Ultrasonic treatment device

The device facilitates alignment of the affected area with the focal point of therapeutic ultrasound by generating real-time B-mode images and predictive displays, enhancing treatment accuracy and reducing patient discomfort.

WO2025243841A1PCT designated stage Publication Date: 2025-11-27SONIRE THERAPEUTICS INC
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Patent Information

Application Number
PCT/JP2025/016790
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-05-24
Filing Date
2025-05-08
Publication Date
2025-11-27

AI Technical Summary

Technical Problem

Existing ultrasonic therapy devices face challenges in aligning the affected area with the focal point of therapeutic ultrasound due to patient movement caused by breathing, making it difficult for patients to stop breathing during treatment.

Method used

A therapeutic ultrasound device with a control unit that generates B-mode image data, sets an irradiation target area, determines the focal point position, and displays a focus indicator superimposed on the image, allowing for real-time alignment and prediction of the affected area with the focal point, facilitated by a robot arm and ultrasound probe system.

Benefits of technology

Enables easier alignment of the affected area with the focal point, reducing patient burden and improving treatment accuracy by providing visual guidance for breath-holding during therapy.

✦ Generated by Eureka AI based on patent content.

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Abstract

The purpose of the present invention is to facilitate, in an ultrasonic treatment device (100), the task of aligning the position of an affected part with the position of the focal point of therapeutic ultrasound. An HIFU control unit (26) executes a B-mode image generation process, a target setting process, a focal point position determination process, and a display process. The B-mode image generation process is a process for causing an ultrasonic probe (10) to transmit / receive imaging ultrasound and generating B-mode image data on the basis of a reception signal outputted from the ultrasonic probe (10). The target setting process is a process for setting an irradiation target region (50) in an image indicated by the B-mode image data. The focal point position determination process is a process for deriving the position of the focal point of the therapeutic ultrasound. The display process is a process for displaying, on a guide display (40), a focal point indicator (52) and the irradiation target region (50) so as to be superimposed on the B-mode image.
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Description

Ultrasonic therapy device

[0001] The present invention relates to an ultrasonic therapy device, and more particularly to a technique for aligning the position of an affected area with the focal point of therapeutic ultrasonic waves.

[0002] A treatment device using high intensity focused ultrasound (HIFU) is widely used. This treatment device is called a HIFU irradiation device or a HIFU irradiation system, and irradiates a treatment site with focused ultrasound to cause necrosis of biological tissue.

[0003] Generally, a HIFU irradiation device includes a plurality of ultrasonic transducers for treatment arranged along a concave surface. The plurality of ultrasonic transducers are arranged so that ultrasonic waves emitted from each of the transducers are irradiated at a single point to form a focal point. During treatment, the focal point is aligned with the treatment area and ultrasonic waves are irradiated. To confirm the irradiation position, an ultrasonic diagnostic device that displays the focal point on an ultrasound image is used.

[0004] The following Patent Document 1 describes an ultrasound treatment device that observes the position of a focal point using an ultrasound diagnostic device that displays B-mode images (tomographic images). In this device, a therapeutic ultrasound transducer emits ultrasound waves at a low level that do not affect tissue, and an ultrasound imaging probe transmits and receives ultrasound waves to display a tomographic image. Because the acoustic properties of the patient's tissue change depending on changes in tissue temperature, the tomographic image shows the position of the focal point by varying brightness. Furthermore, as shown in Non-Patent Document 1, because the irradiation of the patient's tissue with ultrasound causes displacement, the tomographic image shows the position of the focal point by varying brightness.

[0005] Japanese Patent Application Publication No. 8-71069

[0006] Tissue hardness measurement using ARFI via the Internet<https: / / www.innervision.co.jp / sp / ad / suite / siemens / technical_notes / 140368>

[0007] The affected area of ​​a patient moves with the patient's breathing. However, in treatment using high-intensity focused ultrasound, the patient must stop breathing after the affected area is aligned with the focal point of the therapeutic ultrasound. With conventional technology, it can be difficult for the patient to stop breathing so that the affected area can be aligned with the focal point.

[0008] An object of the present invention is to facilitate the task of aligning the position of an affected area with the focal point of therapeutic ultrasound in an ultrasonic therapy device.

