Collapsible-expandable prosthetic heart valves with structures for clamping native tissue

Patent metadata

Field	Value
Publication number	US-9820851-B2
Application number	US-201514688415-A
Country	US
Kind code	B2
Filing date	Apr 16, 2015
Priority date	Sep 28, 2007
Publication date	Nov 21, 2017
Grant date	Nov 21, 2017

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.

First claim

The invention claimed is:

1. A prosthetic heart valve, comprising
a stent extending in a longitudinal direction between an inflow end and an outflow end and having a length from the inflow end to the outflow end;
a valve element mounted within the stent; and
a skirt connected to the stent, the skirt having an inside wall overlapping in the longitudinal direction with the valve element, an outside wall, and a space between the inside wall and the outside wall, the inside wall having a first length in the longitudinal direction less than the length of the stent such that an outflow end of the inside wall is positioned at a spaced distance from the outflow end of the stent and the outside wall having a second length in the longitudinal direction less than the first length.

2. The prosthetic heart valve as claimed in claim 1 , wherein the stent has an expanded condition and a collapsed condition, the outside wall of the skirt being adapted to move radially outward into engagement within a native valve annulus to impede paravalvular leakage.

3. The prosthetic heart valve as claimed in claim 1 , wherein the inside wall of the skirt is disposed around the outside of the inflow end of the stent.

4. The prosthetic heart valve as claimed in claim 1 , wherein the stent is self-expanding.

5. The prosthetic heart valve as claimed in claim 1 , wherein the stent is balloon expandable.

6. The prosthetic heart valve as claimed in claim 1 , 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.

7. The prosthetic heart valve as claimed in claim 6 , wherein the first portion of the stent is sized and shaped for implantation in a native aortic valve annulus of a patient.

8. The prosthetic heart valve as claimed in claim 1 , wherein the skirt is positioned at the inflow end of the stent.

9. The prosthetic heart valve as claimed in claim 8 , wherein the skirt is positioned at a spaced distance from an inflow edge of the stent.

10. The prosthetic heart valve as claimed in claim 1 , 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.

11. The prosthetic heart valve as claimed in claim 1 , 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.

12. The prosthetic heart valve as claimed in claim 1 , wherein the skirt includes a polymer.

13. The prosthetic heart valve as claimed in claim 12 , wherein the valve element is formed from tissue.

14. A prosthetic heart valve, comprising
a stent extending in a longitudinal direction between an inflow end and an outflow end and having a length from the inflow end to the 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 overlapping in the longitudinal direction with the valve element and an outside wall, the inside wall having a first length in the longitudinal direction less than the length of the stent such that an outflow end of the inside wall is positioned at a spaced distance from the outflow end of the stent and the outside wall having a second length in the longitudinal direction less than the first length, the skirt being radially expandable into engagement within a native valve annulus to impede paravalvular leakage.

15. The prosthetic heart valve as claimed in claim 14 , wherein in the expanded condition of the stent, the outside wall is spaced away from the stent in outward radial directions.

16. The prosthetic heart valve as claimed in claim 14 , wherein in the expanded condition of the stent, the outside wall is spaced away from the inside wall in outward radial directions.

17. The prosthetic heart valve as claimed in claim 14 , further comprising a fluid between the inside wall and the outside wall, the fluid spacing the outside wall away from the inside wall.

18. The prosthetic heart valve as claimed in claim 14 , 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.

19. The prosthetic heart valve as claimed in claim 14 , wherein the skirt is positioned at a spaced distance from an inflow edge of the stent.

20. A prosthetic heart valve, comprising
a stent extending in a longitudinal direction between an inflow end and an outflow end and having a length from the inflow end to the 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 overlapping in the longitudinal direction with the valve element and an outside wall, the inside wall having a first length in the longitudinal direction less than the length of the stent 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.

21. A prosthetic heart valve, comprising
a stent extending in a longitudinal direction between an inflow end and an outflow end and having a length from the inflow end to the outflow end;
a valve element mounted within the stent; and
a skirt connected to the stent, the skirt having an inside wall overlapping in the longitudinal direction with the valve element, 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 less than the length of the stent such that an outflow end of the inside wall is positioned at a spaced distance from the outflow end of the stent and the outside wall having a second length in the longitudinal direction less than the first length.

22. The prosthetic heart valve as claimed in claim 21 , wherein the skirt is positioned at the inflow end of the stent.

23. The prosthetic heart valve as claimed in claim 21 , 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.

24. The prosthetic heart valve as claimed in claim 21 , 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.

25. The prosthetic heart valve as claimed in claim 21 , wherein the skirt includes a polymer.

26. The prosthetic heart valve as claimed in claim 25 , wherein the valve element is formed from tissue.

Assignees

• St Jude Medical Llc

Inventors

• Braido Peter N

Classifications

• A61F2230/0054

  V-shaped · CPC title

• A61F2220/0008

  Fixation appliances for connecting prostheses to the body · CPC title

• A61F2230/005

  Rosette-shaped, e.g. star-shaped · CPC title

• A61F2230/0078

  hyperboloidal · CPC title

• A61F2/2433

  using balloon catheter · CPC title