WO2021203910A1 - 高强度聚焦超声设备与控制方法 - Google Patents

高强度聚焦超声设备与控制方法 Download PDF

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Publication number
WO2021203910A1
WO2021203910A1 PCT/CN2021/080490 CN2021080490W WO2021203910A1 WO 2021203910 A1 WO2021203910 A1 WO 2021203910A1 CN 2021080490 W CN2021080490 W CN 2021080490W WO 2021203910 A1 WO2021203910 A1 WO 2021203910A1
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WIPO (PCT)
Prior art keywords
transducer
shape
focused ultrasound
intensity focused
processed
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PCT/CN2021/080490
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English (en)
French (fr)
Inventor
毛佳炜
袁进强
蒋祖平
周佳
高晓彬
Original Assignee
深圳市奥昇医疗科技有限责任公司
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Application filed by 深圳市奥昇医疗科技有限责任公司 filed Critical 深圳市奥昇医疗科技有限责任公司
Priority to US17/916,122 priority Critical patent/US20230330444A1/en
Priority to EP21784745.8A priority patent/EP4115949A1/en
Publication of WO2021203910A1 publication Critical patent/WO2021203910A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N7/02—Localised ultrasound hyperthermia
    • A61N7/022—Localised ultrasound hyperthermia intracavitary
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
    • A61B2090/3782—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument
    • A61B2090/3784—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument both receiver and transmitter being in the instrument or receiver being also transmitter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0039—Ultrasound therapy using microbubbles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0043—Ultrasound therapy intra-cavitary
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0052—Ultrasound therapy using the same transducer for therapy and imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0056—Beam shaping elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0056—Beam shaping elements
    • A61N2007/0065—Concave transducers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0078—Ultrasound therapy with multiple treatment transducers

Definitions

  • This application relates to the technical field of medical equipment, and in particular to a high-intensity focused ultrasound equipment and a control method.
  • High-Intensity Focused Ultrasound has become a hot research field in the field of ultrasound treatment in recent years due to its non-invasive and strong focus characteristics.
  • thermal ablation mechanism mainly uses the thermal effect of ultrasound to focus the ultrasound energy on the target area to form local high-intensity ultrasound energy to ablate the target area tissue, so that the target area tissue is instantly in a high temperature environment, resulting in coagulation necrosis.
  • the Histotripsy mode mainly uses the cavitation mechanical effect of HIFU to smash the target tissue into micron-sized fragments.
  • the ultrasonic energy used to release high-intensity focused ultrasound pulses is all emitted by the ultrasonic energy source set outside the body. Problems with probes or probes for high-intensity focused ultrasound treatment in the body.
  • the present application provides a high-intensity focused ultrasound device, which is applied to the inner cavity of an object to be treated, and includes a transducer assembly and a connecting line that are fixedly connected to each other.
  • the connecting line includes a connecting end, and the connecting line passes through the connecting end.
  • Fixedly connected with the transducer assembly, the transducer assembly includes:
  • Image transducer used to obtain ultrasound images of the inner cavity of the object to be processed
  • the focusing transducer is set in a first shape. After the focusing transducer extends into the cavity of the object to be processed, it can be freely transformed into a second shape for focusing ultrasonic energy and releasing high-intensity focused ultrasonic pulses. The area to be treated in the inner cavity of the object to be treated is irradiated.
  • This application relates to a high-intensity focused ultrasound device.
  • a focusing transducer With a freely transformable shape, the entire transducer assembly can be extended into the cavity of the object to be treated, and the transducer assembly can be extended through a narrow part
  • the inner cavity of the object to be treated and after extending into the inner cavity of the object to be treated, the shape of the focusing transducer in the transducer assembly is changed, the effective area of the focusing transducer increases, the ultrasonic energy generated increases, and the area to be treated is enhanced
  • the irradiation intensity meets the normal working requirements of the transducer assembly.
  • This application also provides a method for controlling high-intensity focused ultrasound equipment, which is applied to the high-intensity focused ultrasound equipment mentioned in the foregoing, including:
  • n is a positive integer and n is greater than 0;
  • the step of sending work instructions to the focus transducer is repeatedly performed to control the focus transducer to complete the ultrasonic pulse processing of n regions to be processed within a total work period T, where the total work period T includes M Work cycles t; M is a positive integer and M is greater than zero.
  • This application relates to a method for controlling high-intensity focused ultrasound equipment.
  • the focusing transducer in the transducer is controlled to perform shape transformation, which not only realizes that the transducer assembly can
  • the narrow part extends into the inner cavity of the object to be treated, and after extending into the inner cavity of the object to be treated, the normal working requirements of the transducer assembly are met.
  • the focus transducer controls the focus transducer to sequentially perform one ultrasonic pulse processing on multiple regions to be processed within a working cycle, the processing time of ultrasonic pulse processing is saved, and the processing efficiency is greatly improved.
  • FIG. 1 is a schematic structural diagram of a high-intensity focused ultrasound device provided by an embodiment of the application
  • FIG. 2 is a three-dimensional structure diagram of the high-intensity focused ultrasound device when the focusing transducer in the embodiment 1 of the application is in the second shape;
  • FIG. 3 is a three-dimensional structure diagram of the high-intensity focused ultrasound equipment when the focusing transducer in the embodiment 1-1 of the application is in the first shape;
  • FIG. 4 is a three-dimensional structural diagram of the high-intensity focused ultrasound equipment when the focusing transducer in the embodiment 1-1 of the application is in the second shape;
  • FIG. 5 is a three-dimensional structural diagram of the high-intensity focused ultrasound equipment when the focusing transducer in the embodiment 1-2 of the application is in the first shape;
  • FIG. 6 is a three-dimensional structural diagram of the high-intensity focused ultrasound equipment when the focusing transducer in the embodiment 1-2 of the application is in the second shape;
  • FIG. 7 is a three-dimensional structural diagram of the high-intensity focused ultrasound device when the focusing transducer is in the first shape in Embodiment 2 of the application; FIG.
  • FIG. 8 is a three-dimensional structural diagram of the high-intensity focused ultrasound device when the focusing transducer is in the second shape in Embodiment 2 of the application; FIG.
  • FIG. 9 is a three-dimensional structural diagram of the high-intensity focused ultrasound equipment when the focusing transducer provided by Embodiment 2-1 of the application is in the first shape;
  • FIG. 10 is a three-dimensional structure diagram of the high-intensity focused ultrasound equipment when the focusing transducer provided in Embodiment 3 of the application is in the first shape;
  • FIG. 11 is a three-dimensional structural diagram of the high-intensity focused ultrasound equipment when the focusing transducer provided in Embodiment 3 of the application is in the second shape;
  • FIG. 12 is a front view of the high-intensity focused ultrasound equipment when the focusing transducer provided by Embodiment 3 of the application is in the second shape;
  • FIG. 13 is a schematic flowchart of a method for controlling a high-intensity focused ultrasound device according to an embodiment of the application
  • FIG. 14 is a timing diagram of a method for controlling a high-intensity focused ultrasound device according to an embodiment of the application.
  • the fifth transducer module a The fifth transducer module a
  • This application provides a high-intensity focused ultrasound device 10, which is applied to the inner cavity of an object to be treated.
  • the high-intensity focused ultrasound device 10 includes a transducer assembly 100 and a connecting wire 200 that are fixedly connected to each other.
  • the connecting line 200 includes a connecting end 210.
  • the connecting wire 200 is fixedly connected to the transducer assembly 100 through the connecting end 210.
  • the transducer assembly 100 includes an image transducer 110 and a focusing transducer 120.
  • the image transducer 110 is used to obtain an ultrasound image of the inner cavity of the object to be processed.
  • the focusing transducer 120 is arranged in a first shape. After the focusing transducer 120 extends into the inner cavity of the object to be processed, it can be freely transformed into a second shape.
  • the focusing transducer 120 is used to focus ultrasonic energy, release high-intensity focused ultrasonic pulses, and irradiate the area to be processed in the inner cavity of the object to be processed.
  • the inner cavity of the object to be treated may be stomach, rectum, and so on.
  • the focusing transducer 120 assumes a first shape, and the first shape is configured to easily enter the inner cavity of the object to be processed. It can be understood that organs such as the stomach or rectum have a relatively narrow entrance, and the focusing transducer 120 in the first shape is easy to enter.
  • the focusing transducer 120 assumes a second shape, which increases the effective area of the focusing transducer 120. It can be understood that the larger the effective area of the focus transducer 120 is, the more ultrasonic energy is generated, and the higher the intensity of irradiation to irradiate the area to be treated in the inner cavity of the object to be treated.
  • the high-intensity focused ultrasound device 10 can be connected to an upper electromechanical device.
  • the host computer is electrically connected to the connecting line 200 for controlling the shape transformation of the focusing transducer 120.
  • the host computer may include one or more processors, and the processors are used to control the shape transformation of the focus transducer 120.
  • the focusing transducer 120 by setting the focusing transducer 120 with a freely transformable shape, after the entire transducer assembly 100 extends into the inner cavity of the object to be treated, it is not only realized that the transducer assembly 100 can extend into the object to be treated through a narrow part After extending into the cavity of the object to be processed, the shape of the focusing transducer 120 in the transducer assembly 100 changes, the effective area of the focusing transducer 120 increases, the ultrasonic energy generated increases, and the processing area is enhanced The irradiation intensity meets the normal working requirements of the transducer assembly 100.
  • the second shape is a cylinder or an elliptic cylinder. At least one end surface of the cylinder or elliptic cylinder is a concave spherical surface.
  • the focusing transducer 120 has a groove 121.
  • the shape of the image transducer 110 is a cylinder or an elliptic cylinder.
  • the image transducer 110 is embedded in the groove 121.
  • the center of the circle of the end surface of the image transducer 110 coincides with the physical center of the end surface of the focusing transducer 120.
