Electrode patch and electric field therapy system

Abstract

The invention provides an electrode patch and an electric field treatment system.The electrode patch is provided with an electrode array used for applying a tumor electric field, the electrode array comprises a plurality of electrode units of different shapes, and at least one electrode unit is provided with a temperature detection unit and a stretching layer used for positioning the temperature detection unit; and the stretching layers divide the corresponding electrode units into a plurality of conductive regions with different areas. An electrode patch is divided into a plurality of electrode units in different shapes to adapt to attachment of different body surface skin positions, and part of the electrode units are provided with stretching layers to further divide the corresponding electrode units into a plurality of conductive areas in different areas to disperse heat accumulation of the corresponding electrode units. And the duration of applying the therapeutic electric field by the electrode patch is prolonged.

Description

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202410622423.0 (22) Application Date 2024.05.17 (71) Applicant Jiangsu Hailai Xinchuang Medical Technology Co., Ltd. Address 214174 7th Floor, Building 7, No. 1699, Huishan Avenue, Huishan Economic Development Zone, Wuxi City, Jiangsu Province (72) Inventors Chen Sheng Yu Jing (74) Patent Agency Beijing Bosijia Intellectual Property Agency Co., Ltd. 11415 Patent Attorney Wang Jian (51) Int.Cl. A61N 1 / 04 (2006.01) A61N 1 / 40 (2006.01) A61N 1 / 36 (2006.01) (54) Invention Title Electrode Patch and Electric Field Therapy System (57) Abstract This application provides an electrode patch and electric field therapy system, An electrode patch has an electrode array for applying an electric field to a tumor. The electrode array includes several electrode units of different shapes. At least one electrode unit is provided with a temperature detection unit and a stretching layer for positioning the temperature detection unit. The stretching layer divides the corresponding electrode unit into several conductive regions of different areas. By dividing the electrode patch into several electrode units of different shapes to adapt to different skin locations, and by providing stretching layers on some electrode units to further divide the corresponding electrode units into several conductive regions of different areas, the heat accumulation of the corresponding electrode units is dispersed, increasing the duration of the therapeutic electric field applied by the electrode patch. Claims 1 page, Description 8 pages, Drawings 3 pages, CN 120960620 A 2025.11.18 CN 1 20 96 06 20 A 1. An electrode patch having an electrode array for applying an electric field to a tumor, characterized in that the electrode array includes several electrode units of different shapes, at least one of the electrode units is provided with a temperature detection unit and a stretching layer for positioning the temperature detection unit, the stretching layer dividing the corresponding electrode unit into several conductive regions of different areas. 2. The electrode patch according to claim 1, wherein the outer contour of the electrode array is teardrop-shaped. 3. The electrode patch according to claim 1, wherein the plurality of electrode units of different shapes include a first electrode unit and second and third electrode units disposed on opposite sides of the first electrode unit. 4. The electrode patch according to claim 3, wherein the temperature detection unit is disposed on the second electrode unit or the third electrode unit. 5. The electrode patch according to claim 1, wherein each electrode unit includes a base, a conductive layer located on the base, and a dielectric layer covering the stretched layer and the conductive layer. 6. The electrode patch according to claim 5, wherein the conductive layer has a through hole or perforation corresponding to the temperature detection unit.7. The electrode patch according to claim 5, wherein: the dielectric layer covers the temperature detection unit and the stretching layer. 8. The electrode patch according to claim 5, wherein: the stretching layer includes an annular band corresponding to the through hole or the perforation, and a plurality of stretching bands extending from the annular band in different contour directions towards the corresponding base portion. 9. The electrode patch according to claim 8, wherein: the plurality of stretching bands are three, and the three stretching bands divide the corresponding electrode unit into three conductive regions with different areas. 10. An electric field treatment system, characterized in that: it includes an electric field generator and a plurality of electrode patches as described in any one of claims 1-9 that are directly or indirectly electrically connected to the electric field generator. Claims 1 / 1 page 2 CN 120960620 A Electrode Patch and Electric Field Treatment System Technical Field

[0001] This application relates to the field of medical devices, and in particular to an electrode patch and an electric field treatment system. Background Art

[0002] Medium-frequency alternating electric field treatment has been proven to be an effective method for tumor treatment. In the entire treatment system, the medium-frequency alternating voltage is generated by an electric field generator, transmitted to the electrode patch through an adapter, and a treatment electric field is coupled by closely attaching the electrode patch to the patient's skin surface. The treatment electric field is alternately applied in at least two perpendicular directions to interfere with the mitotic process of tumor cells.

