Tumor treating fields therapy system, and electrode patch

Abstract

Provided in the present application are a tumor treating fields therapy system, and an electrode patch. The electrode patch comprises an electrode array and several adhesive members. The electrode array comprises several electrode units through which an alternating-current signal passes and several connecting portions located between the several electrode units and connecting two adjacent electrode units, wherein each electrode unit comprises a main body portion, a conductive sheet arranged on the main body portion, and a dielectric layer covering the conductive sheet and electrically connected to the conductive sheet; two adjacent electrode units and a connecting portion electrically connecting the two electrode units form an electrode unit group; the several adhesive members respectively cover corresponding electrode unit groups; and when an alternating-current signal is applied to the electrode array, currents flowing through the respective electrode units have balanced current densities. In the tumor treating fields therapy system and the electrode patch that are provided in the present application, by utilizing the influence of the thickness of the dielectric layer on the current density, dielectric layers having different thicknesses are provided for electrode unit groups or electrode units at different positions of the electrode patch, such that the current densities of the electrode units are more uniform, thereby alleviating an edge effect.

Description

Tumor electric field therapy system and electrode patches Technical Field

[0001] This application relates to a tumor electric field therapy system and electrode patch for tumor treatment. Background Technology

[0002] Intermediate-frequency alternating electric field therapy has been proven to be an effective method for tumor treatment. It can interfere with the mitotic process of cancer cells and induce apoptosis, thus serving as a treatment for tumors. A tumor electric field therapy system typically includes an electric field generator, an adapter, and multiple pairs of electrode patches. The electric field generator produces alternating electrical signals, which are transmitted to the electrode patches via the adapter. The electrode patches are applied in pairs to the skin surface on opposite sides of the tumor site, and an alternating current signal is applied between each pair of electrode patches to non-invasively apply a tumor-treating electric field to the tumor site.

[0003] The effectiveness of electric field therapy on cancer cells varies depending on the strength of the electric field applied to the tumor tissue. Specifically, the stronger the electric field, the better the inhibition of cancer cell death and division. However, current technology has found that among several electrode units in an electrode patch, electrode units located at the edges of the electrode patch have lower impedance to the current flowing through them compared to electrode units located at the center of the electrode patch, resulting in higher current densities in the electrode units located at the edges. Furthermore, electrode units located at the corners or similar sharp bends of the electrode patch also have higher current densities than other electrode units located at the edges. Here, current density refers to volume current density, and according to Lenz's law, the heat of each electrode unit, Q=I, can be obtained. 2 Let Rt be the current density J, R be the resistance of the object, t be the time, and Q be the heat generated when the current flows through it. It is known that heat is directly proportional to current density. In electromagnetic field theory, the relationship between current density J and current intensity I is: I = ∫JdS, which indicates that the current intensity on surface S is equal to the flux of the current density through that surface. That is, the magnitude of the volume current density is directly proportional to the heat generated by the object; in other words, the greater the current density at a certain point on the object, the more heat is generated at that point. In electrode patches, the phenomenon where a large amount of current flows through electrode units located at their edges, especially at their corners, is called the edge effect. The edge effect leads to a large amount of heat generation and a rapid temperature rise in the corresponding electrode unit. Typically, after the temperature of the electrode unit rises, the tumor electric field therapy system will reduce the intensity of the alternating electrical signal applied to the electrode patch by the electric field generator to ensure the safety of the human body and avoid low-temperature burns.

[0004] The edge effect caused by the uneven current distribution of each electrode unit on the electrode patch can cause the temperature of the electrode units at the edge of the electrode patch, especially at the corners, to rise faster. These electrode units will reach the set safe threshold temperature first, which will cause the tumor electric field therapy system to reduce the current to avoid causing low-temperature burns to the patient. This also limits the maximum operating current of the electrode patch, reduces the intensity of tumor electric field therapy, and affects the tumor treatment effect.

[0005] Therefore, improvements are needed to existing tumor electric field therapy systems and electrode patches. Summary of the Invention

[0006] This application provides a tumor electric field therapy system and electrode patch that can alleviate the effects of edge effects.

[0007] Specifically, this application is achieved through the following technical solution: an electrode patch, comprising an electrode array and several adhesive components, wherein the electrode array comprises several electrode units through which AC signals pass and several connecting portions located between the electrode units and connecting adjacent electrode units, wherein each electrode unit comprises a main body, a conductive sheet disposed on the main body, and a dielectric layer covering the conductive sheet and electrically connected to the conductive sheet, wherein two adjacent electrode units and the connecting portions electrically connecting the two electrode units form an electrode unit group, and several adhesive components cover the corresponding electrode unit groups, wherein when an AC signal is applied, the current flowing through each electrode unit has a balanced current density.

[0008] According to one embodiment of the present invention, the thickness of the dielectric layer of the electrode unit in the plurality of electrode unit groups located on the periphery of the electrode array is greater than the thickness of the dielectric layer of the electrode unit in the plurality of electrode unit groups located at the center of the electrode array.

[0009] According to one embodiment of the present invention, the dielectric layer thickness of the electrode unit of a plurality of electrode unit groups located at the outer corner of the electrode array is greater than the dielectric layer thickness of the electrode unit of other plurality of electrode unit groups located on the periphery of the electrode array.

[0010] According to one embodiment of the present invention, the dielectric layer thickness ratio of the electrode units in each electrode unit group located at the center of the electrode array, the periphery of the electrode array but not at the corner, and the corner of the periphery of the electrode array is 1:2:3 or 1:1:3 or 5:7:10.

[0011] According to one embodiment of the present invention, the ratio of the thickness of the dielectric layer in each electrode unit group located at the center of the electrode array to the thickness of the dielectric layer in each electrode unit group located at the outer corner of the electrode array ranges from 1:3 to 1:2.

[0012] According to one embodiment of the present invention, the dielectric layer thickness of the electrode unit located at the center of the electrode array is 0.005 mm; the dielectric layer thickness of each electrode unit located at the outer corner of the electrode array is 0.01 mm to 0.015 mm.

