Temperature Rise Evaluation Device

Abstract

To provide movement mechanism control and information processing means which acquires the temperature distribution so as to be able to suppress the occurrence of a focal shift and acquire a clear image in a system which evaluates a treatment device which can emit an ultrasonic wave that cauterizes a human tissue.SOLUTION: A system comprises: a simulation tissue 10 which has a property that changes a color tone due to the temperature in a specific temperature sensing area and simulates the temperature change of a human tissue when receiving an ultrasonic wave from a treatment device; a light source 12 which is arranged so as to surround the simulation tissue and emits planar light from the whole circumference; an imaging device 14 which captures a cross-section color image on the emission surface of light of the simulation tissue; and a movement mechanism control and information processing unit which acquires the temperature distribution of the simulation tissue from the color tone at each position of the image of the simulation tissue that has been captured by using a color and temperate conversion table 17.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] It relates to a temperature rise evaluation device.

Background Art

[0002] In recent years, as one of the treatment methods for dynamic hypertension treatment, a catheter treatment called renal sympathetic denervation (RDN) has attracted attention. It has been found that when the activity of the sympathetic nerves around the kidneys increases, it causes vasoconstriction and the like, leading to an increase in blood pressure. RDN is a treatment method that targets the sympathetic nerves around the renal artery and suppresses their function to reduce the increase in blood pressure. As ablation means, there are mainly RF treatment that ablates the sympathetic nerves while directly ablating the blood vessel wall with an electrode, and ultrasonic treatment that ablates only the sympathetic nerves in a range of about 5 mm outside the blood vessel diameter without directly damaging the blood vessel wall using an ultrasonic device. As a device evaluation method during the development and clinical application of these devices, one of the problems is that there is no method to automatically and simply visualize the temperature rise around the blood vessels ablated by the device. If the temperature rise in the three-dimensional space around the blood vessels can be easily measured, it is expected to lead to the discovery of damage, defects, etc. in the three-dimensional (XYZ) space of the device during development and clinical application. Also, in the development of new devices, it is expected to be applicable as a device evaluation method for optimizing the temperature rise in the tissue outside the blood vessel diameter. As a prior art, by using a hydrophone (ultrasonic sensor) etc. to three-dimensionally scan and measure the inside of the ultrasonic sound field generated by the device, the three-dimensional ultrasonic sound field distribution by the device can be measured, but the temperature rise in the actual living body or a phantom simulating the living body cannot be actually measured.

[0003] There is also prior art in which a thermocouple is inserted into a biological phantom to directly evaluate the temperature rise. However, basically, it is a measurement at finite points, and it is difficult to measure the temperature rise of all in-vivo and biological phantom in a three-dimensional space (for example, about 50 mm × 50 mm × 50 mm in length × width × depth). There is also a concern that inserting a thermocouple may disturb the sound field of the ultrasonic wave. Therefore, as a method for three-dimensionally visualizing the temperature rise, a method has been proposed in which a phantom encapsulated with a thermosensitive liquid crystal (such as a cholesteric liquid crystal) is created, and the temperature rise by the device is visualized by a slit light source (Non-Patent Document 1).

Prior Art Documents

Non-Patent Documents

[0004]

Non-Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] However, the method of visualizing the temperature rise by the device using a slit light source is mainly aimed at evaluating the temperature rise of a high intensity focused ultrasound (HIFU) treatment device. In the evaluation of the above-mentioned renal denervation treatment device, when the light source is scanned with the camera fixed, the distance between the camera and the subject (the surface illuminated by the slit light source) changes, and the focus is shifted, so there is a possibility that a clear image cannot be obtained.

Means for Solving the Problems

[0006] To solve the above problems, the system according to claim 1 is A system for quantitatively evaluating a treatment device capable of irradiating ultrasonic waves for heating human tissue, A simulated tissue having the property that its hue changes with temperature within a specific temperature-sensitive region, the simulated tissue simulating the temperature change of human tissue when receiving ultrasonic waves from the treatment device, A light source that irradiates planar light onto the simulated tissue, An imaging device that captures a cross-sectional color image of the light irradiation surface of the simulated tissue, A moving mechanism that relatively moves the light source and the imaging device with respect to the simulated tissue in the shooting axis direction of the imaging device, A color-temperature conversion table for converting temperature from the hue of the image of the simulated tissue, The moving mechanism is controlled so that the light source and the imaging device move while keeping the distance between the light irradiation surface and the imaging device constant. Further, using the color-temperature conversion table, the temperature distribution of the simulated tissue at each position of the captured image of the simulated tissue is obtained. Moving mechanism control and information processing means, Characterized by comprising.

[0007] The system according to claim 2 is the system according to claim 1, wherein The moving mechanism control and information processing means uses the color-temperature conversion table to obtain the temperature distribution of the simulated tissue over the shooting axis direction from each of the images captured according to the imaging conditions, and outputs a three-dimensional temperature distribution from the temperature distribution of the simulated tissue. It is preferable because the temperature distribution of the simulated tissue can be grasped three-dimensionally.

[0008] The system according to claim 3 is the system according to claim 1 or 2, wherein It further comprises an image holding means for holding the obtained temperature distribution of the simulated tissue as an image, The moving mechanism control and information processing means outputs the temporal change of the temperature distribution of the simulated tissue based on the held temperature distribution image. It is preferable because, compared with the case of not having this configuration, The change in the temperature distribution of the simulated tissue can be evaluated on the time axis.

[0009] ​The system according to claim 4 is the system according to any one of claims 1 to 3, wherein it further includes a thermocouple disposed within the simulated tissue, and the movement mechanism control and information processing means creates the color-temperature conversion table based on the measured temperature of the thermocouple and the hue of the image of the simulated tissue. Compared with the case where this configuration is not present, it is preferable because the temperature distribution of the simulated tissue can be grasped more accurately.

[0010] The system according to claim 5 is the system according to any one of claims 1 to 3, wherein it further includes a water tank whose water temperature can be adjusted and which can accommodate the simulated tissue, and the movement mechanism control and information processing means creates the color-temperature conversion table based on the water temperature of the water tank and the hue of the image of the simulated tissue accommodated in the water in the water tank. Compared with the case where this configuration is not present, it is preferable because the temperature distribution of the simulated tissue can be grasped more accurately without using a calibration simulated tissue.

[0011] The system according to claim 6 is the system according to any one of claims 1 to 5, wherein the light source surrounds the simulated tissue from a 360° direction, and compared with the case where this configuration is not present, it is preferable because the image of the simulated tissue can be captured by eliminating the influence of the shadow of the treatment device disposed in the insertion hole of the simulated tissue.

[0012] The system according to claim 7 is the system according to any one of claims 1 to 5, wherein the light source is disposed at symmetric positions sandwiching the simulated tissue, and compared with the case where this configuration is not present, it is preferable because the image of the simulated tissue can be captured by reducing the influence of the shadow of the treatment device disposed in the insertion hole of the simulated tissue.

