METHOD OF IMPLANTING A PROSTHETIC VALVE IN A MITRAL VALVE WITH PULMONARY VEIN ANCHORING

• US 20110112632A1
• Filed: 01/14/2011
• Published: 05/12/2011
• Est. Priority Date: 02/25/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen, Son V., Corso, Philip P. JR., Popp, Michael, Olin, Jane M., Golemo, Kevin, Yi, Seung, Chau, Mark
• Granted Patent: US 8,252,051 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A method of implanting a prosthetic mitral valve assembly is disclosed. The prosthetic mitral valve assembly includes a stent and valve combination. The prosthetic mitral valve assembly is provided with an anchoring portion adapted to be positioned in the left atrium. In one embodiment, the anchoring portion includes at least one anchoring arm sized for placement in a pulmonary vein. The stent is radially expandable so that it can expand into position against the walls of the left atrium and accommodate a wide range of anatomies. Contact between the stent and the native tissue in the left atrium reduces paravalvular leakage and prevents migration of the stent once in place.

Claims

1. A method of implanting a prosthetic mitral valve assembly, comprising:

placing a suture at an apex of a heart into which the mitral valve is to be implanted;

inserting a delivery catheter through the apex of the heart at the suture location, the delivery catheter including the prosthetic mitral valve assembly in a collapsed state, the prosthetic mitral valve assembly including a pulmonary vein stent, a mitral valve stent, and an anchoring arm coupled between the pulmonary vein stent and the mitral valve stent;

positioning the pulmonary vein stent in a pulmonary vein, the pulmonary vein stent being coupled to a first end of the anchoring arm;

advancing the pulmonary vein stent from the delivery catheter;

radially expanding the pulmonary vein stent to anchor it within the pulmonary vein;

after expanding the pulmonary vein stent, positioning the mitral valve stent coupled to a second end of the anchoring arm in a native mitral valve;

advancing the mitral valve stent from the delivery catheter;

radially expanding the mitral valve stent to anchor it within the native mitral valve, with the pulmonary vein stent further securing the mitral valve stent in place through coupling of the anchoring arm between the pulmonary vein stent and the mitral valve stent; and

removing the delivery catheter through the apex of the heart and closing the suture.

2. The method of claim 1, wherein the mitral valve stent is radially-expandable and wherein positioning the mitral valve stent includes placing the mitral valve stent above an annulus of the native mitral valve.

3. The method of claim 1, further including a prosthetic valve coupled to the mitral valve stent, the prosthetic valve including prosthetic leaflets and further including coupling tension members to the prosthetic leaflets for preventing the prosthetic leaflets from everting.

4. The method of claim 3, wherein the prosthetic leaflets are coupled at a first end of the tension members and further including coupling an opposite end of the tension members to the stent or to a patient'"'"'s heart.

5. The method of claim 1, further including coupling a tether to the mitral valve stent on one end thereof, the tether being configured to couple the mitral valve stent to a portion of the heart remote from the mitral valve stent.

6. The method of claim 1, wherein the mitral valve stent includes prongs extending outwardly therefrom that are integral therewith.

7. The method of claim 1, wherein the anchoring arm is made of a flexible metal or polymer.

8. The method of claim 1, wherein the mitral valve stent includes an upper portion that is used to anchor it in the mitral valve, a tapered middle portion, and a lower portion, wherein the lower portion has a circumference that is less than a circumference of the upper portion.

9. The method of claim 1, wherein the pulmonary vein stent resists upward migration towards an atrium of the prosthetic mitral valve.

10. A method of implanting a prosthetic mitral valve, comprising:

inserting a prosthetic mitral valve assembly in a collapsed state through an apex of a heart using a delivery catheter, the prosthetic mitral valve assembly including a pulmonary vein stent, a mitral valve stent, and an anchoring arm coupled between the pulmonary vein stent and the mitral valve stent;

radially expanding the pulmonary valve stent in a pulmonary vein;

radially expanding the mitral valve stent in a native mitral valve so that the anchoring arm extends between the pulmonary valve stent and the mitral valve stent; and

removing the delivery catheter through the apex of the heart and closing a suture in the apex.

11. The method of claim 10, wherein the mitral valve stent is radially-expandable and wherein positioning the mitral valve stent includes placing the mitral valve stent above an annulus of the native mitral valve.

12. The method of claim 10, further including a prosthetic valve coupled to the mitral valve stent, the prosthetic valve including prosthetic leaflets and further including coupling tension members to the prosthetic leaflets for preventing the prosthetic leaflets from everting.

13. The method of claim 12, wherein the prosthetic leaflets are coupled at a first end of the tension members and further including coupling an opposite end of the tension members to the mitral valve stent or to a patient'"'"'s heart.

14. The method of claim 10, further including coupling a tether to the mitral valve stent on one end thereof, the tether being configured to couple the mitral valve stent to a portion of the heart remote from the mitral valve stent.

15. The method of claim 10, wherein the mitral valve stent includes prongs extending outwardly therefrom that are integral therewith.

16. The method of claim 10, wherein the anchoring arm is made of a flexible metal or polymer.

17. The method of claim 10, wherein the mitral valve stent includes an upper portion that is used to anchor it in the mitral valve, a tapered middle portion, and a lower portion, wherein the lower portion has a circumference that is less than a circumference of the upper portion.

18. The method of claim 10, wherein the pulmonary vein stent resists upward migration towards an atrium of the prosthetic mitral valve.

19. A method of implanting a prosthetic mitral valve assembly, comprising:

placing a purse string suture at an apex of a heart into which the mitral valve is to be implanted;

passing a guidewire through the apex of the heart at the suture location;

inserting a delivery catheter through the apex of the heart at the suture location, the delivery catheter including the prosthetic mitral valve assembly having a pulmonary vein stent, a mitral valve stent, and an anchoring arm coupled between the pulmonary vein stent and the mitral valve stent;

passing the guidewire into a pulmonary vein;

advancing the pulmonary vein stent from the delivery catheter into the pulmonary vein such that a first end of the anchoring arm is coupled to the pulmonary vein stent;

radially expanding the pulmonary vein stent to anchor it within the pulmonary vein;

positioning a mitral valve stent coupled to a second end of the anchoring arm in a native mitral valve so that the anchoring arm extends from adjacent the native mitral valve to the pulmonary vein;

advancing the mitral valve stent from the delivery catheter;

radially expanding the mitral valve stent to anchor it within the native mitral valve; and

removing the delivery catheter and guidewire through the apex of the heart and closing the purse string suture.

20. The method of claim 19, wherein the mitral valve stent includes an upper portion that is used to anchor it in the mitral valve, a tapered middle portion, and a lower portion, wherein the lower portion has a circumference that is less than a circumference of the upper portion.