Tumor electric field treatment system and electrode patch thereof

Abstract

The utility model provides a tumor electric field treatment system and its electrode patch, the electrode patch comprises an electrode array and a pasting piece arranged on the electrode array, the electrode array is provided with a plurality of electrode units and a plurality of connecting parts connecting two adjacent electrode units, at least part of the electrode units comprise temperature detection units correspondingly arranged on the electrode units, and the pasting piece is arranged on the electrode array. The electrode unit is provided with a protruding part formed by a part corresponding to the temperature detection unit arranged on the electrode unit, and the pasting piece covers the electrode unit and is provided with a groove for containing the protruding part of the electrode unit. According to the electrode patch of the tumor electric field treatment system, the protruding part formed by arranging the temperature detection unit on the electrode unit is contained in the groove of the pasting piece, the protruding part of the electrode unit can make contact with the body surface of a patient to cause discomfort of the patient, and the comfort of the patient when the electrode patch is pasted is improved; and no obvious gap is generated around the temperature detection unit between the sticking piece and the electrode unit, so that the stable electrical performance of the electrode sheet and the electrode patch can be ensured.

Description

Technical Field

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

[0002] Medium frequency alternating electric field therapy has been proven to be an effective method for tumor treatment. It can interfere with the mitosis process of cancer cells, induce apoptosis of cancer cells, and can be used to treat tumors. The tumor electric field therapy system usually includes an electric field generator, an adapter, and multiple pairs of electrode patches. The electric field generator generates an alternating electric signal and transmits the alternating electric signal to the electrode patch through the adapter. The electrode patches are applied in pairs on the skin surface of the subject on opposite sides, and an alternating current signal is applied between each pair of electrode patches, thereby applying a tumor treatment electric field to the target area.

[0003] The existing electrode patch disclosed in China Invention Patent Publication No. 112675421 includes a flexible circuit board, a plurality of insulating electrodes spaced apart on the flexible circuit board, a thermistor disposed on the flexible circuit board, a foam pad disposed around the insulating electrode, and a gel applied to the insulating electrode and the foam pad on the side close to the human body. The insulating electrode is made of ceramic material with a thickness of 0.8-1.2 mm, and a perforation is provided in the middle thereof for accommodating the thermistor. The thermistor is disposed on the flexible circuit board and accommodated in the perforation of the insulating electrode to monitor the temperature at the insulating electrode in real time, and to adjust the current in time when the temperature is abnormal to ensure safe treatment.

[0004] Although the above-mentioned electrode patch adopts an insulating electrode with a thickness of 0.8-1.2mm, which not only makes the insulating electrode have good rigidity and strength to avoid breakage, but also can accommodate thermistors to ensure safe treatment, when the electric field therapy of tumor is carried out for a long time, the insulating electrode generates heat faster than it dissipates due to its large thickness, and it is easy for heat to accumulate quickly, resulting in a short time interval and a large number of times for the thermistor to detect temperature abnormalities and adjust the current. In order to ensure safe treatment and avoid low-temperature burns caused by excessive temperature, it is necessary to reduce the current in time and reduce the heat generated by the insulating electrode, so that the electric field strength formed between the insulating electrodes is lower than the electric field strength required for tumor treatment, thereby greatly shortening the time for effective tumor treatment per unit time. In addition, the thick thickness of the insulating electrode will also increase the weight of the electrode patch, and its hard circular sheet structure made of ceramic material will also make it difficult for the insulating electrode to be well attached to the patient's body surface.

[0005] The electrode patch disclosed in the Chinese invention patent publication No. 115175730 includes a flexible circuit, a plurality of conductive pads arranged at intervals on the side of the flexible circuit facing the patient's body surface, a plurality of flexible polymer regions respectively covering the side of the corresponding conductive pads close to the patient's body surface, a plurality of conductive hydrogels arranged one by one on the corresponding flexible polymer regions, a plurality of thermistors arranged on the flexible circuit away from the patient's body surface and electrically connected to the corresponding conductive pads, and a flexible backing supporting the flexible circuit. The thermistor is sandwiched between the flexible backing and the flexible circuit. Although the electrode patch uses a flexible polymer area composed of at least one of polyVDF-TrFE-CTFE, polyVDF-TrFE-CFE and polyVDE-TrFE-CEF-CTFE and having a thickness of no more than 20 μm to replace the insulating electrode made of ceramic material in the aforementioned electrode patch, making the electrode patch lighter, thinner and able to adhere well to the patient's body surface, its thermistor is electrically connected to the conductive pad provided on the flexible circuit and is provided on the side of the flexible circuit away from the patient's body surface. The thermistor monitors the temperature of the conductive pad rather than the temperature of the conductive hydrogel in contact with the patient's body surface. There is a problem that the thermistor cannot quickly and accurately monitor the patient's body surface temperature, resulting in low-temperature burns on the patient's body surface.

