PARAVALVULAR LEAK SEALING MECHANISM

• US 20150127098A1
• Filed: 09/30/2014
• Published: 05/07/2015
• 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.
• Granted Patent: US 9,668,857 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• 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 2/2469 with resilient valve members, e.g. conical spiral
• 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 prosthetic heart valve includes a stent body with a generally tubular annulus section, which may include one or more circumferential rows of cells. One or more prosthetic valve elements mounted to the stent body operate to allow blood flow in an antegrade direction but to substantially block flow in a retrograde direction. A cuff is attached to the stent body and positioned on a luminal surface of the stent body. At least one sealing member is attached to the cuff. The sealing member may be patch with 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. Flow of blood in the second axial direction will tend to force blood into the sealing member and cause the sealing member to billow outwardly relative to the stent body.

Claims

1. A prosthetic heart valve, comprising:

a stent body including a generally tubular annulus section defining a first circumferential row of cells;

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 and positioned on a luminal surface of the stent body; and

at least one sealing member attached to the cuff, the at least one sealing member 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 at least one sealing member and cause the sealing member to billow outwardly relative to the stent body,

wherein the at least one sealing member has a shape chosen from the group consisting of generally triangular, generally trapezoidal, and generally semicircular.

2. The prosthetic heart valve of claim 1, wherein the at least one sealing member is not directly attached to the stent body.

3. The prosthetic heart valve of claim 1, wherein the at least one sealing member is attached to both the cuff and the stent body.

4. The prosthetic heart valve of claim 1, wherein a plurality of sealing members are attached to the cuff.

5. The prosthetic heart valve of claim 4, wherein each of the plurality of sealing members is individually attached to the cuff.

6. The prosthetic heart valve of claim 4, wherein the plurality of sealing members form a continuous series of sealing members attached to one another.

7. The prosthetic heart valve of claim 4, wherein the plurality of sealing members is attached to the cuff such that one sealing member is positioned substantially within each cell in the first circumferential row of cells.

8. A prosthetic heart valve, comprising:

a stent body including a generally tubular annulus section defining a first circumferential row of cells and a second circumferential row of cells distal to the first circumferential row of cells;

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 and positioned on a luminal surface of the stent body;

at least one proximal sealing member attached to the cuff and positioned substantially within a cell in the first circumferential row of cells, the proximal sealing member having an open side facing in a first axial direction and a closed side facing in a second axial direction opposite the first axial direction so that a flow of blood in the second axial direction will tend to force blood into the proximal sealing member and cause the proximal sealing member to billow outwardly relative to the stent body; and

at least one distal sealing member attached to the cuff and positioned substantially within a cell in the second circumferential row of cells, the distal sealing member 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 distal sealing member and cause the distal sealing member to billow outwardly relative to the stent body.

9. The prosthetic heart valve of claim 8, wherein a plurality of distal sealing members and a plurality of proximal sealing members are attached to the cuff.

10. The prosthetic heart valve of claim 9, wherein the plurality of distal sealing members is circumferentially staggered with respect to the plurality of proximal sealing members such that a center portion of the open side of each distal sealing member aligns generally longitudinally with a point at which the open sides of two adjacent proximal sealing members meet.

11. The prosthetic heart valve of claim 8, wherein one proximal sealing member is attached to the cuff and positioned substantially within each cell in the first circumferential row of cells and one distal sealing member is attached to the cuff and positioned substantially within each cell in the second circumferential row of cells.

12. The prosthetic heart valve of claim 8, further comprising at least one commissure attachment feature defined by the stent body, wherein exactly one distal sealing member is attached to the cuff and positioned substantially within a cell in the second circumferential row of cells directly proximal to the commissure attachment feature, and no distal sealing members are attached to the cuff and positioned substantially within any other cell in the second circumferential row of cells.

13. The prosthetic heart valve of claim 12, further comprising exactly two proximal sealing members for each distal sealing member, the two proximal sealing members being attached to the cuff at two adjacent cells in the first circumferential row of cells such that a center portion of the open side of each distal sealing member aligns generally longitudinally with a point at which the open sides of two adjacent proximal sealing members meet.

14. A prosthetic heart valve, comprising:

a 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 and positioned on a luminal surface of the stent body; and

a sealing member attached to the cuff, the sealing member being generally rectangular 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 sealing member and cause the sealing member to billow outwardly relative to the stent body,

wherein the sealing member is wrapped around an entire circumference of the stent body and defines a pocket divided into a plurality of regions, each of the regions being in fluid communication with adjacent ones of the regions.

15. The prosthetic heart valve of claim 14, wherein the open side of the sealing member is attached to the cuff at spaced locations around the circumference of the stent body.

16. The prosthetic heart valve of claim 15, wherein the sealing member comprises an extension of the cuff, the extension being wrapped around a proximal end of the stent body such that the extension is positioned on an abluminal surface of the stent body.

17. The prosthetic heart valve of claim 16, 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.

18. The prosthetic heart valve of claim 15, wherein the sealing member is formed from a separate piece of material than the cuff.