CN114099963A

CN114099963A - Tumor electric field treatment system

Info

Publication number: CN114099963A
Application number: CN202111580208.1A
Authority: CN
Inventors: 陈晟; 应建俊; 沈琪超; 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, which comprises a first pair of insulated electrodes and a second pair of insulated electrodes, wherein the first pair of insulated electrodes and the second pair of insulated electrodes are respectively configured on the surface of the head of a patient; a control signal generator that generates a periodic control signal having a first output state having a first time period T1 and a second output state having a second time period T2, the first time period T1 and the second time period T2 each being between 400ms and 980 ms; an AC signal generator that generates a first AC signal having a frequency of 200kHz between the first pair of insulated electrodes when the control signal is in a first output state, and generates a second AC signal having a frequency of 200kHz between the second pair of insulated electrodes when the control signal is in a second output state, and switches between the first output state and the second output state. The tumor electric field treatment system can achieve better effect of inhibiting tumor cell proliferation.

Description

Tumor electric field treatment system

Technical Field

The invention relates to an electric field tumor treatment system, and belongs to the field of medical technical equipment.

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 treatment of tumor is one of the current development fronts, and is a tumor treatment method which uses an electric field generator to generate an alternating electric field with low intensity and medium-high frequency to interfere the mitosis process of tumor cells. 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. Studies have shown that mitosis of tumor cells is directional, and that different tumor cells exhibit different directions of mitosis in humans.

Therefore, there is a need to provide a tumor electric field treatment system capable of better inhibiting tumor cell proliferation.

Disclosure of Invention

The invention provides a tumor electric field treatment system with better effect of inhibiting tumor cell proliferation.

The tumor electric field treatment system can be realized by the following technical scheme: an electric field tumor treatment system, comprising: a first pair of insulated electrodes disposed on a surface of a patient's head; a second pair of insulated electrodes disposed on a surface of the patient's head; a control signal generator that generates a periodic control signal having a first output state having a first time period T1 and a second output state having a second time period T2, the first time period T1 and the second time period T2 each being between 400ms and 980 ms; an AC signal generator that generates a first AC signal having a frequency of 200kHz between the first pair of insulated electrodes when the control signal is in a first output state and generates a second AC signal having a frequency of 200kHz between the second pair of insulated electrodes when the control signal is in a second output state, wherein switching is made between generating the first AC signal between the first pair of insulated electrodes and generating the second AC signal between the second pair of insulated electrodes by switching between the first output state and the second output state.

Further, the first period T1 and the second period T2 are the same duration.

Further, the first time period T1 and the second time period T2 are both 50% duty cycles.

Further, the first AC signal in the first time period T1 has a rising amplitude in the third time period T3 and a falling amplitude in the fourth time period T4, and the second AC signal in the second time period T2 has a rising amplitude in the third time period T3 and a falling amplitude in the fourth time period T4.

Further, the durations of the third and fourth periods T3 and T4 are each less than 10% of the duration of the first or second period T1 or T2.

Further, the durations of the third and fourth periods T3 and T4 are each less than 1% of the duration of the first or second period T1 or T2.

Further, the first AC signal is applied to the first pair of insulated electrodes to generate a first electric field, and the second AC signal is applied to the second pair of insulated electrodes to generate a second electric field.

Further, the direction of the first electric field is perpendicular to the direction of the second electric field.

Further, the periodic control signal is a periodic square wave signal.

Further, the first AC signal and the second AC signal both have a field strength of at least 1V/cm.

The control end of the first switch/amplifier module is directly connected with the control signal generator, and the control end of the second switch/amplifier module is connected with the control signal generator through the inverter; the input ends of the first switch/amplifier module and the second switch/amplifier module are connected with an AC signal generator; the output end of the first switch/amplifier module is connected with the first pair of insulated electrodes, and the output end of the second switch/amplifier module is connected with the second pair of insulated electrodes.

Furthermore, the insulated electrode comprises a plurality of electrode units arranged in an array, a plurality of connecting parts for connecting two adjacent electrode units and a wiring part extending from one connecting part, the electrode unit is provided with a dielectric element, the two opposite ends of the connecting part are respectively provided with a conductive disc which is electrically connected with the corresponding dielectric element, the plurality of connecting parts are positioned between two adjacent electrode units arranged in a row and between two adjacent electrode units arranged in a row, the length of the connecting part between two adjacent electrode units arranged in a column is smaller than that of the connecting part between two adjacent electrode units arranged in a row, at least two of the plurality of connecting parts are positioned between two adjacent electrode units arranged in a row, the conductive disc is provided with a plurality of conductive cores which are arranged symmetrically at intervals and welded with the dielectric element.

Furthermore, a plurality of conductive cores of the conductive disc are arranged on the connecting part in a centrosymmetric manner, and the center of the conductive disc is positioned on the central line of the dielectric element.

Furthermore, the plurality of conductive cores of the conductive disc are arranged on the connecting part in an axisymmetric shape and expose one side surface of the connecting part facing the dielectric element.

Furthermore, each conductive core comprises an inner arc and an outer arc which are connected end to end, and the inner arcs and the outer arcs of the conductive cores are arranged in an axial symmetry manner.

Further, the outer arcs of the conductive cores of the same conductive disc are located on the same circumference.

Further, a backing supporting the electrode unit is included.

Further, the backing has a plurality of reentrant corners that are wrinkle resistant, the reentrant corners being located at corners of the backing and communicating with the exterior.

Further, the reentrant corner is formed by inwards recessing the edge at the corner of the backing, and the included angle between two sides of the backing forming the reentrant corner is not less than 90 degrees.

Furthermore, the electrode unit comprises a support member surrounding the electrode unit, wherein the support member is provided with a through hole which penetrates through the support member and is used for accommodating the electrode unit.

Furthermore, the electrode unit also comprises a moisture absorption element arranged between the electrode units.

Furthermore, the supporting part is provided with an opening for accommodating the moisture absorption element in a penetrating way, and the opening and the through hole are arranged at intervals.

Further, the electrode unit further comprises a temperature sensor, and the dielectric element is provided with a through hole for accommodating the temperature sensor in a penetrating manner.

Furthermore, the connecting part is provided with an insulating substrate and a plurality of paths of conductive traces embedded in the insulating substrate, and the conductive discs at the two opposite ends of the connecting part are electrically connected with one path of conductive trace.

Furthermore, the electrode units are arranged in three rows and three columns, and the number of the electrode units is 9.

Further, the insulated electrode comprises a flexible circuit board and a plurality of dielectric elements arranged on the flexible circuit board, the plurality of dielectric elements are arranged in at least three rows and four columns, and the distance between two adjacent dielectric elements arranged in a row is different or the distance between two adjacent dielectric elements arranged in a column is different.

Furthermore, the distance between two adjacent dielectric elements in the same row and adjacent columns is the same, and the distance between two adjacent dielectric elements in the same row and adjacent columns is the same.

Further, the distance between two adjacent dielectric elements in the same row and adjacent columns is smaller than the distance between two adjacent dielectric elements in the same row and adjacent columns.

Further, the distance between two adjacent dielectric elements of the same column in adjacent rows is smaller than the distance between two adjacent dielectric elements of the same column in alternate rows.

Further, the distance between two adjacent dielectric elements of the same row in the adjacent column is equal to the distance between two adjacent dielectric elements of the same column in the adjacent row.

Furthermore, the dielectric elements are arranged in three rows and five columns, and the number of the dielectric elements is 14.

Furthermore, the flexible printed circuit further comprises an insulating plate arranged on the flexible circuit, and the insulating plate and the dielectric element are respectively arranged on two opposite sides of the flexible circuit board.

Furthermore, the flexible printed circuit board further comprises a plurality of temperature sensors arranged on the flexible printed circuit board, and the temperature sensors and the dielectric element are positioned on the same side of the flexible printed circuit board.

Furthermore, the flexible printed circuit board further comprises a backing attached to the flexible printed circuit board, and the backing and the dielectric element are respectively arranged on two opposite sides of the flexible printed circuit board.

Furthermore, the insulated electrode 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 conductive traces which are embedded in the insulating substrate, one conductive trace in the three conductive traces is electrically connected with the dielectric element, one conductive trace is electrically connected with the grounding end of the temperature sensor, one 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 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 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.

Furthermore, the insulated electrode 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, 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 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 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 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 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 bonding pads corresponding to the temperature sensors and located at one end of the wiring portion, and the n pairs of bonding pads and the conductive disc are located at the same end of the wiring portion.

Further, each pair of pads includes a first pad and a second pad, the first pad is soldered to the ground terminal of the corresponding temperature sensor, and the second pad is soldered to the signal terminal 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.

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.

Furthermore, the insulated electrode comprises a flexible circuit board, a dielectric element and a plurality of temperature sensors 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 number of the temperature sensors is n, n is an integer which is more than 1 and not more 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 which are 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, the rest conductive traces are respectively electrically connected with the signal ends of the corresponding temperature sensors, and the lead is electrically connected with the paths of conductive traces of the flexible circuit board.

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

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

Further, the number of the temperature sensors is 2, the number of the conductive traces is 4, and the number of the gold fingers is 4.

Furthermore, the flexible circuit board is provided with n pairs of welding pads, and each pair of welding pads is positioned between the two corresponding conducting cores which are arranged at intervals.

Furthermore, each pair of bonding pads is arranged at the position of the flexible circuit board corresponding to the corresponding temperature sensor, and each pair of bonding pads is exposed out of the insulating substrate of the flexible circuit board.

Furthermore, one of the multiple paths of conductive traces electrically connected to the dielectric element is a first conductive trace, one of the multiple paths of conductive traces electrically connected to the ground terminal of the temperature sensor is a second conductive trace, and the other n paths of conductive traces electrically connected to the signal terminal of the corresponding temperature sensor are all third conductive traces, the flexible circuit board is provided with a conductive pad connected to the first conductive trace, the flexible circuit board is provided with n pairs of pads, one pad of each pair of pads is connected to the second conductive trace, and the other pad is connected to the corresponding third conductive trace.

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

Furthermore, the flexible circuit board is also provided with a plurality of gold fingers welded with the lead, the gold fingers are exposed out of the insulating substrate of the flexible circuit board, the number of the gold fingers is n +2, and n is an integer larger than 1 and not larger than 8.

Furthermore, the number of the gold fingers is four, the number of the temperature sensors is two, the number of the bonding pads is two, and the third conductive trace is provided with two paths.

Further, the gold finger, the conductive disc and the two pairs of bonding pads are located on the same side of the flexible circuit board.

Furthermore, the insulated electrode comprises at least one electrode plate capable of applying an alternating electric field and an electric connector detachably connected with the electrode plate, the electrode plate comprises an independent electrode unit and a first lead electrically connected with the electrode unit, and the electrode plate is detachably connected with the electric connector through the first lead.

Further, the plurality of electrode patches are connected in parallel to the electrical connector by respective first wires.

Furthermore, the first lead of the electrode plate is provided with a first plug detachably connected with the electric connector in an inserting mode, and the first plug and the electrode unit are respectively located at two opposite ends of the first lead.

Further, the electric connector is provided with a plurality of sockets which are detachably plugged with the first plugs of the first leads of the corresponding electrode plates.

Furthermore, the electric connector is further provided with a second lead, and the second lead and the plurality of sockets are respectively positioned at two opposite ends of the electric connector.

Further, the second wire has a second plug provided at an end thereof.

Furthermore, the electric connector is provided with a body, and the plurality of sockets and the second lead are respectively arranged at two opposite ends of the body.

Furthermore, the electrode plate further comprises a wiring portion connected with the electrode unit, and the wiring portion is welded with one end, far away from the first plug, of the first lead.

Furthermore, the electrode unit comprises a main body part and a dielectric element welded on one side of the main body part, and the wiring part extends from the main body part in the lateral direction.

Further, the main body part and the wiring part of the electrode unit form a flexible circuit board of the electrode patch.

Furthermore, the electrode unit further comprises at least one temperature sensor, and the temperature sensor is arranged on the main body part and is located on the same side as the dielectric element.

Furthermore, at least one through hole is formed in the middle of the dielectric element, and the temperature sensors are contained in the corresponding through holes of the dielectric element respectively.

Furthermore, the electrode unit further comprises an insulating plate adhered to the side of the main body part far away from the dielectric element.

Furthermore, a heat-shrinkable sleeve is coated on the periphery of the welding position of the first lead and the wiring part.

Further, the first lead is detachably connected with the electrode unit.

Furthermore, the electrode plate comprises a wiring portion electrically connected with the electrode unit, and a butt joint socket is arranged at one end, far away from the electrode unit, of the wiring portion.

Furthermore, one end of the first wire, which is far away from the first plug, is provided with a butt joint plug, and the butt joint plug is detachably connected with the butt joint socket in an inserting mode.

Furthermore, the electrode plate also comprises a backing adhered to the electrode unit, a support piece arranged around the electrode unit and adhered to the backing, and an adhering piece covering the electrode unit and one side of the support piece far away from the backing.

The AC signal generator of the tumor electric field treatment system provides 200KHz intermediate-frequency alternating current signals, and switches between generating a first AC signal between the first pair of insulated electrodes and generating a second AC signal between the second pair of insulated electrodes through switching between a first output state and a second output state, wherein the duration of the first output state and the second output state is between 400ms and 980ms, so that a better effect of inhibiting tumor cell proliferation is achieved.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application.

Drawings

Fig. 1 is a block diagram of a tumor electric field treatment system.

Fig. 2 is a schematic diagram of control signals for switching on and off a first electric field and a second electric field in an electric field tumor therapy system.

FIG. 3 is a graph of cell growth rate versus electric field duty cycle.

FIG. 4 is a schematic diagram of an AC signal for application to an insulated electrode.

FIG. 5 is a perspective assembly view of a first embodiment of insulated electrodes of the electric field tumor therapy system according to the present application.

Fig. 6 is another perspective assembly view of the insulated electrode shown in fig. 5, with a release liner shown.

Fig. 7 is an exploded perspective view of the insulated electrode of fig. 6.

Fig. 8 is an exploded perspective view of the electrical functional components and leads of the insulated electrode of fig. 7.

Fig. 9 is a perspective view of a dielectric element of the electrical functional assembly of fig. 8.

Fig. 10 is a sectional view of the electrical functional assembly of fig. 7 taken along the line a-a.

Fig. 11 is a front wiring diagram of the flexible circuit board of the electrical functional assembly in fig. 8.

Fig. 12 is a back wiring diagram of the flexible circuit board of the electrical functional assembly in fig. 8.

Fig. 13 is an alternative embodiment of the insulated electrode of the first embodiment of fig. 5, wherein the adhesive member and the release liner are not shown.

FIG. 14 is a perspective view of the insulated electrode assembly of the electric field tumor therapy system of the present application.

Fig. 15 is a top view of the insulated electrode of fig. 14.

Fig. 16 is an exploded perspective view of the insulated electrode of fig. 15.

Fig. 17 is an exploded perspective view of the electrical functional components and leads of the insulated electrode of fig. 16.

Fig. 18 is a top view of the electrical functional assembly of fig. 16.

FIG. 19 is a perspective view of the insulated electrode assembly of the electric field tumor therapy system of the present application.

Fig. 20 is an exploded perspective view of the insulated electrode of fig. 19.

Fig. 21 is an exploded perspective view of the electrical functional components and leads of the insulated electrode of fig. 20.

Fig. 22 is a front wiring diagram of the flexible circuit board of the electrical functional assembly of fig. 21.

Fig. 23 is a reverse wiring diagram of the flexible circuit board of the electrical functional assembly of fig. 21.

FIG. 24 is a perspective view of a fourth embodiment of an insulated electrode of the electric field tumor therapy system of the present application.

Fig. 25 is an exploded perspective view of the insulated electrode of fig. 24.

Fig. 26 is an exploded perspective view of the electrical functional components and leads of the insulated electrode of fig. 25.

Fig. 27 is a schematic plan view of the flexible circuit board of the insulated electrode of fig. 26.

Fig. 28 is a front wiring diagram of the flexible circuit board of the electrical functional assembly of fig. 27.

Fig. 29 is a rear wiring diagram of the flexible circuit board of the electrical functional assembly of fig. 27.

Fig. 30 is a perspective view of an alternate embodiment of the insulated electrode of the fourth embodiment of fig. 24.

FIG. 31 is a perspective view of a fifth embodiment of an insulated electrode of the electric field tumor therapy system of the present application.

Fig. 32 is an exploded perspective view of the electrical functional components and leads of the insulated electrode of fig. 31.

Fig. 33 is a schematic plan view of the flexible circuit board of the insulated electrode of fig. 3.

FIG. 34 is a perspective view of the insulated electrode assembly of the electric field tumor therapy system of the present application.

Fig. 35 is an exploded view of the insulated electrode and electrical connector of fig. 34.

FIG. 36 is a plan view of an alternate embodiment of the insulated electrode of the sixth embodiment in FIG. 34.

Description of reference numerals:

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 application. Rather, they are merely examples of insulated electrodes consistent with certain aspects of the present application, as detailed in the appended claims.

Fig. 1 is a block diagram of a tumor electric field treatment system, and the tumor electric field treatment system 1000 includes a first pair of insulated electrodes 1, a second pair of insulated electrodes 2, a control signal generator 7, an inverter 8, an AC signal generator 9, a first switch/amplifier module 10, and a second switch/amplifier module 10'.

