Catheter for placement of therapeutic devices at the ostium of a bifurcation of a body lumen

• US 6,544,219 B2
• Filed: 12/15/2000
• Issued: 04/08/2003
• Est. Priority Date: 12/15/2000
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Happ, Dorrie M., Torate, Virgilda, Bigus, Stephen J.
• Primary Examiner(s): Preay, Charles G.
• Assistant Examiner(s): Belena, John F.
• Application Number:
  US09/738,577
• Publication Number:
  US 20020077591A1
• Time in Patent Office: 844 Days
• Field of Search: 604/96.01, 604/104, 604/191, 604/192, 604/194, 604/264, 604/284, 604/523, 604/528
• US Class Current: 604/96.01
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

The catheter assembly includes an expandable member mounted to the distal end of a placement catheter, for delivery of a therapeutic device in one of the branch vessels of a bifurcated vessel. The catheter assembly includes lumens for a tracking guide wire and a positioning guide member for placement of the therapeutic device. The therapeutic device is mounted on the expandable member, the tracking guide wire is placed into the target branch vessel, and the placement catheter is then introduced over the tracking guide wire. A positioning guide member is introduced through the catheter, extended through an exit port in the catheter proximal to the expandable member, and then placed in another branch vessel of the bifurcation. The placement catheter then is advanced until the positioning guide member engages the vessel carina between the branch vessels, and the therapeutic device then may be placed accurately in the target branch vessel. In another form of the catheter assembly, a secondary catheter member is mounted to the placement catheter and adapted to receive the positioning guide member for placement of the positioning guide member in the vessel branch not to be treated. An elongated angle member is mounted to the secondary catheter member for engagement with the vessel carina.

Claims

1. A catheter assembly for placement of a therapeutic device for treatment of a patient'"'"'s bifurcated body lumen having a main vessel portion, a plurality of branch vessels extending from the main vessel portion, and a vessel carina between the branch vessels, comprising:

a placement catheter having a proximal end and a distal end, the placement catheter being adapted for mounting a therapeutic device at a location proximal to the distal end of the placement catheter, and for delivery of the therapeutic device in one of the branch vessels, the placement catheter including an expandable member mounted to the placement catheter adjacent to the distal end of the placement catheter, the placement catheter including means for inflating and deflating the expandable member, and the expandable member being adapted for mounting and delivery of the therapeutic device in one of the branch vessels;

a tracking guide wire lumen disposed and extending within at least a portion of the placement catheter, the tracking guide wire lumen adapted to receive a tracking guide wire for slidable movement within the tracking guide wire lumen; and

a positioning guide member lumen disposed and extending within at least a portion of the placement catheter and having an exit port in the catheter, the exit port being toward the proximal end and adjacent to a central location of the expand member on the placement catheter, the positioning guide member lumen adapted to receive a positioning guide member for slidable movement within the positioning guide member lumen.

2. The catheter assembly of claim 1, wherein the placement catheter comprises an adapter hub.

3. A catheter assembly for placement of a therapeutic device for treatment of a patient'"'"'s bifurcated body lumen having a main vessel portion, a plurality of branch vessels extending from the main vessel portion, and a vessel carina between the branch vessels, comprising:

a placement catheter having a proximal end and a distal end, the placement catheter being adapted for mounting a therapeutic device at a location proximal to the distal end of the placement catheter, and for delivery of the therapeutic device in one of the branch vessels;

a tracking guide wire lumen disposed and extending within at least a portion of the placement catheter, the tracking guide wire lumen adapted to receive a tracking guide wire for slidable movement within the tracking guide wire lumen;

a positioning guide member lumen disposed and extending within at least a portion of the placement catheter and having an exit port in the placement catheter, the exit port being toward the proximal end and adjacent to a central location of the therapeutic device on the placement catheter, the positioning guide member lumen adapted to receive a positioning guide member for slidable movement within the positioning guide member lumen;

a secondary catheter member having a distal end and a proximal end, the secondary catheter member mounted to the placement catheter and including a positioning guide member lumen connected in communication with the positioning guide member lumen of the placement catheter, the positioning guide member lumen of the secondary catheter member adapted to receive the positioning guide member for slidable movement within a positioning guide member lumen of the secondary catheter member;

means for coupling and uncoupling the distal end of the secondary catheter member from the distal end of the placement catheter distal to the location of the therapeutic device; and

an elongated angle member having a distal end and a proximal end, the elongated angle member mounted to the secondary catheter member and adapted to be retained by the therapeutic device and extending between the therapeutic device and the location of the therapeutic device so as to form an arch in the elongated angle member between the distal and proximal ends of the elongated angle member proximal to the therapeutic device.

4. The catheter assembly of claim 3, wherein the means for coupling and uncoupling comprises an annular coupling member adapted to receive the distal end of the positioning guide member.

5. The catheter assembly of claim 3, wherein one end of the elongated angle member is mounted adjacent to the distal end of the secondary catheter member.

