Tumor electric field treatment device and electrode patch

Abstract

The application provides a tumor electric field treatment device and an electrode patch. The electrode patch comprises an electrode array, which is provided with a connecting portion, a plurality of electrode units respectively extending outward from the connecting portion in a radiating manner, and a wiring portion. The electrode array comprises a substrate, a plurality of conductive traces, a conductive sheet arranged on the front surface of the substrate, an insulating layer arranged on the front surface of the substrate, a dielectric element arranged on the corresponding part of the conductive sheet, and a plurality of temperature sensors arranged on the back surface of the substrate. The plurality of conductive traces comprise an AC conductive trace arranged on the front surface of the substrate and electrically connected with each conductive sheet, a grounding trace arranged on the back surface of the substrate and electrically connected with the grounding end and the signal end of each temperature sensor, and a plurality of signal traces. The electrode patch of the tumor electric field treatment device of the application arranges the temperature sensors on the back surface of the substrate of the electrode array, and the conductive sheet arranged on the front surface of the substrate does not need to avoid the temperature sensors, so that the manufacturing process difficulty of the conductive sheet can be reduced, and the production cost of the electrode array is reduced.

Description

Technical Field

[0001] This application relates to tumor treating fields (TTF) technology, and more particularly to a tumor treating fields device and electrode patch. Background Technology

[0002] Tumor electric field therapy is a treatment method that uses low-intensity, medium-to-high-frequency alternating electric fields to prevent the formation of spindle microtubules during mitosis in certain tumor cells, thereby inhibiting the separation of intracellular organelles during cell division and inducing apoptosis during mitosis, thus achieving the goal of treating tumors.

[0003] Electric field therapy systems used for tumor treatment typically include an electric field generator, an adapter, and multiple pairs of electrode patches. The electric field generator generates an alternating electrical signal for tumor treatment and transmits the alternating electrical signal to the electrode patches via the adapter. The electrode patches are applied in pairs to the surfaces of opposite sides of the patient's skin, and after the application of the alternating electrical signal, an electric field is formed on each pair of electrode patches to non-invasively apply tumor treatment to the target area.

[0004] The electrode patch features an electrode array comprising multiple electrode units, multiple connecting parts, and wiring parts. Each electrode unit is typically circular and includes a substrate, a conductive sheet on the substrate, a dielectric element on the conductive sheet, and a temperature sensor. Multiple electrode units are arranged in a matrix and connected to each other via the connecting parts. The wiring parts are connected to an electric field generator via wires to receive AC signals. The AC signals are transmitted to each electrode unit through the wiring parts, corresponding connecting parts, and / or conductive traces on the corresponding electrode units. This closed-loop connection method introduces more unnecessary connections between electrode units, increasing the complexity of the electrode array structure, reducing open space, and making the electrode array less adaptable to torso deformation. In particular, electrode units located at the corners of the matrix can generate significant heat due to edge effects, potentially leading to low-temperature burns and affecting treatment outcomes. Furthermore, the conductive sheet, dielectric element, and temperature sensor are all located on the front side of the electrode unit. The temperature sensor needs to be soldered to pads on the substrate; therefore, the conductive sheet must avoid the temperature sensor, and the dielectric element needs to have clearance holes to accommodate the temperature sensor, increasing the manufacturing difficulty of the electrode array.

[0005] Therefore, there is a need to provide an improved electrode patch. Utility Model Content

[0006] The purpose of this application is to provide a tumor electric field therapy device and electrode patch, which can reduce manufacturing steps and reduce manufacturing costs.

[0007] To achieve the above objectives, this application provides the following technical solution: an electrode patch for a tumor electric field therapy device, comprising an electrode array, wherein the electrode array has a connecting portion, a plurality of electrode units and a wiring portion, and the plurality of electrode units extend outwardly from the connecting portion in a radiating manner; the electrode array includes a substrate, a plurality of conductive traces disposed on the substrate, a conductive sheet disposed on the front side of the substrate, an insulating layer covering the front side of the substrate and exposing part of the conductive sheet, and a dielectric element covering the conductive sheet exposed by the insulating layer; the plurality of conductive traces include an A disposed on the front side of the substrate and electrically connected to each of the conductive sheets. C. Conductive traces; The back side of the substrate of the electrode array is provided with a plurality of temperature sensors corresponding to each of the electrode units. Each temperature sensor is provided with a corresponding ground terminal and a corresponding signal terminal. Each electrode unit has a ground pad provided on the back side of the substrate and soldered to the ground terminal of the corresponding temperature sensor, and a signal pad soldered to the signal terminal of the corresponding temperature sensor. The plurality of conductive traces also include a ground trace and a plurality of signal traces provided on the back side of the substrate. The ground trace is electrically connected to the ground pad of each of the electrode units, and the plurality of signal traces are electrically connected to the signal pads of each of the electrode units one by one.

[0008] Furthermore, the connecting portion includes two arc-shaped connecting strips located on the same circle and arranged symmetrically from left to right; each electrode unit extends radially outward from the corresponding connecting strip.

[0009] Furthermore, the plurality of temperature sensors include a plurality of first temperature sensors, each of the first temperature sensors being disposed at the geometric center of the corresponding electrode unit in a one-to-one correspondence.