[0003] The electrode patch disclosed in Chinese Invention Patent Publication No. 112717272 includes an electrode array arranged大致 in a "king" shape. The electrode array includes nine circular electrode units arranged in three rows and three columns. Each electrode unit has a ceramic dielectric sheet for applying an alternating current signal. When this electrode patch is attached to a small application area such as the head, due to the ceramic dielectric sheet of the electrode unit being a hard circular sheet structure, it cannot perfectly conform to the skin surface of the head, and during the tumor electric field process, heat accumulation is likely to occur in the ceramic sheet, affecting the duration of continuous application of the electric field. Therefore, an improved electrode patch and an electric field treatment system are needed. Summary of the Invention

[0004] This application provides an electrode patch and an electric field treatment system that can adapt to body surface attachment and increase the duration of electric field application.

[0005] Specifically, an electrode patch provided in this application has an electrode array for applying a tumor electric field. The electrode array includes a plurality of electrode units with different shapes. Each electrode unit is provided with a temperature detection unit and a stretching layer for positioning the temperature detection unit. The stretching layer divides the corresponding electrode unit into a plurality of conductive regions with different areas.

[0006] According to an embodiment of the present invention, the outer contour of the electrode array is arranged in a water droplet shape.

[0007] According to an embodiment of the present invention, the plurality of electrode units with different shapes include a first electrode unit and second and third electrode units arranged on opposite sides of the first electrode unit.

[0008] According to one embodiment of the present invention, the temperature detection unit is disposed on the second electrode unit or the third electrode unit.

[0009] According to one embodiment of the present invention, each electrode unit includes a base, a conductive layer located on the base, and a dielectric layer covering the stretching layer and the conductive layer.

[0010] According to one embodiment of the present invention, the conductive layer has a through hole or perforation corresponding to the temperature detection unit.

[0011] According to one embodiment of the present invention, the dielectric layer covers the temperature detection unit and the stretching layer.

[0012] According to one embodiment of the present invention, the stretching layer includes an annular band corresponding to the through hole or perforation and a plurality of stretching strips extending from the annular band to different contour directions of the corresponding base.

[0013] According to one embodiment of the present invention, the plurality of stretching strips are three strips, and the three stretching strips divide the corresponding electrode unit into three conductive regions of different areas. Specification 1 / 8 pages 3 CN 120960620 A

[0014] This application also provides an electric field therapy system, including an electric field generator and several of the aforementioned electrode patches that are directly or indirectly electrically connected to the electric field generator.

[0015] This application divides the electrode patch into several electrode units of different shapes to adapt to the attachment of different skin locations, and sets temperature detection units in some electrode units to reduce the number of temperature detection units on the electrode patch and reduce the number of related wires and the amount of temperature data processing. Furthermore, a stretching layer is set corresponding to the temperature detection units to further divide the corresponding electrode units into several conductive areas of different areas to disperse the heat accumulation of the corresponding electrode units, thereby enhancing the duration of the therapeutic electric field applied by the electrode patch.

[0016] It should be understood that the above general description and the following detailed description are merely exemplary and explanatory, and do not limit this application.

[0017] FIG1 is a schematic diagram of the framework of an electric field therapy system according to an embodiment of the present application;

[0018] FIG2 is an exploded perspective view of an electrode patch according to an embodiment of the present application;

[0019] FIG3 is a perspective view of the electrode array shown in FIG2, wherein the dielectric layer is removed;

[0020] FIG4 is similar to FIG3, a perspective view of the electrode array shown in FIG2, wherein the dielectric layer, the first stretching layer, the second stretching layer, the third stretching layer, the first temperature detection unit, and the second temperature detection unit are all removed;

[0021] FIG5 is a cross-sectional view along the A-A direction in FIG2. Detailed Description

[0022] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description refers to the drawings, unless otherwise indicated, the same numbers in different drawings represent 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 only embodiments consistent with this application.Examples of apparatuses, systems, devices, and methods consistent with some aspects of the application.

[0023] As shown in FIG1, the electric field therapy system 100 includes an electric field generator 10 and a plurality of electrode patches 30 directly or indirectly electrically connected to the electric field generator 10. The electric field generator 10 is mainly used to generate alternating electrical signals that meet the treatment requirements, for example, alternating electrical signals with a frequency of 150-250 kHz for treating glioblastoma, alternating electrical signals with a frequency of 50-150 kHz for treating malignant melanoma, etc. The plurality of electrode patches 30 includes at least two electrode patches 30 arranged in pairs and opposite to each other. By attaching them to the body surface of the subject's corresponding target area, the alternating electrical signals received from the electric field generator 10 are applied to the target area of ​​the subject to perform electric field therapy. The electric field therapy system 100 also includes adapters 20 that are electrically connected to the electric field generator 10 and the electrode patches 30 respectively, so as to transmit alternating electrical signals to the corresponding electrode patches 30 in a time-division or simultaneous manner. When the electric field therapy system 100 has a temperature detection unit (unlabeled) for detecting the temperature of the corresponding part of the electrode patch 30 applied to the body surface, the electric field generator 10 can also generate a DC signal for the temperature detection unit (unlabeled) to perform temperature detection.

