MARKER ARRANGEMENT FOR BIFURCATION CATHETER

• US 20070203562A1
• Filed: 02/21/2007
• Published: 08/30/2007
• Est. Priority Date: 02/22/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Malewicz, Andrzej, Gunderson, Richard
• Granted Patent: US 8,821,561 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• 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 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A catheter assembly and related methods include first and second catheter branches that are configured to travel over separate guidewires to a vessel bifurcation treatment site within a patient. The catheter branches can each include a plurality of markers. The position of markers on one catheter branch relative to the position of markers on the other catheter branch provide a visual indication of relative twist between the catheter branches, can help distinguish one catheter branch from the other, and help with visual alignment of the catheter branches relative to the vessel bifurcation.

Claims

1. A catheter assembly, comprising:

a first catheter branch having a distal end portion, the distal end portion of the first catheter branch extending in a first direction;

a second catheter branch having a distal end portion, the distal end portion of the first catheter extending in a second direction that is generally the same direction as the first direction;

a first distal marker and a first proximal marker positioned on the first catheter branch, the first distal marker and the first proximal marker each having a distal portion and a proximal portion; and

a second distal marker and a second proximal marker positioned on the second catheter branch, the second distal marker and the second proximal marker each having a distal portion and a proximal portion, the proximal portion of the first distal marker positioned distal of the distal portion of the second distal marker, and the distal portion of the first proximal marker positioned proximal of the proximal portion of the second proximal marker.

2. The catheter assembly of claim 1, wherein the second catheter branch includes a guidewire shaft that defines a guidewire lumen, an inflation shaft that defines an inflation lumen, and a balloon member coupled in fluid communication with the inflation lumen, and the second proximal and distal markers are positioned on the guidewire shaft.

3. The catheter assembly of claim 1, wherein the first catheter branch includes a guidewire shaft that defines a guidewire lumen, an inflation shaft that defines an inflation lumen, and a balloon member coupled in fluid communication with the inflation lumen, and the first proximal and distal markers are positioned on the guidewire shaft.

4. A catheter assembly, comprising:

a stent having a proximal open end, a distal open end, and a side opening defined in a sidewall of the stent at a location between the proximal and distal open ends;

a first catheter branch having a distal end portion, the distal end portion of the first catheter branch extending in a first direction through the side opening of the stent;

a second catheter branch having a distal end portion, the distal end portion of the second catheter branch extending through the stent between the distal and proximal open ends, the distal end portion of the first catheter extending in a second direction that is generally the same direction as the first direction prior to insertion of the catheter assembly into a body lumen;

a first distal marker and a first proximal marker positioned on the first catheter branch, at least a portion of the first distal marker positioned distally of the side opening of the stent and the first proximal marker positioned proximal of the first distal marker; and

a second distal marker and a second proximal marker positioned on the second catheter branch, at least a portion of the second distal marker positioned further proximally than a proximal portion of the first distal marker, and at least a portion of the second proximal marker positioned further proximally than a proximal portion of the first proximal member.

5. The catheter assembly of claim 4, wherein at least a portion of the first distal marker is positioned distal of a distal end of the stent, and at least a portion of the first proximal marker is positioned proximal of a proximal end of the stent.

6. The catheter assembly of claim 5, wherein at least a portion of the second distal marker is positioned distal of the distal end of the stent, and at least a portion of the second proximal marker is positioned proximal of the proximal end of the stent.

7. The catheter assembly of claim 4, wherein the first distal marker and the first proximal marker each having a distal portion and a proximal portion, the second distal marker and the second proximal marker each having a distal portion and a proximal portion, the proximal portion of the first distal marker is positioned distal of the distal portion of the second distal marker, and the proximal portion of the first proximal marker is positioned distal of the distal portion of the second proximal marker

8. The catheter assembly of claim 7, wherein the first distal marker and the first proximal marker are each imageably distinct from the second distal marker and the second proximal marker.

9. The catheter assembly of claim 4, wherein the second distal marker is aligned axially with the side opening of the stent, and at least a portion of one of the first proximal marker and the second proximal marker extends proximal of the proximal open end of the stent.

10. The catheter assembly of claim 4, wherein the second proximal marker is aligned with the side opening of the stent, and at least a portion of each of the first distal marker and the second distal marker extends distally of the distal open end of the stent.

