MITRAL VALVE REPLACEMENT WITH ATRIAL ANCHORING

• US 20100217382A1
• Filed: 02/25/2009
• Published: 08/26/2010
• Est. Priority Date: 02/25/2009
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences (Edwards Lifesciences Corporation)
• Inventors: Popp, Michael, Corso, Phillip P. JR., Yi, Seung, Chau, Mark, Nguyen, Son V., Olin, Jane M., Golemo, Kevin
• Application Number:
  US12/393,010
• Publication Number:
  US 20100217382A1
• Time in Patent Office: Days
• US Class Current: 623/1.260
• 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 prosthetic mitral valve assembly and method of inserting the same is disclosed. In certain disclosed embodiments, the prosthetic mitral valve assembly includes a stent and valve combination. The stent is designed so that the anchoring portion is positioned above the annulus of the mitral valve and in the left atrium. 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 prosthetic mitral valve assembly for implantation in a heart having a native mitral valve positioned between a left atrium and left ventricle, comprising:

a radially-expandable stent sized so that an anchoring portion of the stent is implantable in the left atrium above an annulus of the native mitral valve with a pressure or friction fit against the atrium walls; and

a valve portion coupled to the stent.

2. The prosthetic mitral valve assembly of claim 1, wherein the valve portion is designed to work in series with the native mitral valve.

3. The prosthetic mitral valve assembly of claim 1, wherein the anchoring portion is an upper portion of the stent and the stent further includes a lower portion for extending into the native mitral valve, the valve portion being mounted in the lower portion of the stent so that the portion of the stent for anchoring the valve is independent of the portion of the stent for anchoring the mitral valve assembly in the heart.

4. The prosthetic mitral valve assembly of claim 1, wherein the stent is made of shape memory material formed in a lattice pattern.

5. The prosthetic mitral valve assembly of claim 1, wherein the stent includes anchoring arms designed to extend from the stent for contacting an upper portion of the atrium.

6. The prosthetic mitral valve assembly of claim 5, wherein each anchoring arm has a first end coupled to the stent and a second end designed to contact an upper portion of the atrium, wherein the second ends of the anchoring arms are coupled together.

7. The prosthetic mitral valve assembly of claim 5, wherein the anchoring arms are made of a flexible metal or polymer.

8. The prosthetic mitral valve assembly of claim 1, wherein the stent includes at least one anchoring arm designed to extend from the stent, the anchoring arm having a distal end for mounting in a pulmonary vein of a patient.

9. The prosthetic mitral valve assembly of claim 1, wherein the stent has an upper domed-shaped portion designed to contact an upper portion of the atrium.

10. The prosthetic mitral valve assembly of claim 1, wherein the valve portion further includes prosthetic leaflets and further including tension members coupled to the prosthetic leaflets for preventing the prosthetic leaflets from everting and reducing stresses induced by ventricular contraction.

11. The prosthetic mitral valve assembly of claim 10, wherein the tension members are coupled to the prosthetic leaflets at a first end of the tension members and coupled at an opposite end to the stent or to a patient'"'"'s heart.

12. The prosthetic mitral valve assembly of claim 1, further including a tether coupled to the stent on one end thereof, the tether being configured to couple the stent to a portion of the heart remote from the stent.

13. The prosthetic mitral valve assembly of claim 1, further including prongs extending outwardly from the stent that are integral with the stent or separate barbs coupled to the stent.

14. A prosthetic mitral valve assembly, comprising:

a radially-expandable stent having an upper portion sized so that an anchoring portion of the stent is implantable in a left atrium above an annulus of a native mitral valve with a pressure or friction fit and a lower portion for extending into the native mitral valve, the upper portion of the stent having a circumference that is greater than a circumference of the lower portion; and

a valve portion coupled within the lower portion to the stent.

15. The prosthetic mitral valve assembly of claim 14, wherein the stent is made of shape memory material formed in a lattice pattern.

16. The prosthetic mitral valve assembly of claim 14, wherein the stent includes anchoring arms designed to extend from the stent for contacting an upper portion of the atrium.

17. The prosthetic mitral valve assembly of claim 16, wherein each anchoring arm has a first end coupled to the stent and a second end designed to contact an upper portion of the atrium, wherein the second ends of the anchoring arms are coupled together.

18. The prosthetic mitral valve assembly of claim 16, wherein the anchoring arms are made of a flexible metal or polymer.

19. The prosthetic mitral valve assembly of claim 14, wherein the stent includes at least one anchoring arm designed to extend from the stent, the anchoring arm having a distal end for mounting in a pulmonary vein of a patient.

20. The prosthetic mitral valve assembly of claim 14, wherein the upper portion of the stent has a domed-shaped end designed to contact an upper portion of the atrium.

21. The prosthetic mitral valve assembly of claim 14, wherein the prosthetic mitral valve assembly is adapted to expand into contact with the native mitral valve tissue to create the pressure or friction fit and secure the mitral valve assembly in a fixed position in the heart.

22. The prosthetic mitral valve assembly of claim 14, wherein the lower portion is tapered and is designed to only partially extend into the native mitral valve.

23. The prosthetic mitral valve assembly of claim 14, wherein the lower portion is designed to fully extend into the native mitral valve.

24. The prosthetic mitral valve assembly of claim 14, further including prongs extending outwardly from the stent that are integral with the stent or separate barbs coupled to the stent.

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

inserting a prosthetic mitral valve assembly in a collapsed state into a heart using a delivery catheter;

expanding the prosthetic mitral valve assembly; and

positioning the prosthetic mitral valve assembly so that an anchoring portion of the stent is implantable in the left atrium above an annulus of the native mitral valve with a pressure fit.

26. The method of claim 25, further including positioning the prosthetic mitral valve assembly so that a first portion of the mitral valve assembly is in contact with a roof of a left atrium or is in contact with pulmonary veins in order to provide a downward force on a second portion of the mitral valve assembly and prevent the mitral valve assembly from upward migration.

27. The method of claim 25, wherein the mitral valve assembly includes a stent and a valve coupled to the stent.

28. The method of claim 25, wherein positioning the prosthetic mitral valve assembly includes wedging the mitral valve assembly into place so that an upper end thereof is prevented from moving upward through contact with a roof of the left atrium or through contact with the pulmonary veins and a lower end thereof is prevented from moving downward by leaflets of the native mitral valve.