Replacement heart valve

• US 10,524,901 B2
• Filed: 04/28/2017
• Issued: 01/07/2020
• Est. Priority Date: 09/29/2009
• 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, Liao, Yen, Komatsu, Stan, Thygarajan, Kalathi, Michiels, Robrecht, Nguyen, Hung, Nguyen, MyKim
• Primary Examiner(s): Lopez, Leslie
• Application Number:
  US15/581,949
• Publication Number:
  US 20170231762A1
• Time in Patent Office: 984 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 mitral valve 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 having a proximal end, a distal end, and a transition portion between the proximal and the distal ends, the expandable frame comprising a row of diamond-shaped foreshortening cells configured to foreshorten upon radial expansion of the expandable frame, wherein, in an expanded configuration;

the proximal end has a first cross-sectional dimension;

the distal end has a second cross-sectional dimension greater than the first cross-sectional dimension; and

the transition portion increases in cross-sectional dimension between the first cross-sectional dimension and the second cross-sectional dimension, the transition portion forming a frustoconical shape;

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, the proximal anchoring portion comprising a plurality of free apices each connected to the expandable frame at a first base and at a second base, the first base and the second base spaced apart from one another and separated by a gap, the first and the second bases located distal of the proximal end of the expandable frame, wherein, in the expanded configuration, each free apex is positioned radially outwardly from the expandable frame;

a plurality of distal anchors sized to be positioned on a ventricular side of the native mitral valve when the prosthesis is deployed within the native mitral valve, each distal anchor connected to a distal apex of an individual cell of the row of diamond-shaped foreshortening cells, the transition portion positioned between the first and the second bases of the proximal anchoring portion and the distal apices of the individual cell of the row of diamond-shaped foreshortening cells connected to the distal anchor, wherein, in the expanded configuration;

each distal anchor extends from a portion of the expandable frame having a greater cross-sectional dimension than the portion of the expandable frame from which the proximal anchoring portion extends; and

an end of each distal anchor extends proximally and is positioned radially outwardly from the expandable frame; and

a valve body configured to open to allow flow in a direction from the proximal end to the distal end of the expandable frame and close so as to inhibit flow in a direction from the distal end to the proximal end of the expandable frame, the valve body extending along an entire length of the transition portion of the expandable frame, the valve body comprising a valve skirt extending circumferentially around an interior of the expandable frame and a plurality of valve leaflets positioned within the valve skirt,

wherein;

the number of free apices and the number of distal anchors are the same;

the free apices of the proximal anchoring portion are circumferentially offset from ends of the plurality of distal anchors; and

when the prosthesis is deployed within the native mitral valve, a portion of the expandable frame having a cross-sectional dimension greater than the first cross-sectional dimension is configured to engage tissue of the native mitral valve.

2. The prosthesis of claim 1, wherein the proximal anchoring portion consists of twelve free apices and the plurality of distal anchors consists of twelve distal anchors.

3. The prosthesis of claim 1, wherein:

the plurality of free apices of the proximal anchoring portion and the plurality of distal anchors extend from the transition portion of the expandable frame;

the plurality of free apices of the proximal anchoring portion are equally circumferentially spaced around the expandable frame; and

the plurality of distal anchors are equally circumferentially spaced around the expandable frame.

4. The prosthesis of claim 1, wherein the valve body has a frustoconical shape such that a distal end of the valve body has a cross-sectional dimension greater than a cross-sectional dimension of a proximal end of the valve body.

