Single conduit heart valve with unitary leaflet and skirt
Embodiments herein relate to prosthetic heart valves constructed with animal tissue wherein the leaflets are unitary with the inner skirt. In an embodiment, an implantable heart valve assembly is included having a plurality of valve leaflets, an inner skirt, and a metal frame, wherein the plurality of valve leaflets and the inner skirt are formed of a continuous piece of animal tissue. In another embodiment, a method of making an implantable heart valve assembly is included, the method including placing a piece of pericardial tissue over a mold, cross-linking the pericardial tissue in place over the mold, removing the pericardial tissue from the mold, and attaching the pericardial tissue to a frame, wherein the pericardial tissue forms a seamless junction between a plurality of valve leaflets and an inner skirt. Other embodiments are also included herein.
1 . An implantable heart valve assembly comprising:
a plurality of valve leaflets, the plurality of valve leaflets comprising an animal tissue, wherein the animal tissue comprises pericardium tissue;
a seamless inner skirt, the seamless inner skirt comprising the animal tissue; and
a metal frame;
wherein the plurality of valve leaflets and the seamless inner skirt are formed of a continuous piece of animal tissue.
2 . The implantable heart valve assembly of claim 1 , wherein the leaflets and seamless inner skirt are attached without suturing.
3 . The implantable heart valve assembly of claim 1 , wherein a first surface of the animal tissue defines an outer portion of the seamless inner skirt and an outer portion of the plurality of valve leaflets.
4 . The implantable heart valve assembly of claim 1 , further comprising:
an outer skirt, the outer skirt comprising an animal tissue.
5 . An implantable heart valve assembly comprising:
a plurality of valve leaflets, the plurality of valve leaflets comprising an animal tissue;
a seamless inner skirt, the seamless inner skirt comprising the animal tissue; and
a metal frame;
wherein the plurality of valve leaflets and the seamless inner skirt are formed of a continuous piece of animal tissue;
wherein a first surface of the animal tissue defines an outer portion of the seamless inner skirt and an outer portion of the plurality of valve leaflets;
wherein the plurality of valve leaflets exhibits a symmetric pericardial fiber orientation.
6 . The implantable heart valve assembly of claim 5 , wherein the animal tissue has a thickness of 100 to 500 microns.
7 . The implantable heart valve assembly of claim 5 , wherein the animal tissue exhibits a different degree of cross-linking in different areas of the implantable heart valve assembly.
8 . The implantable heart valve assembly of claim 5 , further comprising:
an outer skirt, the outer skirt comprising an animal tissue.
9 . The implantable heart valve assembly of claim 8 , wherein the plurality of valve leaflets, the seamless inner skirt, and the outer skirt are formed of the continuous piece of animal tissue.
10 . The implantable heart valve assembly of claim 8 , wherein the plurality of valve leaflets, the seamless inner skirt, and the outer skirt are formed of a single piece of pericardium.
11 . The implantable heart valve assembly of claim 8 , wherein the outer skirt wraps around an end of the metal frame and rests against an outside surface of the metal frame.
12 . The implantable heart valve assembly of claim 5 , wherein the plurality of valve leaflets and the seamless inner skirt are sutured to the metal frame.
13 . The implantable heart valve assembly of claim 5 , wherein the plurality of valve leaflets comprising:
commissures;
a nadir; and
a reinforcing structure, wherein the reinforcing structure is positioned in the area of at least one of the commissures and the nadir.
14 . The implantable heart valve assembly of claim 5 , wherein the plurality of valve leaflets exhibits a curved bias from in situ cross-linking.
15 . The implantable heart valve assembly of claim 5 , wherein the leaflets and seamless inner skirt are attached without suturing.
16 . An implantable heart valve assembly comprising:
a plurality of valve leaflets, the plurality of valve leaflets comprising an animal tissue;
a seamless inner skirt, the seamless inner skirt comprising the animal tissue; and
a metal frame;
wherein the plurality of valve leaflets and the seamless inner skirt are formed of a continuous piece of animal tissue;
wherein a first surface of the animal tissue defines an outer portion of the seamless inner skirt and an outer portion of the plurality of valve leaflets;
wherein the plurality of valve leaflets exhibits an asymmetric pericardial fiber orientation.
17 . The implantable heart valve assembly of claim 16 , wherein the animal tissue has a thickness of 100 to 500 microns.
18 . The implantable heart valve assembly of claim 16 , wherein the animal tissue exhibits a different degree of cross-linking in different areas of the implantable heart valve assembly.
19 . The implantable heart valve assembly of claim 16 , further comprising:
an outer skirt, the outer skirt comprising an animal tissue.
20 . The implantable heart valve assembly of claim 19 , wherein the plurality of valve leaflets, the seamless inner skirt, and the outer skirt are formed of the continuous piece of animal tissue.