[0009] The present invention comprises a therapeutic ultrasound emission unit that transmits ultrasound so as to form a focus in biological tissue, an ultrasound probe, a control unit that controls the therapeutic ultrasound emission unit and the ultrasound probe, and a guidance display, wherein the control unit executes the following processes: a B-mode image generation process that causes the ultrasound probe to transmit and receive imaging ultrasound and generates B-mode image data based on a received signal output from the ultrasound probe; a target setting process that sets an irradiation target area in an image represented by the B-mode image data; a focus position determination process that determines the position of the focus; and a display process that displays a focus indicator that indicates the focus and the irradiation target area on the guidance display, superimposed on the image represented by the B-mode image data.

[0010] In one embodiment, the B-mode image generation process includes a process of generating the B-mode image data sequentially over time, the target setting process includes a process of tracking the irradiation target area based on the B-mode image data sequentially generated over time, and the display process includes a process of superimposing a focus indicator indicating the focus and the tracked irradiation target area on each image indicated by the B-mode image data sequentially generated over time, and sequentially displaying them on the guidance display.

[0011] In one embodiment, the target setting process includes a process of predicting the position of the irradiation target area after a predetermined predicted time based on the B-mode image data generated sequentially over time, and the display process includes a process of sequentially displaying on the guidance display a focus indicator indicating the focus and a predicted area indicating the irradiation target area after the predicted time, together with the tracked irradiation target area, superimposed on each image indicated by the B-mode image data generated sequentially over time.

[0012] In one embodiment, the B-mode image generation process includes a process of generating the B-mode image data sequentially over time, the target setting process includes a process of predicting the position of the irradiation target area after a predetermined predicted time based on the B-mode image data sequentially generated over time, and the display process includes a process of superimposing a focus indicator indicating the focus and a predicted area indicating the irradiation target area after the predicted time on each image indicated by the B-mode image data sequentially generated over time, and sequentially displaying them on the guidance display.

[0013] In one embodiment, the control unit determines the position of the focal point based on a control state of the therapeutic ultrasound emission unit.

[0014] In one embodiment, when executing the focal position determination process, the control unit executes a transmission process that causes the therapeutic ultrasound emission unit to transmit ultrasound waves that are weaker than those used during treatment, and determines the position of the focal point based on the B-mode image data.

[0015] In one embodiment, the display process includes a process of sequentially displaying an irradiation target viewer, in which the position of the irradiation target area is projected onto a straight line, on the guidance display together with each image represented by the B-mode image data sequentially generated over time.

[0016] According to the present invention, the operation of aligning the position of the affected area with the focal position of therapeutic ultrasonic waves in an ultrasonic treatment device can be facilitated.

[0017] 1 is a diagram showing the configuration of a HIFU irradiation device; FIG. 2 is a diagram showing an example of a positioning image; FIG. 3 is a diagram showing an example of a positioning image; FIG. 4 is a diagram showing an example of a positioning image; FIG. 5 is a flowchart showing an example of processing executed by the HIFU irradiation device; FIG. 6 is a diagram showing an example of an irradiation target viewer; FIG. 7 is a diagram showing an example of an irradiation target viewer; FIG. 8 is a diagram showing an example of a predicted positioning image; FIG. 9 is a diagram showing an example of a predicted positioning image; FIG. 10 is a diagram showing an example of a predicted positioning image in which the trajectory of the irradiation target area is displayed; FIG. 11 is a flowchart showing an example of processing executed by the HIFU irradiation device;

[0018] An embodiment of the present invention will be described with reference to the drawings. Identical components shown in multiple drawings are designated by the same reference numerals to simplify the description. FIG. 1 shows the configuration of a HIFU irradiation device 100 (ultrasound treatment device) according to an embodiment of the present invention. The HIFU irradiation device 100 includes an ultrasound probe 10, a therapeutic ultrasound emitting unit 12, a coupling bag 14, a robot arm 18, a controller 22, a practitioner display 24, and a guidance display 40. In FIG. 1 , a surface (observation target surface) on a patient 30 on which an ultrasound image such as a B-mode image is to be observed is defined as a plane parallel to the yz coordinate plane, and a coordinate axis perpendicular to the yz coordinate plane is defined as the x-axis.

[0019] The therapeutic ultrasound emitting unit 12 includes a transducer housing 16 having a concave surface 8 with an opening facing downward, and a plurality of ultrasound transducers 36 arranged along the concave surface 8 of the transducer housing 16 and fixed to the transducer housing 16. The therapeutic ultrasound emitting unit 12 does not necessarily have to have an actual concave surface 8. In this case, the plurality of ultrasound transducers 36 may be fixed to the transducer housing 16 so as to be arranged along a virtual concave surface 8.

