WO2001082777A2 - Caracterisation de tissu non invasive - Google Patents

Caracterisation de tissu non invasive Download PDF

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Publication number
WO2001082777A2
WO2001082777A2 PCT/US2001/013548 US0113548W WO0182777A2 WO 2001082777 A2 WO2001082777 A2 WO 2001082777A2 US 0113548 W US0113548 W US 0113548W WO 0182777 A2 WO0182777 A2 WO 0182777A2
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WIPO (PCT)
Prior art keywords
tissue
data
ofthe
cycle
hlfu
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PCT/US2001/013548
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English (en)
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WO2001082777A3 (fr
Inventor
Narendra T. Sanghvi
Adam J. Wunderlich
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Focus Surgery, Inc.
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Application filed by Focus Surgery, Inc. filed Critical Focus Surgery, Inc.
Priority to AU2001255724A priority Critical patent/AU2001255724A1/en
Publication of WO2001082777A2 publication Critical patent/WO2001082777A2/fr
Publication of WO2001082777A3 publication Critical patent/WO2001082777A3/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N7/02—Localised ultrasound hyperthermia
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01S—RADIO DIRECTION-FINDING; RADIO NAVIGATION; DETERMINING DISTANCE OR VELOCITY BY USE OF RADIO WAVES; LOCATING OR PRESENCE-DETECTING BY USE OF THE REFLECTION OR RERADIATION OF RADIO WAVES; ANALOGOUS ARRANGEMENTS USING OTHER WAVES
    • G01S7/00—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00
    • G01S7/52—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00 of systems according to group G01S15/00
    • G01S7/52017—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00 of systems according to group G01S15/00 particularly adapted to short-range imaging
    • G01S7/52023—Details of receivers
    • G01S7/52036—Details of receivers using analysis of echo signal for target characterisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00084—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings

Definitions

  • This invention relates to the investigation and treatment of the body using high-intensity focused ultrasound energy, or HIFU. It is disclosed in the context of treatment of diseases of the prostate, such as prostate cancer and benign prostatic hyperplasia, or BPH, but it is believed to be useful in other applications as well.
  • Non-surgical therapy of prostate cancer has been previously performed by irradiation and cryosurgery. Both technologies have significant drawbacks, such as lack of control, untoward side effects, and invasiveness.
  • HIFU has been established as a highly effective means of inducing contact-free, ionizing radiation- free intraprostatic coagulative necrosis, the changing of the character of diseased tissue of the prostate on a cellular level.
  • Studies have been conducted which indicate that, indeed, sharply delineated coagulative necrosis of predictable size and location can be achieved while avoiding macroscopic or microscopic change to the surrounding tissue structures.
  • Lesion sizes increase multifold with ultrasound intensity at the focal site of the therapy transducer. The lesion spreads toward the transducer with increasing focal site intensity.
  • a method for controlling high intensity focused ultrasound (HIFU) tissue treatment includes: (a) developing data of the untreated tissue; (b) storing the data of the untreated tissue; (c) treating the tissue to a cycle of HIFU from at least one ultrasound treatment transducer; (d) developing data of cycle (c); (e) comparing the data developed at (d) to the data stored at (b); (f) repeating steps (c) - (e) until a desired value of a tissue modification parameter is obtained; and, (g) providing an indication once the desired value of the tissue modification parameter has been obtained.
  • developing data of the untreated tissue includes using pulse-echo visualization magnitude ultrasound energy and developing the data of the untreated tissue from the return echoes.
  • the method includes developing a treatment regimen from the data of the untreated tissue. Additionally illustratively according to this aspect of the invention, developing a treatment regimen includes establishing at least one of the HIFU power and HIFU duty cycle of the treatment.
  • developing the treatment regimen includes basing the at least one of the HLFU power and HIFU duty cycle upon initial assumptions about the value of the tissue modification parameter. Further illustratively according to this aspect of the invention, developing the treatment regimen includes testing the tissue to be treated before the application of the first cycle of HIFU treatment to determine the initial value of the tissue modification parameter. Additionally illustratively according to this aspect of the invention, developing a treatment regimen includes establishing at least one of the HIFU power and HLFU duty cycle of the treatment to increase the temperature of the tissue a desired amount.
  • treating the tissue to a cycle of HIFU includes treating the tissue to a cycle of HIFU having a duration in the range of about .125 sec. - about .5 sec.