[0013] In order to solve the above problems, the program according to claim 8 is A program used in a system for evaluating a treatment device capable of irradiating ultrasonic waves for heating human tissue, wherein the system A simulated tissue having a property that the hue changes with temperature within a specific temperature-sensitive region and simulating the temperature change of human tissue when receiving ultrasonic waves from the treatment device, and having an insertion hole in which the treatment device can be disposed; Two light sources for irradiating planar light to the simulated tissue, the two light sources being disposed at symmetric positions with the simulated tissue sandwiched therebetween; An imaging device for imaging a cross-sectional color image on the light irradiation surface of the simulated tissue; A moving mechanism for relatively moving the light source and the imaging device with respect to the simulated tissue in the imaging axis direction of the imaging device; A color-temperature conversion table for converting temperature from the hue of the image of the simulated tissue; The moving mechanism is controlled so that the light source and the imaging device move while keeping the distance between the light irradiation surface and the imaging device constant, and further, using the color-temperature conversion table, the temperature distribution of the simulated tissue is obtained from the hue of each position of the image of the simulated tissue captured; A first thermocouple disposed in a first region (Cal_1) near the insertion hole in the simulated tissue and not overlapping the insertion hole of the simulated tissue as viewed from any one of the light sources, and a second thermocouple disposed in a second region (Cal_2) overlapping the insertion hole of the simulated tissue; and the treatment device is disposed in the insertion hole of the simulated tissue, In the program used in the system, in the moving mechanism control / information processing means, A heating step of irradiating the treatment device with ultrasonic waves to heat the simulated tissue; A monitoring step of monitoring, through the imaging device, color changes near the first and second thermocouples of the heated simulated tissue; When a color change near the first and second thermocouples of the simulated tissue is observed, a stopping step of stopping the ultrasonic irradiation by the treatment device; A temperature measurement step of measuring the temperature of the simulated tissue at each of the first and second thermocouples; A first imaging step of causing the imaging device to image the simulated tissue; An image segmentation step of dividing the captured image into the first region (Cal_1) and the second region (Cal_2); A first table calibration step of calibrating a value of a table corresponding to the first region (Cal_1) of the color-temperature conversion table based on the measured temperature and the hue at a position closest to the position of the first thermocouple in the first region (Cal_1); A second table calibration step of calibrating a value of a table corresponding to the second region (Cal_2) of the color-temperature conversion table based on the measured temperature and the hue at a position closest to the position of the second thermocouple in the second region (Cal_2); Executing the above, characterized in that.

[0014] The program according to claim 9 is the program according to claim 8, Furthermore, in the movement mechanism control / information processing means, Until the simulated tissue reaches the lower limit temperature of the temperature-sensitive region, at predetermined time intervals, A second imaging step of causing the imaging device to image the simulated tissue; An image segmentation step of dividing the captured image into the first region (Cal_1) and the second region (Cal_2); A temperature distribution acquisition step of acquiring temperature distributions from the first region (Cal_1) and the second region (Cal_2) of the simulated tissue using the calibrated color-temperature conversion table; Repeatedly executing the above, Characterized in that, compared with the case of not having this configuration, It is preferable because the influence of the shadow of the treatment device disposed in the insertion hole of the simulated tissue can be reduced by using a color-temperature conversion table calibrated for each region.

[0015] The program according to claim 10 is the program according to claim 9, wherein the system further includes an image holding means for holding the temperature distribution of the acquired simulated tissue as an image, the temperature distribution acquisition step includes an image holding step in which the acquired temperature distribution is held by the image holding means, in response to a request from a system user, an output step of outputting a temporal change in the temperature distribution of the simulated tissue is executed for the movement mechanism control / information processing means, characterized in that it is preferable because the change in the temperature distribution can be evaluated on the time axis over the entire temperature-sensitive region of the simulated tissue.

[0016] To solve the above problems, the program according to claim 11 is a program used in a system for evaluating a therapeutic device capable of irradiating ultrasonic waves for cauterizing human tissue, wherein the system a simulated tissue having a property that the hue changes depending on the temperature within a specific temperature-sensitive region and simulating the temperature change of human tissue when receiving ultrasonic waves from the therapeutic device, the simulated tissue having an insertion hole in which the therapeutic device can be disposed, two light sources for irradiating the simulated tissue with planar light, the two light sources being disposed at symmetric positions with the simulated tissue interposed therebetween, an imaging device for imaging a cross-sectional color image on the light irradiation surface of the simulated tissue, a movement mechanism for relatively moving the light source and the imaging device with respect to the simulated tissue in the imaging axis direction of the imaging device, a color-temperature conversion table for converting the temperature from the hue of the image of the simulated tissue, the movement mechanism is controlled so that the light source and the imaging device move while keeping the distance between the light irradiation surface and the imaging device constant, and further, using the color-temperature conversion table, the temperature distribution of the simulated tissue is acquired from the hue at each position of the image of the simulated tissue captured, a movement mechanism control / information processing means, a water tank capable of adjusting the water temperature, the water tank being capable of accommodating the simulated tissue, is provided. In the program used in the system, in the movement mechanism control and information processing means, a temperature control step of controlling the water temperature in the water tank to a predetermined temperature; an imaging step of causing the imaging device to image the simulated tissue stored in the water in the water tank; an image division step of dividing the captured image into a first region (Cal_1) that does not overlap the insertion hole of the simulated tissue and a second region (Cal_2) that overlaps when viewed from the light source; a table calibration step of calibrating the color-temperature conversion table based on the water temperature in the water tank and the hue of the image of the simulated tissue captured in each of the first region (Cal_1) and the second region (Cal_2); are executed, and further, in the movement mechanism control and information processing means, the temperature control step, the imaging step, the image division step, and the table calibration step are repeatedly executed over the entire temperature sensing region from the lower limit temperature to the upper limit temperature of the temperature sensing region of the simulated tissue, which is characterized in that.

[0017] The program according to claim 12 is the program according to claim 11, wherein the system has the treatment device disposed in the insertion hole of the simulated tissue, in the movement mechanism control and information processing means, a heating step of irradiating the treatment device with ultrasonic waves to heat the simulated tissue; an imaging step of causing the imaging device to image the simulated tissue at predetermined time intervals; an image division step of dividing the captured image into the first region (Cal_1) and the second region (Cal_2); a temperature distribution acquisition step of acquiring the temperature distribution of each of the first region (Cal_1) and the second region (Cal_2) of the simulated tissue using the calibrated color-temperature conversion table; are executed, Causing the movement mechanism control and information processing means to repeatedly execute the heating step, the imaging step, the image segmentation step, and the temperature distribution acquisition step over the entire temperature sensing region from the lower limit temperature to the upper limit temperature of the temperature sensing region of the simulated tissue. It is characterized in that It is preferable because changes in the temperature distribution can be acquired over the entire temperature sensing region of the simulated tissue.

[0018] The program according to claim 13 is the program according to claim 12, wherein The system further includes an image holding means for holding the acquired temperature distribution of the simulated tissue as an image. The temperature distribution acquisition step includes an image holding step in which the acquired temperature distribution is held by the image holding means. Causing the movement mechanism control and information processing means to execute an output step of outputting the temporal change of the temperature distribution of the simulated tissue in response to a request from a system user. It is characterized in that It is preferable because changes in the temperature distribution can be evaluated on the time axis over the entire temperature sensing region of the simulated tissue.

