Barry O'brien

A platinum–chromium steel for cardiovascular stents

The desire to reduce the strut thickness of cardiovascular stents has driven the development of a new high strength radiopaque alloy, based on additions of platinum to a chromium-rich iron based matrix. This paper reports on initial development of the alloy and the rationale for selection of the composition. Data is presented for tensile and microstructural characterization, surface oxide analysis, corrosion resistance and endothelial cell response of the alloy. The results demonstrate the solid solution strengthening effect of the platinum, with an average yield strength of 480 MPa achieved. The material surface consists of primarily chromium oxide which contributes to the high corrosion resistance observed. The cell assay result suggests that surfaces of this Pt-enhanced alloy endothelialize in a manner comparable to stainless steel.

Experimental characterisation for micromechanical modelling of CoCr stent fatigue.

Fatigue of CoCr alloy stents has become a major concern in recent times, owing to cases of premature fracture, often driven by microstructural phenomena. This work presents the development of a micromechanical framework for fatigue design, based on experimental characterisation of a biomedical grade CoCr alloy, including both microscopy and mechanical testing. Fatigue indicator parameters (FIPs) within the micromechanical framework are calibrated for the prediction of microstructure-sensitive fatigue crack initiation (FCI). A multi-scale CoCr stent model is developed, including a 3D global J2 continuum stent-artery model and a 2D micromechanical sub-model. Several microstructure realizations for the stent sub-model allow assessment of the effect of crystallographic orientations on stent fatigue crack initiation predictions. Predictions of FCI are compared with traditional Basquin-Goodman total life predictions, revealing more realistic scatter of data for the microstructure-based FIP approach. Comparison of stent predictions with performance of a 316L stent for the same generic design exposes the design as over-conservative for the CoCr alloy. In response, the micromechanical framework is used to modify the stent design for the CoCr alloy, improving design efficiency.

Characterization of an NbTaWZr alloy designed for magnetic resonance angiography compatible stents.

The majority of stent materials are not fully compatible with magnetic resonance imaging due to their ferromagnetic or paramagnetic compositions. This leads to image artifact which can obscure clinical data in the vicinity of the stent. An Nb-28Ta-3.5W-1.3Zr alloy has been developed specifically to provide reduced magnetic susceptibility and therefore reduce image artifact. This study reports on initial surface characterization, corrosion behaviour, endothelial cell response and MR image performance. Surface analysis confirms the presence of a niobium oxide with some tantalum oxide also present. Electrochemical corrosion testing demonstrates the oxide to be stable with no evidence of film breakdown. Leaching of metallic ions during a 60-day immersion test shows low levels of release, comparable to cobalt-chromium L605. A short term endothelial cell adhesion study shows that the Nb-28Ta-3.5W-1.3Zr may be similar to stainless steel for supporting cell growth. The MR artifact assessment shows that the material has significantly reduced artifact compared to stainless steel. In summary, results from this initial study show that the Nb-28Ta-3.5W-1.3Zr meets many on the criteria expected of a stent material and that improved MR imaging behaviour is also obtained.

Evaluation of cover effects on bare stent mechanical response.

Covered tracheobronchial stents are used to prevent tumour growth from reoccluding the airways. In the present work a combination of experimental and computational methods are used to present the mechanical effects that adhered covers can have on stent performance. A prototype tracheobronchial stent is characterised in bare and covered configurations using radial force, flat plate and a novel non-uniform radial force test, while computational modelling is performed in parallel to extensively inform the physical testing. Results of the study show that cover configuration can have a significant structural effect on stent performance, and that stent response (bare or covered) is especially loading specific, highlighting that the loading configuration that a stent is about to be subjected to should be considered before stent implantation.

An ovine in vivo framework for tracheobronchial stent analysis

Tracheobronchial stents are most commonly used to restore patency to airways stenosed by tumour growth. Currently all tracheobronchial stents are associated with complications such as stent migration, granulation tissue formation, mucous plugging and stent strut fracture. The present work develops a computational framework to evaluate tracheobronchial stent designs in vivo. Pressurised computed tomography is used to create a biomechanical lung model which takes into account the in vivo stress state, global lung deformation and local loading from pressure variation. Stent interaction with the airway is then evaluated for a number of loading conditions including normal breathing, coughing and ventilation. Results of the analysis indicate that three of the major complications associated with tracheobronchial stents can potentially be analysed with this framework, which can be readily applied to the human case. Airway deformation caused by lung motion is shown to have a significant effect on stent mechanical performance, including implications for stent migration, granulation formation and stent fracture.