METHOD FOR SECURING MEDICAL DEVICES TO TREAT OBESITY, GASTRO-ESOPHAGEAL REFLUX DISEASE (GERD) AND IRRITABLE BOWEL SYNDROME (iBS) REVERSIBLY

Abstract

A medical staple formed from a nitinol wire, the staple having two elongated arms which extend upwardly and outwardly from a central loop in two opposing generally semicircular courses forming an arc extending upwardly and outwardly and an end second comprising a sharpened endpoint, the endpoint being the arms bendable under resistance, is disclosed. In some embodiments the arms extend upwardly on a parallel course and then outwardly. The material is preferably an alloy with hyperelastic characteristics. The staples are placed in a flexible endoscope and a lumen catheter within the endoscope, using a hook or forceps in the lumen catheter having a distal end in the lumen of the catheter and the staple distal to the forceps in folded configuration with the arms folded inward in the lumen catheter, positioning the distal end of the lumen catheter at a location in the patient's gastrointestinal tract where stapling is desired, moving the forceps distally so as to force the staple forward out of the lumen catheter and cause the end points to pierce the patient's inner wall of the gastrointestinal tract.

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       20 . A surgical method comprising providing a flexible endoscope and a flexible catheter having a lumen within the endoscope, providing a hook or forceps having a distal end in the lumen of the catheter, and providing a medical staple device having two elongated arms and a central loop, each of the arms normally extending from the loop in two opposing generally semicircular courses extending upwardly and outwardly from the loop, each arm having an end comprising a sharpened endpoint, the arms bendable under resistance and resuming their original position upon release distal to the hook or forceps in folded configuration with the two elongated arms folded inward in the lumen of the flexible catheter, positioning the distal end of the hook or forceps at a location in a patient's gastrointestinal tract where stapling is desired, releasing the medical staple to cause the end points to pierce the patient's inner mucosa and staple to the wall of the gastrointestinal tract, the medical staple device formed from a hyperelastic nickel-titanium (“nitinol”) alloy wire by bending the wire around itself, the staple. 
   
   
       21 . The method of  claim 20  comprising stapling a gastrointestinal anti-reflux device (GARD) having a collapsible ring, the method in a hiatus hernia at the juncture of the patient's esophagus and stomach at a plurality of locations. 
   
   
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       23 . The method of  claim 20  wherein the staple is constructed of absorbable material and the medical staple device is comprises a sensor designed for temporary implantation in the patient. 
   
   
       24 . The method of  claim 20  wherein the flexible catheter has a needle comprising a stopper so as to predetermine the depth of penetration of the needle before the medical staple device is released and preventing penetration of the needle beyond the wall of the alimentary tract and causing a lesion to a nearby organ. 
   
   
       25 . The method of  claim 20  wherein the medical staple device comprises a pair of medical staples and is used for pleating the gastric mucosa, closure of tears or perforations, stapling of stomach, or stapling of bowel. 
   
   
       26 . The method of  claim 20  wherein the medical staple device is a used for placement of pace-maker leads and electrodes with a rigid trocar through the abdominal wall into the stomach or from outside the stomach inward. 
   
   
       27 . The method of  claim 20  comprising implanting the medical staple device in the alimentary tract having an electrical lead connected to a pace-setter for pacing the alimentary tract. 
   
   
       28 . The method of  claim 20  comprising repairing a tear in a stomach or esophagus by implanting a pair of the medical staples, one on each side of the tear, and then using surgical thread to draw the two staples toward each other. 
   
   
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       31 . The method of  claim 20  comprising releasing the medical staple by pulling the flexible catheter proximally. 
   
   
       32 . The method of  claim 20  comprising releasing the medical staple by moving the hook or forceps distally so as to force the staple forward. 
   
   
       33 . The method of  claim 20  wherein the medical staple includes surgical thread tied to the central loop. 
   
   
       34 . The method of  claim 20  wherein the medical staple includes surgical thread tied to the central loop and a tilt-tag attached or tied to the surgical thread. 
   
   
       35 . The method of  claim 20  comprising stapling with the medical staple an anti-obesity reservoir at the lower part of the esophagus. 
   
   
       36 . The method of  claim 20  comprising stapling a plurality of pairs of the medical staples create an endoscopically placed vertical banding gastroplasty that is reversible by pulling out the staples. 
   
   
       37 . The method of  claim 20  comprising stapling with the medical staples an inner by-pass tube at the lower end of the intestine to create an internal intestinal by-pass. 
   
   
       38 . The method of  claim 20  comprising stapling pairs of medical staples to create an endoscopically placed horizontal gastroplasty that is reversible by pulling out the staples, and creating a reservoir for food at the cardia. 
   
   
       39 . The method of  claim 20  comprising reversibly stapling with the medical staples an inner gastric and intestinal by-pass tube at the lower esophagus to treat obesity.