Stent and catheter assembly and method for treating bifurcations

• US 20010037116A1
• Filed: 06/14/2001
• Published: 11/01/2001
• Est. Priority Date: 08/13/1997
• Status: Active Grant

• Current Assignee: Kevin M. Mauch, Steve Bigus, Wilson W. Stan
• Original Assignee: Kevin M. Mauch, Steve Bigus, Wilson W. Stan
• Inventors: Wilson, W. Stan, Mauch, Kevin M., Bigus, Steve
• Granted Patent: US 6,508,836 B2
• Time in Patent Office: Days
• US Class Current: 606/108
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/821 Ostial stents
• 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 2250/0014 having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• 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. In one embodiment, a stent delivery assembly is provided for implanting a Y-shaped stent in a bifurcated vessel. A dual balloon Y-shaped catheter is provided having two expandable members. The catheter is delivered over a guide wire while a restraining member holds the expandable members together for low profile delivery.

Claims

1. A stent delivery assembly for implanting a Y-shaped stent in a bifurcated vessel having a side-branch vessel and a main vessel, 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 lumen for receiving a restraining member, the first lumen extending through at least a portion of the catheter including the first expandable member;

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

a restraining member positionable within the first lumen;

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

2. The stent delivery assembly of

claim 1

, wherein the restraining member is a mandril.

3. The stent delivery assembly of

claim 1

, wherein the restraining member is a guide wire.

4. The stent delivery assembly of

claim 1

, wherein the Y-shaped stent is removably mounted on the first and second expandable members.

5. The stent delivery assembly of

claim 1

, further including a removable locking ring for assisting in holding the distal ends of the first expandable member and the second expandable member together prior to implantation of the Y-shaped stent.

6. The stent delivery assembly of

claim 1

, wherein the first lumen includes a distal section, a portion of which extends through at least a portion of the second expandable member.

7. The stent delivery assembly of

claim 6

, wherein the restraining member extends through the first lumen found on the first expandable member and the portion of the lumen on the second expandable member to hold the first and second expandable members together until the assembly is to be deployed.

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

providing a second lumen for receiving a guide wire, the second 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 restraining member and positioning it within the first lumen such that the first expandable member and the second expandable member are normally biased apart, but are restrained and held together by the restraining member;

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

loading the guide wire into the second lumen;

advancing the catheter over the guide wire so that the catheter is advanced proximate the bifurcation;

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

advancing a wire distally through the first lumen into the second vessel branch;

advancing the catheter distally over the wire and guide wire 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, wire, and guide wire

9. The method of

claim 8

, wherein the wire that is advanced through the first lumen into the second vessel branch is a guide wire.

10. The method of

claim 8

, wherein the wire that is advanced through the first lumen into the second distal branch is the restraining member.

11. The method of

claim 8

, further comprising the step of providing a removable locking ring to assist in holding the first and second expandable members together prior to implantation of the Y-shaped stent.