Dilatation and stent delivery system for bifurcation lesions

• US 6,099,497 A
• Filed: 03/05/1998
• Issued: 08/08/2000
• Est. Priority Date: 03/05/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Blaeser, David J., Adams, Daniel O., Mattison, Richard C.
• Primary Examiner(s): Polutta, Mark O.
• Assistant Examiner(s): Bianco, Patricia
• Application Number:
  US09/035,642
• Time in Patent Office: 887 Days
• Field of Search: 604/919, 604/96, 604/101, 604/102, 604/523-27, 606/191-198
• US Class Current: 604/96.01
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61M 2025/1045 for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon

Abstract

The present invention provides a dilatation and stent delivery device which tracks over two guidewires. One guidewire is disposed in each branch vessel of a bifurcation. The present invention provides a dilatation and stent delivery device which enables efficient and accurate stent deployment and dilatation of bifurcation lesions.

Claims

1. A method of treating a lesion in a body at a bifurcation bifurcating a parent vessel into first and second branch vessels, the method comprising:

providing a generally tubular member having a proximal end and a distal end and defining a guidewire lumen therein, the guidewire lumen sized to receive first and second guidewires, the generally tubular member having an elongate aperture extending from the distal end thereof proximally and being configured to engage a selected one of the first and second guidewires;

loading the first and second guidewires into the guidewire lumen;

advancing the first and second guidewires to the bifurcation such that a distal end of the first guidewire is in the first branch vessel and a distal end of the second guidewire is in the second branch vessel;

advancing the generally tubular member to the bifurcation over the first and second guidewires;

selecting the first guidewire; and

advancing the generally tubular member such that the elongate aperture is engaged with the first guidewire so the lumen tracks the second guidewire into the second branch vessel and so the first guidewire exits the guidewire lumen through the elongate aperture and remains in the first branch vessel.

2. The method of claim 1 providing a generally tubular member comprises:

providing a generally tubular wall defining the guidewire lumen, the elongate aperture severing the wall.

3. The method of claim 2 wherein providing the generally tubular member further comprises:

providing a catheter having a distal region forming a second generally tubular member, the catheter further including an inflation lumen extending from the proximal end thereof to the distal end thereof and an elongate aperture extending from a distal end thereof proximally.

4. The method of claim 3 and further comprising:

providing an inflatable member disposed on the distal region of the catheter and having an interior in fluid communication with the inflation lumen wherein the elongate aperture on the catheter extends from the distal end of the catheter proximally to a region of the catheter proximate a proximal end of the inflatable member.

5. The method of claim 4 wherein selecting the first guidewire comprises selecting the first guidewire with the tubular wall and wherein advancing the generally tubular member comprises:

advancing the tubular wall such that the elongate aperture is engaged with the first guidewire so the lumen tracks the second guidewire into the second branch vessel and so the first guidewire exits the guidewire lumen through the elongate aperture and remains in the first branch vessel.

6. The method of claim 5 and further comprising:

selecting the second guidewire with the catheter; and

advancing the catheter such that the elongate aperture is engaged with the second guidewire so the lumen tracks the first guidewire into the first branch vessel and so the second guidewire exits the guidewire lumen through the elongate aperture and remains in the second branch vessel, such that the tubular wall is in the second branch vessel and the inflatable member is in the first branch vessel.

7. The method of claim 6 and further comprising:

inflating the inflatable member.

8. The method of claim 7 and further comprising:

withdrawing the tubular wall and the catheter into the parent vessel.

9. The method of claim 8 and further comprising:

selecting the first guidewire with the catheter; and

advancing the catheter such that the elongate aperture is engaged with the first guidewire so the lumen tracks the second guidewire into the second branch vessel and so the first guidewire exits the guidewire lumen through the elongate aperture and remains in the first branch vessel.

10. The method of claim 9 and further comprising:

selecting the second guidewire with the tubular wall; and

advancing the tubular wall such that the elongate aperture is engaged with the second guidewire so the lumen tracks the first guidewire into the first branch vessel and so the second guidewire exits the guidewire lumen through the elongate aperture and remains in the second branch vessel, such that the inflatable member is in the second branch vessel and the tubular wall is in the first branch vessel.

11. The method of claim 10 and further comprising:

inflating the inflatable member.

12. The method of claim 4 and further comprising:

selecting a same one of the first and second guidewires with both the tubular wall and the catheter;

advancing the tubular wall and the catheter until both reside in a same branch vessel and so the inflatable member resides in the lumen of the tubular wall; and

inflating the inflatable member.

13. The method of claim 1 and further comprising:

withdrawing the generally tubular member into the parent vessel until both the first and second guidewires are in the guidewire lumen at the distal end of the generally tubular member;

selecting the second guidewire; and

advancing the generally tubular member such that the elongate aperture is engaged with the second guidewire so the lumen tracks the first guidewire into the first branch vessel and so the second guidewire exits the guidewire lumen through the elongate aperture and remains in the second branch vessel.

