Method of producing low profile stent and graft combination

• US 20060015167A1
• Filed: 09/19/2005
• Published: 01/19/2006
• Est. Priority Date: 01/22/1999
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Edward H. Cully, Joseph R. Armstrong, Mark J. Ulm, Michael J. Vonesh
• Inventors: Cully, Edward H., Armstrong, Joseph R., Vonesh, Michael J., Ulm, Mark J.
• Granted Patent: US 7,691,109 B2
• Time in Patent Office: Days
• US Class Current: 623/1.200
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• 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 2230/0054 V-shaped
• CPC Class Codes: Y10T 29/53987 Tube, sleeve or ferrule

Abstract

Large diameter self-expanding endoprosthetic devices, such as stents and stent grafts for delivery to large diameter vessels, such as the aorta, are disclosed having very small compacted delivery dimensions. Devices with deployed dimensions of 26 to 40 mm or more are disclosed that are compacted to extremely small dimensions of 5 mm or less, enabling percutaneous delivery of said devices without the need for surgical intervention. Compaction efficiencies are achieved by combining unique material combinations with new forms of restraining devices, compaction techniques, and delivery techniques. These inventive devices permit consistent percutaneous delivery of large vessel treatment devices. Additionally, small endoprosthetic devices are disclosed that can be compacted to extremely small dimensions for delivery through catheter tubes of less than 1 mm diameter.

Claims

1. A method of compacting an endoprosthesis comprising

providing a self-expanding endoprosthesis comprising a stent-element;

providing at least one tapered die proportioned to compact the endoprosthesis;

passing the endoprosthesis through the at least one tapered die to reduce dimensions of the endoprosthesis; and

passing the endoprosthesis through the at least one tapered die at least one additional time.

2. The method of claim 1 that further comprises

providing flutes and grooves on the at least one tapered die;

and

passing the endoprosthesis through the tapered die with with flutes and grooves in order to establish pleated folds in the endoprosthesis when compacted.

3. The method of claim 1 that further comprises

providing the stent-element with forward facing apices and rearward facing apices;

providing a tether line attached to or aligned with one or more of the apices;

pulling the endoprosthesis through the at least one tapered die using the tether line.

4. The method of claim 3 that further comprises

providing an actuation mechanism;

attaching the tether line to the actuation mechanism to pull the endoprosthesis through the at least one tapered die.

5. The method of claim 3 that further comprises

providing multiple flutes and grooves within the at least one tapered die;

providing multiple tether lines;

aligning the tether lines with only forward facing apices so that when the tether lines are pulled through the grooves only the forward facing apices are visible on the outside of the compressed endoprosthesis.

6. The method of claim 2 that further comprises

positioning the flutes evenly around the tapered die so as to produce uniform spacing of pleats around the compressed endoprosthesis.

7. The method of claim 6 that further comprises

providing a uniform spacing of grooves within the at least one tapered die;

providing a tether line to correspond with each groove; and

passing the endoprosthesis through the tapered die using the tether lines.

8. The method of claim 1 that further comprises

including a cover attached to the stent-element.

9. The method of claim 1 that further comprises cooling the endoprosthesis prior to passing through the tapered die.

10. The method of claim 1 that further comprises allowing the endoprosthesis to expand before passing it through the at least one tapered die at least one additional time.

11. A method of compacting an endoprosthesis comprising

providing an endoprosthesis;

providing a first tapered die proportioned to compact the endoprosthesis;

providing a second tapered die;

passing the endoprosthesis through the first tapered die;

subsequently passing the endoprosthesis through the second tapered die.

12. The method of claim 11 that further comprises providing a second die that is approximately the same sized diameter as the diameter of the first die.

13. The method of claim 11 that further comprises providing a second die that is a smaller diameter than the diameter of the first die.

14. The method of claim 11 that further comprises providing flutes and grooves on at least one of the tapered dies.

15. The method of claim 11 that further comprises

providing as part of the endoprosthesis a stent element with forward facing apices and rearward facing apices;

providing a tether line attached to or aligned with one or more of the apices;

pulling the endoprosthesis through the dies using the tether line.

16. The method of claim 15 that further comprises

providing an actuation mechanism;

attaching the tether line to the actuation mechanism to pull the endoprosthesis through the tapered die.

17. The method of claim 14 that further comprises

providing multiple flutes and grooves within the at least one tapered die;

providing multiple tether lines;

aligning the tether lines with only forward facing apices so that when the tether lines are pulled through the grooves only the forward facing apices are visible on the outside of the compressed endoprosthesis.

18. The method of claim 14 that further comprises

positioning the flutes evenly around the tapered die so as to produce uniform spacing of pleats around the compressed endoprosthesis.

19. The method of claim 18 that further comprises

providing a uniform spacing of groves within the at least one tapered die;

providing a tether line to correspond with each groove; and

passing the endoprosthesis through the tapered die using the tether lines.

20. The method of claim 11 that further comprises

providing an endoprosthesis that includes a stent-element and a cover.

21. The method of claim 11 that further comprises

providing as the endoprosthesis a stent.

22. The method of claim 21 that further comprises

providing a stent that is self-expanding.

23. The method of claim 22 that further comprises

providing a graft element attached to the stent.

24. The method of claim 11 that further comprises cooling the endoprosthesis prior to passing through the first tapered die.

25. The method of claim 11 that further comprises allowing the endoprosthesis to expand before passing it through the second tapered die.

26. A method of compacting an endoprosthesis comprising

providing a self-expanding endoprosthesis having a first diameter;

compacting the endoprosthesis to a second diameter smaller than the first diameter;

allowing the endoprosthesis to expand to a diameter larger than the second diameter;

subsequently compacting the endoprosthesis to a third diameter smaller than the second diameter.

27. The method of claim 26 that further comprises

providing at least one tapered die proportioned to compact the endoprosthesis;

passing the endoprosthesis through the at least one tapered die to reduce dimensions of the endoprosthesis.

28. The method of claim 27 that further comprises

providing flutes and grooves on the at least one tapered die;

and

passing the endoprosthesis through the tapered die with with flutes and grooves in order to establish pleated folds in the endoprosthesis when compacted.

29. The method of claim 27 that further comprises pulling the endoprosthesis through the at least one tapered die using at least one tether line.

30. The method of claim 29 that further comprises

providing an actuation mechanism;

attaching the tether line to the actuation mechanism to pull the endoprosthesis through the at least one tapered die.

31. The method of claim 28 that further comprises

positioning the flutes evenly around the tapered die so as to produce uniform spacing of pleats around the compressed endoprosthesis.

32. The method of claim 31 that further comprises

providing a uniform spacing of grooves within the at least one tapered die;

providing a tether line to correspond with each groove; and

passing the endoprosthesis through the tapered die using the tether lines.

33. The method of claim 26 that further comprises

providing an endoprosthesis that comprises a stent-element and an attached cover.

34. The method of claim 26 that further comprises cooling the endoprosthesis prior to compacting it.