Seminars in Pediatric Surgery (2006) 15, 276-283

Biomaterials: A primer for surgeons

Gary Binyamin, PhD,a Bilal M. Shafi, MD, MSE,a,b Carlos M. Mery, MD, MPHa,c

a
From the Biodesign Surgical Innovation Program, Stanford University, Stanford, California;
b
University of Pennsylvania, Philadelphia, Pennsylvania; and the
c
Brigham & Women’s Hospital, Boston, Massachusetts.

INDEX WORDS Biomaterials offer the surgeon a powerful set of clinical tools for patient treatment and are found in
Material science; virtually every instrument, device, implant, or piece of equipment in the operating room. In fact,
Metals; surgeons have historically driven clinical application of biomaterials and stand uniquely positioned to
Polymers; contribute to the ongoing development of biomaterials. Having an understanding of the materials
Ceramics; available and their basic properties can contribute to better and more effective outcomes. This article
Composites; provides an overview of the biomaterials field. It begins with a definition and abbreviated history of the
Nanotechnology; field, highlighting its clinical roots. An introduction to the four material classifications—metals,
MEMS; polymers, ceramics, and composites—is then presented, providing the reader with basic properties of
Pectus excavatum; each group and examples of materials. Sections on nanotechnology and tissue engineering also briefly
Congenital describe development within the field. Finally, the evolution of treatments for pectus excavatum and
diaphragmatic hernia congenital diaphragmatic hernias are presented, highlighting the role of biomaterials. While providing
a primer of the field, this paper shows the broad interdisciplinary reach of material science in surgery
and suggests sources for further investigations.
© 2006 Elsevier Inc. All rights reserved.

Any operative manipulation is dependent on the ability
of the surgeon to visualize and manipulate tissues. Success
lies in the skills of the surgeon and the availability of tools
useful for patient treatment. Throughout the years, material
science has provided a set of powerful clinical tools—the
field of biomaterials. Several definitions of biomaterials
are used; one of the most commonly accepted is from the
National Institutes of Health (NIH), which describes a bio-
material as “any substance (other than a drug) or combination
of substances synthetic or natural in origin, which can be used
for any period of time, as a whole or part of a system which
treats, augments, or replaces tissue, organ, or function of the
body.”1 With the advent of tissue engineering and regenerative
medicine in recent years, the definition has broadened to in-
Address reprint requests and correspondence: Gary Binyamin,
PhD, Stanford University Medical Center, Lucile Packard Children’s Hos-
pital, Division of Pediatric Surgery, 780 Welch Road, Suite 206, Stanford,
CA 94305.
E-mail: Gbinyamin@stanford.edu.
clude “any material used in a medical device intended to
interact with biological systems,” allowing for structures and
combination devices that actively interact with the body to be
included in the field.2 Biomaterials can be synthetic (ie, those
made by man) or biological (ie, those produced by a biological
system). Further classifications based on development stage or
material characteristics are also common.
Materials science has contributed to the practice of sur-
gery since the earliest procedures were performed and the
first implants placed. Although there have been reports of
biomaterial use dating back over 32,000 years, most of the
biomaterial applications have occurred over the past 2000
years.2 Examples of these early materials include wooden
teeth, glass eyes, and metallic dental implants.3 The modern
age of biomaterial science started in the late 1800s with two
key innovations: the implementation of aseptic techniques
reducing the potential of infection-related complications4
and the radiograph techniques pioneered by Roentgen al-
lowing for visualization of skeletal structures.5

1055-8586/$ -see front matter © 2006 Elsevier Inc. All rights reserved.
