Purpose
Catheter-based ultrasound applicators can generate thermal ablation
of tissues adjacent to body lumens, but have limited focusing and
penetration capabilities due to the small profile of integrated transducers
required for the applicator to traverse anatomical passages. This study
investigates a design for an endoluminal or laparoscopic ultrasound
applicator with deployable acoustic reflector and fluid lens components,
which can be expanded after device delivery to increase the effective
acoustic aperture and allow for deeper and dynamically adjustable target
depths. Acoustic and biothermal theoretical studies, along with benchtop
proof-of-concept measurements, were performed to investigate the proposed
design.
Methods
The design schema consists of an array of tubular transducer(s)
situated at the end of a catheter assembly, surrounded by an expandable
water-filled conical balloon with a secondary reflective compartment that
redirects acoustic energy distally through a plano-convex fluid lens. By
controlling the lens fluid volume, the convex surface can be altered to
adjust the focal length or collapsed for device insertion or removal.
Acoustic output of the expanded applicator assembly was modeled using the
rectangular radiator method and secondary sources, accounting for reflection
and refraction at interfaces. Parametric studies of transducer radius
(1–5 mm), height (3–25 mm), frequency (1.5–3 MHz),
expanded balloon diameter (10–50 mm), lens focal length
(10–100 mm), lens fluid (silicone oil, perfluorocarbon), and tissue
attenuation (0–10 Np/m/MHz) on beam distributions and focal gain
were performed. A proof-of-concept applicator assembly was fabricated and
characterized using hydrophone-based intensity profile measurements.
Biothermal simulations of endoluminal ablation in liver and pancreatic
tissue were performed for target depths between 2–10 cm.
Results
Simulations indicate that focal gain and penetration depth scale with
the expanded reflector-lens balloon diameter, with greater achievable
performance using perfluorocarbon lens fluid. Simulations of a 50 mm balloon
OD, 10 mm transducer outer diameter (OD), 1.5 MHz assembly in water resulted
in maximum intensity gain of ~170 (focal dimensions: ~12 mm length ×
1.4 mm width) at ~5 cm focal depth and focal gains above 100 between
24–84 mm depths. A smaller (10 mm balloon OD, 4 mm transducer OD,
1.5 MHz) configuration produced a maximum gain of 6 at 9 mm depth. Compared
to a conventional applicator with a fixed spherically-focused transducer of
12 mm diameter, focal gain was enhanced at depths beyond 20 mm for assembly
configurations with balloon diameters ≥ 20 mm. Hydrophone
characterizations of the experimental assembly (31 mm reflector/lens
diameter, 4.75 mm transducer radius, 1.7 MHz) illustrated focusing at
variable depths between 10–70 mm with a maximum gain of ~60 and
demonstrated agreement with theoretical simulations. Biothermal simulations
(30 s sonication, 75°C maximum) indicate that investigated
applicator assembly configurations, at...