11. The catheter assembly of claim 4, further comprising a first middle marker positioned on the first catheter branch at a location between the first distal marker and the first proximal marker.

12. The catheter assembly of claim 4, further comprising a second middle marker positioned on the second catheter branch at a location between the second distal marker and the second proximal marker.

13. A catheter assembly, comprising:

a first catheter branch having a distal end portion, the distal end portion of the first catheter branch extending through the stent;

a second catheter branch having a distal end portion, the distal end portion of the second catheter branch extending through the stent, the distal end portion of the first catheter branch extending adjacent to the distal end portion of the second catheter branch prior to insertion of the catheter assembly into a body lumen;

a first distal marker and a first proximal marker positioned on the first catheter branch at axially spaced apart locations; and

a second distal marker and a second proximal marker positioned on the second catheter branch at axially spaced apart locations, the first distal marker and the first proximal marker each having a length imageably distinct from a length of each of the second distal marker and the second proximal marker.

14. The catheter assembly of claim 13, wherein the length of the first distal marker and the first proximal marker is at least 25% greater than the length of the second distal marker and the second proximal marker.

15. A stent delivery system, comprising:

a stent having a distal open end, a proximal open end, and a side opening defined in a sidewall of the stent at a location between the proximal and distal open ends;

a main catheter branch, the main catheter branch including a balloon member, the balloon member extending through the stent from the proximal open end to the distal open end, and the main catheter branch configured to advance over a first guidewire to a main vessel of a vessel bifurcation;

a side catheter branch extending into the proximal open end of the stent and extending out of the side opening, the side catheter branch configured to advance over a second guidewire to a branch vessel of the vessel bifurcation;

a main distal marker and a main proximal marker positioned on the main catheter branch; and

a side distal marker and a side proximal marker positioned on the side catheter branch, at least one of the main and side proximal markers being positioned outside of the stent and at least one of the main and side distal markers being positioned outside of the stent, and a relative position of the main and side distal markers and the main and side proximal markers provides an indication of relative twist between the main and side catheter branches and alignment of the stent sidewall opening relative to an opening from the main vessel into the branch vessel of the vessel bifurcation.

16. The stent delivery system of claim 15, wherein at least a portion of the side distal marker is positioned further distally than a distal portion of the main distal marker.

17. The stent delivery system of claim 16, wherein at least a portion of the side proximal marker is positioned further proximally than a proximal portion of the main proximal marker.

18. The stent delivery system of claim 16, wherein relative twist includes twisting of the main and side catheter branches relative to each other at a location between at least the main distal marker and the main proximal marker.

19. A stent delivery system, comprising:

a stent, the stent having a distal open end, a proximal open end, and a side opening at a location between the proximal and distal open ends;

a main catheter branch including an balloon member at least partially positioned within the stent, the main catheter branch configured to advance over a first guidewire into a main vessel of a vessel bifurcation; and

a side catheter branch extending through the side opening of the stent and including marker material along a length of the side catheter branch, the marker material extending along a distal end portion of the side catheter branch and has a length at least as great as a distance from the side opening of the stent to the distal open end of the stent, the side catheter branch configured to advance over a second guidewire into a branch vessel of the vessel bifurcation.

20. The stent delivery system of claim 19, wherein the marker material is part of a material construction of the side catheter branch.

21. The stent delivery system of claim 19, wherein the marker material includes a coil structure.

22. A method of treating a vessel bifurcation, comprising:

positioning a first guidewire in a main vessel of the vessel bifurcation, and positioning a second guidewire in a branch vessel of the vessel bifurcation;

advancing a catheter assembly over the first and second guidewires to the vessel bifurcation, the catheter assembly including a stent, first and second pairs of markers, and first and second catheter members, the first and second catheter members having a fixed axial position relative to each other, and the first and second catheter members extend through portions of the stent;

observing relative positions of the first and second pair of markers;

adjusting a position of the stent relative to the vessel bifurcation based on observed positions of the first and second pairs of markers; and

expanding the stent to treat the vessel bifurcation.

23. The method of claim 22, wherein the first pair of markers is spaced apart a greater axial distance than an axial spacing between the second pair of markers.

24. The method of claim 22, wherein observing relative positions of the first and second pair of markers includes making observations prior to advancing the first catheter member over the first guidewire into the branch vessel and after advancing the first catheter member into the branch vessel.