A Fully Electronically Steerable Therapeutic Ultrasound Phased Array With MR-Guidance.

Recently, MRI-guided focused ultrasound (FUS) has shown great promise in treating various conditions non-invasively. OBJECTIVE: The focus of this article is to introduce an MRI-guided FUS device, which can provide full electronic steering range without mechanical movement and with low near-field heating. A pilot study was conducted in order to investigate the feasibility, and safety of the device in a large animal model and a pilot clinical trial. METHODS: A flat, fully steerable FUS phased array with 4096 elements was designed and manufactured to be compatible with an MR scanner. Pre-clinical experiments were carried out for testing the accuracy of the focus at different steering angles as well as evaluating the ablation efficiency using MR thermometry. Eleven patients with uterine fibroids were treated in the pilot clinical trial. RESULTS: Pre-clinical results showed successful ablation at various steering angles with reasonable targeting accuracy and no off-target heating. During the pilot clinical study, effective fibroid ablation was achieved with significant symptom reduction observed over time. In general, the treatment results showed the system to be effective in ablating deep tissue volumes. The device was successful at efficiently ablating large volumes with minimal near-field heating and eliminating the need for mechanical translation. CONCLUSIONS: Being capable of providing high acoustic power, full electronic steering range in 3D for large volume ablations, this device can provide a safe and efficient treatment option as an outpatient procedure for uterine fibroids and other pelvic and abdominal tumors.

Ultrasound-Guided Focused Ultrasound Treatment for Painful Bone Metastases: A Pilot Study.

Focused ultrasound (FUS) for palliation of bone metastases has typically been performed under magnetic resonance guidance. To address limitations of this approach, this pilot study evaluated a stand-alone, portable FUS device guided by diagnostic ultrasound alone (ultrasound [US]-guided FUS). Nine patients were treated; safety and efficacy were assessed for 10 d after the procedure, and medical charts were evaluated to assess durability of pain response. The procedure was safe and tolerable, with four patients reporting minor skin-related irritations. Average pain score decreased from 6.9 at baseline to 3.2 at day 10; analgesic use on average also decreased from baseline to day 10. Six patients had durable pain relief as assessed after the follow-up period. Our study provides evidence that US-guided FUS is a safe, tolerable and versatile procedure. It appears to be effective in achieving durable pain response in patients with painful bone metastases. Further research is required to refine the technology and optimize its efficacy.

Thermal Therapy With a Fully Electronically Steerable HIFU Phased Array Using Ultrasound Guidance and Local Harmonic Motion Monitoring.

The method of localized harmonic motion (LHM) monitoring has been proposed as an ultrasound-based monitoring technique for in vivo real-time ultrasound-guidance during thermal surgery. OBJECTIVE: The focus of this paper is to study the performance of LHM monitoring in vivo in order to assess the tissue coagulation during ultrasound surgery of bone metastases. This is done through a pre-clinical study on large scale animals (pigs) as well as a first-in-human pilot study, using a hand held ultrasound-guided HIFU phased array. METHODS: A flat, fully steerable HIFU phased array system (1024 elements, 100 mm diameter, 516 kHz), in combination with a co-aligned 64 element imaging system, is used to perform thermal surgery and monitor tissue coagulation using the LHM technique. The in vivo experiments are conducted using thirteen animals, followed by a first-in-human pilot study in which nine patients are enrolled. RESULTS: The pre-clinical results show that the LHM monitoring method is able to detect about 80% of the observed coagulated tissue volumes visible in dissection. In the pilot study, six out of nine patients have durable pain reduction with good correlation observed from LHM detections. CONCLUSION: In general, the results suggest that the LHM monitoring performance is promising in detecting thermal tissue coagulation during focused ultrasound surgery in tissues close to the bone. SIGNIFICANCE: The LHM technique can offer a very accessible and cost-efficient monitoring solution during ultrasound surgery within a clinical setting.

A novel, flat, electronically-steered phased array transducer for tissue ablation: preliminary results.

