Electrode patch and electrofield therapy system

Abstract

The application provides an electrode patch and an electric field treatment system. The electrode patch comprises a backing and an electrode array attached to the backing. The electrode array comprises a flexible circuit board and a plurality of dielectric elements arranged on the flexible circuit board and used for applying alternating current signals. The flexible circuit board comprises a connecting portion located in the middle of the electrode array and a plurality of base portions connected to the connecting portion and arranged at intervals. The dielectric elements are arranged correspondingly to the base portions and cover the base portions. The outer contour of the backing is arranged correspondingly to the outer contour of the electrode array. The effective electric field application area of the electrode array accounts for more than 30% of the attachment area of the backing. The electrode patch and the electric field treatment system can improve the proportion of the effective electric field application area through the compact arrangement of the electrode patches, and realize a larger electric field application area in a limited attachment area.

Description

Technical Field

[0001] This application relates to an electrode patch and an electric field therapy system. Background Technology

[0002] Tumor therapeutic electric fields (TTFields) are low-intensity alternating electric fields in the mid-frequency range (e.g., 50 kHz to 1 MHz) that can interfere with the mitotic process of cancer cells and induce apoptosis, and can be used to treat tumors, as disclosed in U.S. Patent Publication No. 7,565,205. In a tumor therapeutic electric field therapy system, a tumor therapeutic electric field is non-invasively applied to a target area by placing electrode patches on the patient's body and applying an alternating current signal between the electrode patches.

[0003] Existing electrode patches, such as those disclosed in Chinese Invention Patent Publication No. 112717272, include a backing applied to the patient's tumor site on the skin surface and multiple dielectric elements attached to the backing to apply alternating current signals to the tumor site. The dielectric elements are circular ceramic electrode sheets arranged in a spaced array on the backing. While this creates open spaces for heat dissipation between adjacent dielectric elements, the configuration and arrangement result in a low proportion of the effective electric field area applied by the dielectric elements within the backing coverage area. Furthermore, heat tends to accumulate rapidly at locations on the patient's skin corresponding to the outer contour of the dielectric elements.

[0004] Therefore, it is indeed necessary to provide an electrode patch and electric field therapy system that can overcome the above problems. Summary of the Invention

[0005] This application provides an electrode patch and an electric field therapy system that can increase the proportion of the effective electric field application area.

[0006] Specifically, this application is achieved through the following technical solution: an electrode patch, comprising a backing and an electrode array bonded to the backing, the electrode array comprising a flexible circuit board and a plurality of dielectric elements disposed on the flexible circuit board for applying AC signals, the electrode array having a teardrop-shaped, wavy, or fan-shaped outer contour, the flexible circuit board comprising a connecting portion, a plurality of spaced-apart bases, and a wiring portion extending outward from the connecting portion, the connecting portion being strip-shaped and located in the middle of the electrode array, each of the bases being connected to the connecting portion and respectively located on opposite sides of the connecting portion; a conductive sheet is provided on the front side of the base, the dielectric elements being correspondingly disposed with the bases and covering the conductive sheet of the base to be electrically connected to the conductive sheet; a plurality of gold fingers are provided on the wiring portion, a plurality of conductive traces are arranged on the flexible circuit board, and the conductive sheet is electrically connected to the corresponding gold fingers through the corresponding conductive traces; the outer contour of the backing corresponds to the outer contour of the electrode array, and the effective electric field application area of ​​the electrode array accounts for more than 30% of the attachment area of ​​the backing.

[0007] According to one embodiment of the present invention, the flexible circuit board includes two bases that are symmetrically arranged on the left and right sides of the connection portion, and the outer contours of the two dielectric elements that are far apart from each other together surround the teardrop-shaped outer contour of the electrode array.

[0008] According to one embodiment of the present invention, the backing has two side wings located on opposite sides of the electrode array, wherein one side wing has a concave edge and the other side wing has a convex edge.

[0009] According to one embodiment of the present invention, the flexible circuit board includes two bases that are centrally symmetrically disposed on the left and right sides of the connection portion, and the outer contours of the two dielectric elements that are far apart from each other together surround the wavy outer contour of the electrode array.

[0010] According to one embodiment of the present invention, the backing has an annular wing portion surrounding the electrode array, the annular wing portion having a concave edge and a convex edge on opposite sides thereof.

[0011] According to one embodiment of the present invention, a gap region is provided between the two bases, and the connecting portion is located in the middle of the gap region.

[0012] According to one embodiment of the present invention, the outer contours of the dielectric elements located at both ends of the connection portion together form a fan-shaped annular outer contour of the electrode array. The connection portion is arc-shaped, and a plurality of the bases are disposed on opposite inner and outer sides of the connection portion and extend radially.

[0013] According to one embodiment of the present invention, the backing is arranged in a fan-shaped ring with a fan-shaped ring angle of 90°.

[0014] This application is also achieved through the following technical solution: an electric field therapy system for applying electric field therapy to a target area of ​​a subject, comprising a plurality of electrode patches attached to the subject's body surface and surrounding the target area, wherein the electrode patches are the aforementioned electrode patches, and the outer contours of at least two adjacent electrode patches that are close to each other are mutually complementary in terms of concavity and convexity or are close to each other and parallel.

[0015] According to one embodiment of the present invention, a plurality of electrode patches include two pairs of electrode patch combinations, each electrode patch combination including two electrode patches and two adjacent edges of the two backings of the two electrode patches being complementary in shape.

[0016] According to one embodiment of the present invention, a plurality of electrode patches include two pairs of electrode patches, wherein the two edges of any two adjacent backings that are close to each other are close to each other and parallel.

[0017] The electrode patch and electric field therapy system of this application can increase the proportion of the effective electric field application area by using irregularly shaped electrode patches and the compact arrangement between the electrode patches, thus achieving a larger electric field application area within a limited attachment area.

[0018] 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

[0019] Figure 1 This is a system block diagram of an electric field therapy system according to one embodiment of this application; Figure 2 This is a plan view of the electrode patch according to the first embodiment of this application; Figure 3 for Figure 2 A plan view of the electrode array of the electrode patch shown; Figure 4 for Figure 2 A plan view of the backing of the electrode patch shown; Figure 5 For two Figure 2 The diagram shows the usage status of the electrode patch. Figure 6 Eight Figure 2 A schematic diagram showing the usage status of the electrode patches in the diagram; Figure 7 This is a plan view of the electrode patch according to the second embodiment of this application; Figure 8 for Figure 7A plan view of the electrode array of the electrode patch shown; Figure 9 for Figure 7 A plan view of the backing of the electrode patch shown; Figure 10 For two Figure 7 The diagram shows the usage status of the electrode patch. Figure 11 Eight Figure 7 The diagram shows the usage status of the electrode patch. Figure 12 This is a plan view of the electrode patch according to the third embodiment of this application; Figure 13 for Figure 12 A plan view of the electrode array of the electrode patch shown. Figure 14 For four Figure 12 The diagram shows the usage status of the electrode patch. Figure 15 This is a plan view of the electrode patch according to the fourth embodiment of this application; Figure 16 for Figure 15 A plan view of the electrode array of the electrode patch shown; Figure 17 For four Figure 15 The diagram shows the usage status of the electrode patch. Detailed Implementation

[0020] 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.

