Flow optimized polymeric heart valve

Abstract

A polymeric heart valve is disclosed which includes a valve body having a central axis and including a conduit extending along the central axis from an inflow end to an outflow end; and at least three flexible leaflets extending from the body into the conduit, each of the leaflets defining an attachment curve with the body. Respective pairs of leaflets each define a commissure located proximal the body. The at least three leaflets define a partially open position at rest, a fully open position deflecting away from the central axis during forward blood flow along a direction from the inflow end to the outflow end, and a closed position deflecting toward the central axis during reverse blood flow along a direction from the outflow end to the inflow end.

1 .- 41 . (canceled) 
     
     
         42 . A polymeric heart valve, comprising:
 a valve body having a central axis and comprising a conduit extending along the central axis from an inflow end to an outflow end; and   at least three flexible leaflets extending from the valve body into the conduit, each of the at least three leaflets defining an attachment curve with the valve body and each leaflet comprising a pair of free edges coming to a tip near the central axis of the valve body,   wherein each pair of leaflets defines a commissure located proximal the valve body, and   wherein the at least three leaflets define:
 a partially open position at rest, 
 a fully open position deflecting away from the central axis during forward blood flow along a direction from the inflow end to the outflow end, and 
 a closed position deflecting toward the central axis during reverse blood flow along a direction from the outflow end to the inflow end, 
 wherein each of the at least three leaflets comprises at least a four point thickness profile, wherein: a first point in the four point thickness profile is substantially located at the tip of each of the at least three leaflets; a second point in the four point thickness profile and a fourth point in the four point thickness profile in each of the at least three leaflets are substantially located at respective commissures; and a third point is substantially located proximal the valve body substantially midway along the attachment curve between the second point in the four point thickness profile and the fourth point in the four point thickness profile, and wherein the thickness at the first point in the four point thickness profile is less than the thickness at the second point in the four point thickness profile and the fourth point in the four point thickness profile. 
   
     
     
         43 . The polymeric heart valve of  claim 42 , wherein the first point in the four point thickness profile has a thickness ranging between about 0.25 mm and about 0.5 mm. 
     
     
         44 . The polymeric heart valve of  claim 42 , wherein the second point in the four point thickness profile and the fourth point in the four point thickness profile, each has a thickness ranging between about 0.3 mm and about 0.7 mm. 
     
     
         45 . The polymeric heart valve of  claim 42 , wherein the third point in the four point thickness profile has a thickness ranging between about 0.2 mm and about 0.4 mm. 
     
     
         46 . The polymeric heart valve of  claim 42 , wherein the first point in the four point thickness profile has a thickness about equal to or less than two thirds of the thickness of the second point in the four point thickness profile and the fourth point in the four point thickness profile. 
     
     
         47 . The polymeric heart valve of  claim 42 , wherein the first point in the four point thickness profile has a thickness about equal to or less than one half of the thickness of the second point in the four point thickness profile and the fourth point in the four point thickness profile. 
     
     
         48 . The polymeric heart valve of  claim 42 , wherein the third point in the four point thickness profile has a thickness about equal to or less than two thirds of the thickness of the second point in the four point thickness profile and the fourth point in the four point thickness profile. 
     
     
         49 . The polymeric heart valve of  claim 42 , wherein the at rest position opening of adjacent leaflets closest to their respective commissure ranges between 0.1 mm and 0.6 mm. 
     
     
         50 . The polymeric heart valve of  claim 49 , wherein the at rest position opening of adjacent leaflets closest to their respective commissure is 0.25 mm. 
     
     
         51 . The polymeric heart valve of  claim 42 , further comprising, for each leaflet, a respective sinus lobe in the conduit extending along the valve body and located distal the respective leaflet from the inflow end. 
     
     
         52 . The polymeric heart valve of  claim 51 , wherein the valve body, the sinus lobes, and the at least three leaflets are made from a biocompatible polymer. 
     
     
         53 . The polymeric heart valve of  claim 52 , wherein the biocompatible polymer is selected from a group consisting of silicone, polyurethane, or a combination thereof. 
     
     
         54 . The polymeric heart valve of  claim 42 , wherein the valve body, the sinus lobes, and the at least three leaflets are integrally constructed. 
     
     
         55 . The polymeric heart valve of  claim 42 , wherein the at least three leaflets open symmetrically in response to forward blood flow. 
     
     
         56 . The polymeric heart valve of  claim 42 , wherein, in the open position, blood flow velocity through each commissure is substantially the same as blood flow velocity through the other commissures.