Electrode patch and electric field therapy system

Abstract

The present application provides an electrode patch (30, 40, 50, 60) and an electric field therapeutic system (100). The electrode patch (30, 40, 50, 60) comprises a backing (31, 41, 51, 61) and an electrode array (32, 42, 52, 62) adhered to the backing (31, 41, 51, 61). The electrode array (32, 42, 52, 62) comprises a flexible circuit board (33, 43, 53, 63) and a plurality of dielectric elements (34, 44, 54, 64) arranged on the flexible circuit board (33, 43, 53, 63) and configured for applying an alternating current signal. The flexible circuit board (33, 43, 53, 63) comprises a connection part (332, 432, 531, 631) located in the middle of the electrode array (32, 42, 52, 62) and a plurality of base parts (331, 431, 532, 632) separately connected to the connection part (332, 432, 531, 631) and spaced apart from each other. The dielectric elements (34, 44, 54, 64) correspond to the base parts (331, 431, 532, 632) and cover the base parts (331, 431, 532, 632). The outer contour of the backing (31, 41, 51, 61) corresponds to the outer contour of the electrode array (32, 42, 52, 62), and the effective electric field application area of the electrode array (32, 42, 52, 62) accounts for 30% or more of the adhesion area of the backing (31, 41, 51, 61). According to the present application, the electrode patch (30, 40, 50, 60) and the electric field therapeutic system (100), by means of a compact arrangement of the electrode patches (30, 40, 50, 60), can effectively improve the proportion of an effective electric field application area and achieve a larger electric field application area in a limited adhesion area.

Description

Electrode patches and electric field therapy systems Technical Field

[0001] The present application relates to an electrode patch and an electric field therapy system. Background Art

[0002] Tumor Treating Fields (TTFields) are low-intensity alternating electric fields in the medium-frequency range (e.g., 50 kHz to 1 MHz) that can disrupt the mitotic process of cancer cells and induce apoptosis. These fields can be used to treat tumors, as disclosed in U.S. Patent No. 7,565,205. In a Tumor Treating Fields system, an alternating current signal is applied between electrode patches placed on the patient's body to non-invasively apply the TTFields to the target area.

[0003] Existing electrode patches, such as those disclosed in Chinese Invention Patent Publication No. 112717272, comprise a backing applied to the patient's body surface corresponding to the tumor site, and multiple dielectric elements adhered to the backing and applied to the tumor site. The dielectric elements are circular ceramic electrodes arranged in an array on the backing. While this creates open spaces between adjacent dielectric elements for heat dissipation, their configuration and arrangement result in a low proportion of the effective electric field application area formed by the dielectric elements to the backing's surface area. This also results in a significant accumulation of heat at the site of the patient's body corresponding to the outer contours 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.

[0005] Summary of the Invention

[0006] The present application provides an electrode patch and an electric field therapy system, which can increase the proportion of the effective electric field application area.

[0007] Specifically, the present application is implemented through the following technical solution: an electrode patch, which includes a backing and an electrode array adhered to the backing, the electrode array includes a flexible circuit board and a plurality of dielectric elements arranged on the flexible circuit board and used to apply an alternating current signal, the flexible circuit board includes a connecting portion located in the middle of the electrode array and a plurality of base portions respectively connected to the connecting portions and arranged at intervals, the dielectric elements are arranged corresponding to the base portions and cover the base portions, the outer contour of the backing is arranged corresponding 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.

[0008] According to an embodiment of the present invention, the base portions are spaced apart at both ends of the connecting portion in a left-right axially symmetrical manner, and the outer contours of the dielectric elements that are spaced apart from each other jointly form a teardrop-shaped outer contour of the electrode array.

[0009] According to one embodiment of the present invention, the backing has two side wings located on opposite sides of the electrode array, one of the side wings is provided with a concave edge, and the other side wing is provided with a convex edge.

[0010] According to an embodiment of the present invention, the base portions are spaced apart at both ends of the connecting portion in a centrosymmetrical manner, and the outer contours of the dielectric elements that are spaced apart from each other jointly form a wavy outer contour of the electrode array.

[0011] According to one embodiment of the present invention, the backing has a ring wing portion surrounding the electrode array, and the ring wing portion is provided with a concave edge and a convex edge on two opposite sides thereof.

[0012] According to one embodiment of the present invention, the base portions are arranged at intervals around the outer periphery of the connecting portion in a surrounding manner, and the outer peripheries of the dielectric elements away from the connecting portion are jointly arranged to form a circular outer contour of the electrode array.

[0013] According to one embodiment of the present invention, the backing has a ring wing portion surrounding the electrode array, and the ring wing portion is arranged in a regular octagonal shape.

[0014] According to one embodiment of the present invention, the base portions are respectively arranged on opposite sides of the connecting portion, and the outer contours of the dielectric elements located at both ends of the connecting portion are jointly arranged to form a fan-shaped outer contour of the electrode array.

[0015] According to one embodiment of the present invention, the backing is arranged in a fan-shaped ring shape, and the fan-shaped ring has an extension angle of about 90°.

[0016] The present application is also implemented through the following technical solution: an electric field therapy system for applying electric field therapy to a target area of ​​a subject, which includes 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 close to each other are complementary in concave and convex or close to and parallel to each other.

[0017] According to one embodiment of the present invention, the plurality of electrode patches include two pairs of electrode patch combinations, each of the electrode patch combinations includes two electrode patches, and the concave and convex sides of two adjacent edges between the two backings of the two electrode patches are complementary.

[0018] According to one embodiment of the present invention, the plurality of electrode patches include two pairs of electrode patches, and the two edges close to each other between any two adjacent backings are close to and parallel to each other.

[0019] The electrode patch and electric field therapy system of the present application can increase the proportion of effective electric field application area through the compact arrangement of special-shaped electrode patches and the electrode patches, thereby achieving a larger electric field application area within a limited attachment area.

