Abstract:

The SonablateTM system for transrectal image-guided high intensity focused ultrasound (TR-HIFU) treatment of prostate diseases has been in clinical use since 1992. Recently, we developed the third generation of the system, call SonablateTM 500, with major improvements aimed specifically toward localized prostate cancer treatment. Salient features of the SonablateTM 500 include: (1) PC-based digital technology, (2) multifocal lengths probe with split beam transducer to cover a wide range of tissue depths (2.5--4.5 cm), (3) an upgraded treatment planning and control software with safety features such as reflectivity index measurement (RIMTM) and transducer tissue measurement (TTMTM); and (4) 3-D volume image rendering of the prostate. The SonablateTM 500 platform was tested in an in vivo canine experimental study in which the entire prostate was ablated. The prostate ultrasound images before and post HIFU treatment show very good correlation to the planned lesion. Histology delineated that the entire prostate was contiguously ablated without affecting surrounding tissues. Long-term canine survival studies as well as human prostate cancer studies under the FDA's IDE (Investigational Device Exemption) approval are in progress. [We would like to thank the engineering and clinical staff of Focus Surgery, Inc. who made this project possible.]