Tumor electric field treatment device and electrode patch thereof

Abstract

The invention provides a tumor electric field treatment device and an electrode patch thereof, the electrode patch comprises an electrode array and a wire, the electrode array comprises a flexible circuit board and a plurality of electrode units, and each electrode unit is provided with a dielectric element and a temperature sensor. The electrode units are arranged in four rows and four columns on the circuit arrangement, the flexible circuit board is provided with a path of AC trace, four paths of grounding traces and four paths of signal traces, and the AC trace is arranged on the front face of the flexible circuit board and electrically connected with the dielectric elements. The four grounding traces are arranged on the back face of the flexible circuit board and electrically connected with the grounding ends of the corresponding rows of electrode units respectively, the four signal traces are also arranged on the back face of the flexible circuit board and electrically connected with the signal ends of the corresponding columns of electrode units respectively, and the four grounding traces are conducted in turn during temperature detection. According to the tumor electric field treatment device and the electrode patch thereof, the total number of conductive traces required by the temperature sensor can be reduced so as to simplify a wiring scheme, and signal crosstalk can be prevented so as to improve signal transmission quality.

Description

Technical Field

[0001] The present invention relates to a tumor electric field treatment device and an electrode patch thereof, belonging to the technical field of medical equipment. Background Art

[0002] Currently, the main treatments for tumors include surgery, radiotherapy, and chemotherapy, but all have corresponding disadvantages. For example, radiotherapy and chemotherapy can produce side effects and kill normal cells. Using electric fields to treat tumors is also one of the current research and development frontiers. Tumor electric field therapy uses a special electric field generator to generate a low-intensity, medium-high frequency, alternating electric field to interfere with the mitotic process of tumor cells. Studies have shown that tumor electric field therapy is effective in treating diseases such as glioblastoma, non-small cell lung cancer, and malignant pleural mesothelioma. The electric field applied by this treatment method can affect the aggregation of microtubules, prevent spindle formation, inhibit the mitotic process, and induce apoptosis in cancer cells.

[0003] A tumor electric field therapy device used for tumor electric field therapy primarily comprises an electric field generator and an electrode patch electrically connected to the electric field generator. The electrode patch includes an electrode array that transmits an alternating electric field. The electrode array comprises a flexible circuit board (FPCB), multiple dielectric elements disposed on the skin-facing side of the FPCB, and multiple temperature sensors that monitor the temperature of each dielectric element. The FPCB is equipped with several conductive traces to transmit alternating current (AC) signals to each dielectric element and direct current (DC) signals to each temperature sensor. The large number of temperature sensors complicates existing FPCB wiring schemes, significantly impacting their manufacture.

[0004] Therefore, it is indeed necessary to provide an improved electrode patch and tumor electric field treatment device to overcome the problems existing in the above-mentioned electrode patch and tumor electric field treatment device. Summary of the Invention

[0005] The present invention provides a tumor electric field treatment device and an electrode patch thereof, wherein the flexible circuit board has a simple wiring scheme.

[0006] The electrode patch of the present invention is implemented through the following technical solution: an electrode patch for tumor electric field therapy, comprising an electrode array and wires, the electrode array comprising a flexible circuit board and a plurality of electrode units, each of the electrode units being provided with a dielectric element and a temperature sensor, the plurality of electrode units being arranged in four rows and four columns in a circuit layout, the flexible circuit board being provided with one AC trace, four ground traces, and four signal traces, the AC trace being arranged on the front surface of the flexible circuit board and electrically connected to each of the dielectric elements, the four ground traces being arranged on the back surface of the flexible circuit board and respectively electrically connected to the ground terminals of each of the temperature sensors in a corresponding row of the electrode units, and the four signal traces being also arranged on the back surface of the flexible circuit board and respectively electrically connected to the signal terminals of each of the temperature sensors in a corresponding column of the electrode units. During temperature detection, the four signal traces remain conductive, while the four ground traces are alternately conductive to obtain temperature detection signals from each of the temperature sensors row by row.

[0007] Furthermore, the flexible printed circuit board is provided with a plurality of main body parts arranged at intervals, a plurality of connection parts connecting two adjacent main body parts and a wiring part connected to the wire, a conductive plate is provided on the front side of the main body part, the dielectric element is provided on the front side of the main body part and is electrically connected to the conductive plate; the temperature sensor is provided on the front side of the main body part, and a ground pad electrically connected to the ground end and a signal pad electrically connected to the signal end are provided on the front side of the main body part.

[0008] Furthermore, the electrode unit is provided with a diode, and the front of the main body is provided with an anode pad and a cathode pad electrically connected to the diode, the anode pad is electrically connected to the ground pad through a pad trace, and the cathode pad is electrically connected to the ground trace; the diode is connected in series between the ground trace and the temperature sensor.

[0009] Furthermore, the wiring portion is provided with five gold fingers on the front and back sides thereof, the AC trace extends from one of the gold fingers on the front side of the wiring portion and extends on the front side of the flexible circuit board; the four ground traces extend from the other four gold fingers on the front side of the wiring portion and pass through the wiring portion to the back side of the flexible circuit board, and extend on the back side of the flexible circuit board.

[0010] Furthermore, the four signal traces are respectively led out from the four gold fingers on the back of the wiring part and extend on the back of the flexible circuit board, and the remaining gold finger on the back of the wiring part is connected to the shielding layer of the wire.