doi:10.1053/j.sempedsurg.2006.07.007
Binyamin et al Biomaterials 277

Table 1 Select biomaterials classified by material type with examples of their application in medical devices

Classification Biomaterial Examples of applications

Metal 316L stainless steel Surgical instruments, orthopedic fixation devices, stents
Metal Titanium and titanium-containing Fracture fixation, pacemaker encapsulation, joint
alloys replacement
Metal (shape memory alloy) Nickel–Titanium Alloy (Nitinol) Stents, orthodontic wires
Metal Platinum and platinum-containing Electrodes
alloys
Metal Silver Anti-bacterial material
Polymer Polytetrafluoroethylene (PTFE, Vascular grafts, catheters, introducers
Teflon®, Gore-Tex®)*
Polymer Poly(ethylene terephthalate) Vascular graft, drug delivery, non-resorbable sutures
(polyester, Ethibond, Dacron®)
Polymer Poly(methyl methacrylate) Bone cement, intraocular lens
(PMMA)
Polymer Polyurethane Catheters, tubing, wound dressing, heart valves,
artificial hearts
Polymer Silicone rubber Catheters, feeding tubes, drainage tubes, introducer
(polydimethylsiloxane PDMS) tips, flexible sheaths, gas exchange membranes
Polymer Polycarbonate Major component in renal dialysis cartridge, heart-lung
machine, trocars, tubing interconnectors
Polymer Hydrogels (poly(ethylene oxide), Drug delivery, wound healing, hemostasis, adhesion
poly(ethylene glycol), prevention, contact lenses, extracellular matricies,
poly(vinyl alcohol), etc.) reconstruction
Polymer Polyamides (nylon) Non-resorbable sutures
Polymer Polypropylene (ie, prolene) Non-resorbable sutures, hernia mesh
Ceramic Alumina Joint replacement, dental implants, orthopedic
prostheses
Ceramic Carbon Heart valves, biocompatible coatings, electrodes
Ceramic Hydroxyapatite Implant coatings, bone filler
Ceramic Bioglass Metal prostheses coating, dental composites, bone
cement fillers
*Teflon and Dacron are trademarks of E. I. DuPont de Nemours & Co, and Gore-Tex is a trademark of W. L. Gore & Associates, Inc.

Through the end of the 19th and early 20th centuries,
surgeons pioneered the application of materials in a biolog-
ical context, using off-the-shelf materials for the treatment
of patients. Most early implants were applied to the skeletal
system and included devices such as metallic fracture fixa-
tion devices and bone plates.6 Many of these initial attempts
demonstrated the usefulness of biomaterials, although they
were often associated with complications due to poor me-
chanical design or incompatibility with the biological envi-
ronment. These device failures prompted the search for
more suitable materials and improved device designs for
these and other applications. Harold Ridley, an ophthalmol-
ogist, was the first to make the observation that polymer
materials (polymethyl methacrylate) could be useful in the
development of ocular lens implants after studying the ef-
fects of airplane canopy shards remaining in the eyes of
fighter pilots during World War II. Concurrently, other
physicians started working with materials in the fields of
orthopedic prostheses, heart valves, dental implants, vascu-
lar grafts, and kidney dialysis.2,6 Approximately 50 years of
successful development in materials is reflected in the im-
proved quality of life for countless numbers of patients and
the economic growth of the industry, now valued in excess
of $100 billion.2
The process of materials selection should take into ac-
count the general situation in which the material is to be
used and how the characteristics of available materials will
reflect its performance. For examples of biomaterials and
their applications, see Table 1. The characteristics of bio-
materials can be generally divided into two categories: bulk
and surface. Bulk properties are determined by the atomic
composition and interatomic bonding, which result in the
set of mechanical, chemical, electrical, acoustical, optical,
and magnetic characteristics that the material will have. Of
particular note are the mechanical properties which encom-
pass the elastic, stress-strain, tension-compression, shear,
and fracture resistance qualities of the material. Several
reviews of the fundamental material structures and determi-
nation of their physical properties are available for re-
view.7,8 Theoretical analysis has been instrumental in the
evaluation of bulk properties and selection of materials;
mathematical modeling of structures has contributed signif-
icantly to the field of medical device development.7
The surface properties of a material describe the inter-
actions that occur at the interface with its environment. For
implanted biomaterials, one of the key surface properties is
biocompatibility (ie, how the body reacts to the surface of
the material and the impact of the implant on the body). A
278
completely biocompatible material would lack thrombo-
genic, toxic, or inflammatory responses in the short-term
and carcinogenic, mutagenic, or teratogenic effects in the
long-term.9,10 No completely biocompatible material is cur-
rently available. A typical biomaterial will be recognized as
a synthetic material, and the body will induce a foreign body
reaction with formation of a fibrous sheath at the material
interface.9 Other interactions, such as adsorption, leeching,
erosion, and microstructure, are among surface properties
that should be considered when choosing a biomaterial.