[0013] According to one embodiment of the present invention, the dielectric layer thickness of the electrode unit located on the periphery of the electrode array but not at the corner is 0.005 mm to 0.10 mm.

[0014] According to one embodiment of the present invention, the dielectric layer of two electrode units in the same electrode unit group also covers the connection portion between the two electrode units and is continuously disposed and has the same thickness. Each electrode unit group has the same structure and size except for the different dielectric layer thicknesses.

[0015] According to one embodiment of the present invention, the adhesive is a hydrogel, and the adhesive has an extension dimension that extends beyond the corresponding edge of the main body on one side, the extension dimension being in the range of 0mm-3mm.

[0016] This application is also achieved through the following technical solution: an electrode patch, comprising an electrode array and a plurality of adhesive components, wherein the electrode array comprises a plurality of electrode units and a plurality of connecting portions located between the plurality of electrode units and connecting adjacent electrode units, wherein the plurality of adhesive components respectively cover the corresponding electrode unit, wherein the electrode unit comprises a main body, a conductive sheet disposed on the main body, and a dielectric layer covering the conductive sheet and electrically connected to the conductive sheet, wherein when an AC signal is applied, the current flowing through each electrode unit has a uniform current density.

[0017] According to one embodiment of the present invention, the thickness of the dielectric layer of a plurality of electrode units located on the periphery of the electrode array is greater than the thickness of the dielectric layer of a plurality of electrode units located at the center of the electrode array.

[0018] According to one embodiment of the present invention, the dielectric layer thickness of a plurality of electrode units located at the outer corner of the electrode array is greater than the dielectric layer thickness of a plurality of other electrode units located on the outer periphery of the electrode array but not at the corner.

[0019] This application also provides the following technical solution: a tumor electric field therapy system, which includes an electric field generator, an adapter and a plurality of the aforementioned electrode patches, wherein the adapter is electrically connected to the electric field generator and each of the electrode patches.

[0020] The tumor electric field therapy system and electrode patch of this application utilize the influence of dielectric layer thickness on current density. By setting dielectric layers of different thicknesses on electrode unit groups or electrode units at different positions of the electrode patch, the current density of each electrode unit can be more consistent, thus alleviating the problem of edge effect.

[0021] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0022] Figure 1 is a system block diagram of a tumor electric field therapy system according to one embodiment of the present application;

[0023] Figure 2 is a plan view of an electrode patch according to one embodiment of the present application;

[0024] Figure 3 is a plan view of the electrode array of the electrode patch shown in Figure 2;

[0025] Figure 4 shows a plan view of a single electrode unit group C in the electrode array, where the insulating cover film and dielectric layer have not yet been laid;

[0026] Figure 5 is similar to Figure 4, except that an insulating covering film has been further laid out;

[0027] Figure 6 is a schematic diagram of the basic model for modeling the electrode patch;

[0028] Figure 7 is a cross-sectional view at the edge of a single electrode unit in Figure 2, where the backing is omitted;

[0029] Figure 8 is a schematic diagram of the current density distribution of the electrode patch in Comparative Example 1;

[0030] Figure 9 is a schematic diagram of the current density distribution of the electrode patch in Comparative Example 3;

[0031] Figure 10 shows the peak current density data of each electrode unit in Comparative Examples 1 to 3;

[0032] Figure 11 is a comparison of the peak current density uniformity of each electrode unit in Comparative Examples 1 to 3.

[0033] Figure 12 is a schematic diagram of the current density distribution of the electrode patch in Comparative Example 4;

[0034] Figure 13 is a schematic diagram of the current density distribution of the electrode patch in Comparative Example 5;

[0035] Figure 14 is a schematic diagram of the current density distribution of the electrode patch in Comparative Example 6;

[0036] Figure 15 is a graph showing the peak value of the maximum current density for each electrode unit in Comparative Examples 3 to 6.

[0037] Figure 16 is a comparison of the peak current density uniformity of each electrode unit in Comparative Examples 3 to 6.

[0038] Figure 17 is a plan view of a single electrode unit group C of the electrode array shown in Figure 3;

[0039] Figure 18 is a distribution diagram of electrode unit group C of the electrode array shown in Figure 3.

[0040] Explanation of reference numerals in the attached figures:

[0041] Tumor electric field therapy system 100, electric field generator 10, adapter 20, electrode patch 30, backing 31, electrode array 32, electrode unit 320, connecting part 321, boundary line 3211, wiring part 322, gold finger 3221, temperature sensor 323, substrate 325, main body 3250, connecting strip 3251, conductive sheet 326, solder pad 327, insulating cover film 328, dielectric layer 329, adhesive part 33. Detailed Implementation

[0042] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this application. Rather, they are merely examples of apparatuses, systems, devices, and methods consistent with some aspects of this application.

[0043] Referring to Figure 1, the tumor electric field therapy system 100 includes an electric field generator 10, an adapter 20, and several pairs of electrode patches 30. The adapter 20 electrically connects the electric field generator 10 to each electrode patch 30. The electric field generator 10 generates an alternating current signal required for tumor treatment. The adapter 20 receives the alternating current signal output from the electric field generator 10 and transmits it to the electrode patches 30. The electrode patches 30 are attached to the patient's body surface corresponding to the tumor area, applying the alternating current signal to the patient's tumor area for tumor electric field therapy.

[0044] Referring to Figures 2 and 3, the electrode patch 30 includes a backing 31, an electrode array 32, and an adhesive piece 33. The side of the electrode patch 30 facing the patient's skin is defined as the front side. The electrode array 32 is attached to the front side of the backing 31, and the adhesive piece 33 is attached to the front side of the electrode array 32. The electrode array 32 includes twenty electrode units 320 spaced apart, several connecting portions 321 connecting adjacent electrode units 320, and wiring portions 322 connected to the adapter 20 via wires (not shown). The electrode array 32 transmits alternating current signals to the patient's tumor area through the electrode units 320.

