Construction and Validation of a Benchtop Model for Testing of Mechanical Thrombectomy Devices for Pulmonary Embolism.

Abstract

This study aims to define the process of designing and manufacturing 3D printed and glass models of the pulmonary artery (PA) and utilizing them in a test bed for evaluation of devices for mechanical thrombectomy of pulmonary embolism (PE). Patient derived computed tomography angiography (CTA) images of the PA were digitally converted into a hollowed-out structure and translated into clear 3D printed and glass models. A test bed was created using a peristaltic pump and silicone tubing connected to the models. Human clot analogs were then prepared and injected within the models. Thrombectomy testing was done using clinically used predicates and baseline characteristics of the models were evaluated by independent interventionalists. The mean sizes of the main pulmonary artery (MPA) for the 3D printed model and glass model were 30.4mm and 29.2mm, mimicking those of the patient's PA obtained on CTA. Heterogeneous human clot analogs were created with fibrin composition ranging from 60 to 30%. Mechanical thrombectomy was successfully attempted by independent interventionalists. Both the 3D printed, and glass model were appraised as very good for multiple attributes. A complete test bed using 3D printed and glass models of the PA with human clot analogs was created for testing of mechanical thrombectomy devices for PE.