Design of a novel polymeric heart valve

Burriesci, G; Marincola, F. Cavallo; Zervides, Constantinos

doi:10.3109/03091900903261241

Cited by 32 publications

(32 citation statements)

References 44 publications

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“…The same modelling techniques can also be applied to tissue [2] and polymeric [4] valves which also undergo large deformation in response to fluid loads.…”

Section: Discussionmentioning

confidence: 99%

Mitral valve dynamics in structural and fluid–structure interaction models

Lau

Díaz²,

Scambler³

et al. 2010

Medical Engineering & Physics

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Modelling and simulation of heart valves is a challenging biomechanical problem due to anatomical variability, pulsatile physiological pressure loads and 3D anisotropic material behaviour. Current valvular models based on the finite element method can be divided into: those that do model the interaction between the blood and the valve (fluid–structure interaction or ‘wet’ models) and those that do not (structural models or ‘dry’ models).Here an anatomically sized model of the mitral valve has been used to compare the difference between structural and fluid–structure interaction techniques in two separately simulated scenarios: valve closure and a cardiac cycle. Using fluid–structure interaction, the valve has been modelled separately in a straight tubular volume and in a U-shaped ventricular volume, in order to analyse the difference in the coupled fluid and structural dynamics between the two geometries.The results of the structural and fluid–structure interaction models have shown that the stress distribution in the closure simulation is similar in all the models, but the magnitude and closed configuration differ. In the cardiac cycle simulation significant differences in the valvular dynamics were found between the structural and fluid–structure interaction models due to difference in applied pressure loads. Comparison of the fluid domains of the fluid–structure interaction models have shown that the ventricular geometry generates slower fluid velocity with increased vorticity compared to the tubular geometry.In conclusion, structural heart valve models are suitable for simulation of static configurations (opened or closed valves), but in order to simulate full dynamic behaviour fluid–structure interaction models are required.

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“…The same modelling techniques can also be applied to tissue [2] and polymeric [4] valves which also undergo large deformation in response to fluid loads.…”

Section: Discussionmentioning

confidence: 99%

Mitral valve dynamics in structural and fluid–structure interaction models

Lau

Díaz²,

Scambler³

et al. 2010

Medical Engineering & Physics

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“…The TRISKELE leaflets design is based on a novel principle successfully adopted previously for surgical tri-leaflets heart valves [32], which aims to achieve a single curvature in both the open and closed unloaded configurations. This approach has been shown to reduce the energy dissipated during the operating cycle, resulting in an improved hydrodynamic performance and reduced stress levels.…”

Section: Methodsmentioning

confidence: 99%

In Vitro Hydrodynamic Assessment of a New Transcatheter Heart Valve Concept (the TRISKELE)

Rahmani

Tzamtzis

Sheridan

et al. 2016

J. of Cardiovasc. Trans. Res.

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This study presents the in vitro hydrodynamic assessment of the TRISKELE, a new system suitable for transcatheter aortic valve implantation (TAVI), aiming to mitigate the procedural challenges experienced with current technologies. The TRISKELE valve comprises three polymeric leaflet and an adaptive sealing cuff, supported by a novel fully retrievable self-expanding nitinol wire frame. Valve prototypes were manufactured in three sizes of 23, 26, and 29 mm by automated dip-coating of a biostable polymer, and tested in a hydrodynamic bench setup in mock aortic roots of 21, 23, 25, and 27 mm annulus, and compared to two reference valves suitable for equivalent implantation ranges: Edwards SAPIEN XT and Medtronic CoreValve. The TRISKELE valves demonstrated a global hydrodynamic performance comparable or superior to the controls with significant reduction in paravalvular leakage. The TRISKELE valve exhibits enhanced anchoring and improved sealing. The valve is currently under preclinical investigation.

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“…Fluid structure interaction modelling would be more accurate for the simulation of the opening and closing leaflets dynamics. However, the peak of stress in the leaflets during the cardiac cycle is essentially led by the closing transvalvular pressure load,33 so that neglecting the local pressure variation and fluid shear stresses due to blood flow can still yield to sufficiently accurate results for the design evaluation stage 10…”

Section: Discussionmentioning

confidence: 99%

“…Simulations were performed using the FEA software MSC.Marc/Mentat and an implicit solver utilizing single-step Houbolt time integration algorithm, by gradually reducing the diameter of a surround cylindrical contact surface. Critical regions subjected to the highest levels of stress during crimping were identified in the initial geometry and optimised iteratively, using the approach described in Burriesci et al 10 For each portion indicated in Fig. 2, the length, curvature and angle values were updated in each simulation in order to obtain a parameter set minimising the crimping stress on the wireframe.…”

Section: Methodsmentioning

confidence: 99%

Design, Analysis and Testing of a Novel Mitral Valve for Transcatheter Implantation

et al. 2017

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Mitral regurgitation is a common mitral valve dysfunction which may lead to heart failure. Because of the rapid aging of the population, conventional surgical repair and replacement of the pathological valve are often unsuitable for about half of symptomatic patients, who are judged high-risk. Transcatheter valve implantation could represent an effective solution. However, currently available aortic valve devices are inapt for the mitral position. This paper presents the design, development and hydrodynamic assessment of a novel bi-leaflet mitral valve suitable for transcatheter implantation. The device consists of two leaflets and a sealing component made from bovine pericardium, supported by a self-expanding wireframe made from superelastic NiTi alloy. A parametric design procedure based on numerical simulations was implemented to identify design parameters providing acceptable stress levels and maximum coaptation area for the leaflets. The wireframe was designed to host the leaflets and was optimised numerically to minimise the stresses for crimping in an 8 mm sheath for percutaneous delivery. Prototypes were built and their hydrodynamic performances were tested on a cardiac pulse duplicator, in compliance with the ISO5840-3:2013 standard. The numerical results and hydrodynamic tests show the feasibility of the device to be adopted as a transcatheter valve implant for treating mitral regurgitation.Electronic supplementary materialThe online version of this article (doi:10.1007/s10439-017-1828-2) contains supplementary material, which is available to authorized users.

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Design of a novel polymeric heart valve

Cited by 32 publications

References 44 publications

Mitral valve dynamics in structural and fluid–structure interaction models

Mitral valve dynamics in structural and fluid–structure interaction models

In Vitro Hydrodynamic Assessment of a New Transcatheter Heart Valve Concept (the TRISKELE)

Design, Analysis and Testing of a Novel Mitral Valve for Transcatheter Implantation

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