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, the electrode array is provided with a connecting portion, a plurality of electrode units and a wiring portion, and the plurality of electrode units respectively extend outward from the connecting portion in a radiating manner. The electrode array comprises a substrate, a conductive sheet arranged on the front surface of the substrate, an insulating layer arranged on the front surface of the substrate and exposing part of the conductive sheet, and a dielectric element covering the conductive sheet exposed on the insulating layer. The back surface of the substrate of the electrode array is provided with a plurality of temperature sensors corresponding to each electrode unit. The electrode patch of the tumor electric field treatment device of the application is arranged with 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 its 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 is provided with a connecting portion, a plurality of electrode units and a wiring portion, the plurality of electrode units extending outward from the connecting portion in a radiating manner, each electrode unit comprising a 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, wherein the back side of the substrate of the electrode array is provided with a plurality of temperature sensors corresponding to each electrode unit.

[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 centrally symmetrical about the center of the connection portion and respectively disposed on the two electrode units, 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 ratio of the distance from each of the second temperature sensors to the outer edge of the corresponding electrode unit to the length of the electrode unit is less than 1 / 3.

[0012] Furthermore, the electrode array is arranged symmetrically from left to right, and the wiring portion is located between two adjacent electrode units and on the central axis of the electrode array.

[0013] Furthermore, it also includes a backing, which has a plurality of slots that divide the backing into multiple partitions. The electrode array is attached to the front side of the backing, and the electrode units are attached to each partition in a one-to-one correspondence.

[0014] Furthermore, the substrate is provided with a plurality of gold fingers, a plurality of conductive traces, and a plurality of vias located at both ends of each gold finger.

[0015] Furthermore, the dielectric element is a dielectric layer covering the conductive sheet, and there is a 1mm-3mm gap between the edge of the conductive sheet of each electrode unit and the edge of its substrate. The insulating layer is provided on the annular exposed area formed on the substrate of the corresponding electrode unit.

[0016] This application also provides the following technical solution: a tumor electric field therapy device, including the aforementioned electrode patch.

[0017] The electrode patch of the tumor electric field therapy device of this application has a temperature sensor placed on the back of the electrode array substrate, while 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 perspective view of the electrode patch of the tumor electric field therapy device according to one embodiment of this application;

[0020] Figure 2 for Figure 1 3D exploded view of the electrode patch;

[0021] Figure 3 for Figure 1 A plan view of the electrode patch after the adhesive has been removed;

[0022] Figure 4 for Figure 3 A plan view of the electrode array of the electrode patch, showing the front of the electrode array;

[0023] Figure 5 for Figure 4 Wiring diagram of AC conductive traces in the electrode array;

[0024] Figure 6 for Figure 5 A magnified view of a section at point A in the middle;

[0025] Figure 7 for Figure 5 The cross-sectional view obtained by viewing the electrode array along the BB direction;

[0026] Figure 8 for Figure 3 Another plan view of the electrode array, showing the back side of the electrode array;

[0027] Figure 9 for Figure 8 The distribution diagram of the pads in the electrode array;

[0028] Figure 10 for Figure 2 Another simple variation of the electrode array of the electrode patch in the embodiment;

[0029] Figure 11 for Figure 2Another simple variation of the backing of the electrode patch in the embodiment.

[0030] Explanation of reference numerals in the attached figures:

[0031] 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, substrate 201, dielectric element 202, conductive sheet 203, conductive trace 204, AC conductive trace 204A, gold finger 205, solder pad 206, insulating layer 207, adhesive 30, center O, spacing D. Detailed Implementation

[0032] 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.

[0033] refer to Figure 1 and Figure 2 As shown, this application provides an electrode patch 100 for a tumor electric field therapy device. The electrode patch 100 includes a backing 10, an electrode array 20, and a plurality of adhesive members 30. Figure 1 and Figure 2 The upper surface of the electrode patch 100 is the application surface to the patient's skin. 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 of the adhesive piece covers the front surface of the electrode array 20, and the other side is directly applied to the patient's skin to fix the electrode patch 100 to the patient's skin. At the same time, the adhesive pieces 30 can also absorb sweat from the patient's skin to avoid problems such as redness, swelling, and allergies. The electrode array 20 is electrically connected to the electric field generator (not shown) of the tumor electric field therapy device via wires (not shown) to receive alternating current signals. In use, the electrode patches 100 are applied in pairs to the surface of the patient's body corresponding to the tumor site, thereby applying an alternating current electric field to the tumor site for tumor electric field therapy, which helps to inhibit the growth of tumor cells.

