A hinged metalloplastic anastomotic device: a novel method for choledochoduodenostomy

BACKGROUND: In biliary obstruction, the creation of a large-diameter permanent fistula between the bile duct and the duodenum would be attractive. OBJECTIVE: To invent, prototype, and test a new method of forming a biliary duodenal anastomosis. DESIGN: Survival and nonsurvival porcine model. SETTING: An animal laboratory with general anesthesia. INTERVENTION: A novel hybrid metalloplastic 7F anastomosis device that consisted of a central ferrous metallic tube sandwiched between 2 tapered flexible plastic end pieces was used. The device was hinged on either side of the metal insert so that a magnetic force could form an anastomosis and then the plastic components of the device could deform to fall through the compression anastomosis. These devices were inserted into the bile duct of the pigs over a 0.035-inch guidewire with a pusher tube. Cylindrical-shaped magnets were then positioned over the intraduodenal bile duct so that they exerted compressive ischemic force on the duodenum and bile duct above the papilla. MAIN OUTCOME MEASUREMENTS: Choledochoduodenal anastomoses created were inspected at subsequent endoscopy and postmortem for patency and size. RESULTS: Seven anastomosis devices were placed in the bile duct of pigs (weight 22-54 kg). All 4 survival animals were well and eating as soon as they were awake. Anastomoses were successfully accomplished in all survival animals. The supra-ampullary opening into the bile duct ranged from 5 to 10 mm. LIMITATION: The small number of animals. CONCLUSIONS: A new method for achieving larger-diameter biliary drainage was developed. Four animals were euthanized after 2 to 7 days. Our best anastomosis resulted from 2 magnets left in the animals for 4 days.