Int J Adv Manuf Technol DOI 10.

1007/s00170-011-3388-1

ORIGINAL ARTICLE

Comparison of cranioplasty implants produced by machining and by casting in a gypsum mold

Dalberto Dias da Costa & Srgio Fernando Lajarin

Received: 12 August 2009 / Accepted: 12 May 2011 # Springer-Verlag London Limited 2011

Abstract Cranioplasty is a medical technique used to correct craniofacial defects. Depending on the size and location of the defect, a bone substitute to replace the deformed or missing tissue can be manufactured. With the advances in computer-based systems and the invention of new biomaterials, the production of customized implants with good cosmetic and functional results has now become widespread. However, little research has been undertaken into the quality of prefabricated specimens in terms of dimensional and form errors. Because of the geometric complexity involved, measurement of this kind of object is a complicated process. The aim of this paper is to describe two different manufacturing processes used to produce a large polymethylmethacrylate (PMMA) implant for use in cranioplastic surgery and to discuss the results of the evaluation of the dimensional errors and lead times associated with these methods. In the first method, the specimen was directly machined from an acrylic block. In the second, the implant was cast in a machined gypsum mold. Both processes were based on a digital model of a dried human skull scanned by computer tomography. Dimensional errors were evaluated with a coordinated measurement machine. Despite their complexity, the PMMA specimens produced were measured and their dimensional differences established. Compared with direct
D. D. da Costa (*) Mechanical Engineering Department, Universidade Federal do Paran, Curitiba, PR, Brazil e-mail: dalberto@ufpr.br S. F. Lajarin Postgraduate Program in Mechanical Engineering, Universidade Federal do Paran, Paran, Curitiba, PR, Brazil

machining, casting results in a longer lead time and, because of shrinkage, a larger dimensional deviation. Keywords Cranioplasty . Cast implants . Direct machining

1 Introduction The use of prefabricated alloplastic implants for cranioplasty applications has grown in recent years, mainly because such implants help reduce surgical time and allow a satisfactory esthetic restoration, as has been described by several researchers [15]. Firstly, the injured region, or in some cases the whole skull, is scanned by computer tomography (CT). The acquired image set is then processed to separate the region of interest and the edges making up the bone contours. A number of commercial packages are currently available for this kind of application, and some are able to produce a 3D reconstruction of the scanned volume and export it in Initial Graphics Exchange Specification or Standard Tessellation Language (STL) format. Once a computer-aided design (CAD) model has been produced, it can be adjusted digitally to facilitate attachment of the prosthesis as proposed by Weihe et al. [6]. Depending on the geometric complexity and biomaterial chosen, one or more manufacturing processes can be selected. In most cases, more than one manufacturing process is usually required to produce the implant. A number of different manufacturing alternatives have been studied and recommended for the prefabrication of cranioplasty implants. Casting, machining, forming, and layer manufacturing-based processes are the most significant examples. As described by Giannatsis and Dedoussis [7], Leong et al. [8] and Yang et al. [9], the last of these

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techniques allows very intricate geometric forms to be produced and is used to produce biomodels and scaffolds, which have been the object of much attention from the research community in recent years. Direct machining is a very flexible process and has been used in the production of titanium [6] and acrylic implants [10]. Its most important limitation is the interaction (gouging) between the cutting tool and the blind, or even small, cavities found in the surface of the implant. However, as described next, the adoption of smaller cutting tools in the finishing phase can minimize this kind of geometric constraint, particularly when such cavities do not represent important anatomical features. In addition to the problems, they pose in terms of gouging, the free-form surfaces found in implants pose serious difficulties for setup planning insofar as determining datum and fixtures is concerned. Nevertheless, if satisfactory fixture planning can be developed, machining can be considered an alternative. The use of casts offers one significant advantage over other techniques, namely, the possibility of producing composite materials in the same mold, as pointed out by Schiller et al. [11]. The cost of making the mold, however, is one of the shortcomings of this approach. A combination of machining and casting, as proposed by Hieu et al. [12] and Weihe et al. [6] represents a valuable alternative, since a cheaper free-machining material could be used to build the mold cavities. As well as increasing the lead time, a combination of different manufacturing techniques in the production chain of a cranioplasty implant affects the final quality of the implant, in particular its shape and dimensional deviation. A further, significant problem associated with dimensional error assessment in implants arises as a result of their geometric complexity, which makes traditional linear measurements more difficult to apply [13]. The aim of this paper is to describe two different manufacturing processes that were used to produce a large polymethylmethacrylate (PMMA) implant for use in cranioplastic surgery and to discuss the results of the evaluation of the dimensional errors and lead times associated with these methods. The longer manufacturing chain involves mold machining and casting; and the shorter chain, direct machining of the region modeled.

