Bioprinting 21 (2021) e00118

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Bioprinting
journal homepage: www.elsevier.com/locate/bprint

Manufacturing of customized implants for orbital fractures using

3D printing
Manmadhachary A a, *, Aditya Mohan A b, Haranadha Reddy M c
a
Department of Mechanical Engineering, Faculty of Science and Technology, IFHE University, Hyderabad, Telangana, India
b
Dept. of Oral and Maxillofacial Surgery, MNR Dental College and Hospital, Sangareddy, Telangana, India
c
Department of Oral and Maxillofacial Surgery, Panineeya Institute of Dental Sciences and Research Centre, Hyderabad, Telangana, India

A R T I C L E I N F O A B S T R A C T

Keywords: An orbital fracture is a traumatic injury to the bone in the eye socket. These fractures modify the orbital bone
Orbital fractures dimensions and the functioning of the intraorbital contents. In this study, a surgical method that includes posi-
Customized implants tioning, aligning and fixing implants to restore orbital fractures was adapted. Notably, it is difficult to achieve an
Computed tomography
original three-dimensional orbital shape through the process of forming and cutting implants; however, this
3D printing
Material extrusion
problem was solved by creating customized implants using computed tomography (CT) images of the patient. The
objective of this work is to reconstruct the damaged orbital floor defects by means of a 3D printed implant and
restore the orbital floor to its original shape. A case study of an orbital fracture has been included in this study. CT
images were used to create a computer-aided design (CAD) model of orbital floor implants, which were designed
to maintain orbital floor symmetry from right to left and vice versa. Furthermore, the designed implants were
manufactured through a material extrusion process with biocompatible material. The application of the material
extrusion process with biocompatible material resulted in the fabrication of implants at a minimal cost. Therefore,
the customized models used in the patient’s intra-operation can minimize the operational time and maximize
surgical safety.

1. Introduction surgeries using 3D printing technology.

3D printing, commonly referred to as rapid prototyping (RP) or ad-
ditive manufacturing (AM), is a manufacturing method in which mate-
rials are solidified in the form of layers to create three-dimensional (3D)
physical objects from a 3D virtual model [1]. 3D printed objects are
widely used in various medical fields, such as orthopedics, plastic sur-
gery, neurosurgery, otolaryngology (ear, nose and throat surgery) and
pulmonology (respiratory system) [2,3]. In the field of oral and maxil-
lofacial surgery (Dentistry), 3D printed objects are used to reconstruct the
deformed bone [4]. In oral and maxillofacial surgery, the reconstruction
of the orbital fracture is challenging, and it is extremely difficult to regain
its original structure [5]. Orbital fractures affect the position and function
of intraorbital substances, leading to problems such as diplopia, enoph-
thalmos and visual acuity disturbances [6]. To avoid these difficulties, it
is necessary to surgically restore the fractured orbits and repair the
pre-injury anatomy. Orbital fractures may lead to major problems with
imprecise surgical replacements [7]. This study hopes to provide insight
regarding the reconstruction of orbital floor fractures for accurate
Many surgical methods have been adapted in previous studies
(transconjunctival, subsidiary and coronal), and various materials have
also been used to restore orbital fractures (bone, cartilage, titanium and
resorbable mesh). The extant literature has provided various procedures
for the reconstruction of orbital fractures [8–14]. Despite the variety of
surgical procedures, all of them have the same results, with slight simi-
larities. Depending on the skill set of a surgeon, the process of fitting and
aligning implants in the fractured orbital region is a reasonably
time-consuming process [15]. Some researchers recently used autologous
bone graft and titanium mesh, which are shaped according to the size of
the 3D printed orbital models, to achieve a three-dimensional shape. It is
fixed and aligned to match the contours of the orbital floor. Moreover, 3D
printed orbital models are used in surgical procedures as surgical aids to
help recognize anatomical landmarks and the exact fixation of titanium
mesh [16–18]. Furthermore, the complex anatomical shape of the orbit
makes the forming and cutting process of titanium mesh very laborious,
and it is practically difficult to obtain a ‘true-to-original’ 3D shape. To
avoid these problems, some authors have manufactured 3D printed

* Corresponding author.
E-mail address: manmadhachary@yahoo.co.in (M. A).

