PERIVALVULAR SEALING FOR TRANSCATHETER HEART VALVE

• US 20130018458A1
• Filed: 07/13/2012
• Published: 01/17/2013
• Est. Priority Date: 07/15/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yohanan, Ziv, Felsen, Bella, Pelled, Itai, Meiri, Oded, Gurovich, Nik
• Granted Patent: US 8,795,357 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• 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 the body, the frame having an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end, the frame comprising a plurality of struts defining a plurality of cells; and

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

a collapsible and expandable annular sealing member coupled to the frame such that when the frame is in its radially collapsed state, the sealing member can be placed in a delivery orientation in which the sealing member is radially collapsed and extends from the inflow end of the frame in a direction away from the outflow end of the frame and when the frame is expanded to its radially expanded state, the sealing member is caused to move toward the outflow end of the frame in a direction parallel to the longitudinal axis to an operative orientation in which the sealing member covers at least a portion of the cells of the frame.

2. The prosthetic heart valve of claim 1, further comprising:

a tether having first and second end portions and an intermediate portion extending between the first and second end portions, the first and second end portions being secured to the sealing member at spaced apart locations, and the intermediate portion extending through the frame such that when the frame is in its radially collapsed state, the intermediate portion decreases in length and the first and second end portions increase in length to allow the sealing member to be placed in the delivery orientation and when the frame is expanded to its radially expanded state, the radial expansion of the frame causes the intermediate portion to increase in length and the first and second end portions to decrease in length, which is effective to pull the sealing member from the delivery orientation to the operative orientation.

3. The prosthetic valve of claim 2, wherein the first and second end portions are secured to diametrically opposing portions of the sealing member and extend along opposite sides of the outer surface of the frame, and the intermediate portion of the tether extends transversely through the frame from a first location on the frame to a second location on the frame that is diametrically opposed to the first location.

4. The prosthetic heart valve of claim 1, wherein the sealing member is coupled to the frame such that the sealing member extends over the outside surface of the frame when the sealing member is moved to the operative orientation.

5. The prosthetic heart valve of claim 1, wherein the sealing member comprises a fabric.

6. The prosthetic heart valve of claim 2, wherein the tether is configured to pull the sealing member along an outer surface of the frame from the delivery orientation to the operative orientation when the frame is expanded.

7. 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 the body, the frame comprising a plurality of struts defining a plurality of cells;

a collapsible and expandable valve member mounted within the annular frame, the valve member comprising a plurality of leaflets, each leaflet having a pair of opposing tab portions, each tab portion being paired to another tab portion of an adjacent leaflet to form a commissure of the valve member;

a plurality of leaflet clips, each leaflet clip extending over a pair of tab portions of a commissure and applying a compressive force against the tab portions such that the tab portions are held in a compressed state between the clip; and

a commissure securement portion associated with each commissure of the valve member and being sutured to the frame, each commissure securement portion comprising a first layer of material positioned radially outward of a clip of the corresponding commissure and a second layer of material positioned radially inward of the clip so as to hold the commissure in place relative to the frame.

8. The prosthetic heart valve of claim 7, wherein the sutures securing the commissure securement portions to the frame do not extend through the tab portions of the leaflets.

9. The prosthetic heart valve of claim 7, wherein there are no sutures extending through the tab portions of the leaflets.

10. The prosthetic heart valve of claim 7, further comprising an annular sealing member coupled to the frame.

11. The prosthetic heart valve of claim 10, wherein the sealing member is mounted on the inside of the frame and has portions configured to protrude radially outward through the cells of the frame when the frame is in the expanded state.

12. The prosthetic heart valve of claim 10, wherein the sealing member has an inflow edge secured to the frame, an outflow edge secured to the frame, and a slack portion extending between the inflow edge and the outflow edge that is not secured to the frame, the slack portion being configured to protrude radially outward through the cells of the frame when the frame is in the expanded state and subjected to a pressure gradient causing the leaflets to close.

13. The prosthetic heart valve of claim 10, wherein the commissure securement portions are integral extensions of the sealing member.

14. The prosthetic heart valve of claim 7, wherein each clip comprises a substantially U-shaped body comprising two elongated leg portions that apply the compressive force against the tab portions of a corresponding commissure.

15. The prosthetic heart valve of claim 7, wherein the frame comprises a homogenous pattern of hexagonal cells.

16. The prosthetic heart valve of claim 15, wherein each cell comprises six struts, including two side struts extending parallel to the flow axis of the valve, a pair of lower angled struts, and a pair of upper angled struts, the pair of lower angled struts extending downwardly from respective lower ends of the side struts and converging toward each other, and the pair of upper angled struts extending upwardly from respective upper ends of the side struts and converging toward each other.

17. 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 the body, the frame having an inflow end, an outflow end, and a longitudinal axis 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; and

a collapsible and expandable annular sealing member coupled to the frame, the sealing member comprising an annular first portion secured to the struts on the outside of the frame and a second portion comprising a plurality of circumferentially spaced apart flaps that are free to pivot relative to the frame, wherein the flaps comprise a fabric that is heat set such that the flaps extend radially outwardly from the frame when the frame is in the radially expanded state.

18. The prosthetic heart valve of claim 17, wherein the flaps can be folded against the annular first portion of the sealing member when the frame is in the radially collapsed state.

19. The prosthetic heart valve of claim 17, wherein the flaps extend radially outwardly from the inflow end of the frame.

20. The prosthetic heart valve of claim 17, wherein the flaps are not supported by any metal supports extending outwardly from the frame.

21. The prosthetic heart valve of claim 17, wherein the sealing member comprises a first sealing member and the prosthetic heart valve comprises a second annular sealing member, the second annular sealing member comprising a plurality of circumferentially spaced apart flaps that are free to pivot relative to the frame, the flaps of the second sealing member being circumferentially offset from the flaps of the first sealing member such that the flaps of the second sealing member are aligned with the spaces between the flaps of the first sealing member.

22. The prosthetic heart valve of claim 17, wherein the sealing member comprises a polyethylene terephthalate fabric.

23. The prosthetic heart valve of claim 17, wherein the flaps extend longitudinally away from the inflow end of the frame to avoid overlapping the frame when the frame is in the radially collapsed state.