Methods for deploying stents in bifurcations

• US 7,591,846 B2
• Filed: 12/17/2002
• Issued: 09/22/2009
• Est. Priority Date: 11/04/1996
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Vardi, Gil
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/320,719
• Publication Number:
  US 20030181923A1
• Time in Patent Office: 2,471 Days
• Field of Search: 623/1.35, 623/1.11, 623/1.12, 623/1.25, 623/1.3, 623/1.49, 623/1.19, 606191-198
• US Class Current: 623/1.35
• 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 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 first guidewire, a branch lumen for receiving said second guidewire, and an expandable stent;

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

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

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

retracting the distal end of 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 said stent into said first branch vessel, while the proximal end of said stent still remains in said main vessel;

radially expanding said stent; and

removing said stent delivery device.

2. The method according to claim 1, 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.

3. The method according to claim 2, wherein said radial expansion of said proximal end and said distal end of said stent are done separately.

4. The method according to claim 2, further comprising:

deflating said balloon; and

removing said balloon together with said stent delivery device.

5. The method according to claim 1, 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.

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

inserting a first guidewire into said first vessel until a distal end of said first guidewire is positioned distally beyond an opening into said second vessel;

inserting a second guidewire into said first vessel until a distal end of said second guidewire is positioned distally beyond an opening into said second vessel;

inserting a proximal end of said first guidewire into a distal end of a first lumen of a delivery system;

inserting a proximal end of said second guidewire into a distal end of a second lumen of said delivery system;

advancing said delivery system through said first vessel over said first guidewire, and said second guidewire, delivery system including a catheter having said first lumen that slidably engages said first guidewire and said second lumen alongside said first lumen that slidably engages said second guidewire, and a stent mounted to said catheter, said stent including a side aperture, said second lumen extending through said side aperture;

positioning said delivery system in a region of a bifurcation;

retracting said second guidewire until the distal end of the second guidewire is positioned adjacent said opening into said second vessel;

advancing the second guidewire through said second lumen until said distal end of said second guidewire is positioned in said second vessel; and

further advancing the delivery system distally to advance the second lumen into said second vessel.

7. A method as in claim 6, wherein said first and second vessels are blood vessels.

8. A method as in claim 6, wherein said first vessel is a main vessel and said second vessel is a branch vessel.

9. A method as in claim 6, wherein said first vessel is a branch vessel and said second vessel is a main vessel.

10. A method as in claim 6, wherein said first vessel and said second vessel are both branch vessels.

11. A method as in claim 6, wherein said stent has openings, and wherein said side aperture is different than said openings.

12. A method as in claim 6, wherein said stent has openings, and wherein said side aperture is one of said openings.

13. A method as in claim 6, wherein said catheter further comprises an inflatable balloon for the expansion of said stent.

14. A method as in claim 6, wherein said stent is self-expandable.

15. A method as in claim 6, wherein said second lumen has a distal opening which is proximal to a distal opening of said first lumen.

16. A method of advancing a delivery system at a bifurcation, the bifurcation including first and second branch vessels, the method comprising;

positioning a first guidewire in the first branch vessel;

positioning a second guidewire in the first branch vessel;

advancing a delivery system over said first guidewire and said second guidewire to the bifurcation, the delivery system comprising a catheter having a first lumen for insertion of said first guidewire and a second lumen for insertion of a second guidewire, and a stent mounted to said catheter, said stent including a side aperture through which a distal end of said second lumen extends into said second vessel, wherein said first lumen and said second lumen are separated by a barrier and wherein said advancing is done by positioning said first guidewire within said first lumen and by positioning said second guidewire within said second lumen, wherein a proximal end of said first guidewire is inserted into a distal end of said first lumen and a proximal end of said second guidewire is inserted into a distal end of said second lumen so that said delivery system may be advanced over said first guidewire and said second guidewire;

thereafter introducing said second guidewire into said second vessel; and

thereafter further advancing said delivery system to advance said second lumen into said second vessel.

17. A method as in claim 16, wherein said first vessel is a main vessel and said second vessel is a branch vessel.

18. A method as in claim 16, wherein said first vessel is a branch vessel and said second vessel is a main vessel.

19. A method as in claim 16, wherein said first vessel and said second vessel are both branch vessels.

20. A method as in claim 16, wherein said delivery system is a catheter.

21. A method as in claim 16, whereins aid stent has openings, and wherein said side aperture is different than said openings

22. A method as in claim 16, wherein said stent has openings, and wherein said side aperture is one of said openings.

23. A method as in claim 16, wherein said catheter further comprises an inflatable balloon for expansion of said stent.

24. A method as in claim 16, wherein said stent is self-expandable.

25. A method as in claim 16, wherein said second lumen has a distal opening which is proximal to a distal opening of said first lumen.

32. The method according to claim 21, 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.

26. A method of deploying a stent in a bifurcation of a main vessel that 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, a distal end to be deployed in said first branch vessel on the distal side of said bifurcation, and a side aperture positioned between the proximal and distal ends of said stent, the method comprising:

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

introducing a 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 first guidewire, a branch lumen for receiving said second guidewire, and said stent, said branch lumen extending through said side aperture of said stent;

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

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

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

advancing said second guidewire into said second branch vessel;

further 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 until said branch lumen is positioned in said second branch vessel and to bring said distal end of the stent into said first branch vessel, while the proximal end of said stent still remains in said main vessel;

radially expanding said stent; and

removing said main and branch lumens.

27. The method according to claim 26, 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.

28. The method according to claim 27, wherein said radial expansion of said proximal end and said distal end of said stent are done separately.

29. The method according to claim 27, further comprising:

deflating said balloon; and

removing said balloon from within said stent.

30. The method according to claim 27, 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.

31. The method according to claim 26, 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.