[0010] Furthermore, the plurality of temperature sensors include two second temperature sensors, which are respectively disposed on the two electrode units in a centrally symmetrical manner about the center of the connection portion, and each second temperature sensor is closer to the outer edge of the corresponding electrode unit than the first temperature sensor located on the same electrode unit.

[0011] Furthermore, the front and back of the wiring portion are provided with a plurality of gold fingers. One of the gold fingers on the front of the wiring portion is electrically connected to the AC conductive trace, another gold finger on the front of the wiring portion is electrically connected to the ground trace that extends to the front of the substrate, and the other gold fingers are electrically connected to the signal traces one by one.

[0012] Furthermore, the electrode array is provided with six electrode units, and the wiring portion is mounted between two adjacent electrode units. Specifically, the six electrode units are arranged in a clockwise direction from the electrode unit C1 to the electrode unit C6 when viewed from the front of the electrode array. Each of the six electrode units is provided with a first temperature sensor, wherein the electrode unit C3 and the electrode unit C6 are also provided with a second temperature sensor.

[0013] Furthermore, the AC conductive trace extends from the wiring portion to the connection portion, then branches off at the connection point between the connection portion and each of the electrode units and extends to the conductive sheet of each corresponding electrode unit in a one-to-one correspondence.

[0014] Furthermore, there are a total of eight signal traces. Three of the signal traces are guided out by three gold fingers located on the front of the connector, pass through the substrate, extend to the corresponding electrode unit, and are electrically connected to the corresponding signal pads one by one. The remaining five signal traces are guided out by five gold fingers located on the back of the connector, extend to the corresponding electrode unit, and are electrically connected to the corresponding signal pads one by one.

[0015] Furthermore, the grounding trace extends to the left and right from the back of the connection part in two branches. One branch electrically connects all four grounding pads corresponding to the three first temperature sensors and one second temperature sensor disposed in electrode units C1 to C3; the other branch electrically connects all four grounding pads corresponding to the three first temperature sensors and one second temperature sensor disposed in electrode units C4 to C6.

[0016] This application also provides the following technical solution: a tumor electric field therapy device, including an electric field generator, an adapter and the aforementioned electrode patch, wherein the adapter is electrically connected to the electric field generator and the electrode patch.

[0017] The tumor electric field therapy device and electrode patch of this application place the temperature sensor on the back of the electrode array substrate, and the conductive sheet located on the front of the substrate does not need to avoid the temperature sensor, which can reduce the manufacturing process difficulty of the conductive sheet and thus reduce the production cost of the electrode array.

[0018] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the framework of a tumor electric field therapy device according to an embodiment of this application;

[0020] Figure 2This is a perspective view of the electrode patch of the tumor electric field therapy device according to one embodiment of this application;

[0021] Figure 3 for Figure 2 3D exploded view of the electrode patch;

[0022] Figure 4 for Figure 2 A plan view of the electrode patch after the adhesive has been removed;

[0023] Figure 5 for Figure 4 A plan view of the electrode array of the electrode patch, showing the front of the electrode array;

[0024] Figure 6 for Figure 4 Another plan view of the electrode array, showing the back of the electrode array;

[0025] Figure 7 for Figure 5 Front wiring diagram of the electrode array in the image;

[0026] Figure 8 for Figure 6 Backside wiring diagram of the electrode array in the image;

[0027] Figure 9 for Figure 7 A magnified view of a section at point A in the middle;

[0028] Figure 10 for Figure 7 The cross-sectional view obtained by viewing the electrode array along the BB direction;

[0029] Figure 11 for Figure 2 A schematic diagram of the circuit connection between the electrode patch and the adapter of the tumor electric field therapy device;

[0030] Figure 12 for Figure 3 Another simple variation of the electrode array of the electrode patch in the embodiment;

[0031] Figure 13 for Figure 3 Another simple variation of the backing of the electrode patch in the embodiment.

[0032] Explanation of reference numerals in the attached figures:

[0033] Electrode patch 100, backing 10, slot 11, partition 12, through hole 13, wiring groove 14, electrode array 20, connecting part 21, connecting strip 211, hollow area 212, notch 213, electrode unit 22, outer edge 221, wiring part 23, via 231, temperature sensor 24, first temperature sensor 241, second temperature sensor 242, ground terminal 24A, signal terminal 24B, substrate 201, dielectric element 202, conductive sheet 203, conductive trace 204. AC conductive trace 204A, ground trace 204B, signal trace 204C, gold finger 205, pad 206, ground pad 206A, signal pad 206B, insulating layer 207, insulating film 208, adhesive part 30, center O, spacing D, electric field generator 200, adapter 300, controller 310, connector 320, analog-to-digital converter 330, voltage divider resistor 340, communication unit 350, AC line 360, GND line 370, power module 380. Detailed Implementation

[0034] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this application. Rather, they are merely examples of apparatuses, systems, devices, and methods consistent with some aspects of this application.

