A preclinical animal study of a novel, simple, and secure duct and vessel occluder for laparoscopic surgery

Background: Secure occlusion of large blood vessels and ductal structures is critical to all surgeries and remains a challenge in many minimally invasive procedures. This study compares in vivo use of the Amsel Occluder (AO) for secure laparoscopic blood vessel and duct closure, with one of the many commercially available hemoclips (Ligaclip®), in the porcine model. Methods: Laparoscopic closure of vessels and ducts was performed on 12 swine to compare the ease of use, safety and efficacy of the AO with a hemoclip, as well as the tissue response at > 30 days (10 swine). All vessels and ducts were occluded and then transected between the occluding clips. Any bleeding or leakage was noted. In the chronic study, confirmation of satisfactory vessel occlusion post nephrectomy was determined by laparotomy as well as by contrast angiography and venography. The tissue response and healing was evaluated by a histopathological study for the effects of any biological incompatibilities. Results: In the acute laparoscopic study, a total of 24 occlusions between 2 and 10 mm were performed with the AO (n = 19) and hemoclip (n = 5). In the chronic study, 5 nephrectomies (AO n = 3, hemoclip N = 2) and 5 cholecystectomies (AO n = 3, hemoclip n = 2) were performed with survival ranging from 42 to 72 days. One pig who sustained a splenic injury at trocar insertion and suffered a delayed ruptured spleen with massive hemorrhage on postoperative day 22. Unlike occlusion with the AO, multiple hemoclips were used for each vessel occlusion. Histopathological examination showed no difference in the tissue response and healing of the AO and hemoclip. Conclusions: The Amsel Vessel occluder delivered laparoscopically provides an occlusion similar to a hand-sewn transfixion suture, is simple to use, and creates an occlusion which is not only more secure, but also as safe with respect to the health of the surrounding tissues, as that of the widely used hemoclip (Ligaclip®).