This paper will describe four general classes of materials
available to the surgeon: metals, polymers, ceramics, and
composites. Also included are overviews on emerging as-
pects of material science, tissue engineering, and nanotech-
nology. While providing a primer of the field, this paper
shows the broad interdisciplinary reach of material science
in surgery and suggests sources for further investigations.
Metals
Metals are inorganic materials that have unique atomic
arrangements and bonding characteristics leading to en-
hanced mechanical, thermal, and electrical properties. Their
conductivity and mechanical strength, especially the load-
bearing properties, make them ideal for a variety of medical
applications,8 including prostheses for hard tissue replace-
ment, fixation devices, dental implants, and active devices
such as stents, guide wires, and electrodes.11 Examples are
provided in Table 1.5,11-15
The biocompatibility of metals leads to a unique consid-
eration in that they may corrode in physiological environ-
ments. Corrosion is a chemical reaction that leads to dete-
rioration of the material resulting in progressive weakening
and the release of products into the surrounding environ-
ment, potentially leading to adverse effects.5,11,14 Nobel
metals, such as gold, silver, and platinum, are inert and thus
are not subject to corrosion reactions. Other metals have the
ability to form an adherent, inert layer that prevents further
reactivity between the metal and the biological system,
typically a thin oxide. Metals that commonly form robust
oxide layers include titanium and chromium.13 Clinically,
corrosion may present as local pain or swelling without
evidence of infection and discoloration or flaking of the
implant as visualized during surgery.11
A majority of the pure metals are not useful as bioma-
terials because of biocompatibility and corrosion concerns.5
Although nobel metals exhibit excellent biocompatibility
and corrosion resistance, they often do not have ideal load-
bearing properties.13 As a result, the use of these metals for
biomaterial applications represents a minor amount of the
total used. Other pure metals that have found application
include magnesium (Mg), tantalum, and the platinum group
elements (platinum, iridium, palladium, ruthenium, etc.).
Magnesium has very advantageous mechanical properties,
but low corrosion resistance. Uniquely, the magnesium cor-
Seminars in Pediatric Surgery, Vol 15, No 4, November 2006
rosion products are nontoxic and quickly excreted from the
body, making this essentially a biodegradable metal.16,17
Currently, Mg is being investigated for application in or-
thopedic and cardiovascular devices. Whereas neither tan-
talum nor the platinum group of metals have good mechan-
ical properties, they do exhibit high corrosion resistance.
The platinum group also has unique reaction properties that
make them useful as electrodes.11
Alloys are homogenous mixtures of two or more metals.
Vanadium steel was the first metal alloy specifically devel-
oped as a biomaterial, although it is no longer used because
of its susceptibility to corrosion.13 Currently, the most com-
mon alloys are stainless steel, titanium (Ti)-containing,
cobalt– chromium, and shape memory alloys.11,14 Stainless
steels are a mixture of carbon, chromium, nickel, manga-
nese, iron, and other minor components. Type 316L, a
nonparamagnetic material also known as austenitic stainless
steel,15 is most commonly used for implant applications
such as defibrillator casing and hip implants. Cobalt– chro-
mium alloys contain both chromium and cobalt in addition
to other minor elements. The performance is similar to
stainless steels with comparable or slightly higher mechan-
ical properties and improved corrosion resistance, although
slight leeching of metal ions into the tissues is observed.11,18
Titanium and Ti-containing alloys are used extensively
because of their high strength-to-weight ratio, due to good
mechanical properties and a low density, as well as its high
biocompatibility profile.5,11 The latter is due to the forma-
tion of an adherent oxide layer, as previously discussed. The
unique properties of these Ti-containing alloys make them
ideal for orthopedic implants which require high load bear-
ing without adding much weight to the limb or joint.
There are several different Ti-containing materials that
can be utilized5,11,19; of particular note is the nickel–tita-
nium alloy known as nitinol. This unique alloy not only
possesses the previously discussed mechanical and biocom-
patibility properties of Ti but also has shape memory, super
elasticity, force hysteresis, fatigue resistance, thermal de-
ployment, and kink resistance.20,21 One of its most impor-
tant characteristics is shape memory, allowing the material
to return to a thermally preset shape after deformation
simply by raising the temperature above its transition point,
which is usually body temperature. Superelasticity allows
the material to be deformed 20 times more than stainless
steel before being permanently changed. Nitinol is nonpara-
magnetic and therefore MRI compatible.20
Polymers
Polymers are the broadest classification of biomaterials.
