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CHAPTER 1

INTRODUCTION

1.1 RAPID PROTOTYPING

Before commencement of a batch production of a product, a sample


or prototype is often required as part of the design cycle to enable
demonstration, evaluation or testing of the proposed product. Traditional
prototyping requires considerable skilled labour, time and expense, typically
applied to cutting, bending, shaping and assembling parts from standard stock
material. The procedure was often iterative, with a series of prototypes to be
made to test at various options. For many applications, this process has been
revolutionised by a relatively recent technology known as Rapid Prototyping
(RP), in which a part of an arbitrary shape can be produced in a process by
adding successive layers of material. Many different RP processes have now
been developed, using an increasing range of materials. The parts produced
have been of steadily in increasing size, durability and the quality has
improved. RP is being used more and more frequently to fabricate the parts
both for production tools and functional prototypes.

RP is a technique used to quickly fabricate a model of a part or


assembly using Three Dimensional (3D) Computer Aided Design (CAD)
data. It allows parts of completely arbitrary 3D geometry to be fabricated,
offering designers a new freedom to shape parts optimally without the
constraints imposed by forming, machining or joining. It therefore allows a
manufacturing cycle with a seamless transition through the computer design,
simulation, modeling and fabrication procedures. In addition, the profiles used
by the fabrication process are straight forward for the designers and customers
to understand, thus facilitating technical communications.
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RP has also been referred to as Solid Free Form (SFF)


manufacturing, Additive Manufacturing (AM), Computer Automated
Manufacturing and Layered Manufacturing (LM). RP has obvious use as a
vehicle for visualisation. In addition, RP models can be used for testing, such
as when an aerofoil shape is put into a wind tunnel. RP models can be used to
create male models for tooling, such as silicone rubber moulds and investment
casts. In some cases, the RP part can be the final part. RP is suitable for
highly convoluted shapes including parts nested within parts.

RP improves product development by enabling better


communication in a concurrent engineering environment. The trends in
manufacturing industries continue to emphasis the following:

Increasing number of variants of products.


Increasing product complexity.
Decreasing product lifetime before obsolescence.
Decreasing delivery time.

1.1.1 Methodology of RP

The basic methodology for all current RP techniques can be


summarised as follows:

A CAD model is constructed and then converted to STL


format. The resolution can be set to minimise stair stepping.

Part orientation partially determines the amount of time


required to build the model. Placing the shortest dimension in
the Z - direction reduces the number of layers, thereby
shortening build time.
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The RP machine processes the .STL file by creating sliced


layers of the model.

If necessary, support structure is created which supports the


overhanging features of the part during fabrication.

Once all the above parameters were set, the tool path or
scanning path was generated.

The first layer of the physical model is created. The model is


then lowered by the thickness of the next layer, and the
process is repeated until completion of the model.

The model and any supports used are removed. The surface of
the model is then post processed and cleaned.

1.2 RAPID MANUFACTURING

With increased competition from the global economy,


manufacturers face the challenge of delivering new customised products more
quickly than before to meet customer demands. The use of a CAD-based
automated AM process to construct parts that are used directly as finished
products or components is known as Rapid Manufacturing (RM). It has been
developed to shorten the design and production cycle and promise to
revolutionise many traditional manufacturing procedures.

What is commonly considered to be the first RP technique, Stereo


lithography, was developed by 3D Systems of Valencia, CA, USA and since
then, a number of different RP techniques have been developed. Now, the
functional parts are fabricated directly by RM techniques such as Electron
Beam Melting (EBM) and Direct Metal Laser Sintering (DMLS) processes
developed by Arcam EBM systems, Sweden and Electro Optical Systems -
EOS GMBH, Munchen are shown in the Figure 1.1 (a) and (b).
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(a) EBM machine (courtesy M/S Arcam) (b) DMLS machine (courtesy M/S EOS)

Figure 1.1 Rapid Manufacturing machines

The main difference between the EBM process and all of the other
processes listed below is the energy source used to heat the metal powder during
processing. The use of an electron beam, in lieu of a laser, provides much more
energy. This allows for faster processing times, but more importantly EBM
produced parts have a more fully melted microstructure when compared to
sintered structures. The process also builds parts in a vacuum at higher
temperature, both of which are different as compared to laser-based processes.
DMLS is the most established direct metal fabrication technique. Depending on
the particular model the process uses either a CO2 or ytterbium fiber laser to
sinter fine metal powders into near fully dense components.

1.2.1 Benefits of RM

Manufacturing finished parts directly from digital input is a


breakthrough technological advancement. Still in its early stages, RM is
coming into increasingly widespread use in specialised technology
applications where limited quantities of durable precision components are
needed. The benefits of RM include:
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Eliminating costly and time consuming process of tool


making.

Users add significant speed and flexibility to their production


operations with free form fabrication applying additive
manufacturing processes.

Designers are freed from traditional manufacturing processes


allowing them to create with less restriction.

Finished systems can be completed and deployed faster.