[0011] Furthermore, the electrode array includes thirteen electrode units arranged in five rows and five columns in a spatial structure, wherein the first row and the last row are each provided with two of the electrode units and are respectively located on the second column and the fourth column, and the middle three rows are each provided with three of the electrode units and are respectively located on the first column, the third column and the fifth column. These thirteen electrode units are numbered M1 to M13 from top to bottom and from left to right. In terms of circuit arrangement, the first row is electrode units M6, M7, M9, and M12, the second row is electrode units M1, M2, and M3, the third row is electrode units M5, M4, and M8, and the fourth row is electrode units M13, M11, and M10.

[0012] Furthermore, in terms of circuit arrangement, the first column is composed of electrode units M6, M1, M5, and M13, the second column is composed of electrode units M7, M2, M4, and M11, the third column is composed of electrode units M9, M3, M8, and M10, and the fourth column has only one electrode unit M12.

[0013] Furthermore, it also includes a backing, a plurality of supporting members and a plurality of adhesive members, the electrode array is adhered to the backing, the supporting members are adhered to the backing and arranged around each of the electrode units, and the adhesive members cover each of the supporting members and each of the electrode units.

[0014] Furthermore, the electrode array is further provided with a plurality of insulating plates fixed on the back side of each of the main bodies.

[0015] The present invention is also implemented through the following technical solution: a tumor electric field treatment device, including an electric field generator and the above-mentioned electrode patch electrically connected to the electric field generator.

[0016] The tumor electric field therapy device and its electrode patch of the present invention use shared ground traces and signal traces to reduce the total number of conductive traces required for the temperature sensor and simplify the wiring scheme. At the same time, all ground traces and signal traces are arranged on the back of the flexible circuit board to prevent signal crosstalk and improve signal transmission quality. In addition, the front of the flexible circuit board basically only has AC traces, which can provide more sufficient wiring space for the AC traces. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 A three-dimensional combined diagram of electrode patches in one embodiment of the tumor electric field treatment device of the present invention; Figure 2 for Figure 1 Exploded three-dimensional diagram of the electrode patch; Figure 3 for Figure 2 A plan view of the electrode array of the electrode patch; Figure 4 for Figure 3A three-dimensional exploded view of the electrode array in FIG; Figure 5 for Figure 3 A plan view of a flexible circuit board with an electrode array; Figure 6 for Figure 5 A local enlarged view of point A in FIG; Figure 7 for Figure 5 The wiring diagram of the AC traces on the front side of the flexible circuit board; Figure 8 for Figure 5 a wiring diagram of the conductive traces on the back side of the flexible circuit board; Figure 9 for Figure 5 The wiring diagram of the ground trace on the back side of the flexible circuit board; Figure 10 for Figure 5 A wiring diagram of the signal traces on the back of the flexible circuit board; Figure 11 for Figure 1 Schematic diagram of the circuit connection between the electrode array and the adapter.

[0018] Description of reference numerals: Electrode patch 100, electrode array 1, electrode unit 10, flexible circuit board 11, main body 111, connecting portion 112, wiring portion 113, gold finger 1131, open space 114, conductive pad 115, conductive core 1151, pad 116, ground pad 1161, signal pad 1162, anode pad 1163, cathode pad 1164, pad trace 1165, insulating plate 12, dielectric element 13, through-hole 131, temperature sensor 14, ground terminal 141, signal terminal 142, diode 15, conductive trace L, AC trace L1, ground trace L2, first ground trace L21 , second ground trace L22, third ground trace L23, fourth ground trace L24, signal trace L3, first signal trace L31, second signal trace L32, third signal trace L33, fourth signal trace L34, backing 2, support member 3, through hole 31, adhesive member 4, wire 5, heat shrink tubing 51, adapter 200, controller 201, analog-to-digital conversion module 202, communication unit 203, power module 204, ground switch 205, first ground switch 2051, second ground switch 2052, third ground switch 2053, fourth ground switch 2054, voltage divider resistor 206. DETAILED DESCRIPTION

[0019] Exemplary embodiments are described in detail herein, examples of which are 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 invention. Rather, they are merely examples of devices, systems, apparatus, and methods consistent with certain aspects of the present invention.

[0020] refer to Figure 1 and Figure 9 As shown, the tumor electric field treatment device of the present invention includes an electric field generator (not shown), multiple pairs of electrode patches 100, and an adapter 200 electrically connecting the electric field generator (not shown) and each electrode patch 100. The electric field generator (not shown) provides an alternating current signal, which is transmitted to each pair of electrode patches 100 through the adapter 200. After receiving the alternating current signal, each pair of electrode patches 100 forms an alternating electric field. The multiple pairs of electrode patches 100 alternately apply alternating electric fields in different directions to the patient's tumor site, which can produce a certain therapeutic effect on the patient's tumor.

[0021] refer to Figures 1 to 2 As shown, the electrode patch 100 in this embodiment is Figure 1 The electrode patch 100 is applied to the patient's torso with the front side facing the patient, and is positioned corresponding to the patient's tumor. The electrode patch 100 comprises an electrode array 1, a backing 2, several supports 3, several adhesives 4, and a conductive wire 5. The electrode array 1 is adhered to the backing 2 and includes several spaced-apart electrode units 10. The supports 3 are adhered to the backing 2 and surround each electrode unit 10 to support the adhesives 4 covering each support 3 and corresponding electrode unit 10. The adhesives 4 directly adhere to the patient's body surface. The conductive wire 5 electrically connects an electric field generator (not shown) to the electrode array 1 to provide an alternating current signal to the electrode array 1. A biocompatible adhesive is applied to the front side of the backing 2, allowing the electrode patch 100 to be tightly adhered to the patient's body surface corresponding to the tumor site. The paired electrode patches 100 apply an alternating electric field to the patient's tumor site, disrupting or preventing mitosis in the patient's tumor cells, thereby achieving the purpose of tumor treatment.

