HIFU irradiation device

The integration of an ultrasonic transducer, coupling bag, and controller in HIFU devices allows for precise liquid adjustment based on distance and pressure, addressing the challenge of proper contact and alignment in HIFU treatments.

JP7887211B1Active Publication Date: 2026-07-09SONIRE THERAPEUTICS INC
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Patent Information

Application Number
JP2025168605
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Filing Date
2025-10-06
Publication Date
2026-07-09
Estimated Expiration
2045-10-06

AI Technical Summary

Technical Problem

Adjusting the amount of liquid in the coupling bag of HIFU irradiation devices to ensure proper contact with the patient is challenging due to variations in patient body shape and coupling bag design.

Method used

An ultrasonic transducer, coupling bag, transport mechanism, liquid supply device, and controller are integrated to adjust the distance of the transducer from a reference position, determining the corresponding liquid volume to be added or removed from the coupling bag based on distance and pressure differences to achieve proper contact.

Benefits of technology

Facilitates easy adjustment of liquid in the coupling bag, ensuring a tight seal and proper alignment of the focus with the treatment area, enhancing treatment efficacy.

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Abstract

The objective of the present invention is to facilitate the adjustment of the amount of liquid flowing into the coupling bag of a HIFU irradiation device. [Solution] The HIFU irradiation device 100 includes an ultrasonic transducer 34 that generates therapeutic ultrasound, a coupling bag 38 positioned between the ultrasonic transducer 34 and the patient, a robotic arm 12 that transports the ultrasonic transducer 34, a liquid supply device 102 that injects liquid into the coupling bag 38 or discharges liquid from the coupling bag 38, and a controller 20 that controls the robotic arm 12 and the liquid supply device 102. The controller 20 moves the ultrasonic transducer 34 from a predetermined reference position, determines the distance the ultrasonic transducer 34 has moved from the reference position, and performs a positioning process that injects a volume of liquid corresponding to the distance moved into the coupling bag 38 or discharges it from the coupling bag 38.
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Description

Technical Field

[0001] The present invention relates to a HIFU irradiation device, and particularly to its control technology.

Background Art

[0002] Treatment devices using high-density focused ultrasound therapy are widely used. This treatment device is called a HIFU irradiation device, a HIFU treatment device, etc. (High Intensity Foucused Ultrasound), and irradiates ultrasonic waves (sonicate) to a treatment site to necrotize tissues.

[0003] Generally, a HIFU irradiation device includes a plurality of ultrasonic vibrators arranged on a bowl-shaped surface. The plurality of ultrasonic vibrators are arranged such that ultrasonic waves emitted from each of them are irradiated to a single point to form a focus. During treatment, the position of the focus is adjusted to the treatment site and ultrasonic waves are irradiated. For confirmation of the irradiation position, an ultrasonic diagnostic device that represents the focus on an ultrasonic image is used.

[0004] Patent Document 1 below describes an ultrasonic irradiation device that observes the position of a focus using an ultrasonic diagnostic device that displays a B-mode image (tomographic image). In this device, weak-level ultrasonic waves that do not affect tissues are emitted from the ultrasonic vibrator for treatment, and a tomographic image is displayed by transmitting and receiving ultrasonic waves with an ultrasonic imaging probe. Since the acoustic characteristics of the tissue of the subject change according to the temperature change of the tissue, the position of the focus is indicated by the intensity of the brightness in the tomographic image.

[0005] Patent Document 2 describes a HIFU irradiation device. In this HIFU irradiation device, coupling bags are provided to hold liquid between the ultrasonic transducer that emits therapeutic ultrasound and the patient, and between the ultrasonic imaging probe and the patient. The coupling bags are filled with liquid. The coupling bags match the acoustic impedance between the ultrasonic transducer and the patient, and between the ultrasonic imaging probe and the patient. In the HIFU irradiation device described in Patent Document 2, a mechanism is used to adjust the degree of inflation of the coupling bags by supply pumps and discharge pumps. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] Japanese Patent Application Publication No. 8-71069 [Patent Document 2] Japanese Patent Publication No. 2023-84945 [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] Generally, in HIFU irradiation devices, the amount of liquid flowing into the coupling bag is adjusted to ensure that the coupling bag makes appropriate contact with the patient. However, depending on the shape of the coupling bag and the patient's body shape, it can sometimes be difficult to adjust the amount of liquid flowing in to ensure proper contact between the coupling bag and the patient.