Design changes can be implemented with total flexibility at


any time, with no wasted inventory of obsolete parts and no
lag time for expensive and time consuming tool changes.

1.2.2 RP and RM in medical applications

The use of RP technologies in medical applications is relatively


new and innovative, so that designers, doctors or others can generate a
physical, tangible prototype to work with. In medical field, RP has been used
for medical devices and physical anatomical parts.

The design process for new improved medical devices includes the
important step of producing, examining and testing a physical medical
prototype. Engineers and designers like to have a medical prototype to sample
its size and get an idea of its form, fit and feel. The RP process applied to
anatomical parts is another innovative use. Anatomical models of hearts,
bones and joints have also been used as learning tools. Advances in medical
RP models allow medical practitioners use physical models to visualise the
problems and plan treatment. Doctors are using this technology to understand
the depth of problem and to ease out the communication process with patients
before the operation. The key element is taking 2D information from MRI or
CT and using this data to create a 3D medical model.
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The fabrication of medical prostheses is a topical research area


combining knowledge from distinct domains, like engineering, materials and
medical fields. Recent computer assisted technologies have proved to play an
important role in the medical field. The geometric data obtained from reverse
engineering through both Computed Tomography (CT) and laser scanning are
used and manipulated to create accurate representations of these devices using
RM techniques. The reverse engineering data are then used to produce STL
models that are physically reproduced through rapid prototyping and tooling
processes.

Production methods for surgical implants are today typically


performed by making a near-net-shape part that is finished with specialised
surface finishing or treatments for the desired surface, mechanical and
aesthetic effects. Additive manufacturing in metal represents a new fourth
option for production of orthopedic implants. RM offering advantages in the
key areas of: (1) demand-based manufacturing in small to medium size
quantities, (2) customised implants for a specific patient, (3) ease of
manufacturing complex, freeform shapes and (4) an upgrade in material
properties when compared to traditional manufacturing via investment
casting.

1.3 BONE FRACTURE

A bone fracture is a medical condition in which a bone is cracked


or broken. While many fractures are the result of high force impact or stress,
bone fracture can also occur as a result of reduced strength associated with
certain medical conditions such as osteoporosis, certain types of cancer or
osteogenesis imperfecta. Although fractures are commonly referred to as bone
breaks, the word break is not part of formal orthopaedic terminology. In
orthopedic medicine, fractures are classified as closed or open (compound),
simple or multi fragmentary (formerly comminuted) as shown in Figure 1.2.
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Figure 1.2 Types of bone fracture

1.4 TREATMENT FOR FRACTURES

Doctors use both internal and external fixation devices to keep


fractured bones stabilised and in alignment.

Internal fixation methods as shown in the Figure 1.3 hold the


broken pieces of bone in proper position with metal plates,
pins or screws while the bone is healing. The device is
inserted surgically to ensure that the bones remain in an
optimal position during and after the healing process.

External fixation methods as shown in the Figure 1.4 include


plaster and fiberglass casts, cast braces, splints and other
devices. The device can be adjusted externally to ensure the
bones remain in an optimal position during the healing process.
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Figure1.3 Internal fixation methods Figure1.4 External fixation methods

While the patient is pain free (general or local anesthesia), an


incision is made over the fractured bone. The bone is placed in proper
position and screws, pins or plates are attached to or in the bone temporarily
or permanently. If examination of the fracture shows that a quantity of bone
has been lost as a result of the fracture, especially if there is a gap between the
broken bone ends, the surgeon may decide that a bone graft is essential to
avoid delayed healing.

1.5 COMPUTED TOMOGRAPHY (CT)

Doctors usually use an X-ray to diagnose a fracture. Stress fractures


are more difficult to diagnose, because they may not appear on an X-ray;
however, there may be pain, tenderness and mild swelling. CT may be
employed to verify the same.

CT is a sophisticated and painless X-ray procedure. Multiple


images are taken during a CT scan and a computer compiles them into
complete, cross-sectional pictures of soft tissue, bone and blood vessels as
shown in Figure 1.5. A CT scan obtains images of parts of the body that
cannot be seen on a standard X-ray. Therefore, these scans often result in
earlier diagnosis and more successful treatment of many diseases.
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Figure 1.5 CT machine (left) and CT images (right)

CT scanning was developed during the mid-1970s. The original


systems were dedicated to head imaging and were very slow. It took hours to
acquire the images for each individual slice. The newest scanners collect as
many as sixty four slices of data in less than 350 µs. This great improvement
in the speed of CT scanning has been accompanied by increased patient
comfort and higher resolution images.