[0006] In addition, even if the thermistor is arranged at the position of the flexible circuit between the conductive pads and is in direct contact with the conductive hydrogel to monitor the temperature of the conductive hydrogel in direct contact with the patient's body surface, thereby achieving rapid and accurate temperature monitoring and avoiding low-temperature burns on the patient's body surface, since the thickness of the conductive pad is less than 0.3 mm and the thickness of the flexible polymer area is not more than 20 μm, the total thickness of the conductive pad after covering the flexible polymer area is also no more than 0.032 mm, and the thickness of the thermistor is generally greater than 0.4 mm, there is also a problem that the top surface of the thicker thermistor is higher than the top surface of the corresponding flexible polymer area, resulting in the conductive hydrogel and the thermistor pasting The part is lifted up and bulged after the conductive hydrogel is pasted on the flexible polymer area and the thermistor, affecting the patient's comfort; at the same time, there is also a problem that the part where the conductive hydrogel and the thermistor are pasted is bulged, resulting in a gap between the conductive hydrogel and the flexible polymer area, and air easily enters the gap, affecting the electrical performance of the electrode patch.

[0007] Therefore, it is indeed necessary to provide an improved tumor electric field therapy system and its electrode patch to overcome the problems existing in the above-mentioned electrode patch and tumor electric field therapy system. Utility Model Content

[0008] The utility model provides a tumor electric field treatment system and an electrode patch thereof which can improve the comfort of application and provide stable electrical performance.

[0009] The utility model can be implemented through the following technical scheme: an electrode patch for electric field therapy of tumors, comprising an electrode array and an adhesive member arranged on the electrode array, the electrode array is provided with a plurality of electrode units and a plurality of connecting parts connecting two adjacent electrode units, at least some of the electrode units include corresponding temperature detection units arranged thereon, the electrode unit has a protruding part formed with a corresponding part of the temperature detection unit arranged thereon, the adhesive member covers the electrode unit and has a groove for accommodating the protruding part of the electrode unit.

[0010] Furthermore, the groove is a blind hole.

[0011] Furthermore, the electrode unit includes a main body and a dielectric element disposed on the main body, the temperature detection unit is disposed on the main body, and the protruding portion is a portion of the temperature detection unit protruding from the top surface of the dielectric element.

[0012] Furthermore, the dielectric element is provided with a through hole for the temperature detection unit to pass through, and the temperature detection unit includes a temperature sensor arranged on the main body and a sealant that seals the temperature sensor and fills the through hole.

[0013] Furthermore, the thickness of the dielectric element is smaller than the thickness of the temperature detection unit.

[0014] Furthermore, the thickness of the temperature detection unit is 0.4-0.7 mm, and the thickness of the dielectric element is 0.3-0.5 mm.

[0015] Furthermore, the thickness of the adhesive piece is 0.45-0.95 mm.

[0016] Furthermore, the electrode unit includes a substrate and a conductive sheet disposed on the substrate, the temperature detection unit is disposed on the substrate, and the electrode unit also includes a dielectric layer covering the conductive sheet and the temperature detection unit.

[0017] Furthermore, the thickness of the temperature detection unit is greater than the thickness of the conductive sheet, and the portion of the dielectric layer covering the temperature detection unit forms the protrusion.

[0018] Furthermore, the conductive sheet has an opening for the temperature detection unit to pass through, and the dielectric layer is a polymer dielectric layer with a high dielectric constant and low dielectric loss.

[0019] Furthermore, the electrode unit also includes an insulating layer that presses the conductive sheet onto the substrate and exposes a portion of the conductive sheet, and the dielectric layer covers the region of the conductive sheet where the insulating layer is exposed.

[0020] Furthermore, the electrode unit also includes an alloy layer, the alloy layer covers the dielectric layer, and the adhesive member covers the alloy layer.

[0021] Furthermore, the temperature detection unit includes a temperature sensor disposed on the substrate and a sealant filling the opening and sealing the temperature sensor, and the alloy layer and the dielectric layer cover the outside of the sealant.

[0022] Furthermore, the electrode array includes a left part and a right part which are bilaterally symmetrical, and each of the left part and the right part is provided with a plurality of electrode units with different shapes.

[0023] The utility model also provides a tumor electric field treatment system, which comprises an electric field generator, an adapter and the aforementioned electrode patch.

[0024] The tumor electric field treatment system and electrode patch of the utility model accommodate the protruding part formed by the temperature detection unit set on the electrode unit through the groove of the adhesive piece, which can avoid the protruding part formed on the electrode unit causing discomfort to the patient when it is applied to the patient's body surface through the adhesive piece, improve the comfort of the electrode patch application, and there will be no obvious gap between the adhesive piece and the electrode unit around the temperature detection unit, which can also prevent air from entering and causing the impedance of the electrode patch to increase, thereby causing the electric field strength applied to the tumor site through the electrode patch to decrease and affect the treatment effect, ensuring that the electrode unit and the electrode patch have stable electrical performance. In addition, the protruding part of the temperature detection unit set on the electrode unit is accommodated in the groove of the adhesive piece that directly contacts the patient's body surface, so that the temperature detection unit is closer to the patient's body surface, and the accuracy of temperature detection is also provided.