  • treating the tissue to a cycle of HIFU includes turning off the HIFU at intervals of about .05 sec - about .1 sec. during the cycle of HIFU for about 50 ⁇ sec, and developing during the intervals data of the tissue from the portion of the cycle of HIFU which has been conducted prior to the intervals.
  • developing data of the tissue from the portion of the cycle of HIFU which has been conducted prior to the intervals includes using pulse-echo visualization magnitude ultrasound energy and developing the data of the tissue treated during the portion of the cycle of HIFU which has been conducted prior to the intervals from the return echoes.
  • developing data of the cycle of HLFU includes developing data of the tissue treated to a cycle of HIFU using pulse-echo visualization magnitude ultrasound energy and developing the data of the tissue treated to a cycle of HIFU from the return echoes.
  • the method includes processing the data of the untreated tissue before storing the data of the untreated tissue.
  • processing the data of the untreated tissue before storing the data of the untreated tissue includes determining an average value of multiple tissue echo profiles.
  • the method further includes processing the data of a cycle of HIFU after developing data of the cycle of HIFU.
  • comparing the data developed from a cycle of HTFU to the stored data includes comparing processed data developed from a cycle of HLFU to processed stored data.
  • developing data of the untreated tissue includes developing the tissue modification parameter for the untreated tissue.
  • developing data of a cycle of HIFU includes developing the tissue modification parameter for the tissue treated to the cycle of HLFU.
  • the method includes generating an image of the tissue undergoing treatment to provide a visual representation of the effect of the therapy. Additionally illustratively according to this aspect of the invention, the method includes generating such an image after each cycle of HLFU.
  • (c) treating the tissue to a cycle of HIFU, (d) developing data of cycle (c), (e) comparing the data developed at (d) to the data stored at (b), and (f) repeating steps (c) - (e) until a desired value of a tissue modification parameter is obtained include (c) treating the tissue to a cycle of HIFU, (d) developing data of cycle (c), (e) comparing the data developed at (d) to the data stored at (b), and (f repeating steps (c) - (e) until a desired value of a tissue modification parameter is obtained in a closed feedback loop.
  • the method further includes providing a controller for controlling the closed feedback loop. The controller provides an indication once the desired value of the tissue modification parameter has been obtained.
  • the method includes providing at least one variable focus ultrasound transducer.
  • providing at least one variable focus ultrasound transducer includes providing at least one ultrasound transducer whose focus is determined by the phasing of the drive signal to its radiating surface or surfaces.
  • the tissue modification parameter is the attenuation coefficient of tissue between the at least one ultrasound treatment transducer and the tissue being treated.
  • the method includes testing the attenuation coefficient for change greater than a selected threshold, storing the attenuation coefficient, and generating from stored attenuation coefficient data an image of the tissue being treated.
  • storing the attenuation coefficient includes storing multiple attenuation coefficient data, and generating from stored attenuation coefficient data an image of the tissue being treated includes generating a composite image of the tissue being treated from the multiple stored data.
  • generating from the stored attenuation coefficient data an image of the tissue being treated includes generating from the stored attenuation coefficient data a B-mode image or a composite B-mode image of the tissue being treated.
  • apparatus for controlling high intensity focused ultrasound (HIFU) tissue treatment includes at least one ultrasound transducer, a first device coupled to the at least one transducer for driving the at least one transducer, and a second device coupled to the first device to control the first device and to the at least one transducer to receive data of return echoes received by the at least one transducer.
  • the second device controls the first device to:
  • the second device is a second device for using pulse-echo visualization magnitude ultrasound energy and developing the data of the untreated tissue from the return echoes.
  • the second device is a second device for developing a treatment regimen from the data of the untreated tissue. Additionally illustratively according to this aspect of the invention, the second device is a second device for developing a treatment regimen by establishing at least one of the HIFU power and HIFU duty cycle of the treatment. Illustratively according to this aspect of the invention, the second device is a second device for developing the treatment regimen by basing the at least one of the HTFU power and HTFU duty cycle upon initial assumptions about the value of the tissue modification parameter. Further illustratively according to this aspect of the invention, the second device is a second device for developing the treatment regimen by testing the tissue to be treated before the application of the first cycle of HIFU treatment to determine the initial value of the tissue modification parameter.
  • the second device is a second device for developing a treatment regimen by establishing at least one of the HIFU power and HTFU duty cycle of the treatment to increase the temperature of the tissue a desired amount.
