Feasibility of using ultrasound phased arrays for MRI monitorednoninvasive surgery

The purpose of this paper was to evaluate the in vivo feasibility of using phased arrays for MRI guided ultrasound surgery. Two different array concepts were investigated: a spherically curved concentric ring array to move the focus along the central axis and a spherically curved 16 square element array to make the focus larger. Rabbit thigh muscles were exposed in vivo in a 1.5 T MRI scanner to evaluate the array performance. The results showed that both of the arrays performed as expected, and the focus could be moved and enlarged. In addition, adequate power could be delivered from the arrays to necrose in vivo muscle tissue in 10 s. This study was the first implementation of phased arrays for MRI guided ultrasound surgery. The results demonstrate that phased arrays have significant potential for noninvasive tissue coagulation     

A 256-element ultrasonic phased array system for the treatment of large volumes of deep seated tissue

A 256-element phased array has been designed, constructed, and tested for ablative treatment of large focal volumes of deep seated tissue. The array was constructed from a 1.1-MHz, 1-3 composite piezoelectric spherical shell with a 10-cm radius of curvature and a 12-cm diameter. The array was tested to determine its electroacoustic efficiency and inter-element coupling under high acoustic power conditions. A series of in vivo porcine experiments demonstrated the ability to produce deep seated tissue lesions in thigh muscle using the large scale phased array. The array was used to heat and coagulate tissue volumes >5 cm(3) in a single ultrasound exposure using multiple foci and temporally scanned power deposition patterns. The spatial and temporal experimental results for large, heated focal volumes correlated very well with the simulated temperature response model for homogeneous tissue. A 25-cm(3) tissue volume was coagulated in a 90-min period using overlapping large ultrasound exposures.     

A theoretical assessment of the relative performance of spherical phased arrays for ultrasound surgery

Computer modeling of spherical-section phased arrays for ultrasound surgery (tissue ablation) is described. The influence on performance of the number of circular elements (68 to 1024), their diameter (2.5 to 10 mm), frequency (1 to 2 MHz), and degree of sparseness in the array is investigated for elements distributed randomly or in square, annular, and hexagonal patterns on a spherical shell (radius of curvature, 120 mm). Criteria for evaluating the quality of the intensity distributions obtained when focusing the arrays both on and away from their center of curvature, and in both single focus and simultaneous multiple foci modes, are proposed. Of the arrays studied, the most favorable performance, for both modes, is predicted for 256 5-mm diameter, randomly distributed elements. For the single focus mode, this performed better than regular arrays of 255 to 1024 elements and, for the case of nine simultaneous foci produced on a coplanar 3x3 grid with 4-mm spacing, better than square, hexagonal, or annular distributed arrays with a comparable number of elements. Randomization improved performance by suppressing grating lobes significantly. For single focus mode, a several-fold decrease in the number of elements could be made without degrading the quality of the intensity distribution.     

The combined concentric-ring and sector-vortex phased array for MRIguided ultrasound surgery

MRI guided ultrasound surgery requires small surgical equipment volumes to facilitate the treatment of larger patients in the limited space of a conventional MRI magnet. In addition, large focal volumes are required to reduce the treatment time of large tumors. The concentric-ring array is capable of moving the focus in one dimension, and previous studies have shown that a circular array composed of radial sectors is capable of producing enlarged focal volumes. These two array designs may be combined to create an array that is capable of both enlarging the focus and moving the focus along the axis of the array. Simulations were performed to predict the performance and capabilities of various combined array designs by using numerical routines to, calculate the acoustic power field, temperature distribution, and accumulated thermal dose. The results shown predict that the combined array can create necrosed tissue volumes over 30 times larger than the concentric-ring array while maintaining focal range. The simulation results were verified with an experimental array consisting of 13 rings and 4 sectors. In addition, simulations were performed where multiple focal patterns were cycled in the time domain to create an optimized heating pattern characterized by uniform thermal dose over the volume of the lesion. Such heating patterns resulted in a 40°C lower maximum temperature compared to single mode sonications while producing the same necrosed tissue volume, and yielded a rate of necrosis of 26.4 cm³ /h     

Focused beam control for ultrasound surgery with spherical-section phased array: sound field calculation and genetic optimization algorithm

