Arnold Miller, MD1, Nir Lilach, IED2, Raanan A Miller, PhD1, Steven D Schwaitzberg, MD3. 1Amsel Medical, 2Eliachar Technologies Development, Ltd, 3Jacobs School of Medicine
OBJECTIVES: Successful MIS procedures require predictable secure occlusion of vessels and tubular structures. Optimal mechanical methods should include tissue transfixion, cost effectiveness and ease of use. Conventional hemoclips are applied millions of times yearly, but are subject to variable holding strength and can become dislodged leading to significant morbidity or even death. Suture ligation as used in open surgery can be time consuming to perform laparoscopically. Laparoscopic staplers successfully transfix tissue and can be applied relatively quickly, but are expensive. The objective of this study was to evaluate a novel laparoscopic prototype of the Amsel™ Vessel Occluder (AVO) transfixion clip in a porcine model. The open version of the AVO has received FDA pre-market 510(k) clearance for use in conventional surgical procedures for occlusion vessels and tubular structures ranging in diameter from 2-7mm.
DESCRIPTION OF TECHNOLOGY: The AVO is a novel mechanical occlusion clip solution similar to a transfixion suture. It is delivered through an 18G needle-tube, which transfixes the targeted vessel or duct. The AVO is subsequently expanded on either side of the vessel wall, collapsed and locked together to effect secure vascular or ductal occlusion. We have previously shown the safety and efficacy of the AVO in the porcine model with swine weighing >60 kilograms, with both “open” occlusions (n=48) and ultrasound guided percutaneous occlusions (n=30).
PRELIMINARY RESULTS: Using a 70 kg swine model in standard laparoscopic conditions, a prototype multi-loader delivery device (4 AVO clips per device) was used through a 5 mm laparoscopic port. Selected vessels and ducts were occluded with one clip proximally then distally. The structure was then divided between the clips to confirm successful occlusion. The inferior mesenteric artery (n=1), external iliac arteries (n=2), ureter (n=2) and uterine horn (n=1) were successfully targeted and occluded.
CONCLUSIONS: This study demonstrates that the AVO can be effectively delivered laparoscopically in a porcine model to occlude blood vessels and tubular structures. The AVO provides a mechanical means of permanent, secure occlusion, similar to a transfixion suture thus eliminating problems of dislodgement seen with occlusion clips in current clinical practice. This method of permanent occlusion may be a useful, time-saving and cost-effective adjunct to current laparoscopic surgery potentially reducing patient morbidity and their associated care costs.