[0008] The objective of the present invention is to facilitate the adjustment of the amount of liquid flowing into the coupling bag of a HIFU irradiation device. [Means for solving the problem]

[0009] The present invention comprises an ultrasonic transducer that generates therapeutic ultrasound, a coupling bag positioned between the ultrasonic transducer and the patient, a transport mechanism for transporting the ultrasonic transducer, a liquid supply device for introducing liquid into the coupling bag or discharging liquid from the coupling bag, and a controller for controlling the transport mechanism and the liquid supply device, wherein the controller moves the ultrasonic transducer from a predetermined reference position, and the distance the ultrasonic transducer moves from the reference position and the distance traveled from the patient toward the ultrasonic transducer or in the opposite direction. The method is characterized by determining the distance traveled and performing a positioning process in which a volume of liquid corresponding to the travel distance is introduced into or released from the coupling bag.

[0010] In one embodiment, a pressure sensor is provided to measure the pressure of the liquid in the coupling bag, and the controller determines the pressure difference between the pressure measurement value for the coupling bag and a predetermined pressure target value, and according to the pressure difference, allows liquid to flow into the coupling bag or flows liquid out of the coupling bag.

[0011] In one embodiment, the controller measures the pressure inside the coupling bag when the ultrasonic transducer is set to the reference position and determines the target pressure value.

[0012] In one embodiment, the controller causes liquid to flow into or out of the coupling bag so that the pressure difference becomes small or equal to zero.

[0013] In one embodiment, the reference position is the position of the ultrasonic transducer when the focal point of the ultrasonic waves emitted from the ultrasonic transducer is at the lowest position within its range of motion.

[0014] In one embodiment, the alignment process includes aligning the focus of the ultrasound emitted from the ultrasonic transducer to the location of the affected area in the patient.

[0015] In one embodiment, the controller acquires liquid control information indicating the relationship between the moving distance and the volume of the liquid to be filled in the coupling bag. When executing the alignment process, the controller refers to the liquid control information and causes a liquid of a volume corresponding to the moving distance to flow into or out of the coupling bag.

Advantages of the Invention

[0016] According to the present invention, it becomes easy to adjust the amount of liquid flowing into the coupling bag of the HIFU irradiation device.

Brief Description of the Drawings

[0017] [Figure 1] It is a diagram showing the configuration of the HIFU irradiation device. [Figure 2] It is a diagram showing components for driving the ultrasonic probe. [Figure 3] It is a diagram showing the configuration of the liquid supply device. [Figure 4] It is a diagram schematically showing the operation of the alignment process. [Figure 5] It is a flowchart of the first alignment process. [Figure 6] It is a flowchart of the second alignment process. [Figure 7] It is a flowchart of the third alignment process. [Figure 8] It is a flowchart of the fourth alignment process. [Figure 9] It is a flowchart of the fifth alignment process.

Embodiments for Carrying Out the Invention

[0018] Embodiments of the present invention will be described with reference to the accompanying drawings. The same reference numerals are used for the same elements shown in the plurality of drawings, and the description thereof will be omitted. FIG. 1 shows the configuration of a HIFU irradiation device 100 according to an embodiment of the present invention. The HIFU irradiation device 100 includes a movable body 10, a robot arm 12, an ultrasonic image detection device 14, a drive amplifier 16, a robot controller 18, and a controller 20. The movable body 10 includes a HIFU vibrator unit 30, an ultrasonic probe 36, a probe drive mechanism 50, and a coupling bag 38.