[0020] The concave surface 8 of the transducer housing 16 may have a shape similar to the side surface of a pyramid. Here, a pyramid refers to a three-dimensional shape formed by a collection of straight lines extending from a point in space to a bottom surface. The concave surface 8 of the transducer housing 16 may also have a dome-like bulge on the upper side. Each ultrasonic transducer 36 is fixed to the transducer housing 16 so that when each ultrasonic transducer 36 emits ultrasound, the intensities of the ultrasound waves are mutually enhanced at a focus F in the biological tissue below the transducer housing 16.

[0021] The ultrasonic probe 10 is attached to the transducer housing 16 so that ultrasonic waves are transmitted and received at a position below the transducer housing 16 and above the focal point F. In this embodiment, the ultrasonic probe 10 passes through the apex of the transducer housing 16 in the vertical direction, and the probe tip 32 that transmits and receives ultrasonic waves faces downward. The ultrasonic probe 10 has directionality, and ultrasonic waves are transmitted and received on an observation surface that faces in a direction according to the structure of the ultrasonic probe 10. The ultrasonic probe 10 may be movable in the vertical direction. Furthermore, the ultrasonic probe 10 may be rotatable around a longitudinal axis.

[0022] Below the therapeutic ultrasound emitting unit 12, a coupling bag 14 is provided to match the acoustic impedance between each ultrasound transducer 36 and the patient 30, and between the ultrasound probe 10 and the patient 30. The coupling bag 14 may be a bag filled with a liquid such as water. The coupling bag 14 holds the liquid between the ultrasound probe 10 and the patient 30. The coupling bag 14 may be made of a light-transmitting material, and may be transparent or translucent.

[0023] The ultrasonic probe 10, the therapeutic ultrasound emitting unit 12, and the coupling bag 14 are attached to the tip of a robot arm 18 serving as a transport mechanism. The robot arm 18 is composed of multiple arms 18a connected by joints 18b, and is attached to the housing of a controller 22 via the joints 18b. Each arm 18a swings around the joint 18b as a rotation axis, and the robot arm 18 transports a movable body 20 including the ultrasonic probe 10, the therapeutic ultrasound emitting unit 12, and the coupling bag 14 in three directions: the x-axis, y-axis, and z-axis.

[0024] The controller 22 includes a HIFU control unit 26, an operating device 42, and a robot control unit 28. The HIFU control unit 26 includes a computer, an electric circuit for controlling the ultrasound probe 10, and an electric circuit for controlling the therapeutic ultrasound emitting unit 12. The computer included in the HIFU control unit 26 may be a business computer, a personal computer, a tablet computer, or the like. The computer executes a program to perform processes for generating each image and for displaying each image. The HIFU control unit 26 is connected to an operating device 42 that allows the practitioner (user) to operate the HIFU irradiation device 100. The operating device 42 may include a mouse, a touch panel integrated with the practitioner display 24, a switch, a keyboard, or the like.

[0025] The HIFU control unit 26 executes processing for operating the ultrasound probe 10 and the therapeutic ultrasound emitter 12. For example, the HIFU control unit 26 causes the ultrasound probe 10 to transmit and receive imaging ultrasound waves for generating an image. The HIFU control unit 26 generates B-mode image data based on a reception signal based on the imaging ultrasound waves received by the ultrasound probe 10, and causes the practitioner display 24 to display a B-mode image. The HIFU control unit 26 also causes each ultrasound transducer 36 included in the therapeutic ultrasound emitter 12 to transmit therapeutic ultrasound waves. The practitioner display 24 and the guidance display 40, which will be described later, may be a display device such as a liquid crystal panel or an organic EL panel, or a portable information processing device such as a tablet computer that functions as a display device.

[0026] The robot control unit 28 may control the robot arm 18 in accordance with the control of the HIFU control unit 26, and cause the robot arm 18 to transport the movable body 20. The robot control unit 28 may also include a robot arm operation device 44 such as a lever or button for operating the robot arm 18. In this case, the robot control unit 28 may control the robot arm 18 in accordance with the operation of the robot arm operation device 44 by the practitioner.