[0021] refer to Figure 1As shown, the electric field therapy system 100 of this application includes an electric field generator 10, an adapter 20, and several electrode patches 30, 40, 50, and 60. The adapter 20 is electrically connected to the electric field generator 10 and each electrode patch 30, 40, 50, and 60. The electric field generator 10 generates an alternating electrical signal that meets the treatment requirements, such as an alternating electrical signal with a frequency of 150-250 kHz for treating glioblastoma, or an alternating electrical signal with a frequency of 50-150 kHz for treating malignant melanoma. The adapter 20 receives the alternating electrical signal output from the electric field generator 10 and transmits the alternating electrical signal to the paired electrode patches 30, 40, 50, and 60 or combinations of electrode patches. The electrode patches 30, 40, 50, and 60 are attached to the surface of the patient's body corresponding to the tumor area to apply the alternating electrical signal to the patient's tumor area for tumor electric field therapy. This application provides electrode patches 30, 40, 50, and 60 with various embodiments, which are described below.

[0022] First embodiment of electrode patch refer to Figure 2 and Figure 3 As shown, the electrode patch 30 in the first embodiment includes a backing 31 and an electrode array 32 attached to the front of the backing 31. The electrode array 32 includes a flexible circuit board 33 attached to the front of the backing 31, two dielectric elements 34 located on the front of the flexible circuit board 33, and a temperature sensor (not shown) corresponding to the dielectric elements 34. The flexible circuit board 33 includes two bases 331 arranged symmetrically along a left-right axis, a horizontal connecting portion 332 located at the center of the array and connecting the two bases 331, and a vertical wiring portion 333 extending downward from the middle of the connecting portion 332. The free end of the wiring portion 333 is provided with a plurality of gold fingers 3331, which are directly or indirectly electrically connected to the adapter 20. Some of the gold fingers 3331 receive AC signals transmitted by the adapter 20 for generating an AC electric field, and some of the gold fingers 3331 receive DC signals transmitted by the adapter 20 for temperature measurement. The gold fingers 3331 can be understood as conventional gold fingers. Several gold fingers 3331 are arranged on the front and back of the wiring part 333 to reduce the width of the wiring part 333 and avoid problems such as short circuits or signal coupling caused by the close proximity of adjacent gold fingers 3331.

[0023] A dielectric element 34 covers a base 331. A conductive sheet 3311 is provided on the front side of the base 331. The dielectric element 34 directly covers the conductive sheet 3311 and is electrically connected to it. The area of ​​the conductive sheet 3311 is smaller than the area of ​​the base 331 and also smaller than the area of ​​the dielectric element 34. The shape of the conductive sheet 3311 is not limited to being similar to the shape of the base 331 or the dielectric element 34, as long as the electrical connection between the conductive sheet 3311 and the dielectric element 34 can ensure that the current density of the alternating electrical signal passing through the dielectric element 34 is uniformly distributed. The flexible circuit board 33 also has conductive traces (not shown) that electrically connect the gold finger 3331 and the conductive sheet 3311 to transmit the alternating electrical signal received by the gold finger 3331 to the conductive sheet 3311. There is a gap region 334 between the two bases 331. The gap region 334 can provide expansion space for the connection part 332 and release corresponding stress when the electrode patch 30 is attached to the patient's body surface. It can also provide heat dissipation space when the electrode array 32 is subjected to alternating electrical signals. The connection part 332 and the wiring part 333 are both located in the gap region 334.

[0024] The dielectric element 34 is a dielectric sheet or layer with a high dielectric constant and low dielectric loss. It applies alternating electrical signals to the target area for electric field therapy by forming capacitive coupling with the patient's skin. The dielectric element 34 can be made of inorganic materials (such as piezoelectric ceramics), polymers (such as relaxor ferroelectric copolymers), or polymer composites doped with inorganic materials. The shape of the dielectric element 34 is basically consistent with the shape of the base 331, and its area is slightly smaller than or equal to the area of ​​the base 331 to ensure that the base 331 can provide sufficient support for the dielectric element 34. In this embodiment, the dielectric element 34 is made of polymer material, and the shape of the conductive sheet 3311 is basically consistent with the shape of the dielectric element 34. The area of ​​the dielectric element 34 is slightly larger than the area of ​​the conductive sheet 3311, so that the current density distribution of the alternating electrical signal flowing through the conductive sheet 3311 through the dielectric element 34 is basically uniform.

[0025] In this embodiment, two bases 331 are spaced apart in a left-right axially symmetrical manner and together form a roughly teardrop-shaped outer contour of the flexible circuit board 33, which is smaller at the top and larger at the bottom. Each base 331 is roughly half a teardrop shape. Correspondingly, two dielectric elements 34 covering the front surfaces of the two bases 331 are also arranged in a left-right axially symmetrical manner and together form a teardrop-shaped outer contour. The contour of each dielectric element 34 is a closed semi-teardrop shape. The dielectric element 34 includes a first edge 341 near the center of the electrode array 32 and a second edge 342 protruding outward from both ends of the first edge 341. The first edge 341 is a vertical straight line and is arranged parallel to the extension direction of the wiring portion 333. The first edges 341 of the two dielectric elements 34 are spaced adjacent to each other and parallel to each other. The second edge 342 is an outwardly convex curve with a curvature that gradually increases from top to bottom. The electrode array 32 has a teardrop-shaped outer contour formed by the two second edges 342 of the two dielectric elements 34. The two ends of the second edge 342 are connected to the two ends of the first edge 341 respectively and are rounded to avoid sharp corners in the dielectric element 34. With this contour design, the dielectric element 34 can reduce the problem of rapid heating of its edges due to the high current density flowing through its edges (such as circles, triangles, squares or polygons) when AC signals are applied.

[0026] As mentioned above, in this embodiment, the dielectric element 34 is a dielectric layer made of polymer material. The dielectric constant of the dielectric element 34 is not less than 20, and the dielectric strength is not less than 40V / μm to avoid breakdown under normal applied voltage. The dielectric element 34 can be formed on the surface of the conductive sheet 3311 by vapor deposition such as evaporation, sputtering, or ion plating, or by printing, spraying, or casting. The area of ​​the dielectric element 34 is set to be larger than the area of ​​the conductive sheet 3311 so that the dielectric element 34 completely covers the side end face of the conductive sheet 3311, avoiding non-capacitive coupling between the treatment electric field and the patient's skin, and avoiding the phenomenon of excessive heat concentration at the edge of the dielectric element due to the overlap between the edge of the conductive sheet 3311 and the edge of the dielectric element 34. Preferably, the area of ​​the dielectric element 34 is about 1.1 to 1.3 times the area of ​​the conductive sheet 3311. The thickness of the dielectric element 34 does not exceed 300μm, preferably 3-10μm.

[0027] The front side of the dielectric element 34 can also be provided with a biosafety protective layer (not shown) that comes into direct contact with the patient's skin. The biosafety protective layer (not shown) can be made of medical-grade stainless steel or titanium, which can avoid skin discomfort caused by using conventional conductive hydrogel as an adhesive. The electrode patch 30 can also consist only of the electrode array 32 without the backing 31, such as by pressing the electrode patch 30 onto the patient's skin through wearable clothing (not shown) to apply alternating electrical signals for tumor treatment.

