Perivalvular sealing for transcatheter heart valve

• US 8,795,357 B2
• Filed: 07/13/2012
• Issued: 08/05/2014
• Est. Priority Date: 07/15/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yohanan, Ziv, Gurovich, Nik, Felsen, Bella, Pelled, Itai, Meiri, Oded
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US13/549,068
• Publication Number:
  US 20130018458A1
• Time in Patent Office: 753 Days
• Field of Search: 623 111- 154
• US Class Current: 623/2.14
• 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 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 having an inflow end and an outflow end, the sealing member being 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 such that a proximal pulling force on the sealing member causes the sealing member to be displaced axially relative to the frame toward the outflow end of the frame in a direction parallel to the longitudinal axis to an operative orientation in which the outflow end of the sealing member is moved closer to the outflow end of the frame and the inflow end of the sealing member is moved closer to the inflow end of the frame and 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 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.

5. 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.

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

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

at least one tether having a first end portion and a second end portion, the first end portion secured adjacent to the outflow end of the sealing member, the at least one tether dimensioned to permit the second end portion to extend outside of a body of a patient when the frame, the valve member, and the sealing member are inside the patient'"'"'s vasculature, the second end portion operable to move the sealing member axially to cover a portion of the frame when the proximal pulling force is applied to the second end portion of the tether, which in turn transmits the pulling force to the sealing member to cause the sealing member to be axially displaced.

8. The prosthetic heart valve of claim 7, further comprising a knob or actuator, the second end portion coupled to the knob or actuator, the knob or actuator being configured to apply the proximal pulling force to the tether to axially displace the sealing member.

9. The prosthetic valve of claim 7, wherein the at least one tether comprises first and second tethers having respective first portions secured to diametrically opposing sides of the sealing member.

10. The prosthetic valve of claim 1, further comprising at least one tether comprising a thin, flexible metal wire, stainless steel wire, or suture material.

11. 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 having an inflow end and an outflow end, the sealing member being 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 such that a proximal pulling force applied to the sealing member causes the sealing member to move from the delivery orientation to an operative orientation in which the outflow end of the sealing member is moved closer to the outflow end of the frame and the sealing member covers at least a portion of the cells of the frame.

12. The prosthetic valve of claim 11, further comprising at least one tether having a first end portion and a second end portion, the first end portion secured the sealing member, the at least one tether dimensioned to permit the second end portion to extend outside of a body of a patient when the frame, the valve member, and the sealing member are inside the patient'"'"'s vasculature, the second end portion being operable to move the sealing member axially from the delivery orientation to the operative orientation when the proximal pulling force is applied to the second end portion of the tether, which in turn transmits the pulling force to the sealing member to cause the sealing member to be moved to the operative orientation.

13. The prosthetic valve of claim 12, wherein the sealing member is coupled to the frame such that application of the pulling force on the tether is effective to displace the outflow end of the sealing member closer to the outflow end of the frame and displace the inflow end of the sealing member closer to the inflow end of the frame.

14. The prosthetic valve of claim 12, wherein the inflow end of the sealing member is secured to the inflow end of the frame and the application of the pulling force on the tether is effective to pull the sealing member into an everted position extending over the frame.