[Show abstract][Hide abstract] ABSTRACT: The primary objective was to test in vivo for the first time the general operation of a new multifunctional intracardiac echocardiography (ICE) catheter constructed with a microlinear capacitive micromachined ultrasound transducer (ML-CMUT) imaging array. Secondarily, we examined the compatibility of this catheter with electroanatomic mapping (EAM) guidance and also as a radiofrequency ablation (RFA) catheter. Preliminary thermal strain imaging (TSI)-derived temperature data were obtained from within the endocardium simultaneously during RFA to show the feasibility of direct ablation guidance procedures.
The new 9F forward-looking ICE catheter was constructed with 3 complementary technologies: a CMUT imaging array with a custom electronic array buffer, catheter surface electrodes for EAM guidance, and a special ablation tip, that permits simultaneous TSI and RFA. In vivo imaging studies of 5 anesthetized porcine models with 5 CMUT catheters were performed.
The ML-CMUT ICE catheter provided high-resolution real-time wideband 2-dimensional (2D) images at greater than 8 MHz and is capable of both RFA and EAM guidance. Although the 24-element array aperture dimension is only 1.5 mm, the imaging depth of penetration is greater than 30 mm. The specially designed ultrasound-compatible metalized plastic tip allowed simultaneous imaging during ablation and direct acquisition of TSI data for tissue ablation temperatures. Postprocessing analysis showed a first-order correlation between TSI and temperature, permitting early development temperature-time relationships at specific myocardial ablation sites.
Multifunctional forward-looking ML-CMUT ICE catheters, with simultaneous intracardiac guidance, ultrasound imaging, and RFA, may offer a new means to improve interventional ablation procedures.
Journal of ultrasound in medicine: official journal of the American Institute of Ultrasound in Medicine 02/2012; 31(2):247-56. · 1.54 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: A method is introduced to monitor cardiac ablative therapy by examining slope changes in the thermal strain curve caused by speed of sound variations with temperature. The sound speed of water-bearing tissue such as cardiac muscle increases with temperature. However, at temperatures above about 50°C, there is no further increase in the sound speed and the temperature coefficient may become slightly negative. For ablation therapy, an irreversible injury to tissue and a complete heart block occurs in the range of 48 to 50°C for a short period in accordance with the well-known Arrhenius equation. Using these two properties, we propose a potential tool to detect the moment when tissue damage occurs by using the reduced slope in the thermal strain curve as a function of heating time. We have illustrated the feasibility of this method initially using porcine myocardium in vitro. The method was further demonstrated in vivo, using a specially equipped ablation tip and an 11-MHz microlinear intracardiac echocardiography (ICE) array mounted on the tip of a catheter. The thermal strain curves showed a plateau, strongly suggesting that the temperature reached at least 50°C.
IEEE transactions on ultrasonics, ferroelectrics, and frequency control 07/2011; 58(7):1406-17. DOI:10.1109/TUFFC.2011.1960 · 1.51 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Atrial fibrillation, the most common type of cardiac arrhythmia, now affects more than 2.2 million adults in the US alone. Currently, electrophysiological interventions are performed under fluoroscopy guidance, a procedure that introduces harmful ionizing radiation without providing adequate soft-tissue resolution. Intracardiac echocardiography (ICE) provides real-time, high-resolution anatomical information, reduces fluoroscopy time, and enhances procedural success. We have previously developed a forward-looking, volumetric ICE catheter using a ring-shaped, 64-element capacitive micromachined ultrasonic transducer (CMUT) array with a 10MHz center frequency. The Ring array was flip-chip bonded to a flexible PCB along with 8 identical custom ASICs providing a total of 64 dedicated preamplifiers. The flex was then reshaped for integration with the catheter shaft. In the second-generation catheter, 72 micro-coaxial cables (reduced from 100) are terminated on a newly designed flex to provide the connection between the array electronics and the imaging system. The reduced number of cables enhances the catheter's steerability. Furthermore, the new flex allows grounding of the top CMUT electrode through proper level-shifting of the ASIC supplies without additional circuitry. This feature enables complete ground shielding of the catheter, which improves its noise susceptibility and is an important safety measure for its clinical use. Beyond real-time, forward-looking imaging capability, the Ring catheter provides a continuous central lumen, enabling convenient delivery of other devices such as HIFU transducers, RF ablation catheters, etc. Using a PC-based imaging platform from Verasonics and a commercial Vivid7 imaging system from GE, we have demonstrated the in vivo, volumetric, real-time imaging capability of the finalized Ring catheter in a pig heart.
