Fallopian tube occlusion with use of a small intestine submucosa device: evaluation in a rabbit model

PURPOSE: The present study evaluates the short- and midterm efficacy of a small intestinal submucosa (SIS) device for fallopian tube occlusion in rabbits. MATERIALS AND METHODS: In a pilot study, several SIS device designs were tested for positional stability (absence of migration). The design selected for further testing consisted of a center of spongy SIS surrounded by an SIS sheet and held together by a 0.006-inch wire helix with two barbs. It was delivered on the tip of a short coaxial 3-F/5-F catheter set. Using this design, bilateral transuterine fallopian tube occlusion was performed in eight New Zealand White rabbits. Follow-up consisted of plain radiography at 2 weeks and hysterosalpingography at 6 weeks (n = 4 animals; eight tubes), 12 weeks (n = 2 animals; four tubes), or 24 weeks (n = 2 animals; four tubes). Thereafter, the animals were killed and the fallopian tubes were harvested for histologic evaluation. RESULTS: A single device was placed successfully in each fallopian tube. Fifteen of 16 devices (94%) remained in place throughout follow-up. One device migrated into the vagina at 2-week follow-up. Hysterosalpingography of the 15 tubes with occluders in place showed occlusion in seven of seven (100%) at 6 weeks, three of four (75%) at 12 weeks, and two of four (50%) at 24 weeks. Histologic evaluation revealed luminal occlusion by reorganized SIS containing macrophages, fibrocytes, and scant foreign-body giant cells. Only a mild inflammatory reaction was observed around the tube. In the animals with recanalization at 12 and 24 weeks, new channels were found alongside the original still-occluded fallopian tube lumen. CONCLUSIONS: The original lumen of the fallopian tube was effectively occluded by the SIS occluder, which was remodeled within the fallopian tubes of rabbits. Partial peripheral recanalization was observed over time.