A new flexible endoscopic suturing method with laparoscopic protection for safer full-thickness attachment to the gastro-intestinal tract

Background: There are some difficulties associated with placing multiple stitches or tissue anchors at flexible endoscopy in order to achieve long term attachment of devices within the gastrointestinal tract. Precision stitching of an object to the wall of the gut requires accurate penetration of the device attachment points, and knowledge that the anchor has been placed at the correct depth. Risk of injury to adjacent organs or adjacent intestine is an issue. Aim: To develop a new suturing device and method for full-thickness circumferential attachment of a food exclusion device to the wall of the cardio-esophageal junction with multiple attachment points. Devices and Methods: A flexible, hollow, curved nitinol needle was designed and tested. This device was designed to deliver large tilt T-tags and other tissue anchors to the serosal surface. A new laparoscopic assist method was devised to assure safe full-thickness delivery and to prevent inadvertent damage to surrounding tissues. Methods and devices were tested in pigs (n=8) and human cadavers (n=2). Results: Initial attempts to perform precise sutured attachment with straight needles at flexible endoscopy were relatively unsuccessful. It was difficult to cannulate the attachment points and then penetrate the stomach at desired angle. The development of a curved rotatable needle, which could be passed through a gastroscope allowed rapid and precise cannulation of the attachment points. With the laparoscopic view, the precise exit point of the needle could be identified before tissue puncture by seeing the trans-illumination from the gastroscope, indentation from the needle and palpation using laparoscopic forceps. The distance from the aorta or other structures could be identified and adjusted during suturing. A stop on the thread behind the mucosal anchor was used which allowed precise control of stitch length and avoided the need for thread tying. These devices and methods reduced the stitching time to place 8 full thickness attachment times to 20 minutes and increased precision and safety. In separate surgical attachment studies the 8 sutured attachment points were found to be holding the intragastric device in place at 5-12 weeks without device detachments. Conclusion: A new flexible endoscopic suturing device and method was used with laparoscopic assistance for safe and secure anchoring of a food exclusion device to the cardio-esophageal junction.


Session: Podium Presentation

Program Number: S074

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