An endoluminal cylindrical sectored‐ring ultrasound phased‐array applicator for minimally‐invasive therapeutic ultrasound

BACKGROUND: The size of catheter‐based ultrasound devices for delivering ultrasound energy to deep‐seated tumors is constrained by the access pathway which limits their therapeutic capabilities. PURPOSE: To devise and investigate a deployable applicator suitable for minimally‐invasive delivery of therapeutic ultrasound, consisting of a 2D cylindrical sectored‐ring ultrasound phased array, integrated within an expandable paraboloid‐shaped balloon‐based reflector. The balloon can be collapsed for compact delivery and expanded close to the target position to mimic a larger‐diameter concentric‐ring sector‐vortex array for enhanced dynamic control of focal depth and volume. METHODS: Acoustic and biothermal simulations were employed in 3D generalized homogeneous and patient‐specific heterogeneous models, for three‐phased array transducers with 32, 64, and 128 elements, composed of sectored 4, 8, and 16 tubular ring transducers, respectively. The applicator performance was characterized as a function of array configuration, focal depth, phasing modes, and balloon reflector geometry. A 16‐element proof‐of‐concept phased array applicator assembly, consisting of four tubular transducers each divided into four sectors, was fabricated, and characterized with hydrophone measurements along and across the axis, and ablations in ex vivo tissue. RESULTS: Simulation results indicated that transducer arrays (1.5 MHz, 9 mm OD × 20 mm long), balloon sizes (41–50 mm expanded diameter, 20–60 mm focal depth), phasing mode (0–4) and sonication duration (30 s) can produce spatially localized acoustic intensity focal patterns (focal length: 3–22 mm, focal width: 0.7–8.7 mm) and ablative thermal lesions (width: 2.7–16 mm, length: 6–46 mm) in pancreatic tissue across a 10–90 mm focal depth range. Patient‐specific studies indicated that 0.1, 0.46, and 1.2 cm(3) volume of tumor can be ablated in the body of the pancreas for 120 s sonications using a single axial focus (Mode 0), or four, and eight simultaneous foci in a toroidal pattern (Mode 2 and 4, respectively). Hydrophone measurements demonstrated good agreement with simulation. Experiments in which chicken meat was thermally ablated indicated that volumetric ablation can be produced using single or multiple foci. CONCLUSIONS: The results of this study demonstrated the feasibility of a novel compact ultrasound applicator design capable of focusing, deep penetration, electronic steering, and volumetric thermal ablation. The proposed applicator can be used for compact endoluminal or laparoscopic delivery of localized ultrasound energy to deep‐seated targets.