CN218685735U - Tumor electric field treatment system - Google Patents

Abstract

The utility model provides a tumor electric field treatment system, which comprises a first pair of insulated electrodes and a second pair of insulated electrodes which are respectively configured on the surface of the trunk of a patient; a control signal generator that generates a periodic control signal having a first output state and a second output state, wherein the first output state has a first time period T1 and the second output state has a second time period T2, and the first time period T1 and the second time period T2 are both between 500ms and 980 ms; an AC signal generator which generates a first AC signal having a frequency of 150kHz 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 150kHz between the second pair of insulated electrodes when the control signal is in a second output state, the first output state and the second output state being switched. The utility model discloses a tumour electric field treatment system can reach the effect of better suppression tumor cell proliferation.

Description

Tumor electric field treatment system

Technical Field

The application relates to a tumor electric field 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.

Research shows that the treatment effect can be enhanced by using electric fields in multiple directions, and the electric fields are summed like vectors, so that the electric fields in different directions cannot be simultaneously applied to the same target area, and therefore, the existing electric field treatment system for tumors adopts a mode of alternately applying two directions.

In order to achieve better tumor cell proliferation inhibition, it is necessary to provide a suitable time interval for switching the direction.

SUMMERY OF THE UTILITY MODEL

The utility model provides a better tumor electric field treatment system of effect of inhibiting tumor cell proliferation.

The utility model discloses an insulated electrode can realize through following technical scheme: an electric field tumor treatment system, comprising: a first pair of insulated electrodes disposed on a surface of a patient's torso; a second pair of insulated electrodes disposed on a surface of the patient's torso;

a control signal generator that generates a periodic control signal having a first output state and a second output state, wherein the first output state is between 500ms and 980ms in duration and the second output state is between 500ms and 980ms in duration;

an AC signal generator that generates a first AC signal having a frequency of 150kHz between the conductors of 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 150kHz between the conductors of 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 conductors of the first pair of insulated electrodes and generating the second AC signal between the conductors of the second pair of insulated electrodes by switching between the first output state and the second output state.

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

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

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

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

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

Further, the first AC signal applies a first pair of insulated electrodes to generate a first electric field, and the second AC signal applies a 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 each have a field strength of at least 1V/cm.

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 wires electrically connected with the electrode units, wherein at least 10 electrode units are distributed in at least three rows and four columns, each electrode unit is connected with at least two adjacent electrode units, and at least one adjacent two electrode units in the electrode units are arranged in a spaced row or a spaced column.

Furthermore, at least one adjacent two electrode units in the plurality of electrode units are arranged in a disconnected state, and an interval between the two adjacent electrode units arranged in the disconnected state is formed.

And the wire connecting part is electrically connected with the connecting part or the electrode unit, penetrates through the interval and is welded with the lead.

Furthermore, the two adjacent electrode units arranged in rows are arranged in a spaced row, and at least two adjacent electrode units arranged in a same row in the plurality of electrode units arranged in rows are arranged in a spaced row.

Further, the spacing between two adjacent electrode units arranged in a row is the same, and the spacing between two adjacent electrode units arranged in a column is different.

Further, the connecting parts between two adjacent electrode units in the same row have the same length, and the connecting parts between two adjacent electrode units in the same column have different lengths.

Furthermore, the number of the electrode units is 13, and the electrode units are distributed in an area which is arranged in five rows and five columns.

Furthermore, at least one adjacent two electrode units in the plurality of electrode units arranged in rows are arranged in a spaced row, and the plurality of electrode units arranged in rows are all arranged in adjacent rows.

Further, the spacing between two adjacent electrode units arranged in a row is different, and the spacing between two adjacent electrode units arranged in a column is the same.

Further, the connecting parts between two adjacent electrode units in the same row have different lengths, and the connecting parts between two adjacent electrode units in the same column have the same length.

Furthermore, the number of the electrode units is 13, and the electrode units are distributed in an area which is arranged in three rows and five columns.

Furthermore, the connecting part comprises a first connecting part for connecting two adjacent electrode units in the same row and a second connecting part for connecting two adjacent electrode units in the same column.

Furthermore, the connecting part also comprises a third connecting part which is connected between two adjacent electrode units which are positioned in adjacent rows and adjacent columns and arranged in a diagonal shape.

Further, the third connecting portion has a length greater than that of the first connecting portion.

Further, the length of the third connecting portion is greater than half of the length of the first connecting portion.

Further, the length of the third connecting portion is greater than the length of the second connecting portion.

Further, the electrical functional assembly comprises a plurality of electrode units which are arranged in at least three rows and four columns, a plurality of connecting parts for connecting two adjacent electrode units and a wiring part connected with the connecting parts, each electrode unit is at least connected with two connecting parts, at least 10 electrode units are arranged, and the number of the electrode units in each row or each column is not completely the same.

Furthermore, the number of the electrode units is 20, and the electrode units are distributed in an array area surrounded by four rows and six columns.

Furthermore, at least one of the electrode units is arranged in a disconnected manner between two adjacent electrode units in the same row or column.

Further, the electrical function component has a space formed between two adjacent electrode units arranged in an open state, and the wiring portion passes through a space C.

Further, the wire connecting portion is extended from a connecting portion in a direction of the interval C.

Furthermore, the wire connecting portion is perpendicular to the connecting portion, and the wire connecting portion is substantially in a line shape.

Further, the wiring portion is bridged between two connecting portions respectively connected to two adjacent electrode units arranged in a disconnected state.

Further, the wire connecting portion is substantially arranged in a T shape.

Further, the intervals between two adjacent electrode units arranged in a row are the same, and the connecting parts connecting two adjacent electrode units arranged in a row have the same length.

Further, the intervals between the two adjacent electrode units arranged in a row are the same, and the connecting parts of the two adjacent electrode units connected in a row have the same length.

Furthermore, at least two adjacent electrode units arranged in a row in the plurality of electrode units are arranged in a spaced column, and the distances between the two adjacent electrode units arranged in a row are not completely the same.

Furthermore, at least two adjacent electrode units arranged in a row in the plurality of electrode units are arranged in a spaced row, and the distances between the two adjacent electrode units arranged in a row are not completely the same.

Furthermore, the two adjacent electrode units arranged in a row are arranged in an adjacent column, and the distance between the two adjacent electrode units arranged in a row is the same.

Furthermore, the two adjacent electrode units arranged in a row are arranged in an adjacent row, and the distances between the two adjacent electrode units arranged in a row are the same.

Further, the spacing between two adjacent electrode units arranged in a row is the same, and the spacing between two adjacent electrode units arranged in a column is the same.

Furthermore, the electrode units are distributed in an array area with four rows and six columns in a mode that each column of the first column and the last column is respectively provided with two electrode units, and each column of the middle four columns is respectively provided with four electrode units.

Furthermore, the plurality of electrode units are arranged in a line-direction axisymmetric manner and a column-direction axisymmetric manner.

Furthermore, the wire connecting structure also comprises a wire electrically connected with the electrical functional component, and the wire is welded with the wiring part.

Further, the electric functional component wire drawing device further comprises a backing for supporting the electric functional component, and the backing is provided with a wire threading hole for the wire to pass through.

Furthermore, the insulated electrode comprises an electrical functional component for applying an alternating electric field to a tumor part of a patient and a lead electrically connected with the electrical functional component, the electrical functional component comprises a plurality of electrode units arranged at intervals, a plurality of connecting parts for connecting two adjacent electrode units and a wiring part electrically connected with the lead, each electrode unit is connected with at least two connecting parts, and the number of the electrode units is at least 10.

Further, each electrode unit is connected with at least two adjacent electrode units.

Further, the plurality of electrode units are distributed in an array area at least in three rows and four columns, and the number of the electrode units is at least 10 and at most 30.

Further, the plurality of electrode units are distributed in an array area at least in three rows and four columns, and the number of the electrode units in each row is the same and the electrode units are all arranged in alignment in the column direction.

Further, the electrode units are arranged in the same row spacing.

Further, the electrode units are arranged in the shape of the same row spacing.

Further, the plurality of connection parts connecting two adjacent electrode units arranged in a row have the same length.

Further, the connecting portions of the plurality of two adjacent electrode units connected in a column arrangement have the same length.

Furthermore, at least one of the electrode units is arranged in a disconnected manner between two adjacent electrode units in the same row or column, and a space for the wire connection portion to pass through is formed between the two adjacent electrode units in the disconnected manner.

Further, the wire connecting portion is laterally extended from the connecting portion opposite to the space.

Furthermore, the connection portion of the extension-arranged wiring portion is perpendicular to the wiring portion.

Further, the wiring portion is erected between two connecting portions respectively connected with the two electrode units arranged in the disconnected state.

Further, the wire connecting portion is substantially arranged in a T shape.

Further, the plurality of electrode units are arranged in an array of four rows and five columns, and the number of the electrode units is 20.

Furthermore, the electrode unit comprises a main body part arranged at the tail end of the connecting part, an insulating plate arranged on one side of the main body part far away from the skin of the human body and a dielectric element arranged on one side of the main body part facing the skin of the human body.

Further, the electrode unit further comprises a temperature sensor selectively arranged on the main body part, and the temperature sensor and the dielectric element are positioned on the same side of the main body part.

Further, the dielectric member is provided with an opening corresponding to the temperature sensor.

Furthermore, the electrode patch also comprises an adhesive backing for supporting the electrical functional component, and the backing is provided with a threading hole for the lead to pass through.

Furthermore, the lead is provided with a heat-shrinkable sleeve which covers the connection part of the lead and the wiring part.

Furthermore, the insulated electrode includes 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 electrically connected with the flexible circuit board, the number of the temperature sensors is n, n is an integer greater than 1 and not greater than 8, each temperature sensor has a grounding end and a signal end, the flexible circuit board has an insulating substrate and a plurality of conductive traces embedded in the insulating substrate, the plurality of conductive traces are n +2 circuits, one conductive trace in the conductive traces is electrically connected with the dielectric element, one 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 plurality of conductive traces of the flexible circuit board.

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

Furthermore, the golden 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 a conductive disc corresponding to the dielectric element, and the conductive disc is welded with the dielectric element.

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

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

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

Further, 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.

Further, each pair of pads includes 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.

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, 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 corresponding to the temperature sensor, and the temperature sensor is accommodated in the corresponding through hole.

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.

Further, the conductive disc and the bonding pad are arranged on the same side of the flexible circuit board.

Further, 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, and the number of the gold fingers is n +2, wherein 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 pads are located 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.

Furthermore, the flexible printed circuit board further comprises an insulating plate arranged on one side, far away from the dielectric element, of the flexible printed circuit board, 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.

Further, 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 individual 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 inserted with the electric connector, and the first plug and the electrode unit are respectively positioned at two opposite ends of the first lead.

Further, the electrical connector has a plurality of sockets detachably inserted with the first plugs of the first wires of the respective electrode pads.

Furthermore, the electric connector is also 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 also comprises a wiring part connected with the electrode unit, and the wiring part is welded with one end, far away from the first plug, of the first lead.

Further, 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 portion and the wire connection portion of the electrode unit constitute a flexible wiring board of the electrode patch.

Further, 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, the middle of the dielectric element is provided with at least one through hole, and the temperature sensors are respectively accommodated in the corresponding through holes of the dielectric element.

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 to 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 docking plug, and the docking plug is detachably plugged with the docking socket.

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 utility model is used for the tumour electric field treatment system's that applies alternating electric field to the tumour of truck position AC signal generator provides 150 KHz's intermediate frequency alternating current signal, through the switching between first output state and the second output state, and produce first AC signal between first pair of insulating electrode and produce between the second pair of insulating electrode and switch over between the second AC signal, it is 500ms and 980ms between long when first output state and second output state, reach the effect of better suppression tumour cell proliferation with this.

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 an exploded perspective view of the insulated electrode of fig. 5.

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

Fig. 8 is a plan view of a dielectric element of the electrical functional assembly of fig. 7.

Fig. 9 is a plan view of the flexible circuit board of the insulated electrode of fig. 6.

Fig. 10 is a perspective combination view of a second embodiment of the insulated electrode of the electric field tumor therapy system of the present invention.

Fig. 11 is an exploded perspective view of the electrical functional components of the insulated electrode of fig. 10.

Fig. 12 is a perspective combination view of a third embodiment of the insulated electrode of the electric field tumor therapy system of the present invention.

Fig. 13 is a perspective view of the flexible circuit board and the lead of the insulated electrode of fig. 12.

Fig. 14 is a perspective assembly view of a fourth embodiment of the insulated electrode of the electric field tumor therapy system of the present invention.

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

Fig. 16 is an exploded perspective view of the insulated electrode of fig. 14.

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 perspective combination view of the fifth embodiment of the insulated electrode of the electric field tumor therapy system of the present invention.

Fig. 19 is an exploded perspective view of the insulated electrode of fig. 18.

Fig. 20 is a plan view of the electrical functional assembly of fig. 19.

Fig. 21 is a perspective combination view of a sixth embodiment of the insulated electrode of the electric field tumor therapy system of the present invention.

Fig. 22 is an exploded perspective view of the insulated electrode of fig. 21.

Fig. 23 is an exploded perspective view of the electrical functional components and leads of the insulated electrode of fig. 22.

Fig. 24 is a schematic plan view of the flexible circuit board of the insulated electrode of fig. 23.

Fig. 25 is a front wiring diagram of the flexible circuit board of the electrical functional assembly of fig. 24.

Fig. 26 is a rear wiring diagram of the flexible circuit board of the electrical functional assembly of fig. 24.

Fig. 27 is a perspective assembly view of an alternate embodiment of the sixth embodiment in fig. 22.

Fig. 28 is a perspective combination view of the seventh embodiment of the insulated electrode of the electric field tumor therapy system of the present invention.

Fig. 29 is an exploded view of the insulated electrode and electrical connector of the insulated electrode shown in fig. 28.

Fig. 30 is an exploded perspective view of the insulated electrode shown in fig. 29.

Fig. 31 is an exploded perspective view of the electrode unit and the first lead of the insulated electrode shown in fig. 30.

Fig. 32 is a plan view of the flexible circuit board of the insulated electrode shown in fig. 31.

Fig. 33 is an exploded view of an eighth embodiment of the insulated electrode of the electric field tumor therapy system of the present invention.

Fig. 34 is an exploded perspective view of the insulated electrode shown in fig. 33.

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 1000, 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 to invert 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 of insulated electrodes 1,2 comprises an electrical functional component 11, 21, 31, 41, 51 and a backing 12, 22, 32, 42, 42',52, 62, 62',713, 713' supporting the electrical functional component 11, 21, 31, 41, 51. Preferably, the backing 12, 22, 32, 42, 42',52, 62, 62',713, 713' has an adhesive layer that is applied to the torso of the patient to position the electrical functional component 11, 21, 31, 41, 51 on the surface of the torso of the patient. 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, 200, 300, 400, 500, 600, 600',700, 700' will be described in detail later.

As an embodiment, the AC signal generator 9 generates an intermediate frequency alternating current signal of 150 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, a first AC signal with a frequency of 150KHZ is generated between the conductors of the first pair of insulated electrodes 1, a first electric field 3 with a strength of at least 1V/cm is generated in the target sensing region, and at the same time, the AC signal of 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 150KHZ 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 area, the AC signal on the first pair of insulated electrodes 1 is turned off, the first electric field 3 is turned off, at this time, the signal 5 is at low level 0, and the signal 6 is at high level 1.

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

The control signal generator 7 can switch the 150KHZ 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 applying electric fields with different duty cycles on cell proliferation during the culture of hepatocarcinoma cells, the switching rates of the applied electric fields in different directions are different, and the tumor therapeutic electric field has different effects on inhibiting proliferating cells in tissue culture and malignant cells in experimental animal.

In the experiment, liver cancer cells are cultured in a culture dish, two pairs of mutually perpendicular 150KHz alternating current signals are applied to the periphery of the liver cancer cells, and the proliferation condition of the 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 first electric field operates for a time period T1, and the second electric field 4 is switched to the first electric field 3 after the second electric field operates for a time period T2, and repeatedly, T1 and T2 are the same and are half periods of the control signal generator 7. The experimental results show that T1 and T2 have better effect on the inhibition of cell proliferation than other rates at 500ms to 980ms. Preferably, T1 and T2 are more effective in inhibiting cell proliferation at around 500ms and between 700ms and 980ms. In this example, huh-7 hepatoma cells were used as the cell tissue culture, but the turnover rate is not limited to these cells for the inhibition of 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 the time of T1, the AC signal generator 9 applies a first AC signal to the first pair of insulated electrodes 1 and generates a first electric field 3, and a step-by-step boosting manner is adopted in an initial process of formation of the first AC signal, that is, the AC voltage amplitude is gradually raised from 0V to 90% of the peak-to-peak value of the target voltage within a time T3, and then a stable target voltage output is maintained for a plurality of times T5; during the time T4, the voltage slowly decreases from 90% of the target voltage to 0V. Similarly, at the time T2, the AC signal generator 9 applies a second AC signal to the second pair of insulated electrodes 2 and generates the second electric field 4, and a step-by-step boosting manner is adopted in the initial process of the formation of the second AC signal, that is, the AC voltage amplitude is gradually raised from 0V to 90% of the peak-to-peak value of the target voltage within a time T3, and then a stable target voltage output is maintained for a plurality of 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, 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, so that the AC signal generator 9 applies voltage to the first pair of insulated electrodes 1 and the second pair of insulated electrodes 2 at the same time can be effectively avoided, 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 at most not more than 10% of the duration of T1 so as not to reduce the electric field strength per unit time, T5 is the reciprocal of the AC electric field frequency, and the sum of T3, T4 and a number of T5 is equal to T1. During time T2, the first electric field 3 between the first pair of insulated electrodes 1 is turned off and the second electric field 4 between the 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 150KHZ AC intermediate frequency 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 first output state and the second output state have a duration of 500ms to 980ms, thereby achieving 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, 200, 300, 400, 500, 600, 600',700, 700' of the present invention may have different embodiments. The utility model discloses an insulated electrode 100, 200, 300, 400, 500, 600, 600',700, 700' provides following 9 kinds of embodiments: fig. 5 to 9 show a first embodiment of the insulated electrode 100 of the present invention, fig. 10 to 11 show a second embodiment of the insulated electrode 200 of the present invention, fig. 12 to 13 show a third embodiment of the insulated electrode 300 of the present invention, fig. 14 to 17 show a fourth embodiment of the insulated electrode 400 of the present invention, fig. 18 to 20 show a fifth embodiment of the insulated electrode 500 of the present invention, fig. 21 to 26 show a sixth embodiment of the insulated electrode 600 of the present invention, fig. 27 shows a sixth embodiment of the insulated electrode 600 'of the present invention, fig. 28 to 32 show a seventh embodiment of the insulated electrode 700 of the present invention, and fig. 33 to 34 show an eighth embodiment of the insulated electrode 700' of the present invention. The structure of the insulated electrode is specifically described below.

