A synthetic leaflet heart valve with improved opening characteristics.

A new geometry for the design of polyurethane leaflet heart valves has been investigated. The geometry termed the 'alpharabola' has a radius of curvature that increases from the centre of the leaflet at the free edge towards the base of the valve and perimeter of the leaflet. The hydrodynamic function and leaflet opening characteristics of the new valve design have been compared to a valve with a spherical leaflet geometry using the same material. The pressure and flow required to open alpharabola leaflets in steady flow tests was markedly lower than for spherical leaflets. Under pulsatile flow conditions with the valve leaflets fully open, the pressure drop across the alpharabola and spherical leaflets was similar, but much lower than in a porcine bioprosthesis. High speed photography showed that the alpharabola leaflets opened in less than 30 ms with the leaflet opening initiating in the base of the leaflet where the radius of curvature was larger. The synthetic leaflet valve has demonstrated short term durability in accelerated fatigue tests to 100 million cycles.