Low-profile prosthetic valve structure

• US 9,486,314 B2
• Filed: 03/14/2014
• Issued: 11/08/2016
• 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): Tyson, Melanie
• Assistant Examiner(s): Herbermann, Erich
• Application Number:
  US14/212,442
• Publication Number:
  US 20140288639A1
• Time in Patent Office: 970 Days
• Field of Search: 623/2.11
• US Class Current: 1/1
• 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 an extended configuration and a folded configuration and including;

a first end;

a second end;

a single preformed fold between said first end and said second end;

a first portion between said first end and said preformed fold;

a second portion between said second end and said preformed fold;

wherein said preformed fold at least assists in inverting said first portion into said second portion when said support structure is released from a delivery device;

a prosthetic valve structure;

at least one connector hingedly connecting the prosthetic valve structure to the support structure first end such that the at least one connector rotates relative to said support structure first end to allow said support structure first portion to invert into said support structure second portion without inverting said prosthetic valve structure.

2. The implantable device of claim 1 wherein said at least one connector comprises a hinge.

3. The implantable device of claim 1 wherein said at least one connector comprises a link.

4. The implantable device of claim 3 wherein said link comprises two ring connectors separated by a spacer.

5. The implantable device of claim 1 wherein, in said extended configuration, said connector separates said support structure from said valve structure.

6. The implantable device of claim 1 wherein said at least one connector comprises a tether.

7. The implantable device of claim 1 wherein inverting said first portion into said second portion when said support structure is released changes said support structure from said extended configuration to said folded configuration.

8. An implantable device comprising:

a support structure having a single performed fold, and a first portion and a second portion separated from said first portion by said preformed fold;

a valve assembly;

a connector connecting said valve assembly to said first portion 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 and said support structure, said valve assembly, and said connector are axially arranged;

wherein in said second configuration, said connector rotates relative to said first portion of said support structure while said first portion is inverted into said second portion and said valve assembly is drawn at least partially into said first portion by said connector.

9. The implantable device of claim 8 wherein said connector pivots such that said when said first portion 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 elongated 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 with a single preformed circumferential fold, a connector, and a second component axially in a delivery catheter, 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 fold into itself along said circumferential fold while said connector pivots, thereby drawing said second component axially toward said first component.

18. The method of claim 17 wherein allowing said first component to fold into itself comprises creating a preformed fold in said first component prior to arranging, and unfolding said preformed fold during said arranging step such that said preformed fold causes said first component to fold into itself when released.

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 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.