Implantable Prosthetic Valves and Methods Relating to Same

• US 20090164003A1
• Filed: 12/22/2008
• Published: 06/25/2009
• Est. Priority Date: 12/20/2007
• Status: Active Grant

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: University of South Carolina
• Inventors: Kheradvar, Arash
• Granted Patent: US 8,876,897 B2
• Time in Patent Office: Days
• US Class Current: 623/2.100
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

In accordance with one embodiment of the present disclosure, a prosthetic valve is provided. The prosthetic valve includes an annulus, a pair of leaflets, and a pair of support elements. The annulus has a generally saddle-shape formed by a movable pair of first portions separated from each other by a movable pair of second portions. The pair of leaflets extend from the annulus and are separated from each other by the pair of support elements. The first portions of the annulus and the second portions of the annulus are configured to move back and forth from being generally concave to being generally convex such that any movement of the first portions of the annulus occurs at generally the same time as any movement of the second portions of the annulus.

Claims

1. A prosthetic valve comprising an annulus, a pair of leaflets, and a pair of support elements,

the annulus having a generally saddle-shape formed by a movable pair of first portions separated from each other by a movable pair of second portions, the pair of leaflets extending from the annulus and being separated from each other by the pair of support elements,

wherein the first portions of the annulus and the second portions of the annulus are configured to move back and forth from being generally concave to being generally convex such that any movement of the first portions of the annulus occurs at generally the same time as any movement of the second portions of the annulus,

wherein the pair of leaflets are configured to define an opening when the first portions of the annulus are each generally concave and the second portions of the annulus are each generally convex, and

wherein the pair of leaflets are configured to define a seal when the first portions of the annulus are each generally convex and the second portions of the annulus are each generally concave.

2. The prosthetic valve of claim 1, wherein the annulus and the pair of support elements comprise a shape memory material.

3. The prosthetic valve of claim 2, wherein the shape memory material comprises a nickel titanium alloy.

4. The prosthetic valve of claim 1, wherein the pair of leaflets comprise synthetic material, engineered biological tissue, biological valvular leaflet tissue, pericardial tissue, cross-linked pericardial tissue, or combinations thereof.

5. The prosthetic valve of claim 4, wherein the pericardial tissue is selected from the group consisting of bovine, equine, porcine, ovine, human tissue, or combinations thereof.

6. The prosthetic valve of claim 4, wherein the material or tissue comprises a compliant membrane of a single sheet or a compound manifold.

7. The prosthetic valve of claim 1, wherein one support element is adjacent to one second portion of the annulus and the other support element is adjacent to the other second portion of the annulus.

8. The prosthetic valve of claim 1, wherein the support elements are curved away from one another when the pair of leaflets define a seal.

9. The prosthetic valve of claim 1, wherein the support elements are curved towards one another when the pair of leaflets define an opening.

10. The prosthetic valve of claim 1, wherein the pair of leaflets are configured to define a seal during systole.

11. The prosthetic valve of claim 1, wherein the pair of leaflets are configured to define an opening during diastole.

12. A prosthetic valve comprising an annulus, a pair of leaflets, and a pair of support elements,

the annulus having a generally saddle-shape formed by a movable pair of first portions separated from each other by a movable pair of second portions, the pair of leaflets extending from the annulus and being separated from each other by the pair of support elements with one support element being adjacent to one second portion of the annulus and the other support element being adjacent to the other second portion of the annulus,

wherein the first portions of the annulus and the second portions of the annulus are configured to move back and forth from being generally concave to being generally convex such that any movement of the first portions of the annulus occurs at generally the same time as any movement of the second portions of the annulus,

wherein the pair of leaflets are configured to define an opening when the first portions of the annulus are each generally concave, the second portions of the annulus are each generally convex, and the support elements are curved towards one another, and

wherein the pair of leaflets are configured to define a seal when the first portions of the annulus are each generally convex, the second portions of the annulus are each generally concave, and the support elements are curved away from one another.

13. The prosthetic valve of claim 12, wherein the annulus and the pair of support elements comprise a shape memory material.

14. The prosthetic valve of claim 13, wherein the shape memory material comprises a nickel titanium alloy.

15. The prosthetic valve of claim 12, wherein the pair of leaflets comprise synthetic material, engineered biological tissue, biological valvular leaflet tissue, pericardial tissue, cross-linked pericardial tissue, or combinations thereof.

16. The prosthetic valve of claim 15, wherein the pericardial tissue is selected from the group consisting of bovine, equine, porcine, ovine, human tissue, or combinations thereof.

17. The prosthetic valve of claim 15, wherein the material or tissue comprises a compliant membrane of a single sheet or a compound manifold.

18. A method of implanting a prosthetic valve in a patient comprising:

delivering a prosthetic valve to an implant site in a patient, the prosthetic valve comprising an annulus, a pair of leaflets, and a pair of support elements,

the annulus having a generally saddle-shape formed by a movable pair of first portions separated from each other by a movable pair of second portions, the pair of leaflets extending from the annulus and being separated from each other by the pair of support elements,

wherein the first portions of the annulus and the second portions of the annulus are configured to move back and forth from being generally concave to being generally convex such that any movement of the first portions of the annulus occurs at generally the same time as any movement of the second portions of the annulus,

wherein the pair of leaflets are configured to define an opening when the first portions of the annulus are each generally concave and the second portions of the annulus are each generally convex,

wherein the pair of leaflets are configured to define a seal when the first portions of the annulus are each generally convex and the second portions of the annulus are each generally concave; and

deploying the prosthetic valve at the implant site.

19. The method of claim 18, wherein the implant site comprises a cardiovascular system, a venous system, an esophagus, a stomach, a ureter, a urethral, a biliary passage, or an intestine.

20. The method of claim 18, wherein delivering the prosthetic valve to the implant site in the patient further comprises a percutaneous procedure, a trans-apical catheterization, an endoscopic procedure, a laproscopic procedure, or an apical open-chest procedure.