EP0551225A1 - Ultrahochgeschwindigkeitsverfahren und Vorrichtung zur Behandlung mit Hyperthermie durch extrakorporalen Ultraschall - Google Patents

Ultrahochgeschwindigkeitsverfahren und Vorrichtung zur Behandlung mit Hyperthermie durch extrakorporalen Ultraschall Download PDF

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Publication number
EP0551225A1
EP0551225A1 EP93400012A EP93400012A EP0551225A1 EP 0551225 A1 EP0551225 A1 EP 0551225A1 EP 93400012 A EP93400012 A EP 93400012A EP 93400012 A EP93400012 A EP 93400012A EP 0551225 A1 EP0551225 A1 EP 0551225A1
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EP
European Patent Office
Prior art keywords
time
duration
peak power
treatment
frequency
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP93400012A
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English (en)
French (fr)
Inventor
Jacques Dory
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
EDAP International SA
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EDAP International SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by EDAP International SA filed Critical EDAP International SA
Publication of EP0551225A1 publication Critical patent/EP0551225A1/de
Withdrawn legal-status Critical Current

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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
    • 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
    • A61B2017/00137—Details of operation mode
    • A61B2017/00154—Details of operation mode pulsed

Definitions

  • the present invention concerns an ultra-high-speed extracorporeal ultrasound hyuperthermia method and treatment device.
  • the beam is transmitted in the form of periodic wave trains having a predetermined frequency peak power and duration.
  • the beam high frequency is comprised between 0.5 and 5 MHz, for example, the lower frequencies being used to destroy the deeper structures within the body and the electric peak power which excites the transducer is comparatively low (10 to 100 watts, the higher powers being used to destroy the deeper structures).
  • the target temperature is increased to approximately 45°C, a temperature which is sufficiently high in principle to destroy malignant cells. It has been thought previously that an excessive increase in the temperature of the target area could cause serious burns in the surrounding area as the result of thermal diffusion.
  • the invention is based on the discovery that increasing the peak power of the waves used by a factor of 10 to 200 or more, depending on the depth and the absorbing power of the target area, makes it possible, by causing an ultra-high-speed temperature rise, to significantly reduce the effects of thermal diffusion and to destroy the target area in time periods in the order of one second or less.
  • the ultra-high-speed hyperthermia treatment method provides significantly improved echographic examination of changes to the target during treatment.
  • the invention also has for its object specific type A or B echographic methods which facilitate the ultra-high-speed detection of change sustained by the target so that treatment can be terminated as soon as the target is destroyed.
  • Figure 1 is a block diagram of a known type echography device comprising a real time probe 1 including a piezoelectric transducer element 12 which is oscillated by an electric motor 13 through a mechanical transmission system represented by the chain-dotted line.
  • this probe may be as described in US patent No. 4,418,698 granted December 6, 1983 in respect of : "Mechanical sector scanned echographic probe".
  • the piezo-electric element 12 is excited by a pulse generator 2 and the motor is controlled by a sawtooth scanning signal generator (producing the waveform (A) shown in figure 2) to scan a sector of the region to be treated, the scan passing through the focus of the treatment beam emitter.
  • the echo pulses reflected from biological structures are amplified by a receiver 4 whose output is connected to an analog-to-digital converter 5.
  • An electronic switch 6 connects the output of the converter 5 to one or other of two memories 61 and 62. Switching occurs on each scan, the switch 6 being connected to an appropriate output of the sawtoolth generator 3 for this purpose.
  • each memory addressing of the writing operation is effected in a known manner according to the angular position of the beam emitted by the probe and the time elapsed since the start of each pulse transmission, so that a complete image of the treated area is written into one of the two memories on each scan.
  • the memories are also read in a known way and the resulting signals are fed to a digital subtractor through a switch 71 which reverses the connection between its inputs E1 and E2 and its outputs S1 and S2 on each scan (being connected to the appropriate output of the generator 3 to this end).
  • the subtractor which computes the difference between the serial digits which define the successive points of the two images, would subtract the current image from the previous image and then the previous image from the current image, and so on, the inversion being required so that the previous image is always subtracted from the current image in each scan.
  • the output of the subtractor 7 is connected to a digital-to-analog converter 72 which supplies a voltage for modulating the brightness of the cathode ray tube of a display device 8.
  • the output S2 is connected to a second digital-to-analog converter 73.
