Gentamicin Eluting 3D-Printed Implants for Preventing Post-Surgical Infections in Bone Fractures.

A surgically implantable device is an inevitable treatment option for millions of people worldwide suffering from diseases arising from orthopedic injuries. A global paradigm shift is currently underway to tailor and personalize replacement or reconstructive joints. Additive manufacturing (AM) has provided dynamic outflow to the customized fabrication of orthopedic implants by enabling need-based design and surface modification possibilities. Surgical grade 316L Stainless Steel (316L SS) is promising with its cost, strength, composition, and corrosion resistance to fabricate 3D implants. This work investigates the possibilities of application of the laser powder bed fusion (L-PBF) technique to fabricate 3D-printed (3DP) implants, which are functionalized with a multilayered antimicrobial coating to treat potential complications arising due to postsurgical infections (PSIs). Postsurgical implant-associated infection is a primary reason for implantation failure and is complicated mainly by bacterial colonization and biofilm formation at the installation site. PLGA (poly-d,l-lactide-co-glycolide), a biodegradable polymer, was utilized to impart multiple layers of coating using the airbrush spray technique on 3DP implant surfaces loaded with gentamicin (GEN). Various PLGA-based polymers were tested to optimize the ideal lactic acid: glycolic acid ratio and molecular weight suited for our investigation. 3D-Printed PLGA-GEN substrates sustained the release of gentamicin from the surface for approximately 6 weeks. The 3DP surface modification with PLGA-GEN facilitated cell adhesion and proliferation compared to control surfaces. The cell viability studies showed that the implants were safe for application. The 3DP PLGA-GEN substrates showed good concentration-dependent antibacterial efficacy against the common PSI pathogen Staphylococcus aureus (S. aureus) and Staphylococcus epidermidis (S. epidermidis). The GEN-loaded substrates demonstrated antimicrobial longevity and showed significant biofilm growth inhibition compared to control. The substrates offered great versatility regarding the in vitro release rates, antimicrobial properties, and biocompatibility studies. These results radiate great potential in future human and veterinary clinical applications pertinent to complications arising from PSIs, focusing on personalized sustained antibiotic delivery.

Feature-based volumetric defect classification in metal additive manufacturing.

Volumetric defect types commonly observed in the additively manufactured parts differ in their morphologies ascribed to their formation mechanisms. Using high-resolution X-ray computed tomography, this study analyzes the morphological features of volumetric defects, and their statistical distribution, in laser powder bed fused Ti-6Al-4V. The geometries of three common types of volumetric defects; i.e., lack of fusions, gas-entrapped pores, and keyholes, are quantified by nine parameters including maximum dimension, roundness, sparseness, aspect ratio, and more. It is shown that the three defect types share overlaps of different degrees in the ranges of their morphological parameters; thus, employing only one or two parameters cannot uniquely determine a defect's type. To overcome this challenge, a defect classification methodology incorporating multiple morphological parameters has been proposed. In this work, by employing the most discriminating parameters, this methodology has been shown effective when implemented into decision tree (>98% accuracy) and artificial neural network (>99% accuracy).

Hot Isostatic Pressing for Fatigue Critical Additively Manufactured Ti-6Al-4V.

The efficacy of hot isostatic pressing (HIP) for enhancing fatigue performance is investigated for additively manufactured (AM) Ti-6Al-4V. The limitations of HIP are probed by varying the initial material state via the selection of AM system, powder chemical composition, and process parameters. We demonstrate that the fatigue performance of HIP'd AM Ti-6Al-4V depends on the as-built quality of the material. Differences in common material attributes, such as pre-HIP defect populations or post-HIP microstructure morphology, are shown to be insufficient to explain the observed discrepancies in performance. This implies that additional microstructure attributes or localized deviations from the expected structure control the failure of this material. Finally, HIP parameters outside ASTM recommendations were explored, where a reduced temperature and high-pressure treatment yielded significantly improved fatigue performance.

Tribocorrosion Behavior of NiTi Biomedical Alloy Processed by an Additive Manufacturing Laser Beam Directed Energy Deposition Technique.

The purpose of the present study was to experimentally assess the synergistic effects of wear and corrosion on NiTi alloy in comparison with Ti-6Al-4V alloy, the most extensively used titanium alloy in biomedical applications. Both alloys were processed by an additive manufacturing laser beam directed energy deposition (LB-DED) technique, namely laser engineered net shaping (LENS), and analyzed via tribocorrosion tests by using the ball-on-plate configuration. The tests were carried out in phosphate buffered saline solution at 37 °C under open circuit potential (OCP) to simulate the body environment and temperature. The synergistic effect of wear and corrosion was found to result in an improved wear resistance in both materials. It was also observed that, for the process parameters used, the LB-DED NiTi alloy exhibits a lower tendency to corrosion as compared to the LB-DED Ti-6Al-4V alloy. It is expected that, during the service life as an implant, the NiTi alloy is less susceptible to the metallic ions release when compared with the Ti-6Al-4V alloy.

