Replacement heart valve

• US 10,639,146 B2
• Filed: 01/25/2017
• Issued: 05/05/2020
• Est. Priority Date: 06/21/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Quadri, Arshad, Ratz, J. Brent
• Primary Examiner(s): Lopez, Leslie
• Application Number:
  US15/415,794
• Publication Number:
  US 20170354496A1
• Time in Patent Office: 1,196 Days
• Field of Search: None
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0007 for adjusting length
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A replacement heart valve can have an expandable frame configured to engage a native valve annulus. A valve body can be mounted onto the expandable frame to provide functionality similar to a natural valve. The valve body has an upstream end and a downstream end, and a diameter at the downstream end is greater than a diameter at the upstream end.

Claims

1. A method of delivering a replacement valve to a native mitral valve of a heart and securing the replacement valve relative to a native mitral valve annulus, the native mitral valve positioned between a left atrium and a left ventricle, the method comprising:

delivering the replacement valve to the native mitral valve annulus while the replacement valve is in a radially compacted state, the replacement valve comprising;

an expandable frame having a proximal end ending at a proximalmost end and a distal end ending at a distalmost end;

a valve body positioned within a lumen of the expandable frame; and

one or more distal anchors extending from the distal end of the expandable frame and sized to contact tissue on a ventricular side of the native mitral valve when the replacement valve is deployed within the native mitral valve; and

deploying the replacement valve within the native mitral valve annulus such that;

the replacement valve is in an expanded configuration with a cross-sectional diameter of the distalmost end of the expandable frame being greater than a cross-sectional diameter of the proximalmost end of the expandable frame, the replacement valve only decreasing or remaining constant in cross-sectional diameter from the distalmost end to the proximalmost end;

the one or more distal anchors are positioned radially outwardly from the frame;

tips of the one or more distal anchors extend substantially parallel to a longitudinal axis of the expandable frame; and

at least one of the distal anchors extends between chordae tendineae of the native mitral valve.

2. The method of claim 1, wherein:

the expandable frame further comprises a proximal anchoring portion sized to contact tissue on an atrial side of the native mitral valve when the replacement valve is deployed within the native mitral valve; and

deploying the replacement valve within the native mitral valve annulus comprises expanding the replacement valve such that the proximal anchoring portion is positioned radially outwardly from the frame.

3. The method of claim 2, wherein the proximal anchoring portion comprises a plurality of free apices each connected to the expandable frame at a first base and at a second base, the first and the second bases located distal of the proximal end of the expandable frame.

4. The method of claim 2, wherein each distal anchor extends from a portion of the expandable frame having a greater cross-sectional diameter than a portion from which the proximal anchoring portion extends.

5. The method of claim 1, wherein deploying the replacement valve within the native mitral valve annulus comprises engaging at least a first of the one or more distal anchors with a first fibrous trigone of the native mitral valve.

6. The method of claim 5, wherein deploying the replacement valve within the native mitral valve annulus comprises disposing a native leaflet of the native mitral valve between at least the first distal anchor and the expandable frame.

7. The method of claim 5, wherein deploying the replacement valve within the native mitral valve annulus comprises engaging at least a second of the one or more distal anchors with the native mitral valve annulus.

8. The method of claim 1, wherein delivering the replacement valve to the native mitral valve annulus while the replacement valve is in the radially compacted state comprises delivering the replacement valve from a region outside the heart to the left ventricle of the heart.

9. The method of claim 8, wherein delivering the replacement valve to the native mitral valve annulus while the replacement valve is in the radially compacted state comprises transseptally delivering the replacement valve.

10. The method of claim 1, wherein the expandable frame further comprises an engagement zone, and wherein expanding the replacement valve comprises radially expanding the engagement zone of the expandable frame to engage the native mitral valve annulus.

11. The method of claim 1, wherein the valve body comprises a plurality of valve leaflets.

12. The method of claim 11, wherein the replacement valve comprises a plurality of commissures disposed along downstream side edges of the valve leaflets.

13. The method of claim 11, wherein the valve body comprises three leaflets.

14. The method of claim 11, wherein the plurality of valve leaflets are configured to open to allow flow in a first direction from the left atrium to the left ventricle and engage one another so as to close and not allow flow in a second direction opposite the first direction.

15. The method of claim 1, wherein each of the one or more distal anchors is formed by a single strut.

16. The method of claim 1, wherein the tips of the one or more distal anchors are enlarged relative to a remainder of the one or more distal anchors to increase a surface area of the tips in contact with the tissue on the ventricular side of the native mitral valve when the replacement valve is expanded and deployed within the native mitral valve.

17. The method of claim 1, wherein the expandable frame comprises a plurality of cells, and wherein the valve body is fully located radially within the plurality of cells of the expandable frame.