This study aims at a sound field calculation for the spherical-section phased array and an optimization algorithm for the focus patterns of phased array ultrasound surgery. An efficient field calculation formula represented as an explicit expression is derived by the strategies of projection and binomial expansion. An optimization algorithm based on genetic algorithm is constructed by the suitable fitness function and the selection strategies. The simulation results of 256-element spherical-section phased array show the capability of controlling focus accurately and effectively with the combined method made up of the explicit expression method and the genetic optimization algorithm. The simulation results of single focus, multiple foci, on-axial focus, and off-axial focus further convince the feasibility of three-dimensional (3-D) focus steering with excellent acoustic performances. A single focus with the focus dimension of 1.25 mm x 1.25 mm x 7 mm and with the intensity of 6080 W/cm2 is formed. The multiple-focus pattern can enlarge the treatment volume 22 times larger than that of single focus with a sonication. In addition, a comparison between the explicit expression approach and the point source approach testifies to the applicability of the explicit expression approach. The experiment and simulation results of 16-element array actually confirm the feasibility of the combined method.     

Field conjugate acoustic lenses for ultrasound hyperthermia

Multipoint foci have been synthesized by applying the pseudoinverse field conjugation method to a single ultrasonic transducer coupled to a polystyrene lens. The lens design is based on phased array calculations are then fabricated on a computer-controlled milling machine. The measured beam patterns from the lenses agree closely with the beam patterns predicted by theory for the equivalent phased arrays. Temperature distributions from thermal modeling and those measured in tissue equivalent phantoms show that the lens system is capable of generating strongly localized, controlled temperature fields for hyperthermia.     

Noninvasive transesophageal cardiac thermal ablation using a 2-D focused, ultrasound phased array: a simulation study

This simulation study proposes a noninvasive, transesophageal cardiac-thermal ablation using a planar ultrasound phased array (1 MHz, 60 x 10 mm2, 0.525 mm interelement spacing, 114 x 20 elements). Thirty-nine foci in cardiac muscle were defined at 20, 40, and 60-mm distances and at various angles from the transducer surface to simulate the accessible posterior left atrial wall through the esophageal wall window. The ultrasound pressure distribution and the resulting thermal effect in a volume of 60 x 80 x 80 mm3, including esophagus and cardiac muscle, were simulated for each focus. For 1, 10, and 20-s sonications with 60 degrees C and 70 degrees C peak temperatures in cardiac muscle and without thermal damage in esophageal wall, the transducer acoustic powers were 105-727, 28-117, 21-79 W and 151-1044, 40-167, 30-114 W, respectively. The simulated lesions (thermal dose in equivalent minutes at 43 degrees C > or = 240 minutes) at these foci had lengths of 1-6, 3-11, 3-13 mm and 3-15, 5-19, 6-23 mm, respectively, and widths of 1-4, 2-7, 3-9 mm and 3-9, 4-13, 4-17 mm, respectively. As a first step toward feasibility, controllable tissue coagulation in cardiac tissue without damage to the esophagus was demonstrated numerically.     

The feasibility of using electrically focused ultrasound arrays to induce deep hyperthermia via body cavities

The results of a simulation study and subsequent experimental verification on the feasibility of using electrically focused arrays for intracavitary ultrasound hyperthermia are presented. The relative acoustic pressure fields from these cylindrical phased arrays were calculated for different dimensions and acoustic parameters to determine relevant design criteria. A thermal model based on the bioheat transfer equation was used to compute the resulting steady-state temperature distributions in tissue for various array configurations. This study has shown that cylindrical arrays of a practical size (75 mm long, 15 mm OD), resonating at 0.5 MHz with individual elements that are 1.5-mm wide, can preferentially heat regions that are between 20 and 50 mm from the surface of the array. In addition, it was shown that the temperature distribution can be further controlled by varying the focal position within the target volume, producing heated regions up to 40 mm wide. If practical constraints (i.e. number of amplifiers available or minimum element size attainable) become a limiting factor, arrays with wider elements would also be functional, but with certain restrictions applied to their flexible heating patterns. Thus, these electrically focused ultrasound arrays appear to offer a significant improvement over the existing intracavitary hyperthermia methods by producing a deeper and more controlled energy deposition.     

A cylindrical-section ultrasound phased-array applicator for hyperthermia cancer therapy

A phased-array applicator geometry for deep localized hyperthermia is presented. The array consists of rectangular transducer elements forming a section of a cylinder that conforms to the body portals in the abdominal and pelvic regions. Focusing and scanning properties of the cylindrical-section array are investigated in homogeneous lossy media using appropriate computer simulations. The characteristic focus of this array is shown to be spatially limited in both transverse and longitudinal directions with intensity gain values suitable for deep hyperthermia applications. The ability of the cylindrical-section phased array to generate multiple foci using the field conjugation method is examined. The effect of the grating lobes on the power deposition pattern of the scanned field is shown to be minimal. Steady-state temperature distributions are simulated using a three-dimensional thermal model of the normal tissue layers surrounding a tumor of typical volume. The advantages and the limitations of this array configuration are discussed.     

