Stentless Support Structure

• US 20110282439A1
• Filed: 07/27/2011
• Published: 11/17/2011
• Est. Priority Date: 05/27/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: HLT, Inc. (Bracco SPA)
• Inventors: Gainor, John, Banick, Christopher M., Wilson, Robert Foster, Thill, Gary A.
• Granted Patent: US 9,271,831 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• 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:

at least one strand braided to form a tubular structure having a first configuration and a second configuration;

whereby in the first configuration, the tubular structure includes;

a first end and a second end;

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

whereby in the second configuration, the tubular structure includes at least one fold creating a section of the body having more than one ply.

2. The stentless support structure of claim 1 wherein said at least one fold shortens the body longitudinally in the second configuration.

3. The stentless support structure of claim 1 wherein said tubular structure comprises a single ply in the first configuration.

4. The stentless support structure of claim 1 wherein said tubular structure comprises a multi-ply section in the second configuration.

5. The stentless support structure of claim 1 whereby, in the first configuration, said stentless support structure is capable of being housed with a lumen of a 20Fr catheter.

6. The stentless support structure of claim 1 wherein said second end comprises a folded end.

7. The stentless support structure of claim 1 wherein said plurality of strands braided together to form a tubular structure comprises a plurality of strands of a first diameter and at least one fiber of a second diameter larger than the first diameter.

8. The stentless support structure of claim 1 wherein said first end comprises a wire form having a plurality of commissural attachment points.

9. The stentless support structure of claim 1 further comprising a lining in an inner wall of the tubular structure.

10. The stentless support structure of claim 4 further comprising a lining sandwiched between said first and second ply.

11. 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 connected to an end of said tube;

a valve attached to said wireform;

wherein in the elongated configuration, said wireform is longitudinally juxtaposed with said tube; and

,

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

12. The prosthetic valve assembly of claim 11 wherein said tube comprises a mesh structure.

13. The prosthetic valve assembly of claim 11 wherein said wireform comprises three commissural points.

14. The prosthetic valve assembly of claim 11 wherein said wireform comprises connection points between said commissural points that are secured to said end of said tube.

15. The prosthetic valve assembly of claim 11 wherein said valve comprises tissue.

16. The prosthetic valve assembly of claim 11 wherein said valve comprises a skirt that overlaps send end of said tube.

17. The prosthetic valve assembly of claim 11 further comprising fabric secured to an inside surface of an other end of said tube opposite said wireform, such that, in said folded configuration, said fabric becomes interposed between two layers of said tube.

18. The prosthetic valve assembly of claim 11 wherein said valve is sewn to said wireform.

19. The prosthetic valve assembly of claim 11 wherein said wireform comprises Nitinol.

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