CN114099959A

CN114099959A - Tumor electric field treatment system and electrode patch thereof

Info

Publication number: CN114099959A
Application number: CN202111580105.5A
Authority: CN
Inventors: 陈晟; 孙虎; 惠佳杰; 于晶; 张军
Original assignee: Jiangsu Hailai Xinchuang Medical Technology Co Ltd
Current assignee: Jiangsu Hailai Xinchuang Medical Technology Co Ltd
Priority date: 2021-12-22
Filing date: 2021-12-22
Publication date: 2022-03-01

Abstract

The invention provides a tumor electric field treatment system and an electrode patch thereof, wherein the electrode patch comprises a flexible circuit board, a dielectric element and a temperature sensor which are arranged on the same side of the flexible circuit board, and a lead which is electrically connected with the flexible circuit board, the temperature sensor is provided with a grounding end and a signal end, the flexible circuit board is provided with an insulating substrate and three paths of conducting traces which are embedded in the insulating substrate, one path of conducting trace in the three paths of conducting traces is electrically connected with the dielectric element, one path of conducting trace is electrically connected with the grounding end of the temperature sensor, one path of conducting trace is electrically connected with the signal end of the temperature sensor, and the lead is electrically connected with the three paths of conducting traces of the flexible circuit board. The flexible circuit board of the tumor electric field treatment system and the electrode patch thereof is respectively and electrically connected with the grounding ends and the signal ends of the dielectric element and the temperature sensor through the three paths of conductive traces, so that the signal transmission between the flexible circuit board and the dielectric element and the signal ends of the temperature sensor is realized, and the tumor electric field treatment system and the electrode patch thereof are simple in structure and easy to manufacture.

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 defects, for example, radiotherapy and chemotherapy can generate side effects and kill normal cells. The electric field therapy of tumor is one of the current development fronts, and the electric field therapy of tumor generates a tumor therapy method which interferes the mitosis process of tumor cells through a low-intensity, medium-high frequency and alternating electric field by a special electric field generating device. 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, prevent spindle formation, inhibit mitosis process and induce cancer cell apoptosis.

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 plate is electrically connected with the flexible circuit board by welding 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 is composed of 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 plates in series when the nine ceramic plates 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 sheets 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 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 flexible circuit board has a complex structure, increased difficulty in wiring design and increased manufacturing cost; the nine ceramic plates are welded on the flexible circuit board through the corresponding conductive plates, but all the obtained 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 circuit board are all connected in series through one conductive trace, the flexible circuit board needs to be electrically detected before the ceramic sheet is welded to the flexible circuit board, and the flexible circuit board needs to be electrically detected again after the ceramic sheet is welded to the flexible circuit board, so that the process is complicated and the efficiency is low. 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 to provide an improved electrode patch and an improved electric field therapy system for tumors, which 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 invention is realized by the following technical scheme: an electrode patch is used for tumor electric field treatment and comprises a flexible circuit board, a dielectric element and a temperature sensor which are arranged on the same side of the flexible circuit board, and a lead which is electrically connected with the flexible circuit board, wherein the temperature sensor is provided with a grounding end and a signal end, the flexible circuit board is provided with an insulating substrate and three conductive traces which are embedded in the insulating substrate, one conductive trace in the three conductive traces is electrically connected with the dielectric element, the other conductive trace is electrically connected with the grounding end of the temperature sensor, the other conductive trace is electrically connected with the signal end of the temperature sensor, and the lead is electrically connected with the three conductive traces of the flexible circuit board.

Furthermore, the flexible circuit board is provided with three gold fingers which expose the insulating substrate and are electrically connected with the corresponding parts of the leads.

Furthermore, the three gold fingers are respectively and electrically connected with one path of conducting trace of the flexible circuit board.

Furthermore, the flexible circuit board is provided with a conductive disc corresponding to the dielectric element, and the conductive disc is welded with the dielectric element.

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

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 flexible circuit board is provided with a pair of bonding pads which expose the insulating substrate and correspond to the temperature sensor.

