Stentless support structure

• US 9,180,002 B2
• Filed: 04/27/2012
• Issued: 11/10/2015
• Est. Priority Date: 05/27/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: HLT, Inc. (Bracco SPA)
• Inventors: Thill, Gary A., Wilson, Robert Foster, Gainor, John, Banick, Christopher M.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US13/458,023
• Publication Number:
  US 20120209370A1
• Time in Patent Office: 1,292 Days
• Field of Search: 623/1.24, 623/1.26, 623/1.51, 623/1.53, 623/2.18
• US Class Current: 1/1
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A stentless support structure capable of being at least partly assembled in situ. The support structure comprises a braided tube that is very flexible and, when elongated, becomes very long and very small in diameter, thereby being capable of placement within a small diameter catheter. The support structure is preferably constructed of one or more thin strands of a super-elastic or shape memory material such as Nitinol. When released from the catheter, the support structure folds itself into a longitudinally compact configuration. The support structure thus gains significant strength as the number of folds increase. This radial strength obviates the need for a support stent. The support structure may include attachment points for a prosthetic valve.

Claims

1. A stentless support structure comprising:

a strand braided to form a tubular structure having an unfolded delivery configuration and a folded delivered configuration;

whereby in the unfolded delivery configuration, the tubular structure includes;

a first end and a second end;

an elongate tubular body between the first end and the second end;

whereby in the folded delivered configuration, the tubular structure includes;

at least one circumferential fold in the elongate tubular body reducing a length of the tubular structure and creating a tubular section of the body having at least twice as many layers as the elongate tubular body in the unfolded delivery configuration.

2. A prosthetic valve assembly comprising:

a tube having a elongated configuration and a folded configuration;

a wireform defining a plurality of commissural points, said wireform having a distal end;

a valve attached to said wireform;

wherein in the elongated configuration, said distal end of said wireform is connected to a proximal end of said tube such that said wireform is longitudinally adjacent to said tube; and

,

wherein in the folded configuration, said proximal end of said tube folds inwardly such that said wireform is at least partly contained within an interior of said tube.

3. The prosthetic valve assembly of claim 2 wherein said tube comprises a mesh structure.

4. The prosthetic valve assembly of claim 2 wherein said wireform comprises three commissural points.

5. The prosthetic valve assembly of claim 2 wherein said wireform comprises connection points between said commissural points that are secured to said end of said tube.

6. The prosthetic valve assembly of claim 2 wherein said valve comprises tissue.

7. The prosthetic valve assembly of claim 2 wherein said valve comprises a skirt that overlaps said end of said tube.

8. The prosthetic valve assembly of claim 2 further comprising fabric secured to an inside surface of another end of said tube opposite said wireform, such that, in said folded configuration, said fabric becomes interposed between two layers of said tube.

9. The prosthetic valve assembly of claim 2 wherein said valve is sewn to said wireform.

10. The prosthetic valve assembly of claim 2 wherein said wireform comprises Nitinol.

11. The prosthetic valve assembly of claim 2 wherein said tube comprises at least one preformed fold enabling said folded configuration when released.

12. A prosthetic valve assembly comprising:

a tube having a elongated configuration and a folded configuration;

an annular wireform defining a plurality of commissural points, an end of the wireform being connected to an end of the tube;

a valve attached to said wireform;

wherein in the elongated configuration, said wireform is substantially outside of said tube; and

,

wherein in the folded configuration, said wireform is at least partly contained within an interior of said tube.

13. The prosthetic valve assembly of claim 12 wherein said tube comprises a mesh structure.

14. The prosthetic valve assembly of claim 12 wherein said wireform comprises three commissural points.

15. The prosthetic valve assembly of claim 12 wherein said wireform comprises connection points between said commissural points that are secured to said end of said tube.

16. The prosthetic valve assembly of claim 12 wherein said valve comprises tissue.

17. The prosthetic valve assembly of claim 12 wherein said valve comprises a skirt that overlaps said end of said tube.

18. The prosthetic valve assembly of claim 12 further comprising fabric secured to an inside surface of another end of said tube opposite said wireform, such that, in said folded configuration, said fabric becomes interposed between two layers of said tube.

19. The prosthetic valve assembly of claim 12 wherein said valve is sewn to said wireform.

20. The prosthetic valve assembly of claim 12 wherein said tube comprises at least one preformed fold enabling said folded configuration when released.