NiTi alloys possess distinct functional properties (i.e., shape memory effect and superelasticity) and biocompatibility, making them appealing for bone fixation applications. Additive manufacturing offers an alternative method for fabricating NiTi parts, which are known to be very difficult to machine using conventional manufacturing methods. However, poor surface quality, and the presence of impurities and defects, are some of the major concerns associated with NiTi structures manufactured using additive manufacturing. The aim of this study is to assess the in vitro corrosion properties of additively manufactured NiTi structures. NiTi samples (bulk and porous) were produced using selective laser melting (SLM), and their electrochemical corrosion characteristics and Ni ion release levels were measured and compared with conventionally fabricated NiTi parts. The additively manufactured NiTi structures were found to have electrochemical corrosion characteristics similar to those found for the conventionally fabricated NiTi alloy samples. The highest Ni ion release level was found in the case of 50% porous structures, which can be attributed to their significantly higher exposed surface area. However, the Ni ion release levels reported in this work for all the fabricated structures remain within the range of most of values for conventionally fabricated NiTi alloys reported in the literature. The results of this study suggest that the proposed SLM fabrication process does not result in a significant deterioration in the corrosion resistance of NiTi parts, making them suitable for bone fixation applications.

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.

The use of titanium bone fixation plates is considered the standard of care for skeletal reconstructive surgery. Highly stiff titanium bone fixation plates provide immobilization immediately after the surgery. However, after the bone healing stage, they may cause stress shielding and lead to bone resorption and failure of the surgery. Stiffness-modulated or stiffness-matched Nitinol bone fixation plates that are fabricated via additive manufacturing (AM) have been recently introduced by our group as a long-lasting solution for minimizing the stress shielding and the follow-on bone resorption. Up to this point, we have modeled the performance of Nitinol bone fixation plates in mandibular reconstruction surgery and investigated the possibility of fabricating these implants. In this study, for the first time the realistic design of stiffness-modulated Nitinol bone fixation plates is presented. Plates with different levels of stiffness were fabricated, mechanically tested, and used for verifying the design approach. Followed by the design verification, to achieve superelastic bone fixation plates we proposed the use of Ni-rich Nitinol powder for the AM process and updated the models based on that. Superelastic Nitinol bone fixation plates with the extreme level of porosity were fabricated, and a chemical polishing procedure used to remove the un-melted powder was developed using SEM analysis. Thermomechanical evaluation of the polished bone fixation plates verified the desired superelasticity based on finite element (FE) simulations, and the chemical analysis showed good agreement with the ASTM standard.

Hinge-based Ankle Foot Orthosis (HAFO) is one of the most common non-surgical solutions for the foot drop. In conventional HAFOs, the ankle joint is almost locked, and plantar flexion is restricted due to the high stiffness of the hinge mechanism. This often leads to a rigid walking gate cycle, poor muscle activity, and muscle atrophy. Since the ankle torque-angle loop has a non-linear profile, the use of a superelastic NiTi spring within the hinge, due to its nonlinear behavior, could recreate a close-to-normal stiffness of the normal ankle joint, which, in turn, could create a more natural walk. The focus of this study is to evaluate the performance of a superelastic NiTi spring versus a conventional Stainless Steel spring in a hinge mechanism of a custom-fit HAFO. To this aim, a custom-fit HAFO was fabricated via the fast casting technique. Then, motion analysis was performed for two healthy subjects (Case I and Case II): (i) subjects with bare foot; (ii) subjects wearing a conventional HAFO with no spring; (iii) subjects wearing a conventional Stainless Steel-based HAFO; and (iv) subjects wearing a NiTi spring-based HAFO. The data related to the ankle angle and the amount of moment applied to the ankle during walking were recorded using Cortex software and used for the evaluations. Finally, Finite Element Analysis (FEA) was performed to evaluate the safety of the designed HAFO. The NiTi spring offers a higher range of motion (7.9 versus 4.14 degree) and an increased level of moment (0.55 versus 0.36 N·m/kg). Furthermore, a NiTi spring offers an ankle torque-angle loop closer to that of the healthy subjects.

This review paper is related to the biomechanics of additively manufactured (AM) metallic scaffolds, in particular titanium alloy Ti6Al4V scaffolds. This is because Ti6Al4V has been identified as an ideal candidate for AM metallic scaffolds. The factors that affect the scaffold technology are the design, the material used to build the scaffold, and the fabrication process. This review paper includes thus a discussion on the design of Ti6A4V scaffolds in relation to how their behavior is affected by their cell shapes and porosities. This is followed by a discussion on the post treatment and mechanical characterization including in-vitro and in-vivo biomechanical studies. A review and discussion are also presented on the ongoing efforts to develop predictive tools to derive the relationships between structure, processing, properties and performance of powder-bed additive manufacturing of metals. This is a challenge when developing process computational models because the problem involves multi-physics and is of multi-scale in nature. Advantages, limitations, and future trends in AM scaffolds are finally discussed. AM is considered at the forefront of Industry 4.0, the fourth industrial revolution. The market of scaffold technology will continue to boom because of the high demand for human tissue repair.

The current gold standard of care for mandibular segmental defeat reconstruction is the use of Ti-6Al-4V immobilization hardware and fibular double barrel graft. This method is often successful immediately at restoring mandible function, however the highly stiff fixation hardware causes stress shielding of the grafted bone and stress concentration in the fixation device over time which can lead to fixation device failure and revision surgery. The purpose of reconstructive surgery could be to create normal stress trajectories in the mandible following engraftment. We investigate the use of a two stage mechanism which separates the immobilization/healing and regenerative phases of mandibular segmental defect treatment. The device includes the use of a very stiff, Ti-6Al-4V, releasable mechanism which assures bone healing. Therefore it could be released once the reconstructed boney tissue and any of its ligamentous attachments have completely healed. Underneath the released Ti-6Al-4V plate would be a pre-loaded nitinol (NiTi) wire-frame apparatus that facilitates the normal stress-strain trajectory through the engrafted bone after the graft is healed in place and the Ti-6Al-4V fixation device has been released. Due to the use of NiTi wires forming a netting that connects vascularized bone and possibly bone chips, bone grafts are also more likely to be incorporate rather than to resorb. We first evaluated a healthy adult mandible during normal mastication to obtain the normal stress-strain distribution. Then, we developed the finite element (FE) model of the mandibular reconstruction (in the M1-3 region) with the proposed fixation device during the healing (locked state) and post-healing (released state) periods. To recreate normal stress trajectory in the reconstructed mandible, we applied the Response Surface Methodology (RMS) to optimize the Bone Bandaid geometry (i.e., wire diameters and location). The results demonstrate that the proposed mechanism immobilizes the grafted bone in the locked state properly since the maximum resultant gap (21.54 micron) between the graft and host mandible surfaces are in the safe region (less than 300 micron). By considering the von Mises criteria for failure, FE analysis together with experimental studies (i.e., compressive and tensile testing on the inferior and superior fixation devices, respectively) confirm that the proposed fixation devices do not fail, showing safety factor of at least 10.3. Based on the Response Surface Methodology (RSM) technique, the optimal parameter values for the wires are achieved (0.65 mm and 1 mm for the superior and inferior wires, respectively) and the required level of preload on each wire are calculated (369.8 N and 229 N for the inferior and superior wires, respectively). The FE results for stress distribution on the reconstructed mandible during the released state closely match that of a healthy mandible.