[0028] The electrode patch 30 is applied with its front side facing the patient. The portion of the backing 31 not covered by the electrode array 32 is applied to the patient's skin. Therefore, the backing 31 is typically made of breathable materials such as textiles, non-woven fabrics, and microporous membranes. The backing 31 includes a main body 311, a lifting portion 312 located at the upper end of the main body 311 and convex outward, a relief portion 313 located at the lower end of the main body 311 and concave inward, and two side wings 314 located on opposite sides of the main body 311. The outline shape of the main body 311 is basically the same as that of the electrode array 32, but its area is larger than that of the electrode array 32. The electrode array 32 is adhered to the front side of the main body 311. The lifting portion 312 facilitates the removal of the electrode patch 30 to avoid contact with the electrode array 32 and causing contamination of the electrode array 32, and facilitates the subsequent removal of the electrode patch 30 from the patient's skin. The clearance portion 313 is used to accommodate the free end of the wiring portion 333 to facilitate the welding connection of the wiring portion 333 to an external wire (not shown).

[0029] The side wing 314 includes two upper wings 3141 and one lower wing 3142. For each side wing 314, a first notch 3143 is provided between the lifting part 312 and the adjacent upper wing 3141, a second notch 3144 is provided between the two upper wings 3141, and a third notch 3145 is provided between the lower wing 3142 and the adjacent upper wing 3141. The first notch 3143, the second notch 3144 and the third notch 3145 release some stress and relieve the tightness of the backing 31 when it is attached.

[0030] refer to Figure 4 As shown, the four upper wing portions 3141 located on both sides of the main body portion 311 are arranged in a non-axially symmetrical manner, with one side of the upper wing portion 3141 having an inwardly concave edge 3146, and the other side of the upper wing portion 3141 having an outwardly convex edge 3147. (Combined) Figure 5As shown, two electrode patches 30 can be placed adjacently to form an electrode patch assembly. To achieve a more compact arrangement, the concave edges 3146 and corresponding convex edges 3147 of the adjacent side wings 314 that are close to each other in the electrode patch assembly are complementary, so that more electrode patches 30 can be arranged in a limited surface attachment area, which can increase the number or area of ​​dielectric elements 34 for applying alternating electrical signals. The lower wings 3142 located on both sides of the main body 311 do not need to be complementary to the lower wings 3142 of the adjacent electrode patches 30, so they can be arranged in an axially symmetrical manner to improve the aesthetic appearance. In the adjacent side wings 314 of the two electrode patches 30, the first notch 3143 of the side wing 314 of one electrode patch 30 is aligned with the first notch 3143 of the side wing 314 of the other electrode patch 30, the second notch 3144 of the side wing 314 of one electrode patch 30 is aligned with the second notch 3144 of the side wing 314 of the other electrode patch 30, and the third notch 3145 of the side wing 314 of one electrode patch 30 is aligned with the third notch 3145 of the side wing 314 of the other electrode patch 30. That is, by using the notches of the two electrode patches 30 as the application reference, it can be ensured that the two adjacent electrode patches 30 can be accurately positioned.

[0031] A temperature sensor (not shown) is used to detect the temperature of the electrode array 32 to prevent the heat generated by the electrode array 32 when an alternating electrical signal is applied from causing burns to the patient's skin. The temperature sensor (not shown) can be a thermistor, and the electric field therapy system 100 obtains the temperature of the dielectric element 34 or the temperature of the attached skin by generating a DC signal through the electric field generator 10 to detect the temperature change of the thermistor; it can also be a thermocouple, and the electric field therapy system 100 obtains the temperature of the dielectric element 34 or the skin temperature of the corresponding area on the patient's body by detecting the electrical signal generated by the thermocouple due to temperature changes. The temperature sensor (not shown) can be located on the flexible circuit board 33 near the connection 332 of the two dielectric elements 34, or it can be located on the front or back of the base 331 of the flexible circuit board 33 corresponding to each dielectric element 34. If the temperature sensor (not shown) is located on the front of the base 331, the corresponding dielectric element 34 needs to be provided with a clearance hole (not shown) for the temperature sensor (not shown).

[0032] Although the size of a single electrode patch 30 is smaller than that of existing electrode patches such as those disclosed in Chinese Invention Patent Publication No. 112717272 (e.g., an electrode patch with 9 dielectric elements in a 3×3 configuration), it is easier to attach it compactly to the patient's body surface. Figure 6 Eight are shown. Figure 2The schematic diagram of the planar layout of the electrode patches 30 shows eight electrode patches 30 arranged in a circular pattern, roughly in the shape of a flower, with the smaller end of each electrode patch 30 facing the center of the circle. Two adjacent electrode patches 30 are defined as forming an electrode patch combination. Electrode patches 30A and 30B form the first electrode patch combination, electrode patches 30C and 30D form the second electrode patch combination, electrode patches 30E and 30F form the third electrode patch combination, and electrode patches 30G and 30H form the fourth electrode patch combination. The first electrode patch combination 30A and 30B, together with the second electrode patch combination 30C and 30D, form a pair of electrode patch combinations and jointly apply an alternating electrical signal in the first direction to the patient's tumor site. The third electrode patch combination 30E and 30F, together with the fourth electrode patch combination 30G and 30H, form another pair of electrode patch combinations and jointly apply an alternating electrical signal in the second direction to the patient's tumor site. In each electrode patch assembly, the concave edge 3146 and convex edge 3147 in the two adjacent side wings 314 of the two electrode patches 30 are complementary; the concave edge 3146 and convex edge 3147 in the two adjacent side wings 314 of the two adjacent electrode patch assemblies are also complementary; that is, the concave edge 3146 and convex edge 3147 in the two adjacent side wings 314 of any two adjacent electrode patches 30 are complementary. The eight electrode patches 30 form a compactly arranged electric field application combination, which can arrange an effective electric field application area of ​​about 3100 mm² within the 7000 mm² area (i.e., the attachment area) of the backing 31, and the effective electric field application area accounts for about 45%. Compared with the electric field application combination composed of four electrode patches (not shown) disclosed in Chinese Invention Patent Publication No. 112717272, which has an effective electric field application area of ​​2700 mm² in the 15000 mm² area covered by the backing and an effective electric field application area accounting for about 18%, the effective electric field application area utilization rate of the electric field application combination formed by the eight electrode patches 30 in this embodiment is improved by about 23%. The electrode patch combination composed of the electrode patches 30 in this embodiment achieves a larger effective electric field application area within a limited attachment area.

[0033] Second embodiment of electrode patch refer to Figure 7 and Figure 8As shown, the electrode patch 40 in the second embodiment includes a backing 41 and an electrode array 42 attached to the front of the backing 41. The electrode array 42 includes a flexible circuit board 43 attached to the front of the backing 41, two dielectric elements 44 located on the front of the flexible circuit board 43, and a temperature sensor (not shown) corresponding to the dielectric elements 44. The flexible circuit board 43 includes two bases 431 arranged symmetrically at the center, a connecting portion 432 located at the center of symmetry of the two bases 431 and connecting the two bases 431, and a wiring portion 433 extending outward from the middle of the connecting portion 432. The free end of the wiring portion 433 is provided with a plurality of gold fingers 4331. The plurality of gold fingers 4331 are directly or indirectly electrically connected to the electric field generator 10. Some gold fingers 4331 receive the AC signal output by the electric field generator 10 for generating an AC electric field, and some gold fingers 4331 receive the DC signal output by the electric field generator 10 for temperature measurement. The gold fingers 4331 can be understood as conventional gold fingers. Several gold fingers 4331 are arranged on the front and back of the wiring part 433 to reduce the width of the wiring part 433 and avoid problems such as short circuits or signal coupling caused by the close proximity of two adjacent gold fingers 4331.