  • the second device is a second device for treating the tissue to a cycle of HIFU having a duration in the range of about .125 sec. - about .5 sec.
  • the second device is a second device for treating the tissue to a cycle of HIFU by turning off the HLFU at intervals of about .05 sec - about .1 sec. during the cycle of HTFU for about 50 ⁇ sec, and developing during the intervals data of the tissue from the portion of the cycle of HIFU which has been conducted prior to the intervals.
  • the second device is a second device for developing data of the tissue from the portion of the cycle of HIFU which has been conducted prior to the intervals by using pulse- echo visualization magnitude ultrasound energy and developing the data of the tissue treated during the portion of the cycle of HIFU which has been conducted prior to the intervals from the return echoes.
  • the second device is a second device for developing data of the tissue treated to a cycle of HIFU using pulse-echo visualization magnitude ultrasound energy and developing the data of the tissue treated to a cycle of HIFU from the return echoes. Further illustratively according to this aspect of the invention, the second device is a second device for processing the data of the untreated tissue before storing the data of the untreated tissue.
  • the second device is a second device for processing the data of the untreated tissue before storing the data of the untreated tissue by determining an average value of multiple tissue echo profiles.
  • the second device is a second device for processing the data of a cycle of HLFU after developing data of the cycle of HIFU.
  • the second device is a second device for comparing the data developed from a cycle of HTFU to the stored data by comparing processed data developed from a cycle of HLFU to processed stored data. Additionally illustratively according to this aspect of the invention, the second device is a second device for developing data of the untreated tissue by developing the tissue modification parameter for the untreated tissue.
  • the second device is a second device for developing data of a cycle of HLFU by developing the tissue modification parameter for the tissue treated to the cycle of HIFU.
  • the second device is a second device for generating an image of the tissue undergoing treatment to provide a visual representation of the effect of the therapy.
  • the second device is a second device for generating such an image after each cycle of HIFU.
  • the at least one transducer, the first device and the second device are coupled in a closed feedback loop, the second device controlling the closed feedback loop.
  • the at least one transducer includes at least one variable focus ultrasound transducer.
  • the first and second devices control the at least one variable focus transducer by the phasing of the drive signal to the at least one variable focus transducer's radiating surface or surfaces.
  • the second device for repeating steps (c) - (e) until a desired value of a tissue modification parameter is obtained is a second device for repeat steps (c) - (e) until a desired value of the attenuation coefficient of tissue between the at least one ultrasound treatment transducer and the tissue being treated is obtained.
  • the second device is a second device for testing the attenuation coefficient for change greater than a selected threshold, storing the attenuation coefficient, and generating from stored attenuation coefficient data an image of the tissue being treated.
  • the second device for storing the attenuation coefficient is a second device for storing multiple attenuation coefficient data, and for generating from stored attenuation coefficient data a composite image of the tissue being treated from the multiple stored data.
  • the second device for generating from the stored attenuation coefficient data a composite image of the tissue being treated is a second device for generating from the stored attenuation coefficient data a B-mode image or a composite B-mode image of the tissue being treated.
  • the second device for generating from the multiple stored attenuation coefficient data a composite image of the tissue being treated is a second device for generating from the multiple stored attenuation coefficient data a B-mode image or a composite B-mode image of the tissue being treated.
  • Fig. 1 illustrates a plot of an ultrasound visualization/HIFU transducer excitation cycle according to the present invention
  • Figs. 2-9 illustrate plots of averages over a number of pulse/echo imaging cycles of integrated backscatter from tissue being treated during progressive stages of its treatment
  • Figs. lOa-d- 15a-c illustrate plots of MATLAB simulations of certain constants, namely attenuation, signal power (as represented by integrated backscatter), cross-correlation maximum, K, p and c, with the constants plotted on a log 10 scale;
  • Figs. 16a-c illustrate plots of the attenuation intercept in dB versus amplitude, dB/MHz of signal frequency/cm of tissue depth versus frequency and dB/MHz of signal frequency/cm of tissue depth versus phase, respectively;
  • Figs. 17-22 illustrate M-mode false color images using each of the constants on one data set
  • Fig. 23 illustrates an algorithm according to the invention
  • Fig. 24 illustrates a block diagram of an experimental setup to test methods according to the invention.
  • the prostate is first imaged using imaging intensity ultrasound in the range of, for example, a watt per square centimeter.
  • Baseline untreated data results. This baseline data is stored.
