System and method for tissue change monitoring during HIFU treatment

• US 8,235,902 B2
• Filed: 09/11/2007
• Issued: 08/07/2012
• Est. Priority Date: 09/11/2007
• Status: Active Grant

• Current Assignee: Focus Surgery, Inc. (Sonacare Medical, LLC)
• Original Assignee: Focus Surgery, Inc. (Sonacare Medical, LLC)
• Inventors: Chen, Wo-Hsing, Carlson, Roy, Seip, Ralf, Sanghvi, Narendra T., Weis, Clint C.
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): Brutus, Joel F
• Application Number:
  US11/853,191
• Publication Number:
  US 20090069677A1
• Time in Patent Office: 1,792 Days
• Field of Search: 600/407, 600/437, 600/439, 600/471
• US Class Current: 600/439
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A method and apparatus is disclosed for determining the presence of tissue change due to exposure to HIFU Therapy.

Claims

1. An apparatus for treating tissue in a treatment region, the apparatus comprising:

a transducer which is positionable relative to a tissue treatment area of a tissue, the transducer being configured to emit ultrasound energy and to sense ultrasound energy;

a controller operably coupled to the transducer, the controller being configured to estimate changes in reflected backscattered energy in real-time for a plurality of regions of interest, wherein the estimated change in reflected backscattered energy corresponds to a tissue change value;

the controller being further configured to operate the transducer in a pulse-echo mode prior to providing HIFU therapy to a first tissue treatment area, wherein imaging data is generated from the 2-D RF signals received from a first region of interest by the transducer;

the controller being further configured to operate the transducer in a therapy mode wherein HIFU therapy is provided to the first tissue treatment area;

the controller being further configured to operate the transducer in a pulse-echo mode after providing HIFU therapy to the first tissue treatment area, wherein imaging data is generated from the 2-D RF signals received from the first region of interest by the transducer; and

the controller being further configured to analyze at least two 2-D RF signal data sets in the frequency domain, wherein the at least two 2-D RF signal data sets correspond to 2-D RF signals received from the first region of interest prior to and after the application of HIFU therapy, wherein the analysis of the at least two RF signal data sets includes determining the average power spectrum for each frequency band of the 2-D RF signals, wherein the plurality of frequency bands include a fundamental frequency band, a sub-harmonic frequency band, and a harmonic frequency band, wherein the maximum difference between the plurality of frequency bands of the at least two 2-D RF signals correspond to the estimated value of change in reflected backscattered energy for the region of interest.

2. The apparatus of claim 1, wherein the plurality of regions of interest include the tissue in the region between the transducer and the focal zone of the transducer, the tissue located in the region beyond the focal zone of the transducer, and the tissue located in the focal zone of the transducer.

3. The apparatus of claim 1, the controller being further configured to determine if a sufficient tissue change has occurred in the current tissue treatment area due to indirect HIFU treatment of the current tissue treatment area, wherein if a sufficient tissue change has occurred, the tissue treatment area is skipped.

4. The apparatus of claim 3, the controller being further configured to operate the transducer in a therapy mode wherein HIFU therapy is provided to the current tissue treatment area if sufficient tissue change has not occurred due to indirect HIFU treatment of the current tissue treatment area.

5. The apparatus of claim 1, the controller being further configured to provide additional HIFU therapy to a tissue treatment area where the tissue change value is low, wherein the treatment variables of the therapy mode may be modified for further treatment.

6. The apparatus of claim 1, the controller being further configured to determine if the signal to noise level of the received 2-D RF signal is sufficient to estimate changes in reflected backscattered energy, wherein if the mean of the absolute values of the 2-D RF signal is below a threshold, then the gain parameter is increased and the transducer is again operated in the pulse-echo mode and imaging data is generated.

7. The apparatus of claim 1, the controller being further configured to determine if the signal to noise level of the received 2-D RF signal is sufficient to estimate changes in reflected backscattered energy, wherein if the percentage of data points of the 2-D RF signal which are saturated is above a threshold, then the gain parameter is decreased and the transducer is again operated in the pulse-echo mode and imaging data is generated.