[0034] Each dielectric element 44 covers its corresponding base 431. Each base 431 has a conductive sheet 4311 on its front side. Each dielectric element 44 directly covers and is electrically connected to its corresponding conductive sheet 4311. The area of ​​each conductive sheet 4311 is smaller than the area of ​​its corresponding base 431, and the area of ​​each dielectric element 44 is no larger than the area of ​​its corresponding base 431. The shape of each second conductive sheet 3311 is not limited to being similar to the shape of its corresponding base 431 or dielectric element 44, as long as the electrical connection between the conductive sheet 4311 and the corresponding dielectric element 44 ensures a uniform current density distribution of the alternating electrical signal passing through the dielectric element 44. The flexible circuit board 43 also has conductive traces (not shown) that electrically connect the gold fingers 4331 and the conductive sheets 4311 to transmit the alternating electrical signal received by the gold fingers 4331 to the conductive sheets 4311. A gap region 434 exists between the two bases 431. The interval region 434 provides expansion space for the connection portion 432 and releases corresponding stress when the electrode patch 40 is attached to the patient's body surface. It also provides heat dissipation space 435 when an alternating electrical signal is applied to the electrode array 42. The heat dissipation space 435 is formed by the two bases 431 of the flexible circuit board 43 of the electrode array 42 being arranged in an interval. It allows moisture from the patient's body surface to escape when the electrode array 42 applies an alternating electrical signal to the patient's tumor site for tumor treatment, allowing the patient's body surface to exchange heat with the outside air. This avoids heat accumulation on the patient's body surface where the electrode array 42 is applied, which could lead to low-temperature burns. In this embodiment, both the connection portion 432 and the wiring portion 433 are located within the interval region 434. This ensures that the electrode array 42 has sufficient heat dissipation space 435, avoids rapid heat accumulation on the patient's body surface causing low-temperature burns, and increases the effective electric field coverage area of ​​the electrode array 42 when an alternating electrical signal is applied through the dielectric element 44.

[0035] The dielectric element 44 is a dielectric sheet or layer with high dielectric constant and low dielectric loss. It applies alternating electrical signals to the target area for electric field therapy by forming capacitive coupling with the patient's skin. The material constituting the dielectric element 44 can be inorganic (such as piezoelectric ceramics), polymers (such as relaxor ferroelectric copolymers), or polymer composites doped with inorganic materials. The shape of each dielectric element 44 is basically consistent with the shape of the corresponding base 431, and the area of ​​each base 431 is greater than or equal to the area of ​​the corresponding dielectric element 44 to ensure that the base 431 can provide sufficient support for the dielectric element 44. In this embodiment, the dielectric element 44 is mainly composed of polymer material, and the shape of the conductive sheet 4311 is basically consistent with the shape of the dielectric element 44. The area of ​​the dielectric element 44 is slightly larger than the area of ​​the conductive sheet 4311, so that the current density distribution of the alternating electrical signal flowing through the conductive sheet 4311 through the dielectric element 44 is basically uniform.

[0036] In this embodiment, the two bases 431 are arranged at intervals in a centrally symmetrical manner, and the two dielectric elements 44 respectively covering the front surfaces of the two bases 431 have the same structure and are also arranged in a centrally symmetrical manner. The following describes... Figure 7Taking the dielectric element 44 located on the right as an example, the irregular outer contour of the dielectric element 44 includes a first edge 441, a second edge 442, and a third edge 443 that are connected end to end. The first edge 441 is arranged in a diagonal line near the center of the electrode array 42, sloping from top to bottom and to the left, with an angle of about 80° with the horizontal line. The extension direction of the wiring portion 433 is parallel to the extension direction of the first edge 441, and the first edges 441 of the two dielectric elements 44 are arranged adjacent to each other at intervals and parallel to each other. The second edge 442 is shaped like the outer contour of a Coca-Cola glass bottle, and includes a first oblique line segment 4421, a first arc segment 4422, a second arc segment 4423, and a third arc segment 4424 continuously arranged from top to bottom. The first oblique line segment 4421 is inclined downwards and to the right relative to the first edge 441. The first arc segment 4422 protrudes outwards or to the right relative to the first oblique line segment 421. The second arc segment 4423 is concave inwards or to the left relative to the first arc segment 4422. The third arc segment 4424 protrudes outwards or to the right relative to the second arc segment 4423. The third edge 443 is approximately horizontally curved and connects the bottom ends of the first edge 441 and the second edge 442. The top ends of the first edge 441 and the second edge 442 are connected. The first edge 441, the second edge 442, and the third edge 443 all use rounded transitions at the joints between each other to avoid sharp corners on the dielectric element 44. For the dielectric element 44 located on the left side, its third edge 443 is located at the top, and the second edge 442 includes a first oblique line segment 4421, a first arc segment 4422, a second arc segment 4423, and a third arc segment 4424 continuously arranged from bottom to top. The dielectric element 44 adopts this contour design, and its area is slightly larger than that of the corresponding conductive sheet 4311. This can reduce the problem that when the alternating current signal for tumor electric field therapy is applied to the patient through the dielectric element 44, the current density flowing through the outer contour of the dielectric element 44 is higher than that flowing through the middle part of the dielectric element 44, which causes the outer contour of the dielectric element 44 to heat up faster than the middle part. This results in inconsistent body surface temperature rise when the patient applies the dielectric element 44, and the tumor electric field therapy system may interrupt the application of the alternating current signal and shorten the application time of the tumor electric field to avoid low-temperature burns to the patient's body surface.

[0037] As mentioned above, in this embodiment, the dielectric element 44 is a dielectric layer made of polymer material. The dielectric constant of the dielectric element 44 is not less than 20, and the dielectric strength is not less than 40V / μm to avoid breakdown under normal applied voltage. The dielectric element 44 can be formed on the surface of the corresponding conductive sheet 4311 by vapor deposition such as evaporation, sputtering, or ion plating, or by printing, spraying, or casting. The area of ​​the dielectric element 44 is larger than the area of ​​the corresponding conductive sheet 4311. It is disposed on the conductive sheet 4311 in such a way that it completely covers the side end face of the conductive sheet 4311 to avoid non-capacitive coupling between the treatment electric field and the patient's skin, and to avoid the phenomenon of excessive heat concentration on the outer contour of the electrode array 42 due to the outer contour of the conductive sheet 4311 coinciding with the outer contour of the dielectric element 44. Preferably, the area of ​​the dielectric element 44 is about 1.1 to 1.3 times the area of ​​the corresponding conductive sheet 4311. The thickness of dielectric element 44 shall not exceed 300 μm, preferably 3-10 μm.

[0038] The front side of the dielectric element 44 can also be provided with a biosafety protective layer (not shown) that comes into direct contact with the patient's skin. The biosafety protective layer (not shown) can be made of medical-grade stainless steel or titanium, which can avoid skin discomfort caused by using conventional conductive hydrogel as an adhesive. The electrode patch 40 can also consist only of the electrode array 42 without the backing 41, such as by pressing the electrode patch 40 onto the patient's skin through wearable clothing (not shown) to apply alternating electrical signals for tumor treatment.

[0039] The electrode patch 40 is applied with its front side facing the patient. The portion of the backing 41 not covered by the electrode array 42 is applied to the patient's skin. Therefore, the backing 41 is typically made of breathable materials such as textiles, non-woven fabrics, and microporous membranes. The outline shape of the backing 41 is basically the same as that of the electrode array 42, but its area is larger than that of the electrode array 42. The backing 41 includes a main body 411 that is attached to the electrode array 42, a ring wing 412 surrounding the electrode array 42, and a clearance portion 413 provided on the ring wing 412. The ring wing 412 facilitates the removal of the electrode patch 40 to avoid contact with the electrode array 42 and contamination of the electrode array 42, and facilitates the subsequent removal of the electrode patch 40 from the patient's skin. The clearance portion 413 is used to accommodate the free end of the wiring portion 433 to facilitate the soldering connection of the wiring portion 433 to an external wire (not shown).

