Methods And Systems For Performing Submucosal Medical Procedures

Abstract

Instruments, systems and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include a safe access needle injection instrument, a submucosal tunneling instrument, a submucosal dissection instrument, a mucosal resection device. Systems include a combination of one or more of such instruments with or without injectable agents. Embodiments of various methods for performing the procedures are also provided.

What is claimed is: 
     
         1 . An apparatus for resecting a target area of mucosal tissue comprising:
 a sheath having a lumen;   an elongate member having proximal and distal sections and being slidably disposed within the lumen of said sheath, said elongate member having a first state in which a distal section configuration is generally linear and a second state in which the distal section configuration is generally curved wherein said elongate member is operable between said first and second states; and   a resection member having proximal and distal ends wherein the distal end is movably engaged to the distal section of said elongate member such that when said elongate member is in said first or second states said resection member may traverse a path defined by said distal section to thereby resect mucosal tissue along said path.   
     
     
         2 . An apparatus for resecting a target area of mucosal tissue according to  claim 1 , wherein said distal end is slidably engaged to the distal section such that when said elongate member is in said first or second states said resection member may slide along a path defined by said distal section to thereby resect mucosal tissue along said path. 
     
     
         3 . An apparatus for resecting a target area of mucosal tissue according to  claim 2 , wherein said resection member comprises an electrosurgical cutter. 
     
     
         4 . An apparatus for resecting a target area of mucosal tissue according to  claim 2 , wherein said resection member comprises a mechanical cutter. 
     
     
         5 . An apparatus for resecting a target area of mucosal tissue according to  claim 3 , wherein said electrosurgical cutter comprises an electrically insulated tip. 
     
     
         6 . An apparatus for resecting a target area of mucosal tissue according to  claim 2 , wherein said elongate member includes a lumen and said resection member is slidably disposed within the lumen of said elongate member. 
     
     
         7 . An apparatus for resecting a target area of mucosal tissue according to  claim 6 , wherein said elongate member includes a slot through the wall of said distal section of said elongate member. 
     
     
         8 . An apparatus for resecting a target area of mucosal tissue according to  claim 7 , further comprising a cutting tip connected to said resection member wherein said cutting tip extends from the lumen through said slot in the distal section of said elongate member. 
     
     
         9 . An apparatus for resecting a target area of mucosal tissue according to  claim 8 , wherein said cutting tip is an electrosurgical cutter. 
     
     
         10 . An apparatus for resecting a target area of mucosal tissue according to  claim 9 , wherein said cutting tip includes an electrically insulated tip. 
     
     
         11 . An apparatus for resecting a target area of mucosal tissue according to  claim 8 , wherein said cutting tip is a mechanical cutter. 
     
     
         12 . An apparatus for resecting a target area of mucosal tissue comprising:
 a sheath having a lumen;   an elongate member having proximal and distal sections and being slidably disposed within the lumen of said sheath, said elongate member being operably displaceable between a first state and a second state in which the distal section has different configurations; and   a resection member having proximal and distal ends wherein the distal end is movably engaged to the distal section of said elongate member such that when said elongate member is in at least said second state, said resection member may traverse a path defined by said distal section to thereby resect mucosal tissue along said path.   
     
     
         13 . The apparatus according to  claim 12 , wherein the elongate member defines a track member including a wall with a slot, and said resection member is slidably disposed within said track member and through said slot. 
     
     
         14 . The apparatus according to  claim 13 , wherein the resection member includes a wire extending within said track, and a cutter extending through said slot. 
     
     
         15 . The apparatus according to  claim 14 , wherein the cutter is an electrosurgical cutter. 
     
     
         16 . The apparatus according to  claim 15 , wherein the cutter includes an insulator tip. 
     
     
         17 . A method of resecting a target area of mucosal tissue comprising the steps of:
 identifying a target area of mucosal tissue for resection;   elevating a submucosal layer adjacent the target area by injecting a fluid into the submucosal layer;   inserting a submucosal tunneling instrument into the elevated submucosal layer;   operating said submucosal tunneling instrument to create an elongate tunnel in the submucosal layer;   positioning a submucosal dissecting instrument within the elongate tunnel formed by said tunneling instrument;   operating said submucosal dissecting instrument within the elongate tunnel to thereby dissect an area having a diameter larger than a diameter of said elongate tunnel and encompassing said target area;   positioning a tissue resection tool within the dissected area adjacent the boundary between the dissected submucosal layer and an undissected submucosal layer; and   operating said tissue resection tool to resect said target area of mucosal tissue.   
     
     
         18 . A method of resecting a target area of mucosal tissue according to  claim 17 , wherein said submucosal tunneling instrument and said submucosal dissecting instrument are integrally formed. 
     
     
         19 . A method of resecting a target area of mucosal tissue according to  claim 17 , wherein said submucosal tunneling instrument comprises an elongate tubular member having proximal and distal ends and a lumen extending therethrough and an expandable member having proximal and distal ends wherein the proximal end of said expandable member is attached to the distal end of said tubular member and the distal end of said expandable member is everted and positioned within the lumen of said tubular member. 
     
     
         20 . A method of resecting a target area of mucosal tissue according to  claim 17 , wherein said tissue resection tool comprises a sheath, an elongate member having proximal and distal sections and being slidably disposed within a lumen of said sheath, said elongate member having a first state in which a distal section configuration is generally linear and a second state in which the distal section configuration is generally curved wherein said elongate member is operable between said first and second states, and a resection member having proximal and distal ends wherein the distal end is movably engaged to the distal section of said elongate member such that when said elongate member is in said first or second states said resection member may traverse a path defined by said distal section to thereby resect mucosal tissue along said path. 
     
     
         21 . A method of resecting a target area of mucosal tissue according to  claim 20 , wherein said distal end is slidably engaged to the distal section such that when said elongate member is in said first or second states said resection member may slide along a path defined by said distal section to thereby resect mucosal tissue along said path. 
     
     
         22 . A method of resecting a target area of mucosal tissue according to  claim 20 , wherein said tissue resection tool comprises a sheath, an elongate member having proximal and distal sections and being slidably disposed within a lumen of said sheath, said elongate member being operably displaceable between first state and second states in which the distal section has different configurations, and a resection member having proximal and distal ends wherein the distal end is movably engaged to the distal section of said elongate member such that when said elongate member is in at least said second state, said resection member may traverse a path defined by said distal section to thereby resect mucosal tissue along said path.