801382002 TERM WORK

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0

A

TERM WORK REPORT

on

RP in Medicine: Application of Rapid Prototyping in Medical models

Submitted by

AMANPREET SINGH (801382002)

Submitted to

Dr. Anant Kumar Singh

Assistant Professor

MECHANICAL ENGINEERING DEPARTMENT

THAPAR UNIVERSTY, PATIALA

April, 2014

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Acknowledgment

Any sustained effort by untrained minds in a new work environment requires for culmination,

a guiding hand that shows the way. It gives me immense pleasure to be able to present this

Term Work Report in the present form for which I would like to express my sincere and

devoted gratitude to the Assistant Professor, Dr. Anant Kumar Singh, for his continuous

encouragement, support, and guidance throughout this Term Work and has always stood for

any problem, difficult situation whatsoever.

I am also thankful to faculty of Department of Mechanical Engineering for their

invaluable advice, suggestions and encouragement. Under their able leadership and guidance,

I was able to meet the goals of the project in time.

I would like to express my heartfelt appreciation to my loving parents; I am unable to

find words to embed my deep sense of gratitude for them. In the end I am indebted to my

colleagues, who encourage me.

Knowledge is power and unity is strength.

Amanpreet Singh

801382002

ME Production

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Contents

Acknowledgment 1

Introduction 3

Rapid Prototyping techniques 3

Materials 4

RP model fabrication 5

Literature Review 7

Subburaj et al., 2007 ( Customize prosthesis implant) 7

Mahaisavariya et al., 2006 (Preoperative planning) 8

Ciocca et al., 2009; Sachlos and Czernuszka, 2003 (Tissue engineering) 9

Gopakumar 2000 (Cranial reconstructive surgery) 10

New Contribution 12

Surgical planning 12

Medical education and training 12

Design and development of medical devices and instrumentation 13

Customized implant design 13

Scaffoldings and tissue engineering 13

Prosthetics and orthotics 14

Mechanical bone replicas 14

Forensics 14

Anthropology 15

Results and Discussion 16

Conclusion 18

References 19

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Introduction

Rapid Prototyping (RP), a layer-by-layer material deposition technique, started during the

early 1980s, has significantly improved the ability to fabricate physical models with precise

geometries using computer aided designs or data from medical imaging technologies .RP is

beneficial in the field of medicine as this technology has the ability to fabricate complex

shaped anatomical parts directly from scanned data such as computerized tomography (CT)

images. These models provide a better illustration of the human anatomy, use for precise pre-

surgical planning, assistance in the intensive planning of surgical procedures and also help

the surgeons, medical students to rehearse different surgical procedures realistically (Kai et

al ., 1998; Liu et al ., 2006,). RP models can also be used for designing customized implants,

prosthesis, and function as a communication tool between surgeons and patients (Dhakshyani

et al ., 2011).

Rapid prototyping process can be divided into two phases: virtual (modelling and simulating)

and physical (model fabrication) (Rosa et al ., 2004). Before the fabrication of physical

models, firstly comes the virtual phase in which computer aided design (CAD) is prepared by

using medical imaging technology such as CT, magnetic resonance imaging (MRI) and laser

digitizing The fabrication of the physical model is the second phase, a process in which

suitable RP system uses CAD data to develop the physical model. Now a day’s variety of

materials (instead of normal RP material) and some medical grade materials are available,

which can be used to fabricate RP models on the basis of their use in different medical

applications.

Rapid Prototyping techni ques

There are currently a number of RP techniques in the market, based on special sintering,

layering or deposition methods. Each technique has its own limitations and applications in

constructing prototype models. Established RP techniques which are commercially available

are summarized in Table1 and precisely discussed below.