5. The prosthesis of claim 1, wherein the ends of the distal anchors are curved or rounded.

6. A mitral valve 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 having a proximal end, a distal end, and a transition portion between the proximal and the distal ends, the expandable frame comprising a row of foreshortening cells configured to foreshorten upon radial expansion of the expandable frame, wherein, in an expanded configuration;

the proximal end has a first cross-sectional dimension;

the distal end has a second cross-sectional dimension greater than the first cross-sectional dimension; and

the transition portion increases in cross-sectional dimension between the first cross-sectional dimension and the second cross-sectional dimension;

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, the proximal anchoring portion comprising a plurality of free apices each connected to the expandable frame at a first base and at a second base, the first base and the second base spaced apparat from one another and separated by a gap, the first and the second bases located distal of the proximal end of the expandable frame, wherein, in the expanded configuration, each free apex is positioned radially outwardly from the expandable frame;

a plurality of distal anchors sized to be positioned on a ventricular side of the native mitral valve when the prosthesis is deployed within the native mitral valve, each distal anchor connected to a distal portion of an individual cell of the row of diamond-shaped foreshortening cells, wherein, in the expanded configuration, an end of each distal anchor extends proximally and is positioned radially outwardly from the expandable frame; and

a valve body configured to open to allow flow in a direction from the proximal end to the distal end of the expandable frame and close so as to inhibit flow in a direction from the distal end to the proximal end of the expandable frame, the valve body extending along an entire length of the transition portion of the expandable frame, the transition portion positioned between the first and the second bases of the proximal anchoring portion and distal ends of the distal anchors, wherein the valve body has a frustoconical shape such that a cross-sectional dimension of a distal end of the valve body is greater than a cross-sectional dimension of the proximal end of the valve body, the valve body comprising a valve skirt extending circumferentially around an interior of the frame and a plurality of valve leaflets positioned within the valve skirt,

wherein, when the prosthesis is deployed within the native mitral valve, a portion of the expandable frame having a cross-sectional dimension greater than the first cross-sectional dimension is configured to engage tissue of the native mitral valve.

7. The prosthesis of claim 6, wherein the first and the second bases of each of the free apices of the proximal anchoring portion are aligned along an axis parallel to a longitudinal axis of the expandable frame with the ends of the plurality of distal anchors.

8. The prosthesis of claim 6, wherein the first and the second bases of each of the free apices of the proximal anchoring portion are circumferentially aligned with proximal apices of individual cells of the row of diamond-shaped foreshortening cells.

9. The prosthesis of claim 6, wherein the free apices of the proximal anchoring portion are circumferentially offset from ends of the plurality of distal anchors.

10. The prosthesis of claim 6, wherein the plurality of distal anchors extend from distal apices of individual cells of the row of diamond-shaped foreshortening cells.

11. The prosthesis of claim 6, wherein the first and the second bases are located proximal of the row of foreshortening cells.

12. The prosthesis of claim 6, wherein the first and the second bases are located along a portion of the expandable frame having a cross-sectional dimension greater than the first cross-sectional dimension.

13. The prosthesis of claim 6, wherein the prosthesis is configured to be deployed within a native mitral valve and wherein, when the prosthesis is deployed within the native mitral valve, the plurality of distal anchors are sized to extend between chordae tendineae of the native mitral valve.

14. The prosthesis of claim 6, wherein the plurality of free apices of the proximal anchoring portion and the plurality of distal anchors extend from the transition portion of the expandable frame.

15. The prosthesis of claim 6, wherein:

the plurality of free apices of the proximal anchoring portion are equally circumferentially spaced around the expandable frame; and

the plurality of distal anchors are equally circumferentially spaced around the expandable frame.

16. The prosthesis of claim 6, wherein the number of free apices of the proximal anchoring portion and the number of distal anchors are the same.

17. The prosthesis of claim 16, wherein the proximal anchoring portion consists of twelve free apices and the plurality of distal anchors consists of twelve distal anchors.

18. The prosthesis of claim 6, wherein a distal anchor extends from each individual cell of the row of diamond-shaped foreshortening cells.

19. The prosthesis of claim 18, wherein the row of diamond-shaped foreshortening cells consists of twelve individual cells.

20. The prosthesis of claim 6, wherein the prosthesis is configured to be deployed within a native mitral valve and wherein, when the prosthesis is deployed within the native mitral valve, the proximal end of the expandable frame is configured to be positioned within an atrium.