Barry O’Brien

The evolution of cardiovascular stent materials and surfaces in response to clinical drivers: A review

This review examines cardiovascular stent materials from the perspective of a range of clinical drivers and the materials that have been developed in response to these drivers. The review is generally chronological and outlines how stent materials have evolved from initial basic stainless steel devices all the way through to the novel biodegradable devices currently being explored. Where appropriate, pre-clinical or clinical data that influenced decisions and selections along the way is referenced. Opinions are given as to the merit and direction of various ongoing and future developments.

Passivation of nitinol wire for vascular implants--a demonstration of the benefits.

This study investigated a passivation process for polished nitinol wires and vascular stent components, after being given a typical shape setting heat treatment. Heat treated samples were passivated in a nitric acid solution and a series of corrosion tests, surface analysis and chemical analysis was performed. Potentiodynamic polarization tests demonstrated a significant increase in breakdown potential for passivated samples, compared to heat treated surfaces. Surface analysis indicated that the passivation reduces Ni and NiO content in the oxide and increases TiO2 content. Chemical analysis of passivation solutions suggests that the improvement in corrosion resistance is proportional to the quantity of nickel removed. Long term immersion tests demonstrate that nickel release from the surface of the material decreases with time and the quantity of nickel released is lower for passivated samples. The improved corrosion resistance is maintained after extended periods of immersion in saline solution.

A corrosion model for bioabsorbable metallic stents

In this study a numerical model is developed to predict the effects of corrosion on the mechanical integrity of bioabsorbable metallic stents. To calibrate the model, the effects of corrosion on the integrity of biodegradable metallic foils are assessed experimentally. In addition, the effects of mechanical loading on the corrosion behaviour of the foil samples are determined. A phenomenological corrosion model is developed and applied within a finite element framework, allowing for the analysis of complex three-dimensional structures. The model is used to predict the performance of a bioabsorbable stent in an idealized arterial geometry as it is subject to corrosion over time. The effects of homogeneous and heterogeneous corrosion processes on long-term stent scaffolding ability are contrasted based on model predictions.

Development of a new niobium-based alloy for vascular stent applications

This study was performed in order to develop a new stent material that would provide reduced MR image artifact compared to current stent materials. Alloy design rationale is initially presented and following this the development of a Nb-28 Ta-3.5 W-1.3 Zr alloy is described, including the manufacture of stent tubing. Tensile testing of this new alloy showed that it had approximately twice the yield strength of current Nb-1 Zr material with a 25% higher elastic modulus. The new alloy was also confirmed to have suitably low magnetic susceptibility. Mechanical testing of demonstration coronary stents made from the new alloy were shown to have acceptable compression strength and elastic recoil performance. It is concluded that this new Nb-28 Ta-3.5 W-1.3 Zr alloy is a practical candidate stent material for both coronary applications and peripheral uses such as carotid or intracranial stenting, where reduced MR image artifact would be beneficial.

Micro-scale testing and micromechanical modelling for high cycle fatigue of CoCr stent material

This paper presents a framework of experimental testing and crystal plasticity micromechanics for high cycle fatigue (HCF) of micro-scale L605 CoCr stent material. Micro-scale specimens, representative of stent struts, are manufactured via laser micro-machining and electro-polishing from biomedical grade CoCr alloy foil. Crystal plasticity models of the micro-specimens are developed using a length scale-dependent, strain-gradient constitutive model and a phenomenological (power-law) constitutive model, calibrated from monotonic and cyclic plasticity test data. Experimental microstructural characterisation of the grain morphology and precipitate distributions is used as input for the polycrystalline finite element (FE) morphologies. Two microstructure-sensitive fatigue indicator parameters are applied, using local and non-local (grain-averaged) implementations, for the phenomenological and length scale-dependent models, respectively, to predict fatigue crack initiation (FCI) in the HCF experiments.

Coronary Stent Materials and Coatings: A Technology and Performance Update

This paper reviews the current state of the art for coronary stent materials and surface coatings, with an emphasis on new technologies that followed on from first-generation bare metal and drug-eluting stents. These developments have been driven mainly by the need to improve long term outcomes, including late stent thrombosis. Biodegradable drug-eluting coatings aim to address the long term effects of residual durable polymer after drug elution; the SYNERGY, BioMatrix, and Nobori stents are all promising devices in this category, with minimal polymer through the use of abluminal coatings. Textured stent surfaces have been used to attached drug directly, without polymer; the Yukon Choice and BioFreedom stents have some promising data in this category, while a hydroxyapatite textured surface has had less success. The use of drug-filled reservoirs looked promising initially but the NEVO device has experienced both technical and commercial set-backs. However this approach may eventually make it to market if trials with the Drug-Filled Stent prove to be successful. Non-pharmacological coatings such as silicon carbide, carbon, and titanium–nitride-oxide are also proving to have potential to provide better performance than BMS, without some of the longer term issues associated with DES. In terms of biological coatings, the Genous stent which promotes attachment of endothelial progenitor cells has made good progress while gene-eluting stents still have some practical challenges to overcome. Perhaps the most advancement has been in the field of biodegradable stents. The BVS PLLA device is now seeing increasing clinical use in many complex indications while magnesium stents continue to make steady advancements.