[0025] It should be understood that the above general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 This is a structural block diagram of the tumor electric field treatment system of this application;

[0027] Figure 2 is a three-dimensional assembly diagram of an electrode patch according to the first embodiment of the present application;

[0028] Figure 3 for Figure 2 An exploded perspective view of the electrode patch shown in FIG.

[0029] Figure 4 for Figure 3 A perspective exploded view of the electrode array of the electrode patch shown in FIG.

[0030] Figure 5 For along Figure 2A cross-sectional view of a single electrode unit obtained along line AA in FIG. 2 , with the backing omitted;

[0031] Figure 6 is a three-dimensional exploded view of an electrode patch according to a second embodiment of the present application;

[0032] Figure 7 is a three-dimensional exploded view of an electrode patch according to a third embodiment of the present application;

[0033] Figure 8 is a three-dimensional exploded view of an electrode patch according to a fourth embodiment of the present application;

[0034] Fig. 9 for Figure 8 A plan view of the electrode patch shown in , with the backing omitted;

[0035] Fig.10 for Figure 8 Another plan view of the electrode patch in which the dielectric layer and the alloy layer have not yet been provided;

[0036] Fig.11 For along Fig. 9 A cross-sectional view of a single electrode unit obtained along line BB in FIG.

[0037] Fig.12 and Fig.11 Similar, the difference is that the adhesive piece is further provided;

[0038] Fig.13 is a plan view of an electrode patch according to a fifth embodiment of the present application;

[0039] Fig.14 It is a plan view of an electrode patch according to the sixth embodiment of the present application. DETAILED DESCRIPTION

[0040] Exemplary embodiments will be described in detail herein, examples of which are shown in the accompanying drawings. When the following description refers to the drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present utility model. Instead, they are merely examples of electrode patches consistent with some aspects of the present utility model as detailed in the attached claims.

[0041] refer to Figure 1As shown, the tumor electric field treatment system 100 includes an electric field generator 10, an adapter 20 and a plurality of electrode patches arranged in pairs, and the adapter 20 electrically connects the electric field generator 10 and each electrode patch. The electric field generator 10 generates an alternating current signal that meets the treatment requirements, and the adapter 20 receives the alternating current signal output from the electric field generator 10 and transmits the alternating current signal to the electrode patch, so that a therapeutic electric field for treating the tumor is generated between the same pair of electrode patches. When in use, the electrode patch is applied to the body surface of the patient corresponding to the tumor site to apply a therapeutic electric field to the tumor site. The utility model provides a variety of implementation methods of the electrode patch, which are described below.

[0042] refer to Figures 2 to 5 As shown, the electrode patch 30 in the first embodiment of the present application includes a backing 31, an electrode array 32, a plurality of support members 33, a plurality of adhesive members 34 and a wire 35. The backing 31 is a mesh non-woven fabric, and a biocompatible adhesive (not shown) is applied on the side of the backing 31 facing the patient's body surface. The electrode array 32 is bonded to the side of the backing 31 facing the patient's body surface, and includes a plurality of electrode units 321, a plurality of connecting portions 322 connecting two adjacent electrode units 321, and a wiring portion 323 extending laterally from a connecting portion 322 (see FIG. Figure 3 ), the wiring portion 323 is connected to the wire 35 by welding.

[0043] The electrode array 32 is provided with 9 electrode units 321, which are arranged in a matrix of three rows and three columns. The adjacent two electrode units 321 in each row are connected by a corresponding connecting portion 322, and the adjacent two electrode units 321 in the middle column are connected by a corresponding connecting portion 322, forming a roughly "W"-shaped arrangement.

[0044] refer to Figure 4 , and combined with Figure 5As shown, the electrode unit 321 includes a main body 3211, an insulating plate 3212 disposed on the side of the main body 3211 away from the human skin, a dielectric element 3213 disposed on the side of the main body 3211 facing the human skin, and a temperature detection unit 3214 selectively disposed on the main body 3211 and located on the same side as the dielectric element 3213. The main body 3211, the insulating plate 3212, and the dielectric element 3213 are all circular sheet structures, and the centers of the three are located on the same straight line. The thickness of the temperature monitoring unit 3214 is greater than the thickness of the dielectric element 3213, that is, the top of the temperature monitoring unit 3214 facing the human skin protrudes from the top of the dielectric element 3213 facing the human skin. A conductive disk 3215 is provided on the side of the main body 3211 facing the dielectric element 3213, which includes 4 conductive cores (not numbered) spaced and arranged in a central symmetrical shape. The dielectric element 3213 is made of a high dielectric constant material, which has a conductive property of blocking the conduction of direct current and allowing alternating current to pass, which can ensure the safety of the human body. The conductive disk 3215 can be completely covered by the dielectric element 3213, so that the conductive disk 3215 and the dielectric element 3213 can be welded and connected. The edge of the dielectric element 3213 and the conductive disk 3215 are filled with a sealant (unnumbered) to protect the solder joint. Each main body 3211, each connecting part 322 and the wiring part 323 together constitute the flexible circuit board 320 of the electrode array 32. The connecting part 322 directly connects two adjacent main bodies 3211, and the wiring part 323 extends laterally from one of the connecting parts 322. The wiring part 323 is provided with a plurality of gold fingers 3231. The wire 35 is welded with the gold fingers 3231 of the wiring part 323 to realize the electrical connection between the electrode array 32 and the wire 35.