The AC signal generator 9 is used to output a sinusoidal signal with adjustable frequency and amplitude. In this embodiment, the control signal generator 7 is a square wave generator and generates a square wave signal, and the inverter 8 is used for inverting the square wave signal of the control signal generator 7. The control end of the first switch/amplifier module 10 is directly connected with the control signal generator 7, and the control end of the second switch/amplifier module 10' is connected with the control signal generator 7 through the inverter 8; the input ends of the first switch/amplifier module 10 and the second switch/amplifier module 10' are both connected with the AC signal generator 9; the output of the first switch/amplifier module 10 is connected to a first pair of insulated electrodes 1 and the output of the second switch/amplifier module 10' is connected to a second pair of insulated electrodes 2. The first switch/amplifier module 10 and the second switch/amplifier module 10' have a signal amplification function and also function as switches. The control signal generator 7 controls the first switch/amplifier module 10 and the second switch/amplifier module 10' to be turned on, so that the AC signal generated by the AC signal generator 9 is applied to the first pair of insulated electrodes 1 and the second pair of insulated electrodes 2.

The first pair of insulated electrodes 1 generates a first electric field 3 when conducting, the second pair of insulated electrodes 2 generates a second electric field 4 when conducting, and the first pair of insulated electrodes 1 and the second pair of insulated electrodes 2 are arranged in a manner that the electric field directions of the first electric field 3 and the second electric field 4 are vertically crossed. Each insulated electrode of the first and

second pairs

1, 2 comprises an electrical

functional component

11, 21, 31, 41, 51 and a

backing

12, 22, 32, 42, 42', 52 supporting the electrical

functional component

11, 21, 31, 41, 51. Preferably, the

backing

12, 22, 32, 42, 42 ', 52 has an adhesive layer which is applied to the patient's head to position the electrical

functional component

11, 21, 31, 41, 51 on the surface of the patient's head. The first pair of insulated electrodes 1 and the second pair of insulated electrodes 2 are controlled to be alternately turned on, and alternating therapeutic electric fields acting on the target region, i.e., a first electric field 3 and a second electric field 4 which are alternately applied, are formed. The specific structure of the

insulated electrodes

100, 100', 200, 300, 400, 400 ', 500, 600, 600 ' will be described in detail later.

As one embodiment, the AC signal generator 9 generates a medium frequency alternating current signal of 200 KHz. The control signal generator 7 outputs a square wave having a first output state and a second output state. Namely high 1 and low 0.

Fig. 2 is a schematic diagram of control signals for switching on and off the first electric field 3 and the second electric field 4 in the electric field tumor therapy system. The control signal generator 7 inputs a control signal to the first switch/amplifier module 10, similar to the signal 5 in fig. 2, for switching on and off the first electric field 3; due to the arrangement of the inverter 8, the signal received by the signal of the second switch/amplifier module 10', like the signal 6 in fig. 2, is used to switch the first electric field 4 on and off.

At time T1, when the control signal generator 7 outputs the control signal of the first output state, the first switch/amplifier module 10 is turned on and controls the AC signal on the first pair of insulated electrodes 1 to be turned on, so as to generate a first AC signal having a frequency of 200KHZ between the conductors of the first pair of insulated electrodes 1, and generate a first electric field 3 having a strength of at least 1V/cm in the target sensing region, while the AC signal on the second pair of insulated electrodes 2 is turned off and the second electric field 4 is turned off. At this time, the signal 5 is at high level 1, and the signal 6 is at low level 0.

At time T2, the control signal generator outputs a control signal in a second output state, the second switch/amplifier module 10' is turned on and controls the AC signal on the second pair of insulated electrodes 2 to turn on, a second AC signal with a frequency of 200KHZ is generated between the conductors of the second pair of insulated electrodes 2, a second electric field 4 with a strength of at least 1V/cm is generated in the target sensing region, the AC signal on the first pair of insulated electrodes 1 is turned off, the first electric field 3 is turned off, the signal 5 is at low level 0, and the signal 6 is at high level 1.

The time length T1 is the duration of the control signal generator 7 in the first output state, and is the duty cycle of the first electric field 3, and is also the off-time length of the second electric field 4, the time length T2 is the duration of the control signal generator 7 in the second output state, and is the duty cycle of the second electric field 4, and is also the off-time length of the first electric field 3, in the present embodiment, the time length T1 is the same as the time length T2, and T1 and T2 each occupy a half cycle of the control signal generator 7.

The control signal generator 7 can switch the 200KHz intermediate frequency AC signal generated by the AC signal generator 9 between the first pair of insulated electrodes 1 and the second pair of insulated electrodes 2 by controlling the first switch/amplifier module 10 and the second switch/amplifier module 10', so that the first electric field 3 and the second electric field 4 are alternately applied to the target sensing region.

FIG. 3 shows the effect of electric fields of different duty cycles on cell proliferation during glioma cell culture, the switching rates of the applied electric fields in different directions being different, and the inhibitory effect of the tumor treatment electric field on proliferating cells in tissue culture and malignant cells in the experimental animal body being different.

In the experiment, glioma cells are cultured in a culture dish, two pairs of 200KHz alternating current signals which are perpendicular to each other are applied to the periphery of the glioma cells, and the proliferation condition of the glioma cells is observed by changing the switching rate of the first electric field 3 and the second electric field 4. Referring to fig. 2, the first electric field 3 is switched to the second electric field 4 after the time period T1, and the second electric field 4 is switched to the first electric field 3 after the time period T2, wherein the operations are repeated, and T1 is the same as T2, and is a half cycle of the control signal generator 7. The experimental results show that T1 and T2 have better effects on inhibition of cell proliferation than other rates at 400ms to 980 ms. Preferably, T1 and T2 are more effective in inhibiting cell proliferation around 500ms and between 700ms and 980 ms. In this example, the U87MG glioma was used as the cell tissue culture, but the turnover rate is not limited to this cell for the purpose of inhibiting cell proliferation, and other rapidly proliferating cells may be used.

Since the non-pure resistive device exists in the system, for biological applications, the voltage spike caused by the non-pure resistive device needs to be suppressed, and besides the insulation electrode is used for blocking, the phenomenon can be effectively avoided by preferably controlling the climbing rate of the AC signal generated by the AC signal generator 9 when the AC signal is turned on and off. Figure 4 illustrates an AC signal applied to the first pair of insulated electrodes 1, the rate of ramp up of which is optimised when switched on and off.

At time T1, the AC signal generator 9 applies the first AC signal to the first pair of insulated electrodes 1 and generates the first electric field 3, and a step-by-step boosting method is used in the initial process of the formation of the first AC signal, i.e. the AC voltage amplitude is stepped up from 0V to 90% of the peak-to-peak value of the target voltage during time T3, and then the stable target voltage output is maintained for several times T5; during the time T4, the voltage slowly decreases from 90% of the target voltage to 0V. Similarly, at time T2, the AC signal generator 9 applies the second AC signal to the second pair of insulated electrodes 2 and generates the second electric field 4, and a step-by-step boosting method is adopted in the initial process of the formation of the second AC signal, i.e. the AC voltage amplitude is gradually raised from 0V to 90% of the peak-to-peak value of the target voltage during time T3, and then the stable target voltage output is maintained for several times T5; during the time T4, the voltage slowly decreases from 90% of the target voltage to 0V. When the target voltage is reduced to 0V, the T2 is switched again, so that the problem that when the AC signal on the first pair of insulated electrodes 1 is cut off, the target voltage is not reduced to 0V, i.e., the target voltage is converted, which results in the AC signal generator 9 applying voltage to the first pair of insulated electrodes 1 and the second pair of insulated electrodes 2 at the same time, i.e., the situation that the first electric field 3 and the second electric field 4 exist and overlap at the same time is avoided.

Wherein T3 and T4 are generally within 1% of the duration of T1 and do not exceed 10% of the duration of T1 at most, so as not to reduce the electric field strength per unit time, T5 is the inverse of the AC electric field frequency, and the sum of T3, T4 and several T5 is equal to T1. During time T2, first electric field 3 between first pair of insulated electrodes 1 is turned off and second electric field 4 between second pair of insulated electrodes 2 is turned on, thereby completing one cycle. The way this optimization is done is not limited to controlling the gain of the amplifier or using a low pass filter.

Based on the above description, the AC signal generator 9 of the tumor electric field treatment system 1000 of the present application generates 200KHz intermediate frequency AC signals, and forms two electric fields with strength of 1V/cm, which are applied to the target sensing region perpendicularly and alternately through two pairs of

insulated electrodes

1, 2, and switches between generating the first AC signal between the first pair of insulated electrodes 1 and generating the second AC signal between the second pair of insulated electrodes 2 through switching between the first output state and the second output state, wherein the duration of the first output state and the second output state is between 400ms and 980ms, so as to achieve better effect of inhibiting tumor cell proliferation.

The four insulated electrodes of the first pair of insulated electrodes 1 and the second pair of insulated electrodes 2 in the electric field tumor therapy system 1000 have the same structure. The

insulated electrodes

100, 100', 200, 300, 400, 400 ', 500, 600, 600 ' of the present invention may have different embodiments. The insulated electrode of the present invention provides the following 9 embodiments: fig. 5 to 12 show a first embodiment of an insulated electrode 100 according to the present invention, fig. 13 shows an insulated electrode 100' according to the present invention as a modified embodiment of the first embodiment, fig. 14 to 18 show a second embodiment of an insulated electrode 200 according to the present invention, fig. 19 to 23 show a third embodiment of an insulated electrode 300 according to the present invention, fig. 24 to 29 show a fourth embodiment of an insulated electrode 400 according to the present invention, fig. 30 shows a modified embodiment of an insulated electrode 400 ' according to the present invention as a fourth embodiment, fig. 31 to 33 show a fifth embodiment of an insulated electrode 500 according to the present invention, fig. 34 and 35 show a sixth embodiment of an insulated electrode 600 according to the present invention, and fig. 36 shows an insulated electrode 600 ' according to the present invention as a modified embodiment of the sixth embodiment. The structure of the insulated electrode is specifically described below.

First embodiment of insulated electrode 100

Fig. 5 to 12 show a first embodiment of the insulated electrode 100 of the present application, which includes a backing 12, an electrical functional component 11 adhered to the backing 12, a support 13 adhered to the backing 12, a lead 14 electrically connected to the electrical functional component 11, and an adhesive member 15 covering the support 13 and corresponding portions of the electrical functional component 11. The insulated electrode 100 is attached to the body surface of the patient corresponding to the tumor site through the backing 12, and applies an alternating electric field to the tumor site of the patient through the electrical functional component 11 to interfere with or prevent mitosis of the tumor cells of the patient, thereby achieving the purpose of treating the tumor.

The backing 12 is in the form of a sheet-like arrangement, which is primarily made of a flexible, gas-permeable, insulating material. The backing 12 is a mesh fabric, and particularly, the backing 12 is a mesh nonwoven fabric which has the characteristics of softness, lightness, thinness, moisture resistance and air permeability and can keep the skin surface of a patient dry after being applied to the body surface of the patient for a long time. The backing 12 is further coated with a biocompatible adhesive (not shown) on the surface facing the patient's body surface for adhering the backing 12 to the body surface corresponding to the tumor site of the patient.

In the present embodiment, the backing 12 is provided in a substantially rectangular parallelepiped sheet shape. The edge of the backing 12 is arranged concavely and convexly. The backing 12 has two notches 121 recessed inwardly from the centers of its long sides. The gap 121 is aligned with the upper edge of the patient's external auditory meatus bone when applied. The backing 12 further has recessed corners 123 recessed inwards from four corners thereof for preventing wrinkles from being formed when the backing 12 is applied to the body surface corresponding to the tumor, and further preventing air from entering between the adhesive member 15 and the skin from the wrinkles to increase the impedance between the electrical functional component 11 and the skin, which results in increased heat generation of the electrical functional component 11 and low-temperature scald. The reentrant corner 123 communicates with the outside and is disposed in an "L" shape. The included angle between the two sides of the backing 12 forming the reentrant angle 123 is greater than or equal to 90 degrees. The backing 12 also has a plurality of wings 122 extending outwardly from the peripheral side thereof for grasping by an operator to apply the insulated electrode 100 to the body surface of a patient at a location corresponding to a tumor. The two side flaps 122 of the backing 12 on the long sides are symmetrically disposed on the two sides of the notch 121 on the same long side. The lateral wing 122 of the backing 12 located at the short side is arranged at the center of the short side and corresponds to the position of the eyebrow bone or occiput of the patient to assist in applying the insulated electrode 100 to the body surface corresponding to the tumor region of the patient. The side flaps 122 are disposed on the periphery of the backing 12 in an axisymmetric manner.

The electrical functional assembly 11 includes a plurality of electrode units 110 arranged in an array, a plurality of connecting portions 1112 connecting two adjacent electrode units 110, and a wiring portion 1113 extending laterally from one connecting portion 1112. The wiring portion 1113 is soldered to the conductive wire 14, so as to electrically connect the electrical functional component 11 and the conductive wire 14. The electrode units 110 of the electrical functional assembly 11 may have the same column pitch, or may have different column pitches, or the electrical functional assembly 11 may have the same row pitch, or may have different row pitches. Preferably, the electrode units 110 have the same column pitch and the same row pitch, but the column pitch is different from the row pitch. Preferably, the column pitch is greater than the row pitch. That is, the pitch between the electrode units 110 of adjacent rows is smaller than the pitch between the electrode units 110 of adjacent columns. The electrode units 110 are arranged at intervals, and open spaces 118 are formed between the electrode units 110 to allow the skin of the patient, which is covered by the insulated electrodes 100 and corresponds to the tumor region of the patient, to freely breathe after the insulated electrodes 100 are arranged on the body surface of the patient corresponding to the tumor region. The wire portion 1113 is laterally extended from the connecting portion 1112 and partially located in the open space 118.

The connection parts 1112 connecting the two adjacent electrode units 110 in the same column have the same length. The connection parts 1112 connecting the two adjacent electrode units 110 in the same row have the same length. The length of the connection part 1112 connecting the two adjacent electrode units 110 in the same column is different from the length of the connection part 1112 connecting the two adjacent electrode units 110 in the same row. The length of the connecting portion 1112 connecting two adjacent electrode units 110 in the same row is greater than the length of the connecting portion 1112 connecting two adjacent electrode units 110 in the same column. Specifically, the connection portions 1112 include first connection portions 11120 connecting two adjacent electrode units 110 located in the same column and second connection portions 11121 connecting two adjacent electrode units 110 located in the same row. The length of the first connection portion 11120 is smaller than the length of the second connection portion 11121. The wiring portion 1113 is laterally extended from a second connecting portion 11121 in a direction away from the electrical functional assembly 11. The wiring portion 1113 is located between two rows of the electrode units 110, and a portion of the wiring portion 1113 is located in the open space 118 formed by the two adjacent rows of the electrode units 110 at intervals, so as to shorten the distance of the wiring portion 1113 beyond the edge of the electrical functional assembly 11, make the arrangement of the electrical functional assembly 11 more compact, and avoid increasing the overall size of the electrical functional assembly 11 and the manufacturing cost. The wiring portion 1113 is disposed at a distance from the electrode unit 110 adjacent thereto, which provides a larger operating space for the welding between the wiring portion 1113 and the lead wire 14. The wiring portion 1113 is provided perpendicular to the second connection portion 11121. The wiring portion 1113 is provided substantially in parallel with the first connection portion 11120. The first connecting portions 11120 are distributed between all two adjacent electrode units 110 arranged in a row to achieve electrical connection between the electrode units 110 in the same row. At least one second connecting portion 11121 is disposed between the electrode units 110 in adjacent columns to electrically connect the electrode units 110 arranged in each column. The second connection portion 11121 has at least two. All the second connecting portions 11121 between two electrode units 110 arranged in a row may be all the second connecting portions 11121 for electrically connecting two adjacent electrode units 110, or may include the second connecting portions 11121 for partially electrically connecting two adjacent electrode units 110 and the second connecting portions 11121 for only electrically connecting two electrode units 110.

In the present embodiment, the electrode units 110 are arranged in a matrix of three rows and three columns, and the number of the electrode units is 9. The first connection portion 11120 is located between two adjacent electrode units 110 arranged in a row, and the second connection portion 11121 is located between two adjacent electrode units 110 in the middle row, so as to achieve electrical connection between 9 electrode units 110. The electrode units 110 at both ends of each row are freely disposed and connected to only one first connection part 11120. The electrical functional components 11 are arranged substantially in a shape of a king.

In other embodiments, the second connection portions 11121 include not only the second connection portions 11121 that achieve electrical connection between two adjacent electrode units 110 arranged in a row, but also the second connection portions 11121 that only serve to strengthen the connection and not electrically connect two adjacent electrode units 110 arranged in a row. The electrical functional components are arranged in a shape like a Chinese character 'yu'.

