CN114099960B - Tumor electric field treatment system and electrode patch thereof - Google Patents

Abstract

The invention provides a tumor electric field treatment system and an electrode patch thereof, which are used for tumor electric field treatment, wherein the electrode patch comprises a flexible circuit board, a single dielectric element and a plurality of temperature sensors, the single dielectric element is electrically connected with the flexible circuit board, the number of the temperature sensors is n, n is an integer which is more than 1 and not more than 8, the temperature sensors are provided with a grounding end and a signal end, the flexible circuit board is provided with an insulating substrate and a plurality of paths of conductive traces which are embedded in the insulating substrate, the paths of conductive traces are n +2 paths, one path of conductive trace is electrically connected with the dielectric element, one path of conductive trace is electrically connected with the grounding ends of all the temperature sensors, and the rest conductive traces are respectively electrically connected with the signal ends of the corresponding temperature sensors. The electrode patch of the invention applies the alternating electric field to the tumor part of the human body by the single dielectric element for tumor electric field treatment, can be easily replaced when the electrode patch cannot work normally, does not need to scrap the whole electrode patch, and reduces the cost.

Description

Tumor electric field treatment system and electrode patch thereof

Technical Field

The invention relates to an electric field tumor treatment system and an electrode patch thereof, belonging to the technical field of medical instruments.

Background

At present, the treatment modes of tumors mainly comprise operations, radiotherapy, chemotherapy and the like, but the methods have corresponding disadvantages, for example, radiotherapy and chemotherapy can generate side effects and kill normal cells. The use of electric fields to treat tumors is also one of the leading lines of research and development, and electric field therapy of tumors is a method of tumor treatment by interfering with the mitotic progression of cancer cells using low-intensity, medium-high frequency alternating electric fields. Research shows that the electric field treatment has obvious effect in treating diseases such as glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma and the like, and the electric field applied by the treatment method can influence the aggregation of tubulin of dividing cancer cells, prevent the formation of spindles of the dividing cancer cells, inhibit the mitotic process of the cancer cells and induce the apoptosis of the cancer cells.

The existing electrode patch for tumor electric field therapy as disclosed in chinese patent publication No. 112717272 includes a non-woven fabric and an electrical functional component adhered to the non-woven fabric. The electrical functional component is approximately in a shape like a Chinese character 'wang', and comprises a flexible circuit board, nine ceramic plates welded on the flexible circuit board and arranged at intervals, nine temperature sensors welded on the flexible circuit board and a lead electrically connected with the flexible circuit board. The middle part of the ceramic plate is provided with a through hole for accommodating the temperature sensor. The temperature sensor and the ceramic plate are positioned on the same side of the flexible circuit board. The temperature sensor is accommodated in the through hole of the ceramic plate after being welded on the flexible circuit board. The temperature sensor has a signal terminal and a ground terminal. Nine annular conductive discs and nine pairs of bonding pads which are in one-to-one correspondence with the ceramic plates are arranged on the flexible circuit board. The ceramic chip is electrically connected with the flexible circuit board by being welded with the annular conductive disc. Each pair of bonding pads is surrounded by a corresponding annular conductive disc and is respectively connected with a signal end and a grounding end of a temperature sensor. The temperature sensor is electrically connected with the flexible circuit board through the signal end of the temperature sensor welded with one bonding pad in each pair of bonding pads and the grounding end welded with the other bonding pad in each pair of bonding pads.

The flexible circuit board comprises an insulating base body and eleven conductive traces embedded in the insulating base body. One of the eleven conductive traces is electrically connected with the nine annular conductive discs respectively so as to connect the nine conductive discs in series, and further connect the nine ceramic sheets in series when the nine ceramic sheets are welded on the flexible circuit board through the corresponding conductive discs. And the other of the eleven conductive traces is electrically connected with the bonding pad which is welded with the grounding end of the temperature sensor in each pair of bonding pads so as to connect all the bonding pads which are connected with the grounding end of the temperature sensor in series, and further connect the grounding ends of the temperature sensor in series when the temperature sensor is welded on the flexible circuit board. And the rest of the eleven conductive traces are respectively and electrically connected with the corresponding pad which is welded with the signal end of the temperature sensor in each pair of pads, so that the signal ends of the temperature sensors are connected in parallel when the temperature sensors are welded on the flexible circuit board. The electrode patch connects all the ceramic plates together in series through a trace line electrically connected with the ceramic plates by the flexible circuit board so as to transmit electric signals to all the ceramic plates simultaneously, thereby realizing the application of an alternating electric field to the tumor part of a patient for tumor electric field treatment; meanwhile, the detection signals of the temperature sensors are transmitted in parallel through the flexible circuit board and the multi-path traces which are electrically connected with the signal ends of the temperature sensors respectively, so that the body surface temperature of the patient at the corresponding part of each temperature sensor can be monitored timely and efficiently, and low-temperature scalding is avoided.

Although the electrode patch realizes the purposes of applying an alternating electric field to a tumor part of a patient and detecting the body surface temperature of the patient through the flexible circuit board, the ceramic sheet welded on the flexible circuit board and the temperature sensors, the flexible circuit board needs to be provided with 11 paths of conducting traces on an insulating substrate of the flexible circuit board so as to ensure that the signal end of each temperature sensor is provided with one independent conducting trace for signal transmission and realize the temperature monitoring of the corresponding part, so that the structure of the flexible circuit board is complicated, the wiring design difficulty is increased, and the manufacturing cost is increased; the nine ceramic plates are welded on the flexible circuit board through the corresponding conductive plates, but all the conductive plates carry out electric signal transmission through the same conductive trace of the flexible circuit board, so that the problems that the conductive trace of the flexible circuit board is broken or a certain ceramic plate is not well welded, so that the electric signal cannot be transmitted to the ceramic plates, the electrode patch is unqualified to detect and scrap, the electrode patch cannot be used, the product manufacturing yield is low, and the manufacturing cost is increased exist; in addition, since the conductive pads on the flexible printed circuit are all connected in series through one conductive trace, the flexible printed circuit needs to be electrically tested before the ceramic sheet is welded to the flexible printed circuit, and then the ceramic sheet is welded to the flexible printed circuit, which causes complex working procedures and low efficiency. In addition, the welding fracture of the ceramic wafer occurs in the use process of the electrode patch, so that an electric signal cannot be applied to a tumor part of a patient through the ceramic wafer, the electric field intensity of tumor electric field treatment is insufficient, the effect of the tumor electric field treatment is influenced, or the ceramic wafer cannot be discarded and cannot be processed, so that the cost is wasted; the problem that the electrode patch needs to be replaced due to the fact that an electric signal cannot be transmitted to the ceramic chip caused by the fact that a conducting trace of the flexible circuit board connected with the ceramic chip in series is broken exists; the problem that the temperature sensor cannot accurately detect the body surface temperature of the tumor part of the corresponding patient due to the fact that a conducting trace connected with the signal end of the flexible circuit board and the temperature sensor is broken exists, and low-temperature scalding exists.

