Method and apparatus for the treatment of tissue

A method of providing treatment to a treatment region of tissue with a high intensity focused ultrasound (“HIFU”) Treatment, the HIFU Treatment including the provision of HIFU Therapy at spaced apart intervals to a plurality of treatment sites within the treatment region, the method comprising:

• obtaining a pre-treatment image of a first treatment site;
• positioning a transducer proximate to the first treatment site;
• delivering HIFU Treatment to the first treatment site;
• obtaining a post-treatment image of the first treatment site;
• extracting an image characteristic for a region of interest from each of the pre-treatment image and the post-treatment image, the image characteristic being one of an average pixel intensity, a standard deviation of pixel intensity, a geometric mean of pixel intensity, and root-mean-square of pixel intensity;
• comparing the image characteristic corresponding to the region of interest for the pre-treatment image and the image characteristic corresponding to the region of interest for the post-treatment image;
• calculating a difference between the image characteristic corresponding to the region of interest for the post-treatment image and the image characteristic corresponding to the region of interest for the pre-treatment image;
• comparing the difference to a stored threshold value;
• continuing to deliver the HIFU Treatment when the difference is less than the stored threshold value;
• determining a position of the region of interest relative to a focal zone of the transducer or a location of the first treatment site when the difference meets or exceeds the stored threshold value;
• continuing treatment when the region of interest is positioned within the focal zone or the first treatment site;
• and
• pausing the delivery of the HIFU Treatment and generating an alert when the region of interest is positioned outside of the focal zone or the treatment site.

A method of providing treatment to a treatment region of tissue with high intensity focused ultrasound (“HIFU”), the method comprising:

• positioning a transducer proximate to a first treatment site in or on a patient;
• obtaining pre-treatment images of the first treatment site;
• delivering HIFU at a total acoustic power level to the first treatment site;
• obtaining post-treatment images of the first treatment site following the delivery of the HIFU to the first treatment site;
• analyzing the post-treatment images to determine a presence of hyperechoic features in the first treatment site by comparing the post-treatment images to the first treatment site and images representative of hyperechoic features, the comparison comprising utilizing an image processing technique that measures a change in average image intensity;
• delivering HIFU to a second treatment site by maintaining or raising the total acoustic power level when hyperechoic features are not present in the post-treatment images;
• determining whether hyperechoic features in the post-treatment images are focal hyperechoic features, non-focal hyperechoic features, or clouds of micro bubbles when hyperechoic features are present in the post-treatment images;
• and
• delivering HIFU to the second treatment site by maintaining or lowering the total acoustic power level when the hyperechoic features are focal hyperechoic features.