Nitinol stent design – understanding axial buckling

Nitinol׳s superelastic properties permit self-expanding stents to be crimped without plastic deformation, but its nonlinear properties can contribute towards stent buckling. This study investigates the axial buckling of a prototype tracheobronchial nitinol stent design during crimping, with the objective of eliminating buckling from the design. To capture the stent buckling mechanism a computational model of a radial force test is simulated, where small geometric defects are introduced to remove symmetry and allow buckling to occur. With the buckling mechanism ascertained, a sensitivity study is carried out to examine the effect that the transitional plateau region of the nitinol loading curve has on stent stability. Results of this analysis are then used to redesign the stent and remove buckling. It is found that the transitional plateau region can have a significant effect on the stability of a stent during crimping, and by reducing the amount of transitional material within the stent hinges during loading the stability of a nitinol stent can be increased.

Initial exploration of Ti–Ta, Ti–Ta–Ir and Ti–Ir alloys: Candidate materials for coronary stents

The objective of this study was to explore titanium alloys with increased elastic modulus and improved radiopacity, with a view to utilizing titanium in balloon-expandable coronary stents. Ti-50Ta, Ti-45Ta-5Ir and Ti-17Ir alloys were prepared using arc-melting techniques. Microstructural and tensile properties were evaluated in solution-treated conditions for each alloy, and also in aged conditions for the Ti-17Ir. An elastic modulus of 128GPa was recorded for the Ti-17Ir alloy and this high value is attributed to the stiff Ti(3)Ir phase present in the eutectoid structure observed. The mechanical properties recorded, in addition to improved radiopacity, make the Ti-17Ir alloy more suitable for stent applications than commercially available titanium materials. Corrosion resistance and biocompatibility have not been assessed but the noble characteristics of iridium suggest that these aspects will be acceptable.

Transseptal puncture — Review of anatomy, techniques, complications and challenges

In recent years, the transseptal puncture approach has enabled passage of increasingly large and complex devices into the left atrium. Traditional tools remain effective in creating and dilating the initial puncture, with an acceptable safety profile. Even for skilled operators, the procedure is technically demanding and requires sound understanding of atrial anatomy. Intracardiac echocardiography is useful in cases of previous septal repair, poorly defined fossa ovalis anatomy or when considering patent foramen ovale portal crossing. Iatrogenic atrial septal defect (iASD) is the most commonly encountered long-term complication and there is increasing evidence that larger devices are leading to symptomatic defects. The size of the sheath crossing the septum is the strongest predictor of iASD formation but other factors such as longer procedure times, significant catheter manipulation and high pulmonary pressures also contribute. Transcatheter mitral valve repair involves the use of large 22 Fr catheters which carry alarmingly high rates of defect persistence with precipitation of symptoms and possible influence on mortality. Long-term follow up data, particularly beyond the 12-month period are lacking and resultantly, evidence to guide management is sparse. Refinements of conventional instruments, as well as innovations to puncture the septum without mechanical pressure, herald a progressively safer future for the transseptal technique.

Combined anodizing and picosecond laser treatment to control the corrosion rate of biodegradable magnesium alloy AZ31

The corrosion rate of magnesium alloys is generally too high for biodegradable implant applications. This work explored combinations of anodizing and picosecond laser surface treatments to modify the corrosion response of magnesium alloy AZ31. Anodizing of the AZ31 in NaOH solutions produced porous oxide layer structures. Shallow laser treatment of these anodized surfaces, using low pulse powers, resulted mainly in oxide ablation and impaired corrosion resistance. Higher pulse power, resulting in rapid melting and resolidification into the substrate, provided an improved corrosion response. The refined grain structure produced is approximately only 5 µm deep and therefore has minimal influence on bulk mechanical properties. It is therefore a suitable process for surface modifications on small medical device structures. Controlling the initial point of degradation has been demonstrated by the use of selective laser treatment of the AZ31 surface.