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Process parameters and post-processing heat treatment techniques have been developed to produce both shape memory and superelastic NiTi using Additive Manufacturing. By introducing engineered porosity, the stiffness of NiTi can be tuned to the level closely matching cortical bone. Using additively manufactured porous superelastic NiTi, we have proposed the use of patient-specific, stiffness-matched fixation hardware, for mandible skeletal reconstructive surgery. Currently, Ti-6Al-4V is the most commonly used material for skeletal fixation devices. Although this material offers more than sufficient strength for immobilization during the bone healing process, the high stiffness of Ti-6Al-4V implants can cause stress shielding. In this paper, we present a study of mandibular reconstruction that uses a dry cadaver mandible to validate our geometric and biomechanical design and fabrication (i.e., 3D printing) of NiTi skeletal fixation hardware. Based on the reference-dried mandible, we have developed a Finite Element model to evaluate the performance of the proposed fixation. Our results show a closer-to-normal stress distribution and an enhanced contact pressure at the bone graft interface than would be in the case with Ti-6Al-4V off-the-shelf fixation hardware. The porous fixation plates used in this study were fabricated by selective laser melting.

Finite Element Simulation and Additive Manufacturing of Stiffness-Matched NiTi Fixation Hardware for Mandibular Reconstruction Surgery