STENT ASSEMBLY FOR USE IN PROSTHETIC HEART VALVES

• US 20170312075A1
• Filed: 07/14/2017
• Published: 11/02/2017
• 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.
• Granted Patent: US 10,420,641 B2
• Time in Patent Office: 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 use in a prosthetic heart valve for replacing a native valve, comprising:

a stent including a luminal surface defining a lumen;

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

a plurality of elongated members coupled between the stent and cuff, the members configured to arrange the cuff between the first and second orientations, wherein the cuff when in the first orientation is arranged within the lumen to provide a low profile prosthetic heart valve;

wherein the members remain coupled to the stent and cuff when in the second orientation after replacement of the native valve; and

wherein the cuff when arranged in the first orientation is disposed entirely within the lumen, and wherein at least a portion of the cuff when arranged in the second orientation is disposed circumscribing the stent overlying an abluminal surface thereof forming a cuff seal.

2. The stent assembly of claim 1, wherein the plurality of members comprise at least one of an elastic member or at least one coiled member having a tensioned state and a relaxed state.

3. The stent assembly of claim 1, 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.

4. The stent assembly of claim 1, 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.

5. The stent assembly of claim 4, 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.

6. The stent assembly of claim 1, 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.

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 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.

9. The stent assembly of claim 3, wherein the stent includes an abluminal surface, and wherein the cuff is at least partially disposed on the abluminal surface of the stent when the plurality of members is in the relaxed state.

10. A method for preparing a stent assembly for use in a prosthetic heart valve for replacing a native valve, wherein the stent assembly includes a stent having a luminal surface defining a lumen, a cuff coupled to the stent, and a plurality of elongated members coupled between the stent and the cuff, the method comprising:

arranging the cuff in a first orientation positioned within the lumen to provide a low profile prosthetic heart valve;

wherein the members remain coupled to the stent and cuff when at least a portion of the cuff is arranged in a second orientation after replacement of the native valve; and

wherein the cuff when arranged in the first orientation is disposed entirely within the lumen, and wherein the at least a portion of the cuff when arranged in the second orientation is disposed circumscribing the stent overlying an abluminal surface thereof forming a cuff seal.

11. The method of claim 10, wherein the plurality of members comprise at least one of an elastic member or at least one coiled member having a tensioned state and a relaxed state.

12. The method of claim 10, 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.

13. The method 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 proximal ends of the plurality of members.

15. The method of claim 10, 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.

16. The method of claim 10, wherein the plurality of members are attached to the cuff circumferentially along spaced apart longitudinally extending axes of the stent.

17. The method 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.

18. The method of claim 13, wherein the stent includes an abluminal surface, and wherein the cuff is at least partially disposed on the abluminal surface of the stent when the plurality of members is in the relaxed state.

14. The method of claim 14, 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.