In this embodiment, a row of gold fingers 11130 soldered to the wires 14 are respectively disposed on two side surfaces of the wire connecting portion 1113 away from the second connecting portion 11121 in a staggered manner. The periphery of the welding position of the lead 14 and the gold finger 11130 of the wiring portion 1113 is covered with a heat-shrinkable sleeve 141. The heat shrinkable sleeve 141 protects the connection between the wire 14 and the wiring portion 1113 of the electrical functional module 11, and provides a support to prevent the connection between the wire 14 and the wiring portion 1113 of the electrical functional module 11 from being broken, and is dustproof and waterproof. The end of the wire 14 remote from the second connection portion 11121 is provided with a plug 142 for electrical connection with an electric field generator (not shown). A gold finger 11130 having one end of the wire 14 electrically connected to the wiring portion 1113; the other end is electrically connected to an electric field generator (not shown) through a plug 142 to provide an alternating current signal for tumor therapy to the insulated electrode 100 during tumor electric field therapy.

The electrode unit 110 includes a main body 1111 disposed at opposite ends of the connection portion 1112, an insulating plate 112 disposed at a side of the main body 1111 away from the skin of the human body, a dielectric element 113 disposed at a side of the main body 1111 facing the skin of the human body, and a temperature sensor 114 selectively disposed on the main body 1111 and located at the same side as the dielectric element 113. The main body 1111, the insulating plate 112, and the dielectric element 113 are all circular sheet-shaped structures. The insulating plate 112, the main body 1111, and the dielectric element 113 are disposed in a one-to-one correspondence, and centers of the three are located on the same straight line. In other embodiments, the main body portion 1111 may also be a strip-shaped structure extending from the end of the connecting portion 1112.

The side of the body portion 1111 facing the dielectric element 113 is provided with a conductive pad 1114. The conductive pad 1114 of the body portion 1111 can be completely covered by the dielectric member 113 to facilitate the soldering of the conductive pad 1114 to the dielectric member 113 by the solder 115. The conductive pad 1114 of the main body 1111 includes a plurality of conductive cores 11140 arranged in a central symmetrical manner, which can effectively prevent the dielectric element 113 from being displaced due to stacking of the solder 115 during the soldering process. The conductive pad 1114 of the body portion 1111 is centered on the centerline of the body portion 1111. The top surfaces of conductive cores 11140 of conductive pad 1114 are coplanar to avoid cold joint with dielectric element 113 during soldering. The center of conductive pad 1114 is also located on the centerline of dielectric element 113.

In this embodiment, the conductive pad 1114 of the same main body portion 1111 includes 4 conductive cores 11140 which are arranged at intervals and in a central symmetry manner. Conductive disc 1114 conductive core 11140 adopts a multi-point interval arrangement mode, which can reduce the consumption of copper foil for manufacturing conductive core 11140 and reduce material cost; meanwhile, the amount of the solder 115 used for welding the conductive core 11140 and the dielectric element 113 can be saved, and the material cost can be further reduced.

The 4 conductive cores 11140 of the same conductive disc 1114 are all in a petal configuration. Each conductive core 11140 includes inner arcs (not numbered) and outer arcs (not numbered) that are connected end to end. The inner arc (not numbered) and the outer arc (not numbered) of the conductive core 11140 are arranged in an axisymmetric manner. The inner arcs (not numbered) of the 4 conductive cores 11140 of the same conductive pad 1114 are all recessed toward the center of the conductive pad 1114. The outer arcs (not numbered) of the 4 conductive cores 11140 of the same conductive pad 1114 all project away from the center of the conductive pad 1114. The plurality of conductive cores 11140 forming the conductive disc 1114 are arranged in a centrosymmetric manner and in an axisymmetric manner, and each conductive core 11140 is also arranged in an axisymmetric manner, so that when the plurality of conductive cores 11140 of the conductive disc 1114 of the main body portion 1111 are welded with the dielectric element 113, the stress balance of each welding point is ensured, the integral welding balance of the dielectric element 113 is ensured, the welding quality is improved, and the phenomenon that the welding part on the side with larger interval between the dielectric element 113 and the main body portion 1111 is weak in strength and easy to break due to the inclination of the dielectric element 113 caused by the unbalanced welding stress is avoided; and simultaneously, the adhesion degree of the insulated electrode 100 can be prevented from being influenced. The outer arcs (not numbered) of the multiple conductive cores 11140 of the same conductive pad 1114 are located substantially on the same circumference.

The insulating plate 112 is made of an insulating material. Preferably, the insulating plate 112 is an epoxy glass cloth laminate. The insulating plate 112 is adhered to the surface of the main body portion 1111 away from the skin of a human body by a sealant (not shown), so that the strength of the main body portion 1111 can be enhanced, a flat welding plane can be provided for the welding operation between the main body portion 1111 and the dielectric element 113, and the product yield can be improved. Meanwhile, the insulating plate 112 can also isolate the moisture in the air on the side of the insulating electrode 100 away from the skin from contacting the solder 115 between the main body portion 1111 and the dielectric element 113, so as to prevent the moisture from eroding the solder 115 between the main body portion 1111 and the dielectric element 113 and affecting the electrical connection between the main body portion 1111 and the dielectric element 113.

The size of the insulating plate 112 is the same as that of the main body portion 1111, so as to prevent the sealant (not shown) from climbing to the side, facing the skin of the human body, of the main body portion 1111 by capillary effect when the insulating plate 112 is adhered to the side, far away from the skin of the human body, of the main body portion 1111, thereby affecting the filling of the sealant 117 in the gap 116 formed by welding the dielectric element 113 and the main body portion 1111, causing a cavity in the sealant 117, and further preventing the phenomenon that the sealant 117 is burst and popcorn is generated due to rapid expansion of water vapor caused by large difference between the water vapor in the cavity and the coefficient of thermal expansion of the sealant 117 during high-temperature curing, and damaging the product.

The dielectric member 113 is made of a high dielectric constant material, and has a conductive property of blocking conduction of direct current and allowing passage of alternating current, thereby ensuring safety of a human body. Preferably, the dielectric element 113 is a dielectric ceramic sheet. The dielectric element 113 has an annular structure, and a through hole 1131 is formed through the middle thereof to accommodate the temperature sensor 114. An annular metal layer 1132 is attached to a surface of the dielectric element 113 facing the body 1111. The metal layer 1132 of the dielectric element 113 and the conductive core 11140 of the conductive pad 1114 of the main body 1111 are welded point to surface, so that high welding alignment precision is not required, and the welding is more convenient. A gap 116 formed by welding the dielectric element 113 and the main body portion 1111 is filled with a sealant 117 to protect the solder 115 between the dielectric element 113 and the main body portion 1111, so as to prevent the welding position from being broken due to the influence of external force on the dielectric element 113, and further prevent the alternating electric field from being applied to the tumor part of the patient through the dielectric element 113; meanwhile, the moisture in the air can be prevented from entering the gap 116 to erode the solder 115 between the dielectric element 113 and the main body 1111, thereby affecting the electrical connection between the dielectric element 113 and the main body 1111. The inner ring of the metal layer 1132 of the dielectric element 113 is spaced from the edge of the through hole 1131 of the dielectric element 113, so as to prevent the solder 115 between the metal layer 1132 of the dielectric element 113 and the main body 1111 from diffusing toward the through hole 1131 of the dielectric element 113 when being melted by heat, thereby preventing the temperature sensor 114 from being short-circuited. The outer ring of the metal layer 1132 of the dielectric element 113 is spaced from the outer edge of the dielectric element 113, so as to avoid the situation that when the solder 115 arranged between the metal layer 1132 of the dielectric element 113 and the main body 1111 is melted by heat, the solder overflows to the outer side of the main body 1111, and thus when the insulated electrode 100 is attached to the body surface of the tumor region of the patient, direct current which is not blocked by the dielectric element 113 passes through and acts on the body surface of the patient.

The outer diameter of the dielectric element 113 is slightly smaller than the diameter of the main body portion 1111, so that the sealant 117 can be filled into the gap 116 through capillary phenomenon along the edge of the main body portion 1111 located outside the dielectric element 113 when the sealant 117 is filled, and the filling of the sealant 117 in the gap 116 formed by welding the dielectric element 113 and the main body portion 1111 is facilitated. When the sealant 117 is filled in the gap 116 formed by welding the dielectric element 113 and the main body 1111, the air in the gap 116 can be discharged from the through hole 1131 of the dielectric element 113, thereby preventing the sealant 117 filled in the gap 116 from generating a void and improving the product quality.

Referring to fig. 7, the plurality of temperature sensors 114 are respectively accommodated in the through holes 1131 of the corresponding dielectric elements 113. In the present embodiment, the number of the temperature sensors 114 is eight, and the temperature sensors are respectively located on the other eight electrode units 110 except the electrode unit 110 in the middle of the middle row. The 8 temperature sensors 114 are respectively provided at the center of the main body portion 1111 of the corresponding electrode unit 110. The temperature sensor 114 is used for monitoring the temperature of the adhesive member 15 covering the side of the dielectric member 113 of the electrical functional assembly 11 facing the skin of the human body, and further detecting the temperature of the skin of the human body to which the adhesive member 15 is attached. When the temperature detected by the temperature sensor 114 exceeds the upper limit of the safe temperature of the human body, the tumor electric field therapy system (not shown) can timely reduce or turn off the alternating current transmitted to the insulated electrode 100, so as to avoid low-temperature scald of the human body. The temperature sensor 114 is welded to the body portion 1111 and then sealed with a sealant 117 to prevent moisture from attacking the temperature sensor 114 and causing the temperature sensor 114 to fail. The temperature sensor 114 has a signal terminal (not shown) and a ground terminal (not shown). In the present embodiment, the temperature sensor 114 is preferably a thermistor. In other embodiments, the specific number of temperature sensors 114 may be set as desired.

Referring to fig. 7, the main body portion 1111, the insulating plate 112, and the dielectric member 113 are arranged in three rows and three columns. The main body 1111 of the electrode unit 110 arranged in three rows and three columns, a plurality of connecting portions 1112 located between two adjacent electrode units, and a wiring portion 1113 extending outward from the connecting portion 1112 constitute the flexible circuit board 111 of the electrical functional assembly 11. From the perspective of forming the electrode unit 110, the insulating plate 112 is disposed on the side of the main body portion 1111 of the flexible circuit board 111 facing away from the skin of the human body, the dielectric element 113 is disposed on the side of the main body portion 1111 of the flexible circuit board 111 facing the skin of the human body, and the temperature sensor 114 is selectively disposed on the side of the main body portion 1111 of the flexible circuit board 111 facing the skin of the human body. The insulating plate 112 and the dielectric element 113 are respectively disposed on opposite sides of the main body portion 1111 of the flexible circuit board 111. The main body portion 1111 of the flexible circuit board 111 of the electric function module 11 is aligned with the electrode unit 110 of the electric function module 11.

The flexible circuit board 111 is composed of an insulating substrate B and a plurality of conductive traces L embedded in the insulating substrate B. The main body portion 1111, the connection portion 1112, and the wire connection portion 1113 are each constituted by a corresponding insulating substrate B and a plurality of conductive traces L embedded in the insulating substrate B. The conductive trace L embedded in the insulating substrate B of the main body portion 1111 is electrically connected to the conductive trace L embedded in the insulating substrate B of the connection portion 1112 and the conductive trace L embedded in the insulating substrate B of the connection portion 1113. The conductive core 11140 of the conductive pad 1114 disposed on the body 110 is exposed or protrudes from the insulating substrate B. The gold finger 11130 of the wiring portion 1113 is exposed to the insulating substrate B. The insulating substrate B of the flexible circuit board 111 can isolate the moisture in the air around the insulated electrode 100 from the solder 115 between the conductive pad 1114 and the dielectric element 113, so as to prevent the moisture in the air away from the skin from eroding the solder 115 between the conductive pad 1114 and the dielectric element 113 on the main body 1111 of the flexible circuit board 111. The insulating substrate B of the flexible circuit board 111 and the insulating plate 112 perform a dual isolation function, which can prolong the service life of the insulated electrode 100.

Referring to fig. 11 and 12, the conductive trace L of the flexible circuit board 111 is embedded in the insulating substrate B in a layer shape, and includes a first conductive trace L1 connecting all the conductive cores 11140 of the conductive pads 111 disposed on the main body portion 1111 in series, a second conductive trace L2 connecting all the ground terminals (not shown) of the temperature sensors 114 disposed on the main body portion 1111 in series, and a third conductive trace L3 connecting all the signal terminals (not shown) of the temperature sensors 114 disposed on the main body portion 1111 in parallel. In this embodiment, the first conductive trace L1 is provided with a path, which connects all the conductive cores 11140 of the conductive pads 1114 located in the respective main body portions 1111 in series and is electrically connected to the corresponding gold finger 11130 of the wiring portion 1113 exposing the insulating substrate B thereof. The second conductive trace L2 is provided in one path, and ground terminals (not shown) of the temperature sensors 114 provided in the body portions 1111 are connected in series. The third conductive trace L3 is provided in multiple paths, and is connected to the signal terminals (not shown) of the temperature sensors 114 located in the main body portions 1111, respectively, and connects the signal terminals (not shown) of the temperature sensors 114 located in the main body portions 1111 in parallel. Specifically, the third conductive trace L3 is eight paths, and the number of paths is the same as the number of the temperature sensors 114. The first conductive trace L1, the second conductive trace L2, and the third conductive trace L3 are electrically connected to the corresponding gold finger 11130 of the wiring portion 1113, respectively.

From the wiring perspective of the conductive traces L, the conductive traces L are arranged in two layers in the insulating substrate B of the flexible circuit board 111, defining one layer close to the skin of the patient as a first layer, one layer away from the skin of the patient as a second layer, and defining conductive layers between the first layer and the second layer and connecting portions of the conductive traces corresponding to the first layer to portions thereof corresponding to the second layer. The first conductive trace L1, which connects the conductive cores 11140 of all the conductive pads 1114 in series, is located at the first layer and is disposed around the second conductive trace L2 at the peripheral side of the second conductive trace L2. The portion of the second conductive trace L2 that is connected to the ground (not shown) of the temperature sensor 114 is located at the first level. The portion of the second conductive trace L2 that connects with the corresponding gold finger 11130 of the wiring portion 1113 is also located at the first layer. The second conductive trace L2 is connected to the corresponding portion of the temperature sensor 114 connected to the ground terminal (not shown) through a corresponding one of the conductive layers, and then connected to the corresponding portion of the wire portion 1113 through another corresponding conductive layer, so as to bypass the first conductive trace L1 around the corresponding portion of the first layer and avoid crossing the first conductive trace L1.

The third conductive traces L3 connected to the signal terminals (not shown) of the temperature sensors 114 each include a portion located on the second layer and electrically connected to the corresponding gold finger 11130 of the wiring portion 1113, a portion located on the first layer and connected to the signal terminals (not shown) of the temperature sensors 114, and a conductive layer connecting the portion located on the first layer and the portion located on the second layer. The portion of the second conductive trace L2 on the second layer is between corresponding portions of the same layer of multiple third conductive traces L3. The second electrically conductive trace L2 is located at a corresponding portion of the second layer, disposed adjacent to the wiring portion 1113, and has three third electrically conductive traces L3 disposed on one side thereof and five third electrically conductive traces L3 disposed on the other side thereof.

The support 13 is adhered to the backing 12 and surrounds the outside of the dielectric element 113 of the electrode unit 110. A through hole 130 is formed through the support 13 for receiving the dielectric element 113 of the electrode unit 110. The dielectric elements 113 of the electrode units 110 located in the same column may be surrounded by the same support 13. The support 13 may be made of a foam material. In this embodiment, three supporting members 13 are arranged side by side at intervals and respectively surround the dielectric elements 113 of the electrode units 110 in different rows. The support 13 is flush with the surface of the electrode unit 110 on the side remote from the backing 12. That is, the support member 13 is flush with the surface of the electrode unit 110 on the side facing the adhesive member 15.

The adhesive member 15 has double-sided adhesive properties. One side of the adhesive member 15 is adhered to the support member 13 and the surface of the electrode unit 110 on the side away from the backing 12. The other side of the adhesive member 15 is used as a coating layer and is applied to the skin of the human body surface to keep the skin surface moist and relieve local pressure. The adhesive member 15 may preferably be a conductive adhesive member to serve as a conductive medium. The adhesive member 15 has better application property with the skin of the human body under the supporting action of the supporting member 13.

The insulated electrode 100 may further include a release paper 16 covering the adhesive member 15 and the backing 12 to protect the adhesive member 15 and the backing 12 from contamination. The insulated electrode 100 may be covered on the adhesive member 15 and the backing 12 by only one release paper 16, or may be covered on the adhesive member 15 and the backing 12 by two or more release papers 16. When in use, the release paper 16 is torn off, and the insulated electrode 100 is pasted on the body surface corresponding to the tumor part of the human body.