  • a potentiometer 74 provides a variable mix of the output voltage of the converter 72, representing the differential image, and the output voltage of the converter 73, representing the latest image stored.
  • the operator can then observe either the conventional image of the treated area, enabling a preliminary identification of the strucutres concerned, or the differential image, enabling him to observe how the structures change during the treatment.
  • the images cannot be formed during emission of the treatment beam, the energy of which, reflected from the structures concerned, is sufficient to "dazzle" the echographic transducer.
  • the effect of this can continue for one or more microseconds after the end of emission. It is therefore necessary to emit wave trains separated by gaps (waveform (B) in figure 20) slightly longer than the duration of an echographic scan, which might be 1/20 s, for example, and to synchronize the latter with the emission.
  • the emission time could be chosen to obtain an image every 0.5 s at least. This implies that the peak power of the treatment emission be sufficient for significant destruction of the target area cells to occur in a few tenths of a second.
  • Figure 2 shows at (C) the intervals in which the memory 61 is written,at (D) the intervals in which the memory 62 is written, at (E) the intervals in which the memory 61 is read, at (F) the intervals in which the memory 2 is read and at (G) and (H) the resulting states of the outputs S1 and S2.
  • the numbers of the images in memory are shown. This shows that the previous image is always subtracted from the current image.
  • the power transducer T symbolically represented as a spherical cup on which piezo-electric elements are placed, is energized by the treatment beam emitter 10.
  • the transducer is advantageously as described in RE 35,590 and the probe 1, although shown separately, would in practice be attached to the cup, disposed at its center and oriented along its axis, as explained in the aforementioned patent.
  • Figure 1 also shows units that are not used in the embodiment of the invention described thus far, but only in a modified embodiment now to be described.
  • variable ratio frequency divider 9 an AND gate 11, a memory 12, a display device 13 and a switch 14.
  • the divider 9 When the switch 14 is in position a, the divider 9 is connected to the sawtooth generator 3, which is adapted to provide a synchronization signal when the axis of the probe passes through the focus of the treatment beam emitter (the center of the sphere of which the cup T constitutes a portion).
  • the division ratio of the divider is then set to a value between 1 and 5, for example.
  • the short signal is also applied to the gate 11 which is therefore enabled for 1/1 000 s and passes to the memory 12 the digital signal from the converter 5.
  • the memory 12 has the time to acquire information representing a scanning line, the duration of which is in the order of only 0.2 ms (as compared with 0.2 to 0.02 s to acquire a complete image).
  • the treatment beam will be interrupted for one ms during the duration of the treatment beam pulses, and this will occur every 1/20 s, for example, resulting in only a very slight reduction (2% for example) of the mean power as compared with an uninterrupted treatment beam.
  • the echo signals stored in the memory 12 are read out at a rate of 50 Hz, for example, and displayed continuously on the screen of the device 13.
  • This reading frequency promotes visual comfort.
  • the eye of the operator performs the equivalent of the digital subtraction of the information collected during treatment, at a rate such that it can perceive changes in the amplitude of the ultrasound scan.
  • type B ultrasound probe to obtain type A echograms has the advantage of enabling the same probe to be used for type B ultrasound scanning before a target is treated (here the term "target” refers to a part of the tumor which is exactly the same size as the focal spot, and complete treatment of the tumor will entail focussing the beam onto the various target areas constituting it in succession), to locate said target area as described in the previously mentioned RE 33,590.
  • a relocation can even be carried out by the same probe for type B ultrasound scanning during the treatment of a target, by interrupting the treatment beam for a sufficient time to obtain an image (1/20 s).
  • the table illustrated in figure 3a corresponds to a power transducer T having a spherical transmitting surface, with a focal distance of 10 cm and an aperture angle of 60° of the beam.
  • the rate dT/sec. of a temperature rise as a function of frequency F has been calculated, for a given diameter d of the focal spot and a given entry diameter of the beam into the body, for an aperture constant angle of the beam and a transmitted acoustic peak power of 1 Kw, by making the assumption that the energy losses in the tissue which are due to absorption amount to 1% of the transmitted power, other losses, amounting to 9% of the transmitted power, being bound to multiple reflection upon the cell surfaces.
  • the rate of temperature rise has been calculated, for a given diameter d of the focal spot and a given entry diameter of the beam into the body, for an aperture constant angle of the beam and a transmitted acoustic peak power of 1 Kw, by making the assumption that the energy losses in the tissue which are due to absorption amount to 1% of the transmitted power, other losses, amounting to 9% of the transmitted power, being bound to multiple reflection upon the cell surfaces.
  • Figure 3a corresponds to a focal length of 10 cm and an entry diameter of 10 cm