First embodiment of insulated electrode 100

Fig. 5 to 9 show an insulated electrode 100 according to a first embodiment of the present invention, the insulated electrode 100 can be attached to the body surface corresponding to the tumor region of the patient's trunk for performing electric field therapy on the tumor region, and includes a flexible backing 12, an electrical functional component 11 attached to the backing 12, a support 13 attached to the backing 12, an adhesive member 14 attached to the support 13, and a wire 15 electrically connected to the electrical functional component 11. The utility model discloses an insulated electrode 100 laminates in the corresponding body surface of patient's tumour position through backing 12 to exert alternating electric field in order to disturb or prevent the mitosis of patient's tumor cell through electric function assembly 11 to patient's tumour position, thereby realize the purpose of treatment tumour.

Referring to fig. 7, the electrical functional assembly 11 includes a flexible circuit board 111, a plurality of insulating plates 112 and a plurality of dielectric elements 113 respectively disposed on opposite sides of the flexible circuit board 111, and a plurality of temperature sensors 114 fixed on the flexible circuit board 111. The temperature sensor 114 is located on the same side of the flexible circuit board 111 as the dielectric member 113. The plurality of dielectric elements 113 are disposed on a side of the flexible circuit board 111 close to the body surface of the patient, and the plurality of insulating plates 112 are disposed on a side of the flexible circuit board 111 away from the body surface of the patient. The electrical functional component 11 is adhered to the backing 12 through the insulating plate 112 and the corresponding portion of the flexible circuit board 111, respectively, so as to be closely attached to the backing 12. The insulated electrode 100 applies an alternating electric signal generated by an electric field generator (not shown) to a tumor site of a patient through a plurality of dielectric elements 11 provided on a flexible circuit board 111, thereby performing electric field treatment on the tumor site of the patient.

The flexible circuit board 111 includes a plurality of main body portions 1111 arranged in an array, a plurality of connecting portions 1112 located between adjacent main body portions 1111, and a wiring portion 1113 electrically connected to the conductive wire 15. The wiring portion 1113 may be extended laterally from a connection portion 1112, or may be extended laterally from a main body portion 1111 free at one end. The plurality of dielectric elements 113 and the plurality of main bodies 1111 are disposed in one-to-one correspondence. The dielectric element 113 is soldered to the corresponding main body 1111. The body portion 1111 is disposed at a distal end of the connection portion 1112. The main body portion 1111 is extended from the end of the connection portion 1112. Each main body portion 1111 is connected to at least two adjacent main body portions 1111 through a connecting portion 1112. The main body portion 1111 is substantially circular and has a plate shape. Alternatively, the main body portion 1111 may be formed in a strip or belt shape and integrally formed with the connecting portion 1112. The side of the main body portion 1111 facing the dielectric element 113 is provided with a conductive pad 1114 for soldering with the dielectric element 113 by solder (not shown) to assemble the dielectric element 113 on the main body portion 1111 of the flexible circuit board 111. The center of conductive pad 1114 coincides with the center of body portion 1111. Each conductive pad 1114 has 4 conductive cores 1115 protruding or exposed from the body portion 1111. The conductive core 1115 is arranged in a central symmetry manner, so that the position of the dielectric element 113 can be effectively prevented from being shifted due to stacking of soldering tin (not shown) in the welding process. The 4 conductive cores 1115 are arranged at intervals, so that the consumption of copper foil for manufacturing the conductive cores 1115 can be reduced, and the material cost is reduced; meanwhile, the amount of solder (not shown) used for welding the conductive core 1115 and the dielectric element 113 can be saved, thereby further reducing the material cost.

The 4 conductive cores 1115 of the same conductive pad 1114 are all petal-shaped. Each of the conductive cores 1115 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 1115 are arranged in an axisymmetric manner. The inner arcs (not numbered) of the 4 conductive cores 1115 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 1115 of the same conductive pad 1114 all project away from the center of the conductive pad 1114. The 4 conductive cores 1115 forming the conductive pad 1114 are arranged in a centrosymmetric manner and in an axial symmetric manner, and each conductive core 1115 is also arranged in an axial symmetric manner, so that when the 4 conductive cores 1115 of the conductive pad 1114 of the main body portion 1111 are welded with the dielectric element 113, the stress balance of each welding point is ensured, the overall welding balance of the dielectric element 113 is ensured, the welding quality is improved, and the situation that the welding strength of the welding part on the side with a larger interval between the dielectric element 113 and the main body portion 1111 is weak 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 4 conductive cores 1115 of the same conductive pad 1114 are located substantially on the same circumference.

The number of the main body parts 1111 is at least 10, the number of the dielectric elements 113 is at least 10, and the arrangement mode of the dielectric elements is consistent with the arrangement mode of the main body parts 1111, so that the coverage area of the insulated electrode 100 can be increased, the electric field intensity applied to a tumor part for tumor electric field treatment can be enhanced, the range of the alternating electric field covering the tumor part can be enlarged, and the treatment effect can be improved. Preferably, the number of the main body portion 1111 and the number of the dielectric elements 113 are 13, and the main body portion 1111 and the dielectric elements 113 may be distributed in a matrix area with five rows and three columns, or may be distributed in a matrix area with five rows and five columns. From the line arrangement angle, each line of first row and last row all is equipped with 2 main part 1111, and every line of three lines in the middle all is equipped with 3 main part 1111. In the present embodiment, the main body portions 1111 are distributed in an array region arranged in five rows and five columns, and from the column arrangement perspective, 3 main body portions 1111 are respectively disposed in each of the first column, the third column, and the fifth column, and 2 main body portions 1111 are respectively disposed in each of the second column and the fourth column. Specifically, the 2 main body portions 1111 in the first row are respectively located in the second column and the fourth column, the 3 main body portions 1111 in each row in the middle three rows are respectively located in the first column, the third column and the fifth column, and the 2 main body portions 1111 in the last row are respectively located in the second column and the fourth column. The two adjacent main body portions 1111 in each row are arranged in a spaced row. The distance between two adjacent main body portions 1111 in the same row is equal. The distances between two adjacent main body portions 1111 in the same column are equal. The two main body portions 1111 located in the last row are separated from each other, and an interval C is formed between the two main body portions 1111. The wiring portion 1113 is laterally extended from the main body portion 1111 located in the fourth row and the third column. The wiring portion 1113 passes through an interval C formed between the last two main body portions 1111.

The connecting portion 1112 connects two adjacent main body portions 1111, and the conductive pad 1114 is disposed on the main body portion 1111 at the end of the connecting portion 1112. The connecting portions 1112 include a first connecting portion 1112A connecting two adjacent main portions 1111 in the same row and alternate column, a second connecting portion 1112B connecting two adjacent main portions 1111 in the same column and adjacent column, and a third connecting portion 1112C connecting two main portions 1111 in the adjacent row and adjacent column and diagonally distributed. The first connection portions 1112A are located between two adjacent main body portions 1111 in every row and every column, and have the same length. The second connection portion 1112B is located between two adjacent main body portions 1111 in each of the first row, the third row and the fifth row, and has the same length. The length of the third connection portion 1112C is greater than half the length of the first connection portion 1112A. The length of the third connection portion 1112C is greater than the length of the second connection portion 1112B. The first connection portion 1112A and the second connection portion 1112B are substantially disposed in a shape of a straight line. The third connecting portion 1112C is substantially L-shaped or inclined. The number of the third connecting portions 1112C is 8, and the third connecting portions are respectively located between the two main body portions 1111 in the second row and the second column of the first row, between the two main body portions 1111 in the second row and the third column of the second row, between the two main body portions 1111 in the third column and the fourth column of the first row, between the two main body portions 1111 in the fourth column and the fifth column of the second row, between the two main body portions 1111 in the second row and the fourth column of the first row, between the two main body portions 1111 in the second column and the third column of the last row, between the two main body portions 1111 in the third column and the fourth column of the last row, and between the two main body portions 1111 in the fourth column and the fifth column of the last row. Preferably, the length of the first connection portion 1112A is greater than the diameter of the main body portion 1111. The length of the second connection portion 1112B is smaller than the diameter of the body portion 1111. The first connection portion 1112A and the second connection portion 1112B are disposed perpendicularly, the third connection portion 1112C and the first connection portion 1112A adjacent thereto are disposed in an acute angle, and the second connection portion 1112B and the third connection portion 1112C adjacent thereto are also disposed in an acute angle.

The main body portion 1111 may be divided into a peripheral main body portion 1111A located at the periphery of the array and a central main body portion 1111B surrounded by the peripheral main body portion 1111A and located at an inner layer of the array according to the distribution position of the main body portion 1111 in the array. Specifically, the number of the peripheral body portions 1111A is 10, and the number of the central body portions 1111B is 3 and is located in the same column. The peripheral main body portion 1111A and the central main body portion 1111B are connected to each other by two connecting portions 1112. The two adjacent peripheral body portions 1111A are electrically connected to each other through the first connection portion 1112A, the second connection portion 1112B, or the third connection portion 1112C. Specifically, the two adjacent peripheral main body portions 1111A in the same column are connected by a second connection portion 1112B, the two adjacent peripheral main body portions 1111A in the same row are connected by a first connection portion 1112A, and the two adjacent peripheral main body portions 1111A in the adjacent columns in the adjacent rows and diagonally arranged are connected by a third connection portion 1112C. The peripheral body portion 1111A, and the first connection portion 1112A, the second connection portion 1112B, and the third connection portion 1112C located between two adjacent peripheral body portions 1111A are substantially provided in an eight-sided shape having an opening at one end. The peripheral main body portion 1111A is arranged in an axisymmetric manner, and a symmetry axis of the peripheral main body portion 1111A coincides with a straight line where the 3 central main body portions 1111B are located.

The center body portion 1111B is 3 body portions 1111 located in the third column. Each of the central main body portion 1111B and the peripheral main body portion 1111A adjacent thereto are connected to each other by a first connection portion 1112A or a third connection portion 1112C. The two adjacent central main body portions 1111B are electrically connected by a second connection portion 1112B. Specifically, the central main body portion 1111B and the adjacent peripheral main body portion 1111A located in the same row are electrically connected through the first connecting portion 1112A, and the central main body portion 1111B and the adjacent peripheral main body portion 1111A located in the adjacent row and arranged diagonally are electrically connected through the third connecting portion 1112C, so that the central main body portion 1111B and the adjacent peripheral main body portion 1111A are connected through at least two connecting portions 1112, and the relative fixation of the positions of the peripheral main body portion 1111A and the central main body portion 1111B is ensured, the connection is stable, and the dielectric element 113 is conveniently welded on the flexible circuit board 111. That is, the center main body portion 1111B in the third row is connected to the peripheral main body portion 1111A in the same row only by the first connection portion 1112A, and is disposed in a disconnected state between the adjacent peripheral main body portions 111A in the adjacent columns in the adjacent row and arranged diagonally. Each of the remaining two center main body portions 1111B is connected not only to the peripheral main body portion 1111A located in an adjacent row and diagonally arranged thereto through the third connection portion 1112C, but also to the peripheral main body portion 1111A located in the same row through the first connection portion 1112A.

The wiring portion 1113 is provided extending laterally from one of the two main body portions 1111 located at the end among the 3 main body portions 1111 located at the third row. Specifically, the wiring portion 1113 is laterally extended from the main body portion 1111 of the fourth row and the third column. The wiring portion 1113 is provided to extend from the central main body portion 1111B located at the end portion toward a region distant from the array of main body portions 1111. The wire connecting portion 1113 is located between the two third connecting portions 1112C, and connects the central body portion 1111B located at the end portion simultaneously with the two third connecting portions 1112C. The wire connecting portion 1113 and two third connecting portions 1112C which connect the same center body portion 1111B together are provided substantially in an arrow shape. The wiring portion 1113 extends out between two peripheral main body portions 1111A arranged in the same row and in a disconnected state. The wiring portion 1113 is provided substantially perpendicular to the first connection portion 1112A. The wire portion 1113 is provided substantially in parallel with the second connection portion 1112B. The wiring portion 1113 is substantially arranged in a line shape. An angle between the wire connecting portion 1113 and the third connecting portion 1112C connected to the same main body portion 1111 at the same time is acute. In other embodiments, the wiring portion 1113 may also be laterally extended from the main body portion 1111 or the central main body portion 1111B located in the third column of the second row; the two main body portions 1111 located in the first row are separated from each other, and the wiring portion 1113 passes through the space between the two main body portions 1111. In other embodiments, the wire connecting portion 1113 may also be extended laterally from a second connecting portion 1112B located between two adjacent central main body portions 1111B, and the wire connecting portion 1113 is perpendicular to the second connecting portion 1112B; the wire portion 1113 is disposed substantially in a "T" shape with respect to the second connection portion 1112B of the extended wire portion 1113.

The insulating plate 112 is substantially circular and plate-shaped. The insulating plate 112 is made of an insulating material, and is adhered to a side surface of the main body portion 1111 of the flexible circuit board 111 away from the body surface of the patient by a sealant (not shown), so that the strength of the flexible circuit board 111 is enhanced, and a flat welding plane can be provided for the welding operation between the conductive plate 1114 and the dielectric element 113, thereby improving the product yield. The insulating plate 112 can prevent moisture in the air on the side of the electrical functional component 11 away from the surface of the patient from entering the electrical functional component 11, so as to prevent the moisture from contacting with a solder (not shown) between the dielectric element 113 and the main body 1111, and affecting the electrical connection between the main body 1111 and the dielectric element 113. The insulating plates 112 are arranged corresponding to the main body parts 1111 one by one, and the arrangement of the insulating plates is consistent with that of the main body parts 1111.

The dielectric element 113 is arranged in a circular sheet shape. The dielectric element 113 is made of a material having a high dielectric constant, and has a characteristic of blocking direct current and alternating current, thereby ensuring safety of a human body. The dielectric element 113 has a dielectric constant of at least greater than 1000. An annular metal layer 1131 is attached to the side of the dielectric element 113 facing the main body 1111 and is soldered (not shown) to the conductive pad 1114 of the main body 1111. A gap (not shown) formed between the dielectric element 113 and the main body 1111 by welding is filled with a sealant (not shown) to protect the solder (not shown) between the dielectric element 113 and the main body 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, it is avoided that moisture in the air enters the gap (not shown) to erode solder (not shown) 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 outer ring of the metal layer 1131 and the outer edge of the dielectric element 113 are spaced from each other, so as to prevent solder (not shown) between the metal layer 1131 of the dielectric element 113 and the main body 1111 from overflowing toward the main body 1111 when being melted by heat, and prevent direct current not obstructed by the dielectric element 113 from directly acting on the body surface of the patient when the insulated electrode 100 is attached to the body surface corresponding to the tumor site of the patient. The dielectric member 113 has an opening 1132 disposed therethrough for receiving the temperature sensor 114. The edge of the opening 1132 of the dielectric element 113 is spaced from the inner ring of the metal layer 1131 of the dielectric element 113, so as to prevent a solder (not shown) between the metal layer 1131 of the dielectric element 113 and the main body 1111 from diffusing toward the opening 1132 of the dielectric element 113 when being melted by heat and causing a short circuit of the temperature sensor 114. The main body 1111, the insulating plate 112 and the dielectric element 113 are disposed in a one-to-one correspondence, and centers of the three are located on the same line. The arrangement of the insulating plate 112 and the dielectric element 113 is consistent with that of the main body 1111, and both are distributed in an array region arranged in five rows and five columns.

The main body portion 1111 of the flexible circuit board 111, the insulating plate 112 disposed on the side of the main body portion 1111 of the flexible circuit board 111 facing away from the surface of the patient, and the dielectric element 113 disposed on the side of the main body portion 1111 of the flexible circuit board 111 facing the epidermis of the patient together constitute the electrode unit 110 of the electrical functional module 11. The arrangement of the electrode units 110 of the electrical functional assembly 11 is identical to that of the main body portion 1111 of the flexible circuit board 111. The connection portions 1112 are located between two adjacent electrode units 110.

A temperature sensor 114 is attached to the body portion 1111 for monitoring the temperature of the adhesive member 14 and thereby the skin of the person to which the adhesive member 14 is applied. When the temperature monitored by the temperature sensor 114 exceeds the upper limit of the human body safety temperature, the electric field generator (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 soldered to the body portion 1111 and then sealed with a sealant (not shown) to prevent moisture from attacking the temperature sensor 114 and causing the temperature sensor 114 to fail. The temperature sensor 114 is disposed on the peripheral main body portion 1111 of the plurality of main body portions 1111 arranged in an array. That is, the temperature sensor 114 is provided in the peripheral body 1111A.

One end of the lead 15 is soldered to the wiring portion 1113 of the electrical functional component 11, and the other end is provided with a plug (not numbered) electrically connected to an electric field generator (not shown). The plug (not numbered) of the wire 15 can be directly inserted into the electric field generator (not shown) or inserted into an adapter (not shown) of the tumor electric field treatment system, and then the wire 15 and the electric field generator (not shown) are electrically connected through the adapter (not shown) and the electric field generator (not shown) to realize the electrical connection therebetween. The junction cladding of wiring portion 1113 has heat shrinkage bush 151 on wire 15 and the flexible circuit board 111 for the junction of wiring portion 1113 seals, insulation protection on wire 15 and the flexible circuit board 111, and the improvement intensity supports, avoids wire 15 and electric function component 11 junction to break off, simultaneously can also dustproof and waterproof.

