Case Study

Designing and Materialising

a Custom Skull Implant
Case presented by M. Beerens*, Ing. P.Laeven*, Drs. J.Poukens**
(* Custom Made Implant Designer IDEE, the Netherlands ** Cranio-Maxillofacial Surgeon University Hospital of Maastricht, the Netherlands)

After a serious accident, a woman was taken to the hospital with severe head trauma. She
was in critical condition for days when her surgeon decided to perform a craniotomy to
release the pressure on her brain. This resulted in a cranial defect that she lived with for
three years. When the surgical team decided to do a reconstruction, her scalp had already
tightened over the defect. This made it impossible to simply implant a copy of the healthy
side of her skull. After considering several options, they turned to the Mimics Innovation
Suite to design a patient-specific implant that would allow the available skin to cover the
implant. With this technique, they were able to restore the symmetry of her forehead while
covering the defect, protecting the brain and sparing her unnecessarily discomfort.

Transforming CT Data into a Patient-Specific Implant

with the Mimics Innovation Suite
Using Mimics software, the team converted the CT scan data of the patients head into
an accurate 3D model which could be used for the design of a patient-specific implant.
When designing an implant that covers a large defect, it is important to use reliable
design references to ensure the implant fits properly. The surgeon, Drs. Poukens,
decided to use the loose bone parts lying on the meninges and the meninges itself as
a reference for this implant design. They segmented the cranium, the loose bone parts
1
by varying the threshold levels and then also segmented the meninges to ensure that
it would not interfere with inside surface of the designed implant.
Using 3-matic, Maikel Beerens, clinical engineer at IDEE, tried out several design
concepts, which he discussed with Drs. Poukens. In this way, any potential problems
with the design could quickly be detected and an optimal design could be found.
Indeed, the final design did everything it needed to do it covered the defect, offered
protection for the meninges without applying too much pressure, and whats more, it
also reconstructed the cosmetic facial forehead contour without stretching the patients
skin.

Using Materialises software to design a custom-made implant

2
1 Part of the meninges (grey) and bone particles (green)
used as design reference for the implant. Guiding
curves (turquoise) indicate the implants curvature
2 After several designs in 3-matic, this became
the final design
decreased the design time by 68% in comparison to other
CAD software. The option of designing a custom implant makes
performing an operation easier on the surgeon and results in
a 50% reduction of the time needed in the operating theatre.
Materialise software is our preferred software for designing custom
implants
M. Beerens, Custom Made Implant Designer IDEE, the Netherlands
 With 3-matic, they were able to add the following features directly to the implant design:
Five fixation lips to ease attachment of the implant.
Six pairs of holes in order to pull the meninges towards the inner surface of
the implant. This reduced the chance of infection and gave the meninges the
opportunity to grow into the implant surface.
A pattern of holes through which the patients chewing muscle could be
attached since a lattice structure would increase the risk of infection.
3 A product number in order to comply with the European Council Directive 93/42/
EEC for the registration of custom-made medical devices.
The implant was manufactured in titanium using a method called Electron Beam Melting
(EBM) with a machine from Arcam. EBM allowed for the manufacturing of a thoroughly
dense implant that promoted osseo-integration of both bone and soft tissue.

Successfully Reconstructing a Defect,

4
both Efficiently and Aesthetically
During surgery the implant was screwed onto the cranium using titanium medical
grade screws and the fixation lips. The customized implant was a perfect fit and it
enabled the surgical team to reconstruct the shape of the forehead aesthetically while
protecting the patients brain tissue. As mentioned before, the combination of the
different technologies used caused a considerable time decrease.1 Most important
of all, following the procedure, the patient healed without experiencing complications.
For IDEE, Materialises Mimics Innovation Suite is the solution of choice for designing
5 custom-made implants.

3 The implant surgery

4 Patient before surgery with indentation on the forehead
5 Patient after surgery with the forehead reconstructed
cosmetically

1) views expressed in 2006 by Ing. Maikel Beerens, current CEO of Xilloc Medical, who is not
affiliated to Materialise

The standard in Engineering on Anatomy

The Mimics Innovation Suite turns 3D image data into high quality digital models in an accurate and efficient way.
Starting from CT, MRI or 3D Ultrasound images, the Mimics Innovation Suite offers the most advanced image segmentation,
the broadest anatomical measurement options, powerful CAD tools for Engineering on Anatomy and 3D Printing, and
accurate model preparation for FEA and CFD.
The authors used the Mimics Innovation Suite to design a patient-specific implant using following steps:
Convert CT data into a 3D surface model of a cranium
Explore various design concepts to attain an optimal fit
Export the design for EBM manufacturing

Regulatory Information:
Mimics Innovation Suite currently consists of the following medical device software components: Mimics version 16 and 3-matic version 8 (released 2013). Mimics is intended for use as a
software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner. It is also
used as pre-operative software for simulating /evaluating surgical treatment options. 3-matic is intended for use as software for computer assisted design and manufacturing of medical exo-
and endo-prostheses, patient-specific medical and dental/orthodontic accessories and dental restorations.
Materialise Belgium Technologielaan 15 3000 Leuven Belgium
Materialise USA - 44650 Helm Court - Plymouth, MI 48170 USA
Materialise has the appropriate regulatory registrations in Europe and the United States

Mimics is a CE-marked product Copyright 2014 Materialise N.V, L-10011 revision 3, 02/2014

Contact: mimics@materialise.be or biomedical.materialise.com