[0024] As shown in FIG2, the electrode patch 30 is arranged in a near-teardrop shape with a smaller upper part and a larger lower part to adapt to the application on uneven parts of the body surface, such as the head, limbs, or sides of the torso. When the electrode patch 30 is applied to the head, its narrower upper part is close to the top of the head and its wider lower part is away from the top of the head. The electrode patch 30 includes an electrode array 70, a backing 93 located on the back of the electrode array 70, and a conductive adhesive 91 located on the front of the electrode array 70. The electrode array 70, backing 93, and conductive adhesive 91 are all arranged in a near-teardrop-shaped sheet. The backing 93 has the largest projected area, the conductive adhesive 91 has a slightly smaller projected area, and the electrode array 70 has the smallest projected area. When the three are attached together to form the electrode patch 30, their centroids are basically coincident.

[0025] The backing 93 is mainly made of a flexible and breathable insulating material. Specifically, the backing 93 is a mesh nonwoven fabric, which is soft, thin, moisture-proof, and breathable. Even after prolonged application to the subject's body surface, the skin surface can remain dry. A biocompatible adhesive (not shown) is also coated on the side of the backing 93 facing the subject's body surface to tightly adhere the backing 93 to the body surface corresponding to the tumor site. The conductive adhesive 91 is mainly made of a biocompatible gel material. Specifically, the conductive adhesive 91 is a conductive hydrogel, used to form a soft and moist conductive interface between the electrode array 70 and the attached skin to reduce the impedance between the electrode array 70 and the skin.

[0026] The electrode array 70 includes a plurality of electrode units 71, 72, 73 arranged symmetrically with left and right spacing, and disposed in multipleThe electrode array 70 includes multiple connecting portions 46, 48, and 49 between electrode units 71, 72, and 73, and a wiring portion 47 extending laterally outward from a connecting portion 46. The electrode array 70 also has a spacing 74 formed between adjacent electrode units 71, 72, and 73. The multiple electrode units 71, 72, and 73 include two first electrode units 71, two second electrode units 72, and two third electrode units 73 arranged in an axisymmetrical configuration. The multiple connecting portions include a first connecting portion 46 arranged laterally and connecting the two axisymmetrically arranged first electrode units 71, two second connecting portions 48 longitudinally connecting adjacent first electrode units 71 and second electrode units 72, and two third connecting portions 49 longitudinally connecting adjacent first electrode units 71 and third electrode units 73. The wiring portion 47 is arranged perpendicularly to the first connecting portion 46, and has multiple solder pads 42 on its free end (not labeled) outside the electrode array 70 for electrical connection with wires (not shown) to directly or indirectly connect to the electric field generator 10, thereby receiving the corresponding electrical signals output by the electric field generator 10. The first connecting portion 46 is arranged in a straight line and is axially symmetrical. Two second connecting portions 48 are also axially symmetrically arranged on opposite sides of the axis of symmetry of the electrode array 70, and each second connecting portion 48 is arranged in a horizontal S-shape, so that the position of the second electrode unit 72 relative to the first electrode unit 71 in the horizontal or vertical direction can be freely adjusted to better adhere to the body surface, and to eliminate the lifting caused by stress concentration during the application of the first electrode unit 71 and the second electrode unit 72. The second connecting portion 48 has a certain degree of elastic deformation, which can freely adjust the gap 74 formed between the first electrode unit 71 and the second electrode unit 72 while ensuring a good electrical connection between them. This allows for sufficient heat dissipation space between the first electrode unit 71 and the second electrode unit 72, or avoids areas unsuitable for application to the first electrode unit 71 and the second electrode unit 72 based on the skin condition, allowing damaged skin to recover. The two third connecting portions 49 are also axially symmetrically arranged on opposite sides of the axis of symmetry of the electrode array 70, and each third connecting portion 49 is arranged in a horizontal S-shape. This allows the third electrode unit 73 to be freely adjusted relative to the first electrode unit 71 in the horizontal or vertical direction for better application to the skin surface and to eliminate the lifting caused by stress concentration during application of the first electrode unit 71 and the third electrode unit 73. The third connecting part 49 also has a certain degree of elastic deformation, which allows for free adjustment of the gap 74 formed between the first electrode unit 71 and the third electrode unit 73 while ensuring a good electrical connection between them. This provides a sufficiently large heat dissipation space between the first electrode unit 71 and the third electrode unit 73, or, depending on the condition of the skin, avoids applying the first electrode unit 71 and the third electrode unit 73 to areas unsuitable for application, allowing damaged skin to recover. First electrode unit 71, second electrode unit...Both electrode units 72 and 73 are provided with a plurality of heat dissipation through holes 90 arranged around their respective edges.