[0019] In order to solve the above problems, the calibration method according to claim 14 is A method for calibrating the measurement of a system for evaluating a therapeutic device capable of irradiating ultrasonic waves for cauterizing human tissue, wherein the system A simulated tissue having a property that the hue changes with temperature within a specific temperature sensing region and simulating the temperature change of human tissue when receiving ultrasonic waves from the therapeutic device, and having an insertion hole in which the therapeutic device can be disposed, A light source for irradiating planar light onto the simulated tissue, An imaging device for imaging a cross-sectional color image on the light irradiation surface of the simulated tissue, A movement mechanism for relatively moving the light source and the imaging device with respect to the simulated tissue in the imaging axis direction of the imaging device, A color-temperature conversion table for converting the temperature from the hue of the image of the simulated tissue, The moving mechanism is controlled such that the light source and the imaging device move while keeping the distance between the light irradiation surface and the imaging device constant. Further, temperature distribution of the simulated tissue is obtained from hue images of each position of the imaged simulated tissue using the color-temperature conversion table, and a moving mechanism control / information processing means; a thermocouple disposed in the simulated tissue; comprising; the treatment device is disposed in the insertion hole of the simulated tissue; in a calibration method; a step of heating the entire simulated tissue by irradiating the treatment device with ultrasonic waves; a step of monitoring color change in the vicinity of the thermocouple of the heated simulated tissue; when color change in the vicinity of the thermocouple of the simulated tissue is observed, a step of stopping ultrasonic wave irradiation by the treatment device; a step of measuring the temperature of the simulated tissue by the thermocouple; a step of imaging the simulated tissue by the imaging device; a step of calibrating the color-temperature conversion table based on the measured temperature and the hue in the vicinity of the thermocouple in the imaged image; characterized by comprising.

[0020] To solve the above problems, the calibration method according to claim 15 is a method for calibrating measurements of a system for evaluating a treatment device capable of irradiating ultrasonic waves for cauterizing human tissue, wherein the system is a simulated tissue having a property that hue changes with temperature within a specific temperature-sensitive region and simulating temperature change of human tissue when receiving ultrasonic waves from the treatment device, and having an insertion hole in which the treatment device can be disposed; a light source that irradiates planar light to the simulated tissue; an imaging device that images a cross-sectional color image on a light irradiation surface of the simulated tissue; a moving mechanism that relatively moves the light source and the imaging device with respect to the simulated tissue in the imaging axis direction of the imaging device; A color-temperature conversion table for converting temperature from the hue of the image of the simulated tissue, The moving mechanism is controlled so that the light source and the imaging device move while keeping the distance between the light irradiation surface and the imaging device constant, and further, using the color-temperature conversion table, the temperature distribution of the simulated tissue is obtained from the hue at each position of the image of the simulated tissue captured. A moving mechanism control and information processing means, A water tank capable of adjusting the water temperature, the water tank capable of accommodating the simulated tissue, Comprising In a method of calibration, Imaging the simulated tissue stored in the water in the water tank controlled to a predetermined temperature, The step of imaging is repeated by changing the water temperature in the water tank over the entire temperature sensing region from the lower limit temperature to the upper limit temperature of the temperature sensing region of the simulated tissue, and the color-temperature conversion table is calibrated over the entire temperature sensing region based on the water temperature in the water tank and the hue of the image of the simulated tissue captured, Characterized by comprising

Effect of the Invention

[0021] According to the present invention, in a system for evaluating a therapeutic device capable of irradiating ultrasonic waves for cauterizing human tissue, the occurrence of out-of-focus can be suppressed and a clear image can be obtained.

Brief Description of the Drawings

[0022]

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Mode for Carrying Out the Invention

[0023] Hereinafter, the present invention will be described using embodiments applied to a renal denervation treatment device. However, the present invention is not limited thereto and can be applied to the performance evaluation of treatment devices for other diseases and treatment devices using RF catheters. For example, in the treatment of hypertension, renal denervation treatment reduces blood pressure by cauterizing the sympathetic nerves around the renal blood vessels through a catheter. Examples of the application range include RF (electrode) cauterization and ultrasonic cauterization.

[0024] (First Embodiment) FIG. 1 is a schematic diagram showing the configuration of a three-dimensional temperature distribution high-speed measurement system 1 according to the first embodiment, and FIG. 2 is an external view of a light source used in the three-dimensional temperature distribution high-speed measurement system 1 shown in FIG. 1. Here, regarding the expression "high-speed", the expression "high-speed" is used in comparison with the case of measuring the HIFU sound field using the previously described hydrophone (ultrasonic sensor) or the like. In the sound field measurement using a normal hydrophone, since the hydrophone is mechanically scanned, it depends on the measurement pitch and the measurement range, but in two-dimensional sound field measurement, it takes about 1 to 2 hours, and in three-dimensional measurement, it takes about 3 to 4 hours. On the other hand, in this system, a two-dimensional optical image can be acquired instantaneously, and three-dimensional measurement can be performed with only a mechanical scan in only one axis. Therefore, compared with the sound field measurement by a hydrophone, it can be measured at high speed in about 1 / 200 (two-dimensional: several to several tens of seconds, three-dimensional: several tens of seconds to several minutes).

[0025] The three-dimensional temperature distribution high-speed measurement system 1 includes a temperature-sensitive phantom 10 made of a translucent material having the property that its hue changes with temperature, a light source 12 having a donut shape and arranged to surround the temperature-sensitive phantom 10 placed at the position of the hole of the donut, and irradiating the temperature-sensitive phantom 10 with planar light from all around, an imaging device 14 composed of, for example, a CCD camera or the like, and imaging the entire temperature-sensitive phantom 10 from the direction of the imaging axis P perpendicular to the plane of the light irradiated from the light source 12, and a moving mechanism control / information processing unit 16, which is an example of a moving mechanism control / information processing means composed of, for example, an information processing device (CPU), having a color / temperature conversion table 17 for converting the temperature from the hue of the image of the temperature-sensitive phantom 10, acquiring the temperature distribution of the temperature-sensitive phantom 10 from the hue of each position of the image of the temperature-sensitive phantom 10 captured, and controlling the light source moving mechanism 22 and the imaging device moving mechanism 24 described later, and an image holding unit 18, which is an example of an image holding means composed of, for example, a storage means such as a memory or an HD, and holding the temperature distribution acquired from the image of the temperature-sensitive phantom 10 captured as an image. When the light source 12 irradiates the temperature-sensitive phantom 10 with planar light, the imaging device 14 images the cross-sectional color image of the temperature-sensitive phantom 10 on the light irradiation surface.

