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.