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Bioabsorbable radiopaque water-responsive shape memory embolization plug for temporary vascular occlusion.

Yee Shan Wong1, Abhijit Vijay Salvekar2, Kun Da Zhuang3

  • 1School of Materials Science & Engineering, Nanyang Technological University, Singapore, 639798, Singapore.

Biomaterials
|June 21, 2016
PubMed
Summary

A new biodegradable, radiopaque embolization plug uses a water-triggered shape memory effect for temporary vascular occlusion. This device, made from PLGA and PEGDA hydrogel, shows promise for controlled embolization and is ready for safety studies.

Keywords:
BiodegradableEmbolizationPEG hydrogelPoly(lactide-co- glycolide)Shape-memory

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Area of Science:

  • Biomaterials Engineering
  • Medical Devices
  • Vascular Surgery

Background:

  • Temporary vascular occlusion is crucial for various medical procedures.
  • Existing embolic agents may have limitations in control, retrieval, or biocompatibility.
  • Development of advanced embolic devices with tailored properties is ongoing.

Purpose of the Study:

  • To develop and evaluate a biodegradable, radiopaque, water-triggered shape memory embolization plug for temporary vascular occlusion.
  • To characterize the material properties, shape memory behavior, and imaging capabilities of the device.
  • To assess the in vitro and in vivo performance, including occlusion efficacy and biocompatibility.

Main Methods:

  • Fabrication of a composite material using poly(dl-lactide-co-glycolide) (PLGA) and radiopaque filler, coated with crosslinked poly(ethylene glycol) diacrylate (PEGDA) hydrogel.
  • Evaluation of mechanical properties, degradation, shape memory effect under varying programming conditions, and radiopacity.
  • In vitro assessment of occlusion rate using a custom setup and biocompatibility testing.
  • In vivo feasibility study in a rabbit model to evaluate deployment, migration, and vascular occlusion under fluoroscopy.

Main Results:

  • The embolization plug demonstrated a water-induced shape memory effect, elucidated through material characterization.
  • Optimized materials resulted in a prototype with effective in vitro occlusion and good biocompatibility.
  • In vivo studies showed the prototypes were visible under fluoroscopy and achieved complete vascular occlusion within 2 minutes of deployment.
  • No device migration was observed in the rabbit model.

Conclusions:

  • The developed biodegradable, radiopaque embolization plug offers controlled and temporary vascular occlusion.
  • The water-triggered shape memory mechanism facilitates rapid and effective embolization.
  • The device shows significant potential for clinical application and is ready for further safety investigations.