CN115837120B

CN115837120B - Electrode patch, method for manufacturing electrode patch, and tumor electric field therapeutic apparatus

Info

Publication number: CN115837120B
Application number: CN202211678871.XA
Authority: CN
Inventors: 陈晟; 沈琪超
Original assignee: Jiangsu Hailai Xinchuang Medical Technology Co Ltd
Current assignee: Jiangsu Hailai Xinchuang Medical Technology Co Ltd
Priority date: 2022-12-26
Filing date: 2022-12-26
Publication date: 2024-04-09
Anticipated expiration: 2042-12-26
Also published as: CN115837120A; CN117899353A

Abstract

The invention provides an electrode patch for tumor electric field treatment, which comprises at least one electrode unit, an adapter plate detachably connected with at least one electrode unit and a backing adhered to corresponding parts of at least one electrode unit and the adapter plate. The electrode patch is formed by detachably connecting at least one electrode unit with the adapter plate, so that the electrode unit which is invalid on the detachable replacement electrode patch or the adapter plate which is invalid on the detachable replacement electrode patch can be realized, the loss of the whole electrode patch is reduced, and the yield loss of the electrode patch is reduced.

Description

Electrode patch, method for manufacturing electrode patch, and tumor electric field therapeutic apparatus

Technical Field

The application relates to an electrode patch, a manufacturing method of the electrode patch and a tumor electric field therapeutic apparatus, and belongs to the technical field of medical appliances.

Background

At present, the treatment modes of tumors mainly comprise operation, radiotherapy, chemotherapy and the like, but have corresponding defects, such as side effects caused by radiotherapy and chemotherapy, and normal cells can be killed. The use of electric fields to treat tumors is also one of the leading edges of current research and development, and tumor electric field treatment generates a tumor treatment method by using a special electric field generator to interfere with the mitotic progress of tumor cells through low-intensity, medium-high-frequency and alternating electric fields. Research shows that the electric field treatment has obvious effect in treating glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma and other diseases, and the electric field applied by the treatment method can influence the aggregation of tubulin, prevent spindle body formation, inhibit mitosis process and induce cancer cell apoptosis.

The tumor electric field therapeutic apparatus for treating tumor mainly comprises an electric field generator and electrode patches electrically connected with the electric field generator, wherein the electrode patches are applied to the skin of a human body in pairs, and an alternating electric field is applied to focus of the human body for alternating electric field therapy. Each electrode patch comprises a flexible circuit board, a plurality of ceramic plates arranged on the flexible circuit board at intervals and a lead electrically connected with the flexible circuit board, as disclosed in Chinese patent publication No. 11271272 or 113164745. The flexible circuit board comprises a flexible board substrate, a plurality of conductive traces embedded in the flexible board substrate, and a plurality of conductive pads exposed on the flexible board substrate and electrically connected by the same conductive trace. The ceramic plates are welded with the corresponding conductive plates and arranged on the flexible circuit board, and are further connected in series through a path of conductive trace electrically connected with all the conductive plates. One end of the lead is electrically connected with the flexible circuit board, and the other end of the lead is provided with a plug which can be spliced with the electric field generator.

Because the ceramic plate is hard material and the flexible circuit board is flexible material, the flexible circuit board of the electrode patch of the tumor electric field treatment system has stronger mechanical strength at the positions where a plurality of ceramic plates are arranged at intervals than at the positions where the ceramic plates are not arranged, and further the flexible circuit board is easy to bend at the joint of the positions where the ceramic plates are arranged and the positions where the ceramic plates are not arranged, and the risk of breakage of the conductive trace in the flexible circuit board substrate is also caused if the bending is serious. The plurality of ceramic plates of the electrode patch are connected in series through the same conductive trace of the flexible circuit board, and the problems that the electrical signal cannot be transmitted to all the ceramic plates due to the breakage of the conductive trace of the flexible circuit board, the electrode patch is scrapped as a whole due to unqualified detection during manufacturing, cannot be used and reused, the manufacturing yield of products is low and the manufacturing cost is increased are caused.