[Show abstract][Hide abstract] ABSTRACT: Atrial fibrillation, the most common type of cardiac arrhythmia, now affects more than 2.2 million adults in the US alone. Currently, electrophysiological interventions are performed under fluoroscopy guidance, which besides its harmful ionizing radiation does not provide adequate soft-tissue resolution. Intracardiac echocardiography (ICE) provides real-time anatomical information that has proven valuable in reducing the fluoroscopy time and enhancing procedural success. We developed two types of forward-looking ICE catheters using capacitive micromachined ultrasonic transducer (CMUT) technology: MicroLinear (ML) and ring catheters. The ML catheter enables real-time forward-looking 2-D imaging using a 24-element 1-D CMUT phased-array that is designed for a center frequency of 10 MHz. The ring catheter uses a 64-element ring CMUT array that is also designed for a center frequency of 10 MHz. However, this ring-shaped 2-D array enables real-time forward-looking volumetric imaging. In addition, this catheter provides a continuous central lumen that enables convenient delivery of other devices such as RF ablation catheter, EP diagnostic catheter, biopsy devices, etc. Both catheters are equipped with custom front-end IC's that are integrated with the CMUT arrays at the tip of the catheters. The integration of the IC's with the CMUT arrays was accomplished using custom flexible PCB's. We also developed several image reconstruction schemes for the ring catheter on a PC-based imaging platform from VeraSonics. We performed a variety of bench-top characterizations to validate the functionality and performance of our fully integrated CMUT arrays. Using both catheters, we demonstrated in vivo images of the heart in a porcine animal model. We have successfully prototyped the first CMUT-based ICE catheters and proven the capabilities of the CMUT technology for implementing high-frequency miniature transducer arrays with integrated electronics.
[Show abstract][Hide abstract] ABSTRACT: Capacitive micromachined ultrasonic transducer (CMUT) arrays are conveniently integrated with frontend integrated circuits either monolithically or in a hybrid multichip form. This integration helps with reducing the number of active data processing channels for 2D arrays. This approach also preserves the signal integrity for arrays with small elements. Therefore CMUT arrays integrated with electronic circuits are most suitable to implement miniaturized probes required for many intravascular, intracardiac, and endoscopic applications. This paper presents examples of miniaturized CMUT probes utilizing 1D, 2D, and ring arrays with integrated electronics.
Conference proceedings: ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Conference 01/2010; 2010:5987-90. DOI:10.1109/IEMBS.2010.5627580
[Show abstract][Hide abstract] ABSTRACT: Currently the feedback guidance of intracardiac radiofrequency ablation (RFA) is very limited, offering only a catheter electrode (not tissue) temperature estimation and a means to titrate radiofrequency (RF) power delivery to the tissue. Our "MicroLinear" (ML) forward imaging ultrasound catheter design, now at a true 9F (3mm) in size, has been optimized with several features to simultaneously permit, a) high quality intracardiac steering and imaging, b) tracking of 3D position with electroanatomical mapping, c) RF ablation, and d) tissue thermal strain (TS) estimation for direct tissue temperature feedback. Two types of ML catheters have been built and tested in 3 porcine animal models. The first type, in its third generation, is based on a PZT transducer array; the second type, in its second generation, is based on a CMUT array with custom integrated interface circuitry. Both types of devices are true 9F in size and performed well in imaging tests in recent in vivo studies. Both the ML-PZT and ML-CMUT arrays, as described previously, have a fine pitch (65 and 63 micron respectively) 24 element phased arrays operating at 14 MHz which project a B-mode plane directly out from the tip of the catheter. Intracardiac imaging performance was documented to show that the very small array apertures of the ML design (1.2mm × 1.58mm, and 1.1mm × 1.4mm) permit good, high resolution imaging to depths as great as 4 cm. The ML-PZT catheter was equipped with a special low profile ablation tip which allowed simultaneous imaging and ablation at the distal end of the catheter. TS data were acquired during tissue ablations in right atrium (RA) and right ventricle (RV). The TS data of the RF ablations were processed off line. In vivo use of this new technology has shown for the first time the very substantial potential for a single, low profile catheter to simultaneously image within the heart and perform intracardiac ablation therapy with tissue temperature guidance pro- - duced from the incorporation of TS imaging. Work is underway to further assess the temperature estimation accuracy and to integrate the TS processing for real time displays.
[Show abstract][Hide abstract] ABSTRACT: Atrial fibrillation is the most common type of cardiac arrhythmia that now affects over 2.2 million adults in the United States alone. Currently fluoroscopy is the most common method for guiding interventional electrophysiological procedures. We are developing a 9-F forward-looking intracardiac ultrasound catheter for real-time volumetric imaging. We designed and fabricated a 64-element 10-MHz CMUT ring array with through-wafer via interconnects. We also designed custom front-end electronics to be closely integrated with the CMUT array at the tip of the catheter for improved SNR. This integrated circuit (IC) is composed of preamplifiers and protection circuitry, and can directly interface a standard imaging system. This multi-channel IC is capable of passing up to Â±50-V bipolar pulses. An 8-channel front-end IC was fabricated based on this circuit topology. Additionally, a flexible PCB was designed for the integration of ring array with front-end electronics. We have acquired a PC-based real-time imaging platform and demonstrated real-time imaging with the ring array. We have also shown volume images using off-line full synthetic aperture image reconstruction method. The presented experimental results demonstrate the performance of our forward-looking volumetric intracardiac imaging approach. We are currently working on the final catheter integration and further development of our real-time imaging methods.