Apparatus and methods for forming and securing gastrointestinal tissue folds

Abstract

Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point and moving the first tissue contact point from a position initially distal to, or in line with, a second tissue contact point to a position proximal of the second contact point, thereby forming the tissue fold, and extending an anchor assembly through the tissue fold from a vicinity of the second tissue contact point. Adjustable anchor assemblies; as well as anchor delivery systems, shape-lockable guides and methods for endoluminally performing medical procedures, such as gastric reduction, treatment of gastroesophageal reflux disease, resection of lesions, and treatment of bleeding sites; are also provided.

1 . An endoscopic system for suturing tissue, comprising: 
 a needle adapted to suture an area of tissue, the needle being removable from a distal end of an endoscopic device;    an urging mechanism adapted to move the needle from a deployment configuration to a suturing configuration in which the needle is angled relative to the endoscopic device; and    wherein the needle defines at least one opening through which a suture is passed from a first side of tissue to a second side of tissue.    
     
     
         2 . The system of  claim 1  wherein the needle defines a lumen with the at least one opening defined near or at a distal end of the needle.  
     
     
         3 . The system of  claim 1  wherein the needle defines a slot along a length of the needle.  
     
     
         4 . The system of  claim 1  further comprising an anchor assembly removably disposed within the needle.  
     
     
         5 . The system of  claim 1  wherein the suture is disposed within the needle.  
     
     
         6 . The system of  claim 1  wherein the urging mechanism comprises a flexible delivery tube through which the needle is movable, the flexible delivery tube having a bendable section adapted to angle the needle relative to the endoscopic device.  
     
     
         7 . The system of  claim 1  wherein the urging mechanism further comprises an elongate pusher adapted to slide through the needle.  
     
     
         8 . The system of  claim 1  wherein the urging mechanism is adapted to move the needle from the deployment configuration where the needle is parallel with the endoscopic device to the suturing configuration where the needle is perpendicularly angled relative to the endoscopic device.  
     
     
         9 . An endoscopic system for suturing tissue, comprising: 
 a needle adapted to travel a curved path to suture an area of tissue, the needle being removable from a distal end of an endoscopic device;    a transmission mechanism adapted to move the needle from a deployment configuration to a curved suturing configuration in which the needle is angled relative to the endoscopic device; and    wherein the needle defines at least one opening through which a suture is passed from a first side of tissue to a second side of tissue.    
     
     
         10 . The system of  claim 9  wherein the needle defines a lumen with the at least one opening defined near or at a distal end of the needle.  
     
     
         11 . The system of  claim 9  wherein the needle defines a slot along a length of the needle.  
     
     
         12 . The system of  claim 9  further comprising an anchor assembly removably disposed within the needle.  
     
     
         13 . The system of  claim 9  wherein the suture is disposed within the needle.  
     
     
         14 . The system of  claim 9  wherein the urging mechanism comprises a flexible delivery tube through which the needle is movable, the flexible delivery tube having a bendable section adapted to angle the needle relative to the endoscopic device.  
     
     
         15 . The system of  claim 9  wherein the urging mechanism further comprises an elongate pusher adapted to slide through the needle.  
     
     
         16 . The system of  claim 9  wherein the urging mechanism is adapted to move the needle from the deployment configuration where the needle is parallel with the endoscopic device to the suturing configuration where the needle is perpendicularly angled relative to the endoscopic device.  
     
     
         17 . A method of suturing tissue within a hollow body organ, comprising: 
 positioning an endoscopic device relative to a tissue region within the hollow body organ;    piercing the tissue whereby a needle assembly travels a curved path through a flexible tubular member, the needle assembly being removable from a distal end of the endoscopic device; and    passing a length of suture through the tissue via a needle body at a distal end of the needle assembly, the needle body defining at least one opening through which the suture is passed through the tissue.    
     
     
         18 . The method of  claim 17  wherein positioning an endoscopic device comprises passing the endoscopic device through an esophagus and into a stomach of a patient.  
     
     
         19 . The method of  claim 17  wherein positioning an endoscopic device comprises positioning the distal end of the endoscopic device adjacent to the tissue region.  
     
     
         20 . The method of  claim 17  further comprising moving the needle assembly from a deployment configuration to a curved suturing configuration in which the needle assembly is angled relative to the endoscopic device prior to piercing the tissue.  
     
     
         21 . The method of  claim 17  further comprising grasping the tissue via a grasper extending from the distal end of the endoscopic device prior to piercing the tissue.  
     
     
         22 . The method of  claim 17  wherein piercing the tissue comprises passing the needle assembly into or through the tissue.  
     
     
         23 . The method of  claim 17  wherein passing a length of suture comprises delivering the suture within the needle assembly for deployment through the at least one opening.  
     
     
         24 . The method of  claim 17  further comprising deploying the length of suture from the at least one opening.  
     
     
         25 . The method of  claim 17 , further comprising securing the tissue via the length of suture deployed from the needle assembly.  
     
     
         26 . An endoscopic treatment apparatus, comprising: 
 an endoscopic device having a proximal end, a distal end, and a flexible length therebetween;    a needle assembly which is adapted to travel a curved path to suture an area of tissue, the needle assembly being actuatable from the proximal end of the endoscopic device to direct the needle assembly to the curved path; and    a tissue stabilizing member projecting pivotally and translationally from the distal end of the endoscopic device, the stabilizing member being adapted to hold onto the tissue when the tissue is pierced by the needle assembly.    
     
