Focused ultrasound treatment system and method of use thereof

Abstract

The application discloses a focused ultrasound treatment system and a use method thereof, wherein the water tank of the focused ultrasound treatment system is provided with an upper open tank cavity, the side of the water tank is provided with an inlet hole communicating with the tank cavity, the inlet hole is used for inserting an inserting part into the tank cavity, the hole wall of the inlet hole is provided with a sealing part, the sealing part is used for sealing the gap between the inlet hole and the inserting part when the inserting part enters the tank cavity, the inlet hole is arranged at one end of the water tank along the length direction of the tank cavity, and an adjusting partition plate is further arranged at the other end of the water tank and used for limiting the volume of the tank cavity on the side of the inlet hole; a fixing part is further arranged in the tank cavity and used for positioning the inserting part; and the fixing part can be adjusted in position relative to the tank cavity along the length direction of the tank cavity. Through the arrangement of the inlet hole, the body part of a patient can be inserted into the tank cavity, and the sealing of the tank cavity is maintained through the sealing part, so that the body part of the patient can be completely immersed in water by injecting water into the water tank during treatment, and the detection and treatment effects are improved.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a focused ultrasound therapy system and its method of use. Background Technology

[0002] High-intensity focused ultrasound (HIFU) therapy systems, also known as HIFU (High Intensity Focused Ultrasound) therapy systems, include conventional HIFU therapy systems such as... Figure 1 As shown, the system mainly includes an operating console 1, a main control computer 2, a treatment bed 3, a gantry frame 4, a treatment head 5, an ultrasound diagnostic instrument 6, a power drive cabinet 7, and a water treatment system 8. The main control computer 2, located on the operating console 1, is used for positioning, treatment, and other operational control. The treatment bed 3 allows for lying down and three-dimensional movement. The gantry frame 4 houses electrical components (not shown) and the treatment head 5. The treatment head 5 is the core treatment equipment, containing an ultrasound transducer (not shown) and an ultrasound probe (not shown), enabling three-dimensional movement, rotation, and lifting. The ultrasound diagnostic instrument 6 is a common commercially available ultrasound diagnostic device used for diagnosing tumors and locating their position before treatment. The power drive cabinet 7 generates high-frequency power to drive the ultrasound transducer. The water treatment system 8 produces degassed water as a medium for ultrasound propagation, as ultrasound waves attenuate very little when propagating in degassed water.

[0003] The basic working principle of a conventional HIFU treatment system is as follows: the ultrasonic transducer in the treatment head 5 is driven by the power drive cabinet 7 to generate high-intensity focused ultrasound waves. These ultrasound waves are focused on the tumor lesion area through degassing and water coupling. Through the mechanical, thermal and cavitation effects of the ultrasound waves, the tumor tissue is rapidly heated (≥65 degrees Celsius), causing coagulative necrosis in a short time, thereby achieving the purpose of ablating the entire tumor tissue.

[0004] The treatment method using a conventional HIFU treatment system is as follows: Under the positioning and monitoring of the built-in ultrasound probe in the treatment head, the doctor locates the tumor tissue and outlines the edge of the tumor tissue on the ultrasound image; the doctor sets the treatment parameters (such as power, time, etc.); the main control computer 2 calculates all treatment points through image processing; the main control computer 2 controls the ultrasound transducer to align with the first point and performs treatment according to the set parameters, using the thermal effect of high-intensity focused ultrasound waves to ablate the tumor at the focal point; then the ultrasound transducer is moved to the next treatment point to continue treatment until the entire tumor tissue has been treated.

[0005] As can be seen, HIFU treatment is a non-invasive treatment method that does not involve surgery, puncture, or leave scars; it does not involve radiation; the treatment only affects the lesion site and will not harm adjacent tissues or organs; and it is completely tolerable.

[0006] The overall structure of a conventional HIFU treatment system is as follows: Figure 1 Treatment of head structures such as Figure 2 As shown, this HIFU treatment device is suitable for treating various solid tumors in the pelvic and abdominal cavities. However, it is not very suitable for treating leg conditions such as osteosarcoma, varicose veins, and superficial tumors in the legs. The main reason is that the treatment head is relatively large, suitable for coupling over large areas of the abdomen, but difficult to couple to smaller areas, such as the legs. Furthermore, the large treatment head has limited range of motion, preventing easy adjustment based on the shape of the treatment area. The large treatment head also limits its range of motion, hindering long-distance movement, making it difficult to treat leg conditions such as varicose veins that require treatment over long areas. Summary of the Invention

[0007] The technical problem to be solved by the present invention is to overcome the shortcomings of the prior art that cannot be specifically applied to the legs, and to provide a focused ultrasound treatment system suitable for the legs and its method of use.

