CN220632771U

CN220632771U - Transducer, electrode patch and system for human tumor treatment

Info

Publication number: CN220632771U
Application number: CN202321573329.8U
Authority: CN
Inventors: 杨泽宇; 郭仪; 薛迎港; 张冬梅
Original assignee: Chengdu Rotex Technology Co ltd
Current assignee: Chengdu Rotex Technology Co ltd
Priority date: 2023-06-19
Filing date: 2023-06-19
Publication date: 2024-03-22
Anticipated expiration: 2033-06-19

Abstract

The application relates to a transducer, electrode patch and system for human tumor treatment, the transducer includes: an insulating substrate; a first electrode layer disposed on the insulating substrate; a dielectric layer covering the first electrode layer; the packaging layer covers the dielectric layer; the insulating adhesive layer is arranged on the insulating substrate and used for connecting the packaging layer; the packaging layer comprises a central area and an edge area, the central area corresponds to the dielectric layer, the insulating adhesive layer is located between the edge area and the insulating substrate, the edge area is connected to the insulating substrate by the insulating adhesive layer, the packaging layer is tensioned, the dielectric layer and the first electrode layer are pressed towards the insulating substrate through the central area, the central area of the packaging layer is not prone to arching deformation, and then the central area of the packaging layer, the dielectric layer and the first electrode layer are kept pressed, so that air gap ionization phenomenon caused by tiny gaps between the layers is avoided, and the durability of the transducer is improved.

Description

Transducer, electrode patch and system for human tumor treatment

Technical Field

The application relates to the technical field of tumor treatment, in particular to a transducer, an electrode patch and a system for human tumor treatment.

Background

The technical means of tumor treatment are various, such as surgery treatment, radiation treatment, chemical drug treatment, molecular targeting treatment, immunotherapy, interventional treatment and the like, and the treatment modes have various defects, such as the need of treatment under specific environments of specific places, the damage to human bodies in different degrees, even the need of retaining drug delivery pipelines in the human bodies, and the problems of high treatment difficulty, high side effect, easy secondary injury and influence on normal life of the existing treatment modes exist.

At present, tumor electric field treatment is one of important research and development directions of tumor treatment because of the advantages of noninvasive, portable, easy operation, no need of specific environmental requirements and the like. The tumor electric field treatment can inhibit the mitosis process of cancer cells and induce apoptosis of cancer cells by applying an alternating electric field to the treatment site of human body to influence the aggregation of tumor tubulin and prevent the formation of spindle. Specifically, in the existing tumor electric field treatment, electrode patches are mainly attached to the body surface of a patient, for example, attached to opposite sides of a treatment site, and an alternating electric field is applied to the treatment site through electrode plates of transducers on the opposite sides, so that the purpose of tumor treatment is achieved. However, the existing "transducer" is short in service cycle and affected in use effect due to the lack of structural stability, so that the technical problem to be solved in the field is urgent to ensure the treatment effect, how to improve the durability of the transducer and ensure the use effect of the transducer.

Disclosure of Invention

Because the surface of the human body is not a plane, but is a curved surface with an indefinite curvature, fluctuation can also occur along with the movement of the human body, the transducer attached to the human body is easily influenced, a tiny gap is formed between a dielectric layer and an electrode layer, the structural stability of the transducer is influenced, in the electrifying treatment process, an air gap ionization phenomenon is easily formed at the tiny gap between the dielectric layer and the electrode layer, and the discharge is ignited, so that the electrode layer and the dielectric layer are damaged, and the durability of the transducer is influenced.

The application aims to provide a transducer, an electrode patch and a system for human tumor treatment, so as to improve the durability of the transducer.

Embodiments of the present application are implemented as follows:

in a first aspect, embodiments of the present application provide a transducer for tumor treatment in a human, comprising:

an insulating substrate;

a first electrode layer disposed on the insulating substrate;

a dielectric layer disposed on the first electrode layer;

an encapsulation layer covering the dielectric layer;

the insulating adhesive layer is arranged on the insulating substrate and used for connecting the packaging layer;

the packaging layer comprises a central area and an edge area, the central area corresponds to the dielectric layer, the insulating adhesive layer is located between the edge area and the insulating substrate, and the insulating adhesive layer connects the edge area to the insulating substrate so as to tension the packaging layer and compress the dielectric layer and the first electrode layer towards the insulating substrate through the central area.

The utility model provides a transducer for human tumour treatment, encapsulation layer and insulating substrate pass through the insulating glue layer to be connected and form integrated structure, including first electrode layer, dielectric layer encapsulation, wherein, the marginal zone of encapsulation layer is fixed by the insulating glue layer to make encapsulation layer tensioning, make the central zone of encapsulation layer be difficult for arching the deformation, and then make the central zone of encapsulation layer, dielectric layer, first electrode layer keep compressing tightly, in order to avoid appearing tiny space between layer and lead to the air gap ionization phenomenon, thereby improve transducer's durability.

In one embodiment of the present application, a side of the insulating glue layer facing the encapsulation layer is lower than a side of the dielectric layer facing the encapsulation layer.

In the technical scheme, the insulating adhesive layer and the dielectric layer have height differences, and the edge area of the packaging layer is adhered to the insulating adhesive layer to be favorable for tensioning the packaging layer, so that the central area of the packaging layer applies pretightening force to the dielectric layer and the first electrode layer, the compaction between the layers is ensured, and tiny gaps are avoided.

In one embodiment of the present application, the edge area is attached to a surface of the insulating glue layer facing the encapsulation layer.

In the technical scheme, the edge area and the insulating area are attached to one surface of the packaging layer, so that the difficulty of attaching operation is low, and the requirement of tensioning the packaging layer can be met.

In one embodiment of the present application, the insulating glue layer is disposed around the outer peripheral surface of the first electrode layer, and the insulating glue layer covers at least the outer peripheral surface of the first electrode layer.

In the technical scheme, the packaging layer and the insulating substrate form a sealed structure after being connected through the insulating adhesive layer, so that the purpose of compacting each layer is achieved, the dustproof and waterproof effects are achieved, the dielectric layer is prevented from being broken down due to moisture, meanwhile, the first electrode layer and the packaging layer are isolated, the first electrode layer and the packaging layer are prevented from being conducted, and the safety of the transducer is improved.