[0020] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG1 is a system block diagram of an electric field therapy system according to one embodiment of the present application;

[0022] FIG2 is a plan view of an electrode patch according to a first embodiment of the present application;

[0023] FIG3 is a plan view of the electrode array of the electrode patch shown in FIG2 ;

[0024] FIG4 is a plan view of the backing of the electrode patch shown in FIG2 ;

[0025] FIG5 is a schematic diagram of the two electrode patches shown in FIG2 in use;

[0026] FIG6 is a schematic diagram of eight electrode patches in FIG2 in use;

[0027] FIG7 is a plan view of an electrode patch according to a second embodiment of the present application;

[0028] FIG8 is a plan view of the electrode array of the electrode patch shown in FIG7 ;

[0029] FIG9 is a plan view of the backing of the electrode patch shown in FIG7 ;

[0030] FIG10 is a schematic diagram of the two electrode patches shown in FIG7 in use;

[0031] FIG11 is a schematic diagram of the eight electrode patches shown in FIG7 in use;

[0032] FIG12 is a plan view of an electrode patch according to a third embodiment of the present application;

[0033] FIG13 is a plan view of the electrode array of the electrode patch shown in FIG12 ;

[0034] FIG14 is a schematic diagram of the four electrode patches shown in FIG12 in use;

[0035] FIG15 is a plan view of an electrode patch according to a fourth embodiment of the present application;

[0036] FIG16 is a plan view of the electrode array of the electrode patch shown in FIG15 ;

[0037] FIG17 is a schematic diagram of the four electrode patches shown in FIG15 in use. DETAILED DESCRIPTION

[0038] Exemplary embodiments are described in detail herein, with examples illustrated in the accompanying drawings. When the following description refers to the drawings, identical numerals in different figures represent identical or similar elements unless otherwise indicated. The embodiments described in the following exemplary embodiments are not intended to represent all embodiments consistent with the present application. Rather, they are merely examples of devices, systems, apparatus, and methods consistent with certain aspects of the present application.

[0039] As shown in Figure 1, the electric field therapy system 100 of the present application includes an electric field generator 10, an adapter 20, and a plurality of electrode patches 30, 40, 50, and 60. The adapter 20 electrically connects the electric field generator 10 and each electrode patch 30, 40, 50, and 60. The electric field generator 10 generates an alternating electric signal that meets the treatment requirements, for example, an alternating electric signal with a frequency of 150-250kHz for treating glioblastoma, an alternating electric signal with a frequency of 50-150kHz for treating malignant melanoma, etc. The adapter 20 receives the alternating electric signal output from the electric field generator 10 and transmits the alternating electric signal to the paired electrode patches 30, 40, 50, 60 or a combination of electrode patches. The electrode patches 30, 40, 50, and 60 are attached to the surface of the patient's corresponding tumor area to apply the alternating electric signal to the patient's tumor area for tumor electric field therapy. The present application provides electrode patches 30 , 40 , 50 , and 60 in various embodiments, which are described below.

[0040] First embodiment of the electrode patch

[0041] Referring to Figures 2 and 3 , 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 temperature sensors (not shown) disposed corresponding to the dielectric elements 34. The flexible circuit board 33 includes two base portions 331 arranged symmetrically about the left and right axes, a horizontal connecting portion 332 located at the center of the array and connecting the two base portions 331, and a vertical connecting portion 333 extending downward from the middle of the connecting portion 332. The free ends of the connecting portions 333 are provided with a plurality of gold fingers 3331. These gold fingers 3331 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, while others receive DC signals transmitted by the adapter 20 for measuring temperature. The gold fingers 3331 can be understood as conventional gold fingers. Several gold fingers 3331 are arranged on the front and back sides of the wiring portion 333 to reduce the width of the wiring portion 333 and avoid problems such as short circuit or signal coupling caused by the close distance between adjacent gold fingers 3331.

[0042] The dielectric element 34 covers the base 331. A conductive sheet 3311 is provided on the front of the base 331. The dielectric element 34 directly covers the conductive sheet 3311 and is electrically connected to the conductive sheet 3311. 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. It is only necessary to ensure that 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 is also provided with 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 spacing area 334 between the two base parts 331. The spacing area 334 can provide expansion space for the connecting part 332 and release the 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 applies an alternating electrical signal. The connecting part 332 and the wiring part 333 are both located in the spacing area 334.

[0043] The dielectric element 34 is a dielectric sheet or dielectric layer with a high dielectric constant and low dielectric loss, which forms a capacitive coupling by attaching to the patient's skin surface and applies an alternating electric signal to the target area for electric field therapy. The constituent material of the dielectric element 34 can be an inorganic substance (such as piezoelectric ceramics, etc.), a polymer (such as relaxor ferroelectric copolymers, etc.) or a polymer composite doped with an inorganic material. 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 a polymer material, the shape of the conductive sheet 3311 is basically consistent with the shape of the dielectric element 34, and 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 electric signal flowing through the conductive sheet 3311 through the dielectric element 34 is basically uniform in the dielectric element 34.

[0044] In this embodiment, the two base portions 331 are spaced apart in a symmetrical manner along the left-right axis and together form the outer contour of the flexible circuit board 33, which is generally smaller at the top and larger at the bottom. A single base portion 331 is roughly half a teardrop. Accordingly, the two dielectric elements 34 covering the front surfaces of the two base portions 331 are also spaced apart in a symmetrical manner along the left-right axis and together form a teardrop-shaped outer contour. The outline of a single dielectric element 34 is a closed half-teardrop. The dielectric element 34 includes a first edge 341 located near the center of the electrode array 32 and second edges 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 apart and parallel to each other. The second edges 342 are convex and curved, with the curvature gradually increasing 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 ends of the second edge 342 connect to the ends of the first edge 341 with a circular transition, eliminating sharp corners in the dielectric element 34. This contour design of the dielectric element 34 reduces the problem of rapid edge heating caused by high current density flowing through regular edges (such as circles, triangles, squares, or polygons) when an AC signal is applied.

[0045] As previously described, in this embodiment, dielectric element 34 is a dielectric layer made of a polymer material. The dielectric constant of dielectric element 34 is not less than 20, and the dielectric strength is not less than 40 V / μm to prevent breakdown under normal applied voltage. Dielectric element 34 can be formed on the surface of conductive sheet 3311 by vapor deposition methods such as evaporation, sputtering, or ion plating, or by printing, spraying, or casting. The area of ​​dielectric element 34 is configured to be larger than that of conductive sheet 3311 so that dielectric element 34 completely covers the side surfaces of conductive sheet 3311, preventing non-capacitive coupling between the therapeutic electric field and the patient's skin, and preventing the edges of conductive sheet 3311 from overlapping with the edges of dielectric element 34, resulting in excessive heat concentration at the edges of the dielectric element. Preferably, the area of ​​dielectric element 34 is approximately 1.1 to 1.3 times the area of ​​conductive sheet 3311. The thickness of dielectric element 34 does not exceed 300 μm, and is preferably 3-10 μm.

[0046] The front surface of dielectric element 34 may also be provided with a biosafety layer (not shown) that directly contacts the patient's body surface. This layer (not shown) may be made of medical-grade stainless steel or titanium to avoid skin discomfort associated with conventional conductive hydrogel adhesives. Electrode patch 30 may also include only electrode array 32 without backing 31, such as by attaching electrode patch 30 to the patient's body surface via a wearable garment (not shown) to apply alternating electrical signals for tumor treatment.

