Design of Customize Interbody Fusion Cages of Ti64ELI with Gradient Porosity by Selective Laser Melting Process.

Intervertebral fusion surgery for spinal trauma, degeneration, and deformity correction is a major vertebral reconstruction operation. For most cages, the stiffness of the cage is high enough to cause stress concentration, leading to a stress shielding effect between the vertebral bones and the cages. The stress shielding effect affects the outcome after the reconstruction surgery, easily causing damage and leading to a higher risk of reoperation. A porous structure for the spinal fusion cage can effectively reduce the stiffness to obtain more comparative strength for the surrounding tissue. In this study, an intervertebral cage with a porous gradation structure was designed for Ti64ELI alloy powders bonded by the selective laser melting (SLM) process. The medical imaging software InVesalius and 3D surface reconstruction software Geomagic Studio 12 (Raindrop Geomagic Inc., Morrisville, NC, USA) were utilized to establish the vertebra model, and ANSYS Workbench 16 (Ansys Inc., Canonsburg, PA, USA) simulation software was used to simulate the stress and strain of the motions including vertical body-weighted compression, flexion, extension, lateral bending, and rotation. The intervertebral cage with a hollow cylinder had porosity values of 80-70-60-70-80% (from center to both top side and bottom side) and had porosity values of 60-70-80 (from outside to inside). In addition, according to the contact areas between the vertebras and cages, the shape of the cages can be custom-designed. The cages underwent fatigue tests by following ASTM F2077-17. Then, mechanical property simulations of the cages were conducted for a comparison with the commercially available cages from three companies: Zimmer (Zimmer Biomet Holdings, Inc., Warsaw, IN, USA), Ulrich (Germany), and B. Braun (Germany). The results show that the stress and strain distribution of the cages are consistent with the ones of human bone, and show a uniform stress distribution, which can reduce stress concentration.