Design and Experimental Validation of an Active Catheter for Endovascular Navigation

Endovascular techniques have many advantages but rely strongly on operator skills and experience. Robotically steerable catheters have been developed but few are clinically available. We describe here the development of an active and efficient catheter based on shape memory alloys (SMA) actuators. We first established the specifications of our device considering anatomical constraints. We then present a new method for building active SMA-based catheters. The proposed method relies on the use of a core body made of three parallel metallic beams and integrates wire-shaped SMA actuators. The complete device is encapsulated into a standard 6F catheter for safety purposes. A trial-and-error campaign comparing 70 different prototypes was conducted to determine the best dimensions of the core structure and of the SMA actuators with respect to the imposed specifications. The final prototype was tested on a silicon-based arterial model and on a 23 kg pig. During these experiments, we were able to cannulate the supra-aortic trunks and the renal arteries with different angulations and without any complication. A second major contribution of this paper is the derivation of a reliable mathematical model for predicting the bending angle of our active catheters. We first use this model to state some general qualitative rules useful for an iterative dimensional optimization. We then perform a quantitative comparison between the actual and the predicted bending angles for a set of 13 different prototypes. The relative error is less than 20% for bending angles between 100 deg and 150 deg, which is the interval of interest for our applications.