In one embodiment of the present application, the thickness of the insulating glue layer ranges from 0.1um to 1mm.

In the technical scheme, the thickness of the insulating adhesive layer with the thickness ranging from 0.1um to 1mm is easy to control, the defect is small, the adhesive layer with uniform thickness can be formed, the problem that the waterproof insulating effect is weakened due to local loss of the adhesive layer is avoided, the relatively good adhesion quality can be ensured, and relatively uniform tensile force is applied to the packaging layer.

In one embodiment of the present application, the width of the insulating glue layer is 0.2mm-10mm.

In the technical scheme, the adhesive stability is guaranteed by setting the width of the insulating adhesive layer to be 0.2mm-10mm, and then the tensioning packaging layer is guaranteed.

In an embodiment of the present application, the dielectric layer includes a dielectric layer body and a first coating layer, the dielectric layer body is disposed on the first electrode layer, the first coating layer is disposed on a surface of the dielectric layer body facing the packaging layer, and the central area is attached to the first coating layer.

In the above technical scheme, the dielectric layer is arranged to comprise the dielectric layer body and the first coating layer, and the first coating layer can improve the surface flatness of the dielectric layer body so as to relieve the problem that tiny gaps appear between the dielectric layer and the packaging layer and further improve the durability.

In one embodiment of the present application, a surface of the insulating adhesive layer facing the encapsulation layer is lower than a surface of the first coating layer facing the encapsulation layer.

In the technical scheme, the thickness of the insulating adhesive layer does not exceed the thickness of the first coating layer, so that a height difference exists between the insulating adhesive layer and the dielectric layer, and tensioning of the packaging layer is facilitated.

In one embodiment of the present application, the first plating layer has conductivity and ductility.

In the technical scheme, the first coating layer can conduct electricity, so that the first coating layer is connected with the packaging layer in a conducting manner, and because the first coating layer is tightly attached to the dielectric layer body, the problem that an air gap is ionized between the first coating layer which conducts electricity and the dielectric layer which does not conduct electricity and the problem that a tip discharge occurs between the first coating layer and the packaging layer in some cases can be avoided, so that the durability of the transducer is improved.

In one embodiment of the present application, the first plating layer is metallic gold, metallic titanium, or metallic aluminum.

In the technical scheme, the first coating layer made of metals such as gold, titanium, aluminum and the like has better ductility and conductivity.

In one embodiment of the present application, the dielectric layer further includes a second plating layer, the first plating layer is disposed between the second plating layer and the dielectric layer body, and at least the second plating layer has conductivity among the first plating layer and the second plating layer.

In the technical scheme, the dielectric layer body is sequentially provided with the first coating layer and the second coating layer in a laminated manner so as to improve the performance of the dielectric layer, wherein at least the second coating layer has conductivity so as to solve the problem that air gaps between the dielectric layer and the packaging layer are ionized.

In one embodiment of the present application, the first coating layer material is at least one selected from oxide, nitride, carbide, insulating high polymer, metallic gold, metallic aluminum, and metallic titanium; the second coating layer material is selected from metal gold or metal titanium.

In one embodiment of the present application, the transducer further comprises:

And a flexible conductive layer disposed between the dielectric layer and the encapsulation layer to fill a gap between the dielectric layer and the encapsulation layer.

In the technical scheme, the flexible conductive layer is arranged to fill the gap between the dielectric layer and the packaging layer, so that on one hand, the packaging layer can further abut against the dielectric layer and the first electrode layer through the flexible conductive layer; on the other hand, under the condition that the packaging layer is electrified, the problem of air gap ionization between the dielectric layer and the conductive packaging layer can be relieved; under the condition that the surface of the dielectric layer is provided with the conductive coating layer and the packaging layer is electrified, the problem of tip discharge between the coating layer with the conductive performance on the surface of the dielectric layer and the conductive packaging layer can be relieved.

In one embodiment of the present application, the encapsulation layer is a metal sheet.

In the above technical solution, the encapsulation layer of the metal sheet may improve the electrical contact of the transducer with the skin. Meanwhile, the packaging layer is made of the metal sheet, so that the packaging layer has larger hardness, strength and flexibility, and the middle area of the packaging layer can be better pressed against the dielectric layer and the first electrode layer.

In one embodiment of the present application, the encapsulation layer includes a conductive material layer and an insulating film layer, the insulating film layer is connected to the insulating substrate, the conductive material layer is disposed on the insulating film layer, and the conductive material layer is exposed to the insulating film layer at least in the central region.

In the technical scheme, the insulating film layer and the insulating substrate are similar in material, the insulating film layer and the insulating substrate can be well bonded, the insulating substrate and the packaging layer are guaranteed to be connected stably, and meanwhile, the conductive material layer plays a role in reinforcing the structural strength of the insulating film layer in the central area, so that the dielectric layer and the first electrode layer are convenient to compress.

In an embodiment of the present application, the edge area is turned towards the direction where the insulating substrate is located, and is attached to a surface of the insulating substrate facing away from the first electrode layer.

In the technical scheme, the packaging layer is folded and adhered to the back surface of the insulating substrate, so that the adhesion area is increased, the connection stability is improved, and the pressing of each layer is facilitated.

In one embodiment of the present application, the transducer further comprises:

the third coating layer is arranged on one side of the dielectric layer facing the insulating substrate, and the third coating layer is insulated.

In the technical scheme, the insulating property is improved by arranging the insulating third coating layer on one side of the dielectric layer facing the insulating substrate, so that the dielectric layer is prevented from breakdown.

In one embodiment of the present application, the dielectric strength of the third plating layer is greater than the dielectric strength of the dielectric layer.

In the technical scheme, the insulation strength of the third coating layer is larger than that of the dielectric layer, so that a good breakdown preventing effect is achieved.

In one embodiment of the present application, the insulating substrate is a flexible insulating material.

In the technical scheme, the insulating substrate is made of flexible insulating materials so as to adapt to human body activities and surface fluctuation of the human body, and the applicability is improved.