Furthermore, one of the two bonding pads is welded with the grounding end of the temperature sensor, and the other bonding pad is welded with the signal end of the temperature sensor.

Furthermore, one of the two bonding pads is connected with one conductive trace electrically connected with the grounding end of the flexible circuit board and the temperature sensor, and the other bonding pad is connected with one conductive trace electrically connected with the signal end of the flexible circuit board and the temperature sensor.

Furthermore, wire one end and flexible circuit board electric connection, the other end is equipped with the plug.

Furthermore, a heat-shrinkable sleeve is arranged at the joint of the lead and the flexible circuit board.

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

Furthermore, one of the three conductive traces electrically connected to the dielectric element is a first conductive trace, one of the three conductive traces electrically connected to the ground terminal of the temperature sensor is a second conductive trace, one of the three conductive traces electrically connected to the signal terminal of the temperature sensor is a third conductive trace, the flexible circuit board is provided with a conductive pad connected to the first conductive trace, the flexible circuit board is provided with a pair of pads, one pad of the two pads is connected to the second conductive trace, and the other pad is connected to the third conductive trace.

Furthermore, the conductive disc and the welding disc are arranged on the same side of the flexible circuit board.

Furthermore, the conductive disc and the two bonding pads are exposed out of the insulating substrate of the flexible circuit board.

Furthermore, the flexible circuit board is also provided with three gold fingers welded with the lead, and the gold fingers are exposed out of the insulating substrate of the flexible circuit board.

Furthermore, the gold finger, the conductive disc and the two bonding pads are positioned on the same side of the flexible circuit board.

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

The flexible printed circuit board further comprises an insulating plate arranged on one side of the flexible printed circuit board far away from the dielectric element, the insulating plate corresponds to the dielectric element in the thickness direction, and the insulating plate is clamped between the flexible printed circuit board 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.

The electrode patch of the tumor electric field treatment system is respectively and electrically connected with the dielectric element, the grounding end of the temperature sensor and the signal end of the temperature sensor through the three conductive traces of the flexible circuit board so as to apply alternating voltage to the dielectric element and transmit related signals of the temperature sensor, and the electrode patch has the advantages of simple structure, low wiring design difficulty of the flexible circuit board, simplified manufacturing procedures, easiness in manufacturing, capability of reducing manufacturing cost and improved product yield; meanwhile, the electrode patch of the invention applies alternating voltage to the tumor part of the patient by adopting the independent dielectric element, and when the electrode patch cannot work normally, only the electrode patch with the dielectric element needs to be replaced, so that the cost of treating the tumor of the patient can be reduced.

Drawings

Fig. 1 is a perspective assembly view of an electrode patch according to an embodiment 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 perspective view of a dielectric element of the electrical functional assembly of fig. 3.

Fig. 5 is a front wiring diagram of the flexible circuit board of the electrical functional assembly of fig. 3.

Fig. 6 is a reverse wiring diagram of the flexible circuit board of the electrical functional assembly of fig. 3.

Description of reference numerals:

the electrode patch 100, the electrical function component 1, the electrode unit 10, the flexible circuit board 11, the main body portion 111, the wire connection portion 112, the gold finger 1120, the conductive pad 113, the conductive core 1130, the land 114, the first land 114A, the second land 114B, the insulating plate 12, the dielectric element 13, the through hole 131, the metal layer 132, the temperature sensor 14, the backing 2, the support 3, the through hole 31, the adhesive 4, the wire 5, the heat shrink tube 51, the plug 52, the insulating substrate B, the conductive trace L, the first conductive trace L1, the second conductive trace L2, the third conductive trace 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. When the following description refers to the accompanying drawings, like 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 treatment system (not shown) includes an electric field generator (not shown) and an electrode patch 100 connected to the electric field generator (not shown). The electrode patch 100 is 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 therapy of tumors. When the electrode patch 100 sufficiently covers the tumor site, the electrode patch 100 of the embodiment of the present invention may be used alone and directly connected to an electric field generator (not shown). In addition, a plurality of electrode patches 100 according to the embodiment of the present invention may be used in combination, and a plurality of electrode patches 100 are connected to a hub (not shown) to perform electric field therapy of tumor at a tumor site.