Therefore, there is a need for an improved electrode patch and an improved electric field tumor therapy system to overcome the problems of the prior art.

Disclosure of Invention

The invention provides an electrode patch and a tumor electric field treatment system which are low in design difficulty, simple in structure, easy to manufacture and capable of being manufactured at low cost.

The electrode patch is realized by the following technical scheme: an electrode patch is used for tumor electric field treatment and comprises a flexible circuit board, a single dielectric element and a plurality of temperature sensors, wherein the single dielectric element is electrically connected with the flexible circuit board, the temperature sensors are n in number, n is an integer larger than 1 and not larger than 8, each temperature sensor is provided with a grounding end and a signal end, the flexible circuit board is provided with an insulating substrate and a plurality of paths of conductive traces embedded in the insulating substrate, the paths of conductive traces are n +2 paths, one path of conductive trace in the conductive traces is electrically connected with the dielectric element, one path of conductive trace is electrically connected with the grounding ends of all the temperature sensors, and the rest conductive traces are respectively electrically connected with the signal ends of the corresponding temperature sensors.

Furthermore, the flexible circuit board is provided with a wiring part which is electrically connected with the dielectric element and the temperature sensor, and the dielectric element and the temperature sensor are both positioned at one end of the wiring part.

Furthermore, the flexible printed circuit board further comprises a lead, one end of the lead is electrically connected with the wiring portion of the flexible printed circuit board, and the lead and the dielectric element are respectively positioned at two opposite ends of the wiring portion.

Furthermore, one end of the lead is electrically connected with the wiring part of the flexible circuit board, and the other end of the lead is provided with a plug.

Furthermore, a conductive disc welded with the dielectric element is arranged on the flexible circuit board, and the conductive disc is arranged at one end of the wiring portion.

Furthermore, the conductive disc exposes out of the insulating substrate and is connected with a conductive trace electrically connected with the flexible circuit board and the dielectric element.

Furthermore, the n temperature sensors are all arranged in an area formed by surrounding the conductive disc, and the extending direction of the straight line where the n temperature sensors are located is consistent with the extending direction of the wiring part.

Furthermore, the conductive disc comprises a plurality of conductive cores arranged at intervals, and the conductive cores are connected in series by a conductive trace electrically connected with the dielectric element through the flexible circuit board.

Furthermore, the plurality of conductive cores are arranged at intervals in a matrix shape, and 4 conductive cores in adjacent rows and adjacent columns in the plurality of conductive cores are arranged in a central symmetry shape.

Furthermore, the n temperature sensors are respectively arranged in a symmetrical center shape deviating from the 4 conductive cores corresponding to the conductive discs.

Furthermore, the number of the temperature sensors is two, one of the two temperature sensors is arranged on one side, away from the wiring portion, of the symmetry centers of the corresponding 4 conductive cores, and the other temperature sensor is arranged on one side, close to the wiring portion, of the symmetry centers of the corresponding 4 conductive cores.

Furthermore, the flexible circuit board is provided with n pairs of pads corresponding to the temperature sensors and located at one end of the wiring portion, and the n pairs of pads and the conductive disc are located at the same end of the wiring portion.

Further, each pair of pads comprises a first pad and a second pad, the first pad is welded with the grounding end of the temperature sensor, and the second pad is welded with the signal end of the corresponding temperature sensor.

Further, each pair of pads is arranged in a symmetrical center deviating from the corresponding 4 conductive cores.

Furthermore, the two pairs of bonding pads are provided, wherein one pair of bonding pads is arranged on one side, away from the wire connection part, of the symmetry centers of the corresponding 4 conductive cores, and the other pair of bonding pads is arranged on one side, close to the wire connection part, of the symmetry centers of the corresponding 4 conductive cores.

Furthermore, a straight line where the symmetric center of each pair of the n pairs of bonding pads is located is parallel to the extending direction of the wiring portion.

Furthermore, the first bonding pad is connected with a conductive trace electrically connected with the flexible circuit board and the grounding end of the temperature sensor, and the second bonding pads are respectively connected with a conductive trace electrically connected with the flexible circuit board and the signal end of the corresponding temperature sensor.

Furthermore, the dielectric element is provided with a through hole which is arranged corresponding to the temperature sensor, and the temperature sensor is accommodated in the corresponding through hole.

Further, the number of the temperature sensors is 2, the number of the conductive traces is 4, and the number of the conductive cores is 6.

Further, the flexible printed circuit board comprises a backing adhered to the corresponding part of the flexible printed circuit board.

The insulating plate is arranged opposite to the dielectric element, the insulating plate and the dielectric element are arranged correspondingly in the thickness direction, and the insulating plate is clamped between the dielectric element and the backing.

The tumor electric field treatment system is realized by the following technical scheme: an electric field tumor treating system comprises an electric field generator and the electrode patch electrically connected with the electric field generator.

Furthermore, a plug is arranged at the tail end of the lead of the electrode patch and is connected with the electric field generator in an inserting mode.

Furthermore, the electrode patch comprises a concentrator electrically connected with the electric field generator, wherein a plug is arranged at the tail end of a lead of the electrode patch, and the plug is spliced with the concentrator.

