The Apex bileaflet mechanical heart valve.

Mechanical Heart Valves (MHVs) are known for their excellent lifespan and feasibly are the most reliable and stable valves amongst all prosthetic valves. Successful bileaflet MHVs such as the St. Jude Medical (SJM) are known for providing central blood flow and minimal pressure drop across the valve. However, due to their non-physiological flow conditions, they still suffer from hemodynamic complications, that is, red blood cell (RBC) lysis and/or thrombogenicity, to date. Our hypothesis is that the design of MHVs can be improved so that their hemodynamics can be comparable to those of tissue valves. In this study, a new concept for the design of MHVs is proposed. To accomplish this, we identified the major design limitations of bileaflet MHVs, such as the gold standard SJM valve as well as the believed contributing factors to their thrombogenicity. We developed a novel design architecture for bileaflet MHVs that addressed these limitations, and from it, the Apex Valve (AV). Our experimental assessment of the AV found that its hemodynamics were closer to that of a bioprosthetic valve than of a bileaflet MHV. This design has been filed as a US Provisional Patent.