Endoscopic clip devices and related methods for mucosal defect and transmural perforation closure

Abstract

An endoscopic clip device for closure of a mucosal defect or transmural perforation in a gastrointestinal wall may include a sleeve and a clip disposed at least partially within and coupled to the sleeve. The clip may be configured for reversibly moving between an open configuration for positioning relative to the wall and a closed configuration for closing the defect or perforation. The clip may include a first clip arm configured for engaging the mucosal and submucosal layers of the wall and including a first needle extending to a distal end of the first clip arm and configured for advancing through the mucosal layer and into at least the submucosal layer, and a second clip arm disposed opposite the first clip arm and configured for engaging the mucosal layer. The device may be configured for advancing through an operative channel of an endoscope or overtube having a tortuous shape.

1 - 20 . (canceled) 
     
     
         21 . An endoscopic clip device for closure of a mucosal defect or a transmural perforation in a gastrointestinal wall, the endoscopic clip device comprising:
 a sleeve; and   a clip disposed at least partially within and coupled to the sleeve, the clip configured for reversibly moving relative to the sleeve between an open configuration and a closed configuration, the clip comprising:
 a first clip arm comprising:
 a first needle extending to a distal end of the first clip arm, the first needle having a sharp beveled distal tip defining the distal most end of the clip in the open configuration and in the closed configuration, and 
 
 a second clip arm disposed opposite the first clip arm; 
   wherein the endoscopic clip device is configured for advancing through an operative channel of an endoscope or an overtube having a tortuous shape.   
     
     
         22 . The endoscopic clip device of  claim 21 , wherein the first needle is sized to be capable of advancing through the mucosal layer and into at least the submucosal layer of the gastrointestinal wall. 
     
     
         23 . The endoscopic clip device of  claim 21 , wherein the clip is asymmetric such that the first clip arm and the second clip arm are not mirror images of one another. 
     
     
         24 . The endoscopic clip device of  claim 21 , wherein the first clip arm has a first length extending from a proximal end of the first clip arm to the distal end of the first clip arm, wherein the second clip arm has a second length extending from a proximal end of the second clip arm to a distal end of the second clip arm, and wherein the first length is different from the second length. 
     
     
         25 . The endoscopic clip device of  claim 21 , wherein the first clip arm further comprises a first claw spaced apart from the distal end of the first clip arm and extending transverse to the first needle, and wherein the first claw is configured for engaging the mucosal layer of the gastrointestinal wall when the first needle extends through the mucosal layer and into at least the submucosal layer of the gastrointestinal wall. 
     
     
         26 . The endoscopic clip device of  claim 21 , wherein the second clip arm comprises a second claw configured for engaging the mucosal layer of the gastrointestinal wall. 
     
     
         27 . The endoscopic clip device of  claim 26 , wherein the second claw is disposed at a distal end of the second clip arm. 
     
     
         28 . The endoscopic clip device of  claim 26 , wherein the second clip arm further comprises a second needle extending to a distal end of the second clip arm and configured for advancing through the mucosal layer and into at least the submucosal layer of the gastrointestinal wall, wherein the second claw is spaced apart from the distal end of the second clip arm and extends transverse to the second needle, and wherein the second claw is configured for engaging the mucosal layer of the gastrointestinal wall when the second needle extends through the mucosal layer and into at least the submucosal layer of the gastrointestinal wall. 
     
     
         29 . The endoscopic clip device of  claim 21 , wherein the second clip arm comprises a second needle extending to a distal end of the second clip arm and configured for advancing into at least the mucosal layer of the gastrointestinal wall. 
     
     
         30 . The endoscopic clip device of  claim 29 , wherein the first clip arm has a first length extending from a proximal end of the first clip arm to the distal end of the first clip arm, wherein the second clip arm has a second length extending from a proximal end of the second clip arm to a distal end of the second clip arm, and wherein the first length is different from the second length. 
     