[0026] The temperature-sensitive phantom 10 has, at its center, an insertion hole 7 extending in the direction of the imaging axis P of the imaging device 14, the insertion hole 7 being shaped to mimic the blood vessel diameter, and is configured to receive a treatment device 5 (described later). The temperature-sensitive phantom 10 functions as a simulated tissue that simulates the temperature change of human tissue when it is heated by receiving ultrasonic waves from the treatment device 5 disposed in the insertion hole 7. The light source 12 has LEDs arranged in a donut shape and is configured to have a slit for emitting light to the temperature-sensitive phantom 10 inside the hole of the donut (see FIG. 2). The imaging device 14 is arranged such that the imaging axis passes through the center (insertion hole 7) of the temperature-sensitive phantom 10 in order to image the entire temperature-sensitive phantom 10. The image holding unit 18 holds the acquired temperature distribution image of the temperature-sensitive phantom 10, and the movement mechanism control / information processing unit 16 outputs the temporal change of the temperature distribution of the temperature-sensitive phantom 10. Here, the treatment device 5 includes a single plate capable of irradiating ultrasonic waves for cauterizing human tissue, a cylindrical ultrasonic transducer, or an ultrasonic array transducer composed of a plurality of micro ultrasonic vibrators. Further, as an example of human tissue, the sympathetic nerves around the renal artery or the blood vessel wall of the renal artery can be considered.

[0027] In addition, as an example of a moving mechanism that moves the light source 12 and the imaging device 14 relative to the temperature-sensitive phantom 10 in the direction of the imaging axis P, the three-dimensional temperature distribution high-speed measurement system 1 includes, for example, a light source moving mechanism 22 that is composed of a motor and a linear guide, etc., and moves the light source 12 parallel to the direction of the imaging axis P of the imaging device 14, and an imaging device moving mechanism 24 that is also composed of a motor and a linear guide, etc., and moves the imaging device 14 parallel to the direction of the imaging axis P. Before measurement, the moving mechanism control and information processing unit 16 sets the measurement range and preset the distance (pitch, etc.) between measurement surfaces. Here, the light source moving mechanism 22 and the imaging device moving mechanism 24 are controlled by the moving mechanism control and information processing unit 16 to operate in cooperation in the direction of the imaging axis P, and are configured to keep the distance between the light irradiation surface and the imaging device 14 constant. As a result, during the movement, the focus of the imaging device 14 is in a state where it is focused on the light irradiation surface (focusing surface), and the light source 12 and the imaging device 14 are moved in conjunction so that the light irradiation surface moves in the direction of the imaging axis P from the farthest position to the nearest position of the temperature-sensitive phantom 10 as seen from the imaging device 14, and it becomes possible to sequentially capture cross-sectional images of the entire temperature-sensitive phantom 10. The image holding unit 18 holds the captured images of the entire temperature-sensitive phantom 10. Note that the light source moving mechanism 22 can finely adjust the position of the imaging device 14 separately from the operation of the imaging device moving mechanism 24, and can adjust the focus of the imaging device 14 to the light irradiation surface. The three-dimensional temperature distribution high-speed measurement system 1 is arranged in the light-shielding box 28 to exclude the influence of external light.

[0028] Here, the procedures of the specific measurement preparation process and evaluation process by the three-dimensional temperature distribution high-speed measurement system 1 are shown. As a preparation process before starting the evaluation, a calibration operation is performed to associate the change in hue (RGB value obtained by the imaging device 14) due to the temperature rise of the temperature-sensitive phantom 10 with the actual temperature. Here, the calibration method will be described, and then the evaluation method will be described.

[0029] (Calibration Method) FIG. 3 is a schematic diagram showing the configuration during calibration of the three-dimensional temperature distribution high-speed measurement system 1. As shown in FIG. 3, a temperature-sensitive phantom 11 for calibration is installed in the three-dimensional temperature distribution high-speed measurement system 1. Here, the temperature-sensitive phantom 11 for calibration needs to be formed from the same lot as the temperature-sensitive phantom 10 for evaluation and have the same shape, size, etc. This is because if the concentration of the temperature-sensitive material, the phantom shape, etc. in the temperature-sensitive phantom during calibration and evaluation are different, there is a concern that the relationship between color and temperature conversion during calibration and evaluation will change.

[0030] To obtain the relationship between temperature and hue, a thermocouple 60 is inserted into the temperature-sensitive phantom 11 for calibration. FIG. 4 is a front view when the temperature-sensitive phantom 11 for calibration is imaged by the imaging device 14. As shown in FIG. 4, the thermocouple 60 is inserted at a distance of about several millimeters to several centimeters from the treatment device 5. Regarding the insertion position, since the optimal position depends on the treatment device 5 and the size of the temperature-rising region, it cannot be generally defined, but in the temperature-rising region, any region where the relationship between the hue of the temperature-sensitive material and its temperature can be obtained is acceptable.

[0031] (Initial setting (focus adjustment)) A calibration method executed in the three-dimensional temperature distribution high-speed measurement system 1 with the treatment device 5 disposed in the insertion hole 8 of the temperature-sensitive phantom 11 for calibration will be described. FIG. 5 is a flowchart of the calibration method executed by the three-dimensional temperature distribution high-speed measurement system 1. First, the light source 12 irradiates the temperature-sensitive phantom 11 with planar light, and the imaging device 14 captures an image of the temperature-sensitive phantom 11 to check whether the position of the light irradiation surface is in focus with the imaging device 14. When the focus is not achieved, the imaging device moving mechanism 24 operates to finely adjust the position of the imaging device 14 to eliminate the defocus. When the focus is achieved, the light source moving mechanism 22 and the imaging device moving mechanism 24 operate in conjunction to keep the distance between the light irradiation surface and the imaging device 14 constant, and move the position of the light irradiation surface and the imaging device 14 to the initial position (near the center of the temperature-sensitive phantom 11 for calibration in this embodiment) to complete the initial setting step (S102).

[0032] (Obtaining hue-temperature data for calibration) When the initial settings are completed, the movement mechanism control and information processing unit 16 activates the treatment device 5 to start ultrasonic irradiation. Upon receiving the ultrasonic irradiation from the treatment device 5, the calibration thermosensitive phantom 11 vibrates and its overall temperature rises (heating step: S110). At this time, the movement mechanism control and information processing unit 16 monitors the color change of the calibration thermosensitive phantom 11 through the imaging device 14 (monitoring step: S112). When it is monitored that the temperature rise region has expanded to the region including the thermocouple 60, the output of the treatment device 5 is stopped (heating stop step: S114). After the heating is stopped, imaging and temperature measurement are started to obtain the relationship between the hue of the calibration thermosensitive phantom 11 and the actual temperature (temperature and image measurement step: S116). The imaging and temperature measurement are repeated until the thermocouple reaches the lower limit value of the phantom coloring temperature (S118).

[0033] Fig. 6 shows an overview of the steps of the above flowcharts S110 to S118. Fig. 6 is a time history of a front view when the calibration thermosensitive phantom 11 is imaged from the imaging device 14. When the time is 0, the output of the treatment device 5 is turned on to start heating the calibration thermosensitive phantom 11 (S110). The calibration thermosensitive phantom 11 gradually starts to color from near the treatment device 5, and when the colored region has expanded to the thermocouple 60 region (time t = T2), the heating is stopped (S114), and imaging and temperature measurement are started (S116: first imaging step). After that, as described above, the imaging and temperature measurement are repeated until the thermocouple reaches the lower limit value of the phantom coloring temperature (S118).

