Methods and devices for reducing gastric volume

Abstract

The present invention involves new interventional methods and devices for reducing gastric volume, and thereby treating obesity. The procedures are generally performed laparoscopically and may generally be described as laparoscopic plication gastroplasty (LPG) in which, after obtaining abdominal access, spaced apart sites on a gastric wall are engaged and approximated to create one or more tissue folds that are then secured by placing one or more tissue fasteners to produce one or more plications projecting into the gastrointestinal space. The serosal tissue may optionally be treated during the procedure to promote the formation of a strong serosa-to-serosa bond that ensures the long-term stability of the tissue plication. These procedures are preferably carried out entirely extragastrically (i.e. without penetrating through the gastrointestinal wall), thereby minimizing the risks of serious complications. Minimally invasive devices for approximating and fastening soft tissues are disclosed that enable these new interventional methods to be carried out safely, efficiently and quickly. Methods for reversing the procedure are also disclosed.

We claim: 
     
         1 . A method for manipulating tissue, comprising: accessing an external surface of a wall of the gastrointestinal tract; engaging at least two tissue sites spaced apart from one another on the external surface of the wall of the gastrointestinal tract, thereby providing at least two engaged tissue sites; manipulating each of the at least two engaged tissue sites to form a tissue shoulder at each engaged tissue site; approximating the tissue shoulders toward one another and moving the tissue shoulders in proximity to one another to form a tissue fold extending into an internal gastric space; and securing the tissue shoulders to one another by applying a tissue fastener, thereby securing the tissue fold. 
     
     
         2 . The method according to  claim 1  wherein the tissue fastener is selected from the group consisting of sutures, staples, screws, tacks, clips, hooks, clamps and t-tags. 
     
     
         3 . The method according to  claim 1 , wherein the steps of engaging, manipulating, approximating and securing are repeated a plurality of times to extend a dimension of the tissue fold, wherein the dimension is selected from the group consisting of a length dimension and a depth dimension. 
     
     
         4 . The method of  claim 1 , wherein an interior surface of the wall of the gastrointestinal tract is not contacted or penetrated during the steps of engaging, manipulating, approximating and securing tissue. 
     
     
         5 . A device for engaging, approximating and fastening tissue comprising: tool assembly adapted for insertion into a body cavity and having at least two extendible members adjustable between a pre-deployed, insertion condition and a deployed extended condition, each of the extendible members comprising at least one associated tissue engagement mechanism for securely engaging tissue; an actuating mechanism adapted for reversibly positioning at least one of the two tissue engagement mechanisms spaced apart from another tissue engagement mechanism; an integrated tool configured to deploy a plurality of tissue retaining fasteners sequentially for fastening engaged and approximated tissue; and a plurality of tissue retaining fasteners retained in the device. 
     
     
         6 . The device according to  claim 5 , additionally comprising a cartridge loaded with the plurality of fasteners and a mechanism for feeding fasteners from the cartridge to the integrated tool. 
     
     
         7 . The device according to  claim 5 , additionally comprising a proximal handle assembly, wherein the actuating mechanism adapted is located on the handle assembly, and the handle assembly additionally comprises a fastener deployment actuating mechanism adapted to deploy the tissue retaining fasteners. 
     
     
         8 . The device according to  claim 5 , wherein the actuating mechanism is adapted for reversibly positioning at least two tissue engagement mechanisms. 
     
     
         9 . The device according to  claim 5 , wherein the tissue engagement mechanisms are selected from the group consisting of hooks, barbs, grippers, teeth, clamps, jaws, clips, and t-tags. 
     
     
         10 . The device of  claim 5 , additionally incorporating a selection feature allowing user-selection of a distance of separation between the tissue engagement mechanisms when the extendible members are in the deployed extended condition. 
     
     
         11 . The device of  claim 5 , additionally comprising a mechanism for releasably holding the at least two extendible members in the pre-deployed, insertion condition. 
     
     
         12 . A device of  claim 5 , wherein at least one extendible member is configured to provide user control of directions and magnitudes of forces generated on the tissue during deployment and/or retraction of the device. 
     
     
         13 . A device according to  claim 5 , wherein the extendible members are substantially rigid, or are flexible, or have both substantially rigid and flexible portions. 
     
     
         14 . A device of  claim 5 , wherein the tissue retaining fasteners are deformable staples, and the integrated tool comprises a mechanism for feeding, forming and releasing the staples. 
     
     
         15 . A method for forming and securing a fold in tissue comprising: accessing a tissue surface with a device for engaging, approximating and fastening tissue; engaging at least two spaced apart tissue sites on the tissue surface; manipulating the at least two spaced apart tissue sites to form tissue shoulders at each of the spaced apart tissue sites; approximating the tissue shoulders to form an invaginated tissue fold extending away from the distal end of the device; and fastening tissue in proximity to the approximated tissue shoulders to secure the tissue fold. 
     
     
         16 . A method of  claim 15 , wherein approximating the tissue shoulders is accomplished through a combination of motions selected from the group consisting of pushing motions, pulling motions, twisting motions and shearing motions. 
     
     
         17 . A method of  claim 15 , additionally comprising treating the tissue surface to promote bonding between the approximated tissue shoulders. 
     
     
         18 . A method of  claim 15 , wherein approximating the tissue shoulders to form the invaginated tissue fold extending away from the distal end of the device involves a combination of pulling the tissue shoulders toward the distal end of the device while simultaneously pushing the tissue surface between the tissue shoulders away from the distal end of the device. 
     
     
         19 . A method of  claim 15 , wherein the tissue surface is an external surface of the wall of the stomach, and the tissue fold reduces the volume of the stomach by at least 20%. 
     
     
         20 . A method of  claim 15 , wherein the depth of the tissue fold is increased by repeating the recited operational steps on the tissue surface in order to approximate and secure a second set of tissue shoulders over the top of the previously secured tissue fold.