Incisionless Gastric Bypass Method And Devices

Abstract

A system and method for endoscopically forming an anastomosis between two naturally adjacent points in the digestive tract. The system and method utilizes elongate magnetic devices that, when connected across a tissue boundary, necrose tissue until an anastomosis forms and the devices are passed naturally. Despite the elongate shape of the devices, the resulting anastomosis is substantially round. As such, round anastomoses can be formed having increased diameters merely by increasing the lengths of the devices, obviating the need for wider endoscopes.

1 . A method of creating an anastomosis comprising:
 navigating a first probe through the digestive tract of a patient via the esophagus to a first target location in the duodenum of the patient;   navigating a second probe through the digestive tract of the patient via the rectum to a second target location in the bowel, naturally adjacent to the duodenum;   establishing, without puncturing patient tissue, a magnetic connection between a first anastomosis-forming device carried by the first probe and a second anastomosis-forming device carried by the second probe;   releasing said first and second devices from said first and second probes.   
     
     
         2 . The method of  claim 1  wherein navigating a first probe through the digestive tract of a patient via the esophagus to a first location in the duodenum of the patient comprises navigating a first endoscope through the digestive tract of a patient via the esophagus to a first target location in the duodenum of the patient. 
     
     
         3 . The method of  claim 1  wherein navigating a second probe through the digestive tract of the patient via the rectum to a second target location in the bowel, naturally adjacent to the duodenum comprises navigating a second endoscope through the digestive tract of the patient via the rectum to a second target location in the bowel, naturally adjacent to the duodenum. 
     
     
         4 . The method of  claim 1  wherein the first target location and second target location are sufficiently naturally adjacent to allow said magnetic connection without manipulation of either target location. 
     
     
         5 . The method of  claim 1  wherein establishing, without puncturing patient tissue, a magnetic connection between a first anastomosis-forming device carried by the first probe and a second anastomosis-forming device carried by the second probe comprises aligning said first anastomosis-forming device with said second anastomosis-forming device using visual guidance. 
     
     
         6 . The method of  claim 1  wherein establishing, without puncturing patient tissue, a magnetic connection between a first anastomosis-forming device carried by the first probe and a second anastomosis-forming device carried by the second probe comprises aligning said first anastomosis-forming device with said second anastomosis-forming device using fluoroscopic guidance. 
     
     
         7 . A method of creating an anastomosis comprising:
 navigating a first endoscope through the digestive tract of a patient via the esophagus to a first target location in the duodenum of the patient;   navigating a second endoscope through the digestive tract of the patient via the rectum to a second target location in the bowel, naturally adjacent to the duodenum;   advancing through a working channel of said first endoscope, a first elongate anastomosis-forming device;   advancing through a working channel of said second endoscope, a second elongate anastomosis-forming device;   establishing a magnetic connection between said first and second anastomosis-forming devices;   releasing said first and second devices from said first and second endoscopes.   
     
     
         8 . The method of  claim 7  wherein establishing a magnetic connection between said first and second anastomosis forming devices comprises aligning said first and second anastomosis forming devices across tissues from said duodenum and said bowel such that a magnetic attraction occurs between said devices. 
     
     
         9 . The method of  claim 8  wherein aligning said first and second anastomosis forming devices across tissues from said duodenum and said bowel such that a magnetic attraction occurs between said devices comprises visually aligning said first and second anastomosis forming devices across tissues from said duodenum and said bowel such that a magnetic attraction occurs between said devices. 
     
     
         10 . The method of  claim 8  wherein aligning said first and second anastomosis forming devices across tissues from said duodenum and said bowel such that a magnetic attraction occurs between said devices comprises fluoroscopically aligning said first and second anastomosis forming devices across tissues from said duodenum and said bowel such that a magnetic attraction occurs between said devices. 
     
     
         11 . A device for forming a substantially round anastomosis having a radius (r) comprising:
 a first elongate component having a length (l) and a width (w); and,   a second elongate component magnetically attracted to said first component and having a length (l) and a width (w);   wherein width (w) is narrow enough to fit within a working channel of a standard endoscope; and,   wherein length (l) is related to a desired radius (r) of a resulting, substantially round anastomosis according to the formula (l)=(Π)(r)−(w).   
     
     
         12 . The device of  claim 11  wherein (w) is less than 7 mm. 
     
     
         13 . The device of  claim 12  wherein (w) is between 1.5 mm and 7 mm. 
     
     
         14 . The device of  claim 13  wherein (w) is between 1.5 mm and 3.7 mm. 
     
     
         15 . A system for forming an anastomosis in a digestive tract of a patient comprising:
 first and second probes, each probe defining at least one lumen slidingly housing an attachment mechanism and each probe having an optic lens;   a first device carried by said first probe and attached thereto by said attachment mechanism, said first device comprising:
 a magnet; 
 a housing at least partially encasing said magnet, said housing defining a connector releasably and repeatably engageable by said attachment mechanism; 
   a second device carried by said second probe and attached thereto by said attachment mechanism, said second device comprising;
 an element attracted to said magnet of said first device; 
 a housing at least partially encasing said element, said housing defining a connector releasably and repeatably engageable by said attachment mechanism. 
   
     
     
         16 . The system of  claim 15  wherein:
 said first device has a length (l) and a width (w);
 wherein width (w) is narrow enough to fit within a working channel of a standard endoscope; and, 
 wherein length (l) is related to a desired radius (r) of a resulting, substantially round anastomosis according to the formula (l)=(Π)(r)−(w). 
 
 
     
     
         17 . The device of  claim 16  wherein (w) is less than 7 mm. 
     
     
         18 . The device of  claim 17  wherein (w) is between 1.5 mm and 7 mm. 
     
     
         19 . The device of  claim 18  wherein (w) is between 1.5 mm and 3.7 mm. 
     
     
         20 . The device of  claim 15  wherein said connector comprises a knob. 
     
     
         21 . The device of  claim 15  wherein said connector comprises a loop. 
     
     
         22 . A method of forming a round anastomosis comprising:
 positioning two devices on either side of a desired anastomosis site such that tissue is compressed between said two magnets;   wherein each of said devices comprises a single elongate magnet having a length that is approximately half of a desired circumference of a resulting anastomosis;   wherein each of said devices has a width of less than 7 mm.   
     
     
         23 . The method of  claim 22  wherein each of said devices has a width in the range of 1.5 mm to 7 mm. 
     
     
         24 . The method of  claim 22  wherein each of said devices has a width in the range of 1.5 mm to 3.7 mm.