[0022] The backing 2 is a sheet-like material made of a flexible, breathable insulating material, preferably a mesh fabric, preferably a non-woven mesh fabric. It is soft, lightweight, moisture-resistant, and breathable. The electrode array 1 is centrally adhered to the backing 2 using the aforementioned biocompatible adhesive (not shown). The support member 3 is a soft material, preferably foam, and is provided with through-holes 31 surrounding the electrode units 10. The adhesive member 4 is double-sided adhesive, preferably a conductive gel, which keeps the skin surface moist and relieves localized pressure.

[0023] Combine Figure 3As shown, from the perspective of spatial distribution, a number of electrode units 10 are arranged in multiple rows and columns, and the electrode array 1 also includes a plurality of connecting parts 112 connecting two adjacent electrode units 10 and a wiring part 113 connected to the electrode unit 10 or the connecting part 112. The wiring part 113 is used to be welded and connected to the wire 5. A plurality of adjacent electrode units 10 are spaced apart and enclosed together to form a plurality of open spaces 114 to allow the skin covered by the electrode patch 100 to breathe freely after the electrode patch 100 is applied to the patient's body surface. Each electrode unit 10 is connected to a plurality of adjacent electrode units 10 through the connecting part 112, wherein the space between two electrode units 10 is disconnected to allow the wiring part 113 to pass through. The wiring part 113 is provided with a row of gold fingers 1131 on the front and back of its end, respectively. Each gold finger 1131 is welded and connected to the corresponding wire core (not shown) of the wire 5. The connection between the wiring part 113 and the wire 5 is provided with a heat shrink tubing 51 (see FIG. 1 ). Figure 2 ) to protect the connection.

[0024] refer to Figure 4 and Figure 5 As shown, from a hierarchical perspective, the electrode array 1 comprises a flexible circuit board 11, several insulating plates 12 disposed on the back of the flexible circuit board 11, and several dielectric elements 13 disposed on the front of the flexible circuit board 11. The front of the flexible circuit board 11 faces the patient's body surface. The flexible circuit board 11 comprises several spaced-apart main bodies 111, several connecting portions 112 connecting adjacent main bodies 111, and the aforementioned wiring portions 113. A conductive plate 115 is disposed on the front of the main body 111. The conductive plate 115 comprises four annular conductive cores 1151. The insulating plate 12 is adhered to the back of the main body 111. The dielectric elements 13 are welded to the front of the main body 111 and electrically connected to the conductive plates 115. The main body 111, insulating plates 12, and dielectric elements 13 are all circular, with their centers aligned, forming the aforementioned electrode unit 10. The insulating plate 12 is optional for the electrode unit 10; that is, the electrode unit 10 may not have the insulating plate 12.

[0025] The insulating plate 12 is preferably an epoxy glass cloth laminate. Before welding the dielectric element 13 to the main body 111, it is adhered to the back of the main body 111 with glue. This reinforces the main body 111, improves the flatness of the weld surface between the main body 111 and the dielectric element 13, and enhances the weld quality between the main body 111 and the dielectric element 13. The dielectric element 13 is made of a high-dielectric-constant material, which has the conductive property of blocking direct current while allowing alternating current to pass, ensuring human safety. After welding the dielectric element 13 to the conductive plate 115, a sealant (not shown) is used to seal the perimeter of the dielectric element 13. An electric field generator (not shown) transmits an AC signal to the dielectric element 13 via the flexible printed circuit board 11. The dielectric element 13 receives the AC signal and generates an AC electric field that is applied to the patient. In other embodiments, the dielectric element 13 may also be in other forms, such as a polymer dielectric layer with high dielectric constant and low dielectric loss made of a thin film material with non-fixed crystal orientation, high flexibility and high toughness, which can be formed on the main body 111 by evaporation, sputtering or ion plating vapor deposition, printing, spraying or casting.

[0026] The electrode array 1 further includes a plurality of temperature sensors 14 and a plurality of diodes 15. The front surface of the main body 111 is further provided with a plurality of solder pads 116 located at the center of the conductive disk 115. Figure 6 , and combined with Figure 11 As shown, several pads 116 include a ground pad 1161, a signal pad 1162, an anode pad 1163, and a cathode pad 1164. Temperature sensor 14 has a ground terminal 141 and a signal terminal 142. Ground terminal 141 is soldered to ground pad 1161, and signal pad 1162 is soldered to signal terminal 142. The anode (unnumbered) of diode 15 is soldered to anode pad 1163, and the cathode (unnumbered) of diode 15 is soldered to cathode pad 1164. Anode pad 1163 is electrically connected to ground pad 1161 via a pad trace 1165. That is, pad trace 1165 connects diode 15 in series with ground terminal 141 of temperature sensor 14. This arrangement prevents reverse current flow, preventing current from other temperature sensors 14 from affecting this temperature sensor 14. A through-hole 131 is provided at the center of the dielectric element 13 to accommodate and accommodate the temperature sensor 14 and the diode 15. After the temperature sensor 14 and the diode 15 are welded to the corresponding pads 116 and installed at the center of the front surface of the main body 111, a sealant is injected into the through-hole 131 of the dielectric element 13 to seal the temperature sensor 14 and the diode 15.

