Method for replacing a heart valve

• US 10,405,977 B2
• Filed: 04/19/2018
• Issued: 09/10/2019
• Est. Priority Date: 04/21/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Solem, Jan Otto
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US15/957,817
• Publication Number:
  US 20180235757A1
• Time in Patent Office: 509 Days
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• 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 2/2412 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

A method for replacing a native heart valve in need thereof comprises delivering to the native heart valve an apparatus comprising a valve member, a connecting member, and an anchor member suitable for anchoring the apparatus. The valve member reversibly moves between an open position and a closed position to augment or replace the function of the native valve leaflets, thereby reducing valve regurgitation. Some embodiments include a stent that is positioned in the native heart valve with the valve member disposed therein.

Claims

1. A method for treating a native mitral valve, the method comprising:

advancing a delivery catheter toward the native mitral valve;

introducing a restraining catheter through a lumen of the delivery catheter, the restraining catheter having a valve member disposed along a distal end portion thereof, the valve member movable between an open state and a closed state when in an expanded configuration, the valve member in the open state extending primarily in a direction along blood flow, the valve member in the closed state extending in a direction transverse to blood flow, the valve member including a plurality of flaps made from pericardial tissue and treated with glutaraldehye, the flaps arranged side-by-side with adjacent surfaces having coaption areas in close contact with each other to prevent leakage between the flaps;

deploying the valve member within the native mitral valve; and

fixing a position of the valve member within the native mitral valve using an anchoring member, at least a portion of the anchoring member positioned outside the heart wall;

wherein an elongate connecting member has a first end portion coupled to the valve member and a second end portion coupled to the anchoring member, the connecting member extending through the heart wall and axially spacing the valve member from the anchoring member.

2. The method of claim 1, wherein the anchoring member comprises a first disk-shaped element.

3. The method of claim 1, wherein the anchoring member further comprises a second disk-shaped element.

4. The method of claim 1, wherein the anchoring member comprises a shape memory material, nitinol, stainless steel, or spring steel.

5. The method of claim 1, wherein at least a portion of the connecting member is flexible.

6. A method for treating a native mitral valve, the method comprising:

deploying a valve member in the native mitral valve, the valve member movable between an open state and a closed state, the valve member in the open state extending primarily in a direction along blood flow, the valve member in the closed state extending in a direction transverse to blood flow, the valve member including a plurality of flaps arranged side-by-side with adjacent surfaces having coaption areas in close contact with each other to prevent leakage between the flaps; and

fixing a position of the valve member in the native mitral valve using an anchoring member disposed on an outflow side of the valve member;

wherein an elongate connecting member extends between the valve member and the anchoring member, the connecting member axially spacing the valve member from the anchoring member.

7. The method of claim 6, wherein the plurality of flaps is made from pericardial tissue.

8. The method of claim 7, wherein the pericardial tissue is treated with glutaraldehyde.

9. The method of claim 6, further comprising advancing the connecting member through a heart wall.

10. The method of claim 9, wherein a portion of the connecting member remains outside the heart wall.

11. The method of claim 10, wherein the anchoring member is coupled to the portion of the connecting member that is outside the heart wall.

12. The method of claim 6, wherein the anchoring member comprises hooks, barbs, or spikes.

13. The method of claim 6, wherein the anchoring member comprises a shape memory material, nitinol, stainless steel, or spring steel.

14. The method of claim 6, wherein at least a portion of the connecting member is flexible.

15. The method of claim 6, further comprising a stent arranged for placement at the native heart valve with the valve member disposed within the stent.

16. The method of claim 15, wherein the stent is an at least partially covered stent.

17. The method of claim 6, wherein the valve member is delivered to the native mitral valve in a collapsed configuration using an elongate restraining catheter.

18. The method of claim 17, wherein the restraining catheter is advanced through a delivery catheter.

19. The method of claim 18, wherein the delivery catheter is advanced through an interatrial septum into a left atrium and further through the native mitral valve.

20. The method of claim 19, wherein the delivery catheter is advanced over a guide wire.