These long chain, organic molecules are versatile in their
composition and properties, finding use in surgical tools,
implantable devices, device coatings, catheters, vascular
grafts, injectable biomaterials, and therapeutics. An incom-
plete list of synthetic polymers include polyvinyl chloride
Binyamin et al Biomaterials
(PVC), polyethylene (PE), polypropylene (PP), polymethyl-
methacrylate (PMMA), polystyrene (PS), polytetrafluoroethyl-
ene (PTFE), polyesters, polyamides (nylon), polyurethanes,
and polysiloxanes (silicone). Commonly encountered natural
polymers are collagen, hyaluronic acid, heparin, and DNA.
There are several advantages to using polymers for biomed-
ical applications, including relatively low cost, ease of man-
ufacturing, history of use, and versatility. Selection of the
appropriate polymer for a clinical application requires the
consideration of several different parameters to achieve
the ideal set of material properties. This brief summary
highlights basic polymer concepts with more in-depth in-
formation available elsewhere.2,8,11,13,14,19,22-27
Polymers are large molecular chains composed of co-
valently bound repeating units called monomers linked to-
gether to form a common backbone. Chain length is com-
monly defined by the molecular weight (MW), which is a
product of the number of repeat units and the molecular
weight of the individual monomer. It is difficult to produce
multiple polymer chains with identical lengths, so the av-
erage molecular weight is typically reported.5 For medical
applications, caution must be taken to minimize the amount
of unreacted monomers and additives physically bound
within a polymer matrix as they can leech out during use
and provoke a physiological reaction. Depending on their
structure, polymers can be linear, if monomers are arranged
in an end-to-end fashion, or branched, if they have divisions
along the backbone.5,11 Furthermore, networks of polymer
chains can be made through crosslinking, resulting in inter-
connections between the molecules. These crosslinks can be
made with different types of chemical or physical bonding
(eg, covalent, ionic, inclusion complexes, and hydrogen
bonding). As interconnected networks of molecular chains,
polymers can be classified as crystalline, if they have long
range order, or amorphous, if they lack such an order.
Another important property of polymers is their glass tran-
sition temperature (Tg), which is the temperature at which
molecular motion is minimized, marking a transition from
viscous to solid state. All of these factors— choice of mono-
mer(s), arrangement of polymer chains, chain length (mo-
lecular weight), degree of crystallinity, glass transition tem-
perature, and extent of crosslinking— contribute to the
resultant properties of a polymer. The clinical application
will dictate the required properties, which will in turn de-
termine the most appropriate composition.
Polymers can be divided into two general categories:
thermoplastics and thermosets. Thermoplastic polymers are
solid materials that are able to be reshaped by raising the
temperature above Tg. The material is flexible above the
glass transition temperature with a gradual decrease in vis-
cosity as the melting temperature is reached.5,19 Nylon
(catheters and dialysis membranes) and polyethylene (im-
plant coatings) are both examples of thermoplastics.5 Con-
versely, thermosets cannot be reshaped once they have been
crosslinked. Raising the temperature of the material will
cause chemical decomposition without resulting in re-
279
melt.5,19 An example of this material includes vulcanized
rubber used in orthopedic prostheses and select cardiovas-
cular catheters.5 Elastomeric materials are a special subset
belonging to both thermosets and thermoplastics. These
materials are characterized by the ability to stretch several
times the original size under a load with recovery of its
original shape on release.5,19 Polyurethane and silicone are
both elastomers which are commonly used in Foley, periph-
eral intravenous, and central venous catheters.
Biodegradable polymers have evolved over the last
35 years. On implantation, these materials are gradually
replaced by regenerating tissue in vivo, breaking down
into safe products that are subsequently metabolized and/
or eliminated from the body. Poly(lactide-coglycolide)
(PLGA), polycaprolactone, polyanhydrides, and polyphos-
phazenes are common examples of synthetic degradable
polymers, whereas starch, chitin, collagen, and glycosami-
noglycans are examples of natural degradable polymers.
