Recent advances and directions in the development of bioresorbable metallic cardiovascular stents: Insights from recent human and in vivo studies.

Over the past two decades, significant advancements have been made regarding the material formulation, iterative design, and clinical translation of metallic bioresorbable stents. Currently, magnesium-based (Mg) stent devices have remained at the forefront of bioresorbable stent material development and use. Despite substantial advances, the process of developing novel absorbable stents and their clinical translation is time-consuming, expensive, and challenging. These challenges, coupled with the continuous refinement of alternative bioresorbable metallic bulk materials such as iron (Fe) and zinc (Zn), have intensified the search for an ideal absorbable metallic stent material. Here, we discuss the most recent pre-clinical and clinical evidence for the efficacy of bioresorbable metallic stents and material candidates. From this perspective, strategies to improve the clinical performance of bioresorbable metallic stents are considered and critically discussed, spanning material alloy development, surface manipulations, material processing techniques, and preclinical/biological testing considerations. STATEMENT OF SIGNIFICANCE: Recent efforts in using Mg, Fe, and Zn based materials for bioresorbable stents include elemental profile changes as well as surface modifications to improve each of the three classes of materials.  Although a variety of alloys for absorbable metallic stents have been developed, the ideal absorbable stent material has not yet been discovered. This review focuses on the state of the art for bioresorbable metallic stent development. It covers the three bulk materials used for degradable stents (Mg, Fe, and Zn), and discusses their advances from a translational perspective. Strategies to improve the clinical performance of bioresorbable metallic stents are considered and critically discussed, spanning material alloy development, surface manipulations, material processing techniques, and preclinical/biological testing considerations.

Additively manufactured iron-manganese for biodegradable porous load-bearing bone scaffold applications.

Selective laser melting (SLM) can produce complex hierarchical architectures paving the way for highly customisable biodegradable load-bearing bone scaffolds. For the first time, an in-depth analysis on the performance of SLM-manufactured iron-manganese bone scaffolds suitable for load-bearing applications is presented. Microstructural, mechanical, corrosion and biological characterisations were performed on SLM-manufactured iron-manganese scaffolds. The microstructure of the scaffold consisted primarily of γ-austenite, leading to high ductility. The mechanical properties of the scaffold were sufficient for load-bearing applications even after 28 days immersion in simulated body fluids. Corrosion tests showed that the corrosion rate was much higher than bulk pure iron, attributed to a combination of the manufacturing method, the addition of Mn to the alloy and the design of the scaffold. In vitro cell testing showed that the scaffold had good biocompatibility and viability towards mammalian cells. Furthermore, the presence of filopodia showed good osteoblast adhesion. In vivo analysis showed successful bone integration with the scaffold, with new bone formation observed after 4 weeks of implantation. Overall the SLM manufactured porous Fe-35Mn implants showed promise for biodegradable load-bearing bone scaffold applications. STATEMENT OF SIGNIFICANCE: Biodegradable iron scaffolds are emerging as a promising treatment for critical bone defects. Within this field, selective laser melting (SLM) has become a popular method of manufacturing bespoke scaffolds. There is limited knowledge on SLM-manufactured iron bone scaffolds, and no knowledge on their application for load-bearing situations. The current manuscript is the first study to characterise SLM manufactured iron-manganese bone scaffolds for load-bearing applications and also the first study to perform In vivo testing on SLM produced biodegradable iron scaffolds. In this study, for the first time, the mechanical, corrosion and biological properties of an iron-manganese scaffold manufactured using SLM were investigated. In summary the SLM-manufactured porous iron-manganese implants displayed great potential for biodegradable load-bearing bone scaffolds.

Probing multipulse laser ablation by means of self-mixing interferometry.

In this work, self-mixing interferometry (SMI) is implemented inline to a laser microdrilling system to monitor the machining process by probing the ablation-induced plume. An analytical model based on the Sedov-Taylor blast wave equation is developed for the expansion of the process plume under multiple-pulse laser percussion drilling conditions. Signals were acquired during laser microdrilling of blind holes on stainless steel, copper alloy, pure titanium, and titanium nitride ceramic coating. The maximum optical path difference was measured from the signals to estimate the refractive index changes. An amplitude coefficient was derived by fitting the analytical model to the measured optical path differences. The morphology of the drilled holes was investigated in terms of maximum hole depth and dross height. The results indicate that the SMI signal rises when the ablation process is dominated by vaporization, changing the refractive index of the processing zone significantly. Such ablation conditions correspond to limited formation of dross. The results imply that SMI can be used as a nonintrusive tool in laser micromachining applications for monitoring the process quality in an indirect way.

The processing of ultrafine-grained Mg tubes for biodegradable stents.

An investigation was carried out on equal-channel angular pressing (ECAP) and extrusion processing of a ZM21 Mg alloy to obtain an improved candidate material for the manufacturing of biodegradable Mg stents. Ultrafine-grain size billets of the ZM21 alloy were obtained by two-stage ECAP aimed at achieving an initial refining of the structure at 200°C and then reaching the submicrometer grain size range by lowering the processing temperature down to 150°C. The investigation revealed a significant improvement in the properties of the ECAP-treated samples compared with the starting coarse-grained ZM21 alloy. The 0.2% yield strength rose from 180 to 340 MPa after 150°C ECAP processing, while maintaining a fairly high tensile ductility. The ultrafine ZM21 alloy billets were then used for the extrusion of stent precursors having the form of small-size tubes. The grain size after extrusion remained in the submicrometer range while the hardness was revealed to be significantly higher than that of the coarse-grained ZM21 Mg alloy. It was demonstrated that processing of biodegradable Mg stent having an ultrafine-grained microstructure by ECAP and low-temperature extrusion is feasible and that the obtained products feature promising properties.