Deployment system for intraluminal devices

• US 8,308,789 B2
• Filed: 07/16/2004
• Issued: 11/13/2012
• Est. Priority Date: 07/16/2004
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Armstrong, Joseph R.
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US10/893,679
• Publication Number:
  US 20060015171A1
• Time in Patent Office: 3,042 Days
• Field of Search: 623 111- 123, 606191-200
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12081 detachable by inflation
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

A constraining sheath for use around an endoprosthesis (e.g., a stent device, with or without a graft covering), which may be a balloon expandable endoprosthesis but more preferably is a self-expanding prosthesis. The endoprosthesis is coaxially enclosed within and substantially covered by the constraining sheath, which is an outer, removable tubular sheath, preferably made of ePTFE. The sheath is preferably corrugated circumferentially along at least a portion of the length of the endoprosthesis. The constraining sheath and endoprosthesis are preferably mounted together as an assembly at the distal end of a delivery means such as a catheter shaft, for delivery of the endoprosthesis to a desired location within a body conduit such as an artery. The constraining sheath is removed by the application of tension to a tensile member such as a tether to cause sequential pulling out of the corrugations followed by release and deployment of the endoprosthesis. The use of a corrugated constraining sheath in comparison to a non-corrugated sheath results in a more smoothly applied tensile force to effect the endoprosthesis release as well as requiring less maximum force.

Claims

1. A delivery system for an endoprosthesis comprising a self-expanding endoprosthesis having a length, a proximal end and a distal end, a first, small diameter for insertion into a body conduit and a second, larger deployed diameter, said endoprosthesis being constrained at the first smaller diameter by a removable tubular sheath having corrugations and extends over substantially the entire length of the endoprosthesis, wherein a continuing portion of the removable tubular sheath that has been formed into a tether extends proximally beyond the proximal end of the endoprosthesis, wherein said delivery system does not include a balloon, and wherein a tensile force applied to the tether in the proximal direction causes the corrugations to pull out sequentially such that after the corrugations have all been pulled out, the length of the sheath is extended by at least about 10% and axial displacement of the tubular sheath has occurred in the proximal direction.

2. A delivery system according to claim 1 wherein said sheath comprises polytetrafluoroethylene.

3. A delivery system according to claim 2 wherein said polytetrafluoroethylene has a fibrillated microstructure.

4. A delivery system according to claim 1 wherein said endoprosthesis is a stent.

5. A delivery system according to claim 1 wherein said endoprosthesis is a stent-graft.

6. A delivery system according to claim 1 wherein said endoprosthesis is a filter.

7. A delivery system according to claim 6 wherein said filter is a vena cava filter.

8. A delivery system according to claim 1 wherein said endoprosthesis is an occluder.

9. A delivery system according to claim 1 wherein said endoprosthesis is mounted at the small diameter on a portion of a length of a catheter shaft.

10. A delivery system according to claim 1 having a delivery profile of less than about 5.5 French.

11. A delivery system for an endoprosthesis comprising a self-expanding endoprosthesis having a length, a first, small diameter for insertion into a body conduit and a second, larger deployed diameter at which it is interferably fitted against a luminal surface of the body conduit, said endoprosthesis being covered at the first smaller diameter by a removable tubular sheath having corrugations extending over substantially the entire length of the endoprosthesis, said sheath having a length portion that constrains at least a portion of the length of the endoprosthesis at the first, small diameter of the endoprosthesis and wherein a continuing portion of the tubular removable sheath that has been formed into a tether extends proximally beyond the proximal end of the endoprosthesis, wherein a tensile force applied to the tether in the proximal direction causes the corrugations to pull out sequentially such that after the corrugations have all been pulled out, the length of the sheath is extended by at least about 10% and axial displacement of the tubular sheath has occurred in the proximal direction, and wherein said delivery system does not include a balloon.

12. A delivery system according to claim 11 wherein the length of the sheath is extended by the tensile force by at least about 20%.

13. A delivery system according to claim 12 wherein the length of the sheath is extended by the tensile force by at least about 50%.

14. A delivery system according to claim 13 wherein the length of the sheath is extended by the tensile force by at least about 80%.

15. A delivery system according to claim 14 wherein the length of the sheath is extended by the tensile force by at least about 100%.

16. A delivery system according to claim 11 wherein said sheath comprises polytetrafluoroethylene.

17. A delivery system according to claim 16 wherein said polytetrafluoroethylene has a fibrillated microstructure.

18. A delivery system according to claim 17 wherein said fibrillated microstructure has bent fibrils.

19. A delivery system according to claim 11 wherein the longitudinally compressed portion of the sheath is corrugated.

20. A delivery system according to claim 11 wherein said endoprosthesis is a stent.

21. A delivery system according to claim 11 wherein said endoprosthesis is a stent-graft.

22. A delivery system according to claim 11 wherein said endoprosthesis is a filter.

23. A delivery system according to claim 22 wherein said filter is a vena cava filter.

24. A delivery system according to claim 11 wherein said endoprosthesis is an occluder.

25. A delivery system according to claim 11 wherein said endoprosthesis is mounted at the small diameter on a portion of a length of a catheter shaft.

26. A delivery system according to claim 11 wherein said sheath is longitudinally compressed for substantially the entire length of the endoprosthesis.

27. A delivery system according to claim 11 having a delivery profile of less than about 5.5 French.