In a second aspect, embodiments of the present application provide an electrode patch for human tumor therapy, comprising a transducer for human tumor therapy according to any one of the first aspects.

In a third aspect, the present application provides a system for tumour therapy in a human comprising an electrode patch according to the second aspect for tumour therapy in a human.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered limiting the scope, and that other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic plan view of a transducer according to one embodiment of the present application;

FIG. 2 is a cross-sectional view of a transducer according to one embodiment of the present application;

FIG. 3 is a cross-sectional view of a transducer provided in accordance with another embodiment of the present application;

FIG. 4 is a cross-sectional view of a transducer provided in accordance with yet another embodiment of the present application;

FIG. 5 is a cross-sectional view of a transducer according to yet another embodiment of the present application;

FIG. 6 is a schematic diagram of an encapsulation layer according to an embodiment of the present application;

FIG. 7 is a schematic plan view of a transducer stealth encapsulation layer and a dielectric layer according to an embodiment of the present disclosure;

FIG. 8 is a schematic diagram of a package layer adhered to a side of an insulating substrate facing away from a first electrode layer according to an embodiment of the present disclosure;

FIG. 9 is a schematic diagram of a clamping package of an encapsulation layer according to an embodiment of the present application;

FIG. 10 is a simplified process flow diagram of a package layer clamping package according to one embodiment of the present application;

FIG. 11 is a schematic diagram illustrating an edge region of a package layer adhered to a side of an insulating substrate facing away from a first electrode layer according to an embodiment of the present disclosure;

fig. 12 is a schematic view of an edge area of a package layer adhered to a side of an insulating substrate facing away from a first electrode layer according to another embodiment of the present disclosure;

FIG. 13 is a schematic diagram of a transducer with a first plating layer according to an embodiment of the present disclosure;

Fig. 14 is a schematic diagram of the gap between the dielectric layer and the electrode layer of a prior art transducer.

Icon: 1-insulating substrate, 2-first electrode layer, 3-dielectric layer, 31-dielectric layer body, 32-first plating layer, 4-encapsulation layer, 41-conductive material layer, 42-insulating film layer, 5-insulating glue layer, 401-center region, 402-edge region, 4021-first part, 4022-second part.

Detailed Description

The following description of the technical solutions in the embodiments of the present application will be made clearly and completely with reference to the drawings in the embodiments of the present application, and it is apparent that the described embodiments are only some embodiments of the present utility model, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the utility model without making any inventive effort, are intended to fall within the scope of the utility model.

In the description of the present application, it should be understood that the terms "center," "width," "thickness," "upper," "lower," "inner," "outer," and the like indicate orientations or positional relationships based on the orientation or positional relationships shown in the drawings, and are merely for convenience in describing the technical solutions of the present application and simplifying the description, and do not indicate or imply that the devices or elements to be referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present utility model. Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more of the described features. In the description of the present application, the meaning of "a plurality" is two or more, unless explicitly defined otherwise.

In this application, the term "exemplary" is used to mean "serving as an example, instance, or illustration. Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. The following description is presented to enable any person skilled in the art to make and use the utility model. In the following description, details are set forth for purposes of explanation. It will be apparent to one of ordinary skill in the art that the present utility model may be practiced without these specific details. In other instances, well-known structures and processes have not been shown in detail to avoid obscuring the description of the present application with unnecessary detail. Thus, the present application is not intended to be limited to the embodiments shown, but is to be accorded the widest scope consistent with the principles and features disclosed herein.

Tumor electric field therapy is a new means for treating cancer, and utilizes the differential characteristics that most normal cells are in a resting stage and tumor cells proliferate rapidly (the electric field distribution in the normal cells is uniform, and the electric field distribution of the tumor cells is nonuniform), and applies an alternating current electric field with specific intensity to human focuses to inhibit tumor cell mitosis, so that tumor cells apoptosis and inhibit tumor growth.

The transducer is an important device in tumor electric field treatment, two or more transducers are attached to the surface of a human body, and alternating electric fields are applied to a treatment part through the two transducers with opposite positions, so that the purpose of treating tumors is achieved.

Because tumor electric field therapy can be performed anytime and anywhere, a human body can receive therapy and move at the same time, and the transducer attached to the human body is easily influenced, for example, as shown in fig. 14, a tiny gap is formed between a dielectric layer and an electrode layer, when the electric field therapy is electrified, an air gap ionization phenomenon is easily generated at the tiny gap to discharge and strike fire, so that the electrode layer and the dielectric layer are damaged, the durability of the transducer is influenced, and further the electric field intensity and the therapeutic effect are influenced.

The application provides a transducer, an electrode patch and a system for human tumor treatment, which are used for relieving the problems of spark caused by air gap ionization and deficient structural stability so as to improve the durability of the transducer.

As shown in fig. 1 and 2, the transducer comprises an insulating substrate 1, a first electrode layer 2, a dielectric layer 3, a packaging layer 4 and an insulating glue layer 5, which are arranged in this order.

The insulating substrate 1 is made of insulating materials, and serves as a base material for arranging layers, and plays a role in supporting and isolating.

The first electrode layer 2 is made of an electrically conductive material, which constitutes an electrode of the transducer that is connected to an alternating current source, in order to facilitate the passage of an alternating current electrical signal through the first electrode layer 2 to the transducer. In some embodiments, the first electrode layer 2 may be a thin and flexible metal layer, such as 0.005mm to 1mm thick metal copper foil, to allow the first electrode layer 2 to be flexible and to facilitate bending, thereby allowing the transducer to be entirely bent and fully proximate to the skin surface of the human body. It will be appreciated that the first electrode layer 2 may also be made of other metallic or non-metallic materials, such as metallic silver foil, conductive graphite or conductive glue, etc.

The first electrode layer 2 is provided on the insulating substrate 1. Alternatively, the insulating substrate 1 and the first electrode layer 2 form a circuit board, and the first electrode layer 2 may refer to a corresponding metal layer on the circuit board, for example, a part of copper foil area is exposed on the circuit board as the first electrode layer 2, and a power interface of the circuit board is connected with an ac power supply, so as to simplify an electrical connection structure of the transducer.

