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Objective: To implement a skull-conformal phased array for ultrasound-guided transcranial focused ultrasound therapy with improved patient comfort. Methods: Using patient-specific computed tomography and MRI neuroimaging data, tightly-conforming helmet scaffolds were designed computationally. The helmet scaffolds were designed to hold reusable transducer modules at near-normal incidence in an optimal configuration for the treatment location(s) of interest. Numerical simulations of trans-skull ultrasound propagation were performed to evaluate different conformal array designs and to compare with hemispherical arrays similar to those employed clinically. A 4096-element phased array was constructed by 3D printing a helmet scaffold optimised for an ex vivo human skullcap, and its performance was evaluated via benchtop and in vivo experiments. Results: Acoustic field measurements confirmed the system's ability to focus through human skull bone using simulation-based transcranial aberration corrections. Preliminary in vivo testing demonstrated safe trans-human skull blood-brain barrier (BBB) opening in rodents. Conclusion: Patient-specific conformal ultrasound phased arrays appear to be a feasible and safe approach for conducting transcranial BBB opening procedures. Significance: Skull-conformal phased arrays stand to improve patient comfort and have the potential to accelerate the adoption of transcranial FUS therapy by improving access to the technology. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Standing-wave formation in an ex vivo human skull was investigated using a clinical prototype of a 30-cm diameter with 15-cm radius of curvature, low-frequency (230 kHz), hemispherical transcranial magnetic resonance-guided focused ultrasound phased array. Experimental and simulation studies were conducted with changing aperture size and f -number configurations of the phased array and qualitatively and quantitatively examined the acoustic pressure variation at the focus due to standing waves. The results demonstrated that the nodes and antinodes of standing wave produced by the small-aperture array were clearly seen at approximately every 3 mm. The effect of the standing wave became more pronounced as the focus was moved closer to skull base. However, a sharp focus was seen for the full array, and there was no such standing-wave pattern in the acoustic plane or near the skull base. This study showed that the fluctuation pressure amplitude would be greatly reduced by using a large-scale, hemispherical phased array with a low f-number. [ABSTRACT FROM PUBLISHER]