Prosthetic valve for replacing mitral valve

• US 9,433,500 B2
• Filed: 07/16/2015
• Issued: 09/06/2016
• Est. Priority Date: 12/04/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Patterson, Marlowe E., Yi, Seung-Beom, Geist, Stephen C., Oba, Travis
• Primary Examiner(s): Stewart, Jason-Dennis
• Application Number:
  US14/801,713
• Publication Number:
  US 20150320553A1
• Time in Patent Office: 418 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2418 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

A prosthetic apparatus configured for implantation in the native mitral valve region of the heart includes a main body that is self-expandable from a compressed state to a radially expanded state. The prosthetic apparatus comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body for capturing a native valve leaflet between the anchor and an outer surface of the main body. In one preferred method of implantation, the prosthetic apparatus is rotated within the native mitral valve region such that a portion of the anchor moves horizontally behind adjacent chordae for anchoring the prosthetic apparatus in the native mitral valve.

Claims

1. A method of implanting a prosthetic apparatus in a defective native mitral valve without requiring open heart surgery or cardiopulmonary bypass, the method comprising:

advancing a prosthetic apparatus toward a mitral valve annulus, the prosthetic apparatus comprising a main body in a radially compressed state and a valve structure supported within the main body, the prosthetic apparatus further comprising at least one ventricular anchor coupled to the main body and disposed outside the main body;

guiding the ventricular anchor between chordae and behind a native mitral valve leaflet;

rotating the prosthetic apparatus such that the ventricular anchor moves horizontally behind chordae for capturing chordae between the ventricular anchor and the main body; and

allowing the main body to expand from the radially compressed state to a radially expanded state within the mitral valve annulus;

wherein, after implantation, chordae are positioned between the ventricular anchor and the main body for securing the prosthetic apparatus in the mitral valve annulus.

2. The method of claim 1, wherein the ventricular anchor extends upwardly from an outflow end of the main body.

3. The method of claim 1, wherein the ventricular anchor comprises a vertical leg portion and a horizontal foot portion.

4. The method of claim 3, wherein the horizontal foot portion is curved for wrapping around the main body.

5. The method of claim 1, wherein the valve structure comprises pericardial tissue.

6. The method of claim 1, wherein the at least one ventricular anchor comprises a plurality of ventricular anchors.

7. The method of claim 1, wherein the prosthetic apparatus further comprises an atrial sealing member adapted for placement above the mitral valve annulus.

8. The method of claim 1, wherein the prosthetic apparatus comprises a shape-memory material.

9. The method of claim 1, wherein the prosthetic apparatus is advanced toward the mitral valve annulus using a catheter.

10. The method of claim 9, wherein the catheter is steerable.

11. The method of claim 9, wherein the prosthetic apparatus is advanced using a transatrial approach.

12. The method of claim 9, wherein the prosthetic apparatus is advanced using a transseptal approach.

13. A method of implanting a prosthetic apparatus in a defective native mitral valve without requiring open heart surgery or cardiopulmonary bypass, the method comprising:

advancing a prosthetic apparatus toward a mitral valve annulus, the prosthetic apparatus comprising a radially collapsible and expandable main body and a valve structure supported within the main body, the prosthetic apparatus further comprising first and second ventricular anchors coupled to the main body and disposed outside the main body;

guiding the first ventricular anchor behind an anterior leaflet of the native mitral valve;

guiding the second ventricular anchor behind a posterior leaflet of the native mitral valve;

rotating the prosthetic apparatus such that portions of the ventricular anchors move horizontally for capturing chordae between the ventricular anchors and the main body; and

allowing the main body to radially expand from a compressed state to an expanded state within the mitral valve annulus.

14. The method of claim 13, wherein the first and second ventricular anchors are coupled to an outflow end of the main body.

15. The method of claim 13, wherein the first and second ventricular anchors each comprises a vertical leg portion and a horizontal foot portion, the horizontal portion terminating in an engagement portion.

16. The method of claim 15, wherein the horizontal foot portions wrap around the main body.

17. The method of claim 13, wherein the valvular structure comprises pericardial tissue.

18. The method of claim 13, wherein the prosthetic apparatus further comprises an atrial sealing member for placement above the mitral valve annulus.

19. The method of claim 13, wherein the prosthetic apparatus comprises a shape-memory material.

20. The method of claim 13, wherein the prosthetic apparatus is advanced across the septum and toward the mitral valve annulus using a catheterization technique.