Method of producing low profile stent and graft combination

• US 9,056,001 B2
• Filed: 09/25/2009
• Issued: 06/16/2015
• Est. Priority Date: 01/22/1999
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Armstrong, Joseph R., Cully, Edward H., Ulm, Mark J., Vonesh, Michael J.
• Primary Examiner(s): BUI, VY Q
• Application Number:
  US12/567,562
• Publication Number:
  US 20100011976A1
• Time in Patent Office: 2,090 Days
• Field of Search: 623/1.13, 623/1.15, 623/1.23, 623/1.11, 623/1.28, 623/1.2, 623/1.42, 606/108, 606/191, 606/194, 606/195, 606/198
• US Class Current: 1/1
• 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. An implantable device comprising:

a self-expanding endoprosthesis having a length and comprising both a stent element and a cover along a substantial portion of its length, the endoprosthesis having a compacted dimension and an enlarged, deployed dimension;

wherein said cover comprises a proximal and distal end and at least one pleat that extends from the proximal end to the distal end of the cover such that said cover is folded into one or more uniform pleats when in its compacted dimension;

wherein the compacted dimension is no more than 12 F in cross-sectional diameter;

wherein the deployed dimension is at least 23 mm in inner cross-sectional diameter;

wherein the stent element comprises a plurality of forward facing apices and rearward facing apices;

wherein when in the compacted dimension, the plurality of forward facing apices are folded inwardly; and

wherein said uniform pleats were made by passing said implantable device through a tapered die comprising multiple raised flutes and grooves.

2. The implantable device of claim 1, wherein said cover extends over only a portion of the stent element.

3. The implantable device of claim 1, wherein said cover comprises expanded polytetrafluoroethylene.

4. The implantable device of claim 1, wherein said cover comprises a polyester.

5. The implantable device of claim 1, wherein the compacted dimension is no more than 11 F in diameter.

6. The implantable device of claim 1, wherein the compacted dimension is no more than 10 F in diameter.

7. The implantable device of claim 1, wherein the compacted dimension is no more than 9 F in diameter.

8. The implantable device of claim 1, wherein the compacted dimension is no more than 8 F in diameter.

9. The implantable device of claim 1, wherein the compacted dimension is no more than 7 F in diameter.

10. The implantable device of claim 1, wherein the compacted dimension is no more than 6 F in diameter.

11. The implantable device of claim 1, wherein the deployed dimension is at least 26 mm in diameter.

12. The implantable device of claim 1, wherein the deployed dimension is at least 28 mm in diameter.

13. The implantable device of claim 1, wherein the deployed dimension is at least 30 mm in diameter.

14. The implantable device of claim 1, wherein the deployed dimension is at least 35 mm in diameter.

15. The implantable device of claim 1, wherein the deployed dimension is at least 40 mm in diameter.

16. The implantable device of claim 1, wherein said implantable device is passed through said tapered die at least one additional time.

17. The implantable device of claim 1, wherein said implantable device is passed through a second tapered die having a smaller diameter.

18. The implantable device of claim 1, wherein said endoprosthesis has a first longitudinal length in its compacted dimension and a second longitudinal length in its deployed dimension, the second longitudinal length being within at least 90% of the first longitudinal length.

19. An implantable device comprising:

a stent element and cover forming an endoprosthetic device, the endoprosthetic device having a length and comprising both the stent element and the cover along a substantial portion of its length;

the endoprosthetic device being deliverable at a compacted dimension and being expandable to a deployed dimension;

the compacted dimension comprising a cross-sectional diameter of “

b”

;

the deployed dimension comprising a cross-sectional diameter of “

a”

;

wherein a ratio of a;

b is at least 6;

0;

wherein said cover comprises a proximal and distal end and at least one pleat that extends from the proximal end to the distal end of the cover such that said cover is folded into one or more uniform pleats when in its compacted dimension;

wherein the stent element comprises a plurality of forward facing apices and rearward facing apices;

wherein when in the compacted dimension, the plurality of forward facing apices are folded inwardly; and

wherein said uniform pleats were made by passing said implantable device through a tapered die comprising multiple raised flutes and grooves.

20. The implantable device of claim 19, wherein the compacted dimension is no more than 12 F in cross-sectional diameter in its compacted state.

21. The implantable device of claim 19, wherein said endoprosthesis has a first longitudinal length in its compacted dimension and a second longitudinal length in its deployed dimension, the second longitudinal length being within at least 90% of the first longitudinal length.

22. The implantable device of claim 19, wherein the cover comprises expanded polytetrafluoroethylene.

23. The implantable device of claim 19, wherein the cover comprises a polyester.

24. The implantable device of claim 19, wherein said endoprosthesis is self-expanding.

25. The implantable device of claim 19, wherein the cover is attached to the stent element.

26. The endoprosthesis of claim 19, wherein the ratio is at least 9:

1.

27. The endoprosthesis of claim 19, wherein the ratio is at least 8:

1.

28. The endoprosthesis of claim 19, wherein the ratio is at least 7:

1.

29. An endoprosthesis for aortic vessel repair that comprises:

a stent element and a graft element, the stent element and graft element overlapping over a substantial portion of the endoprosthesis;

the endoprosthesis being expandable from a compacted dimension to an enlarged deployed dimension, the deployed dimension being at least 23 mm in diameter and the compacted dimension being a ratio at least 5.75;

1 that of the deployed diameter;

wherein the endoprosthesis has a first longitudinal length in its compacted dimension and a second longitudinal length in its deployed dimension, the second longitudinal length being within at least 90% of the first longitudinal length; and

wherein said cover comprises a proximal and distal end and at least one pleat that extends from the proximal end to the distal end of the cover such that said cover is folded into one or more uniform pleats when in its compacted dimension;

wherein the stent element comprises a plurality of forward facing apices and rearward facing apices;

wherein when in the compacted dimension, the plurality of forward facing apices are folded inwardly; and

wherein said uniform pleats were made by passing said implantable device through a tapered die comprising multiple raised flutes and grooves.