Replacement heart valves and methods of delivery

• US 10,117,744 B2
• Filed: 08/25/2016
• Issued: 11/06/2018
• Est. Priority Date: 08/26/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Ratz, J. Brent, Pesce, Luca, Vad, Siddharth, Johnson, Garrett Dallas
• Primary Examiner(s): Dukert, Brian
• Application Number:
  US15/247,461
• Publication Number:
  US 20170056166A1
• Time in Patent Office: 803 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A valve prosthesis can be configured to be deployed within a native heart valve and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the native heart valve, a flap assembly positioned around an exterior of the expandable frame, a proximal end of the flap assembly being positioned at or proximate a proximal end of the expandable frame. In some embodiments, the flap assembly can extend outward from the frame and have an expanded configuration configured to create a barrier to fluid flow exterior to the frame when deployed within the native heart valve.

Claims

1. A valve prosthesis configured to be deployed within a native heart valve at a native heart valve annulus, the valve prosthesis comprising:

an expandable frame comprising a proximal end, a distal end, a middle portion between the proximal end and the distal end, and a longitudinal axis extending therethrough, the frame configured to collapse radially for delivery and to expand radially upon deployment;

a plurality of circumferentially spaced apart distal anchors extending from the distal end of the frame towards the proximal end and expandable from a collapsed configuration to an expanded configuration, each of the plurality of circumferentially spaced apart distal anchors covered at least partially by a cushion;

a plurality of tips having enlarged ends extending from the proximal end and configured to engage a locking mechanism of a delivery system for the prosthesis, wherein when the valve prosthesis is expanded at the native heart valve the plurality of tips are configured to be located on a first side of the native heart valve annulus and the plurality of circumferentially spaced apart distal anchors are configured to be located on a second side of the native heart valve annulus;

a valve body positioned within an interior of the expandable frame, wherein the valve body comprises a plurality of leaflets configured to allow flow in a first direction and prevent flow in a second opposite direction;

a flap assembly positioned around and secured to an exterior of the expandable frame; and

a biasing outer portion positioned radially outward and extending circumferentially around the middle portion of the frame when the frame is in an expanded configuration, the biasing outer portion being configured to bias the flap assembly radially outward from the longitudinal axis of the frame to provide a space having a distal opening between the flap assembly and the valve body;

wherein when fluid flows into the space, the flap assembly creates a barrier to fluid flow exterior to the middle portion of the frame when the valve prosthesis is deployed within the native heart valve.

2. The valve prosthesis of claim 1, wherein the biasing outer portion comprises a plurality of biasing arms.

3. The valve prosthesis of claim 1, wherein the biasing outer portion extends radially outward from the frame.

4. The valve prosthesis of claim 1, wherein the biasing outer portion extends towards the proximal end of the frame.

5. The valve prosthesis of claim 1, wherein the biasing outer portion extends towards the distal end of the frame.

6. The prosthesis of claim 1, wherein the biasing outer portion is configured to bias the flap assembly radially outward from an exterior of the middle portion of the frame.

7. The prosthesis of claim 1, wherein the biasing outer portion is positioned along an exterior of the flap assembly.

8. The valve prosthesis of claim 1, wherein a proximal end of the flap assembly follows a curvature of the proximal end of the frame.

9. The valve prosthesis of claim 1, wherein a proximal end of the flap assembly extends along an exterior of the proximal end of the frame.

10. The valve prosthesis of claim 1, wherein a proximal end of the flap assembly extends along an interior of the proximal end of the frame.

11. The prosthesis of claim 1, wherein the valve body comprises a liner extending along an interior of the frame.

12. The prosthesis of claim 11, wherein the liner is attached to the leaflets of the valve body.

13. The prosthesis of claim 11, wherein the flap assembly is attached to the liner.

14. The prosthesis of claim 1, further comprising a proximal anchoring feature extending from the frame and expandable from a collapsed configuration to an expanded configuration.

15. The prosthesis of claim 1, further comprising one or more bio-resorbable components.

16. The prosthesis of claim 15, wherein at least one of the one or more bio-resorbable components is configured to engage a delivery system.

17. The prosthesis of claim 15, wherein at least one of the one or more bio-resorbable components is configured to be positioned at or proximate tips of the distal anchoring feature.

19. The prosthesis of claim 1, wherein the proximal end has a zig-zag configuration.

20. The prosthesis of claim 1, wherein each of the plurality of circumferentially spaced apart distal anchors ends at a generally triangular tip.

21. The prosthesis of claim 1, wherein the plurality of tips are inclined radially inwards towards the longitudinal axis.

22. The prosthesis of claim 1, wherein the biasing outer portion is configured to position the flap assembly on an inflow side of the native heart valve when the frame is in the expanded configuration.

23. The prosthesis of claim 1, wherein the flap assembly is located on an exterior of the expandable frame at a first portion of the expandable frame and on an interior of the expandable frame at a second portion of the expandable frame.

24. The prosthesis of claim 1, wherein the middle portion is generally cylindrical.

18. A valve prosthesis configured to be deployed within a native heart valve, the valve prosthesis comprising:

an expandable frame comprising a proximal end, a distal end and a longitudinal axis extending therethrough, the frame configured to collapse radially for delivery and to expand radially upon deployment;

a distal anchoring feature extending from the frame and expandable from a collapsed configuration to an expanded configuration;

a valve body positioned within an interior of the expandable frame, wherein the valve body comprises a plurality of leaflets configured to allow flow in a first direction and prevent flow in a second opposite direction;

a flap assembly positioned around and secured to an exterior of the expandable frame;

a first biasing assembly, the first biasing assembly comprising at least one first biasing arm extending radially outward from the frame and towards the proximal end when the frame is in an expanded configuration, the at least one first biasing arm being configured to bias the flap assembly radially outward from the longitudinal axis of the frame to provide a space between the flap assembly and the valve body; and

a second biasing assembly, the second biasing assembly comprising at least one second biasing arm extending radially outward from the frame and towards the distal end when the frame is in an expanded configuration, the at least one second biasing arm being configured to bias the flap assembly radially outward from the longitudinal axis of the frame to provide a space between the flap assembly and the valve body;

wherein fluid flow into the space causes the flap assembly to move from a first configuration to a second configuration configured to create a barrier to fluid flow exterior to the frame when the valve prosthesis is deployed within the native heart valve.