Because the single dielectric element is adopted to apply the alternating voltage to the tumor part of the patient, when the electrode patch can not work normally, only the electrode patch with the single dielectric element needs to be replaced, and the whole electrode patch containing a plurality of dielectric elements does not need to be scrapped, so that the cost of tumor treatment of the patient can be reduced. In addition, the electrode patches can be freely combined according to the size of the tumor part of the patient, so that the coverage area of the electrode patches for tumor electric field treatment is ensured, and the electric field treatment effect is ensured. Meanwhile, the flexible circuit board of the electrode patch of the tumor electric field treatment system is only provided with one first conductive trace electrically connected with the dielectric element, one second conductive trace electrically connected with the grounding ends of all the temperature sensors and n third conductive traces electrically connected with the signal ends of the corresponding temperature sensors respectively, so that the alternating voltage signal of the electric field generator is transmitted to the dielectric element through the first conductive trace, and the purpose of applying alternating voltage to the tumor part of a patient for tumor treatment is further realized; meanwhile, the temperature signal monitored by the temperature sensor is quickly transmitted to the electric field generator through the second conductive trace and the third conductive trace, so that the signal between the electric field generator and the temperature sensor is quickly transmitted, the wiring design difficulty is low, the structure is simple, the manufacturing process is simplified, the manufacturing is easy, the product manufacturing yield is high, and the manufacturing cost can be greatly reduced.

Drawings

Fig. 1 is a perspective combination view of an electrode patch according to a first embodiment of the electric field tumor therapy system of the present invention.

Fig. 2 is an exploded perspective view of the electrode patch of fig. 1.

Fig. 3 is an exploded perspective view of the electrical functional components and leads of the electrode patch of fig. 2.

Fig. 4 is a schematic plan view of a flexible circuit board of the electrode patch of fig. 3.

Fig. 5 is a plan view of a dielectric element of the electrode patch of fig. 3.

Fig. 6 is a front wiring diagram of the flexible circuit board of the electrical functional assembly of fig. 4.

Fig. 7 is a rear wiring diagram of the flexible circuit board of the electrical functional assembly of fig. 4.

Fig. 8 is a perspective combination view of an electrode patch of a second embodiment of the electric field tumor therapy system according to the present invention.

Description of the reference numerals:

theelectrode patch 100, 100', theelectrical function component 1, theelectrode unit 10, theflexible circuit board 11, thebody portion 111, thewire connection portion 112, thegold finger 1120, theconductive pad 113, theconductive core 1130, thepad 114, thefirst pad 114A, thesecond pad 114B, theinsulating plate 12, thedielectric element 13, the throughhole 131, themetal layer 132, thetemperature sensor 14, thebacking 2,2', the reentrant corner 21', thesupport 3, the throughhole 31, thesticker 4, thewire 5, theheat shrinkable sleeve 51, theplug 52, the insulating substrate B, the conductive trace L, the first conductive trace L1, the second conductive trace L2, the third conductive trace L3, L3', and the space C.

Detailed Description

Reference will now be made in detail to the exemplary embodiments, examples of which are illustrated in the accompanying drawings. The following description refers to the accompanying drawings in which the same numbers in different drawings represent the same or similar elements unless otherwise indicated. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present invention. Rather, they are merely examples of devices, systems, apparatus, and methods consistent with certain aspects of the invention.

The tumor electric field therapy system (not shown) comprises an electric field generator (not shown) andelectrode patches 100, 100' connected to the electric field generator (not shown). Theelectrode patches 100, 100' are applied to the skin surface of a human body, and a therapeutic electric field generated by an electric field generator (not shown) is applied to the human body to perform electric field treatment of tumors. When theelectrode patches 100, 100 'sufficiently cover the tumor site, theelectrode patches 100, 100' of the embodiments of the present invention may be used alone and directly connected to an electric field generator (not shown). In addition, a plurality ofelectrode patches 100 and 100 'according to the embodiment of the present invention may be used in combination, and the plurality ofelectrode patches 100 and 100' are connected to a hub (not shown) to perform electric field therapy of tumors at a tumor site.

Fig. 1 to 7 show anelectrode patch 100 according to a first embodiment of the present invention. Theelectrode patch 100 includes abacking 2, an electricalfunctional component 1 adhered to thebacking 2, asupport member 3 adhered to thebacking 2, anadhesive member 4 covering thesupport member 3 and a corresponding portion of the electricalfunctional component 1 and attached to a body surface skin corresponding to a tumor region of a patient, and alead 5 electrically connected to the electricalfunctional component 1. Theelectrode patch 100 is attached to the body surface of a patient corresponding to the tumor part through thebacking 2, and applies an alternating electric field to the tumor part of the patient through the electricfunctional component 1 to interfere or prevent the mitosis of cancer cells of the patient, thereby achieving the purpose of treating the tumor.

The electricalfunctional assembly 1 includes a singlerectangular electrode unit 10 arranged in a sheet shape, and awiring portion 112 connected to theelectrode unit 10. Thewiring portion 112 is welded to thelead 5, so as to electrically connect the electricalfunctional assembly 1 and thelead 5. A plurality ofgold fingers 1120 are arranged on one side surface of thewire connection part 112. In this embodiment, the number of thegold fingers 1120 is four, and the fourgold fingers 1120 are provided on the surface of theconnection portion 112 facing the skin. The periphery of the welding position of thelead 5 and thegold finger 1120 of thewire connection part 112 is covered with aheat shrinkage sleeve 51. The heat-shrinkable sleeve 51 performs insulation protection on the connection part of thewire 5 and thewiring part 112 of the electricalfunctional assembly 1, provides support, prevents the connection part of thewire 5 and thewiring part 112 of the electricalfunctional assembly 1 from being broken, and can prevent dust and water. The end of thelead 5 away from thewire connection portion 112 is provided with aplug 52 electrically connected to an electric field generator (not shown) or a hub (not shown). One end of thelead 5 is electrically connected to thegold finger 1120 of thewiring portion 112; the other end is electrically connected to an electric field generator (not shown) or a hub (not shown) through theplug 52, so as to provide theelectrode patch 100 with an alternating current signal for tumor therapy during tumor electric field therapy.

