Perivalvular sealing for transcatheter heart valve

• US 10,076,411 B2
• Filed: 08/24/2016
• Issued: 09/18/2018
• Est. Priority Date: 07/15/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yohanan, Ziv, Gurovich, Nikolay, Felsen, Bella, Pelled, Itai, Meiri, Oded
• Primary Examiner(s): Schillinger, Ann
• Application Number:
  US15/246,234
• Publication Number:
  US 20160361163A1
• Time in Patent Office: 755 Days
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0065 telescopic
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

The present disclosure is directed to embodiments of catheter-based prosthetic heart valves, and in particular, prosthetic heart valves having sealing devices configured to seal the interface between the prosthetic valve and the surrounding tissue of the native annulus in which the prosthetic valve is implanted. In one embodiment, a prosthetic heart valve includes an annular sealing member that can be placed in a delivery orientation extending axially away from one end of the valve when the valve is in a radially compressed state. When the valve is expanded, the expansion of the frame causes the sealing member to be pulled to an operative orientation covering a portion of the frame. The present disclosure also discloses new mechanisms and techniques for mounting valve leaflets to a frame of a prosthetic heart valve.

Claims

1. A prosthetic heart valve comprising:

a collapsible and expandable annular frame that is configured to be collapsed to a radially collapsed state for mounting on a delivery apparatus and expanded to a radially expanded state inside a patient'"'"'s body, the frame having an inflow end, an outflow end, and a lumen extending from the inflow end to the outflow end, the frame comprising a plurality of struts defining a plurality of cells;

a collapsible and expandable valve member mounted within the annular frame;

a collapsible and expandable annular sealing member coupled to the annular frame, wherein the sealing member is configured to contact and create a seal against tissue surrounding the prosthetic valve once implanted in a patient'"'"'s body; and

a first suture secured to the annular frame and circumferentially extending across a circumferentially extending row of the cells of the annular frame, wherein the suture extends across a midpoint of each cell in the row of cells;

a second suture securing the sealing member to the annular frame along an inflow end of the sealing member; and

a third suture securing the sealing member to the annular frame along an outflow end of the sealing member;

wherein the first suture is positioned axially between the second suture and the third suture;

wherein portions of the sealing member extending over the row of cells can expand radially outwardly from the frame;

wherein the first suture is secured to opposing side struts of each cell in the row of cells;

wherein the first suture is spaced between an inflow end of the row of cells and an outflow end of the row of cells along a length of the frame;

wherein the first suture extends continuously around the lumen of the frame; and

wherein the first suture is positioned to prevent the annular sealing member from protruding into the lumen of the annular frame in the radially expanded state and contacting the valve member.

2. The prosthetic heart valve of claim 1, wherein the first suture is secured to the annular frame between the inflow end and a third row of struts.

3. The prosthetic heart valve of claim 1, wherein the annular frame has an interior and an exterior, and the annular sealing member is coupled to the interior of the frame.

4. The prosthetic heart valve of claim 3, wherein portions of the annular sealing member are adapted to protrude radially outwardly through cells of the frame to seal against native tissue.

5. A prosthetic heart valve comprising:

a collapsible and expandable annular frame that is configured to be collapsed to a radially collapsed state for mounting on a delivery apparatus and expanded to a radially expanded state inside a patient'"'"'s body, the frame having an inflow end, an outflow end, and a lumen extending from the inflow end to the outflow end, the frame comprising a plurality of struts defining a plurality of cells;

a collapsible and expandable valve member mounted within the annular frame;

a collapsible and expandable annular sealing member coupled to the annular frame, wherein the sealing member is configured to contact and create a seal against tissue surrounding the prosthetic valve once implanted in a patient'"'"'s body;

a first suture secured to the annular frame and extending across at least one of the plurality of cells;

a second suture securing the sealing member to the annular frame along an inlet end of the sealing member; and

a third suture securing the sealing member to the annular frame along an outlet end of the sealing member, wherein the first suture is positioned axially between the second suture and the third suture;

wherein the first suture extends continuously around the lumen of the annular frame across a first set of cells;

wherein the first set of cells comprises a circumferentially extending row of cells disposed between the inflow and outflow ends of the annular frame; and

wherein the first suture extends across a midpoint of each cell in the first set of cells.

6. The prosthetic heart valve of claim 5, wherein the first suture is secured to the annular frame between the inflow end and a third row of struts.

7. The prosthetic heart valve of claim 5, wherein the first suture is secured to opposing side struts of at least one of the plurality of cells.

8. The prosthetic valve of claim 5, wherein the first suture is positioned to prevent slack portions of the annular sealing member from protruding into the lumen of the annular frame in the radially expanded state and contacting the valve assembly.

9. The prosthetic heart valve of claim 5, wherein the annular frame has an interior and an exterior, and the annular sealing member is coupled to the interior of the frame.

10. The prosthetic heart valve of claim 9, wherein portions of the annular sealing member are adapted to protrude radially outwardly through cells of the frame to seal against native tissue.

11. A method of implanting a prosthetic heart valve comprising:

delivering the prosthetic heart valve to a native heart valve region with the prosthetic heart valve in a radially compressed configuration, wherein the prosthetic heart valve comprises;

a collapsible and expandable annular frame that is configured to be collapsed to a radially collapsed state for mounting on a delivery apparatus and expanded to a radially expanded state inside a patient'"'"'s body, the frame having an inflow end, an outflow end, and a lumen extending from the inflow end to the outflow end, the frame comprising a plurality of struts defining a plurality of cells;

a collapsible and expandable valve member mounted within the annular frame;

a collapsible and expandable annular sealing member coupled to the annular frame, wherein the sealing member is configured to contact and create a seal against tissue surrounding the prosthetic valve once implanted in a patient'"'"'s body;

a first suture secured to the annular frame and circumferentially extending across a circumferentially extending row of the cells of the annular frame, wherein the suture extends across a midpoint of each cell in the row of cells;

a second suture securing the sealing member to the annular frame along an inflow end of the sealing member; and

a third suture securing the sealing member to the annular frame along an outflow end of the sealing member;

wherein the first suture is positioned axially between the second suture and the third suture;

wherein portions of the sealing member extending over the row of cells can expand radially outwardly from the frame;

wherein the first suture is secured to opposing side struts of each cell in the row of cells;

wherein the first suture is spaced between an inflow end of the row of cells and an outflow end of the row of cells along a length of the frame;

wherein the first suture extends continuously around the lumen of the frame; and

wherein the first suture is positioned to prevent the annular sealing member from protruding into the lumen of the annular frame in the radially expanded state and contacting the valve member;

expanding the prosthetic heart valve from the radially compressed configuration to a radially expanded configuration; and

positioning the prosthetic heart valve within a native annulus, wherein the sealing member contacts and creates a seal against tissue of the native annulus.

12. The method of claim 11, wherein the suture extends continuously around the lumen of the annular frame across a first set of cells when the prosthetic valve is in the radially expanded configuration.

13. The method of claim 12, wherein the first set of cells comprises a circumferentially extending row of cells disposed between the inflow and outflow ends of the annular frame.

14. The method of claim 11, wherein the suture is secured to the annular frame between the inflow end and a third row of struts.

15. The method of claim 11, wherein the suture extends across a midpoint of at least one of the plurality of cells when the prosthetic valve is in the radially expanded configuration.

16. The method of claim 11, wherein the suture is secured to opposing side struts of at least one of the plurality of cells.