[0019] The HIFU vibrator unit 30 includes a housing 32 having a concave surface 4 with an opening facing downward, and a plurality of ultrasonic transducers 34 arranged along the concave surface 4 of the housing 32 and fixed to the housing 32. The HIFU vibrator unit 30 does not necessarily have a physical concave surface 4. In this case, the plurality of ultrasonic transducers 34 may be fixed to the housing 32 so as to be arranged along a virtual concave surface 4.

[0020] The concave surface 4 of the housing 32 may have a shape similar to the side surface of a cone. Here, a cone refers to a three-dimensional shape formed by a set of straight lines extending from a point in space to a bottom surface. Further, the concave surface 4 of the housing 32 may have a shape that bulges upward in a dome shape. Each ultrasonic transducer 34 is fixed to the housing 32 so as to form a focal point F below the housing 32 when each ultrasonic transducer 34 emits ultrasonic waves.

[0021] The ultrasonic probe 36 is attached to the housing 32 at a position below the housing 32 and above the focal point F so that ultrasonic waves are transmitted and received. In the present embodiment, the ultrasonic probe 36 penetrates the housing 32 in the vertical direction, and the tip for transmitting and receiving ultrasonic waves is directed downward, that is, toward the patient side.

[0022] Below the HIFU transducer unit 30, a coupling bag 38 is provided to match the acoustic impedance between each ultrasonic transducer 34 and the patient, and between the ultrasonic probe 36 and the patient. The coupling bag 38 may be a bag filled with a liquid such as water. The coupling bag 38 may be made of an elastic material such as synthetic rubber or silicone. The coupling bag 38 holds the liquid between the housing 32 and the ultrasonic probe 36.

[0023] The movable body 10 is attached to the tip of a robot arm 12, which serves as a transport mechanism. The robot arm 12 is composed of multiple arms 12a connected by joints 12b, and is attached to a fixed base 40 via the joints 12b. Each arm 12a swings around the joint 12b as an axis of rotation, thereby transporting the movable body 10 in any direction.

[0024] The controller 20 controls the robot controller 18, the drive amplifier 16, the HIFU transducer unit 30, and the ultrasound image detection device 14. The controller 20 may include a computer that controls these devices (robot controller 18, drive amplifier 16, HIFU transducer unit 30, and ultrasound image detection device 14) by executing a program. The computer may be a business computer, a personal computer, a tablet computer, etc. The controller 20 is connected to an operating device (not shown) for the user to operate the HIFU irradiation device 100. The operating device may include a mouse, a touch panel integrated with the display of the ultrasound image detection device 14, switches, a keyboard, etc.

[0025] The robot controller 18 drives the robot arm 12 according to the control of the controller 20, causing the robot arm 12 to transport the movable body 10 and adjust the position of the movable body 10. The robot controller 18 may also be equipped with operating devices. In this case, the robot controller 18 may control the robot arm 12 in response to the operation of the operating devices by the user. The drive amplifier 16 drives the probe drive mechanism 50 according to the control of the controller 20, moving the ultrasound probe 36 in the vertical direction. The HIFU transducer unit 30 transmits therapeutic ultrasound according to the control of the controller 20. The ultrasound image detection device 14 may be an ultrasound diagnostic device that generates and displays B-mode images. The ultrasound image detection device 14 causes the ultrasound probe 36 to send and receive ultrasound according to the control of the controller 20, generates a B-mode image based on the ultrasound received by the ultrasound probe 36, and displays the B-mode image on a display.

[0026] Figure 2 shows the components for driving the ultrasound probe 36: a HIFU transducer unit 30, a probe driving mechanism 50, a drive amplifier 16, and a controller 20. The controller 20 outputs a control signal to the drive amplifier 16. The probe driving mechanism 50 may move the ultrasound probe 36 in a direction from the housing 32 toward the patient, or from the patient toward the housing 32, according to the control signal. The probe driving mechanism 50 may also rotate the ultrasound probe 36 around an axis extending in the vertical direction, according to the control signal.

