Method and apparatus for the treatment of tissue

• US 10,293,188 B2
• Filed: 07/20/2015
• Issued: 05/21/2019
• Est. Priority Date: 07/08/2005
• Status: Active Grant

• Current Assignee: Sonablate Corporation
• Original Assignee: Focus Surgery, Inc. (Sonacare Medical, LLC)
• Inventors: Fedewa, Russell J., Uchida, Toyoaki, Sanghvi, Narendra T., Carlson, Roy F.
• Primary Examiner(s): Roane, Aaron F
• Application Number:
  US14/803,204
• Publication Number:
  US 20150321027A1
• Time in Patent Office: 1,401 Days
• Field of Search: 601 2
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61N 2007/0052 using the same transducer for therapy and imaging
• CPC Class Codes: A61N 2007/0082 Scanning transducers
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A method and apparatus is disclosed for determining the success of a proposed HIFU Treatment, of an ongoing HIFU Treatment, and/or of a completed HIFU Treatment. An energy density of a given HIFU Treatment may be used as a comparison factor between the given HIFU Treatment and other HIFU Treatments and as a predictor of the success of the given HIFU Treatment. One exemplary energy density is the amount of energy deposited in the treatment region divided by the volume of the treatment region. Another exemplary energy density is the amount of energy deposited in the treatment region divided by the pre-treatment mass of the treatment region. A method and apparatus is disclosed to detect the presence of focal hyperechoic features and non-focal hyperechoic features. A method and apparatus is disclosed to detect the presence of an acoustic obstruction.

Claims

1. 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;

positioning a transducer proximate to a first treatment site in or on a patient;

delivering the HIFU Treatment at a particular total acoustic power level to the first treatment site;

obtaining post-treatment images of the first treatment site following the delivery of the HIFU Treatment 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 images representative of hyperechoic features stored in an image library, the image library including images of a focal hyperechoic feature, a non-focal hyperechoic feature, and clouds of micro bubbles, the comparison comprising utilizing an image processing technique that measures a change in average image intensity;

delivering the HIFU Treatment 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 the HIFU Treatment to the second treatment site by maintaining or lowering the total acoustic power level when the hyperechoic features are focal hyperechoic features.

2. The method of claim 1, further comprising:

determining whether to pause the HIFU Treatment when the hyperechoic features are non-focal hyperechoic features; and

delivering the HIFU Treatment to the second treatment site by lowering the total acoustic power level when a decision was made to not pause the HIFU Treatment.

3. The method of claim 1, further comprising:

reducing the total acoustic power for subsequent treatment sites of the HIFU Treatment if a non-focal hyperechoic feature is generated which migrates from the respective focal zone.

4. The method of claim 1, further comprising:

determining whether to maintain the total acoustic power delivered to the first treatment site based on changes in image intensity or signal intensity corresponding to the first treatment region before and after application of HIFU Therapy to the first treatment site.

5. 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.

6. The method of claim 5, wherein obtaining a pre-treatment image of a first treatment site comprises retrieving the pre-treatment image from an image library or other memory accessible by a controller.

7. The method of claim 5, further comprising:

determining if the region of interest corresponds to tissue that has been marked to be excluded from the HIFU Treatment;

continuing to deliver the HIFU Treatment when the region of interest does not correspond to tissue that has been marked to be excluded from the HIFU Treatment; and

pausing the delivery of the HIFU Treatment and generating an alert when the region of interest corresponds to tissue that has been marked to be excluded from the HIFU Treatment.

8. 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.