[0035] refer to Figure 1 As shown, the tumor electric field therapy device includes several pairs of electrode patches 100, an electric field generator 200, and an adapter 300. The electric field generator 200 generates an alternating current signal required for treatment. The adapter 300 electrically connects each electrode patch 100 to the electric field generator 200 to transmit the alternating current signal output by the electric field generator 200 to each electrode patch 100. The pairs of electrode patches 100 are attached to the surface of the patient's body corresponding to the tumor area, and the alternating current signal is applied to the patient's tumor area to perform tumor electric field therapy.

[0036] refer to Figure 2 and Figure 3 As shown, the electrode patch 100 includes a backing 10, an electrode array 20, and several adhesive components 30. Figure 2 and Figure 3The upper surface of the electrode patch 100 is the application surface to the patient's body surface. The upper surfaces of the electrode patch 100, backing 10, electrode array 20, and several adhesive pieces 30 are defined as the front surface. The front surface of the backing 10 is coated with a biocompatible adhesive, and the electrode array 20 is centrally attached to the front surface of the backing 10 using this biocompatible adhesive. The adhesive pieces 30 are conductive gels with double-sided adhesiveness. One side covers the front surface of the electrode array 20, and the other side is directly applied to the patient's body surface to fix the electrode patch 100 to the patient's body surface. The adhesive pieces 30 also absorb sweat from the patient's body surface, preventing redness, swelling, allergies, and other skin problems. The electrode array 20 is electrically connected to the adapter 300 of the tumor electric field therapy device via wires (not shown) to receive alternating current signals.

[0037] refer to Figure 4 and Figure 5 As shown, the electrode array 20 is generally arranged in a daisy shape, including a connecting portion 21, multiple electrode units 22, and a wiring portion 23. The electrode array 20 also has a center O, and the connecting portion 21 is located near the center O. In this embodiment, the connecting portion 21 includes two arc-shaped connecting strips 211 located on the same circle and symmetrically arranged on both sides. The center of the circle containing the arc-shaped connecting strips 211 coincides with the aforementioned center O. The center of the connecting portion 21 has a hollow area 212, which allows the corresponding skin to come into contact with the outside air and exchange heat to improve the heat dissipation of the electrode array 20. Multiple electrode units 22 extend outward from corresponding parts of the connecting portion 21 in a radial pattern and are centrally symmetrically distributed about the center O, resembling flower petals. Adjacent electrode units 22 are spaced apart. This design increases the freedom of movement of each electrode unit 22, allowing for greater adjustment when applied to the patient's skin. Furthermore, when the electrode patch 100 needs replacement after prolonged use, the newly applied electrode patch 100 can rotate around the center O to expose the previously applied skin, allowing the skin at the previous application location to rest and maintaining optimal application position. Each electrode unit 22 is approximately fan-shaped, with its central axis passing through the center O. The outer edges 221 of each electrode unit 22 lie on the same circle centered at the center O, and the two corners at both ends of the outer edge 221 of each electrode unit 22 are rounded. In this embodiment, the electrode array 20 has six electrode units 22 evenly spaced, with the included angle between the central axes of two adjacent electrode units 22 being 60° and the central angle corresponding to the outer edge 221 of each electrode unit 22 being 30°. The wiring portion 23 is approximately "T" shaped, positioned between two adjacent electrode units 22 and extending radially outward away from the center O, for connection to a wire (not shown).

[0038] The electrode array 20 is arranged symmetrically from left to right, comprising two parts, left and right. Each part has three electrode units 22, and the wiring portion 23 is located on the central axis of the electrode array 20. Two spaced-apart connecting strips 211 create a gap 213 between the left and right parts of the electrode array 20. This gap 213 allows each part of the electrode array 20 a certain degree of freedom, enabling the operator to more flexibly adjust the position of each electrode unit 22. The wiring portion 23 is positioned opposite the gap 213. Figure 12 As shown, in another simple variation of electrode array 20', the connecting portion 21' can also be a near-circular arc shape, connecting the left and right parts of electrode array 20 together. Electrode array 20' no longer has a notch 213 similar to that in electrode array 20, resulting in better overall integrity and easier attachment to the backing 10. In other alternative embodiments, the connecting portion 21 can also be a complete closed loop shape (not shown).

[0039] Combination Figure 3 As shown, the shape of the adhesive 30 is basically the same as that of the electrode unit 22. Several adhesives 30 are respectively attached to the corresponding electrode unit 22 in a one-to-one correspondence manner. The size of the adhesive 30 is slightly larger than the size of the electrode unit 22 to ensure that each electrode unit 22 can be completely covered.

[0040] Continue to refer to Figure 3 and Figure 4 As shown, in this embodiment, the backing 10 is arranged in a flower shape corresponding to the electrode array 20. Six slots 11 are evenly spaced radially to divide the backing 10 into six sections 12. Each electrode unit 22 is attached to its corresponding section 12. The slots 11 allow slight overlap between adjacent sections 12 when the backing 10 is applied to the patient's skin, preventing wrinkles and facilitating application. A wiring groove 14, communicating with and perpendicular to one of the slots 11 near its center O, is also provided on the backing 10, allowing the wiring part 23 to pass through and connect to an external wire (not shown) during application. The backing 10 also has a through hole 13 at its center, the center of which coincides with the center of the hollowed-out area 212 of the electrode array 20. Figure 13 As shown, in another simple variation of the backing 10, the backing 10' can be a sheet-like integral structure without the slots 11 found in the backing 10. In other alternative embodiments, the backing 10 can also be other shapes, such as circular, as long as it can completely cover the electrode array 20.