[0045] The insulating plate 3212 is made of an insulating material, preferably an epoxy glass cloth laminate, and is adhered to the side of the main body 3211 away from the human skin to provide support. The dielectric element 3213 is made of a high dielectric constant material, which has a conductive property of hindering the conduction of direct current and allowing alternating current to pass, which can ensure the safety of the human body, and is preferably a ceramic sheet. The dielectric element 3213 is annular in structure, and a perforation 3216 is provided at the center. The temperature detection unit 3214 is partially located in the perforation 3216 of the dielectric element 3213, and partially passes through the perforation 3216 and protrudes from the top surface of the dielectric element 3213, and is used to monitor the temperature of the corresponding adhesive member 34, and further detect the skin temperature of the patient attached to the adhesive member 34 to avoid low-temperature burns. The specific number of temperature detection units 3214 can be set as needed. In this embodiment, the number of temperature detection units 3214 is 8, and only the middle electrode unit 321 is not set.

[0046] Back to Figure 3As shown, the support member 33 is made of foam material, adhered to the backing 31 and arranged in a ring shape around the periphery of the electrode unit 321 in the same row, and the support member 33 is flush with the top surface of the electrode unit 321. The adhesive member 34 covers the electrode units 321 in the same row, and the adhesive member 34 has double-sided adhesiveness. One side of the adhesive member 34 is adhered to the surface of the support member 33 and the electrode unit 321 away from the backing 31, and the other side of the adhesive member 34 is used as a patch layer, which is applied to the skin of the human body to keep the skin surface moist and relieve local pressure. The adhesive member 34 is preferably a conductive gel, which can be made of hydrogel, gelatin, agar, etc. Under the support of the support member 33, the adhesive member 34 has better adhesion to the human skin. The electrode patch 30 is attached to the body surface corresponding to the tumor site of the patient through the backing 31 and the adhesive member 34, and an alternating electric field is applied to the tumor site of the patient through the electrode array 32 to interfere with or prevent the mitosis of the patient's tumor cells, thereby achieving the purpose of treating the tumor.

[0047] refer to Figure 5 As shown, the temperature detection unit 3214 includes a temperature sensor 3217 and a sealant 3218. The temperature sensor 3217 has a signal terminal (not shown) and a ground terminal (not shown). The main body 3211 is provided with a pair of pads 3219 corresponding to the temperature sensor 3217. After the temperature sensor 3217 is welded to the main body 3211, the sealant 3218 is filled into the through hole 3216 to seal and protect the temperature sensor 3217, so as to prevent water vapor from corroding the temperature sensor 3217 and causing the temperature sensor 3217 to fail.

[0048] Since the thickness of the temperature detection unit 3214 is greater than the thickness of the dielectric element 3213, it will protrude from the top surface of the electrode unit 321, that is, the top surface of the dielectric element 3213, through the perforation 3216. The adhesive member 34 is provided with a groove 341 corresponding to the temperature detection unit 3214, which can accommodate the portion of the temperature monitoring unit 3214 protruding from the top surface of the dielectric element 3213 when the temperature monitoring unit 3214 protrudes from the top surface of the dielectric element 3213, thereby ensuring that the portion of the adhesive member 34 corresponding to the temperature detection unit 3214 will not protrude significantly when attached to the patient's body surface, thereby improving the comfort of the electrode patch 30 when attached. The groove 341 is a semi-blind hole that is recessed on one side of the adhesive member 34 facing the dielectric element 3213, so that the adhesive member 34 can completely cover the temperature detection unit 3214 to prevent the temperature detection unit 3214 from being exposed and in direct contact with the patient. Compared with the existing electrode patch that uses a ceramic material to make a dielectric element to accommodate the temperature monitoring unit, the temperature detection unit 3214 of the electrode patch 30 of this embodiment is closer to the patient's body surface, and the temperature it monitors is also closer to the temperature of the patient's body surface. The temperature monitoring is more accurate, and the patient's safety is further ensured. In addition, the groove 341 is used to accommodate the portion of the temperature detection unit 3214 that protrudes from the dielectric element 3213, so that the adhesive 34 and the dielectric element 3213 of the electrode unit 321 can form a tight fit without a gap around the temperature detection unit 3214, thereby preventing air from entering due to a gap between the dielectric element 3213 and the adhesive 34, thereby preventing the impedance of the electrode unit 321 of the electrode array 32 from increasing and affecting the electric field strength applied to the tumor site through the electrode unit 321, thereby ensuring that the electrode unit 321 and the electrode patch 30 have stable electrical properties.