[0034] In this way, by separating the temperature rise of the calibration thermosensitive phantom 11 by ultrasonic irradiation and the imaging of the calibration thermosensitive phantom 11 with the ultrasonic irradiation stopped, the thermocouple 60 vibrates due to the ultrasonic irradiation, and the color - temperature conversion table 17 can be obtained in a state where the influence of the local temperature being higher only in its vicinity than other parts is eliminated.

[0035] (Calibration using the obtained data) Measure the hue (RGB value) and the temperature at that time until the lower limit value of the phantom coloring temperature is reached, and save the time history (S120). Using the saved RGB values and their temperature values, create a color-temperature conversion table (calibration step: S130). Although various methods can be proposed or devised for associating hue and temperature information, here, the method based on principal component analysis of RGB values shown in Non-Patent Document 1 will be described. However, the calibration step is not limited to this method, and any means can be used as long as the RGB value and the temperature can be associated one-to-one and the temperature can be estimated from the actual phantom hue.

[0036] Figure 7(a) shows the relationship between the RGB value (vertical axis) and the temperature (horizontal axis) obtained by imaging 14 and thermocouple 60 when the calibration thermosensitive phantom 11 that colors in the range of 60°C to 70°C is used. Here, by applying principal component analysis to the RGB values, the RGB values are projected onto the first principal component (horizontal axis) and the second principal component (vertical axis) (Figure 7(b)). The phase angle-temperature data of each projection data is obtained from the centroid X of the projection data, and a table in which the phase angle and the temperature correspond one-to-one is created (Figure 7(c)). By doing so, the actual coloring temperature (RGB value) and the temperature are associated, and in actual evaluation, the actual temperature can be estimated from the hue of the calibration thermosensitive phantom 11.

[0037] (Evaluation method) After the above calibration process is completed and the color-temperature conversion table 17 is saved in the movement mechanism control and information processing unit 16, the actual temperature distribution measurement by the treatment device 5 is started according to the system in FIG. 1. The flowchart of the evaluation is shown in FIG. 8. In the initial setting S202, in addition to the focusing in the above calibration process, the range of the three-dimensional distribution that the user wants to obtain, the distance (pitch) between each measurement surface, the set imaging time, etc. are set. After the initial setting is completed, heating is started (S204), and the light source movement mechanism 22 and the imaging device movement mechanism 24 interlock to move the light irradiation surface in the direction of the imaging axis P of the imaging device 14, and the cross-sectional image of the entire evaluation thermosensitive phantom 10 in the direction of the imaging axis P from the farthest position to the nearest position of the evaluation thermosensitive phantom 10 as viewed from the imaging device 14 is imaged (S206: second imaging step). Imaging is repeated until the set imaging time is reached (S208: No), and when the set imaging time is reached (S208: Yes), imaging is stopped (S210). After imaging is stopped, the time history of the imaging data is temporarily saved in the image holding unit 18 (S302), and the movement mechanism control and information processing unit 16 performs temperature conversion using the temperature conversion table 17 saved in advance (S304), and saves the time history of the three-dimensional temperature distribution image in the image holding unit 18 (S306).

[0038] In response to the user's request (input means not shown), the temperature distribution of the evaluation thermosensitive phantom 10 is output to the display means (not shown). Since the image holding unit 18 holds the set time history image of the three-dimensional temperature distribution at the time of evaluation, it is also possible to display the time change of the temperature distribution according to the user's request.

[0039] FIG. 9 shows an example of the time history of a figure in which the temperature distribution is visualized and three-dimensionally displayed. FIG. 9 is the time history of the temperature distribution obtained by extracting only the temperature rising region of 63° C. or higher of the evaluation thermosensitive phantom 10 and cutting it at the cross section of X = 0. After the three-dimensional temperature distribution is obtained, it becomes possible to freely and quantitatively observe the surface, angle, time history, etc. of the temperature distribution that the user wants to observe in this way. By doing so, it becomes possible to quantitatively confirm the state of the four-dimensional temperature rising region including the actual three-dimensional living body and the time dimension, and it is expected to be useful for safety checks of the treatment device and formulation of treatment plans.

[0040] (Second Embodiment) FIG. 10 is a schematic diagram showing the configuration at the time of calibration of the three-dimensional temperature distribution high-speed measurement system 50 according to the second embodiment. For the same or similar elements as those of the three-dimensional temperature distribution high-speed measurement system 1 according to the first embodiment, the same or similar reference numerals are given and the description thereof is omitted. In the three-dimensional temperature distribution high-speed measurement system 1 according to the first embodiment, the temperature-sensitive phantom 11 for calibration and the temperature-sensitive phantom 10 for evaluation are configured to be irradiated with light from all around (see FIGS. 1 and 3). In contrast, in the three-dimensional temperature distribution high-speed measurement system 50 according to the second embodiment described below, the difference lies in that the temperature-sensitive phantom 11 for calibration and the temperature-sensitive phantom 10 for evaluation are irradiated with light from both the left and right sides.

[0041] The three-dimensional temperature distribution high-speed measurement system 50 is configured to include light sources 12a and 12b that irradiate the temperature-sensitive phantom 11 for calibration with planar light. The light sources 12a and 12b are arranged at symmetric positions with the temperature-sensitive phantom 11 for calibration interposed therebetween, and irradiate the entire temperature-sensitive phantom 11 for calibration with planar light from both sides. Each of the light sources 12a and 12b is composed of, for example, LEDs arranged in a row and a slit arranged so as to emit light toward the temperature-sensitive phantom 11 for calibration.

[0042] Here, the state when the light sources 12a and 12b irradiate the calibration thermosensitive phantom 11 with planar light will be described with reference to the drawings. FIG. 11 is a diagram for explaining the state when the calibration thermosensitive phantom 11 is irradiated with light using the light sources 12a and 12b. FIG. 11(a) shows the state when light is irradiated from one direction (from the right direction in the figure with respect to the calibration thermosensitive phantom 11), and FIG. 11(b) shows the state when light is irradiated from both sides with the calibration thermosensitive phantom 11 sandwiched therebetween. As shown in FIG. 11(a), when light is irradiated from the right direction in the figure (light source 12a), a shadow is formed on the side opposite to the light source 12a with the treatment device 5 sandwiched by the treatment device 5 disposed in the insertion hole 8. On the other hand, when the light sources 12a and 12b are arranged at symmetric positions on both sides with the calibration thermosensitive phantom 11 sandwiched therebetween and light is irradiated, as shown in FIG. 11(b), the influence of the shadow of the treatment device 5 can be reduced. However, when the temperature distribution of the calibration thermosensitive phantom 11 is carefully observed, it can be seen that the influence of the shadow of the treatment device 5 has not been completely eliminated.

