A Low-Cost Miniature Histotripsy Transducer for Precision Tissue Ablation.

A miniature, 10 mm aperture histotripsy transducer with an f-number of 0.7 was fabricated using an elliptically shaped aluminum lens, which was epoxy-bonded to an air-backed 5.0 MHz, PTZ-5A, 1-3 dice-and-fill piezoelectric composite, and the lens coupled to water using a quarter-wavelength matching layer of Parylene-C. A Krimholtz-Leedom-Matthaei model of the device and curved lens was developed. The epoxy layer resulted in an increased power output at 6.8 MHz compared to the 5 MHz composite design. Cavitation was observed in water by driving the composite with a 173 V single-cycle, unipolar 6.8 MHz pulse at a pulse repetition frequency of 50 Hz, and a bubble cloud 264 long by 124 wide was measured. A coregistered imaging and ablation device was also fabricated and characterized. The coregistered device was modified to include a mm square hole through the center, allowing access for a high-frequency imaging array, and both imaging and ablation are demonstrated in cerebral tissue with this device. Radial -3 dB beam widths were measured as 0.145 and 0.116 mm, and axial -3 dB depths of field were 0.698 and 0.752 mm for the noncoregistered and coregistered transducers, respectively. Total material cost for the transducer and pulser board is below $200 USD.

A case-controlled study comparing harmonic versus electrosurgery in laparoscopic myomectomy.

OBJECTIVE: To compare the safety and effectiveness of the harmonic scalpel and conventional electrosurgery in laparoscopic myomectomy (LM). MATERIALS AND METHODS: We performed a retrospective chart review of 591 women with symptomatic uterine fibroids who underwent LM. Thirty-three cases of LMs with harmonic scalpel (LMH) were compared with a matched control group that underwent conventional electrosurgery (LME). Outcome measures for both groups were studied comparatively in terms of the amount of blood loss, requirement of blood transfusion, length of operative time, cost, and hospital stay. RESULTS: There was no incidence of switching to abdominal laparotomy. Length of postoperative stay was significantly lower in the LMH group than in the LME group (2.0±0.4 days vs. 2.5±0.7 days, p<0.001), but the hospital charges were significantly higher in the LMH group than in the LME group (39,207.7±9315.0 new Taiwan dollar vs. 24,078.4±11,051.3 new Taiwan dollar, p<0.001). Four minor complications were noted in the LME group; two developed lower-grade febrile morbidity, one had urinary tract infection, and one had subcutaneous ecchymosis at the left ancillary port site. Length of operation, blood loss, hemoglobin decrease, and requirement of blood transfusion were not significantly different between the two groups. CONCLUSION: Harmonic scalpel is as safe and effective as conventional electrosurgery, and may offer an alternative option for patients undergoing LM. Harmonic scalpel has advantage over conventional electrosurgery in less postoperative hospital stay but disadvantage in higher cost.

Assessment of Gold Nanoparticle-Mediated-Enhanced Hyperthermia Using MR-Guided High-Intensity Focused Ultrasound Ablation Procedure.

High-intensity focused ultrasound (HIFU) has gained increasing popularity as a noninvasive therapeutic procedure to treat solid tumors. However, collateral damage due to the use of high acoustic powers during HIFU procedures remains a challenge. The objective of this study is to assess the utility of using gold nanoparticles (gNPs) during HIFU procedures to locally enhance heating at low powers, thereby reducing the likelihood of collateral damage. Phantoms containing tissue-mimicking material (TMM) and physiologically relevant concentrations (0%, 0.0625%, and 0.125%) of gNPs were fabricated. Sonications at acoustic powers of 10, 15, and 20 W were performed for a duration of 16 s using an MR-HIFU system. Temperature rises and lesion volumes were calculated and compared for phantoms with and without gNPs. For an acoustic power of 10 W, the maximum temperature rise increased by 32% and 43% for gNPs concentrations of 0.0625% and 0.125%, respectively, when compared to the 0% gNPs concentration. For the power of 15 W, a lesion volume of 0, 44.5 ± 7, and 63.4 ± 32 mm3 was calculated for the gNPs concentration of 0%, 0.0625%, and 0.125%, respectively. For a power of 20 W, it was found that the lesion volume doubled and tripled for concentrations of 0.0625% and 0.125% gNPs, respectively, when compared to the concentration of 0% gNPs. We conclude that gNPs have the potential to locally enhance the heating and reduce damage to healthy tissue during tumor ablation using HIFU.

Modeling-based design and assessment of an acousto-optic guided high-intensity focused ultrasound system.

Real-time acousto-optic (AO) sensing has been shown to noninvasively detect changes in ex vivo tissue optical properties during high-intensity focused ultrasound (HIFU) exposures. The technique is particularly appropriate for monitoring noncavitating lesions that offer minimal acoustic contrast. A numerical model is presented for an AO-guided HIFU system with an illumination wavelength of 1064 nm and an acoustic frequency of 1.1 MHz. To confirm the model's accuracy, it is compared to previously published experimental data gathered during AO-guided HIFU in chicken breast. The model is used to determine an optimal design for an AO-guided HIFU system, to assess its robustness, and to predict its efficacy for the ablation of large volumes. It was found that a through transmission geometry results in the best performance, and an optical wavelength around 800 nm was optimal as it provided sufficient contrast with low absorption. Finally, it was shown that the strategy employed while treating large volumes with AO guidance has a major impact on the resulting necrotic volume and symmetry.

