Stent assembly for use in prosthetic heart valves

• US 10,420,641 B2
• Filed: 07/14/2017
• Issued: 09/24/2019
• 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 A
• Application Number:
  US15/649,964
• Publication Number:
  US 20170312075A1
• Time in Patent Office: 802 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 having a proximal end, a distal end and a luminal surface defining a lumen;

a cuff coupled to the stent at a position spaced from the proximal end, the cuff having a first configuration and a second configuration; and

a plurality of elongated members coupled to the stent at positions spaced from the proximal end of the stent, the members being configured to arrange the cuff between the first and second configurations, wherein the cuff when in the first configuration is disposed entirely within the lumen to provide a low profile prosthetic heart valve;

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

wherein a first portion of the cuff when arranged in the second configuration is disposed within the lumen of the stent and a second portion of the cuff when arranged in the second configuration circumscribes 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 configuration and a relaxed state when the cuff is in the second configuration.

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

5. The stent assembly of claim 4, wherein the hollow tube defines a lumen, at least one of a filler material or an elongated coiled member being disposed within the lumen of the hollow tube.

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

7. The stent assembly of claim 1, wherein the plurality of members are oriented in a longitudinal direction of the stent and are attached to the cuff at circumferentially spaced apart positions on the stent.

8. The stent assembly of claim 1, wherein the stent includes a plurality of runners, and each of the plurality of members has a distal end and a proximal end, the distal ends of the plurality of members being coupled to respective ones of the runners and the proximal ends of the plurality of members being coupled to a portion of the cuff.

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

10. A method for preparing a stent assembly for use in a prosthetic heart valve for replacing a native valve, the stent assembly including a stent having a proximal end, a distal end, and a luminal surface defining a lumen, a cuff coupled to the stent at a position spaced from the proximal end, and a plurality of elongated members coupled to the stent at positions spaced from the proximal end of the stent, the method comprising:

arranging the cuff in a first configuration positioned entirely within the lumen to provide a low profile prosthetic heart valve wherein a first portion of the cuff when arranged in a second configuration is disposed within the lumen of the stent and a second portion of the cuff when arranged in the second configuration circumscribes the stent overlying an abluminal surface thereof forming a cuff seal, and the members remain coupled to the stent and the cuff when the second portion of the cuff is arranged in the second configuration after replacement of the native valve.

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 configuration and a relaxed state when the cuff is in the second configuration.

13. The method of claim 10, wherein the cuff includes a distal end and a proximal end, and each of the plurality of members includes a distal end and a proximal end, the stent assembly further including a hollow tube coupled to the proximal end of the cuff and to the proximal ends of the plurality of members.

14. The method of claim 13, wherein the hollow tube defines a lumen, at least one of a filler material or an elongated coiled member being disposed within the lumen of the hollow tube.

15. The method of claim 10, wherein at least a portion of the cuff is positioned outward of the proximal end of the stent when arranged in the first configuration and disposed on an abluminal surface of the stent when arranged in the second configuration.

16. The method of claim 10, wherein the plurality of members are oriented in a longitudinal direction of the stent and are attached to the cuff at circumferentially spaced apart positions on the stent.

17. The method of claim 10, wherein the stent includes a plurality of runners, and each of the plurality of members has a distal end and a proximal end, the distal ends of the plurality of members being coupled to respective ones of the runners and the proximal ends of the plurality of members being coupled to a portion of the cuff.

18. The method of claim 12, wherein the cuff is at least partially disposed on the abluminal surface of the stent when the plurality of members are in the relaxed state.