     
         31 . The endoscopic clip device of  claim 29 , wherein the first needle has a curved shape, and wherein the second needle has a curved shape. 
     
     
         32 . The endoscopic clip device of  claim 29 , wherein the first needle has a straight shape extending parallel to or coaxial with a longitudinal axis of the sleeve and configured for extending parallel to or coaxial with a longitudinal axis of the operative channel, and wherein the second needle has a curved shape. 
     
     
         33 . The endoscopic clip device of  claim 29 , wherein the first needle comprises a first arrowhead tip disposed at the distal end of the first clip arm, and wherein the second needle comprises a second arrowhead tip disposed at the distal end of the second clip arm. 
     
     
         34 . The endoscopic clip device of  claim 29 , wherein the first needle comprises a plurality of barbs spaced apart from the distal end of the first clip arm. 
     
     
         35 . The endoscopic clip device of  claim 29 , wherein the first needle comprises a plurality of serrations spaced apart from the distal end of the first clip arm. 
     
     
         36 . The endoscopic clip device of  claim 29 , wherein the second needle is configured for advancing through the mucosal layer and into at least the submucosal layer of the gastrointestinal wall. 
     
     
         37 . The endoscopic clip device of  claim 21 , wherein the first needle extends parallel to a longitudinal axis of the operative channel. 
     
     
         38 . A method of using an endoscopic clip device for closure of a mucosal defect or a transmural perforation in a gastrointestinal wall, the method comprising:
 advancing the endoscopic clip device through an operative channel of an endoscope or an overtube having a tortuous shape, the endoscopic clip device comprising:
 a sleeve; and 
 a clip disposed at least partially within and coupled to the sleeve, the clip configured for reversibly moving relative to the sleeve between an open configuration and a closed configuration, and the clip comprising:
 a first clip arm comprising: 
 a first needle extending to a distal end of the first clip arm, the first needle having a sharp beveled distal tip defining the distal most end of the clip in the open configuration and in the closed configuration, and a second clip arm disposed opposite the first clip arm; 
 
   positioning the clip relative to the gastrointestinal wall while the clip is in the open configuration;   engaging a first margin along the mucosal defect or the transmural perforation with the first clip arm by advancing the first needle into at least the mucosal layer of the gastrointestinal wall;   pulling the first margin toward a second margin along the mucosal defect or the transmural perforation;   advancing the first needle into at least the submucosal layer of the gastrointestinal wall;   engaging the second margin with the second clip arm by engaging the mucosal layer of the gastrointestinal wall; and   moving the clip from the open configuration to the closed configuration such that the first margin and the second margin are approximated in a linear manner.   
     
     
         39 . The method of  claim 38 , further comprising, after engaging the first margin with the first clip arm by advancing the first needle into at least the mucosal layer of the gastrointestinal wall, moving the clip from the open configuration to the closed configuration, wherein pulling the first margin toward the second margin comprises pulling the first margin toward the second margin while the clip is in the closed configuration, and wherein advancing the first needle into at least the submucosal layer of the gastrointestinal wall comprises advancing the first needle into at least the submucosal layer of the gastrointestinal wall while the clip is in the closed configuration. 
     
     
         40 . The method of  claim 39 , wherein advancing the first needle into at least the submucosal layer of the gastrointestinal wall comprises advancing the first needle into at least the submucosal layer of the gastrointestinal wall near the second margin. 
     
     
         41 . The method of  claim 39 , further comprising, after advancing the first needle into at least the submucosal layer of the gastrointestinal wall, moving the clip from the closed configuration to the open configuration, wherein engaging the second margin with the second clip arm comprises engaging the second margin with the second clip arm while the clip is in the open configuration. 
     
     
         42 . The method of  claim 38 , wherein the second clip arm comprises a second needle extending to a distal end of the second clip arm, and wherein engaging the second margin with the second clip arm comprises advancing the second needle into at least the mucosal layer of the gastrointestinal wall.