Fig. 1 Dried skull and the digital model of the region extracted

region represents a substantial challenge both to measure and manufacture, as it contains two highly curved surfaces (the internal one and the external one). The third surface was defined by an arbitrary intersection of the digital model of the skull with a plane parallel to the scanning plane, which is roughly parallel to the occlusal plane. The details of the CT and CAD modeling can be seen in reference [10] and are not repeated here. PMMA was chosen in this study because it is extensively used as biomaterial, is cheap, and can be easily manufactured [3, 12, 14]. The choice of autopolymerizing rather than heat-polymerizing material was influenced by the design of the mold and is explained in the next section. 2.1 Direct machining A prepolymerized powder was hand mixed with the liquid monomer (Classico So Paulo, Brazil) inside an open box. Based on the results reported by Jasper et al. [15], the liquid-to-powder ratio adopted was 0.5 mL/g. The box was then kept inside an autoclave with a positive pressure of 300 kPa, and the rectangular block formed (57146 175 mm) was removed from the box 2 h later. Most of the machining conditions were very similar to those used by Bazan [10], the main difference being the use of smaller cutting tools and the addition of a parallel lace milling strategy during the finishing of both the concave

2 Materials and methods The starting point for this work was a dried human skull that had been tomographed and modeled by Bazan [10] and had its calvarial region digitally extracted as shown in Fig. 1. Despite the fact that it is unique and does not correspond to a real cranial defect, the digitally extracted

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and convex surfaces. The setup was the same as that used by Bazan [10] and involved the use of a sacrificial material for the second fixturing and localization. Schematic representations of the machining strategies for both the surfaces are shown in Figs. 2 and 3, and the main cutting conditions are given in Table 1. All the machining was planned with Edgecam software (Pathtrace Ltd., Reading, UK) and executed in a Discovery 4022 three-axis vertical machining center (Romi, So Paulo, Brazil). 2.2 Casting In most of the literature about acrylic castings for cranioplasty applications, the molds are produced by hand after the cranial defect has been copied using alginate or similar material [16] or by layer manufacture of an implant model [7]. In both cases, the models are then used to create a gypsum-filled mold. The use of mold machining is rare. Hieu et al. [12] proposed this technique as a way of achieving greater quality and reducing cost compared with layer manufacturing-based processes. All the parts of the molds (cores and cavities) they used in their study were machined in hardwood resins and plastics. In this work, we propose a different approach (see Fig. 4) involving the design of a mold based on an aluminum flask that can be reused and filled up with gypsum as necessary. The top of the flask can be moved along a two pin guide so that external pressure can be applied with a press. The first gypsum block was cast in the flask and on the top plate. After it had set, it was removed from the flask while being kept anchored to the top plate by means of machined grooves as shown in Fig. 4. After the flask had been emptied, the second block was cast and kept there until the end of the whole process. The gypsum casts were made from type IV dental stone, and the water-to-powder ratio was 0.2 mL/g in accordance with the manufacturers instructions (Zhermack SpA, Badia Polesine, Italy). The machining planning and conditions were the same as those used for the PMMA milling, which are shown in
Fig. 3 Milling operation at the convex surface

