METHOD AND DEVICES FOR FLOW OCCLUSION DURING DEVICE EXCHANGES

• US 20130046376A1
• Filed: 06/22/2012
• Published: 02/21/2013
• Est. Priority Date: 06/24/2011
• Status: Abandoned Application

• Current Assignee: Access Closure Incorporated (Cardinal Health, Inc.)
• Original Assignee: Access Closure Incorporated (Cardinal Health, Inc.)
• Inventors: Hassan, Ali, To, Kevin, Uchida, Andy, Garcia, Jose, Yang, Yi
• Application Number:
  US13/531,227
• Publication Number:
  US 20130046376A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/10185 Valves

Abstract

A method of reducing the risk of clinical sequelae to catheter induced vascular injuries may include introducing a guide wire into a vascular sheath residing in a blood vessel, proximally retracting the vascular sheath while leaving the wire in place, and observing indicia of the presence or absence of a vascular injury caused to the blood vessel by the vascular sheath or a procedural catheter previously advanced through the vascular sheath. If indicia of a vascular injury are observed, the method may further involve proximally retracting the guide wire to position the inflatable balloon adjacent the injury and inflating the balloon to reduce blood flow past the injury, while leaving the guide wire in place to provide subsequent access to the injury.

Claims

1. A method of reducing the risk of clinical sequelae to catheter induced vascular injuries, the method comprising:

introducing a guide wire into a vascular sheath residing in a blood vessel, the guide wire having a distal end and an inflatable balloon at least 5 cm proximal of the distal end;

proximally retracting the vascular sheath while leaving the wire in place;

observing indicia of the presence or absence of a vascular injury caused to the blood vessel by the vascular sheath or a procedural catheter previously advanced through the vascular sheath; and

if indicia of a vascular injury are observed;

proximally retracting the guide wire to position the inflatable balloon adjacent the injury; and

inflating the balloon to reduce blood flow past the injury, while leaving the guide wire in place to provide subsequent access to the injury.

2. A method as in claim 1, wherein, prior to the introducing step, the vascular sheath is used for performing an intravascular procedure selected from the group consisting of implantation of an aortic valve and abdominal aortic aneurysm repair.

3. A method as in claim 1, wherein observing indicia comprises observing contrast injected into the blood vessel using a radiographic imaging device.

4. A method as in claim 1, wherein the vascular sheath has an external diameter at least about 80 percent as large as an internal diameter of the blood vessel.

5. A method as in claim 1, wherein the vascular sheath is disposed in a femoral artery, wherein the inflatable balloon is at least 15 cm proximal of the distal end, and wherein introducing the guide wire comprises advancing a tip of the wire into an aorta.

6. A method as in claim 1, wherein inflating the balloon comprises inflating at a location of the vascular injury.

7. A method as in claim 1, wherein inflating the balloon comprises inflating at a location upstream of the vascular injury.

8. A method as in claim 1, further comprising:

removing the vascular sheath from the blood vessel;

forming at least a partial seal at a puncture site in the blood vessel through which the vascular sheath was removed from the blood vessel;

deflating the inflatable balloon of the guide wire; and

removing the guide wire from the blood vessel through the seal at the puncture site, wherein the seal closes around a small hole left in the seal when the guide wire is removed.

9. A method as in claim 1, further comprising:

introducing a vascular repair device over the guide wire; and

repairing the vascular injury using the vascular repair device.

10. A method as in claim 9, wherein the vascular repair device comprises a stent deployment catheter, and wherein repairing the vascular injury comprises placing a stent in the blood vessel.

11. A method of treating a patient, the method comprising:

advancing a guide wire into a vascular sheath following an intravascular procedure, the guide wire comprising a distal end and a radially expandable structure spaced at least 5 cm proximally of the distal end;

proximally withdrawing the sheath;

evaluating the presence of a vascular injury caused by the sheath or a device introduced through the sheath; and

if a vascular injury is observed, repositioning the guide wire and expanding the radially expandable structure to stabilize the injury.

12. A method as in claim 11, wherein the vascular sheath is located in an iliofemoral artery, and wherein advancing the guide wire comprises advancing the wire through into the vascular sheath from outside the body.

13. A method as in claim 11, wherein the intravascular procedure comprises implantation of an aortic valve.

14. A method as in claim 11, wherein the intravascular procedure comprises an abdominal aortic aneurysm repair.

15. A method as in claim 11, wherein expanding the radially expandable structure comprises inflating a balloon.

16. A method as in claim 11, wherein expanding the radially expandable structure to stabilize the injury comprises reducing blood flow in an area around the vascular injury.

