Methods for deploying stents in bifurcations

• US 20030181923A1
• Filed: 12/17/2002
• Published: 09/25/2003
• Est. Priority Date: 11/04/1996
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Vardi, Gil
• Granted Patent: US 7,591,846 B2
• Time in Patent Office: Days
• US Class Current: 606/108
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires

Abstract

A method of deploying a stent in a bifurcation includes introducing two guidewires through the main vessel and using the two guidewires for guiding a dual lumen catheter carrying a stent first to an initial position proximal to the stent deployment position, retracting one wire, and projecting it from the catheter and through a side of the stent a branch guidewire into the second branch vessel, and then moving the catheter to the predetermined deployment position while guided by the main guidewire in the first branch vessel, and the branch guidewire in the second branch vessel. The stent is then expanded, and the catheter is removed with the stent remaining in its deployed position An alternative embodiment includes introducing one wire, advancing the system over the one wire and subsequently introducing the second wire.

Claims

1. A method of introducing a first and a second vessel guidewire into two branches of a vessel, said method comprising:

inserting a first guidewire into a first vessel;

inserting a second guidewire into said first vessel;

advancing a delivery system through said first vessel over said first guidewire and said second guidewire, said delivery system having a first lumen that slidably engages said first guidewire and a second lumen alongside said first lumen that slidably engages said second guidewire;

positioning the delivery system in a region of a bifurcation;

retracting said second guidewire proximally until a distal end of said second guidewire is in a region of a bifurcation; and

advancing said second guidewire through said second lumen into said second vessel.

2. A method as in claim 1, wherein said first vessel is a main vessel and said second vessel is a branch vessel.

3. A method as in claim 1, wherein said first vessel is a branch vessel and said second vessel is a main vessel.

4. A method as in claim 1, wherein said first vessel and said second vessel are both branch vessels.

5. A method as in claim 1, wherein said first and second vessels are blood vessels.

6. A method as in claim 1, wherein said delivery system is a catheter.

7. A method as in claim 6, wherein said catheter comprises a stent thereon.

8. A method as in claim 7, wherein said sot has a side hole for placing one of said first and second guidewires through so as to enter a branch vessel.

9. A method as in claim 8, wherein said stent has openings, and wherein said side hole is different than said openings.

10. A method as in claim 8, wherein said stent has openings, and wherein said side hole is one of said openings.

11. A method as in claim 7, wherein said catheter further comprises an inflatable balloon for expansion of said stent.

12. A method as in claim 7, wherein said stent is self-expandable.

13. A method as in claim 1, wherein said second lumen has a distal opening which is proximal to a distal opening of said first lumen.

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

advancing said stent delivery device, while tracked by said first guidewire in said first branch vessel and by said second guidewire m said second branch vessel, to a deployment position in a region of said bifurcation, to bring a distal end of the stent into said first branch vessel, while a proximal end of the stent still remains in said main vessel;

radially expanding said stent; and

removing said stent delivery device.

15. A method as in claim 14, wherein said radial expansion of said proximal end and said distal end of said stent are done separately.

16. A method according to claim 14, wherein said radially expanding is done using a balloon, and further comprising:

deflating said balloon; and

removing said balloon together with said stent delivery device.

17. A method of deploying a stent in a bifurcation of a main vessel which separates into first and second branch vessels, said stent including a proximal end to be deployed in said main vessel on the proximal side of said bifurcation, and a distal end to be deployed in said first branch vessel on the distal side of said bifurcation, the method comprising:

introducing the distal end of a first guidewire through said main vessel and said bifurcation into said first branch vessel;

introducing the distal end of a second guidewire through said main vessel and said bifurcation into said first branch vessel;

providing a stent delivery device including a main lumen for receiving said guidewire, a branch lumen, and an expandable stent;

inserting the proximal end of said first guidewire into the distal end of the main lumen of the stent delivery device;

inserting the proximal end of said second guidewire into the distal end of the branch lumen of the stent delivery device;

guiding said stent delivery device along said first guidewire and said second guidewire through said main vessel to all initial position adjacent to the proximal side of said bifurcation;

retracting said second guidewire;

advancing said second guidewire into said second branch vessel;

advancing said stent delivery device, while tracked by said first guidewire in said first branch vessel, and by said second guidewire in said second branch vessel, to said predetermined deployment position with respect to said bifurcation, to bring said distal end of the stent into said first branch vessel, while the proximal end of the stent still remains in said main vessel;

radially expanding said stent; and

removing said stent delivery device.

18. The method according to claim 17, wherein said stent delivery device farmer comprises an inflatable balloon around which said stent is positioned, and wherein said step of radially expanding said stent comprises inflating said balloon to radially expand said stent and to press the proximal end of the stent against the wall of said main vessel, and the distal end of the stent against the wall of said first branch vessel.

19. The method according to claim 18, wherein said radial expansion of said proximal end and said distal end of said stent are done separately.

20. The method according to claim 18, fisher comprising:

deflating said balloon; and

removing said balloon together with said stent delivery device.

21. The method according to claim 17, wherein said main vessel is a main vessel, said first branch is a continuation of the main vessel, and said second branch is a side branch of said main vessel.

22. A method of introducing two guidewires into a first and a second vessel, said method comprising:

inserting a first guidewire into said first vessel;

advancing a delivery system through said first vessel over said first guidewire, said delivery system having a first lumen that slidably engages said first guidewire and a second lumen alongside said first lumen;

positioning the delivery system in a region of a bifurcation; and

advancing a second guidewire through said second lumen into said second vessel.