[0027] Before the therapeutic ultrasound is irradiated from the therapeutic ultrasound emitting unit 12 to the patient 30, the following positioning process is performed. The position and orientation of the ultrasound probe 10 are set so that the observation surface of the ultrasound probe 10 coincides with the observation target surface of the patient 30. The HIFU control unit 26 causes the ultrasound probe 10 to repeatedly scan the observation target surface of the patient 30 with an ultrasound beam, and generates B-mode image data every time the scan is performed a predetermined number of times (for example, every time it is performed). In this way, the HIFU control unit 26 sequentially generates B-mode image data over time.

[0028] The HIFU control unit 26 displays positioning images on the practitioner display 24 and the guidance display 40 based on the B-mode image data generated sequentially over time. The positioning images are images showing the irradiation target area and a focus indicator superimposed on the B-mode image in real time. The irradiation target area indicates the area occupied by the diseased area, and the focus indicator indicates the planned position of the focus of the therapeutic ultrasound.

[0029] 2A to 2C show examples of positioning images. The positioning images shown in each of FIGS. 2A to 2C are displayed on the practitioner display 24 and the guidance display 40 at different times. The area indicated by diagonal lines in each figure is the irradiation target area 50. The white figure is a focus indicator 52 indicating the focus. The area sandwiched between the dashed line extending diagonally upward to the right from the focus indicator 52 and the dashed line extending diagonally upward to the left from the focus indicator 52 corresponds to the area through which therapeutic ultrasound propagates. These dashed lines do not necessarily have to be displayed. The detailed process of displaying the irradiation target area 50 and the focus indicator 52 will be described later.

[0030] The irradiation target region 50 fluctuates due to the patient's respiratory movement. Fig. 2A shows a positioning image when the patient is inhaling, Fig. 2C shows a positioning image when the patient is exhaling, and Fig. 2B shows a positioning image in a transition state where the patient is transitioning from the inhalation state to the exhalation state.

[0031] When the irradiation target area 50 and the focus indicator 52 overlap, the HIFU control unit 26 changes the display mode of the focus indicator 52. When the irradiation target area 50 and the focus indicator 52 overlap, either one may be displayed in front.

[0032] 2B , when the irradiation target region 50 and the focus indicator 52 overlap, the HIFU control unit 26 changes the color of the focus indicator 52. When the irradiation target region 50 and the focus indicator 52 overlap, the HIFU control unit 26 may change the display mode by, for example, increasing the brightness of the focus indicator 52.

[0033] During treatment, the practitioner controls the robot arm 18 using the robot arm operating device 44 and adjusts the position of the therapeutic ultrasound emitting unit 12 so that the focus indicator 52 is located on the trajectory of the irradiation target area 50, which moves with the patient's breathing. If the focus indicator 52 is not located on the trajectory of the irradiation target area 50, the practitioner operates the robot arm operating device 44 to move the robot arm 18 and change the position or posture of the ultrasound probe 10 and the therapeutic ultrasound emitting unit 12. After confirming that the focus indicator 52 is located on the trajectory of the irradiation target area 50, the practitioner continues the positioning process.

[0034] After positioning the focus indicator 52 on the trajectory of the irradiation target area 50, the practitioner instructs the patient 30 to refer to the positioning image displayed on the guidance display 40. The practitioner also instructs the patient 30 to check the positions of the irradiation target area 50 and the focus indicator 52 displayed on the positioning image. The practitioner further instructs the patient 30 to stop breathing when the irradiation target area 50, which moves with breathing, and the focus indicator 52 overlap.

[0035] With the patient 30 holding their breath so that the irradiation target area 50 and the focal point indicator 52 overlap, the practitioner operates the operating device 42 to cause the therapeutic ultrasound emitter 12 to transmit therapeutic ultrasound. As a result, the affected area at the focal point is irradiated with therapeutic ultrasound, and the affected area is cauterized.

[0036] As described above, the HIFU irradiation device 100 according to the embodiment of the present invention is an ultrasonic treatment device including a HIFU control unit 26 that executes the following processes as a control unit: That is, the HIFU control unit 26 executes a B-mode image generation process, a target setting process, a focal position determination process, and a display process.

