Design and mechanical evaluation of a large cranial implant and fixation parts

Cranial implants are designed based on patient Digital Imaging and Communications in Medicine data. An asymmetric approach is usually employed to design cranial implants, and fixation plates are used to fix the implant. In this study, the use of numerical simulation of 3D (3 Dimension) cranial implants made from Polyether Ether Ketone was investigated. A skull defect reconstruction was conducted using Computer-Aided Design and 3D printing software to evaluate the durability of the implant, increase the surgical accuracy, and reduce surgical costs and risks. The large skull patch was designed by reverse engineering. The subtraction method was applied based on a healthy skull prototype. The large cranial implants on the two halves of the skull were asymmetrical and included fixation parts. Using the finite element method, the asymmetric defect skull model was simulated under intracranial pressures and a static load of 50 N placed at three positions. The results are shown through displacement, stress, and elastic deformation. The cranial implants were implanted, ensuring the material’s durability, and improving the patient’s aesthetics. In this study, a cranial implant design and evaluation method for large skull defects reduces the time and risk of surgery. Generous size skull pieces can be fabricated in compliance with specific design criteria. The design of the cranial implant met the basic operating conditions of the patient through the finite element method. The cranial implants were fabricated by injection molding and successfully implanted into the patient.