[0043] A calibration method for eliminating the influence of the shadow when light is irradiated from the light sources 12a and 12b (FIG. 10) arranged on both sides with the calibration thermosensitive phantom 11 sandwiched therebetween will be described with reference to the drawings. FIG. 12 is a diagram showing a state in which an image obtained by irradiating light by the light sources 12a and 12b is divided into a first region (Cal_1) not affected by the shadow of the treatment device 5 and a second region (Cal_2) affected by the shadow of the treatment device 5. The second region (Cal_2) affected by the shadow of the treatment device 5, that is, the region (Cal_2_12a) opposite to the light source 12a with the treatment device 5 sandwiched therebetween and the region (Cal_2_12b) opposite to the light source 12b with the treatment device 5 sandwiched therebetween receive less light from the light source than the first region (Cal_1) not affected by the shadow of the treatment device 5. That is, the influence of the shadow of the treatment device 5 has not been completely eliminated.

[0044] Therefore, in order to remove the influence of the shadow, the relationship between the two types of phantom hue and temperature is obtained using the first thermocouple 61 inserted into the first region and the second thermocouple 62 inserted into the second region, and separate color-temperature conversions are performed in each region. The flowchart of the calibration method is almost the same as that in FIG. 5, but the points of performing temperature measurement (S116) and creating the color-temperature conversion table for each region (S130) in each of the first region and the second region are different from the calibration method of the first embodiment. FIG. 13 shows an overview of the color-temperature conversion tables for the first region and the second region respectively. Here, the calibration means for associating the hue and temperature one-to-one may be the method using the principal component analysis described above, or any other method.

[0045] (Evaluation method) The flowchart of the evaluation method in the second embodiment is also almost the same as that in the first embodiment (FIG. 8). The differences are that at the initial setting, the user sets the ranges of the first region and the second region, and the saved color-temperature conversion tables for each region (FIG. 13) are used for temperature conversion (S304). In addition, the same as the first embodiment is that according to the user's request (the input means is not shown), the temperature distribution of the temperature-sensitive phantom 10 and the time change of the temperature distribution can be output.

[0046] The problem caused by the difference in the light amounts received from the two light sources on the left and right between the first region (Cal_1) not affected by the shadow of the treatment device 5 and the second region (Cal_2) affected by the shadow will be described with reference to the drawings. FIG. 14(a) shows the temperature distribution of a surface of the temperature-sensitive phantom 10 when calibrated using only the color-temperature conversion table 17 based on the temperature of the temperature-sensitive phantom 10 for evaluation and the hue of the first region (Cal_1). FIG. 14(b) shows the temperature distribution of the same surface of the temperature-sensitive phantom 10 as in FIG. 14(a) when calibrated using only the color-temperature conversion table 17 based on the temperature of the temperature-sensitive phantom 10 and the hue of the second region (Cal_2). FIG. 14(c) shows the result of combining the temperature distribution of the first region (Cal_1) of the temperature distribution shown in FIG. 14(a) and the temperature distribution of the second region (Cal_2) of the temperature distribution shown in FIG. 14(b).

[0047] When calibrating using only the color-temperature conversion table 17 based on the temperature of the temperature-sensitive phantom 10 and the hue of the first region (Cal_1), as shown in Fig. 14(a), the first region (Cal_1) is calibrated and temperature-converted relatively appropriately, but the second region (Cal_2) is displayed higher or lower than the original temperature. On the other hand, when calibrating using only the color-temperature conversion table 17 based on the temperature of the temperature-sensitive phantom 10 and the hue of the second region (Cal_2), as shown in Fig. 14(b), the second region (Cal_2) is calibrated and temperature-converted relatively appropriately, but the first region (Cal_1) tends to be converted and displayed at a lower temperature. Therefore, for calibrating the values of the table corresponding to the first region (Cal_1) of the color-temperature conversion table 17, the first relationship between the temperature of the temperature-sensitive phantom 10 and the hue of the first region (Cal_1) is used, and for calibrating the values of the table corresponding to the second region (Cal_2) of the color-temperature conversion table 17, the second relationship between the temperature of the temperature-sensitive phantom 10 and the hue of the second region (Cal_2) is used to form their respective temperature distributions, and these are combined to obtain the temperature distribution shown in Fig. 14(c).

[0048] (Third Embodiment) Fig. 15 is a schematic diagram showing the configuration of the three-dimensional temperature distribution high-speed measurement system 70 according to the third embodiment. For the same or similar elements as those in the three-dimensional temperature distribution high-speed measurement systems 1 and 50 according to the first or second embodiment, the same or similar reference numerals are given and the description is omitted. In the three-dimensional temperature distribution high-speed measurement system 50 according to the second embodiment, the color-temperature conversion table 17 is calibrated based on the temperature of the temperature-sensitive phantom measured by the thermocouple 60 and the hue of the captured image, whereas the three-dimensional temperature distribution high-speed measurement system 70 according to the third embodiment described below is different in that it includes a water tank 80 whose water temperature can be adjusted, and the color-temperature conversion table 17 is created based on the water temperature in the water tank 80 and the hue of the image of the temperature-sensitive phantom 10. Note that the light source of the three-dimensional temperature distribution high-speed measurement system 70 according to the third embodiment may be the light source of the three-dimensional temperature distribution high-speed measurement system 1 according to the first embodiment or the light source of the three-dimensional temperature distribution high-speed measurement system 50 according to the second embodiment (irradiating light from both the left and right sides of the temperature-sensitive phantom 10).

[0049] The three-dimensional temperature distribution high-speed measurement system 70 according to the third embodiment shown in FIG. 15 includes a water tank 80 that can be adjusted to a predetermined temperature by a heater (not shown), and the water tank 80 houses a temperature-sensitive phantom 10 inside. The movement mechanism control and information processing unit 16 controls the water temperature in the water tank 80 and acquires the hue of the image of the temperature-sensitive phantom 10 in association with the water temperature in the water tank 80. Thereby, the movement mechanism control and information processing unit 16 acquires a color-temperature conversion table 17 based on the temperature and the hue. Regarding the evaluation method, data display, etc., it is substantially the same as in the first embodiment and the second embodiment. Since there is only a difference in the calibration method, the calibration method in the three-dimensional temperature distribution high-speed measurement system 70 according to the third embodiment will be described below.

[0050] (Calibration method) The calibration method executed by the three-dimensional temperature distribution high-speed measurement system 70 according to the third embodiment will be described below. FIG. 16 is a flowchart of a method for acquiring the color-temperature conversion table 17 executed by the three-dimensional temperature distribution high-speed measurement system 70. The focusing is the same as the initial setting focusing in the systems 1 and 50 of the first embodiment or the second embodiment, so the description is omitted. In the initial setting, when using the light source of the first embodiment, one measurement point of the phantom hue is specified, and when using the light source of the second embodiment, two points are specified (the first region: Cal_1 and the second region: Cal_2 described above).

[0051] When the initial setting is completed, the movement mechanism control and information processing unit 16 heats the water in the water tank 80 to the lower limit temperature of the temperature-sensitive region by a heater (not shown) (temperature control step: S410). When the lower limit temperature of the temperature-sensitive region is reached, the heater is stopped and waiting is performed until the temperature of the temperature-sensitive phantom 10 stabilizes (stop step: S412). When the temperature of the entire temperature-sensitive phantom 10 has stabilized, the imaging device 14 images the entire temperature-sensitive phantom 10 and measures the water temperature at that time = the temperature of the temperature-sensitive phantom (imaging and temperature measurement step: S414).