[0008] The present invention solves the above-mentioned technical problems through the following technical solution:

[0009] This invention provides a focused ultrasound therapy system, the focused ultrasound therapy system comprising:

[0010] A water tank, wherein the water tank has an open upper cavity, and the side of the water tank has an inlet hole communicating with the cavity. The inlet hole is used for an extension to extend into the cavity. The wall of the inlet hole is provided with a sealing element, which is used to seal the gap between the inlet hole and the extension when the extension enters the cavity.

[0011] The treatment head and the main unit, wherein the treatment head can be inserted into the slot cavity to perform operations;

[0012] Along the length of the cavity, the inlet is located at one end of the water tank, and an adjusting baffle is provided at the other end of the water tank. The position of the adjusting baffle within the cavity can be adjusted relative to the cavity along the length of the cavity. The adjusting baffle is used to limit the volume of the cavity located on the side of the inlet. A fixing part is also provided within the cavity. The fixing part is used to position the insert and can also be adjusted relative to the cavity along the length of the cavity.

[0013] In this technical solution, the water tank has an inlet hole that allows the patient's body parts to be inserted into the tank cavity, and the tank cavity is kept sealed by a sealing component. This allows the patient's body parts to be completely immersed in the water during treatment, so that the transducer of the treatment head and B-ultrasound equipment can move in the water to examine the entire body part of the patient. During this process, the patient's body parts do not need to move. Therefore, by setting a fixing part to fix the patient's body parts inserted into the tank cavity, the detection and treatment effects are ensured.

[0014] Meanwhile, the aforementioned water tank structure eliminates the need for water bags or other structures on the treatment head, reducing its size and structural complexity, thereby increasing its range of motion and achieving the goals of detection and treatment. Furthermore, by adjusting the partition, the volume of the tank on that side can be adjusted according to the patient's body part size, avoiding water waste caused by excessive volume.

[0015] In addition, by allowing the patient's body part to be inserted into the tank cavity through the inlet located on the side of the tank, the space above the tank can be completely released. The released space can be used for operations that fix the patient's body part, as well as operations that examine and treat the patient through the treatment head, giving the above operations greater operational flexibility.

[0016] Preferably, the water tank is further provided with an inlet and an outlet, the inlet being used for water to enter the tank cavity and the outlet being used for water to exit the tank cavity.

[0017] In this technical solution, by setting an inlet and an outlet on the water tank, the water injected into the tank can be kept circulating, thereby achieving the purposes of purification, heating and degassing.

[0018] Preferably, the fixing part includes a support member and a fixing member, the support member being used to support the extension member, and the fixing member being used to fix the extension member along the height direction.

[0019] In this technical solution, the comfort of fixation is improved by using a support method.

[0020] Preferably, the upper surface of the support member is an arcuate surface adapted to the extension member.

[0021] In this technical solution, a curved surface is used for support, which further improves comfort.

[0022] Preferably, the sealing element is an annular clamp, and the annular clamp is made of rubber or latex.

[0023] In this technical solution, a ring-shaped clamp made of rubber or latex is used for sealing, which ensures high sealing reliability.

[0024] Preferably, the insert is a user's limb.

[0025] The water tank provided in this technical solution is more suitable for immersion and ultrasound examination and treatment of the patient's limbs.

[0026] Preferably, the treatment head includes a built-in ultrasound probe and an external ultrasound probe, and the focused ultrasound treatment system also includes an adjustment mechanism;

[0027] The adjustment mechanism is used to adjust the treatment position and treatment angle of the treatment head. The adjustment mechanism is located in the host computer, which has a main control computer. The main control computer has an adjustment mechanism control module, which is used to control the adjustment mechanism to move the treatment head to a specified position and angle.

[0028] In this technical solution, an adjustment mechanism is designed to address the problem that the movement angle and range of motion of the large treatment head in the existing technology are limited and cannot be arbitrarily adjusted according to the shape of the treatment area. This mechanism can adjust the position and angle of the treatment head, making it more suitable for leg treatment.

[0029] Preferably, the area of ​​the treatment head is coupled to the area of ​​the leg.

[0030] In this technical solution, since the treatment head in the existing technology is relatively large and suitable for coupling over a large area of ​​the abdomen, this treatment head has a higher degree of coupling for smaller areas, such as the legs.

[0031] Preferably, the adjustment mechanism is equipped with a robotic arm, the moving end of which fixes the treatment head, and the fixed end of which is located in the host computer. The main control computer in the host computer controls the movement of the robotic arm through a robotic arm control module.

[0032] In this technical solution, the robotic arm is mounted on the host computer, and the front end is connected to the transducer to control the movement of the transducer and move the transducer to the treatment position.

