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. Author manuscript; available in PMC: 2020 Dec 1.
Published in final edited form as: Biomaterials. 2019 Sep 17;225:119493. doi: 10.1016/j.biomaterials.2019.119493

Table 6:

Polymeric heart valve geometries – description and testing results.

Year Author(s) Geometry/description Results References
Bileaflet valves

1959 Braunwald & Morrow, Boston Shape based on plaster casts of human and animal mitral valves In vivo – Human implant (mitral), 60 hours and 4 months (1st human PU valve [196], [237]
2003 Iwasaki et al., Waseda Valves for pulsatile pumps
Type A – Circular flexible disc attached to a frame along the diameter, producing two flaps.
Type B – 12-spoke structure cast from polyurethane with a 150 μm disc on top
In vitro – Type A: 8.8 × 105 cycles
Type B – 3.7 x106 cycles
[238]
2006 Daebritz et al., Munich Kidney shaped stent with two asymmetrical struts supporting a large anterior and smaller posterior leaflet In vitro – 1 billion (109) cycles [42], [197], [213]

Trileaflet valves

1958, 1966 Roe et al., San Francisco Conical cusps, shown to be less resistant to opening than dome-shaped cusps In vitro - 786 million cycles
In vivo – 18 clinical human implants, 4 post-operative survivors from 79-100 months
[200]–[202], [239]
1977 Reul & Ghista, HIA Analytical determination of shapes for smooth washout, minimum leaflet stress and fatigue lifetime of 20 years In vitro – 350+ million cycles [163], [193]
1982 Wisman et al., Penn State 3 hemicylindrical leaflets of 10 mm diameter each angled with respect to the flow axis, with flexible support framework In vitro – good hydraulic function and efficiency
In vivo – calcification and thrombosis in growing calf, longer survival and less calcification in mature animals
[204]
1994 Fisher et al., Leeds Variable radius of curvature where the radius of curvature of leaflet increases away from the center of the valve towards the base of the leaflet In vitro – 180 μm leaflets produced a pressure drop of less than 1 mmHg [161]
1996 Wheatley et al., Glasgow Leaflet geometry is elliptical radially and continuous hyperbolae circumferentially In vitro – 800 million cycles
In vivo – 6-month survival in sheep
[37], [38], [240]
2004 Jiang et al., Ontario Hyperboloids of revolution: control of central opening and leaflet curvature by varying parameters such as coaptation at commissures and curvature of free edge In vitro – successful demonstration of opening/closing of valve using a cyclic flow tester [205]
2009 Mohammadi et al., Ontario Bezier curves/surfaces FEA showed acceptable opening/closing characteristics and good stress distribution [176]
2009 Bluestein et al., Stony Brook Hemispherical geometry, originating from Thubrikar’s characterization, leaflet thickness varying along the radial direction FEA and fluid dynamic simulations showed superior stress distribution and improved hemodynamics [44], [165]
2010 Burriesci et al., UCL Ruled surface between intersection of the stent cylinder with a plane and an arc joining the commissures, lying on a plane normal to the valve axis. In vitro – 10 cycles testing – less energy loss, blood trauma and clot formation [47], [185], [188], [199]
2015 Gharaie & Morsi, Victoria Sweeping a circumferential curve along a radial curve FSI model showed improved characteristics compared to other polymeric valves, with EOA of 3.22 cm2 and pressure drop of 3.52 mmHg [209]