Low-profile prosthetic heart valve for replacing a mitral valve

• US 10,010,417 B2
• Filed: 04/15/2016
• Issued: 07/03/2018
• 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): Tyson, Melanie
• Application Number:
  US15/130,521
• Publication Number:
  US 20160302922A1
• Time in Patent Office: 809 Days
• Field of Search: 623 211
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

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 method comprising:

introducing a delivery apparatus into a patient'"'"'s body, wherein a prosthetic valve assembly is mounted on a distal end portion of the delivery apparatus;

advancing the prosthetic valve assembly into the left ventricle of the heart of the patient;

radially expanding an anchor of the prosthetic valve assembly;

positioning axially extending fixation members of the anchor behind the native mitral valve leaflets and/or the chordae tendineae; and

radially expanding a valve component of the prosthetic valve assembly within the anchor, which causes the fixation members to pivot inwardly against the native mitral valve leaflets, thereby clamping the native mitral valve leaflets between the anchor and the valve component.

2. The method of claim 1, wherein the valve component and the anchor are axially spaced apart from each other on the delivery apparatus when the prosthetic valve assembly is introduced into the body and advanced into the left ventricle, and wherein after radially expanding the anchor but prior to radially expanding the valve component, the valve component is moved axially to a location within the anchor.

3. The method of claim 2, wherein the prosthetic valve assembly comprises a flexible sleeve having a first end portion secured to the valve component and a second end portion secured to the anchor.

4. The method of claim 3, wherein moving the valve component to a location within the anchor comprises retracting the delivery apparatus and the valve component proximally toward the left atrium while the anchor is engaged with the native mitral valve leaflets.

5. The method of claim 4, wherein the valve component is radially compressed on an inflatable balloon prior to being radially expanded and wherein radially expanding the valve component comprises inflating the balloon.

6. The method of claim 2, wherein radially expanding the anchor comprises deploying the anchor from a sheath, which causes the anchor to radially self-expand to an expanded state.

7. The method of claim 2, wherein the anchor has a tapered shape when radially expanded and becomes cylindrical when the valve component is expanded within the anchor.

8. The method of claim 2, further comprising, after radially expanding the anchor and positioning the fixation members behind the native mitral valve leaflets and/or the native chordae tendineae but prior to radially expanding the valve component, rotating the delivery apparatus relative to a longitudinal axis of the delivery apparatus to rotate the anchor, causing the fixation members to twist and pull the native mitral valve leaflets and/or the native chordae tendineae radially inwardly such that subsequent expansion of the valve component in the anchor clamps the native mitral valve leaflets and/or the native chordae tendineae in a twisted and pulled position between the anchor and the valve component.

9. The method of claim 1, wherein the fixation members define a first angle with respect to a central longitudinal axis of the anchor before the fixation members pivot inwardly and a second angle with respect to the axis after the fixation members pivot inwardly, wherein the first angle is larger than the second angle.

10. The method of claim 1, wherein the anchor comprises an annular base and each of the fixation members has a fixed end connected to the annular base and an opposing free end spaced axially from the annular base, the free ends of the fixation members defining an inflow end of the anchor, and wherein the act of expanding the valve component within the anchor comprises expanding the valve component within the annular base, causing the valve component to exert a radial outwardly directed force against the annular base, which causes the free ends of the fixation members to pivot inwardly.

11. A method comprising:

introducing a delivery apparatus into a patient'"'"'s body, wherein a prosthetic valve assembly is mounted on a distal end portion of the delivery apparatus, wherein the prosthetic valve assembly comprises an anchor having a plurality of cantilevered fixation members extending from an annular base of the anchor and a valve component axially separated from the anchor comprising a radially compressible and expandable frame and a valve structure supported inside the frame;

radially expanding the anchor;

positioning the fixation members behind the native mitral valve leaflets and/or the chordae tendineae of the patient;

after positioning the fixation members behind the native mitral valve leaflets and/or the chordae tendineae of the patient, moving the valve component axially to a location within the anchor; and

after moving the valve component axially to a location within the anchor, radially expanding the valve component, which causes the fixation members to pivot inwardly against the native mitral valve leaflets, thereby clamping the native mitral valve leaflets between the anchor and the valve component.

12. The method of claim 11, wherein radially expanding the valve component causes a radially outwardly directed force to be exerted against the base of the anchor, thereby causing the fixation members to pivot inwardly.

13. The method of claim 11, wherein the fixation members define a first angle with respect to a central longitudinal axis of the anchor before the fixation members pivot inwardly and a second angle with respect to the axis after the fixation members pivot inwardly, wherein the first angle is larger than the second angle.

14. The method of claim 11, wherein the anchor in the expanded state is tapered in a direction extending from the base of the anchor toward the fixation members, and wherein radially expanding the valve component causes the anchor to further expand to a cylindrical shape.

15. The method of claim 11, wherein the prosthetic valve assembly further comprises a flexible sleeve having a first end portion secured to the valve component and a second end portion secured to the anchor.

16. The method of claim 11, wherein the prosthetic valve assembly further comprises a flexible, invertible connector having a first surface, a second surface, a first end portion secured to the frame, and a second end portion secured to the anchor, and wherein moving the valve component axially to a location within the anchor causes the connector to move from a first configuration in which the first surface is an inner surface and the second surface is an outer surface to a second configuration in which the first surface is an outer surface and the second surface is an inner surface.

17. The method of claim 11, wherein radially expanding the valve component comprises radially expanding the valve component until the valve component bears against the annular base of the anchor, thereby causing the annular base to expand radially, which in turn causes the fixation members to pivot inwardly.

18. The method of claim 11, wherein the fixation members extend axially from the annular base and are circumferentially spaced apart from each other around the annular base.

19. The method of claim 18, wherein each fixation member has a fixed end connected to the annular base and an opposing free end spaced axially from the annular base.

20. A method comprising:

introducing a delivery apparatus into a patient'"'"'s body, wherein a prosthetic valve assembly is mounted on a distal end portion of the delivery apparatus;

advancing the prosthetic valve assembly into the left ventricle of the heart of the patient;

radially expanding an anchor of the prosthetic valve assembly, the anchor comprising an annular base defining an outflow end of the anchor and a plurality of cantilevered fixation members extending axially from the annular base, each of the fixation members having a fixed end connected to the annular base and an opposing free end spaced axially from the annular base, the free ends of the fixation members defining an inflow end of the anchor;

positioning the fixation members of the anchor behind the native mitral valve leaflets and/or the chordae tendineae;

positioning a valve component of the prosthetic valve assembly within the annular base of the anchor; and

radially expanding the valve component within the annular base of the anchor, causing the valve component to exert a radial outwardly directed force against the annular base, which causes the free ends of the fixation members to pivot inwardly inwardly against the native mitral valve leaflets, thereby clamping the native mitral valve leaflets between the anchor and the valve component.