Design, Development, and Characterization of a Pipeline Embolization Device

Abstract

Pipeline embolization devices (PED’s) are used to restrict blood flow to an aneurysm, thus receding the aneurysm until it has disappeared. This research demonstrates the design, development, and characterization of a biodegradable, and biocompatible pipeline embolization device for use in the carotid artery. Experimentation was done with polylactic acid, and a photopolymer to determine a suitable construction material for the PED. To confirm polymers chosen for the device are biocompatible and biodegradable, the materials are tested with multiple cellular experiments for compatibility and tested chemically for the degradation rate. Degradation rates were tested for both materials by soaking them in a phosphate buffer solution over 2,4, and 6 weeks periods and low degradation rat was observed. Designs of the PED models were built with SOLIDWORKS™ and fabricated using rapid prototyping. To find the optimal PED design, COMSOL Multiphysics® was used to simulate physiologically realistic pulsating pressure and velocity. The effectiveness was determined by the flow profiles, velocities, and shear stresses inside of an aneurysm. Mechanical testing on the PED included three-point bend test, radial test, tensile test, and ex vivo physical simulations, which were carried out by constructing an artificial artery composed of polydimethylsiloxane (PDMS). The results show that designed PED can effectively reduce fluid flow in the PDMS aneurysmal sac.