Vicryl® suture, a copolymer of lactide and glycolide, is an
example.28 The rate of material degradation is variable and
can be influenced through several methods, including chain
length (molecular weight), chemistry of the backbone, de-
gree of crystallinity, glass transition temperature, and local
conditions. The mechanism of degradation also varies, the
most common being enzymatic and hydrolytic.13
Hydrogels are another useful category of polymeric bio-
materials. These crosslinked polymer networks are insolu-
ble, yet swellable in aqueous medium.2,3,9 On contact with
water, the hydrophilic nature of a hydrogel causes the water
to be absorbed, leading to swelling of the matrix. The extent
of this swelling is dictated by the amount of crosslinking
between the polymer chains. Hydrogels have been devel-
oped for application in medical and pharmaceutical tech-
nologies, such as contact lenses, membranes, vocal chord
reconstruction, drug delivery, and wound healing. More
recently, these materials have been the basis of extracellular
matrices for tissue engineering.29 Hydrogels can also be
chemically tailored to respond to a certain environmental
stimuli. For these smart hydrogels, swelling occurs only
under defined conditions or in the presence of certain spe-
cies.13,30 Analyte-sensitive, pH-sensitive, temperature-re-
sponsive, potential-dependent, and solvent-specific gels are
examples of these materials. Other recent advancements in
polymer science include shape memory polymers,26 the
development of injectable biomaterials introduced to the
body as a liquid and harden in response to an in vivo
stimulus,23 and numerous drug delivery advancements
including complexes having nonbound, inclusion com-
plexes.31,32
An important consideration when choosing a polymer for
medical applications is the impact of sterilization tech-
niques. Although there are several options for the steriliza-
tion of these materials, there are potential instabilities that
can arise during the process. Dry heat is often used at
temperatures in excess of 160ºC, above the Tg and melting
temperature of many polymers. Steam sterilization (auto-
280
claving) occurs at lower temperatures, but there are poten-
tial side reactions between certain polymer chemistries and
the water vapor. The use of radiation treatment has the
potential of altering properties through excessive crosslink-
ing or cleaving of bonds. Chemical sterilization is the most
commonly used sterilization method as it occurs at low
energies and is relatively inert with respect to most poly-
mers.11
Ceramics
Ceramics are inorganic, nonmetallic materials that have
superior compressive strength and biological inertness that
make them useful for medical applications. Examples of
ceramics include silicates, metallic oxides, carbides, sul-
fides, refractory hydrides, selenides, and carbon structures,
such as diamond and graphite.11,14 Traditionally known to
be extremely hard, ceramics are limited by their relative
brittleness and poor mechanical properties. Other advanta-
geous properties of these materials are their high melting
point, low electrical conductivity, and low thermal conduc-
tivity.14 Advancements in the field have led to several useful
bioceramics and biocomposites (see following section) that
are typically classified into one of three categories: com-
pletely reabsorbable, bioreactive, and bioinert.5,13
Reabsorbable bioceramics degrade over time and are
replaced by endogenous tissues resulting in normal, func-
tional bone when used in orthopedic applications. Their
osteoconductive ability, or ability to allow for osteoblast
integration leading to osteoid formation, is a key property.33
Materials including calcium phosphates, hydroxyapatite,
and calcium sulfate dihydrate (plaster of paris) are classified
as reabsorbable bioceramics.11,14 The degradation and os-
teoid formation rates are variable and depend on the type of
material. Typically, the mechanical properties of these ma-
terials are greatly reduced during the reabsorption process,
resulting in a significantly different load-bearing capacity
over the course of integration.5 The use of reabsorbable
scaffolds seeded with cells has been used for tissue engi-
neering applications and has the potential to behave as a
synthetic extracellular matrix.23,29
The ability of a material to chemically bond and interact
with normal tissue at its interface is the key characteristic of
bioreactive bioceramics.5,33 Bioglass and Ceravital are clas-
sified as bioreactive materials and are typically used as bone
cement fillers, interfacial coatings for implants, and restor-
ative composites. The presence of these materials as the
bulk implant or in the form of coatings on other materials
causes the surrounding tissues to bind with them, providing
better integration and less residual stress at the interface.13
The ability to incorporate themselves makes surface reac-
tive bioceramics difficult to extract once they have healed
into place. Bone has been shown to fail before the bone–
bioglass interface, during loading experiments.5
Bioinert ceramics are biocompatible materials that main-
tain their mechanical and physical properties after implan-
Seminars in Pediatric Surgery, Vol 15, No 4, November 2006
tation.11 Characteristics include the lack of biological re-
sponse and noncarcinogenicity. Examples of this type of
materials include alumina (aluminum oxide, Al2O3), zirco-
nia (zirconium oxide, ZrO2), pyrolitic carbon, and silicon
nitirides. Bionert bioceramics are commonly used for struc-
tural support applications and are popular in orthopedic
applications. They are also known to have excellent wear
properties and are therefore useful for gliding functions.