23. A method as in claim 22, wherein said first and second vessels are blood vessels.

24. A method as in claim 22, wherein said first vessel is a main vessel and said second vessel is a branch vessel.

25. A method as in claim 22, wherein said first vessel is a branch vessel and said second vessel is a main vessel.

26. A method as in claim 22, wherein said first vessel and said second vessel are both branch vessels.

27. A method as in claim 22, wherein said first guidewire is pre-loaded in said first lumen.

28. A method as in claim 22, wherein said second guidewire is pre-loaded in said second lumen.

29. A method as in claim 22, wherein said delivery system is a catheter.

30. A method as in claim 29, wherein said catheter comprises a stent thereon.

31. A method as in claim 30, wherein said stent has a side hole for placing one of said first and second guidewires through so as to enter a branch vessel.

32. A method as in claim 31, wherein said stent has openings, and wherein said side hole is different than said openings.

33. A method as in claim 31, wherein said stent has openings, and wherein said side hole is one of said openings.

34. A method as in claim 30, wherein said catheter further comprises an inflatable balloon for expansion of said stent.

35. A method as in claim 30, wherein said stent is self-expandable.

36. A method as in claim 22, wherein said second lumen has a distal opening which is proximal to a distal opening of said first lumen

37. A method of advancing a delivery system at a bifurcation, the method comprising;

advancing a delivery system over a first guidewire, the delivery system comprising a first lumen for insertion of said first guidewire and a second lumen for insertion of a second guidewire, wherein said first lumen and said second lumen are separated by a barrier and wherein said advancing is done by positioning a first guidewire within said first lumen; and

thereafter introducing a second guidewire through said second lumen and into a second vessel.

38. A method as in claim 37, wherein said first vessel is a main vessel and said second vessel is a branch vessel.

39. A method as in claim 37, wherein said first vessel is a branch vessel and said second vessel is a main vessel.

40. A method as in claim 37, wherein said first vessel and said second vessel are both branch vessels.

41. A method as in claim 37, wherein said first guidewire is pre-loaded in said first lumen.

42. A method as in claim 37, wherein said second guidewire is pre-loaded in said second lumen.

43. A method as in claim 37, wherein said delivery system is a catheter.

44. A method as in claim 43, wherein said catheter comprises a stent thereon.

45. A method as in claim 44, wherein said stent has a side hole for placing one of said first and second guidewires through so as to enter a branch vessel.

46. A method as in claim 45, wherein said stent has openings, and wherein said side hole is different than said openings.

47. A method as in claim 45, wherein said sent has openings, and wherein said side hole is one of said openings.

48. A method as in claim 44, wherein said catheter further comprises an inflatable balloon for expansion of said stent.

49. A method as in claim 44, wherein said stent is self-expandable.

50. A method as in claim 37, wherein said second lumen has a distal opening which is proximal to a distal opening of said first lumen.

51. A method of deploying a stent in a bifurcation of a main vessel which separates into first and second branch vessels, said stent including a proximal end to be deployed in said main vessel on the proximal side of said bifurcation, and a distal end to be deployed in said first branch vessel on the distal side of said bifurcation, the method comprising:

introducing the distal end of a first guidewire through said main vessel and said bifurcation into said first branch vessel;

providing a stent delivery device including a main lumen for receiving said guidewire, a branch lumen, and an expandable stent;

inserting the proximal end of said first guidewire into the distal end of the main lumen of the stent delivery device;

guiding said stent delivery device along said first guidewire through said main vessel to an initial position adjacent to the proximal side of said bifurcation;

moving a second guidewire through said branch lumen of the stent delivery device;

advancing said second guidewire into said second branch vessel;

advancing said stent delivery device, while tracked by said first guidewire in said first branch vessel, and by said second guidewire in said second branch vessel, to said predetermined deployment position with respect to said bifurcation, to bring said distal end of the stent into said first branch vessel, while the proximal end of the stent still remains in said main vessel;

radially expanding said stent; and

removing said stent delivery device.

52. The method according to claim 51, wherein said stent delivery device further comprises an inflatable balloon around which said stent is positioned, and wherein said step of radially expanding said stent comprises inflating said balloon to radially expand said stent and to press the proximal end of the stent against the wall of said main vessel, and the distal end of the stent against the wall of said first branch vessel.

53. The method according to claim 52, wherein said radial expansion of said proximal end and said distal end of said stent are done separately.

54. The method according to claim 52, further comprising:

deflating said balloon; and

removing said balloon together with said stent delivery device.

55. The method according to claim 51, wherein said branch guidewire is pre-loaded in the branch lumen of said stoat delivery device before said stent delivery device is inserted into the main vessel, and said stent delivery device is tracked along said guidewire through said main vessel to said initial position, said branch guidewire having a distal end protrudable from a side of said stent, and a proximal end which is manipulated to move said distal end of the branch guidewire through said branch lumen into said second branch vessel, to aid in guiding said stent delivery device when moved from said initial position to said predetermined deployment position.

56. The method according to claim 51, wherein said main guidewire is preloaded in the main lumen of said stent delivery device before said stent delivery device is inserted into the main vessel.

57. The method according to claim 51, wherein the distal end of said branch guidewire is inserted into said branch lumen of the stent delivery device after said device has been moved to said initial position, and is then advanced through said branch lumen into said second vessel branch by manipulating the proximal end of the branch guidewire.

58. The method according to claim 51, wherein said main vessel is a main vessel, said first branch is a continuation of the main vessel, and said second branch is a side branch of said main vessel.

59. The method according to claim 51, wherein an additional guidewire is preplaced through said main vessel into said second branch vessel, said additional guidewire is external to said stent delivery device and said stent, and said additional guidewire is withdrawn from said main vessel prior to inflating said balloon.