[0034] refer to Figure 3 and Figure 4As 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 can improve the heat dissipation and flexibility of the electrode array 20. Multiple electrode units 22 extend outward in a circular array from corresponding portions of the connecting portion 21 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).

[0035] 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 10 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).

[0036] Combination Figure 2 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 it can completely cover each electrode unit 22.

[0037] Continue to refer to Figure 2 and Figure 3 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 11 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.

[0038] refer to Figure 4 and Figure 5 As shown, the electrode array 20 is made of a flexible circuit board. From a hierarchical 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 corresponding to each electrode unit 22, a plurality of conductive traces 204 disposed on corresponding portions of the substrate 201 corresponding to the connection portion 21 and the wiring portion 23, and a plurality of gold fingers 205 disposed on corresponding portions of the substrate 201 corresponding to the wiring portion 23.

[0039] 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.

[0040] Continue to refer to Figure 5 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 6 As shown, the wiring section 23 is also provided with several through holes 231 (only shown in Figure 5 and Figure 6 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.

[0041] Combination Figure 7 As 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 each conductive trace 204 to prevent the conductive trace 204 from being exposed. The insulating layer 207 has windows (not labeled) at the corresponding parts of each gold finger 205 to facilitate the soldering connection between each gold finger 205 and the corresponding wire core in the conductor (not shown).

[0042] 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.

[0043] refer to Figure 8 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 8 The 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 of 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.

[0044] refer to Figure 9As shown, the back of the substrate 201 is provided with several pairs of pads 206 for soldering each temperature sensor 24. The temperature sensors 24 can be soldered to the corresponding pads 206 using SMT. After that, the temperature sensors 24 need to be encapsulated. Therefore, the shape and size of each pad 206 can be designed to be the same to facilitate uniform control of the amount of glue during machine dispensing. The temperature sensors 24 can also be arranged on the corresponding pads using COB packaging to obtain the minimum package height. All pads 206 are arranged in a centrally symmetrical manner about the center O of the electrode array 20, which is stable and not easy to be skewed. The back of the substrate 201 is also provided with several conductive traces (not shown) for connecting the pads 206 and the corresponding gold fingers 205. The conductive traces (not shown) on the back of the substrate 201 are covered by a cover film (not shown) pressed onto the back of the substrate 201. The cover film (not shown) also has corresponding openings (not shown) for each gold finger 205 located on the back of the wiring part 23.

[0045] 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.

[0046] 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 has a connecting portion, a plurality of electrode units and a wiring portion. The plurality of electrode units extend outward from the connecting portion in a radial manner. The electrode array includes a 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 back side of the substrate of the electrode array is provided with a plurality of temperature sensors corresponding to each electrode unit.

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 ratio of the distance from each of the second temperature sensors to the outer edge of the corresponding electrode unit to the length of the electrode unit is less than 1 / 3.

6. The electrode patch according to claim 2, characterized in that, The electrode array is arranged symmetrically from left to right, and the wiring part is located between two adjacent electrode units and on the central axis of the electrode array.

7. The electrode patch according to claim 1, characterized in that, It also includes a backing with a plurality of slots that divide the backing into multiple partitions. The electrode array is attached to the front side of the backing, and each electrode unit is attached to each partition in a one-to-one correspondence.

8. The electrode patch according to claim 1, characterized in that, The substrate is provided with a plurality of gold fingers, a plurality of conductive traces, and a plurality of vias located at both ends of each gold finger.

9. The electrode patch according to claim 1, characterized in that, The dielectric element is a dielectric layer covering the conductive sheet. The edge of the conductive sheet of each electrode unit has a distance of 1mm-3mm between it and the edge of the substrate. The insulating layer is provided on the annular exposed area formed on the substrate of the corresponding electrode unit.

10. A tumor electric field therapy device, characterized in that, Includes the electrode patch as described in any one of claims 1 to 9.

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