[0033] Preferably, the robotic arm is a 2-6 axis robotic arm.

[0034] In this technical solution, the robotic arm adopts a 6-axis collaborative robot, which can realize three-dimensional motion as well as rotation, lifting and lowering functions. It has the characteristics of large range of motion, precise positioning, flexibility and convenience. The controller of the robotic arm is connected to the computer in the host of this equipment and is controlled by the computer. It can drive the transducer to a designated position; it can also be dragged manually.

[0035] Preferably, the treatment head further includes a transducer, which is located at the moving end of the adjustment mechanism and electrically connected to the host. The main control computer in the host controls the ultrasonic transducer to convert electrical signals into acoustic signals and focus them onto the target area in the body through a power control module.

[0036] In this technical solution, the transducer is the treatment component of the device, which can convert electrical signals into sound signals and then focus them on the target area in the body to treat the target tissue point by point.

[0037] Preferably, the transducer housing is adapted to the leg, and an ultrasound probe hole is provided in the middle of the housing, which is used to fix the built-in ultrasound probe.

[0038] In this technical solution, the transducer is specially designed according to the structure of the leg. This leg-specific transducer is one of the core components of the treatment device. The transducer has a small focal side lobe and high precision. The ultrasound probe and transducer are fixed, and the transducer's focal point is on the ultrasound probe's image. The pixel position of the ultrasound image can be calculated to obtain its three-dimensional spatial position. The transducer and ultrasound probe must be immersed in water during use.

[0039] Preferably, the shell is a spherical shell, and the focus is on the center of the sphere, which is the focal point.

[0040] In this technical solution, the transducer is specially designed according to the structure of the leg. The transducer suitable for the leg is one of the core components of the device for treatment. The transducer has a small focal side lobe and high precision.

[0041] Preferably, the focused ultrasound treatment system further includes an ultrasound host, which is installed inside the host and connected to the main control computer in the host via an image transmission cable to transmit ultrasound images to the main control computer in real time; the ultrasound host is connected to the external ultrasound probe and the internal ultrasound probe, and the external ultrasound probe is operated by hand by the doctor.

[0042] In this technical solution, the treatment head includes a built-in ultrasound probe, and the ultrasound diagnostic instrument is connected to an external ultrasound probe.

[0043] Preferably, the focused ultrasound treatment system further includes a water treatment and circulation device, wherein the water tank and the water treatment and circulation device are connected through a water pipe for water convection between the water treatment and circulation device and the water tank.

[0044] In this technical solution, the water tank has an inlet and an outlet, which allows water to circulate between the small water treatment circulation device and the water tank. The small water treatment circulation device can purify, heat, deaerate, and circulate ordinary tap water.

[0045] Preferably, the water treatment circulation device is equipped with a filter at the water inlet, and the small water treatment circulation device is also equipped with a heating component to heat the water before it is transported to the water tank.

[0046] In this technical solution, the small water treatment and circulation device for the legs purifies, heats, degassses, and circulates ordinary tap water. Due to the characteristics of ultrasound, it is best to transmit through degassed water. Therefore, the basic function of the water treatment device is degassing, that is, removing the gas from the tap water. In addition, the small water treatment and circulation device also has a purification function; a filter at the inlet removes impurities from the water. In winter, when the water temperature is low, the water treatment also has a heating function, which can heat the water to a comfortable temperature for the human body, such as 25°C. Two water pipes connect the water treatment device to the water tank, allowing water to enter and exit the tank, circulating the water between the water treatment device and the tank. The degassed and heated water is then delivered to the tank. Excess water in the tank flows back to the water treatment device, where it is degassed and heated again before being sent back to the tank. This cycle repeats, forming a circulation that provides degassed water for treatment.

[0047] This invention provides a method for using a focused ultrasound therapy system, implemented by the focused ultrasound therapy system described above, comprising the following steps:

[0048] The user's limb is inserted into the water tank through the inlet as the insert, and the gap between the inlet and the limb is sealed by the seal.

[0049] Fill the water tank with water so that it at least submerges the area of ​​the limb to be scanned;

[0050] The treatment head is immersed in water and scanned in the area to be examined.

[0051] Preferably, before immersing the treatment head in water and scanning the area to be scanned, the following steps are performed:

[0052] An external ultrasound probe was used to initially scan the patient's affected area, and the area to be scanned was marked on the patient's skin.

[0053] Preferably, the step of immersing the treatment head in water and scanning the area to be scanned specifically includes the following steps:

[0054] The treatment head is moved manually or by computer-controlled electric movement to the initially calibrated area, and the transducer and built-in ultrasound probe of the treatment head are submerged in water.