[0045] The twenty electrode units 320 are arranged in a roughly four-row, six-column array. The first and fourth rows each have four electrode units 320, and the second and third rows each have six electrode units 320. The six electrode units 320 in each of the second and third rows correspond one-to-one and are arranged in roughly six columns. The four electrode units 320 in each of the first and fourth rows are located in the middle four columns. Two adjacent electrode units 320 in each row form an electrode unit group C. These twenty electrode units 320 form ten electrode unit groups C from left to right and top to bottom. Of these ten electrode unit groups C, electrode unit groups C1, C2, C9, and C10 are located at the four corners of the electrode patch 30; four electrode unit groups C3, C5, C6, and C8 are located on the periphery of the electrode patch 30 but not at the corners; and the remaining two electrode unit groups C4 and C7 are located at the center of the electrode patch 30. Some electrode units 320 are equipped with temperature sensors 323, with each electrode unit group C having at most one temperature sensor 323 on one electrode unit 320. The multiple electrode units 320 located in the same row are not distributed in a straight line, but rather roughly in an arc shape. The electrode units 320 in the first and second rows are distributed along an arc with upward-curving ends, while the electrode units 320 in the third and fourth rows are distributed along an arc with downward-curving ends. This shape design makes the electrode array 32 more suitable for application to the waist, improving the adhesion of the electrode patch 30 and preventing wrinkling during application.

[0046] Several adhesive pieces 33 cover each electrode unit 320 and are directly attached to the patient's body surface corresponding to the tumor. Conductive hydrogel is preferably used to enhance the fit and comfort of the electrode unit 320 to the patient's body surface. It also serves as a conductive medium, allowing alternating current signals passing through the electrode unit 320 to be applied to the patient's tumor site. In this embodiment, ten adhesive pieces 33 are used, corresponding to each electrode unit group C. The shape of the adhesive piece 33 is approximately the same as that of the electrode unit group C, but its size is slightly larger than that of the electrode unit group C and is approximately dumbbell-shaped. The thickness of the adhesive piece 33 is 0.1 mm to 1 mm.

[0047] The layered structure of the electrode array 32 is described below. Referring to Figure 3, the electrode array 32 includes a flexible substrate 325 arranged in a sheet shape. The substrate 325 serves as a supporting base plate and is integrally disposed in each electrode unit 320, each connecting portion 321, and each wiring portion 322. For ease of description, the portion of the substrate 325 corresponding to each electrode unit 320 is defined as the main body 3250, and the portion of the substrate 325 corresponding to each connecting portion 321 and wiring portion 322 is defined as the connecting strip 3251. Each main body 3250 and each connecting strip 3251 are different parts of the entire substrate 325. The thickness of the substrate 325 is 0.1mm-0.3mm, and the preferred material is polyimide, which has the characteristics of being lightweight, thin, flexible, and highly flexible. The main body 3250 is circular. The electrode unit 320 has a conductive sheet 326 on the main body 3250. The conductive sheet 326 is annular, with a thickness of 10μm to 50μm, and its outer diameter is smaller than the diameter of the main body 3250. Part of the main body 3250 has a pair of pads 327 for electrical connection with the temperature sensor 323. The pads 327 are also 10μm to 50μm thick. The electrode array 32 has several conductive traces (not shown) on the substrate 325. The wiring portion 322 has several gold fingers 3221. One conductive trace (not shown) for transmitting AC signals extends from a corresponding gold finger 3221 to the conductive sheet 326 of each main body 3250. Other conductive traces (not shown) for acquiring temperature measurement signals from the temperature sensor 323 extend from their respective gold fingers 3221 to the pads 327 of their respective main body 3250.

[0048] Referring to Figure 5, an insulating cover film 328 is integrally deposited on the front side of the substrate 325 of the electrode array 32. The thickness of the insulating cover film 328 is 10μm to 50μm, and the preferred material is polyimide. Note that each insulating cover film 328 can cover each conductive trace (not shown), but the conductive sheet 326, solder pad 327, and gold finger 3221 must be exposed. The insulating cover film 328 on the main body 3250 is hub-shaped, which serves to provide heat insulation and solder resist. Returning to Figure 4, the electrode array 32 also includes a dielectric layer 329. The dielectric layer 329 covers the insulating cover film 328 of each electrode unit group C and the conductive sheet 326 that is not covered by the insulating cover film 328, with each electrode unit group C as the target. That is, the dielectric layer 329 of the two electrode units 320 within the same electrode unit group C is continuously arranged, while the dielectric layer 329 between each electrode unit group C is disconnected, that is, the dielectric layer 329 is divided into multiple spaced regions. The dielectric layer 329 is electrically connected to and completely covers the conductive sheet 326 to prevent direct current conduction from occurring between the conductive sheet 326 and the human body, thus ensuring human safety. The dielectric layer 329 is a polymer dielectric layer with high dielectric constant and low dielectric loss, made of a thin film material with non-fixed crystal orientation, high flexibility, and high toughness. The thickness of the dielectric layer 329 is 5 μm to 1000 μm.

[0049] Referring to Figure 7, the electrode unit 320 consists of, from bottom to top, a substrate 325 with a thickness of 0.1 mm to 0.3 mm, conductive sheets 326 and pads 327 with thicknesses of 10 μm to 50 μm, an insulating cover film 328 with a thickness of 10 μm to 50 μm, and a dielectric layer 329 with a thickness of 5 μm to 1000 μm. Furthermore, the adhesive 33 covering the electrode unit group C has a thickness of 0.1 mm to 1 mm, and the outline edge of the adhesive 33 is greater than or equal to the outer edge outline of the electrode unit group C. That is, the outline of the adhesive 33 is greater than or equal to the outline edge of the corresponding portion of the substrate 325. The dimension by which the adhesive 33 extends beyond the outer edge outline of the corresponding electrode unit group C on one side is defined as the extension dimension. Increasing the outer dimension of the adhesive patch 33, or increasing its coverage area, can reduce the peak current density flowing through the corresponding electrode unit 320, alleviating the edge effect problem of the electrode patch 30. Simultaneously, it can improve the uniformity (equilibrium) of the current density of each electrode unit 320 on the electrode patch 30, making the thermal effect of the corresponding electrode patch 30 more uniform. This helps improve the uniformity of the effective therapeutic electric field intensity in the target area and reduces the requirements for the application location. The outer dimension of the adhesive patch 33 is 0mm-3mm, preferably 3mm.

