Chemical Polishing of Additively Manufactured, Porous, Nickel-Titanium Skeletal Fixation Plates.

Nickel-titanium (NiTi) alloys have shown promise for a variety of biomedical applications because of their unique properties of shape memory, superelasticity, and low modulus of elasticity (Young's modulus). Nevertheless, NiTi bulk components cannot be easily machined (e.g., CNC, rolling, grinding, casting, or press molding) due to their thermomechanical sensitivity as well as inherent superelasticity and shape memory. Thus, powder bed fusion (PBF) additive manufacturing has been used to successfully fabricate NiTi medical devices that match the geometric and mechanical needs of a particular patient's condition. However, NiTi PBF fabrication leaves unmelted particles from the source powder adhered to external surfaces, which cause minor dimensional inaccuracy, increase the risk of mechanical failure, and once loose, may irritate or inflame surrounding tissues. Therefore, there is a need to develop a chemical polishing (cleaning) technique to remove unmelted powder from the surfaces of PBF-fabricated implants, especially from inner surfaces that are difficult to access with mechanical polishing tools. This technique is especially useful for highly porous devices printed at high resolution. In this study, a chemical polishing method utilizing HF/HNO3 solution was used to remove loosely attached (i.e., unmelted) powder particles from surfaces of porous, skeletal fixation plates manufactured by PBF AM. It was observed that 7 min of polishing in an HF/HNO3 solution comprising 7.5 HF: 50 HNO3: 42.5 H2O enabled successful removal of all relatively loose and unmelted powder particles. A microcomputed tomography study examination found that the volumetric accuracy of the polished skeletal fixation plates was ±10% compared with the computer-aided design (CAD) model from which it was rendered. This postprocessing chemical polishing protocol is also likely to be useful for removing loose powder, while maintaining CAD model accuracy and mechanical stability for other complexly shaped, porous, three-dimensional (3D), printed NiTi devices.

Biomechanics of Additively Manufactured Metallic Scaffolds-A Review.

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.

A novel and innovative device to retract rectum during radiation therapy of pelvic tumors.

An effective radiotherapy treatment entails maximizing radiation dose to the tumor while sparing the surrounding and normal tissues. With the advent of SBRT with extreme hypo-fractionation in treating tumors including prostate where ablative dose is delivered in smaller number of fractions, rectum remains a dose-limiting organ and at the risk of rectal toxicity or secondary cancer. The same limitation of rectal toxicity exists for high-dose rate (HDR) treatments of cervical, endometrial, or prostate cancer when creating even a short distance between the anterior rectal wall and field of radiation is ideal in delivering ablative dose to the target. An effective solution to such problem is to physically displace rectum as the organ at risk. This research presents an organ retractor device that is designed to displace the rectum away from the path of radiation beam employing a Nitinol shape memory alloy that is designed for displacing the rectum upon actuation. A control system regulates the motion in a reproducible and safe manner by creating the desirable shape in moving the anterior rectal wall. The study finds the novel organ retractor device to be a promising tool that can be applied in a clinical setting for minimizing dose to the rectum during treatment of pelvic tumors, and creating the potential to deliver an ablative dose to tumor volume or to escalate the dose when needed.

Shape memory response of porous NiTi shape memory alloys fabricated by selective laser melting.

Porous NiTi scaffolds display unique bone-like properties including low stiffness and superelastic behavior which makes them promising for biomedical applications. The present article focuses on the techniques to enhance superelasticity of porous NiTi structures. Selective Laser Melting (SLM) method was employed to fabricate the dense and porous (32-58%) NiTi parts. The fabricated samples were subsequently heat-treated (solution annealing + aging at 350 °C for 15 min) and their thermo-mechanical properties were determined as functions of temperature and stress. Additionally, the mechanical behaviors of the samples were simulated and compared to the experimental results. It is shown that SLM NiTi with up to 58% porosity can display shape memory effect with full recovery under 100 MPa nominal stress. Dense SLM NiTi could show almost perfect superelasticity with strain recovery of 5.65 after 6% deformation at body temperatures. The strain recoveries were 3.5, 3.6, and 2.7% for samples with porosity levels of 32%, 45%, and 58%, respectively. Furthermore, it was shown that Young's modulus (i.e., stiffness) of NiTi parts can be tuned by adjusting the porosity levels to match the properties of the bones.

Application of the Superelastic NiTi Spring in Ankle Foot Orthosis (AFO) to Create Normal Ankle Joint Behavior.

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.

Fixation Release and the Bone Bandaid: A New Bone Fixation Device Paradigm.

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.

Metallic Fixation of Mandibular Segmental Defects: Graft Immobilization and Orofacial Functional Maintenance.

The aim of this study is to investigate the behavior of the healthy mandible under maximum molar bite force to demonstrate the problems associated with the current standard of care procedures for mandibular segmental defect reconstruction (ie, use of Ti-6Al-4V hardware and either a single- or double-barrel fibular graft). With current Ti-6Al-4V mandibular reconstruction hardware, there is a significant stiffness mismatch among the hardware, graft, and the remaining host anatomy. How the distribution of mechanical forces through the mandible is altered after a segmental bone loss and reconstruction is incompletely understood. METHODS: We studied a healthy adult mandible for stress, strain, and reaction force distribution during normal mastication. Stress distribution of this model was then used to study problems encountered after mandibular segmental defect reconstructive surgery. We model the use of both single- and double-barrel fibular grafts to repair the loss of the left M1-3 containing segment of the mandible. These simulations were done using 2 sets of plates with different thicknesses. RESULTS: We found that the stiffness mismatching between the fixation hardware and the graft and host bone causes stress shielding of that bone and stress concentrations in the fixation hardware and screws. These effects are expected, especially during the bone healing period. However, long term, this abnormal stress-strain distribution may lead to either the hardware's failure due to stress concentration or graft failure due to bone resorption as a result of stress shielding. We found that the stress-strain distribution is more normal with a double-barrel fibular graft. Additionally, we found that thinner fixation plates can reduce stress shielding. CONCLUSION: The proposed model can be used to evaluate the performance and optimization of the fixation device.

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

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.