Referring to fig. 1 to 6, the electrode patch 100 includes a backing 2, an electrical functional component 1 adhered to the backing 2, a support member 3 adhered to the backing 2, an adhesive member 4 covering the support member 3 and a corresponding portion of the electrical functional component 1 and attached to a body surface skin of a patient corresponding to a tumor site, and a lead 5 electrically connected to the electrical functional component 1. The electrode patch 100 is attached to the body surface of a patient corresponding to the tumor part through the backing 2, and applies an alternating electric field to the tumor part of the patient through the electric functional component 1 to interfere or prevent mitosis of tumor cells of the patient, thereby achieving the purpose of treating tumors.

The electrical functional assembly 1 includes a single circular plate-shaped electrode unit 10 and a wiring portion 112 connected to the electrode unit 10. The wiring portion 112 is welded to the lead 5, so as to electrically connect the electrical functional assembly 1 and the lead 5. A plurality of gold fingers 1120 are arranged on one side surface of the wire connecting portion 112. In the present embodiment, the plurality of gold fingers 1120 are provided on the skin-facing surface of the wire portion 112. The periphery of the welding position of the lead 5 and the gold finger 1120 of the wire connecting part 112 is covered with a heat-shrinkable sleeve 51. The heat-shrinkable sleeve 51 performs insulation protection on the connection part of the wire 5 and the wiring part 112 of the electrical functional assembly 1, provides support, prevents the connection part of the wire 5 and the wiring part 112 of the electrical functional assembly 1 from being broken, and is dustproof and waterproof. The end of the lead 5 remote from the wire connection portion 112 is provided with a plug 52 electrically connected to an electric field generator (not shown). One end of the lead 5 is electrically connected to the gold finger 1120 of the wire connection portion 112; the other end is electrically connected to an electric field generator (not shown) through the plug 52, so as to provide the electrode patch 100 with an alternating current signal for tumor therapy during tumor electric field therapy.

The electrode unit 10 includes a main body 111, an insulating plate 12 provided on a side of the main body 111 away from the skin of the human body, a dielectric element 13 provided on a side of the main body 111 facing the skin of the human body, and a temperature sensor 14 provided on the main body 111 and located on the same side as the dielectric element 13. The main body 111, the insulating plate 12, and the dielectric element 13 are all circular sheet-shaped structures, and the centers of the three are located on the same straight line. The wire connecting portion 112 is extended laterally from the main body portion 111 of the electrode unit 10.

The main body 111 is composed of an insulating substrate B and three conductive traces L embedded in the insulating substrate B. The three conductive traces are respectively a first conductive trace L1 disposed on the side of the insulating substrate B close to the dielectric element 13, and a second conductive trace L2 and a third conductive trace L3 disposed on the side of the insulating substrate B close to the insulating board 12. The main body 111 has a diameter greater than 20mm, preferably 21mm, and is provided with a conductive pad 113 that exposes the insulating substrate B and is electrically connected to the first conductive trace L1. The conductive plate 113 may be welded to the dielectric member 13 to assemble the dielectric member 13 to the main body 111. The conductive pads 113 can be completely covered by the dielectric element 13 so that the conductive pads 113 and the dielectric element 13 are soldered by a solder (not shown). The conductive pad 113 is centered on the centerline of the body 111. The conductive pad 113 includes a plurality of conductive cores 1130 arranged in a central symmetry manner, which can effectively prevent the dielectric element 13 from being displaced due to stacking of solder (not shown) during the soldering process. The top surfaces of the conductive cores 1130 are located on the same plane, so that cold joint with the dielectric element 13 can be avoided. The plurality of conductive cores 1130 are each connected to a first conductive trace L1. The plurality of conductive cores 1130 are connected together in series by a first conductive trace L1.

