Method for replacing a heart valve

• US 9,949,830 B2
• Filed: 09/15/2017
• Issued: 04/24/2018
• 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 NEILKEN
• Application Number:
  US15/706,251
• Publication Number:
  US 20180000585A1
• Time in Patent Office: 221 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 replacing a function of a native heart valve, the method comprising:

compressing a valve-replacement apparatus to a small diameter;

delivering the valve-replacement apparatus to a native mitral valve using a catheter;

expanding a stent of the valve-replacement apparatus within the native mitral valve, the stent at least partially covered, a valve member disposed within the stent, the valve member including a plurality of pericardial tissue flaps arranged side-by-side with adjacent surfaces having coaptation areas in close contact with each other to prevent leakage between the flaps;

extending a portion of a first end of a flexible connecting member through a tissue wall, a second end of the connecting member coupled to an outflow portion of the valve-replacement apparatus; and

securing a disk-shaped element to the connecting member, the disk-shaped element contacting the tissue wall, to fix a position of the valve member within the native mitral valve.

2. The method of claim 1, wherein extending the portion of the first end of a flexible connecting member through the tissue wall includes extending the portion of the first end of a flexible connecting member through an interventricular muscular septum or a muscular ventricular wall.

3. The method of claim 1, wherein the disk-shaped element is a first disk-shaped element, the method further comprising securing a second disk-shaped element to the connecting member, the first and second disk-shaped elements engaging opposite sides of the tissue wall.

4. A method for replacing a function of a native heart valve, the method comprising:

expanding a stent of a valve-replacement apparatus within a native heart valve, a valve member disposed within the stent, the valve member including a plurality of flaps arranged side-by-side with adjacent surfaces having coaptation areas in close contact with each other to prevent leakage between the flaps; and

anchoring a first end portion of a connecting member to a tissue wall to fix a position of the valve member within the native heart valve, a second end of the connecting member coupled to an outflow portion of the replacement valve.

5. The method of claim 4, wherein expanding the stent includes expanding an at least partially covered stent.

6. The method of claim 4, wherein expanding the stent including the plurality of flaps comprises expanding a stent including a plurality of flaps comprising pericardial tissue.

7. The method of claim 4, wherein anchoring the first end of the connecting member to the tissue wall includes engaging an anchoring member with an arterial vessel wall, a venous vessel wall, an atrial septum, an interventricular muscular septum, a muscular ventricular wall, or an atrial wall.

8. The method of claim 4, wherein expanding the stent includes expanding a first stent, and wherein anchoring the first end of the connecting member to a tissue wall includes expanding a second stent coupled to the first end of the connecting member.

9. The method of claim 4, wherein anchoring the first end of the connecting member to a tissue wall includes extending a portion of the connecting member through the tissue wall and securing a disk-shaped element to the connecting member, the disk-shaped element contacting the tissue wall.

10. The method of claim 9, wherein the disk-shaped element is a first disk-shaped element, the method further comprising securing a second disk-shaped element to the connecting member, the first and second disk-shaped elements engaging opposite sides of the tissue wall.

11. The method of claim 4, wherein anchoring the first end of the connecting member to the tissue wall includes engaging the tissue wall with a hook, barb, or spike.

12. The method of claim 4, wherein expanding the stent of the valve-replacement apparatus within the native heart valve includes expanding the stent of the valve-replacement apparatus within a native aortic valve.

13. The method of claim 4, wherein expanding the stent of the valve-replacement apparatus within the native heart valve includes expanding the stent of the valve-replacement apparatus within a native mitral valve.

14. The method of claim 4, wherein anchoring the first end of the connecting member includes anchoring a first end of an at-least-partially-flexible connecting member.

15. The method of claim 4, further comprising compressing the valve-replacement apparatus to a small diameter.

16. The method of claim 15, further comprising delivering the valve-replacement apparatus to the native valve endoscopically.

17. The method of claim 15, further comprising delivering the valve-replacement apparatus to the native valve using a catheter.