The support 13 is a sheet-like arrangement. The support 13 is provided in plurality. The support 13 is adhered to the backing 12 in a manner surrounding the electrode units 110 arranged in rows. The plurality of supporting members 13 are arranged at intervals. The supporter 13 has a plurality of through-holes 131 provided corresponding to the respective electrode units 110. The plurality of through holes 131 are arranged at intervals. The thickness of the supporting member 13 is substantially consistent with that of the electrode unit 110, and the plane of the top end of the supporting member 13 is at the same vertical height as the surface of the electrode unit 110 facing the patient body surface, that is, the surface of the supporting member 13 close to the patient body surface is flush with the surface of the dielectric element 113 close to the patient body surface, so that the adhesive member 14 can be flatly covered on the supporting member 13 and the electrode unit 110, and the comfort of applying the insulated electrode 100 is improved. The supporting member 13 may be made of Polyethylene (PE) material, PET material, heat conductive silicone sheet, or an insulating material compounded by polyurethane, polyethylene, dispersant, flame retardant, carbon fiber, etc., which is soft, stable in chemical properties, light in weight, not easy to deform, and non-toxic. Preferably, the support 13 is a flexible foam.

The adhesive member 14 is disposed in a sheet shape, and has one side thereof adhered to the supporting member 13 and the dielectric member 113 and the other side thereof adhered to the body surface of the patient. The adhesive member 14 is a conductive hydrogel that acts as a conductive medium to conduct the alternating current through the dielectric member 113 to the tumor site of the patient. The number of the adhesive members 14 is the same as the number of the supporting members 13. The size of the adhesive member 14 is substantially the same as the size of the support member 13.

As shown in connection with fig. 6, the backing 12 is in the form of a sheet-like arrangement, which is made primarily of a material that is compatible with flexibility, breathability, insulation, and sterilization. The backing 12 has a plurality of air holes (not shown) which are arranged through the backing 12, so that when the backing 12 is applied on the surface of a patient, the hair follicles and sweat glands of the skin of the patient covered by the backing 12 can freely breathe, and the skin inflammation caused by the damage to the superficial skin layer of the patient due to the blockage of the hair follicles and sweat glands of the surface of the patient covered by the backing 12 is avoided. The backing 12 is a mesh fabric. Specifically, the backing 12 is a mesh nonwoven fabric. The side of the backing 12 facing the patient's body surface is also coated with a compatible adhesive (not shown) for adhering the backing 12 to the patient's body surface in the desired area.

Second embodiment of insulated electrode 200

Fig. 10 to 11 show an insulated electrode 200 of a second embodiment, which is also applied on the body surface of the patient's trunk for performing the tumor electric field treatment on the tumor region located on the trunk, and which also includes a flexible backing 22, an electric functional component 21 adhered on the backing 22, a support 23 adhered on the backing 22, an adhesive member (not shown) adhered on the support 23, and a lead 25 electrically connected to the electric functional component 21. The electrical functional assembly 21 also includes a flexible circuit board 211, a plurality of insulating plates 212 and a plurality of dielectric elements 213 respectively disposed on opposite sides of the flexible circuit board, and a plurality of temperature sensors 214 fixed on the flexible circuit board 211. The main body portion 2111, the dielectric element 213, and the insulating plate 212 of the flexible circuit board 211 are disposed in one-to-one correspondence, and constitute the electrode unit 210 of the electrical functional assembly 21. The main body portions 2111 are also arranged in five rows and five columns, and the positions thereof distributed in the array region of the five rows and five columns are the same as the arrangement of the main body portions 1111 of the first embodiment.

The insulated electrode 200 in the present embodiment is different from the insulated electrode 100 in the first embodiment in that: the peripheral main body portions 2111A of the flexible circuit board 211 of the electrical functional assembly 21 of the insulated electrode 200 are connected two by the connecting portions, and the central main body portion 2111B is connected only to the peripheral main body portion 2111A adjacent thereto in the same row. Specifically, the two adjacent peripheral body portions 2111A are connected two by two either through the first connection portion 2112A, the second connection portion 2112B, or the third connection portion 2112C. The peripheral body portions 2111A and the first connection portion 2112A, the second connection portion 2112B, and the third connection portion 2112C between two adjacent peripheral body portions 2111A have a substantially racetrack-like configuration. The center body portion 2111B and the peripheral body portions 2111A in the same row are connected by a first connection portion 2112A. The central body portion 2111B is separated from the peripheral body portions 2111A which are located in adjacent rows and columns and arranged diagonally. Two adjacent central body portions 2111B of the 3 central body portions 2111B are provided in a disconnected state. The second connection portion 2112 is not provided between the two adjacent center body portions 2111B provided in a disconnected state. The third connecting portion 2112C is provided in an arc shape. The number of the third connecting portions 2112C is set to 4, and the third connecting portions are respectively located between the two peripheral main body portions 2111A in the first row, the second column and the second row, between the two peripheral main body portions 2111A in the first row, the fourth column and the fifth column, between the two peripheral main body portions 2111A in the last row, the second column and the fourth column, and between the two peripheral main body portions 2111A in the last row, the fourth column and the fifth column. The third connection portion 2112C and the first connection portion 2112A adjacent thereto are both provided substantially in an obtuse angle shape or an acute angle shape. The third connection portion 2112C and the second connection portion 2112B adjacent thereto are both provided substantially at an obtuse angle. The peripheral body portion 2111A and the central body portion 2111B have the same diameter, and the length of the second connecting portion 2112B is slightly greater than the diameter of the peripheral body portion 2111A.

The wire connecting portion 2113 is laterally extended from a second connecting portion 2112B. Specifically, the wire connecting portion 2113 is laterally extended by a second connecting portion 2112B located between two adjacent central body portions 2111B. The wire connecting portion 2113 is provided substantially in a "T" shape with a second connecting portion 2112B to which the wire connecting portion 2113 is extended. The wire connecting portion 2113 is provided perpendicular to the second connecting portion 2112B. The wire connecting portion 2113 is provided substantially in parallel with the first connection portion 2112A.

The flexible circuit board 211 is further provided with a reinforcing portion 2116 opposite to the wiring portion 2113, so that traction can be provided for the wiring portion 2113, and the problem that the insulating electrode 200 is applied due to uneven stress when the insulating electrode 200 is applied to the body surface of the tumor part of the patient is avoided. Specifically, the reinforcing portion 2116 is extended from the second connecting portion 2112B of the laterally extended wire connecting portion 2113. The reinforcing portion 2116 and the wire connection portion 2113 are located on opposite sides of a second connection portion 2112B connected to the wire connection portion 2113, respectively. The reinforcing portion 2116 has one end connected to the second connecting portion 2112B connected to the wire connecting portion 2113, and the other end connected to the second connecting portion 2112B adjacent to the second connecting portion 2112B and located between the two adjacent peripheral body portions 2111A. The reinforcing portion 2116 bridges between two adjacent and parallel second connecting portions 2112B. The reinforcing portion 2116, the wire connecting portion 2113, and the second connecting portion 2112B connected to the wire connecting portion 2113 are arranged substantially in a cross shape.

The backing 22 is provided with a threading hole 221 corresponding to the wiring portion 2113 of the flexible circuit board 211. One end of the lead wire 25 passes through the threading hole 221 to be electrically connected to the wiring portion 2113. The lead wires 25 extend into the flexible circuit board 211 from one side of the backing 22 to be connected with the wiring portion 2113, so that the problem that the comfort of the insulated electrode 200 is reduced when the insulated electrode is applied due to the fact that a large number of lead wires 25 are directly pressed on the skin of a patient is solved.

Third embodiment of insulated electrode 300

Fig. 12-13 show a third embodiment of insulated electrode 300, which is also applied to the body surface of a patient's torso for performing tumor electroporation treatment on tumor sites located on the torso, and which also includes a flexible backing 32, an electrical functional component 31 adhered to the backing 32, a support 33 adhered to the backing 32, an adhesive member (not shown) adhered to the support 33, and a lead 35 electrically connected to the electrical functional component 31.

The insulated electrode 300 in the present embodiment is different from the insulated electrode 100 described in the first embodiment in that: the electrical functional assembly 31 of the insulated electrode 300 includes a flexible circuit board 311, a plurality of insulating plates (not shown) and a plurality of dielectric elements 313, wherein the insulating plates (not shown) and the dielectric elements 313 are respectively disposed on two opposite sides of the main body portion 3111 of the flexible circuit board 311 in a one-to-one correspondence manner to form a plurality of electrode units 310. The body portion 3111 is distributed in an array region of five rows and three columns. From the column arrangement perspective, the first and third columns each have 5 body portions 3111, and the second column has 3 body portions 3111. Specifically, the 2 main body portions 3111 in the first row are respectively located in the first column and the third column. The 2 main body portions 3111 in the last row are also located in the first column and the third column, respectively. The middle three rows of 3 body portions 3111 are respectively located in the first, second and third columns. The main body portions 3111 in the first and last rows are arranged in a row at intervals, and the main body portions 3111 in the first and last rows are arranged in a disconnected manner. The distance between two adjacent body portions 3111 in the same row is different. The distance between two adjacent body portions 3111 in the same column is equal. The 13 body portions 3111 are disposed in an axisymmetric manner, one symmetry axis of the axisymmetric axis coincides with a straight line where the 3 body portions 3111 in the third row are located, and the other symmetry axis of the axisymmetric axis coincides with a straight line where the 3 body portions 3111 in the second row are located. The 13 main body portions 3111 are also arranged in a centrosymmetric manner, and the symmetric center thereof coincides with the center of the main body portion 3111 located in the third row and the third column. The electrode units 310 are arranged in the same manner as the main body portion 3111 and are located in the array region of five rows and three columns.

The main body portion 3111 can be divided into 12 peripheral main body portions 3111A located at the periphery of the array and 1 central main body portion 3111B surrounded by the peripheral main body portions 3111A and located at the inner layer of the array according to the distribution position of the main body portions 3111 in the array. Specifically, the 1 central body portion 3111B is located at the body portion 3111 at the third row and second column position. The 12 peripheral body portions 3111A are all body portions 3111 except the body portion 3111 located in the third row and the second column. The peripheral body portion 3111A is connected either through the second connection portion 3112B or through the third connection portion 3112C. The two adjacent peripheral body portions 3111A in the same column are connected by a second connection portion 3112B. The two peripheral body portions 3111A located in adjacent rows and adjacent columns and arranged diagonally are connected by a third connection portion 3112C. The two adjacent peripheral main body portions 3111A arranged in the same row and at an interval are arranged in a disconnected manner. The peripheral body portion 3111A and the central body portion 3111B are connected to each other through either a first connection portion 3112A or a second connection portion 3112B. Specifically, the peripheral body portion 3111A and the central body portion 3111B adjacent to each other in the same row are connected to each other by a first connection portion 3112A. The peripheral body portion 3111A and the central body portion 3111B adjacent to each other in the same column are connected to each other by a second connection portion 3112B. The first connection portion 3112A is located between the two body portions 3111 in the adjacent columns and rows, and has the same length. The second connecting portion 3112B is located between the two body portions 3111 in the adjacent rows in the same column, and has the same length. The third connection portion 3112C has a length greater than that of the first connection portion 3112A. The number of the third connecting portions 3112C is 4, and the third connecting portions are respectively located between the two peripheral body portions 3111A of the first row and the second column, between the two peripheral body portions 3111A of the second row and the first row and the third column, between the two peripheral body portions 3111A of the fifth row and the fourth row and the second column, and between the two peripheral body portions 3111A of the fourth row and the second column and the fifth row and the third column. The peripheral body portion 3111A is disposed in an axisymmetric manner, and one axis of symmetry coincides with the extending direction of the row in which the central body portion 3111B is located, and the other axis of symmetry coincides with the extending direction of the column in which the central body portion 3111B is located. The wiring portion 3113 is extended from the peripheral body portion 3111A in the fourth row and the second column. The wire connection portion 3113 is located between two adjacent third connection portions 3112C to which the same peripheral body portion 3111A is commonly connected.

The backing 32 is provided with a threading hole 321 corresponding to the wire connection portion 3113 of the flexible circuit board 311. One end of the lead 35 passes through the threading hole 321 to be electrically connected to the wire connection portion 3113. The wires 35 extend into the flexible circuit board 311 from one side of the back lining 32 to be connected with the wiring portion 3113, so that the problem that the comfort of the insulated electrode 300 is reduced when the insulated electrode is applied due to the fact that a large number of wires 35 are directly pressed on the skin of a patient is avoided.

Fourth embodiment of insulated electrode 400

Referring to fig. 14 to 17, the insulated electrode 400 includes a backing 42, an electrical function component 41 adhered to the backing 42, a support 43 adhered to the backing 42, an adhesive member 45 covering a portion of the support 43 corresponding to the electrical function component 41, and a lead 44 electrically connected to the electrical function component 41. The insulated electrode 400 is attached to the body surface of the patient corresponding to the tumor part through the backing 42, and applies an alternating electric field to the tumor part of the patient through the electric functional component 41 to interfere or prevent the mitosis of the tumor cells of the patient, thereby achieving the purpose of treating the tumor.

The electrical functional assembly 41 is disposed in a grid, and includes a plurality of electrode units 410 arranged in an array, a plurality of connecting portions 4112 connecting two adjacent electrode units 410, and a wiring portion 4113 welded to the lead 44. The plurality of electrode units 410 are distributed at intervals on grid points of the electrical functional component 41. Each of the electrode units 410 is connected to at least two adjacent electrode units 410 by a connection portion 4112. Each of the electrode units 410 is connected to at least two connecting portions 4112. The plurality of electrode units 410 are at least ten and distributed in an array area in at least three rows and four columns, so that the coverage area of the electrode units 410 of the insulated electrode 400 can be increased, the electric field intensity applied to a tumor part for tumor electric field treatment is enhanced, the range of the alternating electric field covering the tumor part is enlarged, and the treatment effect is improved.

Preferably, each of the electrode units 410 is connected to at least three adjacent electrode units 410 by a connection portion 4112. Each of the electrode units 410 is connected to at least three connecting portions 4112. The number of the electrode units 410 is twenty, and the electrode units are distributed in an array area with four rows and six columns. The number of electrode units 410 per column is not exactly the same. The number of the electrode units 410 in each row may or may not be identical. At least one adjacent two electrode units 410 of the plurality of electrode units 410 are disposed in a disconnected manner, and a space 4C is formed between the two adjacent electrode units 410 disposed in the disconnected manner and through which the wiring portion 4113 passes. The wire connecting portion 4113 extends laterally from the connecting portion 4112 opposite to the space 4C. The connecting portion 4112 of the extended wiring portion 4113 is perpendicular to the wiring portion 4113, and both are substantially "T" shaped. The wiring portion 4113 is substantially in a line shape. Alternatively, the wire connecting portion 4113 is disposed in a shape of "T", and is erected between two connecting portions 4112 connected to two adjacent electrode units 410 disposed in a disconnected state. The wiring portion 4113 is located between the electrode units 410 and disposed in the space surrounded by the electrode units 410, so as to avoid the increase of the manufacturing cost due to the oversize of the electrical functional assembly 41.

The twenty electrode units 410 are arranged in an array area with four rows and six columns in a manner that two electrode units 410 are arranged in two columns and each column, and four electrode units are arranged in the other four columns and each column. Specifically, the twenty electrode units 410 are distributed in an array area with four rows and six columns in a manner that four columns of four electrode units 410 are adjacent to each other two by two. The intervals between two adjacent electrode units 410 arranged in a row are the same. The plurality of connecting portions 4112 connecting adjacent two electrode units 410 arranged in a row have the same length. Specifically, the electrode units 410 in each of two columns of the two columns only provided with two electrode units 410 are arranged in adjacent rows, the intervals between two adjacent electrode units 410 arranged in a column are the same, and the connecting portions 4112 of the two adjacent electrode units 410 connected in a column arrangement have the same length. The four electrode units 410 in the two columns may be respectively arranged in alignment in the row direction; or can be respectively arranged in a staggered manner in the row direction; one of the two may be aligned in the row direction and the other may be staggered in the row direction. Alternatively, the two electrode units 410 of at least one of the two columns only provided with the two electrode units 410 are arranged in a spaced row, the electrode units 410 arranged in the columns have different pitches, and the connecting portions 4112 connecting two adjacent electrode units 410 in the columns have different lengths.

Optionally, at least two of the twenty electrode units in four rows with four electrode units 410 are distributed in an array area with four rows and six columns in a spaced-apart column shape. The intervals between two adjacent electrode units 410 arranged in a row are different, and the connecting portions 4112 connecting the two adjacent electrode units 410 arranged in a row have different lengths. Specifically, only two electrode units 410 in at least one of two columns of the two electrode units 410 are arranged in a spaced row, the intervals between two adjacent electrode units 410 arranged in a column are different, and the connecting portions 4112 between two adjacent electrode units 410 connected in a column arrangement have different lengths. Alternatively, when only two electrode units 410 in each of two columns of the two electrode units 410 are arranged in an adjacent row, the distances between the two adjacent electrode units 410 arranged in a column are the same, and the connecting portions 4112 between the two adjacent electrode units 410 connected in a column arrangement have the same length.

Optionally, the twenty electrode units 410 are distributed in an array area with four rows and six columns in a manner that one electrode unit 410 is arranged in one column, three electrode units 410 are arranged in one column, and four electrode units 410 are arranged in each of the other four columns. Specifically, the twenty electrode units 410 are distributed in an array area with four rows and six columns in a manner that one electrode unit 410 is arranged in the first column, four electrode units 410 are respectively arranged in each of the middle four columns, and three electrode units 410 adjacent to each other in pairs are arranged in the last column, the distances between two adjacent electrode units 410 arranged in rows are the same, and the distances between two adjacent electrode units 410 arranged in columns are the same. That is, the connecting portions 4112 connecting between two adjacent electrode units 410 in the same row have the same length. The plurality of connecting portions 4112 connecting two adjacent electrode units 410 in the same column have the same length.

Optionally, twenty electrode units 410 are arranged in a first row in an array region, four electrode units 410 are arranged in each middle four rows in a row, and two adjacent electrode units 410 in three electrode units 410 in a last row are arranged in an array region of four rows and six rows in a spaced row manner, the distances between two adjacent electrode units 410 arranged in a row are the same, and the distances between two adjacent electrode units 410 arranged in a row are different. That is, the connecting portions 4112 connecting between two adjacent electrode units 410 in the same row have the same length. The plurality of connecting portions 4112 connecting between two adjacent electrode units 410 in the same column have different lengths.