17. A method of treating a patient, the method comprising:

introducing a guide wire into a blood vessel, the guide wire comprising a distal end and an inflatable balloon spaced at least 5 cm proximally of the balloon;

introducing an index procedure catheter over the wire; and

conducting an index procedure proximally of the balloon.

18. A method as in claim 17, wherein the index procedure comprises implantation of an aortic valve.

19. A method as in claim 17, wherein the index procedure comprises an abdominal aortic aneurysm repair.

20. A method of reducing the risk of clinical sequelae to catheter induced vascular injuries, the method comprising:

introducing a guide wire into a vessel, the guide wire having a distal end and a radially enlargeable structure at least 5 cm proximal of the distal end;

advancing a procedure catheter along the wire; and

performing a procedure with the procedure catheter, such that if the procedure catheter or an access sheath used introduce the procedure catheter produces a vascular injury, the guide wire can be advanced or retracted to position the radially enlargeable structure adjacent the injury, and the structure can be radially enlarged to control the injury while leaving the guide wire in place to provide subsequent access to the injury.

21. A method as in claim 20, wherein the procedure catheter is an over the wire catheter.

22. A method as in claim 20, wherein the procedure catheter is a rapid exchange catheter.

23. A method as in claim 20, wherein the procedure comprises a heart valve repair.

24. A method as in claim 20, wherein the procedure comprises a heart valve replacement.

25. A method as in claim 20, wherein the procedure comprises implantation of an abdominal aortic aneurysm graft.

26. A method as in claim 20, wherein if a vascular injury is not observed, the guide wire is advanced or retracted without radially enlarging the radially enlargeable structure.

27. A method as in claim 20, wherein the radially enlargeable structure comprises an inflatable balloon.

28. A method as in claim 20, further comprising the step of evaluating the presence of a vascular perforation using Doppler ultrasound.

29. A method as in claim 20, further comprising the step of evaluating the presence of a vascular perforation using contrast injection.

30. A method as in claim 20, wherein a vascular perforation is observed, the radially enlargeable structure is enlarged to control the injury, and a repair catheter is advanced along the guide wire.

31. A method as in claim 30, wherein the repair catheter comprises a stent delivery catheter.

32. A method as in claim 30, wherein the repair catheter comprises a graft delivery catheter.

33. A method as in claim 20, wherein a vascular injury is observed, the radially enlargeable structure is enlarged to control the injury, and the injury is thereafter surgically repaired.

34. A method of treating a catheter induced vascular injury, the method comprising:

advancing an inflatable balloon of a guide wire through a vascular sheath disposed in an iliofemoral artery, wherein the vascular sheath was used to perform a catheter based intravascular procedure;

retracting the vascular sheath proximally;

assessing the artery for injury;

repositioning the guide wire within the artery;

inflating the balloon to occlude the artery;

removing an inflation device from the guide wire, wherein the balloon remains inflated after the inflation device is removed;

advancing a vascular repair device over a proximal end of the guide wire;

performing a repair procedure on the artery, using the repair device;

removing the repair device over the guide wire;

deflating the balloon using the inflation device; and

removing the guide wire from the artery.

35. A method as in claim 34, wherein, prior to the advancing step, the vascular sheath was used for performing an intravascular procedure selected from the group consisting of implantation of an aortic valve and abdominal aortic aneurysm repair.

36. A method as in claim 34, wherein observing indicia comprises observing contrast injected into the artery using a radiographic imaging device.

37. A method as in claim 34, wherein the vascular sheath is disposed in a femoral artery, wherein the inflatable balloon is at least 15 cm proximal of a distal end of the guide wire, and wherein advancing the guide wire comprises advancing a tip of the wire into an aorta.

38. A method as in claim 34, wherein inflating the balloon comprises inflating at a location of the vascular injury.

39. A method as in claim 34, wherein inflating the balloon comprises inflating at a location upstream of the vascular injury.

40. A vascular guide wire, comprising:

an elongate tubular body having a proximal end, a distal end and a lumen extending longitudinally through at least part of the body, the elongate body comprising;

a proximal portion;

a flexible distal tip that is at least about 15 cm long and is more flexible than the proximal portion; and

a transition portion between the proximal and distal portions;

an inflatable balloon disposed on the transition portion and in communication with the lumen; and

a valve on the proximal portion of the elongate body configured to couple with an inflation device to allow for inflation and deflation of the balloon.