  • the second shape of the focusing transducer 120 is a cylinder or an elliptical cylinder, that is, the focusing transducer 120 is in the shape after the cavity of the object to be processed is expanded.
  • the second shape is a cylinder
  • the two end faces are circular.
  • the second shape is an elliptical cylinder
  • the two end faces are elliptical.
  • At least one end surface of the cylinder or elliptic cylinder is configured as a concave spherical surface, so that the focusing transducer 120 can better focus the ultrasonic energy.
  • the focusing transducer 120 can focus the ultrasonic energy on the physical center of the end surface of the focusing transducer 120.
  • FIG. 2 shows a schematic diagram of an embodiment in which the second shape is a cylinder, and one end surface of the cylinder is a concave spherical surface.
  • the transducer assembly 100 by arranging the image transducer 110 embedded in the groove 121 of the focusing transducer 120, the transducer assembly 100 not only has the function of releasing high-intensity focused ultrasound pulses, but also has the function of acquiring The function of the ultrasound image of the object.
  • Embodiment 1 has different forms of expanded embodiments, and two expanded embodiments are listed below: embodiment 1-1 and embodiment 1-2. Compared with the two extended embodiments, the first shape of the focusing transducer 120 is different, and the second shape of the focusing transducer 120 is the same.
  • the focusing transducer 120 includes two first transducer modules 122.
  • the shape of the first transducer module 122 is a semi-cylinder formed after the cylinders in the second shape are separated by an axial section.
  • the shape of the first transducer module 122 is a semi-elliptical cylinder formed by dividing the elliptical cylinder in the second shape by an axial section.
  • the first transducer module 122 has a recess 122a.
  • the two first transducer modules 122 are folded and combined to form the focused transducer 120 in the first shape.
  • the first shape is a semi-cylindrical body formed by folding two semi-cylindrical bodies or a semi-elliptical cylinder formed by folding two semi-elliptic cylinders.
  • the first state is that the high-intensity focused ultrasound device 10 is outside the object to be processed.
  • the two first transducer modules 122 are unfolded and spliced to form the focused transducer 120 in the second shape.
  • the recesses 122 a of the two first transducer modules 122 are spliced to form the groove 121.
  • the second state is that the high-intensity focused ultrasound device 10 is in the inner cavity of the object to be treated.
  • the shape and position of the image transducer 110 remain unchanged.
  • the focusing transducer 120 in this embodiment may be applied to the rectum.
  • the first state is that the high-intensity focused ultrasound device 10 is outside the object to be processed.
  • the second state is that the high-intensity focused ultrasound device 10 is in the inner cavity of the object to be treated.
  • the first state and the second state appearing in the following content have the same meaning and will not be repeated.
  • the focusing transducer 120 includes a first transducer module 122 in the shape of two semi-cylindrical bodies or two semi-elliptical cylinders.
  • the focusing transducer 120 shown in FIGS. 3 and 3 includes two semi-cylindrical first transducer modules 122.
  • the rectum has a relatively narrow entrance.
  • the two first transducer modules 122 in the focusing transducer 120 are folded to form a semi-cylindrical structure. rectum.
  • the two semi-cylindrical first transducer modules 122 are stretched and spliced to form a complete cylinder, which facilitates the subsequent release of high-intensity focused ultrasound pulses to irradiate the treatment area.
  • a bias connector (not shown in the figure) may be provided between the two first transducer modules 122.
  • the bias connection member may be a spring.
  • the host computer can control the bias connection to maintain the focus transducer 120 in the first shape.
  • a mechanical transmission mechanism may also be arranged between the first transducer modules 122. The mechanical transmission mechanism is mechanically connected with the bias connector.
  • the host computer can control the mechanical transmission mechanism to drive the bias connector to change the bias state, so that the focus transducer 120 changes shape, Change to the second shape.
  • the high-intensity focused ultrasound device 10 can be folded when it is outside the object to be processed, which is easy to Enter the cavity of the object to be treated.
  • the high-intensity focused ultrasound device 10 when it is in the inner cavity of the object to be processed, it can be expanded and spliced to form a complete cylinder or a complete semi-elliptical cylinder, thereby increasing the effective area of the focusing transducer 120 and focusing the transducer.
  • the overall structure of the device 120 is simple.
  • the focusing transducer 120 includes a second transducer module 123 and two third transducer modules 124.
  • the two third transducer modules 124 are respectively arranged on both sides of the second transducer module 123.
  • the two third transducer modules 124 are respectively movably connected with the second transducer module 123.
  • the groove 121 is disposed on the second transducer module 123.
  • the two third transducer modules 124 are folded and combined to form the focused transducer 120 in the first shape.
  • the first state is that the high-intensity focused ultrasound device 10 is outside the object to be processed.
  • the first shape is the shape of the second transducer module 123.
  • the two third transducer modules 124 are unfolded and spliced to form the focused transducer 120 in the second shape.
  • the second state is that the high-intensity focused ultrasound device 10 is in the inner cavity of the object to be treated.
  • the image transducer 110 is embedded in the groove 121.
  • the shapes and positions of the second transducer module 123 and the image transducer 110 remain unchanged.
  • Embodiment 1-1 divides the cylindrical focus transducer 120 into two semi-cylinders.
  • the cylindrical focusing transducer 120 is divided into three adjacent parts: a second transducer module 123 and two third transducer modules 124.
  • the two third transducer modules 124 are respectively arranged on two sides of the second transducer module 123 and are movably connected to the second transducer module 123.
  • the third transducer module 124 may have a half-moon structure.
  • a bias connection and a mechanical transmission mechanism may be provided between the second transducer module 123 and the third transducer module 124.
  • the mechanical transmission mechanism is mechanically connected with the bias connector.
  • the bias connection member may be a spring.
  • the high-intensity focused ultrasound device 10 is placed in the object to be processed. It can be folded to make it easy to enter the inner cavity of the object to be treated. At the same time, when the high-intensity focused ultrasound device 10 is in the inner cavity of the object to be processed, it can be expanded and spliced to form a complete cylinder, which increases the effective area of the focusing transducer 120, and the overall structure of the focusing transducer 120 is simple.
  • the first shape is a chain structure composed of a plurality of regular hexagonal prisms connected in sequence.
  • the second shape is a ring structure formed by a plurality of regular hexagonal prisms surrounded end to end on the same plane.
  • Embodiment 2 is different from Embodiment 1.
  • the first shape is a chain structure, which is easy to extend into the entrance of the narrow cavity of the object to be treated.
  • the regular hexagonal prism has two regular hexagonal surfaces.
  • the regular hexagonal surfaces of the plurality of regular hexagonal prisms are located in the same plane. After entering the inner cavity of the object to be processed, the plurality of regular hexagonal prisms surround the end to end to form the ring structure, which increases the effective area of the focusing transducer 120.
  • the formed second shape is a regular shape, which can focus the ultrasonic energy on a point, and the energy focus point is located at the physical center of the ring structure.
  • the energy focus points of the focusing transducer 120 are dispersed.
  • the energy focusing points of the focusing transducer 120 overlap, so that the ultrasonic energy can be focused on one point.
  • the effectiveness of the focusing transducer 120 can be increased. Area, can realize the ultrasonic energy is focused on one point.
  • the focusing transducer 120 includes a plurality of fourth transducer modules 125 connected in sequence via a movable pin 130.
  • the shape of the fourth transducer module 125 is a regular hexagonal prism.
  • the shape of the image transducer 110 is a regular hexagonal prism.
  • the plurality of fourth transducer modules 125 are unfolded and combined to form the focused transducer 120 in the first shape.
  • the first state is that the high-intensity focused ultrasound device 10 is outside the object to be processed.
  • the fourth transducer module 125 farthest from the connecting end 210 is directed to the fourth transducer module 125 closest to the connecting end 210 Close so that the plurality of fourth transducer modules 125 surround the focusing transducer 120 presenting in the second shape.
  • the second state is that the high-intensity focused ultrasound device 10 is in the inner cavity of the object to be treated.
  • a bias connection and a mechanical transmission mechanism may be provided between two adjacent fourth transducer modules 125.
  • the mechanical transmission mechanism is mechanically connected with the bias connector.
  • the bias connection member may be a spring.
  • the image transducer 110 is arranged at the end of the chain structure, that is, the image transducer 110 may be a regular hexagonal prism closest to the connecting end 210, or the farthest from the connecting end 210. Regular hexagonal prism.
  • the image transducer 110 may also be arranged between the two fourth transducer modules 125.
  • the energy focus points of the focusing transducer 120 are dispersed.
  • the energy focusing points of the focusing transducer 120 overlap, so that the ultrasonic energy can be focused on one point.
  • a chain structure is formed by arranging a plurality of fourth transducer modules 125 connected in sequence through the movable pin 130, so that after the focusing transducer 120 extends into the inner cavity of the object to be treated, it is separated from the connecting end 210 The farthest fourth transducer module 125 is approached to the fourth transducer module 125 closest to the connecting end 210, and the ring structure is formed around it, which can increase the effective area of the focusing transducer 120 and also Realize that the ultrasonic energy is focused on one point.
  • the focus transducer 120 of the chain structure is deformed into a ring structure connected end to end.
  • the specific deformation method needs to rely on the driving structure of the focus transducer 120 itself.
  • the following describes two different driving structures. Examples.
  • the high-intensity focused ultrasound device 10 further includes two control lines 300 passing through each of the fourth transducer modules 125. There is no crossover between the two control lines 300.
  • the two control lines 300 are relaxed at the same time to realize that the multiple fourth transducer modules 125 surround the focusing transducer 120 in the first shape.
  • one control line 300 is tightened, and the other control line 300 is relaxed, so as to realize that a plurality of fourth transducer modules 125 are surrounded by the second state.
  • the shape of the focusing transducer 120 is presented.
  • a control line 300 is provided in the focus transducer 120 to drive the focus transducer 120 to undergo a shape change.
  • the control line 300 may include two control lines, which are a first control line 310 and a second control line 320 respectively.
  • the first control line 310 and the second control line 320 do not cross.
  • the first control line 310 and the second control line 320 both pass through each fourth transducer module 125. Since the plurality of fourth transducer modules 125 and the image transducer 110 jointly form a chain structure, the first control line 310 and the second control line 320 also penetrate the image transducer 110. In other words, the first control line 310 and the second control line 320 penetrate each regular hexagonal prism in the chain structure.
  • the plurality of fourth transducer modules 125 stretch to form the first shape, that is, the chain structure.
  • Both of the two control lines of the first control line 310 and the second control line 320 can realize that a plurality of fourth transducer modules 125 form the second shape.
  • the chain structure composed of multiple fourth transducer modules 125 and the image transducer 110 can realize the shape during the pulling and/or relaxing process of the control lines.
  • the conversion is easy to operate and low cost.
  • the fourth transducer module 125 closest to the connecting end 210 is a magnet.
  • the fourth transducer module 125 farthest from the connecting end 210 is a magnet.
  • the fourth transducer module 125 farthest from the connecting end 210 When the high-intensity focused ultrasound device 10 is in the second state, by controlling the fourth transducer module 125 farthest from the connecting end 210, it is close to the fourth transducer closest to the connecting end 210 , In order to achieve the attraction of the fourth transducer module 125 farthest from the connecting end 210 and the fourth transducer module 125 closest to the connecting end 210, so that the multiple fourth transducers The energy transducer module 125 surrounds and constitutes the focusing transducer 120 presented in the second shape.
  • Two fourth transducer modules 125 can be set as magnets: one is the fourth transducer module 125 closest to the connecting end 210, and the other is the fourth transducer module farthest from the connecting end 210 125.
  • any one of the two fourth transducer modules 125 is a magnet, and the other one is made of a material of iron alloy, cobalt alloy and nickel alloy.
  • the two magnets can be controlled to be close to each other, so that the head and tail regular hexagonal prisms of the chain structure are attracted and surround to form the second shape.
  • the fourth transducer module 125 closest to the connecting end 210 is a magnet
  • the fourth transducer module 125 farthest from the connecting end 210 is a magnet.
  • the focusing transducer 120 includes a plurality of fifth transducer modules 126. There are multiple connecting lines 200. Each of the fifth transducer modules 126 is fixedly connected to a connecting line 200. The image transducer 110 is fixedly connected to a connecting line 200.
  • the focusing transducer 120 in Embodiment 3 is equivalent to being dispersed into a plurality of fifth transducer modules 126, each fifth transducer module 126 exists independently, and each fifth transducer module 126 is associated with one
  • the connecting line 200 is fixedly connected. It can be understood that the shape of each fifth transducer module 126 is the first shape. When the plurality of fifth transducer modules 126 sequentially extend into the inner cavity of the object to be treated, the plurality of fifth transducer modules 126 are combined to form the focusing transducer 120 in the second shape.
  • the object to be processed has a certain intensity threshold that the ultrasound pulse can withstand, and the released high-intensity focused ultrasound pulse is too strong for the object to be processed.
  • the ultrasound pulses of the stomach and rectum have different intensity thresholds.
  • the number of fifth transducer modules 126 can be adjusted according to different objects to be processed to meet the pulse irradiation requirements of different objects to be processed.
  • the focusing transducer 120 in this embodiment can be applied to different types of objects to be treated, such as the stomach, rectum, and so on.
  • the number of fifth transducer modules 126 can be adjusted in real time according to different objects to be processed to meet the pulse irradiation requirements of different objects to be processed , So that the high-intensity focused ultrasound device 10 is no longer restricted by fixing the object to be processed, saving equipment cost and improving work efficiency.
  • the first shape is a rectangular parallelepiped.
  • the second shape is a rectangular parallelepiped, and the fifth transducer module 126 is a magnet.
  • the shape of the image transducer 110 is a rectangular parallelepiped.
  • the image transducer 110 is a magnet.
  • the plurality of fifth transducer modules 126 are independent of each other.
  • the first state is that the high-intensity focused ultrasound device 10 is outside the object to be processed.
  • the plurality of fifth transducer modules 126 When the high-intensity focused ultrasound device 10 enters the cavity of the object to be processed, the plurality of fifth transducer modules 126 first enter the cavity of the object to be processed in sequence, and the plurality of fifth transducer modules After all the sensor modules 126 enter the internal cavity of the object to be processed, the image transducer 110 enters the internal cavity of the object to be processed. Or the image transducer 110 first enters the cavity of the object to be processed, and after the image transducer 110 enters the cavity of the object to be processed, the plurality of fifth transducer modules 126 first enter the cavity of the object to be processed in order. Process the internal cavity of the object.
  • the N pole of one fifth transducer module 126 and the S pole of the other fifth transducer module 126 are magnetically attracted to each other, so that the plurality of The fifth transducer module 126 collectively constitutes the focusing transducer 120 in the second shape.
  • the second state is that the high-intensity focused ultrasound device 10 is in the inner cavity of the object to be treated.
  • the image transducer 110 and a fifth transducer module 126 are attracted to each other by magnetic force.
  • the fifth transducer module 126 is a rectangular parallelepiped magnet.
  • Each fifth transducer module 126 has an N pole and an S pole.
  • the plurality of fifth transducer modules 126 sequentially enter the cavity of the object to be treated.
  • the plurality of fifth transducer modules 126 naturally attract each other to form the second shape.
  • the second shape is also a rectangular parallelepiped. It can be understood that the surface area of the largest surface of the rectangular parallelepiped corresponding to the second shape is much larger than the surface area of the largest surface of the rectangular parallelepiped corresponding to the first shape.
  • the effective area of the focusing transducer 120 increases, resulting in Ultrasonic energy increases.
  • the entry sequence of the image transducer 110 there is no need to limit it, as long as it does not interfere with the suction of the plurality of fifth transducer modules 126 into the second shape, it can enter the cavity of the object to be processed first, or Finally, it enters the cavity of the object to be treated.
  • the multiple fifth transducer modules 126 naturally attract each other when the high-intensity focused ultrasound device 10 is in the cavity of the object to be treated.
  • a rectangular parallelepiped shape with an increased effective area is formed, so that the effective area of the focusing transducer 120 increases, and the ultrasonic energy generated increases, and the number of fifth transducer modules can be increased or decreased according to the different objects to be processed. It is flexible and convenient in actual use and saves the cost of use.
  • At least one of the two surfaces with the largest area is a concave spherical surface.
  • the physical center of the concave spherical surface is the energy focus point of the focusing transducer 120.
  • At least one of the two surfaces with the largest area is a concave surface.
  • a plurality of concave surfaces of a rectangular parallelepiped corresponding to the first shape are sequentially combined to form a concave spherical surface of a rectangular parallelepiped corresponding to the second shape.
  • each fifth transducer module 126 is the first shape, and the surface with the largest area is set as a concave surface.
  • a plurality of fifth transducers are required to be combined in an orderly manner, so that after the plurality of fifth transducer modules 126 are attracted, the concave surfaces of the plurality of fifth transducer modules 126 are combined to form the second The concave spherical surface of the rectangular parallelepiped corresponding to the shape.
  • the concave spherical surface can fix the energy focus point at a point, that is, the physical center of the concave spherical surface, thereby increasing the ultrasonic energy generated by the focusing transducer 120.
  • the energy focusing point can be fixed at a point, that is, the physical center of the concave spherical surface, thereby increasing the ultrasonic energy generated by the focusing transducer 120.
  • the plurality of fifth transducer modules 126 sequentially enter the object to be processed in a predetermined order Cavity, so that the plurality of concave surfaces of the rectangular parallelepiped corresponding to the first shape are combined in an orderly manner to form the concave spherical surface of the rectangular parallelepiped corresponding to the second shape.
  • the plurality of fifth transducer modules 126 need to be arranged in a predetermined order. Enter the inner cavity of the object to be treated one by one.
  • the predetermined sequence is manually set in advance.
  • the fifth transducer module 126 includes a fifth transducer module a, a fifth transducer module b, a fifth transducer module c, and a fifth transducer module d.
  • a plurality of fifth transducer modules 126 are sequentially placed into the inner cavity of the object to be processed, so that the concave spherical surface of the rectangular parallelepiped corresponding to the second shape can be formed.
  • the formation of the concave spherical surface of the rectangular parallelepiped corresponding to the second shape is realized, so that the energy focus point Fixing at a point, that is, the physical center of the concave spherical surface, in turn increases the ultrasonic energy generated by the focusing transducer 120.
  • This application also provides a method for controlling high-intensity focused ultrasound equipment.
  • the control method of the high-intensity focused ultrasound device is applied to the high-intensity focused ultrasound device 10 mentioned above.
  • the control method of the high-intensity focused ultrasound equipment provided in this application does not limit its execution subject.
  • the execution subject of the method for controlling the high-intensity focused ultrasound device may be an upper computer connected to the high-intensity focused ultrasound device 10.
  • the execution subject of the control method of the high-intensity focused ultrasound equipment may be one or more processors in the host computer.
  • the method for controlling the high-intensity focused ultrasound equipment includes the following steps S100 to S500:
  • S100 Send an extension instruction to the transducer assembly 100 to control the transducer assembly 100 whose shape is the first shape to extend into the inner cavity of the object to be processed.
  • S200 Send a shape transformation instruction to the focus transducer 120 in the transducer assembly 100 to control the focus transducer 120 to complete the shape transformation, from the first shape to the second shape.
  • S300 Set the time length of a working period t and the number n of regions to be processed in a working period t.
  • n is a positive integer and n is greater than zero.
  • S400 Send a work instruction to the focus transducer 120 to control the focus transducer 120 to sequentially perform one ultrasonic pulse processing on n regions to be processed within a working period t.
  • Step S400 is repeatedly executed, and within the total working period T, the focus transducer 120 is controlled to complete the ultrasonic pulse processing on the n regions to be processed.
  • the total working period T includes M working periods t. M is a positive integer and M is greater than zero.
  • the processor may pre-store code for setting the time length of a working period t and the number n of regions to be processed in a working period t.
  • n may be 4.
  • the processor can control the transducer assembly 100 to sequentially process the 4 regions to be processed in one work cycle. Since a single processing of a to-be-processed area cannot complete the processing work, M processing is required to complete the processing work. Therefore, it is necessary to control the focusing transducer 120 to work for M working cycles.
  • n and M are both positive integers, and the values are both greater than zero.
  • the focus transducer 120 in the transducer is controlled to change the shape, which not only realizes that the transducer assembly 100 can be extended into the object to be processed through a narrow part.
  • the inner cavity of the processing object, and after extending into the inner cavity of the object to be processed, satisfies the normal working requirements of the transducer assembly 100.
  • the focusing transducer 120 controls the focusing transducer 120 to sequentially perform one ultrasonic pulse processing on multiple regions to be processed within a working cycle, the processing time of the ultrasonic pulse processing is saved, and the processing efficiency is greatly improved.
  • the step S400 includes the following steps S410 to S460:
  • S430 Send an area transfer instruction to the focus transducer 120 to control the focus transducer 120 to move from one area to be processed to another area to be processed.
  • each parameter in this embodiment satisfies the following formula 1:
  • T is the total work cycle.
  • M is the number of work cycles included in the total work cycle.
  • t is a duty cycle.
  • t 1-S is the first irradiation time period.
  • t 1-R is the first rest period.
  • t 2-S is the second irradiation time period.
  • t 2-R is the second rest period.
  • t nS is the nth irradiation time period.
  • t nR is the nth rest period.
  • n is the number of areas to be processed processed in a working cycle.
  • the pulse irradiation time period between different areas to be treated may be equal or unequal.
  • the rest period for stopping the release of the pulse can be equal or unequal.
  • the first irradiation time period t 1-S may be equal to the second irradiation time period t 2-S
  • the first irradiation time period t 1-S may not be equal to the second irradiation time period t 2-S
  • the first rest period t 1-R may be equal to the second rest period t 2-R
  • the first rest period t 1-R may not be equal to the second rest period t 2-R .
  • the irradiation time period of the pulse may be equal to the rest time period of stopping the release of the pulse, or the two may not be equal.
  • the traditional solution only irradiates the control focusing transducer 120 to the only one area to be treated in one work cycle. After the irradiation ends, the remaining time in the work cycle is all used for rest, and the rest time is t 0 .
  • the traditional solution is compared with the solution in this embodiment. In a single working cycle, the irradiation time is the same, and the rest time is the same. The number of working cycles is equal.

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Abstract

一种高强度聚焦超声设备（10）与控制方法。高强度聚焦超声设备（10），通过设置可自由变换形状的聚焦换能器（120），使得整个换能器组件（100）伸入待处理对象内腔后，不但实现换能器组件（100）可以通过狭小部位伸入待处理对象内腔，而且在伸入待处理对象内腔后，换能器组件（100）中的聚焦换能器（120）形状变换，聚焦换能器（120）的有效面积增大，产生的超声波能量增多，增强对待处理区域的照射强度，满足了换能器组件（100）正常的工作需求。

Description

高强度聚焦超声设备与控制方法 技术领域
本申请涉及医用器械技术领域，特别是涉及一种高强度聚焦超声设备与控制方法。
背景技术
高强度聚焦超声(High-Intensity Focused Ultrasound,简称HIFU)以其非侵入、强聚焦的特点成为超声处理领域近年来的热门研究领域。目前高强度聚焦超声的作用机制有两种：热消融机制和组织毁损机制。热消融机制主要利用了超声的热效应，将超声能量聚焦到靶区，形成局部的高强度超声能量以消融掉靶区组织，使靶区组织瞬间处于高温环境，产生凝固性坏死。组织毁损(Histotripsy)模式主要利用HIFU的空化机械效应，将靶区组织粉碎成微米尺寸的碎片。
然而，传统方案中，由于设备成本与技术难度的限制，用于释放高强度聚焦超声脉冲的超声波能量均由体外设置的超声波能源发出，超声波能源很难设置于体内，导致传统方案产生缺乏用于体内高强度聚焦超声处理的探头或探针的问题。
发明内容
基于此，有必要针对传统方案缺乏用于体内高强度聚焦超声处理的探头或探针的问题，提供一种高强度聚焦超声设备与控制方法。
本申请提供一种高强度聚焦超声设备，应用于待处理对象的内腔，包括互相固定连接的换能器组件与连接线，所述连接线包括连接端，所述连接线通过所述连接端与所述换能器组件固定连接，所述换能器组件包括：
图像换能器，用于获取待处理对象内腔的超声图像；
聚焦换能器，设置为第一形状，所述聚焦换能器伸入所述待处理对象内腔后，能够自由变换为第二形状，用于聚焦超声波能量，释放高强度聚焦超声脉冲，对所述待处理对象内腔的待处理区域进行照射。
本申请涉及一种高强度聚焦超声设备，通过设置可自由变换形状的聚焦换能器，使得整个换能器组件伸入待处理对象内腔后，不但实现换能器组件可以通过狭小部位伸入待处理对象内腔，而且在伸入待处理对象内腔后，换能器组件中的聚焦换能器形状变换，聚焦换能器的有效面积增大，产生的超声波能量增多，增强对待处理区域的照射强度，满足了换能器组件正常的工作需求。
本申请还提供一种高强度聚焦超声设备的控制方法，应用于前述内容提及的高强度聚焦超声设备，包括：
向所述换能器组件发送伸入指令，以控制形状为第一形状的换能器组件伸入待处理对象内腔；
向所述换能器组件中的聚焦换能器发送形状变换指令，以控制所述聚焦换能器完成形状变换，由所述第一形状变换为第二形状；
设定一个工作周期t的时间长度，以及一个工作周期t内待处理区域的数量n；n为正整数且n大于0；
向所述聚焦换能器发送工作指令，以控制所述聚焦换能器在一个工作周期t内对n个待处理区域依次进行一次超声脉冲处理；
反复执行向所述聚焦换能器发送工作指令的步骤，以控制所述聚焦换能器在总工作周期T内，完成对n个待处理区域的超声脉冲处理，所述总工作周期T包括M个工作周期t；M为正整数且M大于0。
本申请涉及一种高强度聚焦超声设备的控制方法，通过在换能器组件伸入受测者体体内后，控制换能器中的聚焦换能器进行形状变换，不但实现换能器组件可以通过狭小部位伸入待处理对象内腔，而且在伸入待处理对象内腔后，满足了换能器组件正常的工作需求。此外，通过控制所述聚焦换能器在一个工作周期内对多个待处理区域依次进行一次超声脉冲处理，节约了超声脉冲处理的处理时间，处理效率大大提高。
附图说明
图1为本申请一实施例提供的高强度聚焦超声设备的结构示意图；
图2为本申请实施例1中聚焦换能器处于第二形状时，高强度聚焦超声设备的立体结构图；
图3为本申请实施例1-1中聚焦换能器处于第一形状时，高强度聚焦超声设备的立体结构图；
图4为本申请实施例1-1中聚焦换能器处于第二形状时，高强度聚焦超声设备的立体结构图；
图5为本申请实施例1-2中聚焦换能器处于第一形状时，高强度聚焦超声设备的立体结构图；
图6为本申请实施例1-2中聚焦换能器处于第二形状时，高强度聚焦超声设备的立体结构图；
图7为本申请实施例2中聚焦换能器处于第一形状时，高强度聚焦超声设备的立体结构图；
图8为本申请实施例2中聚焦换能器处于第二形状时，高强度聚焦超声设备的立体结构图；
图9为本申请实施例2-1提供的聚焦换能器处于第一形状时，高强度聚焦超声设备的立体结构图；
图10为本申请实施例3提供的聚焦换能器处于第一形状时，高强度聚焦超声设备的立体结构图；
图11为本申请实施例3提供的聚焦换能器处于第二形状时，高强度聚焦超声设备的立体结构图；
图12为本申请实施例3提供的聚焦换能器处于第二形状时，高强度聚焦超声设备的正视图；
图13为本申请一实施例提供的高强度聚焦超声设备的控制方法的流程示意图；
图14为本申请一实施例提供的高强度聚焦超声设备的控制方法的时序图。
附图标记：
10     高强度聚焦超声设备
100    换能器组件
110    图像换能器
120    聚焦换能器
121    凹槽
122    第一换能器模块
122a   凹陷
123    第二换能器模块
124    第三换能器模块
125    第四换能器模块
126    第五换能器模块
126a   第五换能器模块a
126b   第五换能器模块b
126c   第五换能器模块c
130    活动销轴
200    连接线
210    连接端
300    控制线
310    第一控制线
320    第二控制线
具体实施方式
为了使本申请的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本申请进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本申请，并不用于限定本申请。
本申请提供一种高强度聚焦超声设备10，应用于待处理对象的内腔。
如图1所示，在本申请的一实施例中，所述高强度聚焦超声设备10包括互相固定连接的换能器组件100与连接线200。所述连接线200包括连接端210。所述连接线200通过所述连接端210与所述换能器组件100固定连接。所述换能器组件100包括图像换能器110与聚焦换能器120。所述图像换能器110用于获取待处理对象内腔的超声图像。所述聚焦换能器120设置为第一形状。所述聚焦换能器120伸入所述待处理对象内腔后，能够自由变换为第二形状。所述聚焦换能器120用于聚焦超声波能量，释放高强度聚焦超声脉冲，对所述待处理对象内腔的待处理区域进行照射。
具体地，所述待处理对象内腔可以为胃部、直肠等等。当所述高强度聚焦超声设备10处于所述待处理对象的外部时，所述聚焦换能器120呈现为第一形状，所述第一形状设置为易于进入所述待处理对象内腔。可以理解，胃部或直肠等器官，入口较为狭窄，呈现为第一形状的聚焦换能器120易于进入。当所述高强度聚焦超声设备10处于所述待处理对象的内腔时，所述聚焦换能器120呈现为第二形状，增大了所述聚焦换能器120的有效面积。可以理解，聚焦换能器120的有效面积越大，产生的超声波能量越多，对所述待处理对象内腔的待处理区域进行照射的照射强度越高。
所述高强度聚焦超声设备10可以与一个上位机电连接。具体地，所述上位机与所述连接线200电连接，用于控制所述聚焦换能器120的形状变换。具体地，所述上位机可以包括一个或多个处理器，所述处理器用于控制所述聚焦换能器120的形状变换。
本实施例中，通过设置可自由变换形状的聚焦换能器120，使得整个换能器组件100伸入待处理对象内腔后，不但实现换能器组件100可以通过狭小部位伸入待处理对象内腔，而且在伸入待处理对象内腔后，换能器组件100中的聚焦换能器120形状变换，聚焦换能器120的有效面积增大，产生的超声波能量增多，增强对待处理区域的照射强度，满足了换能器组件100正常的工作需求。
实施例1
如图2所示，在本申请的一实施例中，所述第二形状为圆柱体或椭圆柱体。所述圆柱体或椭圆柱体的至少一个端面为凹球面。所述聚焦换能器120具有凹槽121。
所述图像换能器110的形状为圆柱体或椭圆柱体。所述图像换能器110嵌设于所述凹槽121。所述图像换能器110的端面的圆心与所述聚焦换能器120的端面的物理中心重合。
具体地，实施例1中，所述聚焦换能器120的第二形状为圆柱体或椭圆柱体，即所述聚焦换能器120处于待处理对象内腔展开后的形状。区别在于，当第二形状为圆柱体时，两个端面为圆形。当第二形状为椭圆柱体时，两个端面为椭圆形。所述圆柱体或椭圆柱体的至少一个端面设置为凹球面，可以使得所述聚焦换能器120更好的将超声能量聚焦。所述聚焦换能器120可以将超声能量聚焦于所述聚焦换能器120端面的物理中心。所述图像换能器110的设置使得所述换能器组件100不仅具有释放高强度聚焦超声脉冲的功能，还具有获得处理对象超声图像的功能。图2展示的是第二形状为圆柱体，且圆柱体的一个端面设置为凹球面的实施例示意图。
本实施例中，通过设置嵌设于所述聚焦换能器120凹槽121的图像换能器110，使得所述换能器组件100不仅具有释放高强度聚焦超声脉冲的功能，还具有获取处理对象超声图像的功能。
实施例1具有不同形式的拓展实施例，下文列举两个拓展实施例：实施例1-1和实施例1-2。这两个拓展实施例相比，聚焦换能器120的第一形状不同，聚焦换能器120的第二形状相同。
实施例1-1
如图3和图4所示，在本申请的一实施例中，所述聚焦换能器120包括两个第一换能器模块122。当所述第二形状为圆柱体时，所述第一换能器模块122的形状为以轴截面分隔所述第二形状呈现的圆柱体后，形成的半圆柱体。当所述第二形状为椭圆柱体时，所述第一换能器模块122的形状为以轴截面分隔所述第二形状呈现的椭圆柱体后，形成的半椭圆柱体。所述第一换能器模块122具有凹陷122a。
当所述高强度聚焦超声设备10处于第一状态时，所述两个第一换能器模块122折叠，组合构成以所述第一形状呈现的聚焦换能器120。所述第一形状为两个半圆柱体折叠形成的半圆柱体或两个半椭圆柱体折叠形成的半椭圆柱体。所述第一状态为所述高强度聚焦超声设备10处于待处理对象的外部。
当所述高强度聚焦超声设备10处于第二状态时，所述两个第一换能器模块122展开，拼接构成以所述第二形状呈现的聚焦换能器120。所述两个第一换能器模块122的凹陷122a拼接构成所述凹槽121。所述第二状态为所述高强度聚焦超声设备10处于待处理对象内腔。在所述聚焦换能器120形状变换的过程中，所述图像换能器110的形状与位置保持不变。
具体地，本实施例中的聚焦换能器120可以应用于直肠。需要说明的是，所述第一状态为所述高强度聚焦超声设备10处于待处理对象的外部。所述第二状态为所述高强度聚焦超声设备10处于待处理对象内腔。后文内容出现的第一状态和第二状态，含义相同，不再做重复说明。所述聚焦换能器120包括两个半圆柱体形状或两个半椭圆柱体的第一换能器模块122。图3和图3示出的聚焦换能器120包括两个半圆柱体形状的第一换能器模块122。以此为例说明，以待处理对象内腔为直肠为例，直肠入口较为狭小，所述聚焦换能器120中的两个第一换能器模块122折叠，形成半圆柱体结构，伸入直肠。在进入直肠内部后，两个半圆柱体形状的第一换能器模块122伸展，拼接形成一个完整的圆柱体，便于后续释放高强度聚焦超声脉冲对待处理区域进行照射。
实施例1-1中，两个第一换能器模块122之间可以设置有偏置连接件(图中未示出)。所述偏置连接件可以为弹簧。当所述高强度聚焦超声设备10处于第一状态时，所述上位机可以控制所述偏置连接件维持所述聚焦换能器120处于所述第一形状。所述第一换能器模块122之间还可以设置有机械传动机构。所述机械传动机构与所述偏置连接件机械连接。当所述高强度聚焦超声设备10处于第一状态时，所述上位机可以控制所述机械传动机构，驱动所述偏置连接件改变偏置状态，使得所述聚焦换能器120改变形状，变为所述第二形状。
本实施例中，通过设置两个半圆柱体形状或两个半椭圆柱体的第一换能器模块122，使得所述高强度聚焦超声设备10处于待处理对象的外部时，可以折叠，易于进入待处理对象内腔。同时使得所述高强度聚焦超声设备10处于待处理对象内腔时，可以展开拼接形成一个完整的圆柱体或一个完整的半椭圆柱体，增大聚焦换能器120的有效面积，聚焦换能器120整体结构简单。
实施例1-2
如图5和图6所示，在本申请的一实施例中，所述聚焦换能器120包括第二换能器模块123和两个第三换能器模块124。 所述两个第三换能器模块124分别设置于所述第二换能器模块123的两侧。所述两个第三换能器模块124分别与所述第二换能器模块123活动连接。所述凹槽121设置于所述第二换能器模块123。
当所述高强度聚焦超声设备10处于所述第一状态时，两个第三换能器模块124折叠，组合构成以所述第一形状呈现的聚焦换能器120。所述第一状态为所述高强度聚焦超声设备10处于待处理对象的外部。所述第一形状为所述第二换能器模块123的形状。
当所述高强度聚焦超声设备10处于所述第二状态时，两个第三换能器模块124展开，拼接构成以第二形状呈现的聚焦换能器120。所述第二状态为所述高强度聚焦超声设备10处于待处理对象内腔。所述图像换能器110嵌设于所述凹槽121。在所述聚焦换能器120的形状变换的过程中，所述第二换能器模块123与所述图像换能器110的形状与位置保持不变。
具体地，实施例1-1是将圆柱体形状的聚焦换能器120分为两个半圆柱体。实施例1-2则是将柱体形状的聚焦换能器120分为依次相邻的三个部分：第二换能器模块123和两个第三换能器模块124。所述两个第三换能器模块124分别设置于所述第二换能器模块123的两侧，且与所述第二换能器模块123活动连接。所述第三换能器模块124可以为半月形结构。当所述高强度聚焦超声设备10处于所述第一状态时，两个第三换能器模块124折叠，所述聚焦换能器120呈现第一形状，便于进入待处理对象内腔。当所述高强度聚焦超声设备10处于所述第二状态时，两个第三换能器模块124展开，且与所述第二换能器模块123拼接为第二形状，所述聚焦换能器有效面积增大。
实施例1-2中，所述第二换能器模块123与所述第三换能器模块124之间可以设置有偏置连接件和机械传动机构(图中未示出)。所述机械传动机构与所述偏置连接件机械连接。所述偏置连接件可以为弹簧。当所述高强度聚焦超声设备10处于第一状态时，所述上位机可以控制所述偏置连接件维持所述聚焦换能器120处于所述第一形状。当所述高强度聚焦超声设备10处于第一状态时，所述上位机可以控制所述机械传动机构，驱动所述偏置连接件改变偏置状态，使得所述聚焦换能器120改变形状，变为所述第二形状。
本实施例中，通过设置第二换能器模块123，以及位于第二换能器模块123两侧的两个第三换能器模块124，使得所述高强度聚焦超声设备10处于待处理对象的外部时，可以折叠，易于进入待处理对象内腔。同时使得所述高强度聚焦超声设备10处于待处理对象内腔时，可以展开拼接形成一个完整的圆柱体，增大聚焦换能器120的有效面积，聚焦换能器120整体结构简单。
实施例2
如图7和图8所示，在本申请的一实施例中，所述第一形状为多个正六棱柱依次相连接组成的链式结构。所述第二形状为多个正六棱柱在同一平面首尾围绕组成的环状结构。
具体地，实施例2与实施例1不同。实施例2中，所述第一形状为链式结构，易于伸入狭窄的待处理对象内腔的入口处。例如直肠入口处。所述正六棱柱有两个正六边形的表面。在所述链式结构中，所述多个正六棱柱的正六边形表面位于同一平面内。在进入待处理对象内腔后，所述多个正六棱柱首尾围绕形成所述环状结构，增大了聚焦换能器120的有效面积。此外，形成的第二形状为规则形状，可以实现将超声能量聚焦于一点，能量聚焦点位于所述环状结构的物理中心。当处于所述第一形状时，聚焦换能器120的能量聚焦点分散。处于所述第二形状时，聚焦换能器120的能量聚焦点重叠，可以实现将超声能量聚焦于一点。
本实施例中，通过设置链式结构的第一形状，以及环状结构的第二形状，使得聚焦换能器120伸入待处理对象内腔后，既可以增大聚焦换能器120的有效面积，又可以实现将超声能量聚焦于一点。
请继续参阅图7和图8，在本申请的一实施例中，所述聚焦换能器120包括多个通过活动销轴130依次连接的第四换能器模块125。所述第四换能器模块125的形状为正六棱柱。所述图像换能器110的形状为正六棱柱。所述聚焦换能器120呈现为所述第一形状的链式结构时，所述图像换能器110设置于所述链式结构的末端或两个第四换能器模块125之间。
当所述高强度聚焦超声设备10处于第一状态时，多个第四换能器模块125展开，组合构成以所述第一形状呈现的聚焦换能器120。所述第一状态为所述高强度聚焦超声设备10处于待处理对象的外部。
当所述高强度聚焦超声设备10处于所述第二状态时，距离所述连接端210最远的第四换能器模块125，向距离所述连接端210最近的第四换能器模块125靠近，以使多个第四换能器模块125围绕构成以所述第二形状呈现的聚焦换能器120。所述第二状态为所述高强度聚焦超声设备10处于待处理对象内腔。
具体地，相邻的两个第四换能器模块125之间可以设置有偏置连接件和机械传动机构。所述机械传动机构与所述偏置连接件机械连接。所述偏置连接件可以为弹簧。当所述高强度聚焦超声设备10处于第一状态时，所述上位机可以控制所述偏置连接件维持所述聚焦换能器120处于所述第一形状。当所述高强度聚焦超声设备10处于第一状态时，所述上位机可以控制所述机械传动机构，驱动所述偏置连接件改变偏置状态，使得所述聚焦换能器120改变形状，变为所述第二形状。
所述图像换能器110设置于所述链式结构的末端，即所述图像换能器110可以为距离所述连接端210最近的正六棱柱，也可以为距离所述连接端210最远的正六棱柱。所述图像换能器110也可以设置于两个第四换能器模块125之间。
当处于所述第一形状时，聚焦换能器120的能量聚焦点分散。处于所述第二形状时，聚焦换能器120的能量聚焦点重叠，可以实现将超声能量聚焦于一点。
本实施例中，通过设置多个通过活动销轴130依次连接的第四换能器模块125形成链式结构，使得聚焦换能器120伸入待处理对象内腔后，离所述连接端210最远的第四换能器模块125，向距离所述连接端210最近的第四换能器模块125靠近，围绕构成环状结构，既可以增大聚焦换能器120的有效面积，又可以实现将超声能量聚焦于一点。
实施例2中，链式结构的聚焦换能器120变形为首尾相连的环状结构，具体的变形方式，需要依托于聚焦换能器120本身的驱动结构，下面介绍运用不同驱动结构的2个实施例。
实施例2-1
如图9所示，在本申请的一实施例中，所述高强度聚焦超声设备10还包括两条控制线300，贯穿每一个所述第四换能器模块125。两条控制线300之间不产生交叉。当所述高强度聚焦超声设备10处于所述第一状态时，通过同时放松两条控制线300，以实现多个第四换能器模块125围绕构成以第一形状呈现的聚焦换能器120。当所述高强度聚焦超声设备10处于所述第二状态时，通过拉紧一条控制线300，放松另一条控制线300，以实现多个第四换能器模块125围绕构成以所述第二形状呈现的聚焦换能器120。
具体地，本实施例中，通过在聚焦换能器120中设置控制线300，以驱动聚焦换能器120发生形状变换。具体地，如图9所示，所述控制线300可以包括两条，分别为第一控制线310和第二控制线320。所述第一控制线310与所述第二控制线320不产生交叉。所述第一控制线310和所述第二控制线320均贯穿每一个第四换能器模块125。由于多个第四换能器模块125和图像换能器110共同形成链式结构，所述第一控制线310与所述第二控制线320也贯穿所述图像换能器110。换言之，所述第一控制线310与所述第二控制线320贯穿链式结构中的每一个正六棱柱。
如图9所示，当同时放松第一控制线310和第二控制线320时，所述多个第四换能器模块125伸展，形成所述第一形状，即链式结构。
形成所述第二形状存在两种控线方式。
1)当放松所述第一控制线310，拉紧所述第二控制线320时，距离所述连接端210最远的第四换能器模块125向下弯折，所述多个第四换能器模块125蜷缩围绕，形成所述第二形状。
2)当拉紧所述第一控制线310，放松所述第二控制线320时，距离所述连接端210最远的第四换能器模块125向上弯折，所述多个第四换能器模块125蜷缩围绕，形成所述第二形状。
这两种第一控制线310和第二控制线320的控线方式，均可以实现多个第四换能器模块125形成所述第二形状。
本实施例中，通过设置两条控制线300，使得多个第四换能器模块125和图像换能器110组成的链式结构能在控制线的牵引和/或放松的过程中，实现形状的变换，操作简便，成本低。
实施例2-2
在本申请的一实施例中，所述距离所述连接端210最近的第四换能器模块125为磁体。距离所述连接端210最远的第四换能器模块125为磁体。
当所述高强度聚焦超声设备10处于所述第二状态时，通过控制距离所述连接端210最远的第四换能器模块125，贴近距离所述连接端210最近的第四换能器，以实现所述距离所述连接端210最远的第四换能器模块125，与距离所述连接端210最近的第四换能器模块125的吸合，使所述多个第四换能器模块125围绕构成以第二形状呈现的聚焦换能器120。
具体地，本实施例通过磁力吸引实现驱动聚焦换能器120发生形状变换。可以设置两个第四换能器模块125为磁体：一个为距离所述连接端210最近的第四换能器模块125，另一个为距离所述连接端210最远的第四换能器模块125。当然，也可以设置上述两个第四换能器模块125中的任意一个为磁体，另一个由铁合金、钴合金和镍合金的一种材料制成。可以通过控制两个磁体互相靠近，实现链式结构的首尾正六棱柱吸合，围绕形成所述第二形状。
本实施例中，通过设置距离所述连接端210最近的第四换能器模块125为磁体，以及距离所述连接端210最远的第四换能器模块125为磁体，通过二者靠近时吸合，实现呈现链式结构的聚焦换能器120的首尾正六棱柱吸合，围绕形成所述第二形状，形状变换速度快。
实施例3
如图10和图11所示，在本申请的一实施例中，所述聚焦换能器120包括多个第五换能器模块126。所述连接线200为多个。所述每一个第五换能器模块126与一个连接线200固定连接。所述图像换能器110与一个连接线200固定连接。
具体地，实施例3中的聚焦换能器120相当于分散为多个第五换能器模块126，每一个第五换能器模块126独立存在，每一个第五换能器模块126与一个连接线200固定连接。可以理解，每一个第五换能器模块126的形状为第一形状。当多个第五换能器模块126依次伸入所述待处理对象内腔后，多个第五换能器模块126组合形成第二形状的聚焦换能器120。待处理对象 存在一定的超声脉冲承受的强度阈值，释放的高强度聚焦超声脉冲过强，待处理对象无法承受。例如胃部和直肠的超声脉冲承受的强度阈值不同。本实施例可以依据待处理对象的不同，调整第五换能器模块126的数量，以满足不同待处理对象的脉冲照射需求。本实施例中的聚焦换能器120可以应用于不同类型的待处理对象，例如胃部、直肠等等。
本实施例中，通过设置多个独立的第五换能器模块126，使得可以依据待处理对象的不同，实时调整第五换能器模块126的数量，以满足不同待处理对象的脉冲照射需求，使得高强度聚焦超声设备10不再受固定待处理对象的限制，节约设备成本，提高工作效率。
请继续参阅图10和图11，在本申请的一实施例中，所述第一形状为长方体。所述第二形状为长方体，所述第五换能器模块126为磁体。所述图像换能器110的形状为长方体。所述图像换能器110为磁体。
当所述高强度聚焦超声设备10处于第一状态时，所述多个第五换能器模块126各自独立。所述第一状态为所述高强度聚焦超声设备10处于待处理对象的外部。
当所述高强度聚焦超声设备10进入所述待处理对象内腔时，所述多个第五换能器模块126先按顺序依次进入待处理对象内腔，待所述多个第五换能器模块126全部进入待处理对象内腔后，所述图像换能器110进入待处理对象内腔。或是所述图像换能器110先进入待处理对象内腔，待所述图像换能器110进入待处理对象内腔后，所述多个第五换能器模块126先按顺序依次进入待处理对象内腔。
当所述高强度聚焦超声设备10处于第二状态时，一个第五换能器模块126的N极与另一个第五换能器模块126的S极通过磁力互相吸引，以使所述多个第五换能器模块126共同构成以所述第二形状呈现的聚焦换能器120。所述第二状态为所述高强度聚焦超声设备10处于待处理对象内腔。所述图像换能器110与一个第五换能器模块126通过磁力互相吸引。
具体地，所述第五换能器模块126为长方体形状的磁体。每一个第五换能器模块126具有N极和S极。当所述高强度聚焦超声设备10进入所述待处理对象内腔时，所述多个第五换能器模块126按顺序依次进入待处理对象内腔。当所述高强度聚焦超声设备10处于所述待处理对象内腔时，多个第五换能器模块126自然而然相互吸合，构成所述第二形状。所述第二形状也为长方体。可以理解，与第二形状对应的长方体中面积最大的表面的表面积，远大于与第一形状对应的长方体中面积最大的表面的表面积，因此，聚焦换能器120的有效面积增大，产生的超声波能量增多。至于所述图像换能器110的进入顺序，可以不做限制，只要不干扰多个第五换能器模块126吸合为第二形状即可，可以最先进入待处理对象内腔，也可以最后进入待处理对象内腔。
本实施例中，通过设置多个第五换能器模块126为磁体，使得所述高强度聚焦超声设备10处于所述待处理对象内腔时，多个第五换能器模块126自然而然相互吸合，构成有效面积增大的长方体形状，使得聚焦换能器120的有效面积增大，产生的超声波能量增多，且可以根据待处理对象的不同，增加或减少第五换能模块的数量，在实际使用过程中灵活方便，节省使用成本。
如图12所示，在本申请的一实施例中，在与所述第二形状对应的长方体中，两个面积最大的面中的至少一个为凹球面。所述凹球面的物理中心为所述聚焦换能器120的能量聚焦点。
在所述第一形状对应的长方体中，两个面积最大的面中的至少一个为凹面。多个与所所述第一形状对应的长方体的凹面通过有序组合，形成所述第二形状对应的长方体的凹球面。
具体地，如图12所示，每一个第五换能器模块126的形状为第一形状，其面积最大的面设置为凹面。本实施例中，需要多个第五换能器进行有序组合，才能使得多个第五换能器模块126吸合后，多个第五换能器模块126的凹面组合形成所述第二形状对应的长方体的凹球面。凹球面可以使得能量聚焦点固定于一点，即所述凹球面的物理中心，进而使得聚焦换能器120产生的超声波能量增多。
本实施例中，通过设置面积最大的面为凹球面，可以使得能量聚焦点固定于一点，即所述凹球面的物理中心，进而使得聚焦换能器120产生的超声波能量增多。
在本申请的一实施例中，当所述高强度聚焦超声设备10进入所述待处理对象内腔时，所述多个第五换能器模块126按预定顺序依次进入所述待处理对象内腔，以使所述多个与第一形状对应长方体的凹面通过有序组合，形成与所述第二形状对应的长方体的凹球面。
具体地，承接上述实施例，为使得多个第五换能器模块126的凹面组合形成所述第二形状对应的长方体的凹球面，需要使得述多个第五换能器模块126按预定顺序依次进入所述待处理对象的内腔。所述预定顺序由人为预先设定。例如，如图12所述，所述第五换能器模块126包括第五换能器模块a、第五换能器模块b、第五换能器模块c和第五换能器模块d。依据a-b-c-d的预定顺序依次将多个第五换能器模块126置入所述待处理对象内腔，方可实现与所述第二形状对应的长方体的凹球面的形成。
本实施例中，通过设置多个第五换能器模块126置入所述待处理对象内腔的先后顺序，实现了与所述第二形状对应的长方体的凹球面的形成，使得能量聚焦点固定于一点，即所述凹球面的物理中心，进而使得聚焦换能器120产生的超声波能量增多。
本申请还提供一种高强度聚焦超声设备的控制方法。所述高强度聚焦超声设备的控制方法应用于上述内容提及的高强度聚 焦超声设备10。
需要说明的是，本申请提供的不限制其应用领域与应用场景。可选地，应用于。
本申请提供的高强度聚焦超声设备的控制方法并不限制其执行主体。可选地，所述高强度聚焦超声设备的控制方法的执行主体可以为与所述高强度聚焦超声设备10连接的上位机。可选地，所述高强度聚焦超声设备的控制方法的执行主体可以所述上位机中的一个或多个处理器。
如图13和图14所示，在本申请的一实施例中，所述高强度聚焦超声设备的控制方法包括如下步骤S100至步骤S500：
S100，向所述换能器组件100发送伸入指令，以控制形状为第一形状的换能器组件100伸入待处理对象内腔。
S200，向所述换能器组件100中的聚焦换能器120发送形状变换指令，以控制所述聚焦换能器120完成形状变换，由所述第一形状变换为第二形状。
S300，设定一个工作周期t的时间长度，以及一个工作周期t内待处理区域的数量n。n为正整数且n大于0。
S400，向所述聚焦换能器120发送工作指令，以控制所述聚焦换能器120在一个工作周期t内对n个待处理区域依次进行一次超声脉冲处理。
S500，反复执行步骤S400，在总工作周期T内，以控制所述聚焦换能器120完成对n个待处理区域的超声脉冲处理。所述总工作周期T包括M个工作周期t。M为正整数且M大于0。
具体地，所述处理器可以预先存储代码，用于设定一个工作周期t的时间长度，以及一个工作周期t内待处理区域的数量n。可选地，n可以为4。当n取4时，在一个工作周期内，所述处理器可以控制所述换能器组件100依次对4个待处理区域进行处理。由于一个待处理区域单次处理并不能完成处理工作，需要M次处理方能完成处理工作。因此，需要控制所述聚焦换能器120工作M个工作周期。其中，n和M均为正整数，且数值均大于0。
本实施例中，通过在换能器组件100伸入待处理对象内腔后，控制换能器中的聚焦换能器120进行形状变换，不但实现换能器组件100可以通过狭小部位伸入待处理对象内腔，而且在伸入待处理对象内腔后，满足了换能器组件100正常的工作需求。此外，通过控制所述聚焦换能器120在一个工作周期内对多个待处理区域依次进行一次超声脉冲处理，节约了超声脉冲处理的处理时间，处理效率大大提高。
在本申请的一实施例中，所述步骤S400包括如下步骤S410至步骤S460：
S410，向所述聚焦换能器120发送脉冲启动指令，以控制所述聚焦换能器120释放高强度聚焦超声脉冲，对所述待处理对象内腔的第一待处理区域进行照射，持续第一时间段t 1-S。
S420，向所述聚焦换能器120发送脉冲关闭指令，以控制所述聚焦换能器120停止释放所述高强度聚焦超声脉冲，持续第一休息时间段t 1-R。
S430，向所述聚焦换能器120发送区域转移指令，以控制所述聚焦换能器120由一个待处理区域移动至另一个待处理区域。
S440，向所述聚焦换能器120发送脉冲启动指令，以控制所述聚焦换能器120释放高强度聚焦超声脉冲，对所述待处理对象内腔的第二待处理区域进行照射，持续所述第二照射时间段t 2-S。
S450，向所述聚焦换能器120发送脉冲关闭指令，以控制所述聚焦换能器120停止释放高强度聚焦超声脉冲，持续所述第二休息时间段t 2-R。
S460，反复执行所述步骤S430至步骤S450，直至控制所述聚焦换能器120完成对所述待处理对象内腔的第n待处理区域的照射，持续第n照射时间段t n-S，以及控制所述聚焦换能器120停止释放高强度聚焦超声脉冲，持续第n休息时间段t n-R。
具体地，可以理解，本实施例中的各项参数满足下述公式1：
T＝M×t＝M×(t 1-S+t 1-R+t 2-S+t 2-R+...t n-S+t n-R)     公式1
其中，T为总工作周期。M为总工作周期内包括的工作周期数量。t为一个工作周期。t 1-S为第一照射时间段。t 1-R为第一休息时间段。t 2-S为第二照射时间段。t 2-R为第二休息时间段。t n-S为第n照射时间段。t n-R为第n休息时间段。n为一个工作周期内处理的待处理区域的数量。
需要说明的是，不同待处理区域之间，脉冲的照射时间段可以相等，也可以不相等。同理，不同待处理区域之间，停止释放脉冲的休息时间段可以相等，也可以不相等。举例说明，第一照射时间段t 1-S可以等于第二照射时间段t 2-S，第一照射时间段t 1-S也可以不等于第二照射时间段t 2-S。第一休息时间段t 1-R可以等于第二休息时间段t 2-R，第一休息时间段t 1-R也可以不等于第二休息时间段t 2-R。
此外，脉冲的照射时间段可以等于停止释放脉冲的休息时间段，二者也可以不相等。
传统方案在一个工作周期内只对控制聚焦换能器120对唯一一个待处理区域进行照射，照射结束后，工作周期内的剩余时间全部用于休息，休息时间为t 0。本实施例中，通过在一个工作周期内设定多组针对于不同待处理区域的脉冲照射持续的时间段与休息的时间段，大大缩短了n个待处理区域的处理总时间，提高了工作效率。对于每个待处理区域，传统方案和本实施例中的方案相比较，单个工作周期内，照射时间相等，休息时间相等。工作周期数量相等。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对本申请专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请的保护范围应以所附权利要求为准。

Claims (14)

  1. 一种高强度聚焦超声设备，其特征在于，包括互相固定连接的换能器组件(100)与连接线(200)，所述连接线(200)包括连接端(210)，所述连接线(200)通过所述连接端(210)与所述换能器组件固定连接，所述换能器组件(100)包括：
    图像换能器(110)，用于获取待处理对象内腔的超声图像；
    聚焦换能器(120)，设置为第一形状，所述聚焦换能器(120)伸入所述待处理对象内腔后，自由变换为第二形状，用于聚焦超声波能量，释放高强度聚焦超声脉冲，对所述待处理对象内腔的待处理区域进行照射。