[0027] Figure 3 shows the configuration of a liquid supply unit 102 that introduces liquid into or discharges liquid from a coupling bag 38. The liquid supply unit 102 includes a tank 60, a supply pump 64, a discharge pump 66, an inflow sensor 68, an outflow sensor 70, a pressure sensor 72, and a degassing device 62. The supply pump 64 and the discharge pump 66 are controlled by a controller 20 to be in an operating or stopped state. Liquid such as water is stored in the tank 60.

[0028] The supply pump 64 draws liquid from the tank 60 via the degassing device 62 and supplies the liquid to the coupling bag 38 via the inflow volume sensor 68. The degassing device 62 removes gas from the liquid. The inflow volume sensor 68 measures the volume of liquid that has flowed into the coupling bag 38 and outputs the measured inflow volume to the controller 20. The discharge pump 66 draws liquid from the coupling bag 38 and supplies the liquid to the tank 60 via the outflow volume sensor 70. The outflow volume sensor 70 measures the volume of liquid that has flowed out of the coupling bag 38 and outputs the measured outflow volume to the controller 20. The controller 20 uses the measured inflow volume and outflow volume to determine the current volume of liquid filled in the coupling bag 38.

[0029] The pressure sensor 72 is installed in at least one of the flow passages from the supply pump 64 to the coupling bag 38, and from the coupling bag 38 to the discharge pump 66. The pressure sensor 72 detects the pressure of the liquid in the flow passage and outputs the detected pressure value to the controller 20. When the flow passage is in communication with the coupling bag 38, the pressure in the flow passage is equal to the pressure inside the coupling bag 38. This detected pressure value indicates the pressure inside the coupling bag 38.

[0030] The controller 20 stops the discharge pump 66 and operates the supply pump 64 to cause liquid to flow from the tank 60 into the coupling bag 38. The controller 20 also stops the supply pump 64 and operates the discharge pump 66 to cause liquid to flow from the coupling bag 38 into the tank 60.

[0031] An example of the alignment process for aligning the focus to the location of the affected area will be described. Figure 4 schematically shows the operation of the alignment process performed in the HIFU irradiation device 100 according to this embodiment. As shown on the left side of Figure 4, the reference point A of the housing 32 is set to the housing reference position S. Here, the reference point A of the housing 32 may be, for example, the position of the apex of the concave surface 4. In the example shown in Figure 4, when the reference point A of the housing 32 is at the housing reference position S, the position of the focus F becomes the lowest position in its movable range, and the focus F is located in the lower part of the patient's body 42. As described above, the multiple ultrasonic transducers 34 are fixed to the housing 32. Therefore, the reference point A of the housing 32 defines not only the position of the housing 32 but also the positions of the multiple ultrasonic transducers 34. The position of each ultrasonic transducer 34 when the reference point A of the housing 32 is at the housing reference position S is the reference position of each ultrasonic transducer 34.

[0032] With the reference point A of the housing 32 set to the housing reference position S, the pressure inside the coupling bag 38 is set to within the target range by flowing liquid into or out of the coupling bag 38. The target range is between a value obtained by subtracting a predetermined error from the target pressure value and a value obtained by adding a predetermined error to the target pressure value.

[0033] After the pressure inside the coupling bag 38 is set within the target range, the supply pump 64 and discharge pump 66 are stopped. With the flow of liquid stopped, the housing 32 is moved upward so that the focal point F is aligned with the location of the affected area.

[0034] Based on the movement of the robot arm 12, the controller 20 continuously determines the vertical movement distance of the reference point A of the housing 32 from the state where the reference point A of the housing 32 is at the housing reference position S until the focal point F is aligned with the position of the affected area. Here, the movement distance is the vertical distance from the housing reference position S to the current position (affected area). personIt is defined as the direction from the HIFU transducer unit 30 toward or toward the HIFU transducer unit 30. Since each ultrasonic transducer 34 moves together with the housing 32, the distance traveled by the housing 32 is equal to the distance traveled by each ultrasonic transducer 34. The controller 20 stores liquid control information that associates the distance traveled with the volume of liquid to be filled into the coupling bag 38.