[0040] A temperature sensor (not shown) is used to detect the temperature of the electrode array 42 to prevent the heat generated by the electrode array 42 when an alternating electrical signal is applied from causing burns to the patient's skin. The temperature sensor (not shown) can be a thermistor, and the electric field therapy system 100 obtains the temperature of the dielectric element 44 or the temperature of the attached skin by generating a DC signal for detecting the temperature change of the thermistor through the electric field generator 10; or it can be a thermocouple, and the electric field therapy system 100 obtains the temperature of the dielectric element 44 or the skin temperature of the corresponding area on the patient's body by detecting the electrical signal generated by the thermocouple due to temperature changes. The temperature sensor (not shown) can be located on the flexible circuit board 43 near the connection 432 of the two dielectric elements 44, or it can be located on the front or back of the base 431 of the flexible circuit board 43 corresponding to each dielectric element 44. If the temperature sensor (not shown) is located on the front of the base 431, the corresponding dielectric element 44 needs to be provided with a clearance hole (not shown) for the temperature sensor (not shown).

[0041] Although the overall size of each electrode patch 40 is smaller than that of existing electrode patches such as those disclosed in Chinese Invention Patent Publication No. 112717272 (e.g., an electrode patch with 9 dielectric elements in a 3×3 configuration), it is easier to attach compactly to the patient's skin. Furthermore, after a period of use, each electrode patch 40 can be rotated around its geometric center by a certain angle (e.g., 90°) to another attachment position, with at least 25% overlap between the two attachment positions. This ensures that the effect of applying the alternating electrical signal remains essentially unchanged while avoiding the problem of skin discomfort (such as allergies or dermatitis) caused by prolonged unchanging attachment positions of the electrode patch 30 during tumor electric field therapy.

[0042] refer to Figure 9 and combined Figure 10 As shown, the two contour lines of the annular wing portion 412 on its left and right sides are basically consistent with the outer contour line of the second edge of the corresponding dielectric element 44 of the two dielectric elements 44. The contour lines of the annular wing portion 412 on its left and right sides each have a convex edge 4121 corresponding to the first arc segment 4422 of the corresponding dielectric element 44 and a concave edge 4122 corresponding to the second arc segment 4423 of the corresponding dielectric element 44. The two electrode patches 40 can be placed adjacent to each other to form an electrode patch combination. In order to achieve a more compact arrangement, the two electrode patches 40 are placed side by side and slightly staggered vertically, so that the convex edge 4121 and concave edge 4122 on the right side of the electrode patch 40 on the left side are complementary to the concave edge 4122 and convex edge 4121 on the left side of the electrode patch 40 on the right side, respectively. This allows more electrode patches 40 to be arranged in a limited body surface attachment area, which can increase the number or area of ​​dielectric elements 44 for applying alternating electrical signals.

[0043] Figure 11 Eight are shown. Figure 8 The diagram shows a planar projection of the electrode patches 40. Eight electrode patches 40 are arranged in a radial, ring-shaped pattern. To increase the effective electric field application area, adjacent electrode patches 40 are paired to form an electrode patch combination. Electrode patches 40A and 40B form the first electrode patch combination, electrode patches 40C and 40D form the second electrode patch combination, electrode patches 40E and 40F form the third electrode patch combination, and electrode patches 40G and 40H form the fourth electrode patch combination. The first electrode patch combination 40A and 40B, together with the second electrode patch combination 40C and 40D, form a pair of electrode patch combinations and jointly apply an alternating electrical signal in the first direction to the patient's tumor site. The third electrode patch combination 40E and 40F, together with the fourth electrode patch combination 40G and 40H, form another pair of electrode patch combinations and jointly apply an alternating electrical signal in the second direction to the patient's tumor site. The electric field application combination composed of eight electrode patches 40 can provide an effective electric field application area of ​​approximately 2,900 mm² (approximately 46% of the area) within an area of ​​6,300 mm² covered by the backing 31. Compared to the electric field application combination composed of four electrode patches, such as those disclosed in Chinese Invention Patent Publication No. 112717272, which has an effective electric field application area of ​​2,700 mm² (approximately 18% of the area) within a backing area of ​​15,000 mm² covered by the backing, the effective electric field application area utilization rate of the electric field application combination composed of electrode patches 30 in this embodiment is improved by approximately 24%, achieving a larger electric field application area within a limited attachment area.

[0044] Third embodiment of electrode patch refer to Figure 12 and Figure 13 As shown, the electrode patch 50 includes a backing 51 and an electrode array 52 attached to the front of the backing 51. The electrode array 52 includes a flexible circuit board 53 attached to the front of the backing 51, a plurality of dielectric elements 54 located on the front of the flexible circuit board 53, and a temperature sensor (not shown) corresponding to the dielectric elements 54. The electrode patch 50 is applied with its front side facing the patient. The portion of the backing 51 not covered by the electrode array 52 is applied to the patient's skin surface. Therefore, the backing 51 is usually made of breathable materials such as textiles, non-woven fabrics, and microporous membranes. In this embodiment, the backing 51 is a regular octagon, including a main body 511 attached to the electrode array 52 and an annular wing portion 512 surrounding the electrode array 52. ​​The annular wing portion 512 facilitates the removal of the electrode patch 50 to avoid contact with the electrode array 52 and contamination of the electrode array 52, and facilitates the subsequent removal of the electrode patch 50 from the patient's skin.

[0045] The flexible circuit board 53 is generally circular in shape. It includes a connecting portion 531 located at the center of the flexible circuit board 53 and arranged in a ring shape, a plurality of bases 532 extending radially outward from the edge of the connecting portion 531 and spaced apart, and wiring portions 533 extending radially outward from the edge of the connecting portion 531. A gap 534 is reserved between two adjacent bases 532 to accommodate the wiring portions 533. The free ends of the wiring portions 533 are provided with a plurality of gold fingers 5331. The gold fingers 5331 are directly or indirectly electrically connected to the electric field generator 10. Some of the gold fingers 5331 receive the AC signal output by the electric field generator 10 for generating an AC electric field, and some receive the DC signal output by the electric field generator 10 for temperature measurement. The gold fingers 5331 are respectively arranged on the front and back of the wiring portions 533 to reduce the width of the wiring portions 533 and avoid problems such as short circuits or signal coupling caused by the gold fingers 5331 being too close together. Several bases 532 are spaced apart to form several open spaces 335 located between the bases 532.