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Table 1 Features of commercial available RP techniques (Pham and Gault, 1998; Mousah,

2011)

Materials

In case of medical applications, the RP models can be fabricated with a variety of materials

and the selection of material depends on the purpose of fabrication. However, some medical

applications (surgical tools or medical implants) require models which have the ability to be

sterilized or remain compatible with human tissue like biomaterials. A biomaterial can be

classified as any material used to manufacture devices that replace a part or a function of the

body in a safe and reliable way. Metallic biomaterials are mainly used in areas of high static

or cyclic stress and well suited for medical implants such as cranial plates and ace tabular

implants. Ceramic materials are typically solid inert compounds and are used where

resistance to wear is of primary importance such as dental implants, crowns, whereas medical

grade polymers are used in various medical applications where stability, flexibility and

controlled porosity are demanded such as tissue repair, drug delivery devices, and medical

implants (Brennan, 2010). Some of categorized biomaterials for medical use are shown in

Table 2

Table 2 Categorized biomaterials for medical applications (Brennan, 2010; Mour, 2010; Vail

et al ., 1999)

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RP model fabrication

RP machine needs CAD information to fabricate a physical model so for that purpose RP

process can be divided into two phases: virtual and physical. As mentioned earlier firstly

comes the virtual phase, which consists of using imaging processing tools

(1) Data Acquisition

(2) Image Processing

(3) Model Fabrication

Data acquisit ion

Data acquisition is a process of capturing the three dimensional (3D) shape of an existing part

by using contact and non contact measuring devices, only non contact methods (medical

imaging technologies) are considered here. Medical imaging technologies are generally used

to visualize the configurations of bones, organs and tissues, but they also have the ability to

export scanned image data and additional information in commonly known medical file

format, such as DICOM (Digital Imaging and Communications in Medicine) (Berce et al .,

2005; Rengier et al ., 2010) and finally make possible to convert scanned image data fromDICOM to STL file format, which is universally accepted RP file format (Milovanovic and

Trajanovic, 2007). Most commonly, CT, MRI and Laser digitizing techniques are used for

this purpose; others are cone beam tomography, X ray, ultrasound etc. (Abbott et al ., 1998;

Chang et al ., 1991; Lambrecht et al ., 2009; Liu et al ., 2006; Meakin et al ., 2004; Schievano

et al ., 2010). It provides important scanned data of anatomical structure for diagnostic

reasons and same data can be used to obtain geometrical information of the body structures

for three-dimensional modeling.

Image processing

Images of the body are taken in thin cross sectional “slices” which can then be layered by

using commercial available software like MIMICS, 3D Doctor and Voxim to create a 3D

model of anatomical parts. These software systems performs the necessary segmentation of

the anatomy through sophisticated 3D selection and editing tools and provides the interface

between scanned data of CT, MRI or technical scanners and RP systems (Noorani, 2006).

These software systems allow, modifying the images by defining various tissue densities for

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display, to select the regions of interest from the general information available from the

scanner. It enables the surgeons and radiologists to control and select the correct

segmentation of CT or MRI scan images. After completing the segmentation and

visualization the data is converted to a standard tessellation language (STL) format. This

format is compatible with most commonly used rapid prototyping machines (Gibson et al .,

2004; Liu et al ., 2006; Tukuru et al ., 2008).

Model fabri cation

This step includes choosing the right rapid prototyping technique according to the demand of

medical application. As we know every RP system has its strength and weaknesses so a

suitable RP system or technique needs to be chosen to fulfil various requirements of a

medical application like accuracy, surface finish, cost, visual appearance of internal

structures, number of desired colours in the model, strength, materials availability,

mechanical properties, etc. Then finally 3D virtual model in STL file format is transferred to

the RP system and building starts. After the fabrication of model, it needs to be evaluated and

validated by the team and in particular surgeon so as to ensure that it is accurate and serves

the purpose. Furthermore, depending on the use of the model, it can be sterilised for

assistance in an operating theatre (Petzold et al ., 1999).

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Literature Review

Subburaj et al ., 2007 (Custom ize prosth esis implant)

Researchers (Subburaj et al ., 2007) in the Department of Mechanical Engineering (IIT,

Mumbai) and Department of Prosthodontics (Government Dental College and Hospital,

Mumbai) considered a patient (male, 19 years) with congenital absence of the right ear for

investigation as presented in Figure 1. The purpose was to use CAD and RP technologies for

the rapid development of auricular prosthesis, and demonstrated a real life case study. The

anatomic morphology of the prosthesis, matching the morphology of the contralateral ear,

was obtained by following these five steps:

(i) tomography images of deficient and contralateral ears with the help of finer CT scanning(0.63 mm slice thickness),

(ii) econstruction of the corresponding 3D models in which the correct geometry and position

of the prosthesis were ensured by stacking the CT scan images of the contralateral normal ear

in reverse order, and joining them using medical modeling software, MIMICS (Materialise,