Optionally, the twenty electrode units 410 are distributed in an array area with four rows and six columns in an arrangement manner that four electrode units 410 are arranged in each of the first to fourth columns, three electrode units 410 are arranged in the fifth column, and only one electrode unit 410 is arranged in the last column. The last column of electrode units 410 and one of the fifth column of three electrode units 410 are aligned in a row direction, the fifth column of three electrode units 410 are all adjacent in a row direction, the spacing between two adjacent electrode units 410 arranged in a row is the same, the spacing between two adjacent electrode units 410 arranged in a column is the same, the plurality of connecting portions 4112 connecting two adjacent electrode units 410 arranged in a row have the same length, and the plurality of connecting portions 4112 connecting two adjacent electrode units 410 arranged in a column have the same length. Optionally, the last column of electrode units 410 and the fifth column of three electrode units 410 are staggered in the row direction, and the fifth column of three electrode units 410 are all adjacent in the row direction, the distance between two adjacent electrode units 410 arranged in a row is different, the distance between two adjacent electrode units 410 arranged in a column is the same, the plurality of connecting portions 4112 connecting two adjacent electrode units 410 arranged in a row have different lengths, and the plurality of connecting portions connecting two adjacent electrode units 410 arranged in a column have the same length. Optionally, the last column of electrode units 10 is staggered from the fifth column of three electrode units 410 in a row direction, two adjacent electrode units 410 in the fifth column of three electrode units 410 are arranged in a spaced row, the distance between two adjacent electrode units 410 arranged in a row is different, the distance between two adjacent electrode units 410 arranged in a column is different, the connecting portions 4112 connecting two adjacent electrode units 410 arranged in a row have different lengths, and the connecting portions 4112 connecting two adjacent electrode units 410 arranged in a column have different lengths.

Optionally, at least two of the twenty electrode units 410 in four rows with four electrode units 410 in each row are distributed in an array region with four rows and six columns in a spaced row shape, the distances between two adjacent electrode units 410 arranged in a row are different, and the connecting portions 4112 connecting two adjacent electrode units 410 arranged in a row have different lengths. The intervals between two adjacent electrode units 410 arranged in a row may be the same or different. The connecting portions 4112 between two adjacent electrode units 410 connected in a row may have the same length or different lengths.

The twenty electrode units 410 in the present embodiment are distributed in an array area of four rows and six columns in a manner that each row of the first row and the last row is provided with four electrode units 410, and each row of the middle two rows is provided with six electrode units 410. From the column arrangement perspective, two electrode units 410 are arranged in each of the first column and the sixth column, and four electrode units 410 are arranged in each of the middle four columns. The electrode units 410 in the same column as the first column and the sixth column are arranged in a row-wise adjacent manner, and the electrode units 410 in the two columns are respectively arranged in a row-wise aligned manner. Specifically, the four electrode units 410 of the first row are respectively located in the second column to the fifth column, the six electrode units 410 of each row of the middle two rows are respectively located in the first column to the sixth column, and the four electrode units 410 of the last row are respectively located in the second column to the fifth column. The plurality of electrode units 410 of the electrical functional assembly 41 are disposed in an axisymmetric manner. The plurality of electrode units 410 of the electrical functional assembly 41 are disposed in a line-wise axisymmetric manner and in a column-wise axisymmetric manner. Twenty electrode units 410 are arranged in an octagonal shape.

The connecting portion 4112 connects all two adjacent electrode units 410 located at the periphery of the array, and at least one adjacent two electrode units 410 of the two adjacent electrode units 410 located at the inner layer of the array are arranged in a disconnected manner. Specifically, the connecting portion 4112 is disposed between all adjacent two electrode units 410 except for two electrode units 410 located between the second row, the third column and the second row, the fourth column and two electrode units 410 located between the third row, the third column and the third row, the fourth column. The connecting portions 4112 connecting two adjacent electrode units 410 arranged in a row have the same length. The connecting portions 4112 of two adjacent electrode units 410 connected in a row have the same length. The connecting portion 4112 is located between two adjacent electrode units 410 arranged in a row, between two electrode units 410 arranged in a column, and around the array and between two adjacent electrode units 410 arranged diagonally in adjacent rows and adjacent columns.

The space 4C is provided between two adjacent electrode units 410 of the second row, the third column and the fourth column, and between two adjacent electrode units 410 of the third row, the third column and the fourth column. The wiring portion 4113 is located between the electrode units 410 in the third and fourth columns. The wire connecting portion 4113 is substantially "T" shaped, passes through the space 4C, and bridges the connecting portion 4112 between two adjacent electrode units 410 in the middle of the third row and the connecting portion 4112 between two adjacent electrode units 410 in the middle of the fourth row. The wiring portion 4113 and two adjacent connecting portions 4112 connected thereto are disposed in an axisymmetrical manner. Alternatively, the terminal portion 4113 is arranged in a line shape and is extended laterally toward the space 4C from the connecting portion 4112 corresponding to the space 4C.

The terminal portion 4113 of the electrical functional component 41 is electrically connected to the lead 44. In this embodiment, a row of gold fingers 41130 welded to the lead wire 44 is provided in a staggered manner on both side surfaces of one end of the wire connecting portion 4113 away from the connecting portion 4112 connected thereto. One end of the lead 44 is electrically connected to the gold finger 41130 of the wiring portion 4113; the other end is electrically connected with an electric field generator (not shown) through a plug 42 arranged on the other end, so as to provide an alternating current signal for tumor therapy for the insulated electrode 400 during tumor electric field therapy. The periphery of the welding position of the lead 44 and the gold finger 41130 of the terminal portion 4113 is covered with a heat shrinkable sleeve 41. The heat-shrinkable sleeve 41 performs insulation protection on the connection between the lead 44 and the wiring portion 4113 of the electrical functional component 41, provides support, prevents the connection between the lead 44 and the wiring portion 4113 of the electrical functional component 41 from being broken, and is dustproof and waterproof.

The electrode unit 410 includes a main body portion 4111 disposed at two opposite ends of the connecting portion 4112, an insulating plate 412 disposed on a side of the main body portion 4111 away from the skin of the human body, a dielectric element 413 disposed on a side of the main body portion 4111 facing the skin of the human body, and a temperature sensor 414 selectively disposed on the main body portion 4111 and located on the same side as the dielectric element 413. The main body 4111, the insulating plate 412 and the dielectric element 413 are all circular sheet-shaped structures. The insulating plate 412, the body 4111, and the dielectric element 413 are disposed in a one-to-one correspondence along the thickness direction, and the centers of the three are located on the same straight line.

A conductive plate 4114 is disposed on a surface of the main body 4111 facing the dielectric element 413. The conductive plate 4114 of the main body 4111 can be completely covered by the dielectric element 413, so that the conductive plate 4114 and the dielectric element 413 are soldered by a solder (not shown). The conductive plate 4114 of the main body 4111 includes a plurality of conductive cores 41140 arranged in a central symmetrical manner, 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 conductive plate 4114 of the main body portion 4111 is centered on the center line of the main body portion 4111. The top surfaces of the conductive cores 41140 of the conductive tray 4114 are located in the same plane, so that a solder joint between the conductive core 41140 and the dielectric element 413 can be prevented from being soldered. The center of the conductive disk 4114 is also located on the centerline of the dielectric element 413.

In this embodiment, the conductive plate 4114 of the same main body 4111 includes 4 conductive cores 41140 arranged in a central symmetrical manner at intervals. The conductive core 41140 adopts a multipoint interval arrangement mode, so that the consumption of copper foil for manufacturing the conductive core 41140 can be reduced, and the material cost is reduced; meanwhile, the amount of solder (not shown) used for welding the conductive core 41140 and the dielectric element 413 can be saved, thereby further reducing the material cost. The 4 conductive cores 41140 of the same conductive plate 4114 are all in a petal-shaped configuration. Each conductive core 41140 includes an inner arc (not numbered) and an outer arc (not numbered) connected end to end. The inner arc (not numbered) and the outer arc (not numbered) of the conductive core 41140 are arranged in an axisymmetric manner. Inner arcs (not numbered) of the 4 conductive cores 41140 of the same conductive plate 4114 are all recessed toward the center of the conductive plate 4114. The outer arcs (not numbered) of the 4 conductive cores 41140 of the same conductive disk 4114 all protrude away from the center of the conductive disk 4114. The 4 conductive cores 41140 forming the conductive disc 4114 are arranged in a central symmetry manner and an axial symmetry manner, and each conductive core 41140 is also arranged in an axial symmetry manner, so that when the 4 conductive cores 41140 of the conductive disc 4114 of the main body portion 4111 are welded with the dielectric element 413, stress balance of each welding point between the conductive disc 4114 and the dielectric element 413 is ensured, integral welding balance of the dielectric element 413 is ensured, welding quality is improved, and the situation that the welding position on 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 welding stress imbalance, which causes the inclination of the dielectric element 413 is avoided; and simultaneously, the adhesion degree of the insulated electrode 400 can be prevented from being influenced.

The insulating plate 412 is made of an insulating material. Preferably, the insulating plate 412 is an epoxy glass cloth laminate. The insulating plate 412 is adhered to the surface of the main body portion 4111 away from the skin of a human body through a sealant (not shown), so that the strength of the main body portion 4111 can be enhanced, a flat welding plane is provided for the welding operation between the main body portion 4111 and the dielectric element 413, and the product yield is improved. Meanwhile, the insulating plate 412 may further isolate the moisture in the air on the side of the insulating electrode 400 away from the skin from contacting the solder (not shown) between the main body portion 4111 and the dielectric element 413, so as to prevent the moisture from eroding the solder (not shown) between the main body portion 4111 and the dielectric element 413 and from affecting the electrical connection between the main body portion 4111 and the dielectric element 413.

The size of insulating board 412 with the size of main part 4111 is the same to when avoiding insulating board 412 to paste in main part 4111 and keep away from human skin one side through sealant (not shown), sealant (not shown) climbs to main part 4111 is to human skin one side through capillary effect, and influence dielectric element 413 with the packing of sealed glue (not shown) in the clearance (not shown) that main part 4111 welding formed leads to sealed glue (not shown) to have a cavity in, and then avoids sealed glue (not shown) because the steam in the cavity leads to steam rapid expansion to cause the blowout because the coefficient of thermal expansion difference of the steam in the cavity and sealed glue (not shown) is big when high temperature curing, produces popcorn phenomenon, damages the product.

The dielectric element 413 is a high dielectric constant material, which has conductive characteristics of blocking conduction of direct current and allowing alternating current to pass through, and can ensure human safety. Preferably, the dielectric element 413 is a dielectric ceramic sheet. The dielectric element 413 is configured in a ring shape, and a through hole 4132 is formed in the middle of the dielectric element for accommodating the temperature sensor 414. An annular metal layer (not shown) is attached to a surface of the dielectric element 413 facing the body portion 4111. The metal layer (not shown) of the dielectric element 413 and the conductive core 41140 of the conductive plate 4114 of the main body 4111 form a point-to-surface welding, so that high welding alignment precision is not required, and the welding is more convenient. A gap (not shown) formed by welding the dielectric element 413 and the main body portion 4111 is filled with a sealant (not shown) to protect a solder (not shown) between the dielectric element 413 and the main body portion 4111, so as to prevent the dielectric element 413 from being affected by an external force to break a welding position, which may result in that an alternating electric field cannot be applied to a tumor region of a patient through the dielectric element 413; while also ensuring that the dielectric element 413 is secured to the body portion 4111 by a sealant (not shown). The inner ring of the metal layer (not shown) of the dielectric element 413 is spaced from the edge of the through hole 4132 of the dielectric element 413, so as to prevent the solder (not shown) between the metal layer (not shown) of the dielectric element 413 and the main body 4111 from diffusing in the direction of the through hole 4132 of the dielectric element 413 when being melted by heat, thereby causing a short circuit of the temperature sensor 414. The outer ring of the metal layer (not shown) of the dielectric element 413 is spaced from the outer edge of the dielectric element 413, so that the solder (not shown) between the metal layer (not shown) of the dielectric element 413 and the main body 4111 can be prevented from overflowing to the outside of the main body 4111 when being melted by heat, and the direct current which is not blocked by the dielectric element 413 can be prevented from passing through and acting on the surface of the tumor part of the patient when the insulated electrode 400 is applied to the surface of the tumor part of the patient.

The outer diameter of the dielectric element 413 is slightly smaller than the diameter of the main body portion 4111, and the sealant (not shown) fills the gap (not shown) along the edge of the main body portion 4111 outside the dielectric element 413 by capillary phenomenon, so as to facilitate filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 413 and the main body portion 4111. When the through hole 4132 of the dielectric element 413 is combined and a sealant (not shown) is filled in a gap (not shown) formed by welding the dielectric element 413 and the main body 4111, air in the gap (not shown) can be discharged from the through hole 4132 of the dielectric element 413, so that a cavity is prevented from being generated in the sealant (not shown) filled in the gap (not shown), and the product quality is improved.

The temperature sensors 414 are disposed in a plurality of through holes 4132 of the corresponding dielectric elements 413. In the present embodiment, the number of the temperature sensors 414 is eight, and the temperature sensors are respectively disposed on the eight electrode units 410 located in the first row third column, the first row fourth column, the last row third column, the last row fourth column, the second row second column, the fifth column of the second row, the third row second column, and the third row fifth column. The eight temperature sensors 414 are respectively disposed at the centers of the main body portions 4111 of the corresponding electrode units 410.

Referring to fig. 17, the main body portions 4111 of the electrode units 410 arranged in four rows and six columns, the connecting portions 4112 connecting two adjacent electrode units, and the wiring portions 4113 bridging between two adjacent connecting portions 4112 together form the flexible circuit board 411 of the electrical functional assembly 41. The flexible circuit board 411 is disposed in a grid shape. The dielectric element 413 is disposed on a grid point of the flexible circuit board 411. It is understood that the main body portion 4111 is a grid point of the flexible circuit board 411. 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 temperature sensor 414 is selectively disposed on the side of the main body portion 4111 of the flexible circuit board 411 facing the skin of the human body. The main body portion 4111 of the flexible circuit board 411 is arranged in accordance with the electrode unit 410.

The flexible circuit board 411 includes an insulating substrate B and a plurality of conductive traces (not shown) embedded in the insulating substrate B. The conductive trace (not shown) embedded in the insulating substrate B of the main body portion 4111, the conductive trace (not shown) embedded in the insulating substrate B of the connecting portion 4112, and the conductive trace (not shown) embedded in the insulating substrate B of the wiring portion 4113 are electrically connected. The insulating substrate B of the connecting portion 4112 is embedded with a conductive trace (not shown), and the remaining connecting portion 4112 only includes the insulating substrate B to enhance the strength of the flexible circuit board 411. The conductive core 41140 is exposed or protruded from the insulating substrate B of the main body 4111. The insulating substrate B of the flexible circuit board 411 can isolate moisture in the air surrounding the insulating electrode 400 from the solder (not shown) between the conductive core 41140 of the conductive pad 4114 of the main body portion 4111 of the flexible circuit board 411 and the dielectric element 413, so as to prevent the moisture in the air away from the skin from eroding the solder (not shown) between the main body portion 4111 and the dielectric element 413 of the flexible circuit board 411. The insulating substrate B of the flexible circuit board 411 and the insulating plate 412 perform a double isolation function, which may prolong the lifespan of the insulated electrode 400. The gold finger 41130 of the terminal 4113 is exposed to the insulating substrate B.

The conductive traces (not shown) of the flexible circuit board 411 include one conductive trace (not shown) connecting all the conductive cores 41140 of the conductive pads 4114 of each main body portion 4111 in series, one conductive trace (not shown) connecting the ground terminals (not shown) of the temperature sensors 414 on the corresponding main body portion 4111 in series, and multiple conductive traces (not shown) electrically connecting the signal terminals (not shown) of the temperature sensors 414 on the corresponding main body portion 4111. The conductive traces (not shown) are electrically connected to the gold fingers 41130 of the terminal portion 4113 in a one-to-one correspondence manner.

The electrical functional component 41 is adhered to a backing 42 centrally by a biocompatible adhesive (not shown), and the backing 42 is provided with threading holes 421 at positions corresponding to the ends of the wire connecting portions 4113. The threading hole 421 allows one end of the wire 44 to pass through and electrically connect with the wiring portion 4113, so as to prevent the wire 44 from being applied between the backing 42 and the skin to affect the close contact between the insulated electrode 400 and the skin, and further prevent air from entering between the electrical functional component 41 and the skin to increase the impedance between the electrical functional component 41 and the skin, which may increase the heat generation of the electrical functional component 41 and cause low-temperature burn.

The supporter 43 has a plurality of through holes 431 provided therethrough, and the through holes 431 correspond to the electrode unit 410. The support member 43 may be of an integral sheet-like construction, which may improve the overall strength of the insulated electrode 400. The through holes 431 are disposed at intervals and are respectively disposed on the support 43 to surround the corresponding electrode units 410. In the present embodiment, the supporting member 43 is formed by a plurality of supporting units 430 having the same structure and independent from each other. The plurality of supporting units 430 are arranged at intervals. Each of the supporting units 430 surrounds the periphery of the corresponding plurality of electrode units 410. Each supporting unit 430 has two through holes 431 formed therethrough for receiving two adjacent electrode units 410 in the same column. The support 43 is composed of 10 support units 430. The thickness of the support member 43 substantially corresponds to the thickness of the electrode unit 410, and the support member 43 and the upper surface of the electrode unit 410 are substantially flush with each other after the support member 43 and the electrical functional assembly 41 are attached to the backing 42. In other embodiments, each support unit 430 may be provided with a single larger through hole 431 surrounding the periphery of the plurality of electrode units 410 in the column.

The adhesive member 45 is applied to the support member 43 and the electrode unit 410 on the side away from the backing 42. The adhesive member 45 has double-sided adhesive property, and can keep the skin surface moist and relieve local pressure by contacting with the skin. The adhesive member 45 is preferably a conductive gel. The shape of the adhesive member 45 is substantially the same as the shape of the support member 43. Since the support member 43 is flush with the upper surface of the electrode unit 410 so that the adhesive member 45 is smoothly overlaid on the support member 43 and the electrode unit 410.

The insulated electrode 400 applies the alternating electric field to the tumor part of the patient through at least 10 electrode units 410 arranged on the insulated electrode to treat the tumor, so that the treatment effect can be prevented from being influenced by insufficient electric field treatment caused by the difference of the size, the position and the position of the tumor, the coverage area of the electrode units 410 of the insulated electrode 400 is increased, the electric field intensity applied to the tumor part for tumor electric field treatment is enhanced, the range of the alternating electric field covering the tumor part is enlarged, and the treatment effect is improved.