6. A catheter assembly for placement of a therapeutic device for treatment of a patient'"'"'s bifurcated body lumen having a main vessel portion, a plurality of branch vessels extending from the main vessel portion, and a vessel carina between the branch vessels, comprising:

a catheter having a proximal end and a distal end, the catheter being adapted for mounting a therapeutic device at a location proximal to the distal end of the catheter, and for delivery of the therapeutic device in a target branch vessel;

a tracking guide wire lumen disposed and extending within at least a portion of the catheter, the tracking guide wire lumen adapted to receive a tracking guide wire for slidable movement within the tracking guide wire lumen;

a positioning guide member lumen disposed and extending within at least a portion of the catheter and having an exit port in the catheter proximal to the location of the therapeutic device, the positioning guide member lumen adapted to receive a positioning guide member for slidable movement within the positioning guide member lumen;

a secondary catheter member having a distal end and a proximal end, the secondary catheter member mounted to the placement catheter and including a positioning guide member lumen connected in communication with the positioning guide member lumen of the placement catheter, the positioning guide member lumen of the secondary catheter member adapted to receive the positioning guide member for slidable movement within the positioning guide member lumen of the secondary catheter member;

means for coupling and uncoupling the distal end of the secondary catheter member from the distal end of the placement catheter distal to the location of the therapeutic device; and

an elongated angle member having a distal end and a proximal end, the elongated angle member mounted to the secondary catheter member and adapted to be retained by the therapeutic device and extending between the therapeutic device and the secondary catheter so as to form an arch in the elongated angle member between the distal and proximal ends of the elongated angle member proximal to the therapeutic device.

7. The catheter assembly of claim 6, wherein the catheter comprises an expandable member mounted adjacent to the distal end of the placement catheter, the catheter including means for inflating and deflating the expandable member, the expandable member being adapted for mounting and delivery of the therapeutic device in a target branch vessel, and wherein the exit port in the placement catheter is located proximal and adjacent to a main body location of the expandable member.

8. The catheter assembly of claim 6, wherein the placement catheter comprises an adapter hub.

9. The catheter assembly of claim 6, wherein the means for coupling and uncoupling comprises an annular coupling member adapted to receive the distal end of the positioning guide member.

10. The catheter assembly of claim 6, wherein one end of the elongated angle member is mounted adjacent to the distal end of the secondary catheter member.

11. A method for placement of a therapeutic device for treatment of a patient'"'"'s bifurcated body lumen having a main vessel portion, a plurality of branch vessels extending from the main vessel portion, and a vessel carina between the branch vessels, comprising the steps of:

providing a placement catheter having a proximal end and a distal end, the placement catheter having an expandable member mounted to the distal end of the placement catheter, a tracking guide wire lumen disposed and extending within at least a portion of the placement catheter, and a positioning guide member lumen disposed and extending within at least a portion of the placement catheter and having an exit port in the catheter proximal and adjacent to main body location of the expandable member;

mounting a therapeutic device on the expandable member for placement in a target branch vessel;

placing a distal end of a tracking guide wire into the target branch vessel;

introducing the placement catheter over the tracking guide wire through the tracking guide wire lumen;

introducing a positioning guide member through the positioning guide member lumen and extending a distal end of the positioning guide member through the exit port in the catheter proximal to the expandable member;

placing the distal end of the positioning guide member in another branch vessel;

advancing the placement catheter distally in the main vessel portion until the positioning guide member engages the vessel carina between the branch vessels; and

placing the therapeutic device in a target branch vessel.

12. A method for placement of a therapeutic device for treatment of a patient'"'"'s bifurcated body lumen having a main vessel portion, a plurality of branch vessels extending from the main vessel portion, and a vessel carina between the branch vessels, comprising the steps of:

providing a placement catheter having a proximal end and a distal end, the placement catheter having a therapeutic device mounted thereon, a tracking guide wire lumen disposed and extending within at least a portion of the placement catheter, a positioning guide member lumen disposed and extending within at least a portion of the placement catheter and having an exit port in the catheter proximal to the therapeutic device mounted on the placement catheter, a secondary catheter member having a distal end and a proximal end, the secondary catheter member mounted to the placement catheter and including a positioning guide member lumen connected in communication with the positioning guide member lumen of the placement catheter, and an elongated angle member having a distal end and a proximal end, the elongated angle member mounted to the secondary catheter member and adapted to be retained by the therapeutic device and extending between the therapeutic device and the placement catheter so as to form an arch in the elongated angle member between the distal and proximal ends of the elongated angle member proximal to the therapeutic device;

placing the distal end of a tracking guide wire into a main vessel portion of a target branch vessel;

coupling the distal end of the secondary catheter member to the distal end of the placement catheter distal to the therapeutic device mounted on the placement catheter;

introducing the placement catheter over the tracking guide wire using the tracking guide wire lumen;

introducing a positioning guide member through the positioning guide member lumen and extending the distal end of the positioning guide member through the exit port in the placement catheter proximal to the therapeutic device mounted on the placement catheter;

uncoupling the distal end of the secondary catheter member from the distal end of the placement catheter distal to the therapeutic device mounted on the placement catheter;

placing the distal end of a positioning guide member disposed in the positioning guide member lumen in another branch vessel;

advancing the placement catheter distally in the main vessel portion until the arch of the elongated angle member engages the vessel carina between the branch vessels; and

placing the therapeutic device in the target branch vessel.

13. The method of claim 12, wherein the placement catheter comprises an expandable member adjacent to the distal end of the placement catheter, and the therapeutic device is mounted on the expandable member.

14. The method of claim 13, wherein the distal end of the placement catheter distal to the expandable member includes an annular coupling member adapted to receive the distal end of the positioning guide member, and wherein a step of coupling the distal end of the secondary catheter member to the distal end of the placement catheter comprises placing the distal end of the positioning guide member in the annular coupling member.

15. The method of claim 14, wherein a step of uncoupling the distal end of the secondary catheter member from the distal end of the placement catheter comprises withdrawing the distal end of the positioning guide member from the annular coupling member.