Collapsible and re-expandable prosthetic heart valve cuff designs and complementary technological applications

• US 8,808,356 B2
• Filed: 07/15/2009
• Issued: 08/19/2014
• Est. Priority Date: 07/15/2008
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., Ashworth, Paul E., Neuman, Julia A.
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US12/737,256
• Publication Number:
  US 20110098802A1
• Time in Patent Office: 1,861 Days
• Field of Search: 623/1.26, 623/2.1
• US Class Current: 623/1.26
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.

Claims

1. A prosthetic heart valve, comprising:

(a) a stent body having a longitudinal axis and a generally tubular annulus region extending from a first position to a second position along the longitudinal axis;

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

(c) a cuff including one or more pockets outside of the annulus region and between the first position and the second position, each of the pockets having an outer wall, an opening 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 pocket.

2. A valve as claimed in claim 1 wherein the cuff includes a plurality of pockets between the first position and the second position, each of the pockets having an open side facing in the first axial direction.

3. A prosthetic heart valve, comprising:

a stent body having a longitudinal axis and a generally tubular annulus region extending from a first position to a second position along the longitudinal axis;

a valve element mounted within the stent body and operative to allow flow in an antegrade direction through the annulus region but to substantially block flow in a retrograde direction through the annulus region; and

a cuff connected to the stent body and including at least one pocket between the first position and the second position, the pocket having an outer wall and an open side facing in a first axial direction so that a flow of blood in a second axial direction opposite the first axial direction will tend to force blood into the pocket.

4. The prosthetic valve of claim 3, wherein the pocket is disposed radially outward of the annulus region.

5. The prosthetic valve of claim 3, wherein the pocket further includes an inner wall, the inner wall and the outer wall being formed as a unitary sheet of material.

6. The prosthetic valve of claim 3, wherein the pocket further includes an inner wall, the inner wall and the outer wall being formed as separate pieces of material.

7. The prosthetic valve of claim 3, wherein the pocket further includes a closed side facing in the second axial direction.

8. The prosthetic valve of claim 3, wherein the cuff includes a plurality of pockets between the first position and the second position, each of the pockets having an open side facing in the first axial direction.

9. The prosthetic valve of claim 8, wherein the plurality of pockets are disposed circumferentially around the stent body.

10. The prosthetic valve of claim 9, wherein each of the plurality of pockets is disposed adjacent another one of the plurality of pockets.

11. The prosthetic valve of claim 8, wherein the cuff further includes a closed portion between each of the open sides of the plurality of pockets, the closed portions facing in the first axial direction.

12. A prosthetic heart valve, comprising:

a unitary stent body having an inlet end, an outlet end, a longitudinal axis extending between the inlet end and the outlet end, and a plurality of commissure attachment features spaced from the inlet end;

a valve element mounted within the stent body and operative to allow flow through the stent body in an antegrade direction and to substantially block flow through the stent body in a retrograde direction; and

a cuff connected to the stent body and including at least one pocket between the inlet end and the commissure attachment features, the pocket having an outer wall and an open side facing in a first axial direction so that a flow of blood in a second axial direction opposite the first axial direction will tend to force blood into the pocket.

13. The prosthetic valve of claim 12, wherein the pocket is disposed radially outward of the stent body.

14. The prosthetic valve of claim 12, wherein the pocket further includes an inner wall, the inner wall being disposed on an inner side of the stent body and the outer wall being disposed on an outer side of the stent body.

15. The prosthetic valve of claim 12, wherein the pocket further includes an inner wall, the inner wall and the outer wall being formed as a unitary sheet of material.

16. The prosthetic valve of claim 12, wherein the pocket further includes a closed side facing in the second axial direction.

17. The prosthetic valve of claim 12, wherein the cuff includes a plurality of pockets, each of the pockets having an open side facing in the first axial direction.

18. The prosthetic valve of claim 17, wherein the cuff further includes a closed portion between each of the open sides of the plurality of pockets, the closed portions facing in the first axial direction.

19. A prosthetic heart valve, comprising:

a stent body having an inlet end, an outlet end, a radially collapsed condition and a radially expanded condition;

a valve element mounted within the stent body and operative to allow flow through the stent body in an antegrade direction and to substantially block flow through the stent body in a retrograde direction; and

a cuff connected to the stent body, the cuff including an inner wall adjacent the stent body and an outer wall spaced outwardly from the inner wall so as to define a space between the inner wall and the outer wall, the outer wall being movable relative to the inner wall so that a flow of blood entering the space can move the outer wall away from the inner wall.

20. A prosthetic heart valve, comprising:

a stent body having an inlet end, an outlet end, a radially collapsed condition and a radially expanded condition;

a valve element mounted within the stent body and operative to allow flow through the stent body in an antegrade direction and to substantially block flow through the stent body in a retrograde direction; and

a cuff connected to the stent body and including at least one pocket having an inner wall, an outer wall spaced from the stent body and a closed end adjacent the inlet end of the stent body so that a flow of blood in the retrograde direction can enter the pocket.

21. A prosthetic heart valve, comprising:

a stent body having a longitudinal axis and a generally tubular annulus region extending from a first position to a second position along the longitudinal axis;

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

a cuff including a pocket comprising an outer wall and an opening, the pocket being attached to the stent body and disposed to retard perivalvular leakage when in engagement with a native heart valve annulus.

22. A prosthetic heart valve, comprising:

a stent body having a longitudinal axis and a generally tubular annulus region extending from a first position to a second position along the longitudinal axis;

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

a cuff including a pocket comprising an outer wall and an opening, the pocket being attached to the stent body and disposed to retard perivalvular leakage when in engagement with native heart valve leaflets.

23. A prosthetic heart valve, comprising:

a stent body having a longitudinal axis and a generally tubular annulus region extending from a first position to a second position along the longitudinal axis;

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

a cuff including a pocket comprising an outer wall and an opening, the pocket being attached to the stent body and disposed to retard perivalvular leakage when implanted by biasing the outer surface of the pocket outwardly for engagement with a native heart valve annulus.

24. A prosthetic heart valve, comprising:

a stent body having a longitudinal axis and a generally tubular annulus region extending from a first position to a second position along the longitudinal axis;

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

a cuff including a pocket comprising an outer wall and an opening, the pocket being attached to the stent body and disposed to retard perivalvular leakage when implanted by biasing the outer surface of the pocket outwardly for engagement with native heart valve leaflets.

25. A prosthetic heart valve, comprising:

a stent body having a longitudinal axis and a generally tubular annulus region extending from a first position to a second position along the longitudinal axis;

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

a cuff defining one or more pockets, wherein, when the valve is implanted, the one or more pockets can be biased outwardly into engagement with a native heart valve annulus to retard perivalvular leakage by biasing a portion of the pocket outwardly for engagement with the native heart valve annulus.

26. A prosthetic heart valve, comprising:

a stent body having a longitudinal axis and a generally tubular annulus region extending from a first position to a second position along the longitudinal axis;

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

a cuff defining one or more pockets, wherein, when the valve is implanted, the one or more pockets can be biased outwardly into engagement with native heart valve leaflets to retard perivalvular leakage by biasing a portion of the pocket outwardly for engagement with the native heart valve leaflets.