Deployment system for intraluminal devices

• US 20060015171A1
• Filed: 07/16/2004
• Published: 01/19/2006
• 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.
• Granted Patent: US 8,308,789 B2
• Time in Patent Office: Days
• US Class Current: 623/1.120
• 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 an endoprosthesis having a length, a first, small diameter for insertion into a body conduit and a second, larger deployed diameter, said endoprosthesis being covered at the first smaller diameter by a removable sheath that is corrugated along at least a portion of the length of the endoprosthesis.

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 4 wherein said stent is a self-expanding stent.

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

7. A delivery system according to claim 6 wherein said stent-graft is self-expanding.

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

9. A delivery system according to claim 8 wherein said filter is a vena cava filter.

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

11. 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.

12. A delivery system according to claim 1 wherein said sheath is removable from the endoprosthesis by the application of tension to the corrugated portion of the sheath.

13. A delivery system according to claim 12 wherein tension is applied via a tether.

14. A delivery system according to claim 12 wherein tension is applied via an extension of the sheath.

15. A delivery system according to claim 1 wherein said sheath is corrugated for substantially the entire length of the endoprosthesis.

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

17. A delivery system for an endoprosthesis comprising an 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 sheath that is longitudinally compressed over at least a portion of the length of the endoprosthesis, said sheath having a length portion that covers at least a portion of the length of the endoprosthesis at the first, small diameter of the endoprosthesis wherein a tensile force applied to the removable sheath in a direction parallel to the length of the endoprosthesis extends the length portion of the sheath by at least about 10%.

18. A delivery system according to claim 17 wherein the length of the sheath is extended by the tensile force by at least about 20%.

19. A delivery system according to claim 18 wherein the length of the sheath is extended by the tensile force by at least about 50%.

20. A delivery system according to claim 19 wherein the length of the sheath is extended by the tensile force by at least about 80%.

21. A delivery system according to claim 20 wherein the length of the sheath is extended by the tensile force by at least about 100%.

22. A delivery system according to claim 17 wherein said sheath comprises polytetrafluoroethylene

23. A delivery system according to claim 22 wherein said polytetrafluoroethylene has a fibrillated microstructure.

24. A delivery system according to claim 23 wherein said fibrillated microstructure has bent fibrils.

25. A delivery system according to claim 17 wherein the longitudinally compressed portion of the sheath is corrugated.

26. A delivery system according to claim 17 wherein said endoprosthesis is a stent.

27. A delivery system according to claim 26 wherein said stent is a self-expanding stent.

28. A delivery system according to claim 17 wherein said endoprosthesis is a stent-graft.

29. A delivery system according to claim 28 wherein said stent-graft is self-expanding.

30. A delivery system according to claim 17 wherein said endoprosthesis is a filter.

31. A delivery system according to claim 30 wherein said filter is a vena cava filter.

32. A delivery system according to claim 17 wherein said endoprosthesis is an occluder.

33. A delivery system according to claim 17 wherein said endoprosthesis is mounted at the small diameter on a portion of a length of a catheter shaft.

34. A delivery system according to claim 17 wherein said sheath is removable from the endoprosthesis by the application of tension to the longitudinally compressed portion of the sheath.

35. A delivery system according to claim 34 wherein tension is applied via a tether.

36. A delivery system according to claim 34 wherein tension is applied via an extension of the sheath.

37. A delivery system according to claim 17 wherein said sheath is longitudinally compressed for substantially the entire length of the endoprosthesis.

38. A delivery system according to claim 17 having a delivery profile of less than about 5.5 French.

39. A method of deploying an endoprosthesis within a body conduit, said endoprosthesis having a length, a first, small diameter for insertion into the body conduit and a second, larger diameter at which it is interferably fitted against a luminal surface of the body conduit, comprising:

a. providing an endoprosthesis constrained at the first smaller diameter within a sheath that has been longitudinally compressed over at least a portion of the length of the endoprosthesis; and

b. applying tension to the sheath to release the endoprosthesis thereby allowing deployment to the larger diameter.

40. A method according to claim 39 wherein the longitudinally compressed portion of the sheath is corrugated.

41. A method according to claim 40 wherein the sheath comprises polytetrafluoroethylene.

42. A method according to claim 39 wherein the sheath comprises polytetrafluoroethylene.

43. A method according to claim 42 wherein the polytetrafluoroethylene has a fibrillated microstructure.

44. A method according to claim 43 wherein the fibrillated microstructure has bent fibrils within the longitudinally compressed portion.

45. A method according to claim 39 wherein said sheath containing said endoprosthesis has a delivery profile of less than about 5.5 French.