Design, Prototyping and Testing of a Tool for Intracardiac Delivery and Anchoring of a Prosthetic MitraI Valve

Abstract

The mitral valve in the heart sometimes struggles with diseases and complications, and needs to be replaced. This problem becomes more frequent with the ageing of the population in developed countries. The most common practice consists of suturing a prosthetic valve into place. However, newer methods are being devised and tested to make the surgery faster and less invasive. In particular, various types of new sutureless heart valve systems exist on the market. However, there is still a need for a tool designed for the intracardiac delivery and anchoring of a prosthetic mitral valve, as addressed here. A number of criteria and specifications were set by researchers at the Robarts Research Institute (London, ON) who came up with the design task. To address their request, ten conceptual designs of a sutureless, virtual-reality guided, self-anchoring, intracardiac system were developed to hold a prosthetic mitral valve, deliver it safely, and quickly affix it in position. The winning concept adequately met the design criteria. Two prototypes were manufactured. The attachment of a prosthetic valve to a simulated mitral valve annulus was tested with the first prototype to verify feasibility and measure leakage. The second prototype was pressure tested in a dynamic surgical phantom reproducing the circulatory conditions during surgery. While the preliminary feasibility of the concept was established, recommendations were made to develop a less bulky design.