[0055] Precisely control the movement of the built-in ultrasound probe to locate the lesion;

[0056] In the computer, the lesion area is delineated layer by layer to determine the entire lesion area;

[0057] Set treatment parameters;

[0058] The computer calculates all treatment points and their coordinates based on the ultrasound images and the doctor's delineation, and performs point-by-point treatment according to the treatment parameters.

[0059] After the treatment is completed, the doctor can use an external probe to evaluate the treatment effect on the treated area again.

[0060] In this technical solution, the method of using this focused ultrasound therapy system is more suitable for local detection of the legs.

[0061] The positive and progressive effects of this invention are as follows:

[0062] This invention proposes a focused ultrasound therapy device suitable for treating leg diseases. Compared with traditional HIFU for treating pelvic and abdominal cavities, this device has the following advantages:

[0063] 1. The water tank of the focused ultrasound therapy device of the present invention allows the patient's body to be completely immersed in water during treatment. This enables the transducer of the treatment head and ultrasound equipment to move within the water to examine the entire body. During this process, the patient's body does not need to move. Therefore, a fixing part is provided to secure the patient's body part inserted into the tank, ensuring effective detection and treatment. Simultaneously, the movement of the ultrasound transducer within the water eliminates the need for water bags or other structures on the treatment head, reducing its size and structural complexity, and increasing its range of motion. This allows for underwater detection and treatment with a relatively simple device.

[0064] 2. By allowing the patient's body part to extend into the tank cavity through the inlet located on the side of the tank, the space above the tank can be completely freed up. This freed-up space can be used for operations such as fixing the patient's body part, as well as operations such as testing and treating the patient through the treatment head, thus providing greater operational flexibility for these operations.

[0065] 3. Because the ultrasound machine is immersed in degassed water, there is no membrane present, resulting in minimal ultrasound propagation loss and clear images. Simultaneously, the close proximity of the ultrasound machine to the skin allows for near-field imaging, with image clarity comparable to that of an external handheld ultrasound probe.

[0066] 4. The transducer of this invention is also immersed in degassed water, and there is no membrane present, so the treatment ultrasound loss is small, ensuring high treatment efficiency. At the same time, the transducer is immersed in water and coupled with the leg with water. The coupling area is large enough to ensure a large contact area with the skin, so high power can be used and the skin is less likely to be burned.

[0067] 5. The water tank in the focused ultrasound therapy device of this invention is a component specifically designed for treating leg ailments. It can accommodate the entire leg and can treat any part of the leg. Depending on the actual needs, the patient can lie supine or prone to ensure treatment of ailments on the entire leg.

[0068] 6. This invention employs a robotic arm for movement. The robotic arm is flexible, reliable, and has a wide range of applications. When used in HIFU equipment, it offers advantages such as convenience, flexibility, stability, precision, and reliability. High motion precision and product stability represent the future direction of development.

[0069] 7. The focused ultrasound therapy system of this invention is compact, flexible, occupies little space, and is intelligent and convenient to operate. Attached Figure Description

[0070] Figure 1 A schematic diagram of a high-intensity focused ultrasound therapy system in existing technology.

[0071] Figure 2 Diagram showing the usage status of existing high-intensity focused ultrasound (HIFU) therapy systems.

[0072] Figure 3A This is a first-view structural diagram of the high-intensity focused ultrasound therapy system of the present invention.

[0073] Figure 3B This is a second-view structural diagram of the high-intensity focused ultrasound therapy system of the present invention.

[0074] Figure 3C This is a third-view structural diagram of the high-intensity focused ultrasound therapy system of the present invention.

[0075] Figure 3D This is a fourth-view structural diagram of the high-intensity focused ultrasound therapy system of the present invention.

[0076] Figure 4A This is a first-view structural diagram of the water tank structure of the present invention.

[0077] Figure 4B This is a second-view structural diagram illustrating the water tank structure of the present invention.

[0078] Figure 4C This is a schematic third-view structural diagram of the water tank structure of the present invention.

[0079] Figure 4D This is a fourth-view structural diagram of the water tank structure of the present invention.

[0080] Figure 5A This is a first-view structural diagram illustrating the transducer structure of the present invention.

[0081] Figure 5B This is a second-view structural diagram illustrating the transducer structure of the present invention.

[0082] Figure 5C This is a third-view structural diagram illustrating the transducer structure of the present invention.

[0083] Figure 5D This is a fourth-view structural diagram illustrating the transducer structure of the present invention.

[0084] Figure 6 This is a flowchart illustrating the method of using the high-intensity focused ultrasound therapy system of the present invention.

