In vitro and In vivo assessment of a novel organ perfusion stent for successful flow separation in donation after cardiac death

Abstract

Shortage of healthy donors’ organs has appeared as one of the main challenges for organ transplantation. This study focuses on the novel endovascular device development to increase the number of available organs from cardiac death donors. The primary objective of this study is the design validation of a newly developed stent graft for the abdominal organ perfusion with cardiac blood flow isolation. In this paper, the effectiveness of the device design has been validated via the assessment of the device performance both in vitro and in vivo. The radial force of stent structure was first numerically analyzed using finite element method, then was quantified experimentally. The blood perfusion parameters were investigated to demonstrate their effect on the blood delivered to the abdominal organs, maintaining the organs healthy for donation. In vitro flow leakage was measured using a 3-D printing-based silicone aortic model to evaluate the isolation between cardiac flow and perfusion flow with minimum values. Following the design validation process, a functional prototype stent graft has been successfully fabricated using optimized laser welding conditions and subsequent joining processes. In vivo porcine study results have demonstrated smooth delivery and successful placement of the device showing complete cardiac flow separation isolating abdominal regions only with the oxygenated blood flow.