Bifurcated dual-balloon catheter system for bifurcated vessels

Abstract

A bifurcated dual-balloon catheter apparatus for deploying one or more stents to a bifurcated vessel or for use in angioplasty procedures involving bifurcated vessels. The apparatus is particularly suited for bifurcated vessels of the type comprising a main branch from which a side branch extends therefrom. The apparatus has loon and a side branch balloon. A conduit is provided in the main branch balloon through which a portion of the side branch balloon extends. The first balloon is positionable within the main branch of the vessel while the distal portion of the second balloon is positionable within the side branch such that when the first and second balloons are inflated, the first balloon expands radially in the main branch while the distal portion of said second balloon maintains registration with the side branch by expanding radially therein.

1 . An inflatable apparatus for use in a bifurcated vessel having a main branch from which a side branch extends therefrom, comprising:
 a first balloon and a second balloon each having proximal and distal ends and proximal and distal portions;   a conduit extending longitudinally through said first balloon from a first opening proximate the distal end of said first balloon to a second opening disposed between said proximal and distal ends of said first balloon;   said second balloon being arranged such that its proximal portion is accommodated within said conduit and its distal portion extends through the second opening;   said first balloon being positionable within said main branch while the distal portion of said second balloon is positionable within said side branch such that when said first and second balloons are inflated, said first balloon expands radially in said main branch while the distal portion of said second balloon maintains registration with said side branch by expanding radially therein.   
     
     
         2 . The apparatus of  claim 1  wherein said second opening is located approximately midway between the proximal and distal ends of said first balloon. 
     
     
         3 . The apparatus of  claim 1  wherein the shape of the first balloon and the shape of the distal portion of said second balloon are selected based on predetermined shapes of the main and side branches, respectively. 
     
     
         4 . The apparatus of  claim 1 , wherein said first and second balloons are inflatable concurrently. 
     
     
         5 . The apparatus of  claim 1 , wherein said first and second balloons are inflatable separately. 
     
     
         6 . The apparatus of  claim 1  further comprising a catheter extending through each of said first and second balloons. 
     
     
         7 . The apparatus of  claim 6 , wherein said catheters each accommodate a guide wire system for use in the positioning of the main branch balloon in the main branch of the vessel and the distal portion of the side branch balloon in the side branch of the vessel. 
     
     
         8 . The apparatus of  claim 7 , wherein said main branch guide wire system is a rapid exchange wire system. 
     
     
         9 . The apparatus of  claim 7 , wherein said main branch guide wire system is an over the wire exchange system. 
     
     
         10 . The apparatus of  claim 7 , wherein said side branch guide wire system is a rapid exchange wire system. 
     
     
         11 . The apparatus of  claim 7 , wherein said side branch guide wire system is an over the wire exchange system. 
     
     
         12 . The apparatus of  claim 1 , further comprising a first radially-expandable stent positioned on said first balloon, wherein when said first balloon is inflated, said first stent radially expands within said main branch. 
     
     
         13 . The apparatus of  claim 12 , wherein said first radially-expandable stent comprises a side opening through which the distal end of said second balloon extends. 
     
     
         14 . The apparatus of  claim 13 , further comprising a second radially-expandable stent positionable on the distal end of said second balloon, wherein when said second balloon is inflated, said second stent radially expands within said side branch. 
     
     
         15 . The apparatus of  claim 14 , wherein said second stent has a proximal and distal end and said proximal end is shaped to cooperate with said opening of said first stent upon expansion. 
     
     
         16 . The apparatus of  claim 15 , wherein said second stent further comprises alignment means for orienting the proximal end of said second stent with the opening of said first stent. 
     
     
         17 . The apparatus of  claim 1 , wherein the second balloon includes a bend section located where the distal portion of the second balloon extends through the second opening of said first balloon. 
     
     
         18 . The apparatus of  claim 17 , wherein the bend section includes a reverse bend to allow the distal portion of said second balloon to remain substantially parallel to the first balloon for ease of insertion. 
     
     
         19 . The apparatus of  claim 1 , wherein the secondary balloon portion is extendable at an angle of between 10° and 170° from said first balloon when said balloons are inflated. 
     
     
         20 . The use of the apparatus of  claim 1  for deployment of one or more stents to a bifurcated vessel. 
     
     
         21 . The use of the apparatus of  claim 1  for angioplasty of a bifurcated vessel. 
     
     
         22 . The apparatus of  claim 1 , wherein the main and side branch balloon are made using a stretch blow moulding process. 
     
     
         23 . The apparatus of  claim 22 , wherein the main branch balloon is made in a double split mould comprising a lower half and an upper half, said upper half being further split into lower half halves across a section which includes a mandrel for forming said conduit so as to also split said mandrel, whereby a formed main branch conduited balloon can be removed from said double split mould by separating the lower and upper mould halves and the lower half halves.