[0047] The electrode patch 30 is applied with its front side facing the patient, and the portion of the backing 31 not covered by the electrode array 32 is applied to the patient's body surface. Therefore, the backing 31 is usually 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 arranged in a convex shape, a avoiding portion 313 located at the lower end of the main body 311 and arranged in a concave shape, and two side wings 314 located on opposite sides of the main body 311. The contour shape of the main body 311 is basically the same as the contour shape of the electrode array 32, but its area is larger than the area of ​​the electrode array 32. The electrode array 32 is attached to the front of the main body 311. The lifting portion 312 can facilitate 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 body surface. The avoidance portion 313 is used to accommodate the free end of the wiring portion 333 to facilitate welding connection between the wiring portion 333 and an external wire (not shown).

[0048] The side wings 314 include two upper wings 3141 and a lower wing 3142. For each side wing 314, a first notch 3143 is provided between the lifting portion 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 relieve some stress when the backing 31 is attached, alleviating the tightness of the attachment.

[0049] As shown in FIG4 , the four upper wings 3141 located on either side of the main body 311 are arranged in a non-axisymmetric manner, with the upper wing 3141 on one side having an inwardly concave edge 3146, while the upper wing 3141 on the other side has an outwardly convex edge 3147. As shown in FIG5 , two electrode patches 30 can be placed adjacent to each other to form an electrode patch assembly. To achieve a more compact arrangement, the concave edges 3146 of adjacent wings 314 in the electrode patch assembly complement the corresponding convex edges 3147. This allows more electrode patches 30 to be arranged within a limited surface attachment area, thereby increasing the number or area of ​​dielectric elements 34 for applying alternating electrical signals. The lower wings 3142 located on either side of the main body 311 do not need to complement the lower wings 3142 of adjacent electrode patches 30 and can therefore be arranged in an axisymmetric manner, enhancing the aesthetic appearance. In the adjacent side wings 314 of the two electrode patches 30 that are close to each other, 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 a reference for application, it can be ensured that the two adjacent electrode patches 30 can be accurately positioned.

[0050] 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 applying an alternating electrical signal from causing burns to the patient's skin. The temperature sensor (not shown) can be a thermistor. The electric field therapy system 100 uses the electric field generator 10 to generate a DC signal for detecting the temperature change of the thermistor to obtain the temperature of the dielectric element 34 or the temperature of the attached skin. Alternatively, the temperature sensor can be a thermocouple. The electric field therapy system 100 detects the electrical signal generated by the thermocouple due to temperature changes to obtain the temperature of the dielectric element 34 or the skin temperature at the corresponding location on the patient's body surface. The temperature sensor (not shown) can be located on the flexible circuit board 33 near the connection 332 between the two dielectric elements 34, or it can be located on the front or back side of the base 331 of the flexible circuit board 33 for each dielectric element 34. If the temperature sensor (not shown) is located on the front side of the base 331, a clearance hole (not shown) must be provided in the corresponding dielectric element 34 for the temperature sensor (not shown).

[0051] Although the size of a single electrode patch 30 is smaller than existing electrode patches such as those disclosed in Chinese Invention Patent Publication No. 112717272 (e.g., an electrode patch with nine dielectric elements arranged in a 3×3 pattern), it is easier to compactly attach to the patient's body surface. FIG6 shows a schematic planar layout of eight electrode patches 30 shown in FIG2 . The eight electrode patches 30 are arranged in a circular pattern, roughly forming a flower shape, with the smaller end of the electrode patch 30 oriented toward the center of the ring. It is defined that two adjacent electrode patches 30 are combined to form an electrode patch combination, wherein electrode patches 30A and 30B constitute a first electrode patch combination, electrode patches 30C and 30D constitute a second electrode patch combination, electrode patches 30E and 30F constitute a third electrode patch combination, and electrode patches 30G and 30H constitute a fourth electrode patch combination. The first electrode patch combination 30A and 30B and the second electrode patch combination 30C and 30D constitute a pair of electrode patch combinations and jointly apply an alternating electric signal in a first direction to the patient's tumor site; the third electrode patch combination 30E and 30F and the fourth electrode patch combination 30G and 30H constitute another pair of electrode patch combinations and jointly apply an alternating electric signal in a second direction to the patient's tumor site. The concave edges 3146 and convex edges 3147 of the two adjacent side wings 314 of the two electrode patches 30 in each electrode patch combination are complementary; the concave edges 3146 and convex edges 3147 of the two adjacent side wings 314 of the two adjacent electrode patch combinations are also complementary; that is, the concave edges 3146 and convex edges 3147 of the two adjacent side wings 314 of any two adjacent electrode patches 30 are complementary. The eight electrode patches 30 form a compact arrangement of electric field application combinations, which can be applied to the 7000mm of the backing 31. 2 The layout area (i.e. the attachment area) is about 3100mm 2The 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 a 15000mm 2 The effective electric field application area under the area is 2700mm 2 , the effective electric field application area accounts for about 18%. The effective electric field application area utilization rate of the electric field application combination formed by the eight electrode patches 30 of this embodiment is improved by about 23%. The electrode patch combination composed of the electrode patches 30 of this embodiment realizes a larger effective electric field application area within a limited attachment area.

[0052] Second embodiment of the electrode patch

[0053] Referring to Figures 7 and 8 , 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 temperature sensors (not shown) disposed corresponding to the dielectric elements 44. The flexible circuit board 43 includes two base portions 431 arranged symmetrically, a connecting portion 432 located at the symmetrical center of the two base portions 431 and connecting the two base portions 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. These gold fingers 4331 are electrically connected directly or indirectly to the electric field generator 10. Some of the gold fingers 4331 receive the AC signal output by the electric field generator 10 for generating the AC electric field, while some receive the DC signal output by the electric field generator 10 for measuring temperature. The gold fingers 4331 can be understood as conventional gold fingers. Several gold fingers 4331 are arranged on the front and back sides of the wiring portion 433 to reduce the width of the wiring portion 433 and avoid problems such as short circuit or signal coupling caused by the close distance between two adjacent gold fingers 4331.

