Bifurcated stent delivery system having retractable sheath

• US 20020111675A1
• Filed: 04/16/2002
• Published: 08/15/2002
• Est. Priority Date: 12/10/1999
• Status: Active Grant

• Current Assignee: Wilson W. Stan
• Original Assignee: Wilson W. Stan
• Inventors: Wilson, W. Stan
• Granted Patent: US 6,802,856 B2
• Time in Patent Office: Days
• US Class Current: 623/1.35
• 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2250/006 modular

Abstract

An improved catheter assembly and method are provided for treating bifurcated vessels. The catheter assembly of the present invention includes a tubular sheath for restraining dual balloons normally biased apart. Withdrawal of the sheath allows the balloons to separate and deploy intravascular stents in a bifurcated vessel. The catheter assembly also includes the feature of containing two guide wire lumens in a single catheter designed to track over a single wire prior to arrival at the bifurcation, thus preventing wire wrapping and crossing of the wires.

Claims

1. A stent delivery assembly for treating bifurcated vessels, comprising:

a dual balloon Y-shaped catheter having a proximal end and a distal end, the catheter including a first expandable member having a proximal end and a distal end, the catheter further including a second expandable member having a proximal end and a distal end;

a first guide wire lumen for receiving a first guide wire, the first guide wire lumen extending through at least a portion of the catheter including the first expandable member;

a second guide wire lumen for receiving a second guide wire, the second guide wire lumen extending through at least a portion of the catheter including the second expandable member; and

a tubular member;

wherein the first expandable member and the second expandable member are normally biased apart, but are restrained and releasably held together by the tubular member to provide a low profile during delivery of a Y-shaped stent.

2. The assembly of claim 1, wherein the tubular member is a sheath.

3. The assembly of claim 1, wherein the Y-shaped stent is removably mounted on the first and second expandable members.

4. The assembly of claim 1, further including an inflation lumen for inflating the first and second expandable members.

5. The assembly of claim 4, wherein the first and second expandable members inflate simultaneously.

6. The assembly of claim 1, wherein the second expandable member is longer than the first expandable member.

7. The assembly of claim 6, wherein when the first expandable member and the second expandable member are restrained and held together by the tubular member, a distal portion of the second expandable member protrudes from a distal end of the tubular member.

8. A method of stenting a bifurcated vessel having a bifurcation, a first vessel branch, and a second vessel branch, comprising the steps of:

providing a dual balloon Y-shaped catheter having a first expandable member and a second expandable member;

providing a Y-shaped stent mounted on the first and second expandable members;

providing a tubular member and placing it about the first and second expandable members such that the first and second expandable members are normally biased apart, but are restrained and held together by the tubular member;

delivering the Y-shaped stent to a target area;

withdrawing the tubular member proximally until the first expandable member and the second expandable member are released and spring apart;

implanting the Y-shaped stent by inflating the first and second expandable members;

deflating the first and second expandable members; and

withdrawing the catheter.

9. The method of claim 8, wherein the tubular member is a sheath.

10. A method of stenting a bifurcated vessel having a bifurcation, a first vessel branch, and a second vessel branch, comprising the steps of:

providing a dual balloon Y-shaped catheter having a proximal end and a distal end, the catheter including a first expandable member having a proximal end and a distal end, the catheter further including a second expandable member having a proximal end and a distal end;

providing a first guide wire lumen for receiving a first guide wire, the first guide wire lumen extending through at least a portion of the catheter including the first expandable member;

providing a second guide wire lumen for receiving a second guide wire, the second guide wire lumen extending through at least a portion of the catheter including the second expandable member;

providing a Y-shaped stent mounted on the first and second expandable members;

providing a tubular member and placing it about the first and second expandable members such that the first and second expandable members are normally biased apart, but are restrained and held together by the tubular member;

providing a second guide wire and positioning the second guide wire distally of the bifurcation in the first vessel branch;

loading the second guide wire into the second guide wire lumen;

advancing the catheter and tubular member over the second guide wire so that the catheter is advanced distally of the bifurcation in the first vessel branch;

withdrawing the tubular member proximally until the first expandable member and the second expandable member are released and spring apart;

withdrawing the catheter proximally to a position proximal of the bifurcation;

providing a first guide wire;

advancing the first guide wire out of the first guide wire lumen and into the second vessel branch distally of the bifurcation;

advancing the catheter distally over the first and second guide wires until the Y-shaped stent is positioned at the bifurcation;

implanting the Y-shaped stent by inflating the first and second expandable members;

deflating the first and second expandable members; and

withdrawing the catheter.

11. The method of claim 10, wherein the tubular member is a sheath.

13. The method of claim 12, wherein the tubular member is a sheath.

12. A method of stenting a bifurcated vessel having a bifurcation, a first vessel branch, and a second vessel branch, comprising the steps of:

providing a dual balloon Y-shaped catheter having a proximal end and a distal end, the catheter including a first expandable member having a proximal end and a distal end, the catheter further including a second expandable member having a proximal end and a distal end;

providing a first guide wire lumen for receiving a first guide wire, the first guide wire lumen extending through at least a portion of the catheter including the first expandable member;

providing a second guide wire lumen for receiving a second guide wire, the second guide wire lumen extending through at least a portion of the catheter including the second expandable member;

providing a Y-shaped stent mounted on the first and second expandable members;

providing a tubular member and placing it about the first and second expandable members such that the first and second expandable members are normally biased apart, but are restrained and held together by the tubular member;

providing a second guide wire and positioning the second guide wire distally of the bifurcation in the first vessel branch;

loading the second guide wire into the second guide wire lumen;

advancing the catheter and tubular member over the second guide wire so that the catheter is advanced proximally of the bifurcation in the first vessel branch;

withdrawing the tubular member proximally until the first expandable member and the second expandable member are released and spring apart;

providing a first guide wire;

advancing the first guide wire out of the first guide wire lumen and into the second vessel branch distal of the bifurcation;

advancing the catheter distally over the first and second guide wires until the Y-shaped stent is positioned at the bifurcation;

implanting the Y-shaped stent by inflating the first and second expandable members;

deflating the first and second expandable members; and

withdrawing the catheter.