[0027] The electric field generator (not shown) provides a DC signal to the temperature sensor 14 through the flexible circuit board 11 and receives a temperature signal fed back by the temperature sensor 14. The temperature sensor 14 is preferably a thermistor, which monitors the temperature of the corresponding electrode unit 10 and feeds back the temperature to the electric field generator (not shown). When the monitored temperature value exceeds the upper limit of the human body's safe temperature, the AC signal is promptly reduced or turned off to prevent the corresponding electrode unit 10 from causing low-temperature burns to the human body; when the detected temperature value is lower than a preset minimum value, the intensity of the AC signal is increased to increase the intensity of the AC electric field and enhance the therapeutic effect.

[0028] In this embodiment, the electrode array 1 includes thirteen electrode units 10, spatially arranged in an array of five rows and five columns. The first and last rows of the electrode array 1 each include two electrode units 10, located in the second and fourth columns, respectively; the middle three rows each include three electrode units 10, located in the first, third, and fifth columns, respectively. The thirteen electrode units 10 are distributed symmetrically along both the row and column axes. The electrode array 1 includes thirteen temperature sensors 14 and thirteen diodes 15, each corresponding to a corresponding electrode unit 10.

[0029] refer to Figures 7 to 10 , and combined with Figure 11 As shown, the flexible printed circuit board 11 is provided with multiple conductive traces L, including one AC trace L1, four ground traces L2, and four signal traces L3. Five gold fingers 1131 are provided on each side of the connection portion 113. One gold finger 1131 on the front side is connected to the end of the AC trace L1, while the other four gold fingers 1131 on the front side are connected to the ends of the four ground traces L2, one-to-one. Four gold fingers 1131 on the back side are connected to the ends of the four signal traces L3, one-to-one. The remaining gold finger 1131 on the back side is connected to the shielding layer (not shown) of the conductor 5 and is grounded to provide electromagnetic shielding and prevent signal interference.

[0030] For the convenience of description, Figures 7 to 10 In the figure, the thirteen electrode units 10 of the electrode array 1 are numbered M1 to M13 from top to bottom and from left to right. The electrode units M1 and M2 are located in the first row of the electrode array 1, the electrode units M3, M4, and M5 are located in the second row of the electrode array 1, the electrode units M6, M7, and M8 are located in the third row of the electrode array 1, the electrode units M9, M10, and M11 are located in the fourth row of the electrode array 1, and the electrode units M12 and M13 are located in the fifth row of the electrode array 1. Figures 7 to 10 There is no dielectric element 13, but the arrangement of the main body 111 is the same as the arrangement of the electrode unit 10, so the numbers M1 to M13 are used to mark them. The specific arrangement of each conductive trace L is described below.

[0031] Key References Figure 7 As shown, the AC trace L1 is provided on the front surface of the flexible printed circuit board 11. It is led out from a gold finger 1131 on the front surface of the connection portion 113, extends along the connection portion 113, the corresponding main body portion 111 and the corresponding connecting portion 112, and is electrically connected to each conductive plate 115. This transmits an AC signal to each conductive plate 115, and then to each dielectric element 13. Each dielectric element 13 receives the AC signal to generate a therapeutic AC electric field between the paired electrode patches 100.

[0032] The specific routing of AC trace L1 is as follows: AC trace L1 first extends upward from connection portion 113 to electrode unit M10, then passes leftward from electrode unit M10 through electrode unit M9 to electrode unit M12, then turns back upward from electrode unit M12, passes sequentially through electrode units M9, M6, and M3 to electrode unit M1, then turns back from electrode unit M1 through electrode unit M3 to electrode unit M4; then turns back from electrode unit M4 through electrode units M3, M6, M9, M10, M11, and M8 to electrode unit M7, then turns back from electrode unit M7 through electrode units M8 and M5 to electrode unit M2, then turns back from electrode unit M2 through electrode units M5, M8, and M11 to electrode unit M13, and finally turns back from electrode unit M13 through electrode unit M11 to electrode unit M10. AC trace L1 electrically connects to the corresponding conductive core 1151 as it passes through each electrode unit 10. The connecting portion 112, which is provided with AC traces L1, has two sections of AC traces L1 disposed on opposite sides thereof. The two sections of AC traces L1 extend along the length of the connecting portion 112 and connect different conductive cores 1151 of the conductive disk 115. Some connecting portions 112 are not provided with conductive traces L and serve only to connect adjacent electrode units 10.

[0033] refer to Figures 8 to 10 , and combined with Figure 11 As shown, the ground terminals 141 of the temperature sensors 14 in multiple electrode units 10 are connected in parallel to the same ground trace L2. Meanwhile, the signal terminals 142 of the temperature sensors 14 in multiple electrode units 10 connected to different ground traces L2 are connected in parallel to the same signal trace L3. Each signal trace L3 remains conductive, and by alternately grounding the four ground traces L2, temperature detection signals from each temperature sensor 14 can be acquired in batches. The specific temperature detection control method will be described later. Compared to providing a separate signal trace for each temperature sensor 14, this wiring method increases the number of temperature sensors 14, enabling comprehensive temperature detection of each electrode unit 10 while reducing the total number of conductive traces. This reduces the wiring complexity of the flexible circuit board 11 and simplifies the manufacturing process of the flexible circuit board 11.

