Paravalvular leak sealing mechanism

• US 9,913,715 B2
• Filed: 05/06/2016
• Issued: 03/13/2018
• Est. Priority Date: 11/06/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Braido, Peter N., Fahim, Mina S.
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US15/148,322
• Publication Number:
  US 20160250022A1
• Time in Patent Office: 676 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0061 swellable
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A collapsible and expandable stent body includes a generally tubular annulus section, one or more prosthetic valve elements mounted to the stent body, and a cuff attached to the stent body. The prosthetic valve is operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction. The prosthetic heart valve may include paravalvular leak mitigation features in the form of first and second sealing members. The sealing members are attached to the cuff and extend circumferentially around an abluminal surface of the stent body. The sealing members each have an open side facing in a first axial direction and a closed side facing in an opposite second axial direction. Flow of blood in the second axial direction will tend to force blood into the sealing members and cause the sealing members to billow outwardly relative to the stent body, helping to mitigate paravalvular leak.

Claims

1. A prosthetic heart valve, comprising:

a collapsible and expandable stent body including a generally tubular annulus section;

one or more prosthetic valve elements mounted to the stent body and operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction through the annulus section;

a cuff attached to the stent body;

a first sealing member attached to the cuff, the first sealing member extending circumferentially around an abluminal surface of the stent body and having an open side facing in a first axial direction and a closed side facing in a second axial direction opposite to the first axial direction so that a flow of blood in the second axial direction will tend to force blood into the first sealing member and cause the first sealing member to billow outwardly relative to the stent body; and

a second sealing member attached to the cuff, the second sealing member extending circumferentially around the abluminal surface of the stent body and having an open side facing in the first axial direction and a closed side facing in the second axial direction so that the flow of blood in the second axial direction will tend to force blood into the second sealing member and cause the second sealing member to billow outwardly relative to the stent body,

wherein the open sides of the first sealing member and the second sealing member are attached to the cuff at spaced locations around a circumference of the stent body so that the open side of the first sealing member includes a first plurality of openings offset in a circumferential direction from a second plurality of openings in the open side of the second sealing member.

2. The prosthetic heart valve of claim 1, wherein the first sealing member defines a first pocket having a plurality of first regions, each of the first regions being in fluid communication with adjacent ones of the first regions.

3. The prosthetic heart valve of claim 2, wherein the second sealing member defines a second pocket having a plurality of second regions, each of the second regions being in fluid communication with adjacent ones of the second regions.

4. The prosthetic heart valve of claim 1, wherein the first sealing member is wrapped around an entire circumference of the stent body.

5. The prosthetic heart valve of claim 4, wherein the second sealing member is wrapped around the entire circumference of the stent body.

6. The prosthetic heart valve of claim 1, wherein the first sealing member is positioned nearer an inflow end of the stent body than the second sealing member.

7. The prosthetic heart valve of claim 6, wherein the open side of the first sealing member is axially spaced apart from the closed side of the second sealing member.

8. The prosthetic heart valve of claim 1, wherein the first sealing member comprises an extension of the cuff, the extension being wrapped around an inflow end of the stent body such that the extension is positioned on an abluminal surface of the stent body.

9. The prosthetic heart valve of claim 8, wherein a proximal portion of the extension on the abluminal surface of the stent body is connected to a proximal portion of the cuff on the luminal surface of the stent body with a seam.

10. The prosthetic heart valve of claim 1, wherein the second sealing member is formed from a separate piece of material from the cuff.

11. The prosthetic heart valve of claim 10, wherein the first sealing member is formed from a separate piece of material from the cuff.

12. The prosthetic heart valve of claim 1, wherein the first sealing member is formed of a single piece of material.

13. The prosthetic heart valve of claim 1, wherein the second sealing member is formed of a single piece of material.

14. The prosthetic heart valve of claim 1, wherein the first sealing member is formed from a plurality of pieces of material.

15. The prosthetic heart valve of claim 1, wherein the second sealing member is formed from a plurality of pieces of material.

16. The prosthetic heart valve of claim 1, wherein the first sealing member is substantially rectangular.

17. The prosthetic heart valve of claim 16, wherein the second sealing member is substantially rectangular.