A method of reducing grating lobes associated with an ultrasoundlinear phased array intended for transrectal thermotherapy

Some practical aspects of planar linear ultrasound phased arrays for transrectal thermotherapy of prostate diseases are discussed. Several regimens for driving the array are investigated and spatial distributions of ultrasound intensities are measured in water and compared with computer simulations. Practical recommendations for suppressing grating lobes based on the use of subsets of elements and de-activation of several elements in the array are given. Treatment safety could be increased by adopting these measures since the relative intensities and power in grating lobes and other secondary intensity peaks are decreased, as is the overall ultrasound energy introduced into the body without significant reduction in the maximum power at the focus     

Thermal dose optimization via temporal switching in ultrasound surgery

Temporal switching has been simulated and implemented in vivo experiments as a method to optimize thermal dose in ultrasound surgery. By optimizing the thermal dose over a tissue volume, the peak temperature is decreased, less average power is expended, and overall treatment time is shortened. To test this hypothesis, a 16 element, spherically sectioned array has been constructed for application in ultrasound surgery guided by magnetic resonance imaging. A simulation study for the array was performed to determine an optimal treatment from a set of multiple focus fields. These fields were generated using the mode scanning technique with power levels determined numerically using a direct weighted gradient search in the attempt to create an optimally uniform thermal dose over a 0.6x0.6x1.0 cm(3) tissue volume. Comparisons of the switched fields and a static multiple focus field indicate that the switching technique can lower power requirements and decrease treatment time by 20%. More importantly, the peak temperature of the sonication was lowered 13 degrees C, thus decreasing the possibility of cavitation. The simulated results of the 16 element array were then experimentally tested using MRI to noninvasively monitor temperature elevations and predict lesion size in rabbit thigh muscle in vivo. In addition, the results show that the switching technique can be less sensitive to tissue inhomogeneities than static field sonication while creating contiguous necrosis regions at equal average powers.     

Treatment planning for hyperthermia with ultrasound phased arrays

Treatment planning for ultrasound phased arrays suggests a strategy for hyperthermia therapy which satisfies therapeutic conditions at the target and spares other sensitive anatomical structures. To predict both desirable and harmful interactions between ultrasound and important structures such as the tumor, bones, and air pockets, a hyperthermia treatment planning system has been developed for ultrasound phased arrays. This collection of treatment planning routines consists of geometric and thermal optimization procedures specific to ultrasound phased arrays, where geometric treatment planning, combined with thermal treatment planning and three-dimensional visualization, provides essential information for the optimization of individual patient treatments. A patient image data set for cancer of the prostate, a difficult target situated in the midst of multiple pelvic bone obstructions, illustrates the geometric treatment planning algorithm and other tools for treatment analysis. The results indicate that the analysis of complex three-dimensional relationships between the applicator, anatomical structures, and incident fields provides an important means of predicting treatment limiting conditions, thereby allowing the hyperthermia applicator to electronically adapt to individual patients and specific sites     

Sparse random ultrasound phased array for focal surgery

Ultrasound phased arrays offer several advantages over single focused transducer technology, enabling electronically programmable synthesis of focal size and shape, as well as position. While phased arrays have been employed for medical diagnostic and therapeutic (hyperthermia) applications, there remain fundamental problems associated with their use for surgery. These problems stem largely from the small size of each array element dictated by the wavelength employed at surgical application frequencies (2-4 MHz), the array aperture size required for the desired focal characteristics, and the number of array elements and electronic drive channels required to provide RF energy to the entire array. The present work involves the theoretical and experimental examination of novel ultrasound phased arrays consisting of array elements larger than one wavelength, minimizing the number of elements in an aperture through a combination of geometric focusing, directive beams, and sparse random placement of array elements, for tissue ablation applications. A hexagonally packed array consisting of 108 8-mm-diameter circular elements mounted on a spherical shell was modeled theoretically and a prototype array was constructed to examine the feasibility of sparse random array configurations for focal surgery. A randomly selected subset of elements of the prototype test array (64 of 108 available channels) was driven at 2.1 MHz with a 64-channel digitally controlled RF drive system. The performance of the prototype array was evaluated by comparing field data obtained from theoretical modeling to that obtained experimentally via hydrophone scanning. The results of that comparison, along with total acoustic power measurements, suggest that the use of sparse random phased arrays for focal surgery is feasible, and that the nature of array packing is an important determinant to observed performance     