In some embodiments, the insulating substrate 1 may be provided as a flexible insulating material to accommodate body movements and body surface undulations, improving the usability. For example, the insulating substrate 1 adopts a flexible high polymer insulating film such as PI (Polyimide), PET (polyethylene glycol terephthalate, polyethylene terephthalate), PP (polypropylene), PMMA (polymethyl methacrylate ) and the like, so that the insulating substrate 1 has flexibility and a thinner thickness, and the overall thickness of the transducer can be thinner and lighter in weight, thereby facilitating the firm attachment of the transducer to a human body.

For example, the insulating substrate 1 is a flexible high polymer insulating film such as polyimide or polyester film, and the insulating substrate 1 and the first electrode layer 2 form a flexible circuit board, so that the transducer can be flexibly bent while simplifying the electrical connection structure of the transducer.

The dielectric layer 3 is made of insulating material, and can prevent current from flowing through, so that the current connected to the first electrode layer 2 of the transducer is prevented from directly acting on a human body.

In some embodiments, the dielectric layer 3 may be made of an organic material or an inorganic material, such as ceramic, glass, mica, polypropylene, polystyrene, polyethylene terephthalate, or the like.

Preferably, the material of the dielectric layer 3 may comprise one or more of poly (vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene), poly (vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene) or a double bond polymer of poly (vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene) or vinylidene fluoride, which has a higher dielectric constant and thus helps to increase the capacitance of the transducer with a certain thickness and area of the dielectric layer 3, thereby better applying the tumour therapy alternating electric field to the patient treatment site.

In some embodiments, the thickness of the dielectric layer 3 is 1um to 10um. Preferably, the thickness of the dielectric layer 3 is 2um to 8um. The thickness of the dielectric layer 3 is within the above range, so that the transducer has high capacitance, and the phenomenon of breakdown of the transducer caused by the thinner thickness of the dielectric layer 3 is avoided.

In some embodiments, the dielectric layer 3 is formed on the first electrode layer 2 by spin coating, doctor blading, atomization, casting or screen printing, etc. using the first electrode layer 2 as a substrate; or other functional layers (such as waterproof improvement, conductivity improvement, adhesion improvement, flatness improvement and the like) are arranged on the surface of the electrode layer, which is away from the insulating substrate 1, and the dielectric layer 3 is formed on the other functional layers arranged on the first electrode layer 2 in a spin coating, knife coating, atomization, tape casting or screen printing mode and the like.

In other embodiments, the dielectric layer 3 is first formed into a finished film and then attached to the first electrode layer 2 or to other functional layers disposed on the first electrode layer 2.

The encapsulation layer 4 is a structure for encapsulating the dielectric layer 3 and the first electrode layer 2 in cooperation with the insulating substrate 1. The encapsulation layer 4 comprises a central region 401 and an edge region 402, wherein the central region 401 corresponds to the dielectric layer 3 and the edge region 402 extends beyond the edge of the dielectric layer 3.

The insulating glue layer 5 is a material for bonding the layers of the transducer, for example, a chemical glue, such as epoxy, polyurethane, acrylic, silicone rubber, or a composite double sided adhesive material composed of an insulating material and an adhesive.

The insulating glue layer 5 is located between the edge area 402 and the insulating substrate 1, and the insulating glue layer 5 connects the edge area 402 to the insulating substrate 1, so that the packaging layer 4, the insulating substrate 1 and the insulating glue layer 5 form a packaging structure, and at least the first electrode layer 2 and the dielectric layer 3 are packaged in the packaging structure, so that all layers form a whole, and all layers are prevented from being separated. Because the edge area 402 of the packaging layer 4 is fixed by the insulating adhesive layer 5 and the packaging layer 4 is tensioned, the central area 401 of the packaging layer 4 is not easy to arch and deform, so that the central area 401 is prevented from arching and deforming to cause the packaging layer 4, the dielectric layer 3 and the first electrode layer 2 to loosen, the central area 401, the dielectric layer 3 and the first electrode layer 2 of the packaging layer 4 are always kept pressed, the structural stability of the transducer is improved, tiny gaps between the layers are avoided, air gap ionization phenomenon is avoided, and the durability of the transducer is improved.

The encapsulation layer 4 may also be provided with conductive properties to act as a second electrode layer of the transducer to connect to an ac power source, i.e. one of the first electrode layer 2 and the encapsulation layer 4 is connected to an ac power source, the other being attached to the human body.

In some embodiments, as shown in fig. 3, the encapsulation layer 4 comprises a conductive material, such as one or more of a metal sheet, a plating layer, a flexible circuit board, conductive silicone, or conductive paper. The encapsulation layer 4 is laid flat on the skin-facing side of the dielectric layer 3 (or the side of the dielectric layer 3 facing away from the first electrode layer).

In other embodiments, the encapsulation layer 4 includes a conductive material layer 41 and an insulating film layer 42, the insulating film layer 42 covers the dielectric layer 3, the conductive material layer 41 is disposed on the insulating film layer 42, and the conductive material layer 41 is exposed on the insulating film layer 42 at a position corresponding to the dielectric layer 3 on the insulating film layer 42 so as to be correspondingly attached to the dielectric layer 3. Wherein the conductive material layer 41 and the insulating film layer 42 may together form a circuit board to facilitate electrical connection of the encapsulation layer 4 with an ac power source. Preferably, the insulating film layer 42 may be made of a flexible material, for example, a flexible high polymer insulating film such as polyimide or mylar, so that the encapsulation layer 4 is a flexible printed circuit board in order to make the transducer flexibly bendable while simplifying the electrical connection structure of the transducer.

In embodiments where the encapsulation layer 4 is entirely made of a conductive material, both the central region 401 and the edge regions 402 are of a conductive material, as shown in fig. 2.

In the embodiment in which the encapsulation layer 4 is formed by compounding the conductive material layer 41 and the insulating film layer 42, as shown in fig. 3, at the position of the central region 401, the conductive material layer 41 is exposed to the insulating film layer 42 so that the conductive material layer 41 is bonded to the dielectric layer 3.