Therefore, it is necessary to provide an improved electrode patch and an electric tumor field therapeutic apparatus, so as to solve the technical problems of the electrode patch of the electric tumor field therapeutic apparatus.

Disclosure of Invention

The invention provides an electrode patch capable of avoiding scrapping of a whole electrode patch, a manufacturing method of the electrode patch and a tumor electric field therapeutic apparatus.

Aiming at the problems existing in the prior art, the electrode patch provided by the invention is realized by the following technical scheme: an electrode patch for tumor electric field therapy comprising at least one electrode unit, an adapter plate detachably connected to at least one of the electrode units, and a backing attached to respective portions of at least one of the electrode units and the adapter plate.

Further, each electrode unit comprises a flexible plate base body, a supporting plate and a ceramic transduction piece which are respectively arranged on two sides of the flexible plate base body, and a male seat which is arranged on the same side surface of the flexible plate base body and positioned on the ceramic transduction piece.

Further, the ceramic transduction piece and the male seat are respectively positioned at two opposite ends of the flexible board matrix, and the ceramic transduction piece and the supporting plate are both positioned at the same end of the flexible board matrix.

Further, the electrode unit further comprises a temperature sensor which is arranged on the flexible board substrate and is positioned on the same side with the ceramic transduction piece.

Further, the ceramic transduction piece is provided with a penetrating opening, and the temperature sensor is accommodated in the opening of the ceramic transduction piece.

Further, the adapter plate is provided with at least one female seat which corresponds to the male seat of the electrode unit and is electrically connected with the male seat of the electrode unit, and the female seat of the adapter plate is detachably connected with the male seat of the electrode unit.

Further, the adapter plate comprises a body and a wiring part connected with the body, at least one female seat of the adapter plate is arranged on the body, and the wiring part is positioned at one end of the body.

Further, the body has a trunk, and the at least one female seat is located on the trunk.

Further, the trunk of the body is provided with at least one hollow hole which is arranged in a penetrating mode, and the hollow hole is arranged corresponding to the corresponding female seat.

Furthermore, the hollowed-out holes allow the corresponding ceramic transduction pieces of the electrode units to pass through, and the ceramic transduction pieces of the electrode units are exposed to one side, far away from the mother base, of the adapter plate when the electrode units are assembled on the adapter plate.

Further, the body further comprises a plurality of branches positioned at two sides of the trunk, and the female seats are arranged on the branches.

Further, a space allowing the ceramic transduction piece of the corresponding electrode unit to pass through is arranged between two adjacent limbs positioned on the same side of the trunk, and the ceramic transduction piece of the electrode unit is exposed at one side of the connecting plate, which is far away from the mother seat, after passing through the space.

Further, the electrode patch further comprises a wire electrically connected with the wiring part of the adapter plate, one end of the wire is electrically connected with the wiring part of the adapter plate, and the other end of the wire is provided with a plug.

Further, the periphery of the joint of the wire and the wiring part is also covered with a circle of heat-shrinkable sleeve.

Furthermore, the plug of the wire is detachably connected with a transfer wire.

Further, the backing is arranged in a sheet shape and is provided with at least one through hole which corresponds to the electrode unit and is arranged in a penetrating manner, and the through hole of the backing allows the corresponding part of the electrode unit to be exposed out of the surface of one side of the backing away from the adapter plate.

Further, the electrode patch further comprises a support member which is arranged around the corresponding part of the electrode unit in a surrounding manner and is adhered to the back lining, and an adhesive member which covers the support member and the corresponding part of the electrode unit and is adhered to the body surface skin corresponding to the tumor part of the patient.

Further, the support member is provided with at least one through hole.

Further, the perforation includes a first perforation corresponding to the respective electrode unit and receiving a respective portion of the respective electrode unit.