[0054] Each dielectric element 44 overlies its corresponding base portion 431. A conductive sheet 4311 is provided on the front surface of each base portion 431. Each dielectric element 44 directly overlies and is electrically connected to its corresponding conductive sheet 4311. The area of ​​each conductive sheet 4311 is smaller than that of the corresponding base portion 431, and the area of ​​each dielectric element 44 is no larger than that of the corresponding base portion 331. The shape of each second conductive sheet 3311 is not limited to being similar to that of its corresponding base portion 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 distribution of the current density of the alternating electrical signal passing through the dielectric element 44. Conductive traces (not shown) are also arranged within the flexible circuit board 43 to electrically connect the gold fingers 4331 and the conductive sheets 4311, thereby transmitting the alternating electrical signal received by the gold fingers 4331 to the conductive sheets 4311. A spacing region 434 is defined between the two base portions 431. The spacing region 434 can provide expansion and contraction space for the connection portion 432 and relieve corresponding stress when the electrode patch 40 is attached to the patient's body surface. It can also provide a heat dissipation space 435 when the electrode array 42 applies an alternating electrical signal. The heat dissipation space 435 is formed by the two base portions 431 of the flexible circuit board 43 of the electrode array 42 being arranged in a spaced-apart manner. When the electrode array 42 applies an alternating electrical signal to the patient's tumor site for tumor treatment, it allows moisture from the patient's body surface to escape, allowing heat exchange between the patient's body surface and the outside air, thereby preventing heat accumulation on the patient's body surface where the electrode array 42 is applied, which could cause low-temperature burns on the patient's body surface. In this embodiment, the connection portion 432 and the wiring portion 433 are both located within the spacing region 434. This ensures that the electrode array 42 has sufficient heat dissipation space 435, preventing rapid heat accumulation on the patient's body surface from causing low-temperature burns on the patient's body surface, while also increasing the effective electric field coverage area of ​​the electrode array 42 applying the alternating electrical signal through the dielectric element 44.

[0055] The dielectric element 44 is a dielectric sheet or dielectric layer with a high dielectric constant and low dielectric loss, which forms a capacitive coupling by attaching to the patient's skin surface and applies an alternating electric signal to the target area for electric field therapy. The material constituting the dielectric element 44 can be an inorganic substance (such as piezoelectric ceramics, etc.), a polymer (such as relaxor ferroelectric copolymers, etc.) or a polymer composite material doped with an inorganic material. 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 a polymer material, the shape of the conductive sheet 4311 is basically consistent with the shape of the dielectric element 44, and 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 electric signal flowing through the conductive sheet 4311 through the dielectric element 44 is basically uniform in the dielectric element 44.

[0056] In this embodiment, the two base portions 431 are spaced apart in a centrally symmetrical manner, and the two dielectric elements 44 correspondingly covering the front surfaces of the two base portions 431 have the same structure and are also centrally symmetrically arranged. The following is an explanation using the dielectric element 44 located on the right side of Figure 7 as an example. The special-shaped outer contour line of the dielectric element 44 includes a first edge 441, a second edge 442, and a third edge 443 connected end to end. The first edge 441 is arranged in an oblique line shape close to the center of the electrode array 42, and it is inclined from top to bottom to the left, and the angle with the horizontal line is about 80°. The extension direction of the wiring portion 433 is arranged 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 and parallel to each other. Second edge 442 is similar in shape to the outer contour of a Coca-Cola glass bottle, comprising a first oblique line segment 4421, a first curved line segment 4422, a second curved line segment 4423, and a third curved line segment 4424, arranged sequentially from top to bottom. First oblique line segment 4421 is inclined downward and rightward relative to first edge 441, first curved line segment 4422 is convex outward or rightward relative to first oblique line segment 421, second curved line segment 4423 is recessed inward or leftward relative to first curved line segment 4422, and third curved line segment 4424 is convex outward or rightward relative to second curved line segment 4423. Third edge 443 is generally horizontal and arc-shaped, connecting the bottom ends of first edge 441 and second edge 442, respectively. First edge 441 is connected to the top of second edge 442. The first edge 441, second edge 442, and third edge 443 all utilize arc transitions at their respective junctions to avoid sharp corners in the dielectric element 44. For the dielectric element 44 on the left, its third edge 443 is located at the top, while 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, arranged sequentially from bottom to top. The dielectric element 44 adopts this contour design, and its area is slightly larger than the area of ​​the corresponding conductive sheet 4311. This can reduce the problem that when an AC signal for tumor electric field therapy is applied to a patient through the dielectric element 44, the current density of the AC signal flowing through the outer contour of the dielectric element 44 is higher than the current density flowing through the middle part of the dielectric element 44, causing the outer contour part of the dielectric element 44 to heat up faster than the middle part, resulting in inconsistent temperature rise on the patient's body surface where the dielectric element 44 is applied, causing the tumor electric field therapy system to interrupt the application of the AC signal and shorten the tumor electric field application time to avoid causing low-temperature burns on the patient's body surface.

[0057] As previously described, in this embodiment, dielectric element 44 is a dielectric layer composed of a polymer material. Dielectric element 44 has a dielectric constant of no less than 20 and a dielectric strength of no less than 40 V / μm to prevent breakdown under normal applied voltage. Dielectric element 44 can be formed on the surface of the corresponding conductive sheet 4311 by vapor deposition methods such as evaporation, sputtering, or ion plating, or by printing, spraying, or casting. The area of ​​dielectric element 44 is larger than the area of ​​the corresponding conductive sheet 4311. Dielectric element 44 is positioned on conductive sheet 4311 to completely cover the side surface of conductive sheet 4311, thereby preventing non-capacitive coupling between the therapeutic electric field and the patient's skin and preventing the outer contours of conductive sheet 4311 from coinciding with the outer contours of dielectric element 44, which could lead to excessive heat concentration on the outer contour of electrode array 42. Preferably, the area of ​​dielectric element 44 is approximately 1.1 to 1.3 times the area of ​​the corresponding conductive sheet 4311. The thickness of the dielectric element 44 does not exceed 300 μm, and is preferably 3-10 μm.

[0058] The front surface of dielectric element 44 may also be provided with a biosafety shield (not shown) that directly contacts the patient's body surface. The biosafety shield (not shown) may be made of medical stainless steel or titanium to avoid skin discomfort associated with conventional conductive hydrogel adhesives. Electrode patch 40 may also include only electrode array 42 without backing 41, such as by attaching electrode patch 40 to the patient's body surface via a wearable garment (not shown) to apply alternating electrical signals for tumor treatment.

[0059] The electrode patch 40 is applied with its front side facing the patient, and the portion of the backing 41 not covered by the electrode array 42 is applied to the patient's body surface, so the backing 41 is usually made of breathable materials such as textiles, non-woven fabrics and microporous membranes. The contour shape of the backing 41 is basically the same as the contour shape of the electrode array 42, but its area is larger than the area of ​​the electrode array 42. The backing 41 includes a main body 411 adhered to the electrode array 42, a ring wing portion 412 surrounding the electrode array 42, and a avoidance portion 413 provided on the ring wing portion 412. The ring wing portion 412 can facilitate the removal of the electrode patch 40 to avoid contact with the electrode array 42 and causing the electrode array 42 to be contaminated, and facilitates the subsequent removal of the electrode patch 40 from the patient's body surface. The avoidance portion 413 is used to accommodate the free end of the wiring portion 433 to facilitate the welding connection of the wiring portion 433 with an external wire (not shown).

