Background: Transoral intraluminal surgery is less painful. However, endoscopic antireflux procedures have been unsuccessful, endoscopic foregut mucosal excision procedures are often difficult to perform, and endoscopic intra-luminal suturing is both imprecise and too shallow. We have endeavored to correct these deficiencies and report here new devices for GERD, obesity, and Barrett's mucosal excision. Method: A retrospective review of ex vivo and in vivo animal experiments using sharp blade mucosal excision for esophageal and gastric mucosa and a suturing device with transverse needles designed to full thickness penetrate the gastric wall were completed. A total of 338 excisions were performed in 134 ex vivo tissue experiments and in 119 in vivo attempts. Suture needle testing was performed in ex vivo human stomachs and porcine stomachs and in in vivo canine and baboon stomachs. Results: One excision perforation (0.9%) occurred in a live animal. Satisfactory mucosal excision depth for the Barrett's device was reproducible. Progressive suture actuation reliability improved from 83% during ex vivo testing to 96.7% in in vivo experiments. Conclusion: The results demonstrate feasibility, reliability, and safety for gastric and esophageal mucosal excision. Suturing reliability improved and further studies will be performed to finalize the instrument designs, the operative techniques, and the other device applications.
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