In order to improve the electrical contact of the transducer with the body in order to efficiently transfer the electrical signal and to improve the electric field distribution uniformity, in the embodiment in which the encapsulation layer 4 is formed by compounding the conductive material layer 41 and the insulating film layer 42, as shown in fig. 4, the conductive material layer 41 is exposed not only to the side of the insulating film layer 42 facing the dielectric layer 3 but also to the side of the insulating film layer 42 facing away from the dielectric layer 3, so that the conductive material layer 41 is adhered to the dielectric layer 3 while being adhered to the skin, at the position of the central region 401.

Illustratively, in some embodiments, as to the manner in which the conductive material layer 41 is exposed to the insulating film layer 42, as shown in fig. 5, the conductive material layers 41 are provided on both sides of the insulating film layer 42, respectively, and holes are perforated on the insulating film layer 42 so that the conductive materials on both sides are conductively connected.

Alternatively, in other embodiments, as shown in fig. 6, an insulating film layer 42 is covered on a surface of the conductive material layer 41 facing the dielectric layer 3, where the insulating film layer 42 is located in the edge region 402. Since the insulating film 42 is more similar to the material of the insulating substrate 1, the edge region 402 is more easily connected to the insulating substrate 1; while in the central region 401 the layer of conductive material 41 is in contact with the dielectric layer 3, while the side of the layer of conductive material 41 facing away from the dielectric layer 3 is in contact with the skin. Wherein the conductive material layer 41 is raised in the central area 401 to ensure that the conductive material layer 41 is able to closely fit the dielectric layer 3.

Further, as shown in fig. 2, the surface of the insulating adhesive layer 5 facing the encapsulation layer 4 is lower than the surface of the dielectric layer 3 facing the encapsulation layer 4, so that the insulating adhesive layer 5 and the dielectric layer 3 have a height difference H, and the edge area 402 of the encapsulation layer 4 is adhered to the insulating adhesive layer 5 to be beneficial to tensioning the encapsulation layer 4, so that the central area 401 of the encapsulation layer 4 applies a pretightening force to the dielectric layer 3 and the first electrode layer 2, and compression between the layers is ensured, so that tiny gaps are avoided.

As shown in fig. 2, the width L of the insulating glue layer 5 is preferably 0.2mm-10mm, ensuring the adhesion stability and thus the tensioning of the encapsulation layer 4.

The thickness D of the insulating glue layer 5 may be chosen to be 0.1um-1mm. The thickness of the insulating adhesive layer 5 with the thickness ranging from 0.1um to 1mm is easy to control, the defect is small, the adhesive layer with uniform thickness can be formed, the relatively uniform tensile force applied to the packaging layer 4 and the relatively good adhesion quality are ensured, and the problem that the waterproof insulating effect is weakened due to the local defect of the adhesive layer is also avoided. Preferably, the thickness of the insulating adhesive layer 5 ranges from 0.1um to 10um, so that the transducer has a thinner thickness and meets the requirement of human deformation.

Preferably, the insulating adhesive layer 5 is a medical pressure-sensitive adhesive with a thickness ranging from 0.1mm to 1mm. The medical pressure-sensitive adhesive has good adhesive property, can form a firm bonding relation with the surfaces of various materials, is not easy to fall off, and can ensure the stability of the transducer in the use process; the medical pressure-sensitive adhesive has better flexibility and stretchability, can adapt to the requirements of different parts, can change the shape according to the movement of the human body part, and improves the use comfort of the transducer; the medical pressure-sensitive adhesive is also a nontoxic, non-irritating and pollution-free adhesive, and cannot cause harmful effects on human bodies. And the medical pressure-sensitive adhesive with the thickness of 0.1mm-1mm not only can be firmly bonded and nontoxic, but also can ensure the flexibility better and improve the use comfort of the transducer.

There are various ways to attach the edge area 402 of the encapsulation layer 4 to the insulating glue layer 5.

In some embodiments, the edge region 402 is attached to a side of the insulating glue layer 5 facing the encapsulation layer 4. Through laminating marginal zone 402 and the one side towards encapsulation layer 4 of insulating glue film 5, paste the operation degree of difficulty lower, and can satisfy the demand of tensioning encapsulation layer 4. In a specific operation, it is only necessary to tension the encapsulation layer 4 and adhere the edge area 402 of the encapsulation layer 4 to the insulating adhesive layer 5.

The insulating adhesive layer 5 may be distributed along the periphery of the first electrode layer 2, so as to achieve the functions of tensioning and fixing the encapsulation layer 4, and avoid micro gaps between layers.

In some embodiments, as shown in fig. 2 and 7, an insulating adhesive layer 5 is disposed around the outer circumferential surface of the first electrode layer 2, and the insulating adhesive layer 5 covers at least the outer circumferential surface of the first electrode layer 2. The packaging layer 4 and the insulating substrate 1 are connected through the insulating adhesive layer 5 to form a sealed structure, so that the waterproof and dustproof sealing effect is achieved. Therefore, the purpose of compacting each layer is achieved, dust is prevented from being discharged, the dielectric layer 3 is prevented from being broken down by moisture, the first electrode layer 2 is prevented from being conducted with the packaging layer 4, and safety is improved.

In other embodiments, as shown in fig. 8, the edge area 402 includes a first portion 4021 and a second portion 4022, where the first portion 4021 is attached to a surface of the insulating adhesive layer 5 facing the encapsulation layer 4, and meanwhile, a surface of the insulating substrate 1 facing away from the first electrode layer 2 is also provided with the insulating adhesive layer 5, and the second portion 4022 extends outwards and is attached to a surface of the insulating substrate 1 facing away from the first electrode layer 2 after being folded, so that an attaching area of the encapsulation layer 4 is increased, encapsulation stability is better, and a tensioning force of the encapsulation layer 4 can be increased.

The encapsulation layer 4 in the embodiment of the present application is made of a ductile material, and the edge area 402 does not have cracks after being folded. For example, the encapsulation layer 4 is a metal sheet, so that the encapsulation layer 4 has a large hardness, strength and flexibility, so that the middle region of the encapsulation layer 4 can be better pressed against the dielectric layer 3 and the first electrode layer 2.