Bending properties of additively manufactured commercially pure titanium (CPTi) limited contact dynamic compression plate (LC-DCP) constructs: Effect of surface treatment.

Additive manufacturing of metallic materials, a layer-wise manufacturing method, is currently gaining attention in the biomedical industry because of its capability to fabricate complex geometries including customized parts fitting to patient requirements. However, one of the major challenges hindering the full implementation of additively manufactured parts in safety-critical applications is their poor mechanical performance under cyclic loading. This study investigated both quasi-static bending properties (bending stiffness, bending structural stiffness, and bending strength) and bending fatigue properties of additively manufactured (AM) commercially pure titanium (CPTi) limited contact dynamic compression plate (LC-DCP) constructs based on ASTM International standard for metallic bone plates (ASTM F382). In addition, the effect of post surface treatment methods including single shot-peened (SP), dual shot-peened (DP), and chemically assisted surface enhancement (CASE) on bending fatigue performance was also evaluated. Results indicated that bending stiffness and bending structural stiffness of AM CPTi LC-DCPs are comparable to conventionally manufactured (CM) counterparts; however, the bending strength of AM CPTi LC-DCPs is lower than CM counterparts. While the fatigue strength of as-built AM CPTi LC-DCPs is lower compared to the CM counterparts, AM CPTi LC-DCPs after post surface treatments (SP, DP, and CASE) exhibit statistically comparable fatigue strength to the CM CPTi LC-DCPs.

Phase-Selective and Localized TiO2 Coating on Additive and Wrought Titanium by a Direct Laser Surface Modification Approach.

Titanium has been the material of interest in biological implant applications due to its unique mechanical properties and biocompatibility. Their design is now growing rapidly due to the advent of additive manufacturing technology that enables the fabrication of complex and patient-customized parts. Titanium dioxides (TiO2) coatings with different phases (e.g., anatase, rutile) and morphologies have shown to be effective in enhancing osteointegration and antibacterial behavior. This enhanced antibacterial behavior stems from the photocatalytic activity generated from crystalline TiO2 coatings. Anatase has commonly been shown to be a more photocatalytic oxide phase compared to rutile despite its larger band gap. However, more recent studies have suggested that a synergistic effect leading to increased photocatalytic activity may be produced with a combination of oxides containing both anatase and rutile phases. Here, we demonstrate the selective and localized formation of TiO2 nanostructures on additive and wrought titanium parts with anatase, rutile, and mixed phases by a laser-induced transformation approach. Compared to conventional coating processes, this technique produces desired TiO2 phases simply by controlled laser irradiation of titanium parts in an oxygen environment, where needed. The effects of processing conditions such as laser power, scanning speed, laser pulse duration, frequency, and gas flow on the selective transformation were studied. The morphological and structural evolutions were investigated using various characterization techniques. This method is specifically of significant interest in creating phase-selective TiO2 surfaces on titanium-based bioimplants, including those fabricated by additive manufacturing technologies.

Dexamethasone eluting 3D printed metal devices for bone injuries.

Aim: Additively manufactured (3D printed), stainless steel implants were coated with dexamethasone using gelatin, chondroitin sulfate for use in bone graft surgeries. Materials & methods: The drug and polymers were deposited on the implants with a rough surface using a high precision air brush. The gelatin-chondroitin sulfate layers were cross-linked using glutaraldehyde. Results: The drug content uniformity was within 100 ± 5%, and the thickness of the polymer layer was 410 ± 5.2 µm. The in vitro release studies showed a biphasic pattern with an initial burst release followed by slow release up to 3 days. Conclusion: These results are very promising as the slow release implants can be further tested in vivo in large animals, such as cattle and horses to prevent the inflammatory cascade following surgeries.

Fatigue data for laser beam powder bed fused 17-4 PH stainless steel specimens in different heat treatment and surface roughness conditions.

