Finite-element analysis of temperature rise and lesion formation from catheter ultrasound ablation transducers

A model using finite-element analysis (FEA) has been developed to calculate the temperature rise in tissue from intracardiac ultrasound ablation catheters and to predict if this temperature rise is adequate for producing a lesion in the tissue. In the model, acoustic fields are simulated with Field II, and heat transfer is modeled with an FEA program. To validate the model, we compare its results to experimental results from an integrated, real-time three-dimensional (3-D) ultrasound imaging and ultrasound ablation catheter. The ultrasound ablation transducer is a ring transmitting at 10 MHz capable of producing an acoustic intensity of 16 W/cm2. It was used to ablate four lesions in tissue, and temperature rise as a function of time was monitored by embedded thermocouples. The average absolute difference between final temperatures predicted by FEA and those measured is 1.95 +/- 0.72 degrees C. Additionally, model and experimental lesion size are in good agreement. The model then is used to design a new ultrasound catheter with a 7.5 MHz linear phased array for ablation. Eight designs are modeled, and acoustic intensity, temperature rise, and ablation ability are compared.     

Integrated catheter for 3-D intracardiac echocardiography and ultrasound ablation

A catheter device with integrated ultrasound imaging array and ultrasound ablation transducer is introduced. This device has been designed for use in interventional cardiac procedures in which the cardiac anatomy is first imaged using real-time three-dimensional (3-D) ultrasound, then ablated to treat arrhythmias. The imaging array includes 112 elements operating at 5.4 MHz arranged in a 2-D matrix. Individual elements have a bandwidth of 21% and an insertion loss of 80 dB. The array has an azimuth resolution of 12 degrees and an elevation resolution of 8.7 degrees. The ablation transducer is a concentric piezoelectric transducer PZT-4 ring (outside diameter (O.D.), 4.5 mm, inside diameter (I.D.), 3.1 mm) operating at 10 MHz that surrounds the imaging array. It can produce a spatial-peak, temporal-average intensity up to 16 W/cm2. The entire device fits into a 9 Fr lumen with a 14 Fr tip to accommodate the ablation ring. With this device we have imaged, in realtime 3-D, a variety of targets including wire phantoms, fixed sheep hearts, and fresh bovine tissue. The ablation ring has been used to heat tissue-mimicking rubber 14 degrees C, as well as create lesions in fresh bovine tissue.     

Axial control of thermal coagulation using a multi-element interstitial ultrasound applicator with internal cooling

A multi-element, direct-coupled ultrasound (US) applicator with internal water cooling was investigated for axial control of interstitial thermal coagulation. A prototype implantable applicator was constructed with a linear array of three tubular PZT ultrasound transducers (each 2.5 mm OD, 10 mm length, 360 degrees emittance). Acoustic beam distributions from each element were measured and found to be collimated within the transducer length. The internally cooled applicator could sustain high levels of applied power to each transducer (0 to 40 W) and maintain acceptable applicator surface temperatures (<100 degrees C). Thermal performance of the applicator was investigated through heating trials in vivo (porcine thigh muscle and liver) and in vitro (bovine liver). The radial depth of thermal lesions produced was dependent on the applied power and sonication time and was controlled independently with power levels to each transducer element. With 18 W per element (applied electrical power) for 3 min, cylindrical thermal lesions were produced with a diameter of ~3 cm and a length ranging from 1.2 cm (with one element) to 3.5 cm (three elements). Higher powers (24 to 30 W) for 3 to 5 min provided increased depths of coagulation (~4 cm diameter lesions). Analysis of axial lesion shapes demonstrated that individual variation of power to each transducer element provided control of axial heating and depth of coagulation (for custom lesion shapes); lesion lengths corresponded to the number of active transducers. This ability to control the heating distribution dynamically along the length of the applicator has potential for improved target localization of thermal coagulation and necrosis in high temperature thermal therapy.     

