Guidewire introducer sheath

• US 6,682,536 B2
• Filed: 03/22/2001
• Issued: 01/27/2004
• Est. Priority Date: 03/22/2000
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Advanced Stent Technologies Inc. (Boston Scientific Corporation)
• Inventors: Williams, Eric, Vardi, Gil M., Bourang, Henry, Chavez, Elsa, Beyhan, Niyazi U.
• Primary Examiner(s): Izaguirre, Ismael
• Application Number:
  US09/816,690
• Publication Number:
  US 20010044622A1
• Time in Patent Office: 1,041 Days
• Field of Search: 606/108, 623/1.11, 600/588
• 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 2250/006 modular
• 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

Systems and methods for positioning a first guidewire (25) in a primary vessel (M) and a second guidewire (27) in a branch vessel (B). One embodiment comprises an introducer (10) having first (12) and second lumens (14) adapted to slidably receive the first guidewire within the first lumen and the second guidewire within the second lumen. One method embodiment includes inserting the first guidewire into the main vessel, introducing the introducer over the first guidewire, and inserting the second guidewire within the second lumen such that the second guidewire extends into the branch vessel. The introducer is withdrawn while maintaining the first and second guidewires in the respective vessels.

Claims

1. A system for introducing a guidewire into a branch vessel, said system comprising:

a guidewire introducer having a first lumen, and a second lumen adjacent said first lumen, each of said first and second lumens having a distal opening,

wherein said second lumen comprises a deflector located proximate said second lumen distal opening, said deflector configured to deflect a guidewire end through said second lumen distal opening;

a first marker having a first radiopacity, said first marker disposed on a first side of said introducer adjacent said second distal opening; and

a second marker having a second radiopacity, said second marker disposed on a second side of said introducer adjacent said second distal opening, wherein said first side is opposite said second side, and wherein said first radiopacity is different from said second radiopacity.

2. The system as in claim 1 wherein said second lumen comprises a longitudinal axis, and wherein said deflector is positioned at a non-parallel angle relative to said longitudinal axis.

3. The system as in claim 2 wherein said non-parallel angle is about forty five (45) degrees.

4. The system as in claim 1 further comprising:

a first guidewire adapted to receive said first lumen thereover; and

a first catheter having a balloon disposed proximate a first catheter distal end, said first catheter adapted to be inserted over said first guidewire into a main vessel after removal of said guidewire introducer.

5. The system as in claim 1 further comprising:

a second guidewire adapted to be slidably received by said second lumen; and

a second catheter having a balloon disposed proximate a second catheter distal end, said second catheter adapted to be inserted over said second guidewire into a main vessel after removal of said guidewire introducer.

6. The system as in claim 1 wherein the distal opening of the first lumen is disposed at a more distal location along the guidewire introducer with respect to the distal opening of the second lumen.

7. The system as in claim 2 wherein said second lumen distal opening is positioned at a non-parallel angle relative to said longitudinal axis.

8. The system as in claim 1, wherein the difference in said first and second radiopacities is due to differences in thickness of said first and second radiopaque markers.

9. The system as in claim 1, wherein the difference in said first and second radiopacities is due to differences in size of said first and second radiopaque markers.

10. The system as in claim 1, wherein the difference in said first and second radiopacities is due to differences in material of said first and second radiopaque markers.

11. The system as in claim 1 further comprising:

a second guidewire adapted to be slidably received by said second lumen; and

a second catheter having a balloon disposed proximate a second catheter distal end, said second catheter adapted to be inserted over said second guidewire into a main vessel after removal of said guidewire introducer.

20. The system as in claim 1 further comprising:

a first guidewire adapted to receive said first lumen thereover; and

a first catheter having a balloon disposed proximate a first catheter distal end, said first catheter adapted to be inserted over said first guidewire into a main vessel after removal of said guidewire introducer.

12. A method of introducing a branch vessel guidewire, said method comprising:

inserting a first guidewire into a main vessel;

advancing a guidewire introducer through said main vessel over said first guidewire, said guidewire introducer having a first lumen that slidably engages said first guidewire;

positioning the guidewire introducer such that a distal end of the first lumen is disposed past a bifurcation of the main and branch vessels, and a radiopaque marker on the guidewire introducer is proximate said bifurcation; and

thereafter advancing a second guidewire through a second guidewire introducer lumen adjacent said first lumen, said second guidewire introducer lumen having an opening proximate a distal end of said second lumen.

13. The method of claim 12, further comprising:

removing the guidewire introducer from the main vessel;

inserting a first catheter into said main vessel; and

expanding a first balloon on said catheter when said balloon is proximate said bifurcation.

14. The method of claim 13, further comprising:

inserting a second catheter into a branch vessel; and

expanding a second balloon on said second catheter.

15. The method of claim 14 wherein said expanding a balloon on said second catheter comprises expanding said second catheter balloon when said second catheter balloon is at least partially disposed in said branch vessel.

16. The method as in claim 14 wherein said expanding said first and second balloons comprises a kissing balloon technique.

17. The method as in claim 14 wherein said expanding said first and second balloons comprises expanding said first balloon in said main vessel and expanding said second balloon in said branch vessel.

18. The method of claim 12, wherein said second lumen has a deflector and wherein said advancing the second guidewire comprises deflecting said second guidewire with said deflector so that an end of said second guidewire advances into said branch vessel.

19. A system for introducing a guidewire into a branch vessel, said system comprising:

a guidewire introducer having first and second lumens, each of said first and second lumens having a distal opening,

a first marker having a first radiopacity, said first marker disposed adjacent said first distal opening; and

a second marker having a second radiopacity, said second marker disposed adjacent said second distal opening, wherein said first radiopacity is different from said second radiopacity.

21. The system as in claim 19 wherein the distal opening of the first lumen is disposed at a more distal location along the guidewire introducer with respect to the distal opening of the second lumen.