14. The method of claim 13 and further comprising:

providing a guidewire sleeve having a lumen therein sized to slidably receive the first and second guidewires and having an outer periphery sized to slidably fit within the guidewire lumen.

15. The method of claim 14 wherein advancing the generally tubular member to the bifurcation comprises:

advancing the guidewire sleeve over the first and second guidewires until a distal end thereof is just proximal of the bifurcation; and

advancing the generally tubular member over the guidewire sleeve.

16. The method of claim 15 wherein withdrawing the generally tubular member comprises:

withdrawing the generally tubular member until the distal end thereof is proximal of the distal end of the guidewire sleeve.

17. The method of claim 1 wherein providing the generally tubular member comprises:

providing a catheter having a distal region forming the generally tubular member, the catheter further including an inflation lumen extending from the proximal end thereof to the distal end thereof.

18. The method of claim 17 and further comprising:

providing an inflatable member disposed on the distal region of the catheter and having an interior in fluid communication with the inflation lumen wherein the elongate aperture extends from the distal end of the catheter proximally to a region of the catheter proximate a proximal end of the inflatable member.

19. The method of claim 1 providing a generally tubular member comprises:

providing a generally tubular wall defining the guidewire lumen, the elongate aperture severing the wall.

38. The catheter of claim 2 and further comprising:

a guidewire sleeve having a lumen therein sized to slidably receive the first and second guidewires and having an outer periphery sized to slidably fit within the guidewire lumen in the elongate member.

20. A system for treating a lesion at a bifurcation in a body, the bifurcation bifurcating a parent vessel into first and second branch vessels, the system comprising:

a generally tubular member having a proximal end and a distal end and defining a guidewire lumen therein, the guidewire lumen sized to receive first and second guidewires, the generally tubular member having an elongate aperture extending from the distal end thereof proximally and being configured to engage a selected one of the first and second guidewires such that advancement of the generally tubular member after the elongate aperture is engaged with the selected one of the first and second guidewires causes the lumen to track the unselected guidewire and causes the selected guidewire to exit the guidewire lumen through the elongate aperture; and

an elongate member having a distal end coupled to the proximal end of the generally tubular member and having a proximal end, the elongate member having sufficient length to extend from the bifurcation to a region external to the body.

21. The system of claim 20 wherein the generally tubular member comprises a distal region of the elongate member, the elongate member further including an inflation lumen extending from the proximal end thereof to the distal end of the generally tubular member.

22. The system of claim 21 and further comprising:

an inflatable member disposed on the generally tubular member and having an interior in fluid communication with the inflation lumen; and

the elongate aperture extending from the distal end of the generally tubular member proximally to a region of the elongate member proximate a proximal end of the inflatable member.

23. The system of claim 22 wherein the guidewire lumen has a proximal ostium disposed proximate a proximal end of the inflatable member.

24. The system of claim 20 wherein the generally tubular member comprises:

a generally tubular wall defining the guidewire lumen, the elongate aperture severing the wall.

25. The system of claim 20 and further comprising:

a guidewire sleeve having a lumen therein sized to slidably receive the first and second guidewires and having an outer periphery sized to slidably fit within the guidewire lumen.

26. The system of claim 20 wherein the guidewire lumen extends through the elongate member to the proximal end thereof.

31. The system of claim 24 wherein the second elongate member is external to, and unattached to, the first inflatable member.

27. A system for treating a lesion at a bifurcation bifurcating a parent vessel into first and second branch vessels, the system comprising:

an elongate member having a proximal end and a distal end and an inflation lumen extending therethrough; and

a first inflatable member having a proximal end and a distal end and being disposed at the distal end of the elongate member and having an interior in fluid communication with the inflation lumen, the first inflatable member including a first guidewire lumen extending from the proximal end thereof to the distal end thereof and a second guidewire lumen extending from the proximal end thereof to an intermediate region thereof between the proximal and distal ends;

wherein the first inflatable member includes a generally tubular wall having a wall thickness and wherein the second guidewire lumen is formed as a cavity within the wall thickness of the generally tubular wall.

28. The system of claim 27 and further comprising:

a coil having an inner surface defining the second guidewire lumen and an outer surface in engagement with an inner wall of the cavity.

29. The system of claim 28 wherein the cavity is expanded to receive the coil and is then shrunk to frictionally engage the coil.

30. A system for treating a lesion at a bifurcation bifurcating a parent vessel into first and second branch vessels, the system comprising:

an elongate member having a proximal end and a distal end and an inflation lumen extending therethrough;

a first inflatable member having a proximal end, an intermediate region and a distal end and being disposed at the distal end of the elongate member and having an interior in fluid communication with the inflation lumen, the first inflatable member including a first guide wire lumen extending from a proximal opening at the proximal end thereof to a distal opening at the distal end thereof; and

a second elongate member having a proximal end and a distal end, the distal end disposed at the intermediate region of the first inflatable member, the second elongate member having a lumen therethrough defining a second guide wire lumen with corresponding proximal and distal openings.