Magnetic resonance imaging assessment of effective ablated volume following high intensity focused ultrasound.

Under magnetic resonance (MR) guidance, high intensity focused ultrasound (HIFU) is capable of precise and accurate delivery of thermal dose to tissues. Given the excellent soft tissue imaging capabilities of MRI, but the lack of data on the correlation of MRI findings to histology following HIFU, we sought to examine tumor response to HIFU ablation to determine whether there was a correlation between histological findings and common MR imaging protocols in the assessment of the extent of thermal damage. Female FVB mice (n = 34), bearing bilateral neu deletion tumors, were unilaterally insonated under MR guidance, with the contralateral tumor as a control. Between one and five spots (focal size 0.5 × 0.5 × 2.5 mm3) were insonated per tumor with each spot receiving approximately 74.2 J of acoustic energy over a period of 7 seconds. Animals were then imaged on a 7T MR scanner with several protocols. T1 weighted images (with and without gadolinium contrast) were collected in addition to a series of T2 weighted and diffusion weighted images (for later reconstruction into T2 and apparent diffusion coefficient maps), immediately following ablation and at 6, 24, and 48 hours post treatment. Animals were sacrificed at each time point and both insonated/treated and contralateral tumors removed and stained for NADH-diaphorase, caspase 3, or with hematoxylin and eosin (H&E). We found the area of non-enhancement on contrast enhanced T1 weighted imaging immediately post ablation correlated with the region of tissue receiving a thermal dose CEM43 ≥ 240 min. Moreover, while both tumor T2 and apparent diffusion coefficient values changed from pre-ablation values, contrast enhanced T1 weighted images appeared to be more senstive to changes in tissue viability following HIFU ablation.

Photoacoustic detection and optical spectroscopy of high-intensity focused ultrasound-induced thermal lesions in biologic tissue.

PURPOSE: The aims of this study are: (a) to investigate the capability of photoacoustic (PA) method in detecting high-intensity focused ultrasound (HIFU) treatments in muscle tissues in vitro; and (b) to determine the optical properties of HIFU-treated and native tissues in order to assist in the interpretation of the observed contrast in PA detection of HIFU treatments. METHODS: A single-element, spherically concaved HIFU transducer with a centre frequency of 1 MHz was utilized to create thermal lesions in chicken breast tissues in vitro. To investigate the detectability of HIFU treatments photoacoustically, PA detection was performed at 720 and 845 nm on seven HIFU-treated tissue samples. Within each tissue sample, PA signals were acquired from 22 locations equally divided between two regions of interest within two volumes in tissue - a HIFU-treated volume and an untreated volume. Optical spectroscopy was then carried out on 10 HIFU-treated chicken breast specimens in the wavelength range of 500-900 nm, in 1-nm increments, using a spectrophotometer with an integrating sphere attachment. The authors' optical spectroscopy raw data (total transmittance and diffuse reflectance) were used to obtain the optical absorption and reduced scattering coefficients of HIFU-induced thermal lesions and native tissues by employing the inverse adding-doubling method. The aforementioned interaction coefficients were subsequently used to calculate the effective attenuation coefficient and light penetration depth of HIFU-treated and native tissues in the wavelength range of 500-900 nm. RESULTS: HIFU-treated tissues produced greater PA signals than native tissues at 720 and 845 nm. At 720 nm, the averaged ratio of the peak-to-peak PA signal amplitude of HIFU-treated tissue to that of native tissue was 3.68 ± 0.25 (mean ± standard error of the mean). At 845 nm, the averaged ratio of the peak-to-peak PA signal amplitude of HIFU-treated tissue to that of native tissue was 3.75 ± 0.26 (mean ± standard error of the mean). The authors' spectroscopic investigation has shown that HIFU-treated tissues have a greater optical absorption and reduced scattering coefficients than native tissues in the wavelength range of 500-900 nm. In fact, at 720 and 845 nm, the ratio of the optical absorption coefficient of HIFU-treated tissues to that of native tissues was 1.13 and 1.17, respectively; on the other hand, the ratio of the reduced scattering coefficient of HIFU-treated tissues to that of native tissues was 13.22 and 14.67 at 720 and 845 nm, respectively. Consequently, HIFU-treated tissues have a higher effective attenuation coefficient and a lower light penetration depth than native tissues in the wavelength range 500-900 nm. CONCLUSIONS: Using a PA approach, HIFU-treated tissues interrogated at 720 and 845 nm optical wavelengths can be differentiated from untreated tissues. Based on the authors' spectroscopic investigation, the authors conclude that the observed PA contrast between HIFU-induced thermal lesions and untreated tissue is due, in part, to the increase in the optical absorption coefficient, the reduced scattering coefficient and, therefore, the deposited laser energy fluence in HIFU-treated tissues.