This article presents the data demonstrating the synergistic effect of surface roughness and heat treatment on the fatigue behavior of 17-4 PH stainless steel (SS) fabricated via laser beam powder bed fusion (LB-PBF) [1]. Two sets of specimens, in as-built and machined surface conditions, were heat treated using five different recommended procedures for 17-4 PH SS by ASTM A693. Axial fully-reversed fatigue tests (R = -1) were conducted on heat treated as-built and machined specimens. The stable hysteresis stress-strain data, as well as the maximum and minimum stress and strain values for the cycle in a log10 increment are included for all conducted fatigue experiments. In addition, fractography images are provided for selected set of specimens.

Residual stress measurements via neutron diffraction of additive manufactured stainless steel 17-4 PH.

Neutron diffraction was employed to measure internal residual stresses at various locations along stainless steel (SS) 17-4 PH specimens additively manufactured via laser-powder bed fusion (L-PBF). Of these specimens, two were rods (diameter=8 mm, length=80 mm) built vertically upward and one a parallelepiped (8×80×9 mm3) built with its longest edge parallel to ground. One rod and the parallelepiped were left in their as-built condition, while the other rod was heat treated. Data presented provide insight into the microstructural characteristics of typical L-PBF SS 17-4 PH specimens and their dependence on build orientation and post-processing procedures such as heat treatment. Data have been deposited in the Data in Brief Dataverse repository (doi:10.7910/DVN/T41S3V).

Cyclic deformation and fatigue data for Ti-6Al-4V ELI under variable amplitude loading.

This article presents the strain-based experimental data for Ti-6Al-4V ELI under non-constant amplitude cyclic loading. Uniaxial strain-controlled fatigue experiments were conducted under three different loading conditions, including two-level block loading (i.e. high-low and low-high), periodic overload, and variable amplitude loading. Tests were performed under fully-reversed, and mean strain/stress conditions. For each test conducted, two sets of data were collected; the cyclic stress-strain response (i.e. hysteresis loops) in log10 increments, and the peak and valley values of stress and strain for each cycle. Residual fatigue lives are reported for tests with two-level block loading, while for periodic overload and variable amplitude experiments, fatigue lives are reported in terms of number of blocks to failure.

Data indicating temperature response of Ti-6Al-4V thin-walled structure during its additive manufacture via Laser Engineered Net Shaping.

An OPTOMEC Laser Engineered Net Shaping (LENS(™)) 750 system was retrofitted with a melt pool pyrometer and in-chamber infrared (IR) camera for nondestructive thermal inspection of the blown-powder, direct laser deposition (DLD) process. Data indicative of temperature and heat transfer within the melt pool and heat affected zone atop a thin-walled structure of Ti-6Al-4V during its additive manufacture are provided. Melt pool temperature data were collected via the dual-wavelength pyrometer while the dynamic, bulk part temperature distribution was collected using the IR camera. Such data are provided in Comma Separated Values (CSV) file format, containing a 752×480 matrix and a 320×240 matrix of temperatures corresponding to individual pixels of the pyrometer and IR camera, respectively. The IR camera and pyrometer temperature data are provided in blackbody-calibrated, raw forms. Provided thermal data can aid in generating and refining process-property-performance relationships between laser manufacturing and its fabricated materials.

Strain-based fatigue data for Ti-6Al-4V ELI under fully-reversed and mean strain loads.

This article presents the experimental data supporting the study to obtain the mean strain/stress effects on the fatigue behavior of Ti-6Al-4V ELI. A series of strain-controlled fatigue experiments on Ti-6Al-4V ELI were performed at four strain ratios (-1, -0.5, 0, and 0.5). Two types of data are included for each specimen. These are the hysteresis stress-strain responses for the cycle in a log10 increment, and the maximum and minimum stress-strain responses for each cycle. Fatigue lives are also reported for all the experiments.

Fatigue data for polyether ether ketone (PEEK) under fully-reversed cyclic loading.

In this article, the data obtained from the uniaxial fully-reversed fatigue experiments conducted on polyether ether ketone (PEEK), a semi-crystalline thermoplastic, are presented. The tests were performed in either strain-controlled or load-controlled mode under various levels of loading. The data are categorized into four subsets according to the type of tests, including (1) strain-controlled fatigue tests with adjusted frequency to obtain the nominal temperature rise of the specimen surface, (2) strain-controlled fatigue tests with various frequencies, (3) load-controlled fatigue tests without step loadings, and (4) load-controlled fatigue tests with step loadings. Accompanied data for each test include the fatigue life, the maximum (peak) and minimum (valley) stress-strain responses for each cycle, and the hysteresis stress-strain responses for each collected cycle in a logarithmic increment. A brief description of the experimental method is also given.

Data related to cyclic deformation and fatigue behavior of direct laser deposited Ti-6Al-4V with and without heat treatment.