In this embodiment, the conductive pad 113 of the main body 111 includes 4 conductive cores 1130 arranged at intervals and in a central symmetry. The conductive core 1130 is arranged in a multi-point interval mode, so that the using amount of copper foil for manufacturing the conductive core 1130 can be reduced; meanwhile, the amount of solder (not shown) used for welding the conductive core 1130 and the dielectric element 13 can be reduced, thereby reducing the manufacturing cost. The 4 conductive cores 1130 of the conductive pad 113 are all in a petal-shaped configuration. Each of the conductive cores 1130 includes inner arcs (not numbered) and outer arcs (not numbered) that are connected end to end. The inner arcs (not numbered) and the outer arcs (not numbered) of the conductive core 1130 are axisymmetrically arranged. The inner arcs (not numbered) of the 4 conductive cores 1130 of the same conductive pad 113 are all recessed toward the center of the conductive pad 113. The outer arcs (not numbered) of the 4 conductive cores 1130 of the same conductive disc 113 all project away from the center of the conductive disc 113.

The 4 conductive cores 1130 forming the conductive disc 113 are arranged in a centrosymmetric manner and an axisymmetric manner, and each conductive core 1130 is also arranged in an axisymmetric manner, so that when the 4 conductive cores 1130 of the main body portion 111 are welded with the dielectric element 13, the stress of each welding point is balanced, the overall welding balance of the dielectric element 13 is ensured, the welding quality is improved, and the problem that the welding position on the side with a larger interval between the dielectric element 13 and the main body portion 111 is easy to break due to weak strength of the welding position caused by the inclination of the dielectric element 13 due to the unbalanced welding stress is avoided; while also avoiding an impact on the degree of fit of the electrode patch 100. The outer arcs (not numbered) of the 4 conductive cores 1130 of the conductive pad 113 are located substantially on the same circumference and are connected together in series by a first conductive trace L1. The 4 conductive cores 1130 of the conductive pad 113 are arranged at intervals, and an interval C is formed between two adjacent conductive cores 1130. The 4 spaces C are arranged substantially in a cross shape. The adjacent intervals C are arranged in a communicated manner. The extending direction of the two opposite intervals C is the same as the extending direction of the wire connecting portion 112.

The main body 111 is further provided with a pair of pads 114 exposing the insulating substrate B, and the temperature sensor 14 and the main body 111 can be electrically connected by soldering at a position corresponding to the temperature sensor 14. The two pads 114 are surrounded by four conductive cores 1130 of the conductive pad 113. The two pads 114 are located substantially at the center of symmetry of the plurality of conductive cores 1130. One of the two pads 114 is connected to the second conductive trace L2, and the other pad is connected to the third conductive trace L3. The pad connected to the second conductive trace L2 of the two pads 114 is a first pad 114A, and the pad connected to the third conductive trace L3 is a second pad 114B. The temperature sensor 14 has a signal terminal (not shown) and a ground terminal (not shown). The first pad 114A is soldered to a ground terminal (not shown) of the temperature sensor 14, and the second pad 114B is soldered to a signal terminal (not shown) of the temperature sensor 14.

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

The size of the insulating plate 12 is substantially the same as that of the main body 111, so that when the insulating plate 12 is stuck to one side of the main body 111 away from the skin of the human body through a sealant (not shown), the sealant (not shown) climbs to one side of the main body 111 facing the skin of the human body through a capillary effect, and the filling of the sealant (not shown) in a gap (not shown) formed by welding the dielectric element 13 and the main body 111 is affected, so that a cavity exists in the sealant (not shown), and further, the phenomenon that when the sealant (not shown) is cured at a high temperature, because the difference between the water vapor in the cavity and the thermal expansion coefficient of the sealant (not shown) is large, the water vapor rapidly expands to cause bursting, so that popcorn phenomenon is generated, and the product is damaged is avoided.