[0085] Explanation of markings in the diagram:

[0086] Control Panel 1

[0087] Main control computer 2

[0088] Treatment Bed 3

[0089] Gantry Frame 4

[0090] Treatment of head 5

[0091] Ultrasound diagnostic instrument 6

[0092] Power drive cabinet 7

[0093] Water treatment system 8

[0094] sink 10

[0095] Cavity 101

[0096] Inlet / outlet 102

[0097] Leg opening 103

[0098] Adjustment baffle 104

[0099] Leg fixation part 105

[0100] Transducer 11

[0101] Ultrasound probe hole 111

[0102] spherical shell 112

[0103] Built-in ultrasound probe 12

[0104] robotic arm 13

[0105] Host 14. Detailed Implementation

[0106] The present invention will be further illustrated by way of embodiments below, but the present invention is not limited to the scope of the embodiments.

[0107] Example 1

[0108] like Figure 3A , 3B As shown in Figures 3C and 3D, this embodiment provides a high-intensity focused ultrasound therapy system. The system includes a treatment head 5, an adjustment mechanism for the treatment head 5, a water tank 10, a small water treatment and circulation device, a treatment bed 3, and a main unit 14 (trolley). Each component of the system is described in detail below.

[0109] The treatment head 5 in this embodiment includes an ultrasound scanner and a transducer 11. In this embodiment, the area of ​​the treatment head 5 is coupled to the area of ​​the leg. For small parts, such as the leg, the coupling degree is higher.

[0110] The transducer 11 is the treatment component of the device, which can convert electrical signals into sound signals and then focus them on the target area in the body to treat the target tissue point by point.

[0111] The specific structure is as follows: Figure 5A , 5B As shown in Figures 5C and 5D, in this embodiment, the transducer 11 is specially designed according to the structure of the leg, and the transducer 11 also adopts the following... Figure 5B and 5C The shape of the spherical shell 112 shown is focused at the center of the sphere, which is the focal point. The focal point has small side lobes and high precision. An ultrasound probe hole 111 is opened in the middle of the transducer 11, and an ultrasound probe is installed. The ultrasound probe is fixed to the transducer 11. The focal point of the transducer 11 is on the image of the ultrasound probe. The pixel position of the ultrasound image can be calculated to obtain its three-dimensional spatial position. The transducer 11 and the ultrasound probe are immersed in the water in the water tank 10 during use.

[0112] During installation, the transducer 11 is installed on the moving end of the adjustment mechanism. The transducer is electrically connected to the host 14, which controls the ultrasonic transducer 11 to convert electrical signals into acoustic signals and focus them onto the target area in the body.

[0113] In this embodiment, the ultrasound scanner is chosen for leg treatment because leg lesions are generally superficial, but require high resolution. If treating varicose veins, clear images of the blood vessels are also necessary. Due to space constraints, the ultrasound scanner needs to be installed inside the main unit 14. The ultrasound scanner connects to the computer inside the main unit 14 via an image transmission cable, transmitting ultrasound images to the computer in real time. Simultaneously, the ultrasound scanner needs to connect to both an external ultrasound probe and a built-in ultrasound probe 12. The external probe is operated by the doctor by hand, while the built-in probe is fixedly installed inside the transducer 11.

[0114] In this embodiment, the ultrasound includes an ultrasound host, a built-in ultrasound probe 12, and an external ultrasound probe. The ultrasound host is installed inside the host 14 and is connected to the main control computer 2 in the host 14 via an image transmission cable to transmit ultrasound images to the main control computer 2 in real time. The ultrasound host is connected to the external ultrasound probe and the built-in ultrasound probe 12. The external ultrasound probe is operated by the doctor by hand.

[0115] In another embodiment, the ultrasound is a laptop-style portable ultrasound unit housed within the main unit 14. This embodiment offers greater portability and ease of operation for the ultrasound.

[0116] To address the limitation of the movement position and angle of the large treatment head 5 in existing technologies, which prevents it from being adjusted according to the shape of the treatment area, an adjustment mechanism was designed to adjust the position and angle of the treatment head 5, making it more suitable for leg treatment.

[0117] The adjustment mechanism adjusts the treatment angle and position of the treatment head 5 by moving it. The adjustment mechanism is located on the host 14, which contains a main control computer 2. The main control computer 2 contains an adjustment mechanism control module, which is used to control the adjustment mechanism to move the treatment head 5 to a designated position.

[0118] In this embodiment, the adjustment mechanism employs a 2-6 axis robotic arm 13. The moving end of the robotic arm 13 is fixed to the treatment head 5, and the fixed end of the robotic arm 13 is located on the host computer 14. The main control computer 2 within the host computer 14 controls the movement of the robotic arm 13 through a robotic arm control module, thereby changing the position and angle of the fixed treatment head 5. The fixed end of the robotic arm 13 is mounted on the host computer 14, and the moving end is connected to a transducer 11 to control the movement of the transducer 11, moving the transducer 11 to the treatment position. For the robotic arm 13 used, the more axes of freedom the robotic arm 13 has, the greater the range of motion of the adjustment mechanism.

