DEVICE FOR RAPID REPAIR OF BODY CONDUITS

• US 20070198077A1
• Filed: 01/18/2007
• Published: 08/23/2007
• Est. Priority Date: 01/20/2006
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Off, Philip, Vonesh, Michael, Cully, Edward, O'Shea, Daniel, Wiersdorf, Jason, House, Wayne, Duncan, Jeffrey, Goodman, Paul, Flury, Keith, Levering, Vrad
• Granted Patent: US 9,375,215 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/3071 Identification means; Administration of patients
• 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 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2250/0087 colour-coded

Abstract

A self-expanding stent-graft provided in a diametrically compacted state for implantation and retained preferably by a constraining sheath, useful for the temporary or permanent repair of injured, partially or entirely transected body conduits including blood vessels. It may be used under direct visualization to quickly stop or substantially reduce loss of blood from such damaged vessels and to quickly re-establish perfusion distal to the injury site. The device would typically be implanted under emergency room conditions but also be used in field situations by trained medical technicians. After an end of the device is inserted into a blood vessel through the injury access, deployment preferably initiates from the device end in a direction moving toward the middle of the length of the device by directionally releasing the constraining sheath. In a preferred embodiment, the two opposing ends of the device are individually deployable from the compacted, small diameter intended for insertion into a vessel, to the larger diameter at which they fit interferably into a portion of the vessel.

Claims

1. An intraluminal device comprising a self-expanding stent having at least two ends, said device provided with a covering over at least a portion of the stent, said ends having a compacted state for insertion into a body conduit and an expanded state, each of said ends having a release filament individually operable by the application of tension to cause the end to deploy from the compacted state to the expanded state.

2. An intraluminal device according to claim 1 wherein at least one of said filaments extends from one end toward a middle length portion of said intraluminal device.

3. An intraluminal device according to claim 2 wherein at least one of said ends is retained in the compacted state by a constraining sheath.

4. An intraluminal device according to claim 3 wherein said constraining sheath is released from said at least one end by the application of tension to the filament.

5. An intraluminal device according to claim 4 wherein said constraining sheath is released in a direction beginning at said at least one end and progressing toward a middle length portion of said intraluminal device.

6. An intraluminal device according to claim 5 wherein said constraining sheath extends beyond said at least one end to form a pointed introducer tip of smaller diameter than a diameter of said end in said compacted state.

7. An intraluminal device according to claim 1 wherein at least one of said ends is retained in the compacted state by a constraining sheath.

8. An intraluminal device according to claim 7 wherein said constraining sheath is released from said at least one end by the application of tension to the filament.

9. An intraluminal device according to claim 8 wherein said constraining sheath is released in a direction beginning at said at least one end and progressing toward a middle length portion of said intraluminal device.

10. An intraluminal device according to claim 9 wherein said constraining sheath extends beyond said at least one end to form a pointed introducer tip of smaller diameter than a diameter of said end in said compacted state.

11. An intraluminal device according to claim 7 wherein said constraining sheath is released in a direction beginning at said at least one end and progressing toward a middle length portion of said intraluminal device.

12. An intraluminal device according to claim 7 wherein said constraining sheath extends beyond said at least one end to form a pointed introducer tip of smaller diameter than a diameter of said end in said compacted state.

13. An intraluminal device according to claim 7 wherein an axial stiffener extends axially along at least a portion of a length of said intraluminal device.

14. An intraluminal device according to claim 13 wherein said axial stiffener extends between said constraining sheath and said intraluminal device.

15. An intraluminal device according to claim 14 wherein said axial stiffener comprises a wire.

16. An intraluminal device according to claim 13 wherein said axial stiffener comprises a rod.

17. An intraluminal device according to claim 13 wherein said axial stiffener comprises a tube.

18. An intraluminal device according to claim 13 wherein said axial stiffener has variable stiffness along at least a portion of a length of said axial stiffener.

19. An intraluminal device according to claim 1 wherein said device is manually implantable under direct visualization.

20. An intraluminal device according to claim 1 wherein said self-expanding stent having a covering has a lumen extending between the ends and contains no other component within the lumen.

21. An intraluminal device according to claim 1 wherein said self-expanding stent having a covering has a lumen extending between the ends and contains an axial stiffening component within the lumen.

