Objective
To develop a high resolution, near field optimized 14 MHz 24-element broad bandwidth forward-looking array for integration on a steerable 9 French (Fr) electrophysiology (EP) catheter.
Methods
Several generations of prototype imaging catheters with bi-directional steering, termed the Micro-Linear (ML), have been built and tested as an integrated catheter design with EP sensing electrodes near the tip. The wide bandwidth ultrasound array is mounted on the very tip, equipped with an aperture of only 1.2 mm by 1.58 mm. The array pulse echo performance has been fully simulated and its construction offers shielding from ablation noise. Both ex-vivo and in-vivo imaging with a porcine animal model were performed.
Results
The array pulse-echo performance is concordant with KLM simulation. Three generations of prototype devices were tested in four acute pig studies in the right atrium and ventricle for a) image quality, b) anatomic identification, c) visualization of other catheter devices, and d) for a mechanism for stabilization when imaging ablation. The ML catheter is capable of both low artifact ablation imaging on a standard clinical imaging system and high frame rate myocardial wall strain rate imaging for detecting changes in cardiac mechanics associated with ablation.
Conclusions
The imaging resolution performance of this very small array device, together with its penetration beyond 2cm, is excellent considering its very small array aperture. The forward looking intracardiac catheter has been adapted to work easily on an existing commercial imaging platform with very minor software modifications.