When the packaging layer 4 is made of a metal sheet, as shown in fig. 9, the packaging insulating substrate 1, the first electrode layer 2 and the dielectric layer 3 can be clamped and packaged by the first portion 4021 and the second portion 4022, so that interlayer gaps are further avoided, the durability of the transducer is improved, and the insulating adhesive layer 5 not only plays a role in connection, but also prevents the first electrode layer 2 from being conducted with the packaging layer 4. In the embodiment in which the encapsulation is clamped by the encapsulation layer 4, the insulating glue layer 5 may also have no connection effect, only an insulating isolation effect. Illustratively, as shown in fig. 10: step1, firstly, putting the packaging layer 4 on the surface of the dielectric layer 3; step2, then folding the second portion 4022 along the edge of the dielectric layer 3 by stamping or other processing, and then compressing the insulating substrate 1, the first electrode layer 2, the dielectric layer 3, and the encapsulation layer 4 in the axial direction; step3, finally, the second portion 4022 is pressed against the surface of the insulating substrate 1 facing away from the first electrode layer 2 by means of rolling, so that the encapsulation is achieved by the first portion 4021 and the second portion 4022 of the encapsulation layer 4. Each layer is pressed tightly along the axial direction, so that each layer is tightly attached, and after encapsulation is completed, the tightly attached state of each layer is kept through the clamping effect of the encapsulation layer 4, so that tiny gaps are avoided.

The metal sheet in the embodiment of the application can be formed in a stamping, shearing, laser cutting, mould pressing, physical deposition and other modes, for example, a metal raw material is placed on a workbench of a laser cutting machine, a metal sheet with a required shape and size is cut by using a high-energy laser beam, and deburring, polishing and the like are performed on the metal sheet, so that the surface of the metal sheet is flat and smooth. Further, the packaging layer 4 is made of stainless steel sheets or titanium sheets, and the titanium sheets and the food-grade stainless steel sheets are low in biotoxicity, wear-resistant, acid-base-resistant, corrosion-resistant, not easy to oxidize and rust, and have the effects of environmental protection and no harm to human bodies.

In some embodiments, when the edge area 402 of the encapsulation layer 4 has the insulating film layer 42, as shown in fig. 11 and 12, the insulating adhesive layer 5 may be disposed on only a side of the insulating substrate 1 facing away from the first electrode layer 2, so as to adhere the edge area 402 to the insulating substrate 1.

In some embodiments, as shown in fig. 13, the dielectric layer 3 includes a dielectric layer body 31 and a first coating layer 32, the dielectric layer body 31 is disposed on the first electrode layer 2, the first coating layer 32 is disposed on a surface of the dielectric layer body 31 facing the encapsulation layer 4, and the central region 401 is attached to the first coating layer 32.

The dielectric layer body 31 is made of dielectric material and can prevent current from flowing. The dielectric layer body 31 is formed by the above-mentioned method, or the above-mentioned finished film is adopted, so that the requirement of increasing capacitance is met by reducing the thickness of the dielectric layer 3, however, when the thickness of the dielectric layer 3 is set to be thinner, the thickness uniformity is difficult to control, and a tiny gap is easy to occur between the dielectric layer body 31 and the first electrode layer 2.

The first coating layer 32 is a coating film formed on the surface of the dielectric layer body 31, and is used for making up the surface recess of the dielectric layer body 31, and improving the surface flatness of the dielectric layer body 31, so as to alleviate the problem of tiny gaps between the dielectric layer 3 and the encapsulation layer 4, and further improve the safety.

The first coating layer 32 may be at least one of non-conductive oxide, nitride, carbide, and insulating high molecular polymer, for example: oxides, nitrides, carbides (optionally at least one of silicon dioxide, silicon nitride, zirconium oxide, boron nitride, aluminum nitride, chromium carbide, and aluminum oxide); the insulating high molecular polymer (optionally at least one of silicone polymer, silazane polymer, polymethyl methacrylate (PMMA), polyimide (PI), polyethylene (PE), polyethylene terephthalate (PET), polyphenylene sulfide (PPS), polyurethane (PU), fluorinated ethylene propylene copolymer (FEP), fusible Polytetrafluoroethylene (PFA), ethylene-tetrafluoroethylene copolymer (ETFE), polyetheretherketone (PEEK), polysilazane, polycarbonate, silicone, fluoride material, and rubber). Illustratively, the silicon dioxide is formed into a first coating layer by PVD (Physical Vapor Deposition ) process.

In some embodiments, the first plating layer 32 has conductive properties, for example, the first plating layer 32 comprises a metallic material, graphite, or the like, wherein the metallic material is selected from one or a combination of several of Al, ti, au, ag, zn, cu, pt, cr, fe, sn or Ni. Air gap ionization generally occurs between a conductive structure and a non-conductive structure, that is, when there is a tiny gap between the conductive encapsulation layer 4 and the non-conductive dielectric layer 3, by disposing the conductive first coating layer 32 on the surface of the dielectric layer body 31, the first coating layer 32 is directly formed on the surface of the dielectric layer body 31, and a tiny gap is not easily generated between the conductive structure and the non-conductive structure, thereby avoiding the tiny gap between the conductive structure and the non-conductive structure, further avoiding the problem of air gap ionization, and improving the durability of the transducer. The central area 401 of the packaging layer 4 is tightly pressed against the dielectric layer 3, so that the central area 401 is tightly attached to the first coating layer 32, the electrical connectivity of the packaging layer 4 and the first coating layer 32 is ensured, and the influence of gaps between the central area 401 and the first coating layer 32 on the electric field distribution uniformity is avoided.

