Inflatable annular sealing device for prosthetic mitral valve

• US 9,486,306 B2
• Filed: 01/14/2014
• Issued: 11/08/2016
• Est. Priority Date: 04/02/2013
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Inventors: Tegels, Zachary J., Ekvall, Craig A., Vidlund, Robert M.
• Primary Examiner(s): Sevilla, Christian
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US14/154,910
• Publication Number:
  US 20140296975A1
• Time in Patent Office: 1,029 Days
• Field of Search: 623/2.17, 623 236- 237
• US Class Current: 1/1
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

This invention relates to a pre-configured compressible transcatheter prosthetic cardiovascular valve having an improved anterior leaflet sealing component comprising an inflatable annular sealing device made of a shell of elastomeric material, stabilized tissue or synthetic material, attached to the stent, and wherein during deployment of the valve the shell is filled to form a subvalvular seal. The invention also relates to methods for deploying such a valve for treatment of a patient in need thereof.

Claims

1. An apparatus, comprising:

a prosthetic heart valve configured to be implanted within a native mitral valve annulus and including a stent body portion and a collar portion coupled to the stent body portion, the collar portion being self-expandable, the stent body portion being tubular and defining an outer circumference,

an inflatable sealing member coupled to at least one of the stent body portion or the collar portion and disposed along only a portion of the outer circumference of the stent body portion, the sealing member configured to provide a subvalvular seal to the anterior leaflet of the native mitral valve when the prosthetic heart valve is disposed in the native mitral valve annulus with at least part of the collar portion disposed on an atrial side of the annulus.

2. The apparatus of claim 1, wherein the inflatable sealing member includes an inflatable shell formed of at least one of an elastomeric material, a stabilized tissue or a synthetic material.

3. The apparatus of claim 1, wherein the inflatable sealing member can be filled with one of a surgical cement, a two-part epoxy, a silicone gel, a biocompatible gel, a saline, a coiled material, a spring-like material, or an elastic material.

4. The apparatus of claim 1, wherein the inflatable sealing member includes a first commissural sealing portion and a second commissural sealing portion and an A2 segment sealing portion disposed between the first commissural sealing portion and the second commissural sealing portion, the A2 segment portion configured to correspondingly provide a subvalvular seal with the A2 segment of the native mitral valve when implanted therein.

5. The apparatus of claim 4, wherein the first commissural sealing portion and the second commissural sealing portion extend outwardly from the stent body portion a greater distance than the A2 segment sealing portion.

6. The apparatus of claim 1, wherein the prosthetic heart valve has a D-shape in top view including a curved portion and a substantially flat portion.

7. The apparatus of claim 6, wherein the sealing member is coupled to the at least one of the stent body portion or the collar portion along the substantially flat portion of the prosthetic valve.

8. The apparatus of claim 1, wherein the collar portion has a greater outer perimeter than the outer perimeter of the stent body portion.

9. An apparatus, comprising:

a prosthetic heart valve configured to be implanted within a native mitral valve annulus and including a stent body portion and a collar portion coupled to the stent body portion, the collar portion being self-expandable,

the prosthetic heart valve further including an inflatable sealing member coupled to at least one of the stent body portion or the collar portion and disposed circumferentially around at least a portion of an outer perimeter of the stent body portion, the sealing member including a first commissural sealing portion, a second commissural sealing portion and an A2 segment sealing portion disposed between the first commissural sealing portion and the second commissural sealing portion, the first commissural sealing portion and the second commissural sealing portion extending outwardly from the stent body portion a greater distance than the A2 segment sealing portion to form a substantially curved outer edge in a top view, the sealing member configured to provide a subvalvular seal to the anterior leaflet of the native mitral valve when the prosthetic heart valve is disposed in the native mitral valve annulus with at least part of the collar portion disposed on an atrial side of the annulus.

10. The apparatus of claim 9, wherein the inflatable sealing member is disposed circumferentially about the entire outer perimeter of the stent body portion.

11. The apparatus of claim 9, wherein the inflatable sealing member includes an inflatable shell formed of at least one of an elastomeric material, a stabilized tissue or a synthetic material.

12. The apparatus of claim 9, wherein the inflatable sealing member can be filled with one of a surgical cement, a two-part epoxy, a silicone gel, a biocompatible gel, a saline, a coiled material, a spring-like material, or an elastic material.

13. The apparatus of claim 9, wherein the A2 segment sealing portion is configured to correspondingly provide a subvalvular seal with the A2 segment of the native mitral valve when implanted therein.

14. The apparatus of claim 9, wherein the prosthetic heart valve has a D-shape in a top view including a curved portion and a substantially flat portion.

15. The apparatus of claim 14, wherein the sealing member is coupled to the at least one of the stent body portion or the collar portion along the substantially flat portion of the prosthetic valve.

16. The apparatus of claim 9, wherein the sealing member is disposed circumferentially about only a portion of the outer perimeter of the stent body portion.

17. The apparatus of claim 9, wherein the sealing member has a substantially curved outer edge in the top view that curves inwardly toward the stent body portion.