Methods and Systems for Submucosal Implantation of a Device for Diagnosis and Treatment of a Body

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 and a submucosal tunneling instrument, a submucosal dissection instrument, and 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. In accordance with one aspect there is provided a submucosal implant device for diagnosing and treating disorders of the body. The submucosal implant device may take the form of a gastric stimulator in which signals are supplied to the muscular wall of a mammal to treat motility disorders. In accordance with yet another aspect there is provided a method for performing a submucosal medical procedure to deploy a submucosal implant device in the digestive tract of a mammal.

What is claimed is: 
     
         1 . A submucosal implant system for use under a mucosal layer and within the submucosal layer of a mammal, the mammal having a muscular wall beneath the mucosal layer, comprising:
 a gastric stimulator; and   a submucosal tunneling instrument having 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 the expandable member is attached to the distal end of the tubular member and the distal end of the expandable member is everted and positioned within the lumen of the tubular member, the expandable member when expanded expanding substantially greater in a lengthwise dimension than in diameter,   wherein the distal end of the elongate tubular member is adapted to enter an opening through the mucosal layer and into the submucosal layer of the mammal and adapted such that when the expandable member is positioned in the submucosal layer and expanded, the expandable member is adapted to longitudinally expand into the submucosal layer to form a submucosal elongate tunnel having a diameter and a length substantially greater than the diameter.   
     
     
         2 . A submucosal implant system according to  claim 1  wherein the expandable member is size to form tunnel suitable in size to receive the gastric stimulator. 
     
     
         3 . A submucosal implant system according to  claim 1  wherein the gastric stimulator comprises an electrode adapted to engage and deliver electrical signals to the muscular wall beneath the mucosal layer. 
     
     
         4 . A submucosal implant system according to  claim 1  wherein the gastric stimulator comprises self contained electronics for controlling the gastric stimulator. 
     
     
         5 . A submucosal implant system according to  claim 1  wherein the gastric stimulator is controlled externally by telemetry to deliver electrical signals to the muscular wall beneath the mucosal layer. 
     
     
         6 . A submucosal implant system according to  claim 1  wherein the gastric stimulator comprises an anchor adapted to engage the muscular wall beneath the mucosal layer. 
     
     
         7 . A submucosal implant system according to  claim 3  wherein the gastric stimulator comprises an anchor adapted to engage the muscular wall beneath the mucosal layer. 
     
     
         8 . A submucosal implant system according to  claim 3  wherein the gastric stimulator comprises self contained electronics for controlling the gastric stimulator. 
     
     
         9 . A submucosal implant system according to  claim 3  wherein the gastric stimulator is controlled externally by telemetry to deliver electrical signals to the muscular wall beneath the mucosal layer. 
     
     
         10 . A submucosal implant system according to  claim 7  wherein the gastric stimulator comprises self contained electronics for controlling the gastric stimulator. 
     
     
         11 . A submucosal implant system according to  claim 7  wherein the gastric stimulator is controlled externally by telemetry to deliver electrical signals to the muscular wall beneath the mucosal layer. 
     
     
         12 . A submucosal implant system according to  claim 7  wherein the anchor and the electrode are integrally formed. 
     
     
         13 . A submucosal implant system according to  claim 12  wherein the gastric stimulator comprises self contained electronics for controlling the gastric stimulator. 
     
     
         14 . A submucosal implant system according to  claim 12  wherein the gastric stimulator is controlled externally by telemetry to deliver electrical signals to the muscular wall beneath the mucosal layer. 
     
     
         15 . A submucosal implant system according to  claim 1  wherein the expandable member is a balloon member. 
     
     
         16 . A submucosal implant system according to  claim 15  wherein the gastric stimulator comprises an electrode adapted to engage and deliver electrical signals to the muscular wall beneath the mucosal layer. 
     
     
         17 . A submucosal implant system according to  claim 16  wherein the gastric stimulator comprises self contained electronics for controlling the gastric stimulator. 
     