[0050] Referring to Figure 17, each electrode unit group C has the same structure, all arranged in a dumbbell shape. Electrode unit group C has a horizontal axis X1 and a vertical axis Y1, and is symmetrically arranged along the horizontal axis X1 and vertical axis Y1. The center distance between two electrode units 320 within a single electrode unit group C is 32-35 mm, preferably 33.5 mm, and the radius of a single electrode unit 320 is 9-11 mm, preferably 11 mm. The boundary line 3211 of the connecting portion 321 within the electrode unit group C is two symmetrical arc segments, with the central angle corresponding to the boundary line 3211 being 40°-44°, preferably 42°. The upper boundary line 3211 is arranged with both ends curving upwards, and the lower boundary line 3211 is arranged with both ends pressing downwards.

[0051] Figure 18 shows the distribution of the ten electrode unit groups C of the electrode patch 30. Electrode unit groups C1, C2, C3, C5, C6, C8, C9, and C10 located at the outer edge of the electrode patch 30 are defined as peripheral electrode unit groups C, and electrode unit groups C4 and C7 located at the center of the electrode patch 30 are defined as central electrode unit groups C. At least a portion of the perimeter of each peripheral electrode unit group C constitutes the outer boundary M of the entire electrode array 32, and the overlapping portion of the outer boundary M with each peripheral electrode unit group C does not exceed 10% of the perimeter of each peripheral electrode unit group C. Furthermore, the outer boundary M has both concave and convex boundaries; specifically, its upper and lower edges are concave, and its left and right edges are convex. The area where these ten electrode unit groups C are located has a horizontal center line X2 and a vertical center line Y2. These ten electrode unit groups C are arranged symmetrically along the horizontal center line X2 and the vertical center line Y2. The intersection of the horizontal center line X2 and the vertical center line Y2 is the center point of these ten electrode unit groups C.

[0052] Electrode unit groups C4 and C7, located at the center of the second and third rows, are horizontally positioned, meaning that the horizontal axis X1 of electrode unit groups C4 and C7 is a horizontal line parallel to the horizontal center line X2. Other electrode unit groups C are all inclined relative to the horizontal center line X2, so that the center of each electrode unit 320 in each row is located on the same arc. The center of each electrode unit 320 in the first row is defined as being located on arc H1, the center of each electrode unit 320 in the second row is located on arc H2, the center of each electrode unit 320 in the third row is located on arc H3, and the center of each electrode unit 320 in the fourth row is located on arc H4. Arcs H1 and H4 are symmetrical along the axis of the horizontal center line X2, and arcs H2 and H3 are symmetrical along the axis of the horizontal center line X2. Arcs H1, H2, H3, and H4 are each symmetrically arranged along the vertical center line Y2. Arcs H1 and H2 curve upwards at both ends, while arcs H3 and H4 curve downwards at both ends.

[0053] Electrode unit groups C1 and C2 are both inclined relative to the horizontal centerline X2 and symmetrical relative to the vertical centerline Y2. Taking electrode unit group C1 as an example, the angle α1 between the horizontal axis X1 of electrode unit group C1 and the horizontal line is 8°-12°, preferably 10°; the central angle corresponding to the arc segment AB of electrode unit group C1 on arc H1 is 11°-21°, preferably 16°. In this embodiment, the radius of the circle containing arc H1 is approximately 192 mm, the central angle corresponding to arc H1 is approximately 36°, and the arc length of arc H1 is approximately 121 mm. In this embodiment, the horizontal line is parallel to the horizontal centerline X2.

[0054] Electrode unit groups C3 and C5 are both inclined relative to the horizontal centerline X2 and symmetrical relative to the vertical centerline Y2. Taking electrode unit group C3 as an example, the angle α2 between the horizontal axis X1 of electrode unit group C3 and the horizontal line is 8°-12°, preferably 10°; the central angle corresponding to the arc segment DE of electrode unit group C3 on arc H2 is 7-11°, preferably 9°. In this embodiment, the radius of the circle containing arc H2 is approximately 361 mm, the central angle corresponding to arc H2 is approximately 29°, and the arc length of arc H2 is approximately 183 mm. Electrode unit group C4 is horizontally arranged relative to the horizontal centerline X2 and symmetrical along the vertical centerline Y2.

[0055] Electrode unit group C9 is symmetrically arranged with electrode unit group C1, electrode unit group C10 is symmetrically arranged with electrode unit group C2 along the transverse center line X2. Electrode unit group C6 is symmetrically arranged with electrode unit group C3, electrode unit group C7 is symmetrically arranged with electrode unit group C4, electrode unit group C8 is symmetrically arranged with electrode unit group C5 along the transverse center line X2. The relevant arrangement can be found in the relevant content of electrode unit groups C1 to C5.

[0056] It is understandable that the arc lengths of arc segments AB and DE are similar, but the central angle corresponding to arc segment AB is larger than that corresponding to arc segment DE. This means that the curvature of arc H1 is greater than that of arc H2, and arc H1 is more curved. The vertical distances between adjacent arcs H1, H2, H3, and H4 are basically consistent, approximately 33-35 mm. The vertical distance between the center of the electrode unit 320 in electrode unit group C1 that is far from the vertical center line Y2 and the center of the electrode unit 320 in the third electrode unit group C3 that is close to the vertical center line Y2 is d1. That is, the vertical distance between the centers of the two electrode units 320 located in the first row and the second row, both in the second column, is d1, which is approximately 38 mm. The vertical distance d2 between the center of another electrode unit 320 in electrode unit group C1, which is closer to the vertical center line Y2, and the center of an electrode unit 320 in the adjacent fourth electrode unit group C4, is the vertical distance between the centers of two electrode units 320 located in the first and second rows, both in the third column. d2 is less than d1 and is approximately 35 mm. The horizontal dimension K1 of the gap between electrode unit groups C1 and C2 is approximately 11.5 mm, and the horizontal dimension K2 of the gap between electrode unit groups C3 and C4 is approximately 7.5 mm.