Fifth embodiment of insulated electrode 500

Referring to fig. 18 to 20, the insulated electrode 500 includes a backing 52, an electrical function component 51 adhered to the backing 52, a support 53 adhered to the backing 52, an adhesive member (not shown) covering the support 53 and a corresponding portion of the electrical function component 51, and a lead 54 electrically connected to the electrical function component 51.

The insulated electrode 500 in the present embodiment is substantially the same as the insulated electrode 400 in the fourth embodiment, and differs only in the specific arrangement of the electrode units 510 on the electrical functional assembly 51, and only the differences will be described below, and the fourth embodiment may be referred to for other contents.

The electrical functional assembly 51 includes a plurality of electrode units 510 arranged in a rectangular array, a plurality of connecting portions 5112 connecting two adjacent electrode units 510, and a wire connecting portion 5113 electrically connected to the conductive wire 54. Each of the electrode units 510 is connected to at least two adjacent electrode units 510 thereof by a connection portion 5112. Each of the electrode units 510 is connected to at least two connection portions 5112. The plurality of electrode units 510 are distributed at intervals on grid points of the electrical functional assembly 51. The plurality of electrode units 510 are distributed in an area surrounded by an array with at least three rows and four columns, and at least 12 and at most 30 electrode units can increase the coverage area of the electrode units 510 of the insulated electrode 500, enhance the electric field intensity applied to a tumor part for tumor electric field treatment, increase the range of the alternating electric field covering the tumor part, and improve the treatment effect. The plurality of electrode units 510 are distributed in an array area with three rows and four columns, and the number of the electrode units is 12; or distributed in array areas of three rows and five columns, the number of the array areas is at least 12 and at most 15; or distributed in array areas of four rows and four columns, and the number of the array areas is at least 12 and at most 16; or distributed in array areas of four rows and five columns, and the number of the array areas is at least 12 and at most 20; or distributed in array areas of four rows and six columns, and the number of the array areas is at least 12 and at most 24; or distributed in an array area with five rows and five columns, and the number of the array areas is at least 12 and at most 25; or distributed in an array area with five rows and six columns, and the number of the array areas is at least 12 and at most 30.

The electrode units 510 of each row are equal in number and arranged in column-wise alignment. The electrode units 510 of each column are equal in number and are arranged in line alignment. The intervals between the two adjacent electrode units 510 arranged in a row are equal, and the intervals between the two adjacent electrode units 510 arranged in a column are also equal. The two adjacent electrode units 510 in the same row are arranged in an adjacent row, and the two adjacent electrode units 510 in the same row are arranged in an adjacent row. The connecting portion 5112 is located between two adjacent electrode units 510 in the same row or the same column. The plurality of connection parts 5112 connecting between two adjacent electrode units 510 arranged in a row have the same length. The connection portions 5112 between two adjacent electrode units 510 connected in a column arrangement have the same length. The spacing between two adjacent electrode units 510 arranged in a row is different from the spacing between two adjacent electrode units 510 arranged in a column. That is, the length of the connection part 5112 between two adjacent electrode units 510 arranged in a row is different from the length of the connection part 5112 between two adjacent electrode units 510 arranged in a column. Alternatively, the spacing between two adjacent electrode units 510 arranged in a row is the same as the spacing between two adjacent electrode units 510 arranged in a column. That is, the length of the connection part 5112 between two adjacent electrode units 510 arranged in a row is the same as the length of the connection part 5112 between two adjacent electrode units 510 arranged in a column.

At least one adjacent two electrode units 510 of the plurality of electrode units 510 are arranged in a disconnected shape. An interval 5C through which the wire connection part 5113 passes is formed between the two adjacent electrode units 510 arranged in the disconnected state. The wire connecting portion 5113 may be disposed in a line shape and laterally extended from a connecting portion 5112 opposite to the space 5C, or may be disposed in a T shape and erected between two connecting portions 5112 respectively connected to the two electrode units 510 disposed in a disconnected shape. The electrode units 510 arranged in a disconnected state are located at an inner layer of the array region where the electrode units 510 are located. The electrode units 510 of the electrical functional assembly 51 located at the periphery are connected two by the connecting portions 5112. That is, all the adjacent two electrode units 510 located at the periphery of the electrical functional assembly 51 are connected two by the connecting portion 5112. At least one of the electrode units 510 is disposed in a disconnected manner between two adjacent electrode units 510 disposed in adjacent rows and adjacent columns and in a diagonal manner. The wire connecting portion 5113 is located between the plurality of electrode units 510, and it is possible to avoid an increase in manufacturing cost due to an excessive size of the entire electrical functional assembly 51.

The plurality of electrode units 510 may be divided into a plurality of peripheral electrode units 510A located at the periphery and a plurality of central electrode units 510B surrounded by the peripheral electrode units 510A, as viewed from the distribution positions of the electrode units 510 in the array. The number of the peripheral electrode units 510A is at least 10, and the number of the central electrode units 510B is at least 2. All the peripheral electrode units 510A are connected two by the connection portions 5112. That is, the connection portion 5112 is provided between all adjacent two peripheral electrode units 510A. At least one of the plurality of central electrode units 510B is disposed in a disconnected state between one peripheral electrode unit 510A or the central electrode unit 510B adjacent to the central electrode unit in the same row or in the same column, and a gap 5C is formed therebetween for the wire connection portion 5113 to pass through.

The wire connecting portion 5113 may be formed by a connecting portion 5112 opposite to the space 5C and extending laterally in the direction of the space 5C, and may have a substantially line-shaped configuration. The connecting portion 5112 of the laterally extending wire connecting portion 5113 is perpendicular to the wire connecting portion 5113, and both are disposed in a substantially "T" shape. The connecting portion 5112 of the laterally extending wire connecting portion 5113 is located between two adjacent peripheral electrode units 510A, between one peripheral electrode unit 510A and one central electrode unit 510B adjacent thereto, or between two adjacent central electrode units 510B. That is, the connection portion 5112 of the laterally extending wire connection portion 5113 connects two adjacent peripheral electrode units 510A, or connects two adjacent central electrode units 510B, or connects one peripheral electrode unit 510A and the central electrode unit 510B adjacent thereto. The wire connecting portion 5113 may be disposed in a T-shape and bridged between two connecting portions 5112 connected to two central electrode units 510B disposed in a disconnected shape, or bridged between two connecting portions 5112 connected to a central electrode unit 510B disposed in a disconnected shape and a peripheral electrode unit 510A adjacent to the central electrode unit 510B.

In other embodiments, at least two adjacent peripheral electrode units 510A of the plurality of peripheral electrode units 510A are disposed in a disconnected manner, and at least one of the disconnected peripheral electrode units 510A is connected to the central electrode unit 510B, which is located in an adjacent row and an adjacent column and arranged diagonally, through the connection portion 5112. That is, two peripheral electrode units 510 that are partially adjacent are connected by a connection portion 5112; two adjacent peripheral electrode units 510A are partially arranged in a disconnected state, and a connecting part 5112 is not arranged between the two peripheral electrode units; the connection portion 5112 is disposed between a peripheral electrode unit 510A and a central electrode unit 510B located in adjacent rows and columns and arranged diagonally, between two adjacent peripheral electrode units 510A, between two adjacent central electrode units 510B, between a peripheral electrode unit 510A and a central electrode unit 510B located in adjacent rows and columns.

In the present embodiment, the plurality of electrode units 510 of the electrical functional assembly 51 are arranged in four rows and five columns. The number of electrode units 510 of the electrical functional assembly 51 is 20. The number of electrode units 510 per row is the same and the number of electrode units 510 per column is the same. The number of each row electrode unit 510 is 5. The number of each column electrode unit 510 is 4. The electrode units 510 in the second row and the third column and the electrode units 510 in the second row and the fourth column are arranged in a disconnected manner, and a gap 5C is formed between the two electrode units. The electrode units 510 in the third row and the third column are arranged in a disconnected manner with the electrode units 510 in the third row and the fourth column, and a gap 5C is formed between the two. The wire connecting portion 5113 is arranged in a T-shape and is bridged between the connecting portion 5112 positioned in the middle of the third row and the connecting portion 5112 positioned in the middle of the fourth row. The connection portion 5112 in the middle of the third column is disposed between the two electrode units 510 located in the second row of the third column and the fourth row of the third column. The connection portion 5112 in the middle of the fourth column is disposed between the two electrode units 510 located in the second row of the fourth column and the third row of the fourth column. The connecting portion 5112 is located between two adjacent electrode units 510 located in the same row or column except for the two electrode units 510 located in the second row, the third column and the fourth column and the two electrode units 510 located in the third row, the third column and the fourth column.

Sixth embodiment of insulated electrode 600

Fig. 21 to 26 show an insulated electrode 600 of a sixth embodiment. The insulated electrodes 600 of this embodiment can be used in combination, and a plurality of insulated electrodes 600 are connected to a hub (not shown) to perform electric field treatment of tumor at the tumor site. The insulated electrode 600 includes a backing 62, an electrical functional component 61 adhered to the backing 62, a support member 63 adhered to the backing 62, an adhesive member 64 covering the support member 63 and a corresponding portion of the electrical functional component 61 and attached to the body surface skin of the patient corresponding to the tumor site, and a lead 65 electrically connected to the electrical functional component 61. The insulated electrode 600 is attached to the body surface of the patient corresponding to the tumor part through the backing 62, and applies an alternating electric field to the tumor part of the patient through the electric functional component 61 to interfere or prevent the mitosis of the cancer cells of the patient, thereby realizing the purpose of treating the tumor.

The electrical functional assembly 61 includes a single electrode unit 610 having a square plate shape, and a wire connecting portion 6112 connected to the electrode unit 610. The wiring portion 6112 is welded to the conductive wire 65, so as to electrically connect the electrical functional component 61 and the conductive wire 65. A plurality of gold fingers 61120 are arranged on the surface of one side of the wiring portion 6112. In this embodiment, there are four gold fingers 61120, and the four gold fingers 61120 are disposed on the surface of the connection portion 6112 facing the skin. The periphery of the welding position between the lead 65 and the gold finger 61120 of the wire connection portion 6112 is covered with a heat-shrinkable sleeve 651. The heat-shrinkable sleeve 651 is used for insulating and protecting the joint of the wire 65 and the wiring portion 6112 of the electrical functional assembly 61, and provides support, so that the joint of the wire 65 and the wiring portion 6112 of the electrical functional assembly 61 is prevented from being broken, and meanwhile, the heat-shrinkable sleeve is dustproof and waterproof. The end of the lead 65 away from the wiring portion 6112 is provided with a plug 652 electrically connected to an electric field generator (not shown) or a hub (not shown). One end of the wire 65 is electrically connected to the gold finger 61120 of the wiring portion 6112; the other end is electrically connected with an electric field generator (not shown) or a concentrator (not shown) through a plug 652, so as to provide an alternating current signal for tumor therapy to the insulated electrode 600 during tumor electric field therapy.

The electrode unit 610 includes a main body 6111, an insulating plate 612 disposed on a side of the main body 6111 away from the skin of the human body, a dielectric element 613 disposed on a side of the main body 6111 facing the skin of the human body, and two temperature sensors 614 disposed on the main body 6111 and located on the same side as the dielectric element 613. The main body 6111, the insulating plate 612 and the dielectric element 613 have substantially the same shape, and are all square sheet-shaped. The main body 6111, the insulating plate 612, and the dielectric element 613 are disposed correspondingly in the thickness direction of the main body 6111, and the centers of the three are located on the same line. In this embodiment, the main body 6111, the insulating plate 612 and the dielectric element 613 are all square plate-shaped structures with arc-shaped corners. Preferably, the body portion 6111 is in a square sheet-like configuration with dimensions of about 32mm × 32 mm. The wiring portion 6112 of the electrical functional component 61 is extended laterally from the main body portion 6111 of the electrode unit 610.

The main body 6111 includes 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 613, a second conductive trace L2 disposed on the insulating substrate B near the insulating plate 612, and two third conductive traces L3 and L3' located on the same side of the second conductive trace L2. A conductive pad 6113, which exposes the insulating substrate B and is electrically connected to the first conductive trace L1, is centrally disposed on the main body portion 6111. The conductive plate 6113 may be welded to the dielectric element 613 to mount the dielectric element 613 on the main body 6111. The conductive plate 6113 can be completely covered by the dielectric element 613, so that the conductive plate 6113 and the dielectric element 613 can be welded by soldering tin (not shown). The center of the conductive plate 6113 is located on the central line of the main body 6111. The conductive plate 6113 includes a plurality of conductive cores 61130 arranged in a central symmetry manner, so that the position deviation of the dielectric element 613 caused by stacking of soldering tin (not shown) in the welding process can be effectively prevented. The top surfaces of the conductive cores 61130 are located on the same plane, so that cold joint with the dielectric element 613 can be avoided. The plurality of conductive cores 61130 are each connected to a first conductive trace L1. The plurality of conductive cores 61130 are connected together in series by a first conductive trace L1.

In this embodiment, the conductive plate 6113 of the main body 6111 has a substantially square configuration, and the symmetry axis thereof coincides with the symmetry axis of the main body cloth 111. The conductive plate 6113 includes 4 conductive cores 61130 at four corners and arranged at intervals. The conductive core 61130 adopts a multi-point interval arrangement mode, so that the use amount of copper foil for manufacturing the conductive core 61130 can be reduced; meanwhile, the amount of solder (not shown) used for welding the conductive core 61130 and the dielectric element 613 can be saved, thereby reducing the manufacturing cost. Each conductive core 61130 is of rectangular configuration with dimensions of about 9mm by 6 mm. Preferably, each conductive core 61130 has a rectangular configuration with rounded corners. The longitudinal axis of each conductive core 61130 is parallel to the extending direction of the wire connecting portion 6112. In other embodiments, each conductive core 61130 of the conductive plate 6113 may also be round, square, etc.

In this embodiment, the 4 conductive cores 61130 forming the conductive plate 6113 are arranged in a matrix, and the 4 conductive cores 61130 are arranged in two rows and two columns. The gap between two columns of conductive cores 61130 is about 8.5mm, and the gap between two rows of conductive cores 61130 is about 4mm. The 4 conductive cores 61130 forming the conductive plate 6113 are arranged in a central symmetry manner and an axial symmetry manner, and each conductive core 61130 is also arranged in an axial symmetry manner, so that when the 4 conductive cores 61130 of the main body part 6111 are welded with the dielectric element 613, the stress of each welding point is balanced, the integral welding balance of the dielectric element 613 is ensured, the welding quality is improved, and the problem that the welding part on the side with a larger interval between the dielectric element 613 and the main body part 6111 is easy to break due to weak strength of the welding part on the side with the larger interval between the dielectric element 613 and the main body part 6111 caused by the inclination of the dielectric element 613 due to unbalanced welding stress is avoided; meanwhile, the degree of adhesion of the insulated electrode 600 can be prevented from being affected. The 4 conductive cores 61130 of the conductive plate 6113 are arranged in a pairwise interval manner, and an interval 6C is formed between two adjacent conductive cores 61130. The 4 spaces 6C are arranged in a substantially cross-shaped communication. The adjacent spaces 6C are arranged in a communicating manner. The extending direction of 2 of the 4 intervals 6C between two conductive cores 61130 in the same row is the same as the extending direction of the wiring portion 6112.

The main body 6111 is further provided with two pairs of pads 6114 exposing the insulating substrate B, and the two pairs of pads 6114 can be respectively welded with corresponding portions of the corresponding temperature sensors 614 to realize electrical connection between the temperature sensors 614 and the main body 6111. Each pair of pads 6114 is located between two corresponding conductive cores 61130 arranged in the same row at intervals. The two pairs of bonding pads 6114 are located in the extending direction of the wiring portion 6112, each pair of bonding pads 6114 has a symmetry center, and a connecting line of the two symmetry centers of the two pairs of bonding pads 6114 is parallel to the extending direction of the wiring portion 6112. Each pair of pads 6114 includes a first pad 6114A and a second pad 6114B. The first bonding pad 6114A of each pair of bonding pads 6114 is electrically connected to the second conductive trace L2, one of the two second bonding pads 6114B is electrically connected to the third conductive trace L3, and the other is electrically connected to the third conductive trace L3'. Each temperature sensor 614 has a signal terminal (not shown) and a ground terminal (not shown). The first bonding pad 6114A is bonded to a ground terminal (not shown) of the temperature sensor 614, and the second bonding pad 6114B is bonded to a signal terminal (not shown) of the corresponding temperature sensor 614.

The insulating plate 612 is made of an insulating material. Preferably, the insulating plate 612 is an epoxy glass cloth laminated plate. The insulating plate 612 is adhered to the surface of the main body portion 6111 away from the skin of the human body by a sealant (not shown), so that the strength of the main body portion 6111 can be enhanced, a flat welding plane can be provided for the welding operation between the main body portion 6111 and the dielectric element 613, and the product yield can be improved. Meanwhile, the insulating plate 612 can also isolate the moisture in the air on the side of the insulating electrode 600 away from the skin from contacting the solder (not shown) between the main body 6111 and the dielectric element 613, so as to prevent the moisture from eroding the solder (not shown) between the main body 6111 and the dielectric element 613 and affecting the electrical connection between the main body 6111 and the dielectric element 613.

The size of the insulating plate 612 is the same as that of the main body portion 6111, so that when the insulating plate 612 is attached to one side, away from the skin of the human body, of the main body portion 6111 through a sealant (not shown), the sealant (not shown) climbs to one side, facing the skin of the human body, of the main body portion 6111 through a capillary effect, and filling of the sealant (not shown) in a gap (not shown) formed by welding the dielectric element 613 and the main body portion 6111 is affected, so that a cavity exists in the sealant (not shown), and further, the phenomenon that when the sealant (not shown) is cured at a high temperature, because the difference between water vapor in the cavity and the thermal expansion coefficient of the sealant (not shown) is large, the water vapor rapidly expands to cause bursting, so that popcorn phenomenon is generated, and the product is damaged is avoided.