[0027] As shown in Figures 3 to 5, the first electrode unit 71 has a nearly trapezoidal outer contour and is located at the middle position of the electrode array 70. The second electrode unit 72 has a nearly triangular outer contour and is located above the corresponding first electrode unit 71, and is electrically connected to the first electrode unit 71 through the second connecting part 48. The third electrode unit 73 has a nearly fan-shaped outer contour and is located below the corresponding first electrode unit 71, and is electrically connected to the first electrode unit 71 through the third connecting part 49. The outer contours of the two first electrode units 71 that are far apart from each other, the outer contours of the two second electrode units 72 that are far apart from each other, and the outer contours of the two third electrode units 73 that are far apart from each other together form the teardrop-shaped outer contour of the electrode array 70. The area of ​​the second electrode unit 72 is smaller than the area of ​​the first electrode unit 71, and the area of ​​the first electrode unit 71 is smaller than the area of ​​the third electrode unit 73. When the electrode array 70 is applied to the uneven skin of the subject, such as the small application area on the head for the treatment of glioma, the teardrop-shaped outer contour of the electrode array 70 can be more easily applied in a limited area. It can also be adapted to the configuration of the application area by setting first electrode units 71, second electrode units 72 or third electrode units 73 with different shapes and areas, so that the applied therapeutic electric field is more concentrated on the target site.

[0028] The first electrode unit 71 includes a first base 711, a first conductive sheet 712 located on the first base 711, and a first dielectric layer 714 covering the first conductive sheet 712, wherein the first base 711, the first conductive sheet 712 and the first dielectric layer 714 are all arranged in a near-trapezoidal shape. The first electrode unit 71 further includes a first stretching layer 715, which is hollow and nearly trapezoidal in shape. The inner edge of the first stretching layer 715 covers the outer edge of the first conductive sheet 712, and the outer edge of the first stretching layer 715 overlaps with the first base 711. A first dielectric layer 714 covers the first stretching layer 715 and the first conductive sheet 712 exposed above the first stretching layer 715. The first conductive sheet 712 receives alternating electrical signals transmitted by the wiring portion 47 and applies alternating electrical signals through the first dielectric layer 714, which is capacitively coupled to the subject's skin. The projected area of ​​the first dielectric layer 714 is larger than the projected area of ​​the first conductive sheet 712, so that the first dielectric layer 714 completely covers the first conductive sheet 712, thereby preventing non-capacitive coupling caused by direct contact between the first conductive sheet 712 and the subject's skin. The projected area of ​​the first base 711 is larger than the projected area of ​​the first conductive sheet 712 and larger than the projected area of ​​the first dielectric layer 714, so as to fully support the first conductive sheet 712 and the first dielectric layer 714. In this embodiment, the projected area of ​​the first conductive sheet 712 is 290 mm² - 310 mm².mm2, the projected area of ​​the first dielectric layer 714 is 1.1 to 1.3 times the projected area of ​​the first conductive sheet 712.

[0029] The second electrode unit 72 includes a second base 721, a second conductive sheet 722 located on the second base 721, and a second dielectric layer 724 covering the second conductive sheet 722, wherein the second base 721, the second conductive sheet 722, and the second dielectric layer 724 are all arranged in a near-triangular shape. The second conductive sheet 722 receives the alternating electrical signal transmitted by the wiring portion 47 and applies the alternating electrical signal through the second dielectric layer 724, which is capacitively coupled to the subject's skin. The projected area of ​​the second dielectric layer 724 is larger than the projected area of ​​the second conductive sheet 722 to completely cover the second conductive sheet 722, thereby preventing non-capacitive coupling caused by direct contact between the second conductive sheet 722 and the subject's skin. The projected area of ​​the second base 721 is larger than the projected area of ​​the second conductive sheet 722 and larger than the projected area of ​​the second dielectric layer 724, so as to fully support the second conductive sheet 722 and the second dielectric layer 724. In this embodiment, the projected area of ​​the second conductive sheet 722 is 100 mm2-110 mm2, and the projected area of ​​the second dielectric layer 724 is 1.1 to 1.3 times the projected area of ​​the second conductive sheet 722.