Further, the perforation further comprises a second perforation which is positioned among the first perforation and is opposite to the adapter plate.

Further, the electrode patch further comprises at least one release paper which is positioned on one side of the adhesive piece, which is away from the back lining, and covers the adhesive piece and the back lining.

The invention also provides a manufacturing method of the electrode patch, which is realized by the following technical scheme: a method of manufacturing an electrode patch, comprising the steps of:

s11, providing an adapter plate, wherein the adapter plate is provided with at least one group of third bonding pads and a wiring part;

s12, providing at least one female seat, and respectively welding the female seats on corresponding third bonding pads of the adapter plate;

s13, providing a wire, and arranging a wire group on a wiring part of the adapter plate;

s14, providing a heat-shrinkable sleeve, and coating the heat-shrinkable sleeve at the joint of the adapter plate and the lead;

S15, providing at least one electrode unit detachably connected with the adapter plate, and clamping the electrode unit with a female seat on the adapter plate;

s16, providing a backing, and adhering the corresponding part of the surface of one side of the adapter plate provided with the mother seat and the surface of the electrode unit positioned on the same side on the backing.

Further, after the step S16, the method further includes the following steps:

s17, providing a supporting piece, and adhering the supporting piece on the backing in a shape of surrounding the corresponding part of the electrode unit;

s18, providing an adhesive piece, and adhering the adhesive piece to the surface of one side, far away from the back lining, of the corresponding parts of the support piece and the electrode unit;

and S19, providing release paper, and covering the release paper on the surface of the back lining and the surface of the adhesive piece, which is close to the skin of the patient.

Further, the manufacturing method of the electrode unit includes the steps of:

s21, providing a flexible board substrate, wherein one end of the flexible board substrate is provided with a plurality of conductive plates arranged at intervals and two first bonding pads positioned in the surrounding area of the conductive plates, and the other end of the flexible board substrate is provided with a plurality of second bonding pads;

s22, providing a supporting plate, and respectively assembling the supporting plate on the flexible plate base body in a one-to-one correspondence manner with a plurality of conductive plates, wherein the supporting plate and the conductive plates are respectively positioned on two opposite sides of the flexible plate base body;

S23, providing a temperature sensor, and welding the temperature sensor on the two first bonding pads;

s24, providing a ceramic transduction piece with an opening, and welding the ceramic transduction piece on a plurality of conductive plates in a mode of accommodating corresponding temperature sensors in the opening;

s25, providing a male seat, and welding the male seat on the plurality of second bonding pads.

The tumor electric field therapeutic apparatus provided by the invention is realized by the following technical scheme: an electric field therapeutic apparatus for tumor comprises an electric field generator and at least one pair of electrode patches electrically connected with the electric field generator.

Further, the electrode patch further comprises an adapter electrically connected between the electrode patch and the electric field generator.

The electrode patch of the tumor electric field therapeutic apparatus is formed by detachably connecting at least one electrode unit with the adapter plate, so that the electrode unit which is invalid on the electrode patch can be detachably replaced, or the adapter plate which is invalid on the electrode patch can be detachably replaced, the replacement of the whole electrode patch is avoided, and the yield loss of the electrode patch is reduced.

Drawings

Fig. 1 is a schematic diagram of an electrode patch of a tumor electric field therapeutic apparatus according to a first embodiment of the present invention;

FIG. 2A is an exploded pictorial view of the electrode unit of FIG. 1;

FIG. 2B is a schematic diagram of the electrode unit of FIG. 1;

FIG. 3 is a wiring diagram of a flexible board base of the electrode unit of FIG. 2A;

fig. 4 is a schematic structural diagram of the interposer of fig. 1;

fig. 5A is a front wiring diagram of the interposer of fig. 4;

FIG. 5B is a reverse wiring diagram of the interposer of FIG. 4;