Theelectrode unit 10 includes amain body 111 provided at the end of thewire connection portion 112, an insulatingplate 12 provided on the side of themain body 111 away from the skin of the human body, adielectric element 13 provided on the side of themain body 111 facing the skin of the human body, and twotemperature sensors 14 provided on themain body 111 and located on the same side as thedielectric element 13. Themain body portion 111 and thelead wire 5 are provided at opposite ends of thewire connection portion 112, respectively. Thedielectric element 13 is provided with two throughholes 131, the number of which is the same as that of thetemperature sensors 14, for receiving thecorresponding temperature sensors 14 respectively. Themain body 111, the insulatingplate 12, and thedielectric element 13 have substantially the same shape, and are all rectangular sheet-like structures. Themain body 111, the insulatingplate 12, and thedielectric element 13 are provided correspondingly in the thickness direction of themain body 111, and the centers of the three are located on the same line. In the present embodiment, themain body 111, the insulatingplate 12, and thedielectric element 13 are each a rectangular sheet-like structure with rounded corners. Preferably, themain body 111 has a rectangular plate-like configuration with dimensions of about 43.5mm × 23.5 mm. Thewire connection portion 112 of the electricalfunctional assembly 1 is extended laterally from themain body portion 111 of theelectrode unit 10. In other embodiments, themain body 111 may also be a strip or belt-like structure extending from the end of thewire connection portion 112.

Themain body 111 is composed of an insulating substrate B and four conductive traces L embedded in the insulating substrate B. The four conductive traces are respectively a first conductive trace L1 arranged on one side of the insulating substrate B close to thedielectric element 13, a second conductive trace L2 arranged on one side of the insulating substrate B close to the insulatingplate 12, and two third conductive traces L3 and L3' positioned on the same side of the second conductive trace L2. Themain body 111 is centrally provided with aconductive pad 113 exposing the insulating substrate B and electrically connected to the first conductive trace L1. Theconductive plate 113 may be welded to thedielectric member 13 to assemble thedielectric member 13 to themain body 111. Theconductive pads 113 can be completely covered by thedielectric element 13 so that theconductive pads 113 and thedielectric element 13 are soldered by a solder (not shown). Theconductive pad 113 is centered on the centerline of thebody 111. Theconductive pad 113 includes a plurality ofconductive cores 1130 arranged in a central symmetry manner, which can effectively prevent thedielectric element 13 from being displaced due to stacking of solder (not shown) during the soldering process. The top surfaces of theconductive cores 1130 are located on the same plane, so that cold joint with thedielectric element 13 can be avoided. The plurality ofconductive cores 1130 are each connected to a first conductive trace L1. The plurality ofconductive cores 1130 are connected together in series by a first conductive trace L1.

In the present embodiment, theconductive pads 113 of themain body 111 have a substantially rectangular configuration, and the symmetry axes thereof coincide with the respective symmetry axes of themain body 111. Theconductive pad 113 includes 6conductive cores 1130 located at four corners and middle portions of two long sides thereof and arranged at intervals. Theconductive core 1130 is arranged in a multi-point interval mode, so that the using amount of copper foil for manufacturing theconductive core 1130 can be reduced; meanwhile, the amount of solder (not shown) used for welding theconductive core 1130 and thedielectric element 13 can be reduced, thereby reducing the manufacturing cost. Each of theconductive cores 1130 is of rectangular configuration having dimensions of about 8mm by 4 mm. Preferably, each of theconductive cores 1130 has a rectangular configuration with rounded corners. The longitudinal axis of each of theconductive cores 1130 is perpendicular to the extending direction of thewire connecting portion 112. In other embodiments, eachconductive core 1130 of theconductive disc 113 may also be circular, square, or the like.

In this embodiment, the 6conductive cores 1130 constituting theconductive pad 113 are arranged at intervals in a matrix, and the 6conductive cores 1130 are arranged in three rows and two columns along the longitudinal direction of themain body 111. The first row has 2conductive cores 1130, the middle row has 2conductive cores 1130, and the last row has 2conductive cores 1130. The spacing between two rows ofcores 1130 is about 2.4mm, and the spacing between adjacent rows ofcores 1130 is about 12.8mm. The 6conductive cores 1130 forming theconductive disc 113 are arranged in a centrosymmetric manner and an axisymmetric manner, and eachconductive core 1130 is also arranged in an axisymmetric manner, so that when the 6conductive cores 1130 of themain body portion 111 are welded with thedielectric element 13, the stress of each welding point is balanced, the overall welding balance of thedielectric element 13 is ensured, the welding quality is improved, and the problem that the welding part on the side with a larger interval between thedielectric element 13 and themain body portion 111 is easy to break due to weak strength of the welding part caused by the inclination of thedielectric element 13 due to the unbalanced welding stress is avoided; while also avoiding an impact on the degree of fit of theelectrode patch 100. The 6conductive cores 1130 of theconductive disc 113 are arranged at intervals, and a space C is formed between two adjacentconductive cores 1130. The 4conductive cores 1130 in adjacent rows are arranged in a spaced-apart manner, and the 4 spaces C between the 4conductive cores 1130 are arranged in a cross-shaped communication manner. The dimension of the space C between two adjacentconductive cores 1130 in the same column is greater than the dimension of the space C between twoconductive cores 1130 in the same row. The 6conductive cores 1130 form 7 intervals C therebetween, and the 7 intervals C are arranged in a substantially "≠" shaped communication. The adjacent spaces C are also arranged in a communicated manner. The straight lines of 3 intervals C between two adjacentconductive cores 1130 in the same row in the 7 intervals C are consistent with the extending direction of thewire connecting portion 112.

Themain body 111 is further provided with two pairs ofpads 114 exposing the insulating substrate B, and the pads can be respectively welded to corresponding portions of thecorresponding temperature sensors 14 to electrically connect thetemperature sensors 14 and themain body 111. Each pair oflands 114 is provided at a corresponding connected region of 4 spaces C formed by the spacing of 4conductive cores 1130 in adjacent rows. The straight line of the connection line of the respective symmetric centers of the two pairs ofbonding pads 114 is consistent with the extending direction of thewire connecting portion 112. The straight line connecting the two symmetrical centers of the two pairs ofpads 114 coincides with the longitudinal axis of themain body 111. The straight line of the connecting line of the two symmetrical centers of the two pairs ofbonding pads 114 is coincident with the longitudinal axis of theconductive plate 113. The first row and the middle 4conductive cores 1130 are arranged in a central symmetry manner, and the middle row and the last row of 4conductive cores 1130 are also arranged in a central symmetry manner. The two pairs ofpads 114 are each disposed off-center from the symmetry of the 4conductive cores 1130 in two adjacent rows. Specifically, the pair ofpads 114 is disposed on a side of a symmetry center of a rectangle surrounded by the 4conductive cores 1130 in the first row and the middle row, which is far from thewire connection portion 112. The other pair ofpads 114 is disposed on a side of a symmetry center of a rectangle surrounded by the 4conductive cores 1130 in the middle row and the last row, the side being close to thewire connection portion 112. Each of the pairs ofpads 114 includes afirst pad 114A and asecond pad 114B. Thefirst pad 114A of each pair ofpads 114 is electrically connected to the second conductive trace L2. One of the twosecond pads 114B is electrically connected to the third conductive trace L3, and the other is electrically connected to the third conductive trace L3'. Thetemperature sensor 14 has a signal terminal (not shown) and a ground terminal (not shown). Thefirst pad 114A is soldered to a ground terminal (not shown) of thetemperature sensor 14, and thesecond pad 114B is soldered to a signal terminal (not shown) of thetemperature sensor 14.

