Low-profile prosthetic heart valve for replacing a mitral valve

• US 10,064,718 B2
• Filed: 04/06/2016
• Issued: 09/04/2018
• Est. Priority Date: 04/16/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Keidar, Yaron
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/092,437
• Publication Number:
  US 20160302918A1
• Time in Patent Office: 881 Days
• Field of Search: 623 21- 219
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

In one representative embodiment, a prosthetic valve assembly comprises a valve component comprising a radially compressible and expandable frame and a valve structure supported inside of the frame. The valve structure is configured to allow blood to flow through the valve component in one direction and block the flow of blood in the opposite direction. The assembly further comprises a radially compressible and expandable anchor comprising an annular base and a plurality of cantilevered fixation members extending from the base. The fixation members are configured to pivot inwardly toward the valve component when the valve component is radially expanded within the anchor.

Claims

1. A prosthetic valve assembly comprising:

a valve component comprising a radially compressible and expandable frame and a valve structure supported inside of the frame, the valve structure configured to allow blood to flow through the valve component in one direction and block the flow of blood in the opposite direction; and

a radially compressible and expandable anchor comprising an annular base and a plurality of cantilevered fixation members extending from the base, wherein the base of the anchor is radially compressible and expandable between a radially compressed state for delivery and a radially expanded state, wherein the valve component is sized to be radially expanded within the base of the anchor after the base is radially expanded, wherein when the base of the anchor is in a radially expanded state and the valve component is in a radially compressed state, the fixation members are in a first position, and wherein the fixation members are configured to pivot inwardly from the first position to a second position toward the valve component when the valve component is radially expanded within the radially expanded base of the anchor as a result of the valve component exerting a radially outwardly directed force against the annular base.

5. The prosthetic valve assembly of claim 1, wherein the fixation members extend radially outwardly relative to a longitudinal axis of the anchor in a direction extending away from the base.

6. The prosthetic valve assembly of claim 1, wherein the fixation members extend radially outwardly and circumferentially relative to a longitudinal axis of the anchor.

7. The prosthetic valve assembly of claim 1, wherein the anchor is self-expandable from the radially compressed state to the radially expanded state and the frame of the valve component is plastically-expandable from a radially compressed state to a radially expanded state.

8. The prosthetic valve assembly of claim 1, wherein the anchor is self-expandable from the radially compressed state to the radially expanded state, the anchor in the expanded state being tapered in a direction extending from the base toward the fixation members, the anchor being configured to further expand to a cylindrical shape when the valve component is radially expanded inside of the base of the anchor.

9. The prosthetic valve assembly of claim 1, wherein the fixation members are configured to extend between native chordae tendineae at locations adjacent the commissures of the native mitral valve.

2. A prosthetic valve assembly comprising:

a valve component comprising a radially compressible and expandable frame and a valve structure supported inside of the frame, the valve structure configured to allow blood to flow through the valve component in one direction and block the flow of blood in the opposite direction;

a radially compressible and expandable anchor comprising an annular base and a plurality of cantilevered fixation members extending from the base, wherein the valve component is sized to be radially expanded within the anchor after the anchor is radially expanded, wherein when the anchor is in a radially expanded state and the valve component is in a radially compressed state, the fixation members are in a first position, and wherein the fixation members are configured to pivot inwardly from the first position to a second position toward the valve component when the valve component is radially expanded within the radially expanded anchor as a result of the valve component exerting a radially outwardly directed force against the annular base; and

a flexible sleeve having a first end portion secured to the frame of the valve component and a second end portion secured to the anchor, the sleeve configured to allow the valve component and the anchor to move between a delivery configuration in which the valve component and the anchor are axially spaced from each other and an operating configuration in which the valve component is positioned co-axially within the anchor.

3. The prosthetic valve assembly of claim 2, wherein the sleeve comprises a fabric.

4. The prosthetic valve assembly of claim 2, wherein the first end portion of the sleeve comprises an annular sealing member extending around the outside of the frame of the valve component and is disposed co-axially between the frame of the valve component and the anchor when valve assembly is in the operating configuration.

10. A prosthetic mitral valve assembly for replacing a native mitral valve comprising:

a valve component comprising a radially compressible and expandable frame and a valve structure supported inside of the frame, the valve structure configured to allow blood to flow through the valve component in one direction and block the flow of blood in the opposite direction;

a radially compressible and expandable anchor comprising an annular base and a plurality of cantilevered ventricular fixation members extending from the base, wherein the fixation members are configured to extend radially outside of the native mitral valve leaflets when implanted at the native mitral valve; and

a flexible connector having a first end portion secured to the frame of the valve component and a second end portion secured to the anchor, the connector configured to allow the valve component and the anchor to move between a delivery configuration in which the valve component and the anchor are axially spaced from each other and an operating configuration in which the valve component is positioned co-axially within the anchor;

wherein the connector has first and second surfaces and is invertible when the valve component is moved from the delivery configuration to the operating configuration, the first surface being an inner surface and the second surface being an outer surface when the valve component is in the delivery configuration, and the first surface being an outer surface and the second surface being an inner surface when the valve component is in the operating configuration.

11. The prosthetic mitral valve assembly of claim 10, wherein the fixation members are configured to pivot inwardly toward the valve component and compress the native mitral valve leaflets between the fixation members and the valve component when the valve component is radially expanded within the anchor.

12. The prosthetic mitral valve assembly of claim 10, wherein the fixation members extend radially outwardly relative to a longitudinal axis of the anchor in a direction extending away from the base.

13. The prosthetic mitral valve assembly of claim 10, wherein the anchor is self-expandable from a radially compressed state to a radially expanded state, the anchor in the expanded state being tapered in a direction extending from the base toward the fixation members, the anchor being configured to further expand to a cylindrical shape when the valve component is radially expanded inside of the anchor.

14. A prosthetic valve assembly comprising:

a valve component comprising a radially compressible and expandable frame and a valve structure supported inside of the frame, the valve structure configured to allow blood to flow through the valve component in one direction and block the flow of blood in the opposite direction; and

a radially compressible and expandable anchor separate from the valve component comprising an annular base and a plurality of cantilevered fixation members extending from the base, wherein the base of the anchor is radially compressible and expandable between a radially compressed state for delivery and a radially expanded state;

wherein the valve component and the anchor are configured to move between a delivery configuration in which the valve component and the anchor are axially spaced from each other and an operating configuration in which the valve component is positioned co-axially within the anchor;

wherein the fixation members are configured to move from a first position, in which the fixation members are positioned at a first angle with respect to a central longitudinal axis of the frame, to a second position, in which the fixation members are positioned at a second angle with respect to the axis of the frame that is less than the first angle;

wherein the valve component is configured to be radially expanded within the base of the anchor after the base is radially expanded;

wherein when the base of the anchor is in the radially expanded state and the valve component is in a radially compressed state, the fixation members are in the first position; and

wherein the fixation members are configured to move to the second position when the valve component is radially expanded within the radially expanded base of the anchor as a result of the valve component exerting a radially outwardly directed force against the annular base.

15. The prosthetic valve of claim 14, further comprising a flexible sleeve having a first end portion secured to the frame of the valve component and a second end portion secured to the anchor.