Real-time, 3-D ultrasound with multiple transducer arrays

Modifications were made to a commercial real-time, three-dimensional (3-D) ultrasound system for near simultaneous 3-D scanning with two matrix array transducers. As a first illustration, a transducer cable assembly was modified to incorporate two independent, 3-D intra-cardiac echo catheters, a 7 Fr (2.3 mm O.D.) side scanning catheter and a 14 Fr (4.7 mm O.D) forward viewing catheter with accessory port, each catheter using 85 channels operating at 5 MHz. For applications in treatment of atrial fibrillation, the goal is to place the sideviewing catheter within the coronary sinus to view the whole left atrium, including a pulmonary vein. Meanwhile, the forward-viewing catheter inserted within the left atrium is directed toward the ostium of a pulmonary vein for therapy using the integrated accessory port. Using preloaded, phasing data, the scanner switches between catheters automatically, at the push of a button, with a delay of about 1 second, so that the clinician can view the therapy catheter with the coronary sinus catheter and vice versa. Preliminary imaging studies in a tissue phantom and in vivo show that our system successfully guided the forward-viewing catheter toward a target while being imaged with the sideviewing catheter. The forward-viewing catheter then was activated to monitor the target while we mimicked therapy delivery. In the future, the system will switch between 3-D probes on a line-by-line basis and display both volumes simultaneously.     

Acoustic radiation force impulse imaging of myocardial radiofrequency ablation: initial in vivo results

Acoustic radiation force impulse (ARFI) imaging techniques were used to monitor radiofrequency (RF) ablation of ovine cardiac tissue in vivo. Additionally, ARFI M-mode imaging methods were used to interrogate both healthy and ablated regions of myocardial tissue. Although induced cardiac lesions were not visualized well in conventional B-mode images, ARFI images of ablation procedures allowed determination of lesion location, shape, and relative size through time. The ARFI M-mode images were capable of distinguishing differences in behavior through the cardiac cycle between healthy and damaged tissue regions. As conventional sonography is often used to guide ablation catheters, ARFI imaging, which requires no additional equipment, may be a convenient modality for monitoring lesion formation in vivo.     

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.     

Annular phased-array high-intensity focused ultrasound device for image-guided therapy of uterine fibroids

An ultrasound (US), image-guided high-intensity focused ultrasound (HIFU) device was developed for noninvasive ablation of uterine fibroids. The HIFU device was an annular phased array, with a focal depth range of 30-60 mm, a natural focus of 50 mm, and a resonant frequency of 3 MHz. The in-house control software was developed to operate the HIFU electronics drive system for inducing tissue coagulation at different distances from the array. A novel imaging algorithm was developed to minimize the HIFU-induced noise in the US images. The device was able to produce lesions in bovine serum albumin-embedded polyacrylamide gels and excised pig liver. The lesions could be seen on the US images as hyperechoic regions. Depths ranging from 30 to 60 mm were sonicated at acoustic intensities of 4100 and 6100 W/cm2 for 15 s each, with the latter producing average lesion volumes at least 63% larger than the former. Tissue sonication patterns that began distal to the transducer produced longer lesions than those that began proximally. The variation in lesion dimensions indicates the possible development of HIFU protocols that increase HIFU throughput and shorten tumor treatment times.     

Monitoring of thermal therapy based on shear modulus changes: II. Shear wave imaging of thermal lesions

The clinical applicability of high-intensity focused ultrasound (HIFU) for noninvasive therapy is currently hampered by the lack of robust and real-time monitoring of tissue damage during treatment. The goal of this study is to show that the estimation of local tissue elasticity from shear wave imaging (SWI) can lead to a precise mapping of the lesion. HIFU treatment and monitoring were respectively performed using a confocal setup consisting of a 2.5-MHz single element transducer focused at 34 mm on ex vivo samples and an 8-MHz ultrasound diagnostic probe. Ultrasound-based strain imaging was combined with shear wave imaging on the same device. The SWI sequences consisted of 2 successive shear waves induced at different lateral positions. Each wave was created with pushing beams of 100 μs at 3 depths. The shear wave propagation was acquired at 17,000 frames/s, from which the elasticity map was recovered. HIFU sonications were interleaved with fast imaging acquisitions, allowing a duty cycle of more than 90%. Thus, elasticity and strain mapping was achieved every 3 s, leading to real-time monitoring of the treatment. When thermal damage occurs, tissue stiffness was found to increase up to 4-fold and strain imaging showed strong shrinkages that blur the temperature information. We show that strain imaging elastograms are not easy to interpret for accurate lesion characterization, but SWI provides a quantitative mapping of the thermal lesion. Moreover, the concept of shear wave thermometry (SWT) developed in the companion paper allows mapping temperature with the same method. Combined SWT and shear wave imaging can map the lesion stiffening and temperature outside the lesion, which could be used to predict the eventual lesion growth by thermal dose calculation. Finally, SWI is shown to be robust to motion and reliable in vivo on sheep muscle.     