[0057] Furthermore, the current density flowing through the electrode units 320 in the corresponding electrode unit assembly C can be improved by using dielectric layers 329 of different thicknesses, thereby improving the edge effect. In the electrode patch 30 of the tumor electric field therapy system 100 of this application, the electrode units 320 of the electrode unit groups C located at different positions have dielectric layers 329 of different thicknesses. Specifically, the thickness of the dielectric layer 329 of the electrode units 320 of the electrode unit groups C located on the periphery of the electrode array 32 of the electrode patch 30 is greater than the thickness of the dielectric layer 329 of the electrode units 320 of the electrode unit groups C located on the center of the electrode array 32 of the electrode patch 30. Further, the thickness of the dielectric layer 329 of the electrode units 320 of the electrode unit groups C located at the corners on the periphery of the electrode array 32 of the electrode patch 30 is greater than the thickness of the dielectric layer 329 of the electrode units 320 of other electrode unit groups C located on the periphery of the electrode array 32 but not at the corners of the electrode array 32 of the electrode patch 30. In this embodiment, each electrode unit group C includes two adjacent electrode units 320. It is understood that in other embodiments, the electrode unit group C can also be replaced by a single electrode unit 320, i.e., a dielectric layer 329 of different thicknesses is provided for electrode units 320 at different locations. Each individual electrode unit 320 is provided with a corresponding adhesive piece 33. The remaining structures are similar to the aforementioned electrode patch 30 and will not be described in detail here. This design allows the current density of each electrode unit 320 in the entire electrode patch 30 to tend to be consistent, alleviating the edge effect problem and reducing the requirements for the application position of the electrode patch 30. This increases the maximum operating current of the electrode patch 30, improves the intensity of the electric field for tumor treatment, and enhances the tumor treatment effect. This application provides the following three implementation schemes regarding the thickness of the dielectric layer 329 of each electrode unit 320:

[0058] In the first embodiment: the dielectric layer 329 thickness of each electrode unit 320 in the four electrode unit groups C1, C2, C9, and C10 located at the outer corner of the electrode array 32 is 0.015 mm, and the dielectric layer 329 thickness of each electrode unit 320 in the other electrode unit groups C3 to C8 is 0.005 mm. The thickness ratio of the dielectric layer 329 of each electrode unit 320 in the electrode unit groups C1, C2, C9, and C10 located at the outer corner of the electrode array 32 to the dielectric layer 329 of each electrode unit 320 in the other electrode unit groups C3 to C8 is 3. The dielectric layer 329 thickness ratio of each electrode unit 320 in the electrode unit group C located at the center of the electrode array 32, the outer periphery but not at the corner, and the outer corner is 1:1:3.

[0059] Second embodiment: The dielectric layer 329 thickness of each electrode unit 320 in the four electrode unit groups C1, C2, C9, C10 located at the outer corner of the electrode array 32 is 0.01 mm; the dielectric layer 329 thickness of each electrode unit 320 in the electrode unit groups C3, C5, C6, C8 located on the outer periphery of the electrode array 32 but not at the corner is 0.007 mm; the dielectric layer 329 thickness of each electrode unit 320 in the electrode unit groups C4, C7 located at the center of the electrode array 32 is 0.005 mm; the dielectric layer 329 thickness of each electrode unit 320 located at the outer corner of the electrode array 32 is 2. The dielectric layer 329 thickness ratio of each electrode unit 320 in the three electrode unit groups C located at the center of the electrode array 32, the periphery but not at the corner, and the periphery corner is 5:7:10.

[0060] Third embodiment: The dielectric layer 329 thickness of each electrode unit 320 in the four electrode unit groups C1, C2, C9, C10 located at the outer corner of the electrode array 32 is 0.015 mm; the dielectric layer 329 thickness of each electrode unit 320 in the electrode unit groups C3, C5, C6, C8 located on the outer periphery of the electrode array 32 but not at the corner is 0.01 mm; the dielectric layer 329 thickness of each electrode unit 320 in the electrode unit groups C4, C7 located at the center of the electrode array 32 is 0.005 mm; the thickness ratio of the dielectric layer 329 of the electrode unit 320 located at the outer corner of the electrode array 32 to that of the electrode unit 320 located at the center of the electrode array 32 is 3. The dielectric layer 329 thickness ratio of each electrode unit 320 in the electrode unit group C located at the center of the electrode array 32, the periphery but not at the corner, and the periphery corner is 1:2:3.

[0061] The electrode patches 30 in the first, second, and third embodiments are identical in structure and size, except that the dielectric layer 329 of the electrode unit 320 is of different thickness.

[0062] The following modeling method is used to simulate the actual heat generation of the electrode patch 30 on the human body, and to analyze the influence of the coverage area of ​​the adhesive 33 and the thickness of the dielectric layer 329 on the peak current density of each electrode unit 310. Referring to Figure 6, the electrode patch 30 is applied in pairs to both sides of the cuboid structure, with the electrode units 320 corresponding one-to-one. The width of the cuboid structure is based on the waist circumference of a normal adult male, which is 220mm × 200mm × 180mm, for the model construction. The materials, dimensions, and related electrical parameters of the dielectric layer 329, conductive sheet 326, adhesive 33, and insulating covering film 328 on the electrode patch 30 in the tumor electric field therapy system 100 are shown in the table below.

[0063]

[0064] Since two adjacent electrode units 320 form an electrode unit group C, and the dielectric layer 329 is laid on the electrode unit group C, each electrode unit group C is taken as the object of current density analysis; the current density of the connection part 321 between each electrode unit group C is negligible because its surface is covered with an insulating covering film 328 and no dielectric layer 329 is provided.

[0065] The influence of the outer dimensions of the adhesive component 33 on the current density is analyzed below, using Comparative Examples 1 to 3.