The insulatingplate 12 is made of an insulating material. Preferably, the insulatingplate 12 is an epoxy glass cloth laminate. The insulatingplate 12 is adhered to the surface of themain body 111 away from the skin of the human body by a sealant (not shown), so that the strength of themain body 111 can be enhanced, a flat welding plane can be provided for the welding operation between themain body 111 and thedielectric element 13, and the product yield can be improved. Meanwhile, the insulatingplate 12 can also isolate the moisture in the air on the side of theelectrode patch 100 away from the skin from contacting the solder (not shown) between themain body 111 and thedielectric element 13, so as to prevent the moisture from eroding the solder (not shown) between themain body 111 and thedielectric element 13 and affecting the electrical connection between themain body 111 and thedielectric element 13.

The size of the insulatingplate 12 is the same as that of themain body 111, so as to prevent the insulatingplate 12 from climbing to the side of themain body 111 facing the skin of the human body through the capillary effect when the insulatingplate 12 is stuck to the side of themain body 111 away from the skin of the human body through a sealant (not shown), thereby affecting the filling of the sealant (not shown) in a gap (not shown) formed by welding thedielectric element 13 and themain body 111, resulting in a void in the sealant (not shown), and further preventing the sealant (not shown) from causing the rapid expansion of water vapor to cause bursting, generating popcorn phenomenon and damaging the product due to the large difference of the thermal expansion coefficients of the water vapor in the void and the sealant (not shown) during the high-temperature curing.

Thedielectric element 13 is made of a high dielectric constant material, and has a conductive characteristic of blocking conduction of direct current and allowing passage of alternating current, so that safety of a human body can be guaranteed. Preferably, thedielectric element 13 is a dielectric ceramic sheet. Ametal layer 132 is attached to a surface of thedielectric element 13 facing thebody 111. Themetal layer 132 of thedielectric element 13 and theconductive core 1130 of theconductive pad 113 of themain body 111 are welded point to surface, so that high welding alignment precision is not required, and the welding is more convenient. The inner edge of themetal layer 132 of thedielectric element 13 is spaced from the edge of the throughhole 131 of thedielectric element 13, so that the solder (not shown) between themetal layer 132 of thedielectric element 13 and themain body 111 is prevented from spreading toward the throughhole 131 of thedielectric element 13 when being melted by heat, thereby preventing thetemperature sensor 14 from being short-circuited. The outer edge of themetal layer 132 of thedielectric element 13 is spaced from the outer edge of thedielectric element 13, so that the solder (not shown) between themetal layer 132 of thedielectric element 13 and themain body 111 is prevented from overflowing to the outside of themain body 111 when being melted by heat, and thus, when theelectrode patch 100 is applied to the body surface of the tumor region of the patient, direct current that is not blocked by thedielectric element 13 passes through and acts on the body surface of the patient.

A gap (not shown) formed by welding thedielectric element 13 and themain body part 111 is filled with a sealant (not shown) to protect a soldering tin (not shown) between thedielectric element 13 and themain body part 111, so as to avoid the fracture of the welding position caused by the influence of an external force on thedielectric element 13, and further prevent an alternating electric field from being applied to a tumor part of a patient through thedielectric element 13; meanwhile, it is avoided that moisture in the air enters the gap (not shown) to erode solder (not shown) between themain body 111 and thedielectric element 13, thereby affecting the electrical connection between themain body 111 and thedielectric element 13. The size of thedielectric element 13 is slightly smaller than that of themain body 111, so that when the sealant (not shown) is filled, the sealant (not shown) can be filled into the gap (not shown) along the edge of themain body 111 located outside thedielectric element 13 by capillary phenomenon, which is beneficial to filling the sealant (not shown) in the gap (not shown) formed by welding thedielectric element 13 and themain body 111. When the sealant (not shown) is filled in the gap (not shown) formed by welding thedielectric element 13 and thebody 111, the air in the gap (not shown) can be discharged from the throughhole 131 of thedielectric element 13, thereby preventing the sealant (not shown) filled in the gap (not shown) from generating a cavity and improving the product quality.