The dielectric element 613 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 613 is a dielectric ceramic sheet. The dielectric element 613 is penetrated by two through holes 631, the number of which is equal to that of the temperature sensors 614, and the two through holes are respectively used for accommodating the corresponding temperature sensors 614. A metal layer (not shown) is attached to a surface of the dielectric element 613 facing the body portion 6111. The metal layer (not shown) of the dielectric element 613 and the conductive core 61130 of the conductive plate 6113 of the main body 6111 are welded point to face, so that high welding alignment precision is not required, and the welding is more convenient. The inner edge of the metal layer (not shown) of the dielectric element 613 is spaced from the edge of the through hole 631 of the dielectric element 613, so that the solder (not shown) between the metal layer (not shown) of the dielectric element 613 and the main body 6111 is prevented from diffusing in the direction of the through hole 631 of the dielectric element 613 and causing a short circuit of the temperature sensor 614 when being melted by heat. The outer edge of the metal layer (not shown) of the dielectric element 613 is spaced from the outer edge of the dielectric element 613, so that the solder (not shown) between the metal layer (not shown) of the dielectric element 613 and the main body 6111 is prevented from overflowing to the outside of the main body 6111 when being melted by heat, and thus, when the insulated electrode 600 is applied to the surface of the tumor region of the patient, the direct current which is not blocked by the dielectric element 613 is applied to the surface of the tumor region of the patient.

Each temperature sensor 614 is soldered to the first pad 6114A disposed on the main body portion 6111 through a ground terminal (not shown) thereof, and is soldered to the second pad 6114B disposed on the main body portion 6111 through a signal terminal (not shown) thereof, so as to achieve electrical connection between the temperature sensor 614 and the main body portion 6111. Since the two first pads 6114A of the main body portion 6111 are electrically connected to the second conductive trace L2, one of the two second pads 6114B is electrically connected to the third conductive trace L3, and the other of the two second pads 6114B is electrically connected to the third conductive trace L3', the two first pads 6114A are respectively soldered to the corresponding ground terminals (not shown) of the two temperature sensors 614, and the two second pads 6114B are respectively soldered to the corresponding signal terminals (not shown) of the two temperature sensors 614, therefore, the ground terminals (not shown) of the two temperature sensors 614 are both electrically connected to the second conductive trace L2 of the main body portion 6111, and the signal terminals (not shown) of the two temperature sensors 614 are respectively electrically connected to the third conductive traces L3, L3' of the main body portion 6111. That is, the two temperature sensors 614 transmit their monitored temperature signals through the second and third conductive traces L2 and L3, L3'. The two temperature sensors 614 are respectively received in the corresponding through holes 631 of the dielectric element 613 after being welded to the main body portion 6111. Preferably, the temperature sensor 614 is a thermistor. The temperature sensor 614 is used for monitoring the temperature of the adhesive member 64 covering the side of the dielectric element 613 of the electrical functional assembly 61 facing the skin of the human body, and further for detecting the temperature of the skin of the human body to which the adhesive member 64 is attached. When the temperature monitored by the temperature sensor 614 exceeds the upper limit of the human body safe temperature, the tumor electric field treatment system (not shown) can timely reduce or turn off the alternating voltage applied to the insulated electrode 600 to avoid low-temperature scald of the human body. The two temperature sensors 614 are symmetrically arranged on the main body 6111, so that the temperature of the skin of the human body corresponding to different positions can be detected, and the reliability of the detected data is ensured. The two temperature sensors 614 are welded to the main body portion 6111 through the two pairs of welding pads 6114 of the main body portion 6111 and then sealed by a sealant (not shown), so that the temperature sensors 614 are prevented from being damaged due to moisture erosion.

The wiring portion 6112 has the same structure as the main body portion 6111, 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 wire connection portion 6112 are also electrically connected to the corresponding conductive traces L of the main body portion 6111. The 4 gold fingers 61120 of the wiring portion 6112 are exposed from one side of the insulating substrate B close to the dielectric element 613. The four conductive traces L of the wiring portion 6112 are electrically connected to the gold finger 61120 respectively. The four conductive traces L of the wire connection portion 6112 are also the first conductive trace L1, the second conductive trace L2, and the third conductive traces L3, L3', respectively. The first conductive trace L1 of the wire connection portion 6112 is extended from the first conductive trace L1 of the main body portion 6111. The second conductive trace L2 of the wire connection portion 6112 is extended from the second conductive trace L2 of the main body portion 6111. 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 6111.

The wire connection portion 6112 is connected to the first conductive trace L1 of the main body portion 6111 through the first conductive trace L1, and the first conductive trace L1 of the main body portion 6111 is connected to the conductive pad 6113 on the main body portion 6111 to achieve electrical connection with the conductive pad 6113 of the main body portion 6111, and further, the conductive pad 6113 of the main body portion 6111 is welded to the dielectric element 613 to achieve electrical connection with the dielectric element 613. The wire connecting portion 6112 is electrically connected to the first pad 6114A of the main body portion 6111 through connection between the second conductive trace L2 of the wire connecting portion and the second conductive trace L2 of the main body portion 6111 and the first pad 6114A of the main body portion 6111, and further electrically connected to a ground terminal (not shown) of the temperature sensor 614 through welding between the first pad 6114A and the ground terminal (not shown) of the temperature sensor 614. The wire connecting portion 6112 is correspondingly connected to the third conductive traces L3 and L3' of the main body portion 6111 through the third conductive traces L3 and L3', the third conductive traces L3 and L3' of the main body portion 6111 are respectively connected to the two second pads 6114B to electrically connect to the two second pads 6114B of the main body portion 6111, and the two second pads 6114B are welded to the signal terminals (not shown) of the two temperature sensors 614 in a one-to-one correspondence manner to electrically connect to the signal terminals (not shown) of the two temperature sensors 614, so that the temperature signals monitored by the temperature sensors 614 are transmitted to the electric field generator (not shown) in parallel, and the electric field generator (not shown) can timely and efficiently adjust the alternating voltage or alternating current applied to the dielectric element 613 to achieve the purpose of avoiding low-temperature scald caused by excessive temperature.

The main body portion 6111 and the wire connection portion 6112 together constitute the flexible circuit board 611 of the electrical functional assembly 61. The insulating substrates B of the main body portion 6111 and the wire connection portion 6112 together constitute an insulating substrate B of the flexible circuit board 611. The conductive traces L of the main body portion 6111 and the conductive traces L of the wire connection portion 6112 form conductive traces L of the flexible circuit board 611 in a one-to-one correspondence. The insulating substrate B of the flexible circuit board 611 can isolate moisture in the air around the insulated electrode 600 from the solder (not shown) between the conductive pad 6113 and the dielectric element 613, so as to prevent the moisture in the air away from the skin from eroding the solder (not shown) between the conductive pad 6113 on the main body portion 6111 of the flexible circuit board 611 and the dielectric element 613. The insulating substrate B of the flexible circuit board 611 and the insulating plate 612 perform a dual-isolation function, which may extend the lifespan of the insulated electrode 600.

From the perspective of the electrode unit 610, the insulating plate 612 is disposed on the side of the main body portion 6111 of the flexible circuit board 611 facing away from the skin of the human body, the dielectric element 613 is disposed on the side of the main body portion 6111 of the flexible circuit board 611 facing the skin of the human body, and the two temperature sensors 614 are disposed on the side of the main body portion 6111 of the flexible circuit board 611 facing the skin of the human body. The insulating plate 612 and the dielectric element 613 are respectively disposed on two opposite sides of the main body portion 6111 of the flexible circuit board 611. The first conductive trace L1 of the flexible circuit board 611 connects the 4 spaced conductive cores 61130 of the conductive pads 6113 in series, the second conductive trace L2 is electrically connected to the ground terminals (not shown) of the two temperature sensors 614 through the two first pads 6114A, and the third conductive traces L3 and L3' are electrically connected to the signal terminals (not shown) of the two temperature sensors 614 through the two second pads 6114B, respectively. The first conductive trace L1 is located in a layer of the insulating substrate B adjacent to the skin of the human body. The second conductive trace L2 and the third conductive traces L3, L3' are each located within the insulating substrate B one layer adjacent to the insulating plate 612. In order to facilitate the layout of the conductive trace L, the width of the wiring portion 6112 is 7 to 9mm. Preferably, the width of the wiring portion 6112 is 8mm.

The gold finger 61120 of the wire connection portion 6112, the 4 conductive cores 61130 of the conductive pads 6113 and the bonding pad 6114 are exposed out of one side surface of the insulating substrate B of the flexible circuit board 611 close to the dielectric element 613. The gold finger 61120, the 4 conductive cores 61130 of the conductive plate 6113 and the soldering pad 6114 are all located on one side of the flexible circuit board 611 close to the body surface of the patient. One end of a gold finger 61120 of the wiring portion 6112 is electrically connected to the dielectric element 613 through the first conductive trace L1 connected thereto, and the other end is welded to a corresponding portion of the wire 65, so as to transmit an alternating voltage signal generated by an electric field generator (not shown) to the dielectric element 613. One end of one gold finger 61120 of the other three gold fingers 61120 of the wire connecting portion 6112 is electrically connected to a ground terminal (not shown) of the temperature sensor 614 through the second conductive trace L2 connected thereto, and one ends of the other two gold fingers 61120 are electrically connected to signal terminals (not shown) of the two temperature sensors 614 through the third conductive traces L3 and L3' connected thereto, respectively. The other ends of the three gold fingers 61120 of the wire connecting portion 6112 are respectively welded with corresponding portions of the wires 65, so that the relevant signals detected by the temperature sensor 614 are transmitted to the electric field generator (not shown) through the second conductive traces L2, the third conductive traces L3, L3' and the wires 65 in parallel.

The backing 62 is in the form of a sheet-like arrangement made primarily of a flexible, gas permeable, insulating material. The backing 62 is a mesh fabric. Specifically, the backing 62 is a mesh-like nonwoven fabric, has the characteristics of softness, lightness, thinness, moisture resistance and air permeability, and can keep the skin surface of the patient dry after being applied to the body surface of the patient for a long time. The backing 62 is also coated with a biocompatible adhesive (not shown) on the side facing the patient's body surface for adhering the backing 62 to the body surface of the patient corresponding to the tumor site. In this embodiment, the backing 62 is generally provided in the form of an octagonal sheet.

The support 63 is adhered to the backing 62 and surrounds the outside of the electrode unit 610. A through hole 631 is disposed through the support 63 for receiving the electrode unit 610. The support 63 may be made of a foam material. The support 63 is flush with the surface of the electrode unit 610 on the side remote from the backing 62. That is, the support member 63 is flush with a surface of the electrode unit 610 on a side facing the adhesive member 64 to support the adhesive member 64.

The adhesive member 64 has a double-sided adhesive. One surface of the adhesive member 64 is adhered to the support member 63 and the surface of the electrode unit 610 on the side away from the backing 62. The other side of the adhesive member 64 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. Preferably, the adhesive member 64 is a conductive hydrogel to act as a conductive medium. The adhesive member 64 has better adhesion to the skin of the human body under the supporting action of the supporting member 63.

Alternative implementation of the sixth embodiment of insulated electrode 600

Fig. 27 shows an alternative insulated electrode 600' of the sixth example, differing from the insulated electrode 600 of the sixth example only in that the backing 62' is recessed at four corners with recessed corners 621'. The backing 62 is generally in a cross-shaped configuration. The concave angle 621' communicates with the outside and is disposed in an "L" shape. When the insulated electrode 600 'is applied on the body surface corresponding to the tumor region of the patient, the concave angle 621' can prevent the backing 62 from arching at the corner to cause wrinkles, and further prevent air from entering the space between the electrode unit 610 and the skin from the wrinkles to increase the impedance between the electrical functional component 61 and the skin, so that the heat generation of the electrical functional component 61 is increased to cause low-temperature scald.

The utility model discloses an alternating voltage is applyed to patient's tumour position owing to adopt solitary electrode unit 610 to insulating electrode 600, 600', and at its unable normal during operation, only need to change insulating electrode 600, 600 'that have solitary electrode unit 610 can, need not to scrap the processing to the whole piece insulating electrode that contains a plurality of electrode unit 610, can reduce patient tumour treatment's cost. Furthermore, the utility model discloses an insulated electrode 600, 600' can carry out the independent assortment according to patient's tumour position size, ensures insulated electrode 600, 600' and carries out the coverage area that tumour electric field treated, ensures the electric field treatment effect. Meanwhile, the flexible circuit board 611 of the insulated electrodes 600 and 600 'of the present invention is only provided with one path of the first conducting trace L1 electrically connected to the dielectric element 613, one path of the second conducting trace L2 electrically connected to the ground terminals (not shown) of the two temperature sensors 614 together, and two paths of the third conducting traces L3 and L3' electrically connected to the signal terminals (not shown) of the two temperature sensors 614 respectively, so as to transmit the alternating voltage signal of the electric field generator (not shown) to the dielectric element 613 through the first conducting trace L1, thereby achieving the purpose of applying the alternating voltage to the tumor site of the patient for tumor treatment; meanwhile, the second conductive trace line L2 and the third conductive trace lines L3 and L3' are respectively electrically connected with the two temperature sensors 614 to realize signal transmission between the electric field generator (not shown) and the two temperature sensors 614, 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.

Seventh embodiment of insulated electrode 700

Fig. 28 to 32 show an embodiment of an insulated electrode 700, in which the insulated electrode 700 includes an electrical connector 72 electrically connected to an electric field generator (not shown) or an adaptor (not shown), and a plurality of electrode pads 71 detachably assembled to the electrical connector 72. The plurality of electrode plates 71 of the insulated electrode 700 are detachably assembled on the electric connector 72, and the plurality of electrode plates 71 are connected to the electric connector 72 in parallel, so that the damaged electrode plates 71 can be easily replaced when one electrode plate 71 is damaged and cannot work, and the plurality of electrode plates 71 are not required to be scrapped, so that the manufacturing cost can be reduced, the waste can be avoided, and the electric field intensity is enough when tumor electric field treatment is carried out; meanwhile, the electrode plates 71 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 among the electrode plates 71 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 part of the tumor part of the patient, which is applied with the electrode plates 71, is quickly gathered and cannot be timely dissipated to cause the sweating of the body surface of the patient, which is applied with the electrode plates 71, and the skin inflammation caused by pore blockage due to long-time electric field treatment is avoided.

Please refer to fig. 30 to 32, in which a plurality of electrode plates 71 are detachably inserted into corresponding portions of the electrical connector 72 to achieve parallel connection between the electrode plates 71 and the electrical connector 72, and electrical connection between the electrode plates 71 and an electric field generator (not shown) can be achieved through the electrical connector 72, so that when a certain electrode plate 71 is damaged, the electrode plate can be replaced timely and conveniently to ensure sufficient electric field intensity applied to the tumor portion, thereby improving the therapeutic effect. Each electrode sheet 71 includes a single electrode unit 710 for applying an alternating electric field to a tumor site of a patient, a wire connecting portion 711 electrically connected to the electrode unit 710, a first lead 712 welded to the wire connecting portion 711, a backing 713 adhered to the electrode unit 710, a support 714 adhered to the backing 713 in a shape surrounding the electrode unit 710, and an adhesive 715 for covering corresponding sites of the electrode unit 710 and the support 714. One end of the first wire 712 is welded to the wiring portion 711, and the other end is detachably connected to the electrical connector 72 via a first plug 7121 disposed at the end thereof, so as to electrically connect the electrode unit 710 and the electrical connector 72, and further transmit an alternating electrical signal generated by an electric field generator (not shown) to the electrode unit 710 via the electrical connector 72 for tumor electric field therapy. Optionally, the electrode tab 71 may be directly plugged into the electric field generator (not shown) through the first plug 7121 of the first wire 712 or plugged into an adaptor (not shown) and then electrically connected to the electric field generator (not shown) through the adaptor (not shown) to electrically connect the electrode tab 71 to the electric field generator (not shown).

The electrode unit 710 of the electrode tab 71 includes a main body portion 7101 disposed at an end of the wire connecting portion 711 and electrically connected to the wire connecting portion 711, insulating plates 7102 and dielectric elements 7103 disposed at opposite sides of the main body portion 7101, and a temperature sensor 7104 disposed on the main body portion 7101 and located at the same side as the dielectric elements 7103. The electrode unit 710 has an overall circular sheet-like configuration. The main body portion 7101, the insulating plate 7102 and the dielectric element 7103 are all circular sheet-shaped structures, and the three are approximately same in size and are arranged in a one-to-one correspondence along the thickness direction. The centers of the main body portion 7101, the insulating plate 7102, and the dielectric element 7103 are aligned.

The main body 7101 has a conductive pad 7105 on a side facing the skin of the human body, and the conductive pad 7105 is welded to the dielectric element 7103 to assemble the dielectric element 7103 to the main body 7101. The conductive pads 7105 can be completely covered by the dielectric elements 7103 such that the conductive pads 7105 are soldered to the dielectric elements 7103 by solder (not shown). The conductive pad 7105 is centered on the centerline of the body portion 7101. The conductive disc 7105 comprises a plurality of conductive cores 71051 which are arranged in a central symmetry manner, and the position deviation of the dielectric element 7103 caused by stacking of soldering tin (not shown) in the welding process can be effectively prevented. The top surfaces of the conductive cores 71051 are positioned on the same plane, so that cold joint with the dielectric element 7103 can be avoided during welding. A pair of welding pads 7106 are arranged between the plurality of conductive cores 71051, and the temperature sensor 7104 and the main body part 7101 can be electrically connected by welding at the corresponding part of the temperature sensor 7104. The two pads 7106 include a first pad 7106A and a second pad 7106B. The temperature sensor 7104 has a signal terminal (not shown) and a ground terminal (not shown). The first pad 7106A is soldered to a ground terminal (not shown) of the temperature sensor 7104, and the second pad 7106B is soldered to a signal terminal (not shown) of the temperature sensor 7104.

The insulating plate 7102 is made of an insulating material. Preferably, the insulating plate 7102 is an epoxy glass cloth laminated plate. The insulating plate 7102 is adhered to the surface of the main body portion 7101 away from the skin of a human body through a sealant (not shown), so that on one hand, the strength of the main body portion 7101 can be enhanced, and a flat welding plane is provided for the welding operation between the main body portion 7101 and the dielectric element 7103; on the other hand, the moisture in the air on the side of the electrode sheet 71 away from the skin can be isolated from the solder (not shown) between the main body portion 7101 and the dielectric element 7103, so that the moisture can be prevented from eroding the solder (not shown) between the main body portion 7101 and the dielectric element 7103 and affecting the electrical connection between the main body portion 7101 and the dielectric element 7103. The size of the insulating plate 7102 is substantially the same as that of the main body part 7101, so that when the insulating plate 7102 is adhered to the side, away from the skin of a human body, of the main body part 7101 through a sealant (not shown), the sealant (not shown) climbs to the side, facing the skin of the human body, of the main body part 7101 through a capillary effect, and the filling of the sealant (not shown) in a gap (not shown) formed by welding the dielectric element 7103 and the main body part 7101 is influenced, so that a cavity exists in the sealant (not shown), and further, the phenomenon that when the sealant (not shown) is cured at a high temperature, because the difference between water vapor in the cavity and the thermal expansion coefficient of the sealant (not shown) is large, the water vapor rapidly expands to cause bursting, popcorn phenomenon is generated, and the product is damaged is avoided.