[0030] In this embodiment, the second electrode unit 72 is also provided with a first temperature detection unit 60 for detecting the temperature at the body surface when an AC signal is applied, and a pair of first connection terminals 61 corresponding to the first temperature detection unit 60 and disposed on the second base 721. The first connection terminals 61 receive the DC signal transmitted by the wiring portion 47, and detect the temperature at the body surface where the second electrode unit 72 is attached through the first temperature detection unit 60 which is fixedly electrically connected to it. The first temperature detection unit 60 detects the temperature at the point where the second electrode unit 72 is applied to the body surface to prevent the surface temperature of the application site from becoming too high (e.g., above 41°C) due to heat generation during the application of an AC signal, thus preventing low-temperature burns to the subject's skin. The second conductive sheet 722 has a through hole (not labeled) for accommodating the first connecting terminal 61. The second conductive sheet 722 and the first connecting terminal 61 are spaced apart to prevent short circuits caused by electrical connection. The second dielectric layer 724 is disposed above the second conductive sheet 722 and in direct electrical contact with the sealed first temperature detection unit 60, allowing the first temperature detection unit 60 to be closer to the skin where the second electrode unit 72 is applied, enabling more accurate and rapid temperature detection. In this embodiment, the first temperature detection unit 60 of the second electrode unit 72 is disposed on the second base 721, closer to the first electrode unit 71. After the first temperature detection unit 60 is fixedly electrically connected to the first connection terminal 61, the through hole (unlabeled) of the second conductive sheet 722 is sealed with adhesive.The first temperature detection unit 60 and the first connection terminal 61 are completely sealed to prevent moisture intrusion and short circuit of the first temperature detection unit 60. (Instruction manual, page 4 / 8, CN 120960620 A)

[0031] To quickly and accurately weld the first temperature detection unit 60 and the first connection terminal 61, and to avoid poor connection between the first temperature detection unit 60 and the first connection terminal 61 affecting the accuracy of temperature detection, the second electrode unit 72 is also provided with a second stretching layer 723. The second stretching layer 723 includes a first ring band 7231 corresponding to the through hole (not labeled) of the second conductive sheet 722, a first stretching band 7232, a second stretching band 7233, and a third stretching band 7234 extending from the first ring band 7231 toward the outer periphery of the second base 721, and a first outer ring band 7235 located around the first stretching band 7232, the second stretching band 7233, and the third stretching band 7234. The first ring band 7231 is hollow and circular, with its inner edge pressed against the outer edge of the first connecting terminal 61, and its outer edge pressed against the inner edge of the second conductive sheet 722 near the through hole (unlabeled), thus exposing the first connecting terminal 61. This allows for rapid positioning and precise welding of the first connecting terminal 61 to the first temperature detection unit 60 during electrical connection. The first stretching band 7232 and the third stretching band 7234 are approximately collinear and are approximately parallel to the side of the second electrode unit 72 near the first electrode unit 71. The second stretching band 7233 extends to the side of the second electrode unit 72 near the first electrode unit 71. The first outer ring band 7235 is approximately hollow and triangular, with its inner edge covering the outer edge of the second conductive sheet 722, and its outer edge overlapping the outer edge of the second base 721. A second stretching layer 723 is provided on the second base 721 by the second electrode unit 72, so as to press the inner and outer edges of the second conductive sheet 722 onto the second base 721, so that the inner and outer edges of the second conductive sheet 722 are electrically insulated, and the first temperature detection unit 60 can be quickly and accurately fixed to the first connection terminal 61.

[0032] The second dielectric layer 724 covers the second conductive sheet 722 and also covers the first temperature detection unit 60 and the second stretching layer 723 with corresponding adhesive, so as to avoid the second dielectric layer 724 having gaps near the edge of the second conductive sheet 722 close to the first temperature detection unit 60 or the edge of the second stretching layer 723, which would cause the second dielectric layer 724 to break and cause the temperature of a certain part of the second electrode unit 72 to rise rapidly during the application of AC signal, resulting in uneven temperature rise. The first stretching strip 7232, the second stretching strip 7233, and the third stretching strip 7234 of the second stretching layer 723 divide the second conductive sheet 722 into three conductive regions 7221, 7222, and 7223 with different areas. The projected area of ​​the first conductive region 7221 is 65 mm².The projected area of ​​the second conductive region 7222 is 5mm²-10mm², and the projected area of ​​the third conductive region 7223 is 20mm²-25mm². The second conductive sheet 722 of the second electrode unit 72 is divided into a first conductive region 7221, a second conductive region 7222, and a third conductive region 7223 with different areas by the first stretching strip 7232, the second stretching strip 7233, and the third stretching strip 7234 of the second stretching layer 723. When an AC signal is applied through the second electrode unit 72, the current flowing through the first conductive region 7221, the second conductive region 7222, and the third conductive region 7223 can be separated from each other. This allows the heat generated by the second electrode unit 72 during tumor electric field therapy with an AC signal applied for a long time to be dispersed to the three regions corresponding to the second dielectric layer 724 and the first conductive region 7221, the second conductive region 7222, and the third conductive region 7223, thus avoiding excessive heat accumulation at the edge of the second electrode unit 72.