[0041] refer to Figure 5 and Figure 6As shown, the electrode array 20 is made of a flexible circuit board. From a hierarchical structure perspective, the electrode array 20 includes a substrate 201, a conductive layer disposed on corresponding portions of the front side of the substrate 201, an insulating layer 207 disposed on the substrate 201 and corresponding portions of the conductive layer, and dielectric elements 202 mainly disposed on corresponding portions of the conductive layer. The substrate 201 serves as a supporting base plate and is integrally disposed in each electrode unit 22, each connection portion 21, and each wiring portion 23. The conductive layer includes conductive sheets 203 disposed on corresponding portions of the substrate 201 of each electrode unit 22, and a plurality of conductive traces 204 disposed on corresponding portions of the substrate 201 of the corresponding connection portions 21 and wiring portions 23 (see reference). Figure 7 and Figure 8 And a plurality of gold fingers 205 provided on the corresponding part of the substrate 201 of the corresponding wiring part 23.

[0042] The shape of the conductive sheet 203 is basically the same as that of the electrode unit 22, but its size is slightly smaller than that of the electrode unit 22. Specifically, each conductive sheet 203 is centrally located on the front side of the substrate 201 of the corresponding electrode unit 22, and its edge (unlabeled) has a distance D of about 1mm-3mm between it and the edge (unlabeled) of the substrate 201 of the corresponding electrode unit 22.

[0043] refer to Figure 7 As shown in the figure, only one AC conductive trace 204A, located on the front side of the electrode array 20, is illustrated among the several conductive traces 204 of the electrode array 20. The AC conductive trace 204A originates from a corresponding gold finger 205 located on the front side of the connector 23, extends to each connecting strip 211 of the connector 21, and branches off at corresponding locations on the connecting strip 211, extending to each conductive sheet 203 and electrically connecting to each conductive sheet 203, so that each conductive sheet 203 can receive the AC signal transmitted by the AC conductive trace 204A. Combined with... Figure 9 As shown, the wiring section 23 is also provided with several through holes 231 (only shown in Figure 7 , Figure 8 and Figure 9 In this embodiment, each gold finger 205 has two through holes 231 at its opposite ends to enhance its stability and prevent it from cracking due to external pulling after soldering the corresponding wire core. In this embodiment, the wiring portion 23 has five gold fingers 205 arranged in an equally spaced row on both its front and back sides.

[0044] Combination Figure 10As shown, the insulating layer 207 is applied to the front side of the substrate 201 using a thermosetting bonding process or a COB (Chip On Board) process, with a thickness of 10μm to 50μm. The portion of the insulating layer 207 corresponding to each electrode unit 22 has the same shape as the electrode unit 22 and is arranged in a hollow pull ring shape. The substrate 201 covering the corresponding electrode unit 22 is exposed on the annular exposed area of ​​the conductive sheet 203. The inner edge of the portion of the insulating layer 207 corresponding to each electrode unit 22 is slightly smaller than the outer edge of the corresponding conductive sheet 203, so as to expose the corresponding conductive sheet 203 and further press the outer edge of the conductive sheet 203 onto the corresponding substrate 201 to prevent lifting. The insulating layer 207 also completely covers the AC conductive trace 204A to prevent the AC conductive trace 204A from being exposed. The insulating layer 207 has a window (not labeled) on the part of the gold finger 205 that is electrically connected to the AC conductive trace 204A on the front side of the substrate 201, so that the gold finger 205 can be soldered to the corresponding wire core in the wire (not shown).

[0045] The dielectric element 202 is a polymer dielectric layer with high dielectric constant and low dielectric loss, made of a thin film material with non-fixed crystal orientation, high flexibility, and high toughness. The dielectric element 202 can be formed on the conductive sheet 203 and completely cover the conductive sheet 203 by vapor deposition, sputtering, or ion plating. The insulating layer 207 is formed between the conductive sheet 203 and the dielectric element 202 as a heat-insulating solder resist layer, and the adhesive 30 is directly covered on the dielectric element 202.

[0046] refer to Figure 6 As shown, the electrode array 20 also includes several temperature sensors 24, all of which are disposed on the back side of the substrate 201. These temperature sensors 24 do not interfere with the conductive sheets 203 located on the front side of the substrate 201, therefore the conductive sheets 203 do not need to avoid the temperature sensors 24. Each electrode unit 22 has at least one first temperature sensor 241, and each first temperature sensor 241 is located at the geometric center point of its corresponding electrode unit 22. This geometric center point is also the location of each conductive sheet 203 (in...). Figure 6The geometric center point is shown as a dashed line. Two electrode units 22 also have a second temperature sensor 242. That is, in this embodiment, the electrode array has six first temperature sensors 241 and two second temperature sensors 242. The two electrode units 22 with the second temperature sensors 242 are centrally symmetrical about the center O, and the two second temperature sensors 242 are also centrally symmetrical about the center O. On the corresponding electrode unit 22 with both first and second temperature sensors 241 and 242, both the first and second temperature sensors 241 are located on the central axis of the electrode unit 22, and the second temperature sensor 242 is closer to the outer edge 221 of the electrode unit 22. Specifically, the ratio of the distance from the second temperature sensor 242 along the central axis of its corresponding electrode unit 22 to the outer edge 221 of the electrode unit 22 is less than 1 / 3, preferably between 1 / 5 and 1 / 3. The first temperature sensors 241 and 242 have identical structures, differing only in their placement. The second temperature sensor 242 can detect the temperature at the edge of the corresponding electrode unit 22, which facilitates the correction of temperature errors and the statistical analysis of differences in edge heat transfer. At the same time, in conjunction with the first temperature sensor 241 corresponding to multiple electrode units 22, the temperature of the electrode array 20 can be detected more comprehensively.

