Ab ovo: Factors Affecting the Radial Stiffness of Thoracic Aorta Stent-Grafts.

Abstract

The aim of the investigation was to study the factors influencing the radial stiffness of the thoracic aorta stent-grafts with the stent elements made of nitinol tubes by laser cutting and thermal shape setting.

Materials and methods: The work used stent elements made by different technologies by two different manufacturers from a nitinol tube with a wall thickness of 0.5 mm (E1) and 0.4 mm (E2), with a final diameter of 20 mm. Height of cells E1 - 15 mm, E2 - 12.5 mm. The stents were manually attached to a tubular woven non-crimped base (PTGO Sever, Russia) with a 6/0 suture, resulting in either single or continuous stitches. In the RLU124 radial force tester (Blockwise Engineering LLC, USA), each of the four stent-grafts, as well as their individual stent elements, were compressed by 10 mm from the initial diameter. The dependence of the radial forces on deformation under loading and unloading was graphically presented. The temperature and enthalpy of phase transitions of nitinols into the austenite (Af) and martensitic (Mf) phases were studied using differential scanning calorimetry (DSC-3; Mettler Toledo, USA). All indicators were compared with the characteristics of two commercial models - Cronus (China) and E-vita Open Plus (Germany).

Results: Four prototypes of SibHybrid stent-grafts were tested; those differed in their stent elements, distances between them, and the type of sutures (single or continuous). The stent elements of the models studied differed in the values of Af, Mf, and the enthalpy of phase transitions of nitinols. The hardest stent was the E2 prototype. The fixation of stent elements to the woven fabric in the graft increased the radial force by 4.0-5.5 times. During compression by 50 and 20% of the original diameter, the SibHybrid models developed radial force 4.5-6.0 times greater compared with the E-vita Оpen Plus model. The radial force values of SibHybrid models were almost the same as for the Cronus and models at 20% compression. Using continuous twining round suturing increased the radial force by about 10 N; accordingly, SibHybrid E2 had the highest radial force because it was fixed by a continuous suture. The density of the stent elements fixed on the fabric did not affect the radial force of the stent-graft as a whole.

Conclusion: In the manufacture of stent elements from nitinol tubes, the main factor determining the radial stiffness is the technology of nitinol shape setting. With the standard technology of thermal shape setting, radial force can be changed by varying the height of the structure cell element and the cross-sectional area of the cell bars, as well as the suturing technique.