[0037] The B-mode image generation process is a process of causing the ultrasound probe 10 to transmit and receive imaging ultrasound and generating B-mode image data based on the received signals output from the ultrasound probe 10. The target setting process is a process of setting an irradiation target region 50 in an image represented by the B-mode image data. The focal position determination process is a process of determining the position of the focal point. The display process is a process of displaying a focus indicator 52 indicating the focal point and the irradiation target region 50 on the guidance display 40, superimposed on the image represented by the B-mode image data.

[0038] A positioning image in which the irradiation target region 50 and the focus indicator 52 are superimposed on the B-mode image is displayed on the guidance display 40 and is referred to by the patient 30, making it easier for the patient 30 to hold their breath at the appropriate timing. This makes the positioning process easier and reduces the burden on the patient 30 during treatment.

[0039] A specific example of the process of drawing the irradiation target region 50 and the focus indicator 52 will be described. Before treatment is started, the HIFU irradiation device 100 is set to a state in which a B-mode image is displayed on the practitioner display 24. This B-mode image may be a still image that is not updated over time, or may be a real-time image that is updated over time.

[0040] In this state, the practitioner operates the operation device 42 connected to the HIFU control unit 26 to set the irradiation target region 50 on the B-mode image displayed on the practitioner display 24. The irradiation target region 50 may be set by drawing a curve surrounding the irradiation target region 50 that appears on the B-mode image, or by applying a pattern to the irradiation target region 50. The HIFU control unit 26 generates irradiation target data that shows an image of the irradiation target region 50.

[0041] The HIFU control unit 26 may generate irradiation target data based on template matching processing for B-mode image data, without relying on the operator's operation. In this case, the HIFU control unit 26 stores template image data in advance. For example, the HIFU control unit 26 performs a correlation calculation between a B-mode image represented by the B-mode image data and a template image represented by the template image data, while changing the positional relationship between the B-mode image and the template image and the scaling ratio of the template image. The HIFU control unit 26 recognizes the irradiation target region 50 based on the positional relationship between the B-mode image and the template image and the scaling ratio of the template image when the correlation value obtained by the correlation calculation exceeds a predetermined threshold and becomes maximum. The HIFU control unit 26 may perform a correlation calculation on multiple template images with different characteristics of the affected area, thereby generating irradiation target data for affected areas with various characteristics.

[0042] The process by which the HIFU control unit 26 displays a positioning image on the practitioner display 24 and the guidance display 40 will be described. The HIFU control unit 26 tracks and displays the irradiation target region 50 in the real-time positioning image based on the irradiation target data. That is, the HIFU control unit 26 tracks a region that has a high degree of similarity to the image indicated by the irradiation target data in each B-mode image indicated by the B-mode image data generated sequentially over time. Here, tracking refers to a process of identifying the position of a region that has a high degree of similarity to the image indicated by the irradiation target data on each B-mode image. The region that has a high degree of similarity may be, for example, a region where the correlation value with the image indicated by the irradiation target data exceeds a predetermined threshold or is maximized.

[0043] The HIFU control unit 26 displays the focus indicator 52 and an image in which the irradiation target region 50 tracked on each B-mode image is superimposed on each B-mode image on the practitioner display 24 and the guidance display 40 as a positioning image.

[0044] The display position of the focus indicator 52 is determined by the control state of each ultrasonic transducer 36 included in the therapeutic ultrasound emitter 12. The control state of each ultrasonic transducer 36 is determined, for example, according to the delay time of the ultrasound emitted by each ultrasonic transducer 36. Therefore, the HIFU control unit 26 may determine the position of the focus based on the control state of the therapeutic ultrasound emitter 12, and may determine the display position of the focus indicator 52.

[0045] The display position of the focus indicator 52 may be determined as follows: That is, the HIFU control unit 26 may execute a transmission process to cause the therapeutic ultrasound emitter 12 to transmit ultrasonic waves weaker than those used during treatment, and the HIFU control unit 26 may determine the position at which a change in brightness appears on the B-mode image as the display position of the focus indicator 52. In this case, when executing the above-described focus position determination process, the HIFU control unit 26 may execute a transmission process to cause the therapeutic ultrasound emitter 12 to transmit ultrasonic waves weaker than those used during treatment, and may execute a process to determine the position of the focus that appears in the image indicated by the B-mode image data.

[0046] 3 shows a flowchart illustrating an example of processing executed by the HIFU irradiation device 100 from the start of the positioning process to the end of treatment. The HIFU control unit 26 sets the irradiation target region 50 on the B-mode image displayed on the practitioner display 24 in accordance with the operator's operation (S101). The HIFU control unit 26 tracks and displays the irradiation target region 50 on the positioning image (S102). The following steps S103 to S105 are executed sequentially over time while the positioning image is displayed.

