In Situ Microstructure Modification Using a Layerwise Surface-Preheating Laser Scan of Ti-6Al-4V during Laser Powder Bed Fusion.

An innovative in situ thermal approach in the domain of LPBF for Ti-6Al-4V fabrication has been carried out with results directing towards an improved fatigue life without the need for post-processing. The thermal process involves an additional laser scan with different process parameters to preheat the selected regions of each layer of the powder bed prior to their full melting. This preheating step influences the cooling rate, which in turn affects surface characteristics and subsurface microstructure, both of which are directly correlated with fatigue properties. A thorough analysis has been conducted by comparing the preheated samples with reference samples with no preheating. Without any additional thermal processing, the preheated samples showed a significant improvement over their reference counterparts. The optimized preheated sample showed an improved prior ß-grain distribution with a circular morphology and thicker α laths within the even finer prior ß-grain boundaries. Also, an overall increment of the c/a ratio of the HCP α has been observed, which yielded lattice strain relaxation in the localized grain structure. Furthermore, a less-profound surface roughness was observed in the preheated sample. The obtained microstructure with all these factors delivered a 10% improvement in its fatigue life with better mechanical strength overall.

Application of NiTi in Assistive and Rehabilitation Devices: A Review.

Shape memory alloys (SMAs) have found widespread applications as biomedical devices. Biocompatibility, corrosion resistance, and ductility make these alloys attractive for medical devices such as stents and filters. For these implants, the superelastic property is the primary function of SMAs. Additionally, these alloys, such as NiTi as the prime example, can be used for actuation. Several modes of actuation such as displacement control, force control, and compliance control have been used as harnesses with SMA devices. These two unique properties have opened another application in the form of neurosurgery and robot-assisted surgery devices, as well as controlled assistive and rehabilitation devices. This paper reviews the state of the art of application of SMAs in the latter category where control is applied to harness innovative medical devices. To this end, two major subsets of these devices: prosthesis and orthosis which take the advantage of SMAs in assistive and rehabilitation devices are studied. These devices are further categorized to hand prosthetics, elbow, knee and ankle orthotics. In most of these designs, SMA wires act as artificial muscles to mimic the motion of limbs in the target joints. The evolution of each category is explained, and the specific results of them are reported. The paper also reviews the SMA applications for neurological and neuromuscular rehabilitation. To this end, different categories of rehabilitation devices as a passive and aided exercise for the ankle, knee, and elbow are highlighted. The SMA actuator in these devices can be EMG-controlled to improved patient outcome. In addition to providing a comprehensive overview of the biomedical devices, this paper identifies several possible future directions of SMA related research in the area of assistive and rehabilitation devices.

Achieving superelasticity in additively manufactured NiTi in compression without post-process heat treatment.

Shape memory alloys (SMAs), such as Nitinol (i.e., NiTi), are of great importance in biomedical and engineering applications due to their unique superelasticity and shape memory properties. In recent years, additive manufacturing (AM) processes have been used to produce complex NiTi components, which provide the ability to tailor microstructure and thus the critical properties of the alloys, such as the superelastic behavior and transformation temperatures (TTs), by selection of processing parameters. In biomedical applications, superelasticity in implants play a critical role since it gives the implants bone-like behavior. In this study, a methodology of improving superelasticity in Ni-rich NiTi components without the need for any kind of post-process heat treatments will be revealed. It will be shown that superelasticity with 5.62% strain recovery and 98% recovery ratio can be observed in Ni-rich NiTi after the sample is processed with 250 W laser power, 1250 mm/s scanning speed, and 80 µm hatch spacing without, any post-process heat treatments. This superelasticity in as-fabricated Ni-rich SLM NiTi was not previously possible in the absence of post-process heat treatments. The findings of this study promise the fast, reliable and inexpensive fabrication of complex shaped superelastic NiTi components for many envisioned applications such as patient-specific biomedical implants.

Predicting the Biodegradation of Magnesium Alloy Implants: Modeling, Parameter Identification, and Validation.

Magnesium (Mg) and its alloys can degrade gradually up to complete dissolution in the physiological environment. This property makes these biomaterials appealing for different biomedical applications, such as bone implants. In order to qualify Mg and its alloys for bone implant applications, there is a need to precisely model their degradation (corrosion) behavior in the physiological environment. Therefore, the primary objective develop a model that can be used to predict the corrosion behavior of Mg-based alloys in vitro, while capturing the effect of pitting corrosion. To this end, a customized FORTRAN user material subroutine (or VUMAT) that is compatible with the finite element (FE) solver Abaqus/Explicit (Dassault Systèmes, Waltham, MA, USA) was developed. Using the developed subroutine, a continuum damage mechanism (CDM) FE model was developed to phenomenologically estimate the corrosion rate of a biocompatible Mg⁻Zn⁻Ca alloy. In addition, the mass loss immersion test was conducted to measure mass loss over time by submerging Mg⁻Zn⁻Ca coupons in a glass reactor filled with simulated body fluid (SBF) solution at pH 7.4 and 37 °C. Then, response surface methodology (RSM) was applied to calibrate the corrosion FE model parameters (i.e., Gamma (γ), Psi (ψ), Beta (ß), and kinetic parameter (Ku)). The optimum values for γ, ψ, ß and Ku were found to be 2.74898, 2.60477, 5.1, and 0.1005, respectively. Finally, given the good fit between FE predictions and experimental data, it was concluded that the numerical framework precisely captures the effect of corrosion on the mass loss over time.

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.

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.

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.

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.