Rapid Prototyping and Rapid Machining of Medical Implants
Rapid Prototyping and Rapid Machining of Medical Implants
1. Introduction
In recent years several research institutions, medical companies and commercial organizations
have integrated Computer Aided Design (CAD) and Rapid Prototyping (RP) to produce 3D
physical medical models. These models are being used for several applications: visualization,
diagnosis, surgery planning, design of implants, external prosthesis, surgical templates, production
of artificial organs, communication (between the medical team and/or medical doctors and
patients), and teaching, or didactic aids. Another application field is the production of medical
surgical instrumentation tooling.
The use of RP in medicine is not satisfactory high since it is relatively young field with very
wide potentials to be reached. The main limitations for wider application of this manufacturing
procedure, so far, are: biological incompatibility of the existing materials used in RP processes;
relatively high costs of model production; time and work intensive process to achieve an
appropriate model quality (surface finish and anatomical accuracy).
Therefore, it seems that the most practical way of surgery is early implant machining (on
milling machine) and fixing on the certain tolerances (using the user friendly interface and
visualization techniques) based on the CT data (enhanced with additionally SSD technique for 3D
object obtaining). This platform containing digital model data provides that implant materials
produced in blocks can be machined or even tested on the model of the origin bone material before
the surgery act starts in practice. This procedure doesn’t suffer from sterilization problem as one
can expect if the implant is made during the surgery (that means reshaping of the implants
produced in the sheet (folia) forms.
Finally, the product created in this way i.e. modeled from one massive piece of biomaterial,
will match exactly (3D shape) patient’s anatomical region to be cured (changed or replaced). For
each patient the customized 3D models of anatomical regions to be surgically treated and replaced
after the tumor process has been removed, will be manufactured. This approach exhibits a huge
benefit for surgery practice, because it ensures properly postoperative functioning of patient’s
anatomical/organic system, which by this means, becomes in fact almost the same to its original
natural model.
2. Background
The possibility of exact preoperative, non-invasive visualization of the spatial relationships of
anatomic and pathologic structures, including extremely fragile ones, size and extent of pathologic
process, and of precisely predicting the course of surgical procedure, allows the surgeon to achieve
considerable advantage in the preoperative examination of the patient and to reduce the risk of
intraoperative complications, all this by use of virtual surgery (VS) or diagnosis per viam 3D
models. It could be done by using patient’s images created for diagnostic purposes. Storage of the
patient's images and diagnoses in a multimedia form in computer systems allows them to be
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subsequently searched and some specific cases re-examined for analysis and physician education,
even via Internet (e.g. Eurorad Project). By use of DICOM protocol, not only image recordings but
all general data of the patient, that have previously been entered onto the diagnostic device console
as well as all data on the device setting during patient's image production are transferred from the
diagnostic device to computer systems [1].
Concerning the implants, medical models obtained by RP are normally used indirectly, as
masters, to produce prosthesis in biocompatible conventional materials (e.g. titanium, cobalt-
chrome alloys, medical-grade aluminum, medical-grade silicone etc.) mainly by casting and spray
metal molding [2,3].
However, RP technology has the ability to fabricate models with complex geometric forms,
and so is very suitable to reproduce the intricate forms of human body. By using of RP models,
visualization of intricate and hidden details of traumas by surgeon is enhanced.
The majority of the references found in literature on this subject are concerned with the
production of medical models via Stereolitography (SL). However, SL medical models,
unfortunately, cannot be used inside the human body, as direct implants, due to the resin toxicity,
which creates concerns about the long-term biocompatibility of SL models. Nevertheless, the range
of applications of those models is very large [3].
Some recent researches aiming to improve the use of RP in the production of medical
implants are directed toward producing implants of biocompatible materials directly in the RP
process. Among this group of materials, high-purity calcium phosphate ceramics (hydroxyapatite,
HA or HAp) alone, or in composites with biodegradable polymers (poly (L-lactide), PLLA) offer
long-term biocompatibility and therefore have a large potential to be used in medical applications
[3,4].
On the other hand, there is a group of porous polymeric materials (e.g. Porex) which can be
used as implants while these materials are biocompatible [5]. Those materials can be produced
either in thin films forms and be individually reshaped for certain application either in block forms
for wider application. This technique allows the in-vitro planning and implant shaping while the
first one means shaping on the human body models (produced by RP) or directly during the surgery
on real object.
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Ultrasound System (US), Mammography, Radiography (Plain X-Ray) and Laser Digitizer. Most
medical models are produced via CT for bone structures and MRI for soft tissue [6-7].
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Machining of PE-UHMW and PE-HD with conventional manufacturing processes is possible
and is not problematic but nevertheless it is specific technique and suffer from some restricted
demands. Generally, there is no necessity for classic application of coolants because of relatively
low specific cutting forces. Furthermore, cutting speeds can be increased in order to obtain better
surface quality till the value when the temperature rapidly becomes higher and so far that can
damage or even destroy the implants. Assuming that the implants have to be machined with very
low roughness and neck free some test have to be performed in order to define acceptable
overlapping of the milling tool paths. Because of porousity of the material blocks (e.g. Porex),
machining has to prevent that residual particles with micro size left into porous structure.
