Systems and methods for treating dysfunctions in the intestines and rectum that adapt to the anatomic form and structure of different individuals

Abstract

A family of barrel structures is provided in a kit. Each barrel structure is differently sized and configured for advancement into anal canals of different anatomic morphologies. Instructions are provided for using the barrel structures to treat an individual. The instructions instruct assessing an anatomic morphology of an anal canal of an individual to be treated and selecting one of the barrel structures based upon the assessed anatomic morphology. Each barrel structure carries an electrode sized and configured to be coupled to a source of tissue ablation energy to be applied through the electrode to form a lesion. Each barrel structure includes a transparent side wall visualized by a direct line of sight from an end portion of the first barrel structure. The instructions instruct inserting the selected barrel structure into the anal canal and visualizing by the direct line of sight through the transparent side wall of the selected barrel structure the dentate line and the targeted tissue region. The instructions instruct, while visualizing, aligning the electrode in a desired location in the targeted tissue region above the dentate line, advancing the electrode to penetrate tissue at or near a sphincter, and applying energy through the electrode to create a lesion in the sphincter.

1 - 6 . (canceled) 
     
     
         7 . A device for treating tissue in an anal canal of a patient to treat fecal incontinence, the device comprising a
 a handle portion;   a tubular barrel extending from the handle portion and sized and configured for insertion into the anal canal through an anal orifice, the barrel having a proximal portion and a distal portion, the barrel further including an array of openings at the distal portion, the array of openings arranged along an arc along a circumference of the barrel;   an array of needle electrodes, the needle electrodes having penetrating tips, the needle electrodes advanceable from a first retracted position to a second extended position so the penetrating tips extend radially from the barrel to pierce sphincter muscle above the dentate line, the needle electrodes having distal portions with a bend; and   an actuator operatively associated with the needle electrodes and actuable to advance and retract the needle electrodes, the needle electrodes applying energy to the sphincter muscle to treat tissue in the anal canal to treat fecal incontinence.   
     
     
         8 . The device of  claim 7 , wherein the handle portion extends at an angle to the barrel. 
     
     
         9 . The device of  claim 7 , wherein each of the needle electrodes bend in a first direction. 
     
     
         10 . The device of  claim 7 , wherein a wall of the barrel is transparent to enable visualization of the target tissue within the anal canal. 
     
     
         11 . The device of  claim 7 , wherein the barrel is couplable to a light source to illuminate the distal portion of the barrel, and the device further comprises a light pipe extending through the barrel for illuminating the distal portion of the barrel. 
     
     
         12 . The device of  claim 7 , wherein the device is couplable to generator to apply ablation energy to the needle electrodes. 
     
     
         13 . The device of  claim 7 , wherein the device further comprises an electrode carrier having a plurality of channels, the needle electrodes mounted within the channels of the carrier. 
     
     
         14 . The device of  claim 7 , wherein the barrel includes a blunt distal end to facilitate passage of the barrel through the anal canal without need for a separate introducer. 
     
     
         15 . The device of  claim 7 , wherein the handle portion includes a fitting fluidly communicating with a fluid delivery apparatus, the fluid deliverable to tissue adjacent each needle electrode. 
     
     
         16 . The device of  claim 7 , wherein the needle electrodes are locked in the extended position. 
     
     
         17 . The device of  claim 7 , wherein the device includes a viewing port to enable a user to look into a hollow interior of the barrel. 
     
     
         18 . The device of  claim 17 , wherein the viewing port is aligned with the barrel. 
     
     
         19 . The device of  claim 7 , wherein the barrel includes a plurality of channels, and the needle electrodes are movable within the channels. 
     
     
         20 . The device of  claim 19 , wherein a fluid manifold is carried by the barrel distal to a termination of the channels. 
     
     
         21 . The device of  claim 7 , wherein the device includes a fitting couplable to an aspirating apparatus, and liquid is aspirated through a distal opening in the barrel. 
     
     
         22 . The device of  claim 7 , further comprising a plurality of temperature sensing elements carried by the barrel to control radiofrequency energy applied by the needle electrodes to the tissue. 
     
     
         23 . The device of  claim 7 , wherein the device further comprises a carrier, the carrier containing a plurality of channels to receive the needle electrodes, the needle electrodes carried in the carrier in a side by side relationship. 
     
     
         24 . The device of  claim 7 , wherein the needle electrodes occupy an arc of about 67.5 degrees. 
     
     
         25 . The device of  claim 7 , wherein the barrel includes marker band on an outside thereof. 
     
     
         26 . The device of  claim 7 , wherein the tubular barrel defines a first surface and a second surface, and the handle portion extends at an angle from the first surface and the arcuate segment extends about the first surface.