[0060] 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 applying an alternating electrical signal from causing burns to the patient's skin. The temperature sensor (not shown) can be a thermistor. The electric field therapy system 100 uses the electric field generator 10 to generate a DC signal for detecting the temperature change of the thermistor to obtain the temperature of the dielectric element 44 or the temperature of the attached skin. Alternatively, the temperature sensor can be a thermocouple. The electric field therapy system 100 detects the electrical signal generated by the thermocouple due to temperature changes to obtain the temperature of the dielectric element 44 or the skin temperature at the corresponding location on the patient's body surface. The temperature sensor (not shown) can be located on the flexible circuit board 43 near the connection 432 between the two dielectric elements 44, or it can be located on the front or back side of the base 431 of the flexible circuit board 43 for each dielectric element 44. If the temperature sensor (not shown) is located on the front side of the base 431, a clearance hole (not shown) must be provided in the corresponding dielectric element 44 for the temperature sensor (not shown).

[0061] Although the overall size of each electrode patch 40 is smaller than existing electrode patches such as those disclosed in Chinese Invention Patent Publication No. 112717272 (e.g., an electrode patch with nine dielectric elements arranged in a 3×3 pattern), it is easier to compactly attach to the patient's body surface. 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 the overlap between the front and rear attachment positions being at least 25%. This ensures that the effect of applying the alternating electrical signal remains essentially unchanged while avoiding the problem of the electrode patch 30 remaining in the same attachment position for a long time during tumor electric field therapy, which may cause skin discomfort (e.g., allergies or dermatitis) on the subject's body surface.

[0062] Referring to FIG9 and in conjunction with FIG10 , the contour lines of the annular wing portion 412 of the backing 41 on its left and right sides respectively substantially coincide with the outer contour lines of the second edge of a corresponding one of the two dielectric elements 44. The contour lines of the annular wing portion 412 on both 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. Two electrode patches 40 can be placed adjacent to each other to form an electrode patch assembly. To achieve a more compact arrangement, the two electrode patches 40 are placed side by side and slightly offset vertically, such that the convex edge 4121 and concave edge 4122 on the right side of the electrode patch 40 on the left complement the concave edge 4122 and convex edge 4121 on the left side of the electrode patch 40 on the right. This allows more electrode patches 40 to be arranged within a limited body surface attachment area, thereby increasing the number or area of ​​the dielectric elements 44 to which the alternating electrical signal is applied.

[0063] FIG11 is a schematic diagram of a plane projection of the eight electrode patches 40 shown in FIG8 . The eight electrode patches 40 are arranged in a circular divergent shape. In order to increase the effective electric field application area, two adjacent electrode patches 40 are combined to form an electrode patch combination, wherein the electrode patches 40A and 40B form a first electrode patch combination, the electrode patches 40C and 40D form a second electrode patch combination, the electrode patches 40E and 40F form a third electrode patch combination, and the electrode patches 40G and 40H form a fourth electrode patch combination. The first electrode patch combination 40A and 40B and the second electrode patch combination 40C and 40D form a pair of electrode patch combinations and jointly apply an alternating electric signal in a first direction to the patient's tumor site; the third electrode patch combination 40E and 40F and the fourth electrode patch combination 40G and 40H form another pair of electrode patch combinations and jointly apply an alternating electric signal in a second direction to the patient's tumor site. The electric field application combination composed of eight electrode patches 40 can be applied on the 6300mm covered by the backing 31. 2 The layout area is about 2900mm 2 The effective electric field application area (area accounting for about 46%) is 15000mm in the backing covered by the electric field application combination composed of four electrode patches as disclosed in China Invention Patent Publication No. 112717272. 2 The effective electric field application area under the backing area is 2700mm 2 (Area accounts for about 18%), the effective electric field application area utilization rate formed by the electric field application combination composed of the electrode patch 30 of this embodiment is increased by about 24%, achieving a larger electric field application area within a limited attachment area.

[0064] Third embodiment of the electrode patch

[0065] 12 and 13 , 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) provided corresponding to the dielectric element 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 body surface. Therefore, the backing 51 is generally made of a breathable material such as a textile, a non-woven fabric, and a microporous membrane. In this embodiment, the backing 51 is a regular octagon and includes a main body 511 adhered to the electrode array 52 and a ring wing portion 512 surrounding the electrode array 52. ​​The ring wing portion 512 can facilitate 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 body surface.

[0066] The flexible circuit board 53 is generally circular in shape and includes a connecting portion 531 located at the center of the flexible circuit board 533 in a circular pattern; a plurality of base portions 532 extending radially outward from the edge of the connecting portion 531 and arranged at intervals; and a wiring portion 533 extending radially outward from the edge of the connecting portion 531. A space 534 is provided between two adjacent base portions 532 to accommodate the wiring portion 533. The free end of the wiring portion 533 is provided with a plurality of gold fingers 5331. These gold fingers 5331 are directly or indirectly electrically connected to the electric field generator 10. Some of these gold fingers 5331 receive the AC signal output by the electric field generator 10 for generating an AC electric field, while others receive the DC signal output by the electric field generator 10 for temperature measurement. The gold fingers 5331 are located on the front and back of the wiring portion 533 to reduce its width and prevent problems such as short circuits or signal coupling caused by the close proximity of the gold fingers 5331. The base portions 532 are spaced apart to form a plurality of open spaces 335 between the base portions 532 .

