Bifurcation lesion stent delivery using multiple guidewires

• US 6,884,258 B2
• Filed: 02/26/2001
• Issued: 04/26/2005
• Est. Priority Date: 06/04/1999
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Advanced Stent Technologies Inc. (Boston Scientific Corporation)
• Inventors: Williams, Eric, Vardi, Gil M., Davidson, Charles
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US09/794,740
• Publication Number:
  US 20010049548A1
• Time in Patent Office: 1,520 Days
• Field of Search: 623/1.11, 623/1.23, 623/1.34, 623/1.35, 606/108, 606/153, 606/195, 604/98.01, 604/103.04, 604/264, 604/523
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/954 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 2002/821 Ostial stents
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• 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

Abstract

A method for placing a stent into a main vessel such that the stent side hole aligns with a branch vessel ostium comprises inserting a main vessel guidewire into the main vessel and a branch vessel guidewire into the main vessel until a distal end of the branch vessel guidewire passes into the branch vessel. A catheter system is positioned over the main vessel guidewire and the branch vessel guidewire. The catheter system is advanced over the guidewires until the catheter body passes beyond the ostium of the branch vessel and the side member extends into the branch vessel. Marker separation is observed to indicate the catheter body passed beyond the ostium and the side member extends into the branch vessel. The balloon is inflated to deploy the stent with the side hole being aligned with the ostium. The balloon is deflated, and the catheter system is withdrawn.

Claims

1. A method for placing a stent having a side hole into a main vessel such that the side hole is aligned with an ostium of a branch vessel that extends from the main vessel, the method comprising:

inserting a main vessel guidewire into the main vessel until a distal end of the main vessel guidewire passes beyond the ostium of the branch vessel;

inserting a backup branch vessel guidewire into the main vessel until a distal end of the backup branch vessel guidewire passes into the branch vessel;

positioning a catheter system over the main vessel guidewire, the catheter system comprising a catheter body having a main vessel guidewire lumen and a branch vessel guidewire lumen, and a side member operably coupled to the catheter body, wherein the branch vessel guidewire lumen continues through the side member, wherein the catheter body includes at least one marker and the side member includes at least one marker, wherein the catheter body further includes a balloon with the stent being disposed over the balloon, wherein the side member extends into the stent and exits the stent through the side hole, and wherein the main vessel guidewire extends through the main vessel guidewire lumen;

advancing the catheter system over the main vessel guidewire until a distal end of the catheter body is near a distal end of a guiding catheter, and wherein the backup branch guidewire extends alongside the catheter system

inserting a branch vessel guidewire through the branch vessel guidewire lumen of the catheter system until a distal end of the branch vessel guidewire passes into the branch vessel;

further advancing the catheter system over the main vessel guidewire and the branch vessel guidewire until the catheter body extends beyond the ostium and the side member extends into the branch vessel;

observing separation of the markers to indicate that the catheter body has passed beyond the ostium and the side member extends into the branch vessel using angiographic imaging;

withdrawing the backup branch vessel guidewire from the branch vessel;

inflating the balloon to deploy the stent within the main vessel, with the side hole being aligned with the ostium;

deflating the balloon; and

withdrawing the catheter system from the main vessel and the branch vessel while leaving the main vessel guidewire and the branch vessel guidewire in place.

2. A method as in claim 1, wherein if the guidewires cross prior to final advancement of the catheter body, withdrawing the main vessel guidewire into the catheter body and re-advancing the main vessel guidewire back into the main vessel to uncross the guidewires and to correctly orient the side member.

3. A method as in claim 1, further comprising delivering a branch stent within the branch vessel through the side hole in the main stent.

4. A method as in claim 1, wherein if the guidewires cross prior to final advancement of the catheter body, withdrawing the branch vessel guidewire into the catheter body and re-advancing the branch vessel guidewire back into the main vessel to uncross the guidewires and to correctly orient the side member.