Belgium)

(iii) design of the final model of missing ear (prosthesis) was obtained by subtracting the

CAD model of the remnant portion of the defective ear from the CAD model of the mirrored

contralateral ear using a haptic CAD system (FreeForm, SensAble Technologies, USA),

(iv) fabrication of prosthesis master using a suitable RP system (FDM), the dimensions of

fabricated model was measured as per the standards (standard auricular morphological

measurement) and compared with the original CAD model to determine the accuracy

(dimensional error)

Figure 1 A patient (male, 19 years) with congenital absence of the right ear (Subburaj et al .,

2007)then finally,

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(v) the fabrication of the final prosthesis using a mould made from the master (FDM model)

in which medical grade silicone rubber of the appropriate color was packed into the mould to

fabricate the final ear prosthesis. The final fabricated prosthesis was also measured as per

standards, and percentage difference was calculated with respect to the CAD model and then

successfully fitted to the deficient side of the patient using medical grade adhesive. The

prosthesis may change its color or deteriorate over time, and may require replacement in

future. This can be facilitated by the availability of the digital model of the prosthesis. The

postoperative appearance showed the excellent result in terms of aesthetics.

Mahaisavariya et al ., 2006 (Preoperative planning)

Report of two cases (female patients of age 23 and 18 years with cubitus deformity) as shown

in Figure 2 are presented by a group of researchers (Mahaisavariya et al ., 2006) in which they

reported some work on surgical planning of corrective osteotomy for cubitus varus using RP

models. First of all a CT scan was performed on both the deformed and normal elbow using a

Philip spiral CT scanner (Thomoscan, AV), CT scan acquisition was performed with 2mm

slice thickness and reconstruction was performed with 1 mm slice thickness then this scanned

data was used to construct a 3D CAD model using medical imaging and digital CAD

software ( MIMICS and Magics RP, Materialise, N.V. Belgium) and surgical planning of

corrective osteotomy was virtually planned and simulated in the 3D CAD model. The proper

location of osteotomy, the amount of wedging bone and the tilting of the plane for osteotomy

cut was measured by performing 3D evaluation of the deformed and mirrored normal

humerus on screen. After calculating and determining the optimal configuration, the data of

deformed and normal humerus was used to fabricate

Figure 2 A patient (female, 18 years) with cubitus varus of left elbow (Mahaisavariya et al .,

2006)

RP models using 3D printing machine (Z Corp Inc.). These RP models were used by

surgeons to rehearse the osteotomy before a real surgery. Both patients were successfully

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operated as surgical planning and shown excellent post operative results in terms of cosmetic

and functional result. This case study clearly shows that RP and associated technology (CT)

can facilitate surgeons in preoperative planning for certain complex cases like planning of

osteotomy of complex deformity of hip, pelvis and spine, also allows the surgeons to choose

proper configuration and most appropriate location of osteotomy according to individual

patient need.

Ciocca et al ., 2009; Sachlos and Czernuszka, 2003 (Tissue engineering)

RP has been used as an alternative to conventional scaffold fabrication methods within the

tissue engineering field. Tissue engineering is process of growing the relevant cell(s) in vitro

into required 3D organ or tissue (Ciocca et al ., 2009; Sachlos and Czernuszka, 2003). This

method has been used for the pair of damaged tissue and organs. The main element for cell

structure is scaffold, a prefabricated porous structure which is seeded with cells or nutritants

and provides necessary support and shape to growing tissue (Armillotta and Pelzer, 2008).

Researchers (Williams et al ., 2005) at the University of Michigan have explored the potential

of SLS (a RP technique) to fabricate polycaprolactone (PCL) scaffolds as presented in Figure

3. Polycaprolactone (PCL) is bioresorbable polymer which has sufficient mechanical

properties for bone tissue engineering applications. Furthermore, researchers evaluated the

biological properties of these SLS manufactured scaffolds by seeding with bone

morphogenetic protein -7 (BMP-7) transduced human fibroblasts and evaluated the growth of

generated tissue. They found that SLS fabricated scaffolds matched the design well, had

mechanical strength within the range of trabecular bone and supported the growth of tissue. It

is concluded that PCL scaffolds fabricated by SLS have great potential for the replacement of

skelton tissue in the field of tissue engineering.