FIG. 6A is a schematic view of the electrode patch of FIG. 1, wherein the support and the adhesive are not disclosed;

FIG. 6B is another schematic view of the electrode patch of FIG. 1, wherein the support and the adhesive are not disclosed;

FIG. 7 is a schematic diagram of the electrode unit, interposer, wire, backing, and support combination of FIG. 1;

FIG. 8A is a schematic diagram of the electrode patch of FIG. 1;

FIG. 8B is a schematic view of the electrode patch of FIG. 1 from another perspective;

fig. 9A is an exploded schematic view of an electrode patch of a tumor electric field therapeutic apparatus according to a second embodiment of the present invention, wherein release paper is not shown;

FIG. 9B is a schematic combination of the electrode patch shown in FIG. 9A, wherein the release paper is not shown;

FIG. 10A is an exploded view of the interposer and leads of FIG. 9A;

FIG. 10B is a schematic diagram illustrating the combination of the interposer and the wires of FIG. 10A;

fig. 11A is a front wiring diagram of the interposer in fig. 10A;

FIG. 11B is a reverse wiring diagram of the interposer of FIG. 10A;

FIG. 12 is a flow chart of a method for manufacturing electrode patches of an electric tumor field therapeutic apparatus according to the present invention;

fig. 13 is a flow chart of a method for manufacturing the electrode unit of the electrode patch shown in fig. 12.

Detailed Description

Reference will now be made in detail to exemplary embodiments, examples of which are illustrated in the accompanying drawings. When the following description refers to the accompanying drawings, the same numbers in different drawings refer to 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 apparatus, devices, systems, and methods that are consistent with aspects of the present application as detailed in the accompanying claims.

The tumor electric field therapeutic apparatus (not shown) of the present invention includes an electric field generator (not shown) and electrode patches 100, 100' connected to the electric field generator (not shown). The electrode patches 100 and 100' are applied to the skin surface of a human body, and a therapeutic electric field generated by an electric field generator (not shown) is applied to the human body to perform tumor electric field therapy. The electrode patches 100, 100' of the embodiments of the present application are applied to the head of a human body for the adjuvant treatment of brain tumors, such as glioblastoma multiforme. In other embodiments, an adapter (not shown) may be provided between the electrode patches 100, 100' of the tumor electric field therapy apparatus (not shown) and the electric field generator (not shown). The adapter (not shown) is electrically connected between the electrode patches 100, 100' and the electric field generator (not shown).

Fig. 1 to 8 show an electrode patch 100 according to a first embodiment of the present invention. The electrode patch 100 may be directly connected to the electric field generator (not shown) by plugging, or may be directly connected to the adaptor (not shown) by plugging, and then electrically connected to the electric field generator (not shown) by the adaptor (not shown). The electrode patch 100 includes at least one electrode unit 10, an adapter plate 20 detachably connected to the at least one electrode unit 10, a lead 30 electrically connected to the adapter plate 20, a backing 40 attached to respective portions of the electrode unit 10 and the adapter plate 20, a support member 50 surrounding the respective portions of the electrode unit 10 and attached to the backing 40, and an adhesive member 60 covering the support member 50 and the respective portions of the electrode unit 10 and adhering to the body surface skin corresponding to the tumor site of the patient. The electrode patch 100 is attached to the body surface corresponding to the tumor site of the patient through the backing 40, and an alternating electric field is applied to the tumor site of the patient through at least one electrode unit 10 detachably connected with the adapter plate 20 to interfere or prevent the mitosis of tumor cells of the patient, thereby achieving the purpose of treating tumors. The electrode patch 100 is formed by detachably connecting at least one electrode unit 10 and the adapter plate 20, so that the electrode unit 10 with failure can be detachably replaced or the adapter plate 20 with failure can be detachably replaced, the loss of the whole electrode patch 100 can be reduced before the product is delivered, the yield loss of the electrode patch 100 is reduced, the scrapping of the whole electrode patch 100 can be avoided when the electrode patch 100 is used, and the cost is saved; the intensity of the alternating electric field applied by the electrode patch 100 can also be adaptively adjusted according to the tumor size by freely selecting the number of electrode units 10 plugged onto the adapter plate 20.

