COLLAPSIBLE-EXPANDABLE PROSTHETIC HEART VALVES WITH STRUCTURES FOR CLAMPING NATIVE TISSUE

• US 20150216658A1
• Filed: 04/16/2015
• Published: 08/06/2015
• Est. Priority Date: 09/28/2007
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N.
• Granted Patent: US 9,820,851 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

A prosthetic heart valve is designed to be circumferentially collapsible for less invasive delivery into the patient. At the implant site the valve re-expands to a larger circumferential size, i.e., the size that it has for operation as a replacement for one of the patient'"'"'s native heart valves. The valve includes structures that, at the implant site, extend radially outwardly to engage tissue structures above and below the native heart valve annulus. These radially outwardly extending structures clamp the native tissue between them and thereby help to anchor the prosthetic valve at the desired location in the patient.

Claims

1. (canceled)

2. A prosthetic heart valve, comprising

a stent extending in a longitudinal direction between an inflow end and an outflow end;

a valve element mounted within the stent; and

a skirt connected to the stent, the skirt having an inside wall, an outside wall movable away from the inside wall, and a space between the inside wall and the outside wall, the inside wall having a first length in the longitudinal direction and the outside wall having a second length in the longitudinal direction less than the first length.

3. The prosthetic heart valve as claimed in claim 2, wherein the stent has an expanded condition and a collapsed condition, the outside wall of the skirt being adapted to move radially outward from the inside wall of the skirt in the expanded condition into engagement within a native valve annulus to impede paravalvular leakage.

4. The prosthetic heart valve as claimed in claim 2, wherein the inside wall of the skirt is disposed around the outside of the inflow end of the stent.

5. The prosthetic heart valve as claimed in claim 2, wherein the stent is self-expanding.

6. The prosthetic heart valve as claimed in claim 2, wherein the stent is balloon expandable.

7. The prosthetic heart valve as claimed in claim 2, wherein the stent has a first portion adjacent the inflow end of the stent and a second portion adjacent the outflow end of the stent, the first portion of the stent in an expanded condition having a first diameter and the second portion of the stent in the expanded condition having a second diameter larger than the first diameter.

8. The prosthetic heart valve as claimed in claim 7, wherein the first portion of the stent is sized and shaped for implantation in a native aortic valve annulus of a patient.

9. The prosthetic heart valve as claimed in claim 2, wherein the skirt is positioned at the inflow end of the stent.

10. The prosthetic heart valve as claimed in claim 9, wherein the skirt is positioned at a spaced distance from an inflow edge of the stent.

11. The prosthetic heart valve as claimed in claim 2, wherein the skirt extends from an inflow end to an outflow end positioned at a spaced distance from the outflow end of the stent.

12. The prosthetic heart valve as claimed in claim 2, wherein the valve element has a length in the longitudinal direction that is less than a length of the stent from the inflow end to the outflow end.

13. The prosthetic heart valve as claimed in claim 2, wherein the stent includes a plurality of closed cells disposed around a circumference of the stent, each of the closed cells having an area, the area of each of the closed cells at the outflow end of the stent being greater than the area of each of the closed cells at the inflow end of the stent.

14. The prosthetic heart valve as claimed in claim 2, wherein the skirt includes a polymer.

15. The prosthetic heart valve as claimed in claim 14, wherein the valve element is formed from tissue.

16. A prosthetic heart valve, comprising

a stent extending in a longitudinal direction between an inflow end and an outflow end, the stent having an expanded condition and a collapsed condition;

a valve element mounted within the stent; and

a skirt at the inflow end of the stent, the skirt including an inside wall and an outside wall movable away from the inside wall, the inside wall having a first length in the longitudinal direction and the outside wall having a second length in the longitudinal direction less than the first length, in the expanded condition of the stent the skirt being radially expandable into engagement within a native valve annulus to impede paravalvular leakage.

17. The prosthetic heart valve as claimed in claim 16, wherein in the expanded condition of the stent, the outside wall is movable away from the stent in outward radial directions.

18. The prosthetic heart valve as claimed in claim 16, wherein in the expanded condition of the stent, the outside wall is movable away from the inside wall in outward radial directions.

19. The prosthetic heart valve as claimed in claim 16, further comprising a fluid in the empty space, the fluid moving the outside wall away from the inside wall.

20. The prosthetic heart valve as claimed in claim 16, wherein the skirt includes a generally toroidal section having a first radial thickness and a remaining portion having a second radial thickness, the first radial thickness being greater than the second radial thickness to allow extra sealing capacity to prevent paravalvular leakage.

21. The prosthetic heart valve as claimed in claim 16, wherein the skirt is positioned at a spaced distance from an inflow edge of the stent.

22. A prosthetic heart valve, comprising

a stent extending in a longitudinal direction between an inflow end and an outflow end, the stent having an expanded condition and a collapsed condition;

a valve element mounted within the stent; and

a skirt connected to the stent, the skirt having an inside wall and an outside wall, the inside wall having a first length in the longitudinal direction and the outside wall having a second length in the longitudinal direction less than the first length, in the expanded condition of the stent the outside wall of the skirt being positioned at a radially outward spaced distance from the stent to provide extra sealing capacity to prevent paravalvular leakage.

23. A prosthetic heart valve, comprising

a stent extending in a longitudinal direction between an inflow end and an outflow end;

a valve element mounted within the stent; and

a skirt connected to the stent, the skirt having an inside wall, an outside wall and a chamber between the inside wall and the outside wall, the inside wall having a first length in the longitudinal direction and the outside wall having a second length in the longitudinal direction less than the first length.

24. The prosthetic heart valve as claimed in claim 23, wherein the skirt is positioned at the inflow end of the stent.

25. The prosthetic heart valve as claimed in claim 23, wherein the skirt extends from an inflow end to an outflow end positioned at a spaced distance from the outflow end of the stent.

26. The prosthetic heart valve as claimed in claim 23, wherein the valve element has a length in the longitudinal direction that is less than a length of the stent from the inflow end to the outflow end.

27. The prosthetic heart valve as claimed in claim 23, wherein the stent includes a plurality of closed cells disposed around a circumference of the stent, each of the closed cells having an area, the area of each of the closed cells at the outflow end of the stent being greater than the area of each of the closed cells at the inflow end of the stent.

28. The prosthetic heart valve as claimed in claim 23, wherein the skirt includes a polymer.

29. The prosthetic heart valve as claimed in claim 28, wherein the valve element is formed from tissue.