[0119] In another embodiment, the robotic arm 13 employs a 6-axis collaborative robot, capable of three-dimensional motion, rotation, and lifting, featuring a large range of motion, precise positioning, and flexibility. The controller of the robotic arm 13 is connected to the computer within the host device 14 and is controlled by the computer. It can move the transducer 11 to a designated position or be manually dragged. Even with manual dragging, the current position is displayed. Manual dragging is suitable for initial large-scale movements, while computer-controlled precise movement is suitable for fine, layer-by-layer, point-by-point movements.

[0120] like Figure 4A , 4B As shown in Figures 4C and 4D, in this embodiment, the high-intensity focused ultrasound (HIFU) treatment system also includes a water tank 10. The water tank 10 has a cavity 101, and the cavity 101 has inlet / outlet ports 102 for water intake and exhaust. The treatment head 5 extends into the cavity 101 for operation. In this embodiment, the water tank 10 has an inlet and an outlet for water intake and exhaust. In this embodiment, the inlet of the inlet / outlet ports 102 is located at a high position in the water tank 10, and the outlet is located at a low position in the water tank 10. Water is injected into the water tank through the inlet. Specifically, during treatment, water needs to be injected into the water tank 10, ensuring that the water can at least submerge the patient's treatment area, allowing the transducer 11 and the ultrasound machine to move in the water of the water tank 10. This eliminates the need for a water bag or other structures on the treatment head, reducing the size and structural complexity of the treatment head, thereby increasing the range of motion of the treatment head for patient treatment.

[0121] In this embodiment, the front end of the groove 101 is provided with a leg inlet 103, the rear end of the groove 101 is provided with a groove 101 length adjustment baffle 104, and a leg fixing part 105 is provided inside the groove 101. The leg fixing part 105 is used to fix the patient's ankle or knee. The treatment head 5 is inserted into the groove 101 for operation. The water tank 10 suitable for the leg is adapted to fit the patient's thigh. The leg inlet 103 is for the patient to insert their leg. An annular sealing element is provided on the wall of the leg inlet 103 to seal the gap between the leg inlet 103 and the patient's leg after the patient inserts their leg, thereby sealing and preventing water leakage. In this embodiment, the sealing element is a ring hoop made of rubber, which can simply and effectively seal the gap between the leg inlet 103 and the patient's leg. More preferably, the ring band can also be made of latex. By setting the inner hole size of the ring band to be smaller than the size of the patient's thigh, when the patient's thigh is inserted into the ring band, the latex is compressed by the tight contact with the inner hole surface of the ring band, thus ensuring a sealing effect.

[0122] The rear end of the water tank 10 has an adjustable baffle 104. In this embodiment, the adjustable baffle 104 is inserted downward relative to the side wall of the water tank 10 to adjust and change its position within the water tank 10, so as to adjust according to the length of the patient's leg and change the volume of the tank cavity 101 to avoid wasting water. In other embodiments, the adjustable baffle 104 may also adopt other structural forms to achieve the purpose of adjusting the volume of the tank cavity 101 by changing its position within the water tank 10. In this embodiment, the leg fixing part 105 inside the tank cavity 101 includes at least a support member capable of supporting the leg and a fixed hoop (i.e., Figure 4A (As indicated by the leg fixation part 105), the aforementioned clamp can be fixed at the patient's ankle to prevent leg movement. There is also a fixation device at the patient's knee, which can be fixed according to the patient's condition. The upper surface of the support is an arc-shaped surface adapted to the shape of the leg, improving patient comfort. The specific structure of the clamp in the fixation part can be implemented using existing clamps, with a flip-open structure. After the patient's leg is placed in the clamp, it can be flipped closed to achieve temporary leg fixation.

[0123] In this embodiment, the water tank 10 is connected to the small water treatment circulation device through a water pipe via an inlet / outlet for water convection between the small water treatment circulation device and the water tank 10.

[0124] In this embodiment, the water tank 10 has a water inlet and a water outlet, so that water can circulate between the small water treatment circulation device and the water tank 10. The small water treatment circulation device can purify, heat, deaerate and circulate ordinary tap water.

[0125] In this embodiment, a small water treatment circulation device is provided with a filter at the inlet, and the outlet of the small water treatment circulation device is connected to the inlet of the water tank 10. The small water treatment circulation device is also provided with a heating component to heat the water and then transport it into the water tank 10.