22. An intraluminal device according to claim 1 wherein said covering has a portion everted back over itself.

23. An intraluminal device according to claim 1 wherein said covering has at least one corrugated portion.

24. An intraluminal device according to claim 23 wherein said covering has a portion everted back over itself.

25. An intraluminal device comprising a self-expanding stent having first and second ends, said device provided with a covering over at least a portion of the stent, said first and second ends having a compacted state for insertion into a body conduit and an expanded state, said first end being retained in the compacted state by a first constraining sheath individually deployable from the compacted state to the expanded state by a first release filament configured to release said first constraining sheath, and said second end being retained in the compacted state by a second constraining sheath individually deployable from the compacted state to the expanded state by a second release filament configured to release said second constraining sheath, wherein deployment is initiated at the ends and proceeds toward a middle length portion of the device.

26. An intraluminal device according to claim 25 wherein said first constraining sheath is provided with an end portion that extends beyond said first end of said self-expanding stent wherein said end portion is a pointed introducer with a diameter smaller than the compacted state of the self-expanding stent.

27. An intraluminal device according to claim 25 wherein said self-expanding stent has a length and said intraluminal device incorporates an axial stiffening component along at least a portion of the length of said self-expanding stent.

28. An intraluminal device according to claim 25 wherein said intraluminal device is manually implantable under direct visualization.

29. An intraluminal device comprising a self-expanding stent having at least one end, said device provided with a covering over at least a portion of the stent, said at least one end having a compacted state for insertion into a body conduit and an expanded state, said at least one end being retained in the compacted state by a first constraining sheath wherein said constraining sheath extends beyond said first end to incorporate an introducer of diameter smaller than said compacted at least one end.

30. An intraluminal device according to claim 29 wherein said at least one end is deployable from the compacted state to the expanded state by a release filament configured to release the constraining sheath.

31. An intraluminal device according to claim 30 wherein said at least one end deploys in a direction extending generally from said first end toward a middle portion of said device.

32. An intraluminal device according to claim 29 wherein said intraluminal device is manually implantable under direct visualization.

34. A method according to claim 30 wherein deploying the first compacted end results in substantially stopping loss of blood.

35. A method according to claim 34 comprising the additional steps of:

c) by direct visualization, inserting a compacted second end of the self-expanding stent-graft into the damaged blood vessel in a distal direction;

d) deploying the second compacted end of the self-expanding stent-graft to an expanded state by pulling a release filament to extend the passageway from the expanded second end of the self-expanding stent-graft into the damaged distal portion of the blood vessel.

38. A method according to claim 34 wherein deploying the first compacted end results in substantially stopping loss of blood.

39. A method according to claim 38 comprising the additional steps of:

c) by direct visualization, inserting a compacted second end of the self-expanding stent-graft into the damaged blood vessel in a proximal direction;

d) deploying the second compacted end of the self-expanding stent-graft to an expanded state by pulling a release filament to extend the passageway from the expanded second end of the self-expanding stent-graft into the damaged distal portion of the blood vessel.

33. A method of repairing a damaged blood vessel having proximal and distal portions comprising,

a) by direct visualization, inserting a compacted first end of a self-expanding stent-graft into the damaged blood vessel in a proximal direction;

b) deploying the first compacted end of the self-expanding stent-graft to an expanded state by pulling a release filament to create a passageway from the damaged proximal portion of the blood vessel into the expanded first end of the self-expanding stent-graft.

36. A method according to claim 33 comprising the additional steps of:

c) by direct visualization, inserting a compacted second end of the self-expanding stent-graft into the damaged blood vessel in a distal direction;

d) deploying the second compacted end of the self-expanding stent-graft to an expanded state by pulling a release filament to extend the passageway from the expanded second end of the self-expanding stent-graft into the damaged distal portion of the blood vessel.

37. A method of repairing a damaged blood vessel having proximal and distal portions comprising,

a) by direct visualization, inserting a compacted first end of a self-expanding stent-graft into the damaged blood vessel in a distal direction;

b) deploying the first compacted end of the self-expanding stent-graft to an expanded state by pulling a release filament to create a passageway from the damaged distal portion of the blood vessel into the expanded first end of the self-expanding stent-graft.

40. A method according to claim 37 comprising the additional steps of:

c) by direct visualization, inserting a compacted second end of the self-expanding stent-graft into the damaged blood vessel in a proximal direction;

d) deploying the second compacted end of the self-expanding stent-graft to an expanded state by pulling a release filament to extend the passageway from the expanded second end of the self-expanding stent-graft into the damaged distal portion of the blood vessel.

41. A method of repairing a damaged blood vessel comprising,

a) by direct visualization, inserting a compacted first end of a self-expanding stent-graft into the damaged blood vessel;

and

b) deploying the first compacted end of the self-expanding stent-graft to an expanded state, thereby substantially occluding blood flow from said damaged blood vessel without recourse to pinching said stent-graft.