[0047] refer to Figure 8 As shown, the back of the substrate 201 has several pads 206 for soldering various temperature sensors 24. The temperature sensors 24 are mounted on the corresponding pads 206 using SMT soldering or COB packaging. Since the temperature sensors 24 need to be encapsulated in subsequent processing, the shape and size of each pad 206 can be designed to be the same, which facilitates uniform control of the amount of glue dispensing during machine dispensing. All the pads 206 are arranged in a centrally symmetrical manner about the center O of the electrode array 20, which ensures that the substrate 201 is heated evenly during reflow soldering in SMT soldering, so that the finally soldered temperature sensors 24 are stable and not easily tilted.

[0048] Combination Figure 10 As shown, each pair of pads 206 includes a ground pad 206A and a signal pad 206B. The temperature sensor 24 has a ground terminal 24A soldered to the ground pad 206A and a signal terminal 24B soldered to the signal pad 206B. As mentioned above, the electrode array 20 has eight temperature sensors. Correspondingly, the back side of the substrate 201 has eight pairs of pads 206. A plurality of conductive traces 204 include a ground trace 204B connecting all the ground pads 206A and eight signal traces 204C electrically connected to each signal pad 206B respectively. The ground trace 204B and the signal traces 204C are both located on the back side of the substrate 201. The ground trace 204B is located on the back side of the substrate 201. Figure 8The signal trace 204C is shown in blue in the middle. Figure 8 It is highlighted in black to distinguish it from the ground trace 204B.

[0049] Continue to refer to Figure 8 and Figure 9 As shown, the grounding trace 204B is led out from a gold finger 205 located on the far right of the front side of the wiring section 23, passes through two corresponding vias 231, passes through the substrate 201 of the wiring section 23 to its back side, and splits into two branches. For ease of description, ... Figure 8 The back side of the electrode array 20 shown is the observation surface. Figure 8 The six electrode units 22 are numbered C1 to C6 in a counterclockwise direction starting from the terminal 23. At the same time, the eight temperature sensors 24 are numbered R1 to R8 in a similar manner. Temperature sensor R1 is located on the back side of the substrate 201 corresponding to electrode unit C1, temperature sensor R2 is located on the back side of the substrate 201 corresponding to electrode unit C2, temperature sensors R3 and R4 are both located on the back side of the substrate 201 corresponding to electrode unit C3, temperature sensor R5 is located on the back side of the substrate 201 corresponding to electrode unit C4, temperature sensor R6 is located on the back side of the substrate 201 corresponding to electrode unit C5, and temperature sensors R7 and R8 are both located on the back side of the substrate 201 corresponding to electrode unit C6.

[0050] Key reference Figure 8 As shown, the ground trace 204B branches out from the two corresponding vias 231 on the back of the wiring part 23 corresponding to the two front of the wiring part 23, and extends along the two connecting strips 211 of the electrode array 20 respectively. Specifically, the ground trace 204B located on the right side of the back of the electrode array 20 branches at the connection between the connecting strip 211 and the electrode unit C1. One branch extends to the ground pad 206A on the electrode unit C1, and the other branch continues to extend along the connecting strip 211 to the ground pad 206A on the electrode unit C2, then returns to the connecting strip 211 along the electrode unit C2 and continues to extend to the two ground pads 206A on the electrode unit C3. The ground trace 204B located on the left side of the back of the electrode array 20 branches off at the connection point between the connecting strip 211 and the electrode unit C6. One branch extends to the two ground pads 206A on the electrode unit C6, while the other branch continues along the connecting strip 211 to the ground pad 206A on the electrode unit C5, then returns along the electrode unit C5 to the connecting strip 211 and continues to the ground pad 206A on the electrode unit C4. The ground trace 204B solders to the corresponding ground pad 206A as it extends to it. With this design, the branches of the ground trace 204B on both sides of the back of the electrode array 20 can connect to all the ground pads 206A located on the left and right sides of the back of the electrode array 20.

