System and methods for treating a bifurcation with a fully crimped stent

• US 9,364,356 B2
• Filed: 03/12/2013
• Issued: 06/14/2016
• Est. Priority Date: 02/08/2011
• Status: Active Grant

• Current Assignee: Advanced Bifurcation Systems, Inc.
• Original Assignee: Advanced Bifurcation Systems, Inc.
• Inventors: Bourang, Henry
• Primary Examiner(s): Rodjom, Katherine
• Application Number:
  US13/796,424
• Publication Number:
  US 20140100647A1
• Time in Patent Office: 1,190 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties

Abstract

A system for treating a bifurcation includes first and second delivery catheters. The first catheter has a first shaft, a first expandable member adjacent the distal end of the first shaft, an auxiliary expandable member disposed under the first expandable member, and a first radially expandable stent disposed over both the first expandable member and the auxiliary expandable member. The second delivery catheter has a second shaft, and a second expandable member adjacent the distal end of the second shaft. A portion of the second catheter is disposed under a portion of the first stent, and a portion of the second delivery catheter passes through a side hole in the first stent. The first stent is crimped over the first and second catheters such that the first stent remains attached to the first and the second catheters during advancement of the catheters through a blood vessel.

Claims

1. A method of treating a bifurcated vessel, said method comprising:

providing a first delivery catheter and a second delivery catheter, wherein the first delivery catheter comprises a first elongate shaft, a first expandable member, an auxiliary expandable member disposed under the first expandable member, and a first stent disposed over both the first expandable member and the auxiliary expandable member, and

the second delivery catheter comprises a second elongate shaft, and a second expandable member, wherein a portion of the second elongate shaft is disposed under the first stent and the second elongate shaft passes through a side hole in the first stent;

advancing both the first delivery catheter and the second delivery catheter through a main branch vessel to a bifurcation in the main branch, the bifurcation comprising a side branch vessel;

radially expanding the auxiliary expandable member to an expanded configuration, wherein in the expanded configuration the expanded auxiliary expandable member engages and expands a first portion of the first expandable member, and wherein in the expanded configuration, the expanded auxiliary expandable member also radially expands to expand a first portion of the first stent from a crimped configuration to a partially expanded configuration, while a second portion of the first stent remains crimped to the first delivery catheter;

radially contracting the auxiliary expandable member from the expanded configuration to a collapsed configuration, thereby radially contracting the first expandable member, and forming an annular gap between an inside surface of the first stent and an outer surface of the first elongate shaft and an outer surface of the second elongate shaft, while the second portion of the first stent remains crimped to the first delivery catheter; and

slidably moving the second elongate shaft relative to the first elongate shaft after forming the annular gap, wherein the second elongate shaft slides under a portion of the first stent and passes through the side hole in the first stent, while the second portion of the first stent remains crimped to the first delivery catheter thereby preventing movement of the first stent relative to the first delivery catheter.

2. The method of claim 1, wherein advancing comprises advancing both the first and the second delivery catheters through a patient'"'"'s vasculature toward the bifurcation until resistance against further advancement is felt by an operator, the resistance provided by one or more of the first and the second delivery catheters engaging a carina of the bifurcation.

3. The method of claim 1, wherein the auxiliary expandable member comprises a balloon, and radially expanding the auxiliary member comprises inflating the balloon.

4. The method of claim 3, wherein radially contracting the auxiliary member comprises deflating the balloon.

5. The method of claim 1, wherein slidably moving the second elongate shaft comprises proximally retracting the second elongate shaft under a portion of the first stent until a portion of the second expandable member enters the side hole of the first stent and is disposed under the first stent.

6. The method of claim 1, further comprising radially expanding the first expandable member, thereby expanding the first stent into engagement with a portion of the bifurcated vessel.

7. The method of claim 6, wherein the second delivery catheter further comprises a second stent disposed over the second expandable member, the method further comprising radially expanding the second expandable member, and expanding the second stent into engagement with another portion of the bifurcated vessel.

8. The method of claim 1, further comprising eluting a therapeutic agent from the first stent, or one of the expandable members into the bifurcated vessel.

9. The method of claim 8, wherein the therapeutic agent comprises an anti-restenosis agent.