[0046] Each base 532 is symmetrically arranged along its length axis. Along the radial direction of the circle containing the flexible circuit board 53, it sequentially includes a first base 5321, a bridging portion 5322 connected to the first base 5321, and a second base 5323 connected to the bridging portion 5322. The outlines of the left and right sides of the first base 5321 and the outlines of the left and right sides of the second base 5323 extend radially along the circle containing the electrode array 52 and are collinear. The first base 5321 is connected to the connecting portion 531 and is arranged in a near-triangular fan shape. The second base 5323 is arranged in a near-trapezoidal shape, with its outline near the first base 5321 being arc-shaped and its outline away from the first base 5321 being straight. The two ends of the straight side of the second base 5323 are smoothly connected to the two sides along the radial direction of the circle containing the electrode array 52. The bridging portion 5322 is arranged in a strip shape and connects the first base 5321 and the second base 5323 radially along the circle containing the electrode array 32. The side of the first base 5321 near the second base 5323 and the side of the second base 5323 near the first base 5321 are both arc-shaped and spaced parallel to each other, forming an open space 535 between the first base 5321 and the second base 5323 for heat dissipation and ventilation of the patient's skin. A first conductive sheet 5324 is provided on the front side of the first base 5321, and a second conductive sheet 5325 is provided on the front side of the second base 5323. The first conductive sheet 5324 and the second conductive sheet 5325 can be collectively referred to as conductive sheets (unlabeled). The flexible circuit board 53 also has conductive traces (not shown) that electrically connect the gold finger 5331 to the first conductive sheet 5324 and the first conductive sheet 5324 to the second conductive sheet 5325, so as to transmit the alternating electrical signal received by the gold finger 5331 to the first conductive sheet 5324 and the second conductive sheet 5325, and then to the corresponding dielectric element 54. There is a gap region 534 between two adjacent bases 532, which can provide expansion space for the connection part 531 and release corresponding stress when the electrode patch 50 is attached, and can also provide heat dissipation space 535 when the dielectric element 54 is subjected to alternating electrical signals. The above-mentioned open space 335 for heat dissipation is formed between two adjacent first bases 3321, between two adjacent second bases 3323, and between two adjacent bridge parts 3322.

[0047] The dielectric element 54 is disposed corresponding to the base 532, and includes a first dielectric portion 541 covering the first conductive sheet 5324 and a second dielectric portion 542 covering the second conductive sheet 5325. The shapes of the first conductive sheet 5324 and the first dielectric portion 541 are basically consistent with the shape of the first base 5321, and the area of ​​the first dielectric portion 541 is larger than the area of ​​the first conductive sheet 5324 but not larger than the area of ​​the first base 5321. This allows the first dielectric portion 541 to completely cover the first conductive sheet 5324 to prevent the first conductive sheet 5324 from directly contacting the subject's skin and causing discomfort to the subject, while also being fully supported by the first base 5321. Similarly, the shapes of the second conductive sheet 5325 and the second dielectric portion 542 are basically consistent with the shape of the second base 5323. The area of ​​the second dielectric portion 542 is larger than the area of ​​the second conductive sheet 5325 but not larger than the area of ​​the second base 5323. This allows the second dielectric portion 542 to completely cover the second conductive sheet 5325 to prevent direct contact between the second conductive sheet 5325 and the subject's skin, thus preventing discomfort, while also receiving full support from the second base 5323. This contour design of the dielectric element 54 reduces the problem of rapid edge heating due to high edge current density caused by its regular edges, which leads to heat accumulation at the corresponding body surface.

[0048] The dielectric element 54 is a dielectric sheet or layer with a high dielectric constant and low dielectric loss. It applies alternating electrical signals to the target area for electric field therapy by forming capacitive coupling with the patient's skin. The electrode array 52 has 11 dielectric elements 54, each having an angle between 20-30° on the circle containing the electrode array 32, allowing for a sufficiently large open space 335 between adjacent dielectric elements 34 to accelerate heat dissipation from the body surface. The dielectric element 54 can be made of inorganic materials (such as piezoelectric ceramics), polymers (such as relaxor ferroelectric copolymers), or polymer composites doped with inorganic materials. In this embodiment, the dielectric element 54 is a dielectric layer made of polymer material, with a dielectric constant of not less than 20 and a dielectric strength of not less than 40V / μm to prevent breakdown under normal applied voltage. The first dielectric portion 541 and the second dielectric portion 542 can be formed on the surfaces of the first conductive sheet 5324 and the second conductive sheet 5325 respectively by vapor deposition methods such as evaporation, sputtering, or ion plating, or by printing, spraying, or casting. The area of ​​the first dielectric portion 541 is larger than the area of ​​the first conductive sheet 5324 so that the first dielectric portion 541 completely covers the side end face of the first conductive sheet 5324. This avoids non-capacitive coupling between the treatment electric field and the patient's skin, and prevents the edge of the first conductive sheet 5324 from coinciding with the edge of the first dielectric portion 541, which would lead to excessive heat concentration at the edge of the electrode unit 55 formed by the dielectric element 54 and the corresponding base 532 of the flexible circuit board 53. Similarly, the area of ​​the second dielectric portion 542 is larger than the area of ​​the second conductive sheet 5325. Preferably, the area of ​​the first dielectric portion 541 is approximately 1.1 to 1.3 times the area of ​​the first conductive sheet 5324, and the area of ​​the second dielectric portion 542 is approximately 1.1 to 1.3 times the area of ​​the second conductive sheet 5325. The thickness of the dielectric element 54 does not exceed 300 μm, and is preferably 3-10 μm.

[0049] The front side of the dielectric element 54 can also be provided with a biosafety protective layer (not shown) that comes into direct contact with the patient's skin. The biosafety protective layer (not shown) can be made of medical-grade stainless steel or titanium, which can avoid skin discomfort caused by using conventional conductive hydrogel as an adhesive. The electrode patch 50 can also consist only of the electrode array 52 without the backing 51, such as by pressing the electrode patch 50 onto the patient's skin through wearable clothing (not shown) to apply alternating electrical signals for tumor treatment.

[0050] A temperature sensor (not shown) is used to detect the temperature of the electrode array 52 to prevent the heat generated by the electrode array 52 when an alternating electrical signal is applied from causing burns to the patient's skin. The temperature sensor (not shown) can be a thermistor, and the electric field therapy system 100 obtains the temperature of the dielectric element 54 or the temperature of the attached skin by generating a DC signal for detecting the temperature change of the thermistor through the electric field generator 10; it can also be a thermocouple, and the electric field therapy system 100 obtains the temperature of the dielectric element 54 or the skin temperature of the corresponding area on the patient's body by detecting the electrical signal generated by the thermocouple due to temperature changes. The temperature sensor (not shown) can be located on the flexible circuit board 53 near the connection 531 of the two dielectric elements 54, or it can be located on the front or back of the base 532 of the flexible circuit board 53 corresponding to each dielectric element 54. If the temperature sensor (not shown) is located on the front of the base 532, the corresponding dielectric element 54 needs to be provided with a clearance hole (not shown) for the temperature sensor (not shown). A temperature sensor (not shown) may be disposed on a first base 5321 or a second base 5323.

[0051] Each electrode patch 50 is smaller than existing electrode patches such as those disclosed in Chinese Patent No. CN112717272 (e.g., an electrode patch with 9 dielectric elements in a 3×3 configuration), making it easier to attach compactly to the patient's skin. After a period of use, each electrode patch 50 can be rotated around its geometric center by a certain angle (e.g., 90°) to another attachment position. The two attachment positions of the electrode patch 50 are staggered, with at least 50% overlap between them. An open space 535 for heat dissipation is formed between adjacent two electrode units 55. This ensures that the subject's skin does not experience discomfort (such as allergies or dermatitis) due to heat accumulation, even with a sufficiently large open space 535 that accelerates heat dissipation from the skin, while also increasing the effective electric field application area.