[0034] The four ground traces L2 and the four signal traces L3 are generally disposed on the back side of the flexible circuit board 11. Each ground trace L2 extends from a gold finger 1131 on the front side of the connection portion 113, passes through the flexible circuit board 11, and reaches the back side of the flexible circuit board 11. It then extends along the connection portion 113, the corresponding main portion 111, and the corresponding connecting portion 112 to the main portion 11 of the corresponding electrode unit 10. The traces then pass through the corresponding main portion 11 to electrically connect to the corresponding cathode pad 1164, thereby grounding the cathode pad 1164, which is electrically connected to the diode 15. Since cathode pad 1164 is electrically connected to ground pad 1161 via diode 15, anode pad 1163, and pad trace 1165, the connection of ground trace L2 to cathode pad 1164 is equivalent to the connection to ground pad 1161, thereby grounding ground pad 1161. Later, when describing the specific routing of each ground trace L2, the connection between each ground trace L2 and each cathode pad 1164 will be directly described as the connection between ground trace L2 and each ground pad 1161, to more clearly illustrate the connection between each ground trace L2 and temperature sensor 14. Each signal trace L3 is led out from a gold finger 1131 on the back of the wiring portion 113, extends along the wiring portion 113, the corresponding main portion 111, and the corresponding connecting portion 112, and is respectively connected to the signal pad 1162 on the main portion 11 of the corresponding electrode unit 10.

[0035] Key References Figure 9 , and combined with Figure 11 As shown, the four ground traces L2 are respectively a first ground trace L21 , a second ground trace L22 , a third ground trace L23 and a fourth ground trace L24 . The following describes the specific wiring method of the four signal traces L3 from the back side of the flexible circuit board 11 .

[0036] The first ground trace L21 short-circuits all the ground pads 1161 corresponding to the temperature sensors 14 of the electrode units M6, M7, M9, and M12, so as to ground the ground terminals 141 of the temperature sensors 14 of the electrode units M6, M7, M9, and M12. The specific routing of the first ground trace L21 is as follows: it is led out from the corresponding gold finger 1131 on the front of the connection portion 113, passes through the back of the connection portion 113, and then extends upward to the top of the connection portion 113, then extends to the right along the connection portion 112 between the electrode unit M10 and the electrode unit M12, and then connects to the electrode unit M10. 12, then continues to extend rightward and upward through the connecting portion 112 between the electrode unit M12 and the electrode unit M9 to be connected with the grounding pad 1161 corresponding to the electrode unit M9, then continues to extend upward through the connecting portion 112 between the electrode unit M9 and the electrode unit M6 to be connected with the grounding pad 1161 corresponding to the electrode unit M6, and finally extends leftward through the connecting portion 112 between the electrode unit M6 and the electrode unit M7 to be connected with the grounding pad 1161 corresponding to the electrode unit M7.

[0037] The second ground trace L22 short-circuits all the ground pads 1161 corresponding to the temperature sensors 14 of the electrode units M1, M2, and M3, so as to ground the ground terminals 141 of the temperature sensors 14 of the electrode units M1, M2, and M3. The specific routing of the second ground trace L22 is as follows: it is led out from the corresponding gold finger 1131 on the front of the wiring portion 113, passes through the back thereof, and then extends upward to the top thereof and then extends to the right, and then goes down along the connection portion 112 between the electrode unit M10 and the electrode unit M12, passes through the electrode unit M10, and passes through the electrode unit M10. Element M12, then upward along the connecting portion 112 between the electrode unit M10 and the electrode unit M12, passes through the electrode units M9 and M6 in sequence, and is connected to the grounding pad 1161 corresponding to the electrode unit M3, and then continues to extend upward through the connecting portion 112 between the electrode unit M3 and the electrode unit M1, and is connected to the grounding pad 1161 corresponding to the electrode unit M1, and finally extends to the left through the connecting portion 112 between the electrode unit M1 and the electrode unit M2, and is connected to the grounding pad 1161 corresponding to the electrode unit M2.

[0038] The third ground trace L23 short-circuits all the ground pads 1161 corresponding to the temperature sensors 14 of the electrode units M4, M5, and M8 to ground the ground terminals 141 of the temperature sensors 14 of the electrode units M4, M5, and M8. The specific routing of the third ground trace L23 is as follows: it is led out from the corresponding gold finger 1131 on the front of the wiring portion 113, passes through the back thereof, and extends upward to the electrode unit M10, then extends downward to the left along the connection portion 112 between the electrode unit M10 and the electrode unit M13, passes through the electrode unit M13, and then extends along the connection portion 112 between the electrode unit M10 and the electrode unit M13. The connecting portion 112 between the electrode unit M13 and the electrode unit M11 extends upward and passes through the electrode unit M11, then extends along the connecting portion 112 between the electrode unit M11 and the electrode unit M8 and connects to the grounding pad 1161 corresponding to the electrode unit M8, then continues to extend upward along the connecting portion 112 between the electrode unit M8 and the electrode unit M5 and connects to the grounding pad 1161 corresponding to the electrode unit M5, and finally extends to the right along the connecting portion 112 between the electrode unit M5 and the electrode unit M4 and connects to the grounding pad 1161 of the electrode unit M4.

[0039] The fourth ground trace L24 short-circuits all the ground pads 1161 corresponding to the temperature sensors 14 of the electrode units M10, M11, and M13 to ground the ground ends 141 of the temperature sensors 14 of the electrode units M10, M11, and M13. The specific routing method of the fourth ground trace L24 is: it is led out from the corresponding gold finger 1131 on the front of the wiring part 113, passes through its back side, extends upward to the electrode unit M10, and is connected to the ground pad 1161 corresponding to the electrode unit M10, then extends leftward and downward along the connecting part 112 between the electrode unit M10 and the electrode unit M13 to the electrode unit 13 and then connects to the ground pad 1161 corresponding to the electrode unit M13, and finally extends upward and leftward along the connecting part 112 between the electrode unit M13 and the electrode unit M11 to connect to the ground pad 1161 of the electrode unit M11.

