ARTIFICIAL, FLEXIBLE VALVES AND METHODS OF FABRICATING AND SERIALLY EXPANDING THE SAME
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)