[0033] The third electrode unit 73 includes a third base 731, a third conductive sheet 732 located on the third base 731, and a third dielectric layer 734 covering the third conductive sheet 732. The third base 731, the third conductive sheet 732, and the third dielectric layer 734 are all arranged in a near-fan shape. The third conductive sheet 732 receives alternating electrical signals transmitted by the wiring portion 47 and applies alternating electrical signals through the third dielectric layer 734, which is capacitively coupled to the subject's skin. The projected area of ​​the third dielectric layer 734 is larger than the projected area of ​​the third conductive sheet 732, so that the third dielectric layer 734 completely covers the third conductive sheet 732, thereby preventing non-capacitive coupling caused by direct contact between the third conductive sheet 732 and the subject's skin. The projected area of ​​the third base 731 is larger than the projected area of ​​the third conductive sheet 732 and larger than the projected area of ​​the third dielectric layer 734, so that the third base 731 completely supports the third conductive sheet 732 and the third dielectric layer 734. In this embodiment, the projected area of ​​the third conductive sheet 732 is 360 mm²-370 mm², and the projected area of ​​the third dielectric layer 734 is 1.1 to 1.3 times the projected area of ​​the third conductive sheet 732.

[0034] In this embodiment, the third electrode unit 73 is also provided with a second temperature detection unit 62 for detecting the temperature at the surface of the body when an AC signal is applied, and a second connection terminal 63 corresponding to the second temperature detection unit 62 and disposed on the third base 731. The second connection terminal 63 receives the DC signal transmitted by the wiring part 47, and detects the temperature of the third dielectric layer 734 through the second temperature detection unit 62 which is fixedly electrically connected to it, thereby detecting the temperature at the surface of the body where the third electrode unit 73 is attached. The second temperature detection unit 62 detects the temperature at the surface of the body where the third electrode unit 73 is attached to preventDuring the application of an AC signal, the third electrode unit 73 generates heat, causing excessively high temperatures (e.g., above 41°C), which can result in low-temperature burns to the skin of the subject against which it is attached. The third conductive sheet 732 has perforations (unlabeled) corresponding to the second connection terminal 63 to accommodate it. This allows the second temperature detection unit 62, after being sealed with adhesive, to be covered by the third dielectric layer 734 of the third electrode unit 73, bringing it closer to the skin against which it is attached, thus enabling more accurate temperature detection. In this embodiment, the second temperature detection unit 62 is positioned closer to the first electrode unit 71 on the third base 731 of the third electrode unit 73. After the second temperature detection unit 62 is electrically connected to the second connection terminal 63, the perforations (unlabeled) of the third conductive sheet 732 are sealed with adhesive to completely seal the second temperature detection unit 62 and the second connection terminal 63, preventing moisture from entering and causing a short circuit in the second temperature detection unit 62.

[0035] In order to quickly and accurately achieve a good electrical connection between the second temperature detection unit 62 and the second connection terminal 63, and to avoid welding displacement or poor welding between the second temperature detection unit 62 and the second connection terminal 63 which would affect the accuracy of temperature detection, the third electrode unit 73 is provided with a third stretching layer 733. The third stretching layer 733 includes a second ring band 7331 corresponding to the perforation (not labeled) of the third conductive sheet 732, a fourth stretching band 7332, a fifth stretching band 7333 and a sixth stretching band 7334 extending from the second ring band 7331 toward the outer contour of the third base 731, and a second outer ring band 7335 located around the fourth stretching band 7332, the fifth stretching band 7333 and the sixth stretching band 7334. The second ring band 7331 is circularly arranged, with its inner edge pressed against the outer edge of the second connecting terminal 63, and its outer edge pressed against the inner edge of the third conductive sheet 732 near the through hole (unlabeled) to expose the second connecting terminal 63. This allows for rapid positioning and precise welding between the second temperature detection unit 62 and the second connecting terminal 63 during welding. The fourth stretching band 7332 and the sixth stretching band 7334 are approximately collinear and parallel to the contour of the third electrode unit 73 near the first electrode unit 71. The fourth stretching band 7332 extends from the second ring band 7331 away from the axis of symmetry of the electrode array 70 to the arc-shaped outer contour of the third base 731 of the third electrode unit 73. The sixth stretching band 7334 extends from the second ring band 7331 near the axis of symmetry of the electrode array 70 to the contour of the side where the third base 731 of the two third electrode units 73 are close to each other. The fifth stretching band 7333 extends from the second ring band 7331 toward the side of the third electrode unit 73 that is close to the first electrode unit 71.The third base 731 is located near the contour of the first base 711. The second outer ring 7335 is arranged in a fan shape, and its inner edge covers the outer edge of the third conductive sheet 732. The outer edge of the second outer ring 7335 overlaps with the outer edge of the third base 731. The third electrode unit 73 presses the inner and outer edges of the third conductive sheet 732 onto the third base 731 by laying a third stretching layer 733 on the third base 731, so that the inner and outer edges of the third conductive sheet 732 are electrically insulated.