Figs. 2 and 3 and Table 1. A circular groove was milled along the upper surface of the gypsum and a rubber O-ring was inserted in the groove to provide a mechanical seal during the pressing phase. A sufficient volume of PMMA mixture was prepared to provide the 150 mL required for the casting itself and the excess portion that flows out of the mold, thus guaranteeing that the mold would be completely filled. Five minutes after the PMMA was prepared, the mold was closed and secured to the table of a hydraulic press. An axial load of 2 kN was applied for 2 h to guarantee complete polymerization. The setup and run times for each task were recorded to enable the process times for both manufacturing processes to be compared. 2.3 Dimensional error assessment After the manufacturing phases had been completed, the skull, gypsum mold (core and die) and directly machined and molded acrylic implants were all measured against the digital STL model. Because the skull was a complete piece, its inner surface was not inspected. All measurements were carried out with a coordinated measuring machine (CMM) (Discovery II from Sheffield, WI, USA) equipped with a 2-mm spherical touch tip and an accuracy of 5+L/200 m. PC-DMIS CAD++ software (Wilcox, UT, USA) was used for the localization procedure and measurement analysis. This package has a special best-fit resource based on the least-squares method that allows the automatic localization of complex parts. The Design Coordinate System (DCS) was based on the STL model and used to determine the Measurement Coordinate System (MCS) for all the inspected parts. The procedure to localize the MCS consisted of three steps, which were applied to the seven surfaces. Firstly, based on the 3-2-1 principle, six points were manually defined to achieve rough localization. In the second stage, a grid composed of 160 points was created in the DCS and used by the PC-DMIS localization algorithm. This second stage was applied iteratively until the system reported

Fig. 2 Milling operation at the concave surface

Int J Adv Manuf Technol Table 1 Machining conditions Cutting conditions Surface Concave Operation End milling the sacrificial material Roughing First finishing pass at Z=32 mm Second finishing pass at the end Roughing First finishing pass at Z=6 mm Second finishing pass at Z=40 mm End milling to cut off the sacrificial material Strategy Z constant Z constant Z constant Parallel lace Z constant Parallel lace Z constant Z constant Cutting speed (m/min) 157 157 44 44 157 44 44 44 Feed per tooth (mm/rev) 0.3 0.3 0.22 0.22 0.3 0.22 0.22 0.22 Cutting tool 20 mm end mill 20 mm end mill 4 mm ball nose 4 mm ball nose 20 mm end mill 4 mm ball nose 4 mm ball nose 4 mm end mill

Convex

convergence. In the last stage, a regular grid with 5,000 points was defined to cover the visible surfaces. For every digitized point, the difference (T) between the point in the MCS and the corresponding point on the digital surface in the DCS was computed according to the following equation:

3 Results The machined surfaces resemble the surfaces in the digital model very closely. As shown in Fig. 5, even small anatomical marks, such as those in the calcified sutures, were reproduced. As aluminum alloys have good mechanical strength, the reusable mold case could be easily referenced and fixed to the machine table. The case also increased the stiffness of the gypsum, thus helping reproduce the small details found in the STL model. The machined core and cavity can be seen in Fig. 6. As the core moves into the cavity, the excess PMMA flows out of the mold; once the core is fully inserted into the cavity, the rubber O-ring forms a seal between the two parts of the mold allowing a positive pressure to be maintained during polymerization. After the setting time, the casting was easily removed without damaging the machined gypsum. As shown in Fig. 7, minor flash formation alternating with small unfilled regions occurred at the mold parting line. The flashes were manually cut off before any measurements were taken.

T i x m x d j y m y d k z m z d

where the unit vector i, j, k defines the direction in which the touch trigger approaches the surface, xm, ym, and zm are the Cartesian coordinates of the point measured in the MCS, and Xd, yd, and zd are the Cartesian coordinates of the digital model in the DCS. The root mean square (RMS) of the measurements was used to estimate the dimensional deviation for the inspected surfaces. In addition, to improve the RMS-based analysis, the bounding boxes were calculated for the manufactured specimens using the digitized points. Their dimensions were defined by the differences between the largest and smallest values in the X, Y, and Z directions.

