BIFURCATION STENT DELIVERY SYSTEM AND METHODS

• US 20090171430A1
• Filed: 12/31/2008
• Published: 07/02/2009
• Est. Priority Date: 12/31/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Baim, Donald, Quillin, Daniel, Meyer, Michael, Friesen, David L., Malewicz, Andrzej, Gunderson, Richard
• Granted Patent: US 8,747,456 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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 2002/061 provided with means for allowing access to secondary lumens
• 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 25/1011 Multiple balloon catheters

Abstract

A catheter assembly may include a main balloon arranged to reside within the main vessel, and a branch balloon configured to extend from the main vessel into the branch vessel. A stent may be situated around the main balloon and may include a branch aperture at a location between proximal and distal open ends of the stent. The branch balloon may extend from within the stent, through the branch aperture, and into the branch vessel. The branch balloon, when inflated, may extend into the branch vessel. The main balloon, when inflated, may also expand the stent within the main vessel. In some arrangements, the branch balloon, when inflated, can function as an anchor within the branch vessel that resists radial and axial movement of the stent relative to the branch vessel and main vessel during expansion of the stent by the main balloon.

Claims

1. A catheter assembly for treatment of a vessel bifurcation, the catheter assembly comprising:

a main catheter shaft having a proximal end portion and a distal end portion;

a stent having proximal and distal open ends and a branch aperture, the branch aperture defined in a sidewall of the stent at a location between the proximal and distal open ends;

a main balloon extending from the distal end portion of the main catheter shaft, the main balloon extending through the stent from the proximal open end to the distal open end; and

a branch balloon, the branch balloon extending in a direction radially outward relative to the main balloon and through the branch aperture of the stent, the branch balloon when inflated having a maximum length dimension that is at least twice as great as a maximum width dimension of that portion of the branch balloon extending through the branch aperture.

2. The catheter assembly of claim 1, wherein the branch balloon is positioned on the main balloon.

3. The catheter assembly of claim 1, further comprising a branch catheter shaft, the branch catheter shaft having a distal end portion, wherein the branch balloon is positioned at the distal end portion of the branch catheter shaft.

4. The catheter assembly of claim 1, wherein the branch balloon has at least first and second sections along a length of the branch balloon, the first and second section having different maximum width dimensions.

5. The catheter assembly of claim 1, further comprising a main guidewire housing defining a main guidewire lumen, the main guidewire housing extending from the proximal end portion to the distal end portion of the main balloon, and a branch guidewire housing defining a branch guidewire lumen, the branch guidewire housing extending from the proximal end portion to the distal end portion of the branch balloon, the main guidewire lumen being sized to advance over a main guidewire positioned in the main vessel and the branch guidewire lumen being sized to advance over a branch guidewire positioned in the branch vessel.

6. The catheter assembly of claim 5, wherein a portion of the branch balloon surrounds the branch guidewire housing, and a portion of the branch guidewire housing extends through the branch aperture of the stent.

7. A catheter assembly adapted for treatment of a vessel bifurcation, comprising:

a main catheter shaft having a proximal end portion and a distal end portion;

a main balloon positioned at the distal end portion of the main catheter shaft, the main balloon extending within a main vessel of the vessel bifurcation;

a branch balloon when inflated extending radially outward at an acute branch angle relative to the main balloon, the branch balloon having a length sufficient to extend into a branch vessel of the vessel bifurcation when the main balloon is in a deflated state and the branch balloon is in an inflated state.

8. The catheter assembly of claim 7, wherein the branch balloon is molded integral with the main balloon.

9. The catheter assembly of claim 7, further comprising a branch guidewire housing that defines a branch guidewire lumen, wherein the branch guidewire housing extends through branch balloon.

10. The catheter assembly of claim 7, further comprising a stent, the stent having a proximal open end, a distal open end, and a branch aperture, the branch aperture defined in a sidewall of the stent at a location between the proximal and distal open ends of the stent, wherein the branch balloon extends through the branch aperture when inflated.

11. The catheter assembly of claim 7, wherein the acute branch angle is within the range of 25°

to 90°

inclusive relative to a longitudinal axis of the main balloon.

12. The catheter assembly of claim 10, wherein a maximum width dimension of that portion of the branch balloon extending outside of the stent is less than a maximum internal width dimension of the branch vessel.

13. The catheter assembly of claim 9, further comprising a main guidewire housing defining a main guidewire lumen that extends through the main balloon.

14. The catheter assembly of claim 7, further comprising a branch catheter defining a branch guidewire lumen and having a distal end portion, wherein the branch balloon is positioned at the distal end portion of the branch catheter.

15. The catheter assembly of claim 7, further comprising a tether member, the tether member having a distal end mounted to the branch balloon and a proximal end mounted to the main balloon, wherein the tether defines in part the acute branch angle when the branch balloon is inflated.