Model-based feasibility assessment and evaluation of prostate hyperthermia with a commercial MR-guided endorectal HIFU ablation array.

PURPOSE: Feasibility of targeted and volumetric hyperthermia (40-45 °C) delivery to the prostate with a commercial MR-guided endorectal ultrasound phased array system, designed specifically for thermal ablation and approved for ablation trials (ExAblate 2100, Insightec Ltd.), was assessed through computer simulations and tissue-equivalent phantom experiments with the intention of fast clinical translation for targeted hyperthermia in conjunction with radiotherapy and chemotherapy. METHODS: The simulations included a 3D finite element method based biothermal model, and acoustic field calculations for the ExAblate ERUS phased array (2.3 MHz, 2.3 × 4.0 cm(2), ∼1000 channels) using the rectangular radiator method. Array beamforming strategies were investigated to deliver protracted, continuous-wave hyperthermia to focal prostate cancer targets identified from representative patient cases. Constraints on power densities, sonication durations and switching speeds imposed by ExAblate hardware and software were incorporated in the models. Preliminary experiments included beamformed sonications in tissue mimicking phantoms under MR temperature monitoring at 3 T (GE Discovery MR750W). RESULTS: Acoustic intensities considered during simulation were limited to ensure mild hyperthermia (Tmax < 45 °C) and fail-safe operation of the ExAblate array (spatial and time averaged acoustic intensity ISATA < 3.4 W/cm(2)). Tissue volumes with therapeutic temperature levels (T > 41 °C) were estimated. Numerical simulations indicated that T > 41 °C was calculated in 13-23 cm(3) volumes for sonications with planar or diverging beam patterns at 0.9-1.2 W/cm(2), in 4.5-5.8 cm(3) volumes for simultaneous multipoint focus beam patterns at ∼0.7 W/cm(2), and in ∼6.0 cm(3) for curvilinear (cylindrical) beam patterns at 0.75 W/cm(2). Focused heating patterns may be practical for treating focal disease in a single posterior quadrant of the prostate and diffused heating patterns may be useful for heating quadrants, hemigland volumes or even bilateral targets. Treatable volumes may be limited by pubic bone heating. Therapeutic temperatures were estimated for a range of physiological parameters, sonication duty cycles and rectal cooling. Hyperthermia specific phasing patterns were implemented on the ExAblate prostate array and continuous-wave sonications (∼0.88 W/cm(2), 15 min) were performed in tissue-mimicking material with real-time MR-based temperature imaging (PRFS imaging at 3.0 T). Shapes of heating patterns observed during experiments were consistent with simulations. CONCLUSIONS: The ExAblate 2100, designed specifically for thermal ablation, can be controlled for delivering continuous hyperthermia in prostate while working within operational constraints.

Quantitative assessment of acoustic intensity in the focused ultrasound field using hydrophone and infrared imaging.

With the popularity of ultrasound therapy in clinics, characterization of the acoustic field is important not only to the tolerability and efficiency of ablation, but also for treatment planning. A quantitative method was introduced to assess the intensity distribution of a focused ultrasound beam using a hydrophone and an infrared camera with no prior knowledge of the acoustic and thermal parameters of the absorber or the configuration of the array elements. This method was evaluated in both theoretical simulations and experimental measurements. A three-layer model was developed to calculate the acoustic field in the absorber, the absorbed acoustic energy during the sonication and the consequent temperature elevation. Experiments were carried out to measure the acoustic pressure with the hydrophone and the temperature elevation with the infrared camera. The percentage differences between the derived results and the simulation are <4.1% for on-axis intensity and <21.1% for -6-dB beam width at heating times up to 360 ms in the focal region of three phased-array ultrasound transducers using two different absorbers. The proposed method is an easy, quick and reliable approach to calibrating focused ultrasound transducers with satisfactory accuracy.

Volumetric ablation of uterine fibroids using Sonalleve high-intensity focused ultrasound in a 3 Tesla scanner--first clinical assessment.

INTRODUCTION: The purpose of this study was to evaluate the feasibility and safety of the Sonalleve high-intensity focused ultrasound (HIFU; Philips Healthcare, Vantaa, Finland) system in ablating uterine fibroids in a 3T magnet. MATERIAL AND METHODS: Seven women were included in this study. Treatment was performed according to the manufacturer's recommendation. Technical data describing the HIFU procedures were collected. On MR images at baseline, immediately and 30 days after ablation, we evaluated the volumes of the uterus, the dominant fibroid and the ablation zone. The Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire was used to assess potential clinical response. RESULTS: The procedure was technically feasible in all patients. The median number of sonications performed during each procedure was 20 (range 2-27) per patient, the maximum temperature in all sonication cells was about 68°C. The median procedure time was 156 minutes (range 95-164). The non-perfused volume after treatment ranged from 1 to 27 ml and was unchanged or decreased in all but one patient at 30 days follow-up. There were no major adverse events. DISCUSSION: In our 3T magnet the system was able to heat tissue and induce areas of non-enhancement within uterine fibroids without major complications. Clinical benefit remains to be proven.