Alternative embodiments of the first embodiment of insulated electrode 100

Referring to fig. 13, an insulated electrode 100' is an alternate embodiment of insulated electrode 100 in the first embodiment. The insulated electrode 100' is similar to the insulated electrode 100 of the first embodiment, and includes a backing 12, an electrical functional component 11 disposed on the backing 12, a lead 14 electrically connected to the electrical functional component 11, an adhesive member (not shown) covering the electrical functional component 11, and a release paper (not shown) disposed over the adhesive member (not shown) and attached to the backing 12, where the reference numerals of the insulated electrode 100 of the first embodiment are used. The insulated electrode 100' differs from the insulated electrode 100 in the first embodiment in that: the insulated electrode 100 'further comprises at least one moisture absorption element 17 which is arranged on the backing 12 and is positioned among the plurality of electrode units 110 which are arranged at intervals on the electric functional component 11, and is used for absorbing and storing sweat or water vapor generated on the body surface of a patient at the corresponding part where the insulated electrode is applied, so that the phenomenon that the sweat or the water vapor blocks hair follicles to cause skin problems is avoided, and the comfort of applying the insulated electrode 100' is improved. The support 13 ' of the insulated electrode 100' is of one-piece sheet-like construction, provided with openings 131 ' corresponding to the hygroscopic element 17. The openings 131' are adapted to receive the respective absorbent elements 17 therethrough. The supporting member 13 'is provided with a through hole 130' identical to the through hole 130 of the supporting member 13 of the insulated electrode 100 of the first embodiment. The openings 131 'are located between adjacent through holes 130'. The support member 13 'has a covering region 132' covering the junction of the electrical functional component 11 and the conductive line 14. The opening 131 'for receiving the moisture absorbing element 17 is disposed away from the covering region 132' to prevent the liquid absorbed by the moisture absorbing element 17 from affecting the electrical connection between the conductive wire 14 and the electrical functional component 11. The moisture absorbing element 17 is located between the plurality of electrode units 110 of adjacent columns. The thickness of the moisture absorbing element 17 may be slightly greater than that of the supporting member 13' in order to have more water absorbing and storing properties.

The adhesive member (not shown) applied to the support 13 ' may be a one-piece adhesive member (not shown) having substantially the same size as the support 13 ', covering the support 13 ', the dielectric member 113 of the electrode unit 110, and the moisture absorbing member 17. As a simple alternative, the adhesive members (not shown) may be three adhesive members (not shown) respectively applied to the electrode units 110 arranged in a row. Each of the adhesive members (not shown) is attached to the electrode units 110 arranged in the column direction and the corresponding portion of the support member 13'.

In the insulated electrode 100 and the insulated electrode 100 'of the embodiment, the conductive disc 1114 arranged on the flexible circuit board 11 transmits alternating voltage to the dielectric element 113 welded with the conductive disc 1114 and acts on the tumor part of a patient to realize tumor electric field treatment, the conductive disc 1114 is provided with a plurality of conductive cores 11140 symmetrically arranged at intervals, so that the dielectric element 113 can be welded smoothly, the phenomenon that the dielectric element 113 inclines to influence the joint degree of the insulated electrode 100 and 100' is avoided, meanwhile, the using amount of copper foil for manufacturing the conductive disc 1114 can be reduced, the using amount of soldering tin 115 for welding the conductive disc 1114 and the dielectric element 113 is saved, and the manufacturing cost is reduced.

Second embodiment of insulated electrode 200

Referring to fig. 14 to 18, the insulated electrode 200 in this embodiment includes a backing 22, an electrical function component 21 adhered to the backing 22, a support 23 adhered to the backing 22, and a lead 24 electrically connected to the electrical function component 21 and an adhesive (not shown) adhered to the backing 22 and covering the support 23 and corresponding portions of the electrical function component 21. The backing 22 is identical to the backing 12 of the insulated electrode 100 in the first embodiment, and the edge of the backing 22 is provided with a notch 221, a wing 222, a concave angle 223, and other structures, which are not described herein again, and reference may be made to the first embodiment for related contents.

The electrical functional component 21 is similar to the electrical functional component 11 of the insulated electrode 100 in the first embodiment, and includes a plurality of electrode units 210 arranged in a substantially rectangular array, a plurality of connecting portions 2112 located between adjacent electrode units 210 and electrically connecting two adjacent electrode units 210, and a wire connecting portion 2113 extending from the connecting portion 2112. The adjacent two electrode units 210 are connected to each other by the connection portions 2112, so that the electrical functional assembly 21 forms a mesh structure. The plurality of electrode units 210 are arranged in at least three rows and four columns. The number of electrode units 210 is at least 10. The plurality of connection portions 2112 connecting adjacent two electrode units 210 arranged in a row have different lengths or the plurality of connection portions 2112 connecting adjacent two electrode units 210 arranged in a column have different lengths. That is, adjacent two electrode units 210 arranged in a row have different pitches, or adjacent two electrode units 210 arranged in a column have different pitches. Specifically, the pitch between two adjacent electrode units 210 located in adjacent columns in the same row is different from the pitch between two adjacent electrode units 210 located in alternate columns in the same row. The pitch between two adjacent electrode units 210 of adjacent rows in the same column is different from the pitch between two adjacent electrode units 210 of intermediate interlaced rows in the same column. Preferably, the spacing between two adjacent electrode units 210 located in adjacent columns in the same row is smaller than the spacing between two adjacent electrode units 210 located in alternate columns in the same row. The spacing between two adjacent electrode units 210 of adjacent rows in the same column is smaller than the spacing between two adjacent electrode units 210 of intermediate alternate rows in the same column. The spacing between two adjacent electrode units 210 in adjacent columns in the same row is equal to the spacing between two adjacent electrode units 210 in adjacent rows in the same column, between 1mm and 3mm, preferably 2.1 mm.

The connection portion 2112 includes a first connection portion 21121 connecting two adjacent electrode units 210 and connected to the wiring portion 2113, and a plurality of second connection portions 21122 connecting only two adjacent electrode units 210 in the same row or column. The wire portion 2113 extends laterally from the first connection portion 21121 in a direction away from the electrode unit 210, and is electrically connected to the lead 24. The wire connecting portion 2113 may be provided so as to be perpendicular to the first connection portion 21121, or may be provided so as to be perpendicular to a corresponding portion of the first connection portion 21121. The second connection portions 21122 are provided substantially in a straight line shape, and may have the same length or different lengths. The second connection portions 21122 connecting two adjacent electrode units 210 in adjacent columns in the same row or connecting two adjacent electrode units 210 in adjacent rows in the same column have the same length, and the length thereof is smaller than that of the first connection portions 21121. The first connection portion 21121 may be disposed in an "L" shape, and is located at the periphery of the electrical functional assembly 21 to connect the two electrode units 210 in adjacent columns or adjacent rows. Specifically, the first connection portion 21121 is disposed in an "L" shape, and may connect two adjacent electrode units 210 located in adjacent rows and adjacent columns, or connect two electrode units 210 located in adjacent columns and spaced apart from each other, or connect two electrode units 210 located in adjacent rows and spaced apart from each other. The first connection portion 21121 may also be disposed in a "straight" shape, and is connected to two adjacent electrode units 210 disposed in alternate columns in the same row or connected to two adjacent electrode units 210 disposed in alternate rows in the same column. The electrical function component 21 may further include a reinforcing portion 2114 having one end connected to the first connection portion 21121 and the other end connected to the electrode unit 210 corresponding to the first connection portion 21121. The reinforcing portion 2114 and the first connecting portion 21121 are disposed in an "F" shape or a "T" shape. The reinforcing portion 2114 and the wire connecting portion 2113 are located on opposite sides of the first connection portion 21121, respectively. The reinforcing portion 2114 can reinforce the strength of the wire portion 2113 disposed opposite thereto. The length of the reinforcing portion 2114 is not less than the length of the second connecting portion 21122. That is, the length of the reinforcing portion 2114 is greater than or equal to the length of the second connecting portion 21122 connecting two adjacent electrode units 210 of adjacent columns in the same row, or greater than or equal to the length of the second connecting portion 21122 connecting two adjacent electrode units 210 of adjacent rows in the same column.

Referring to fig. 18, in the present embodiment, the electrical functional assembly 21 includes electrode units 210 arranged in three rows and five columns, and a connection portion 2112 connecting two adjacent electrode units 210 in the same row or the same column. The number of the electrode units 210 is 14 in total. The electrode units 210 include 5 electrode units 210 located in the first row, 5 electrode units 210 located in the middle row, and 4 electrode units 210 located in the last row, from the row arrangement perspective. The connection portions 2112 between two adjacent electrode units 210 in the first or middle row have the same length and are between 1mm and 3mm, preferably 2.1 mm. The connecting portions 2112 between two adjacent electrode units 210 in the last row have different lengths, wherein the length of the connecting portion 2112 between two adjacent electrode units 210 in adjacent columns in the last row is equal to the length of the connecting portion 2112 between two adjacent electrode units 210 in the first or middle row, and the length of the connecting portion 2112 between two adjacent electrode units 210 in adjacent columns in the last row is smaller than the length of the connecting portion 2112 between two adjacent electrode units 210 in alternate columns in the last row. The length of the connection portion 2112 between two adjacent electrode units 210 of adjacent columns in the last row is between 1mm and 3mm, preferably 2.1 mm. The length of the connecting portion 2112 between two adjacent electrode units 210 in the last row and column is between 22mm and 27 mm.

In the electrode units 210, from the arrangement of the columns, only 2 electrode units 210 are arranged in the middle column, and 3 electrode units 210 are arranged in each of the remaining four columns. The connection portions 2112 connecting two adjacent electrode units 210 in each column have the same length, and are equal to the length of the connection portion 2112 connecting two adjacent electrode units 210 in the first or middle row. The length of the connecting portion 2112 connecting two adjacent electrode units 210 in each row is between 1mm and 3mm, and preferably 2.1 mm. The connecting portions 2112 between two adjacent electrode units 210 arranged in a row have the same length, which is between 1mm and 3mm, and preferably 2.1 mm. The connecting portions 2112 between two adjacent electrode units 210 arranged in a row are different in length. The length of the connection portion 2112 connecting the two electrode units 210 positioned in adjacent columns in the same row is smaller than the length of the connection portion 2112 connecting the two electrode units 210 disposed in alternate columns in the same row. The connection portions 2112 between two adjacent electrode units 210 in adjacent rows in the same column are both second connection portions 21122. The connection portion 2112 between two adjacent electrode units 210 in adjacent columns in the same row is also a second connection portion 21122. The length of the second connecting parts is between 1mm and 3mm, and preferably 2.1 mm. The connection portion 2112 between two adjacent electrode units 210 in alternate columns in the same row is a first connection portion 21121. The first connection portion 21121 and the second connection portion 21122 are both provided in a line shape. The length of the first connection portion 21121 is different from the length of the second connection portion 21122. The length of the first connection portion 21121 is greater than the length of the second connection portion 21122.

The wire connection portion 2113 is provided extending laterally from the first connection portion 21121 in a direction away from the electrical function component 21. The wire portion 2113 is provided perpendicular to the first connection portion 21121. The wire portion 2113 is provided in a "T" shape with the first connection portion 21121. The length of the first connection portion 21121 connecting two adjacent electrode units 210 of alternate columns in the same row is greater than the length of the second connection portion 21122 connecting only two adjacent electrode units 210 of adjacent columns in the same row. The first connection portion 21121 is electrically connected to the wiring portion 2113. The electrical function assembly 21 further includes a reinforcing portion 2114 having one end connected to the first connection portion 21121 connected to the wire connection portion and the other end connected to the electrode unit 210 opposite to the first connection portion 21121. Specifically, the reinforcing portion 2114 has one end connected to the electrode unit 210 located in the middle column of the middle row and the other end connected to the middle of the first connection portion 21121. The reinforcing portion 2114 and the first connecting portion 21121 are arranged in an inverted "T" shape. The reinforcing portion 2114 and the wire connecting portion 2113 are respectively located at two opposite sides of the first connecting portion 21121, which can provide traction for the wire connecting portion 2113, and avoid the influence on the application of the insulated electrode 200 due to uneven stress when the insulated electrode 200 is applied to the body surface of the tumor portion of the patient. The reinforcing portion 2114 is located on the same line as the wire connecting portion 2113. The reinforcing portion 2114 is provided perpendicular to the first connection portion 21121.

In the present embodiment, the electrode unit 210 has a substantially circular sheet-like configuration, and the diameter of the electrode unit 210 is about 21 mm. The length of the second connecting portion 21122 is 1mm to 3mm, so that the number of electrode units 210 per unit area of the insulated electrode 200 can be increased, the coverage area of the electrode units 210 of the insulated electrode 200 can be increased without increasing the entire area of the insulated electrode 200, the electric field intensity applied to a tumor part for TTF treatment can be increased, the range of the alternating electric field covering the tumor part can be increased, and the treatment effect can be improved. In the present embodiment, the length of each of the second connection portions 21122 is 2.1 mm. In another embodiment, the first connecting portions 21121 are arranged in a line shape, and may be connecting portions 2112 connecting two adjacent electrode units 210 positioned in alternate rows in the same row or connecting portions 2112 connecting two adjacent electrode units 210 positioned in alternate rows in the same row; the second connection portion 21122 is a connection portion 2112 connecting two adjacent electrode units 210 in adjacent columns in the same row or a connection portion 2112 connecting two adjacent electrode units 210 in adjacent rows in the same column. In another embodiment, the first connecting portion is substantially "L" shaped, and is located at a corner of the electrical functional assembly 21 to connect two electrode units 210 in adjacent rows. The second connection portion is disposed in a line shape, and connects two adjacent electrode units 210 located in adjacent rows in the same row or connects two adjacent electrode units 210 located in adjacent rows in the same row.

The periphery of the welding part of the lead 24 and the gold finger 21130 of the wire connecting part 2113 is covered with a heat-shrinkable sleeve 241. The corresponding portion of the wire portion 2113 near the connecting portion 2112 is located between the two electrode units 210 in the middle of the last row to shorten the distance by which the wire portion 2113 exceeds the edge of the electrode unit 210 by the space between the electrode units 210, thereby avoiding an increase in manufacturing cost due to an excessive size of the entire electrical functional assembly 21. The wire connection portion 2113 is provided at a distance from the electrode unit 210 adjacent thereto, which provides a larger operation space for welding the wire connection portion 2113 to the lead wire 24.

The electrode unit 210 is substantially the same as the electrode unit 110 of the insulated electrode 100 in the first embodiment, and the electrode unit 210 includes a main body portion 2111, an insulating plate 212 provided on a side of the main body portion 2111 away from the skin of the human body, a dielectric member 213 provided on a side of the main body portion 2111 facing the skin of the human body, and a temperature sensor 14 selectively provided on the main body portion 2111 and on the same side as the dielectric member 213. A conductive plate 2115 is provided on a surface of the main body portion 2111 facing the dielectric element 213, and the conductive plate 2115 includes a plurality of petaloid conductive cores 21150 arranged in a central symmetry. The conductive core 21150 is soldered to the dielectric element 213 by solder. A temperature sensor 14 is welded to the body portion 2111 at the center of the conductive plate 2115. The dielectric element 213 is provided with a through hole 2131 in the middle for accommodating the temperature sensor 14. The structures and corresponding functions of the electrode unit 210 are not described herein again, and reference may be made to the first embodiment for relevant contents.

Referring to fig. 18, the temperature sensor 214 is provided in a plurality of through holes 2131, which are respectively received in the corresponding dielectric elements 213. In the present embodiment, there are thirteen temperature sensors 214, and the thirteen temperature sensors are respectively located on the thirteen electrode units 210 other than the electrode unit 210 in the middle of the middle row. Referring to fig. 4, thirteen temperature sensors 214 are provided at the centers of the thirteen main body portions 2111, respectively.

Referring to fig. 17, the body portion 2111, the insulating plate 212, and the dielectric member 213 are arranged in three rows and five columns. The main body portions 2111 of the electrode units 210 arranged in three rows and five columns, a plurality of connection portions 2112 located between two adjacent electrode units, wire connection portions 2113 extending outward from the connection portions 2112, and reinforcing portions 2114 provided corresponding to the wire connection portions 2113 together constitute the flexible circuit board 11 of the electrical functional module 21. From the perspective of the formation of the electrode unit 210, the insulating plate 212 is disposed on the side of the main body portion 2111 of the flexible circuit board 11 away from the skin of the human body, the dielectric element 213 is disposed on the side of the main body portion 2111 of the flexible circuit board 11 facing the skin of the human body, and the temperature sensor 214 is selectively disposed on the side of the main body portion 2111 of the flexible circuit board 11 facing the skin of the human body. The main body portion 2111 of the flexible circuit board 11 of the electrical function assembly 21 is aligned with the electrode unit 210 of the electrical function assembly 21.

The flexible circuit board 211 is composed of an insulating substrate B and a plurality of conductive traces (not shown) embedded in the insulating substrate B. Each of the main body portion 2111 and the wire connection portion 2113 has an insulating substrate B and a plurality of conductive traces (not shown) embedded in the insulating substrate B. Each of the connection portion 2112 and the reinforcing portion 2114 has an insulating substrate B. The connection portion 2112 has a plurality of conductive traces (not shown) embedded in the insulating substrate B. Conductive traces (not shown) in the insulating substrate B of the main body portion 2111, conductive traces (not shown) in the insulating substrate B of the connection portion 2112, and conductive traces (not shown) in the insulating substrate B of the wire connection portion 2113 are electrically connected. Conductive traces (not shown) may be embedded in the insulating substrate B of the reinforcing portion 2114. The reinforcing portion 2114 may not provide conduction (not shown) in the insulating substrate B, and the reinforcing portion 2114 may reinforce only the strength of the wire portion 2113. The plurality of connection portions 2112 may have a plurality of conductive traces (not shown) embedded in the insulating substrate B only in a part of the connection portions 2112, and no conductive trace (not shown) may be embedded in the insulating substrate B in a part of the connection portions 2112.

