Heart valve

• US 10,646,334 B2
• Filed: 05/14/2018
• Issued: 05/12/2020
• Est. Priority Date: 09/29/2008
• 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): Mathew, Seema
• Application Number:
  US15/979,271
• Publication Number:
  US 20180256324A1
• Time in Patent Office: 729 Days
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: Y10T 29/49426 including metal shaping and diverse operation

Abstract

A method of deploying a prosthesis within a native mitral valve is disclosed. The expandable frame preferably includes about twelve proximal anchors, wherein the proximal anchors have free ends positioned radially outwardly from the frame in an expanded configuration. The expandable frame preferably includes about twelve distal anchors, wherein the distal anchors also have a free ends positioned radially outwardly from the frame and extend toward a proximal end when the frame is in the expanded configuration. A valve body is supported within the frame for preventing blood flow in one direction. The expandable frame is radially expanded during deployment, which causes the free ends of the proximal and distal anchors to move closer together. In the expanded configuration, the proximal anchors are positioned on an inflow side of the native mitral valve and the distal anchors are positioned on an outflow side of the native mitral valve.

Claims

1. A method of deploying a prosthesis within a native mitral valve, the method comprising:

delivering an expandable frame configured to radially expand and collapse between an expanded configuration and a collapsed configuration to the native mitral valve in the collapsed configuration, the expandable frame comprising;

a proximal end having a number of proximal anchors, the number of proximal anchors each connected to the frame and having a free end positioned radially outward from the frame when the frame is in the expanded configuration, wherein each of the number of proximal anchors comprises first and second struts connected to and extending radially outward from the frame when the frame is in the expanded configuration, the first and second struts each comprising a substantially straight segment;

a distal end having a number of distal anchors, the number of distal anchors equal to the number of proximal anchors, the number of distal anchors each having a free end positioned radially outward from the frame and extending toward the proximal end when the frame is in the expanded configuration, wherein each of the number of proximal anchors has a different shape from a shape of each of the number of distal anchors; and

a valve body attached to the expandable frame, wherein the valve body can move between (i) an open position wherein blood can flow from the proximal end toward the distal end; and

(ii) a closed position which blocks blood from flowing from the distal end toward the proximal end; and

radially expanding the expandable frame to the expanded configuration, wherein the radially expanding causes the free ends of the number of proximal anchors and the number of distal anchors to draw closer together;

wherein, in the expanded configuration, the number of proximal anchors are on an inflow side of the native mitral valve and the number of distal anchors are on an outflow side of the native mitral valve.

2. The method of claim 1, wherein the free ends of the proximal and distal anchors grasp tissue after the radially expanding.

3. The method of claim 1, wherein the free ends of the proximal and distal anchors contact opposite ends of a native annulus of the native mitral valve after the radially expanding.

4. The method of claim 1, wherein the expandable frame comprises a foreshortening portion having a plurality of foreshortening cells, each of the number of distal anchors connected to a distal apex of a foreshortening cell.

5. The method of claim 4, wherein the foreshortening portion comprises a row of foreshortening cells and wherein the number of proximal anchors and the number of distal anchors is the same as the number of foreshortening cells in the row.

6. The method of claim 4, wherein the first and second struts are each connected to the frame at a connection point and wherein a distance between the connection points of the first and second struts is approximately equal to a distance between two lateral sides of at least one of the foreshortening cells.

7. The method of claim 1, wherein each of the number of distal anchors comprises an enlarged portion at its free end.

8. The method of claim 1, wherein when the frame is in an expanded configuration, the free ends of the proximal anchors are equally spaced around an entire circumference of the frame.

9. The method of claim 8, wherein when the frame is in the expanded configuration, the free ends of the distal anchors are equally spaced around the entire circumference of the frame.

10. The method of claim 9, wherein the free ends of the proximal anchors and the distal anchors are circumferentially offset when the frame is in an expanded configuration.

11. The method of claim 1, wherein a distance between the first and second struts where the first and second struts connect to the frame is greater than a distance between the first and second struts near the free end of each proximal anchor.

12. The method of claim 11, wherein the first and second struts form a V-shape.

13. The method of claim 1, wherein the frame comprises twelve proximal anchors and twelve distal anchors.

14. The method of claim 1, wherein the expandable frame further comprises a skirt extending at least partially over the number of distal anchors.

15. The method of claim 14, wherein the skirt is attached to the distal end of the expandable frame and the valve body.

16. The method of claim 1, further comprising deploying the number of distal anchors between chordae tendineae.

17. A method of deploying a prosthesis within a native mitral valve, the method comprising:

delivering an expandable frame configured to radially expand and collapse between an expanded configuration and a collapsed configuration to the native mitral valve in the collapsed configuration, the expandable frame comprising;

a proximal end having a number of proximal anchors, the number of proximal anchors each connected to the frame and having a free end positioned radially outward from the frame when the frame is in the expanded configuration, wherein each of the number of proximal anchors comprises first and second struts connected to and extending radially outward from the frame when the frame is in the expanded configuration, the first and second struts each comprising a substantially straight segment;

a distal end having a number of distal anchors, the number of distal anchors equal to the number of proximal anchors, the number of distal anchors each having a free end positioned radially outward from the frame and extending toward the proximal end when the frame is in an expanded configuration, wherein the free ends of the proximal anchors and the distal anchors are circumferentially offset when the frame is in an expanded configuration; and

a valve body attached to the expandable frame, wherein the valve body can move between (i) an open position wherein blood can flow from the proximal end toward the distal end; and

(ii) a closed position which blocks blood from flowing from the distal end toward the proximal end; and

radially expanding the expandable frame to the expanded configuration, wherein the radially expanding causes the free ends of the number of proximal anchors and the number of distal anchors to draw closer together;

wherein, in the expanded configuration, the number of proximal anchors are on an inflow side of the native mitral valve and the number of distal anchors are on an outflow side of the native mitral valve.

18. The method of claim 17, wherein the expandable frame comprises a foreshortening portion having a plurality of foreshortening cells, each of the number of distal anchors connected to a distal apex of a foreshortening cell.

19. A method of deploying a prosthesis within a native mitral valve, the method comprising:

delivering an expandable frame configured to radially expand and collapse between an expanded configuration and a collapsed configuration to the native mitral valve in the collapsed configuration, the expandable frame comprising;

a proximal end having a twelve proximal anchors, the twelve proximal anchors each connected to the frame and having a free end positioned radially outward from the frame when the frame is in the expanded configuration, wherein each of the twelve proximal anchors comprises first and second struts connected to and extending radially outward from the frame when the frame is in the expanded configuration, the first and second struts each comprising a substantially straight segment;

a distal end having twelve distal anchors, the twelve distal anchors each having a free end positioned radially outward from the frame and extending toward the proximal end when the frame is in the expanded configuration; and

a valve body attached to the expandable frame, wherein the valve body can move between (i) an open position wherein blood can flow from the proximal end toward the distal end; and

(ii) a closed position which blocks blood from flowing from the distal end toward the proximal end; and

radially expanding the expandable frame to the expanded configuration, wherein the radially expanding causes the free ends of the twelve proximal anchors and the twelve distal anchors to draw closer together;

wherein, in the expanded configuration, the twelve proximal anchors are on an inflow side of the native mitral valve and the twelve distal anchors are on an outflow side of the native mitral valve.

20. The method of claim 19, wherein the expandable frame comprises a foreshortening portion having a plurality of foreshortening cells, each of the twelve distal anchors connected to a distal apex of a foreshortening cell.