  • figure 3b corresponds to a focal length of 1.5 cm and an entry diameter of 1.5 cm.
  • the operating frequency F will be selected as follows : First, the focal length which is nearer from the depth of the target within the body (i.e. the distance along the beam path between skin and tumor) will be selected.
  • the selected frequency will be that which both corresponds to the maximum value of k and to the maximum rate of temperature rise.
  • the table of figure 3b shows that the selected frequency will be 6 MHz.
  • the curves of figure 4 show, for a small heat source (in this example a small diameter focal spot), the experimentally determined increase in the temperature T of the area acted on by an ultrasound beam as a function of the application time, for two different applied power levels (curves II and II).
  • the temperature rise is seen to be quasi-linear over a time t o which is substantially the same for both curves, but corresponds to different temperatures, respectivly T o1 and T o2 .
  • t o is independent of the applied power and is in direct proprotion to the focal spot diameter.
  • the frequency is 1 MHz
  • the focal spot diameter is 1.5 mm
  • t o 0.5 s.
  • the applicant has determined similar curves from tests carried out for various values of the operating frequency and of the focal spot diameter, in particular for the values which are indicated in the tables.
  • the applicant's method consisting in selecting a peak power such that a total or at least a substantial destruction of the target cells will be obtained after a time of t o at most, it will result, according to the applicant's discovery, that minimal damage will be caused to tissues in the area surrounding the target.
  • a preferred value of the gap is at least ten times the wave train duration.
  • the time t to destroy tumor cells is inversely proportional to the temperature T to which they are subjected from a threshold value T i of the latter which is 40°C, for example.
  • T i 40°C
  • the graph of figure 5 shows that the value of t is in the order of 0.5 s.
  • the application time t is substantially halved for each increase in temperature of 10°C above 43°C, so that it is divided by 4096 on increasing from 58°C to 70°C, for example.
  • the factor of power conversion of the transducer T being about 1/4, and account being taken of the transmission losses along the path of the beam, an electric peak power of about 20 Kw shall finally be used.
  • the latter will consist of a spherical cap having for instance a diameter of 300 mm and a focal length of 300 mm with an aperture angle of 60°.
  • the operator will displace the transducer for bringing it to a distance from the skin equalling the target depth, thus obtaining coincidence between the target and the focal spot.
  • a single apparatus having a maximum electric peak power of 20 Kw, and the power of which is controllable, and having a wave train duration which may be varied between 0.01 and 1 s for instance, will enable the practician to treat targets of any depth ranging from a few cm to 10-12 cm.
  • a graph will be provided by the manufacturer to indicate the optimal duration of the wave train for each tumor, as a function of its depth.
  • the power may be adjusted, it being understood that the deeper tumors will require the maximum power.
  • the respective optimal frequencies will be 3 and 1.5 MHz and the respective rates of temperature increase will be 384.89°C/s and 135.91 C/s. Powers of between 2 and 5 Kw will then for instance be used.
  • the optimum frequency will be 6 MHz and the temperature increase 1 539.57°C, requiring in practice a power level in the order of 1 Kw.
  • the peak powers used in ultra-high-speed hyperthermia treatment require that special provisions are embodied in the construction of the device.
  • the supply of power to the electrical generator may require the use of auxiliary power supplies.
  • the frequencies and powers chosen enable the beam to pass with little damage through the outer layers of tissue and to produce a thermal effect at the focal spot.
  • the beam additionally has a mechanical effect which complements its thermal effect for increased treatment efficiency.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)
  • Surgical Instruments (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)
EP93400012A 1992-01-07 1993-01-05 Ultrahochgeschwindigkeitsverfahren und Vorrichtung zur Behandlung mit Hyperthermie durch extrakorporalen Ultraschall Withdrawn EP0551225A1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR9200051 1992-01-07
FR9200051A FR2685872A1 (fr) 1992-01-07 1992-01-07 Appareil d'hyperthermie ultrasonore extracorporelle a tres grande puissance et son procede de fonctionnement.

Publications (1)

Publication Number Publication Date
EP0551225A1 true EP0551225A1 (de) 1993-07-14

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EP93400012A Withdrawn EP0551225A1 (de) 1992-01-07 1993-01-05 Ultrahochgeschwindigkeitsverfahren und Vorrichtung zur Behandlung mit Hyperthermie durch extrakorporalen Ultraschall

Country Status (8)

Country Link
US (1) US5354258A (de)
EP (1) EP0551225A1 (de)
JP (1) JPH0678944A (de)
CN (1) CN1076128A (de)
BR (1) BR9300021A (de)
CA (1) CA2086772A1 (de)
FR (1) FR2685872A1 (de)
IL (1) IL104216A0 (de)

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US5354258A (en) 1994-10-11
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CN1076128A (zh) 1993-09-15
FR2685872A1 (fr) 1993-07-09
IL104216A0 (en) 1993-05-13
BR9300021A (pt) 1993-07-13

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