The conductive traces (not shown) of the flexible circuit board 211 include one conductive trace (not shown) that connects all the conductive cores 21150 of the conductive pads 2115 located on the respective main body portions 2111 in series, one conductive trace (not shown) that connects the ground terminals (not shown) of the respective temperature sensors 214 located on the main body portions 2111 in series, and a plurality of conductive traces (not shown) that connects the signal terminals (not shown) of the respective temperature sensors 214 located on the main body portions 2111 in parallel. The conductive traces (not shown) are electrically connected to the corresponding gold fingers 21130 of the wire portion 2113, respectively. To facilitate routing of conductive traces (not shown), the wire portions 2113 are wider than the connection portions 2112. Preferably, the connecting portion 2112 has a width of 4 to 6mm, and the wire connecting portion 2113 has a width of 7 to 9 mm. In the present embodiment, the connection portion 2112 has a width of 4.5mm, and the wire connection portion 2113 has a width of 8 mm. It is understood that the partial connection portions 2112 may not be used for routing conductive traces (not shown), but are used only for increasing the strength of the flexible circuit board 211.

The support 23 is a one-piece foam. The support 23 is provided with a plurality of through holes 230 corresponding to the electrode units 210 of the electrical functional assembly 21 for receiving the respective electrode units 210. The supporting member 230 surrounds each electrode unit 210 of the electrical function assembly 21, and may improve the overall strength of the insulated electrode 200. The through holes 230 include a plurality of first through holes 231 and a plurality of second through holes 232. The first through holes 231 are disposed in a communicating manner and surround the electrode units 210 disposed in a row, so as to receive the connecting portions 2112 connecting the two adjacent electrode units 210 in the same row, thereby reducing the contact between the supporting member 23 and the connecting portions 2112 of the electrical functional assembly 21, and enabling the supporting member 23 to be attached to the backing 22 more smoothly. The second through holes 232 are provided at intervals on the support 23, and each surround one electrode unit 210 arranged in a row. In the present embodiment, the plurality of first through holes 231 are respectively formed to surround the three electrode units 210 in the first row, the two electrode units 210 in the third row, and the three electrode units 210 in the fifth row. The second through holes 232 are respectively formed around the second and fourth electrode units 210. The plurality of second through holes 232 are arranged in a row, and the plurality of second through holes 232 arranged in a row are arranged at intervals to ensure the strength of the support 23 and avoid breakage caused by external force. The first through-hole 231 is substantially racetrack-shaped.

The adhesive member (not shown) is a one-piece member having a size slightly larger than that of the supporting member 23. The adhesive means (not shown) is preferably a conductive gel. The adhesive member (not shown) has double-sided adhesive properties and is capable of maintaining the skin surface moist and relieving local pressure when in contact with the skin.

In the insulated electrode 200 of the present embodiment, the 14 electrode units 210 disposed thereon apply the alternating electric field to the tumor region of the patient for tumor treatment, so as to avoid the insufficient electric field treatment caused by the difference in size, position and location of the tumor from affecting the treatment effect, increase the coverage area of the electrode units 210 of the insulated electrode 200, enhance the electric field intensity applied to the tumor region for TTF treatment, increase the range of the alternating electric field covering the tumor region, and improve the treatment effect.

Third embodiment of insulated electrode 300

Referring to fig. 19 to 23, the insulated electrode 300 of the present embodiment includes a backing 32, an electrical functional component 31 adhered to the backing 32, a supporting member 33 adhered to the backing 32, an adhesive member 34 covering the supporting member 33 and a corresponding portion of the electrical functional component 31 and contacting with the body surface skin corresponding to the tumor region of the patient, and a lead 35 electrically connected to the electrical functional component 31.

The electrical function assembly 31 includes a single circular plate-shaped electrode unit 310 and a wire connection portion 3112 connected to the electrode unit 310. The wire connecting portion 3112 is welded to the lead 35 to electrically connect the electrical functional component 31 and the lead 35. A plurality of golden fingers 31120 are arranged on one side surface of the wiring portion 3112. In the present embodiment, the plurality of gold fingers 31120 are provided on the skin-facing surface of the wire portion 3112. The lead 35 is welded to the gold finger 31120 of the wire connection portion 3112, and a heat shrinkable sleeve 351 is wrapped around the welded portion. The end of the lead 35 away from the wire connection portion 3112 is provided with a plug 352 electrically connected to an electric field generator (not shown).

The backing 32 is generally in the form of a cube sheet, with the four corners of the backing 32 being rounded in angular disposition. The support 33 is adhered to the backing 32 and surrounds the outside of the electrode unit 310. A through hole 331 is formed through the middle of the support 33 for receiving the electrode unit 310. The adhesive member 34 covers the support member 33 and the surface of the electrode unit 310 on the side away from the backing 32 and is applied to the skin of the patient.

The insulated electrode 300 in the third embodiment is provided with only one electrode unit 310, and the specific structure of the electrode unit 310 is the same as that of the electrode unit 110 of the insulated electrode 100 in the first embodiment, and includes a body portion 3111, an insulating plate 312, a dielectric member 313, and a temperature sensor 314. The main body portion 3111 is provided with a conductive plate 3113, and the conductive plate 3113 is provided with 4 petal-shaped conductive cores 31130 arranged at intervals and in a central symmetry. The dielectric element 313 is provided with a perforation 3131 accommodating the temperature sensor 314. The temperature sensor 314 is welded to the main body portion 3111 and is accommodated in the through hole 3131 of the dielectric element 313. The structures and corresponding functions of the electrode unit 310 are not described herein, and reference may be made to the first embodiment for relevant contents. The main body portion 3111 is composed of an insulating substrate B and three conductive traces L embedded in the insulating substrate B. The following describes the layout of the three-way conductive traces L. 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 313, 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 plate 312. The body portion 3111 has a diameter greater than 20mm, preferably 21mm, and the plurality of conductive cores 31130 are each connected to a first conductive trace L1. The plurality of conductive cores 31130 are connected together in series by a first conductive trace L1. The 4 conductive cores 31130 are arranged at intervals, and a space C is formed between two adjacent conductive cores 31130. 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 spaces C is the same as the extending direction of the wire connecting portion 3112.

Main body portion 3111 is further provided with a pair of pads 3114 exposing insulating board B, and is soldered to a portion corresponding to temperature sensor 314 to electrically connect temperature sensor 314 and main body portion 3111. The two pads 3114 are surrounded by four conductive cores 31130 of the conductive disc 3113. The two pads 3114 are located approximately at the symmetrical center of the plurality of conductive cores 31130. One of the two pads 3114 is connected to the second conductive trace L2, and the other pad is connected to the third conductive trace L3. Of the two pads 3114, a pad connected to the second conductive trace L2 is a first pad 3114A, and a pad connected to the third conductive trace L3 is a second pad 3114B. The temperature sensor 314 has a signal terminal (not shown) and a ground terminal (not shown). The first pad 3114A is soldered to a ground terminal (not shown) of the temperature sensor 314, and the second pad 3114B is soldered to a signal terminal (not shown) of the temperature sensor 314.

The temperature sensor 314 is soldered to a first land 3114A provided on the body portion 3111 via a ground terminal (not shown) thereof, and is provided on the body portion 3111 via a signal terminal (not shown) thereof and a second land 3114B provided on the body portion 3111. Since the first pad 3114A of the main body portion 3111 is connected to the second conductive trace L2, the second pad 3114B is connected to the third conductive trace L3, the first pad 3114A is soldered to a ground terminal (not shown) of the temperature sensor 314, and the second pad 3114B is soldered to a signal terminal (not shown) of the temperature sensor 314, the ground terminal (not shown) of the temperature sensor 314 is electrically connected to the second conductive trace L2 of the main body portion 3111, and the signal terminal (not shown) is electrically connected to the third conductive trace L3 of the main body portion 3111. That is, the temperature sensor 314 performs signal transmission with the third conductive trace L3 through the second conductive trace L2. The temperature sensor 314 is welded to the main body portion 3111 and then accommodated in the through hole 3131 of the dielectric element 313.

The wire connection portion 3112 has the same structure as the main body portion 3111, 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 connection portion 3112 are also electrically connected to the corresponding conductive traces L of the main body portion 3111. The number of the gold fingers 31120 of the wiring portion 3112 is 3, and the insulating substrate B is exposed on the side close to the dielectric element 313. The three conductive traces L of the wiring portion 3112 are electrically connected to the gold finger 31120 respectively. The three conductive traces of the wire connection portion 3112 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 3112 is provided extending from the first conductive trace L1 of the body portion 3111. The second conductive trace L2 of the wire connection portion 3112 is provided extending from the second conductive trace L2 of the body portion 3111. The conductive trace L3 of the wire connection portion 113 is extended by the third conductive trace L3 of the main body portion 3111.

The wire connecting portion 3112 is connected to the first conductive trace L1 of the main body portion 3111 through the first conductive trace L1 thereof, and the first conductive trace L1 of the main body portion 3111 is connected to the conductive pad 3113 of the main body portion 3111, so as to be electrically connected to the conductive pad 3113 of the main body portion 3111, and further electrically connected to the dielectric element 313 through the soldering between the conductive pad 3113 of the main body portion 112 and the dielectric element 313. The wire connecting portion 3112 is electrically connected to the pad 3114A of the main body portion 3111 through connection of the second conductive trace L2 and the second conductive trace L2 of the main body portion 3111, connection of the second conductive trace L2 of the main body portion 3111 and the pad 3114A of the main body portion 3111, and further electrically connected to a ground terminal (not shown) of the temperature sensor 314 through welding of the pad 3114A and the ground terminal (not shown) of the temperature sensor 314. The wire connecting portion 3112 is electrically connected to the pad 3114B of the main body portion 3111 through the connection between the third conductive trace L3 and the third conductive trace L3 of the main body portion 3111, and the connection between the third conductive trace L3 and the pad 3114B of the main body portion 3111, and further electrically connected to the signal terminal (not shown) of the temperature sensor 314 through the soldering between the pad 3114B and the signal terminal (not shown) of the temperature sensor 314.

The main body portion 3111 and the wire connection portion 3112 together constitute the flexible circuit board 311 of the electrical functional module 31. The insulating substrates B of the main body portion 3111 and the wire connection portion 3112 together constitute an insulating substrate B of the flexible circuit board 311. The conductive traces L of the main body portion 3111 and the conductive traces L of the wire connection portion 3112 form conductive traces L of the flexible circuit board 311 in a one-to-one correspondence. The insulating substrate B of the flexible circuit board 311 can isolate moisture in the air surrounding the insulated electrode 300 from the solder (not shown) between the conductive pad 3113 and the dielectric element 313, so as to prevent moisture in the air away from the skin from eroding the solder (not shown) between the conductive pad 3113 and the dielectric element 313 on the main body 3111 of the flexible circuit board 311. The insulating substrate B of the flexible circuit board 311 and the insulating plate 312 perform a double-isolation function, which may prolong the service life of the insulated electrode 300.

From the perspective of forming the electrode unit 310, the insulating plate 312 is disposed on the side of the body portion 3111 of the flexible circuit board 311 away from the skin of the human body, the dielectric member 313 is disposed on the side of the body portion 3111 of the flexible circuit board 311 facing the skin of the human body, and the temperature sensor 314 is disposed on the side of the body portion 3111 of the flexible circuit board 311 facing the skin of the human body. The insulating plate 312 and the dielectric element 313 are respectively disposed on opposite sides of the main body portion 3111 of the flexible circuit board 311. The first conductive trace L1 of the flexible circuit board 311 connects the 4 spaced conductive cores 31130 of the conductive disc 3113 in series, the second conductive trace L2 is electrically connected to the ground terminal (not shown) of the temperature sensor 314 through the pad 3114A, and the third conductive trace L3 is electrically connected to the signal terminal (not shown) of the temperature sensor 314 through the pad 3114B. 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 312. In order to facilitate the routing of the conductive traces L, the width of the wiring portion 3112 is 7 to 9 mm. Preferably, the wire connection portion 3112 has a width of 8 mm.

The gold finger 31120 of the wire connection portion 3112, the plurality of conductive cores 31130 of the conductive plate 3113 and the land 3114 are exposed from a side surface of the insulating substrate B of the flexible circuit board 311 near the dielectric member 313. The golden finger 31120, the plurality of conductive cores 31130 of the conductive disc 3113 and the pad 3114 are located on a side of the flexible circuit board 311 that is adjacent to the patient's body surface. A gold finger 31120 of the wire connection portion 3112 is electrically connected to the dielectric element 313 through a first conductive trace L1 connected thereto at one end, and is soldered to a corresponding portion of the lead wire 35 at the other end, so as to transmit an alternating voltage signal generated by an electric field generator (not shown) to the dielectric element 313. One end of one gold finger 31120 of the other two gold fingers 31120 of the wire connecting portion 3112 is electrically connected to a ground terminal (not shown) of the temperature sensor 314 through the second conductive trace L2 connected thereto, and one end of the other gold finger 31120 is electrically connected to a signal terminal (not shown) of the temperature sensor 314 through the third conductive trace L3 connected thereto. The other ends of the two gold fingers 31120 of the wire connection portion 3112 are respectively soldered to corresponding portions of the lead wires 35, so that the relevant signals detected by the temperature sensor 314 are transmitted to the electric field generator (not shown) through the second conductive trace L2, the third conductive trace L3 and the lead wires 35.

In this embodiment, the flexible circuit board 311 of the insulated electrode 300 is provided with only one first conductive trace L1 electrically connected to the dielectric element 313, one second conductive trace L2 electrically connected to a ground terminal (not shown) of the temperature sensor 314, and a third conductive trace L3 electrically connected to a signal terminal (not shown) of the temperature sensor 314, so as to transmit an alternating voltage signal of the electric field generator (not shown) to the dielectric element 313 through the first conductive trace L1, and achieve the purpose of applying an alternating voltage to a tumor region of a patient for tumor treatment; meanwhile, the second conductive trace line L2 and the third conductive trace line L3 are respectively electrically connected with the temperature sensor 314 to realize signal transmission between the electric field generator (not shown) and the temperature sensor 314, 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. In addition, since the insulated electrode 300 applies the alternating voltage to the tumor part of the patient by using the single electrode unit 310, when the insulated electrode cannot work normally, only the insulated electrode 300 with the single electrode unit 310 needs to be replaced, and the whole insulated electrode containing a plurality of electrode units 310 does not need to be scrapped, so that the cost of tumor treatment of the patient can be reduced. In addition, the insulated electrodes 300 in this embodiment can be freely combined according to the size of the tumor region of the patient, so as to ensure the coverage area of the insulated electrodes 300 for tumor electric field treatment and ensure the electric field treatment effect.

Fourth embodiment of insulated electrode 400

Referring to fig. 24 to 29, the insulated electrode 400 of the present embodiment includes a backing 42, an electrical functional component 41 adhered to the backing 42, a supporting member 43 adhered to the backing 42, an adhesive member 44 covering the supporting member 43 and a corresponding portion of the electrical functional component 41 and contacting the body surface skin corresponding to the tumor region of the patient, and a lead 45 electrically connected to the electrical functional component 41. The backing 42 and the supporting member 43 have the same relative functions and materials as the backing 12 and the supporting member 13 of the insulated electrode 100 in the first embodiment except for the slightly different shapes, and the description thereof is omitted, and the related contents refer to the first embodiment.

The electrical function assembly 41 includes a single rectangular plate-shaped electrode unit 410 and a terminal portion 4112 connected to the electrode unit 410. A single through hole 431 is penetratingly formed at the center of the supporter 43 to receive the electrode unit 410. The wiring portion 4112 is welded to the lead 45 to electrically connect the electrical functional component 41 to the lead 45. The surface of the wire portion 4112 facing the skin is provided with four gold fingers 41120. The periphery of the welding position of the lead 45 and the gold finger 41120 of the terminal portion 4112 is covered with a heat-shrinkable sleeve 451. The end of the conducting wire 45 away from the wiring portion 4112 is provided with a plug 452 electrically connected to an electric field generator (not shown) or a hub (not shown).

The electrode unit 410 includes a main body portion 4111 disposed at the end of the wire connecting portion 4112, an insulating plate 412 disposed on the side of the main body portion 4111 away from the skin of the human body, a dielectric element 413 disposed on the side of the main body portion 4111 facing the skin of the human body, and two temperature sensors 414 disposed on the main body portion 4111 and located on the same side as the dielectric element 413. The main body portion 4111 and the lead 45 are respectively disposed at two opposite ends of the wiring portion 4112. The dielectric element 413 is penetrated by two through holes 4131 with the number equal to that of the temperature sensors 414, and the two through holes are respectively used for accommodating the corresponding temperature sensors 414. The main body 4111, the insulating plate 412, and the dielectric element 413 are substantially the same in shape, and all have a rectangular sheet-like structure. The main body 4111, the insulating plate 412, and the dielectric element 413 are disposed correspondingly along the thickness direction of the main body 4111, and the centers of the three are located on the same straight line. In this embodiment, the main body 4111, the insulating plate 412 and the dielectric element 413 are all rectangular sheet-shaped structures with rounded corners. Preferably, the main body portion 4111 has a rectangular plate-like configuration with dimensions of about 43.5mm × 23.5 mm. The terminal portion 4112 of the electrical functional component 41 is laterally extended from the main body portion 4111 of the electrode unit 410.