Fig. 4 Mold design

Int J Adv Manuf Technol Fig. 5 Comparison of the digital STL model and the machined specimen

Figure 8 shows a histogram of the T values and a graphical representation of the distribution of these values over the skull surface generated with the PC-DMIS software. The darker areas (red and dark blue) indicate the values outside a range of 0.3 mm. The maximum values for T+ and T are also identified. A similar analysis was conducted for all the surfaces inspected. The results are summarized in Table 2, which gives the RMS values and the amplitude of the points measured. Table 3 gives the results of the bounding box calculations for the external surfaces of both the cast and the machined specimen. The values for the STL model were used for comparative purposes. The elapsed times for each task in both processes are shown in Tables 4 and 5. The setup time includes planning, machine preparation, and material handling. The process times are the sum of the setup or run times for each task in the sequence in which they are carried out to produce a single PMMA specimen.

4 Discussion and conclusion Starting from a digital STL model produced by Bazan [10] of a large hypothetical cranioplasty implant, two specimens
Fig. 6 Visual comparison of the digital model (convex surface) with the machined (concave) gypsum cavity

were produced using two different manufacturing processes. The specimens, which were made of PMMA, were evaluated with a CMM. Dimensional error assessment was based on a comparison of the surfaces of the specimens with the surfaces of the STL model. Because of the high degree of geometric complexity imposed by this kind of surface, PC-DMIS software was used to run an automatic localization procedure. As a real clinical case was not available for study, a large region of the skull corresponding to the top of the calvarium was analyzed. It is reasonable to suppose that such a specimen is representative, from the point of view of the geometry, of a great number of the skull defects reported in the specialized literature [1719]. Of course, in the case of smaller implants, especially those with small cavities, more effort is needed to design and machine the gypsum molds. However, as pointed out by Hue et al. [12], correct planning of the parting line and selection of small cutting tools can minimize the problem, allowing the molds to be satisfactorily milled in a three-axis machine tool. The largest RMS value (0.169 mm), which coincided with the second largest amplitude (T+ =0.816 mm and T =0.669 mm), was observed when the digital model (STL) was compared with the original dried skull. This difference can be attributed to three sources of error. The

Int J Adv Manuf Technol Fig. 7 Cast implant with minor flash formation at the mold parting line

first, which is known as the partial-volume effect, is a consequence of the use of computed tomography. As pointed out by Mazzoli et al. [13] and Bouyssi et al. [20], this kind of deviation depends on the scanning parameters adopted, such as section thickness, pitch, tube current, and voltage. The second source is related to the 3D reconstruction and factors such as the bone segmentation, contour vectorization, tessellation, and interpolation methods. The millimeter-to-pixel ratio adopted in the model evaluated was 250/512, as reported by Bazan [10]. Despite the facilities available in the software for image segmentation, contour interpolation and tessellation, a certain amount of error, albeit small, can be expected from this kind of processing. Mazzoli et al. [13] and Choi et al. [21]
Fig. 8 Histogram of T values and a graphical representation of these on the digital STL model after measurements of the skull were taken

highlighted the importance of the threshold value adopted during image segmentation as a factor that has a significant effect on the quality of the digital model. The third source of error can be attributed to the localization procedure. Despite the large point set adopted here, a certain amount of error should be expected, which, as pointed out by Lai and Chen [22], depends mainly on the quality of the points measured. The analysis in Fig. 8 helps to corroborate the last error source discussed above. The histogram indicates a wellcentered distribution of the T values, i.e., roughly 50% of the points are positive. However, their spatial distribution over the skull surface reveals two patterns. The first, corresponding to the dark blue area, is mainly composed

Int J Adv Manuf Technol Table 2 Results of the dimensional error assessment of the different surfaces inspected Surface inspected T (amplitude) (mm) T+ Skull External (cast) Internal (cast) Gypsum mold (cavity) Gypsum mold (core) External (machined) Internal (machined) 0.816 0.516 0.517 0.314 0.462 0.986 0.637 T 0.669 0.706 1.373 0.141 0.090 0.373 0.175 T (RMS) (mm) 0.161 0.121 0.117 0.022 0.028 0.043 0.045 Preparing the gypsum Machining the mold cavity Machining the core Machining the circular groove Casting the PMMA Process time 15 40 35 10 30 130 200 100 95 5 135 535 Table 4 Setup and run times for the main casting tasks Task Setup time (min) Run time (min)

