Method and device for use in tissue approximation and fixation

Abstract

Methods and devices for use in tissue approximation and fixation are described herein. The present invention provides, in part, methods and devices for acquiring tissue folds from the anterior and posterior portions of a hollow body organ, e.g., a stomach, positioning the tissue folds for affixing within a fixation zone of the stomach, preferably to create a pouch or partition below the esophagus, and fastening the tissue folds such that a tissue bridge forms excluding the pouch from the greater stomach cavity. The present invention further provides devices for performing a transoral, endoscopic hollow organ division, including a tissue acquisition device capable of acquiring the desired tissue, a tensioning device for positioning the acquired tissue, and a fastening element to secure the outer layers of the acquired tissue such that the desired healing response is achieved.

We claim:  
     
         1 . A tissue acquisition device, comprising: 
 an elongate main body having a proximal end, a distal end, and a length therebetween;    a first jaw member and a second jaw member each pivotally connected to the distal end of the main body,    wherein the first and the second jaw members are adapted to move from a first configuration to a second expanded configuration in which the jaw members are translationally positioned into apposition with each other, and    wherein the first and the second jaw members each define an opening for acquiring tissue therewithin, each opening being in fluid communication with at least one lumen defined in the main body.    
     
     
         2 . The device of  claim 1  wherein the main body defines additional lumens within the length.  
     
     
         3 . The device of  claim 1  further comprising at least one wire disposed within the main body for reinforcing the main body.  
     
     
         4 . The device of  claim 1  further comprising at least one pull wire disposed within the main body and attached along the length for selectively articulating the device.  
     
     
         5 . The device of  claim 1  further comprising at least one push rod disposed within the main body and attached along the length for selectively articulating the device.  
     
     
         6 . The device of  claim 1  further comprising a handle attached to the proximal end of the main body, the handle defining a main port therethrough which is in communication with the at least one lumen defined in the main body.  
     
     
         7 . The device of  claim 6  wherein the handle further comprises a lever for actuating the first and the second jaw member in a scissoring motion.  
     
     
         8 . The device of  claim 1  wherein the first and the second jaw members are connected to the main body via first and second hinging members, respectively.  
     
     
         9 . The device of  claim 8  wherein each hinging member comprises two crescent-shaped cutaways spaced longitudinally along the length of the main body at 180° from one another.  
     
     
         10 . The device of  claim 1  wherein each opening on the first and the second jaw members are each defined at 180° from one another.  
     
     
         11 . The device of  claim 1  wherein each opening has a length of about 1 in. longitudinally along each jaw member.  
     
     
         12 . The device of  claim 1  wherein each opening extends about 0-5 cm. into each jaw member.  
     
     
         13 . The device of  claim 1  further comprising at least one guide rod affixed to at least the first or the second jaw member, wherein the guide rod is adapted to tension the tissue when acquired within the opening.  
     
     
         14 . The device of  claim 13  wherein the guide rod comprises a rigid bar member affixed to the first and the second jaw member.  
     
     
         15 . The device of  claim 13  wherein the guide rod is curved to extend longitudinally adjacent to the first or the second jaw member.  
     
     
         16 . The device of  claim 1  further comprising a mechanical post adapted to be inserted down the lumen of the main body for securing the tissue.  
     
     
         17 . The device of  claim 1  further comprising a fastening assembly having a handle, a delivery body, and a clamping portion with clamping jaws attached to a distal end of the delivery body, the fastening assembly being adapted to be inserted through the main body.  
     
     
         18 . The device of  claim 17  further comprising at least one fastening element releasably disposed within the clamping jaws.  
     
     
         19 . The device of  claim 18  wherein the fastening element comprises a staple.  
     
     
         20 . The device of  claim 18  wherein the fastening element comprises a rivet and a receiving rivet portion for attachably receiving the rivet.  
     
     
         21 . The device of  claim 18  wherein the fastening element comprises an implantable clamp having a penetrating clamp portion for interfacing with a receiving clamp portion.  
     
     
         22 . The device of  claim 21  wherein the penetrating clamp portion comprises a patterned or textured tissue engagement surface.  
     
     
         23 . The device of  claim 21  wherein the receiving clamp portion comprises a patterned or textured tissue engagement surface.  
     
     
         24 . The device of  claim 21  wherein the implantable clamp has a curved configuration.  
     
     
         25 . The device of  claim 21  wherein the implantable clamp further comprises a hinge pivotally connecting the penetrating clamp portion to the receiving clamp portion.  
     
     
         26 . The device of  claim 18  wherein the fastening element is comprised of a material adapted to assist in tissue ingrowth and healing.  
     
     
         27 . The device of  claim 26  wherein the material is selected from the group consisting of meshes, grafts, microporous membranes, and biomaterials, collagen, and porcine biointestinal submucosa.  
     
     
         28 . The device of  claim 1  wherein the opening in the first and the second jaw members comprise a plurality of fenestrations defined along each of the jaw members.  
     
     
         29 . The device of  claim 1  wherein the opening in the first and the second jaw members comprise at least one fenestration.