The main body portion 4111 is composed of an insulating substrate B and four conductive traces L embedded in the insulating substrate B. The four conductive traces are a first conductive trace L1 disposed on the insulating substrate B near the dielectric element 413, a second conductive trace L2 disposed on the insulating substrate B near the insulating plate 412, and two third conductive traces L3 and L3' disposed on the same side as the second conductive trace L2. The main body portion 4111 is centrally disposed with a conductive pad 4113 exposing the insulating substrate B and electrically connected to the first conductive trace L1. A metal layer 4132 is attached to a surface of the dielectric element 413 facing the main body 4111, and the conductive plate 4113 is welded to the dielectric element 413 to assemble the dielectric element 413 on the main body 4111. The conductive disc 4113 can be completely covered by the dielectric element 413, so that the conductive disc 4113 and the dielectric element 413 are soldered (not shown). The conductive plate 4113 is centered on the center line of the main body 4111. The conductive plate 4113 includes a plurality of conductive cores 41130 arranged in a central symmetry, which can effectively prevent the position of the dielectric element 413 from shifting due to stacking of solder (not shown) during the soldering process. The top surfaces of the plurality of conductive cores 41130 are coplanar, so as to avoid cold joint with the dielectric element 413 during soldering. The plurality of conductive cores 41130 are each connected to a first conductive trace L1. The plurality of conductive cores 41130 are connected together in series by a first conductive trace L1.

In this embodiment, the conductive plate 4113 of the main body 4111 has a substantially rectangular configuration, and the symmetry axes thereof coincide with the corresponding symmetry axes of the main body 4111. The conductive pad 4113 includes 6 conductive cores 41130 spaced apart at four corners and two long sides of the conductive pad. The conductive core 41130 adopts a multi-point interval arrangement mode, so that the use amount of copper foil for manufacturing the conductive core 41130 can be reduced; meanwhile, the amount of solder (not shown) used for welding the conductive core 41130 and the dielectric element 413 can be saved, and the manufacturing cost can be reduced. Each of the conductive cores 41130 is configured as a rectangle having dimensions of about 8mm by 4 mm. Preferably, each of the conductive cores 41130 has a rectangular configuration with rounded corners. The longitudinal axis of each conductive core 41130 is perpendicular to the extending direction of the wire connecting portion 4112. In other embodiments, each conductive core 41130 of the conductive plate 4113 may also be circular, square, etc.

In this embodiment, the 6 conductive cores 41130 forming the conductive pad 4113 are arranged in a matrix at intervals, and the 6 conductive cores 41130 are arranged in three rows and two columns along the longitudinal direction of the main body 4111. The first row has 2 conductive cores 41130, the middle row has 2 conductive cores 41130, and the last row has 2 conductive cores 41130. The spacing between two rows of conductive cores 41130 is about 2.4mm, and the spacing between adjacent rows of conductive cores 41130 is about 12.8 mm. The 6 conductive cores 41130 constituting the conductive disc 4113 are arranged in a central symmetry manner and an axial symmetry manner, and each conductive core 41130 is also arranged in an axial symmetry manner, so that when the 6 conductive cores 41130 of the main body portion 4111 are welded with the dielectric element 413, stress at each welding point is balanced, the overall welding balance of the dielectric element 413 is ensured, the welding quality is improved, and the situation that the welding position of the side, with a larger interval between the dielectric element 413 and the main body portion 4111, of the dielectric element 413 is weak in strength and easy to break due to inclination of the dielectric element 413 caused by unbalanced welding stress is avoided; and simultaneously, the adhesion degree of the insulated electrode 400 can be prevented from being influenced. The 6 conductive cores 41130 of the conductive plate 4113 are arranged at intervals, and a space C is formed between two adjacent conductive cores 41130. The 4 conductive cores 41130 in adjacent rows are arranged in a spaced manner, and the 4 spaces C between the 4 conductive cores 41130 are arranged in a cross-shaped communication manner. The dimension of the space C between two adjacent conductive cores 41130 in the same column is larger than the dimension of the space C between two conductive cores 41130 in the same row. 7 intervals C are formed among the 6 conductive cores 41130, and the 7 intervals C are approximately arranged in a shape of a Chinese character ≠ h. The adjacent spaces C are also arranged in a communicated manner. The straight lines of 3 intervals C between two adjacent conductive cores 41130 in the same row among the 7 intervals C are consistent with the extending direction of the wire connecting portion 4112.

The main body portion 4111 is further provided with two pairs of bonding pads 4114 exposing the insulating substrate B, and the two pairs of bonding pads can be respectively soldered to corresponding portions of the corresponding temperature sensor 414 to realize electrical connection between the temperature sensor 414 and the main body portion 4111. Each pair of lands 4114 is disposed at a corresponding connected region of 4 spaces C formed by the spaces of 4 conductive cores 41130 in adjacent rows. The line connecting the symmetric centers of the two pairs of bonding pads 4114 is consistent with the extending direction of the wiring portion 4112. The straight line where the connecting lines of the two symmetrical centers of the two pairs of bonding pads 4114 are located coincides with the longitudinal axis of the main body 4111. The straight line of the connecting line of the two symmetrical centers of the two pairs of bonding pads 4114 is coincident with the longitudinal axis of the conductive pad 4113. The first row and the middle 4 conductive cores 41130 are arranged in a central symmetry manner, and the middle row and the last row of 4 conductive cores 41130 are also arranged in a central symmetry manner. The two pairs of lands 4114 are each disposed in a symmetrical center offset from the 4 conductive cores 41130 in two adjacent rows. Specifically, the pair of bonding pads 4114 is disposed on a side, away from the terminal portion 4112, of a symmetric center of a rectangle surrounded by the 4 conductive cores 41130 in the first and middle rows. The other pair of bonding pads 4114 is disposed on a side of a symmetric center of a rectangle surrounded by the 4 conductive cores 41130 in the middle row and the last row, which is close to the terminal portion 4112. Each pair of pads 4114 includes a first pad 4114A and a second pad 4114B. The first pad 4114A of each pair of pads 4114 is electrically connected to the second conductive trace L2. One of the two second pads 4114B is electrically connected to the third conductive trace L3, and the other is electrically connected to the third conductive trace L3'. The temperature sensor 414 has a signal terminal (not shown) and a ground terminal (not shown). The first bonding pad 4114A is bonded to a ground terminal (not shown) of the temperature sensor 414, and the second bonding pad 4114B is bonded to a signal terminal (not shown) of the temperature sensor 414.

One of the two temperature sensors 414 is located at 4 intervals C connected regions between the first row and the middle row of 4 conductive cores 41130, and the other is located at 4 intervals C connected regions between the middle row and the last row of 4 conductive cores 41130. The temperature sensor 414 located in the area surrounded by the 4 conductive cores 41130 in the first row and the middle row is arranged on one side, away from the wiring portion 4112, of the symmetric center of the area surrounded by the 4 conductive cores 41130 in the first row and the middle row. The other temperature sensor 414 located in the area surrounded by the 4 conductive cores 41130 in the middle row and the last row is arranged on one side, close to the wiring portion 4112, of the symmetric center of the area surrounded by the 4 conductive cores 41130 in the middle row and the last row. The two temperature sensors 414 are both disposed in an area surrounded by the conductive plate 4113. Each temperature sensor 414 is soldered to a first solder pad 4114A disposed on the main body 4111 via a ground terminal (not shown) thereof, and soldered to a corresponding second solder pad 4114B disposed on the main body 4111 via a signal terminal (not shown) thereof, so as to be electrically connected to the main body 4111. Since the two first pads 4114A of the main body 4111 are electrically connected to the second conductive trace L2, one of the two second pads 4114B is electrically connected to the third conductive trace L3, and the other of the two second pads 4114B is electrically connected to the third conductive trace L3 ', the first pads 4114A are soldered to the ground terminal (not shown) of the temperature sensor 414, and the two second pads 4114B are soldered to the corresponding signal terminals (not shown) of the two temperature sensors 414, respectively, so that the ground terminals (not shown) of the two temperature sensors 414 are electrically connected to the second conductive trace L2 of the main body 4111, and the signal terminals (not shown) of the two temperature sensors 414 are electrically connected to the third conductive traces L3 and L3' of the main body 4111, respectively. That is, the two temperature sensors 414 transmit their monitored temperature signals in parallel with the third conductive trace L3, L3' via the second conductive trace L2. The two temperature sensors 414 are respectively accommodated in the corresponding through holes 4131 of the dielectric element 413 after being welded to the main body portion 4111. Preferably, the temperature sensor 414 is a thermistor.

The wiring portion 4112 has the same structure as the main body portion 4111, 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 the wiring portion 4112 are electrically connected to the corresponding conductive traces L of the main portion 4111 in a one-to-one correspondence manner. The 4 gold fingers 41120 of the wiring portion 4112 are exposed from a side of the insulating substrate B close to the dielectric element 413. The four conductive traces L of the wiring portion 4112 are electrically connected to the gold fingers 41120, respectively. The four conductive traces L of the wire connecting portion 4112 are also a first conductive trace L1, a second conductive trace L2, and third conductive traces L3, L3', respectively. The first conductive trace L1 of the terminal portion 4112 is extended from the first conductive trace L1 of the body portion 4111. The second conductive trace L2 of the terminal portion 4112 is extended from the second conductive trace L2 of the body portion 4111. The third conductive traces L3, L3 'of the wire connection portion 113 are respectively extended from the corresponding third conductive traces L3, L3' of the main body portion 4111.

The wire connecting portion 4112 is electrically connected to the first conductive trace L1 of the main body portion 4111 through the connection of the first conductive trace L1 thereof, the first conductive trace L1 of the main body portion 4111 is connected to the conductive pad 4113 of the main body portion 4111, so as to electrically connect to the conductive pad 4113 of the main body portion 4111, and further electrically connect to the dielectric element 413 through the soldering between the conductive pad 4113 of the main body portion 112 and the dielectric element 413. The wire connecting portion 4112 is electrically connected to the first pad 4114A of the main body 4111 by connecting the second conductive trace L2 to the second conductive trace L2 of the main body 4111, and connecting the second conductive trace L2 of the main body 4111 to the first pad 4114A of the main body 4111, and further electrically connected to the ground terminal (not shown) of the temperature sensor 414 by welding the first pad 4114A to the ground terminal (not shown) of the temperature sensor 414. The wire connecting portion 4112 is electrically connected to the two second pads 4114B on the main body portion 4111 by connecting the third conductive traces L3 and L3 ' to the corresponding third conductive traces L3 and L3 ' of the main body portion 4111, and connecting the third conductive traces L3 and L3 ' to the corresponding second pads 4114B of the main body portion 4111, and then the two second pads 4114B are soldered to the corresponding signal terminals (not shown) of the two temperature sensors 414 respectively to realize parallel electrical connection between the two second pads and the signal terminals (not shown) of the two temperature sensors 414, thereby realizing the parallel and rapid transmission of the temperature signals monitored by the 2 temperature sensors to the electric field generator (not shown), so that the electric field generator (not shown) can timely and efficiently adjust the alternating voltage or alternating current applied to the dielectric element 413 to achieve the purpose of avoiding low-temperature scald caused by overhigh temperature. .

The main body portion 4111 and the terminal portion 4112 together constitute a flexible circuit board 411 of the electrical functional component 41. The insulating substrates B of the main body portion 4111 and the wiring portion 4112 together constitute an insulating substrate B of the flexible circuit board 411. The conductive traces L of the main body portion 4111 and the conductive traces L of the terminal portion 4112 form conductive traces L of the flexible circuit board 411 in a one-to-one correspondence.

From the perspective of the electrode unit 410, the insulating plate 412 is disposed on the side of the main body portion 4111 of the flexible circuit board 411 away from the skin of the human body, the dielectric element 413 is disposed on the side of the main body portion 4111 of the flexible circuit board 411 facing the skin of the human body, and the two temperature sensors 414 are disposed on the side of the main body portion 4111 of the flexible circuit board 411 facing the skin of the human body. The insulating plate 412 and the dielectric element 413 are respectively disposed on two opposite sides of the main body portion 4111 of the flexible circuit board 411. The first conductive trace L1 of the flexible circuit board 411 connects the 6 spaced conductive cores 41130 of the conductive tray 4113 in series, the second conductive trace L2 is electrically connected to the ground terminals (not shown) of the two temperature sensors 414 via the two first pads 4114A, respectively, and the third conductive traces L3, L3' are electrically connected to the signal terminals (not shown) of the two temperature sensors 414 via the two second pads 4114B, respectively. 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 traces L3, L3' are each located within the insulating substrate B at a level adjacent to the insulating board 412. In order to facilitate the layout of the conductive traces L, the width of the wiring portion 4112 is 7-9 mm. Preferably, the width of the wire connecting portion 4112 is 8 mm.

The gold finger 41120 of the wire connecting portion 4112, the 6 conductive cores 41130 of the conductive pads 4113, and the land 4114 all expose one side of the insulating substrate B of the flexible circuit board 411 close to the dielectric element 413. The gold finger 41120, the 6 conductive cores 41130 of the conductive plate 4113 and the solder pad 4114 are located on the side of the flexible circuit board 411 close to the surface of the patient. A gold finger 41120 of the wiring portion 4112 is electrically connected to the dielectric element 413 through a first conductive trace L1 connected thereto at one end, and is soldered to a corresponding portion of the lead 45 at the other end, so as to transmit an alternating voltage signal generated by an electric field generator (not shown) to the dielectric element 413. One end of one gold finger 41120 in the other three gold fingers 41120 of the wiring portion 4112 is electrically connected to the ground terminal (not shown) of the temperature sensor 414 through the second conductive trace L2 connected thereto, and one ends of the other two gold fingers 41120 are electrically connected to the signal terminals (not shown) of the two temperature sensors 414 through the third conductive traces L3 and L3' connected thereto, respectively; the other end of the three gold fingers 41120 is soldered to the corresponding portion of the lead 45, so that the relevant signals monitored by the temperature sensor 414 can be quickly and parallelly transmitted to the electric field generator (not shown) through the second conductive trace L2, the third conductive traces L3, L3' and the lead 45; so that the alternating voltage or alternating current applied to the dielectric element 413 can be timely and rapidly changed by an electric field generator (not shown) to achieve the purpose of avoiding low-temperature scald.

Alternative implementation of the fourth embodiment of insulated electrode 400

Referring to fig. 30, an insulated electrode 400 'is an alternate embodiment of the insulated electrode 400 of the fourth embodiment, and the insulated electrode 400' differs from the insulated electrode 400 only in that the four corners of the backing 42 'are recessed with recessed corners 421'. The backing 42 is generally in a cross-shaped configuration. The concave angle 421' is communicated with the outside and is arranged in an L shape. When the insulated electrode 400 'is applied on the body surface corresponding to the tumor region of the patient, the concave angle 421' can prevent the corner of the backing 42 from arching to cause wrinkles, thereby preventing air from entering the space between the electrode unit 410 and the skin from the wrinkles to increase the impedance between the electrical functional component 41 and the skin, which results in increased heat generation of the electrical functional component 41 and low-temperature scald.

The insulated electrodes 400 and 400' in this embodiment are conveniently replaced by the single electrode unit 410, and can be freely combined according to the size of the tumor part of the patient, so as to ensure the electric field treatment effect. Meanwhile, the flexible circuit board 411 of the insulated electrodes 400 and 400 'of the present invention is only provided with one first conductive trace L1 electrically connected to the dielectric element 413, one second conductive trace L2 electrically connected to the ground terminals (not shown) of the two temperature sensors 414, and two third conductive traces L3 and L3' electrically connected to the signal terminals (not shown) of the two temperature sensors 414, respectively, so as to transmit the alternating voltage signal of the electric field generator (not shown) to the dielectric element 413 through the first conductive trace L1, and achieve the purpose of applying the alternating voltage to the tumor site of the patient for tumor therapy; meanwhile, the second conductive trace line L2, the third conductive trace lines L3 and L3' are respectively electrically connected with the two temperature sensors 414 to realize signal transmission between the electric field generator (not shown) and the two temperature sensors 414, and the electric field generator has the advantages of low wiring design difficulty, simple structure, simplified manufacturing process, easy manufacturing, high product manufacturing yield and capability of greatly reducing the manufacturing cost.

Fifth embodiment of insulated electrode 500

Referring to fig. 31 to 33, the insulated electrode 500 in the present embodiment includes a backing 52, an electrical function assembly 51, a support 53, an adhesive member 54, and a lead wire 55. The electrical functional assembly 51 includes a single electrode unit 510 and a wire connection portion 5112 connected to the electrode unit 510. The wire connecting portion 5112 is solder-connected to the lead 55. The electrode unit 510 includes a body portion 5111, an insulating plate 512, a dielectric member 513, and two temperature sensors 514. The body portion 5111 and the wire connection portion 5112 constitute the flexible circuit board 511. The insulated electrode 500 of the present embodiment is substantially the same as the insulated electrode 400 of the fourth embodiment, except for the shape and size of the electrode unit 510 and the shape, size or arrangement of the corresponding conductive pad 5113 and two pairs of pads 5114 disposed on the main body portion 5111, and only for the difference points, the fourth embodiment can be referred to for other contents.