The acoustic lens design and in vivo use of a multifunctional catheter combining intracardiac ultrasound imaging and electrophysiology sensing

A multifunctional 9F intracardiac imaging and electrophysiology mapping catheter was developed and tested to help guide diagnostic and therapeutic intracardiac electrophysiology (EP) procedures. The catheter tip includes a 7.25-MHz, 64-element, side-looking phased array for high resolution sector scanning. Multiple electrophysiology mapping sensors were mounted as ring electrodes near the array for electrocardiographic synchronization of ultrasound images. The catheter array elevation beam performance in particular was investigated. An acoustic lens for the distal tip array designed with a round cross section can produce an acceptable elevation beam shape; however, the velocity of sound in the lens material should be approximately 155 m/s slower than in tissue for the best beam shape and wide bandwidth performance. To help establish the catheter's unique ability for integration with electrophysiology interventional procedures, it was used in vivo in a porcine animal model, and demonstrated both useful intracardiac echocardiographic visualization and simultaneous 3-D positional information using integrated electroanatomical mapping techniques. The catheter also performed well in high frame rate imaging, color flow imaging, and strain rate imaging of atrial and ventricular structures.     

Multifunctional catheters combining intracardiac ultrasound imaging and electrophysiology sensing

A family of 3 multifunctional intracardiac imaging and electrophysiology (EP) mapping catheters has been in development to help guide diagnostic and therapeutic intracardiac EP procedures. The catheter tip on the first device includes a 7.5 MHz, 64-element, side-looking phased array for high resolution sector scanning. The second device is a forward-looking catheter with a 24-element 14 MHz phased array. Both of these catheters operate on a commercial imaging system with standard software. Multiple EP mapping sensors were mounted as ring electrodes near the arrays for electrocardiographic synchronization of ultrasound images and used for unique integration with EP mapping technologies. To help establish the catheters' ability for integration with EP interventional procedures, tests were performed in vivo in a porcine animal model to demonstrate both useful intracardiac echocardiographic (ICE) visualization and simultaneous 3-D positional information using integrated electroanatomical mapping techniques. The catheters also performed well in high frame rate imaging, color flow imaging, and strain rate imaging of atrial and ventricular structures. The companion paper of this work discusses the catheter design of the side-looking catheter with special attention to acoustic lens design. The third device in development is a 10 MHz forward-looking ring array that is to be mounted at the distal tip of a 9F catheter to permit use of the available catheter lumen for adjunctive therapy tools.     

Intravascular Raman spectroscopic catheter for molecular diagnosis of atherosclerotic coronary disease

An intravascular catheter for Raman spectroscopic detection and analysis of coronary atherosclerotic disease has been developed. The catheter, having an outer diameter of 2 mm, consisted of a side-view-type micro-Raman probe, an imaging fiber bundle, a working channel (injection drain), and a balloon. By inflating the balloon, the probe was brought close to the inner wall of a modeled blood flow system and detected a phantom target buried in the wall. Results obtained demonstrate the possibility of using the spectroscopic catheter for molecular diagnosis of coronary lesions.     

An ultrasonic transducer for second harmonic imaging using a LiNbO3 plate with a local ferroelectric inversion layer

A new lithium niobate (LiNbO3) transducer of separated transmitter-receiver configuration is proposed for application to second harmonic imaging in a high-frequency range. In this transducer, a domain-inverted layer of half the plate thickness is formed selectively by Ti-diffusion and heat treatment in the central part of a LiNbO3 plate. The uniformly polarized surrounding region is used as the transmitter that will generate the fundamental wave component. A transducer with the transmission frequency of 50 MHz and the reception frequency of 100 MHz is fabricated using a 36 degrees rotated Y-cut LiNbO3 plate, and its performance is demonstrated.     