[0066] In Comparative Example 1: The outer dimension of the adhesive component 33 is 3 mm. The dielectric layer 329 thickness of each electrode unit 320 in each electrode unit group C is 0.005 mm. In Comparative Example 2: The outer dimension of the adhesive component 33 is 1 mm. The dielectric layer 329 thickness of each electrode unit 320 in each electrode unit group C is 0.005 mm. In Comparative Example 3: The outer dimension of the adhesive component 33 is 0 mm. The dielectric layer 329 thickness of each electrode unit 320 in each electrode unit group C is 0.005 mm.

[0067] In the three comparative examples above, apart from the difference in the outer dimension of the adhesive 33, the parameters of all other structures of the electrode patch 30 are exactly the same. A ±80V (160Vpp), 150KHz AC signal was applied to each electrode patch 30 in Comparative Examples 1 to 3 for simulation. The differences in edge effects (current density) caused by the three electrode patches 30 in Comparative Examples 1 to 3, where only the outer dimension of the adhesive 33 differs, were calculated using finite element simulation software.

[0068] Referring to Figures 8 and 9, the current density distribution of Comparative Example 1 and Comparative Example 3 verifies that the edge effect does exist. That is, the electrode unit 320 located on the periphery of the electrode array 32 has a lower resistance, resulting in a higher current density flowing through the electrode unit 320 located on the periphery of the electrode array 32. Furthermore, the current density flowing through the electrode unit 320 located at the corner or similar sharp bend of the electrode array 32 is higher than the current density flowing through other electrode units 320 located on the periphery of the electrode array 32.

[0069] Referring to Figure 10, which shows the peak current density of each electrode unit 320 in Comparative Examples 1 to 3, it can be seen from the data in the figure that as the outer dimension of the adhesive 33 increases, that is, as the area of ​​the adhesive 33 increases, the peak current density of each electrode unit 320 decreases. In other words, appropriately increasing the area of ​​the adhesive 33 can alleviate the edge effect problem of the electrode patch 30. Figure 11 shows a comparison of the peak current density uniformity of each electrode unit 320 in Comparative Examples 1 to 3. It illustrates that the standard deviation of the current density of each electrode unit 320 decreases as the outer dimension of the adhesive 33 increases. Specifically, the standard deviation of the current density flowing through each electrode unit 320 of the electrode patch 30 in Comparative Example 1 (with an outer dimension of 3 mm for the adhesive 33) is 2.8; the standard deviation of the current density flowing through each electrode unit 320 of the electrode patch 30 in Comparative Example 2 (with an outer dimension of 1 mm for the adhesive 33) is 3.36; and the standard deviation of the current density flowing through each electrode unit 320 of the electrode patch 30 in Comparative Example 3 (with an outer dimension of 0 mm for the adhesive 33) is 4.83. This demonstrates that the electrode patch 30 in Comparative Example 1 (with an outer dimension of 3 mm for the adhesive 33) exhibits better current density uniformity, resulting in a more uniform thermal effect. This contributes to improving the uniformity of the effective therapeutic electric field intensity in the target area and reducing the requirements for the application location.

[0070] The following analysis, using Comparative Examples 4 to 6, examines the effect of the thickness of dielectric layer 329 on current density.

[0071] Comparative Example 4: The dielectric layer 329 thickness of each electrode unit 320 in the four electrode unit groups C1, C2, C9, and C10 located at the outer corner of the electrode array 32 is 0.015 mm, and the dielectric layer 329 thickness of each electrode unit 320 in the other electrode unit groups C3 to C8 is 0.005 mm. The dielectric layer 329 thickness ratio of each electrode unit 320 in the electrode unit groups C1, C2, C9, and C10 located at the outer corner of the electrode array 32 is 3 compared to the dielectric layer 329 thickness of each electrode unit 320 in the other electrode unit groups C3 to C8. The dielectric layer 329 thickness ratio of each electrode unit 320 in the electrode unit group C located at the center of the electrode array 32, the outer periphery but not at the corner, and the outer corner is 1:1:3.

[0072] Comparative Example 5: The dielectric layer 329 thickness of each electrode unit 320 in the four electrode unit groups C1, C2, C9, and C10 located at the outer corner of the electrode array 32 is 0.01 mm. The dielectric layer 329 thickness of each electrode unit 320 in the electrode unit groups C3, C5, C6, and C8 located on the outer periphery of the electrode array 32 but not at the corner is 0.007 mm. The dielectric layer 329 thickness of each electrode unit 320 in the electrode unit groups C4 and C7 located at the center of the electrode array 32 is 0.005 mm. The thickness ratio of the dielectric layer 329 of the electrode unit 320 located at the outer corner of the electrode array 32 to that of the electrode unit 320 located at the center of the electrode array 32 is 2. The dielectric layer 329 thickness ratio of electrode unit 320 in electrode unit group C located at the center, the periphery but not at the corner, and the periphery corner of electrode array 32 is 5:7:10.

[0073] Comparative Example 6: The dielectric layer 329 thickness of each electrode unit 320 in the four electrode unit groups C1, C2, C9, and C10 located at the outer corner of the electrode array 32 is 0.015 mm. The dielectric layer 329 thickness of each electrode unit 320 in the electrode unit groups C3, C5, C6, and C8 located on the outer periphery of the electrode array 32 but not at the corner is 0.01 mm. The dielectric layer 329 thickness of each electrode unit 320 in the electrode unit groups C4 and C7 located at the center of the electrode array 32 is 0.005 mm. The thickness ratio of the dielectric layer 329 of the electrode unit 320 located at the outer corner of the electrode array 32 to that of the electrode unit 320 located at the center of the electrode array 32 is 3. The dielectric layer 329 thickness ratio of electrode unit 320 in electrode unit group C located at the center, the periphery but not at the corner, and the periphery corner of electrode array 32 is 1:2:3.

[0074] In the aforementioned Comparative Example 3, the dielectric layer 329 thickness of each electrode unit 320 is 0.005 mm. The dielectric layer 329 thickness ratio of the three electrode units 320 located at the center of the electrode array 32, the periphery but not at the corner, and the periphery corner is 1:1:1.