  • the treatment region is visualized, and a treatment regimen is established.
  • the target region is visualized and the power and duty cycle of the therapy transducer are established.
  • the therapy beam power and duty cycle are selected, based upon initial assumptions about the absorption coefficient of the tissue to be treated or prior testing to determine the actual absorption coefficient of the tissue undergoing treatment (see, for example, U. S. Patent 5,873,902), to provide a desired temperature elevation at the treatment site.
  • An initial HIFU therapy pulse for example, in the KW/cm 2 range, is applied to the target region.
  • the therapy transducer may be of a variable focus type, whose focal length is determined by the phasing of the drive signal to its various active surfaces. Or a therapy transducer may be selected based upon the depth d, that is, the distance of the target treatment region from the surface of the therapy transducer.
  • the tissue may first be exposed to a characterization of its parameters, for example, integrated backscatter ⁇ 0 at any depth d in the tissue at time t
  • the tissue can be characterized, for example, by subjecting it to a number, M, of pulses 24 of visualizing ultrasound, receiving the return echoes from these visualizing pulses 24, and obtaining the mean
  • ⁇ (d) can be FFTed to X( ⁇ ), where the ⁇ s are the radian frequencies present in the ultrasound visualization pulses 24.
  • the tissue is then exposed to a first burst 20 of HTFU having a duration t,_ in the range of, for example, .125 sec. - .5 sec.
  • t,_ duration of, for example, .125 sec. - .5 sec.
  • the HIFU is turned off for, for example, 50 ⁇ sec, and the visualization transducer is energized (or the visualization HIFU transducer is operated in visualization mode) 24 and return echoes from the treatment field and intervening tissue are recovered.
  • the visualization during intervals 22 may be RF and/or two-dimensional imaging
  • the visualization during intervals 28 may be RF and B-mode imaging.
  • tissue echo profiles ofthe treatment field from the visualization pulses 24 are taken and stored, or taken, processed (for example, by determining a mean value of multiple tissue echo profiles) and stored (or the thus-processed tissue echo profiles are stored).
  • the attenuation coefficient, a, at depth d based upon the received echo(es) from this (these) first post-therapy visualization pulse(s) 24 is calculated from the relation
  • T ransm i tted is the intensity ofthe transmitted ultrasound visualization pulses
  • T- rece i ved is the intensity ofthe received ultrasound visualization pulses
  • e is the base ofthe natural logarithms
  • ⁇ is then tested for any significant change, and stored.
  • a B-mode image (or a composite B-mode image if multiple post-therapy echo pulses 24 have been generated) ofthe tissue undergoing treatment may be generated from the data collected thus far to provide a visual representation ofthe effect ofthe first duty cycle 20, 26 of therapy.
  • the next burst 20 of HIFU is then applied, illustratively, but not necessarily using the same duty cycle and treatment power. Indeed, it is contemplated that these variables may be among those adjusted based upon feedback ofthe progress ofthe treatment.
  • the same format 20, 22, 24, 26, 28 can be followed. That is, during and after the second burst 20, (a) second treatment tissue echo profile(s) produced by visualization pulse(s) 24 is (are) taken and stored, or taken, processed and stored. This visualization interval 28 yields an integrated backscatter
  • HIFU HIFU
  • the rehrrn echoes are first digitized and stored as lines in a raster or display.
  • each set of echoes sometimes referred to hereinafter as RF, can be averaged line by line to created a composite RF display.
  • the composite RF lines can then be fast Fourier transformed (FFTed) using a sliding window technique, where each RF line is broken up into multiple, overlapping windows.
  • FFTed fast Fourier transformed
  • a sliding window technique where each RF line is broken up into multiple, overlapping windows. This permits windows from different RF lines to be compared via a constant measuring their similarity.
  • windows from a given RF line were compared to windows in a reference RF line (that is, a line corresponding to the same tissue depth from the composite RF display created before any application ofthe therapy beam).
  • Columns of constants relate the windows of each subsequent line to the windows vertically above them in the first line. These constants may further be normalized by dividing them by the constants relating the first line to the second. This further enhances the changes from RF line to RF line.
  • the display is enlarged to its original size. For regions which are contained in overlapping windows, the constants representing the overlapping windows are averaged. This provides a smoothing ofthe image.
  • Six different constants are investigated herein for their ability to characterize tissue changes during therapy. It is believed that other constants may be equally useful, and perhaps more useful, in characterizing the changes in tissue subject to the HLFU treatment. However, these six constants are capable of characterizing such changes sufficiently well to permit their use in feedback control of HLFU treatment according to the invention.