     
         27 . The apparatus of  claim 26  further comprising a tissue anchoring assembly deployable from the needle assembly.  
     
     
         28 . The apparatus of  claim 27  wherein the tissue anchoring assembly is adapted to be disposed within the needle assembly.  
     
     
         29 . The apparatus of  claim 26  wherein the needle assembly comprises a needle body which defines at least one opening therein.  
     
     
         30 . The apparatus of  claim 29  wherein the needle body defines a slot along a length thereof.  
     
     
         31 . The apparatus of  claim 26  further comprising a length of suture disposed within the needle assembly.  
     
     
         32 . The apparatus of  claim 26  further comprising an urging mechanism adapted to move the needle assembly from a deployment configuration to a suturing configuration in which the needle is angled relative to the endoscopic device.  
     
     
         33 . The apparatus of  claim 32  wherein the urging mechanism comprises a flexible delivery tube through which the needle assembly is movable, the flexible delivery tube having a bendable section adapted to angle the needle assembly relative to the endoscopic device.  
     
     
         34 . The apparatus of  claim 26  further comprising a transmission mechanism adapted to move the needle assembly from a deployment configuration to a curved suturing configuration in which the needle assembly is angled relative to the endoscopic device.  
     
     
         35 . The apparatus of  claim 26  wherein the tissue stabilizing member comprises a tissue grasper.  
     
     
         36 . The apparatus of  claim 26  wherein the tissue stabilizing member is adapted to pivotally angle relative to the endoscopic device.  
     
     
         37 . The apparatus of  claim 26  wherein the tissue stabilizing member is adapted to pivot when translated proximally relative to the endoscopic device.  
     
     
         38 . A system for endoscopic treatment of tissue, comprising: 
 an endoscopic device having a proximal end, a distal end, and a flexible length therebetween;    a needle assembly which is adapted to suture an area of tissue, the needle assembly being actuatable from the proximal end of the endoscopic device to direct the needle assembly over a curved path;    a tissue stabilizing member projecting pivotally and translationally from the distal end of the endoscopic device, the stabilizing member being adapted to stabilize the tissue when the tissue is pierced by the needle assembly; and    a tissue anchoring assembly adapted to be deployed from the needle assembly for securing the tissue.    
     
     
         39 . The system of  claim 38  wherein the needle assembly comprises a needle body which defines at least one opening therein.  
     
     
         40 . The system of  claim 39  wherein the needle body defines a slot along a length thereof.  
     
     
         41 . The system of  claim 38  wherein the tissue stabilizing member comprises a tissue grasper.  
     
     
         42 . The system of  claim 38  wherein the tissue stabilizing member is adapted to pivotally angle relative to the endoscopic device.  
     
     
         43 . The system of  claim 38  wherein the tissue stabilizing member is adapted to pivot when translated proximally relative to the endoscopic device.  
     
     
         44 . The system of  claim 38  further comprising an urging mechanism adapted to move the needle assembly from a deployment configuration to a suturing configuration in which the needle assembly is angled relative to the endoscopic device.  
     
     
         45 . The system of  claim 44  wherein the urging mechanism comprises a flexible delivery tube through which the needle assembly is movable, the flexible delivery tube having a bendable section adapted to angle the needle assembly relative to the endoscopic device.  
     
     
         46 . The system of  claim 38  further comprising a transmission mechanism adapted to move the needle assembly from a deployment configuration to a curved suturing configuration in which the needle assembly is angled relative to the endoscopic device.  
     
     
         47 . The system of  claim 38  wherein the tissue anchor assembly comprises a length of suture disposed within the needle assembly.  
     
     
         48 . A method of endoscopically treating tissue within a hollow body organ, comprising: 
 positioning a distal end of an endoscopic device relative to a region of tissue within the hollow body organ;    stabilizing the tissue via a stabilizing member projecting pivotally and translationally from the distal end of the endoscopic device;    piercing the tissue with a needle assembly which is adapted to suture the tissue by actuating the needle assembly from a proximal end of the endoscopic device such that the needle assembly is directed over a curved path; and    passing a length of suture through the tissue via the needle assembly.    
     
     
         49 . The method of  claim 48  wherein positioning a distal end of an endoscopic device comprises advancing the endoscopic device through an esophagus and into a stomach of a patient.  
     
     
         50 . The method of  claim 48  wherein stabilizing the tissue via a stabilizing member comprises articulating the stabilizing member proximally while grasping the tissue.  
     
     
         51 . The method of  claim 48  wherein stabilizing the tissue via a stabilizing member comprises pulling the tissue proximally and pivoting the stabilizing member relative to the tissue.  
     
     
         52 . The method of  claim 48  wherein piercing the tissue comprises passing a needle body positioned at a distal end of the needle assembly into or through the tissue.  
     
     
         53 . The method of  claim 48  further comprising flexing a portion of a tubular member through which the needle assembly is translatable to form the curved path prior to piercing the tissue.  
     
     
         54 . The method of  claim 48  wherein passing a length of suture comprises deploying the suture from the needle assembly after piercing the tissue.  
     
     
         55 . The method of  claim 48  further comprising deploying a tissue anchor assembly from the needle assembly.  
     
     
         56 . The method of  claim 55  further comprising securing the tissue via the tissue anchor assembly.