[0052] Subsequently, the water in the water tank 80 is heated by a predetermined temperature range (temperature control step: S410). Similar to the above, when the temperature of the entire temperature-sensitive phantom 10 has stabilized (stop step: S412), an image of the entire temperature-sensitive phantom 10 is captured and the temperature is measured (imaging and temperature measurement step: S414). The relationship between the phantom hue and temperature is obtained until the upper limit temperature of the temperature-sensitive region is reached. When the upper limit temperature is reached, the captured image and the time history of temperature measurement are saved (saving step: S120). Thereafter, using the method described above, a color-temperature conversion table is created (calibration step: S130). In S130, when the light source of the first embodiment is used, one type of color-temperature change table is created. When the light source of the second embodiment is used, two types (the aforementioned first region: Cal_1 and second region: Cal_2) of color-temperature change tables are created.

[0053] In the above description, an example of obtaining a temperature distribution image during the temperature rise process of the temperature-sensitive phantom 10 has been described. However, with the same configuration, it is possible to obtain a temperature distribution image during the natural cooling process of the temperature-sensitive phantom 10.

[0054] (Evaluation method) The flowchart of the evaluation method in the third embodiment is also substantially the same as that in the first embodiment (Fig. 8). As described above, the number of color-temperature conversion tables differs depending on the type of light source used. In addition, in response to the user's request (the input means is not shown), the temperature distribution of the temperature-sensitive phantom 10 and the time change of the temperature distribution can be output, which is the same as in the first embodiment and the second embodiment.

[0055] The advantage of the third embodiment is that there is no need to separately prepare a temperature-sensitive phantom for calibration. In the first embodiment and the second embodiment, since the temperature-sensitive phantom is invaded by the thermocouple, it is necessary to separately prepare a temperature-sensitive phantom for evaluation. However, in the third embodiment, after the calibration using the temperature-sensitive phantom is completed, it is possible to shift to the evaluation without replacing the temperature-sensitive phantom.

Claims

1. A system for quantitatively evaluating a therapeutic apparatus capable of irradiating ultrasonic waves for heating human tissue, comprising: A simulated tissue having a property that its hue changes according to temperature within a specific temperature-sensitive region, which simulates the temperature change of human tissue when receiving ultrasonic waves from the therapeutic apparatus; A light source for irradiating planar light onto the simulated tissue; An imaging device for imaging a cross-sectional color image on the light-irradiated surface of the simulated tissue; A moving mechanism for relatively moving the light source and the imaging device with respect to the simulated tissue in the direction of the imaging axis of the imaging device; A color-temperature conversion table for converting temperature from the hue of the image of the simulated tissue; The moving mechanism is controlled so that the light source and the imaging device move while keeping the distance between the light-irradiated surface and the imaging device constant. Further, using the color-temperature conversion table, a moving mechanism control and information processing means for obtaining the temperature distribution of the simulated tissue from the hue of each position of the image of the simulated tissue captured; A system comprising the above.

2. The moving mechanism control and information processing means uses the color-temperature conversion table to obtain the temperature distribution of the simulated tissue in the direction of the imaging axis from each of the images captured according to the imaging conditions, and outputs a three-dimensional temperature distribution from the temperature distribution of the simulated tissue. The system according to Claim 1.

3. Further comprising an image holding means for holding the obtained temperature distribution of the simulated tissue as an image, The moving mechanism control and information processing means outputs the temporal change of the temperature distribution of the simulated tissue based on the held temperature distribution image. The system according to Claim 1 or 2.

4. Further comprising a thermocouple disposed within the simulated tissue, The moving mechanism control and information processing means creates the color-temperature conversion table based on the measured temperature of the thermocouple and the hue of the image of the simulated tissue. The system according to any one of Claims 1 to 3.

5. An aquarium whose water temperature can be adjusted, further comprising an aquarium capable of accommodating the simulated tissue, The moving mechanism control and information processing means creates the color-temperature conversion table based on the water temperature of the aquarium and the hue of the image of the simulated tissue accommodated in the water within the aquarium. The system according to any one of Claims 1 to 3.

6. The light source surrounds the simulated tissue from 360°. The system according to any one of Claims 1 to 5.

7. The system according to any one of claims 1 to 5, wherein the light sources are arranged at symmetric positions with the simulated tissue therebetween.

8. A program used in a system for evaluating a therapeutic device capable of irradiating ultrasonic waves for heating human tissue, wherein the system includes a simulated tissue having a property that its hue changes with temperature within a specific temperature-sensitive region and simulating the temperature change of human tissue when receiving ultrasonic waves from the therapeutic device, and having an insertion hole in which the therapeutic device can be arranged; two light sources that irradiate planar light onto the simulated tissue, the two light sources being arranged at symmetric positions with the simulated tissue therebetween; an imaging device that captures a cross-sectional color image of the light-irradiated surface of the simulated tissue; a moving mechanism that relatively moves the light sources and the imaging device with respect to the simulated tissue in the imaging axis direction of the imaging device; a color-temperature conversion table for converting temperature from the hue of the image of the simulated tissue; the moving mechanism is controlled so that the light sources and the imaging device move while keeping the distance between the light-irradiated surface and the imaging device constant, and further, using the color-temperature conversion table, the temperature distribution of the simulated tissue is obtained from the hue of each position of the captured image of the simulated tissue; a moving mechanism control / information processing means; a first thermocouple arranged in a first region (Cal_1) near the insertion hole in the simulated tissue and not overlapping the insertion hole of the simulated tissue as viewed from either one of the light sources, and a second thermocouple arranged in a second region (Cal_2) overlapping the insertion hole of the simulated tissue; and comprising the therapeutic device is arranged in the insertion hole of the simulated tissue; In the program used in the system, in the moving mechanism control / information processing means, a heating step of irradiating the therapeutic device with ultrasonic waves to heat the simulated tissue; a monitoring step of monitoring, through the imaging device, the color change near the first and second thermocouples of the heated simulated tissue; a stopping step of stopping the ultrasonic wave irradiation by the therapeutic device when the color change near the first and second thermocouples of the simulated tissue is observed; a temperature measurement step of measuring the temperature of the simulated tissue at each of the first and second thermocouples; a first imaging step of imaging the simulated tissue with the imaging device; an image division step of dividing the captured image into the first region (Cal_1) and the second region (Cal_2); A first table calibration step of calibrating the value of the table corresponding to the first region (Cal_1) of the color-temperature conversion table based on the measured temperature and the hue at the position closest to the position of the first thermocouple in the first region (Cal_1); A second table calibration step of calibrating the value of the table corresponding to the second region (Cal_2) of the color-temperature conversion table based on the measured temperature and the hue at the position closest to the position of the second thermocouple in the second region (Cal_2); A program for executing the above.

9. In the program according to claim 8, further, in the movement mechanism control / information processing means, Until the lower limit temperature of the temperature-sensitive region of the simulated tissue is reached, at predetermined time intervals, A second imaging step of causing the imaging device to image the simulated tissue; An image segmentation step of dividing the captured image into the first region (Cal_1) and the second region (Cal_2); A temperature distribution acquisition step of acquiring the temperature distribution of each of the first region (Cal_1) and the second region (Cal_2) of the simulated tissue using the calibrated color-temperature conversion table; A program for repeatedly executing the above.