[0047] The HIFU control unit 26 calculates the determination distance between the position of the irradiation target region 50 and the position of the focus indicator 52 for the positioning images displayed sequentially over time (S103). Here, the position of the irradiation target region 50 may be a representative point predetermined in the irradiation target region 50. This representative point may be, for example, the center of gravity of the irradiation target region 50.

[0048] If the judgment distance is equal to or less than a predetermined threshold, the HIFU control unit 26 displays a message on the practitioner display 24 indicating that therapeutic ultrasound can be emitted, and changes the display mode of the focus indicator 52 displayed on the practitioner display 24 and the guidance display 40 (S104).

[0049] The HIFU control unit 26 determines whether or not a therapeutic operation for irradiating therapeutic ultrasound has been performed by the practitioner (S105). If no therapeutic operation has been performed, the HIFU control unit 26 returns to the process of step S102. On the other hand, if a therapeutic operation has been performed, the HIFU control unit 26 causes the therapeutic ultrasound emitting unit 12 to transmit therapeutic ultrasound (S106) to perform the treatment.

[0050] The HIFU control unit 26 may display an irradiation target viewer, in which the position of the irradiation target region 50 is projected on a straight line, on the guidance display 40 together with the positioning image. An example of an irradiation target viewer 60 is shown in FIGS. 4A and 4B . The irradiation target viewer 60 is composed of a respiratory phase presentation bar 62 and an irradiation target indicator 64. The respiratory phase presentation bar 62 is a strip-shaped graphic extending horizontally on the display screen of the guidance display 40. The irradiation target viewer 60 may be displayed superimposed on the positioning image or displayed alongside the positioning image. The irradiation target indicator 64 moves left and right along the respiratory phase presentation bar 62 as the irradiation target region 50 moves.

[0051] The position of the right end of the respiratory phase indicator bar 62 corresponds to the position on the positioning image when the irradiation target region 50 is in the exhalation phase position (the position when the patient is exhaling) in the positioning image. The position of the left end of the respiratory phase indicator bar 62 corresponds to the position on the positioning image when the irradiation target region 50 is in the inhalation phase position (the position when the patient is inhaling) in the positioning image. The horizontal axis coordinate position on the respiratory phase indicator bar 62 is normalized so that the length between the exhalation phase position and the inhalation phase position corresponds to the length of the respiratory phase indicator bar 62. Note that the right end position of the respiratory phase indicator bar 62 may correspond to the average value of the H-axis coordinate values ​​when the irradiation target region 50 has reached the exhalation phase position a predetermined number of times, going back from the last time the irradiation target region 50 reached the exhalation phase position to the last time the irradiation target region 50 reached the exhalation phase position. Here, the H-axis is a coordinate axis defined in the positioning image with the right direction as positive. Similarly, the inspiratory phase position may be associated with the average value of the H-axis coordinate values ​​when the irradiation target region 50 reaches the inspiratory phase position over a predetermined number of times, going back from the last time the irradiation target region 50 reached the inspiratory phase position to the last time the irradiation target region 50 reached the inspiratory phase position. A focus mark 66 corresponding to the position of the focus is displayed on the respiratory phase indication bar 62.

[0052] 4B shows an example of the illumination target viewer 60 when the illumination target area 50 and the focus indicator 52 overlap in the positioning image. When the illumination target area 50 and the focus indicator 52 overlap, the illumination target indicator 64 is displayed in a more emphasized manner than when the illumination target area 50 and the focus indicator 52 do not overlap. In the example shown in FIG. 4B , when the illumination target area 50 and the focus indicator 52 overlap, the illumination target indicator 64 is displayed larger than when the illumination target area 50 and the focus indicator 52 do not overlap. Note that the illumination target indicator 64 may be highlighted by changing the color or brightness.

[0053] In the above, an embodiment has been described in which a positioning image is displayed in real time to show the irradiation target area 50 and the focus indicator 52. In addition to such a positioning image, a predicted positioning image may be displayed that sequentially shows the predicted area 70 predicted as the irradiation target area 50 a predetermined predicted time T later, the irradiation target area 50, and the focus indicator 52 over time.