Nevetheless, residual particles could be reduced by posterior cleaning with air.
Geometrical complexity of geometry of implants is oneother constraining parameter
concerned with material handling and fixing since the implants geometry could be very thin and so
far the selection of the base plane for fixing and applied value of fixing forces is of big importance.
Complex geometry of implants result with demands on construction of machine tool which has to
allow 4D or even 5D machining. Nevertheless, application of tools with small diameter for
obtaining very small radii of convergence on implants is possible only if the main spindle can
rotate at very high values. Concerning depth of cutting, there is restriction when the production is
close to final shape of implants.
Also, attention has to be paid on tool trajectory in the area where the radii of the curvature is
small in the way that cutting feed has to be lowered. This restriction is powered when the tools with
small diameter are used and when the surface feeding speed is high. This condition, with very high
value of acceleration and deceleration of the spindle (frequently higher than 1 G – 9,81 m/s2), could
be problematic on the geometric accuracy of the implants. Appropriate tool geometry and cutting
feed and depth of cutting has to be chosen in order to achieve good chip transportation.
The RP models obtained by 3D Printing process (Z-Corp ZPrint 310 System) will be used in
planning of implants surgery i.e. to test whether the implants produced by machining of porous
biomaterial blocks fit appropriately in complex neighboring anatomical structure modeled by RP
technique. Secondly, we will compare shape characteristics of implants obtained by machining
with those produced in RP process.
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Figure 2. STL model of the hip bone
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Figure 4. Hip bone after rough machining
6. Conclusion
In accordance with solid model obtained after CT it is possible to manufacture hip bone
implants from block material on milling machine. Approach in bone surgery treatment that was
presented in this paper offers great potentials in time saving and eventually possible postoperative
treatments. This procedure is revolutionized since it could be planed and starts at the moment when
the preventive CT is performed. All the phases are based only on CT data and procedure of implant
production is automatically linked with CT report. That means that the human errors and its
leakage are reduced to minimum and the surgery results because of that become more successful.
Machining time has to be improved and we pointed out a tool selection (number and paths) as very
important and critical in that manner. Also, there is consideration regarding tool path overlapping
to achieve better surface quality. In following work we will try to apply our theoretical
considerations addressed on machining process. Also, our future work will be directed toward
investigation of machining capabilities of special biocompatible polymeric materials.
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7. References
[1] Klapan, I., Šimičić, Lj: "Telemedicine assisted surgery: Tele-3D-Computer assisted surgery in
Rhinology", Telemedicine e-Health, 8(2), 2002, pp 217.
[2] Gebhardt, A.: "Rapid Prototyping", Hanser Verlag, München, 2000.
[3] Cruz, F. et al.: "Selective Laser Sintering of Customised Medical Implants Using Biocomposite
Materials", Tehnički vjesnik 10(2), 2003, pp 23-27
[4] Ravaglioli, A.; Krajewsky, A.: "Bioceramics: Materials, Properties & Applications", Chapman & Hall,
London, 1992.
[5] N.N.: "2000 Product Catalog", Porex Surgical Inc., College Park, 1999.
[6] Raos, P., Stoić, A.: "Computer aided implant machining", Proceedings of The 2nd Croatian Congress
on Telemedicine with International Participation TeleMED 2004, Zagreb, Croatia, (Printed abstracts +
CD-Book), May, 19-21, 2004, pp 78-79.
[7] Raos, P., Galeta, T.: "Rapid Prototyping", Proceedings of The 2nd Croatian Congress on Telemedicine
with International Participation TeleMED 2004, Zagreb, Croatia, (Printed abstracts + CD-Book), May,
19-21, 2004, pp 74-75.
[8] Raos, P., Stoić, A., Kopač, J.: "Manufacturing of customized medical implants", Proceedings of 8th
International Research/Expert Conference TMT 2004, Neum 2004, pp 99-102.
[9] Raos, P., Stoić, A.: "An Approach In Manufacturing of Medical Implants", Proceedings of The 8th
ESAFORM Conf. on Material Forming, Cluj-Napoca, 27.-29.04.2005.
[10] Lim, T., Corney, J., Ritchie, J.M., Clark D.E.R.: "Optimising Automatic Tool Selection For 2 1/2D
Components", Proceedings of DETC’00: ASME 2000 Design Engineering Technical Conferences and
Computers and Information in Engineering Conference Baltimore, Maryland (2000) DETC2000/DFM-
14032
Acknowledgement
Authors would like to thank to Croatian Ministry of science for financial support provided by Bilateral
Croatian-Slovenian Project "Rapid manufacturing of moulds with complex tool surface".