[0067] Each base portion 532 is generally arranged in a symmetrical pattern along its length. Along the radial direction of the circle encompassing the flexible circuit board 53, it comprises, in order, a first base portion 5321, a bridge portion 5322 connected to the first base portion 5321, and a second base portion 5323 connected to the bridge portion 5322. The left and right contour lines of the first base portion 5321 and the left and right contour lines of the second base portion 5323 extend radially along the circle encompassing the electrode array 52 and are collinear. The first base portion 5321 is connected to the connecting portion 531 and is arranged in a nearly triangular sector shape. The second base portion 5323 is arranged in a nearly trapezoidal shape, with an arc-shaped contour on the side closest to the first base portion 5321 and a straight contour on the side away from the first base portion 5321. The ends of the straight sides of the second base portion 5323 are smoothly connected to the radial sides of the circle encompassing the electrode array 52. The bridge portion 5322 is arranged in a strip shape and connects the first base portion 5321 and the second base portion 5323 along the radial direction of the circle containing the electrode array 32. The side of the first base portion 5321 near the second base portion 5323 and the side of the second base portion 5323 near the first base portion 5321 are both arranged in an arc shape and spaced parallel to each other, forming an open space 535 between the first base portion 5321 and the second base portion 5323 for heat dissipation and ventilation of the patient's skin. A first conductive sheet 5324 is provided on the front surface of the first base portion 5321, and a second conductive sheet 5325 is provided on the front surface of the second base portion 5323. The first conductive sheet 5324 and the second conductive sheet 5325 can be collectively referred to as conductive sheets (unnumbered). The flexible circuit board 53 is also internally provided with 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. This allows the alternating electrical signal received by the gold finger 5331 to be transmitted to the first conductive sheet 5324 and the second conductive sheet 5325, and then to the corresponding dielectric element 54. A spacing region 534 is provided between two adjacent base portions 532. This provides space for the connection portion 531 to expand and contract when the electrode patch 50 is attached, relieving the corresponding stress. It also provides heat dissipation space 535 when the alternating electrical signal is applied to the dielectric element 54. Open spaces 335 for heat dissipation are formed between two adjacent first base portions 3321, between two adjacent second base portions 3323, and between two adjacent bridge portions 3322.

[0068] The dielectric element 54 is disposed corresponding to the base portion 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 substantially identical to those of the first base portion 5321. The area of ​​the first dielectric portion 541 is larger than that of the first conductive sheet 5324 but not larger than that of the first base portion 5321. This ensures that the first dielectric portion 541 fully covers the first conductive sheet 5324, preventing it from directly contacting the subject's skin and causing discomfort, while also being fully supported by the first base portion 5321. Similarly, the shapes of the second conductive sheet 5325 and the second dielectric portion 542 are substantially identical to the shape of the second base portion 5323. The area of ​​the second dielectric portion 542 is larger than that of the second conductive sheet 5325 but not larger than that of the second base portion 5323. This allows the second dielectric portion 542 to completely cover the second conductive sheet 5325, preventing it from directly contacting the subject's skin and causing discomfort, while also being fully supported by the second base portion 5323. This contour design of the dielectric element 54 can mitigate the problem of high edge current density caused by its regular edges, which can lead to rapid heating at the edges and consequently heat accumulation at the corresponding body surface.

[0069] The dielectric element 54 is a dielectric sheet or layer with a high dielectric constant and low dielectric loss. It forms capacitive coupling with the patient's skin surface, applying an alternating electrical signal to the target area for electric field therapy. The electrode array 52 is provided with 11 dielectric elements 54. Each dielectric element 54 has an angle of 20-30° on the circle of the electrode array 32, which allows 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 an inorganic material (such as piezoelectric ceramics), a polymer (such as a relaxor ferroelectric copolymer), or a polymer composite material doped with an inorganic material. In this embodiment, the dielectric element 54 is a dielectric layer made of a polymer material. The dielectric constant of the dielectric element 54 is not less than 20 and the dielectric strength is not less than 40V / μm to avoid 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 that of the first conductive sheet 5324, so that the first dielectric portion 541 completely covers the side end surfaces of the first conductive sheet 5324. This prevents non-capacitive coupling between the therapeutic electric field and the patient's skin, and prevents the edges of the first conductive sheet 5324 and the first dielectric portion 541 from overlapping, which could lead to excessive heat concentration at the edges of the electrode unit 55 formed by the dielectric element 54 and the corresponding base portion 532 of the flexible circuit board 53. Similarly, the area of ​​the second dielectric portion 542 is larger than that of the second conductive sheet 5325. Preferably, the area of ​​the first dielectric portion 541 is about 1.1 to 1.3 times that of the first conductive sheet 5324, and the area of ​​the second dielectric portion 542 is about 1.1 to 1.3 times that of the second conductive sheet 5325. The thickness of the dielectric element 54 does not exceed 300 μm, preferably 3-10 μm.

[0070] The front surface of dielectric element 54 may also be provided with a biosafety layer (not shown) that directly contacts the patient's body surface. The biosafety layer (not shown) may be made of medical stainless steel or titanium to avoid skin discomfort associated with conventional conductive hydrogel adhesives. Electrode patch 50 may also include only electrode array 52 without backing 51, such as by attaching electrode patch 50 to the patient's body surface via a wearable garment (not shown) to apply alternating electrical signals for tumor treatment.

[0071] 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 applying an alternating electrical signal from causing burns to the patient's skin. The temperature sensor (not shown) can be a thermistor. The electric field therapy system 100 uses the electric field generator 10 to generate a DC signal for detecting the temperature change of the thermistor to obtain the temperature of the dielectric element 54 or the temperature of the attached skin. Alternatively, the temperature sensor can be a thermocouple. The electric field therapy system 100 detects the electrical signal generated by the thermocouple due to temperature changes to obtain the temperature of the dielectric element 54 or the skin temperature at the corresponding location on the patient's body surface. The temperature sensor (not shown) can be located on the flexible circuit board 53 near the connection 531 between the two dielectric elements 54, or it can be located on the front or back side of the base portion 532 of the flexible circuit board 53 for each dielectric element 54. If the temperature sensor (not shown) is located on the front side of the base portion 532, a clearance hole (not shown) must be provided in the corresponding dielectric element 54 for the temperature sensor (not shown). A temperature sensor (not shown) may be provided on the first base portion 5321 or the second base portion 5323 .

[0072] Each electrode patch 50 is smaller than the existing electrode patch disclosed in Chinese Patent No. CN112717272 (for example, an electrode patch with 9 dielectric elements arranged in a 3×3 pattern), making it easier to compactly attach to the patient's body surface. After being used for a period of time, each electrode patch 50 can be rotated around its geometric center by a certain angle (for example, 90°) to another attachment position. The front and rear attachment positions of the electrode patch 50 are staggered and overlap by at least 50%. An open space 535 for heat dissipation is formed between adjacent electrode units 55. This ensures that the subject's skin will not experience discomfort (such as allergies or dermatitis) due to heat accumulation when there is a sufficiently large open space 535 to accelerate heat dissipation from the body surface, while also increasing the effective electric field application area.