[0035] The controller 20 determines the volume of liquid to be added to and removed from the coupling bag 38 as the inflow / outflow volume by referring to the volume of liquid currently filled in the coupling bag 38, the distance traveled, and liquid control information. The controller 20 controls the supply pump 64 or the discharge pump 66 to allow liquid to flow into the coupling bag 38 by the inflow / outflow volume. Here, the inflow / outflow volume represents the increase or decrease in the volume of liquid to be filled into the coupling bag 38. The inflow / outflow volume is the volume of liquid to be added to the coupling bag 38, or the volume of liquid to be removed from the coupling bag 38. Adding liquid with a negative inflow / outflow volume to the coupling bag 38 means removing a volume of liquid equal to the absolute value of the inflow / outflow volume from the coupling bag 38.

[0036] The controller 20 measures the pressure inside the coupling bag 38 after the liquid has flowed into the coupling bag 38 by the amount of the inflow and outflow volume, with the focal point F aligned to the location of the affected area. If the pressure measurement is not within the target range, the controller 20 sets the pressure measurement within the target range by either inflowing liquid into the coupling bag 38 or outflowing liquid from the coupling bag 38. That is, if the pressure measurement is below the target range, the controller 20 inflows liquid into the coupling bag 38, and if the pressure measurement is above the target range, the controller 20 outflows liquid from the coupling bag 38.

[0037] The alignment process is completed when the focal point F is aligned with the location of the affected area and the pressure measurement value for the coupling bag 38 falls within the target range.

[0038] According to this process, a volume of liquid determined according to the distance traveled by the reference point A of the housing 32 flows into or out of the coupling bag 38. This ensures that an appropriate volume or close to it of liquid flows into or out of the coupling bag 38, and a tight seal is quickly established between the coupling bag 38 and the patient 42. Furthermore, by flowing liquid into and out of the coupling bag 38 in such a way that the pressure measurement value against the coupling bag 38 is adjusted, a proper tight seal is reliably achieved between the coupling bag 38 and the patient 42.

[0039] Furthermore, if the coupling bag 38 is made of an elastic material, the contact between the coupling bag 38 and the patient 42 will be appropriate over a wide range of positions on the housing 32. Therefore, in some cases, the alignment process can be completed simply by allowing liquid of the specified inflow and outflow volumes to flow into and out of the coupling bag 38, and control to set the pressure measurement value within the target range may not be necessary.

[0040] Figure 5 shows a flowchart of the first alignment process. The controller 20 sets the reference point A of the housing 32 to the housing reference position S and brings the coupling bag 38 into close contact with the patient 42 (S101). The controller 20 also stores the housing reference position S (S102). At this time, the coupling bag 38 may be filled with a volume of liquid such that the pressure measurement value falls within the target range. The controller 20 moves the housing 32 to change the position of the focal point (S103) and determines the distance moved by the reference point A of the housing 32 (S104).

[0041] The controller 20 injects liquid into the coupling bag 38 or injects liquid out of the coupling bag 38 so that the coupling bag 38 is filled with a volume of liquid corresponding to the distance traveled (S105). The controller 20 determines whether the focal point F is aligned with the location of the affected area (S106). If the focal point F is not aligned with the location of the affected area, the controller 20 returns to the process in step S103. If the focal point F is aligned with the location of the affected area, the controller 20 terminates the process.

[0042] Here, the determination in step S106 may be made in response to user operations referring to the B-mode image displayed on the display, or it may be made by image recognition processing of the B-mode image data. That is, the B-mode image data generated by the ultrasound image detection device 14 shows the focal point F and the affected area. The user determines whether or not the focal point F is aligned with the position of the affected area based on the B-mode image displayed on the display. The user operates the controller 20 and inputs information indicating the determination result. Alternatively, the controller 20 may perform image recognition processing on the B-mode image data to determine whether or not the focal point F is aligned with the position of the affected area.