of negative values less than 0.30 mm. The second, which follows the calcified sutures, contains positive values greater than 0.30 mm (red area) and is a result of a discontinuity in the modeled surface. The dimensional error found in the cast implant was less for both surfaces (RMS=0.121 and 0.117 mm for the external and internal surfaces, respectively) than that observed for the skull, but with a larger amplitude (T+ = 0.517 and T =1.373 mm for the internal surface). As with the skull, a similar pattern for the more negative T values was observed, but this is largely explained by the shrinkage that occurs after the setting and curing time for the PMMA. This shrinkage can be confirmed by analysis of the bounding box values given in Table 3. The mean value of the difference between the cast and the digital model was estimated to be 0.63%. However, this cannot be entirely attributed to shrinkage alone as other sources of error are present, such as the localization procedure, the machined gypsum mold, and the distortion caused by demolding. The value observed lies in the linear shrinkage range reported by Keenan et al. [23] during injection molding of PMMA dentures. While according to Silikas et al. [24], the estimated theoretical value for the proportion of monomer used could be expected to be larger, the smaller shrinkage observed in the present study can be explained by the fact that positive pressure was maintained throughout the polymerization phase and, as reported by Gilbert el al. [25], by the mixing

procedure adopted here, i.e., hand mixing instead of vacuum mixing. As the PMMA specimen was cooled inside the mold, the expansion and contraction caused by the exothermic reaction during polymerization were constrained by the mold walls suggesting that residual stress may be present in the cast specimen. Both the machined surfaces were found to have low RMS values, with more than 98% of all the points measured lying within a range of 0.1 mm. Larger values were considered to be outliers, particularly those occurring at the calcified sutures. This close visual and dimensional resemblance to the digital model agrees with the results reported by Da Costa [26]. The RMS T value measured for the gypsum mold (core and cavity) was slightly lower than that observed for the machined PMMA surfaces. The small difference can be attributed to the greater stiffness afforded by the gypsum and the aluminum flask. As milling was done after the setting time had elapsed, no significant expansion of the gypsum was expected, contrary to what is observed when an implant is molded in gypsum slurry [27]. The casting time was longer than that recorded for direct machining, as it includes the time required for tasks related to the production of the mold as well as the molding phase itself. The process times shown in Tables 4 and 5 are the sum of the setup or run times for each task in the sequence in which they are carried out. However, as preparation of the gypsum and casting of the PMMA block can be carried out beforehand, both the cast and direct-machining process times can be shortened to 7.5 and 4.7 h, respectively. Layer-manufactured patterns are extensively used to produce molds for cast PMMA implants [1, 7]. DUrso et
Table 5 Setup and run times for the main direct-machining tasks Task Setup time (min) Run time (min) 15 30 15 70 130 120 25 65 80 290

Table 3 The bounding box dimensions for the manufactured specimens and the STL model External surface Directions X (mm) Digital model Cast Machined 133.077 131.704 132.688 Y (mm) 163.588 161.885 163.297 Z (mm) 44.680 44.756 44.446

Casting the PMMA block Machining the sacrificial material Machining the concave surface Machining the convex surface Process time

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al. [1] reported an average time of 10 h to produce casting patterns and 4 h to cast the PMMA implant. However, despite the time saving afforded by the processes investigated here, these cannot compete with layer-based technology when the implant geometry is highly complex, particularly when the implants contains hollow regions and small cavities. The main goal of this work was achieved. Despite their complexity, the PMMA specimens produced were measured and the dimensional differences for each specimen were determined. Compared with direct machining, casting implies a longer lead time and larger dimensional deviation. However, if a proper offset value is adopted in the molddesign phase, shrinkage can be minimized. Accordingly, the inherent advantages of casting, such as the possibility of producing implants made of composite materials, as proposed by Schiller et al. [11], can compensate for the longer lead time associated with this technique.

Acknowledgments The authors would like to express their gratitude to CAPES, the Brazilian Agency for Postgraduate Education.

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