Comparison of computational modelling techniques for braided stent analysis.

Braided stents are associated with a number of complications in vivo. Accurate computational modelling of these devices is essential for the design and development of the next generation of these stents. In this study, two commonly utilised methods of computationally modelling filament interaction in braided stents are investigated: the join method and the weave method. Three different braided stent designs are experimentally tested and computationally modelled in both radial and v-block configurations. The results of the study indicate that while both methods are capable of capturing braided stent performance to some degree, the weave method is much more robust.

Comparison of Covered Laser-cut and Braided Respiratory Stents: From Bench to Pre-Clinical Testing.

Lung cancer patients often suffer from severe airway stenosis, the symptoms of which can be relieved by the implantation of stents. Different respiratory stents are commercially available, but the impact of their mechanical performance on tissue responses is not well understood. Two novel laser-cut and hand-braided nitinol stents, partially covered with polycarbonate urethane, were bench tested and implanted in Rhön sheep for 6 weeks. Bench testing highlighted differences in mechanical behavior: the laser-cut stent showed little foreshortening when crimped to a target diameter of 7.5 mm, whereas the braided stent elongated by more than 50%. Testing also revealed that the laser-cut stent generally exerted higher radial resistive and chronic outward forces than the braided stent, but the latter produced significantly higher radial resistive forces at diameters below 9 mm. No migration was observed for either stent type in vivo. In terms of granulation, most stents exerted a low to medium tissue response with only minimal formation of granulation tissue. We have developed a mechanical and in vivo framework to compare the behavior of different stent designs in a large animal model, providing data, which may be employed to improve current stent designs and to achieve better treatment options for lung cancer patients.

PulmoStent: In Vitro to In Vivo Evaluation of a Tissue Engineered Endobronchial Stent.

Currently, there is no optimal treatment available for end stage tumour patients with airway stenosis. The PulmoStent concept aims on overcoming current hurdles in airway stenting by combining a nitinol stent with a nutrient-permeable membrane, which prevents tumour ingrowth. Respiratory epithelial cells can be seeded onto the cover to restore mucociliary clearance. In this study, a novel hand-braided dog bone stent was developed, covered with a polycarbonate urethane nonwoven and mechanically tested. Design and manufacturing of stent and cover were improved in an iterative process according to predefined requirements for permeability and mechanical properties and finally tested in a proof of concept animal study in sheep for up to 24 weeks. In each animal two stents were implanted, one of which was cell-seeded by endoscopic spraying in situ. We demonstrated the suitability of this membrane for our concept by glucose transport testing and in vitro culture of respiratory epithelial cells. In the animal study, no migration occurred in any of the twelve stents. There was only mild granulation tissue formation and tissue reaction; no severe mucus plugging was observed. Thus, the PulmoStent concept might be a step forward for palliative treatment of airway stenosis with a biohybrid stent device.

A Review of Material Degradation Modelling for the Analysis and Design of Bioabsorbable Stents.

The field of percutaneous coronary intervention has witnessed many progressions over the last few decades, more recently with the advancement of fully degradable bioabsorbable stents. Bioabsorbable materials, such as metallic alloys and aliphatic polyesters, have the potential to yield stents which provide temporary support to the blood vessel and allow native healing of the tissue to occur. Many chemical and physical reactions are reported to play a part in the degradation of such bioabsorbable materials, including, but not limited to, corrosion mechanisms for metals and the hydrolysis and crystallization of the backbone chains in polymers. In the design and analysis of bioabsorbable stents it is important to consider the effect of each aspect of the degradation on the material's in vivo performance. The development of robust computational modelling techniques which fully capture the degradation behaviour of these bioabsorbable materials is a key factor in the design of bioabsorable stents. A critical review of the current computational modelling techniques used in the design and analysis of these next generation devices is presented here, with the main accomplishments and limitations of each technique highlighted.

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.