One of the twotemperature sensors 14 is located at a 4-interval C connected region between the 4conductive cores 1130 of the first and middle rows, and the other is located at a 4-interval C connected region between the 4conductive cores 1130 of the middle and last rows. Thetemperature sensor 14 in the area surrounded by the 4conductive cores 1130 in the first row and the middle row is arranged on one side, away from thewiring portion 112, of the symmetric center of the area surrounded by the 4conductive cores 1130 in the first row and the middle row. Theother temperature sensor 14 in the area enclosed by the 4conductive cores 1130 in the middle row and the last row is arranged on one side, close to thewiring portion 112, of the symmetry center of the area enclosed by the 4conductive cores 1130 in the middle row and the last row. The twotemperature sensors 14 are both arranged in the area enclosed by theconductive plate 113. Each of thetemperature sensors 14 is soldered to afirst pad 114A provided on themain body portion 111 through a ground terminal (not shown) thereof and to a correspondingsecond pad 114B provided on themain body portion 111 through a signal terminal (not shown) thereof to achieve electrical connection with themain body portion 111. Since the twofirst pads 114A of themain body 111 are electrically connected to the second conductive trace L2, one of the twosecond pads 114B is electrically connected to the third conductive trace L3, and the other of the twosecond pads 114B is electrically connected to the third conductive trace L3', thefirst pads 114A are soldered to the ground (not shown) of thetemperature sensor 14, and the twosecond pads 114B are soldered to the corresponding signal terminals (not shown) of the twotemperature sensors 14, respectively, so that the ground (not shown) of the twotemperature sensors 14 are electrically connected to the second conductive trace L2 of themain body 111, and the signal terminals (not shown) of the twotemperature sensors 14 are electrically connected to the third conductive traces L3, L3' of themain body 111, respectively. I.e. the twotemperature sensors 14 transmit their monitored temperature signals in parallel with the third conducting trace L3, L3' via the second conducting trace L2. The twotemperature sensors 14 are respectively accommodated in the corresponding throughholes 131 of thedielectric element 13 after being soldered to themain body 111. Preferably, thetemperature sensor 14 is a thermistor. Thetemperature sensor 14 is used for monitoring the temperature of theadhesive member 4 covering the side of thedielectric element 13 of the electricalfunctional assembly 1 facing the skin of the human body and further for detecting the temperature of the skin of the human body to which theadhesive member 4 is attached. When the temperature monitored by thetemperature sensor 14 exceeds the upper limit of the human body safe temperature, the tumor electric field treatment system (not shown) can timely reduce or turn off the alternating voltage applied to theelectrode patch 100 to avoid low-temperature scald of the human body. The twotemperature sensors 14 are symmetrically arranged on themain body 111, and can detect the temperature of the human skin corresponding to different positions, thereby ensuring the reliability of the detected data. The twotemperature sensors 14 are soldered to themain body 111 through two pairs ofsoldering pads 114 of themain body 111 and then sealed with a sealant (not shown) to prevent moisture from attacking thetemperature sensors 14 and causing thetemperature sensors 14 to fail.

Thewire connecting portion 112 has the same configuration as themain body portion 111, and also has a corresponding insulating substrate B and four conductive traces L embedded in the insulating substrate B. The four conductive traces L of thewire connection portion 112 are electrically connected to the corresponding conductive traces L of themain body portion 111 in a one-to-one correspondence manner. The 4gold fingers 1120 of thewiring portion 112 are exposed from one side of the insulating substrate B close to thedielectric element 13. The four conductive traces L of thewiring portion 112 are electrically connected to thegold fingers 1120 respectively. The four conductive traces L of thewire connection portion 112 are also the first conductive trace L1, the second conductive trace L2 and the third conductive traces L3 and L3', respectively. The first conductive trace L1 of thewire connection portion 112 is extended from the first conductive trace L1 of themain body portion 111. The second conductive trace L2 of thewire connection portion 112 is extended from the second conductive trace L2 of themain body portion 111. The third conductive traces L3, L3 'of thewire connection portion 112 are respectively extended from the corresponding third conductive traces L3, L3' of themain body portion 111.

Thewire connection portion 112 is connected to the first conductive trace L1 of themain body portion 111 through the first conductive trace L1, the first conductive trace L1 of themain body portion 111 is connected to theconductive pad 113 on themain body portion 111, so as to electrically connect to theconductive pad 113 of themain body portion 111, and further electrically connect to thedielectric element 13 through the soldering between theconductive pad 113 of themain body portion 111 and thedielectric element 13. Thewire connecting portion 112 is electrically connected to thefirst pad 114A of themain body portion 111 by connecting the second conductive trace L2 of the wire connecting portion to the second conductive trace L2 of themain body portion 111, and connecting the second conductive trace L2 of themain body portion 111 to thefirst pad 114A of themain body portion 111, and further electrically connected to a ground terminal (not shown) of thetemperature sensor 14 by welding thefirst pad 114A to the ground terminal (not shown) of thetemperature sensor 14. Thewire connecting portion 112 is connected to the corresponding third conductive traces L3, L3' of themain body portion 111 through the third conductive traces L3, L3', and the third conductive traces L3, L3' of themain body portion 111 are connected to the correspondingsecond pads 114B respectively to realize electrical connection with the twosecond pads 114B on themain body portion 111, and further, the twosecond pads 114B are welded to the corresponding signal terminals (not shown) of the twotemperature sensors 14 respectively to realize parallel electrical connection with the signal terminals (not shown) of the twotemperature sensors 14, so that the temperature signals monitored by the 2 temperature sensors are quickly transmitted to the electric field generator (not shown) in parallel, so that the electric field generator (not shown) can timely and efficiently adjust the alternating voltage or the alternating current applied to thedielectric element 13 to achieve the purpose of avoiding low-temperature scald caused by too high temperature.

Themain body portion 111 and thewire connection portion 112 together constitute theflexible circuit board 11 of the electricalfunctional assembly 1. The insulating substrates B of themain body portion 111 and thewire connection portion 112 together constitute an insulating substrate B of theflexible circuit board 11. The conductive traces L of themain body portion 111 and the conductive traces L of thewire connection portion 112 form the conductive traces L of theflexible circuit board 11 in a one-to-one correspondence. The insulating substrate B of theflexible circuit board 11 can isolate moisture in the air around theelectrode patch 100 from the solder (not shown) between theconductive pad 113 and thedielectric element 13, so as to prevent the moisture in the air away from the skin from eroding the solder (not shown) between theconductive pad 113 on themain body 111 of theflexible circuit board 11 and thedielectric element 13. The insulating substrate B of theflexible circuit board 11 and the insulatingplate 12 perform a dual isolation function, which may extend the lifespan of theelectrode patch 100.

From the perspective of forming theelectrode unit 10, the insulatingplate 12 is disposed on the side of themain body portion 111 of theflexible circuit board 11 away from the skin of the human body, thedielectric element 13 is disposed on the side of themain body portion 111 of theflexible circuit board 11 facing the skin of the human body, and the twotemperature sensors 14 are disposed on the side of themain body portion 111 of theflexible circuit board 11 facing the skin of the human body. The insulatingplate 12 and thedielectric element 13 are respectively provided on opposite sides of themain body 111 of theflexible circuit board 11. The first conductive trace L1 of theflexible circuit board 11 connects the 6 spacedconductive cores 1130 of theconductive pads 113 in series, the second conductive trace L2 is electrically connected to the ground terminals (not shown) of the twotemperature sensors 14 through the twofirst pads 114A, respectively, and the third conductive traces L3 and L3' are electrically connected to the signal terminals (not shown) of the twotemperature sensors 14 through the twosecond pads 114B, respectively. The first conductive trace L1 is located in a layer of the insulating substrate B adjacent to the skin of the human body. The second conductive trace L2 and the third conductive traces L3, L3' are located in the insulating substrate B at a layer near the insulatingboard 12. In order to facilitate the routing of the conductive traces L, the width of thewire connection portion 112 is 7 to 9mm. Preferably, the width of thewire connection portion 112 is 8mm.