Feasibility of MR-temperature mapping of ultrasonic heating from a CMUT

In the last decade, high intensity focused ultrasound (HIFU) has gained popularity as a minimally invasive and noninvasive therapeutic tool for treatment of cancers, arrhythmias, and other medical conditions. HIFU therapy is often guided by magnetic resonance imaging (MRI), which provides anatomical images for therapeutic device placement, temperature maps for treatment guidance, and postoperative evaluation of the region of interest. While piezoelectric transducers are dominantly used for MR-guided HIFU, capacitive micromachined ultrasonic transducers (CMUTs) show competitive advantages, such as ease of fabrication, integration with electronics, improved efficiency, and reduction of self-heating. In this paper, we will show our first results of an unfocused CMUT transducer monitored by MR-temperature maps. This 2.51 mm by 2.32 mm, unfocused CMUT heated a HIFU phantom by 14 degrees C in 2.5 min. This temperature rise was successfully monitored by MR thermometry in a 3.0 T General Electric scanner.     

Dual-mode IVUS catheter for intracranial image-guided hyperthermia: feasibility study

In this study, we investigated the feasibility of modifying 3-Fr IVUS catheters in several designs to potentially achieve minimally-invasive, endovascular access for image-guided ultrasound hyperthermia treatment of tumors in the brain. Using a plane wave approximation, target frequencies of 8.7 and 3.5 MHz were considered optimal for heating at depths (tumor sizes) of 1 and 2.5 cm, respectively. First, a 3.5-Fr IVUS catheter with a 0.7-mm diameter transducer (30 MHz nominal frequency) was driven at 8.6 MHz. Second, for a low-frequency design, a 220-μm-thick, 0.35 x 0.35-mm PZT-4 transducer--driven at width-mode resonance of 3.85 MHz--replaced a 40-MHz element in a 3.5-Fr coronary imaging catheter. Third, a 5 x 0.5-mm PZT-4 transducer was evaluated as the largest aperture geometry possible for a flexible 3-Fr IVUS catheter. Beam plots and on-axis heating profiles were simulated for each aperture, and test transducers were fabricated. The electrical impedance, impulse response, frequency response, maximum intensity, and mechanical index were measured to assess performance. For the 5 x 0.5-mm transducer, this testing also included mechanically scanning and reconstructing an image of a 2.5-cm-diameter cyst phantom as a preliminary measure of imaging potential.     

Design and fabrication of PZN-7%PT single crystal high frequency angled needle ultrasound transducers

A high-frequency angled needle ultrasound transducer with an aperture size of 0.4 x 0.56 mm2 was fabricated using a lead zinc niobate-lead titanate (PZN- 7%PT) single crystal as the active piezoelectric material. The single crystal was bonded to a conductive silver particle matching layer and a conductive epoxy backing material through direct contact curing. A parylene outer matching layer was formed by vapor deposition. Angled needle probe configuration was achieved by dicing at 45 degrees to the single crystal poling direction to satisfy a clinical request for blood flow measurement in the posterior portion of the eye. The electrical impedance magnitude and phase of the transducer were 42 Omega and -63 degrees , respectively. The measured center frequency and the fractional bandwidth at -6 dB were 43 MHz and 45%, respectively. The two-way insertion loss was approximately 17 dB. Wire phantom imaging using fabricated PZN-7%PT single crystal transducers was obtained and spatial resolutions were assessed.     

Single-element ultrasound transducer for combined vessel localization and ablation

This report describes a system that utilizes a single high-intensity focused ultrasound (HIFU) transducer for both the localization and ablation of arteries with internal diameters of 0.5 and 1.3 mm. In vitro and in vivo tests were performed to demonstrate both the imaging and ablation functionalities of this system. For imaging mode, pulsed acoustic waves (3 cycles for in vitro and 10 cycles for in vivo tests, 2 MPa peak pressure) were emitted from the 2-MHz HIFU transducer, and the backscattered ultrasonic signal was collected by the same transducer to calculate Doppler shifts in the target region. The maximum signal amplitude of the Doppler shift was used to determine the location of the target vessel. The operation mode was then switched to the therapeutic mode and vessel occlusion was successfully produced by high-intensity continuous HIFU waves (12 MPa) for 60 s. The system was then switched back to imaging mode for residual flow to determine the need for a second ablation treatment. The new system might be used to target and occlude unwanted vessels such as vasculature around tumors, and to help with tumor destruction.     