[0049] In addition, the electrode patch 30 of the present application uses a dielectric element 3213 with a thickness smaller than that of the temperature detection unit 3214 to accommodate the corresponding part of the temperature detection unit 3214, which can reduce the thickness of the dielectric element 3213 while ensuring that the dielectric element 3213 is not easy to break, thereby reducing the heat generated by the dielectric element 3213 itself when the AC signal is applied for a long time, thereby slowing down the temperature rise rate of the electrode unit 321 when the tumor electric field therapy is performed for a long time, extending the effective application time of the AC signal for tumor electric field therapy per unit time, and reducing the frequency of adjusting the AC signal due to temperature abnormality, that is, extending the effective time of applying the AC signal for tumor treatment per unit time. When the thickness of the dielectric element 3213 is reduced, the weight of the dielectric element 3213 is also reduced, and the application performance of the electrode patch 30 to the human body surface is also improved, which prevents the electrode patch 30 from being too heavy and falling off from the patient's body surface.

[0050] In this embodiment, the thickness of the dielectric element 3213 made of ceramic sheet is 0.3-0.6 mm, the thickness of the temperature detection unit 3214 is 0.4-0.7 mm, and the thickness of the adhesive member 34 is 0.45-0.95 mm. Preferably, the thickness of the dielectric element 3213 is 0.3-0.5 mm, the thickness of the temperature detection unit 3214 is 0.4-0.6 mm, and the thickness of the adhesive member 34 is 0.45-0.8 mm.

[0051] It is understandable that the shape of the electrode patch 30 can be adjusted. Specifically, the shape, number, matrix arrangement of the electrode units 321 of the electrode array 32 can be changed and adjusted; the number and shape of the connecting parts 322 can also be changed and adjusted. The connecting parts 322 can be straight strips or arc strips. The number of connecting parts 322 can be appropriately adjusted, as long as the AC signal connected by the wiring part 323 can be transmitted to each electrode unit 321. A relatively simple way is that the electrode units 321 in each row are connected to each other through the connecting parts 322 and the rows are also connected through the connecting parts 322. The number of electrode units 321 covered by each adhesive member 34 can also be adjusted. There can be only one adhesive member 34 covering all electrode units 321, or a separate adhesive member 34 can be set for each electrode unit 321. These structures of the electrode array 32 and the adhesive member 34 do not constitute limitations on the utility model.

[0052] refer to Figure 6 As shown, the electrode patch 30' electrode array 32' in the second embodiment of the present application is applied to the patient's body surface through a backing 31' and is provided with thirteen electrode units 321', and the electrode units 321' are also surrounded by a support member 33'. The electrode units 321' are arranged in five rows and five columns, and each of the first and last rows is provided with two electrode units 321', and each of the middle three rows is provided with three electrode units 321'. The electrode units 321' in the first and last rows are staggered with the electrode units 321' in the middle three rows, and each electrode unit 321' is connected to at least two electrode units 321' around it through a corresponding connecting portion 322'. The electrode array 32' is provided with five adhesive members 34', and each adhesive member 34' covers a row of electrode units 321'. In other embodiments, each electrode unit 321' can also be connected to at least one electrode unit 321' adjacent to it through a corresponding connecting portion 322'.

[0053] refer to Figure 7As shown, in the third embodiment of the present application, the electrode array 32” of the electrode patch 30” is also attached to the body surface corresponding to the patient's tumor site through the backing 31”. It is provided with twenty electrode units 321” arranged in six rows and four columns. Each of the first row and the last row has two electrode units 321”, and each of the middle four rows has four electrode units 321”. The two electrode units 321” in the first row and the last row are respectively located on the middle two columns. Each electrode unit 321” is connected to at least three surrounding electrode units 321” through the corresponding connecting part 322”. A support 33” also surrounds each electrode unit 321”. The electrode array 32” is provided with ten adhesive parts 34”. Each adhesive part 34” covers two adjacent electrode units 321” in the same row. In other embodiments, each electrode unit 321” can also be connected to at least one adjacent electrode unit 321” through the corresponding connecting part 322”. There can be multiple adhesive parts 34” and they are respectively arranged in one-to-one correspondence with the electrode units 321”.

[0054] Figure 6 The electrode patch 30’ shown in Figure 7 and the electrode patch 30” shown in Figures 2 to 5 both have the same hierarchical structure as the electrode patch 30 shown in

[0055] Refer to Figure 8 As shown, the electrode patch 40 in the fourth embodiment of the present application includes a backing 41, a plurality of electrode arrays 42 and adhesive parts 43. The electrode array 42 is in the shape of a “king” and includes nine matrix-shaped electrode units 421, a plurality of connecting parts 422 connecting two adjacent electrode units 421 and a wiring part 423. The overall shape of the electrode array 42 is the same as that of the electrode array 32 of the electrode patch 30 in the first embodiment. The main difference between it and the electrode array 32 is the hierarchical structure of its electrode units 421.

