A large puncture closer of aortic wall by multi-memory actions with thrombo-hemodynamic control

Abstract

The vascular wall regulates the pattern and pressure of blood flow. In cardiovascular interventions, catheters are deployed by puncturing the vessel wall, without exception. Despite continuous progress, the outcomes remain highly operator-dependent, and large punctures with high-pressure bleeding continue to pose clinical challenges. As a translatable solution, this study introduces a shape memory vascular wall plug (VWP) that automates both the Body and Wing functions within a single component, supported by a Ring assembly to maximize pressure resistance. The VWP is deployed into a 6-mm puncture in a porcine thoracic aorta under peak blood pressure, and shape recovery is triggered by a 45 degrees C saline flush to enable automated activation. Upon recovery, Body expansion combined with Ring compression tightly seals the puncture tract. The curved Wing induces hemostatic sealing and then flattens to maintain healthy blood flow and physiologic pressures. The VWP achieves suturinglevel performance in aortic puncture closure, demonstrating effective hemostasis, patency, and endothelialization. The flow-blockage ratio required to balance hemostasis with hemodynamics is computationally modeled and validated using whole-blood microfluidics. Pressure resistance is maximized by tuning Ring strain through polymer blending, indicating multi-level strategies in polymer, device design, and memory function to advance the vascular closure technology.