Medical device fixation tool and method of fixation of a medical device

Abstract

A device fixation tool and method of fixation of a medical device within a hollow organ or cavity through a natural orifice includes providing a needle driver and a shaft. The needle driver is adapted for use with at least one needle. At least a portion of the needle driver is positioned with the shaft at a hollow organ or cavity through the natural orifice. Sufficient force is transmitted with the needle driver to the at least one needle to penetrate mammalian tissue and a portion of the medical device.

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows: 
     
         1 . A method of fixing a bariatric device against distal migration, said bariatric device having an esophageal member with an esophageal wall that is configured to the shape and size of a portion of the esophagus and a cardiac member having a cardiac wall that is configured to generally conform to the shape and size of a portion of the cardiac portion of the stomach, said method comprising:
 positioning the bariatric device with the esophageal member at the abdominal portion of the esophagus and the cardiac member at the cardiac portion of the stomach;   passing a tether through the esophageal wall of the esophageal member, through a wall of the esophagus, through a wall of the stomach and through the cardiac wall of the cardiac member, one end portion of the tether restrained at the esophageal wall and an opposite end portion of the tether restrained at the cardiac wall.   
     
     
         2 . The method as claimed in  claim 1  wherein said passing a tether includes passing a needle assembly through the esophageal wall of the esophagus member, through the wall of the esophagus, through the wall of the stomach and through the cardiac wall of the cardiac member, said tether connected with said needle assembly. 
     
     
         3 . The method as claimed in  claim 2  wherein said needle assembly includes a tubular member having a sharpened end portion at a distal end thereof and a T-shaped device in a cavity in said needle assembly, said tether attached to said T-shaped device, said tether restrained at the cardiac wall with said T-shaped device. 
     
     
         4 . The method as claimed in  claim 3  wherein said tubular member is hollow and including fastener deployment filament passing through said tubular member to deploy said T-shaped device from said needle assembly. 
     
     
         5 . The method as claimed in  claim 2  including positioning a support at said cardiac wall and supporting said cardiac wall and said esophageal wall with said support while passing said needle assembly through the esophageal wall of the esophagus member, through the wall of the esophagus, through the wall of the stomach and through the cardiac wall of the cardiac member. 
     
     
         6 . The method as claimed in  claim 5  wherein said positioning a support comprises passing a shaft with said support attached thereto through the esophagus and into the stomach. 
     
     
         7 . The method as claimed in  claim 6  including a needle guide attached to said shaft and wherein said passing a needle assembly includes guiding said needle assembly in said needle guide. 
     
     
         8 . The method as claimed in  claim 6  including aligning said support with said shaft to pass said support though the esophagus and into the stomach and deploying said support at an angle to said shaft when said support is in the stomach. 
     
     
         9 . The method as claimed in  claim 1  wherein the bariatric device includes a connector connecting said esophageal member and said cardiac member, said method further including positioning said connector at the esophageal-gastric junction. 
     
     
         10 . The method as claimed in  claim 9  including positioning said connector opposite the angle of His and passing said tether at the angle of His. 
     
     
         11 . The method as claimed in  claim 9  including connecting said connector with said esophageal member and said cardiac member external the recipient of the bariatric device and passing said tether in situ. 
     
     
         12 . The method as claimed in  claim 1  wherein said passing a tether includes passing a plurality of tethers, each through the esophageal wall of the esophageal member, through a wall of the esophagus, through a wall of the stomach and through the cardiac wall of the cardiac member. 
     
     
         13 . A method of fixing a bariatric device against distal migration, said bariatric device having an esophageal member with an esophageal wall that is configured to the shape and size of a portion of the esophagus, a cardiac member with a cardiac wall that is configured to generally conform to the shape and size of a portion of the cardiac portion of the stomach and a connector connecting said esophageal member and said cardiac member, said method comprising:
 positioning the bariatric device with the esophageal member at the abdominal portion of the esophagus, the cardiac member at the cardiac portion of the stomach and the connector passing through the esophageal-gastric junction;   positioning a support at said cardiac wall, wherein said support is positioned at a distal end portion of a shaft, wherein said positioning said support includes passing said shaft through the esophagus and into the stomach;   passing a needle assembly with a tether attached thereto through the esophageal wall of the esophagus member, through a wall of the esophagus, through a wall of the stomach and through the cardiac wall of the cardiac member with said support providing resistance to movement of said esophageal member and said cardiac member as said needle assembly penetrates said esophageal member and said cardiac member; and   terminating said tether at said esophageal wall and said cardiac wall.   
     
     
         14 . The method as claimed in  claim 13  wherein said needle assembly includes a tubular member having a sharpened end portion at a distal end thereof and a T-shaped device in a cavity in said needle assembly, said tether attached to said T-shaped device, wherein said terminating said tether includes positioning with said T-shaped device against said cardiac wall. 
     
     
         15 . The method as claimed in  claim 14  wherein said tubular member is hollow and including fastener deployment filament passing through said tubular member to deploy said T-shaped device from said needle assembly. 
     
     
         16 . The method as claimed in  claim 15  including aligning said support with said shaft to pass said support though the esophagus and into the stomach and deploying said support at an angle to said shaft when said support is in the stomach. 
     
     
         17 . The method as claimed in  claim 13  including aligning said support with said shaft to pass said support though the esophagus and into the stomach and deploying said support at an angle to said shaft when said support is in the stomach. 
     
     
         18 . The method as claimed in  claim 13  including positioning said connector opposite the angle of His and passing said tether at the angle of His. 
     
     
         19 . The method as claimed in  claim 13  including passing a plurality of tethers, each through the esophageal wall of the esophageal member, through a wall of the esophagus, through a wall of the stomach and through the cardiac wall of the cardiac member. 
     
     
         20 . The method as claimed in  claim 13  including a needle guide attached to said shaft and wherein said passing a needle assembly includes guiding said needle assembly in said needle guide.