Carbon is a versatile member of this category, providing the
ability to tune lubricity and conductivity while maintaining
high strength and excellent biocompatibility.11,33
Composites
Composite materials are combinations of two or more dis-
tinct biomaterials on a macroscopic scale, allowing for the
desirable physical and mechanical properties of each of
them to be leveraged.8,11,14,19,34 They are usually composed
of at least one discontinuous phase immobilized or imbed-
ded in a continuous phase (the matrix). This is distinctly
different from the homogenous mixtures, such as metallic
alloys, in that each of the components retains its own prop-
erties. The transfer of forces at the interface of the materials
is crucial to the overall behavior of composites. Along with
the interfacial interaction, other considerations for compos-
ite materials include the shape, orientation, and volume
fraction of the inclusive moieties.11,14 There are typically
two different types of composite biomaterials: particulate
and fibrous composites.
The inclusion of small particulates in a continuous
matrix is called a particulate composite. These materials
are typically isotropic, having increased toughness in all
directions at the expense of flexibility/stiffness. Examples
of these materials are rubber catheters reinforced with silica
(SiO2) particles and ceramic matrices with silica particles
used as dental composites. Porous materials are a special
class of particulate composites where the inclusion phase is
air. Used in both soft- and hard-tissue applications, porous
composites promote tissue ingrowth.11 Fibrous composites
are fibers immobilized in a matrix. Carbon-reinforced poly-
ethylene for joint replacement is an example of a fibrous
composite. A special class of fibrous composites are lami-
nates, composed of multiple stacked fiber composite lami-
nae.19
Tissue engineering
Regenerative medicine and cellular engineering have been
the focus of a significant amount of biomaterial science
research and are shifting the discipline from the application
of synthetic materials for treatment of patients to the use of
synthetic materials for the production of biological products
for the treatment of patients. In fact, biomaterials are seen as
Binyamin et al Biomaterials
central in the design of milieus that will direct cell behavior
and function.29
The extracellular matrix (ECM) is the natural structural
environment found in tissues for the three-dimensional or-
ganization and support of cells. Several strategies have been
utilized to mimic the ECM resulting in scaffolds for cell
migration and proliferation. Natural ECMs are those matri-
ces composed of biological molecules and can be divided
into those derived from decellularization of tissue and those
constructed from biological molecules. Acellular tissue is
the native ECM that remains after all cells and cell debris
have been removed. The resulting structure retains many of
the properties of the original tissue and has reduced immune
response.2 Porcine heart valves, cadaveric human dermis,
and porcine small intestinal submucosa are approved appli-
cations of acellular tissues. These materials have success-
fully demonstrated the ability to assist repair of human
tissue. Naturally-occurring biological molecules, such as
collagen and alginate, can be used to construct ECMs with
unique mechanical and biochemical properties.35-37 A vari-
ety of synthetic polymers are also used in the production of
ECMs, the most common being polylactide, polyglycolide,
and the copolymer of the two, all of which are biodegrad-
able, nontoxic, and are approved for various applica-
tions.22,37 Scaffolds have been used to engineer various
types of tissues, including vascular, bladder, and cartilage.35
Other material applications for tissue engineering in-
clude the formation of isolation barriers and the local de-
livery of therapeutics.13 Polymers can be used for the en-
capsulation of cells3 or biomolecules.38 These materials
protect the contents from potentially harmful chemical or
biochemical reactions while allowing for the passage of
nutrients and wastes through the barrier, which is useful in
the development of artificial organs and protection of cel-
lular transplants.13
Nanotechnology
Nanotechnology has been defined as “purposeful engineer-
ing on a scale of less than 100 nm to achieve desired
properties, functions, and performance characteristics.”39
A nanometer is one-billionth of a meter. This has impacted
the field of biomaterials in several areas, including the
manipulation of surface characteristics, the production of
cellular-sized materials, and the use of microfabrication.
