Vessel treatment devices

Abstract

A catheter system for treating lesions is provided. The system is suitable for treatment of bifurcation lesions, has a low profile and provides substantially predictable translational and rotational positioning. In one embodiment, the system includes a fixed wire balloon catheter and a partially attached guidewire lumen, wherein the guidewire lumen is attached to the catheter at a crotch point. The location of the crotch point is predetermined so as to provide substantially predictable positioning. Several embodiments of the system are described for various types of lesions and vessel configurations.

1 . A system for positioning a stent at a bifurcation, the system comprising:
 a catheter having a main body including a main body proximal end and a main body distal end;   a balloon positioned at the main body distal end, the balloon including a balloon proximal end and a balloon distal end, the balloon having an inflated configuration and a pre-inflated configuration;   a wire positioned at the balloon distal end, the wire immovable with respect to the balloon in the pre-inflated configuration;   a core wire positioned through the balloon;   an auxiliary elongated element attached to the catheter to form a crotch point, the auxiliary elongated element including an auxiliary elongated element proximal end and an auxiliary elongated element distal end;   a stent positioned on the balloon, the stent having a plurality of stent edges; and   first, second, and third radiopaque markers immovable with respect to the catheter main body, two of the first, second, and third radiopaque markers are positioned on a first longitudinal axis and longitudinally aligned, respectively, with a first and second of the stent edges, one of the first, second, and third radiopaque markers positioned on a second longitudinal axis different from the first longitudinal axis.   
     
     
         2 . The system according to  claim 1 , wherein the stent includes a stent proximal end and a stent distal end, and wherein the first and second radiopaque markers are longitudinally aligned, respectively, with the stent proximal end and the stent distal end. 
     
     
         3 . The system according to  claim 1 , wherein two of the first, second, and third radiopaque markers are positioned on the core wire. 
     
     
         4 . The system according to  claim 1 , wherein one of the first, second, and third radiopaque markers is positioned at the crotch point. 
     
     
         5 . The system according to  claim 1 , wherein one of the first, second, and third radiopaque markers comprises a different shape. 
     
     
         6 . The system according to  claim 1 , wherein one of the first, second, and third radiopaque markers includes an apex pointing away from the longitudinal axis of the catheter. 
     
     
         7 . The system according to  claim 1 , wherein the stent includes a stent opening, and wherein the plurality of stent edges comprise a stent distal end, a stent proximal end, a stent opening distal end, and a stent opening proximal end. 
     
     
         8 . The system according to  claim 7 , further comprising a fourth radiopaque marker, wherein each of the first, second, third, and fourth radiopaque marker is aligned with one of the stent proximal end, the stent distal end, the stent opening distal end, and the stent opening proximal end. 
     
     
         9 . The system according to  claim 1 , wherein two of the first, second, and third radiopaque markers are longitudinally distanced from each other to approximate an average diameter of a vessel side branch. 
     
     
         10 . The system according to  claim 9 , wherein the distance is approximately 2 to 3 mm. 
     
     
         11 . The system according to  claim 9 , wherein the distance is approximately 2 to 2.5 mm. 
     
     
         12 . The system according to  claim 1 , wherein the crotch point is positioned so that a guidewire positioned within the auxiliary elongated element forms an angle with a longitudinal axis of the catheter less than 90 degrees. 
     
     
         13 . The system according to  claim 1 , wherein said wire is a fixed wire attached to the balloon distal end. 
     
     
         14 . The system according to  claim 1 , wherein said wire is a movable wire when the balloon is in the inflated configuration, and wherein when the balloon is in the pre-inflated configuration, said wire is trapped inside the balloon and stent so that said wire is immovable with respect to the balloon. 
     
     
         15 . A method for treating a vessel at a bifurcation, the method comprising:
 providing a catheter having a main body, a balloon positioned at a distal end of the main body, the balloon having an inflated configuration and a pre-inflated configuration, a wire positioned at a distal end of the balloon, the wire immovable with respect to the balloon in the pre-inflated configuration, a core wire positioned through the balloon, an auxiliary elongated element positioned alongside at least a portion of the balloon and having a distal end attached to the catheter to form a crotch point, a stent positioned on the balloon, the stent having a plurality of stent edges, first, second, and third radiopaque markers immovable with respect to the catheter main body, two of the first, second, and third radiopaque markers are positioned on a first longitudinal axis and longitudinally aligned, respectively, with a first and second of the stent edges, one of the first, second, and third radiopaque markers positioned on a second longitudinal axis different from the first longitudinal axis;   positioning a guidewire within a branch vessel;   introducing the catheter over the guidewire and into a main vessel in a vicinity of the bifurcation between the main vessel and the branch vessel;   rotating the catheter until the third radiopaque marker is at a vertical distance from at least one of the first and second radiopaque markers;   advancing the catheter until the crotch point prevents further advancement and until at least one of the first, second, and third radiopaque markers is aligned with an opening of the branch vessel; and   deploying the stent by inflating the balloon.   
     
     
         16 . The method according to  claim 15 , further comprising:
 releasing said wire upon inflation of the balloon such that said wire is movable with respect to the balloon;   deflating the balloon; and   removing the catheter from the main vessel, leaving the guidewire in the branch vessel and said wire in the main vessel.