Motion artifact reduction for IVUS-based thermal strain imaging

Thermal strain imaging (TSI) using intravascular ultrasound (IVUS) has the potential to identify lipid pools within rupture-prone arterial plaques and serve as a valuable supplement to current IVUS systems in diagnosing acute coronary syndromes. The major challenge for in vivo application of TSI will be cardiac motion, including bulk motion and tissue deformation. Simulations based on an artery model, including a lipid-filled plaque, demonstrate that effective bulk motion compensation can be achieved within a certain motion range using spatial interpolation. We also propose a practical imaging scheme to minimize mechanical strains caused by tissue deformation based on a linear least squares fitting strategy. This scheme was tested on clinical data by artificially superimposing thermal displacements corresponding to different temperature rises. Results suggest a 1-2 degrees C temperature rise is required to detect lipids in an atherosclerotic plaque in vivo.     

Vector-velocity estimation in swept-scan using a K-space approach

The swept-scan technique (i.e., continuously moving a single-crystal transducer during pulse-echo data acquisition) is used in high-frequency, ultrasonic flow imaging. Relative to the conventional step-scan technique, swept scanning improves the rate of data acquisition and enables near-real-time, high-frequency color flow mapping. However, the continuous transducer movement may have non-negligible effects on accuracy of velocity estimation. This paper introduces a spatial frequency domain (i.e., k-space) approach that quantifies the effects of both lateral and axial motions in a swept scan. It is shown that the k-space representation is equivalent to a Doppler-radio frequency (RF) frequency domain representation, and that transducer movement in the swept-scan technique results in a change in Doppler bandwidth. In addition, a vector velocity estimator is developed based on the proposed k-space approach. Both simulations and flow-phantom experiments were performed to evaluate the performance of the proposed vector velocity estimator. A 45-MHz transducer was scanned at 20 mm/s. The Doppler angle ranged from 29 degrees to 90 degrees, and the flow velocities ranged from 15 to 30 mm/s. The results show that the proposed k-space vector velocity estimator exhibited a mean error of 2.6 degrees for flow-direction estimation, with the standard deviation ranging from 2.2 degrees to 8.2 degrees. In comparison, for the conventional spectral-broadening-based vector velocity estimator ignoring the swept-scan effect, the mean error became 15 degrees and the standard deviations were from 2.7 degrees to 6.6 degrees.     

Lithium niobate transducers for MRI-guided ultrasonic microsurgery

Focused ultrasound surgery (FUS) is usually based on frequencies below 5 MHz-typically around 1 MHz. Although this allows good penetration into tissue, it limits the minimum lesion dimensions that can be achieved. In this study, we investigate devices to allow FUS at much higher frequencies, in principle, reducing the minimum lesion dimensions. Furthermore, FUS can produce deep-sub-millimeter demarcation between viable and necrosed tissue; high-frequency devices may allow this to be exploited in superficial applications which may include dermatology, ophthalmology, treatment of the vascular system, and treatment of early dysplasia in epithelial tissue. In this paper, we explain the methodology we have used to build high-frequency high-intensity transducers using Y-36°-cut lithium niobate. This material was chosen because its low losses give it the potential to allow very-high-frequency operation at harmonics of the fundamental operating frequency. A range of single-element transducers with center frequencies between 6.6 and 20.0 MHz were built and the transducers' efficiency and acoustic power output were measured. A focused 6.6-MHz transducer was built with multiple elements operating together and tested using an ultrasound phantom and MRI scans. It was shown to increase phantom temperature by 32°C in a localized area of 2.5 x 3.4 mm in the plane of the MRI scan. Ex vivo tests on poultry tissue were also performed and shown to create lesions of similar dimensions. This study, therefore, demonstrates that it is feasible to produce high-frequency transducers capable of high-resolution FUS using lithium niobate.     

Intracardiac catheter 2-D arrays on a silicon substrate

The design, fabrication, and characterization of a 7 MHz, two-dimensional (2-D) array transducer built on a silicon substrate is described. The array fits inside a 9-French (2.9 mm O.D.) catheter for use in real-time intracardiac volumetric imaging. The -6 dB fractional bandwidth of the transducer is 30%, the 50 /spl Omega/ pitch-catch insertion loss is 78 dB, and the interelement crosstalk is -25 dB. Realtime volumetric images in phantoms and in-vitro images of a sheep heart have been acquired yielding measured spatial resolution of 2 mm at a depth of 1 cm. The cardiac structures imaged include ventricular chambers, interventricular septum, mitral and tricuspid valves and real-time 3-D rendered volumes of the tricuspid valve in the open and closed position.