[0052] Figure 14The diagram shows a planar layout of four electrode patches 50. First electrode patch 50A and second electrode patch 50B form a pair of electrode patches and jointly apply an alternating electrical signal in a first direction to the tumor site. Third electrode patch 50C and fourth electrode patch 50D form another pair of electrode patches and jointly apply an alternating electrical signal in a second direction to the tumor site. The four electrode patches 50 are arranged in a ring, with the wiring portions 533 of the paired electrode patches 50 extending back to back. The two adjacent sides 513 of any two adjacent electrode patches 50 are close together and parallel, allowing the four electrode patches 50 to form a compact arrangement. The two adjacent sides 513 are roughly aligned end-to-end, serving as a positioning reference during application. The electric field application combination composed of four electrode patches 50 can provide an effective electric field application area of ​​approximately 2600 mm² within an area of ​​7200 mm² covered by the backing 31 (approximately 36% of the area). Compared to the electric field application combination composed of four electrode patches disclosed in Chinese Patent No. CN1127172, which has an effective electric field application area of ​​2700 mm² within an area of ​​15000 mm² covered by the backing (approximately 18% of the area), the effective electric field application area utilization rate of the electric field application combination composed of electrode patches 50 in this embodiment is improved by approximately 18%, enabling the electrode patches 50 to provide a larger effective electric field application area within a limited attachment area.

[0053] Fourth embodiment of electrode patch refer to Figure 15 and Figure 16 As shown, the electrode patch 60 includes a backing 61 and an electrode array 62 attached to the front of the backing 61. The electrode array 62 includes a flexible circuit board 63 attached to the front of the backing 61, several dielectric elements 64 located on the front of the flexible circuit board 63, and temperature sensors (not shown) corresponding to the dielectric elements 64. The electrode patch 60 is applied with its front side facing the patient. The portion of the backing 61 not covered by the electrode array 62 is applied to the patient's skin surface. Therefore, the backing 61 is typically made of breathable materials such as textiles, non-woven fabrics, and microporous membranes. The overall outline of the backing 61 and the electrode array 62 is basically the same, but the area of ​​the backing 61 is larger than the area of ​​the electrode array 62. In this embodiment, the backing 61 is fan-shaped with a spread angle of approximately 90°.

[0054] The flexible circuit board 63 has an overall fan-shaped outline and includes a connecting portion 631, several bases 632 connected to the connecting portion 631, and wiring portions 633 connected to the connecting portion 631. The connecting portion 631 is an arc-shaped strip that runs across the flexible circuit board 63. The several bases 632 are located on opposite sides of the connecting portion 631 and extend radially along the flexible circuit board 63. The wiring portions 633 extend radially outward from the middle of the connecting portion 631 along the flexible circuit board 63. The flexible circuit board 63 is symmetrical about its left and right axes. The wiring portions 633 are located on the axis of symmetry of the flexible circuit board 63. The several bases 632 are: a central base 6321 located inside the connecting portion 631 and on the axis of symmetry of the flexible circuit board 63; four inner bases 6322 located inside the connecting portion 631 and symmetrically located on both sides of the central base 6321; and four outer bases 6323 located outside the connecting portion 631 and symmetrically located on both sides of the wiring portions 633. Each base base 632 is approximately fan-shaped, and the unfolding angle of each inner base base 6322 is the same, approximately between 10° and 20°. The four outer base bases 6323 are arranged in a radially aligned manner with the four inner base bases 6322. The angle between the two outermost contour lines of the two outermost outer base bases 6323 is approximately 90°, meaning the unfolding angle of the overall fan-shaped contour of the flexible circuit board 63 is approximately 90°. There are gaps 634 between adjacent inner base bases 6322 and between adjacent outer base bases 6323. These gaps 634 provide expansion and contraction space for the connection portion 631 and release corresponding stress when the electrode patch 60 is attached, and also provide heat dissipation space when alternating electrical signals are applied to the dielectric element 64. The central base base 6321 and the four inner base bases 6322 are evenly distributed, and the four gaps 634 are also fan-shaped, with each forming approximately the same unfolding angle.

[0055] The free end of the wiring section 633 is provided with a plurality of gold fingers 6331. The plurality of gold fingers 6331 are directly or indirectly electrically connected to the electric field generator 10. Some of the gold fingers 6331 receive the AC signal output by the electric field generator 10 for generating an AC electric field, and some receive the DC signal for temperature measurement. The gold fingers 6331 can be understood as conventional gold fingers. The plurality of gold fingers 6331 are respectively arranged on the front and back of the wiring section 633 to reduce the width of the wiring section 633 and avoid problems such as short circuits or signal coupling caused by the close proximity of two adjacent gold fingers 6331.

[0056] Each base 632 has a conductive sheet 6324 on its front side, and a dielectric element 64 covers the conductive sheet 6324 and is electrically connected to it. The flexible circuit board 63 also has conductive traces (not shown) that electrically connect the gold finger 6331 and the conductive sheet 6324, transmitting the alternating electrical signal received by the gold finger 6331 to the conductive sheet 6324, and then to the dielectric element 64. The area of ​​the conductive sheet 6324 is smaller than the area of ​​the corresponding base 632 and also smaller than the area of ​​the corresponding dielectric element 64. The shape of the conductive sheet 6324 is not limited, as long as its electrical connection with the dielectric element 64 ensures a uniform current density distribution of the alternating electrical signal passing through the dielectric element 64. This prevents the patient's skin temperature from rising too quickly due to high current density flowing through its edges when an alternating current signal is applied to the dielectric element 64.

[0057] The dielectric element 64 is a dielectric sheet or layer with high dielectric constant and low dielectric loss. It applies alternating electrical signals to the target area for electric field therapy by forming capacitive coupling with the patient's skin. The material constituting the dielectric element 64 can be inorganic (such as piezoelectric ceramics), polymers (such as relaxor ferroelectric copolymers), or polymer composites doped with inorganic materials. The shape of the dielectric element 64 is substantially consistent with the shape of the corresponding base 632, wherein the area of ​​the dielectric element 64 is not larger than the area of ​​the corresponding base 632 to ensure that the base 632 provides sufficient support for the dielectric element 64.

[0058] In this embodiment, the dielectric element 64 is a dielectric layer made of polymer material. The dielectric constant of the dielectric element 64 is not less than 20, and the dielectric strength is not less than 40V / μm to avoid breakdown under normal applied voltage. The dielectric element 64 can be formed on the surface of the conductive sheet 6324 by vapor deposition methods such as evaporation, sputtering, or ion plating, or by printing, spraying, or casting. The shape of the conductive sheet 6324 is basically consistent with the shape of the dielectric element 64 to ensure that the current density distribution of the alternating electrical signal flowing through the conductive sheet 6324 through the dielectric element 64 is basically uniform. The area of ​​the dielectric element 64 is larger than the area of ​​the conductive sheet 6324, and the dielectric element 64 completely covers the side end face of the corresponding conductive sheet 6324 to avoid non-capacitive coupling between the treatment electric field and the patient's skin, and to avoid the phenomenon of excessive heat concentration at the edge of the dielectric element 64 due to the edge of the conductive sheet 6324 coinciding with the edge of the dielectric element 64. Preferably, the area of ​​the dielectric element 64 is approximately 1.1 to 1.3 times the area of ​​the conductive sheet 6324. The thickness of the dielectric element 64 does not exceed 600 μm, and is preferably 3-10 μm.

[0059] Each dielectric element 64 is arranged in a fan-shaped ring, including a first side 641 near the connection portion 631, a second side 642 opposite to the first side 641, and a third side 643 and a fourth side 644 connecting the first side 641 and the second side 642. The third side 643 and the fourth side 644 are approximately located in the radial direction of the circle where the flexible circuit board 63 is located. The included angle formed by the third side 643 and the fourth side 644 is between 10° and 20°. The third side 643, the fourth side 644 and the second side 642 are all smoothly connected by an arc. The connecting portion 631 is roughly located in the middle of the electrode array 62. The dielectric elements 64 distributed on both sides of the connecting portion 631 can be regarded as being located on the periphery. Therefore, this arrangement of the dielectric elements 64 can reduce the problem of the dielectric elements 64 located on the periphery of the electrode patch 30 heating up quickly. The independent arrangement of the dielectric elements 64 can also be appropriately cut according to different attachment conditions without affecting the operation of other dielectric elements 64.