The dielectric 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, the dielectric element 13 is a dielectric ceramic sheet. The dielectric element 13 has a ring-shaped structure, and a through hole 131 corresponding to the pair of pads 114 of the main body 111 is formed through the middle thereof to accommodate the temperature sensor 14. An annular metal layer 132 is attached to a surface of the dielectric element 13 facing the body 111. The metal layer 132 of the dielectric element 13 and the conductive core 1130 of the conductive pad 113 of the main body 111 are welded point to surface, so that high welding alignment precision is not required, and welding is more convenient. The inner ring of the metal layer 132 of the dielectric element 13 is spaced from the edge of the through hole 131 of the dielectric element 13, so that it is possible to prevent a solder (not shown) provided between the metal layer 132 of the dielectric element 13 and the main body 111 from diffusing in the direction of the through hole 131 of the dielectric element 13 when melted by heat and causing a short circuit of the temperature sensor 14. The outer ring of the metal layer 132 of the dielectric element 13 is spaced from the outer edge of the dielectric element 13, so that the solder (not shown) between the metal layer 132 of the dielectric element 13 and the main body 111 can be prevented from overflowing to the outside of the main body 111 when being melted by heat, and thus, when the electrode patch 100 is applied to the body surface of the tumor region of the patient, direct current without being blocked by the dielectric element 13 can be prevented from passing through and acting on the body surface of the patient.

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

The temperature sensor 14 is soldered to a first land 114A provided on the main body 111 via a ground terminal (not shown) thereof, and provided on the main body 111 via a signal terminal (not shown) thereof and a second land 114B provided on the main body 111. Since the first pad 114A of the main body portion 111 is connected to the second conductive trace L2, the second pad 114B is connected to the third conductive trace L3, the first pad 114A is soldered to a ground terminal (not shown) of the temperature sensor 14, and the second pad 114B is soldered to a signal terminal (not shown) of the temperature sensor 14, the ground terminal (not shown) of the temperature sensor 14 is electrically connected to the second conductive trace L2 of the main body portion 111, and the signal terminal (not shown) is electrically connected to the third conductive trace L3 of the main body portion 111. That is, the temperature sensor 14 performs signal transmission with the third conductive trace L3 through the second conductive trace L2. The temperature sensor 14 is soldered to the body 111 and then accommodated in the through hole 131 of the dielectric element 13. Preferably, the temperature sensor 14 is a thermistor. The temperature sensor 14 is used for monitoring the temperature of the adhesive member 4 covering the side of the dielectric element 13 of the electrical functional assembly 1 facing the skin of the human body and further for detecting the temperature of the skin of the human body to which the adhesive member 4 is attached. When the temperature monitored by the temperature 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 the electrode patch 100, so as to avoid low-temperature scald of the human body. The temperature sensor 14 is soldered to the main body 111 through a pair of soldering pads 114 of the main body 111 and then sealed with a sealant (not shown) to prevent moisture from attacking the temperature sensor 14 and causing the temperature sensor 14 to fail.

The wiring portion 112 has the same configuration as the main body portion 111, and also has a corresponding insulating substrate B and three conductive traces L embedded in the insulating substrate B. The three conductive traces L of the wire connecting portion 112 are also electrically connected to the corresponding conductive traces L of the main body portion 111. The number of the gold fingers 1120 of the wiring portion 112 is 3, and the insulating substrate B is exposed on the side close to the dielectric element 13. The three conductive traces L of the wiring portion 112 are electrically connected to the gold fingers 1120, respectively. The three conductive traces of the wire connection portion 112 are also a first conductive trace L1, a second conductive trace L2, and a third conductive trace L3, respectively. The first conductive trace L1 of the wire connection portion 112 is extended from the first conductive trace L1 of the main body portion 111. The second conductive trace L2 of the wire connection portion 112 is extended from the second conductive trace L2 of the main body portion 111. The conductive trace L3 of the wire connection portion 112 is extended by the third conductive trace L3 of the main body portion 111.

