Stent assembly for use in prosthetic heart valves

• US 9,757,230 B2
• Filed: 05/15/2015
• Issued: 09/12/2017
• Est. Priority Date: 05/16/2014
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Fahim, Mina S., Braido, Peter N.
• Primary Examiner(s): Dukert, Brian
• Application Number:
  US14/713,399
• Publication Number:
  US 20150327996A1
• Time in Patent Office: 851 Days
• 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 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve having a cuff attached to a stent provides a seal for preventing paravalvular leakage. The cuff may be constructed from known sealing materials to fill in and around paravalvular leakage gaps, while continuously collapsing down into a low profile volume within the stent. The cuff is coupled circumferentially about the stent by members which may be in the nature of dimension and/or shape memory material having a tensioned and relaxed state. The members may be in the form of elongated elastic members or coiled members. When in the tensioned state, the cuff is located within the stent volume to provide a low profile prosthetic heart valve. Upon relaxing of the members, the cuff is pulled over the abluminal surface of the stent to form a cuff seal circumscribing the stent for preventing paravalvular leakage.

Claims

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

a stent having a luminal surface and an abluminal surface extending between a distal end and a proximal end thereof;

a cuff coupled to the stent having a first orientation and a second orientation; and

,

a plurality of members having a distal end coupled to the stent and a proximal end coupled to the cuff, the plurality of members having a tensioned state when the cuff is arranged in the first orientation and a relaxed state when the cuff is arranged in the second orientation, the plurality of members have a first axial length dimension between a proximal portion and a distal portion thereof when in the tensioned state and a second axial length dimension between the proximal portion and the distal portion thereof when in the relaxed state wherein the first length dimension is greater than the second length dimension.

2. The stent assembly of claim 1, wherein the proximal end of the plurality of members are coupled to the cuff at spaced apart circumferential locations around the stent.

3. The stent assembly of claim 1, wherein the stent includes a plurality of runners, and wherein the distal end of the plurality of members are coupled to the runners.

4. The stent assembly of claim 1, wherein the cuff includes a distal end and a proximal end, and further including a hollow tube coupled to the proximal end of the cuff and the proximal ends of the plurality of members.

5. The stent assembly of claim 4, wherein the hollow tube defines a lumen, and further including an insert disposed within the lumen.

6. The stent assembly of claim 5, wherein the insert comprises at least one of a filler material or an elongated coiled member.

7. The stent assembly of claim 1, wherein the plurality of members are attached to the cuff circumferentially along spaced apart longitudinally extending axes of the stent.

8. The stent assembly of claim 1, wherein at least a portion of the cuff is at least partially positioned outward of the proximal end of the stent when arranged in the first orientation and at least partially disposed on the abluminal surface of the stent when arranged in the second orientation.

9. The stent assembly of claim 1, wherein the members comprise elastic members.

10. A stent assembly for a prosthetic heart valve for replacing a native valve, comprising:

a stent having a proximal end and an abluminal surface; and

a cuff coupled to the stent by a plurality of members having a relaxed state and a tensioned state for orienting at least a portion of the cuff at least partially disposed on the abluminal surface when the plurality of members are in a relaxed state, the plurality of members have a first axial length dimension between a proximal portion and a distal portion thereof when in the tensioned state and a second axial length dimension between the proximal portion and distal portion thereof when in the relaxed state, wherein the first axial length dimension is greater than the second axial length dimension.

11. The stent assembly of claim 10, wherein at least a portion of the cuff is arranged at least partially outward of the proximal end of the stent when the plurality of members are in the tensioned state.

12. The stent assembly of claim 10, wherein the stent includes a plurality of runners, and wherein the plurality of members have a distal end and a proximal end, the distal end of the plurality of members coupled to one of the runners and the proximal end of the plurality of members is coupled to a portion of the cuff.

13. The stent assembly of claim 10, wherein the cuff is at least partially disposed on the abluminal surface of the stent when the plurality of members is in the tensioned state and relaxed state.

14. The stent assembly of claim 13, wherein the plurality of members are attached to the cuff circumferentially along spaced apart longitudinally extending axes of the stent.

15. The stent assembly of claim 10, wherein the cuff includes a distal end and a proximal end, and wherein the plurality of members include a distal end and a proximal end, and further including a hollow tube coupled to the proximal end of the cuff and the proximal ends of the plurality of members, and an insert comprising at least one of a filler material or an elongated coiled member disposed within the hollow tube.

