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

Abstract

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.

Validation and Extension of a Fluid–Structure Interaction Model of the Healthy Aortic Valve

“…The Ogden model expresses the strain energy ( W ) by principal stretches ( λ α ), α = 1, 2, 321:where and N are material characteristic constants. The material constants used in the analysis were taken from a previous study,8 and fitted using a four parameters equation with μ 1 = 7.6 × 10 −6 MPa; μ 2 = 5.7 × 10 −4 MPa; α 1 = α 2 = 26.26. A density of 1100 kg/m 3 was selected, as this is typical for biological soft tissues 19…”

Hydrodynamic Noise of Pulsating Jets through Bileaflet Mechanical Mitral Valve

“…Water was entering inside the atrium model (2) and the left ventricular model (3) through the inlet fitting (1). A device (5) was made between the atrium and the ventricle, where the bileaflet mechanical heart valve was installed.…”

“…In recent years, a large number of heart valve prostheses of various forms and principles have been developed and put into practice, which are grouped into three groups: bioprostheses, mechanical, and transcatheter valves [2][3][4][5]. Most valves are manufactured by world-renowned firms such as Edwards Lifesciences, Medtronic, St. Jude Medical, Sorin Group, and Boston Scientific.…”

Comparison of different transcatheter interventions for treatment of mitral regurgitation

“…[ 8 , 9 ] Transcatheter techniques to treat MR are based on the existing surgical heart valve procedures including leaflet and chordae repair, annuloplasty, left ventricular remodeling and replacement, and there were several corresponding devices which combines the respective advantages of cardiac surgery have aroused great interest. [ 10 – 12 ]…”