[0040] Combine Figure 7 As shown, the ends of the four ground traces L2 on the connection portion 113 are connected one-to-one with four corresponding gold fingers 3121 located on the front of the connection portion 113. A small jumper for the second ground trace L22 and a small jumper for the fourth ground trace L24 are also located on the front of the connection portion 113. The short circuit between each ground trace L2 and each ground pad 1161 is achieved through a diode 15, rather than a direct connection. That is, a diode 15 is connected in series between each ground trace L2 and the corresponding temperature sensor 14. Please note that each ground trace L2 must pass through the main body 111 from the back of the corresponding main body 111 through a corresponding via (unnumbered) to the front of the main body 111 to connect to the corresponding ground pad 1161.

[0041] Key References Figure 10 , and combined with Figure 11 As shown, the four signal traces L3 are respectively a first signal trace L31 , a second signal trace L32 , a third signal trace L33 and a fourth signal trace L34 . The specific routing of the four signal traces L3 will be described in detail below from the back side perspective of the flexible circuit board 11 .

[0042] The first signal trace L31 short-circuits all the signal pads 1162 corresponding to the temperature sensors 14 of the electrode units M1, M5, M6, and M13, so as to connect the signal ends 142 of the temperature sensors 14 of the electrode units M1, M5, M6, and M13 to the same detection channel (see below for details). The specific routing method of the first signal trace L31 is as follows: it is led out from the corresponding gold finger 1131 on the back of the wiring part 113 and is divided into two branches. One branch passes through the electrode units M12 and M9 to the right and is connected to the signal pad 1162 corresponding to the electrode unit M6, and then continues to extend upward through the electrode unit M3 and is connected to the signal pad 1162 corresponding to the electrode unit M1; the other branch first passes upward through the electrode unit M10 and then extends to the left and is connected to the signal pad 1162 corresponding to the electrode unit M13, and then passes through the electrode units M11 and M8 to the electrode unit M5 and is connected to the signal pad 1162 corresponding to the electrode unit M5.

[0043] The second signal trace L32 short-circuits all the signal pads 1162 corresponding to the temperature sensors 14 of the electrode units M2, M4, M7, and M11, so as to connect the signal terminals 142 of the temperature sensors 14 of the electrode units M2, M4, M7, and M11 to the same detection channel (see below for details). The specific routing of the second signal trace L32 is as follows: it is led out from the corresponding gold finger 1131 on the back of the wiring portion 113 and then divided into two branches, one of which extends to the right through the electrode units M12 and M9 to the electrode unit M6 and then divides into two branches at the electrode unit M6. One branch extends to the left to the electrode unit M7 and is connected to the signal pad 1162 corresponding to the electrode unit M7, and the other branch continues upward through the electrode units M3 and M1 to the electrode unit M2 and is connected to the signal pad 1162 corresponding to the electrode unit M2; the other branch first passes upward through the electrode unit M10 and then passes left through the electrode unit M13 to the electrode unit M11 and is connected to the signal pad 1162 corresponding to the electrode unit M11, and then continues upward through the electrode units M8 and M5 to the electrode unit M4 and is short-circuited with the signal pad 1162 corresponding to the electrode unit M4.

[0044] The third signal trace L33 short-circuits all the signal pads 1162 corresponding to the temperature sensors 14 of the electrode units M3, M8, M9, and M10, so as to connect the signal ends 142 of the temperature sensors 14 of the electrode units M3, M8, M9, and M10 to the same detection channel (see below for details). The specific routing method of the third signal trace L33 is: it is led out from the corresponding gold finger 1131 on the back of the wiring part 113 and is divided into two branches, one of which passes through the electrode unit M12 to the electrode unit M9 to the right and is connected to the signal pad 1162 corresponding to the electrode unit M9, and then passes through the electrode unit M6 to the electrode unit M3 upward and is connected to the signal pad 1162 corresponding to the electrode unit M3; the other branch first connects upward to the signal pad 1162 corresponding to the electrode unit M10, and then passes through the electrode units M13 and M11 to the electrode unit M8 and is short-circuited with the signal pad 1162 corresponding to the electrode unit M8.

[0045] The fourth signal trace L34 is only connected to the signal pad 1162 of the electrode unit M12 to connect the signal end 142 of the temperature sensor 14 of the electrode unit M12 to a detection channel (see below for details). The specific routing method of the fourth signal trace L33 is: it is led out from a corresponding gold finger 1131 on the back of the wiring part 113 and extends to the right to the electrode unit M12 and is connected to the signal pad 1162 corresponding to the electrode unit M12.

[0046] Please note that each signal trace L3 needs to pass through the corresponding via hole (not numbered) from the back side of the corresponding main body portion 111 to the front side thereof and connect to the corresponding signal pad 1162 .

[0047] The following key references Figure 11 The control method of temperature detection of the electrode patch 100 of the present application is described in detail. The wire 5 of the electrode patch 100 is plugged into the connector (unnumbered) of the adapter 200 to realize the circuit connection between the electrode patch 100 and the adapter 200.