[0056] Refer to Figures 9 and 10As shown, the electrode unit 421 includes a main body (not numbered), which includes a substrate 4211 made of polyimide or polyester film and a conductive sheet 4212 disposed on the upper surface of the substrate 4211. The thickness of the substrate 4211 is 10-50 μm, and the thickness of the conductive sheet 4212 is 10-75 μm. The electrode unit 421 also includes an insulating layer 4213 covering the substrate 4211 and partially covering the conductive sheet 4212, a dielectric layer 4214 covering the insulating layer 4213 and the portion of the conductive sheet 4212 that exposes the insulating layer 4213, and an alloy layer 4215 covering the dielectric layer 4214. The connecting portion 422, the wiring portion 423, and the main body (not numbered) of the electrode unit 421 together constitute a flexible circuit board (not numbered) of the electrode array 42. The conductive sheet 4212 has a through hole 4216 at its center. The electrode unit 421 also includes a pair of pads 4217 disposed on the substrate 4211 and located in the hole 4216 for electrically connecting to the temperature detection unit 4218. The temperature detection unit 4218 has a thickness of approximately 0.3-0.7 mm.

[0057] Fig.10 The shaded portion in the figure shows the insulating layer 4213, which presses the conductive sheet 4212 onto the substrate 4211 and exposes part of the conductive sheet 4212. The insulating layer 4213 is generally arranged in a hub shape, and the four sector-shaped areas 4219 of the conductive sheet 4212 expose the insulating layer 4213, and the pad 4217 also exposes the insulating layer 4213. The insulating layer 4213 covers part of the conductive sheet 4212 to prevent the part of the conductive sheet 4212 covered by the insulating layer 4213 from transmitting electrical signals to the dielectric layer 4214, thereby reducing the heating area of ​​the electrode unit 421 and improving the heat dissipation effect of the electrode unit 421. The insulating layer 4213 can be extended to each connecting portion 422 and the wiring portion 423.

[0058] The dielectric layer 4214 is laid with each electrode unit 421 as the object. The dielectric layer 4214 completely covers the upper surface of the conductive sheet 4212 to prevent the conductive sheet 4212 from directly contacting the patient, so as to avoid affecting the patient's safety due to the non-capacitive coupling between the electrode unit 421 and the patient. The dielectric layer 4214 is a polymer dielectric layer with a high dielectric constant and low dielectric loss, which is made of a thin film material with a non-fixed crystal orientation, high flexibility and high toughness. The material of the dielectric layer 4214 is a polymer with a dielectric constant of not less than 20 and a dielectric strength of not less than 40V / μm to avoid breakdown under normal applied voltage. The polymer is a polymer with relaxor ferroelectric behavior, which can be a vinyl fluoride polymer, such as P(VDF-TrFE-CTFE), P(VDF-TrFE-CFE) or P(VDF-TrFE-CFE-CTFE); it can also be a polyamide composite material, such as piperazine-biuret Biuret copolymer polyamide. The dielectric layer 4214 can be formed on the surface of the conductive sheet 4212 by evaporation, sputtering or ion plating vapor deposition, or by printing, spraying or casting. The thickness of the dielectric layer 4214 does not exceed 300 μm, and preferably, the thickness of the dielectric layer 4214 is 3 μm-10 μm.

[0059] The alloy layer 4215 disposed on the dielectric layer 4214 is used as an auxiliary layer to increase the conductivity between the dielectric layer 4214 and the adhesive member 43. The size of the alloy layer 4215 is slightly smaller than the size of the dielectric layer 4214, that is, the edge of the alloy layer 4215 is located inside the edge of the dielectric layer 4214. The material of the alloy layer 4215 can be one or more of zinc-aluminum alloy, zinc-copper alloy, silver-titanium, or graphite. The alloy layer 4215 can be deposited on the surface of the dielectric layer 4214 using a vapor deposition method. The thickness of the alloy layer 4215 is 3nm-100nm.

[0060] refer to Fig.11 As shown, the temperature detection unit 4218 includes a temperature sensor 4218A, and the temperature sensor 4218A has a signal terminal (not shown) and a ground terminal (not shown), which are respectively connected to the corresponding pad 4217 by welding or electrically connected to the corresponding pad 4217 through a lead 4218B. The temperature detection unit 4218 also includes a sealant 4218C that fills the through hole 4216 to seal the temperature sensor 4218A after the temperature sensor 4218A is welded to the substrate 4211 to prevent water vapor from corroding the temperature sensor 4218A and causing the temperature sensor 4218A to fail. The dielectric layer 4214 and the alloy layer 4215 cover the sealant 4218C.