The wire connecting portion 112 is connected to the first conductive trace L1 of the main body portion 111 through the first conductive trace L1 thereof, and the first conductive trace L1 of the main body portion 111 is connected to the conductive pad 113 of the main body portion 111 to electrically connect to the conductive pad 113 of the main body portion 111, and further electrically connect to the dielectric element 13 through the soldering between the conductive pad 113 of the main body portion 111 and the dielectric element 13. The wire connecting portion 112 is electrically connected to the second conductive trace L2 of the main body portion 111 through the connection of the second conductive trace L2 thereof, the second conductive trace L2 of the main body portion 111 is electrically connected to the pad 114A of the main body portion 111, and the pad 114A is electrically connected to the ground (not shown) of the temperature sensor 14 through the soldering of the pad 114A to the ground (not shown) of the temperature sensor 14. The wire connecting portion 112 is electrically connected to the third conductive trace L3 of the main body portion 111 through the third conductive trace L3 thereof, the third conductive trace L3 of the main body portion 111 is connected to the pad 114B, and the pad 114B is soldered to the signal terminal (not shown) of the temperature sensor 14, so as to electrically connect to the signal terminal (not shown) of the temperature sensor 14.

The main body portion 111 and the wire connection portion 112 together constitute the flexible circuit board 11 of the electrical functional assembly 1. The insulating substrates B of the main body portion 111 and the wire connection portion 112 together constitute the insulating substrate B of the flexible circuit board 11. The conductive traces L of the main body portion 111 and the conductive traces L of the wire connection portion 112 constitute conductive traces L of the flexible circuit board 11 in one-to-one correspondence. The insulating substrate B of the flexible circuit board 11 can isolate moisture in the air around the electrode patch 100 from the solder (not shown) between the conductive pad 113 and the dielectric element 13, so as to prevent the moisture in the air away from the skin from eroding the solder (not shown) between the conductive pad 113 and the dielectric element 13 on the main body 111 of the flexible circuit board 11. The insulating substrate B of the flexible circuit board 11 and the insulating plate 12 perform a dual isolation function, which may extend the lifespan of the electrode patch 100.

From the perspective of forming the electrode unit 10, the insulating plate 12 is disposed on the side of the main body portion 111 of the flexible circuit board 11 away from the skin of the human body, the dielectric element 13 is disposed on the side of the main body portion 111 of the flexible circuit board 11 facing the skin of the human body, and the temperature sensor 14 is disposed on the side of the main body portion 111 of the flexible circuit board 11 facing the skin of the human body. The insulating plate 12 and the dielectric element 13 are respectively provided on opposite sides of the main body 111 of the flexible circuit board 11. The first conductive trace L1 of the flexible circuit board 11 connects the 4 spaced conductive cores 1130 of the conductive pads 113 in series, the second conductive trace L2 is electrically connected to the ground terminal (not shown) of the temperature sensor 14 through the pad 114A, and the third conductive trace L3 is electrically connected to the signal terminal (not shown) of the temperature sensor 14 through the pad 114B. The first conductive trace L1 is located in a layer of the insulating substrate B adjacent to the human skin. The second conductive trace L2 and the third conductive trace L3 are located within the insulating substrate B at a level close to the insulating board 12. In order to facilitate the layout of the conductive traces L, the width of the wiring portion 112 is 7-9 mm. Preferably, the width of the wire connection portion 112 is 8 mm.

The gold fingers 1120 of the wire connecting portion 112, the plurality of conductive cores 1130 of the conductive pad 113 and the land 114 are exposed from one side of the insulating substrate B of the flexible circuit board 11 close to the dielectric element 13. The gold finger 1120, the plurality of conductive cores 1130 of the conductive pad 113 and the soldering pad 114 are all located on the side of the flexible circuit board 11 close to the body surface of the patient. One end of a gold finger 1120 of the wire connecting portion 112 is electrically connected to the dielectric element 13 through a first conductive trace L1 connected thereto, and the other end is welded to a corresponding portion of the lead 5, so as to transmit an alternating voltage signal generated by an electric field generator (not shown) to the dielectric element 13. One end of one of the other two gold fingers 1120 of the wire connecting portion 112 is electrically connected to a ground terminal (not shown) of the temperature sensor 14 through the second conductive trace L2 connected thereto, and one end of the other gold finger 1120 is electrically connected to a signal terminal (not shown) of the temperature sensor 14 through the third conductive trace L3 connected thereto. The other ends of the two gold fingers 1120 of the wire connecting portion 112 are respectively soldered to corresponding portions of the wires 5, so that the relevant signals detected by the temperature sensor 14 are transmitted to the electric field generator (not shown) through the second conductive trace L2, the third conductive trace L3 and the wires 5.