32. The system of claim 30 and further comprising:

a first guidewire insertable through the first guidewire lumen and corresponding proximal and distal openings;

and

a second guidewire insertable through the second guidewire lumen and corresponding proximal and distal opening.

33. A system for treating a lesion at a bifurcation bifurcating a parent vessel into first and second branch vessels, the system comprising:

an elongate member having a proximal end and a distal end and an inflation lumen extending therethrough;

a first inflatable member having a proximal end, an intermediate region and a distal end and being disposed at the distal end of the elongate member and having an interior in fluid communication with the inflation lumen, the first inflatable member including a first guide wire lumen extending from a proximal opening at the proximal end thereof to a distal opening at the distal end thereof; and

a second inflatable member disposed external to the first inflatable member and having a proximal end adjacent the proximal end of the first inflatable member and a distal end disposed at the intermediate region of the first inflatable member, the second inflatable member having an interior defining at least a distal region of a second guide wire lumen with a corresponding distal opening.

34. The system of claim and further comprising:

a first guidewire insertable and slidable through the first guidewire lumen and corresponding proximal and distal openings; and

a second guidewire insertable and slidable through the second guidewire lumen and corresponding distal opening.

35. A system for treating a lesion at a bifurcation bifurcating a parent vessel into first and second branch vessels, the system comprising:

a first elongate member having at least one lumen therethrough;

a second elongate member having a lumen therethrough and communicating with a lumen of the first elongate member;

a third elongate member having a lumen therethrough and communicating with a lumen of the first elongate member;

a first inflatable member having a proximal end, an intermediate portion and a distal end and an interior in fluid communication with the lumen in the second elongate member, and having a guidewire lumen extending therethrough from the proximal end to the distal end, the first inflatable member having a first outer diameter, when inflated, between the proximal end and the intermediate portion and a second outer diameter, when inflated, between the intermediate portion and the distal end, the first outer diameter being smaller than the second outer diameter; and

a second inflatable member having a proximal end, an intermediate portion and a distal end and an interior in fluid communication with the lumen in the third elongate member, and having a guidewire lumen extending therethrough from the proximal end to the distal end, the second inflatable member having a first outer diameter, when inflated, between the proximal end and the intermediate portion and a second outer diameter, when inflated, between the intermediate portion and the distal end, the first outer diameter being smaller than the second outer diameter.

36. The system of claim 35 wherein the first inflatable member is preformed such that, upon inflation, the portion between the proximal end and the intermediate portion thereof has a first longitudinal axis and the portion between the intermediate portion and the distal end thereof has a second longitudinal axis disposed at an angle relative to the first longitudinal axis, the angle being different from 180 degrees.

37. A catheter, comprising:

an elongate member having a proximal end, a distal end and an inflation lumen therethrough;

an inflatable member disposed at the distal end of the elongate member and having an interior in fluid communication with the inflation lumen;

the elongate member having a guidewire lumen extending from a proximal end of the balloon to a distal end of the balloon, the elongate member having a slit therein communicating with the guidewire lumen, the slit extending from the distal end of the elongate member proximally to a region of the elongate member proximate a proximal end of the inflatable member.

39. A system for treating a lesion at a bifurcation bifurcating a parent vessel into first and second branch vessels, the system comprising:

an elongate member having a proximal end and a distal end and an inflation lumen extending therethrough; and

a first inflatable member having a proximal end and a distal end and being disposed at the distal end of the elongate member and having an interior in fluid communication with the inflation lumen, the first inflatable member including a first guidewire lumen extending from the proximal end thereof to the distal end thereof and a second guidewire lumen extending from the proximal end thereof to an intermediate region thereof between the proximal and distal ends;

wherein the first inflatable member includes a second inflatable member disposed within the interior of the first inflatable member, the second inflatable member having a proximal end with a proximal ostium disposed at the proximal end of the first inflatable member and a distal end with a distal ostium disposed at the intermediate region of the first inflatable member and communicating with an exterior of the first inflatable member, the second inflatable member having an interior between the proximal and distal ostiums forming at least a distal region of the second guidewire lumen.

40. A system for treating a lesion at a bifurcation bifurcating a parent vessel into first and second branch vessels, the system comprising:

an elongate member having a proximal end and a distal end and an inflation lumen extending therethrough;

a first inflatable member having a proximal end, an intermediate region and a distal end and being disposed at the distal end of the elongate member and having an interior in fluid communication with the inflation lumen, the first inflatable member including a first guidewire lumen extending from the proximal end thereof to the distal end thereof; and

a sheath disposed over the proximal end of the first inflatable member and attached to an exterior surface of the first inflatable member to form a channel between the exterior surface of the first inflatable member and the sheath, the channel having a distal ostium at the intermediate region of the first inflatable member and forming at least a distal region of a second guidewire lumen.