Development of small-scale technologies has seen clinical
relevance in the areas of both diagnosis and treatment with
devices such as intraocular pressure sensors, microneedles
for transdermal delivery, and miniature stimulators.23 Two
approaches are typically used to fabricate these devices:
top-down and bottom-up. The former builds on the fabrica-
tion techniques found in the microelectronics industry, start-
ing with a bulk material and building functionality into it.
The latter relies on the molecule-by-molecule approach,
often utilizing biomimetic or self-assembly concepts that
leverage molecular interactions to produce structures.
281
BioMEMS (Biological MicroElectrical Mechanical Sys-
tems) and BioNEMS (Biological NanoElectrical Mechani-
cal Systems) are subsets of nanotechnology focused on the
production of miniature devices. According to recent stud-
ies, over 25 groups and companies were working on surgical
applications of MEMS as of January 2004.40 The resulting
instruments and tools allow for experimentation to occur on
the cellular-scale, allowing for the exploration of the phys-
ics that occur at this level. The area includes the develop-
ment of microfluidic networks containing actuators and ap-
propriately sized sensor systems, with the ultimate goal of
producing a complete laboratory-on-a-chip. Current devices
allow for assays to be performed with decreased reagent
volumes and shorter reaction times.2 Drugs can also be
delivered through the use of these devices, providing con-
trolled release or local delivery systems.23 MEMS technol-
ogy has produced a host of biosensors, allowing for the
monitoring and detection of biological events. Examples of
BioMEMS products currently in use or being developed
include implantable pressure sensors (EndoSure Wireless
AAA Pressure Sensor®, CardioMEMS, Atlanta, GA), cath-
eter-based flow sensors (Verimetra, Pittsburgh, PA), blood
pressure sensors, blood chemistry analysis, and gene arrays
(Affymetrix, Santa Clara, CA).
Selected clinical applications
The field of biomaterials has been essential to the develop-
ment of surgery, allowing for the expansion of treatment
options, more effective treatments, and the creation of op-
tions for less invasive treatment. Material selection must
correlate to the chemical and mechanical properties in
which it is intended to be used, while maintaining biocom-
patibility and safety. Medical devices and procedures have
evolved over time with the development of more versatile
and effective materials. The influence of biomaterials on
the treatment of two clinical examples is described, show-
ing the evolution of treatment for pectus excavatum and
congenital diaphragmatic hernias.
Pectus excavatum, the most common chest wall defor-
mity in children, affects 1 in 400 children, and until the
1950s, there were limited treatment options. Mark Ravitch
developed a technique to correct the deformity, requiring
the surgeon to partially resect the costal cartilages and
perform a sternal osteotomy, displacing the sternum anteri-
orly and expanding the chest cavity.41,42 The procedure was
later modified to include an internal brace to maintain the
stability of the sternum. The initial material selection for
this brace was stainless steel, due to its biocompatibility and
mechanical strength. In the late 1980s and early 1990s,
Donald Nuss developed a minimally invasive approach to
treating pectus excavatum, requiring the surgeon to insert
the stainless steel bar through two incisions on opposite
sides of the chest. The bar needed to be flexible enough to
be bent into a form which would allow for the procedure,
282
while stiff enough to provide the needed support in correct-
ing the abnormality. The Pectus Bar (Walter Lorenz Surgi-
cal, Jacksonville, FL) has material properties which provide
for easy manipulation perioperatively, enough elasticity to
maintain proper pulmonary function, and necessary stiff-
ness to support pectus repair.42,43 Over time, the limitations
of stainless steel became evident; some patients could not
get proper chest imaging and others were prevented from
receiving the bar due to allergic response to nickel. In
response to this, a bar composed of titanium alloy that was
MRI compatible and radiolucent was developed.44 This new
material does not trigger airport metal detectors. As a tem-
porary support measure, the bars are typically removed once
the chest is stabilized. In response to this, a further evolution
in materials selection occurred to provide the internal sup-
port needed for the sternum in a permanent implant:
polypropylene mesh bands (Marlex Mesh, Davol Inc., Card
Cardiosurgery). This advancement offered a single-stage
procedure to treat pectus, eliminating the complications of
migration, erosion, and/or reoperation, while maintaining
the mechanical advantage of a bar.45
Congenital diaphragmatic hernias (CDH) affect approx-
imately 1 in 2500 children. It was considered a fatal disease
until the 1940s, when Ladd and Gross reported successful
surgical management of the disease. With the advancement
in technology over the next 50 years, including extracorpo-
real membrane oxygenation (ECMO) and the introduction
of biomaterials, survival has improved from nearly 0% to
close to 63%.46,47 Biomaterials allowed for the repair of
larger defects which could not previously be closed primar-
ily. Initially the most common material used was a polymer
polytetraflouroethylene (PTFE®) (Dual Mesh®, W. L. Gore,
Flagstaff, AZ). This material had enough tensile strength to
allow for a secure repair while ensuring biocompatibility.
