We present a detailed step-by-step approach for the low-cost production and surgical implantation of cranial prostheses, aimed at restoring aesthetics, cerebral protection, and facilitating neurological rehabilitation. This protocol uses combined scan computed tomography (CT) cross-sectional images, in DICOM format, along with a 3D printing (additive manufacturing) setup. The in-house developed software InVesalius®️ is an open-source tool for medical imaging manipulation. The protocol describes image acquisition (CT scanning) procedures, and image post-processing procedures such as image segmentation, surface/volume rendering, mesh generation of a 3D digital model of the cranial defect and the desired prostheses, and their preparation for use in 3D printers. Furthermore, the protocol describes a detailed powder bed fusion additive manufacturing process, known as Selective Laser Sintering (SLS), using Polyamide (PA12) as feedstock to produce a 3-piece customized printed set per patient. Each set consists of a “cranial defect printout” and a “testing prosthesis” to assemble parts for precision testing, and a cranial “prostheses mold” in 2 parts to allow for the intraoperative modeling of the final implant cast using the medical grade Poly(methyl methacrylate) (PMMA) in a time span of a few min. The entire 3D processing time, including modelling, design, production, post-processing and qualification, takes approximately 42 h. Modeling the PMMA flap with a critical thickness of 4 mm by means of Finite Element Method (FEM) assures mechanical and impact properties to be slightly weaker than the bone tissue around it, a safety design to prevent fracturing the skull after a possible subsequent episode of head injury. On a parallel track, the Protocol seeks to provide guidance in the context of equipment, manufacturing cost and troubleshooting. Customized 3D PMMA prostheses offers a reduced operating time, good biocompatibility, and great functional and aesthetic outcomes. Additionally, it offers greater than 15-fold cost advantage over the usage of other materials, including metallic parts produced by additive manufacturing.

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This is a list of supplementary files associated with this preprint. Click to download.
Table 1. Adult Routine Head CT parameters adopted from existing CT protocols (link B). 1The amount of tissue inferior and superior to the prescribed scan range that is irradiated by over ranging can vary, * lower mA values for bone structures, higher mA values to include soft tissues. 2The amount of tissue inferior and superior to the prescribed scan range that is irradiated by over ranging can vary, depending on the scanner model and how the scan is performed (pitch value, collimation, etc.). 3Collimation in CT serves to ensure good image quality and to reduce unnecessary radiation for the patient. The tube collimator is used to shape de X-ray fan beam before it penetrates the patient. Values adopted for the Brilliance 16 slice scanner (Philips) are 16 x 1.5 mm.
Table 2. CT Imaging of Adult Head. Routine suggested image thickness and interval sets. Topogram: cranio-caudal direction.
Table 3. 3D manufacturing: minimum requirement and recommended hardware.
Table 4. Quantity of nodes and cranial and prosthetic elements for simulation of cranial repair.
Table 5. Properties of materials used in the finite element simulation.
Table 6. Understanding 3D manufacturing cost to produce cranial prostheses.
Table 7. Troubleshooting.
Table 8. Mean time required for each stage of the set of cranial prostheses fabrication process using 3D printed PA smoothed molds. Processes requiring human input are shown in bold, automatic/unattended processes are shown in italics.
Table 9. Individual data listings through the cranioplasty study at HMMC and HR, for patients assisted by the Brazilian Universal Health System (SUS).
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Posted 01 Apr, 2021
Posted 01 Apr, 2021
We present a detailed step-by-step approach for the low-cost production and surgical implantation of cranial prostheses, aimed at restoring aesthetics, cerebral protection, and facilitating neurological rehabilitation. This protocol uses combined scan computed tomography (CT) cross-sectional images, in DICOM format, along with a 3D printing (additive manufacturing) setup. The in-house developed software InVesalius®️ is an open-source tool for medical imaging manipulation. The protocol describes image acquisition (CT scanning) procedures, and image post-processing procedures such as image segmentation, surface/volume rendering, mesh generation of a 3D digital model of the cranial defect and the desired prostheses, and their preparation for use in 3D printers. Furthermore, the protocol describes a detailed powder bed fusion additive manufacturing process, known as Selective Laser Sintering (SLS), using Polyamide (PA12) as feedstock to produce a 3-piece customized printed set per patient. Each set consists of a “cranial defect printout” and a “testing prosthesis” to assemble parts for precision testing, and a cranial “prostheses mold” in 2 parts to allow for the intraoperative modeling of the final implant cast using the medical grade Poly(methyl methacrylate) (PMMA) in a time span of a few min. The entire 3D processing time, including modelling, design, production, post-processing and qualification, takes approximately 42 h. Modeling the PMMA flap with a critical thickness of 4 mm by means of Finite Element Method (FEM) assures mechanical and impact properties to be slightly weaker than the bone tissue around it, a safety design to prevent fracturing the skull after a possible subsequent episode of head injury. On a parallel track, the Protocol seeks to provide guidance in the context of equipment, manufacturing cost and troubleshooting. Customized 3D PMMA prostheses offers a reduced operating time, good biocompatibility, and great functional and aesthetic outcomes. Additionally, it offers greater than 15-fold cost advantage over the usage of other materials, including metallic parts produced by additive manufacturing.

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16
This is a list of supplementary files associated with this preprint. Click to download.
Table 1. Adult Routine Head CT parameters adopted from existing CT protocols (link B). 1The amount of tissue inferior and superior to the prescribed scan range that is irradiated by over ranging can vary, * lower mA values for bone structures, higher mA values to include soft tissues. 2The amount of tissue inferior and superior to the prescribed scan range that is irradiated by over ranging can vary, depending on the scanner model and how the scan is performed (pitch value, collimation, etc.). 3Collimation in CT serves to ensure good image quality and to reduce unnecessary radiation for the patient. The tube collimator is used to shape de X-ray fan beam before it penetrates the patient. Values adopted for the Brilliance 16 slice scanner (Philips) are 16 x 1.5 mm.
Table 2. CT Imaging of Adult Head. Routine suggested image thickness and interval sets. Topogram: cranio-caudal direction.
Table 3. 3D manufacturing: minimum requirement and recommended hardware.
Table 4. Quantity of nodes and cranial and prosthetic elements for simulation of cranial repair.
Table 5. Properties of materials used in the finite element simulation.
Table 6. Understanding 3D manufacturing cost to produce cranial prostheses.
Table 7. Troubleshooting.
Table 8. Mean time required for each stage of the set of cranial prostheses fabrication process using 3D printed PA smoothed molds. Processes requiring human input are shown in bold, automatic/unattended processes are shown in italics.
Table 9. Individual data listings through the cranioplasty study at HMMC and HR, for patients assisted by the Brazilian Universal Health System (SUS).
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