[0051] Continue to refer to Figure 8 and combined Figure 11As shown, eight signal traces 204C are respectively led out from three gold fingers 205 located in the middle of the front side of the connector 23 and five gold fingers 205 on the back side of the connector 23, and extend to the back side of the substrate 201. The signal traces 204C led out from the gold fingers 205 on the front side pass through the vias 231 corresponding to the three gold fingers 205 in the middle of the front side of the connector 23, and pass through the substrate 201 to the back side of the substrate 201. The eight signal traces 204C correspond to the signal pads 206B of the eight temperature sensors R1 to R8, which are respectively signal traces 204C-1 to 204C-8. Among them, the three signal traces 204C-1, 204C-7, and 204C-8, which are electrically connected to the three signal pads 206B corresponding to the temperature sensors R1, R7, and R8 near the two electrode units C1 and C6 of the connector 23, extend directly from the connector 23 to the corresponding signal pads 206B. Specifically, signal trace 204C-1 is led out from the rightmost gold finger 205 on the back of the wiring part 23, extends upward along the back of the wiring part 23, and extends to the right at the connection between the wiring part 23 and the electrode unit C1, and is electrically connected to the signal pad 206B corresponding to the temperature sensor R1; signal trace 204C-8 is led out from the leftmost gold finger 205 on the back of the wiring part 23, extends upward along the back of the wiring part 23, and extends to the left at the connection between the wiring part 23 and the electrode unit C6, and is electrically connected to the signal pad 206B corresponding to the temperature sensor R8; signal trace 204C-7 is led out from the fourth gold finger 205 on the front of the wiring part 23, passes through the substrate 201 to the back of the substrate 201 through the corresponding via 231 above the gold finger 205, extends upward along the back of the wiring part 23, extends to the left at the connection between the wiring part 23 and the electrode unit C6, and is electrically connected to the signal pad 206B corresponding to the temperature sensor R7. The other five signal traces 204C-2, 204C-3, 204C-4, 204C-5, and 204C-6 extend from the wiring section 23 to each connecting strip 211 and continue to the signal pad 206B of the corresponding electrode unit 22 at the connection point between each remaining electrode unit 22 and the corresponding connecting strip 211.Specifically, signal trace 204C-2 is led out from the fourth gold finger 205 on the back of the wiring part 23, extends upward along the back of the wiring part 23 via electrode unit C1 to the corresponding connecting strip 211, and extends to the right at the connection point of the connecting strip 211 and electrode unit C2 to electrically connect to the signal pad 206B corresponding to the temperature sensor R2; signal trace 204C-3 is led out from the gold finger 205 in the middle on the back of the wiring part 23, extends upward along the back of the wiring part 23 via electrode unit C1 to the corresponding connecting strip 211, and extends to the upper right at the connection point of the connecting strip 211 and electrode unit C3 to electrically connect to the signal pad 206B corresponding to the temperature sensor R3; signal trace 204C-4 is led out from the second gold finger 205 on the front of the wiring part 23, passes through the substrate 201 through the corresponding via 231 above the gold finger 205 to the back of the substrate 201, and extends upward along the back of the wiring part 23 via electrode unit C1 to the back of the substrate 201. A corresponding connecting strip 211 extends upward to the right from the connection point of the connecting strip 211 and the electrode unit C3, and is electrically connected to the signal pad 206B corresponding to the temperature sensor R4; a signal trace 204C-6 is led out from the second gold finger 205 on the back of the wiring part 23, extends upward along the back of the wiring part 23 through the electrode unit C6 to the corresponding connecting strip 211, and extends to the left from the connection point of the connecting strip 211 and the electrode unit C5, and is electrically connected to the signal pad 206B corresponding to the temperature sensor R6; a signal trace 204C-5 is led out from the gold finger 205 in the middle of the front of the wiring part 23, passes through the corresponding via 231 above the gold finger 205 through the substrate 201 to the back of the substrate 201, extends upward along the back of the wiring part 23 through the electrode unit C6 to the corresponding connecting strip 211, and extends upward to the left from the connection point of the connecting strip 211 and the electrode unit C4, and is electrically connected to the signal pad 206B corresponding to the temperature sensor R5. Thus, the eight signal traces 204C-1 to 204C-8 are electrically connected to the signal pads 206B corresponding to the eight temperature sensors R1 to R8 in a one-to-one correspondence.

[0052] The electrode array 20 also includes an insulating film 208 covering the back of the substrate 201 to press the ground traces 204B and signal traces 204C arranged on the back of the substrate 201 onto the substrate 201, preventing the ground traces 204B and signal traces 204C from being exposed. The insulating film 208 has corresponding openings (not labeled) at each gold finger 205 on the back of the substrate 201, so that each gold finger 205 can be soldered to the corresponding wire core in the conductor (not shown). The insulating film 208 also has corresponding openings (not shown) at the locations corresponding to each pad 206, so that the corresponding ground pad 206A can be exposed for soldering to the ground terminal 24A of the corresponding temperature sensor 24, and the corresponding signal pad 206B can be exposed for soldering to the signal terminal 24B of the corresponding temperature sensor 24.