[0075] In Comparative Examples 3 to 6 above, except for the difference in the thickness of the dielectric layer 329 in the electrode unit 320, the parameters of each structure of the other electrode patches 3 are exactly the same, and the outer dimension of the adhesive part 33 in these four comparative examples is 0 mm. The differences in edge effects (current density) caused by different dielectric layer thicknesses in the electrode unit 320 in Comparative Examples 4 to 6 are calculated by finite element simulation.

[0076] Referring to Figure 12 and comparing it with Figure 9, observing the current density distribution of Comparative Examples 3 and 4 reveals that in Comparative Example 3, the current density peak values ​​of electrode unit groups C1, C2, C9, and C10 of electrode patch 30 are the highest, followed by electrode unit groups C3, C5, C6, and C8, with the lowest being electrode unit groups C4 and C7. Similarly, in Comparative Example 4, the current density peak values ​​of electrode unit groups C3, C5, C6, and C8 of electrode patch 30 are the highest, followed by electrode unit groups C4 and C7, with the lowest being electrode unit groups C1, C2, C9, and C10. Comparing the current density distributions of Comparative Examples 3 and 4 shows that, due to the increased thickness of the dielectric layer 329, the current density peak values ​​of electrode unit groups C1, C2, C9, and C10 decrease from the highest to the lowest among all electrode unit groups C. It can be seen that increasing the thickness of the dielectric layer 329 of the electrode unit 320 located at the outer corner of the electrode array 32 can effectively reduce the peak current density of the corresponding electrode unit 320.

[0077] Referring to Figures 12 to 14, and in conjunction with Figures 15 and 16, Figure 15 shows the peak value of the maximum current density in each electrode unit 320 of Comparative Examples 3 to 6, and Figure 16 compares the uniformity of the peak value of the current density in each electrode unit 320 of Comparative Examples 3 to 6. Specifically, referring to Figure 15, the peak value of the maximum current density in each electrode unit 320 of the electrode patch 30 of Comparative Example 3, which has an epitaxial dimension of 0 mm for the adhesive 33 and a dielectric layer 329 thickness of 0.005 mm for each electrode unit 320 in each electrode unit group C, is 42.165 mA / cm². 2The peak current density of each electrode unit 320 in the electrode patch 30 of Comparative Example 4, which has an outer dimension of 0 mm and is located at the corner of the electrode array 32, is 41.429 mA / cm². The dielectric layer 329 thickness of each electrode unit 320 in the four electrode unit groups C1, C2, C9, and C10 is 0.015 mm, and the dielectric layer 329 thickness of each electrode unit 320 in the other electrode unit groups C3 to C8 is 0.005 mm. 2 The peak current density of each electrode unit 320 in the electrode patch 30 of Comparative Example 5 is 40.959 mA / cm². The dielectric layer 329 thickness of each electrode unit 320 in the four electrode unit groups C1, C2, C9, and C10 (with an outer dimension of 0 mm and located at the corner of the electrode array 32) is 0.01 mm; the dielectric layer 329 thickness of each electrode unit 320 in the electrode unit groups C3, C5, C6, and C8 (located on the periphery of the electrode array 32 but not at the corner) is 0.007 mm; and the dielectric layer 329 thickness of each electrode unit 320 in the electrode unit groups C4 and C7 (located at the center of the electrode array 32) is 0.005 mm. 2 The peak current density of each electrode unit 320 in the electrode patch 30 of Comparative Example 6 is 38.079 mA / cm². The dielectric layer 329 thickness of each electrode unit 320 in the four electrode unit groups C1, C2, C9, and C10 (with an outer dimension of 0 mm and located at the corner of the electrode array 32) is 0.015 mm; the dielectric layer 329 thickness of each electrode unit 320 in the electrode unit groups C3, C5, C6, and C8 (located on the periphery of the electrode array 32 but not at the corner) is 0.01 mm; and the dielectric layer 329 thickness of each electrode unit 320 in the electrode unit groups C4 and C7 (located at the center of the electrode array 32) is 0.005 mm. 2Referring to Figure 16, the standard deviation of the current density flowing through each electrode unit 320 of the electrode patch 30 in Comparative Example 3, where the epitaxial dimension of the adhesive 33 is 0 mm and the dielectric layer 329 thickness of each electrode unit 320 in each electrode unit group C is 0.005 mm, is 4.83. The dielectric layer 329 thickness of each electrode unit 320 in the four electrode unit groups C1, C2, C9, and C10 located at the corners of the electrode array 32, where the epitaxial dimension of the adhesive 33 is 0 mm, is 0.015 mm. The standard deviation of the current density of each electrode unit 320 in the electrode patch 30 of Comparative Example 4, where the dielectric layer 329 thickness of each electrode unit 320 in other electrode unit groups C3 to C8 is 0.005 mm, is 4.77. The current flows through the dielectric layer 329 thickness of each electrode unit 320 in four electrode unit groups C1, C2, C9, and C10, which have an outer dimension of 0 mm and are located at the corner of the electrode array 32, but are located on the periphery of the electrode array 32, but not at the corner. 3. The dielectric layer 329 thickness of each electrode unit 320 in Comparative Example 5, where the dielectric layer 329 thickness of each electrode unit 320 in C5, C6, and C8 is 0.007 mm and the dielectric layer 329 thickness of each electrode unit 320 in electrode unit groups C4 and C7 located at the center of electrode array 32 is 0.005 mm, has a standard deviation of 3.52 for the current density of each electrode unit 320 in the electrode patch 30. The current flows through the four electrode unit groups C1, C2, C9, and C10 located at the corners of electrode array 32 with an outer dimension of 0 mm for the adhesive 33. The standard deviation of the current density of each electrode unit 320 in the electrode patch 30 of Comparative Example 6 is 3.30, where the dielectric layer 329 thickness of each electrode unit 320 is 0.015 mm, the dielectric layer 329 thickness of each electrode unit 320 in electrode unit groups C3, C5, C6, and C8 located on the periphery of the electrode array 32 but not at the corners is 0.01 mm, and the dielectric layer 329 thickness of each electrode unit 320 in electrode unit groups C4 and C7 located at the center of the electrode array 32 is 0.005 mm. As can be seen from Figures 9 and 12 to 16, by setting different thicknesses for the dielectric layer 329 of the electrode units 320 located at different positions in the electrode array 32, the peak value of the maximum current density in the entire electrode patch 30 can be effectively reduced. Furthermore, the stepped arrangement of the dielectric layer 329 thickness of the electrode units 320 at different positions demonstrates better performance in terms of current density uniformity compared to simply increasing the thickness of the dielectric layer 329 of a portion of the electrode units 320. Specifically, depending on the position of the electrode unit 320 in the electrode patch 30, dielectric layers 329 of different thicknesses are selected, which can effectively reduce the peak current density of each electrode unit 320 flowing through the electrode patch 30 and balance the current density and heat generation of each electrode unit 320.