https://doi.org/10.1016/j.bprint.2020.e00118
Received 16 October 2020; Received in revised form 2 December 2020; Accepted 2 December 2020
2405-8866/© 2020 Elsevier B.V. All rights reserved.
M. A et al.
Fig. 1. The right and left orbitals of the 3D CAD model.
customized orbital implants made of titanium powder, which can provide
an exact anatomical shape of the orbital [19]. However, these implants
are expensive and heavier than the weight of the orbital anatomy being
replaced. Few authors have contributed to their research in weight
optimization of orbital implants. These weight-optimized structural im-
plants have also been manufactured using 3D printing with titanium
powder [20]. 3D printed thermoplastic polymer models are used in
pre-planning surgical procedures and as implants in the medical industry
[21–23]. Biocompatible polymer implants can be used in orbital floor
fractures to reduce weight during implant design. The use of thermo-
plastic polymer implants in treatment is affordable and economical. This
paper explains a simple and reliable method for designing,
manufacturing, and placing implants for the treatment of orbital frac-
tures using computer-assisted simulation and 3D printing technology.
2. Materials and methods
This study considered a 40-year-old male patient who was diagnosed
with orbital floor fracture, and designated and fabricated a customized
implant. The patient was treated at the Department of Oral and Maxil-
lofacial Surgery, Panineeya Institute of Dental Science and Research
Centre, Hyderabad, India. The surgical procedures for the patient were
performed with the approval of the Institutional Ethical Committee (IEC).
The following sections describe the methodology adopted to develop
patient-specific orbital floor implants.
2.1. CT data acquisition
The patient’s CT images were obtained using a 64-slice spiral CT
scanner (Light Speed VCT, GE Medical Systems). The patient’s skull
(orbital cavity and the surrounding bone structure) was scanned with
parameters of a tube current of 500 mA, a tube voltage of 80 kV, a pitch of
1.34, and a gantry rotation time 0.4 s. The scanning parameters were set
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Bioprinting 21 (2021) e00118
on 64 detectors with a slice thickness of 0.625 mm, a slice increment of
0.3 mm, a matrix size of 512 x 512 and a gantry tilt angle of 0 [24]. The
scan was carried out for the patient on the same day of admission at the
hospital.
2.2. CT data processing and design of an implant
With the help of Mimics® (Materialise NV, Leuven, Belgium) soft-
ware, CT images in the form of Digital Imaging and Communications in
Medicine (DICOM) standard were processed to develop a 3D CAD model.
DICOM images consist of voxels (cube) based data, where these voxels
are arranged sequentially according to the principle behind the marching
cubes algorithm, and a region-growing technique was applied to form the
patient’s anatomy of the 3D CAD model. The orbitals are indicated in
violet colour as shown in Fig. 1. The damaged (right) and healthy (left)
orbitals are shown in Fig. 1.
A mask editing tool was used to select and deselect pixels in the 2D
view, in which these selected and deselected pixels added and removed
voxels in their respective 3D CAD models. The initial CAD model con-
tained numerous artifacts that had been removed by the mask editing
tool. In order to produce an orbital implant, only two orbitals CAD model
is extracted from the maxillary CAD model using the mask editing tool.
The left and right orbital anatomical models were separated using the
axis of symmetry. Finally, orbital anatomical models were obtained in the
3D CAD model, as shown in Fig. 2.
The above two separate orbital CAD models (Fig. 2) were used to
design the implant. The healthy orbital (left side) CAD model was used to
design the implant using a mirror tool. Furthermore, the left side
(healthy) orbital was mirrored onto the right side, that is, the injured
orbital. Likewise, a mirror plane was required to mirror the part on the
other side of the 3D CAD model. The Mimics simulation module gener-
ated a default sagittal plane, but made some adjustment to this plane to
ensure that it was suitable for the required data set. Using the mirror tool,
M. A et al. Bioprinting 21 (2021) e00118

Fig. 2. Separation of the right and left orbitals as using the axis of asymmetry.

the 3D CAD model of the healthy orbital side was mirrored by the
midsagittal plane to maintain the symmetry of the orbital counter. The
mirrored part (yellow color) is shown in Fig. 3.
The mirrored orbital CAD model (Fig. 3) was used to design the
implant. This CAD model was subtracted from the initially developed
right-sided orbital CAD model. Now, the inner surface of the subtracted
CAD model is exactly aligned on the top surface of the initially developed
right-sided orbital model. Furthermore, the area of the subtracted portion
was reduced to provide a curved linear shape and a uniform surface on a
fractured orbital. Finally, the designed implant (red color model) main-
tained symmetry and improved the surface of the fractured orbital, as
shown in Fig. 4. This simulation tool is used to effectively design the
implant and accurately mount it on the patient’s orbital surface during
surgery. The 3D CAD models of the maxilla and designed implants were
converted into Standard Triangle Language (STL) file format to produce
3D printed models.
2.3. Manufacturing of medical models by 3D printing
During the 3D printing process, the STL file was divided into multiple
layers and controlled by a computer. Based on these layer data, the 3D
printer fabricates medical models. The designed implant model is shown
in Fig. 5(a). As shown in Fig. 5(b), it was manufactured using a Stratasys
Fused Deposition Modeling (FDM®) Fortus 900mc machine with a bio-
compatible PC-ISO material. The PC-ISO has a low material density
compared to bone density, so weight optimization in implant design is
disregarded. The PC-ISO material is used for making filaments with a
diameter of 1.75 mm, which are wound in the form of coils. It is extruded
as a thin filament from a heated nozzle, deposited on top of a printer base
plate where it solidifies. The bottom layer on the base plate is formed by a
controlled extrusion head, which deposits thin layers of material onto the
plate. The next layer is deposited on the previous layer, which develops
the model from bottom to top; this process is carried out layer by layer

Fig. 3. Left orbital mirrored with symmetry axis.