[0043] In this manner, the controller 20 moves each ultrasonic transducer 34 from a predetermined reference position, determines the distance traveled by the ultrasonic transducer 34 from the reference position, and either flows a volume of liquid corresponding to the distance traveled into the coupling bag 38 or out of the coupling bag 38.

[0044] Here, if the travel distance of the housing 32 is less than or equal to a predetermined distance limit, it is not necessary to allow liquid to flow in or out of the coupling bag 38. Figure 6 shows a flowchart of such a second alignment process.

[0045] After determining the distance traveled by the housing 32 (S104), the controller 20 determines whether the travel distance exceeds the distance limit (S201). If the travel distance exceeds the distance limit, the controller 20 allows liquid to flow into or out of the coupling bag 38 so that the coupling bag 38 is filled with a volume of liquid corresponding to the travel distance (S105), and proceeds to step S106. On the other hand, if the travel distance is less than or equal to the distance limit, the controller 20 does not allow liquid to flow into or out of the coupling bag 38 and proceeds to step S106. In step S106, the controller 20 determines whether the focal point F is aligned with the location of the affected area (S106). If the focal point F is not aligned with the location of the affected area, the controller 20 returns to step S103. If the focal point F is aligned with the location of the affected area, the controller 20 terminates the process.

[0046] With this process, if the movement distance of the housing 32 does not exceed the distance limit, the flow of liquid is stopped. This prevents the difficulty in alignment caused by frequent changes in the state of the coupling bag 38.

[0047] Figure 7 shows a flowchart of the third alignment process. In this process, in step S201, if the controller 20 determines that the travel distance exceeds the distance limit, the controller 20 issues a warning that liquid needs to be added to and removed from the coupling bag 38 (S301). The warning may be given by sounding an alarm, or by turning on or flashing a light source such as an LED. Alternatively, text or a graphic indicating that liquid needs to be added to and removed from the coupling bag 38 may be displayed on the display.

[0048] After the warning, the controller 20 enters a state where it waits for the adjustment button provided on the controller 20 to be pressed (S302). The adjustment button may consist of an icon displayed on the display, or it may be a mechanical button. The adjustment button may be a momentary type that remains on only when pressed and returns to the off state when released, or an alternate type that remains on even after being released after being pressed once.

[0049] When the adjustment button is ON (S302), the controller 20 injects liquid into the coupling bag 38 or injects liquid from the coupling bag 38 (S105) so that the coupling bag 38 is filled with a volume of liquid corresponding to the distance traveled, and then proceeds to step S106. If the focus F is not aligned with the affected area, the controller 20 returns to step S103. If the focus F is aligned with the affected area, the controller 20 terminates the process.

[0050] According to this process, whether or not liquid flows into or out of the coupling bag 38 is determined in response to the user's operation of the adjustment button. If the user does not press the adjustment button, the controller 20 enters a state of waiting for the adjustment button to be pressed, and the process stops at step S302. At this time, the user may operate the robot arm 12, supply pump 64, discharge pump 66, etc., by operating the controller 20 to adjust the focus F to the location of the affected area, not according to the flowchart in Figure 7.

[0051] Figure 8 shows a flowchart of the fourth alignment process. The fourth alignment process adds a process to the second alignment process shown in the flowchart of Figure 6, which involves the inflow and outflow of liquid to the coupling bag 38 according to the pressure measurement value of the coupling bag 38.

[0052] In step S101, the controller 20 sets the reference point A of the housing 32 to the housing reference position S and then tightly attaches the coupling bag 38 to the patient 42 (S101). After this, the controller 20 stores the target pressure value in addition to the housing reference position S (S401). Here, the target pressure value is a value predetermined as the pressure at which the coupling bag 38 tightly attaches to the patient 42. Here, the controller 20 may set the pressure measurement value in the state of step S101 as the target pressure value. For example, the controller 20 may set the pressure measurement value in the state of step S101 at the time when the user determines, by visual inspection and palpation, that the degree of contact between the coupling bag 38 and the patient 42 is good.