  • ⁇ A is the slope ofthe line that is the best fit to the first half of the frequency range over which diff is calculated.
  • the attenuation intercept ofthe best fit line yields similar results.
  • Other methods of calculating attenuation may yield comparable, or better, results, and the invention is not limited to a particular method of calculating or estimating attenuation or change in attenuation.
  • Integrated backscatters can be thought of as the signal powers present in each ofthe vectors Si and S 2 .
  • Signal power is a highly accurate indicator ofthe extent of a lesion. However, it may not be an appropriate mechanism for ' feedback control of HTFU treatment in every instance, because it is quite sensitive to patient movement.
  • the fifth constants are defined as where ⁇ once again indicates the transpose operator and II II indicates the Euclidean norm operator. The value of c is the cosine ofthe angle between the vectors Si and S 2 .
  • MATLAB simulations were run plotting these constants against amplitude, frequency and phase, with the other two independent variables in each plot being held constant. Plots of these simulations, with the constants plotted on a log 10 scale, are illustrated in Figs. lOa-d - 15a-c. Plots ofthe attenuation intercept in dB versus amplitude, dB/MHz of signal frequency/cm of tissue depth versus frequency and dB/MHz of signal frequency/cm of tissue depth versus phase are illustrated in Figs. 16a-c, respectively. M-mode false color images using each ofthe constants on one data set are illustrated in Figs. 17-22. Another method for developing feedback control ofthe therapy transducer was also investigated.
  • This method permitted the beginning of each window to have a variable position in each RF line.
  • the beginning location of each window was determined by sliding the window around in the vicinity of its designated original position and choosing its position based upon how closely its contents correlated with the contents ofthe corresponding window in the RF reference line. That is, a matching algorithm identified the starting location for each window that provided the best match with the contents ofthe corresponding window in the reference line.
  • One possible advantage of such a strategy is that it may permit changes in the character of tissue to be distinguished from thermal expansion ofthe tissue. Thermal expansion of tissue in the range of interest is fairly linear.
  • the coefficients correlating windows in different RF lines are linearly related, it can be concluded that the differences are related to thermal expansion ofthe tissue during treatment, not to changes in the character ofthe tissue at the cellular level.
  • the signal processing algorithm can be made to adjust the coefficients dynamically to account for these thermal expansion effects.
  • the coefficients are not linearly related, it can be concluded that the character ofthe tissue has been affected by the therapy beam.
  • Such an algorithm is only useful if there is relatively high correlation in the RF data. If there is not, that is, if there is substantial change in the tissue, such an algorithm would not be useful.
  • a centroid or other similar method can also be used to recover from the tissue images data which can be developed into information on whether the character ofthe tissue at the cellular level has been changed.
  • a description ofthe use ofthe centroid and auto-regressive spectral analysis to implement an accurate measurement of relative attenuation in a general sense is contained in T. Baldeweck, P. Laugier, A Herment and G. Berger, "Application of Autoregressive Spectral Analysis for Ultrasound Attenuation Estimation: Interest in Highly Attenuating Medium," IEEE Trans. Ultrason. Ferr. & Freq. Control vol. 42, no. 1, pp. 99-110, Jan. 1995, the disclosure of which is incorporated herein by reference.
  • FIG. 23 An illustration of an algorithm according to the invention operating on one set of data is illustrated in Fig. 23.
  • imaging ofthe prostate is initiated at 40, and the tissue to be treated is located.
  • RF that is, image
  • This data is stored as the reference RF line of data.
  • a burst 20 of HLFU therapy is initiated. Again, the profile ofthe therapy and imaging cycle 20, 22, 24, 26, 28 is illustrated in Fig. 1.
  • a visualization cycle 26, 28 is initiated and RF data and perhaps other data, such as B- mode image data, are obtained.
  • these data are processed as described above to generate the constants, and the processed data are tested for indications ofthe desired tissue changes due to the HIFU treatment application 20. If the processed data indicate that the desired changes in the character ofthe tissue at the treatment site have been achieved, 50, the HIFU and visualization transducer(s) is (are) reaimed 54 at the next treatment site. If not, 52, the algorithm returns to step 44.
  • the application of an optimal dose of HLFU provides another opportunity for the use of feedback in HLFU treatment.
