Development of a novel steerable embolization microcatheter

Abstract

Microcatheters are used for endovascular diagnosis and treatment purposes. Variations of this minimally invasive instrument, accompanied by guidewires, are manipulated through the vasculature towards the target of the intervention. The human vascular anatomy can however present complex pathways towards a target, for example a distal tumor. Interventions are challenged by limited 2D imaging, and a limited degree of motion and control of the instruments. This thesis therefore focuses on developing a novel endovascular microcatheter with a steerable tip, a project commissioned by Mencius Medical BV. It elaborates on the theoretical substantiation of the designed distal steering mechanism, that is developed based on an existing patent. It covers part of the design process and documents the development from patent to working prototype. The design process commences with observations in the operating theatre and specialist interviews, allowing for thorough understanding of the clinical need. Based on this need, the catheter tip is designed with a unique mechanism, enabling controlled tip deflection while inside vascular environment. A user-centered approach enabled fast and efficient convergence of design choices. The concept is evaluated on its technical feasibility, producibility, and functionality. A thorough mechanical and computational (FEA) analysis evaluates the material choice and feasibility of the design by simulating the system’s behavior in context of use. This analysis confirms a theoretical proof of principle. A user test with various prototypes in pre-clinical environment provides the first step towards practical proof of principle. A recommendation is done for further in-vivo validation for final proof of concept. The device potentially allows the interventionalist to take the entire route through the vascular roadmap with one device, eliminating a trial and error process and the need for exchanging multiple instruments during the procedure. Consequently, operation time, radiation, frustration, vessel trauma, and equipment waste are minimized. Lastly, it might increase the accessibility of more distally located tumors, which is groundbreaking for tumor treatment and interventional radiology in general.