Artificial, flexible valves and methods of fabricating and serially expanding the same

Abstract

One aspect of the invention provides an artificial, flexible valve including: a stent defining a wall and a plurality of leaflets extending from the wall of the stent. The plurality of leaflets form a plurality of coaptation regions between two adjacent leaflets. The coaptation regions include extensions along a z-axis and adapted and are configured to form a releasable, but substantially complete seal when the leaflets are in a closed position. Another aspect of the invention provides an artificial, flexible valve including: a stent defining a wall and a plurality of leaflets extending from the wall of the stent. Each of the plurality of leaflets terminates in a commissure line. The commissure lines deviate from a hyperbola formed in the x-y plane by at least one deviation selected from the group consisting of: a deviation in the z-direction and one or more curves relative to the hyperbola.

1 . An artificial, flexible valve comprising:
 a stent defining a wall; and   a plurality of leaflets extending from the wall of the stent, the plurality of leaflets forming a plurality of coaptation regions between two adjacent leaflets, the coaptation regions each having a substantially hyperbolic profile including extensions along a z-axis and adapted and configured to form a releasable, but substantially complete seal when the leaflets are in a closed position.   
     
     
         2 . The valve of  claim 1 , wherein the extensions have a length along the z-axis between about 1 mm and about 10 mm. 
     
     
         3 . The valve of  claim 1 , wherein the extensions have a curved profile. 
     
     
         4 . The valve of  claim 3 , wherein the curved profile lies in an x-y plane. 
     
     
         5 . The valve of  claim 3 , wherein the curved profile is a variance in extension length along the z-axis. 
     
     
         6 . (canceled) 
     
     
         7 . The valve of  claim 1 , wherein each of the plurality of leaflets has a substantially elliptical leaflet-stent attachment line. 
     
     
         8 . (canceled) 
     
     
         9 . The valve of  claim 1 , wherein one or more from the group consisting of: the leaflets, the coaptation regions, and the leaflet stent attachment lines are reinforced with one or more selected from the group consisting of: reinforcing materials and directional fibers. 
     
     
         10 . (canceled) 
     
     
         11 . The valve of  claim 1 , wherein adjacent leaflets are coupled to a wide post of the stent. 
     
     
         12 . The valve of  claim 11 , wherein the wide post includes one or more windows. 
     
     
         13 .- 15 . (canceled) 
     
     
         16 . The valve of  claim 1 , wherein:
 the leaflets are formed from a first polymer; and   the stent is dip-coated in a second polymer; and   the leaflets are coupled to the second polymer mechanically, chemically, or by one or more techniques selected from the group consisting of: gluing, chemical fusing, thermal fusing, sonic welding, stitching, and mechanical fastening.   
     
     
         17 .- 23 . (canceled) 
     
     
         24 . The valve of  claim 1 , wherein:
 a leaflet-stent attachment line for each of the plurality of leaflets substantially approximates a frame of the stent; and   the leaflet-stent attachment line lies within about 3 mm of the frame of the stent.   
     
     
         25 . (canceled) 
     
     
         26 . The valve of  claim 1 , wherein the stent includes one or more anchor points. 
     
     
         27 . (canceled) 
     
     
         28 . The valve of  claim 1 , wherein the valve is adapted and configured for replacement of one or more cardiac valves selected from the group consisting of: aortic, mitral, tricuspid, and pulmonary or insertion in a subject's veins in order to treat venous insufficiency. 
     
     
         29 . (canceled) 
     
     
         30 . (canceled) 
     
     
         31 . An artificial, flexible valve comprising:
 a stent defining a wall; and   a plurality of leaflets extending from the wall of the stent, each of the plurality of leaflets terminating in a commissure line, the commissure lines deviating from a hyperbola formed in the x-y plane by at least one deviation selected from the group consisting of: a deviation in the z-direction and one or more curves relative to the hyperbola.   
     
     
         32 .- 60 . (canceled) 
     
     
         61 . An artificial, flexible valve comprising:
 an expandable, cylindrical stent defining a wall; and   a plurality of leaflets extending from the wall of the stent, wherein adjacent leaflets are coupled to a relatively wide post of the stent.   
     
     
         62 .- 90 . (canceled) 
     
     
         91 . A mandrel comprising:
 a cylindrical profile; and   a plurality of recesses adapted and configured to define a plurality of leaflets forming a plurality of coaptation regions between two adjacent leaflets, the coaptation regions including extensions along a z-axis and adapted and configured to form a releasable, but substantially complete seal when the leaflets are in a closed position.   
     
     
         92 . The mandrel of  claim 91 , further comprising:
 one more cutting guides located between the plurality of recesses.   
     
     
         93 . The mandrel of  claim 91 , further comprising:
 one or more heating elements.   
     
     
         94 . A mandrel comprising:
 a cylindrical profile; and   a plurality of recesses adapted and configured to define a plurality of leaflets, each of the plurality of leaflets terminating in a commissure line, the commissure lines deviating from a hyperbola formed in the x-y plane by at least one deviation selected from the group consisting of: a deviation in the z-direction and one or more curves relative to the hyperbola.   
     
     
         95 . (canceled) 
     
     
         96 . (canceled) 
     
     
         97 . A method for fabricating an artificial, flexible valve, the method comprising:
 dip coating a cylindrical mandrel having a plurality of recesses each approximating a profile of a leaflet; and   coupling the leaflets to an inner wall of a stent;   
       wherein the stent and the mandrel have larger diameters than a target location for the valve. 
     
     
         98 .- 100 . (canceled)