Referring to fig. 2A and 2B, each electrode unit 10 includes a flexible board base 11, support plates 13 and ceramic transduction plates 12 respectively disposed at both sides of the flexible board base 11, and a male base 15 disposed at the same side surface of the flexible board base 11 as the ceramic transduction plates 12. The ceramic transduction piece 12 and the male seat 15 are respectively positioned at two opposite ends of the flexible board substrate 11, and the ceramic transduction piece 12 and the supporting plate 13 are positioned at the same end of the flexible board substrate 11. In this embodiment, the dimensions of the support plate 13 and the ceramic transduction piece 12 are slightly smaller than those of the flexible plate substrate 11.

The ceramic transducer sheet 12 is made of a high dielectric constant material, and has conductive properties that prevent the conduction of direct current and allow the passage of alternating current, so that the safety of users can be ensured during tumor electric field treatment. The ceramic transduction sheet 12 has a through-hole 121 at its center. The electrode unit 10 further includes a temperature sensor 14 provided on the flexible board base 11 and located on the same side as the ceramic transduction sheet 12. The temperature sensor 14 is accommodated in the opening 121 in the center of the ceramic transduction sheet 12 to sense the temperature of the skin of the patient to which the electrode patch 100 is applied. The temperature sensor 14 has a ground terminal 14A and a signal terminal 14B. Preferably, the temperature sensor 14 is a thermistor.

Referring to fig. 3, the flexible board base 11 is embedded with three first conductive traces 114. The three first conductive traces 114 include a first ground line 114A electrically connected to the ground end 14A of the temperature sensor 14 and the male base 15, a first signal line 114B electrically connected to the signal end 14B of the temperature sensor 14 and the male base 15 for transmitting a temperature signal, and a first AC line 114C annularly disposed and electrically connected to the ceramic transducer 12 and the male base 15. The first ground line 114A and the first signal line 114B are each extended in the longitudinal direction of the flexible board substrate 11. The first AC line 114C is disposed along the periphery of the flexible board substrate 11 in a sealed ring shape, and includes a first AC line segment 115 disposed at the same end as the ceramic transducer sheet 12 in a circular arc shape, and a second AC line segment 116 extending from the first AC line segment 115 and disposed in an inverted "n" shape. The first AC line segment 115 is electrically connected to the ceramic transduction sheet 12 disposed on the flexible board substrate 11. One end of the second AC line segment 116 is connected to opposite ends of the first AC line segment 115, and the other end is welded to the male socket 15 provided on the flexible board base 11. The electrode unit 10 is electrically connected with the first AC line segment 115 of the first AC line 114C of the flexible board substrate 11 through the ceramic transduction piece 12, one end of the first AC line segment 115 of the first AC line 114C of the flexible board substrate 11 is connected with the second AC line segment 116, and the other end of the second AC line segment 116 of the first AC line 114C of the flexible board substrate 11 is electrically connected with the male socket 15, so that the electrical connection between the ceramic transduction piece 12 and the male socket 15 is realized.