Trans-skull ultrasound therapy: the feasibility of using image-derived skull thickness information to correct the phase distortion

Recent papers have shown that focused ultrasound therapy may be feasible in the brain through an intact human skull by using phased arrays to correct the phase distortion induced by the skull bone. The hypothesis of this study is that the required phase shifts for the phased array can be calculated from the skull shape and thickness provided by modern imaging techniques. The shape and thickness of a piece of human skull was traced from the serial images and used in a theoretical model to calculate the phase distribution for a phased array. A 76-element phased array was manufactured and used in the tests. The piece of skull and the transducer array were positioned in a waterbath, and the ultrasound field distributions were mapped with and without the phase correction. The image-derived phase correction produced a sharp focus through the skull. These results showed that ultrasound brain therapy may be executed completely noninvasively through an intact skull by using a phased array and the skull thickness information derived from MRI scans.     

Ultrasound surgery: comparison of strategies using phased arraysystems

In this paper the possibility of using phased array generated multiple-focus patterns to reduce the overall treatment time in ultrasound surgery while restraining prefocal heating was investigated. This was done by comparing through computer simulation the performance of different possible schemes, i.e., single-focus scans, multiple-focus scans, and simultaneous multiple focusing without scanning, when used to “ablate” a 10×10×10 mm³ tissue volume 100 mm deep. In all cases, 41 foci were used to cover the treatment volume. Multiple-focus scans were arranged into nine groups which were scanned in a raster fashion, as with single-focus scans. Keeping the treatment time constant, the maximum intensities, maximum thermal doses, dose distributions, and prefocal necrosis zones for the different schemes were compared. It was found that the nonscanned simultaneous multiple-focus case required the smallest maximum intensity and dose, and resulted in the most even dose distribution. Single-focus raster scanning of individual lesions, as currently used with fixed-focus transducers, gave the worst results. These results show that multiple-focus patterns help considerably in reducing the maximum intensity and dose, and in generating a more even dose distribution assuming the same treatment time and prefocal heating. Alternatively, multiple-focus patterns can be used to significantly reduce treatment time while keeping the maximum intensity and prefocal heating below predetermined limits     

Simulations of scanned focused ultrasound hyperthermia. the effects of scanning speed and pattern on the temperature fluctuations at the focal depth

A transient three-dimensional simulation program has been developed to investigate the effects of scanning speed, scanning pattern, blood perfusion, and transducer choice on the temperature fluctuations that occur during scanned focused ultrasound hyperthermia treatments. The model uses the bioheat transfer equation with uniform tissue properties to solve for the temperature field. The results show that the largest temperature fluctuations are always located on the scanning path in the acoustical focal plane and that the temperature fluctuation pattern and magnitudes are essentially the same, regardless of the focal depth. The results also show that the magnitude of these temperature fluctuations increases linearly with increasing scan times (decreasing scanning speeds) and increases as a weak exponential with the magnitude of the blood perfusion rate. Moreover, the smaller the diameter of the focus of the power field, the larger the temperature fluctuations. To avoid temperature fluctuations inside the scanned volume, scan time of 10 s of less were needed when single 2-cm-diameter circular scans were simulated at practical blood flow values. The general trends predicted by the simulations agree with the trends present in previously reported experiments, indicating that the simulations could be an important tool in patient treatment planning and temperature field approximations.     

Evaluation of accuracy of a theoretical model for predicting thenecrosed tissue volume during focused ultrasound surgery

The concept of thermal dose as a predictor for the size of the necrosed tissue volume during high-intensity focussed ultrasound surgery was tested. The sensitivity of the predicted lesion size to the uncertainties in the iso-dose constant, attenuation coefficient, and thermal dose threshold of necrosis was studied. The predicted lesion size appears to be independent of attenuation at some high attenuation values and certain depth in tissue. Thus, for a given target depth, a proper selection of frequency could minimize the lesion size variability due to uncertainty in the tissue attenuation. The predicted lesion size was less dependent on the uncertainties in the iso-dose constant and thermal dose of necrosis. The predictions of the model were compared with experimental data in rabbit muscle, and experimental data in cat and rat brain measured by others. The agreement was found to be good in most of the experiments. Similarly, the model was found to predict well the trends of increasing power and pulse duration     

Capacitive micromachined ultrasonic transducers: next-generation arrays for acoustic imaging?

