Prosthetic valve for replacing mitral valve

Patent metadata

Field	Value
Publication number	US-10111748-B2
Application number	US-201715455713-A
Country	US
Kind code	B2
Filing date	Mar 10, 2017
Priority date	Dec 4, 2009
Publication date	Oct 30, 2018
Grant date	Oct 30, 2018

Abstract

A prosthetic apparatus for implantation in a native mitral valve includes a main body for placement within the native mitral annulus. The main body is compressible to a radially compressed state for delivery into the heart and is self-expandable from the compressed state to a radially expanded state for implantation. A valve structure is mounted within a lumen of the main body and preferably forms three leaflets made of pericardium. An atrial sealing member is disposed along an atrial portion of the main body and ventricular anchors are coupled to a ventricular portion of the main body. The atrial sealing member impedes the flow of blood between the main body and the native annulus. The ventricular anchors are positioned outside the main body for capturing native mitral valve leaflets between the main body and the ventricular anchors.

First claim

We claim:

1. A method for implanting a prosthetic valve at a mitral valve region of a heart, the mitral valve region having a native mitral annulus, the method comprising:
delivering to the native mitral annulus a prosthetic valve comprising:
a frame having an expanded and a collapsed state, the frame having a longitudinal axis and comprising:
a main body having an atrial end and a ventricular end, the main body defining inner and outer surfaces;
a lower anchoring portion at the ventricular end of the main body that comprises a plurality of anchors, each of the anchors having a first end that is attached to the main body and a second end that is spaced from the first end; and
an upper anchoring portion at the atrial end of the main body that comprises an atrial portion configured to be positioned on an atrial side of the native mitral annulus, the atrial portion comprising a plurality of struts, the atrial portion having a first end that is attached to the main body and a second end that is spaced from the first end; and

a valve structure attached to the inner surface of the main body of the frame;
wherein when the frame is in the collapsed state, the upper and lower anchoring portions are oriented substantially along the longitudinal axis of the frame;
wherein when the frame transitions from the collapsed state to the expanded state, the lower anchoring portion transitions to a configuration that is no longer oriented substantially along the longitudinal axis of the frame; and
wherein the lower anchoring portion is configured to capture tissue at the ventricular side of the native mitral annulus between the lower anchoring portion and the outer surface of the main body as the frame transitions from the collapsed state to the expanded state; and

expanding the frame to anchor the prosthetic valve at the native mitral annulus.

2. The method according to claim 1 , wherein:
the plurality of anchors comprise curling anchors; and
when the frame is in the collapsed state, the curling anchors are oriented substantially along the longitudinal axis of the frame; and
when the frame transitions from the collapsed state to the expanded state, the curling anchors transition to a configuration that is no longer oriented substantially along the longitudinal axis of the frame.

3. The method according to claim 2 , wherein the curling anchors each extend from two or more attachment points on the main body.

4. The method according to claim 2 , wherein the curling anchors are finger-like.

5. The method according to claim 4 , wherein curling anchors each extend from one attachment point on the main body.

6. The method according to claim 1 , wherein
the plurality of anchors comprise curling anchors; and
when the frame is in the collapsed state, the curling anchors extend in a ventricular direction and are substantially straightened; and
when the frame transitions from the collapsed state to the expanded state, the curling anchors transition to a shape in which the curling anchor is curled.

7. The method according to claim 1 , wherein the prosthetic valve is delivered to the native mitral annulus via a delivery sheath.

8. The method according to claim 1 , wherein the prosthetic valve is delivered to the implantation site transatrially, transapically, or via the patient's vasculature.

9. The method according to claim 1 , further comprising positioning the prosthetic valve at the native mitral annulus after the delivering step.

10. The method according to claim 9 , comprising positioning the prosthetic valve so that the lower anchoring portion anchors the frame within the native mitral annulus by capturing tissue at a ventricular side of the native mitral annulus when the frame is expanded.

11. The method according to claim 10 , comprising positioning the prosthetic valve so that the upper anchoring portion anchors the frame within the native mitral annulus by contacting tissue at the atrial side of the native mitral annulus when the frame is expanded.

12. The method according to claim 10 , wherein the lower anchoring portion anchors the frame within the native mitral annulus by capturing tissue of a subvalvular portion of the native mitral valve on the ventricular side of the native mitral annulus.

13. The method according to claim 10 , wherein the lower anchoring portion anchors the frame within the mitral annulus by capturing native leaflets of the native mitral valve.

14. The method according to claim 1 , wherein the atrial portion extends radially outward from an atrial end of the main body.

15. The method according to claim 1 , wherein each strut has a first end that is attached to the main body and a second end that is spaced from the first end.

16. A method for implanting a prosthetic valve at a mitral valve region of a heart, the mitral valve region having a native mitral annulus, the method comprising:
delivering to the native mitral annulus a prosthetic valve comprising:
a frame having an expanded and a collapsed state, the frame having a longitudinal axis and comprising:
a main body having an atrial end and a ventricular end, the main body defining inner and outer surfaces;
a lower anchoring portion at the ventricular end of the main body that comprises a plurality of anchors, each of the anchors having a first end that is attached to the main body and a second end that is spaced from the first end; and
an upper anchoring portion at the atrial end of the main body that comprises an atrial portion configured to be positioned on an atrial side of the native mitral annulus, the atrial portion comprising a plurality of struts, the atrial portion having a first end that is attached to the main body and a second end that is spaced from the first end; and

a valve structure attached to the inner surface of the main body of the frame;
wherein when the frame is in the collapsed state, the upper and lower anchoring portions are oriented substantially along the longitudinal axis of the frame;
wherein when the frame transitions from the collapsed state to the expanded state, the lower anchoring portion transitions to a configuration having a different orientation than when the frame is in the collapsed state; and
wherein the lower anchoring portion is configured to capture tissue at the ventricular side of the native mitral annulus between the lower anchoring portion and the outer surface of the main body as the frame transitions from the collapsed state to the expanded state; and

expanding the frame to anchor the prosthetic valve at the native mitral annulus.

17. The method according to claim 16 , wherein:
the plurality of anchors comprise flip-up anchors; and
when the frame is in the collapsed state, the flip-up anchors are oriented substantially along the longitudinal axis of the frame; and
when the frame transitions from the collapsed state to the expanded state, the flip-up anchors transition to a configuration having a different orientation than when the frame is in the collapsed state.

18. The method according to claim 17 , wherein the flip-up anchors extend from two or more attachment points on the main body.

19. The method according to claim 17 , wherein the flip-up anchors are finger-like.

20. The method according to claim 19 , wherein the flip-up anchors extend from one attachment point on the main body.

21. The method according to claim 16 , wherein:
the plurality of anchors comprise flip-up anchors;
when the frame is in the collapsed state, the flip-up anchors extends

Assignees

• Edwards Lifesciences Corp

Inventors

• Chau Mark
• Patterson Marlowe E
• Yi Seung-Beom
• Geist Stephen C
• Oba Travis Zenyo

Classifications

• A61F2250/0063

  Nested prosthetic parts · CPC title

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title

• A61F2/2427

  Devices for manipulating or deploying heart valves during implantation · CPC title

• A61F2220/0008

  Fixation appliances for connecting prostheses to the body · CPC title

• A61F2210/0014

  using shape memory or superelastic materials, e.g. nitinol · CPC title