Development of a transoral fundoplication device and related experimental research

This paper describes a device and surgical techniques developed between 1999 and 2003 to enable an entirely transoral approach to fundoplication. The Endofundoplication System (EFS) system consisted of a multifunctional flexible tube for oral introduction (18 mm) as the key component, with a specially designed retroverted grasper that was used to grasp the lower esophageal sphincter (LES) area of the esophagus, for invaginating the LES into the stomach and folding the gastric wall onto the wall of the intraabdominal esophagus. The EFS system was finally studied in a consecutive series of animal experiments in the domestic pig (n = 10). In nine out of the ten cases the procedure could be successfully completed and the animals survived six weeks according to the study protocol. The clinical follow-up of the nine animals went without problems. The animals behaved normally the first day after the procedure and tolerated regular diet very well. No signs of pain or any abdominal pathology were found in the clinical follow-up. Follow-up by endoscopy and fluoroscopy showed a subsequent postoperative migration of fasteners within the tissue. After autopsy and macroscopic inspection of the gastroesophageal junction (GEJ), we found firm tissue indurations around the fasteners. This may indicate that the fastener as a foreign body leads to a sufficient amount of scar tissue formation to contribute to permanent fixation of the tissue layers. The basic advantage of the EFS technique was seen by our group in the fact that it comes closer to the shape and function of a classical fundoplication than any other techniques proposed at the time we did our development. The nipple valve created by the EFS technique is, however, geometrically not identical to any existing fundoplication technique and is not directly comparable to any such procedure.