Stent and catheter assembly and method for treating bifurcations

• US 6,387,120 B2
• Filed: 04/26/2001
• Issued: 05/14/2002
• Est. Priority Date: 12/09/1999
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Wilson, W. Stan, Mauch, Kevin M.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/844,926
• Publication Number:
  US 20010016768A1
• Time in Patent Office: 383 Days
• Field of Search: 623/1.11, 623/1.23, 623/1.35, 623/1.36, 606/108, 606/192, 606/195, 606/194, 604/96.01, 604/101.01, 604/101.02, 604/101.03
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2250/006 modular

Abstract

An apparatus and method is provided for stenting bifurcated vessels. A proximal angled stent is configured for implanting in a side-branch vessel wherein the proximal angled stent has an angulated portion that corresponds to the angle formed by the intersection of the side-branch vessel and the main vessel so that all portions of the side-branch vessel at the bifurcation are covered by the proximal angled stent. A main-vessel stent is provided for implanting in the main vessel, wherein the main-vessel stent has an aperture or stent cell that aligns with the opening to the side-branch vessel to permit unobstructed blood flow between the main vessel and the side-branch vessel. Side-branch and main-vessel catheter assemblies are advanced over a pair of guide wires for delivering, appropriately orienting, and implanting the proximal angled stent and the apertured stent.

Claims

1. A method of implanting a proximal angled stent in a side-branch vessel adjacent to a bifurcation with a main vessel, the method steps comprising:

providing a side-branch catheter assembly having a tracking guide wire lumen extending through at least a portion thereof, an expandable member associated with the catheter and having the proximal angled stent mounted thereon, a stent-positioning guide wire lumen associated with the expandable member, a tracking guide wire sized for slidable movement within the tracking guide wire lumen, and a stent-positioning guide wire sized for slidable movement within the stent-positioning guide wire lumen;

advancing a distal end of the tracking guide wire into the side-branch vessel and distal to a target area;

advancing the side-branch catheter along the tracking guide wire and simultaneously advancing the stent-positioning lumen attached to the outer proximal surface of the expandable member with the stent-positioning guide wire contained therein;

advancing the side-branch catheter in the main vessel to a position just proximal of the side-branch vessel;

advancing a distal end of the stent-positioning guide wire through the main vessel and distal to the side-branch vessel;

further advancing the side-branch catheter so that the positioning guide wire creates rotation of the side-branch catheter as the expandable member and proximal angled stent advance into the side-branch vessel and the side-branch catheter anchors at the side-branch ostium;

aligning the proximal angled stent across the target area and aligning a proximal end of the proximal angled stent with the intersection of the side-branch vessel and the main vessel so that the proximal angled stent does not extend into the main vessel;

inflating the expandable member thereby expanding and implanting the proximal angled stent at the target area in the side-branch vessel;

deflating the expandable member and withdrawing the side-branch catheter from the patient; and

withdrawing the tracking and stent-positioning guide wires from the patient.

2. The method of claim 1, further comprising implanting a main-vessel stent in the main vessel, including after the step of withdrawing the side-branch catheter and while the stent-positioning guide wire remains in position in the main vessel:

providing a main-vessel catheter having a proximal end and a distal end and a tracking guide wire lumen extending through at least a portion thereof, an expandable member adjacent the distal end of the main-vessel catheter and having the main-vessel stent mounted thereon, a positioning guide wire lumen attached to the outer surface of the main-vessel catheter and extending over at least a portion of the surface of the expandable member;

providing a tracking guide wire contained in the stent-positioning guide wire lumen;

inserting the proximal end of the stent-positioning guide wire into the tracking guide wire lumen;

advancing the main-vessel catheter and the expandable member over the stent-positioning guide wire in the main vessel until the main-vessel catheter is distal end about one cm proximal to the side-branch vessel;

advancing the tracking guide wire out of the stent-positioning guide wire lumen so that the tracking guide wire distal end advances into the side-branch vessel;

manipulating and torquing the tracking and stent-positioning guide wires until the expandable member and main-vessel stent are in the main vessel and adjacent the side-branch vessel;

inflating the expandable member and the main-vessel stent into contact with the main vessel thereby implanting the stent in the main vessel;

deflating the expandable member and withdrawing the main-vessel catheter from the patient; and

withdrawing the tracking and stent-positioning guide wires from the patient.

3. The method of claim 2, wherein providing the stent-positioning guide wire lumen step further comprises providing the stent-positioning lumen having a straight portion and an angulated portion.

4. A method of stenting a bifurcated vessel, the method steps comprising:

providing a main-vessel catheter for delivering and implanting a main-vessel stent having a plurality of stent cells formed by stent struts;

implanting the main-vessel stent in a main vessel of the bifurcation, the main-vessel stent spanning an opening to a side-branch vessel and precisely orienting the main-vessel stent cells with respect to the side-branch ostium so that subsequent access to the side-branch vessel is not compromised;

withdrawing the main-vessel catheter from the patient;

providing a balloon catheter and advancing the balloon catheter through the main vessel and through a targeted stent cell and into the opening of the side-branch vessel;

expanding a balloon portion of the balloon catheter so that the stent struts of the targeted stent cell adjacent the opening of the side-branch vessel are deformed thereby forming an opening in main-vessel stent that substantially corresponds to the opening from the main vessel to the side-branch vessel;

providing a side-branch vessel catheter having a proximal angled stent mounted on a balloon portion thereof and advancing the side-branch vessel catheter to the main vessel and through the opening in the main-vessel stent so that the side-branch catheter is advanced into the side-branch vessel;

expanding the balloon portion of the side-branch vessel catheter so that the proximal angled stent on the balloon portion expands into contact with the side-branch vessel, thereby covering all portions of the side-branch vessel immediately adjacent the main vessel; and

withdrawing the side-branch vessel catheter from the patient'"'"'s vascular system.