[0073] FIG14 is a schematic diagram of the planar layout of four electrode patches 50. The first electrode patch 50A and the second electrode patch 50B form a pair of electrode patches and jointly apply an alternating electric signal in a first direction acting on the tumor site; the third electrode patch 50C and the fourth electrode patch 50D form another pair of electrode patches and jointly apply an alternating electric signal in a second direction acting on the tumor site. The four electrode patches 50 are arranged in a circle along a ring, and the wiring portions 533 of the paired electrode patches 50 extend back to back. The two side edges 513 close to each other in any two adjacent electrode patches 50 are close and parallel, so that the four electrode patches 50 can be compactly arranged, and the two side edges 513 close to each other are roughly aligned head to tail, which can be used as a positioning reference when attaching. The electric field application combination composed of four electrode patches 50 can be within the 7200mm covered by the backing 31. 2 The layout area is about 2600mm2 The effective electric field application area (accounting for about 36%) is 15000mm thick, compared with the electric field application combination consisting of four electrode patches disclosed in Chinese Patent No. CN1127172. 2 The effective electric field application area is 2700mm 2 (The area accounts for about 18%). The effective electric field application area utilization rate of the electric field application combination composed of the electrode patch 50 of this embodiment is increased by about 18%, thereby realizing a larger effective electric field application area of ​​the electrode patch 50 within a limited attachment area.

[0074] Fourth embodiment of the electrode patch

[0075] 15 and 16 , 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, a plurality of dielectric elements 64 located on the front of the flexible circuit board 63, and a temperature sensor (not shown) provided corresponding to the dielectric element 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 body surface. Therefore, the backing 61 is usually made of breathable materials such as textiles, non-woven fabrics, and microporous membranes. The overall contour of the backing 61 is basically the same as that of the electrode array 62, but the area of ​​the backing 61 is larger than that of the electrode array 62. In this embodiment, the backing 61 is in the shape of a fan ring with an angle of about 90°.

[0076] The flexible circuit board 63 has a generally circular sector shape and comprises a connecting portion 631, a plurality of base portions 632 connected to the connecting portion 631, and a connection portion 633 connected to the connecting portion 631. The connecting portion 631 is an arc-shaped strip extending across the flexible circuit board 63. The base portions 632 are located on opposite sides of the connecting portion 631 and extend radially along the flexible circuit board 33. The connection portion 633 extends radially outward from the center of the connecting portion 631. The flexible circuit board 63 is arranged bilaterally symmetrically, with the connection portion 633 located on the axis of symmetry of the flexible circuit board 33. The base portions 632 include a central base portion 6321 located inside the connecting portion 631 and on the axis of symmetry of the flexible circuit board 33; four inner base portions 6322 located inside the connecting portion 631 and symmetrically arranged on either side of the central base portion 6321; and four outer base portions 6323 located outside the connecting portion 631 and symmetrically arranged on either side of the connection portion 633. Each base portion 632 is roughly fan-shaped, and each inner base portion 6322 has the same corresponding spread angle, approximately between 10° and 20°. The four outer base portions 6323 are arranged in a radially aligned manner with the four inner base portions 6322, one-to-one. The angle between the two outermost contour lines of the two outer base portions 6323 is approximately 90°, meaning that the spread angle corresponding to the overall fan-shaped outline of the flexible circuit board 63 is approximately 90°. A gap 634 is provided between adjacent inner base portions 6322 and adjacent outer base portions 6323. The gap 634 can provide expansion space for the connecting portion 631 and relieve corresponding stress when the electrode patch 60 is attached, and can also provide heat dissipation space when an alternating electrical signal is applied to the dielectric element 64. The central base portion 6321 and the four inner base portions 6322 are evenly distributed, and the four gaps 634 are also arranged in a fan-shaped pattern, with each gap having a roughly identical spread angle.

[0077] The free end of the connection portion 633 is provided with several gold fingers 6331. These gold fingers 6331 are directly or indirectly electrically connected to the electric field generator 10. Some of these gold fingers 6331 receive the AC signal output by the electric field generator 10 for generating the AC electric field, while others receive the DC signal for temperature measurement. These gold fingers 6331 can be understood as conventional gold fingers. These gold fingers 6331 are located on the front and back of the connection portion 633 to reduce its width and prevent short circuits or signal coupling caused by the close proximity of adjacent gold fingers 6331.

[0078] A conductive sheet 6324 is provided on the front surface of each base portion 632, and the dielectric element 64 covers and is electrically connected to the conductive sheet 6324. Conductive traces (not shown) are also arranged inside the flexible circuit board 63 to electrically connect the gold fingers 6331 and the conductive sheet 6324. This allows the alternating electrical signal received by the gold fingers 6331 to be transmitted 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 portion 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 that the current density of the alternating electrical signal passing through the dielectric element 64 is uniformly distributed. This prevents the patient's skin from heating up too quickly when the dielectric element 64 is applied due to the high current density flowing through its edge.

[0079] The dielectric element 64 is a dielectric sheet or dielectric layer with a high dielectric constant and low dielectric loss, which forms a capacitive coupling with the patient's skin surface and applies an alternating electric signal to the target area for electric field therapy. The material constituting the dielectric element 64 can be an inorganic substance (such as piezoelectric ceramics, etc.), a polymer (such as relaxor ferroelectric copolymers, etc.) or a polymer composite material doped with an inorganic material. The shape of the dielectric element 64 is substantially consistent with the shape of the corresponding base portion 632, wherein the area of ​​the dielectric element 64 is not greater than the area of ​​the corresponding base portion 632 to ensure that the base portion 632 provides sufficient support for the dielectric element 64.

[0080] In this embodiment, the dielectric element 64 is a dielectric layer made of a 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 can be formed on the conductive sheet 6324 by printing, spraying, or casting. The shape of the conductive sheet 6324 is also substantially consistent with the shape of the dielectric element 64, so that the current density distribution of the alternating electrical signal flowing through the dielectric element 64 through the conductive sheet 6324 is substantially uniform in the dielectric element 64. 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 corresponding side end surface of the conductive sheet 6324 to avoid non-capacitive coupling between the therapeutic electric field and the patient's skin, and to avoid the edge of the conductive sheet 6324 and the edge of the dielectric element 64 overlapping, resulting in excessive heat concentration at the edge of the dielectric element 64. Preferably, the area of ​​the dielectric element 64 is about 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.

[0081] Each dielectric element 64 is arranged in a fan-shaped ring shape, including a first side 641 adjacent to the connecting portion 631, a second side 642 opposite 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 on which the flexible circuit board 63 is located. The 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 connected by smooth arcs. The connecting portion 631 is roughly located in the middle of the electrode array 62, and the several dielectric elements 64 scattered on both sides of the connecting portion 631 can be considered to be located on the periphery. Therefore, this arrangement of the dielectric elements 64 can reduce the problem of rapid heating of the dielectric elements 64 located on the periphery of the electrode patch 30; the several dielectric elements 64 are arranged independently of each other and can be appropriately cut according to different attachment conditions without affecting the operation of other dielectric elements 64.

