High-Pressure Low-Frequency Lateral Mode Phased-Array Transducer System for the Treatment of Deep Vein Thrombosis: An In Vitro Study.

Abstract

Deep vein thrombosis (DVT) can lead to a fatal disease known as pulmonary embolism. Application of high-power ultrasound has been successful in studies to mechanically fragment the clots. Single-element ultrasound transducers were used in most of the studies. Challenges associated with phased arrays, such as high electrical impedance and element breakdown at high voltages, were addressed in the previous study, and a high-power 64-element transducer module was designed and fabricated. In this study, a cylindrical array of 16 modules with the frequency of 260 kHz was modeled and constructed for DVT thrombolysis. The maximum pressure, focal size, and steering ability of the array were examined. In vitro experiments were conducted to assess the performance of the array. The simulated pressure amplitude of 34 MPa at the depth of 55 mm (average femoral vein (FV) distance from the inner surface of the thigh) was in consistent with the experiments and satisfied the purpose of this study. Moreover, the employed module distribution resulted in a focal spot dimension of 2.4×2.8×7.3 mm3 (at the 75% pressure amplitude level) that can be confined in a human FV with the average diameter of 12 mm. In vitro experiments manifested a partial and complete clot breakdown at 11.5- and 15-MPa pressure at the focus. The design and engineering of the array system was succeeded in maintaining the desired pressure and focal size even when steered. The results presented in this study suggest the potential of the designed array system for clinical applications.