[0078] The electrode patch 30 of the tumor electric field therapy system 100 of this application has a dielectric layer 329 of different thicknesses for the electrode units 320 of the electrode unit group C at different locations, based on the influence of the dielectric layer 329 thickness on the current density. Specifically, the dielectric layer 329 thickness of the electrode units 320 of the electrode unit group C located at the periphery of the electrode array 32 is greater than that of the electrode units 320 of the electrode unit group C located at the center of the electrode array 32. More preferably, the dielectric layer 329 thickness of the electrode units 320 of the electrode unit group C located at the corner of the electrode array 32 is greater than that of the electrode units 320 of the electrode unit group C located at the corner of the electrode array 32. The thickness of the dielectric layer 329 of the electrode unit 320 located on the periphery of the electrode array 32 but not at the corner is greater than the thickness of the dielectric layer 329 of the electrode unit 320 located at the center of the electrode array 32. The dielectric layer 329 of the electrode unit 320 located at the center of the electrode array 32 is the thinnest. This design can make the current density of the electrode unit 320 at each position in the entire electrode patch 30 tend to be consistent, which can alleviate the edge effect problem, reduce the requirements for the application position of the electrode patch 30, thereby increasing the maximum working current of the electrode patch 30, increasing the intensity of the electric field for tumor treatment, and enhancing the tumor treatment effect.

[0079] The above are merely preferred embodiments of this application and are not intended to limit this application. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. An electrode patch, comprising an electrode array and a plurality of adhesive members, wherein the electrode array includes a plurality of electrode units through which alternating current signals pass and a plurality of connecting portions located between the plurality of electrode units and connecting adjacent electrode units, wherein each electrode unit includes a main body, a conductive sheet disposed on the main body, and a dielectric layer covering the conductive sheet and electrically connected to the conductive sheet, characterized in that: Two adjacent electrode units and the connecting portion electrically connecting the two electrode units form an electrode unit group. Several adhesive pieces cover the corresponding electrode unit group. When an AC signal is applied, the current flowing through each electrode unit has a balanced current density.

2. The electrode patch according to claim 1, characterized in that: The thickness of the dielectric layer of the electrode unit in the plurality of electrode unit groups located on the periphery of the electrode array is greater than the thickness of the dielectric layer of the electrode unit in the plurality of electrode unit groups located at the center of the electrode array.

3. The electrode patch according to claim 2, characterized in that: The dielectric layer thickness of the electrode unit in a plurality of electrode unit groups located at the outer corner of the electrode array is greater than the dielectric layer thickness of the electrode unit in a plurality of electrode unit groups located on the periphery of the electrode array.

4. The electrode patch according to claim 3, characterized in that: The dielectric layer thickness ratio of the electrode units in each electrode unit group located at the center of the electrode array, the periphery of the electrode array but not at the corner, and the corner of the periphery of the electrode array is 1:2:3, 1:1:3, or 5:7:

10.

5. The electrode patch according to claim 2, characterized in that: The ratio of the thickness of the dielectric layer in each electrode unit group located at the center of the electrode array to the thickness of the dielectric layer in each electrode unit group located at the outer corner of the electrode array ranges from 1:3 to 1:

2.

6. The electrode patch according to claim 3 or 5, characterized in that: The dielectric layer thickness of the electrode unit located at the center of the electrode array is 0.005 mm; the dielectric layer thickness of each electrode unit located at the outer corner of the electrode array is 0.01 mm to 0.015 mm.

7. The electrode patch according to claim 6, characterized in that: The dielectric layer thickness of the electrode unit located on the periphery of the electrode array but not at the corner is 0.005 mm to 0.10 mm.

8. The electrode patch according to claim 1, characterized in that: The dielectric layer of two electrode units in the same electrode unit group also covers the connection between the two electrode units and is continuously arranged with the same thickness. Each electrode unit group has the same structure and size except for the different thickness of the dielectric layer.

9. The electrode patch according to claim 1, characterized in that: The adhesive is a hydrogel, and the adhesive has an extension dimension that extends beyond the corresponding edge of the main body on one side, with the extension dimension ranging from 0mm to 3mm.

10. An electrode patch, characterized in that: The device includes an electrode array and several adhesive components. The electrode array includes several electrode units and several connecting portions located between the electrode units and connecting adjacent electrode units. The adhesive components cover the corresponding electrode units one by one. Each electrode unit includes a main body, a conductive sheet disposed on the main body, and a dielectric layer covering the conductive sheet and electrically connected to the conductive sheet. The device is characterized in that when an alternating current signal is applied, the current flowing through each electrode unit has a uniform current density.

11. The electrode patch according to claim 10, characterized in that: The thickness of the dielectric layer of a plurality of electrode units located on the periphery of the electrode array is greater than the thickness of the dielectric layer of a plurality of electrode units located at the center of the electrode array.

12. The electrode patch according to claim 11, characterized in that: The dielectric layer thickness of a number of electrode units located at the corner of the outer periphery of the electrode array is greater than the dielectric layer thickness of a number of other electrode units located on the outer periphery of the electrode array but not at the corner.

13. A tumor electric field therapy system, characterized in that: It includes an electric field generator, an adapter, and several pairs of electrode patches as described in any one of claims 1 to 12, wherein the adapter electrically connects the electric field generator to each of the electrode patches.

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