The dielectric element 7103 is made of a high dielectric constant material, has the conductive characteristics of blocking the conduction of direct current and allowing the passage of alternating current, and can ensure the safety of a user during tumor electric field treatment. Preferably, the dielectric element 7103 is a dielectric ceramic sheet. A through hole 71031 corresponding to the pair of pads 7106 of the main body portion 7101 is formed through the dielectric element 7103 to receive the temperature sensor 7104. A metal layer (not shown) is attached to a surface of the dielectric element 7103 facing the main body portion 7101. The metal layer (not shown) of the dielectric element 7103 and the conductive core 71051 of the conductive plate 7105 of the main body part 7101 are welded point to face, so that higher welding alignment precision is not required, and the welding is more convenient. The inner edge of the metal layer (not shown) of the dielectric element 7103 is spaced apart from the edge of the through hole 71031 of the dielectric element 7103, so that the solder (not shown) between the metal layer (not shown) of the dielectric element 7103 and the main body 7101 can be prevented from diffusing in the direction of the through hole 71031 of the dielectric element 7103 when melted by heat, thereby preventing the temperature sensor 7104 from being short-circuited. The outer edges of the metal layers (not shown) of the dielectric elements 7103 are spaced from the outer edges of the dielectric elements 7103, so that when solder (not shown) provided between the metal layers (not shown) of the dielectric elements 7103 and the main body portion 7101 is melted by heat, the solder may not overflow to the outside of the main body portion 7101, and thus, when the electrode sheet 71 is attached to the surface of the tumor region of the patient, direct current not blocked by the dielectric elements 7103 may pass through and act on the surface of the patient.

A gap (not shown) formed by welding the dielectric element 7103 and the main body portion 7101 is filled with a sealant (not shown) to protect a soldering tin (not shown) between the dielectric element 7103 and the main body portion 7101, so as to prevent the welding position from being broken due to the influence of an external force on the dielectric element 7103, and further prevent an alternating electric field from being applied to a tumor part of a patient through the dielectric element 7103; meanwhile, the water vapor in the air can be prevented from entering the gap (not shown) to erode the solder (not shown) between the dielectric element 7103 and the main body portion 7101, thereby affecting the electrical connection between the dielectric element 7103 and the main body portion 7101. The outer diameter of the dielectric element 7103 is slightly smaller than the diameter of the body portion 7101, so that the sealant (not shown) can be filled into the gap (not shown) along the edge of the body portion 7101 located outside the dielectric element 7103 by capillary phenomenon when the sealant (not shown) is filled, which is advantageous for filling the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 7103 and the body portion 7101. When the sealant (not shown) is filled in the gap (not shown) formed by welding the dielectric element 7103 and the body portion 7101, air in the gap (not shown) can be discharged from the through hole 71031 of the dielectric element 7103, thereby preventing the sealant (not shown) filled in the gap (not shown) from generating a cavity and improving the product quality.

The temperature sensor 7104 is welded to a first land 7106A provided on the main body portion 7101 through a ground terminal (not shown) thereof, and is welded to a second land 7106B provided on the main body portion 7101 through a signal terminal (not shown) thereof. The temperature sensor 7104 is welded to the body portion 7101 and then received in the through hole 71031 of the dielectric element 7103. Preferably, the temperature sensor 7104 is a thermistor. The temperature sensor 7104 is used to monitor the temperature of the adhesive member 715 covering the side of the dielectric member 7103 of the electrode unit 710 facing the skin of the human body, and further to detect the temperature of the skin of the human body to which the adhesive member 715 is attached. When the temperature monitored by the temperature sensor 7104 exceeds the upper limit of the safe temperature of the human body, the tumor electric field treatment system can timely reduce or close the alternating voltage applied to the electrode plates 71 by the electric field generator (not shown) so as to avoid low-temperature scald of the human body. The temperature sensor 7104 is welded to the main body portion 7101 through a pair of welding pads 7106 of the main body portion 7101 and then sealed with a sealant (not shown) to prevent the temperature sensor 7104 from being damaged by moisture and causing the temperature sensor 7104 to fail.

The wire connecting portion 711 extends laterally from the main body portion 7101 of the electrode unit 710. The welding position of the wiring portion 711 and the first lead 712 is covered with a heat-shrinkable sleeve 7122. The heat-shrinkable sleeve 7122 performs insulation protection on the joint of the first lead 712 and the wiring part 711, provides support, prevents the joint of the first lead 712 and the wiring part 711 from being broken, and is dustproof and waterproof.

The main body portion 7101 of the electrode unit 710 and the wire connection portion 711 together constitute a flexible circuit board 716 of the electrode sheet 71. From the perspective of the electrode unit 710, the insulating plate 7102 is disposed on the side of the main body portion 7101 of the flexible circuit board 716 facing away from the skin of the human body, the dielectric element 7103 is disposed on the side of the main body portion 7101 of the flexible circuit board 716 facing the skin of the human body, and the temperature sensor 7104 is disposed on the side of the main body portion 7101 of the flexible circuit board 716 facing the skin of the human body.

The flexible circuit board 716 includes an insulating substrate 7B and a plurality of conductive traces (not shown) embedded in the insulating substrate 7B, that is, the main body portion 7101 and the wire connecting portion 711 of the electrode unit 710 include the insulating substrate 7B and the plurality of conductive traces (not shown) embedded in the insulating substrate 7B. The plurality of conductive traces (not shown) in the insulating substrate 7B of the main body portion 7101 are electrically connected to the corresponding plurality of conductive traces (not shown) in the insulating substrate 7B of the wiring portion 711, respectively. In this embodiment, the flexible circuit board 716 has three paths of conductive traces (not shown), including one path of conductive trace (not shown) connecting all the conductive cores 71051 of the conductive pads 7105 of the main body portion 7101 in series, one path of conductive trace (not shown) electrically connected to the ground terminal (not shown) of the temperature sensor 7104 located on the main body portion 7101, and one path of conductive trace (not shown) electrically connected to the signal terminal (not shown) of the temperature sensor 7104 located on the main body portion 7101. The side of the wiring part 711 facing the skin of the human body is provided with three gold fingers 7111. The three gold fingers 7111 of the wiring portion 711 are electrically connected to three conductive traces (not shown), respectively. The three gold fingers 7111 of the wiring portion 711 are soldered to an end of the first conductive trace 712 away from the first plug 7121, so as to electrically connect the main body portion 7101 of the electrode unit 710 with the first conductive trace 712, and further electrically connect the dielectric element 7103, the temperature sensor 7104 and the first conductive trace 712 through the main body portion 7101.

The conductive core 71051 is exposed to the insulating substrate 7B of the main body portion 7101. The insulating substrate 7B of the flexible circuit board 716 can isolate the moisture in the air around the electrode sheet 71 from the solder (not shown) between the conductive pad 7105 and the dielectric element 7103, so as to prevent the moisture in the air away from the skin from eroding the solder (not shown) between the conductive pad 7105 and the dielectric element 7103 on the main body portion 7101 of the flexible circuit board 716. The insulating substrate 7B of the flexible circuit board 716 and the insulating plate 7102 have double isolation functions, so that the service life of the electrode sheet 71 can be prolonged.

The backing 713 is a sheet-like arrangement made primarily of a flexible, gas permeable, insulating material. The backing 713 is a mesh fabric. Specifically, the backing 713 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 the patient dry after being applied to the body surface of the patient for a long time. The surface of the backing 713 facing the patient's body surface is further coated with a biocompatible adhesive (not shown) for adhering the backing 713 in close proximity to the corresponding body surface of the patient at the tumor site. In this embodiment, only one electrode unit 710 is adhered to the backing 713. The backing 713 is generally a cube-like configuration. The four corners of the backing 713 are rounded corner-shaped.

The support 714 is adhered to the backing 713 and surrounds the outside of the electrode unit 710. A through hole 7141 is formed through the middle of the supporting member 714 for receiving the electrode unit 710. The support 714 may be made of a foam material. The support 714 is flush with the surface of the electrode unit 710 on the side remote from the backing 713. That is, the supporting member 714 is flush with the surface of the electrode unit 710 on the side facing the sticker 715.

The adhesive 715 has a double-sided adhesive. One surface of the adhesive member 715 is adhered to the support member 714 and the surface of the electrode unit 710 on the side away from the backing 713. The other side of the adhesive piece 715 is used as a coating layer, which is applied to the skin of the human body surface to keep the skin surface moist and relieve local pressure. Preferably, the adhesive element 14 may be a conductive hydrogel to act as a conductive medium. The adhesive member 715 has better adhesion to the skin of the human body under the supporting action of the supporting member 714.

Referring to fig. 29 to 30, the electrical connector 72 has a plurality of sockets 721 for receiving the first plugs 7121 of the first leads 712 of the corresponding electrode pads 71, and a second lead 722 for receiving an adapter (not shown) or an electric field generator (not shown). The end of the second wire 722 far from the electrical connector 72 is provided with a second plug 7221, which can be directly plugged with the electric field generator (not shown) or plugged with an adaptor (not shown) first, and then plugged with 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 721 and the second conducting wires 722 are respectively disposed at two opposite ends of the electrical connector 72. The electrical connector 72 is plugged with the first plug 7121 of the first lead 712 of the electrode plate 71 through the socket 721 thereof, so as to connect the electrode plates 71 to the electrical connector 72 respectively, thereby realizing electrical connection between the electrode plates 71 and the electrical connector 72, and further realizing electrical connection between the electrode plates 71 and an electric field generator (not shown) through the second plug 7221 plugged with the electric field generator (not shown) or an adapter (not shown). When the electric tumor treating device is used, the electrode plates 71 are attached to the corresponding body surface of a tumor part of a patient, the electrode plates 71 are inserted into the corresponding sockets 721 of the electric connector 72 through the first plugs 7121 of the electrode plates, and the electric connector 72 is electrically connected with the electric field generator (not shown) through the second plugs 7221 of the electric connector 72, so that an alternating electric field generated by the electric field generator (not shown) is transmitted to the electrode plates 71 through the electric connector 72 and acts on the tumor part of the patient through the electrode plates 71 to interfere or prevent mitosis of tumor cells of the patient, and the purpose of treating tumors is achieved. The utility model discloses an electrode slice 71 of insulated electrode 700 can dismantle the grafting setting rather than electric connector 72, electrode slice 71 only contains an electrode unit 710, and every electrode unit 710 is separately through a first wire 712 and electric field generator (not shown) electric connection rather than electric connection, when there is electrode unit 710 or first wire 712 to damage and unable during operation, only need replace corresponding electrode slice 71 can, can reduce the cost of patient's tumour treatment. The number of the electrode plates 71 of the insulated electrode 700 can be freely combined according to the tumor part and the tumor size of the patient, so that the coverage area of the insulated electrode 700 for tumor electric field treatment is ensured, the electric field intensity of the insulated electrode 700 for tumor electric field treatment is ensured, and the tumor electric field treatment effect is improved. In addition, the relative positions of the electrode plates 71 of the insulated electrode 100 can be freely adjusted according to the body difference, the tumor position and the tumor size of the patient, so as to obtain the optimal electric field intensity and electric field coverage area for tumor treatment, and simultaneously, the skin on the body surface of the patient, which is pasted with the electrode plates 71, can be allowed to freely breathe, so that the phenomenon that the heat on the body surface of the patient cannot be timely dissipated due to the fact that the tumor electric field treatment is carried out for a long time, and the skin inflammation caused by sweat blocking pores is avoided.

In the present embodiment, the number of the sockets 721 of the electrical connector 72 is 9, and the number of the electrode pads 71 is 9. The electrical connector 72 is provided with a body 720, the body 720 having a substantially polyhedral configuration. In this embodiment, the body 720 has a generally hexagonal prism configuration. The 9 sockets 721 are respectively arranged on a plurality of adjacent side surfaces of the body 720, and an obtuse angle is formed between the adjacent side surfaces. The second lead 722 is disposed on a side of the body 720 away from the socket 721. In the present embodiment, the 9 sockets 721 are equally disposed on 3 adjacent side surfaces of the body 720, and each 3 sockets 721 are disposed on the same side surface of the body 720 of the electrical connector 72. Terminals (not shown) in the 9 sockets 721 of the electrical connector 72 may be connected in series, so that the 9 electrode pads 71 are connected in series. Terminals (not shown) in the 9 sockets 721 of the electrical connector 72 may be connected in parallel so that the 9 electrode plates 71 are connected in parallel. When terminals (not shown) in the socket 721 of the electrical connector 72 are connected in series, all the electrode tabs 71 need to be inserted into the electrical connector 72 for use. When the terminals (not shown) in the socket 721 of the electrical connector 72 are connected in parallel, a part of the electrode plate 71 can be selected to be inserted into the electrical connector 72 according to the requirement, so that the use is more convenient and flexible. Alternatively, the terminals (not shown) in the 9 sockets 721 of the electrical connector 72 may be connected partially in series and partially in parallel. Terminals (not shown) in the socket 721 of the electrical connector 72 may be connected in series, in parallel, in series or in parallel, in part, as needed, so that the plurality of electrode pads 71 connected to the electrical connector 72 are connected in series, in parallel, in series or in parallel, in part. When the size of the tumor is large, the appropriate number of electrode plates 71 can be selected and the interval between the electrode plates 71 can be freely adjusted according to the requirement, so as to ensure the coverage area and the electric field treatment effect of the insulated electrode 700 for the 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 application quantity of the electrode plates 71 of the insulated electrodes 700 properly so as to enhance the electric field intensity of the side far away from the tumor.

Eighth embodiment of insulated electrode 700

Fig. 33 and 34 disclose another embodiment of an insulated electrode, an insulated electrode 700', which also includes a plurality of electrode pads 71' for applying an alternating electric field to a tumor site of a patient and an electrical connector 72' for electrically connecting to an adapter (not shown) or an electric field generator (not shown). The electrode plates 71 'are detachably assembled to the electrical connector 72' by inserting and connecting, so as to electrically connect the electrode plates to the electrical connector 72', and further electrically connect the electrode plates to the electric field generator (not shown) through the electrical connector 72'. Each electrode tab 71' includes an electrode unit 710', a wire connecting portion 711 connected to the electrode unit 710', a first lead 712 welded to the wire connecting portion 711', a backing 713 adhered to the electrode unit 710', a support member 714' surrounding the electrode unit 710' and adhered to the backing 713', and an adhering member 715' covering the electrode unit 710' and the support member 714 '. The insulated electrode 700' differs from the insulated electrode 700 of the first embodiment in that: the insulated electrode 700' includes 3 electrode pads 71', the body 720' of the electrical connector 72' is generally in a triangular prism configuration, the electrical connector 72' is provided with 3 receptacles 721', and the 3 receptacles 721' are all disposed on the same side of the body 720' of the electrical connector 72'. The connection portion 711' of each electrode plate 71' is detachably connected to the corresponding first lead 712' by plugging. The wiring portion 711 'of the electrode plate 71' is electrically connected to the first conductive wire 712 'through a connector 7123'. The connector 7123' includes a pair of receptacle 7123A ' and a pair of plug 7123B '. The mating receptacle 7123A ' is connected to the wire connecting portion 711', and the mating plug 7123B ' is connected to an end of the first wire 712' that is distal from the first plug 7121 '. Also, the mating receptacle 7123A ' is disposed at the end of the wiring portion 711', and the mating plug 7123B ' is disposed at the end of the first conductive wire 7121' distal from the first plug 7121 '. The mating receptacle 7123A ' and the electrode unit 710' are located at opposite ends of the wire connecting portion 711', respectively. The mating plug 7123B ' and the first plug 7121' are disposed at opposite ends of the first conductive trace 712', respectively. When the electrode unit 710' of the electrode plate 71' is damaged and cannot work, only the part of the electrode plate 71' except the first lead 712' can be replaced, and the first lead 712' can be continuously used, so that the tumor treatment cost of the patient is further reduced.

The backing 713 'of the electrode sheet 71' is generally of a "male" configuration. The backing 713 'has two reentrant corners 7131' recessed from its two corners, respectively. The two reentrant corners 7131' are located at two corners of the backing 713' away from the wire portion 711', respectively. The concave angle 7131 'at the corner of the backing 713' communicates with the outside and is disposed in an "L" shape. The included angle between the two side edges of the concave angle 7131' formed by the backing 713' is greater than or equal to 90 degrees, so that when the electrode sheet 71' is pasted on the body surface corresponding to the tumor part of a patient, the corner of the backing 713' is prevented from being arched to cause wrinkles, and further, air enters the space between the electrode unit 710' and the skin from the wrinkles to increase the impedance between the electrode unit 710' and the skin, so that the heat of the electrode unit 710' is increased to cause low-temperature scald.

The electrode unit 710' has a substantially square sheet-like configuration. The main body 7101', the insulating plate 7102' and the dielectric element 7103 'of the electrode unit 710' are all in a square sheet structure. Two temperature sensors 7104' are provided at one side of the main body portion 7101' where the dielectric element 7103' is provided. The dielectric element 7103' has two through holes 71031' for respectively receiving the temperature sensors 7104'. The two temperature sensors 7104 'are symmetrically arranged on the main body part 7101', so that the temperature of the skin of the human body corresponding to different positions can be detected, and the accuracy of detected data is ensured. Four conductive traces (not shown) are embedded in the insulating substrate 7B ' of the flexible circuit board 716' formed by the body portion 7101' and the wire connection portion 711' of the electrode unit 710 '. The four conductive traces (not shown) of the flexible circuit board 716' are a conductive trace (not shown) connecting all the conductive cores (not shown) of the conductive pads (not shown) of the main body portion 7101' in series, a conductive trace (not shown) connecting the ground terminals (not shown) of the two temperature sensors 7104' on the main body portion 7101' in series, and two conductive traces (not shown) connecting the signal terminals (not shown) of the two temperature sensors 7104' in parallel. The wire portion 711' has four gold fingers (not shown) on a side facing the skin of the human body. The four conductive traces (not shown) are electrically connected to four gold fingers (not shown) of the wiring portion 711', respectively.

