Low-profile prosthetic valve structure

• US 9,931,205 B2
• Filed: 10/07/2016
• Issued: 04/03/2018
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: HLT, Inc. (Bracco SPA)
• Inventors: Gainor, John P.
• Primary Examiner(s): Yabut, Diane
• Assistant Examiner(s): HERBERMANN, ERICH G.
• Application Number:
  US15/288,543
• Publication Number:
  US 20170020667A1
• Time in Patent Office: 543 Days
• Field of Search: 623 211
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type

Abstract

A prosthetic valve assembly that includes a stent, a tissue sleeve and an anchoring mechanism. By loading the three components of the valve assembly into a delivery catheter in a series formation, such that no two components are located within each other, the size of the delivery catheter can be reduced.

Claims

1. An implantable device comprising:

a support structure having a single preformed fold and an unfolded configuration and a folded configuration and including;

a first end;

a second end directed away from said first end; and

,

a lumen extending between said first end and said second end;

wherein said support structure is biased toward a folded configuration in which said first end is inverted into said lumen, such that the first end and the second end are both oriented in a common direction;

wherein said support structure tends to assume said folded configuration when said support structure is released from a delivery device;

a prosthetic valve structure hingedly attached to said support structure first end such that said prosthetic valve structure is not inverted when said support structure inverts.

2. The implantable device of claim 1 wherein said hinged end is attached to said support structure first end with a connector.

3. The implantable device of claim 2 wherein said connector comprises a hinge.

4. The implantable device of claim 2 wherein said connector comprises a link.

5. The implantable device of claim 4 wherein said link comprises two ring connectors separated by a spacer.

6. The implantable device of claim 1 wherein, in said unfolded configuration, said connector separates said support structure from said valve assembly.

7. The implantable device of claim 1 wherein said connector comprises a tether.

8. An implantable device comprising:

a support structure having a first end and a second end and a lumen therebetween, and a single preformed fold;

a valve assembly;

a connector connecting said valve assembly to said first end of said support structure;

wherein said implantable device has a first configuration and a second configuration;

wherein in said first configuration, said support structure is unfolded, said first end faces a first direction and said second end faces a second direction opposite said first direction, and said support structure, said valve assembly, and said connector are axially arranged;

wherein in said second configuration, said single preformed fold is folded and said first end is inverted into said lumen such that said first end faces said second direction and said valve assembly is drawn at least partially into said lumen by said connector.

9. The implantable device of claim 8 wherein said connector pivots such that said when said support structure inverts, said valve assembly does not invert.

10. The implantable device of claim 8 wherein said connector comprises a hinge.

11. The implantable device of claim 8 wherein said connector comprises a link.

12. The implantable device of claim 11 wherein said link comprises two ring connectors separated by a spacer.

13. The implantable device of claim 8 wherein, in said first configuration, said connector separates said support structure from said valve assembly.

14. The implantable device of claim 8 wherein said connector comprises a tether.

15. The implantable device of claim 14 wherein said tether comprises a first end tied to the support structure and a second end tied to the valve assembly.

16. The implantable device of claim 8 wherein said connector comprises a loop.

17. A method of delivering an implantable device comprising:

arranging a first component, a connector, and a second component axially in a delivery catheter, said first component in an unfolded configuration but having a single preformed fold that is biased toward a folded configuration;

said connector connecting said first component and said second component such that said first and second components do not overlap;

releasing said first component, said connector, and said second component at a target site from said catheter;

allowing said first component to assume said folded configuration such that opposite ends thereof face a common direction while said connector pivots, thereby drawing said second component axially toward said first component.

18. The method of claim 17 wherein releasing said first component, said connector, and said second component at a target site from said catheter comprises first releasing said first component followed by releasing said connector and said second component.

19. The method of claim 17 wherein arranging a first component, a connector and a second component axially in a delivery catheter comprises arranging a support structure, a connector, and a valve assembly in a delivery catheter.

20. The method of claim 17 wherein arranging a first component, a connector, and a second component axially in a delivery catheter, said first component in an unfolded configuration but biased toward a folded configuration;

said connector connecting said first component and said second component such that said first and second components do not overlap, comprises arranging said first component, said connector, and said second component axially in said delivery catheter such that said first component and said second component are spaced apart from each other.