Figure 3 (a) STL design file for the porous scaffold. (b) PCL scaffold fabricated by SLS

(Williams et al .2005)

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Gopakumar 2000 (Cranial reconstructive surgery)

A patient was selected for the case study with a cranial injury, sustained during an accident,

on the frontal region of the skull cage. The injured area measured 100mm in length and

around 80mm in width approximately. CT scans were performed on the patient using a spiral

CT scanner. Slice images were taken at a 2mm inter-slice distance. Traditionally in CT

scanning, an X-ray tube and a detector array travel on a circular path around the patient

collecting a complete set of data over 3608; thereafter, the respective image is reconstructed

and the patient is shifted a small distance through the gantry for the next transverse section to

be measured. This procedure is repeated slice by slice. In spiral CT, the data from the

scanned area of the patient are acquired as the patient is moved continuously through the

gantry while the X-ray tube and detector system rotate around the patient. The patient travels

at a speed of typically one slice thickness per 360 rotation (Kalendar and Polacin, 1991).

Figure 4 shows the approaches that are possible to manufacture the implant, starting with the

CT scans.

Figure 4 Three approaches to manufacture from CT (Gopakumar, 2000)

Figure 5 3D reconstructed image of the trauma location (Gopakumar, 2000)

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Figure 6 Implant design methodology

Figure 7 Implant obtained in medical modeller Figure 8 2D image of the fit of

implant in 2D in medical modeler

Figure 9 Fit of designed implant in 3D

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New Contribution

Rapid prototyping has been recently introduced in the field of medicine when compared to its

longstanding use in various engineering applications so numerous researchers have reported

the influence of RP technology in various areas of medical field. Some of areas in which RP

technology has been successfully contributed are discussed below.

Surgical planni ng

RP has proven to be beneficial to surgical planning as the these models provide the physician

and surgical team a visual aid that can be used in order to better plan a surgery, to study the

bone structure of patient before the surgery, to decrease surgery time and risk during surgeryas well as costs, to predict problem cause during operation and to facilitate the diagnostic

quality. These RP models can be used to rehearse complex procedure and for better

understanding the complex anomaly so these models are especially beneficial in surgeries

where there are anatomical abnormalities and deformities (Kai et al ., 1998; Liu et al ., 2006).

Some studies in heart surgery (Sodian et al ., 2007), spine surgery (Guarino et al ., 2007;

Mizutani, et al ,. 2008; Paiva, 2007), craniofacial and maxillofacial surgery (Faber et al .,

2006; Maravelakis et al ., 2008; Mehra et al ., 2011; Peltola et al ., 2012; Poukens et al ., 2003;

Zenha et al ., 2011) and hip surgery (Dhakshyani, et al ., 2012; Monahan. and Shimada, 2007)

have shown the potential and benefit of RP models in the field of surgery and reported a

significant improvement in diagnosis. In addition, surgeons estimated that the use of RP

models reduced operating time by a mean of 17.63% (D'urso, et al ., 1999).

Medical education and train ing

RP models provide a better demonstration of external and internal structure of human

anatomy, can be made in many colors so these models can be used as teaching aids in

research, medical education and in museums for educational and display purposes. RP

models can be distributed in kits to schools and museums for a better illustration of anatomy

and medical training purposes. Furthermore these models can be used by medical students or

young doctors to better understand the problems or surgical procedures without causing

discomfort to an actual patient (Liu et al ., 2006; Mori et al ., 2009; Nyaluke et al ., 1995).

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Design and development of medical devices and instrumentati on

Another application of RP is in fabricating medical devices and instrumentations. RP

techniques can be used to design, develop, and manufacture medical devices and instruments.

It includes dental devices, hearing aids, and surgical aid tools (Noort, 2012).

Customized implant design

RP technology is very much able to fabricate customized implants and fixtures due to the

inherent strength of this technology to fabricate complex geometry with in very short time.

The combination of medical imaging technologies, rapid prototyping, and CAD packages

makes it possible to manufacture customized implants and fixtures that precisely fit a patient

at a reasonable cost (Balazic and Kopac, 2007). This technology allows the physicians to

create accurate implants for their patients rather than the use of standard sized implants such

as dental implants, hip sockets, knee joints and spinal implants could greatly benefit the

patients (Milovanovic and Trajanovic, 2007). Using RP, surgical implants have become more

precise, surgery time and risk of surgical complication has been significantly reduced, and to

make customized implants it’s an alternative to standard implants (Liu et al ., 2006; Noorani,

2006).