The electrode unit 510 is a square sheet, and the body 5111, the insulating plate 512, and the dielectric element 513 are all square sheet structures with arc corners. The body portion 5111 has dimensions of about 32mm x 32 mm. Conductive plate 5113 of body portion 5111 has a generally square configuration with an axis of symmetry that coincides with the axis of symmetry of body portion 5111. The conductive pad 5113 includes 4 conductive cores 51130 at four corners and spaced apart from each other. Each of the conductive cores 51130 is configured in a rectangular shape having dimensions of about 9mm by 6 mm. Preferably, each of the conductive cores 51130 has a rectangular configuration with rounded corners. The longitudinal axis of each of the conductive cores 51130 is parallel to the extending direction of the wire connecting portion 5112.

The 4 conductive cores 51130 constituting the conductive pad 5113 are arranged in a matrix, and the 4 conductive cores 51130 are arranged in two rows and two columns. The gap between two columns of conductive cores 51130 is about 8.5mm, and the gap between two rows of conductive cores 51130 is about 4 mm. The 4 conductive cores 51130 constituting the conductive plate 5113 are arranged in a central symmetrical manner and an axial symmetrical manner, and each conductive core 51130 is also arranged in an axial symmetrical manner, so that when the 4 conductive cores 51130 of the main body 5111 are welded with the dielectric element 513, the stress of each welding point is balanced, and the welding quality is improved. The 4 conductive cores 51130 of the conductive disc 5113 are arranged in a pairwise interval manner, and an interval C is formed between two adjacent conductive cores 51130. The 4 spaces C are arranged in a substantially cross-shaped communication. The adjacent intervals C are arranged in a communicated manner. The extending direction of 2 intervals C between two conductive cores 51130 in the same row in the 4 intervals C is the same as the extending direction of the wire connecting portion 5112.

The two pairs of pads 5114 of the body 5111 are respectively located between two corresponding conductive cores 51130 spaced in the same row. Two pairs of pads 5114 are located in the extending direction of the wire connecting portion 5112. each pair of pads 5114 has a center of symmetry, and the line connecting the two centers of symmetry of the two pairs of pads 5114 is parallel to the extending direction of the wire connecting portion 5112.

Sixth embodiment of insulated electrode 600

Referring to fig. 34 and 35, the insulated electrode 600 in the present embodiment includes a plurality of electrode pads 61 and an electrical connector 62, and the plurality of electrode pads 61 are detachably assembled to the electrical connector 62. The electrical connector 62 is electrically connected to the electric field generator (not shown) directly or through an adapter (not shown)

The electrode pad 61 is provided with a first wire 612, the first wire 612 having a first plug 6121 for mating with the electrical connector 62. The specific structure of the electrode sheet 61 in the present embodiment is substantially the same as that of the insulated electrode 300 in the third embodiment, except that: the insulated electrode 300 of the third embodiment is connected to an electric field generator (not shown) or an adaptor (not shown), but the insulated electrode 600 of the present embodiment needs to be connected to the electric field generator (not shown) or the adaptor (not shown) through the electric connector 62, so the shape of the first plug 6121 of the first wire 612 is slightly different from the shape of the end of the wire 35 of the insulated electrode 300 of the third embodiment. Other structures of the electrode sheet 61 can refer to the related description of the insulated electrode 300 in the third embodiment, and are not described herein again.

The electrical connector 62 is provided with a plurality of sockets 621 and second wires 622, the sockets 621 are inserted into the first plugs 6121 of the first wires 612 of the electrode plates 61, and one end of the second wires 622, which is far away from the electrical connector 62, is provided with second plugs 6221, which can be directly inserted into the electric field generator (not shown) or firstly inserted into the adaptor (not shown), and then inserted into the electric field generator (not shown) through the adaptor (not shown) to realize the electrical connection between the electric field generator and the electric field generator (not shown). The plurality of sockets 621 and the second conductive wires 622 are respectively disposed at two opposite ends of the electrical connector 62. The electrical connector 62 is plugged with the first plug 6121 of the first lead 612 of the electrode plate 61 through the socket 621 thereof, so as to connect the electrode plates 61 to the electrical connector 62 respectively to realize the electrical connection between the electrode plates 61 and the electrical connector 62, and further realize the electrical connection between the electrode plates 61 and the electric field generator through the second plug 6221 plugged with the electric field generator or the adaptor. When the device is used, the electrode plates 61 are attached to the corresponding body surface of the tumor part of the patient, the electrode plates 61 are inserted into the corresponding sockets 621 of the electric connector 62 through the first plugs 6121 of the electrode plates, and the electric connector 62 is electrically connected with the electric field generator (not shown) through the second plugs 6221 of the electric connector, so that the alternating electric field generated by the electric field generator is transmitted to the electrode plates 61 through the electric connector 62, and acts on the tumor part of the patient through the electrode plates 61 to interfere or prevent the mitosis of the tumor cells of the patient, and the purpose of treating the tumor is achieved.

In the present embodiment, the number of the sockets 621 of the electrical connector 62 is 9, and the number of the electrode pads 61 is 9. The electrical connector 62 is provided with a body 620, the body 620 having a generally polyhedral configuration. In this embodiment, the body 620 has a generally hexagonal prism configuration. The 9 sockets 621 are respectively disposed on a plurality of adjacent sides of the body 620, and an obtuse angle is formed between the adjacent sides. The second conductive wire 622 is disposed on a side of the body 620 away from the socket 621. In this embodiment, 9 sockets 621 are disposed on 3 adjacent sides of the body 620, and each 3 sockets 621 are disposed on the same side of the body 620 of the electrical connector 62. The terminals (not shown) in the 9 sockets 621 of the electrical connector 62 may be connected in series, so that the 9 electrode pads 61 are connected in series. Terminals (not shown) in the 9 sockets 621 of the electrical connector 62 may be connected in parallel so that the 9 electrode pads 61 are connected in parallel. When terminals (not shown) in the socket 621 of the electrical connector 62 are connected in series, all the electrode tabs 61 need to be inserted into the electrical connector 62 for use. When the terminals (not shown) in the socket 621 of the electrical connector 62 are connected in parallel, a part of the electrode sheet 61 can be selected to be inserted into the electrical connector 62 according to the requirement, so that the use is more convenient and flexible. Alternatively, the terminals (not shown) in the 9 sockets 621 of the electrical connector 62 may be connected partially in series and partially in parallel. Terminals (not shown) in the socket 621 of the electrical connector 62 may be connected in series, in parallel, in series, in part, and in parallel, as needed, so that the electrode pads 61 connected to the electrical connector 62 are connected in series, in parallel, in series, in part, and in parallel. When the tumor is large, the appropriate number of electrode slices 61 and the interval between the electrode slices 61 can be selected and freely adjusted according to the requirement, so as to ensure the coverage area and the electric field treatment effect of the insulated electrode 600 for tumor electric field treatment. When the tumor position is deviated to one side of the corresponding body part, the body surface corresponding to the side far away from the tumor can increase the number of the electrode pieces 61 of the insulated electrode 600 to increase the electric field intensity of the side far away from the tumor.

Alternative implementation of the sixth embodiment of insulated electrode 600

Referring to fig. 36, the insulated electrode 600 ' is an alternative implementation of the insulated electrode 600 in the previous embodiment, and includes a plurality of electrode pads 61 ' and an electrical connector 62 ', the plurality of electrode pads 61 ' are electrically connected to the electrical connector 62 ' in a pluggable manner, and the electrical connector 62 ' is electrically connected to an adaptor (not shown) or an electric field generator (not shown), so as to achieve electrical connection between the plurality of electrode pads 61 ' and the electric field generator (not shown).

Insulated electrode 600' is substantially identical to insulated electrode 600, with the main differences being as follows:

1. the shape of the electrical connector 62' and the number of receptacles provided are different

The insulated electrode 600 ' includes 3 electrode pads 61 ', the body 620 ' of the electrical connector 62 ' is generally triangular prism shaped, the electrical connector 62 ' is provided with 3 receptacles 621 ', and the 3 receptacles 621 ' are all disposed on the same side of the body 620 ' of the electrical connector 62 '. The connection portion 611 ' of the electrode tab 61 ' is detachably connected to the corresponding first lead 612 ' by plugging.

2. The first wire 612 'of the electrode plate 61' is pluggable

The wiring portion 611 'of the electrode plate 61' is electrically connected to the first conductive wire 612 'through a connector 6123'. The connector 6123 ' includes a docking socket 6123A ' and a docking plug 6123B '. The butt socket 6123A ' is connected to the wire connecting portion 611 ', and the butt plug 6123B ' is connected to an end of the first wire 612 ' away from the first plug 6121 '. Also, the docking socket 6123A ' is disposed at the end of the wiring portion 611 ', and the docking plug 6123B ' is disposed at an end of the first wire 6121 ' away from the first plug 6121 '. The docking socket 6123A 'and the electrode unit (not shown) are located at opposite ends of the wire connection portion 611', respectively. The butt plug 6123B ' and the first plug 6121 ' are respectively disposed at two opposite ends of the first conductive line 612 '. When the electrode unit (not shown) of the electrode plate 61 'is damaged and cannot work, only the part of the electrode plate 61' except the first lead 612 'can be replaced, and the first lead 612' can be continuously used, so that the cost of tumor treatment of a patient is further reduced.

3. Shape of electrode sheet 61

The electrode sheet 61' in the present embodiment is substantially the same as the insulated electrode 400 in the fourth embodiment, except that: (1) the docking socket 6123A 'at the end of the wire connecting portion 611' is electrically connected to the connector 62 'via the docking plug 6123B' and the first wire 612 ', and the insulated electrode 400 of the fourth embodiment is electrically connected to the electric field generator (not shown) or the adaptor (not shown), so the shape of the docking socket 6123A' is slightly different. (2) The backing 613 'of the electrode sheet 61' is slightly different in shape. The backing 613 'is generally of a "male" configuration having two reentrant corners 6131' recessed from its two corners, respectively. The two reentrant corners 6131 ' are located at two corners of the backing 613 ' away from the wire segment 611 ', respectively. The reentrant corners 6131 'at the corners of the backing 613' communicate with the exterior and are disposed in an "L" shape. The included angle between the two side edges of the back lining 613 ' forming the reentrant angle 6131 ' is greater than or equal to 90 degrees, so that when the electrode sheet 61 ' is pasted on the body surface corresponding to the tumor position of a patient, the corner of the back lining 613 ' is prevented from being arched to cause wrinkles, and further, air enters the space between the insulated electrode 600 ' and the skin from the wrinkles to increase the impedance between the insulated electrode 600 ' and the skin, so that the heat of the insulated electrode 600 ' is increased to cause low-temperature scald.

The insulated electrode 600 and the plurality of electrode plates 61, 61 'of the insulated electrode 600' of the alternative embodiment thereof are connected to the electric connectors 62, 62 ', and the damaged electrode plates 61, 61' can be easily replaced when one electrode plate 61, 61 'is damaged and cannot work, without scrapping the plurality of electrode plates 61, 61', the manufacturing cost can be reduced, the waste can be avoided, and the electric field intensity is ensured to be enough when tumor electric field treatment is carried out; meanwhile, the electrode plates 61 and 61' can be freely combined in quantity and adjusted in position according to the body difference, the tumor part, the tumor size and the like of the patient, so that the electric field intensity applied to the tumor part of the patient is optimal; in addition, the application positions and the intervals of the electrode plates 61 and 61 ' can be freely adjusted according to the self condition of the patient, so that the skin at the tumor part of the patient can be ensured to freely breathe, and the phenomenon that the heat generated at the parts of the electrode plates 61 and 61 ' applied to the tumor part of the patient is quickly accumulated and cannot be timely dissipated to cause the body surface sweating of the electrode plates 61 and 61 ' applied to the patient and the skin inflammation caused by pore blockage due to long-time electric field treatment is avoided.

The present application is only a preferred embodiment of the present application and should not be limited to the above embodiments, and any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present application should be included in the protection scope of the present application.

Claims

1. An electric field tumor treatment system, comprising:

a first pair of insulated electrodes disposed on a surface of a patient's head;

a second pair of insulated electrodes disposed on a surface of the patient's head;

a control signal generator that generates a periodic control signal having a first output state having a first time period T1 and a second output state having a second time period T2, the first time period T1 and the second time period T2 each being between 400ms and 980 ms;

an AC signal generator that generates a first AC signal having a frequency of 200kHz between the first pair of insulated electrodes when the control signal is in a first output state and generates a second AC signal having a frequency of 200kHz between the second pair of insulated electrodes when the control signal is in a second output state, wherein switching is made between generating the first AC signal between the first pair of insulated electrodes and generating the second AC signal between the second pair of insulated electrodes by switching between the first output state and the second output state.

2. The electric field tumor therapy system according to claim 1, wherein: the first period T1 and the second period T2 are the same duration.

3. The electric field tumor therapy system according to claim 2, wherein: the first time period T1 and the second time period T2 are both 50% duty cycles.

4. The electric field tumor therapy system according to claim 2, wherein: during the first time period T1, the first AC signal has a rising amplitude during a third time period T3 and a falling amplitude during a fourth time period T4; during the second time period T2, the second AC signal has a rising amplitude during the third time period T3 and a falling amplitude during the fourth time period T4.

5. The electric field tumor therapy system according to claim 4, wherein: the durations of the third and fourth periods T3 and T4 are each less than 10% of the duration of the first or second period T1 or T2.

6. The electric field tumor therapy system according to claim 4, wherein: the durations of the third and fourth periods T3 and T4 are each less than 1% of the duration of the first or second period T1 or T2.

7. The electric field tumor therapy system according to claim 1, wherein: the first AC signal is applied to the first pair of insulated electrodes to generate a first electric field, and the second AC signal is applied to the second pair of insulated electrodes to generate a second electric field.

8. The electric field tumor therapy system according to claim 7, wherein: the direction of the first electric field is perpendicular to the direction of the second electric field.

9. The electric field tumor therapy system according to claim 1, wherein: the periodic control signal is a periodic square wave signal.

10. The electric field tumor therapy system according to claim 1, wherein: the first AC signal and the second AC signal each have a field strength of at least 1V/cm.

11. The electric field tumor therapy system according to claim 1, wherein: the control end of the first switch/amplifier module is directly connected with the control signal generator, and the control end of the second switch/amplifier module is connected with the control signal generator through the inverter; the input ends of the first switch/amplifier module and the second switch/amplifier module are connected with an AC signal generator; the output end of the first switch/amplifier module is connected with the first pair of insulated electrodes, and the output end of the second switch/amplifier module is connected with the second pair of insulated electrodes.

12. The electric field tumor therapy system according to any one of claims 1 to 11, wherein: the insulated electrode comprises a plurality of electrode units arranged in an array, a plurality of connecting parts for connecting two adjacent electrode units and a wiring part extending from one connecting part, wherein the electrode units are provided with dielectric elements, the two opposite ends of each connecting part are respectively provided with a conductive disc electrically connected with the corresponding dielectric elements, the connecting parts are positioned between the two adjacent electrode units arranged in a row and between the two adjacent electrode units arranged in a row, the length of the connecting part between the two adjacent electrode units arranged in a row is smaller than that of the connecting part between the two adjacent electrode units arranged in a row, at least two connecting parts between the two adjacent electrode units arranged in a row in the connecting parts are provided, and the conductive disc is provided with a plurality of conductive cores which are symmetrically arranged at intervals and are welded with the dielectric elements.

13. The electric field tumor therapy system according to claim 12, wherein the conductive cores of the conductive disk are disposed on the connecting portion in a central symmetrical manner, and the center of the conductive disk is located on the central line of the dielectric element.

14. The electric field tumor therapy system according to claim 12, wherein the conductive cores of the conductive plate are disposed on the connecting portion in an axisymmetric manner and expose a side surface of the connecting portion facing the dielectric element.

15. The electric field tumor treatment system according to claim 12, wherein each of the conductive cores comprises an inner arc and an outer arc connected end to end, and the inner arc and the outer arc of the conductive core are arranged in an axial symmetry.

16. The electrical field tumor therapy system according to claim 15, wherein the outer arcs of the plurality of conductive cores of the conductive disk are located on the same circumference.

17. The electric field tumor therapy system according to claim 12, further comprising a backing supporting the electrode unit.

18. The electrical field tumor treatment system according to claim 17, wherein the backing has a plurality of reentrant corners that are wrinkle-proof, the reentrant corners being located at corners of the backing and communicating with the exterior.

19. The electric field tumor therapy system according to claim 18, wherein the reentrant corner is formed by an inward recess at the edge of the corner of the backing, and the included angle between the two sides of the reentrant corner formed by the backing is not less than 90 degrees.

20. The electrical field tumor therapy system according to claim 17, further comprising a support member surrounding the electrode unit, the support member having a through hole disposed therethrough for receiving the electrode unit.

21. The electric field tumor therapy system according to claim 20, further comprising a moisture absorbing element disposed between the electrode units.

22. The electric field tumor therapy system according to claim 21, wherein the supporting member has an opening formed therethrough for receiving the moisture-absorbing element, the opening being spaced from the through hole.

23. The electrical field tumor treatment system of claim 12, wherein the electrode unit further comprises a temperature sensor, and the dielectric element has a bore therethrough for receiving the temperature sensor.