The backing 2 is in the form of a sheet-like arrangement, which is mainly made of a flexible, gas-permeable insulating material. The backing 2 is a mesh fabric. Specifically, the back 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 the backing 2 facing the surface of the patient is further coated with a biocompatible adhesive (not shown) for closely adhering the backing 2 to the surface of the patient corresponding to the tumor site. In the present embodiment, only one electrode unit 10 is adhered to the backing 2. The backing 2 is of a generally square sheet-like configuration. The four corners of the backing 2 are rounded corner-shaped. In other embodiments, the backing 2 is substantially "cross" shaped, and the four corners of the backing 2 are each provided with a reentrant corner (not shown). The concave corners (not shown) of the corners of the backing 2 communicate with the outside and are arranged in an "L" shape. The included angle between the two sides of the backing 2 forming a reentrant corner (not shown) is 90 degrees or greater. When the electrode patch 100 is applied on the body surface corresponding to the tumor region of the patient, the concave angle (not shown) can prevent the corners of the backing 2 from arching to form wrinkles, thereby preventing air from entering the space between the electrode unit 10 and the skin from the wrinkles to increase the impedance between the electrical functional component 1 and the skin, which results in increased heat generation of the electrical functional component 1 and low-temperature scald.

The support 3 is adhered to the backing 2 and surrounds the outside of the electrode unit 10. A through hole 31 is formed through the support 3 to receive the electrode unit 10. The support 3 may be made of a foam material. The support 3 is flush with the surface of the electrode unit 10 on the side remote from the backing 2. That is, the support member 3 is flush with the surface of the electrode unit 10 on the side facing the adhesive member 4.

The adhesive member 4 has double-sided adhesive properties. One surface of the adhesive member 4 is adhered to the surface of the support member 3 and the electrode unit 10 on the side away from the backing 2. The other side of the pasting 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. The adhesive element 4 may preferably be a conductive adhesive element to act as a conductive medium. The adhesive member 4 has better application property with the skin of the human body under the supporting action of the supporting member 3.

The flexible circuit board 11 of the electrode patch 100 of the present invention is only provided with a first conductive trace L1 electrically connected to the dielectric element 13, a second conductive trace L2 electrically connected to the ground terminal (not shown) of the temperature sensor 14, and a third conductive trace L3 electrically connected to the signal terminal (not shown) of the temperature sensor 14, so as to transmit the alternating voltage signal of the electric field generator (not shown) to the dielectric element 13 through the first conductive trace L1, and to apply the alternating voltage to the tumor region of the patient for tumor therapy; meanwhile, the second conductive trace line L2 and the third conductive trace line L3 are respectively electrically connected with the temperature sensor 14 to realize signal transmission between the electric field generator (not shown) and the temperature sensor 14, and the electric field generator has the advantages of low wiring design difficulty, simple structure, simplified manufacturing process, easy manufacture, high product manufacturing yield and capability of greatly reducing the manufacturing cost. In addition, because the electrode patch 100 of the present invention applies alternating voltage to the tumor site of the patient by using the single electrode unit 10, when the electrode patch cannot work normally, only the electrode patch 100 having the single electrode unit 10 needs to be replaced, and the whole electrode patch including a plurality of electrode units 10 does not need to be discarded, so that the cost of tumor treatment of the patient can be reduced. In addition, the electrode patch 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 the electrode patch 100 for the electric field treatment of the tumor and ensuring the electric field treatment effect.

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

1. An electrode patch is used for tumor electric field treatment and is characterized by comprising a flexible circuit board, a dielectric element and a temperature sensor which are arranged on the same side of the flexible circuit board, and a lead which is electrically connected with the flexible circuit board, wherein the temperature sensor is provided with a grounding end and a signal end, the flexible circuit board is provided with an insulating substrate and three conductive traces which are embedded in the insulating substrate, one conductive trace in the three conductive traces is electrically connected with the dielectric element, the other conductive trace is electrically connected with the grounding end of the temperature sensor, the other conductive trace is electrically connected with the signal end of the temperature sensor, and the lead is electrically connected with the three conductive traces of the flexible circuit board.