Scaff oldings and tissue engineering

RP techniques are very much suitable for generating implants with special geometrical

characteristics, such as scaffolds for the restoration of tissues and serve as an alternative to

conventional scaffold fabrication methods (Hutmacher et al ., 2004). Scaffolds are porous

supporting structures serve as an adhesion substrate for the cells and provide temporary

mechanical support and guidance to the growing tissue in damaged or defective bones of the

patient (Kim and Mooney, 1998; Yeong et al ., 2004). RP techniques like SLS, 3DP and FDM

have proved to be suitable for fabricating controlled porous structures through the use of

biomaterials and it has significantly contributed in the field of scaffolding and tissue

engineering. RP technology has increased the ability to create complex geometries,

customized products and provide high accuracy features, and also enhance the possibilities to

control pore size and distribution of pores within the scaffold (Peltola et al ., 2008).

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Prosthetics and orthotics

Rapid prototyping has proven to be beneficial to the fields of prosthetics and orthotics as it

starts with specific patient anatomy. The patient’s specific alignment characteristics are

included in the model, allowing for development of a biomechanically correct geometry that

improves the fit, comfort, and stability (Noorani, 2006). There are always patients outside the

standard range, between sizes, or with special requirements caused by disease or genetics.

With the aid of RP, it becomes possible to manufacture a custom prosthesis that precisely fits

a patient at reasonable cost. For example, patterns for dental crowns and implant structures

can be fabricated using an RP machine (Liu et al ., 2006).

Mechanical bone replicas

Rapid prototyping can be used for the fabrication of mechanical bone replicas. With the aid

of RP, it becomes easy to replicate the material variations and mechanical characteristics

within a bone. A composite structure built with a lattice structure of SLA can create two

distinct regions that have properties similar to cortical and trabecular bones. These replicas of

bones can be used to observe the bone strength under different conditions. Additionally, it

can be beneficial to recreate events and the stresses, fractures, and other changes in the bone

can be observed, which would definitely help the doctors and researchers (Noorani, 2006;

http://www.rpc.msoe.edu/medical).

Forensics

RP can be a beneficial tool in criminal investigation especially in the homicide cases, where it

is very important to reconstruct the crime scene for investigation. RP models can be kept as

evidence in criminal investigation and will help investigators find answers to some questions.

In many cases, the ability to reconstruct scenes and events accurately would help forensic

experts to understand and solve the cases more quickly. These models are accurate enough to

see the effects of wounds and allow for accurate predictions of the forces, implements and

other key events can be determined using these models.

Especially, in the case of a surviving victim where a wound is of difficult access, e.g. for the

skull, a model can be used for detailed analysis. Using RP models, scenes can be re-created in

the court room as well as it can help prosecutors to throw some light on what really happened

(Liu et al ., 2006; http://www.rpc.msoe.edu/medical).

http://www.rpc.msoe.edu/medical







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Anthropology

This is an another application where RP technology can be very beneficial to anthropologists

because replication of delicate bones, teeth and other artifact can be made so that molding,

measuring, and dissecting of the remains can be performed without causing harm to original

finding. Especially, in cases where only one or two specimens exist, research can be done on

built models without harming the original or rare specimen. The models that are built can also

be used to show changes in evolution that have taken place over vast periods of time

(Noorani, 2006; http://www.rpc.msoe.edu/medical).

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Results and Discussion

In Customize prosthesis implant (Subburaj et al ., 2007), The prosthesis may change its color

or deteriorate over time, and may require replacement in future. This can be facilitated by the

availability of the digital model of the prosthesis. The postoperative appearance showed the

excellent result in terms of aesthetics. Researchers concluded that the use of RP and

associated technology provided a high degree of accuracy in term of shape, size and position

of the prosthesis, and enabled accurate reproduction customized prosthesis without requiring

sculpting skills, and was much faster than the conventional (manual) method.