[0053] Thus, the controller 20 may measure the pressure inside the coupling bag 38 when the housing 32 is set to the housing reference position S, that is, when the ultrasonic transducer 34 is set to the reference position, before performing the alignment process, and determine the target pressure value.

[0054] After the controller 20 stores the housing reference position S and the pressure target value (S401), it proceeds to the process of moving the housing 32 (S103).

[0055] If the controller 20 determines in step S201 that the travel distance is less than or equal to the distance limit, it proceeds to step S106. If the controller 20 determines in step S201 that the travel distance exceeds the distance limit, it calculates a pressure difference value by subtracting the pressure target value from the pressure measurement value for the coupling bag 38 (S402). The pressure difference value has significance as a pressure difference representing the difference between the pressure measurement value for the coupling bag 38 and the pressure target value. The controller 20 determines whether the pressure difference value exceeds the pressure threshold (S403). If the pressure difference value is less than or equal to the pressure threshold, the controller 20 proceeds to step S106.

[0056] When the pressure difference value exceeds the pressure threshold, the controller 20 either flows liquid into the coupling bag 38 or flows liquid out of the coupling bag 38 so that the coupling bag 38 is filled with a volume of liquid corresponding to the distance traveled (S105). The controller 20 again calculates the pressure difference value by subtracting the pressure target value from the pressure measurement value for the coupling bag 38 (S501) and determines whether the pressure difference value exceeds the pressure threshold (S502). If the pressure difference value is less than or equal to the pressure threshold, the controller 20 proceeds to step S106.

[0057] When the pressure difference value exceeds the pressure threshold, the controller 20 causes liquid to flow into or out of the coupling bag 38 (S503) so that the pressure measurement value falls within the target range, and then proceeds to the process in step S106.

[0058] In step S106, the controller 20 determines whether the focal point F is aligned with the location of the affected area (S106). If the focal point F is not aligned with the location of the affected area, the controller 20 returns to the process in step S103. If the focal point F is aligned with the location of the affected area, the controller 20 terminates the process.

[0059] With this process, the inflow and outflow of liquid to and from the coupling bag 38 is determined not only by the distance traveled by the housing 32, but also by the pressure measurement value of the coupling bag 38. That is, the controller 20 calculates a pressure difference value as the pressure difference between the pressure measurement value of the coupling bag 38 and a predetermined pressure target value, and in accordance with the pressure difference value, it causes liquid to flow into or out of the coupling bag 38. In step S503, the controller 20 causes liquid to flow into or out of the coupling bag 38 so that the pressure difference value becomes small or equal to zero. This ensures that an appropriate tight seal is achieved between the coupling bag 38 and the patient 42.

[0060] Figure 9 shows a flowchart of the fifth alignment process. In the fifth alignment process, when it is determined that the travel distance has exceeded the limit value (S201), and further determined that the pressure difference value has exceeded the pressure threshold (S403), the controller 20 issues a warning that liquid needs to be inflowed into or out of the coupling bag 38 (301).

[0061] After the warning, the controller 20 waits for the adjustment button provided on the controller 20 to be pressed (S302). When the adjustment button is ON, the controller 20 either flows liquid into the coupling bag 38 or flows liquid out of the coupling bag 38 so that the coupling bag 38 is filled with a volume of liquid corresponding to the distance traveled (S105). The controller 20 again calculates the pressure difference value by subtracting the pressure target value from the pressure measurement value for the coupling bag 38 (S501), and determines whether the pressure difference value exceeds the pressure threshold (S502). If the pressure difference value is less than or equal to the pressure threshold, the controller 20 proceeds to step S106.

[0062] When the pressure difference value exceeds the pressure threshold, the controller 20 causes liquid to flow into or out of the coupling bag 38 (S503) so that the pressure measurement value falls within the target range, and then proceeds to the process in step S106.