16. The stent assembly of claim 10, wherein the plurality of members comprise elastic members or springs.

17. A stent assembly for use in a prosthetic heart valve for replacing a native valve, comprising:

a stent;

a cuff coupled to the stent having a first orientation and a second orientation; and

a plurality of members coupled between the stent and cuff having a tensioned state and a relaxed state, the members configured to arrange the cuff between the first and second orientations, wherein the members remain coupled to the stent and cuff after replacement of the native valve, the plurality of members have a first axial length dimension between a proximal portion and a distal portion thereof when in the tensioned state and a second axial length dimension between the proximal portion and the distal portion thereof when in the relaxed state, wherein the first length dimension is greater than the second length dimension.

18. The stent assembly of claim 17, wherein the stent defines a lumen, and wherein the cuff when arranged in the first orientation is disposed within the lumen, and wherein the cuff when arranged in the second orientation is disposed circumscribing the stent overlying an abluminal surface thereof forming a cuff seal.

19. The stent assembly of claim 17, wherein the plurality of members comprise at least one of an elastic member or a coiled member having a tensioned first state and a relaxed second state.

20. The stent assembly of claim 17, wherein the plurality of members comprise inverting members which are in a tensioned state when the cuff is in the first orientation and a relaxed state when the cuff is in the second orientation.

21. The stent assembly of claim 17, wherein the stent includes a luminal surface defining a stent volume.

22. The stent assembly of claim 21, wherein the cuff when in the first orientation is arranged within the stent volume to provide a low profile prosthetic heart valve.

23. The stent assembly of claim 17, wherein the cuff includes a distal end and a proximal end, and wherein the plurality of members include a distal end and a proximal end, and further including a hollow tube coupled to the proximal end of the cuff and proximal ends of the plurality of members.

24. The stent assembly of claim 23, wherein the hollow tube defines a lumen, and further including an insert disposed within the lumen comprising at least one of a filler material or an elongated coiled member.

25. The stent assembly of claim 17, wherein at least a portion of the cuff is at least partially positioned outward of a proximal end of the stent when arranged in the first orientation and at least partially disposed on an abluminal surface of the stent when arranged in the second orientation.

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

a stent configured to have a collapsed condition and an expanded condition, the stent having a luminal surface and an abluminal surface extending between a distal end and a proximal end thereof;

a cuff having a portion at least partially disposed on the luminal surface of the stent, wherein at least a portion of the cuff having a first orientation extending outwardly of the proximal end of the stent or at least partially disposed on the abluminal surface of the stent, and a second orientation with a portion of the cuff at least partially disposed on the abluminal surface of the stent;

a valve assembly disposed within the stent, the valve assembly including a plurality of leaflets; and

a plurality of elongated members having a distal end coupled to the stent and a proximal end coupled to the cuff at circumferentially spaced apart locations, the plurality of members having a tensioned state when the cuff is arranged in the first orientation and a relaxed state when the cuff is arranged in the second orientation, the plurality of members have a first axial length dimension between a proximal portion and a distal portion thereof when in the tensioned state and a second axial length dimension between the proximal portion and distal portion thereof when in the relaxed state, wherein the first axial length dimension is greater than the second axial length dimension.

27. The prosthetic heart valve of claim 26, wherein the stent includes a plurality of runners, and wherein the distal end of the plurality of members are coupled to the runners.

28. The prosthetic heart valve of claim 26, wherein the cuff includes a distal end and a proximal end, and further including a hollow tube coupled to the proximal ends of the cuff and the plurality of members, and an insert comprising at least one of a filler material or an elongated coiled member disposed within the hollow tube.

29. The prosthetic heart valve of claim 26, wherein at least a portion of the cuff is at least partially disposed on the abluminal surface of the stent when arranged in the second orientation and at least partially positioned outward of the proximal end of the stent when arranged in the first orientation.

30. The prosthetic heart valve of claim 26, wherein the cuff is at least partially disposed on the abluminal surface of the stent when the plurality of members are in the first orientation and second orientation.

31. The prosthetic heart valve of claim 26, wherein the plurality of members comprise at least one of an elastic member or a coiled member each having a tensioned first state and a relaxed second state.