[0061] refer to Fig.12As shown, since the thickness of the temperature detection unit 4218 is 0.3-0.7 mm, it is much larger than the thickness of the conductive sheet 4212 disposed on the substrate 4211 and on which the dielectric layer 4213 is disposed, so that after the temperature detection unit 4218 is welded and sealed with the pad 4217 located in the opening 4216 of the conductive sheet 4212 of the substrate 4211, its top end close to the patient's body surface protrudes far beyond the top surface of the conductive sheet 4212 close to the patient's body surface, so that after the dielectric layer 4214 and the alloy layer 4215 are laid, the portion corresponding to the dielectric layer 4214 and the alloy layer 4215 and the temperature detection unit 4218 protrudes far beyond the portion corresponding to the dielectric layer 4214 and the alloy layer 4215 and the conductive sheet 4212. The adhesive member 43 is provided with a groove 431 corresponding to the temperature detection unit 4218, which is used to accommodate the protruding portion corresponding to the electrode unit 421 and the temperature detection unit 4218. Due to the setting of the groove 431, the adhesive member 43 does not protrude significantly at the temperature detection unit 4218, which can avoid discomfort to the patient due to the protruding part of the electrode unit 421 close to the patient's body surface when the electrode patch 40 is applied to the patient's body surface, thereby improving the patient's comfort when applying the electrode patch 40. There is no obvious gap between the adhesive member 43 and the electrode unit 421 around the temperature detection unit 4218, which can ensure that the electrode unit 421 and the electrode patch 40 have stable electrical performance. In addition, the electrode patch 40 of this embodiment uses a dielectric layer 4214 made of a high molecular polymer to replace the dielectric element made of a traditional ceramic material, so that the electrode unit 421 of the electrode patch 40 is lighter, thinner, softer, and easier to form a tight fit with the patient's body surface. In addition, the temperature detection unit 4218 is also covered by the adhesive piece 43 which is in direct contact with the patient's body surface and is closer to the patient's body surface. The temperature of the adhesive piece 43 can be directly monitored more accurately and it is easier to quickly adjust the alternating electric signal when the temperature is abnormal, thereby improving the safety of tumor electric field therapy.

[0062] In this embodiment, the thickness of the temperature detection unit 4218 is 0.3-0.7 mm, and the thickness of the adhesive member 43 is 0.5-0.95 mm. The groove 431 is in the form of a blind hole, and the adhesive member 43 can completely cover the temperature detection unit 4218 to prevent the temperature detection unit 4218 from being exposed and directly contacting the patient.

[0063] refer to Fig.13 As shown, the electrode array 42' of the electrode patch 40 in the fifth embodiment of the present application has the same layer frame structure as the electrode array 42 of the electrode patch 40 in the fourth embodiment of the present application, and the difference between the two is only the number and arrangement of the electrode units 421'. The electrode array 42' is provided with twenty electrode units 421', which are roughly arranged in four rows and six columns, wherein the first row and the second row are arranged in an arc segment that is concave in the middle and upturned at both ends, and the third row and the fourth row are arranged in an arc segment that is convex in the middle and pressed down at both ends.

[0064] Fig.14 Shown is the electrode array 52 of the electrode patch in the sixth embodiment of the present application. The electrode array 52 of the electrode patch 50 in this embodiment has the same layer frame structure as the electrode array 42 of the electrode patch 40 in the fourth embodiment of the present application. The difference between the two is that the shape of the electrode array is different and the shape, number and arrangement of the electrode units are also different. However, the hierarchical structure of a single electrode unit 521 is the same as the electrode unit 421 of the electrode patch 40. The following mainly describes the differences.

[0065] The outer contour of the electrode array 52 is roughly arranged in a water drop shape, and the portion of the outer contour line covered by the adhesive 53 is shown in dotted lines. The electrode array 52 includes six electrode units 521 arranged at intervals, a plurality of connecting portions 522 connecting two adjacent electrode units 521, and a wiring portion 523 extending outward from one of the connecting portions 522. The six electrode units 521 are divided into a left part and a right part that are spaced apart and symmetrical on the left and right sides. The left part and the right part are symmetrically arranged in a roughly half water drop shape, wherein the left part includes a first electrode unit 521A, a second electrode unit 521B, and a third electrode unit 521C that are spaced apart from top to bottom, and the right part includes a fourth electrode unit 521D, a fifth electrode unit 521E, and a sixth electrode unit 521F that are spaced apart from top to bottom.

[0066] Each electrode unit 521 is arranged in a sheet shape, the first electrode unit 521A and the fourth electrode unit 521D are arranged roughly in a triangle shape, the second electrode unit 521B and the fifth electrode unit 521E are arranged roughly in a trapezoidal shape, and the third electrode unit 521C and the sixth electrode unit 521F are arranged roughly in a fan shape. The electrode array 52 uses electrode units 521 of different areas to better meet the attachment requirements of different positions on the patient's body surface, especially suitable for tumor electric field therapy in areas such as the head with a small attachment area and few flat areas. Among them, a temperature sensing unit (not shown) is each provided on the first electrode unit 521A, the third electrode unit 521C, the fourth electrode unit 521D and the sixth electrode unit 521F.