[0054] 5A and 5B show examples of predicted positioning images. Fig. 5A shows a predicted positioning image when the patient is exhaling, and Fig. 5B shows a predicted positioning image when the patient is transitioning from an exhaling state to an inhaling state. The area surrounded by a dashed line in Fig. 5A and Fig. 5B is a predicted area 70 relative to the irradiation target area 50.

[0055] The HIFU controller 26 sequentially generates B-mode image data over time, and calculates the position and range of a prediction region 70 a prediction time T after the latest B-mode image data is generated based on past B-mode image data sequentially generated over time. The prediction region 70 may be calculated by applying an estimation algorithm such as a Kalman filter to the past B-mode image data. The prediction time T is, for example, 0.3 to 2 seconds, preferably 0.5 to 1.5 seconds.

[0056] The HIFU control unit 26 sequentially generates predicted image data indicating predicted positioning images over time. The predicted positioning images are images in which the irradiation target region 50, the predicted region 70, and the focus indicator 52 are superimposed on a B-mode image. The HIFU control unit 26 causes the practitioner display 24 and the guidance display 40 to sequentially display the predicted positioning images over time based on the predicted image data sequentially generated over time.

[0057] The irradiation target region 50 and the predicted region 70 displayed on the B-mode image on the practitioner display 24 and the guidance display 40 move sequentially over time in accordance with the patient's breathing. When at least one of the irradiation target region 50 and the predicted region 70 overlaps with the focus indicator 52, the HIFU control unit 26 may change the display mode of the focus indicator 52, such as color, brightness, size, etc.

[0058] Depending on the position of the affected area on the patient, it may be difficult to hold breathing when the current irradiation target area 50 and the focus indicator 52 overlap. For example, if the patient begins to hold their breath when they visually recognize that the current irradiation target area 50 and the focus indicator 52 overlap, they may stop breathing when the irradiation target area 50 passes the position of the focus indicator 52. In this case, the practitioner instructs the patient to stop breathing when the predicted area 70 and the focus indicator 52 overlap. This increases the likelihood that the patient will be able to stop breathing when the irradiation target area 50 and the focus indicator 52 overlap.

[0059] The HIFU control unit 26 may display the past trajectory and future trajectory of the irradiation target region 50 on predicted positioning images that are sequentially displayed over time. Examples of predicted positioning images displaying the past trajectory and future trajectory of the irradiation target region 50 are shown in Figures 6A and 6B. Figure 6A shows a predicted positioning image in a state where the patient is exhaling, and Figure 6B shows a predicted positioning image in a transition state where the patient is changing from an exhaling state to an inhaling state. The past trajectory of the irradiation target region 50 is displayed based on previously generated B-mode image data. Furthermore, the past trajectory of the irradiation target region 50 is displayed by applying an estimation algorithm such as a Kalman filter to previously generated B-mode image data.

[0060] 6A and 6B , three curved lines extending horizontally and aligned vertically on the left side of the irradiation target area 50 represent the past trajectory of the irradiation target area 50. Furthermore, three curved lines extending horizontally and aligned vertically on the right side of the irradiation target area 50 represent the future trajectory of the irradiation target area 50. Furthermore, three curved lines extending horizontally and aligned vertically superimposed on the irradiation target area 50 represent the immediate past and immediate future trajectories of the irradiation target area 50. Note that the immediate past or immediate future trajectories of the irradiation target area 50 do not necessarily have to be displayed.

[0061] In this way, by displaying the trajectory of the irradiation target area 50, the patient can easily hold their breath and the practitioner can easily align the irradiation target area 50 with the focus indicator 52.

[0062] 7 is a flowchart showing the flow of processing executed by the HIFU irradiation device 100. The HIFU control unit 26 sets the irradiation target region 50 on the B-mode image displayed on the practitioner display 24 in accordance with the operator's operation (S201). The HIFU control unit 26 tracks and displays the irradiation target region 50 in the predicted positioning image (S202). The HIFU control unit 26 also estimates a predicted region 70 in the positioning image, and further displays the predicted region 70 in the predicted positioning image that tracks and displays the irradiation target region 50 (S203). The following steps S204 to S206 are executed sequentially over time while the predicted positioning image is being displayed.