In the embodiment where the dielectric layer 3 includes the dielectric layer body 31 and the first coating layer 32, as shown in fig. 13, the surface of the insulating adhesive layer 5 facing the encapsulation layer 4 is lower than the surface of the first coating layer 32 facing the encapsulation layer 4, so that a height difference exists between the insulating adhesive layer 5 and the dielectric layer 3, which is favorable for tensioning the encapsulation layer 4, avoiding the deformation of the encapsulation layer 4 and ensuring that the layers below are compressed through the central region 401. "the side of the insulating adhesive layer 5 facing the encapsulation layer 4 is lower than the side of the first plating layer 32 facing the encapsulation layer 4" means that: the insulating adhesive layer 5 is higher than the surface of the first electrode layer 2 facing the packaging layer 4 and lower than the surface of the dielectric layer body 31 facing the packaging layer 4; alternatively, the insulating adhesive layer 5 is higher than the surface of the dielectric layer body 31 facing the encapsulation layer 4 and lower than the surface of the first coating layer 32 facing the encapsulation layer 4.

In addition, the dielectric layer 3 may further include a second plating layer, a third plating layer, and the like, and the plating layers may be stacked one on top of another. Illustratively, the dielectric layer 3 includes a first coating layer 32 and a second coating layer disposed on the dielectric layer body 31, wherein the first coating layer 32 is aluminum and the second coating layer is zinc. The aluminum coating layer has good ductility and conductivity, the zinc coating layer has good ductility and stable chemical property, and the zinc coating layer covers the surface of the aluminum coating layer to prevent the oxidation of the aluminum coating layer so as to maintain good conductivity. In addition, other conductive metallic or non-metallic materials are also within the scope of the present application, such as aluminum for the first coating layer 32, gold for the second coating layer, or titanium for the first coating layer 32.

In some embodiments, the dielectric layer 3 includes a dielectric layer body 31, a first plating layer 32, and a second plating layer sequentially stacked, at least the second plating layer of the first plating layer and the second plating layer has conductivity, that is, at least the second plating layer is a metal material, graphite, or the like, wherein the metal material is selected from one or a combination of several of A l, T i, au, ag, zn, cu, pt, cr, fe, sn, or N i.

In some embodiments, especially when a finished film made of a dielectric material is used as the dielectric layer body 31, the surface of the dielectric layer body 31 facing the first electrode layer 2 is easy to be uneven, and a coating layer may be disposed on the surface of the dielectric layer body 31 facing the first electrode layer 2 to improve the contact between the dielectric layer body 31 and the first electrode layer 2, avoid the problem of air gap ionization or improve other performances. Illustratively, the transducer further comprises a third plating layer disposed on a side of the dielectric layer facing the insulating substrate, the third plating layer having insulating properties to improve breakdown preventing properties of the dielectric layer. Optionally, the dielectric strength of the third plating layer is greater than the dielectric strength of the dielectric layer.

The material of the third coating layer is at least one of non-conductive oxide, nitride, carbide and insulating high molecular polymer, for example: oxides, nitrides, carbides (optionally at least one of silicon dioxide, silicon nitride, zirconium oxide, boron nitride, aluminum nitride, chromium carbide, and aluminum oxide); the insulating high molecular polymer (optionally at least one of silicone polymer, silazane polymer, polymethyl methacrylate (PMMA), polyimide (PI), polyethylene (PE), polyethylene terephthalate (PET), polyphenylene sulfide (PPS), polyurethane (PU), fluorinated ethylene propylene copolymer (FEP), fusible Polytetrafluoroethylene (PFA), ethylene-tetrafluoroethylene copolymer (ETFE), polyetheretherketone (PEEK), polysilazane, polycarbonate, silicone, fluoride material, and rubber). Illustratively, the silicon dioxide is formed into a third coating layer by PVD (Physical Vapor Deposition ) method.

In the above embodiment, when the plating layer is made of a metal material, by providing the metal plating layer on the surface of the dielectric layer body 31, such as the aluminum plating, the zinc plating, the gold plating, the titanium plating, and the like, the problem of ionization of the air gap between the dielectric layer and the encapsulation layer can be solved when the plating layer replaces the dielectric layer body 31 to be in contact with the charged encapsulation layer 4. When the coating layer is made of insulating materials, the silicon dioxide coating layer obtained by self-leveling and drying the solution can make up the uneven surface condition of the dielectric layer and avoid the problem of air gap ionization.

In some embodiments, the transducer further comprises a flexible conductive layer disposed between the dielectric layer 3 and the encapsulation layer 4 to fill the gap between the dielectric layer 3 and the encapsulation layer 4. The flexible conductive layer can be conductive paper, conductive adhesive, etc., which has a certain elastic modulus. On the one hand, when the packaging layer 4 is packaged and extruded, the flexible conducting layer is arranged to further ensure that the first electrode layer 2 and the dielectric layer 3 are compressed, so that the stability of the packaging structure is improved, gaps between the packaging layer and the dielectric layer can be eliminated, the electrical connectivity is improved, and the problem of air gap ionization or tip discharge is solved.

Further, in order to better implement the transducer in the embodiment of the present application, the present application further provides a tumor treatment electrode patch based on the transducer, where the tumor treatment electrode patch includes the transducer in any one of the embodiments described above. Because the tumor treatment electrode patch in the embodiment of the present application is provided with the transducer in the above embodiment, all the beneficial effects of the transducer are provided, and will not be described herein.

The transducer can set up coupling layer such as silica gel, hydrogel in the one side of pressing close to skin, as shown in fig. 2, sets up coupling layer with the encapsulation layer 4 and pastes in skin, guarantees on the one hand that the transducer can be comparatively firm paste in the human body, on the other hand can avoid the space between transducer and the human body, improves the electric contact of transducer and human body, improves electric field homogeneity, guarantees that the electric field can be directional and accurately act on the focus, promotes the treatment, simultaneously, can also improve the use travelling comfort.

Further, in order to better implement the tumor treatment electrode patch in the embodiment of the present application, the present application further provides a tumor treatment system based on the tumor treatment electrode patch, where the tumor treatment system includes the tumor treatment electrode patch according to any one of the embodiments described above. The tumor treatment system in the embodiment of the present application has all the beneficial effects of the transducer due to the transducer in the above embodiment, and will not be described herein.

In the foregoing embodiments, the descriptions of the embodiments are focused on, and the portions of one embodiment that are not described in detail in the foregoing embodiments may be referred to in the foregoing detailed description of other embodiments, which are not described herein again.

