Engineering Analysis of Non-Braided Polycaprolactone Bioresorbable Flow Diverters for Aneurysms.

Abstract

This paper reports a nonbraided, bioresorbable polycaprolactone (PCL) flow diverter (FD) for the endovascular treatment of aneurysms. Bioresorbable FDs can reduce the risk associated with the permanent metallic FDs as they are resorbed by the body after curing of aneurysms. PCL FDs were designed and fabricated using an in-house hybrid electromelt spinning-fused deposition fabrication unit. Flow diverter's properties, surface qualities, and mechanical characteristics of PCL FDs of 50%, 60%, and 70% porosities were studied using scanning electron microscope (SEM), atomic force microscopy (AFM), and high precision universal testing machine (UTM). The deployability through a clinically relevant catheter was demonstrated in a PDMS aneurysm model. The angiographic visibility of the developed PCL FDs was evaluated using BaSO4 and Bi2O3 coatings of various concentration. The average strut thicknesses were 74.12 ± 6.63 μm, 63.07 ± 1.26 μm, and 56.82 ± 2.09 μm for PCL FDs with 50%, 60%, and 70% porosities, respectively. They average pore areas for the 50%, 60% and 70% porosities FDs were 0.055 ± 0.0056 mm2, 0. 0605 ± 0.0065 mm2, and 0.0712 ± 0.012 mm2, respectively. The surface quality was great with an RMS roughness value of 14.45 nm. The tensile, radial strength, and flexibility were found to be satisfactory and comparable to the nonbraided coronary stents. The developed PCL FDs were highly flexible and demonstrated to be deployable through conventional delivery system as low as 4 Fr catheters in a PDMS aneurysm model. The visibility under X-ray increases with the increasing concentration of coating materials BaSO4 and Bi2O3. The visibility intensity was slightly higher with Bi2O3 coating of PCL FDs. The overall results of the engineering analysis of the developed nonbraided PCL FDs are promising.