Marker arrangement for bifurcation catheter

• US 8,821,561 B2
• Filed: 02/21/2007
• Issued: 09/02/2014
• Est. Priority Date: 02/22/2006
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Malewicz, Andrzej, Gunderson, Richard C.
• Primary Examiner(s): McEvoy, Thomas
• Assistant Examiner(s): SZPIRA, JULIE ANN
• Application Number:
  US11/677,337
• Publication Number:
  US 20070203562A1
• Time in Patent Office: 2,750 Days
• Field of Search: 623/1.11, 623/1.35, 606/194, 606/108
• US Class Current: 623/1.11
• 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 second catheter branch extending in a second direction that is generally the same direction as the first direction;

wherein the first and second catheter branches are secured together at a proximal location and the distal end portions of the first and second catheter branches are free to twist around each other along a longitudinal axis of the catheter assembly;

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;

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, when the first catheter branch and the second catheter branch are in an untwisted configuration, the distal portion of the first proximal marker is positioned proximal of the proximal portion of the second proximal marker and the proximal portion of the first distal marker is positioned distal of the distal portion of the second distal marker; and

when the first catheter branch and the second catheter branch are in a twisted configuration such that the first catheter branch and the second catheter branch are twisted around one another along a longitudinal axis of the catheter assembly, the proximal portion of the first distal marker is positioned proximal of the distal portion of the second distal 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 branch 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, wherein the second catheter branch includes a main balloon and a side balloon for deploying the stent, the side balloon configured to extend radially outward relative to the main balloon;

wherein the first and second catheter branches are secured together at a proximal location and the distal end portions of the first and second catheter branches are free to twist around each other along a longitudinal axis of the catheter assembly;

a first distal marker and a first proximal marker positioned on the first catheter branch, 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, the second distal marker positioned proximal of the first distal marker and distal of the first proximal marker, and the second proximal marker positioned proximal of the first proximal member when the first catheter branch and the second catheter branch are in an untwisted configuration and, when the first catheter branch and the second catheter branch are in a twisted configuration such that the first catheter branch is twisted around the second catheter branch and the second catheter branch is twisted around the first catheter branch, the second distal marker is positioned distal of both the first distal marker and the first proximal marker.

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 a 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, wherein the first and second catheter branches are secured together at a proximal location and the distal end portions of the first and second catheter branches are free to twist around each other along a longitudinal axis of the catheter assembly;

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;

wherein the first distal marker and second distal marker are in a first longitudinal arrangement when the first catheter branch and the second catheter branch are in an untwisted configuration, and the first distal marker and the second distal marker are in a second different longitudinal arrangement when the first catheter branch and the second catheter branch are twisted around one another in a twisted configuration.

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 having a distal end portion including a main balloon member and a side balloon member, the main balloon member extending through the stent from the proximal open end to the distal open end, the side balloon member configured to extend radially outward from the main balloon when inflated, and the main catheter branch configured to advance over a first guidewire to a main vessel of a vessel bifurcation;

a side catheter branch having a distal end portion 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;

wherein the main and side catheter branches are secured together at a proximal location and the distal end portions of the main and side catheter branches are free to twist around each other along a longitudinal axis of the stent delivery system;

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 the main and side distal markers and the main and side proximal markers having a first relative position when the main catheter branch and the side catheter branch are untwisted, and the main and side distal markers and the main and side proximal markers having a second relative position when the main catheter branch and the side catheter branch are twisted, wherein when twisted, the main catheter branch and the side catheter branch are twisted around one another along the longitudinal axis.

16. The stent delivery system of claim 15, wherein at least a portion of the side distal marker is positioned distal of a distal portion of the main distal marker when in the first relative position and wherein at least a portion of the side distal marker is positioned proximal of a distal portion of the main distal marker when in the second relative position.

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 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 main catheter branch having a distal portion, the distal portion of the main catheter branch extending through the stent between the proximal and distal open ends of the stent;

the main catheter branch including a first distal marker positioned distal of the stent, and a first proximal marker positioned proximal of the stent;

a side catheter branch having a distal portion, the distal portion of the side catheter branch extending into the stent at a proximal open end of the stent and extending out of the side opening of the stent, the distal portion of the side catheter branch including a distal section extending distally from the side opening of the stent and having a distal end;

wherein the main and side catheter branches are secured together at a proximal location and the distal portions of the main and side catheter branches are free to twist around each other along a longitudinal axis of the stent delivery system;

the side catheter branch including a second proximal marker positioned proximal of the stent and a second distal marker on the distal section and positioned distal of the stent;

the first and second proximal markers having a predetermined longitudinal position relative to each other;

the stent delivery system having a first configuration wherein the distal section extends generally parallel with the main catheter branch such that the distal end is in general radial alignment with the side opening in the stent, and when in this first configuration, the first and second distal markers have a first predetermined longitudinal position relative to each other; and

the stent delivery system having a second configuration wherein the distal section and the main catheter branch are twisted about one another such that the distal end is not in general radial alignment with the side opening in the stent, and when in this second configuration, the first and second distal markers are in a second longitudinal position relative to each other that is different from the first predetermined longitudinal position relative to each other.

20. The stent delivery system of claim 19 wherein the first distal marker and the first proximal marker each have a length that is imageably distinct from a length of each of the second distal marker and the second proximal marker.