Simulation Based Design and Evaluation of a Transcatheter Mitral Heart Valve Frame.

In certain populations, open heart surgery to replace a diseased mitral valve is not an option, leaving percutaneous delivery a viable alternative. However, a surgical transcatheter based delivery of a metallic support frame incorporating a tissue derived valve puts considerable constraints on device specifications. Expansion to a large diameter from the catheter diameter without mechanical fracture involves advanced device design and appropriate material processing and selection. In this study, a new frame concept is presented with a desirable feature that incorporates wings that protrude during expansion to establish adequate fixation. Expansion characteristics of the design in relation to annulus fixation were quantified through finite element analysis predictions of the frame wing span and angles. Computational modeling and simulation was used to identify many favorable design features for the transcatheter mitral valve frame and obtain desired expansion diameters (35-45mm), acceptable radial stiffness (2.7N/mm), and ensure limited risk of failure based on predicted plastic deformations.