[0060] The front side of the dielectric element 64 can also be provided with a biosafety protective layer (not shown) that comes into direct contact with the patient's skin. The biosafety protective layer (not shown) can be made of medical-grade stainless steel or titanium, which can avoid skin discomfort caused by using conventional conductive hydrogel as an adhesive. The electrode patch 60 can also consist only of the electrode array 62 without the backing 61, such as by pressing the electrode patch 60 onto the patient's skin through wearable clothing (not shown) to apply alternating electrical signals for tumor treatment.

[0061] A temperature sensor (not shown) is used to detect the temperature of the electrode array 62 to prevent the heat generated by the electrode array 62 when an alternating electrical signal is applied from causing burns to the patient's skin. The temperature sensor (not shown) can be a thermistor, and the electric field therapy system 100 obtains the temperature of the dielectric element 64 or the temperature of the attached skin by generating a DC signal for detecting the temperature change of the thermistor through the electric field generator 10; or it can be a thermocouple, and the electric field therapy system 100 obtains the temperature of the dielectric element 64 or the skin temperature of the corresponding area on the patient's body by detecting the electrical signal generated by the thermocouple due to temperature changes. The temperature sensor (not shown) can be located on the flexible circuit board 63 near the connection 631 of the two dielectric elements 64, or it can be located on the front or back of the base 632 of the flexible circuit board 63 corresponding to each dielectric element 64. If the temperature sensor (not shown) is located on the front of the base 632, the corresponding dielectric element 64 needs to be provided with a clearance hole (not shown) for the temperature sensor (not shown). The temperature sensor (not shown) can be set on the base 632 or the connecting part 631. When the temperature sensor (not shown) is set on the base 632, it can be set only on the base 632 on one side of the connecting part 631, or it can be set separately on the base 632 on both sides of the connecting part 631, or it can be set alternately on the base 632 on both sides of the connecting part 631.

[0062] Each electrode patch 60 is smaller than existing electrode patches such as those disclosed in Chinese Patent Publication No. 112717272 (e.g., an electrode patch with 9 dielectric elements in a 3×3 configuration), so as to be compactly attached to the patient's body surface. Figure 17The diagram shows a planar layout of four electrode patches 60. First electrode patch 60A and second electrode patch 60B form a pair of electrode patches and jointly apply an alternating electrical signal in a first direction to the patient's tumor site. Third electrode patch 60C and fourth electrode patch 60D form another pair of electrode patches and jointly apply an alternating electrical signal in a second direction to the patient's tumor site. The four electrode patches 60 are arranged in a ring, with the wiring portions 633 extending outwards. As previously described, the backing 61 is arranged in a fan-shaped ring, including two edges 611 extending radially along its circle. The two adjacent edges 611 of any two adjacent electrode patches 60 are close together and parallel, thus allowing the four electrode patches 60 to form a compact electric field application combination. The two edges 611 of two electrode patches 60 that are close to each other are roughly aligned end-to-end, serving as a positioning reference during attachment. The electric field application combination consisting of four electrode patches 60 can provide an effective electric field application area of ​​approximately 4,000 mm² (approximately 36% of the area) within an area of ​​11,000 mm² covered by the backing 61. Compared to the electric field application combination consisting of four electrode patches as disclosed in Chinese Patent No. 112717272, which has an effective electric field application area of ​​2,700 mm² (approximately 18% of the area) within an area of ​​15,000 mm² covered by the backing, the utilization rate of the effective electric field application area is increased by approximately 18%, giving the electrode patches 60 a larger effective electric field application area within a limited attachment area.

[0063] In summary, the dielectric elements of the electrode patches in each embodiment of the electric field therapy system of this application can reduce the problem of rapid heating of the peripheral dielectric elements caused by edge effects; and when the various electrode patches are used in combination, they can be arranged compactly to increase the proportion of the effective electric field application area in the application area, thereby achieving a larger electric field application area within a limited application area.

[0064] 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, characterized in that, The device includes a backing and an electrode array bonded to the backing. The electrode array includes a flexible circuit board and several dielectric elements disposed on the flexible circuit board for applying alternating current signals. The electrode array has a teardrop-shaped, wavy, or fan-shaped outer contour. The flexible circuit board includes a connecting portion, several spaced-apart bases, and wiring portions extending outward from the connecting portion. The connecting portion is strip-shaped and located in the middle of the electrode array. Each base is connected to the connecting portion and located on opposite sides of the connecting portion. A conductive sheet is provided on the front side of the base. The dielectric elements are correspondingly disposed on the bases and cover the conductive sheet of the base for electrical connection. Several gold fingers are provided on the wiring portions. Several conductive traces are arranged on the flexible circuit board. The conductive sheet is electrically connected to the corresponding gold fingers through the corresponding conductive traces. The outer contour of the backing corresponds to the outer contour of the electrode array. The effective electric field application area of ​​the electrode array accounts for more than 30% of the attachment area of ​​the backing.

2. The electrode patch according to claim 1, characterized in that: The flexible circuit board includes two bases that are symmetrically arranged on the left and right sides of the connection portion, and the outer contours of the two dielectric elements that are far apart from each other together form the teardrop-shaped outer contour of the electrode array.

3. The electrode patch according to claim 2, characterized in that: The backing has two side wings located on opposite sides of the electrode array, one of which has a concave edge and the other has a convex edge.

4. The electrode patch according to claim 1, characterized in that: The flexible circuit board includes two bases that are centrally symmetrically spaced on the left and right sides of the connection portion, and the outer contours of the two dielectric elements that are far apart from each other together form the wavy outer contour of the electrode array.

5. The electrode patch according to claim 4, characterized in that: The backing has a ring wing portion surrounding the electrode array, and the ring wing portion has a concave edge and a convex edge on opposite sides.

6. The electrode patch according to claim 2 or 4, characterized in that: There is a gap between the two bases, and the connecting portion is located in the middle of the gap.

7. The electrode patch according to claim 1, characterized in that: The outer contours of the dielectric elements located at both ends of the connection portion together form the fan-shaped outer contour of the electrode array. The connection portion is arc-shaped, and several bases are located on opposite sides of the inner and outer sides of the connection portion and extend radially.

8. The electrode patch according to claim 7, characterized in that: The backing is arranged in a fan-shaped ring with a fan-shaped ring angle of 90°.

9. An electric field therapy system for applying electric field therapy to a target area of ​​a subject, characterized in that, The device includes a plurality of electrode patches attached to the surface of the subject and surrounding the target area, wherein the electrode patches are the electrode patches as described in any one of claims 1-8, and the outer contours of at least two adjacent electrode patches that are close to each other are mutually complementary in terms of concavity and convexity or are close to each other and parallel.

10. The electric field therapy system according to claim 9, characterized in that: A plurality of electrode patches include two pairs of electrode patch assemblies, each of the electrode patch assemblies including two of the electrode patches and the two adjacent edges of the two backings of the two electrode patches being complementary in shape.

11. The electric field therapy system according to claim 9, characterized in that: The electrode patches include two pairs of electrode patches, with the two edges of any two adjacent backings being close to each other and parallel.

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