Viscerotomy closure device and method of use

Abstract

Viscerotomy closure devices and methods of use close a hole in a bodily organ, such as one created during a natural orifice transgastric surgery procedure. A mesh with a hole in its center and an attached loop of suture having a Roeder knot is mounted on the protruding rod of an end-to-end anastomosis stapler between the anvil and the staple carrying member. The mesh covers the staple receiving slots. When rotated when in contact with tissue, an augur-shaped blade attached to the anvil's exterior self-feeds the tissue through a notch in the anvil's base into the space between the anvil and the staple carrying member. After the stapler is fired to staple the mesh to the tissue and create a viscerotomy, a knot pusher cinches the loop of suture and subsequently tightens the Roeder knot to maintain the cinch.

1 . A tissue closure device comprising:
 an end-to-end anastomosis stapler having a staple carrying member, a plurality of staple receiving slots defined by the staple carrying member, a plurality of staples enclosed by the staple receiving slots, a protruding rod having opposing ends with one end inserted into the staple carrying member, and an anvil having a tip, a base, and an exterior, wherein the base is attached to the opposing end of the protruding rod opposite the staple carrying member;   a mesh having a center hole, wherein the opposing end of the protruding rod opposite the staple carrying member is inserted through the center hole in the mesh such that the mesh covers at least a portion of the staple receiving slots and is positioned between the staple carrying member and the anvil; and   a loop of suture having a knot, wherein the loop of suture is attached to the mesh so that tension on the suture adjusts the size of the center hole in the mesh.   
     
     
         2 . The tissue closure device of  claim 1 , further comprising an augur-shaped blade attached to the exterior of the anvil and extending from the tip to the base, the base of the anvil defining a notch sized such that when the augur-shaped blade is passed through an opening in tissue, the opening is sized smaller than an inner diameter of a staple line defined by the staple receiving slots. 
     
     
         3 . The tissue closure device of  claim 1 , wherein the anvil is generally conical in shape. 
     
     
         4 . The tissue closure device of  claim 1 , wherein the base of the anvil defines a plurality of staple clinching grooves corresponding to the staple receiving slots in the staple carrying member. 
     
     
         5 . The tissue closure device of  claim 1 , further comprising a knot pusher connected to the loop of suture. 
     
     
         6 . The tissue closure device of  claim 1 , wherein the loop of suture is attached to the mesh by being woven through the mesh. 
     
     
         7 . The tissue closure device of  claim 1 , wherein the base is removably attached to the opposing end of the protruding rod. 
     
     
         8 . A method of closing an opening in tissue, the method comprising the steps of:
 providing a tissue closure device comprising an end-to-end anastomosis stapler, a mesh, and a loop of suture, wherein
 the end-to-end anastomosis stapler has a staple carrying member, a plurality of staple receiving slots defined by the staple carrying member, a plurality of staples enclosed by the staple receiving slots, a protruding rod having opposing ends with one end inserted into the staple carrying member, and an anvil having a tip, a base, and an exterior, the base of the anvil attached to the opposing end of the protruding rod opposite the staple carrying member, 
 the mesh has a center hole, wherein the opposing end of the protruding rod opposite the staple carrying member is inserted through the center hole in the mesh such that the mesh covers at least a portion of the staple receiving holes and is positioned between the staple carrying member and the anvil, and 
 the loop of suture has a knot, whereby the loop of suture is attached to the mesh so that tension on the suture adjusts the size of the center hole in the mesh; 
   positioning the tissue closure device such that the tissue is located between the anvil and the staple carrying member with the protruding rod extending through the opening in the tissue;   firing the end-to-end anastomosis stapler to staple the mesh to the tissue; and   tensioning the loop of suture to decrease the size of the center hole in the mesh and close the opening in the tissue.   
     
     
         9 . The method of  claim 8 , wherein the anvil is removably attached to the protruding rod, and wherein the step of providing the tissue closure device includes the steps of:
 inserting the protruding rod through the hole in the mesh's center so that the mesh and loop of suture cover the staple receiving slots of the end-to-end anastomosis stapler's staple carrying member; and   attaching the base of the anvil to the protruding rod so that the mesh and loop of suture are between the anvil's base and the staple carrying member.   
     
     
         10 . The method of  claim 8 , wherein the opening is a viscerotomy, and further comprising the step of creating a viscerotomy by passing a hollow needle through a patient's skin into a patient's bodily organ. 
     
     
         11 . The method of  claim 10 , further comprising the steps of:
 advancing one end of a wire through the hollow needle into the bodily organ;   pulling the end of the wire through the patient's mouth;   attaching the end of said wire to the tip of the anvil; and   bringing the tip of the anvil into contact with tissue by pulling on the wire.   
     
     
         12 . The method of  claim 8 , wherein the tissue closure device further comprises an augur-shaped blade attached to the exterior of the anvil and extending from the tip to the base, and further comprising the step of rotating the augur shaped blade until the tissue is fed through the notch into the space between the anvil and the staple carrying member. 
     
     
         13 . The method of  claim 8 , wherein the base of the anvil defines a notch sized such that when the augur-shaped blade is passed through the opening in tissue, the opening is sized smaller than an inner diameter of a staple line defined by the staple receiving slots. 
     
     
         14 . The method of  claim 8 , further comprising the step of maintaining the tension on the loop of suture to maintain closure of the opening in the tissue. 
     
     
         15 . The method of  claim 14 , wherein the loop of suture includes a knot, and wherein the step of maintaining tension includes:
 providing a knot pusher;   cinching down the loop of suture; and   tightening the knot with the knot pusher.   
     
     
         16 . The method of  claim 8 , further comprising the steps of passing the tissue closure device through the center hole of the mesh and the opening in the tissue.