Hemodynamic research shows that thrombosis formation is closely tied to flow field turbulent stress. Design limitations cause flow separation at leaflet edges and the annular valve base, vortex mixing downstream, and high turbulent shear stress. The trileaflet design opens like a physiologic valve with central flow. Leaflet curvature approximates a completely circular orifice, maximizing effective flow area of the open valve. Semicircular aortic sinuses downstream of the valve allow vortex formation to help leaflet closure. The new trileaflet design was hemodynamically evaluated via digital particle image velocimetry and laser-Doppler anemometry. Measurements were made during peak flow of the fully open valve, immediately downstream of the valve, and compared with the 27-mm St. Jude Medical (SIM) bileaflet valve. The trileaflet valve central flow produces sufficient pressure to inhibit separation shear layers. Absence of downstream turbulent wake eddies indicates smooth, physiologic blood flow. In contrast, SIM produces strong turbulence because of unsteady separated shear layers where the jet flow meets the aortic sinus wall, resulting in higher turbulent shear stresses detrimental to blood cells. The trileaflet valve simulates the physiologic valve better than previous designs, produces smoother flow, and allows large scale recirculation in the aortic sinuses to help valve closure.
