Replacement heart valve

• US 10,485,660 B2
• Filed: 02/01/2017
• Issued: 11/26/2019
• 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:
  US15/422,397
• Publication Number:
  US 20170354497A1
• Time in Patent Office: 1,028 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 prosthesis configured to be deployed within a native mitral valve, the prosthesis comprising:

an expandable frame configured to radially expand and collapse for deployment within the native mitral valve, the expandable frame comprising a proximal portion having an inflow end, a distal portion having an outflow end and a longitudinal axis extending from the inflow end to the outflow end, the inflow end configured to be positioned upstream of the outflow end when the prosthesis is deployed within the native mitral valve, a cross-sectional dimension perpendicular to the longitudinal axis of the outflow end being greater than a cross-sectional dimension perpendicular to the longitudinal axis of the inflow end when the expandable frame is in an expanded configuration;

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

one or more distal anchors extending from the outflow end of the expandable frame, wherein the distal anchors are sized such that, when the prosthesis is expanded and deployed within the native mitral valve;

at least one of the distal anchors is positioned radially outwardly from the expandable frame;

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

at least one of the distal anchors contact tissue on a ventricular side of the native mitral valve; and

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

2. The prosthesis of claim 1, wherein the prosthesis further comprises a proximal anchoring portion sized to contact tissue on an atrial side of the native mitral valve when the prosthesis is deployed within the native mitral valve, an end of the proximal anchoring portion being positioned radially outwardly from the expandable frame when the expandable frame is in the expanded configuration.

3. The prosthesis 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 inflow end of the expandable frame.

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

5. The prosthesis of claim 1, wherein the distal anchors are sized such that, when the prosthesis is expanded and deployed within the native mitral valve, at least a first of the distal anchors contacts a first fibrous trigone of the native mitral valve.

6. The prosthesis of claim 5, wherein the prosthesis is sized such that, when the prosthesis is expanded and deployed within the native mitral valve, a native leaflet of the native mitral valve is positioned between at least the first distal anchor and the expandable frame.

7. The prosthesis of claim 5, wherein the distal anchors are sized such that, when the prosthesis is expanded and deployed within the native mitral valve, at least a second of the distal anchors contacts the native mitral valve annulus.

8. The prosthesis of claim 5, wherein the distal anchors are sized such that, when the prosthesis is expanded and deployed within the native mitral valve, at least a second of the distal anchors contacts a second fibrous trigone of the native mitral valve.

9. The prosthesis of claim 1, wherein the expandable frame further comprises an engagement zone, and wherein the engagement zone is sized such that, when the prosthesis is expanded and deployed within the native mitral valve, the engagement zone engages the native mitral valve annulus.

10. The prosthesis of claim 9, wherein the engagement zone is positioned between ends of the distal anchors and an end of a proximal anchoring portion.

11. The prosthesis of claim 10, wherein the engagement zone is sized such that, when the prosthesis is expanded, a cross-sectional dimension of the engagement zone is greater than a cross-sectional dimension of a proximal end of the expandable frame.

12. The prosthesis of claim 10, wherein the valve body comprises an inflow end and an outflow end and wherein the engagement zone is sized such that, when the prosthesis is expanded and deployed within the native mitral valve, a cross-sectional dimension of the engagement zone is greater than a cross-sectional dimension of the inflow end of the valve body.

13. The prosthesis of claim 1, wherein the valve body comprises a plurality of valve leaflets.

14. The prosthesis of claim 13, wherein the prosthesis comprises a plurality of commissures disposed along downstream side edges of the valve leaflets.

15. The prosthesis of claim 13, wherein the valve body comprises three leaflets.

16. The prosthesis of claim 13, wherein the plurality of valve leaflets are configured to open to allow flow in a first direction from an atrium to a ventricle and engage one another so as to close and not allow flow in a second direction opposite the first direction.

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

18. The prosthesis 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 when the prosthesis is expanded and deployed within the native mitral valve.

19. A prosthesis configured to be deployed within a native mitral valve, the prosthesis comprising:

an expandable frame configured to radially expand and collapse for deployment within the native mitral valve, the expandable frame comprising a proximal portion having an inflow end, a distal portion having an outflow end, a transition portion between the distal portion and the proximal portion, and a longitudinal axis extending from the inflow end to the outflow end, the inflow end configured to be positioned upstream of the outflow end when the prosthesis is deployed within the native mitral valve, a cross-sectional dimension perpendicular to the longitudinal axis of the outflow end being greater than a cross-sectional dimension perpendicular to the longitudinal axis of the inflow end when the expandable frame is in an expanded configuration, wherein the proximal portion and the distal portion have a constant cross-sectional diameter perpendicular to the longitudinal axis, and wherein the transition portion decreases in cross-sectional diameter perpendicular to the longitudinal axis moving from the distal portion to the proximal portion;

a valve body positioned within a lumen of the expandable frame, the valve body comprising a proximal end, a distal end, wherein a diameter at the distal end is greater than a diameter at the proximal end, and a plurality of valve leaflets;

one or more proximal anchors each connected to the expandable frame such that when the expandable frame is in the expanded configuration an end of each of the one or more proximal anchors is positioned radially outward from the frame, wherein the one or more proximal anchors are configured to contact tissue on an atrial side of the native mitral valve;

one or more distal anchors extending from the outflow end of the expandable frame, wherein the distal anchors are sized such that, when the prosthesis is expanded and deployed within the native mitral valve;

at least one of the distal anchors is positioned radially outwardly from the expandable frame;

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

at least one of the distal anchors contact tissue on a ventricular side of the native mitral valve; and

tips of the one or more distal anchors extend parallel to the longitudinal axis of the expandable frame.