Two-step/dual-diameter balloon angioplasty catheter for bifurcation and side-branch vascular anatomy

• US 20090048655A1
• Filed: 08/27/2008
• Published: 02/19/2009
• Est. Priority Date: 09/17/2004
• Status: Abandoned Application

• Current Assignee: Jang G. David
• Original Assignee: Jang G. David
• Inventors: Jang, G. David
• Application Number:
  US12/229,991
• Publication Number:
  US 20090048655A1
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

The present invention tackles the challenging anatomic characteristics of the coronary artery disease in the bifurcation point and the origin of side-branch. The invention has a specifically designed angioplasty balloon catheter, particularly the balloon shape and profile, to be used in the diseased vessels at these difficult anatomic locations. In stent implanting into a coronary artery, a balloon catheter application is an inseparable requirement. A stent is a passive device that cannot be deployed in a diseased or stenosed artery without a pre-stent, with-stent and/or post-stent balloon dilatation. In majority (more than 95%) of available coronary stents, a stent is deployed by balloon expandable mode, meaning that the stent is delivered and expanded inside a vessel lumen by expanding a delivery balloon. This is done by crimping a stent over a folded balloon for delivery into a coronary artery. When expanded by balloon inflation, a stent is expanded and shaped passively by the inflated balloon shape and profile. The balloon catheter is designed to do angioplasty in the bifurcation and side-branch anatomy of coronary arteries, while minimizing the side effect. This specially designed balloon catheter is not only for balloon angioplasty dilatation of the bifurcation and side-branch anatomy, but is also for delivering and deploying specially designed bifurcation or side-branch stents into these difficult anatomic locations, as a stent delivery system.

Claims

1. A shaped angioplasty balloon catheter for use at a transition point of a vessel at which the vessel has a main branch and a side branch of relatively larger and smaller diameters, respectively, and the transition point between them, the catheter comprising:

a catheter body including a catheter shaft having a first lumen, which is adapted to receive a guide wire, and a second lumen configured to provide an inflation and deflation path for inflation fluid,

a dual-diameter single balloon positioned at a distal portion of the catheter body inflatable from deflated condition to a relatively larger diameter inflated condition by fluid pressure applied through said second lumen, the dual-diameter balloon having an outer skin profile of two dissimilar diameters when inflated, said dual-diameter balloon having a first proximal section with a first average inflated diameter, and a second distal section with a second average inflated diameter positioned toward the distal end of said catheter body, the second average inflated diameter of said dual-diameter balloon being smaller than the first average inflated diameter, the first proximal and second distal sections of said dual-diameter balloon being joined by a balloon transition section, the first and second diameters and transition section of said balloon in their inflated condition being sized and shaped to reduce vessel damage when positioned at the transition point of the vessel,

at least one radiopaque marker positioned on said catheter shaft in alignment with the transition section of said balloon, said radiopaque marker being positioned during an angioplasty procedure at the vessel transition point under fluoroscopy prior to balloon inflation;

whereby said balloon, in its inflated condition, is positioned such that the first proximal section occupies the main branch, the second distal section occupies the side branch, and the transition section is positioned at the transition point of the vessel.

2. A stent delivery system for installing a shaped in situ dual diameter stent in a vessel which has a main branch and a side branch of relatively larger and smaller diameters, respectively, and a transition point between them, the stent delivery system comprising:

a catheter body including a catheter shaft having a first lumen, which is adapted to receive a guide wire, and a second lumen configured to provide an inflation and deflation path for inflation fluid, and

a dual-diameter single balloon positioned at a distal portion of the catheter body inflatable from deflated condition to a relatively larger diameter inflated condition by fluid pressure applied through said second lumen, the dual-diameter balloon having an outer skin profile of two dissimilar diameters when inflated, said dual-diameter balloon having a first proximal section with a first average inflated diameter, and a second distal section with a second average inflated diameter positioned toward the distal end of said catheter body, the second average inflated diameter of said dual-diameter balloon being smaller than the first average inflated diameter, the first proximal and second distal sections of said dual-diameter balloon being joined by a balloon transition section, the first and second diameters and transition section of said balloon in their inflated condition being sized and shaped to to be positioned within the main branch, side branch and transition point, respectively

at least one radiopaque marker positioned on said catheter shaft in alignment with the transition section of said balloon, said radiopaque marker being positioned at the vessel transition point under fluoroscopy during an angioplasty procedure prior to balloon inflation; and

an expandable stent closely fitted over and carried by said balloon in its deflated condition, inflation of said balloon to its inflated condition after said radiopaque marker has been positioned at the vessel transition point molding said stent in situ into a dual diameter shape positioned in the main branch, side branch and transition point of the vessel.

3. A method of treating a vascular vessel having a transition point at which the vessel has a main branch and a side branch of relatively larger and smaller diameters, respectively, and the transition point between them, the method comprising the steps of:

providing a catheter which includes;

a catheter body having a catheter shaft with a first lumen, which is adapted to receive a guide wire, and a second lumen configured to provide an inflation and deflation path for inflation fluid;

a dual-diameter single balloon positioned at a distal portion of the catheter body inflatable from a deflated condition to a relatively larger diameter inflated condition by fluid pressure applied through the second lumen, the dual-diameter balloon having an outer skin profile of two dissimilar diameters when inflated, said dual-diameter balloon having a first proximal section with a first average inflated diameter, and the second distal section with a second average inflated diameter positioned toward the distal end of said catheter body, the second average inflated diameter of said dual-diameter balloon being smaller than the first average inflated diameter, the first proximal and second distal sections of said dual-diameter balloon being joined by a balloon transition section, said first proximal, second distal and transition sections of the balloon being sized and shaped in their inflated condition to reduce vessel damage when positioned at the transition point of the vessel; and

at least one radiopaque marker positioned on said catheter shaft aligned with said balloon transition section;

mounting a cardiovascular stent in overlapping contact with said balloon in its deflated condition;

advancing said catheter and said stent through the vessel in an angioplasty procedure under fluoroscopy until the radiopaque marker is positioned at the transition point of the vessel;

applying inflation pressure through the second lumen to inflate the balloon thereby causing the first proximal, second distal and transition sections of said balloon to inflate within the interior of the main branch, side branch and transition point, respectively of the vessel;

whereby the step of applying inflation pressure through the second lumen to inflate the balloon molds the stent in situ into a dual diameter shape sized to reduce vessel damage when the transition section of the balloon is positioned at the transition point junction of the vessel.