     
         18 . A submucosal implant system according to  claim 16  wherein the gastric stimulator is controlled externally by telemetry to deliver electrical signals to the muscular wall beneath the mucosal layer. 
     
     
         19 . A method of placing an implantable device within a submucosal layer of a digestive tract of a mammal, comprising:
 providing a submucosal implant system having a gastric stimulator and submucosal tunneling instrument according to  claim 1 ;   elevating a mucosal layer above the submucosal layer in the digestive tract;   inserting the submucosal tunneling instrument into the elevated mucosal layer;   operating the submucosal tunneling instrument to expand greater longitudinally than radially to create an elongate tunnel in the submucosal layer to at least partially define a submucosal space for the gastric stimulator; and   depositing the gastric stimulator in the defined submucosal space.   
     
     
         20 . A method according to  claim 19  wherein the expandable member of the submucosal tunneling instrument is an elongate balloon, and the balloon is inflated greater in length than in diameter to create the elongate tunnel. 
     
     
         21 . A method according to  claim 19  wherein the gastric stimulator comprises an anchor adapted to engage the muscular wall beneath the mucosal layer and the method further comprising anchoring the gastric stimulator within the tunnel. 
     
     
         22 . A method according to  claim 19  wherein the gastric stimulator includes an electrode adapted to engage and deliver electrical signals, and the electrode is controllable by telemetry to deliver electrical signals to the muscular wall beneath the mucosal layer, the method further comprising telemetrically controlling the electrode to deliver electrical signals to the muscular wall beneath the mucosal layer. 
     
     
         23 . A method according to  claim 19  further comprising providing a needle assembly, and wherein the mucosal layer is elevated relative to the submucosal layer by injecting a fluid into the submucosal layer using the needle assembly. 
     
     
         24 . A method according to  claim 19  further comprising closing the submucosal space after the gastric stimulator has been deposited in the submucosal space. 
     
     
         25 . A method according to  claim 24  further comprising providing a clip applier, and wherein the closing includes closing the tunnel using closure clips applied with the clip applier. 
     
     
         26 . A method according to  claim 19  further comprising inserting an endoscope through a mucosal opening into the area beneath the mucosal layer. 
     
     
         27 . A method according to  claim 26  wherein the submucosal tunneling instrument is inserted through the endoscope. 
     
     
         28 . A method according to  claim 27  wherein the endoscope includes a working channel, and the gastric implant is inserted through the working channel of the endoscope in the submucosal space. 
     
     
         29 . A method according to  claim 26  wherein the endoscope is inserted into the submucosal space. 
     
     
         30 . A method according to  claim 19  wherein the submucosal space into which the gastric stimulator is inserted has a length substantially greater than its diameter. 
     
     
         31 . A method according to  claim 19  wherein the elevating, the inserting, the operating, and the depositing are performed under view of an endoscope. 
     
     
         32 . A method of placing an implantable device within a submucosal layer, comprising:
 elevating a mucosal layer by delivering a fluid into the submucosal layer;   inserting a submucosal tunneling instrument into the elevated mucosal layer;   operating the submucosal tunneling instrument to expand greater longitudinally than radially to create an elongate tunnel in the submucosal layer; and   depositing an implant device within the elongate tunnel created by the submucosal tunneling instrument.   
     
     
         33 . A method according to  claim 32  wherein the 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 the expandable member is attached to the distal end of the tubular member and the distal end of the expandable member is everted and positioned within the lumen of the tubular member. 
     
     
         34 . A method according to  claim 32  wherein the implant device is a gastric stimulator. 
     
     
         35 . A method according to  claim 32 , wherein the submucosal tunneling instrument comprises a balloon that is expandable greater longitudinally than radially. 
     
     
         36 . A method according to  claim 35 , wherein the submucosal tunneling instrument comprises a needle knife. 
     
     
         37 . A method according to  claim 34  wherein the step of depositing an implant device includes depositing a plurality of gastric stimulators.