The utility model discloses a tumour electric field treatment system 700, 700' at least one insulated electrode 71, 71' detachably pegs graft to electric field generator (not shown) through the first wire 712, 712' that sets up on it, or detachably peg graft to adapter (not shown) earlier, and then through adapter (not shown) and electric field generator (not shown) electric connection, or detachably peg graft to electric connector 72, 72' on, and then electric connector 72, 2' and electric field generator (not shown) electric connection, so as to realize its and electric field generator (not shown) between electric connection, and every insulated electrode 71, 71' only contains one and corresponding first wire 712, 712' electric connection ' ' the electrode unit 710, 710', when there is electrode unit 710, 710' to damage and can't work, only need replace corresponding insulated electrode 71, 71', can reduce patient's tumour treatment's cost. In addition, the tumor electric field treatment systems 700 and 700 'of the present invention can perform the free combination or the free adjustment of the position of the insulated electrodes 71 and 71' according to the tumor position, the tumor position and the tumor size of the patient, so as to ensure the coverage area of the tumor electric field treatment systems 700 and 700 'for the tumor electric field treatment, ensure the electric field intensity of the tumor electric field treatment systems 700 and 700' for the tumor electric field treatment, and improve the electric field treatment effect; meanwhile, the relative interval between the insulated electrodes 71 and 71' can allow the skin of the patient to freely breathe and exchange heat with the outside air, so as to avoid skin diseases caused by sweat and pore blockage due to the accumulation of heat on the body surface of the patient treated by the electric field for a long time.

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 (103)

1. An electric field tumor treatment system, comprising:

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

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

a control signal generator which outputs a periodic square wave control signal;

an AC signal generator outputting an AC signal;

an inverter for inverting the square wave signal of the control signal generator;

a first switch/amplifier module having a control terminal directly connected to the control signal generator, an input terminal connected to the AC signal generator, and an output terminal connected to the first pair of insulated electrodes;

a second switch/amplifier module having a control terminal connected to the control signal generator through an inverter, an input terminal connected to the AC signal generator, and an output terminal connected to the second pair of insulated electrodes;

the insulated electrode is provided with one or more electrode units, and each electrode unit comprises a main body part, an insulating plate arranged on one side of the main body part far away from the skin of the human body and a dielectric element welded on one side of the main body part facing the skin of the human body.

2. The electric field tumor therapy system according to claim 1, wherein: the AC signal generator outputs an intermediate frequency alternating current signal of 150 KHZ; the control signal generator outputs a high level state and a low level state, the duration of the high level state is a first time period T1, the duration of the low level state is a first time period T2, and the duration of the first time period T1 is the same as that of the second time period T2.

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% of the duty cycle.

4. The electric field tumor therapy system according to claim 1, wherein: during the first time period T1, the AC signal generated by the AC signal generator is applied to the first pair of insulated electrodes through the first switching/amplifier module and forms a first AC signal between the first pair of insulated electrodes, the first AC signal having 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 AC signal generated by the AC signal generator is applied across the second pair of insulated electrodes through the second switch/amplifier module and forms a second AC signal between the second pair of insulated electrodes, the second AC signal having 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 duration of the third time period T3 and the fourth time period T4 is less than 10% of the duration of the first time period T1 or the second time period T2.

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

7. The electric field tumor therapy system according to claim 4, 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 2, wherein: the first time period T1 and the second time period T2 are 500ms to 980ms, respectively.

10. The electric field tumor therapy system according to claim 4, 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 any one of claims 1 to 10, for performing electric field therapy on a tumor site of a trunk of a patient during electric field tumor therapy, 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 wires electrically connected with the electrode units, wherein the number of the electrode units is at least 10, the electrode units are distributed in at least three rows and four columns, each electrode unit is connected with at least two adjacent electrode units, and at least one adjacent two electrode units in the electrode units are arranged in a spaced row or a spaced column.

12. The electric field tumor treatment system of claim 11, wherein at least two adjacent electrode units of the plurality of electrode units are disposed in a disconnected state and form a space between the two adjacent electrode units disposed in the disconnected state.

13. The electric field tumor therapy system according to claim 12, further comprising a wire portion electrically connected to the connecting portion or the electrode unit, the wire portion passing through the space and being soldered to the lead.

14. The electric field tumor therapy system according to claim 13, wherein two adjacent electrode units arranged in a row are arranged in a spaced row, and at least two adjacent electrode units arranged in a same column of the plurality of electrode units arranged in a column are arranged in a spaced row.

15. The electric field tumor therapy system according to claim 14, wherein the spacing between two adjacent electrode units arranged in a row is the same, and the spacing between two adjacent electrode units arranged in a column is different.

16. The electric field tumor therapy system according to claim 14, wherein the plurality of connecting portions between two adjacent electrode units in the same row have the same length, and the plurality of connecting portions between two adjacent electrode units in the same column have different lengths.

17. The electric field tumor therapy system according to claim 14, wherein said number of said electrode units is 13, and said electrode units are distributed in a region with five rows and five columns.

18. The electric field tumor therapy system according to claim 13, wherein at least two adjacent electrode units of the plurality of electrode units arranged in a row are disposed in a spaced row, and the plurality of electrode units arranged in a column are all arranged in an adjacent row.

19. The electric field tumor therapy system according to claim 18, wherein the spacing between two adjacent electrode units arranged in a row is different, and the spacing between two adjacent electrode units arranged in a column is the same.

20. The electric field tumor therapy system according to claim 18, wherein the connecting portions between two adjacent electrode units in the same row have different lengths, and the connecting portions between two adjacent electrode units in the same column have the same length.

21. The electric field tumor therapy system according to claim 17, wherein said number of said electrode units is 13, and said electrode units are distributed in a region arranged in three rows and five columns.

22. The electric field tumor therapy system according to claim 13, wherein the connecting portion comprises a first connecting portion connecting two adjacent electrode units located in the same row and a second connecting portion connecting two adjacent electrode units located in the same column.

23. The electric field tumor therapy system according to claim 12, wherein the connecting portion further comprises a third connecting portion connecting two adjacent electrode units in adjacent rows and adjacent columns and arranged diagonally.

24. The electrical field tumor treatment system of claim 13, wherein the third connection portion has a length greater than a length of the first connection portion.

25. The electrical tumor field treatment system of claim 13, wherein the length of the third connection portion is greater than half the length of the first connection portion.

26. The electrical field tumor treatment system of claim 13, wherein the third connection portion has a length greater than the second connection portion.

27. The electric field tumor therapy system according to any one of claims 1 to 10, wherein the insulated electrodes comprise a plurality of electrode units arranged in at least three rows and four columns, a plurality of connecting portions for connecting two adjacent electrode units, and a wire connecting portion connected to the connecting portions, each electrode unit is connected to at least two connecting portions, at least 10 electrode units are provided, and the number of electrode units in each row or each column is not identical.

28. The electric field tumor therapy system according to claim 27, wherein the number of the electrode units is 20, and the electrode units are distributed in an array area surrounded by four rows and six columns.

29. The electric field tumor therapy system according to claim 27, wherein at least one of the electrode units is disposed in a broken shape between two adjacent electrode units in the same row or column.

30. The electric field therapy system for tumor according to claim 27, wherein said insulated electrode comprises an electrical function member having a space formed between two adjacent electrode units disposed in an open state, said wire portion passing through a space C.

31. The electric field tumor therapy system according to claim 29, wherein the wire portion is extended from a connecting portion in a direction of the interval C.

32. The electric field tumor therapy system according to claim 30, wherein the wire portion is perpendicular to the connecting portion, and the wire portion is substantially in a line shape.

33. The electric field tumor therapy system according to claim 30, wherein said wire connecting portion is bridged between two connecting portions respectively connected to two adjacent electrode units disposed in a disconnected state.

34. The electric field tumor treatment system according to claim 33, wherein the wire portion is substantially "T" shaped.

35. The electric field tumor therapy system according to claim 28, wherein the spacing between two adjacent electrode units arranged in a row is the same, and the plurality of connecting portions connecting the two adjacent electrode units arranged in a row have the same length.

36. The electric field tumor therapy system according to claim 28, wherein the adjacent two electrode units arranged in a row have the same spacing therebetween, and the connecting portions of the plurality of adjacent two electrode units connected in a row have the same length.

37. The electric field tumor therapy system according to claim 28, wherein at least two adjacent electrode units arranged in a row of the plurality of electrode units are disposed in a spaced array, and the spacing between two adjacent electrode units arranged in a row is not completely the same.

38. The electric field tumor therapy system according to claim 28, wherein at least two adjacent electrode units arranged in a row are disposed in a spaced row, and the distance between two adjacent electrode units arranged in a row is not completely the same.

39. The electric field tumor therapy system according to claim 28, wherein two adjacent electrode units arranged in a row are disposed in an adjacent row, and the spacing between two adjacent electrode units arranged in a row is the same.

40. The electric field tumor therapy system according to claim 28, wherein two adjacent electrode units arranged in a row are disposed in adjacent rows, and the distance between two adjacent electrode units arranged in a row is the same.

41. The electric field tumor therapy system according to claim 28, wherein the spacing between two adjacent electrode units arranged in a row is the same, and the spacing between two adjacent electrode units arranged in a column is the same.

42. The electric field tumor therapy system according to claim 41, wherein the plurality of electrode units are distributed in an array area with four rows and six columns in a manner that the first column and the last column are respectively provided with two electrode units, and the middle four columns are respectively provided with four electrode units.

43. The electrical field tumor treatment system according to claim 42, wherein the plurality of electrode units are arranged in a row-wise and a column-wise axisymmetric arrangement.

44. An EER system according to claim 43, further comprising a wire electrically connected to said electrical functional element, said wire being soldered to said wire connecting portion.

45. The electric field tumor treatment system according to claim 44, further comprising a backing supporting the electrical functional assembly, wherein the backing is provided with threading holes for passing the wires therethrough.

46. The electric field tumor therapy system according to any one of claims 1 to 10, wherein the insulated electrode comprises an electrical functional assembly for applying an alternating electric field to a tumor site of a patient and a lead electrically connected to the electrical functional assembly, the electrical functional assembly comprises a plurality of electrode units arranged at intervals, a plurality of connecting portions for connecting two adjacent electrode units, and a wiring portion electrically connected to the lead, each electrode unit is connected to at least two connecting portions, and the number of the electrode units is at least 10.

47. The electrical field tumor treatment system according to claim 46, wherein each electrode unit is connected to at least two adjacent electrode units.

48. The electrical field tumor therapy system according to claim 46, wherein said plurality of electrode units are distributed in an array area having at least three rows and four columns, and the number of said electrode units is at least 10 and at most 30.

49. The electrical field tumor treatment system according to claim 46, wherein the plurality of electrode units are distributed in an array region having at least three rows and four columns, and the number of electrode units in each row is the same and the electrode units are arranged in alignment in the column direction.

50. The electric field tumor therapy system according to claim 49, wherein the electrode units are arranged in a row with the same pitch.

51. The electric field tumor therapy system according to claim 49, wherein the electrode units are arranged in a row with the same pitch.

52. The electric field tumor therapy system according to claim 49, wherein the connecting portions connecting two adjacent electrode units arranged in a row have the same length.

53. The electric field tumor therapy system according to claim 49, wherein the connecting portions of the plurality of two adjacent electrode units connected in a row have the same length.

54. The electric field therapy system for tumor according to claim 46, wherein at least one of the electrode units is disposed in a broken shape, and a space for the wire portion to pass through is formed between the two adjacent electrode units.

55. The electrical field tumor treatment system of claim 54, wherein the wire portion is laterally extended from the connection portion opposite the gap.

56. The electric field tumor therapy system according to claim 55, wherein the connection portion of the extension wire portion is perpendicular to the wire portion.

57. The electric field tumor therapy system according to claim 54, wherein the wire connecting portion is erected between two connecting portions respectively connected to the two electrode units arranged in the disconnected state.

58. An electric field tumor treatment system according to claim 57, wherein said wire portion is substantially "T" shaped.

59. The electric field tumor therapy system according to claim 46, wherein the plurality of electrode units are arranged in an array of four rows and five columns, and the number of the electrode units is 20.

60. The system of claim 1, wherein the electrode unit further comprises a temperature sensor selectively disposed on the body portion, the temperature sensor being located on the same side of the body portion as the dielectric element.

61. The electric field tumor therapy system according to claim 60, wherein said dielectric element is provided with an opening corresponding to a temperature sensor.

62. The electric field tumor treatment system according to claim 61, wherein the insulated electrode further comprises an adhesive backing supporting the electrical functional assembly, the backing being provided with threading holes for the wires to pass through.

63. The electric field tumor therapy system according to claim 62, wherein said lead wire has a heat shrink sleeve covering the connection between said lead wire and said wire connection portion.

64. The electric field tumor therapy system according to any one of claims 1 to 10, wherein the insulated electrode comprises a flexible circuit board, a single dielectric element and a plurality of temperature sensors disposed on the same side of the flexible circuit board, and a lead electrically connected to the flexible circuit board, the number of the temperature sensors is n, n is an integer greater than 1 and not greater than 8, each temperature sensor has a ground terminal and a signal terminal, the flexible circuit board has an insulating substrate and multiple conductive traces embedded in the insulating substrate, the multiple conductive traces are n +2, one of the conductive traces is electrically connected to the dielectric element, one of the conductive traces is electrically connected to the ground terminals of all the temperature sensors, the remaining conductive traces are respectively electrically connected to the signal terminals of the corresponding temperature sensors, and the lead is electrically connected to the multiple conductive traces of the flexible circuit board.

65. The electric field therapy system for tumor according to claim 64, 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.

66. The electric field tumor treatment system according to claim 65, wherein the gold fingers are electrically connected to one conductive trace of the flexible printed circuit board.

67. The electrical field tumor therapy system according to claim 65, wherein said temperature sensors are 2 in number, said conductive traces are 4 traces, and said gold fingers are 4 fingers.

68. The electric field tumor treatment system according to claim 64, 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.

69. The system of claim 68, 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.

70. The system of claim 68, wherein the conductive disc includes a plurality of spaced apart conductive cores connected in series by a conductive trace electrically connecting the flexible circuit board to the dielectric element.

71. The system of claim 70, wherein the flexible circuit board has n pairs of pads, each pair of pads being located between a respective two of the spaced apart conductive cores.

72. The electrical field tumor treatment system according to claim 71, 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.

73. The electrical tumor field treatment system according to claim 71, wherein each pair of pads comprises a first pad soldered to a ground terminal of the corresponding temperature sensor and a second pad soldered to a signal terminal of the corresponding temperature sensor.

74. The electrical field therapy system for tumor according to claim 73, 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.

75. The electric field tumor therapy system according to claim 64, wherein one end of said wire is electrically connected to said flexible circuit board, and the other end of said wire is provided with a plug.

76. The electric field tumor treatment system according to claim 75, wherein a heat shrinkable sleeve is disposed at the connection of the lead and the flexible circuit board.

77. The electric field tumor treatment system according to claim 64, wherein the dielectric element has a through hole corresponding to the temperature sensor, and the temperature sensor is received in the corresponding through hole.

78. The system of claim 64, 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 terminal of the corresponding temperature sensor are all third conductive traces, the flexible printed circuit board is provided with a conductive pad connected to the first conductive trace, the flexible printed 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.

79. The system of claim 78, wherein the conductive pad and the solder pad are disposed on a same side of the flexible circuit board.

80. The electrical field tumor treatment system of claim 78, wherein the conductive pads and the solder pads are exposed from the insulating substrate of the flexible circuit board.

81. The electric field tumor therapy system according to claim 78, wherein the flexible circuit board further has 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.

82. The system of claim 81, wherein there are four gold fingers, two temperature sensors, two pairs of pads, and two paths of third conductive traces.

83. The system of claim 81, wherein the gold finger, the conductive pad, and the two pairs of pads are on the same side of a flexible circuit board.

84. The system of claim 83, further comprising a backing affixed to a corresponding portion of the flexible circuit board.

85. The electric field therapy system according to claim 84, wherein an insulating plate is 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.

86. The electric tumor treatment system according to any one of claims 1 to 10, wherein the insulated electrode comprises at least one electrode pad for applying an alternating electric field, the electrode pad comprising a separate electrode unit and a first wire electrically connected to the electrode unit, and an electrical connector detachably connected to the electrode pad, the electrode pad being detachably connected to the electrical connector through the first wire.

87. The electrical field tumor treatment system of claim 86, wherein a plurality of insulated electrodes are connected in parallel to the electrical connector by respective first wires.

88. The electric field therapy system for tumor according to claim 87, 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 located at two opposite ends of the first lead.

89. The oncological electric field treatment system of claim 88, wherein the electrical connector has a plurality of sockets that removably mate with the first plugs of the first wires of the respective electrode pads.

90. The system of claim 89, 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.

91. The electrical field tumor treatment system of claim 90, wherein the second lead has a second plug disposed at an end thereof.

92. The system of claim 91, wherein the electrical connector has a body, and the plurality of sockets and the second wires are disposed at opposite ends of the body.

93. The electric field tumor treatment system according to claim 88, 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.

94. The electrical field tumor treatment system of claim 93, wherein the wire portion extends laterally from the main body portion.

95. The electrical field therapy system for tumor according to claim 94, wherein the main body portion and the wire connection portion of the electrode unit constitute a flexible circuit board of the insulated electrode.

96. The electrical field tumor treatment system of claim 94, wherein the electrode unit further comprises at least one temperature sensor disposed on the same side of the body portion as the dielectric element.

97. The electrical field tumor treatment system according to claim 96, wherein at least one through hole is formed in the middle of the dielectric member, and the temperature sensors are respectively received in the corresponding through holes of the dielectric member.

98. The electric field therapy system for tumor according to claim 94, wherein said insulating plate is adhered to a side of said main body portion away from said dielectric element.

99. The electric field tumor therapy system according to claim 93, wherein a heat shrinkable sleeve is wrapped around the welding portion of the first lead and the wire connection portion.

100. The electrical field tumor treatment system of claim 88, wherein the first lead is removably coupled to the electrode unit.

101. The electric field tumor treatment system according to claim 100, wherein the electrode plate comprises a wire connecting portion electrically connected to the electrode unit, and a docking socket is provided at an end of the wire connecting portion away from the electrode unit.

102. The system of claim 101, 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.

103. The electric field tumor treatment system according to claim 86, 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.

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