THE MECHANISM OF LESION FORMATION BY FOCUSED ULTRASOUND ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION.

The application of therapeutic ultrasound for the treatment of atrial fibrillation (AF) is investigated. The results of theoretical and experimental investigation of ultrasound ablation catheter are presented. The major components of the catheter are the high power cylindrical piezoelectric element and parabolic balloon reflector. Thermal elevation in the ostia of pulmonary veins is achieved by focusing the ultrasound beam in shape of a torus that transverses the myocardial tissue. High intensity ultrasound heating in the focal zone results in a lesion surrounding the pulmonary veins that creates an electrical conduction blocks and relief from AF symptoms. The success of the ablation procedure largely depends on the correct choice of reflector geometry and ultrasonic power. We present a theoretical model of the catheter's acoustic field and bioheat transfer modeling of cardiac lesions. The application of an empirically derived relation between lesion formation and acoustic power is shown to correlate with the experimental data. Developed control methods combine the knowledge of theoretical acoustics and the thermal lesion formation simulations with experiment and thereby establish rigorous dosimetry that contributes to a safe and effective ultrasound ablation procedure.

Comparison of modelled and observed in vivo temperature elevations induced by focused ultrasound: implications for treatment planning.

Two numerical models for predicting the temperature elevations resulting from focused ultrasound heating of muscle tissue were tested against experimental data. Both models use the Rayleigh-Sommerfeld integral to calculate the pressure field from a source distribution. The first method assumes a source distribution derived from a uniformly radiating transducer whereas the second uses a source distribution obtained by numerically projecting pressure field measurements from an area near the focus backward toward the transducer surface. Both of these calculated ultrasound fields were used as heat sources in the bioheat equation to calculate the temperature elevation in vivo. Experimental results were obtained from in vivo rabbit experiments using eight-element sector-vortex transducers at 1.61 and 1.7 MHz and noninvasive temperature mapping with MRI. Results showed that the uniformly radiating transducer model over-predicted the peak temperature by a factor ranging from 1.4 to 2.8, depending on the operating mode. Simulations run using the back-projected sources were much closer to experimental values, ranging from 1.0 to 1.7 times the experimental results, again varying with mode. Thus, a significant improvement in the treatment planning can be obtained by using actual measured ultrasound field distributions in combination with backward projection.

Method of reduction of the number of driving system channels for phased-array transducers using isolation transformers.

Phased-array technology offers an incredible advantage to therapeutic ultrasound due to the ability to electronically steer foci, create multiple foci, or to create an enlarged focal region by using phase cancellation. However, to take advantage of this flexibility, the phased-arrays generally consist of many elements. Each of these elements requires its own radio-frequency generator with independent amplitude and phase control, resulting in a large, complex, and expensive driving system. A method is presented here where in certain cases the number of amplifier channels can be reduced to a fraction of the number of transducer elements, thereby simplifying the driving system and reducing the overall system complexity and cost, by using isolation transformers to produce 180 degrees phase shifts.

Low-profile lenses for ultrasound surgery.

Several flat lens designs have been simulated that focus a planar transducer at various depths and angular deflections. The use of flat lenses with planar phased arrays to create multiple focus patterns has also been explored. The simulations have shown that the discrete element size is practical to machine. Simulations predict that a flat polystyrene lens with an f number of 1.0 can produce a focal peak intensity that is 80% that of a geometrically focused transducer with the same focal depth, including the attenuation through the lens, by utilizing four discrete phase steps. These predictions were verified with a simplified experimental lens utilizing only two phase steps. Simulations predicted an attenuation within the lens of 18% and a focal peak intensity of 38%. Measurements resulted in an attenuation of 30% and a focal peak intensity of 30%. Experimental lens studies have indicated that sufficient power can be transmitted through the lenses for these designs to be feasible for use in ultrasound surgery.

Design and evaluation of a feedback based phased array system for ultrasound surgery.

A driving system has been designed for phased array ultrasound applicators. The system is designed to-operate in the bandwidth 1.2 to 1.8 MHz, with independent channel power control up to 60 W (8 bit resolution) for each array element. To reduce power variation between elements, the system utilizes switching regulators in a feedback loop to automatically adjust the DC supply of a class D/E power converter. This feedback reduces the RF electrical power variation from 20% to 1% into a 16 element array. DC-to-RF efficiencies close to 70% for all power levels eliminates the need for large heat sinks. In addition to power control, each channel may be phase shifted 360 degrees with a minimum of 8 bit resolution. To ensure proper operation while driving ultrasound arrays with varying element sizes, each RF driving channel implements phase feedback such that proper phase of the driving signal is produced either at the amplifier output before the matching circuitry or after the matching circuitry at the transducer face. This feedback has been experimentally shown to increase the focal intensities by 20 to 25% of two tested phased arrays without array calibration using a hydrophone.

Design and experimental verification of thin acoustic lenses for the coagulation of large tissue volumes.

Large focal volumes are desired in ultrasound surgery to reduce the total treatment time when large tumours are thermally coagulated. Phased arrays are capable of producing enlarged focal volumes in addition to providing the ability for on-line modification of focal shape and location. Although phased arrays have several advantages over their non-phased counterparts, the complexity of these arrays also presents some disadvantages regarding cost and complexity. One less costly alternative is the use of thin acoustic lenses to alter the field shape of a single-focus transducer. Four polystyrene lenses have been designed using the sector-vortex principle developed for phased arrays by Cain and Umemura. Measurements of the acoustic fields produced with the lenses are in good agreement with the simulated fields. The transmission measurements through each of the four lenses ranged from 76% to 84%, and over 52 W of total acoustic power has been delivered through each of the lenses during in vivo experiments without any damage to the lenses or the transducer. The in vivo results showed an increase in rate of necrosis to 10.1 +/- 1.4 cm3 h-1 using the mode 4 lens, or 5.2 +/- 0.7 times higher than the focused transducer alone.

A parametric study of the concentric-ring transducer design for MRI guided ultrasound surgery.

Noninvasive surgery using high-powered, focused ultrasound transducers in conjunction with magnetic resonance imaging has been shown to be feasible in previous studies. For clinical treatments, the geometry of standard MRI equipment limits the space available for ultrasound surgical equipment. This space requirement can be reduced in one dimension by using phased arrays to control the focal depth, thus eliminating the space required for the motion of a fixed focus transducer. Because of its symmetry, an annular array is ideal for changing the focal depth. Previous works have simulated, built, and characterized various concentric-ring transducers; however, no study has thoroughly examined the potential and limitations of the concentric-ring design for MRI guided ultrasound surgery. The present work is a systematic examination of the capabilities of the concentric-ring array, using numerical simulations to predict the power field, temperature distribution, and accumulated thermal dose. The results presented here illustrate the effects of ring size, center-to-center spacing configurations, number of rings, and radius of curvature on transducer performance. A 10-cm radius of curvature transducer with 14 evenly spaced rings has been built and characterized in order to verify the accuracy of the numerical simulations. The pressure-squared fields produced by this transducer are in excellent agreement with the simulated fields.