[0048] The thirteen electrode units 10 on the electrode patch 100 are arranged in a two-dimensional array in a circuit arrangement, and are arranged in four rows and four columns. Specifically, from the row upward, the first row includes four electrode units 10, which are electrode units M6, M7, M9, and M12, and the ground terminals 1161 of the temperature sensors 14 of these electrode units 10 are connected in parallel to the first ground trace L21; the second row includes three electrode units 10, which are electrode units M1, M2, and M3, and the temperature sensors 14 of these electrode units 10 are connected in parallel to the first ground trace L21. The ground terminals 1161 of the sensors 14 are all connected in parallel to the second ground trace L22; the third row includes three electrode units 10, namely electrode units M5, M4, and M8, and the ground terminals 1161 of the temperature sensors 14 of these electrode units 10 are all connected in parallel to the third ground trace L23; the fourth row includes three electrode units 10, namely electrode units M13, M11, and M10, and the ground terminals 1161 of the temperature sensors 14 of these electrode units 10 are all connected in parallel to the fourth ground trace L24. Looking upward from the columns, the first column includes four electrode units 10, namely electrode units M6, M1, M5, and M13, and the signal ends 1162 of the temperature sensors 14 of these electrode units 10 are all connected in parallel to the first signal trace L31; the second column includes four electrode units 10, namely electrode units M7, M2, M4, and M11, and the signal ends 1162 of the temperature sensors 14 of these electrode units 10 are all connected in parallel to the second signal trace L32; the third column includes four electrode units 10, namely electrode units M9, M3, M8, and M10, and the signal ends 1162 of the temperature sensors 14 of these electrode units 10 are all connected in parallel to the third signal trace L33; the fourth column has only one electrode unit M12, and its signal end 1162 is connected to the fourth signal trace L34.

[0049] The adapter 200 includes a controller 201, an analog-to-digital conversion module 202 connected to the controller 201, a communication unit 203, and a power module 204 connected to the controller 201, the analog-to-digital conversion module 202 and the communication unit 203. The power module 204 provides a DC power supply VCC for each electronic component of the adapter 200. Figure 11 The electrical connection between one electrode patch 100 and the adapter 200 is only taken as an example for detailed description. Corresponding to each electrode patch 100 , the adapter 200 is further provided with a set of grounding switches 205 and a set of voltage divider resistors 206 .

[0050] The adapter 200 is provided with an AC line (unnumbered) electrically connected to the AC trace L1 to transmit an alternating current signal to the electrode patch 100; multiple ground lines (unnumbered) electrically connected one-to-one with the multiple ground traces L2 and connected to ground via a corresponding grounding switch 205 to ground each temperature sensor 14; and multiple signal lines (unnumbered) electrically connected one-to-one with the multiple signal traces L3 and connected to the power module 204 via a corresponding voltage divider resistor 206 to provide a DC power supply to each temperature sensor 14. The grounding switch 205 can control the opening or closing of the corresponding ground trace L2.

[0051] The controller 201 is communicatively connected to each set of grounding switches 205 to control the on / off status of each grounding switch 205, thereby controlling the conduction and disconnection of each grounding trace L2. The analog-to-digital conversion module 202 includes four detection channels A, B, C, and D. The first through fourth signal traces L31 are connected to detection channels A, B, C, and D via corresponding circuit lines (unnumbered). Each detection channel A, B, C, and D receives a temperature detection signal from the temperature sensor 14 connected to the corresponding signal trace L3. The analog-to-digital conversion module 202 converts the temperature detection signal from an analog signal to a digital signal. The communication unit 203 receives the digital signal output by the analog-to-digital conversion module 202 and transmits the digital signal to an electric field generator (not shown). The electric field generator (not shown) is further configured to control and adjust the voltage, current, or power of the AC signal provided to the multiple electrode units 10 of the electrode patch 100 based on the received digital signal. For example, when any of the multiple received digital signals exceeds a preset safety threshold temperature (e.g., 41°C, 42°C, etc.) stored in controller 201, the voltage, current, or power of the AC signal output by the electric field generator (not shown) can be appropriately reduced to prevent low-temperature burns on the patient's skin. The above-mentioned preset threshold temperature and preset threshold can be determined based on human safety thresholds. Communication unit 203 is controlled by controller 201 and serially transmits the digital signals converted by multiple analog-to-digital conversion modules 202.

[0052] The transmission of AC signals to the electrode units 10 and the transmission of DC signals to the electrode units 10 for temperature detection signal collection are staggered. When an AC signal is required to be applied to each electrode unit 10 of the electrode patch 100, all four grounding switches 205 are disconnected, and the electric field generator (not shown) outputs the AC signal to the AC line in the adapter 200. The AC signal is then applied to the dielectric element 13 of each electrode unit 10 via the AC trace L1 connected to the AC line. When the temperature detection signal of each temperature sensor 14 in the electrode patch 100 is required to be collected, the electrical connection between the AC trace L1 of the electrode patch 100 and the AC line of the adapter 200 is disconnected.

