Method and apparatus for treatment of tissue

• US 9,095,695 B2
• Filed: 10/23/2007
• Issued: 08/04/2015
• 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:
  US11/877,348
• Publication Number:
  US 20080091124A1
• Time in Patent Office: 2,842 Days
• Field of Search: 606/27, 128/898, 601/2, 601/3
• US Class Current: 1/1
• 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 treating tissue in a treatment region with a HIFU Treatment, the method comprising the steps of:

initiating a HIFU Therapy to treat a portion of the tissue with an ultrasound transducer;

obtaining an image of the treatment region subsequent to attempting to treat the portion of the tissue with HIFU Therapy;

extracting a sub-image from the image, the sub-image being at least a portion of the image;

producing a line image that displays an average of intensity values of pixels in the sub-image, the line image providing an averaged intensity value as a function of time;

automatically detecting an acoustic obstruction proximate to the ultrasound transducer by analyzing the line image for a repetitive pattern, and determining the presence of the acoustic obstruction based on the presence of the repetitive pattern in the portion of the image; and

pausing the HIFU Treatment.

2. A method of treating tissue in a treatment region with a HIFU Treatment, the method comprising the steps of:

initiating a HIFU Therapy to treat a portion of the tissue with an ultrasound transducer;

obtaining an image of the treatment region subsequent to attempting to treat the portion of the tissue with HIFU Therapy;

automatically detecting an acoustic obstruction proximate to the ultrasound transducer; and

pausing the HIFU Treatment, wherein the step of automatically detecting the acoustic obstruction comprises the steps of;

analyzing a portion of an image for a repetitive pattern, and determining the presence of the acoustic obstruction based on the presence of the repetitive pattern in the portion of the image, wherein the transducer is positioned within a probe behind an acoustic membrane of the probe and wherein the step of analyzing a portion of the image for a repetitive pattern comprises the steps of;

analyzing a first portion of the image at a position corresponding to the acoustic membrane and the tissue to determine if a first intensity characteristic associated with the first portion meets or exceeds a first upper threshold;

analyzing a second portion of the image at 1.5 times the position corresponding to the acoustic membrane and the tissue to determine if a second intensity characteristic associated with the second portion is below a first lower threshold; and

analyzing a third portion of the image at twice the position corresponding to the acoustic membrane and the tissue to determine if a third intensity characteristic associated with the third portion meets or exceeds a second upper threshold.

3. The method of claim 2, wherein the position corresponding to the acoustic membrane corresponds to an interface between the tissue and the acoustic membrane of the probe.

4. A method of treating tissue in a treatment region with a HIFU Treatment, the method comprising the steps of:

initiating a HIFU Therapy to treat a portion of the tissue with an ultrasound transducer;

obtaining an image of the treatment region subsequent to attempting to treat the portion of the tissue with HIFU Therapy;

producing a line image that displays an average of intensity values of pixels in a portion of the image, the line image providing an averaged intensity value as a function of time;

analyzing the line image to determine if a first condition is satisfied, the first condition being whether an intensity value associated with a first region meets or exceeds a first upper threshold;

analyzing the line image to determine if a second condition is satisfied, the second condition being whether an intensity value associated with a second region is below a lower threshold;

analyzing the line image to determine if a third condition is satisfied, the third condition being whether an intensity value associate with a third region meets or exceeds a second upper threshold; and

pausing the HIFU Treatment if each of the first, second and third conditions is satisfied.