A Novel Vascular Anastomotic Coupling Device for End-to-End Anastomosis of Arteries and Veins.

Objective: Hand-sutured (HS) techniques remain the gold standard for most microvascular anastomoses in microsurgery. HS techniques can result in endothelial lacerations and back wall suturing, leading to complications such as thrombosis and free tissue loss. A novel force-interference-fit vascular coupling device (FIF-VCD) system can potentially reduce the need for HS and improve end-to-end anastomosis. This study aims to describe the development and testing of a novel FIF-VCD system for 1.5 to 4.0 mm outside diameter arteries and veins.

Methods: Benchtop anastomoses were performed using porcine cadaver arteries and veins. Decoupling force and anastomotic leakage were tested under simulated worst-case intravital physiological conditions. The 1.5 mm FIF-VCD system was used to perform cadaver rat abdominal aorta anastomoses.

Results: Benchtop testing showed that the vessels coupled with the FIF-VCD system could withstand simulated worst-case intravital physiological conditions with a 95% confidence interval for the average decoupling force safety factor of 8.2 ± 1.0 (5.2 ± 1.0 N) and a 95% confidence interval for the average leakage rate safety factor of 26 ± 3.6 (8.4 ± 0.14 and 95 ± 1.4 μL/s at 150 and 360 mmHg, respectively) when compared to HS anastomotic leakage rates (310 ± 14 and 2,100 ± 72 μL/s at 150 and 360 mmHg, respectively). The FIF-VCD system was successful in performing cadaver rat abdominal aorta anastomoses.

Conclusion: The FIF-VCD system can potentially replace HS in microsurgery, allowing the safe and effective connection of arteries and veins. Further studies are needed to confirm the clinical viability and effectiveness of the FIF-VCD system.