Inside out t-fastener system

Abstract

A medical device for providing wall apposition of two bodily walls in accordance with the teachings of the present invention. The medical device is used at a previously formed puncture site having perforations formed in the walls. By way of example, the two walls are described herein as the abdominal and gastric walls, although it will be recognized that any two bodily walls may be fastened together utilizing the medical device and the methods described herein. It will also be understood that the procedures described herein may be performed using image guidance such as fluoroscopy, although the device and method may readily be performed without such assistance.

1 . A medical device for providing wall apposition of two bodily walls, the medical device comprising:
 an access cannula;   a guide tube sized to be slidably received by the access cannula, the guide tube operable between a first linear configuration and a second non-linear configuration, a distal end of the guide tube being laterally spaced from the access cannula in the second non-linear configuration; and   a flexible puncturing device sized to be slidably received by the guide tube in the second non-linear configuration.   
   
   
       2 . The medical device of  claim 1 , wherein the guide tube retroflexes in the second configuration for engagement of one of the bodily walls. 
   
   
       3 . The medical device of  claim 1 , wherein a distal end of the guide tube in the second configuration is rotated about 180 degrees relative the distal end in the first configuration. 
   
   
       4 . The medical device of  claim 1 , wherein a distal end of the guide tube faces generally proximally in the second configuration. 
   
   
       5 . The medical device of  claim 1 , wherein the guide tube is formed of a shape memory material. 
   
   
       6 . The medical device of  claim 1 , wherein the guide tube is formed of a polymer and includes a strip of shape memory material extending longitudinally along at least a distal portion of the guide tube. 
   
   
       7 . The medical device of  claim 5 , wherein the shape memory of the guide tube is temperature dependent, and wherein the transition temperature between the first and second configurations is at about body temperature. 
   
   
       8 . The medical device of  claim 1 , wherein the guide tube is biased to the second non-linear configuration. 
   
   
       9 . The medical device of  claim 1 , wherein a distal end of the guide tube includes an inflatable balloon. 
   
   
       10 . The medical device of  claim 1 , wherein the access cannula is rigid. 
   
   
       11 . The medical device of  claim 1 , further comprising fastening means selectively connectable to the flexible puncturing device. 
   
   
       12 . The medical device of  claim 11 , wherein the fastening means comprises a tissue fastener having an anchor and suture material. 
   
   
       13 . The medical device of  claim 12 , wherein the flexible puncturing device is a flexible puncturing needle, and wherein the anchor is sized to be received within a lumen of the flexible puncturing needle. 
   
   
       14 . A method for providing apposition of two bodily walls, the method comprising the steps of:
 a) forming a puncture site through the two walls;   b) inserting an access cannula into the puncture site;   c) passing a guide tube through the access cannula, the guide tube retroflexing after passing beyond a distal end of the access cannula;   d) positioning a distal end of the guide tube proximate one of the walls;   e) passing a flexible puncturing device through the guide tube and puncturing the two walls at a second location;   f) connecting a fastener to the puncturing device;   g) retracting the puncture device to draw the fastener through the two walls at the second location; and   h) securing the fastener to maintain apposition of the two walls at the second location.   
   
   
       15 . The method of  claim 14 , wherein step d) includes retracting the guide tube to engage one of the walls at a desired location. 
   
   
       16 . The method of  claim 14 , wherein steps d)-h) are repeated with a second fastener at a third location. 
   
   
       17 . The method of  claim 15 , further comprising the steps of:
 i) advancing the guide tube to disengage the bodily wall at the second location;   j) rotating the guide tube; and   k) retracting the guide tube to position a distal end of the guide tube proximate the bodily wall at a third location.   
   
   
       18 . The method of  claim 14 , steps d)-h) are repeated with a plurality of fasteners that are placed in a generally circular configuration around the puncture site. 
   
   
       19 . The method of  claim 14 , wherein the positioning step includes inflating a balloon at a distal end of the guide tube. 
   
   
       20 . The method of  claim 14 , wherein the flexible puncturing device comprises a flexible puncturing needle, and wherein the connecting step includes positioning an anchor of the fastener within the flexible puncturing needle. 
   
   
       21 . The method of  claim 14 , further comprising the steps of:
 i) removing the puncturing device, guide tube, and access cannula; and   j) placing a gastrostomy tube at the puncture site.   
   
   
       22 . A medical kit for placement of a gastrostomy tube, the kit comprising:
 a first puncture device;   a wire guide;   a dilator;   an access cannula;   a guide tube sized to be slidably received by the access cannula, the guide tube operable between a first linear configuration and a second non-linear configuration;   a second flexible puncturing device sized to be slidably received by the guide tube;   at least one fastener connectable to the second flexible puncturing device; and   a gastrostomy tube.