Piezoelectric materials have dominated the ultrasonic transducer technology. Recently, capacitive micromachined ultrasonic transducers (CMUTs) have emerged as an alternative technology offering advantages such as wide bandwidth, ease of fabricating large arrays, and potential for integration with electronics. The aim of this paper is to demonstrate the viability of CMUTs for ultrasound imaging. We present the first pulse-echo phased array B-scan sector images using a 128-element, one-dimensional (1-D) linear CMUT array. We fabricated 64- and 128-element 1-D CMUT arrays with 100% yield and uniform element response across the arrays. These arrays have been operated in immersion with no failure or degradation in performance over the time. For imaging experiments, we built a resolution test phantom roughly mimicking the attenuation properties of soft tissue. We used a PC-based experimental system, including custom-designed electronic circuits to acquire the complete set of 128 x 128 RF A-scans from all transmit-receive element combinations. We obtained the pulse-echo frequency response by analyzing the echo signals from wire targets. These echo signals presented an 80% fractional bandwidth around 3 MHz, including the effect of attenuation in the propagating medium. We reconstructed the B-scan images with a sector angle of 90 degrees and an image depth of 210 mm through offline processing by using RF beamforming and synthetic phased array approaches. The measured 6-dB lateral and axial resolutions at 135 mm depth were 0.0144 radians and 0.3 mm, respectively. The electronic noise floor of the image was more than 50 dB below the maximum mainlobe magnitude. We also performed preliminary investigations on the effects of crosstalk among array elements on the image quality. In the near field, some artifacts were observable extending out from the array to a depth of 2 cm. A tail also was observed in the point spread function (PSF) in the axial direction, indicating the existence of crosstalk. The relative amplitude of this tail with respect to the mainlobe was less than -20 dB.     

Soft tissue temperature rise caused by scanned, diagnostic ultrasound

An acoustic-thermal model was developed for scanned diagnostic ultrasound in soft tissue. An adiabatic surface between the transducer and the skin was justified, and the model accounted for attenuation and focusing. The temperature along the central plane of the temporally averaged acoustic field was calculated by integration of line sources of heat that result from the tissue's absorption of ultrasound. The temperature profiles were calculated for 1400 transducers. The results show that current diagnostic transducers heat more significantly at the transducer-tissue interface than at the focus. The temperature rise in the focal region is typically less than 25% of that at the surface. The acoustic power per scan length that results in a 1 degrees C temperature rise at the surface is calculated as (210 mW-MHz/cm)/f. These results apply to both linear arrays and sectorlike scan formats. The temperature rises for simultaneous multimode scanned beams are additive as the peak temperatures of each mode will occur on the surface. Consideration was given to the surface boundary condition for such models. This boundary is considered adiabatic for calculation of heating due to acoustic absorption alone. Additional heating or cooling resulting from the transducer can then be superimposed on this solution.     

Transurethral ultrasound array for prostate thermal therapy:initial studies

This study presents the initial evaluation of an applicator designed for transurethral ultrasound thermotherapy (TUST) of prostate tissue in the treatment of benign prostatic hyperplasia (BPH) and cancer. A tubular multitransducer applicator, consisting of four piezoceramic tubes (2.5 mm diameter, 6 mm long, 6.8 MHz) under separate power control, was designed to fit within a semiflexible water-cooled temperature-regulated delivery catheter to be placed within the prostatic urethra during therapy. Sonication patterns were tailored to produce power depositions which avoid nontargeted tissues, such as the rectum. Computer simulations have demonstrated that 1.4-2.0 cm radial therapeutic zones (temperatures ⩾50-55°C, thermal doses >300 EM₄₃) with concurrent sparing of the urethral mucosa can be produced within prostate tissue having blood perfusion as high as 10 kg m^-3 s^-1 within 15-30 min. Acoustic distributions and power output measurements of a prototype applicator have demonstrated acoustic power levels approaching 10 W per each sectored transducer segment are attainable, with beam profiles collimated within the transducer length and with desired circumferential distributions. In vivo thermal dosimetry characterizations of these transurethral applicators have indicated that therapeutic temperatures between 50 and 90°C are attainable, controllable in the longitudinal and circumferential directions, and have effective radial heating. These results clearly indicate that transurethral ultrasound applicators have potential to provide improved spatial localization and control of the heating distribution over existing transurethral thermal therapy techniques for both hyperthermia and thermal coagulative therapy of the prostate