16. A method of treating a vessel bifurcation with a catheter assembly, the vessel bifurcation including a main vessel and a branch vessel extending from the main vessel, the catheter assembly including a stent having a branch aperture positioned at a location between proximal and distal open ends of the stent, a main catheter shaft having a distal end portion, a main balloon positioned at the distal end portion of the main catheter shaft, and a branch balloon, the main balloon extending from the proximal open end to the distal open end of the stent, and the branch balloon extending through the branch aperture of the stent, the method comprising:

positioning the catheter assembly adjacent the vessel bifurcation with the main balloon positioned within the main vessel and the branch aperture facing an ostium of the branch vessel;

inflating the branch balloon within the branch vessel, a maximum width dimension of the branch balloon when inflated being less than a length of the branch balloon when inflated; and

expanding the stent with the main balloon, the inflated branch balloon resisting axial and rotational movement of the catheter assembly relative to the branch vessel and main vessel while the stent is expanded.

17. The method of claim 16, wherein the catheter assembly further includes a branch guidewire housing having a distal end portion, the branch guidewire housing defining a branch guidewire lumen sized to receive a branch guidewire, the branch balloon positioned at the distal end portion of the branch catheter housing, the branch guidewire housing extending through the branch aperture of the stent.

18. The method of claim 16, wherein branch balloon is molded integral with and in fluid communication with the main balloon, the method further comprising simultaneously delivering inflation fluid to the main balloon and the branch balloon.

19. The method of claim 16, further comprising:

deflating the main and branch balloons;

removing the main and branch balloons from within the stent;

advancing a post delivery dilating balloon through the branch aperture of the stent and into the branch vessel; and

inflating the dilating balloon to expand portions of the stent.

20. The method of claim 16, wherein positioning the catheter assembly includes advancing the catheter assembly over a main guidewire positioned in the main vessel and a branch guidewire positioned in the branch vessel.

21. A catheter assembly for treatment of a vessel bifurcation, the catheter assembly comprising:

a main catheter shaft having a proximal end portion and a distal end portion;

a main balloon extending from the distal end portion of the main catheter shaft, the main balloon having a proximal end portion and a distal end portion;

a branch balloon, the branch balloon having a proximal end portion and a distal end portion, the branch balloon extending in a direction radially outward relative to the main balloon;

a first guidewire housing, the first guidewire housing defining a first guidewire lumen and extending through a portion of the main catheter shaft and through the main balloon between the proximal and distal end portions of the main balloon; and

a second guidewire housing, the second guidewire housing defining a second guidewire lumen and extending through a portion of the main catheter shaft, into the main balloon through the proximal end portion of the main balloon, and through the branch balloon between the proximal and distal ends of the side balloon.

22. The catheter assembly of claim 21, wherein the first and second guidewire housings are formed as a single shaft that defines the first and second guidewire lumens.

23. The catheter assembly of claim 21, wherein at least a portion of the main catheter shaft and at least a portion of the first and second guidewire housings are formed as a single shaft that defines the first and second guidewire lumens.

24. The catheter assembly of claim 23, wherein the single shaft further defines an inflation lumen, the inflation lumen in fluid communication with at least the main balloon.

25. The catheter assembly of claim 21, wherein the branch balloon is integral with the main balloon.

26. The catheter assembly of claim 21, wherein the branch balloon is positioned within an interior portion of the main balloon when the branch balloon is in a deflated state, and the branch balloon is positioned exterior of the main balloon when in an inflated state.

27. A catheter assembly for treatment of a vessel bifurcation, the catheter assembly comprising:

a main catheter shaft having a proximal end portion and a distal end portion;

a main balloon extending from the distal end portion of the main catheter shaft, the main balloon having a proximal end portion, a distal end portion, and an main balloon interior; and

a branch balloon, the branch balloon having a proximal end portion and a distal end portion, the branch balloon extending in a direction radially outward relative to the main balloon when in an inflated state;

wherein the branch balloon is positioned within the main balloon interior prior to inflation.

28. The catheter assembly of claim 27 further comprising a stent, the stent having a branch aperture positioned at a location between proximal and distal open ends of the stent, the main balloon extending within the stent from the proximal open end to the distal open end of the stent, the branch balloon extending through the branch aperture of the stent when inflated and positioned within the stent prior to inflation.

29. The catheter assembly of claim 27, further comprising:

a first guidewire housing, the first guidewire housing defining a first guidewire lumen and extending through a portion of the main catheter shaft and through the main balloon between the proximal and distal end portions of the main balloon; and

a second guidewire housing, the second guidewire housing defining a second guidewire lumen and extending through a portion of the main catheter shaft, into the main balloon through the proximal end portion of the main balloon, and through the branch balloon between the proximal and distal ends of the side balloon.

30. The catheter assembly of claim 27, wherein the distal end of the branch balloon is folded into the branch balloon when uninflated.