A Robotically Steerable Guidewire With Forward-Viewing Ultrasound: Development of Technology for Minimally-Invasive Imaging.

Abstract

The current standard of care for peripheral chronic total occlusions involves the manual routing of a guidewire under fluoroscopy. Despite significant improvements in recent decades, navigation remains clinically challenging with high rates of procedural failure and iatrogenic injury. To address this challenge, we present a proof-of-concept robotic guidewire system with forward-viewing ultrasound imaging to allow visualization and maneuverability through complex vasculature. A 0.035" guidewire-specific ultrasound transducer with matching layer and acoustic backing was designed, fabricated, and characterized. The effect of guidewire motion on signal decorrelation was assessed with simulations and experimentally, driving the development of a synthetic aperture beamforming approach to form images as the transducer is steered on the robotic guidewire. System performance was evaluated by imaging wire targets in water. Finally, proof-of-concept was demonstrated by imaging an ex vivo artery. The designed custom transducer was fabricated with a center frequency of 15.7 MHz, 45.4% fractional bandwidth, and 31dB SNR. In imaging 20 μm wire targets at a depth of 6mm, the lateral -6dB target width was 0.25 ± 0.03mm. The 3D artery reconstruction allowed visualization of vessel wall structure and lumen. Initial proof-of-concept for an ultrasound transducer-tipped steerable guidewire including 3D image formation without an additional sensor to determine guidewire position was demonstrated for a sub-mm system with an integrated ultrasound transducer and a robotically-steered guidewire. The developed forward-viewing, robotically-steered guidewire may enable navigation through occluded vascular regions that cannot be crossed with current methods.