41. A guide wire as in claim 40, wherein the valve comprises an axially movable occluder, positioned within the lumen, and wherein the valve is configured to lock inflation fluid inside the lumen when in a closed position, to allow the inflation device to be removed, thus leaving a hubless proximal end over which one or more devices may be advanced.

42. A guide wire as in claim 41, wherein the occluder is movable between a proximal position and a distal position, and the valve is closed when the occluder is in the distal position.

43. A guide wire as in claim 40, wherein the distal tip comprises:

a proximal section having a first flexibility; and

a J-tip at the distal end of the elongate body having a second flexibility that is greater than the first flexibility.

44. A guide wire as in claim 43, wherein the proximal section has a length of at least about 15 cm, and wherein the J-tip has a length of at least about 5 cm.

45. A guide wire as in claim 40, wherein the distal tip has a length of at least about 20 cm.

46. A guide wire as in claim 40, wherein the distal tip has a length approximately equal to an average length of an iliofemoral artery.

47. A guide wire as in claim 40, wherein the proximal portion comprises a tube with a spiral cut along a portion of its length nearer its distal end, wherein the spiral cut has decreasing spacing toward the distal end.

48. A guide wire as in claim 47, wherein the distal tip comprises a core wire wrapped in a coil, and wherein the core wire extends through the transition portion and into the proximal portion.

49. A guide wire as in claim 47, further comprising a coating over the spiral cut to prevent fluid from passing out of the lumen through the cut.

50. A vascular guide wire, comprising:

an elongate tubular body having a proximal end, a distal end, and a lumen extending longitudinally through at least part of the body, the elongate body comprising;

a proximal section having a first average stiffness;

a transition section having a second average stiffness that is less than the first stiffness; and

a distal tip having a length of at least about 15 cm and a third average stiffness that is less than the second stiffness; and

an expandable member disposed on the transition section, wherein the expandable member is expandable via fluid advanced through the central lumen of the elongate body.

51. A guide wire as in claim 50, wherein the distal tip has approximately the same stiffness as the transition section immediately adjacent a distal end of the transition section and becomes significantly more flexible toward the distal end of the elongate body.

52. A guide wire as in claim 50, further comprising a valve within the tubular body.

53. A guide wire as in claim 52, wherein the valve includes a locking feature for locking in an inflated configuration to maintain the expandable member in an expanded configuration even after an inflation device is removed from the wire.

54. A guide wire as in claim 50, wherein the distal tip comprises a preformed J-tip such that a curved sidewall of the J-tip rather than the distal end of the elongate body is the leading structure during normal transvascular advance.

55. A guide wire as in claim 50, further comprising at least one radiopaque marker for indicating a position of the expandable member.

56. A guide wire as in claim 50, wherein the expandable member comprises an inflatable balloon.

57. A guide wire as in claim 50, wherein the distal tip has a length of at least about 20 cm.

58. A guide wire as in claim 50, wherein the distal tip has a length approximately equal to an average length of an iliofemoral artery.

59. A guide wire as in claim 50, wherein proximal end of the elongate body is hubless, such that at least one additional device may be passed over the proximal end while the guide wire device is in the patient with the expandable member in an expanded configuration.

60. A vascular guide wire system, comprising:

a guide wire device comprising;

an elongate tubular body comprising a proximal portion, a flexible distal tip that is at least about 15 cm long and is more flexible than the proximal portion, a transition portion between the proximal and distal portions, and a lumen extending longitudinally through at least part of the body;

an inflatable balloon disposed on the transition portion and in communication with the lumen; and

a valve on the proximal portion of the elongate body; and

an inflation device configured to couple with the elongate body to open and close the valve and allow for inflation of the inflatable balloon.

61. A guide wire system as in claim 60, wherein the valve comprises an axially movable occluder, positioned within the lumen, and wherein the valve is configured to lock inflation fluid inside the lumen when in a closed position, to allow the inflation device to be removed, thus leaving a hubless proximal end of the elongate body, over which one or more devices may be advanced.

62. A guide wire system as in claim 60, further comprising an inflation medium injection device selected from the group consisting of a syringe and a pump.

63. A guide wire system as in claim 60, wherein the distal tip of the guide wire device comprises a J-tip and has a length of at least about 20 cm.

64. A guide wire system as in claim 60, wherein a proximal end of the elongate body is hubless.

65. A guide wire system as in claim 60, wherein the distal tip of the guide wire device comprises a core wire wrapped in a coil, and wherein the core wire extends through the transition portion and into the proximal portion.