Coherent design based on four essential requirements: patient safety, clinical efficacy, treatment reliability and procedure cost effectiveness.
Patient safety in the case of thermal ablation with focused ultrasound requires real time monitoring of the temperature in and around the tumor during the treatment. Currently, this can only be accomplished reliably with MRI. As a consequence, our focused ultrasound devices are specifically designed for MR compatibility. Another consequence of the need for reliable temperature images during treatment is that the transducer should not move during heating periods because this causes artifacts in temperature images.
Clinical efficacy simply means the targeted tumor should be destroyed completely and healthy tissues around it should be spared. To guaranty that the whole tumor volume is indeed destroyed without the possibility that some islands of surviving tumorous tissues might eventually regrow and spread, we raise the complete tumor volume above a lethal temperature threshold. This is called volumetric ablation. The most effective way to perform volumetric ablation without transducer motion is through electronic steering of the focal spot. This is done using phased array technology. To ensure that no collateral damage is done to the surrounding healthy tissue, we monitor the temperature continuously in the volume of interest.
Treatment reliably means the procedure should be effective on all patient in all institutions, not just selected academic hospital with few accepted patients. This requires an easy learning curve for the clinician and some form of adaptation of the treatment protocol to the patient. We use adaptive feedback to adjust the treatment parameters during the procedure based on actual temperature measurements. Using phased array technology, the focal spot trajectories can be updated very rapidly to take into account the latest temperature measurements
Focused ultrasound devices are intrinsically cost effective due to non invasiveness of the procedure and the reduced hospital stay compared to alternative therapies. There are practical ways to increase this cost effectiveness: