CN113558716A

CN113558716A - Coupling membrane assembly and high-intensity focused ultrasound equipment

Info

Publication number: CN113558716A
Application number: CN202110808148.8A
Authority: CN
Inventors: 毛佳炜; 袁进强; 高晓彬; 李焕
Original assignee: Shenzhen Aosheng Medical Technology Co ltd
Current assignee: Shenzhen Aosheng Medical Technology Co ltd
Priority date: 2021-07-16
Filing date: 2021-07-16
Publication date: 2021-10-29
Anticipated expiration: 2041-07-16
Also published as: CN113558716B

Abstract

The invention discloses a coupling membrane assembly and high-intensity focused ultrasound equipment. The coupling membrane assembly comprises a water-based membrane, a sound-transmitting membrane and a fixing device, wherein the sound-transmitting membrane and the water-based membrane are overlapped to form a composite piece; the fixing device is used for fixing the water-based membrane and the sound transmission membrane. The high intensity focused ultrasound device includes a coupling membrane assembly. The coupling membrane assembly can realize the balance between the material strength and the sound transmission characteristic, achieves the dual purposes of small sound attenuation and high product strength, and has good coupling effect with the skin of a patient. The coupling membrane component forms a composite part by compounding the water-based membrane and the sound-transmitting membrane, so that the strength between the water-based membrane and the sound-transmitting membrane can be improved, and the water-based membrane and the sound-transmitting membrane are mutually cooperated, so that the structural strength of the coupling membrane component is improved, the transmission of sound waves is not influenced, the sound attenuation is not caused, and the balance between the material strength and the sound-transmitting characteristic is realized.

Description

Coupling membrane assembly and high-intensity focused ultrasound equipment

Technical Field

The invention relates to the field of medical instruments, in particular to a coupling membrane assembly and high-intensity focused ultrasound equipment.

Background

Histotripsy and lithotripsy are non-invasive forms of tissue ablation that utilize high intensity focused ultrasound devices to focus pulsed ultrasound from outside the body to targeted tissue inside the body. Histotripsy generally uses histotripsy to mechanically damage tissue by cavitated microbubbles, which homogenize cellular tissue into cell-free liquid that can be expelled or absorbed by the human body. Lithotripsy is usually accomplished by breaking up the urinary stones by sound waves. Histotripsy mechanically destroys target tissue by cavitation of the target tissue volume or tissue contents by high intensity focused ultrasound as part of a surgical or other therapeutic procedure. Histotripsy requires high peak acoustic pulses, which means that a large surface area is required to focus the transducer, and therefore histotripsy is a demanding requirement for high intensity focused ultrasound devices. In histotripsy, the coupling membrane of the high intensity focused ultrasound device needs to be coupled to the surface of the area to be treated on the skin of the patient.

The coupling is generally performed by a water bath method, a silica gel film method, or the like. The water bath method, i.e. the skin of the target channel of the patient and the focused ultrasound transducer of the high-intensity focused ultrasound device are both immersed in water, resulting in certain limitations on coupling. The silica gel film method is common in ultrasonic lithotripsy, but the silica gel film in the method can cause larger sound attenuation; in addition, because the silica gel film is dry, the traditional medical coupling agent is required to be smeared between the skin of a patient and the coupling film to realize coupling, and the operation is often difficult to remove air bubbles between the coupling film and the skin of the patient, so that the treatment effect is poor, and even the side effects of skin burn and the like are brought to the patient. In recent years, some solid coupling agents are used for replacing the traditional silica gel coupling membrane method or water bath method, but the solid coupling agent needs to balance the strength and the sound transmission characteristic of the material, so the solid coupling agent cannot achieve higher strength, the application of the solid coupling agent is greatly limited, the solid coupling agent is difficult to popularize, and the market demand is difficult to meet.

Disclosure of Invention

In view of the above, there is a need to provide a coupling membrane assembly for the problems of sound attenuation, poor therapeutic effect, and the inability of solid couplant to achieve high strength in conventional coupling.

The coupling membrane assembly can realize the balance between the material strength and the sound transmission characteristic, achieves the purposes of small sound attenuation and high product strength, and has good coupling effect with the skin of a patient.

A coupling membrane assembly comprising:

an aqueous film;

an acoustically transparent membrane disposed in overlapping relation with the aqueous membrane to form a composite; and

a fixing device for fixing the aqueous membrane and the sound-transmitting membrane.

It is also an object of the present invention to provide a high intensity focused ultrasound device.

The high-intensity focused ultrasound equipment comprises the coupling membrane component, and the coupling membrane component is connected with a high-intensity focused ultrasound probe of the high-intensity focused ultrasound equipment.

The coupling membrane assembly can realize the balance between the material strength and the sound transmission characteristic, achieves the dual purposes of small sound attenuation and high product strength, and has good coupling effect with the skin of a patient. Specifically, the coupling membrane assembly of the present invention forms a composite member by compounding the water-based membrane and the sound-transmitting membrane, which can improve the strength between the water-based membrane and the sound-transmitting membrane, and the water-based membrane and the sound-transmitting membrane cooperate with each other, so that on one hand, the structural strength of the coupling membrane assembly is improved, on the other hand, the transmission of sound waves is not affected, sound attenuation is not caused, and the balance between the material strength and the sound-transmitting characteristic is realized. In addition, the coupling membrane assembly can be well coupled with the skin of a patient, a traditional solid couplant is not needed, and the coupling effect is good.

Drawings

FIG. 1 is a schematic view of a coupling membrane module according to an embodiment of the invention;

FIG. 2 is a schematic cross-sectional view of a coupling membrane module according to an embodiment of the present invention.

Description of the reference numerals

10. A coupling membrane module;

100. an aqueous film;

200. an acoustically transparent membrane;

300. a fixing device;

310. a first fixing member;

311. an annular groove;

312. a first step structure;

320. a second fixing member;

321. an annular boss;

322. a second step structure;

400. fixing the butt joint piece;

500. a strength reinforcement;

510. and (4) reinforcing the silk.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the invention.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.

In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the present invention, unless otherwise expressly stated or limited, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through an intermediate. Also, a first feature "on," "over," and "above" a second feature may be directly or diagonally above the second feature, or may simply indicate that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature may be directly under or obliquely under the first feature, or may simply mean that the first feature is at a lesser elevation than the second feature.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

The embodiment of the application provides a coupling membrane component to solve the problem that the coupling effect of the coupling membrane component of the existing high-intensity focused ultrasound equipment and the skin of a patient is poor. The following description will be made with reference to the accompanying drawings.

Fig. 1 and fig. 2 show an exemplary coupling membrane module provided in an embodiment of the present invention, where fig. 1 is a schematic structural diagram of the coupling membrane module provided in an embodiment of the present invention, and fig. 2 is a schematic cross-sectional diagram of the coupling membrane module according to an embodiment of the present invention. The coupling membrane assembly of the present application can be used in conjunction with a high intensity focused ultrasound device.

For a more clear description of the structure of the coupling membrane module, the following description will be made with reference to the accompanying drawings.

Referring to fig. 1, a coupling membrane assembly 10 includes an aqueous membrane 100, an acoustic membrane 200, and a fixing device 300. The aqueous film 100 is disposed to overlap the aqueous film 100.

The fixing device 300 is used to fix the aqueous membrane 100 and the sound-transmitting membrane 200. The composite formed by the overlapping of the water-based film 100 and the sound-transmitting film 200 can improve the strength of the coupling membrane module 10.

The connection between the water-based film 100 and the sound-transmitting film 200 may be achieved without using a specific connection method, for example, only the water-based film 100 and the sound-transmitting film 200 need to be attached. The connection between the aqueous membrane 100 and the sound-permeable membrane 200 may also be achieved by a direct connection, for example, in a specific embodiment, the aqueous membrane 100 and the sound-permeable membrane 200 may be connected by adhesion, and the adhesive connection between the aqueous membrane 100 and the sound-permeable membrane 200 may be made by an adhesive, glue, etc. suitable for coupling. In another embodiment, the aqueous membrane 100 and the sound-transmitting membrane 200 may not be directly connected, the aqueous membrane 100 and the sound-transmitting membrane 200 may be bonded, the edge of the bonded aqueous membrane 100 and the sound-transmitting membrane 200 is sealed, a vacuum state is realized between the two layers of the aqueous membrane 100 and the sound-transmitting membrane 200, and the two layers of membranes can be tightly fitted under the action of atmospheric pressure.

The above-mentioned aqueous film 100, also called solid coupling agent, is made of cementing material, and its sound transmission performance is close to that of water, but its strength is weak and it cannot bear larger pressure. The sound-transmitting membrane 200 may be made of PU, silica gel, or other materials, and has a high strength. But is limited by its acoustically transparent properties and needs to be made of a thin material, which when used alone needs to be assisted by water or a liquid couplant to achieve good coupling to the skin. Thus, the present invention combines the aqueous membrane 100 with the sound-permeable membrane 200 to meet both structural strength requirements and sound-permeable functions.

In some embodiments, the fixture 300 includes a first fixture 310 and a second fixture 320. The first fixing member 310 is coupled to the second fixing member 320. Specifically, the first fixing element 310 and the second fixing element 320 may be overlapped, for example, the first fixing element 310 and the second fixing element 320 sandwich the composite element, and the first fixing element 310, the composite element and the second fixing element 320 form an overlapped structure. The first fixing element 310 and the second fixing element 320 may also be embedded, for example, the first fixing element 310 is embedded in the second fixing element 320, and the edge of the composite element is sandwiched between the first fixing element 310 and the second fixing element 320.

In some embodiments, the first fixing member 310 has a ring-shaped structure. The edge of the composite member is attached to the inner edge of the first fastening member 310. For example, the first fixing member 310 has a circular ring structure. It is understood that, in other embodiments, the structure and shape of the first fixing member 310 are not limited to the above, and the structure and shape of the first fixing member 310 may also be a square ring structure, an elliptical ring structure, or the like.

In some embodiments, the second fixing member 320 has a ring-shaped structure. The edge of the composite member is attached to the inner edge of the second attachment member 320. For example, the second fixing member 320 has a circular ring structure. It is understood that, in other embodiments, the structure and shape of the second fixing member 320 are not limited to the above, and the structure and shape of the second fixing member 320 may also be a square ring structure, an elliptical ring structure, or the like.

Preferably, as shown in fig. 1, the first fixing member 310 has a substantially circular ring-shaped structure in structure and shape, and the second fixing member 320 has a substantially circular ring-shaped structure in structure and shape. The fixing device 300 formed by the first fixing element 310 and the second fixing element 320 is substantially a circular ring structure, and it should be noted that, when the fixing device 300 formed by the first fixing element 310 and the second fixing element 320 is substantially a circular ring structure, the shape of the composite element is adapted to the shape of the fixing device 300, and at this time, the outer edge of the composite element is connected with the inner edge of the fixing device 300 in a matching manner.

In some embodiments, referring to fig. 2, the outer circumferential surface of the first fixing member 310 is provided with an annular groove 311 in a surrounding manner, and it should be noted that the annular groove 311 surrounds at least one circumference of the outer circumferential surface of the first fixing member 310 in the surrounding manner. The inner circumferential surface of the second fixing element 320 is provided with an annular boss 321 in an annular manner, and it should be noted that the annular boss 321 surrounds the inner circumferential surface of the second fixing element 320 at least once. The first fixing member 310 is disposed inside the second fixing member 320, and the annular groove 311 is engaged with the annular protrusion 321. The fixing device 300 is provided with the annular groove 311 on the first fixing member 310 and the annular boss 321 on the second fixing member 320 to realize the clamping fit connection, and the connection relationship between the first fixing member 310 and the second fixing member 320 is simple, so that the detachment and installation are easy to realize. When the water-based film 100 and/or the sound-transmitting film 200 needs to be replaced, only the first fixing member 310 and the second fixing member 320 need to be separated by force, and when the water-based film 100 and/or the sound-transmitting film 200 is installed again, only the first fixing member 310 needs to be arranged in the second fixing member 320, and the first fixing member 310 and the second fixing member 320 need to be fastened by force. It should be noted that the whole of the first fixing member 310, the second fixing member 320 and the composite member can be used as a consumable, and can be used as a disposable product.

In some embodiments, referring to fig. 2, the first fixing member 310 is further provided with a first step structure 312 around the outer circumferential surface. The inner circumferential surface of the second fixing member 320 is further surrounded by a second stepped structure 322 capable of cooperating with the first stepped structure 312. The first step structure 312 is snap-fit with the second step structure 322.

Preferably, as shown in fig. 2, the first stepped structure 312 extends toward the outside of the first fixing member 310, the first stepped structure 312 includes at least two steps, the second stepped structure 322 extends toward the outside of the second fixing member 320, and the second stepped structure 322 includes at least two steps. Since the first stepped structure 312 and the second stepped structure 322 need to be adapted, the step of the first stepped structure 312 faces downward, and the step of the second stepped structure 322 faces upward, so that a snap-fit relationship is formed between the first stepped structure 312 and the second stepped structure 322.

Preferably, the first fixing member 310 has a certain elasticity. The first fixing member 310 has a certain elasticity and can be appropriately deformed so as to be engaged with the second fixing member 320. In order to realize the elastic deformation function of the first fixing member 310, the first fixing member 310 may be made of rubber, resin, metal, or the like. Preferably, the first fixing member 310 may be a rubber ring. The rubber ring can satisfy the structural strength of first mounting 310 on the one hand, and on the other hand can reduce material cost, reduces the preparation cost of whole coupling membrane module 10. The thickness of the first fixing member 310 may be set according to actual needs, and the thickness of the first fixing member 310 may satisfy the deformation and structural strength of the first fixing member 310.

The second fixing member 320 has a certain elasticity. The second fixing member 320 has a certain elasticity and can be appropriately deformed so as to be engaged with the first fixing member 310. In order to realize the elastic deformation function of the second fixing member 320, the second fixing member 320 may be made of rubber, resin, metal, or the like. Preferably, the second fixing member 320 may be a rubber ring. The rubber ring can satisfy the structural strength of first mounting 310 on the one hand, and on the other hand can reduce material cost, reduces the preparation cost of whole coupling membrane module 10. The thickness of second mounting 320 can set up according to actual need, and the thickness of second mounting 320 satisfies that second mounting 320 can be deformed and structural strength can.

The first fixing element 310 with elasticity and the second fixing element 320 with elasticity can be deformed to be connected and matched with each other.

In some embodiments, coupling membrane assembly 10 further includes a fixed abutment 400. The fixed docking member 400 is coupled to an outer circumferential surface of the second fixing member 320. For example, in one embodiment, the fixed interface element 400 is bent in a hook-like configuration, preferably, the fixed interface element 400 is bent outward. The fixed docking piece 400 is used to connect a high-intensity focused ultrasound probe of a high-intensity focused ultrasound device.

It will be appreciated that in other embodiments, the fixed interface 400 may be of other configurations and shapes. The function of the fixed docking member 400 is to enable connection with a high-intensity focused ultrasound probe of the high-intensity focused ultrasound device, and therefore, only the fixed docking member 400 needs to be connected with the high-intensity focused ultrasound probe of the high-intensity focused ultrasound device. For example, in a specific embodiment, the fixed docking piece 400 may also be a snap, and correspondingly, a snap ring may be disposed on the high-intensity focused ultrasound probe of the high-intensity focused ultrasound device, and the fixed docking piece 400 and the high-intensity focused ultrasound probe of the high-intensity focused ultrasound device may be connected by the snap ring and the snap ring. For example, in another embodiment, the fixed docking member 400 may be a locking ring, the locking ring is provided with a locking hole, correspondingly, the locking ring may be provided on the high-intensity focused ultrasound probe of the high-intensity focused ultrasound device, the locking ring is also provided with a locking hole, and the fixed docking member 400 and the high-intensity focused ultrasound probe of the high-intensity focused ultrasound device may be connected by two locking rings and a bolt.

In some embodiments, the first fixture 310 is provided with a recess for receiving at least a portion of the fixed interface 400 at a position corresponding to the fixed interface 400. The relief recess is located at the edge of the first fixing member 310, and the fixing interface member 400 protrudes outwards. The arrangement of the receding concave part is used for accommodating a part of the structure of the fixed butt joint piece 400, and the receding concave part is used for vacating at least a part of the accommodating space for the fixed butt joint piece 400, so that excessive outgoing of the fixed butt joint piece 400 is avoided, the structure of the whole coupling membrane module 10 is more compact, and the space occupied by the coupling membrane module 10 is reduced. It should be noted that, a part of the fixed docking piece 400 is located in the receding recess, and the other part of the fixed docking piece 400 protrudes from the edge of the first fixing member 310, so that on one hand, a part of the fixed docking piece 400 can be accommodated, and on the other hand, the part of the fixed docking piece 400 protruding from the edge of the first fixing member 310 is convenient for being connected with the edge of the first fixing member 310, thereby facilitating the operation of a worker.

In some embodiments, the number of fixed abutments 400 is multiple. A plurality of fixed abutments 400 are arranged at equal intervals. Referring to fig. 1, the fixed docking member 400 is shown as four in number. It is understood that in other embodiments, the number of the fixing abutments 400 is not limited to the above number, and the number of the fixing abutments 400 may also be other numbers, such as two, three, five, etc., and particularly, the edges of the first fixing member 310 may be adjusted as needed, and is not further limited herein.

In some embodiments, coupling membrane assembly 10 further comprises strength reinforcement 500. The strength reinforcement 500 is disposed between the aqueous membrane 100 and the sound-transmissive membrane 200. The aqueous film 100, the strength reinforcement 500, and the sound-transmitting film 200 are sequentially stacked. The aqueous membrane 100, the strength reinforcement 500, and the sound-transmitting membrane 200 are arranged in an overlapping manner to form a composite.

In some embodiments, the strength reinforcement 500 is a mesh structure. The strength reinforcement member 500 having a mesh structure can improve the strength of the composite member composed of the water-based and the sound-transmitting membrane 200; on the other hand, the strength reinforcement member 500 with the mesh structure can give way to the sound wave, and the mesh of the strength reinforcement member 500 with the mesh structure can be penetrated by the ultrasonic wave, so that the sound attenuation is reduced.

In some embodiments, strength enhancer 500 includes a plurality of reinforcing filaments 510. The mesh structure of the strength reinforcement 500 may be woven from a plurality of reinforcing filaments 510, for example, in one embodiment, the plurality of reinforcing filaments 510 are interwoven along a first direction and a second direction to form a mesh structure, and the first direction and the second direction may be perpendicular to each other or may have an angle. The mesh shape of the plurality of reinforcing filaments 510 interwoven along the first direction and the second direction to form the mesh structure may be square holes, prismatic holes, etc. The mesh sizes of the plurality of reinforcing wires 510 interwoven along the first direction and the second direction to form the mesh structure may be equal.

Referring to fig. 2, the mesh shape of the mesh structure formed by interweaving a plurality of reinforcing wires 510 along the first direction and the second direction is substantially a square structure, and the edges of the mesh structure are partially non-square structures due to position limitation, but the mesh shape of the main part of the mesh structure is not affected to be square structure.

The mesh number of the mesh structure is not limited, and can be appropriately set and adjusted as needed. The density of the plurality of reinforcing fibers 510 when they are interlaced along the first direction and the second direction may be set according to actual needs, for example, the number of meshes per unit area may be adjusted according to actual testing requirements. In production, multiple sizes of strength reinforcement 500 may be produced, with different sizes of strength reinforcement 500 having different mesh sizes. Therefore, the coupled membrane module 10 formed by compounding the water-based membrane 100, the sound-transmitting membrane 200 and the strength reinforcement 500 has a plurality of specifications, and the selection range is expanded.

In some embodiments, the shape of the strength enhancer 500 conforms to the shape of the aqueous membrane 100, the shape of the sound permeable membrane 200. When the shape of the aqueous membrane 100 and the shape of the sound-transmitting membrane 200 are circular, the shape of the strength reinforcement 500 is circular. The provision of the strength reinforcement 500 can improve the structural strength of the aqueous membrane 100. According to the coupling membrane assembly 10, the strength reinforcing piece 500 is added, so that the balance between the material strength and the sound transmission characteristic is realized, the strength reinforcing piece 500 improves the structural strength of the water-based membrane 100, and meanwhile, the sound attenuation can be reduced by matching with the sound transmission membrane 200.

In one particular embodiment, referring to fig. 1, the aqueous membrane 100 and the acoustically transparent membrane 200 are circular in configuration. The fixture 300 is in the form of a ring structure.

Another embodiment of the present invention also provides a high intensity focused ultrasound device.

A high-intensity focused ultrasound device comprises the coupling membrane assembly 10, and the coupling membrane assembly 10 is connected with a high-intensity focused ultrasound probe of the high-intensity focused ultrasound device through a fixed butt piece 400 arranged on the coupling membrane assembly.

The coupling membrane assembly 10 of the present invention can achieve a balance between material strength and sound transmission characteristics, achieve the dual purposes of low sound attenuation and high product strength, and simultaneously, can have a good coupling effect with the skin of a patient. Specifically, the coupling membrane assembly 10 of the present invention is formed by compounding the aqueous membrane 100 and the sound-transmitting membrane 200 to form a composite member, which can improve the strength between the aqueous membrane 100 and the sound-transmitting membrane 200, and the aqueous membrane 100 and the sound-transmitting membrane 200 cooperate with each other, so that on one hand, the structural strength of the coupling membrane assembly 10 is improved, and on the other hand, the transmission of sound waves is not affected, sound attenuation is not caused, and the balance between the material strength and the sound-transmitting characteristics is realized. In addition, the coupling membrane assembly 10 of the present invention can be well coupled to the skin of a patient without the need for a conventional solid coupling agent, and has a good coupling effect.

In the foregoing embodiments, the descriptions of the respective embodiments have respective emphasis, and for parts that are not described in detail in a certain embodiment, reference may be made to related descriptions of other embodiments.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the present invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A coupling membrane assembly, comprising:

an aqueous film (100);

an acoustically transparent membrane (200) disposed in superimposition with the aqueous membrane (100) to form a composite; and

a fixture (300) for fixing the composite.

2. The coupling membrane assembly of claim 1, wherein the fixture (300) comprises a first fixture (310) and a second fixture (320), the first fixture (310) being cooperatively connected with the second fixture (320), the composite being connected to the first fixture (310) and/or the second fixture (320).

3. The coupling film assembly of claim 2, wherein the first fixture (310) is of an annular configuration and the second fixture (320) is of an annular configuration;

the outer peripheral surface of the first fixing piece (310) is annularly provided with an annular groove (311), the inner peripheral surface of the second fixing piece (320) is annularly provided with an annular boss (321), the first fixing piece (310) is arranged in the second fixing piece (320), and the annular groove (311) is embedded and matched with the annular boss (321).

4. The coupling membrane assembly of claim 3, wherein the outer circumferential surface of the first fixing member (310) is further provided with a first step structure (312) and the inner circumferential surface of the second fixing member (320) is further provided with a second step structure (322), and the first step structure (312) is in snap fit with the second step structure (322);

and/or the fixing device further comprises a fixing butt joint piece (400), wherein the fixing butt joint piece (400) is connected to the outer peripheral surface of the second fixing piece (320), and the fixing butt joint piece (400) is bent to be of a hook-shaped structure.

5. The coupling membrane assembly of claim 4, wherein the first fixing member (310) is provided with a recess for receiving at least a portion of the fixing interface member (400) at a position corresponding to the fixing interface member (400).

6. The coupling membrane assembly of any one of claims 1-5, further comprising a strength reinforcement (500), said strength reinforcement (500) being disposed between said aqueous membrane (100) and said sound-permeable membrane (200), said strength reinforcement, said aqueous membrane (100) and said sound-permeable membrane (200) being disposed in an overlapping manner and constituting said composite.

7. The coupling film assembly of claim 6, wherein the strength reinforcement (500) is a mesh structure, the strength reinforcement (500) comprising a plurality of reinforcing filaments (510), the plurality of reinforcing filaments (510) being interwoven along a first direction and a second direction to form the mesh structure.

8. The coupling film assembly of claim 7, wherein said first direction is perpendicular to said second direction.

9. The coupling membrane module according to any one of claims 1-5, 7-8, wherein said water-based membrane (100) and said sound-permeable membrane (200) are of circular configuration and said fixing means (300) are of circular configuration.

10. A high intensity focused ultrasound device comprising the coupling membrane assembly of any of claims 1-9, wherein the coupling membrane assembly is connected to the high intensity focused ultrasound device.