Flat, λ/2-spaced phased arrays for therapeutic ultrasound were examined in silico and in vitro. All arrays were made by combining modules made of 64 square elements with 1.5 mm inter-element spacing along both major axes. The arrays were designed to accommodate integrated, co-aligned diagnostic transducers for targeting and monitoring. Six arrays of 1024 elements (16 modules) and four arrays of 6144 elements (96 modules) were modelled and compared according to metrics such as peak pressure amplitude, focal size, ability to be electronically-steered far off-axis and grating lobe amplitude. Two 1024 element prototypes were built and measured in vitro, producing over 100 W of acoustic power. In both cases, the simulation model of the pressure amplitude field was in good agreement with values measured by hydrophone. Using one of the arrays, it was shown that the peak pressure amplitude dropped by only 24% and 25% of the on-axis peak pressure amplitude when steered to the edge of the array (40 mm) at depths of 30 mm and 50 mm. For the 6144 element arrays studied in in silico only, similarly high steerability was found: even when steered 100 mm off-axis, the pressure amplitude decrease at the focus was less than 20%, while the maximum pressure grating lobe was only 20%. Thermal simulations indicate that the modules produce more than enough acoustic power to perform rapid ablations at physiologically relevant depths and steering angles. Arrays such as proposed and tested in this study have enormous potential: their high electronic steerability suggests that they will be able to perform ablations of large volumes without the need for any mechanical translation.

Contrast-enhanced transcranial two-dimensional ultrasound imaging using shear-mode conversion at low frequency.

The distortion and attenuation of transcranial ultrasound (US) signals are significant problems in US imaging of the brain. Of the variety of proposed solutions, shear-mode transmission through the skull is one of the more recent options and has been shown to reduce distortion of the US beam. This study examined the effects of transcranial shear-mode transmission on the images of a contrast-agent-filled polytetrafluoroethylene tube produced by a 32-element 750 kHz linear phased array transducer through an ex vivo human skull section. Although the tube was successfully imaged using shear-mode transmission with subharmonic imaging in 6 of 9 cases, the tube was visible in only 1 of 9 cases for both the fundamental and the second harmonic frequencies. Some improvement in the location of the axial image was seen at the fundamental frequency using shear mode. No improvement was seen at the other two frequencies, but this may be due to low transducer sensitivity. As well, neither the presence of the skull nor the incident angle changed the distance at which signals from the two tubes could be resolved. With this transducer, these distances were found to be 5 mm laterally and 3 mm axially for the fundamental and second harmonic images, and 10 mm and 5 mm for the subharmonic images. The results show that the subharmonic signal was the most successful of the three examined in penetrating a thick skull but that the success comes at the cost of image resolution.

Large improvement of the electrical impedance of imaging and high-intensity focused ultrasound (HIFU) phased arrays using multilayer piezoelectric ceramics coupled in lateral mode.

With a change in phased-array configuration from one dimension to two, the electrical impedance of the array elements is substantially increased because of their decreased width (w)-to-thickness (t) ratio. The most common way to compensate for this impedance increase is to employ electrical matching circuits at a high cost of fabrication complexity and effort. In this paper, we introduce a multilayer lateral-mode coupling method for phased-array construction. The direct comparison showed that the electrical impedance of a single-layer transducer driven in thickness mode is 1/(n²(1/(w/t))²) times that of an n-layer lateral mode transducer. A large reduction of the electrical impedance showed the impact and benefit of the lateral-mode coupling method. A one-dimensional linear 32-element 770-kHz imaging array and a 42-element 1.45-MHz high-intensity focused ultrasound (HIFU) phased array were fabricated. The averaged electrical impedances of each element were measured to be 58 Ω at the maximum phase angle of -1.2° for the imaging array and 105 Ω at 0° for the HIFU array. The imaging array had a center frequency of 770 kHz with an averaged -6-dB bandwidth of approximately 52%. For the HIFU array, the averaged maximum surface acoustic intensity was measured to be 32.8 W/cm² before failure.