Abstract
We describe the preparation, characterization and evaluation of a biodegradable radiopaque water-triggered shape memory embolization plug for temporary vascular occlusion. The shape memory occluding device consists of a composite of a radio-opaque filler and a poly (dl-lactide-co-glycolide) (PLGA) blend, which was coated with a crosslinked poly (ethylene glycol) diacrylate (PEGDA) hydrogel. The mechanical properties, the degradation timeframe, the effect of programming conditions on the shape memory behaviour and the extent of radio-opacity for imaging were evaluated. Based on the tests, the mechanism responsible for the water-induced shape memory effect in such an embolization plug was elucidated. Suitable materials were optimized to fabricate an embolic plug prototype and its invitro performance was evaluated as an occlusion rate (using a custom-built set up) and its biocompatibility. Finally, a feasibility study was conducted invivo in a rabbit model to investigate the ease of device deployment, device migration and extent of vessel occlusion. The invivo results demonstrated that the prototypes were visible under fluoroscopy and complete vascular occlusion occurred within 2min of deployment of the prototypes invivo. In conclusion, the developed embolization plug enables controlled and temporary vascular embolization, and is ready for safety studies.
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