1.6 RECONSTRUCTION OF CT IMAGES

CT scanners offer isotropic or near isotropic resolution, display of


images need not to be restricted to the conventional axial images. Instead, it is
possible for a software program to build a volume by "stacking" the
individual slices one on top of the other. Multi Planar Reconstruction (MPR)
is the simplest method of reconstruction. A volume is built by stacking the
axial slices. The software then cuts slices through the volume in a different
plane (usually orthogonal). Optionally, a special projection method can be
used to build the reconstructed slices. Modern software allows reconstruction
in non-orthogonal (oblique) planes so that the optimal plane can be chosen to
display an anatomical structure.
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1.6.1 3D rendering techniques

Surface rendering

A threshold value of radio density is set by the operator (e.g. a level


that corresponds to bone). From this, a 3D model can be constructed using
edge detection image processing algorithms and displayed on screen. Multiple
models can be constructed from various different thresholds, allowing
different colours to represent each anatomical component such as bone,
muscle and cartilage. However, the interior structure of each element is not
visible in this mode of operation.

Volume rendering

Surface rendering is limited in that it will only display surfaces


which meet a threshold density and will only display the surface that is closest
to the imaginary viewer. In volume rendering, transparency and colors are
used to allow a better representation of the volume to be shown in a single
image e.g. the bones of the pelvis could be displayed as semi transparent, so
that even at an oblique angle, one part of the image does not conceal another.

Image segmentation
Where different structures have similar radio density, it can become
impossible to separate them simply by adjusting volume rendering
parameters. The solution is called segmentation, a manual or automatic
procedure that can remove the unwanted structures from the image.

1.7 3D CAD MODELING

As in the manual drafting of technical and engineering drawings,


the output of CAD must convey information, such as materials, processes,
dimensions and tolerances according to application-specific conventions.
CAD may be used to design curves and figures in 2D space or curves,
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surfaces and solids in 3D objects. CAD is an important industrial art


extensively used in many applications including automotive, ship building,
aerospace industries, prosthetics and many more. CAD is mainly used for
detailed engineering of 3D models and 2D drawings of physical components,
but it is also used throughout the engineering process from conceptual design
and layout of products, through strength and dynamic analysis of assemblies
to definition of manufacturing methods of components. It has become an
important technology within the scope of computer-aided technologies, with
benefits such as lower product development costs and a greatly shortened
design cycle. It enables designers to lay out and develop work on screen, print
it out and save it for future editing and saving time on their drawings.

Recent advances in computing technologies both in terms of


hardware and software have helped in the advancement of CAD in
applications beyond that of traditional design and analysis. CAD is now being
used extensively in the biomedical industry in applications ranging from
clinical medicine, customised medical implant design to tissue engineering
(Wei Sun, et al (2004)). Bio-CAD models are necessary for the field of
Computer aided tissue scaffold fabrication since the outer shape of the
scaffold is determined from the CAD model structure.

1.8 FINITE ELEMENT ANALYSIS

Finite Element Analysis (FEA) is one of the most widely used


engineering analysis techniques in the world today. It is used to simulate how
a physical system will respond to expected loading conditions. FEA is based
on the fundamental physical principles that govern the behaviour of these
physical systems. Since the biological systems must obey the same
fundamental physical principles, the physical response of biological systems
to known loading conditions can also be predicted using FEA.
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FEA is a numerical technique for finding approximate solutions of


Partial Differential Equations (PDE) as well as of integral equations. Modern
FEA programs simulate static, dynamic, linear, nonlinear, thermal, random
vibrations and more. Structural analysis finds deformations, strains and
stresses caused by structural loads such as force, pressure and gravity.
Thermal analysis finds temperatures, temperature gradients and heat flow
caused by thermal loads such as heat flux or heat power.

Simulation and modeling allows the prediction of behaviour before


any physical building occurs. This allows the designer to examine any number
of "what if" scenarios in optimising the design. Simulation can also provide
detailed insight into the mechanical behavior of the design, which may not be
discoverable through normal testing and experimentation. Simulation cannot
be done without physical properties and some simplifying assumptions are
inevitably made. Thus simulation is a complement and amplifier to testing,
rather than a substitute.

FEA is an accepted theoretical technique used in the solution of


medical problems (Ming-Yih Lee et al (2002)). The distribution of forces in
bone and implant has been investigated in several studies (Singare (2005)).
FEA modeling not only can simulate complex geometric shapes and material
properties, but also can simulate various boundary conditions, which are very
difficult to replicate in experiments (Ola Harryson et al (2007)).
Biomechanics models of bone are usually formulated as linear elastic
problems, solved with static FEA. FEA are computer-based methods of stress
analysis which are used when the shapes, numbers or types of materials and
the loading conditions are too complicated to yield to analytical methods
(Fazilat et al (2002)). In many aspects, the mechanical environment in bones
is considered a major factor influencing biological processes and therefore
vital for surgical procedures, healing processes as well as therapeutic
regimens (George Duda (1997)).
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Medical technology continues to advance rapidly as physicians and


engineers move closer to and understand better each other’s needs. Nowhere
is this in better evidence in the development of advanced medical implants.
Finite element modeling and analysis can greatly reduce testing and time to
market by allowing the designer to computer test his product in advance of
any prototypes. Modern and advanced FEA problems require the
consideration of nonlinear material behavior, multi-body and self-contact,
structural instabilities and transient or steady state loading for effective
modeling.

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