[0053] refer to Figure 11 As shown, the temperature control method of the electrode patch 100 of this application is described in detail. The wires (not shown) of the electrode patch 100 are connected to the adapter 300 through the connector 320 to realize the circuit connection between the electrode patch 100 and the adapter 300. In terms of circuit layout, in this embodiment, the six electrode units (C1 to C6) are arranged in a roughly two-dimensional array on the substrate 201, in two rows and three columns. Specifically, the first row has three electrode units, namely electrode units C6, C5, and C4, which are located in the first to third columns. The ground terminals 24A of their respective temperature sensors 24 are shorted in parallel to the ground trace 204B. The second row has three electrode units, namely electrode units C1, C2, and C3, which are located in the first to third columns. The grounding terminal 24A of each temperature sensor 24 is also shorted in parallel to the grounding trace 204B. That is, the grounding terminals 24A of the eight temperature sensors 24 on the six electrode units are all shorted in parallel to the same grounding trace 204B. Furthermore, the signal terminals 24B of each of the eight temperature sensors 24 connected to this grounding trace 204B are respectively connected to eight different signal traces 204C. In other words, the signal terminals 24B of the eight temperature sensors 24 are connected one-to-one with eight different detection channels in the adapter 300 through eight different signal traces 204C. During temperature measurement, all eight signal traces 204C and the grounding trace 204B remain conductive, allowing for the simultaneous measurement of the temperature detection signals from each temperature sensor 24.

[0054] The adapter 300 includes a controller 310, multiple analog-to-digital converters 330 connected to the controller 310 and corresponding to multiple electrode patches 100, multiple voltage divider resistors 340 corresponding to multiple detection channels of the analog-to-digital converters 330, a communication unit 350, and a power module 380 connected to the communication unit 350, the controller 310, and the analog-to-digital converters 330. The power module 380 provides DC power VCC to each electronic component of the adapter 300. The adapter 300 also includes multiple circuit lines (unlabeled). These multiple circuit lines (unlabeled) are electrically connected to the ground trace 204B, multiple signal trace 204C, and AC signal trace 204A in the substrate 201 of the corresponding electrode patch 100 through the wires of the respective electrode patch 100. The multiple circuit lines (unlabeled) include multiple AC lines 360 that transmit AC signals to the corresponding electrode patches 100 and are electrically connected to the AC conductive traces 204A in the substrate 201 of the electrode patch 100; multiple GND lines 370 that are electrically connected to the ground traces 204B in the substrate 201 of the corresponding electrode patches 100; and multiple signal lines (unlabeled) that connect the signal traces 204C of the corresponding electrode patches 100 to the analog-to-digital converter 330 and are used to power the temperature sensors 24 of the electrode patches 100 or transmit the temperature detection signals of the electrode patches 100. In this embodiment, the analog-to-digital converter 330 is electrically connected to each signal trace 204C of the substrate 201 in the corresponding electrode patch 100 through multiple signal lines (unlabeled) within the adapter 300, and is configured to receive temperature detection signals transmitted from the multiple signal traces 204C of the corresponding electrode patch 100, and convert the temperature detection signals from analog signals to digital signals. Each analog-to-digital converter 330 includes eight detection channels A to H, and each detection channel is used to connect to one corresponding signal trace 204C among the eight signal traces 204C of the corresponding electrode patch 100.Specifically, the first detection channel A is connected to signal trace 204C-7, which is connected to signal terminal 24B corresponding to temperature sensor R7 of electrode unit C6; the second detection channel B is connected to signal trace 204C-8, which is connected to signal terminal 24B corresponding to temperature sensor R8 of electrode unit C6; the third detection channel C is connected to signal trace 204C-1, which is connected to signal terminal 24B corresponding to temperature sensor R1 of electrode unit C1; and the fourth detection channel D is connected to signal trace 204C-1, which is connected to signal trace 204C-7, which is connected to signal terminal 24B corresponding to temperature sensor R6 of electrode unit C5. 6. The fifth detection channel E is connected to signal trace 204C-2, which is connected to signal terminal 24B corresponding to temperature sensor R2 of electrode unit C2. The sixth detection channel F is connected to signal trace 204C-5, which is connected to signal terminal 24B corresponding to temperature sensor R5 of electrode unit C4. The seventh detection channel G is connected to signal trace 204C-3, which is connected to signal terminal 24B corresponding to temperature sensor R3 of electrode unit C3. The eighth detection channel H is connected to signal trace 204C-4, which is connected to signal terminal 24B corresponding to temperature sensor R4 of electrode unit C3. Each detection channel A to H is used to receive the temperature detection signal collected by temperature sensor 24 of electrode unit 22 connected to the corresponding signal trace 204C. In addition, each detection channel A to H is connected to a power supply module 380, which provides detection voltage to the detection channel, via a corresponding voltage divider resistor 340 in the adapter 300. The power supply module 380 provides a DC signal.

[0055] In this embodiment, the communication unit 350 is configured to acquire the digital signal output by the analog-to-digital converter 330 and send the digital signal to the electric field generator 200. The electric field generator 200 is also configured to control and adjust the voltage, current, or power of the AC signal provided to the plurality of electrode units 22 of the electrode patch 100 according to the received digital signal. For example, when any of the received digital signals exceeds a preset threshold stored in the controller 310, it indicates that the temperature detected by at least one temperature sensor 24 in the electrode patch 100 at the corresponding dielectric element 202 applied to the human body surface exceeds the preset threshold temperature (e.g., 41°C, 42°C, etc.). At this time, the voltage, current, or power of the AC signal output by the electric field generator 200 can be appropriately reduced to avoid the electrode unit 22 of the electrode patch 100 becoming too hot when the AC signal is applied, causing low-temperature burns to the patient's skin. The aforementioned preset threshold temperature and preset threshold can be determined according to human safety thresholds. The communication unit 350 is controlled by the controller 310 and serially transmits the digital signal converted by the analog-to-digital converter 330. In this embodiment, the preset temperature threshold can be a value within the range of 36℃-45℃.