Fig. 4. Implant CAD Model (Red color). (For interpretation of the references to color in this figure legend, the reader is referred to the Web version of this article.)

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Fig. 5. (a) Implant 3D CAD model, (b) 3D printed implant, (c) Maxilla 3D CAD model, and (d) 3D Printed maxilla.

Fig. 6. Pre-planning surgery on (a) CAD models and (b) 3D Printed models.

until the model is completed. The patient’s maxilla CAD model was
developed in the Mimics software, as shown in Fig. 5(c). It was manu-
factured with the Stratasys FDM Dimension SST 768 machine using
Acrylonitrile Butadiene Styrene (ABS) filaments, as shown in Fig. 5(d).
2.4. Pre-surgical planning
The motive for this surgery is to reconstruct the area of the orbital
floor by rebuilding the bone defect. In this work, a virtual pre-planning
surgery was performed by simulating (positioning) the maxilla and
implant CAD models in the simulation tool (Mimics software), as shown
in Fig. 6(a). Another method of pre-planning surgery was also performed
on the 3D printed maxilla (white model) with 3D printed orbital implant
(transparent model), as shown in Fig. 6(b). In this pre-planning surgery,
the surgeons obtained information on the position of the implant and
studied the contoured orbital end areas, where the screws must be fixed.
Rigid fixation can be achieved through a 3D printing technique compared
to virtual simulation. Osteotomy, reduction and fixation, fractured
segment displacement, and facial contour reconstruction were all simu-
lated to ensure a better surgical outcome.

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Fig. 7. (a) Reduction of orbital tissues and (b) Fixing the implant with titanium screw.

Fig. 8. Orbital floor (a) pre and (b) post-surgery evaluation.

2.5. Surgical procedure aligned with the orbital floor and fixed with titanium screws.

For sterilization, the 3D printed manufactured implant was sub-
merged in an iodine solution for 8 h. In the case of general anesthesia, the
transconjunctival approach was used for the patient and a review of the
lower orbital wall was performed. Herniated orbital tissue was reduced
to restore intraorbital structures, as shown in Fig. 7(a). The 3D printed
implant was positioned to support the area of the orbital floor, which is
placed above the infraorbital bundle and below the lower rectus muscle.
It is fixed to the inferior orbital margin to support orbital structures. The
surgeons were able to identify the removal of bone sections and the
location of the implant by the shape and position of the reduced bone
segments. As shown in Fig. 7(b), the 3D printed implant was properly
2.6. Post-surgical follow-up
Based on the orthoptic observation, the patient’s globe position and
visual disturbances were noticed. In addition, a significant development
was detected after implanting the 3D printed model, and eliminating
diplopia and enophthalmos enhanced vision. The morphology of the pre
and post reconstructive surgery for orbital floors using the 3D printed
implant is observed in Fig. 8(a) and (b). In this case study, the patient
eventually regained a reasonable orbital floor and a better facial
appearance.

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3. Conclusion
Computer-assisted surgical tools were taken into consideration in this
study, which reduced the operational time and provided an accurate
design along with simulation (positioning) of orbital implants. Compared
to earlier methods, the application of FDM 3D printing technology in the
medical industry using a combination of biocompatible materials resul-
ted in fabrications of implants at a minimal cost and less production time.
Moreover, with the aid of FDM-based 3D printing techniques, the fabri-
cation of pre-surgical prototypes becomes economical and can signifi-
cantly streamline the reconstruction process of a specific orbital floor.
Depending on the appropriate pre- planned surgical procedures, a perfect
fit can be obtained during surgery, with 3D printed medical models being
effective. 3D printing technique and CAD models are used together in
orbital floor restoration to provide satisfactory aesthetic results. There-
fore, the customized models used in the patient’s intra-operation can
minimize the operational time and maximize surgical safety.
CRediT authorship contribution statement
Manmadhachary A: Methodology, Software, Writing - review &
editing. Aditya Mohan A: CT Data acquisition, Writing - original draft,
preparation. Haranadha Reddy M: Conceptualization, Surgical
Procedures.
Declaration of competing interest
The authors declare that they have no known competing financial
interests or personal relationships that could have appeared to influence
the work reported in this paper.
Acknowledgments
The author would like to thank Dr. Y. Ravi Kumar, Associate Pro-
fessor, Department of Mechanical Engineering, National Institute of
Technology Warangal, Telangana, India for their support and providing
Mimics software.
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