8. The apparatus of claim 1, wherein fine adjustments for independent gain control are provided for the transducer operating in the pulse-echo mode.

9. The apparatus of claim 1, further comprising a display for displaying the image generated after providing HIFU therapy to the first tissue treatment area, wherein the display includes a visual indicator of the tissue change value corresponding to the region of interest and the visual indicator is superimposed upon a location corresponding to the first tissue treatment area and preferably includes a color-coded visual indicator associated with the level of tissue change for the first tissue treatment area.

10. A method of treating tissue in a treatment region, the method comprising the steps of:

estimating changes in reflected backscattered energy in real-time for a plurality of regions of interest, wherein the estimated change in reflected backscattered energy corresponds to a tissue change value;

operating a transducer in a pulse-echo mode prior to providing HIFU therapy to a first tissue treatment area, wherein imaging data is generated from the 2-D RF signals received from a first region of interest by the transducer;

operating the transducer in a therapy mode, wherein HIFU therapy is provided to the first tissue treatment area;

operating the transducer in a pulse-echo mode after providing HIFU therapy to the first tissue treatment area, wherein imaging data is generated from the 2-D RF signals received from the first region of interest by the transducer;

analyzing the at least two 2-D RF signal data sets in the frequency domain, wherein the at least two 2-D RF signal data sets correspond to 2-D RF signals received from the first region of interest prior to and after the application of HIFU therapy, wherein the analysis of the at least two 2-D RF signal data sets includes determining the average power spectrum for each frequency band of the 2-D RF signals, wherein the plurality of frequency bands include a fundamental frequency band, a sub-harmonic frequency band, and a harmonic frequency band, wherein the maximum difference between the plurality of frequency bands of the at least two 2-D RF signals correspond to the estimated value of change in reflected backscattered energy for the region of interest.

11. The method of claim 10, wherein the plurality of regions of interest include the tissue in the region between the transducer and the focal zone of the transducer, the tissue located in the region beyond the focal zone of the transducer, and the tissue located in the focal zone of the transducer.

12. The method of claim 10, further comprising the steps of

determining if a sufficient tissue change has occurred in the current tissue treatment area due to indirect HIFU treatment of the current tissue treatment area, wherein if a sufficient tissue change has occurred, the tissue treatment area is skipped.

13. The method of claim 12, further comprising the steps of

operating the transducer in a therapy mode wherein HIFU therapy is provided to the current tissue treatment area if sufficient tissue change has not occurred due to indirect HIFU treatment of the current tissue treatment area.

14. The method of claim 10, further comprising the steps of

providing additional HIFU therapy to a tissue treatment area where the tissue change value is low, wherein the treatment variables of the therapy mode may be modified for further treatment.

15. The method of claim 10, further comprising the steps of

determining if the signal to noise level of the received 2-D RF signal is sufficient to estimate changes in reflected backscattered energy, wherein if the mean of the absolute values of the 2-D RF signal is below a threshold, then the gain parameter is increased and the transducer is again operated in the puke-echo mode and imaging data is generated.

16. The method of claim 10, further comprising the steps of

determining if the signal to noise level of the received 2-D RF signal is sufficient to estimate changes in reflected backscattered energy, wherein if the percentage of data points of the 2-D RF signal which are saturated is above a threshold, then the gain parameter is decreased and the transducer is again operated in the pulse-echo mode and imaging data is generated.

17. The method of claim 10, further comprising the steps of

providing fine adjustments for independent gain control for operating the transducer in the pulse-echo mode.

18. The method of claim 10, further comprising the steps of

displaying the image generated after providing HIFU therapy to the first tissue treatment area, wherein the image includes a visual indicator of the tissue change value corresponding to the region of interest and the visual indicator is superimposed upon a location corresponding to the first tissue treatment area and preferably includes a color-coded visual indicator associated with the level of tissue change for the first tissue treatment area.