[0056] The electrode patch 100 of the tumor electric field therapy device of this application has a temperature sensor 24 disposed on the back side of the substrate 201 of the electrode array 20. The temperature sensor 24 does not interfere with the conductive sheet 203 on the front side of the substrate 201. The conductive sheet 203 does not need to avoid the temperature sensor 24, which simplifies the structure of the conductive sheet 203, reduces the manufacturing process difficulty of the conductive sheet 203, and further reduces the production cost of the electrode array 20.

[0057] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and not to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. These modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application, and they should all be covered within the scope of the claims and specification of this application. In particular, as long as there is no structural conflict, the various technical features mentioned in the embodiments can be combined in any way. This application is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

Claims

1. An electrode patch for use in a tumor electric field therapy device, comprising an electrode array, characterized in that, The electrode array includes a connecting portion, several electrode units, and a wiring portion. The several electrode units extend outward from the connecting portion in a radial pattern. The electrode array includes a substrate, several conductive traces disposed on the substrate, conductive sheets disposed on the front side of the substrate, an insulating layer covering the front side of the substrate and exposing part of the conductive sheets, and a dielectric element covering the conductive sheets exposed by the insulating layer. The several conductive traces include an AC conductive trace disposed on the front side of the substrate and electrically connected to each of the conductive sheets. The back side of the substrate of the electrode array is provided with several temperature sensors corresponding to each of the electrode units. Each temperature sensor has a corresponding ground terminal and a signal terminal. Each electrode unit has a ground pad disposed on the back side of the substrate and soldered to the ground terminal of the corresponding temperature sensor, and a signal pad soldered to the signal terminal of the corresponding temperature sensor. The several conductive traces also include a ground trace and several signal traces disposed on the back side of the substrate. The ground trace is electrically connected to the ground pad of each of the electrode units, and the several signal traces are electrically connected to the signal pads of each of the electrode units one-to-one.

2. The electrode patch according to claim 1, characterized in that, The connecting portion includes two arc-shaped connecting strips located on the same circle and symmetrically arranged on the left and right; each electrode unit extends radially outward from the corresponding connecting strip.

3. The electrode patch according to claim 1, characterized in that, The plurality of temperature sensors include a plurality of first temperature sensors, each of the first temperature sensors being disposed at the geometric center of the corresponding electrode unit in a one-to-one correspondence.

4. The electrode patch according to claim 3, characterized in that, The plurality of temperature sensors include two second temperature sensors, which are respectively disposed on the two electrode units in a centrally symmetrical manner about the center of the connection portion, and each second temperature sensor is closer to the outer edge of the corresponding electrode unit than the first temperature sensor located on the same electrode unit.

5. The electrode patch according to claim 4, characterized in that, The wiring portion is provided with a plurality of gold fingers on both the front and back sides. One of the gold fingers on the front side of the wiring portion is electrically connected to the AC conductive trace, another gold finger on the front side of the wiring portion is electrically connected to the ground trace that extends to the front side of the substrate, and the other gold fingers are electrically connected to each of the signal traces respectively.

6. The electrode patch according to claim 5, characterized in that, The electrode array has six electrode units, and the wiring portion is mounted between two adjacent electrode units. Specifically, the six electrode units are arranged in a clockwise direction from the electrode unit C1 to electrode unit C6 when viewed from the front of the electrode array. Each of the six electrode units is provided with a first temperature sensor, and electrode unit C3 and electrode unit C6 are also provided with a second temperature sensor.

7. The electrode patch according to claim 6, characterized in that, The AC conductive trace extends from the wiring portion to the connection portion, then branches off at the connection point between the connection portion and each of the electrode units and extends to the conductive sheet of each corresponding electrode unit in a one-to-one correspondence.

8. The electrode patch according to claim 6, characterized in that, There are a total of eight signal traces. Three of the signal traces are guided out by three gold fingers located on the front of the connector, pass through the substrate, extend to the corresponding electrode unit, and are electrically connected to the corresponding signal pads one by one. The remaining five signal traces are guided out by five gold fingers located on the back of the connector, extend to the corresponding electrode unit, and are electrically connected to the corresponding signal pads one by one.

9. The electrode patch according to claim 6, characterized in that, The grounding trace extends to the left and right from the back of the connection part in two branches. One branch electrically connects all four grounding pads corresponding to the three first temperature sensors and one second temperature sensor in the electrode units C1 to C3. The other branch electrically connects all four grounding pads corresponding to the three first temperature sensors and one second temperature sensor in the electrode units C4 to C6.

10. A tumor electric field therapy device, characterized in that, It includes an electric field generator, an adapter, and an electrode patch as described in any one of claims 1 to 9, wherein the adapter is electrically connected to the electric field generator and the electrode patch.

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