[0053] When collecting temperature detection signals from each temperature sensor 14 in the electrode patch 100, the four signal traces L3 remain connected. Then, the ground switches 205 are turned on in turn, thereby turning on the temperature sensors 14 in each row of electrode units 10 in turn, thereby acquiring temperature detection signals from each row of temperature sensors 14 in batches. The specific process is as follows: The four ground switches 205 connected to the first ground trace L21 to the fourth ground trace L24 are defined as the first ground switch 2051 to the fourth ground switch 2054, respectively. First, close the first grounding switch 2051 and open the other grounding switches 2052, 2053, and 2054. The four detection channels A, B, C, and D of the analog-to-digital conversion module 202 can simultaneously obtain temperature detection signals from the four electrode units M6, M7, M9, and M12 in the first row. Then, close the second grounding switch 2052 and open the other grounding switches 2051, 2053, and 2054. The four detection channels A, B, C, and D of the analog-to-digital conversion module 202 can simultaneously obtain temperature detection signals from the three electrode units M1, M2, and M3 in the second row. Then, by closing the third grounding switch 2053 and opening the other grounding switches 2051, 2052, and 2054, the four detection channels A, B, C, and D of the analog-to-digital conversion module 202 can simultaneously obtain the temperature detection signals of the three electrode units M5, M4, and M8 in the third row. Finally, by closing the fourth grounding switch 2054 and opening the other grounding switches 2051, 2052, and 2053, the four detection channels A, B, C, and D of the analog-to-digital conversion module 202 can simultaneously obtain the temperature detection signals of the three electrode units M13, M11, and M10 in the fourth row. In this way, the temperature detection signals of all temperature sensors 14 can be collected.

[0054] The thirteen electrode units 10 of the electrode patch 100 of the present invention are equipped with a total of thirteen temperature sensors 14. The use of shared ground traces L2 and signal traces L3 can reduce the total number of conductive traces required for the temperature sensors 14 and simplify the wiring scheme. At the same time, all ground traces L2 and signal traces L3 are arranged on the back side of the flexible circuit board 11 to prevent signal crosstalk and improve signal transmission quality. In addition, the front side of the flexible circuit board 11 basically only has AC traces L1, which provides more sufficient wiring space for AC traces L1.

[0055] The above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. An electrode patch for electric field therapy of tumors, comprising an electrode array and a conductor, wherein the electrode array comprises a flexible circuit board and a plurality of electrode units, each of which is provided with a dielectric element and a temperature sensor, and wherein: The electrode units are arranged in four rows and four columns in the circuit layout. The flexible circuit board is provided with one AC trace, four ground traces and four signal traces. The AC trace is arranged on the front side of the flexible circuit board and is electrically connected to each of the dielectric elements. The four ground traces are arranged on the back side of the flexible circuit board and are respectively electrically connected to the ground ends of each of the temperature sensors corresponding to a row of the electrode units. The four signal traces are also arranged on the back side of the flexible circuit board and are respectively electrically connected to the signal ends of each of the temperature sensors corresponding to a column of the electrode units. During temperature detection, the four signal traces remain conductive, and the four ground traces are turned on in turn to obtain the temperature detection signals of each of the temperature sensors row by row.

2. The electrode patch according to claim 1, characterized in that The flexible printed circuit board is provided with a plurality of main body parts arranged at intervals, a plurality of connection parts connecting two adjacent main body parts, and a wiring part connected to the wire. A conductive plate is provided on the front side of the main body part, and the dielectric element is provided on the front side of the main body part and electrically connected to the conductive plate. The temperature sensor is provided on the front side of the main body part, and a ground pad electrically connected to the ground end and a signal pad electrically connected to the signal end are provided on the front side of the main body part.

3. The electrode patch according to claim 2, characterized in that: The electrode unit is provided with a diode, and the front of the main body is provided with an anode pad and a cathode pad electrically connected to the diode, the anode pad is electrically connected to the ground pad through a pad trace, the cathode pad is electrically connected to the ground trace, and the diode is connected in series between the ground trace and the temperature sensor.

4. The electrode patch according to claim 3, characterized in that: The connection part is provided with five gold fingers on the front and back sides thereof. The AC trace extends from one of the gold fingers on the front side of the connection part and extends on the front side of the flexible circuit board; the four ground traces extend from the other four gold fingers on the front side of the connection part and pass through the connection part to the back side of the flexible circuit board and extend on the back side of the flexible circuit board.

5. The electrode patch according to claim 4, characterized in that: The four signal traces are respectively led out from the four gold fingers on the back of the wiring part and extend on the back of the flexible circuit board, and the remaining gold finger on the back of the wiring part is connected to the shielding layer of the wire.

6. The electrode patch according to claim 3, characterized in that: The electrode array includes thirteen electrode units arranged in five rows and five columns in a spatial structure, wherein the first row and the last row are each provided with two electrode units and are located on the second column and the fourth column respectively, the middle three rows are each provided with three electrode units and are located on the first column, the third column and the fifth column respectively, and these thirteen electrode units are numbered M1 to M13 from top to bottom and from left to right; in terms of circuit arrangement, the first row is electrode units M6, M7, M9, M12, the second row is electrode units M1, M2, M3, the third row is electrode units M5, M4, M8, and the fourth row is electrode units M13, M11, M10.

7. The electrode patch according to claim 6, characterized in that: In the circuit arrangement, the first column is electrode units M6, M1, M5, and M13 in sequence; the second column is electrode units M7, M2, M4, and M11 in sequence; the third column is electrode units M9, M3, M8, and M10 in sequence; and the fourth column has only one electrode unit M12.

8. The electrode patch according to claim 7, characterized in that: It also includes a backing, a plurality of supporting members and a plurality of adhesive members. The electrode array is adhered to the backing. The supporting members are adhered to the backing and arranged around each of the electrode units. The adhesive members cover each of the supporting members and each of the electrode units.

9. The electrode patch according to claim 8, characterized in that: The electrode array is further provided with a plurality of insulating plates fixed on the back side of each of the main body parts.

10. A tumor electric field treatment device, characterized in that: The invention comprises an electric field generator and an electrode patch according to any one of claims 1 to 9 electrically connected to the electric field generator.

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