Prosthetic heart valves with elastic support structures and related methods

Abstract

Prosthetic heart valves having elastic leaflets and an elastic support structure are described. The support structure can exhibit a precursory transition from the closed position to the open position. The support structures can exhibit a sinusoidal movement profile at a base edge during the precursory transition.

1 . A prosthetic heart valve, comprising:
 a. plurality of leaflets, wherein each leaflet is synthetic; and   a support structure comprising
 a plurality of projections coupled with the plurality of leaflets; and 
 a base upstream of the plurality of projections, wherein the plurality of projections and the base are elastic, 
   wherein the prosthetic heart valve has a closed position and an open position and the plurality of leaflets and the support structure move between the closed position and the open position,   wherein the prosthetic heart valve is configured to permit fluid flow in a proper upstream to downstream direction when a transvalve fluid pressure is positive, and configured such that the plurality of leaflets are in a coapted state when the transvalve fluid pressure is a peak negative pressure, and   wherein the prosthetic heart valve is configured such that, when the transvalve fluid pressure is a negative value less than the peak negative pressure, the plurality of projections automatically begin movement from the closed position to the open position.   
     
     
         2 . The prosthetic heart valve of  claim 1 , wherein the leaflet support structure has a periphery and the base comprises an edge that extends around the periphery of the leaflet support structure. 
     
     
         3 . The prosthetic heart valve of  claim 2 , wherein each leaflet of the plurality of leaflets has an upstream end, and wherein each projection of the plurality of projections has a downstream end, the edge comprising: a first location directly upstream from each downstream end of the plurality of projections such that a plurality of first locations are present on the edge; and a second location directly upstream from each upstream end of the plurality of leaflets such that a plurality of second locations are present on the edge, wherein the prosthetic heart valve is configured such that, at a first time during movement of the leaflet support structure from the closed position to the open position, each first location moves in a upstream direction and each second location moves in an downstream direction. 
     
     
         4 . The prosthetic heart valve of  claim 3 , wherein the first time is when the transvalve fluid pressure is 90-99.9% of the peak negative pressure. 
     
     
         5 . The prosthetic heart valve of  claim 3 , wherein the first time is when the transvalve fluid pressure is 85-95% of the peak negative pressure. 
     
     
         6 . The prosthetic heart valve of  claim 3 , wherein the first time is when the transvalve fluid pressure is 25-75% of the peak negative pressure. 
     
     
         7 . The prosthetic heart valve of  claim 3 , wherein the first time is when the transvalve fluid pressure is at the negative value. 
     
     
         8 . The prosthetic heart valve of  claim 3 , configured such that each first location of the edge moves in a downstream direction and each second location of the edge moves in an upstream direction continually as the transvalve fluid pressure transitions from 75% of the peak negative pressure to zero. 
     
     
         9 . The prosthetic heart valve of  claim 3 , configured such that each first location of the edge moves in a downstream direction and each second location of the edge moves in an upstream direction in immediate response to the transvalve fluid pressure transitioning from the peak negative pressure to a less negative pressure. 
     
     
         10 . The prosthetic heart valve of  claim 3 , configured such that, at the first time, each downstream end of the plurality of projections moves in a radially outward direction. 
     
     
         11 . The prosthetic heart valve of  claim 1 , wherein the plurality of leaflets are polymeric. 
     
     
         12 . The prosthetic heart valve of  claim 1 , whetein the plurality of leaflets have a first elasticity and the leaflet support structure has a second elasticity, the first elasticity being in the range of 10-45 MegaPascals (MPa) and the second elasticity being in range of 3000-5000 MPa. 
     
     
         13 . The prosthetic heart valve of  claim 1 , wherein the plurality of leaflets have a first elasticity and the leaflet support structure has a second elasticity, the first elasticity being in the range of 20-35 MegaPascals (MPa) and the second elasticity being in the range of 3300-3500 MPa. 
     
     
         14 . The prosthetic heart valve of  claim 1 , wherein the plurality of leaflets have a first elasticity and the leaflet support structure has a second elasticity, the first elasticity being in the range of 25-30 Megapascals (MPa) and the second elasticity being in the range of 3300-3500 MPa. 
     
     
         15 . The prosthetic heart valve of  claim 1 , wherein the leaflet support structure has a convex portion proximate to each apex. 
     
     
         16 . The prosthetic heart valve of  claim 1 , wherein the leaflet support structure is radially collapsible and insertable into an intra vascular delivery device. 
     
     
         17 . The prosthetic heart valve of  claim 1 , wherein the upstream edge alternates to a reverse profile sinusoidally shaped surface in the open position.