  • One method for continuously updating the applied HIFU intensity is to assume that the tissue subject to treatment lies in the focal zone, that is, that the beam intensity is substantially constant, that the average speed of sound in a particular sample of tissue is approximately constant, and that the transducer power as a function of distance has not changed since the last calibration.
  • the attenuation, a can be estimated by comparing the latest RF (image) line to a reference line taken in water from a perfect reflector.
  • I site (TAP/TI)e- ( ⁇ 0 + ⁇ )D
  • TAP the total acoustic power
  • TI the transducer index, or beam area.
  • tissue 120 for example, a 1.5 inch by 1.5 inch by 1 inch (about 3.8 cm by 3.8 cm by 2.5 cm) sample of thawed turkey breast containing homogeneous tissue to reduce reflections due to tissue interfaces, is immersed in a degassed water bath 122 and permitted to equilibrate at the temperature ofthe water bath, 37°C.
  • Thermocouple 124 and hydrophone 126 probes are inserted into a target region in the tissue 120.
  • Thermocouple probe 124 illustratively is a Physitemp model T150, T-type, .002 inch (about .05 mm) diameter, copper-constantan thermocouple.
  • Hydrophone probe 126 illustratively is a DAPCO Yale model B-D 19 needle hydrophone.
  • the target region is the focal zone of an ultrasound transducer 128 which is, for example, a dual-element transducer used for both HLFU and pulse/echo image acquisition and having an outer element with a focal length of 3.5 cm and a resonant frequency of 4 MHz and an inner element with a focal length of 3.5 cm and a resonant frequency of 6 MHz.
  • the transducer 128 is driven by an ultrasound generator/driver 130 such as, for example, a Focus Surgery, Inc., model SonablateTM 200TM ultrasound generator/driver. Since the imaging element ofthe transducer 128 had a resonant frequency of 6 MHz, the input filter on the receiving amplifier ofthe ultrasound generator/driver 130 was modified from a 2-5 MHz passband to a 5-10 MHz passband. The pulser/receiver portion ofthe ultrasound generator/driver 130 was only used during image acquisition. The images generated during image acquisition were printed on a screen printer.
  • the ultrasound generator/driver 130 is controlled by a personal computer (PC) 132 such as, for example, a 400 MHz Intel machine equipped with a Gage A/D board.
  • the LPT1 port of PC 132 is coupled to a function generator 134 such as, for example, a Hewlett-Packard model 8116A pulse/function generator, and directly to the ultrasound generator/driver 130.
  • PC personal computer
  • the output port ofthe function generator 134 is coupled to an input port of an ultrasound power amplifier 136 such as, for example, an ENI model AP400B controllable power amplifier.
  • the output port of amplifier 136 is coupled to the HLFU control input port ofthe ultrasound generator/driver 130.
  • the HLFU output port of ultrasound generator/driver 130 is coupled to the outer, HIFU element of transducer 128.
  • Data is acquired from the output of amplifier 136 by coupling the output port of amplifier 136 to the channel 2 input port of an oscilloscope such as, for example, a Tektronix model 7603 oscilloscope.
  • the Transmit/Receive port of a pulser/receiver 138 such as, for example, a Panametrics model 5050PR pulser/receiver, is coupled to the imaging control port ofthe ultrasound generator/driver 130.
  • the imaging port of ultrasound generator/driver 130 is coupled to the inner, imaging element of transducer 128.
  • the signal output port of pulser/receiver 138 is coupled to the channel A input port of PC 132.
  • the + sync output port of pulser/receiver 38 is coupled to the Trigger input port of PC 132.
  • thermocouple 124 is processed using a thermometry system such as, for example, a Labthermics Technologies model LT-100 multichannel thermometry system 145, and is recorded on a PC 146 such as, for example, a Texas struments model Extensa 515 laptop PC.
  • the temperature ofthe water bath 122 is maintained substantially constant by a closed loop thennometry system including a thermocouple 148, a temperature controller 150 and a heater 152.
  • temperature controller 150 is an Omega model CN9000
  • a temperature controller and heater 152 is an aquarium Systems model Visitherm aquarium heater.
  • a water pump (not shown) was used to circulate the water continuously to promote even water temperature.
  • raw RF data for the image was acquired using the Gage A/D board in the PC 132.
  • the A D board received a trigger signal from the ultrasound generator/driver 130.
  • the PC 132 also received a synchronization signal from the ultrasound generator/driver 130 through the PC 132's LPT1 port for digitizing the images.