Data is presented describing the strain-controlled, fully-reversed uniaxial cyclic deformation and fatigue behavior of Ti-6Al-4V specimens additively manufactured via Laser Engineered Net Shaping (LENS) - a Direct Laser Deposition (DLD) process. The data was collected by performing multiple fatigue tests on specimens with various microstructural states/conditions, i.e. in their 'as-built', annealed (below the beta transus temperature), or heat treated (above the beta transus temperature) condition. Such data aids in characterizing the mechanical integrity and fatigue resistance of DLD parts. Data presented herein also allows for elucidating the strong microstructure coupling of the fatigue behavior of DLD Ti-6Al-4V, as the data trends were found to vary with material condition (i.e. as-built, annealed or heat treated) [1]. This data is of interest to the additive manufacturing and fatigue scientific communities, as well as the aerospace and biomedical industries, since additively-manufactured parts cannot be reliably deployed for public use, until their mechanical properties are understood with high certainty.

Data demonstrating the effects of build orientation and heat treatment on fatigue behavior of selective laser melted 17-4 PH stainless steel.

Axial fully-reversed strain-controlled ([Formula: see text]) fatigue experiments were performed to obtain data demonstrating the effects of building orientation (i.e. vertical versus horizontal) and heat treatment on the fatigue behavior of 17-4 PH stainless steel (SS) fabricated via Selective Laser Melting (SLM) (Yadollahi et al., submitted for publication [1]). This data article provides detailed experimental data including cyclic stress-strain responses, variations of peak stresses during cyclic deformation, and fractography of post-mortem specimens for SLM 17-4 PH SS.

Multiaxial fatigue modeling for Nitinol shape memory alloys under in-phase loading.

The realistic loading condition for many components is multiaxial arising from multidirectional loading or geometry complexities. In this study, some multiaxial stress-based classical and critical plane fatigue models are briefly reviewed and their application for martensitic Nitinol under torsion and in-phase axial-torsion loading is evaluated. These models include von Mises equivalent stress, Tresca, Findley, McDiarmid, and a proposed stress-based Fatemi-Socie-type model. As the fatigue cracks appear to be on the maximum shear plane for the martensitic Nitinol, all the models examined here consider the shear stress as the primary damage parameter. Among all the models considered in this study, the proposed Fatemi-Socie-type model provides a better prediction for fatigue lives when compared to torsion and in-phase multiaxial fatigue experimental data from literature. Analyses indicate that critical plane approaches are more appropriate for multiaxial fatigue prediction of Nitinol alloys, at least in martensitic phase. Finally, recommendations are made to calibrate more reliable multiaxial fatigue models for Nitinol.

Effects of microstructural inclusions on fatigue life of polyether ether ketone (PEEK).

In this study, the effects of microstructural inclusions on fatigue life of polyether ether ketone (PEEK) was investigated. Due to the versatility of its material properties, the semi-crystralline PEEK polymer has been increasingly adopted in a wide range of applications particularly as a biomaterial for orthopedic, trauma, and spinal implants. To obtain the cyclic behavior of PEEK, uniaxial fully-reversed strain-controlled fatigue tests were conducted at ambient temperature and at 0.02 mm/mm to 0.04 mm/mm strain amplitudes. The microstructure of PEEK was obtained using the optical and the scanning electron microscope (SEM) to determine the microstructural inclusion properties in PEEK specimen such as inclusion size, type, and nearest neighbor distance. SEM analysis was also conducted on the fracture surface of fatigue specimens to observe microstructural inclusions that served as the crack incubation sites. Based on the experimental strain-life results and the observed microstructure of fatigue specimens, a microstructure-sensitive fatigue model was used to predict the fatigue life of PEEK that includes both crack incubation and small crack growth regimes. Results show that the employed model is applicable to capture microstructural effects on fatigue behavior of PEEK.

Fatigue of Nitinol: The state-of-the-art and ongoing challenges.

Nitinol, a nearly equiatomic alloy of nickel and titanium, has been considered for a wide range of applications including medical and dental devices and implants as well as aerospace and automotive components and structures. The realistic loading condition in many of these applications is cyclic; therefore, fatigue is often the main failure mode for such components and structures. The fatigue behavior of Nitinol involves many more complexities compared with traditional metal alloys arising from its uniqueness in material properties such as superelasticity and shape memory effects. In this paper, a review of the present state-of-the-art on the fatigue behavior of superelastic Nitinol is presented. Various aspects of fatigue of Nitinol are discussed and microstructural effects are explained. Effects of material preparation and testing conditions are also reviewed. Finally, several conclusions are made and recommendations for future works are offered.