[0063] The HIFU controller 26 calculates the determination distance between the position of the prediction region 70 and the position of the focus indicator 52 for the predicted positioning images displayed sequentially over time (S204). Here, the position of the prediction region 70 may be a representative point predetermined for the prediction region 70. This representative point may be, for example, the center of gravity of the prediction region 70.

[0064] When the judgment distance is equal to or less than a predetermined threshold, the HIFU control unit 26 displays a message on the practitioner display 24 indicating that therapeutic ultrasound can be emitted, and changes the display mode of the focus indicator 52 displayed on the practitioner display 24 and the guidance display 40 (S205).

[0065] The HIFU control unit 26 determines whether or not a therapeutic operation for irradiating therapeutic ultrasound has been performed by the practitioner (S206). If no therapeutic operation has been performed, the HIFU control unit 26 returns to the process of step S202. On the other hand, if a therapeutic operation has been performed, the HIFU control unit 26 causes the therapeutic ultrasound emitting unit 12 to transmit therapeutic ultrasound (S207) to perform the treatment.

[0066] 8 concave surface, 10 ultrasound probe, 12 therapeutic ultrasound emission unit, 14 coupling bag, 16 transducer housing, 18 robot arm, 18a arm, 18b joint, 20 movable body, 22 controller, 24 practitioner display, 26 HIFU control unit, 28 robot control unit, 30 patient, 32 probe tip, 36 ultrasound transducer, 40 guidance display, 42 operation device, 44 robot arm operation device, 50 irradiation target area, 52 focus indicator, 60 irradiation target viewer, 62 respiratory phase display bar, 64 irradiation target indicator, 66 focus mark, 70 prediction area, 100 HIFU irradiation device.

Claims

1. An ultrasonic treatment device comprising: a therapeutic ultrasound emission unit that transmits ultrasound so as to form a focus in biological tissue; an ultrasonic probe; a control unit that controls the therapeutic ultrasound emission unit and the ultrasonic probe; and a guidance display, wherein the control unit executes the following: a B-mode image generation process that causes the ultrasonic probe to transmit and receive imaging ultrasound and generates B-mode image data based on the received signal output from the ultrasonic probe; a target setting process that sets an irradiation target area in an image represented by the B-mode image data; a focus position determination process that determines the position of the focus; and a display process that displays a focus indicator that indicates the focus and the irradiation target area on the guidance display, superimposed on the image represented by the B-mode image data.

2. An ultrasonic treatment device according to claim 1, wherein the B-mode image generation process includes a process of generating the B-mode image data sequentially over time, the target setting process includes a process of tracking the irradiation target area based on the B-mode image data sequentially generated over time, and the display process includes a process of superimposing a focus indicator indicating the focus and the tracked irradiation target area on each image indicated by the B-mode image data sequentially generated over time, and sequentially displaying them on the guidance display.

3. An ultrasonic treatment device according to claim 2, wherein the target setting process includes a process of predicting the position of the irradiation target area after a predetermined predicted time based on the B-mode image data generated sequentially over time, and the display process includes a process of sequentially displaying on the guidance display a focus indicator indicating the focus and a predicted area indicating the irradiation target area after the predicted time, together with the tracked irradiation target area, superimposed on each image indicated by the B-mode image data generated sequentially over time.

4. An ultrasonic treatment device according to claim 1, wherein the B-mode image generation process includes a process of generating the B-mode image data sequentially over time, the target setting process includes a process of predicting the position of the irradiation target area after a predetermined predicted time based on the B-mode image data sequentially generated over time, and the display process includes a process of superimposing a focus indicator indicating the focus and a predicted area indicating the irradiation target area after the predicted time on each image indicated by the B-mode image data sequentially generated over time, and sequentially displaying them on the guidance display.

5. An ultrasonic treatment device according to any one of claims 1 to 4, characterized in that the control unit determines the position of the focus based on the control state of the therapeutic ultrasonic radiation unit.

6. An ultrasonic treatment device as described in any one of claims 1 to 4, characterized in that when executing the focal position determination process, the control unit executes a transmission process that causes the therapeutic ultrasonic radiation unit to transmit ultrasonic waves that are weaker than those used during treatment, and determines the position of the focal point based on the B-mode image data.

7. An ultrasonic treatment device according to any one of claims 2 to 4, characterized in that the display processing includes processing for sequentially displaying on the guidance display an irradiation target viewer in which the position of the irradiation target area is projected on a straight line, together with each image represented by the B-mode image data sequentially generated over time.

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