Preoperative planning (Mahaisavariya et al ., 2006), the proper location of osteotomy, theamount of wedging bone and the tilting of the plane for osteotomy cut was measured by

performing 3D evaluation of the deformed and mirrored normal humerus on screen. After

calculating and determining the optimal configuration, the data of deformed and normal

humerus was used to fabricate RP models using 3D printing machine (Z Corp Inc.). These RP

models were used by surgeons to rehearse the osteotomy before a real surgery. Both patients

were successfully operated as surgical planning and shown excellent post operative results in

terms of cosmetic and functional result. Result clearly shows that RP and associated

technology (CT) can facilitate surgeons in preoperative planning for certain complex cases

like planning of osteotomy of complex deformity of hip, pelvis and spine, also allows the

surgeons to choose proper configuration and most appropriate location of osteotomy

according to individual patient need.

Tissue engineering (Ciocca et al ., 2009; Sachlos and Czernuszka, 2003), they found that

SLS fabricated scaffolds matched the design well, had mechanical strength within the range

of trabecular bone and supported the growth of tissue. It is concluded that PCL scaffolds

fabricated by SLS have great potential for the replacement of skelton tissue in the field of

tissue engineering.

Cranial reconstructive surgery (Gopakumar, 2000), during the surgery, the skin flap was

raised and the skull defect location was exposed. The cranial implant was then inserted on to

the defect and checked for proper fit. Once, the fit was confirmed, stainless steel wires were

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used to secure the implant to the skull, after holes were drilled in the overlap area of the

implant with the skull. The implant designed had a good degree of fit with the skull. The cost

of an implant, for a case study such as the one above, cannot be estimated directly. The cost

of the implant depends primarily on the complexity of the part that is built in the RP machine.

The above case study was conducted as a part of a feasibility study of the manufacture of

customized implant in the south eastern region and hence, a direct estimation of the cost of

the implant was not done. Moreover, the saving in surgery times, pre-operation planning, and

patient recovery time are not easily quantifiable. The build time of the RP implant in the

FDM was nearly 8 h.

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Conclusion

RP is making a significant effect in the field of medicine with a variety of medical

applications also itspotential has been demonstrated in several studies (Dhakshyani et al .,

2012; Esses et al . 2011; Mao et al , 2010; Sanghera et al ., 2001). A prospective trial (45

patients with craniofacial, maxillofacial, and skull base cervical spinal pathology cases were

selected) with the objective of assessing the utility of 3D models in complex surgery

performed by researchers (D'urso, et al ., 1999), concluded that these models significantly

improved the quality of pre-operative planning and diagnosis, reduced operative time and

risk, enhances team communication, and assists the patients to better understand their

pathology. Another study of 47 complex mandibular reconstruction cases (between 2003 and2009), concluded that 95.7% of the patients were found to have at least a satisfactory result

and the majority (38 out of 47) of patients were in a good and very good end result categories

(Zenha et al ., 2011).. Additionally, this technology makes the previously manual operations

much faster, accurate, and cheaper (Noort, 2012). The outcome based on literature review

and four case studies strongly suggests that RP technology might become part of standard

protocol in medical sector in the near future. However, presently this technology cannot be

employed in daily clinical practices due to some issues such as suitable material, time, and

high cost of the procedure. Therefore, these issues restrict the utilization of RP in complex

cases where considerable cost savings and quality benefits are generally expected (Giannatsis

and Dedoussis, 2009). Furthermore, this technology can be used as an alternative to

conventional fabrication methods with in the field of tissue engineering (Leong et al ., 2003),

customize implants (Noort, 2012; Traini et al ., 2008), and medical devices (Bertol et al .,

2010). Further research is required to reduce the overall cost (virtual planning and fabrication

cost) of RP technology, for the development of suitable biomaterials and development of RP

systems designed specifically for medical applications.

The design of the implant was carried out for the case study and the prototype of the implant

was manufactured. Further to the work, the medical implant produced from the RP model

was successfully implanted on the patient and the cosmetic effects of the surgery were found

to be good. There was a considerable reduction in the operation time. The model of the

implant also proved useful for the surgeons to rehearse the surgery prior to the actual

operation.

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Figure 7 Implant fixation during cranioplasty RP in medicine: a case study in cranial

reconstructive surgery

Sunil Gopakumar Rapid Prototyping Journal

Volume 10 · Number 3 · 2004 · 207 – 211 211

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