[0126] In this embodiment, the small-scale water treatment and circulation device can purify, heat, deaerate, and circulate ordinary tap water. Due to the characteristics of ultrasound, it is best to propagate in deaerated water. Therefore, the basic function of the water treatment device is deaeration, that is, to remove the gas from the tap water. In addition, the small-scale water treatment and circulation device also has a purification function. At the water inlet, a filter is used to remove impurities from the water. In winter, when the water temperature is relatively low, the water treatment also has a heating function, which can heat the water to a comfortable temperature for the human body, such as 25°C. There are two water pipes connecting the water treatment and the water tank 10, which can allow water to enter and exit the water tank 10, circulating the water between the water treatment and the water tank 10. The deaerated and heated water is delivered to the water tank 10. Excess water in the water tank 10 flows back to the water treatment, is deaerated and heated again, and then sent back to the water tank 10. This process is repeated to form a cycle, providing deaerated water for treatment.

[0127] The host computer 14 contains a main computer, an ultrasound control module, a robotic arm control module, and a transducer 11 control and power module. The main control computer 2 is connected to each module and controls them to perform their functions. Most of the doctor's operations are completed via computer; the general operation process is shown in the operation flowchart. The host computer 14 contains the control module, including electrical components, a computer, and a monitor.

[0128] Treatment bed 3 is used to accommodate patients.

[0129] It should be clearly stated that the high-intensity focused ultrasound therapy system provided in this embodiment is used to detect and treat the patient's legs. However, by adjusting the size of the water tank, the above-mentioned high-intensity focused ultrasound therapy system can also be used to treat other parts of the patient's body, including the limbs.

[0130] Example 2

[0131] like Figure 6 As shown, this embodiment provides a method for using a high-intensity focused ultrasound (HIFU) therapy system, implemented by the HIFU therapy system in any of the above embodiments, including the following steps:

[0132] S1, The patient is lying on the treatment bed;

[0133] S2, the patient's legs are placed in the water tank and sealed.

[0134] S3, Use an external ultrasound probe to initially scan the patient's affected area and mark the area on the patient's skin with a marker;

[0135] S4, start the equipment, start the small water treatment circulation device, degas, and fill the water tank with water so that the water completely submerges the patient's legs; at the same time, make the water circulate between the small water treatment circulation device and the water tank.

[0136] S5, manually or by computer-controlled electric movement, move the treatment head to the initially marked area and immerse the transducer and built-in ultrasound probe 12 in water;

[0137] S6 precisely controls the movement of the built-in ultrasound probe 12 to locate the lesion.

[0138] S7, In the computer, the lesion area is delineated layer by layer to determine the entire lesion area;

[0139] S8, set treatment parameters;

[0140] S9: Based on the ultrasound image and the doctor's delineation area, the computer calculates all treatment points and their coordinates, and performs point-by-point treatment according to the treatment parameters.

[0141] S10. After the treatment is completed, the doctor can use an external probe to evaluate the treatment effect on the treated area again.

[0142] In this embodiment, the method of using this high-intensity focused ultrasound therapy system is more suitable for local detection of the legs.

[0143] In step S4 above, the water injected into the tank can only submerge the patient's leg area to be tested, in order to save water.

[0144] The method doctors use to delineate treatment points:

[0145] The doctor observes the patient's lesion area using the built-in ultrasound image and delineates the lesion region on the ultrasound image. Because the ultrasound image is a two-dimensional cross-sectional image, after delineating one cross-section, the doctor needs to move the built-in ultrasound probe 12 to the next cross-section and delineate the lesion area to be treated on the new cross-section again, repeating this process until the entire treatment area is delineated. The interval between the ultrasound cross-sections cannot be too large, as this affects the accuracy of the delineation; nor can it be too small, as this results in too many cross-sections being manipulated by the doctor, making the process very tedious. A more optimal interval is 3mm. After the entire treatment area is delineated, the computer calculates the spatial coordinates of all treatment points.

[0146] The doctor sets the treatment parameters; ultrasound treatment includes the following parameters:

[0147] 1. Ultrasonic output power: The ultrasonic output power of this HIFU device is generally expressed in watts (W);

[0148] 2. Ultrasonic treatment time: The treatment time for each treatment point is generally measured in seconds (s). The ultrasonic treatment time can be further divided into two types: continuous emission mode and pulse mode. In pulse mode, the pulse width and duty cycle must also be set.

[0149] 3. The time interval between any two points is generally expressed in seconds (s);

[0150] 4. The treatment path, which is the order in which all treatment points are treated.

[0151] 5. The computer operates the machine to perform point-by-point treatment according to the spatial coordinates of each point and the treatment parameters.