  • the purpose ofthe hydrophone 126, RF amplifier 142 and spectrum analyzer 144 was to detect half-harmonic emissions, which would indicate that cavitation was taking place in the tissue 120.
  • the setup illustrated in Fig. 24, operating according to the algorithm illustrated in Fig. 23, was used to generate the echo profiles illustrated in Figs. 2-9. The prominent echoes were generated at tissue interfaces.
  • the character of the tissue from which the composite echo profile illustrated in Fig. 2 was generated was unaffected, since no HIFU treatment had yet been applied.
  • the echo profile illustrated in Fig. 3 was generated after a first duration, illustratively, a half-second of HIFU pulse 20 on-time.
  • the HLFU treatment was stopped, 26, as discussed above, and visualization pulses 28 were directed into the tissue.
  • the composite echo profile illustrated in Fig. 4 was generated.
  • the tissue was affected somewhat by this first HIFU pulse 20. The effect is most noticeable at a depth corresponding to the 3.5 cm focal length ofthe transducer 128 when it is operated in HLFU mode.
  • another illustratively half-second pulse 20 of HIFU is applied, after which another visualization interval 26 is applied.
  • the effect ofthe second HIFU pulse 20 again is most noticeable in the region ofthe focus ofthe transducer 128 when the transducer 128 is operating in HLFU mode. It will be appreciated from a comparison ofthe echo profiles illustrated in Figs. 4 and 6 that there is some "spreading" ofthe region of tissue affected by the HIFU treatment toward the surface ofthe transducer 128. This is predicted by the regions ofthe false color images illustrated in Figs. 17-22. Continuing, another burst 20 of HLFU is applied to the tissue, followed by another visualization interval 26.
  • this third burst can be appreciated by comparing the echo profiles illustrated in Figs. 7 and 8. Again, it will be appreciated from a comparison of these Figs, that spreading ofthe region of tissue affected by the HLFU treatment toward the surface ofthe transducer 128 continues. Additionally, the effect ofthe additional pulse of HLFU on the tissue in the region ofthe focal zone ofthe transducer 128 when it is operated in HLFU mode is more pronounced, indicating that the tissue in the focal zone, and continuously back from the focal zone toward the surface ofthe transducer 128 is being affected by the application ofthe HLFU according to this protocol.
  • the continuing change in the character ofthe treated tissue can be characterized, and the algorithm written to predict this continuing change.
  • This effect can result in a somewhat shorter HTFU pulse cycle 20, or in the application of fewer treatment cycles 20, 22, 24, 26, 28, before the effect on the character ofthe tissue is judged sufficient by the treatment algorithm to have achieved the desired treatment.

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Abstract

L'invention concerne un appareil permettant de commander un traitement tissulaire ultrasonore focalisé à haute intensité (HIFU), qui comprend au moins un transducteur ultrasonore (128), un premier dispositif (130) couplé audit transducteur ultrasonore (128) afin d'entraîner ce transducteur ultrasonore (128), un second dispositif (132) couplé au premier dispositif (130) afin de commander ledit premier dispositif (130) et le transducteur (128), ce qui permet de recevoir des données d'écho de retour reçues par ledit transducteur (128). Le second dispositif (132) commande le premier dispositif (130) de façon a) à développer des données de tissu non traité; b) à stocker ces données; c) à traiter le tissu selon un cycle de HIFU à partir du transducteur (128); d) à développer des données du cycle (c); e) à comparer les données développées au niveau (d) aux données stockées au niveau de (b); f) à répéter les étapes (c) - (e) jusqu'à obtenir une valeur désirée d'un paramètre α de modification de tissu; et g) à fournir une indication une fois la valeur désirée du paramètre α de modification de tissu obtenue. L'invention concerne également un procédé permettant de commander un traitement tissulaire ultrasonore focalisé à haute intensité (HIFU) consistant a) à développer des données de tissu non traité; b) à stocker ces données; c) à traiter le tissu selon un cycle de HIFU à partir du transducteur (128); d) à développer des données du cycle (c); e) à comparer les données développées au niveau (d) aux données stockées au niveau de (b); f) à répéter les étapes (c) - (e) jusqu'à obtenir une valeur désirée d'un paramètre α de modification de tissu; et g) à terminer le traitement.
PCT/US2001/013548 2000-04-29 2001-04-27 Caracterisation de tissu non invasive WO2001082777A2 (fr)

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