[0067] The plurality of connection parts 522 include a first connection part 5221 and a plurality of second connection parts 5222. The first connection part 5221 connects the second electrode unit 521B and the fifth electrode unit 521E to realize the electrical connection between the left part and the right part of the electrode array 52. ​​The first connection part 5221 is located in the interval (not numbered) formed between the left part and the right part of the electrode array 52. ​​The plurality of second connection parts 5222 are respectively connected between two adjacent electrode units 521 located in the left part and between two adjacent electrode units 521 located in the right part. The second connection part 5222 is arranged in an S shape, and the relative position of the two electrode units 521 connected thereto can be appropriately adjusted for convenient application. The wiring part 523 extends downward from the first connection part 5221 along the interval between the left part and the right part.

[0068] Adhesive pieces 53 are provided corresponding to the electrode units 521, and there are 6 pieces in total. Their shapes are consistent with the outer contour lines of the corresponding electrode units 521. The way in which adhesive pieces 53 cover the electrode units 521 is the same as the way in which adhesive pieces 34 in the first embodiment of the present application described above cover the electrode units 321. Adhesive pieces 53 cover the corresponding electrode units 521 in a one-to-one manner. The adhesive member 53 is provided with a groove (not shown) corresponding to the temperature detection unit (not shown) of the electrode unit 521 to accommodate the protruding parts corresponding to the electrode unit 521 and the temperature detection unit (not shown), thereby avoiding discomfort to the patient due to the protruding parts of the electrode unit 521 when the electrode patch 50 is applied, thereby improving the comfort of the patient when applying the electrode patch 50, and avoiding the presence of a gap between the adhesive member 53 and the electrode unit 521 through which air can enter due to the protrusions of the corresponding parts of the electrode unit 521 and the temperature detection unit (not shown) when the adhesive member 53 is applied on the electrode unit 521, thereby affecting the electrical performance of the electrode unit 521, thereby ensuring that the electrode unit 521 and the electrode patch 50 have stable electrical performance.

[0069] The above are only preferred implementation modes of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention shall 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 an adhesive member arranged on the electrode array, wherein the electrode array is provided with a plurality of electrode units and a plurality of connecting portions connecting two adjacent electrode units, and at least some of the electrode units include corresponding temperature detection units arranged thereon, characterized in that: The electrode unit has a protruding portion formed corresponding to the portion of the temperature detection unit arranged thereon, and the adhesive member covers the electrode unit and has a groove for accommodating the protruding portion of the electrode unit.

2. The electrode patch according to claim 1, characterized in that: The groove is a blind hole.

3. The electrode patch according to claim 1, characterized in that: The electrode unit includes a main body and a dielectric element arranged on the main body, the temperature detection unit is arranged on the main body, and the protruding portion is a portion of the temperature detection unit protruding from the top surface of the dielectric element.

4. The electrode patch according to claim 3, characterized in that: The dielectric element is provided with a through hole for the temperature detection unit to pass through, and the temperature detection unit includes a temperature sensor arranged on the main body and a sealant that seals the temperature sensor and fills the through hole.

5. The electrode patch according to claim 3, characterized in that: The thickness of the dielectric element is smaller than the thickness of the temperature detection unit.

6. The electrode patch according to claim 5, characterized in that: The thickness of the temperature detection unit is 0.4-0.7 mm, and the thickness of the dielectric element is 0.3-0.5 mm.

7. The electrode patch according to any one of claims 1 to 6, characterized in that: The thickness of the adhesive piece is 0.45-0.95 mm.

8. The electrode patch according to claim 1, characterized in that: The electrode unit includes a substrate and a conductive sheet arranged on the substrate. The temperature detection unit is arranged on the substrate. The electrode unit also includes a dielectric layer covering the conductive sheet and the temperature detection unit.

9. The electrode patch according to claim 8, characterized in that: The thickness of the temperature detection unit is greater than the thickness of the conductive sheet, and the portion of the dielectric layer covering the temperature detection unit forms the protrusion.

10. The electrode patch according to claim 8, characterized in that: The conductive sheet has an opening for the temperature detection unit to pass through, and the dielectric layer is a polymer dielectric layer with high dielectric constant and low dielectric loss.

11. The electrode patch according to claim 8, characterized in that: The electrode unit further includes an insulating layer which presses the conductive sheet onto the substrate and exposes a portion of the conductive sheet, and the dielectric layer covers the region of the conductive sheet where the insulating layer is exposed.

12. The electrode patch according to claim 10, characterized in that: The electrode unit further includes an alloy layer, the alloy layer covers the dielectric layer, and the adhesive member covers the alloy layer.

13. The electrode patch according to claim 12, characterized in that: The temperature detection unit includes a temperature sensor disposed on the substrate and a sealant filling the opening and sealing the temperature sensor, and the alloy layer and the dielectric layer cover the outside of the sealant.

14. The electrode patch according to any one of claims 1 to 6 and 8 to 13, characterized in that: The electrode array includes a left part and a right part which are bilaterally symmetrical, and each of the left part and the right part is provided with a plurality of electrode units with different shapes.

15. A tumor electric field treatment system, characterized in that: The invention comprises an electric field generator, an adapter and a plurality of electrode patches arranged in pairs as claimed in any one of claims 1 to 14.

Images