10. In the program according to claim 9, The system further includes an image holding means for holding the temperature distribution of the acquired simulated tissue as an image, The temperature distribution acquisition step includes an image holding step in which the acquired temperature distribution is held by the image holding means, A program for causing the movement mechanism control / information processing means to execute an output step of outputting the temporal change of the temperature distribution of the simulated tissue in response to a request from a system user.

11. A program used in a system for evaluating a therapeutic device capable of irradiating ultrasonic waves for cauterizing human tissue, The system includes A simulated tissue having a property that the hue changes with temperature within a specific temperature-sensitive region and simulating the temperature change of human tissue when receiving ultrasonic waves from the therapeutic device, and having an insertion hole in which the therapeutic device can be disposed; Two light sources for irradiating the simulated tissue with planar light, the two light sources being disposed at symmetric positions sandwiching the simulated tissue; An imaging device for imaging a cross-sectional color image on the light irradiation surface of the simulated tissue; A movement mechanism for relatively moving the light source and the imaging device with respect to the simulated tissue in the imaging axis direction of the imaging device; A color-temperature conversion table for converting the temperature from the hue of the image of the simulated tissue. Controlling the moving mechanism such that the light source and the imaging device move while keeping the distance between the light irradiation surface and the imaging device constant, and further, using the color-temperature conversion table to obtain the temperature distribution of the simulated tissue from the hue at each position of the image of the simulated tissue captured, a moving mechanism control and information processing means; A water tank with adjustable water temperature, comprising a water tank capable of accommodating the simulated tissue; Comprising; In the program used in the system, to the moving mechanism control and information processing means, A temperature control step of controlling the water in the water tank to a predetermined temperature; An imaging step of causing the imaging device to image the simulated tissue housed in the water in the water tank; An image segmentation step of dividing the captured image into a first region (Cal_1) that does not overlap with the insertion hole of the simulated tissue as seen from the light source and a second region (Cal_2) that overlaps; A table calibration step of calibrating the color-temperature conversion table based on the water temperature in the water tank and the hue of the image of the simulated tissue captured in each of the first region (Cal_1) and the second region (Cal_2); To execute, and further, to the moving mechanism control and information processing means, A program that repeatedly executes the temperature control step, the imaging step, the image segmentation step, and the table calibration step over the entire temperature sensing region from the lower limit temperature to the upper limit temperature of the temperature sensing region of the simulated tissue.

12. In the program according to claim 11, In the system, the treatment device is disposed in the insertion hole of the simulated tissue, To the moving mechanism control and information processing means, A heating step of irradiating the treatment device with ultrasonic waves to heat the simulated tissue; An imaging step of causing the imaging device to image the simulated tissue at predetermined time intervals; An image segmentation step of dividing the captured image into the first region (Cal_1) and the second region (Cal_2); A temperature distribution acquisition step of using the calibrated color-temperature conversion table to acquire the temperature distribution from each of the first region (Cal_1) and the second region of the simulated tissue; To execute, A program that repeatedly executes the heating step, the imaging step, the image segmentation step, and the temperature distribution acquisition step over the entire temperature sensing region from the lower limit temperature to the upper limit temperature of the temperature sensing region of the simulated tissue to the moving mechanism control and information processing means.

13. In the program according to claim 12, The system further includes an image holding means for holding the temperature distribution of the acquired simulated tissue as an image. The temperature distribution acquisition step includes an image holding step in which the acquired temperature distribution is held by the image holding means. A program for causing the movement mechanism control / information processing means to execute an output step of outputting a temporal change in the temperature distribution of the simulated tissue in response to a request from a system user.

14. A method for calibrating measurements of a system for evaluating a therapeutic device capable of irradiating ultrasonic waves for cauterizing human tissue, wherein the system is a simulated tissue having a property that the hue changes depending on temperature within a specific temperature-sensitive region and simulating a temperature change of human tissue when receiving ultrasonic waves from the therapeutic device, and having an insertion hole in which the therapeutic device can be disposed, a light source for irradiating the simulated tissue with planar light, an imaging device for imaging a cross-sectional color image on the light-irradiated surface of the simulated tissue, a moving mechanism for relatively moving the light source and the imaging device with respect to the simulated tissue in the imaging axis direction of the imaging device, a color-temperature conversion table for converting temperature from the hue of the image of the simulated tissue, controlling the moving mechanism so that the light source and the imaging device move while keeping the distance between the light-irradiated surface and the imaging device constant, and further, using the color-temperature conversion table, obtaining the temperature distribution of the simulated tissue from the hue images of each position of the imaged simulated tissue, a moving mechanism control / information processing means, a thermocouple disposed in the simulated tissue, and comprising the therapeutic device is disposed in the insertion hole of the simulated tissue, In the calibration method, a step of heating the entire simulated tissue by irradiating the therapeutic device with ultrasonic waves, a step of monitoring a color change near the thermocouple of the heated simulated tissue, a step of stopping the ultrasonic wave irradiation by the therapeutic device when a color change near the thermocouple of the simulated tissue is observed, a step of measuring the temperature of the simulated tissue by the thermocouple, a step of imaging the simulated tissue by the imaging device, a step of calibrating the color-temperature conversion table based on the measured temperature and the hue near the thermocouple of the imaged image, and comprising a calibration method.

15. A method for calibrating measurements of a system for evaluating a therapeutic device capable of irradiating ultrasonic waves for cauterizing human tissue, wherein the system is A simulated tissue having a property that its hue changes with temperature within a specific temperature-sensitive region and simulating the temperature change of human tissue when receiving ultrasonic waves from the treatment device, the simulated tissue having an insertion hole in which the treatment device can be placed, A light source that irradiates planar light onto the simulated tissue, An imaging device that captures a cross-sectional color image of the light irradiation surface of the simulated tissue, A moving mechanism that relatively moves the light source and the imaging device with respect to the simulated tissue in the imaging axis direction of the imaging device, A color-temperature conversion table for converting temperature from the hue of the image of the simulated tissue, The moving mechanism is controlled so that the light source and the imaging device move while keeping the distance between the light irradiation surface and the imaging device constant. Further, using the color-temperature conversion table, the temperature distribution of the simulated tissue is obtained from the hue of each position of the image of the simulated tissue captured. Moving mechanism control and information processing means, A water tank whose water temperature can be adjusted, the water tank being capable of accommodating the simulated tissue, Comprising, In a method of calibration, A step of imaging the simulated tissue housed in the water in the water tank controlled to a predetermined temperature, The step of imaging is repeated by changing the water temperature in the water tank over the entire temperature-sensitive region from the lower limit temperature to the upper limit temperature of the temperature-sensitive region of the simulated tissue, and the color-temperature conversion table is calibrated over the entire temperature-sensitive region based on the water temperature in the water tank and the hue of the image of the simulated tissue captured, A calibration method comprising.

Images