Method of implanting a prosthetic valve in a mitral valve with pulmonary vein anchoring

• US 8,252,051 B2
• Filed: 01/14/2011
• Issued: 08/28/2012
• Est. Priority Date: 02/25/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Yi, Seung, Corso, Philip, Popp, Michael J., Golemo, Kevin, Olin, Jane, Nguyen, Son V.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US13/007,378
• Publication Number:
  US 20110112632A1
• Time in Patent Office: 592 Days
• Field of Search: 623 21- 219
• US Class Current: 623/2.12
• 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 first pulmonary vein stent comprising a self-expanding metal lattice, a second pulmonary vein stent comprising a self-expanding metal lattice, a self-expanding mitral valve stent, a first anchoring arm coupling the first pulmonary vein stent and the mitral valve stent, and a second anchoring arm coupled between the second pulmonary vein stent and the mitral valve stent;

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

advancing the first pulmonary vein stent from the delivery catheter;

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

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

advancing the second pulmonary vein stent from the delivery catheter;

radially expanding the second pulmonary vein stent, thereby anchoring the second pulmonary vein stent entirely within the second pulmonary vein;

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

advancing an inner catheter shaft of the delivery catheter relative to an outer catheter shaft thereof, thereby advancing the mitral valve stent from the delivery catheter;

releasing extension arms extending from a lower end of the mitral valve stent from engagement with the inner catheter shaft;

radially expanding the mitral valve stent to contact an upper portion thereof against a wall of the left atrium, to anchor prongs extending from and integral with a tapered middle portion thereof against the wall of the left atrium, and to contact a lower portion thereof within an annulus of the native mitral valve, a circumference of the lower portion less than a circumference of the upper portion, the mitral valve stent including a pericardium sheet coupled to an inner surface thereof and a prosthetic valve comprising a plurality of pericardium leaflets disposed in the lower portion thereof, with the first pulmonary vein stent and the second pulmonary vein stent further securing the mitral valve stent in place through coupling of the first anchoring arm and the second anchoring arm between the first and second pulmonary vein stents 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 coupling tension members to the pericardium leaflets for preventing the pericardium leaflets from everting.

4. The method of claim 3, wherein the pericardium 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 first and second anchoring arms are made of a flexible metal or polymer.

7. The method of claim 1, wherein the first and second pulmonary vein stents resist upward migration of the mitral valve stent towards the atrium.

8. 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 entirely within 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, with an upper portion of the mitral valve stent contacting a wall of the left atrium, and a lower portion anchored in an annulus of the native mitral valve, a circumference of the lower portion less than a circumference of the upper portion, a tapered middle portion coupling the upper portion and the lower portion, a prosthetic valve comprising a plurality of pericardium leaflets disposed in the lower portion; and

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

9. The method of claim 8, 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.

10. The method of claim 8, further including coupling tension members to the pericardium leaflets for preventing the pericardium leaflets from everting.

11. The method of claim 10, wherein the pericardium 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.

12. The method of claim 8, 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.

13. The method of claim 8, wherein the mitral valve stent includes prongs extending outwardly therefrom that are integral therewith.

14. The method of claim 8, wherein the anchoring arm is made of a flexible metal or polymer.

15. The method of claim 8, wherein the pulmonary vein stent resists upward migration towards an atrium of the prosthetic mitral valve.

16. 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 first pulmonary vein stent, a second pulmonary vein stent, a mitral valve stent, a first anchoring arm coupling the first pulmonary vein stent and the mitral valve stent, and a second anchoring arm coupled between the second pulmonary vein stent and the mitral valve stent;

passing the guidewire into a pulmonary vein;

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

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

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

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

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

17. The method of claim 16, wherein radially expanding the mitral valve stent comprises radially expanding an upper portion to contact a wall of a left atrium, radially expanding a tapered middle portion, and radially expanding a lower portion within an annulus of the mitral valve, wherein the lower portion has a circumference that is less than a circumference of the upper portion.

18. The method of claim 16, wherein the prosthetic mitral valve assembly comprises a prosthetic valve disposed in the mitral valve stent, the prosthetic valve comprising a plurality of pericardium leaflets.

19. The method of claim 16, further comprising releasing extension arms extending from a lower end of the mitral valve stent from engagement with the delivery catheter.