[0082] The front surface of dielectric element 64 may also be provided with a biosafety layer (not shown) that directly contacts the patient's body surface. The biosafety layer (not shown) may be made of medical stainless steel or titanium to avoid skin discomfort associated with conventional conductive hydrogel adhesives. Electrode patch 60 may also include only electrode array 62 without backing 61, such as by attaching electrode patch 60 to the patient's body surface via a wearable garment (not shown) to apply alternating electrical signals for tumor treatment.

[0083] A temperature sensor (not shown) is used to detect the temperature of the electrode array 62 to prevent heat generated by the electrode array 62 when applying an alternating electrical signal from causing burns to the patient's skin. The temperature sensor (not shown) can be a thermistor. The electric field therapy system 100 uses the electric field generator 10 to generate a DC signal for detecting the temperature change of the thermistor to obtain the temperature of the dielectric element 64 or the temperature of the attached skin. Alternatively, the temperature sensor can be a thermocouple. The electric field therapy system 100 detects the electrical signal generated by the thermocouple due to temperature changes to obtain the temperature of the dielectric element 64 or the skin temperature at the corresponding location on the patient's body surface. The temperature sensor (not shown) can be located on the flexible circuit board 63 near the connection 631 between the two dielectric elements 64, or it can be located on the front or back side of the base 632 of the flexible circuit board 63 for each dielectric element 64. If the temperature sensor (not shown) is located on the front side of the base 632, a clearance hole (not shown) must be provided in the corresponding dielectric element 64 for the temperature sensor (not shown). The temperature sensor (not shown) can be set on the base 632 or the connecting portion 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 portion 631, or it can be set on the base 632 on both sides of the connecting portion 631 respectively, or it can be set at intervals on the base 632 on both sides of the connecting portion 631 in an alternating manner.

[0084] Each electrode patch 60 is smaller than existing electrode patches, such as those disclosed in Chinese Invention Publication Patent No. 112717272 (e.g., an electrode patch with nine dielectric elements arranged in a 3×3 pattern), allowing for compact attachment to the patient's body surface. Figure 17 shows a schematic planar layout of four electrode patches 60. The first electrode patch 60A and the second electrode patch 60B form a pair of electrode patches that together apply an alternating electrical signal in a first direction to the patient's tumor site. The third electrode patch 60C and the fourth electrode patch 60D form another pair of electrode patches that together apply an alternating electrical signal in a second direction to the patient's tumor site. The four electrode patches 60 are arranged in a circle, with the wiring portions 633 extending outward. As previously mentioned, the backing 61 is arranged in a fan-shaped ring, including two edges 611 extending radially along the circle in which it is located. The two adjacent edges 611 of any two adjacent electrode patches 60 are arranged close together and parallel to each other, thus allowing the four electrode patches 60 to form a compact arrangement for applying an electric field. The two edges 611 of the two electrode patches 60 that are close to each other are roughly aligned head to tail, which can be used as a positioning reference when attaching. The electric field application combination composed of four electrode patches 60 can be applied within the 11000mm covered by the backing 61. 2 The layout area is about 4000mm 2The effective electric field application area (about 36% of the area) is larger than that of the electric field application combination composed of four electrode patches as disclosed in China Invention Publication Patent No. 112717272, which covers 15000mm on its backing. 2 The effective electric field application area under the area of ​​​​2700mm 2 (area accounts for about 18%), the utilization rate of the effective electric field application area is increased by about 18%, so that the electrode patch 60 has a larger effective electric field application area within the limited attachment area.

[0085] In summary, the dielectric elements of the electrode patches in each embodiment of the electric field therapy system of the present application can reduce the problem of rapid heating of the peripheral dielectric elements caused by the edge effect; and the various electrode patches can be arranged compactly when used in combination, thereby increasing the proportion of the effective electric field application area in the application area, and achieving a larger electric field application area within a limited attachment area.

[0086] The above is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present application should be included in the scope of protection of the present application.

Claims

1. An electrode patch, characterized in that: The invention comprises a backing and an electrode array bonded to the backing, wherein the electrode array comprises a flexible circuit board and a plurality of dielectric elements disposed on the flexible circuit board and used for applying an alternating current signal. 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 spaced apart. The dielectric elements are disposed correspondingly to and cover the base portions. The outer contour of the backing is disposed 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.

2. The electrode patch according to claim 1, characterized in that: The base portions are spaced apart at both ends of the connecting portion in a left-right axially symmetrical manner, and the outer contours of the dielectric elements, which are spaced apart from each other, jointly surround a 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 respectively located at two opposite sides of the electrode array, wherein one of the side wings is provided with a concave edge, and the other side wing is provided with a convex edge.

4. The electrode patch according to claim 1, characterized in that: The base portions are spaced apart at both ends of the connecting portion in a centrally symmetrical manner, and the outer contours of the dielectric elements, which are spaced apart from each other, jointly surround and form a 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 is provided with a concave edge and a convex edge on two opposite sides thereof.

6. The electrode patch according to claim 1, characterized in that: The base portions are arranged at intervals around the outer periphery of the connecting portion in a surrounding manner, and the outer peripheries of the dielectric elements away from the connecting portion are jointly arranged to form a circular outer contour of the electrode array.

7. The electrode patch according to claim 6, characterized in that: The backing has a ring wing portion surrounding the electrode array, and the ring wing portion is arranged in a regular octagonal shape.

8. The electrode patch according to claim 1, characterized in that: The base portions are respectively arranged at opposite sides of the connecting portion, and the outer contours of the dielectric elements located at both ends of the connecting portion are jointly arranged to form a fan-shaped outer contour of the electrode array.

9. The electrode patch according to claim 8, characterized in that: The backing is arranged in a fan-shaped ring shape, and the spreading angle of the fan-shaped ring is about 90°.

10. An electric field therapy system for applying electric field therapy to a target area of a subject, characterized in that It comprises a plurality of electrode patches attached to the subject's body surface and surrounding the target area, wherein the electrode patches are the electrode patches according to any one of claims 1 to 9, and the outer contours of at least two adjacent electrode patches close to each other are complementary in concave and convex directions or close to and parallel to each other.

11. The electric field therapy system according to claim 10, wherein: The plurality of electrode patches include two pairs of electrode patch combinations, each of the electrode patch combinations includes two electrode patches, and the concave and convex sides of two adjacent edges between the two backings of the two electrode patches are complementary.

12. The electric field therapy system according to claim 10, wherein: The plurality of electrode patches include two pairs of electrode patches, and the two edges close to each other between any two adjacent backings are close to and parallel to each other.

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