REPLACEMENT HEART VALVES AND METHODS OF DELIVERY

• US 20170056166A1
• Filed: 08/25/2016
• Published: 03/02/2017
• 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: Johnson, Garrett Dallas, Ratz, J. Brent, Pesce, Luca, Vad, Siddharth
• Granted Patent: US 10,117,744 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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, 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; and

at least one biasing arm extending radially outward from the frame when the frame is in an expanded configuration, the at least one 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.

2. The valve prosthesis of claim 1, wherein the at least one biasing arm comprises a plurality of biasing arms.

3. The valve prosthesis of claim 1, wherein the at least one biasing arm extends from a middle portion of the frame.

4. The valve prosthesis of claim 1, wherein the at least one biasing arm extends towards a proximal end of the frame.

5. The valve prosthesis of claim 1, wherein the at least one biasing arm extends towards a distal end of the frame.

6. The prosthesis of claim 1, wherein the at least one biasing arm is configured to bias the flap assembly radially outward from an exterior of the frame.

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

8. The valve prosthesis of claim 1, wherein an internal volume of the flap assembly in the second configuration is greater than the internal volume of the flap assembly in the first configuration.

9. The valve prosthesis of claim 1, wherein a distal end of the flap assembly comprises a plurality of tabs, wherein each of the tabs are configured to attach to at least a portion of the distal anchoring feature.

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

11. 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.

12. 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.

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

14. The prosthesis of claim 13, wherein the liner is attached to the leaflets of the valve body.

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

16. 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.

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

18. The prosthesis of claim 17, wherein at least one of the one or more bio-resorbable components is configured to engage a delivery system.

19. The prosthesis of claim 17, 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.

20. 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.