Furthermore, it could be manipulated easily to fit different
types of defects, in both open and laparoscopic procedures,
restoring the dome shape of the diaphram. The introduction
of PTFE® allowed for the treatment of a larger number of
patients, but these patients still had higher mortality rates
than those undergoing primary repair due to increased risk
of developing an infection (15%), recurrent hernias (20-
30%), and/or small bowel obstruction resulting from adhe-
sions. A second material was subsequently developed: flu-
oropolymer-coated knitted polyester (Flurosoft®, Vascutex,
Refrewshire, Scotland). Although this material had a similar
infection rate, adhesion formation was decreased due to
tissue in-growth minimizing foreign body reaction.47 This
second generation material was never incorporated into
clinical practice.
Further efforts in material evolution led to the develop-
ment of acellularized tissue: Surgisis (SIS)® (Cook Inc,
Bloomington, IN). One of the major challenges in pediatric
surgery and biomaterials is to ensure that growth of the
child does not affect implant function, and the lack of
growth with PTFE® led to chest wall deformities in some
cases. SIS® is a natural ECM biomaterial harvested from
Seminars in Pediatric Surgery, Vol 15, No 4, November 2006
porcine small intestine and processed to create a natural
polymer mesh. This mesh of collagen, proteins, glycosami-
noglycans, and proteoglycans acts as a scaffold, allowing
for the interpenetration of native tissue and growth with the
patient. Unfortunately, this is not the ideal material since the
rate of hernias with SIS® is higher than PTFE®.48 Bioma-
terials have advanced the success of treating CDH, yet there
is still more work needed to find a more ideal material
which will avoid the complications and limitations of cur-
rent treatments.
Conclusion and future considerations
Considerable progress in biomaterials has been made
since the early days of wooden teeth and gold dental
implants, yet there is still significant development that
lies ahead. The clinicians at the interface of biomaterial
applications and patient care have the ability to drive that
development, taking a critical view of the currently avail-
able products and defining future needs. Clinicians can
identify the places where improvements need to be made
and lead investigations into areas that have no accepted
solution.
An area of investigation includes the growth or adjust-
ment of materials implanted into the pediatric population.
Biomaterial applications can benefit children, but the re-
versibility or adjustability of the material to the growing
environment is key. Another important area of development
is biocompatibility, to allow patients to heal without a
foreign body response. By muting or completely preventing
this response through use of alternative materials or alter-
ations in exposed surfaces, seamless integration of synthetic
and physiological systems could be achieved. A third area
of development lies in the field of personalized medical
materials that allow for individualization of the material for
each patient’s particular needs. The variability in anatomy
from patient to patient is not reflected in the number of
available patient-specific materials; in many cases, person-
alization requires approximation made by the surgeon peri-
operatively. The ability to customize materials either pre-
operatively or intraoperatively may allow the use of
materials with more appropriate profiles for a particular
application.
Material science has been described as part of a health
care puzzle that will be driven by clinical need, with the
ultimate goal of being able to replace function in part of a
failed organism through the use of biomaterial science.49
Advancements will result from interdisciplinary efforts that
require the combination of fields and the collaboration of
experts with the ultimate goal of manipulating and main-
taining the very complex physiological system known as the
human body. Clinicians play a key role in that process and
should continue to pioneer material science applications in
patient treatment.
Binyamin et al Biomaterials
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