Thegold fingers 1120 of thewire connecting portion 112, the 6conductive cores 1130 of theconductive pads 113 and thelands 114 are exposed from one side of the insulating substrate B of theflexible circuit board 11 close to thedielectric element 13. Thegold fingers 1120, the 6conductive cores 1130 of theconductive pads 113 and thesoldering pads 114 are all located on one side of theflexible circuit board 11 close to the surface of the patient body. One end of agold finger 1120 of thewire connecting portion 112 is electrically connected to thedielectric element 13 through a first conductive trace L1 connected thereto, and the other end is welded to a corresponding portion of thelead 5, so as to transmit an alternating voltage signal generated by an electric field generator (not shown) to thedielectric element 13. One end of onegold finger 1120 of the other threegold fingers 1120 of thewiring portion 112 is electrically connected to a grounding end (not shown) of thetemperature sensor 14 through a second conductive trace L2 connected thereto, and one ends of the other twogold fingers 1120 are electrically connected to signal ends (not shown) of the twotemperature sensors 14 through third conductive traces L3, L3' connected thereto, respectively; the other end of the threegold fingers 1120 is respectively welded with the corresponding part of thelead 5, so that the related signals monitored by thetemperature sensor 14 are quickly transmitted to the electric field generator (not shown) in parallel through the second conductive trace L2, the third conductive traces L3, L3' and thelead 5; so that the alternating voltage or alternating current applied to thedielectric element 13 can be timely and rapidly changed by an electric field generator (not shown) to achieve the purpose of avoiding low-temperature scald.

Thebacking 2 is in the form of a sheet-like arrangement, which is mainly made of a flexible, gas-permeable insulating material. Thebacking 2 is a mesh fabric. Specifically, theback lining 2 is a mesh non-woven fabric, has the characteristics of softness, lightness, thinness, moisture resistance and air permeability, and can keep the skin surface of a patient dry after being pasted on the body surface of the patient for a long time. The surface of thebacking 2 facing the surface of the patient is further coated with a biocompatible adhesive (not shown) for closely adhering thebacking 2 to the surface of the patient corresponding to the tumor site. In the present embodiment, thebacking 2 is provided in a substantially octagonal sheet shape.

Thesupport 3 is adhered to thebacking 2 and surrounds theelectrode unit 10. A throughhole 31 is formed through thesupport 3 for receiving theelectrode unit 10. Thesupport 3 may be made of a foam material. Thesupport 3 is flush with the surface of theelectrode unit 10 on the side remote from thebacking 2. That is, thesupport member 3 is flush with the surface of theelectrode unit 10 on the side facing theadhesive member 4 to support and position theadhesive member 4.

Theadhesive member 4 has double-sided adhesive properties. One surface of theadhesive member 4 is adhered to thesupport member 3 and the surface of theelectrode unit 10 on the side away from thebacking 2. The other side of thepasting piece 4 is used as a pasting layer and is pasted on the skin of the surface of a human body to keep the skin surface moist and relieve local pressure. Preferably, theadhesive element 4 is an electrically conductive hydrogel to act as a conductive medium. Theadhesive member 4 has better application property with the skin of the human body under the supporting action of the supportingmember 3.

Fig. 8 shows an electrode patch 100' according to another embodiment of the present invention, which is different from theelectrode patch 100 according to the previous embodiment only in that concave corners 21' are provided at the four corners of the backing 2' to be concave inward. Thebacking 2 is generally of a cross-shaped configuration. The concave angle 21' is communicated with the outside and is arranged in an L shape. When the electrode patch 100 'is applied to the body surface corresponding to the tumor region of a patient, the concave angle 21' can prevent the corners of thebacking 2 from being arched to cause wrinkles, and further prevent air from entering the space between theelectrode unit 10 and the skin from the wrinkles to increase the impedance between the electricalfunctional component 1 and the skin, so that the electricalfunctional component 1 generates heat to increase and low-temperature scald is caused.

In theelectrode patches 100 and 100 'of the present invention, since theindividual electrode units 10 are used to apply the alternating voltage to the tumor sites of the patients, when the patient cannot work normally, only theelectrode patches 100 and 100' having theindividual electrode units 10 need to be replaced, and the disposal of the entire electrode patch including a plurality of electrode units is not required, which can reduce the cost of the tumor treatment of the patients. In addition, theelectrode patches 100 and 100 'of the present invention can be freely combined according to the size of the tumor site of the patient, thereby ensuring the coverage area of theelectrode patches 100 and 100' for performing the electric field therapy of the tumor and ensuring the electric field therapy effect. Meanwhile, theflexible circuit board 11 of theelectrode patches 100 and 100 'of the present invention is only provided with one first conductive trace L1 electrically connected to thedielectric element 13, one second conductive trace L2 electrically connected to the ground terminals (not shown) of the twotemperature sensors 14, and two third conductive traces L3 and L3' electrically connected to the signal terminals (not shown) of the twotemperature sensors 14, respectively, so as to transmit the alternating voltage signal of the electric field generator (not shown) to thedielectric element 13 through the first conductive trace L1, and achieve the purpose of applying an alternating voltage to the tumor site of the patient for tumor treatment; meanwhile, the second conductive trace line L2 and the third conductive trace lines L3 and L3' are respectively electrically connected with the twotemperature sensors 14 to realize signal transmission between the electric field generator (not shown) and the twotemperature sensors 14, the wiring design difficulty is low, the structure is simple, the manufacturing process is simplified, the manufacturing is easy, the product manufacturing yield is high, and the manufacturing cost can be greatly reduced.

The present invention is not limited to the above preferred embodiments, but rather should be construed as broadly within the spirit and scope of the invention as defined in the appended claims.