While the basic concepts have been described above, it will be apparent to those skilled in the art that the foregoing detailed disclosure is by way of example only and is not intended to be limiting. Although not explicitly described herein, various modifications, improvements, and adaptations of the present application may occur to one skilled in the art. Such modifications, improvements, and modifications are intended to be suggested within this application, and are therefore within the spirit and scope of the exemplary embodiments of this application.

Meanwhile, the present application uses specific words to describe embodiments of the present application. Reference to "one embodiment," "an embodiment," and/or "some embodiments" means that a particular feature, structure, or characteristic is associated with at least one embodiment of the present application. Thus, it should be emphasized and should be appreciated that two or more references to "an embodiment" or "one embodiment" or "an alternative embodiment" in various positions in this specification are not necessarily referring to the same embodiment. Furthermore, certain features, structures, or characteristics of one or more embodiments of the present application may be combined as suitable.

Likewise, it should be noted that in order to simplify the presentation disclosed herein and thereby aid in understanding one or more embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not intended to imply that more features than are presented in the claims are required for the subject application. Indeed, less than all of the features of a single embodiment disclosed above.

In some embodiments, numbers describing the components, number of attributes are used, it being understood that such numbers being used in the description of embodiments are modified in some examples by the modifier "about," approximately, "or" substantially. Unless otherwise indicated, "about," "approximately," or "substantially" indicate that the number allows for a 20% variation. Accordingly, in some embodiments, numerical parameters set forth in the specification and claims are approximations that may vary depending upon the desired properties sought to be obtained by the individual embodiments. In some embodiments, the numerical parameters should take into account the specified significant digits and employ a method for preserving the general number of digits. Although the numerical ranges and parameters set forth herein are approximations that may be employed in some embodiments to confirm the breadth of the range, in particular embodiments, the setting of such numerical values is as precise as possible.

For each patent, patent application publication, and other material, such as articles, books, specifications, publications, documents, etc., cited in this application, the entire contents of which are hereby incorporated by reference into this application, except for the application history documents which are inconsistent or conflict with the contents of this application, and for documents which have limited the broadest scope of the claims of this application (currently or hereafter attached to this application). It is noted that the descriptions, definitions, and/or terms used in the subject matter of this application are subject to such descriptions, definitions, and/or terms if they are inconsistent or conflicting with such descriptions, definitions, and/or terms.

Claims

1. A transducer for use in the treatment of a human tumor, comprising:

an insulating substrate;

a first electrode layer disposed on the insulating substrate;

a dielectric layer disposed on the first electrode layer;

an encapsulation layer covering the dielectric layer;

an insulating adhesive layer arranged on the insulating substrate;

2. The transducer for human tumor therapy according to claim 1, wherein a side of the insulating adhesive layer facing the encapsulation layer is lower than a side of the dielectric layer facing the encapsulation layer.

3. The transducer for treatment of human tumors of claim 2, wherein said edge region is bonded to a side of said insulating glue layer facing said encapsulation layer.

4. The transducer for human tumor therapy according to claim 1, wherein the insulating adhesive layer is disposed around the outer peripheral surface of the first electrode layer, the insulating adhesive layer covering at least the outer peripheral surface of the first electrode layer.

5. The transducer for human tumor therapy according to claim 1, wherein the thickness of the insulating glue layer ranges from 0.1um to 1mm.

6. The transducer for human tumor therapy according to claim 1, wherein the thickness of the insulating gel layer ranges from 0.1um to 10um.

7. The transducer for human tumor therapy according to claim 1, wherein the width of the insulating glue layer is 0.2mm-10mm.

8. The transducer for treatment of human tumors of claim 1, wherein the dielectric layer comprises a dielectric layer body and a first coating layer, the dielectric layer body is disposed on the first electrode layer, the first coating layer is disposed on a surface of the dielectric layer body facing the encapsulation layer, and the central region is attached to the first coating layer.

9. The transducer for treatment of human tumors of claim 8, wherein the side of said insulating gel layer facing said encapsulation layer is lower than the side of said first plating layer facing said encapsulation layer.

10. The transducer for human tumor therapy according to claim 8, wherein the first plating layer has electrical conductivity and ductility.

11. The transducer for human tumor therapy according to claim 10, wherein the first plating layer is metallic gold, metallic titanium, or metallic aluminum.

12. The transducer for treatment of human tumors of claim 8, wherein said dielectric layer further comprises a second plating layer, said first plating layer being disposed between said second plating layer and said dielectric layer body, at least said second plating layer being electrically conductive among said first and second plating layers.

13. The transducer for human tumor treatment according to claim 12, wherein the first plating layer material is at least one selected from the group consisting of oxides, nitrides, carbides, insulating polymers, metallic gold, metallic aluminum, metallic titanium; the second coating layer material is selected from metal gold or metal titanium.

14. The transducer for human tumor therapy according to claim 1, wherein the transducer further comprises:

15. The transducer for human tumor therapy according to claim 1, wherein the encapsulation layer is made of a metal sheet or a conductive nonmetallic material.

16. The transducer for human tumor therapy according to claim 1, wherein the encapsulation layer comprises a conductive material layer and an insulating film layer, the insulating film layer is connected to the insulating substrate, the conductive material layer is disposed on the insulating film layer, and the conductive material layer is exposed to the insulating film layer at least in the central region.

17. The transducer for treatment of human tumors of claim 1, wherein the edge region is folded over toward the direction in which the insulating substrate is located and is attached to the side of the insulating substrate facing away from the first electrode layer.

18. The transducer for human tumor therapy according to claim 1, wherein the transducer further comprises:

19. The transducer for human tumor therapy according to claim 18, wherein the dielectric strength of the third plating layer is greater than the dielectric strength of the dielectric layer.

20. The transducer for human tumor therapy according to claim 1, wherein the insulating substrate is a flexible insulating material.

21. An electrode patch for the treatment of human tumors, comprising a transducer according to any one of claims 1-20.

22. A system for the treatment of human tumors comprising the electrode patch for the treatment of human tumors of claim 21.