24. The electric field tumor therapy system according to claim 12, wherein the connecting portion has an insulating substrate and a plurality of conductive traces embedded in the insulating substrate, and the conductive pads at opposite ends of the connecting portion are electrically connected to one of the conductive traces.

25. The electric field tumor therapy system according to claim 12, wherein the electrode units are arranged in three rows and three columns, and the number of the electrode units is 9.

26. The electric field tumor therapy system according to any one of claims 1 to 11, wherein: the insulated electrode comprises a flexible circuit board and a plurality of dielectric elements arranged on the flexible circuit board, the plurality of dielectric elements are arranged in at least three rows and four columns, and the distance between two adjacent dielectric elements arranged in a row is different or the distance between two adjacent dielectric elements arranged in a column is different.

27. The electrical field tumor treatment system of claim 26, wherein the spacing between two adjacent dielectric elements in the same row in adjacent columns is the same, and the spacing between two adjacent dielectric elements in the same row in alternate columns is the same.

28. The electrical field tumor treatment system of claim 26, wherein the spacing between two adjacent dielectric elements in the same row in adjacent columns is less than the spacing between two adjacent dielectric elements in the same row in alternate columns.

29. The electrical field tumor treatment system of claim 28, wherein the spacing between two adjacent dielectric elements of the same column in adjacent rows is less than the spacing between two adjacent dielectric elements of the same column in alternate rows.

30. The electrical field tumor treatment system of claim 29, wherein the spacing between two adjacent dielectric elements in the same row in adjacent columns is equal to the spacing between two adjacent dielectric elements in the same column in adjacent rows.

31. The electrical field tumor treatment system of claim 30, wherein the number of said dielectric elements is 14, and the number of said dielectric elements is three rows and five columns.

32. The system of claim 30, further comprising an insulating plate disposed on the flexible circuit, wherein the insulating plate and the dielectric element are disposed on opposite sides of the flexible circuit.

33. The electrical field tumor treatment system of claim 32, further comprising a plurality of temperature sensors disposed on the flexible circuit board, the temperature sensors being located on the same side of the flexible circuit board as the dielectric element.

34. The electric field tumor therapy system according to claim 30, further comprising a backing attached to the flexible circuit board, wherein the backing and the dielectric element are disposed on opposite sides of the flexible circuit board.

35. The electric field tumor therapy system according to any one of claims 1 to 11, wherein: the insulated electrode 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, one conductive trace is electrically connected with the grounding end of the temperature sensor, one 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.

36. The electric field tumor therapy system according to claim 35, wherein said flexible circuit board has three gold fingers exposing the insulating substrate thereof and electrically connected to the corresponding portions of said conductive wires.

37. The electrical field tumor treatment system of claim 36, wherein each of the three gold fingers is electrically connected to one of the conductive traces of the flexible circuit board.

38. The electric field tumor therapy system according to claim 35, wherein the flexible circuit board is provided with a conductive pad corresponding to the dielectric element, and the conductive pad is welded to the dielectric element.

39. The system of claim 38, wherein the conductive pad exposes the insulating substrate and is connected to a conductive trace electrically connecting the flexible circuit board and the dielectric element.

40. The system of claim 38, wherein the conductive plate comprises a plurality of spaced apart conductive cores, the plurality of cores being connected in series by a conductive trace electrically connecting the flexible circuit board to the dielectric element.

41. The electric field tumor therapy system according to claim 37, wherein the flexible circuit board has two pads exposed from the insulating substrate and corresponding to the temperature sensor.

42. The tumor electric field treatment system according to claim 41, wherein one of the two bonding pads is bonded to a ground terminal of the temperature sensor, and the other of the two bonding pads is bonded to a signal terminal of the temperature sensor.

43. The electrical field therapy system for tumor according to claim 41, wherein one of the two bonding pads is connected to a conductive trace electrically connecting the flexible circuit board and the ground terminal of the temperature sensor, and the other bonding pad is connected to a conductive trace electrically connecting the flexible circuit board and the signal terminal of the temperature sensor.

44. The electric field tumor therapy system according to claim 35, wherein one end of the wire is electrically connected to the flexible circuit board, and the other end of the wire is provided with a plug.

45. The electric field tumor therapy system according to claim 44, wherein a heat shrink sleeve is disposed at the connection of the lead and the flexible circuit board.

46. The electric field tumor therapy system according to claim 35, wherein said dielectric element has a through hole disposed therethrough, and said temperature sensor is received in said through hole.

47. The system of claim 35, wherein 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 two bonding pads, one bonding pad of the two bonding pads is connected to the second conductive trace, and the other bonding pad of the two bonding pads is connected to the third conductive trace.

48. The system of claim 47, wherein the conductive pad and the solder pad are disposed on the same side of the flexible circuit board.

49. The system of claim 47, wherein the conductive pad and the two pads are exposed from the insulating substrate of the flexible circuit board.

50. The electric field tumor therapy system according to claim 47, wherein the flexible circuit board further has three gold fingers soldered to the wires, the gold fingers exposing the insulating substrate of the flexible circuit board.

51. The electrical field tumor treatment system of claim 50, wherein the gold finger, the conductive pad and the two solder pads are located on the same side of the flexible circuit board.

52. The electric field tumor therapy system according to claim 35, further comprising a backing affixed to a corresponding portion of the flexible circuit board.

53. The electric field therapy system for tumor according to claim 52, further comprising an insulating plate disposed on a side of the flexible circuit board away from the dielectric element, the insulating plate corresponding to the dielectric element in a thickness direction, the insulating plate being sandwiched between the flexible circuit board and the backing.

54. The electric field tumor therapy system according to any one of claims 1 to 11, wherein: the insulating electrode 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 arranged on the flexible circuit board, the number of the temperature sensors is n, 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.

55. The electric field tumor treatment system according to claim 54, wherein the flexible circuit board has a wire portion electrically connected to both the dielectric element and the temperature sensor, and the dielectric element and the temperature sensor are located at one end of the wire portion.

56. The electric field tumor treatment system according to claim 55, further comprising a lead wire, wherein one end of the lead wire is electrically connected to the wiring portion of the flexible circuit board, and the lead wire and the dielectric element are respectively located at two opposite ends of the wiring portion.

57. The electric field therapy system for tumor according to claim 56, wherein one end of said lead is electrically connected to said wiring portion of said flexible circuit board, and the other end is provided with a plug.

58. The electric field tumor treatment system according to claim 55, wherein the flexible circuit board is provided with a conductive pad soldered to the dielectric element, the conductive pad being provided at one end of the wire connection portion.

59. The system of claim 58, wherein the conductive pad exposes the insulating substrate and is connected to a conductive trace electrically connecting the flexible circuit board and the dielectric element.

60. The electric field therapy system for tumor according to claim 58, wherein the n temperature sensors are all disposed in the region surrounded by the conductive plate, and the extension direction of the straight line of the n temperature sensors is consistent with the extension direction of the wire connection portion.

61. The system of claim 58, wherein the conductive plate comprises a plurality of spaced apart conductive cores, the plurality of cores being connected in series by a conductive trace electrically connecting the flexible circuit board to the dielectric element.

62. The electrical field tumor treatment system according to claim 61, wherein the plurality of conductive cores are arranged at intervals in a matrix, and 4 of the plurality of conductive cores in adjacent rows and adjacent columns are arranged in a central symmetry.

63. The electrical field tumor treatment system of claim 62, wherein each of said n temperature sensors is disposed in a symmetrical center offset from the corresponding 4 conductive cores of the conductive plate.

64. The electrical field therapy system for tumor treatment according to claim 63, wherein there are two temperature sensors, one of the two temperature sensors is disposed on the side of the symmetry center of the corresponding 4 conductive cores away from the wire portion, and the other is disposed on the side of the symmetry center of the corresponding 4 conductive cores close to the wire portion.

65. The electric field therapy system for tumor according to claim 61, wherein the flexible circuit board has n pairs of pads corresponding to the temperature sensors and located at one end of the wiring portion, and the n pairs of pads are located at the same end of the wiring portion as the conductive pads.

66. The electrical field tumor treatment system according to claim 65, wherein each pair of pads comprises a first pad soldered to the ground terminal of the corresponding temperature sensor and a second pad soldered to the signal terminal of the corresponding temperature sensor.

67. The electrical field tumor treatment system of claim 65, wherein each pair of pads is disposed in a symmetrical center offset from its corresponding 4 conductive cores.

68. The electrical field tumor treatment system according to claim 67, wherein the bonding pads are provided in two pairs, one pair of the bonding pads is provided on a side of the corresponding 4 conductive cores with their centers of symmetry away from the wire connecting portion, and the other pair of the bonding pads is provided on a side of the corresponding 4 conductive cores with their centers of symmetry close to the wire connecting portion.

69. The electric field tumor therapy system according to claim 65, wherein a line along which the centers of symmetry of each of the n pairs of pads are located is parallel to the extending direction of the wire portion.

70. The electrical field therapy system for tumor according to claim 66, wherein said first pads are connected to a conductive trace electrically connecting the flexible circuit board to the ground terminal of the temperature sensor, and said second pads are each connected to a conductive trace electrically connecting the flexible circuit board to the signal terminal of the corresponding temperature sensor.

71. The electric field tumor treatment system according to claim 54, wherein the dielectric element has a through hole corresponding to the temperature sensor, and the temperature sensor is received in the corresponding through hole.

72. The electrical field tumor treatment system according to claim 54, wherein the number of said temperature sensors is 2, the number of said conductive traces is 4, and the number of said conductive cores is 6.

73. The electric field tumor treatment system according to claim 55, further comprising a backing attached to a corresponding portion of the flexible circuit board.

74. The electric field tumor treatment system according to claim 73, further comprising an insulating plate disposed opposite to the dielectric element, the insulating plate being disposed corresponding to the dielectric element in a thickness direction, the insulating plate being interposed between the dielectric element and the backing.

75. The electric field tumor therapy system according to any one of claims 1 to 11, wherein: the insulated electrode comprises a flexible circuit board, a dielectric element and a plurality of temperature sensors 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 number of the temperature sensors is n, n is an integer which is more than 1 and not more 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 which are 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, the rest conductive traces are respectively electrically connected with the signal ends of the corresponding temperature sensors, and the lead is electrically connected with the paths of conductive traces of the flexible circuit board.

76. The electric field therapy system for tumor according to claim 75, wherein the flexible circuit board has a plurality of gold fingers exposing the insulating substrate and electrically connected to the corresponding portions of the conductive wires.

77. The electric field therapy system for tumor according to claim 76, wherein said gold fingers are electrically connected to one conductive trace of the flexible circuit board.

78. The electrical field tumor therapy system according to claim 76, wherein said temperature sensors are 2 in number, said conductive traces are 4 traces, and said gold fingers are 4 fingers.

79. The electric field tumor treatment system according to claim 75, wherein the flexible circuit board is provided with a conductive pad corresponding to the dielectric element, and the conductive pad is welded to the dielectric element.

80. The system of claim 79, wherein the conductive pad exposes the insulating substrate and is connected to a conductive trace electrically connecting the flexible circuit board and the dielectric element.

81. The system of claim 79, wherein the conductive plate 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 and the dielectric element.

82. An oncological electric field treatment system according to claim 81, wherein the flexible circuit board has n pairs of pads thereon, each pair of pads being located between a respective two spaced apart conductive cores.

83. The electrical field tumor treatment system according to claim 82, wherein each pair of pads is disposed on the flexible circuit board at a location corresponding to the corresponding temperature sensor, each pair of pads exposing the insulating substrate of the flexible circuit board.

84. The electrical field tumor treatment system according to claim 82, wherein each pair of pads comprises a first pad soldered to the ground terminal of the corresponding temperature sensor and a second pad soldered to the signal terminal of the corresponding temperature sensor.

85. The electrical field therapy system for tumors according to claim 84, wherein said first bonding pad is connected to a conductive trace electrically connecting the flexible circuit board to the ground terminal of the temperature sensor, and said second bonding pads are each connected to a conductive trace electrically connecting the flexible circuit board to the signal terminal of the corresponding temperature sensor.

86. The electric field tumor therapy system according to claim 75, wherein the wires are electrically connected to the flexible circuit board at one end and provided with a plug at the other end.

87. The electric field tumor treatment system according to claim 86, wherein a heat shrink sleeve is disposed at the connection of the lead and the flexible circuit board.

88. The electrical field tumor treatment system according to claim 75, wherein the dielectric element has a through hole corresponding to the temperature sensor, and the temperature sensor is received in the corresponding through hole.

89. The electrical field tumor treatment system according to claim 75, wherein one of the plurality of conductive traces electrically connected to the dielectric element is a first conductive trace, one of the plurality of conductive traces electrically connected to the ground terminal of the temperature sensor is a second conductive trace, and the remaining n conductive traces electrically connected to the signal terminals of the corresponding temperature sensors are all third conductive traces, the flexible circuit board is provided with a conductive pad connected to the first conductive trace, the flexible circuit board is provided with n pairs of pads, one pad of each pair of pads is connected to the second conductive trace, and the other pad of each pair of pads is connected to the corresponding third conductive trace.

90. The electrical field tumor treatment system of claim 89, wherein the conductive pad and the solder pad are disposed on the same side of the flexible circuit board.

91. The electrical field tumor treatment system of claim 89, wherein the conductive pads and the solder pads are exposed from the insulating substrate of the flexible circuit board.

92. The electric field tumor therapy system according to claim 89, wherein the flexible circuit board further comprises a plurality of gold fingers soldered to the wires, the gold fingers each exposing the insulating substrate of the flexible circuit board, the number of the gold fingers is n +2, wherein n is an integer greater than 1 and not greater than 8.

93. The electrical field tumor treatment system according to claim 92, wherein there are four gold fingers, two temperature sensors, two pairs of pads, and two paths of third conductive traces.

94. The electrical field tumor treatment system of claim 92, wherein the gold finger, the conductive pad, and the two pairs of pads are located on a same side of the flexible circuit board.

95. The electric field tumor treatment system according to claim 76, further comprising a backing attached to a corresponding portion of the flexible circuit board.

96. The electric field therapy system for tumor according to claim 95, further comprising an insulating plate disposed on a side of the flexible circuit board away from the dielectric element, wherein the insulating plate is corresponding to the dielectric element along the thickness direction, and the insulating plate is sandwiched between the flexible circuit board and the backing.

97. The electric field tumor therapy system according to any one of claims 1 to 11, wherein: the insulated electrode comprises at least one electrode plate capable of applying an alternating electric field and an electric connector detachably connected with the electrode plate, the electrode plate comprises an independent electrode unit and a first lead electrically connected with the electrode unit, and the electrode plate is detachably connected with the electric connector through the first lead.

98. The electrical tumor field treatment system of claim 97, wherein a plurality of electrode patches are connected in parallel to the electrical connector by respective first wires.

99. The electric field tumor treatment system according to claim 97, wherein the first lead of the electrode pad has a first plug detachably connected to the electric connector, and the first plug and the electrode unit are respectively disposed at two opposite ends of the first lead.

100. The system of claim 99, wherein the electrical connector has a plurality of sockets for removably receiving the first plugs of the first wires of the respective electrode pads.

101. The system of claim 100, wherein the electrical connector has a second conductive wire, and the second conductive wire and the plurality of sockets are located at opposite ends of the electrical connector.

102. The electrical field tumor treatment system of claim 101, wherein the second lead has a second plug disposed at an end thereof.

103. The system of claim 102, wherein the electrical connector has a body, and the plurality of sockets and the second wires are disposed at opposite ends of the body.

104. The electric field tumor treatment system according to claim 99, wherein the electrode plate further comprises a wire portion connected to the electrode unit, and the wire portion is welded to an end of the first wire away from the first plug.

105. The electrical field tumor therapy system according to claim 104, wherein said electrode unit comprises a main body portion and a dielectric element welded to one side of the main body portion, and said wire connecting portion extends laterally from said main body portion.

106. The electrical field tumor therapy system according to claim 105, wherein the main body portion and the wire connection portion of the electrode unit constitute a flexible circuit board of the electrode patch.

107. The electrical field tumor treatment system of claim 106, wherein the electrode unit further comprises at least one temperature sensor disposed on the same side of the body portion as the dielectric element.

108. The electrical field tumor treatment system according to claim 107, wherein the dielectric member has at least one through hole formed in a middle thereof, and the temperature sensors are respectively received in the corresponding through holes of the dielectric member.

109. The electrical field therapy system for tumors of claim 105, wherein said electrode unit further comprises an insulating plate affixed to a side of said body portion distal from said dielectric element.

110. The electric field tumor therapy system according to claim 104, wherein a heat shrinkable sleeve is wrapped around the welding portion of the first lead and the wire connecting portion.

111. The electrical field tumor treatment system of claim 99, wherein the first lead is removably coupled to the electrode unit.

112. The electric field therapy system for tumor according to claim 111, wherein the electrode pad comprises a wire portion electrically connected to the electrode unit, and a docking socket is disposed at an end of the wire portion away from the electrode unit.

113. The system of claim 112, wherein the end of the first wire distal to the first plug is provided with a docking plug, and the docking plug is removably attachable to the docking receptacle.

114. The electric field tumor therapy system according to claim 97, wherein the electrode sheet further comprises a backing adhered to the electrode unit, a support member disposed around the electrode unit and adhered to the backing, and an adhesive member covering the electrode unit and the support member on a side away from the backing.