[0036] The third dielectric layer 734 covers the third conductive sheet 732 and also covers the corresponding encapsulated second temperature detection unit 62 and the third stretching layer 733, so as to avoid the corresponding part of the third conductive sheet 732 being exposed and directly contacting the skin surface, which would cause safety hazards. The fourth stretching strip 7332, the fifth stretching strip 7333, and the sixth stretching strip 7334 of the third stretching layer 733 divide the third conductive sheet 732 into three conductive regions 7321, 7322, and 7323 with different areas. The projected area of ​​the fourth conductive region 7321 is 174 mm2-179 mm2, the projected area of ​​the fifth conductive region 7322 is 47 mm2-52 mm2, and the projected area of ​​the sixth conductive region 7323 is 112 mm2-117 mm2. The third electrode unit 73 is divided into three conductive regions 7321, 7322, and 7323 of different areas by the fourth stretching strip 7332, fifth stretching strip 7333, and sixth stretching strip 7334 of the third stretching layer 733. This results in a lower current density at the locations covered by the fourth stretching strip 7332, fifth stretching strip 7333, and sixth stretching strip 7334, thereby separating the current flowing through the fourth conductive region 7321, fifth conductive region 7322, and sixth conductive region 7323. This disperses the heat generated by the third electrode unit 73 during prolonged tumor electric field therapy to the fourth conductive region 7321, fifth conductive region 7322, and sixth conductive region 7323, preventing excessive heat accumulation in any part of the third electrode unit 73.

[0037] The first base 711, the second base 721, the third base 731, the first connecting part 46, the second connecting part 48, the third connecting part 49, and the wiring part 47 together constitute the flexible circuit board (unlabeled) of the electrode array 70. The flexible circuit board (unlabeled) is made of high-temperature resistant, high-strength, and high-insulation materials such as polyimide (PI) or polyester (PET) resin with a thickness of 10μm-50μm. The first conductive sheet 712, the second conductive sheet 722, the third conductive sheet 732, the first connecting terminal 61, and the second connecting terminal 63 are all made of rolled copper foil or electrolytic copper foil with a thickness of 10μm-75μm, and are fixed by electroplating or adhesive film.On the corresponding first base 711, second base 721, and third base 731, the flexible circuit board (unlabeled) is also provided with a plurality of conductive traces (unlabeled) extending from the corresponding pads 42 to the first conductive sheet 712, second conductive sheet 722, third conductive sheet 732, first connecting terminal 61, and second connecting terminal 63, respectively, to transmit corresponding electrical signals. The first stretch layer 715, second stretch layer 723, and third stretch layer 733 are all made of polyimide (PI), polyester (PET) resin, or polyurethane with a thickness of 10μm-50μm, and cover the corresponding first base 711, second base 721, and third base 731 to expose the corresponding first conductive sheet 712, second conductive sheet 722, third conductive sheet 732, first connecting terminal 61, and second connecting terminal 63.

[0038] The first dielectric layer 714, the second dielectric layer 724, and the third dielectric layer 734 are all dielectric materials with high dielectric constants and low dielectric losses. In this embodiment, the first dielectric layer 714, the second dielectric layer 724, and the third dielectric layer 734 are made of polymer materials with non-fixed crystal orientation, high flexibility, and high toughness. Their dielectric constant is not less than 20, and their dielectric strength is not less than 40V / μm to avoid breakdown under normal applied voltage. The first dielectric layer 714, the second dielectric layer 724, and the third dielectric layer 734 can be ternary copolymers based on relaxor ferroelectrics, such as vinylidene fluoride-trifluoroethylene-trifluorochloroethylene copolymers or vinylidene fluoride-trifluoroethylene-chlorofluoroethylene copolymers, or piperazine biuret Biuret copolyamide films. The first dielectric layer 714, the second dielectric layer 724, and the third dielectric layer 734 can be formed on the surfaces of the corresponding first conductive sheet 712, second conductive sheet 722, third conductive sheet 732, first stretching layer 715, second stretching layer 723, third stretching layer 733, first temperature detection unit 60, and second temperature detection unit 62 by vapor deposition methods such as evaporation, sputtering, or ion plating. Alternatively, they can be formed on the surfaces of the corresponding first conductive sheet 712, second conductive sheet 722, third conductive sheet 732, first stretching layer 715, second stretching layer 723, third stretching layer 733, first temperature detection unit 60, and second temperature detection unit 62 by printing, spraying, or casting. The thickness of the first dielectric layer 714, second dielectric layer 724, and third dielectric layer 734 does not exceed 300 μm, and is preferably 3 μm-10 μm.