Claims (24)

1. An electrode patch is used for tumor electric field treatment and is characterized by comprising a flexible circuit board, a single dielectric element and n temperature sensors which are electrically connected with the flexible circuit board, an adhesive piece arranged on one side, far away from the flexible circuit board, of the dielectric element, a back lining adhered to the corresponding part of the flexible circuit board and a lead wire electrically connected with the flexible circuit board, wherein n is an integer larger than 1 and not larger than 8, each temperature sensor is provided with a grounding end and a signal end, the flexible circuit board is provided with an insulating substrate and multiple paths of conducting traces embedded in the insulating substrate, the multiple paths of conducting traces are n +2 paths, one conducting trace in the conducting traces is electrically connected with the single dielectric element, one conducting trace is electrically connected with the grounding ends of all the temperature sensors, the rest n paths of conducting traces are respectively electrically connected with the signal ends of the corresponding temperature sensors, the single dielectric element is arranged on the back lining through the flexible circuit board and is provided with n through holes with the number consistent with the number of the temperature sensors, the n temperature sensors are respectively accommodated in the corresponding through holes, and the temperature sensors monitor the temperature of the adhesive piece.

2. The electrode patch as claimed in claim 1, wherein the flexible circuit board has a wiring portion electrically connected to each of the single dielectric element and the n temperature sensors, the dielectric element and the temperature sensors being located at one end of the wiring portion, one end of the wire being electrically connected to the wiring portion of the flexible circuit board, the other end of the wire being provided with a plug, the wire and the dielectric element being located at opposite ends of the wiring portion, respectively.

3. The electrode patch as claimed in claim 2, wherein the flexible circuit board further has a main body portion provided at a terminal end of the wiring portion, the single dielectric element and the n temperature sensors are provided on the main body portion, the main body portion and the wiring portion each have a respective insulating substrate and n +2 conductive traces embedded in the respective insulating substrate, the respective insulating substrates of the main body portion and the wiring portion together constitute the insulating substrate of the flexible circuit board, and the n +2 conductive traces of the main body portion and the n +2 conductive traces of the wiring portion are connected in one-to-one correspondence and together constitute the n +2 conductive traces of the flexible circuit board.

4. The electrode patch as claimed in claim 3, wherein the main body portion has a rectangular sheet-like configuration of 43.5mm x 23.5mm, and the wire portion has a width of 7 to 9mm.

5. The electrode patch as claimed in claim 3, wherein the flexible circuit board is provided with a conductive pad soldered to the dielectric member, the conductive pad being provided on the main body portion.

6. The electrode patch as recited in claim 5, wherein the conductive pad exposes the dielectric substrate and connects to a conductive trace of a flexible circuit board electrically connected to the dielectric element.

7. The electrode patch as claimed in claim 5, wherein the n temperature sensors are disposed in an area surrounded by the conductive plate, and the extension direction of the straight line in which the n temperature sensors are disposed is identical to the extension direction of the wire connection portion.

8. The electrode patch as claimed in claim 5, wherein the conductive disc comprises a plurality of spaced apart conductive cores, the plurality of conductive cores being connected in series by a conductive trace electrically connecting the flexible circuit board to the dielectric element.

9. The electrode patch as recited in claim 8 wherein the plurality of conductive cores are spaced apart in a matrix, and wherein 4 of the plurality of conductive cores in adjacent rows and adjacent columns are arranged in a central symmetry.

10. The electrode patch as claimed in claim 9, wherein the n temperature sensors are respectively disposed in a symmetrical center shape which is offset from the corresponding 4 conductive cores of the conductive disk.

11. The electrode patch as claimed in claim 10, wherein the temperature sensors are two, one of which is provided on a side of the symmetry center of the corresponding 4 conductive cores away from the terminal portion, and the other of which is provided on a side of the symmetry center of the corresponding 4 conductive cores close to the terminal portion.

12. The electrode patch according to claim 8, wherein the flexible circuit board is provided with n pairs of pads corresponding to the temperature sensor and located at one end of the wiring portion, the n pairs of pads being located at the same end of the wiring portion as the conductive pad.

13. The electrode patch as claimed in claim 12, wherein each pair of the pads comprises a first pad soldered to a ground terminal of the corresponding temperature sensor and a second pad soldered to a signal terminal of the corresponding temperature sensor.

14. The electrode patch as recited in claim 12, wherein each pair of the lands are disposed in a symmetrical center that is offset from its respective 4 conductive cores.

15. The electrode patch according to claim 14, wherein the lands are provided in two pairs, one pair of the lands being provided on a side of the center of symmetry of the corresponding 4 conductive cores thereof remote from the terminal portion, and the other pair of the lands being provided on a side of the center of symmetry of the corresponding 4 conductive cores thereof close to the terminal portion.

16. The electrode patch according to claim 12, wherein a line on which a center of symmetry of each pair of the pads is located is parallel to an extending direction of the wiring portion.

17. The electrode patch as claimed in claim 13, wherein the first bonding pad is connected to a conductive trace electrically connecting the flexible printed circuit board and the ground terminal of the temperature sensor, and the second bonding pads are respectively connected to a conductive trace electrically connecting the flexible printed circuit board and the signal terminal of the corresponding temperature sensor.

18. The electrode patch as claimed in claim 8, wherein the number of the temperature sensors is 2, the conductive trace is 4, and the conductive core is 6.

19. The electrode patch according to any one of claims 9 to 18, wherein the conductive cores are in a rectangular configuration of 8mm x 4mm, with a gap of 2.4mm between conductive cores in adjacent columns and a gap of 12.8mm between conductive cores in adjacent rows.

20. The electrode patch as claimed in any one of claims 1 to 18, further comprising an insulating plate disposed opposite the dielectric member, the insulating plate being disposed corresponding to the dielectric member in a thickness direction, the insulating plate being sandwiched between the dielectric member and the backing.

21. The electrode patch as claimed in any one of claims 1 to 18, wherein the backing has a reentrant corner at the four corners thereof and disposed concavely inward.

22. An electric field tumor treatment system comprising an electric field generator and an electrode patch according to any one of claims 1 to 21 electrically connected to the electric field generator.

23. The electric field tumor therapy system according to claim 22, wherein the electrode patch has a plug at the end of the wire, and the plug is plugged with the electric field generator.

24. The electric field tumor therapy system according to claim 22, further comprising a hub electrically connected to the electric field generator, wherein the electrode patch has a plug at the end of the wire, and the plug is connected to the hub.

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