[0063] According to this process, similar to the third alignment process, whether or not to allow liquid to flow in or out of the coupling bag 38 is determined in response to the user's operation of the adjustment button. If the user does not press the adjustment button, the controller 20 enters a state of waiting for the adjustment button to be pressed, and the process flow stops at step S302. At this time, the user may operate the robot arm 12, supply pump 64, discharge pump 66, etc., by operating the controller 20 to adjust the focus F to the location of the affected area, not according to the flowchart in Figure 9.

[0064] Furthermore, similar to the fourth alignment process, the inflow and outflow of liquid to and from the coupling bag 38 is performed not only based on the distance traveled by the housing 32, but also based on pressure measurements of the coupling bag 38. This ensures that a proper seal is achieved between the coupling bag 38 and the patient 42. [Explanation of Symbols]

[0065] 4 concave surface, 10 movable body, 12 robot arm, 14 ultrasonic image detection device, 16 drive amplifier, 18 robot controller, 20 controller, 30 HIFU transducer unit, 32 housing, 34 ultrasonic transducer, 36 ultrasonic probe, 38 coupling bag, 50 probe drive mechanism, 42 patient, 60 tank, 62 degassing device, 64 supply pump, 66 discharge pump, 68 inflow sensor, 70 outflow sensor, 72 pressure sensor, 100 HIFU irradiation device, 102 liquid supply device.

Claims

1. An ultrasonic transducer that generates therapeutic ultrasound, A coupling bag to be positioned between the ultrasonic transducer and the patient, A transport mechanism for transporting the ultrasonic transducer, A liquid supply device that introduces liquid into the coupling bag or releases liquid from the coupling bag, The system comprises a controller for controlling the transport mechanism and the liquid supply device. The controller is, A HIFU irradiation device characterized by performing a positioning process, which involves moving the ultrasonic transducer from a predetermined reference position, determining the distance the ultrasonic transducer moves from the reference position in the direction from the patient toward the ultrasonic transducer or in the opposite direction, and flowing a volume of liquid corresponding to the distance moved into or out of the coupling bag.

2. The HIFU irradiation apparatus according to claim 1, The coupling bag is equipped with a pressure sensor for measuring the pressure of the liquid inside the coupling bag. The controller is, The pressure difference between the pressure measurement value for the coupling bag and a predetermined target pressure value is determined. A HIFU irradiation apparatus characterized by allowing liquid to flow into the coupling bag or out of the coupling bag in accordance with the pressure difference.

3. The HIFU irradiation apparatus according to claim 2, The controller is, A HIFU irradiation device characterized by measuring the pressure inside the coupling bag when the ultrasonic transducer is set to the reference position, and determining the target pressure value.

4. The HIFU irradiation apparatus according to claim 2, The controller is, A HIFU irradiation apparatus characterized by introducing liquid into the coupling bag or discharging liquid from the coupling bag so that the pressure difference becomes small or equal to zero.

5. The HIFU irradiation apparatus according to claim 2, The aforementioned reference position is, A HIFU irradiation device characterized in that the position of the ultrasonic transducer is the position of the ultrasonic transducer when the focal point of the ultrasonic waves emitted from the ultrasonic transducer is at the lowest position within its movable range.

6. A HIFU irradiation apparatus according to any one of claims 1 to 5, The aforementioned alignment process is, A HIFU irradiation device characterized by including a process of aligning the focus of the ultrasound emitted from the ultrasonic transducer to the location of the affected area in the patient.

7. A HIFU irradiation apparatus according to any one of claims 1 to 5, The controller is, Liquid control information showing the relationship between the travel distance and the volume of liquid to be filled into the coupling bag is acquired. The HIFU irradiation apparatus is characterized in that, when the controller performs the alignment process, it refers to the liquid control information and causes a volume of liquid corresponding to the movement distance to flow into or out of the coupling bag.

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