[0039] The first base 711, the second base 721, and the third base 731 together constitute the base (unlabeled) of the flexible circuit board (unlabeled) of the electrode array 70. The first stretching layer 715, the second stretching layer 723, and the third stretching layer 733 together constitute the stretching layer (unlabeled) covering the flexible circuit board (unlabeled) of the electrode array 70. The first stretching layer 715, the second stretching layer 723, and the third stretching layer 733 disposed on the first base 711A conductive sheet 712, a second conductive sheet 722 disposed on a second base 721, and a third conductive sheet 732 disposed on a third base 731 together constitute a conductive sheet (unlabeled) disposed on a flexible circuit board (unlabeled). A first dielectric layer 714 disposed on a first stretching layer 715 and a first conductive sheet 712, a second dielectric layer 724 disposed on a second stretching layer 723 and a second conductive sheet 722, and a third dielectric layer 734 disposed on a third stretching layer 733 and a third conductive sheet 732 together constitute a dielectric layer (unlabeled) laid on the flexible circuit board (unlabeled) and the conductive sheet (unlabeled). The second conductive sheet 722 is stretched by a first stretching strip 7232. The first conductive region 7221, the second conductive region 7222, the third conductive region 7223, and the third conductive sheet 732 divided by the second stretching strip 7233 to the third stretching strip 7234, and the fourth conductive region 7321, the fifth conductive region 7322, and the sixth conductive region 7323 divided by the fourth stretching strip 7332, the fifth stretching strip 7333, and the sixth stretching strip 7334, are all conductive areas (unlabeled) of the electrode unit divided by the stretching layer of the stretching strip, and together with the first conductive sheet 712, they constitute the electrode array 70 disposed on the conductive layer (unlabeled) on the flexible circuit board (unlabeled) specification page 7 / 8 9 CN 120960620 A.

[0040] The above are only 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. Instruction manual, page 8 / 8, CN 120960620 A, Figure 1, Figure 2; Instruction manual drawing, page 1 / 3, CN 120960620 A, Figure 3; Instruction manual drawing, page 2 / 3, CN 120960620 A, Figure 4, Figure 5; Instruction manual drawing, page 3 / 3, CN 120960620 A {JSHL-26025-HKSPT / 02487848v1} Abstract: This invention provides an electrode patch and an electric field therapy system. The electrode patch is provided with an electrode array for applying tumor electric fields. The electrode array comprises a plurality of different-shaped electrode units, and at least one...electrode unit is provided with a temperature detection unit and a stretching layer for positioning the temperature detection unit; and the stretching layer divides the corresponding electrode units into a plurality of conductive regions with different areas. The electrode patch can be adapted to be attached to different body surface skin positions by dividing the electrode units into different shapes, and the heat accumulation of the corresponding electrode units can be dispersed through providing a part of electrode units with the stretching layer to further divide the corresponding electrode units into a plurality of conductive regions with different areas, thereby increasing the duration of the therapeutic electric field applied by the electrode patch.

Claims

1. An electrode patch having an electrode array for applying an electric field to a tumor, characterized in that, The electrode array includes several electrode units of different shapes. At least one of the electrode units is provided with a temperature detection unit and a stretching layer for positioning the temperature detection unit. The stretching layer divides the corresponding electrode unit into several conductive regions of different areas.

2. The electrode patch according to claim 1, characterized in that: The outer contour of the electrode array is arranged in a teardrop shape.

3. The electrode patch according to claim 1, characterized in that: The plurality of electrode units of different shapes include a first electrode unit and a second electrode unit and a third electrode unit disposed on opposite sides of the first electrode unit.

4. The electrode patch according to claim 3, characterized in that: The temperature detection unit is located in the second electrode unit or the third electrode unit.

5. The electrode patch according to claim 1, characterized in that: Each of the electrode units includes a base, a conductive layer on the base, and a dielectric layer covering the stretching layer and the conductive layer.

6. The electrode patch according to claim 5, characterized in that: The conductive layer has through holes or perforations corresponding to the temperature detection unit.

7. The electrode patch according to claim 5, characterized in that: The dielectric layer covers the temperature detection unit and the stretching layer.

8. The electrode patch according to claim 5, characterized in that: The stretch layer includes an annular band corresponding to the through hole or the perforation, and a plurality of stretch bands extending from the annular band in different contour directions toward the corresponding base.

9. The electrode patch according to claim 8, characterized in that: The stretching strips are in the form of three strips, which divide the corresponding electrode unit into three conductive regions of different areas.

10. An electric field therapy system, characterized in that: It includes an electric field generator and several electrode patches as described in any one of claims 1-9 that are directly or indirectly electrically connected to the electric field generator.

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