System and method for transluminal access

Abstract

A translumenal access system includes a translumenal access catheter, a trocar, and one or more guidewires. The trocar may be introduced through adjacent tissue layers, typically from an endoscope, and the translumenal access catheter introduced through the resulting penetration over the trocar. A balloon on the catheter may be used to dilate the penetration, and an enlarged distal portion of the balloon may be used to draw the tissue layers into apposition. The first stent may be exchanged for the trocar and a second stent may be introduced through a side port on the access catheter. The stents may be then used to introduced catheters or other interventional tools, optionally for delivering one or more stents to the enlarged tissue penetration.

1 . A method for positioning two guidewires between a first body lumen and a second body lumen, said method comprising:
 advancing a tissue penetrating tool from the first body lumen into the second body lumen to form a passage through the luminal walls;   advancing a balloon catheter over the trocar to position a dilation balloon within the passage;   inflating the balloon to dilate the passage;   exchanging a first guidewire for the tool;   advancing the catheter further into the second body lumen so that a side wire port on the catheter proximal of the balloon is within the second body lumen;   advancing a second guidewire through the side port into the second body lumen; and   withdrawing the balloon catheter to leave the first and second guidewires in place through the dilated passage.   
     
     
         2 . A method as in  claim 1 , further comprising advancing a first stent placement catheter over the first guidewire and placing a first stent in the dilated passage. 
     
     
         3 . A method as in  claim 1 , wherein the first body lumen is selected from the group consisting of the esophagus, the stomach, the duodenum, the small intestines and the large intestines and the second body lumen or structure is selected from the group consisting of a bile duct, a gallbladder, a pancreas, a pancreatic duct, a pancreatic pseudocyst, a urinary bladder, and a liver. 
     
     
         4 . A method as in  claim 2 , further comprising advancing a second stent placement catheter over the second guidewire and placing a second stent in the dilated passage adjacent to the first stent. 
     
     
         5 . A method as in  claim 3 , wherein the first body lumen is a stomach and the second body lumen is a pseudocyst. 
     
     
         6 . A method for dilating a tissue passage between a first body lumen and a second body lumen or structure, said method comprising:
 advancing a tissue penetrating tool from the first body lumen into the second body lumen to form a passage through the luminal walls;   advancing a balloon catheter over the tool to position a distal portion of a dilation balloon beyond the passage to within the second body lumen or structure;   inflating said distal portion of the balloon beyond the passage while a proximal portion of the balloon remains uninflated;   tensioning the balloon catheter proximally so that said inflated distal portion of the balloon engages the wall of the second body lumen and draws the second wall against the first wall to place said walls in apposition; and   inflating the proximal portion of the balloon to dilate the passage through the tissue layers.   
     
     
         7 . A method as in  claim 6 , wherein the first body lumen is selected from the group consisting of the esophagus, the stomach, the duodenum, the small intestines and the large intestines and the second body lumen or structure is selected from the group consisting of a bile duct, a gallbladder, a pancreas, a pancreatic duct, a pancreatic pseudocyst, a urinary bladder, and a liver. 
     
     
         8 . A method as in  claim 6 , further comprising exchanging the trocar for a guidewire. 
     
     
         9 . A method as in  claim 8 , further comprising advancing a stent placement catheter over the guidewire and placing a stent in the dilated passage. 
     
     
         10 . A translumenal access system comprising:
 a first guidewire;   a second guidewire;   a tissue penetrating tool; and   a translumenal access catheter including:   (a) a catheter body having a proximal end, a distal end, a central lumen and a side lumen; and   (b) a dilation balloon on the catheter body near the distal end;   wherein the central lumen extends from the proximal to the distal end of the catheter body and exchangeably receives the tool and the first guidewire and wherein the side lumen extends from the proximal end of the catheter body to a location immediately proximal of the dilation balloon and removably receives the second guidewire.   
     
     
         11 . A system as in  claim 10 , wherein the catheter further includes
 (c) a handle assembly attachable to the proximal end of the catheter body, wherein the handle is configured to lock to an endoscope when the catheter body is within a working channel of the endoscope.   
     
     
         12 . A system as in  claim 11 , wherein the handle comprises an inner core which couples to the catheter body and an outer grip which couples to the tool, wherein a user can advance and retract the grip relative to the inner core to advance and retract the tool relative to the catheter body. 
     
     
         13 . A system as in  claim 12 , further comprising a catheter body adjustment mechanism movably positioned in the inner core to axially advance and retract the catheter body relative to the inner core, outer grip, and the tool. 
     
     
         14 . A system as in  claim 13 , further comprising a tool depth adjustment mechanism on the catheter body to limit the distal motion of the outer grip and the tool puncture depth. 
     
     
         15 . A system as in  claim 13 , further comprising a tool looking mechanism on the outer grip to holder the outer grip and tool in a fixed position relative to the inner core. 
     
     
         16 . A catheter and penetrating tool assembly comprising:
 a catheter body having a proximal end, and distal end, and a central lumen;   a tissue penetrating tool slidably disposed in the central lumen, said tool having a tissue-penetrating distal end; and   a handle attachable to the proximal end of the catheter body, said handle including an inner core with a catheter advancement mechanism which couples to the catheter body and an outer grip which couples to the tool, wherein a user can advance and retract the grip relative to the inner core to advance and retract the tool relative to the catheter body.   
     
     
         17 . An assembly as in  claim 16 , further comprising a catheter body adjust mechanism on the inner core to axially advance and retract the catheter body relative to the handle and the tool. 
     
     
         18 . An assembly as in  claim 17 , further comprising a tool adjustment mechanism on the outer grip to axially advance and retract the tool relative to the handle and the catheter body. 
     
     
         19 . An assembly as in  claim 16 , wherein the tissue penetrating tool comprises a trocar. 
     
     
         20 . An assembly as in  claim 16 , wherein the tissue penetrating tool has an electrosurgical tip which permits radiofrequency current assisted tissue penetration.