bond and determine the biomaterial chemical
stability and reactivity. The corporeal ambience is harsh and may cause corrosion of biomaterials.
Corrosion products may cause adverse reactions to the implant neighborhood. Body fluids are in
balance with specific ions under normal physiological conditions. When a biomaterial is implanted
the concentration of these ions increases significantly around it and may cause swelling and pain,
besides the fact that the corrosion wastes may migrate to other parts of the body and cause
undesirable reactions, both for the tissues and the implant. Corrosion of biomaterials alters not
only chemical stability, but also affects the mechanical integrity, with possible premature failure of
the material.
Mechanical Properties :
Advances in engineering and medicine require the development of ever more specialized
properties for biomaterials Characteristics and Properties mechanical application, some of the
requirements studied are Young’s modulus, ductility, tensile strength, yield strength, compression
strength and fatigue, and wear debris. These properties are evaluated on account of the fact that the
human body has different properties for each tissue. For example, elasticity varies from very soft
as is the case of brain tissues (*0.1–1 kPa) up to extremely hard or stiff (30 kPa and above), which
is the case for the completely mineralized bone.

Surface Modification :

Modifications at the biomaterial surfaces are considered as a promising alternative to improve

biomaterial–tissue interactions and promote better biocompatibility and biofunctionality results
without altering the materials’ bulk properties. Surface modifications can be two kinds , such as
physicochemical modifications and surface coating.

Classification of Biomaterials

There are the following types of Biomaterials

 1. Metallic Biomaterials

 2. Ceramic Biomaterials

 3. Composite Biomaterials

 4. Polymeric Biomaterials

 5. Biodegradable Polymeric Biomaterials

Metallic Biomaterials :
The first metal alloy developed specifically for human use was the “vanadium steel” which was
used to manufacture bone fracture plates (Sherman plates) and screws. Most metals such as iron
(Fe), chromium (Cr), cobalt (Co), nickel (Ni), titanium (Ti), tantalum (Ta), niobium (Nb),
molybdenum (Mo), and tungsten (W) that were used to make alloys for manufacturing implants
can only be tolerated by the body in minute amounts. Sometimes those metallic elements, in
naturally occurring forms, are essential in red blood cell functions (Fe) or synthesis of a vitamin
B-12 (Co), but cannot be tolerated in large amounts in the body [15]. The biocompatibility of the
metallic implant is of considerable concern because these implants can corrode in an in vivo
environment [16]. The consequences of corrosion are the disintegration of the implant material
per se, which will weaken the implant, and the harmful effect of corrosion products on the
surrounding tissues and organs [17].
 Ceramic Biomaterials :
The most important properties like: (a) Should be non-toxic, (b) Should be non-carcinogenic, (c)
Should be non-allergic, (d) Should be non-inflammatory, (e) Should be biocompatible, (f) Should be
biofunctional for its lifetime in the host. Ceramics are generally hard; in fact, the measurement of
hardness is calibrated against ceramic materials & are focused on a general overview of the relatively
bioinert, bioactive or surface reactive ceramics, and biodegradable or resorbable bioceramics.
Ceramics used in fabricating implants can be classified as nonabsorbable (relatively inert), bioactive or
surface reactive (semi-inert) [18], and biodegradable or resorbable (non-inert) [19]. Alumina, zirconia,
silicone nitrides, and carbons are inert bioceramics. Certain glass ceramics and dense hydroxyapatites
are semi-inert (bioreactive), and calcium phosphates and calcium aluminates are resorbable ceramics
[20].
Composite Biomaterials :
The term “composite” is usually reserved for those materials in which the distinct phases are separated on
a scale larger than the atomic, and in which properties such as the elastic modulus are significantly altered
in comparison with those of a homogeneous material. Accordingly, reinforced plastics such as fiberglass
as well as natural materials such as bone are viewed as composite materials, but alloys such as brass are
not. Foam is a composite in which one phase is empty space. Natural composites include bone, wood,
dentin, cartilage, and skin. Natural foams include lung, cancellous bone, and wood. Natural composites
often exhibit hierarchical structures in which particulate, porous, and fibrous structural features are seen
on different micro-scales [22]. In biomaterials, it is important that each constituent of the composite be
biocompatible. Moreover, the interface between constituents should not be degraded by the body
environment. Some applications of composites in biomaterial applications are: (1) dental filling
composites (2) reinforced methyl methacrylate bone cement and ultra-high-molecular-weight
polyethylene, and (3) orthopedic implants with porous surfaces. Moisture absorption by polymer
constituents also causes swelling. Such swelling can be beneficial in dental composites, since it offsets
some of the shrinkage due to polymerization. Flexible composite bone plates are effective in promoting
healing [23], but particulate debris from composite bone plates gives rise to a foreign body reaction
similar to that caused by ultrahighmolecular- weight polyethylene [24].

Polymeric Biomaterials :
Synthetic polymeric materials have been widely used in medical disposable supplies, prosthetic
materials, dental materials, implants, dressings, extracorporeal devices, encapsulants, polymeric drug
delivery systems, tissue engineered products, and orthodoses like those of metal and ceramics
substituents. The main advantages of the polymeric biomaterials compared to metal or ceramic materials
are ease of manufacturability to produce various shapes (latex, film, sheet, fibers, etc.), ease of
secondary processability, reasonable cost, and availability with desired mechanical and physical
properties. The required properties of polymeric biomaterials are similar to other biomaterials, that is,
biocompatibility, sterilizability, adequate mechanical and physical properties, and manufacturability
[21].
Biodegradable Polymeric Biomaterials :
The term biodegradation is loosely associated with materials that could be broken down by nature either
through hydrolytic mechanisms without the help of enzymes and/or enzymatic mechanism.Other terms
such as absorbable, erodible , and resorbable have also been used in the literature to indicate
biodegradation. Interest in biodegradable polymeric biomaterials for biomedical engineering use has
increased dramatically during the past decade. This is because this class of biomaterials has two major
advantages that non-biodegradable biomaterials do not have. First, they do not elicit permanent chronic
foreign-body reactions due to the fact that they are gradually absorbed by the human body and do not
permanently leave traces of residual in the implantation sites. Second, some of them have recently been
found to be able to regenerate tissues, so-called tissue engineering, through the interaction of their
biodegradation with immunologic cells like macrophages. Hence, surgical implants made from
biodegradable biomaterials could be used as a temporary scaffold for tissue regeneration. This approach
toward the reconstruction of injured, diseased, or aged tissues is one of the most promising fields in the
21st century. While aromatic polyesters are almost totally resistant to microbial attack, most aliphatic
polyesters are biodegradable due to their potentially hydrolysable ester bonds: Naturally Produced:
Polyhydroxyalkanoates like the poly-3-hydroxybutyrate (PHB), polyhydroxyvalerate &
polyhydroxyhexanoate; Renewable Resource: Polylactic acid; Synthetic: Polybutylene succinate,
polycaprolactone, Polyanhydrides, Polyvinyl alcohol, Most of the starch derivatives, Cellulose esters like
cellulose, acetate and nitrocellulose and their derivatives (celluloid) are recently used [25].

General Applications of Biomaterials