Non-axisymmetric and Steerable Acoustic Field for Enhanced Stone Comminution in Shock Wave Lithotripsy

The primary goal of this dissertation was to assess the feasibility of transforming an electromagnetic (EM) shock wave lithotripter with an acoustic lens as its focusing device from the original axisymmetric pressure distribution to a non-axisymmetric steerable acoustic field. This work was motivated by the desire to better match the distribution of effective acoustic pressure and pulse energy with the trajectory and anatomical features around renal and ureteral calculi during clinical shock wave lithotripsy (SWL). The acoustic field transformation was accomplished by the design of a fan-shaped acoustic barrier (mask) placed on top of the lithotripter acoustic lens to selectively reduce the source aperture along the direction of the barrier axis, therefore effectively broadening the beam width (BW) of the lithotripter field in this preferred direction. Moreover, the geometry of the original lens (L₁) was modified so that the acoustic focus of the new lens (L₂) at high output voltages (necessitated by the incorporation of the mask) is closely aligned with the lithotripter focus. The mask was further driven by a motor-controlled gear system to rotate around the lithotripter axis, generating a steerable and non-axisymmetric acoustic field. In this dissertation project, a linear acoustic model was first used for parametric studies to assess the effects of mask geometry (opening angle and thickness) on beam elongation and peak pressure reduction. Based on this analysis, two mask geometries (L₂+M₈₀₂₅ and L₂+M₉₀₃₀) were selected for modest and maximum beam elongation within the acceptable output range of the shock wave source. The acoustic and cavitation fields of the new lens with masks, as well as the corresponding field produced by the original lens, were characterized using fiber optical probe hydrophone measurements and stereoscopic high-speed imaging. Different output voltage settings were used for each lens configuration (i.e., 14 kV for L₁, 15.8 kV for L₂+M₈₀₂₅, and 17 kV L₂+M₉₀₃₀) to produce equivalent acoustic pulse energy of 45 mJ in all setups, measured in the lithotripter focal plane. Under this condition, L₂+M₈₀₂₅ and L₂+M₉₀₃₀ generate lower peak pressure (38.2 and 36.8 MPa) with a significantly broadened BW_y (11.4 and 14.3 mm) along the y-axis (head-to-toe direction of the patient), which is aligned with the mask axis, compared to the high peak pressure (44.1 MPa) and moderate BW (7.5 mm) of L₁. It is worth noting that L₂+M₈₀₂₅ and L₂+M₉₀₃₀ produce a BW_x (7.6 and 7.5 mm) in the orthogonal direction to the mask axis, which is also comparable to L₁. Similarly, the beam width of the cavitation field was broadened from 8.1 to 12.2 mm for L₂+M₈₀₂₅, and from 10.9 to 17.9 mm for L₂+M₉₀₃₀, compared to the range of 8.8 to 9.4 mm measured from L₁. In comparison, L₂+M₈₀₂₅ produces a denser and narrower bubble cloud along the y-axis than L₂+M₉₀₃₀. In vitro stone comminution (SC) tests in a tube holder (Diameter = 14 mm) have demonstrated that L₂+M₈₀₂₅ and L₂+M₉₀₃₀ are more effective at off-axis positions and during simulated respiratory motion along the elongated beam direction. The results of SC also confirmed the correlation between SC and the average peak pressure, p_+(avg), and effective acoustic pulse energy, E_eft, delivered to the stone, as shown in previous studies. Furthermore, a ureter model was developed and used to assess the performance of L₂+M₉₀₃₀, which has the maximally elongated BW under various static and simulated respiratory motion conditions. The results suggest that L₂+M₉₀₃₀ can produce significantly better SC than L₁ when the elongated beam is effectively aligned with the stone/fragments in the ureter or with their motion trajectory during the course of SWL treatment. Altogether, the results of this dissertation work have demonstrated in vitro that a non-axisymmetric and steerable acoustic field can significantly enhance stone comminution under clinically relevant SWL conditions. Future work is warranted to optimize the mask design and steering protocol to maximize the benefit of such an adaptable and versatile design to improve the performance and safety of clinical EM lithotripters.