  2. 根据权利要求1所述的高强度聚焦超声设备，其特征在于，所述第二形状为圆柱体或椭圆柱体，所述圆柱体或椭圆柱体的至少一个端面为凹球面；所述聚焦换能器(120)具有凹槽(121)；
    所述图像换能器(110)的形状为圆柱体或椭圆柱体，所述图像换能器(110)嵌设于所述凹槽(121)，且所述图像换能器(110)的端面的圆心与所述聚焦换能器(120)的端面的物理中心重合。
  3. 根据权利要求2所述的高强度聚焦超声设备，其特征在于，所述聚焦换能器(120)包括两个第一换能器模块(122)；
    当所述第二形状为圆柱体时，所述第一换能器模块(122)的形状为以轴截面分隔所述第二形状呈现的圆柱体后，形成的半圆柱体；当所述第二形状为椭圆柱体时，所述第一换能器模块(122)的形状为以轴截面分隔所述第二形状呈现的椭圆柱体后，形成的半椭圆柱体；所述第一换能器模块(122)具有凹陷(122a)；
    当所述高强度聚焦超声设备(10)处于第一状态时，所述两个第一换能器模块(122)折叠，组合构成以所述第一形状呈现的聚焦换能器(120)；所述第一形状为两个半圆柱体折叠形成的半圆柱体或两个半椭圆柱体折叠形成的半椭圆柱体；所述第一状态为所述高强度聚焦超声设备(10)处于待处理对象的外部；
    当所述高强度聚焦超声设备(10)处于第二状态时，所述两个第一换能器模块(122)展开，拼接构成以所述第二形状呈现的聚焦换能器(120)，所述两个第一换能器模块(122)的凹陷(122a)拼接构成所述凹槽(121)；所述第二状态为所述高强度聚焦超声设备(10)处于待处理对象内腔；
    在所述聚焦换能器(120)形状变换的过程中，所述图像换能器(110)的形状与位置保持不变。
  4. 根据权利要求2所述的高强度聚焦超声设备，其特征在于，所述聚焦换能器(120)包括第二换能器模块(123)和两个第三换能器模块(124)，所述两个第三换能器模块(124)分别设置于所述第二换能器模块(123)的两侧，且与所述第二换能器模块(123)活动连接；所述凹槽(121)设置于所述第二换能器模块(123)；
    当所述高强度聚焦超声设备(10)处于所述第一状态时，两个第三换能器模块(124)折叠，组合构成以所述第一形状呈现的聚焦换能器(120)；所述第一状态为所述高强度聚焦超声设备(10)处于待处理对象的外部；所述第一形状为所述第二换能器模块(123)的形状；
    当所述高强度聚焦超声设备(10)处于所述第二状态时，两个第三换能器模块(124)展开，拼接构成以第二形状呈现的聚焦换能器(120)；所述第二状态为所述高强度聚焦超声设备(10)处于待处理对象内腔；
    所述图像换能器(110)嵌设于所述凹槽(121)，在所述聚焦换能器(120)的形状变换的过程中，所述第二换能器模块(123)与所述图像换能器(110)的形状与位置保持不变。
  5. 根据权利要求1所述的高强度聚焦超声设备，其特征在于，所述第一形状为多个正六棱柱依次相连接组成的链式结构，所述第二形状为多个正六棱柱在同一平面首尾围绕组成的环形结构。
  6. 根据权利要求5所述的高强度聚焦超声设备，其特征在于，所述聚焦换能器(120)包括多个通过活动销轴(130)依次连接的第四换能器模块(125)，所述第四换能器模块(125)的形状为正六棱柱；所述图像换能器(110)的形状为正六棱柱，所述聚焦换能器(120)呈现为所述第一形状的链式结构时，所述图像换能器(110)设置于所述链式结构的末端或两个第四换能器模块(125)之间；
    当所述高强度聚焦超声设备(10)处于第一状态时，多个第四换能器模块(125)展开，组合构成以所述第一形状呈现的聚焦换能器(120)；所述第一状态为所述高强度聚焦超声设备(10)处于待处理对象的外部；
    当所述高强度聚焦超声设备(10)处于所述第二状态时，距离所述连接端(210)最远的第四换能器模块(125)，向距离所述连接端(210)最近的第四换能器模块(125)靠近，以使多个第四换能器模块(125)围绕构成以所述第二形状呈现的聚焦换能器(120)；所述第二状态为所述高强度聚焦超声设备(10)处于待处理对象内腔。
  7. 根据权利要求6所述的高强度聚焦超声设备，其特征在于，还包括两条控制线(300)，贯穿每一个所述第四换能器模块(125)，用于控制所述第四换能器模块(125)的形状变换；两条控制线(300)之间不产生交叉；
    当所述高强度聚焦超声设备(10)处于所述第一状态时，通过同时放松两条控制线(300)，以实现多个第四换能器模块(125)围绕构成以第一形状呈现的聚焦换能器(120)；
    当所述高强度聚焦超声设备(10)处于所述第二状态时，通过拉紧一条控制线(300)，放松另一条控制线(300)，以实现 多个第四换能器模块(125)围绕构成以所述第二形状呈现的聚焦换能器(120)。
  8. 根据权利要求6所述的高强度聚焦超声设备，其特征在于，所述距离所述连接端(210)最近的第四换能器模块(125)，以及距离所述连接端(210)最远的第四换能器模块(125)均为磁体；
    当所述高强度聚焦超声设备(10)处于所述第二状态时，通过控制距离所述连接端(210)最远的第四换能器模块(125)，贴近距离所述连接端(210)最近的第四换能器模块(125)，以实现所述距离所述连接端(210)最远的第四换能器模块(125)，与距离所述连接端(210)最近的第四换能器模块(125)的吸合，使所述多个第四换能器模块(125)围绕构成以第二形状呈现的聚焦换能器(120)。
  9. 根据权利要求1所述的高强度聚焦超声设备，其特征在于，所述聚焦换能器(120)包括多个第五换能器模块(126)，所述连接线(200)为多个，所述每一个第五换能器模块(126)与一个连接线(200)固定连接；所述图像换能器(110)与一个连接线(200)固定连接。
  10. 根据权利要求9所述的高强度聚焦超声设备，其特征在于，所述第一形状为长方体，所述第二形状为长方体，所述第五换能器模块(126)为磁体；所述图像换能器(110)的形状为长方体，所述图像换能器(110)为磁体；
    当所述高强度聚焦超声设备(10)处于第一状态时，所述多个第五换能器模块(126)各自独立；所述第一状态为所述高强度聚焦超声设备(10)处于待处理对象的外部；
    当所述高强度聚焦超声设备(10)进入所述待处理对象内腔时，所述多个第五换能器模块(126)先按顺序依次进入待处理对象内腔，待所述多个第五换能器模块(126)全部进入待处理对象内腔后，所述图像换能器(110)进入待处理对象内腔，或是所述图像换能器(110)先进入待处理对象内腔，待所述图像换能器(110)进入待处理对象内腔后，所述多个第五换能器模块(126)按顺序依次进入待处理对象内腔；
    当所述高强度聚焦超声设备(10)处于第二状态时，一个第五换能器模块(126)的N极与另一个第五换能器模块(126)的S极通过磁力互相吸引，以使所述多个第五换能器模块(126)共同构成以所述第二形状呈现的聚焦换能器(120)；所述第二状态为所述高强度聚焦超声设备(10)处于待处理对象内腔；
    所述图像换能器(110)与一个第五换能器模块(126)通过磁力互相吸引。
  11. 根据权利要求10所述的高强度聚焦超声设备，其特征在于，在与所述第二形状对应的长方体中，两个面积最大的面中的至少一个为凹球面，所述凹球面的物理中心为所述聚焦换能器(120)的能量聚焦点；
    在所述第一形状对应的长方体中，两个面积最大的面中的至少一个为凹面，多个与所述第一形状对应的长方体的凹面通过有序组合，形成所述第二形状对应的长方体的凹球面。
  12. 根据权利要求11所述的高强度聚焦超声设备，其特征在于，当所述高强度聚焦超声设备(10)进入所述待处理对象内腔时，所述多个第五换能器模块(126)按预定顺序依次进入所述待处理对象的内腔，以使所述多个与第一形状对应长方体的凹面通过有序组合，形成与所述第二形状对应的长方体的凹球面。
  13. 一种高强度聚焦超声设备的控制方法，其特征在于，应用于权利要求1-12任一项所述的高强度聚焦超声设备(10)，所述高强度聚焦超声设备的控制方法包括：
    S100，向所述换能器组件(100)发送伸入指令，以控制形状为第一形状的换能器组件(100)伸入待处理对象内腔；
    S200，向所述换能器组件(100)中的聚焦换能器(120)发送形状变换指令，以控制所述聚焦换能器(120)完成形状变换，由所述第一形状变换为第二形状；
    S300，设定一个工作周期t的时间长度，以及一个工作周期t内待处理区域的数量n；n为正整数且n大于0；
    S400，向所述聚焦换能器(120)发送工作指令，以控制所述聚焦换能器(120)在一个工作周期t内对n个待处理区域依次进行一次超声脉冲处理；
    S500，反复执行步骤S400，在总工作周期T内，以控制所述聚焦换能器(120)完成对n个待处理区域的超声脉冲处理，所述总工作周期T包括M个工作周期t，M为正整数且M大于0。
  14. 根据权利要求13所述的高强度聚焦超声设备的控制方法，其特征在于，所述步骤S400包括：
    S410，向所述聚焦换能器(120)发送脉冲启动指令，以控制所述聚焦换能器(120)释放高强度聚焦超声脉冲，对所述待处理对象内腔的第一待处理区域进行照射，持续第一照射时间段t 1-S；
    S420，向所述聚焦换能器(120)发送脉冲关闭指令，以控制所述聚焦换能器(120)停止释放所述高强度聚焦超声脉冲，持续第一休息时间段t 1-R；
    S430，向所述聚焦换能器(120)发送区域转移指令，以控制所述聚焦换能器(120)由一个待处理区域移动至另一个待处理区域；
    S440，向所述聚焦换能器(120)发送脉冲启动指令，以控制所述聚焦换能器(120)释放高强度聚焦超声脉冲，对所述待 处理对象内腔的第二待处理区域进行照射，持续第二照射时间段t 2-S；
    S450，向所述聚焦换能器(120)发送脉冲关闭指令，以控制所述聚焦换能器(120)停止释放高强度聚焦超声脉冲，持续第二休息时间段t 2-R；
    S460，反复执行所述步骤S430至步骤S450，直至控制所述聚焦换能器(120)完成对所述待处理对象内腔的第n待处理区域的照射，持续第n照射时间段t n-S，以及控制所述聚焦换能器(120)停止释放高强度聚焦超声脉冲，持续第n休息时间段t n-R。
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