[0152] 6. After treatment, the doctor can use an external probe to evaluate the treatment effect on the treated area again. The clinical evaluation method is as follows:

[0153] • Contrast-enhanced ultrasound to evaluate blood flow in the treatment area;

[0154] • Ultrasonic Doppler effect, used to evaluate blood flow in the treatment area;

[0155] • Ultrasound elastography to evaluate tissue degeneration in the treatment area;

[0156] While specific embodiments of the present invention have been described above, those skilled in the art should understand that these are merely illustrative examples, and the scope of protection of the present invention is defined by the appended claims. Those skilled in the art can make various changes or modifications to these embodiments without departing from the principles and essence of the present invention, but all such changes and modifications fall within the scope of protection of the present invention.

Claims

1. A focused ultrasound therapy system, characterized in that, The focused ultrasound therapy system includes: A water tank, wherein the water tank has an open upper cavity, and the side of the water tank has an inlet hole communicating with the cavity. The inlet hole is used for an extension to extend into the cavity. The wall of the inlet hole is provided with a sealing element, which is used to seal the gap between the inlet hole and the extension when the extension enters the cavity. The treatment head and the main unit, wherein the treatment head can be inserted into the slot cavity to perform operations; The treatment head includes a built-in ultrasound probe and an external ultrasound probe, and the focused ultrasound treatment system also includes an adjustment mechanism; The adjustment mechanism is used to adjust the treatment position and treatment angle of the treatment head. The adjustment mechanism is located in the host computer, which is equipped with a main control computer. The main control computer is equipped with an adjustment mechanism control module, which is used to control the adjustment mechanism to move the treatment head to a specified position and angle. The treatment head also includes a transducer, which is located at the moving end of the adjustment mechanism. The transducer is electrically connected to the host computer. The main control computer in the host computer controls the ultrasonic transducer to convert electrical signals into sound signals and focus them onto the target area in the body through the power control module. The transducer housing is adapted to the leg. An ultrasound probe hole is opened in the middle of the housing. The ultrasound probe hole fixes the built-in ultrasound probe. The housing is a spherical shell, and the focus is on the center of the sphere, which is the focal point. Along the length of the cavity, the inlet is located at one end of the water tank, and an adjusting baffle is provided at the other end of the water tank. The position of the adjusting baffle within the cavity can be adjusted relative to the cavity along the length of the cavity. The adjusting baffle is used to limit the volume of the cavity located on the side of the inlet. A fixing part is also provided within the cavity. The fixing part is used to position the insert and can also be adjusted relative to the cavity along the length of the cavity.

2. The focused ultrasound therapy system as described in claim 1, characterized in that, The water tank is also provided with an inlet and an outlet. The inlet is used for water to enter the tank cavity, and the outlet is used for water to exit the tank cavity.

3. The focused ultrasound therapy system as described in claim 1, characterized in that, The fixing part includes a support member and a fixing member. The support member is used to support the extension member, and the fixing member is used to fix the extension member along the height direction.

4. The focused ultrasound therapy system as described in claim 3, characterized in that, The upper surface of the support member is an arc-shaped surface adapted to the extension member.

5. The focused ultrasound therapy system as described in claim 1, characterized in that, The area of ​​the treatment head is coupled to the area of ​​the leg.

6. The focused ultrasound therapy system as described in claim 1, characterized in that, The adjustment mechanism is equipped with a robotic arm. The moving end of the robotic arm is fixed to the treatment head, and the fixed end of the robotic arm is located in the host computer. The main control computer in the host computer controls the movement and rotation of the robotic arm through the robotic arm control module.

7. The focused ultrasound therapy system as described in claim 6, characterized in that, The robotic arm is a 2-6 axis robotic arm.

8. The focused ultrasound therapy system as described in claim 1, characterized in that, The focused ultrasound treatment system also includes an ultrasound host, which is installed inside the host and connected to the main control computer in the host via an image transmission cable to transmit ultrasound images to the main control computer in real time. The ultrasound host is connected to the external ultrasound probe and the internal ultrasound probe, with the external ultrasound probe being operated by hand by the doctor.

9. The focused ultrasound therapy system as described in claim 1, characterized in that, The ultrasound therapy system also includes a water treatment and circulation device. The water tank and the water treatment and circulation device are connected through a water pipe for water convection between the water treatment and circulation device and the water tank.

10. The focused ultrasound therapy system as described in claim 9, characterized in that, The water treatment circulation device is equipped with a filter at the water inlet and a heating component to heat the water before it is fed into the water tank.

11. The focused ultrasound therapy system according to any one of claims 1-10, characterized in that, The sealing element is an annular clamp, and the material of the annular clamp is rubber or latex.

12. The focused ultrasound therapy system according to any one of claims 1-10, characterized in that, The insert is the user's limb.

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