SUBANNULAR SEALING FOR PARAVALVULAR LEAK PROTECTION

• US 20170086971A1
• Filed: 05/12/2015
• Published: 03/30/2017
• Est. Priority Date: 05/16/2014
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Khouengboua, Sounthara (Ott), Kumar, Saravana B., Braido, Peter N., Smith, Kent J., McCarthy, Andrea L., Para, Andrea N., Benson, Thomas M., Moseman, Bruce, Satam, Gaurav
• Granted Patent: US 10,130,467 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent extending between a proximal end and a distal end. The stent includes an annulus section adjacent the proximal end and having a first diameter, a plurality of first struts forming cells, and a plurality of second struts connected to the annulus section and forming a plurality of deflecting cells expandable to define a second diameter larger than the first diameter. A valve assembly is disposed within the stent and a cuff is coupled to the stent and covers the plurality of deflecting cells.

Claims

1. A prosthetic heart valve for replacing a native valve, comprising:

a collapsible and expandable stent extending between a proximal end and a distal end, the stent including an annulus section adjacent the proximal end and having a first diameter, a plurality of first struts forming cells, and a plurality of second struts connected to the annulus section and forming a plurality of deflecting cells expandable to define a second diameter larger than the first diameter;

a valve assembly disposed within the stent; and

a cuff coupled to the stent and covering the plurality of deflecting cells.

2. The prosthetic heart valve of claim 1, wherein each of the deflecting cells includes upper struts and lower struts, the upper struts being joined to the lower struts at an angle of between about 90 degrees and about 145 degrees.

3. The prosthetic heart valve of claim 1, wherein the heart valve is implantable within a native valve annulus and a portion of the deflecting cells is disposed below the native valve annulus when implanted.

4. The prosthetic heart valve of claim 1, wherein the second diameter is about 4.0 mm to about 6.0 mm larger than the first diameter in an expanded condition.

5. The prosthetic heart valve of claim 1, wherein each of the deflecting cells includes upper struts and lower struts, the upper struts being about 9.0 mm to about 10.0 mm in length.

6. The prosthetic heart valve of claim 1, wherein the first struts have a first thickness and the second struts have a second thickness, the first thickness being greater than the second thickness.

7. The prosthetic heart valve of claim 6, wherein the first thickness is twice as large as the second thickness.

8. The prosthetic heart valve of claim 1, wherein the cuff is formed of multiple fragments.

9. The prosthetic heart valve of claim 1, wherein the cuff is at least partially disposed on an abluminal surface of the stent.

10. The prosthetic heart valve of claim 9, wherein the stent includes a plurality of commissure features and the cuff includes a first layer and a second layer, the first layer being disposed on the abluminal surface of the stent and extending from the plurality of commissure features to a proximal edge, the cuff being folded at the proximal edge away from the stent to form a second layer on the first layer.

11. The prosthetic heart valve of claim 10, wherein the first layer and second layer are sutured together to define a plurality of pockets open at second edges, the pockets being configured to expand upon receiving back-flowing blood.

12. The prosthetic heart valve of claim 1, wherein the cuff includes a first portion disposed on an abluminal surface of the stent, and a second portion disposed on a luminal surface of the stent.

13. The prosthetic heart valve of claim 12, wherein the stent includes a plurality of commissure features and the cuff extends from the plurality of commissure features to the proximal edge on an abluminal surface of the stent, and folds over the deflecting cells so that the second portion is disposed on the luminal surface of the stent.

14. A prosthetic heart valve for replacing a native valve, comprising:

a collapsible and expandable stent extending between a proximal end and a distal end and including an annulus section adjacent the proximal end and having a first diameter, the stent including a plurality of first struts forming cells, and a plurality of projecting struts joined to proximal-most cells, each of the projecting struts having a free end and an attached end joined to an intersection of first struts;

a valve assembly disposed within the stent; and

a cuff coupled to the stent and covering the projecting struts.

15. The prosthetic heart valve of claim 14, wherein each of the projecting struts includes an eyelet disposed at the free end.

16. The prosthetic heart valve of claim 14, wherein the each of the projecting struts is capable of independent movements from others of the projecting struts.

17. The prosthetic heart valve of claim 14, wherein the projecting struts are arranged in pairs, each two of the projecting struts being attached to a same intersection of first struts.

18. The prosthetic heart valve of claim 14, wherein the projecting struts are angled between about 15 degrees and about 35 degrees away from a longitudinal axis of the stent.

19. The prosthetic heart valve of claim 14, wherein the cuff is at least partially disposed on an abluminal surface of the stent.

20. The prosthetic heart valve of claim 14, wherein the cuff is at least partially disposed on a luminal surface of the stent.

21. A prosthetic heart valve for replacing a native heart valve comprising:

(a) a collapsible and expandable stent having proximal and distal ends, the stent including an annulus section adjacent the proximal end, the annulus section having a first expanded diameter and a first radial spring constant, the stent further including a plurality of deflecting features which project outwardly from the annulus section when the stent is in an expanded condition, the deflection features having a lower radial spring constant than the first section;

(b) a valve disposed within the annulus section distal to the deflection features, the valve being operative to permit flow toward the distal end of the stent and to substantially block flow toward the proximal end of the stent; and

(c) a cuff, a portion of the cuff being coupled to the deflection features.