Fluid injectable single operator exchange catheters and methods of use

Abstract

A single operator exchange biliary catheter having a tubular member extending proximally from the proximal guidewire port. The tubular member defines a guidewire lumen extension adapted to permit the guidewire to be retracted from guidewire lumen and re-inserted therein. By retracting the guidewire from the guidewire lumen and into the guidewire lumen extension, fluid may be readily injected via the guidewire lumen without encountering resistance to fluid flow from the guidewire. The guidewire lumen extension also maintains guidewire lumen access such that the guidewire may be easily re-inserted into the guidewire lumen.

1 . (canceled) 
     
     
         2 . A catheter, comprising:
 an elongate catheter shaft having a proximal end and a distal end;   wherein a first lumen is defined in the catheter shaft;   wherein a fluid injection lumen is defined in the catheter shaft;   wherein a guidewire lumen is defined in the catheter shaft that extends between a distal port disposed at the distal end of the catheter shaft and a proximal port disposed distally of the proximal end of the catheter shaft;   a sleeve disposed about the catheter shaft and positioned proximally of the distal end of the catheter shaft; and   wherein a fourth lumen is defined between an inner surface of the sleeve and an outer surface of the catheter shaft, the fourth lumen being longitudinally aligned with the guidewire lumen.   
     
     
         3 . The catheter of  claim 2 , wherein the injection lumen is a fluid tight lumen. 
     
     
         4 . The catheter of  claim 2 , wherein a distal end of the sleeve is disposed adjacent to the proximal port. 
     
     
         5 . The catheter of  claim 2 , wherein a distal end of the sleeve is disposed distally of the proximal port. 
     
     
         6 . The catheter of  claim 5 , wherein a proximal end of the sleeve is disposed proximally of the proximal port. 
     
     
         7 . The catheter of  claim 2 , wherein a distal end of the sleeve is sealed against the catheter shaft. 
     
     
         8 . The catheter of  claim 2 , wherein a balloon is coupled to the catheter shaft, the balloon being in fluid communication with the first lumen. 
     
     
         9 . The catheter of  claim 8 , wherein the balloon is longitudinally spaced from a distal end of the sleeve. 
     
     
         10 . The catheter of  claim 2  wherein along at least a region of the catheter shaft, the injection lumen and the fourth lumen are longitudinally aligned. 
     
     
         11 . The catheter of  claim 2 , wherein along at least a region of the catheter shaft, the first lumen, the injection lumen, and the fourth lumen are longitudinally aligned. 
     
     
         12 . The catheter of  claim 2 , wherein a distal region of the injection lumen merges with the guidewire lumen. 
     
     
         13 . The catheter of  claim 2 , wherein a distal end of the first lumen is disposed proximally of the distal end of the catheter shaft. 
     
     
         14 . A catheter, comprising:
 a catheter shaft having a distal end and a proximal end, the catheter shaft defining a first lumen, a fluid-tight injection lumen, and a guidewire lumen;   wherein the guidewire lumen extend along only part of the length of the catheter shaft;   a tubular member disposed about the catheter shaft wherein a distal end of the tubular member is positioned proximally of the distal end of the catheter shaft;   wherein at least a portion of an inner surface of the tubular member is radially spaced from an outer surface of the catheter shaft and defines a guidewire extension lumen; and   wherein the guidewire extension lumen is continuous and longitindially-aligned with the guidewire lumen.   
     
     
         15 . The catheter of  claim 14 , wherein the guidewire lumen extends between a distal port disposed at the distal end of the catheter shaft and a proximal port positioned distally of the proximal end of the catheter shaft. 
     
     
         16 . The catheter of  claim 15 , wherein the distal end of the tubular member extends distally from the proximal port and is sealed against the catheter shaft. 
     
     
         17 . The catheter of  claim 16 , wherein a proximal end of the tubular member extends proximally from the proximal port. 
     
     
         18 . The catheter of  claim 14 , wherein a balloon is coupled to the catheter shaft, the balloon being in fluid communication with the first lumen. 
     
     
         19 . The catheter of  claim 18 , wherein the balloon is longitudinally spaced from a distal end of the tubular member. 
     
     
         20 . The catheter of  claim 14 , wherein along at least a region of the catheter shaft, the first lumen, the fluid-tight injection lumen, and the guidewire extension lumen are longitudinally aligned. 
     
     
         21 . A catheter, comprising:
 a catheter shaft having a distal end and a proximal end, the catheter shaft defining an inflation lumen, a fluid-tight injection lumen, and a guidewire lumen;   a balloon coupled to the catheter shaft, the balloon being in fluid communication with the inflation lumen;   wherein the guidewire lumen extends between a distal port disposed at the distal end of the catheter shaft and a proximal port positioned distally of the proximal end of the catheter shaft;   a tubular member disposed about the catheter shaft;   wherein a distal end of the tubular member extends distally from the proximal port and is sealed against the catheter shaft;   wherein the distal end of the tubular member is disposed proximally of the distal end of the catheter shaft;   wherein a proximal end of the tubular member extends proximally from the proximal port;   wherein at least a portion of an inner surface of the tubular member is radially spaced from an outer surface of the catheter shaft and defines a guidewire extension lumen;   wherein the guidewire extension lumen is continuous and longitindially-aligned with the guidewire lumen;   wherein the balloon is longitudinally spaced from a distal end of the tubular member; and   wherein along at least a region of the catheter shaft, the inflation lumen, the fluid-tight injection lumen, and the guidewire extension lumen are longitudinally aligned.