Development of innovative system of universal stent graft for endovascular treatment of aneurysm and aortic displacement in various locations

This study presents the technology of developing a universal stent graft for endovascular treatment of aneurysms and aortic dissection of various localizations, without considering the vessel diameter. A self-expanding nitinol stent was used as the frame of the main trunk of the stent graft. During the study, several variants of the aortic linear graft were manufactured and tested. The optimal stiffness and diameter of the nitinol wire were selected based on the results. When creating a bifurcation module, special attention was paid to simplifying the positioning and “intravascular assembly” of the structure. Implantable modules have been developed for the prosthetics of the main branches of the aorta. Dacron, optimal in terms of fiber structure, was chosen as the material of the woven shell of the graft. Linear extensibility, compactness of the pile, and tensile strength during fenestration were evaluated. To determine the heparin-controlled surgical porosity, experimental samples of stent grafts were tested on a stand simulating arterial blood flow. The wall material of the developed device had a heparin-controlled surgical porosity of 50–150 mL/min/cm² at 120 mm Hg with the possibility of maintaining a controlled endolic. The graft wall created a pressure gradient of no more than 3 mm Hg, and the flow velocity indicators were quite sufficient for adequate perfusion of vital organs. After the inactivation of heparin, blood permeability became zero. The implantation technique of the developed product was implemented on a silicone aortic phantom simulating aneurysm expansion with and without dissection. The phantom contour was filled with a solution simulating the rheological properties of native blood. Pulsating blood flow was simulated using a perfusion pump. Under X-ray control, a stent graft was installed on five large biological samples (sheep). Implantation was performed in the aortic arch with prosthetics of the brachiocephalic trunk and the suprarenal aorta with prosthetics of the visceral branches. With the experiment, we hope that the result will allow us to minimally invasively help patients suffering from aneurysms of any localization.