Narges Shayesteh Moghaddam

Metals for bone implants. Part 1. Powder metallurgy and implant rendering.

New metal alloys and metal fabrication strategies are likely to benefit future skeletal implant strategies. These metals and fabrication strategies were looked at from the point of view of standard-of-care implants for the mandible. These implants are used as part of the treatment for segmental resection due to oropharyngeal cancer, injury or correction of deformity due to pathology or congenital defect. The focus of this two-part review is the issues associated with the failure of existing mandibular implants that are due to mismatched material properties. Potential directions for future research are also studied. To mitigate these issues, the use of low-stiffness metallic alloys has been highlighted. To this end, the development, processing and biocompatibility of superelastic NiTi as well as resorbable magnesium-based alloys are discussed. Additionally, engineered porosity is reviewed as it can be an effective way of matching the stiffness of an implant with the surrounding tissue. These porosities and the overall geometry of the implant can be optimized for strain transduction and with a tailored stiffness profile. Rendering patient-specific, site-specific, morphology-specific and function-specific implants can now be achieved using these and other metals with bone-like material properties by additive manufacturing. The biocompatibility of implants prepared from superelastic and resorbable alloys is also reviewed.

Load bearing and stiffness tailored NiTi implants produced by additive manufacturing: A simulation study

Common metals for stable long-term implants (e.g. stainless steel, Titanium and Titanium alloys) are much stiffer than spongy cancellous and even stiffer than cortical bone. When bone and implant are loaded this stiffness mismatch results in stress shielding and as a consequence, degradation of surrounding bony structure can lead to disassociation of the implant. Due to its lower stiffness and high reversible deformability, which is associated with the superelastic behavior, NiTi is an attractive biomaterial for load bearing implants. However, the stiffness of austenitic Nitinol is closer to that of bone but still too high. Additive manufacturing provides, in addition to the fabrication of patient specific implants, the ability to solve the stiffness mismatch by adding engineered porosity to the implant. This in turn allows for the design of different stiffness profiles in one implant tailored to the physiological load conditions. This work covers a fundamental approach to bring this vision to reality. At first modeling of the mechanical behavior of different scaffold designs are presented as a proof of concept of stiffness tailoring. Based on these results different Nitinol scaffolds can be produced by additive manufacturing.

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.

Modeling and Experiment of a Flexible Module Actuated by Shape Memory Alloy Wire

In recent years many investigations have been performed on design and fabrication of micro mechanical manipulators. One of the practical usages of this manipulator is endoscopy. In an endoscopy system, a small manipulator with high maneuverability and flexibility is required to support the probe’s movement into a colon easier than classic manipulators. In this paper a basic flexible module is presented for use in such an application. The structure of presented module is simple and includes a compressive spring which could be bent to the sides. This tends to more simplicity in addition to proper flexibility. Connecting three wires of shape memory alloy (SMA) uniformly distributed in circumference of spring with an angle of 120 degrees, it is possible to provide an almost large displacement and orientation change between the end planes of module. By using three wires and stimulating them individually or together, different rotation regimes are provided. The flexible module deformation is modeled in this paper thoroughly. Deflection and orientation of spring as the basic structure of the module is studied under the loads. Also, Brinson model is used for modeling the shape memory alloy wire. Afterward, the spring model is coupled with SMA model to describe the dynamic behavior of module under a defined activation. The simulation is implemented in MATLAB-Simulink Though the developed simulation platform, the trajectory of module may be extracted and used for developing a modular manipulator. An experimental setup is prepared to verify the simulation results. Through the simulations, module performance in addition to proper geometrical parameters for the considered application is calculated through the simulations. It is shown that a proper relation between geometrical parameters of spring (like outer diameter, spring wire diameter and number of coils) in combination with a suitable SMA wire in diameter, affect the maximum deformation of SMA-actuated module.Copyright

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 numerical simulation of the effect of using porous superelastic Nitinol and stiff Titanium fixation hardware on the bone remodeling

The aim of this article is to investigate the effect of two different fixation hardware materials on bone remodeling after a mandibular reconstruction surgery and to restore the mandible’s function, healthy appearance, mastication, swallowing, breathing, and speech. The hypothesis is that using fixation hardware with stiffness close to that of the surrounding bone will result in a more successful healing process in the mandible bone. The finite element model includes the material properties and forces of the cancellous bone, cortical bone, ligaments, muscles, and teeth. The reconstruction surgery is modeled by including the fixation hardware and the grafted bone. In the sectioned mandible, to best mimic the geometry of the mandible, two single barrel grafts are placed at the top of each other to form a double barrel graft set. Two different materials were used as the mandibular fixation parts, stiff Ti-6Al-4V, and porous superelastic Nickel-Titanium (NiTi) alloys. A comparison of these two alloys demonstrates that using porous NiTi alloy as the fixation part results in a faster healing pace. Furthermore, the density distribution in the mandibular bone after the healing process is more similar to the normal mandible density distribution. The simulations results indicate that the porous superelastic NiTi fixation hardware transfers and distributes the existing forces on the mandible bone more favorably. The probability of stress shielding and/or stress concentration decrease. This type of fixation hardware, therefore, is more appropriate for mandible bone reconstruction surgery. These predictions are in agreement with the clinical observations.

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.

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

AbstractPorous 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.

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.