2. The electrode patch as claimed in claim 1, wherein the flexible circuit board has three gold fingers exposing the insulating substrate thereof and electrically connected to corresponding portions of the conductive wires.

3. The electrode patch as claimed in claim 2, wherein each of the three gold fingers is electrically connected to one of the conductive traces of the flexible circuit board.

4. The electrode patch as claimed in claim 1, wherein the flexible circuit board is provided with a conductive pad corresponding to the dielectric member, and the conductive pad is soldered to the dielectric member.

5. The electrode patch as claimed in claim 4, wherein the conductive pad exposes the insulating substrate and connects to a conductive trace of the flexible circuit board electrically connected to the dielectric member.

6. The electrode patch as claimed in claim 4, wherein the conductive disc comprises a plurality of spaced apart conductive cores connected in series by a conductive trace electrically connecting the flexible circuit board to the dielectric member.

7. The electrode patch as claimed in claim 3, wherein the flexible circuit board is provided with a pair of pads exposed from the insulating substrate thereof and corresponding to the temperature sensor.

8. The electrode patch as claimed in claim 7, wherein one of the pair of pads is soldered to a ground terminal of the temperature sensor, and the other of the pair of pads is soldered to a signal terminal of the temperature sensor.

9. The electrode patch as claimed in claim 7, wherein one of the pair of pads is connected to a conductive trace electrically connecting the flexible circuit board to the ground terminal of the temperature sensor, and the other pad is connected to a conductive trace electrically connecting the flexible circuit board to the signal terminal of the temperature sensor.

10. The electrode patch as claimed in claim 1, wherein one end of the lead is electrically connected to the flexible circuit board, and the other end is provided with a plug.

11. The electrode patch as claimed in claim 10, wherein a heat-shrinkable sleeve is provided at the junction of the lead and the flexible circuit board.

12. The electrode patch as claimed in claim 1, wherein the dielectric member has a through hole disposed therethrough, and the temperature sensor is received in the through hole.

13. The electrode patch as claimed in claim 1, wherein one of the three conductive traces electrically connected to the dielectric element is a first conductive trace, one of the conductive traces electrically connected to a ground terminal of the temperature sensor is a second conductive trace, one of the conductive traces electrically connected to a signal terminal of the temperature sensor is a third conductive trace, the flexible circuit board is provided with a conductive pad connected to the first conductive trace, the flexible circuit board is provided with a pair of pads, one pad of the pair of pads is connected to the second conductive trace, and the other pad of the pair of pads is connected to the third conductive trace.

14. The electrode patch of claim 13, wherein the conductive pad and the land are disposed on a same side of the flexible circuit board.

15. The electrode patch as claimed in claim 13, wherein the conductive pad and the pair of pads are exposed from an insulating substrate of the flexible circuit board.

16. The electrode patch as claimed in claim 13, wherein the flexible circuit board further has three gold fingers soldered to the lead, the gold fingers exposing the insulating substrate of the flexible circuit board.

17. The electrode patch as recited in claim 16, wherein the gold finger, the conductive pad, and the pair of pads are on a same side of the flexible circuit board.

18. The electrode patch of any one of claims 1-17, further comprising a backing affixed to a corresponding portion of the flexible circuit board.

19. The electrode patch as claimed in claim 18, further comprising an insulating plate provided on a side of the flexible circuit board remote from the dielectric member, the insulating plate corresponding to the dielectric member in a thickness direction, the insulating plate being sandwiched between the flexible circuit board and the backing.

20. An electric field tumor treatment system comprising an electric field generator and an electrode patch according to any one of claims 1 to 19 electrically connected to the electric field generator.

21. The electric field tumor therapy system according to claim 20, wherein the electrode patch has a plug at the end of the wire, and the plug is plugged with the electric field generator.

22. The electric field tumor therapy system according to claim 20, 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.