Amirhesam Amerinatanzi

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.

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

Background: 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.

A novel 3D approach for determination of frontal and coronal plane tibial slopes from MR imaging.

BACKGROUND The proximal tibia is geometrically complex, asymmetrical, and variable, is heavily implicated in arthrokinematics of the knee joint, and thus a contributor to knee pathologies such as non-contact anterior cruciate ligament injury. Medial, lateral, and coronal tibial slopes are anatomic parameters that may increase predisposition to knee injuries, but the extent to which each contributes has yet to be fully realized. Previously, two-dimensional methods have quantified tibial slopes, but more reliable 3D methods may prove advantageous. AIMS (1) to explore the reliability of two-dimensional methods, (2) to introduce a novel three-dimensional measurement approach, and (3) to compare data derived from traditional and novel methods. METHODS Medial, lateral, and coronal tibial slope geometry from both knees (left and right) of one subject were obtained via magnetic resonance images and measured by four trained observers from two-dimensional views. The process was repeated via three-dimensional approaches and data evaluated for intra- and inter-rater reliability. RESULTS The conventional method presented a weaker Intraclass Correlation Coefficient (ICC) for the measured slopes (ranging from 0.43 to 0.81) while the resultant ICC for the proposed method indicated greater reliability (ranging from 0.84 to 0.97). Statistical analysis supported the novel approach for production of more reliable and repeatable results for tibial slopes. CONCLUSIONS The novel three-dimensional method for calculating tibial plateau slope may be more reliable than previously established methods and may be applicable in assessment of susceptibility to osteoarthritis, as part of anterior cruciate ligament injury risk assessment, and in total knee implant design.

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.

Automated Measurement of Patient-Specific Tibial Slopes from MRI

Background: Multi-planar proximal tibial slopes may be associated with increased likelihood of osteoarthritis and anterior cruciate ligament injury, due in part to their role in checking the anterior-posterior stability of the knee. Established methods suffer repeatability limitations and lack computational efficiency for intuitive clinical adoption. The aims of this study were to develop a novel automated approach and to compare the repeatability and computational efficiency of the approach against previously established methods. Methods: Tibial slope geometries were obtained via MRI and measured using an automated Matlab-based approach. Data were compared for repeatability and evaluated for computational efficiency. Results: Mean lateral tibial slope (LTS) for females (7.2°) was greater than for males (1.66°). Mean LTS in the lateral concavity zone was greater for females (7.8° for females, 4.2° for males). Mean medial tibial slope (MTS) for females was greater (9.3° vs. 4.6°). Along the medial concavity zone, female subjects demonstrated greater MTS. Conclusion: The automated method was more repeatable and computationally efficient than previously identified methods and may aid in the clinical assessment of knee injury risk, inform surgical planning, and implant design efforts.

Mechanical evaluation of the SLM fabricated, stiffness-matched, mandibular bone fixation plates

The standard of the care for the treatment of mandibular segmental defects is the use of Ti-6Al-4V bone fixation plates and screws to immobilize the grafted bone and the host mandible. While Ti-6Al-4V bone fixation plates provide strong immobilization during the healing period, they may disturb the stress distribution in the repaired mandible. The highly stiff Ti-6Al-4V fixation carries a great portion of the load which was previously borne by the mandible, and stress shielding may occur on the surrounding cortical bone. Based on the bone remodeling theory, stress shielding causes bone resorption in the effected region and may eventually lead to the failure of the surgical reconstruction. To address this issue, we have developed a new generation of the patient-specific, porous NiTi bone fixation plates which benefit from stiffness-matching of the adjacent bone. Using the CT scan data of the patient’s defective mandible, the geometry for the required bone fixation plates is designed and the stiffness of the surrounding regions is measured. By introducing specific level and type of porosity to the bone fixation plate, its stiffness can be tuned. Finite Element simulations has verified the reduced level of stress shielding on the reconstructed mandible, in case of using the proposed bone fixation plates. Selective Lase Sintering has been used for fabrication of the porous NiTi bone fixation plates with six different levels of stiffness. Finite element simulations, and mechanical tests have been done to verify the performance of the fabricated parts resulting from our design and fabrication method.

Influence of SLM on compressive response of NiTi scaffolds

Porous Nickel-Titanium shape memory alloys (NiTi-SMAs) have attracted much attention in biomedical applications due to their high range of pure elastic deformability (i.e., superelasticity) as well as their bone-level modulus of elasticity (E≈12-20 GPa). In recent years, Selective Laser Melting (SLM) has been used to produce complex NiTi components. The focus of this study is to investigate the superelasticity and compressive properties of SLM NiTi-SMAs. To this aim, several NiTi components with different level of porosities (32- 58%) were fabricated from Ni50.8Ti (at. %) powder via SLM PXM by Phenix/3D Systems, using optimum processing parameter (Laser power-P=250 W, scanning speed-v=1250mm/s, hatch spacing-h=120μm, layer thickness-t=30μm). To tailor the superelasticity behavior at body temperature, the samples were solution annealed and aged for 15 min at 350°C. Then, transformation temperatures (TTs), superelastic response, and cyclic behavior of NiTi samples were studied. As the porosity was increased, the irrecoverable strain was observed to be higher in the samples. At the first superelastic cycle, 3.5%, 3.5%, and 2.7% strain recovery were observed for the porosity levels of 32%, 45%, and 58%, respectively. However, after 10 cycles, the superelastic response of the samples was stabilized and full strain recovery was observed. Finally, the modulus of elasticity of dense SLM NiTi was decreased from 47 GPa to 9 GPa in the first cycle by adding 58% porosity.

Selective laser melting of Ni-rich NiTi: selection of process parameters and the superelastic response

Material and mechanical properties of NiTi shape memory alloys strongly depend on the fabrication process parameters and the resulting microstructure. In selective laser melting, the combination of parameters such as laser power, scanning speed, and hatch spacing determine the microstructural defects, grain size and texture. Therefore, processing parameters can be adjusted to tailor the microstructure and mechanical response of the alloy. In this work, NiTi samples were fabricated using Ni50.8Ti (at.%) powder via SLM PXM by Phenix/3D Systems and the effects of processing parameters were systematically studied. The relationship between the processing parameters and superelastic properties were investigated thoroughly. It will be shown that energy density is not the only parameter that governs the material response. It will be shown that hatch spacing is the dominant factor to tailor the superelastic response. It will be revealed that with the selection of right process parameters, perfect superelasticity with recoverable strains of up to 5.6% can be observed in the as-fabricated condition.

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.