The second AC line segment 116 is closed at an end far from the first AC line segment 115 after extending from opposite ends of the first AC line segment 115 along the length direction of the flexible board base 11, respectively. The second AC line segment 116 extends from one end of the first AC line segment 115 toward a direction away from the ceramic transduction piece 12, then bends and extends toward the other end of the first AC line segment 115, and then extends toward the other end of the first AC line segment 115 until being connected to the other end of the first AC line segment 115. The second AC line segment 116 includes a portion extending from one end of the first AC line segment 115 and having an "L" configuration and a portion extending from the other end of the first AC line segment 115 and having an "I" configuration. The second AC line segment 116 has two parts respectively connected to two opposite ends of the first AC line segment 115, and can be connected to the other end of the first AC line segment 115 through the other part thereof when one part thereof is disconnected from the one end of the first AC line segment 115 due to bending, so as to ensure the electrical connection between the second AC line segment and the first AC line segment 115, thereby realizing good and stable electrical connection between the ceramic transducer 12 and the male base 15. That is, the second AC line segment 116 of the first AC line 114C is connected to opposite ends of the arc-shaped first AC line segment 115 at the same time, and even when one end of the second AC line segment 116 and the first AC line segment 115 is disconnected by bending, an electrical signal can be transmitted to the ceramic transduction piece 12 through the connection between the second AC line segment 116 and the other end of the first AC line segment 115, so that the reliability of the electrical connection between the ceramic transduction piece 12 of the electrode unit 10 and the flexible board substrate 11 is ensured, the product quality is improved, and the product reject ratio is reduced. The first ground line 114A and the first signal line 114B are both located in the area surrounded by the first AC line 114C, so as to facilitate wiring and reduce wiring difficulty.

The same side surface of the flexible board substrate 11 is also provided with a plurality of conductive pads 111 which are arranged at intervals and welded with the ceramic transduction piece 12, two first bonding pads 112 which are respectively welded with the grounding end 14A and the signal end 14B of the temperature sensor 14, and a plurality of second bonding pads 113 which are welded with the male base 15. The conductive pad 111 and the first pad 112 are both positioned at the same end of the flexible board base 11, and the second pad 113 is positioned at the other end of the flexible board base 11. The plurality of conductive plates 111 are respectively electrically connected with the first AC line segments 115 of the first AC lines 114C embedded in the flexible board substrate 11, and are connected in series through the arc-shaped first AC line segments 115. The flexible board substrate 11 is electrically connected with the conductive disc 111 through the first AC line segment 115 of the first AC line 114C, and the conductive disc 111 is welded with the ceramic transduction piece 12 to realize the electrical connection between the conductive disc and the ceramic transduction piece 12.

The two first pads 112 are located at intermediate positions surrounded by the plurality of conductive pads 111. The first pad 112 soldered to the ground terminal 14A of the temperature sensor 14 is a first pad 112A, and the first pad 112 soldered to the signal terminal 14B of the temperature sensor 14 is a first pad 112B. The first pad 112A is disposed at an end of the first ground line 114A within the first AC line segment 115 of the first AC line 114C, and the first pad 112B is disposed at an end of the first signal line 114B within the first AC line segment 115 of the first AC line 114C. The first pad 112A is electrically connected to an end of the first ground line 114A, and the first pad 112B is electrically connected to an end of the first signal line 114B. The flexible board substrate 11 is electrically connected with the temperature sensor 14 by welding the grounding end 14A of the temperature sensor 14 through the first bonding pad 112A connected with the first grounding wire 114A and welding the signal end 14B of the temperature sensor 14 through the first bonding pad 112B connected with the first signal wire 114B.

The second pads 113 and the first pads 112 are respectively provided at opposite ends of the flexible board base 11. The second bonding pad 113 is disposed at one end of the flexible board substrate 11 far away from the ceramic transduction piece 12 and is welded with the male seat 15, so as to realize electrical connection with the male seat 15. The at least 3 second pads 113 include a second pad 113A electrically connected to the first pad 112A through the first ground line 114A, a second pad 113B electrically connected to the first pad 112B through the first signal line 114B, and at least one second pad 113C electrically connected to the conductive pad 111 through the first AC line 114. The second bonding pad 113A and the first bonding pad 112A are respectively disposed at two opposite ends of the first ground line 114A, and are electrically connected through the first ground line 114A. The second bonding pad 113B and the first bonding pad 112B are respectively disposed at two opposite ends of the first signal line 114B, and are electrically connected in time through the first signal line 114B. The second pads 113C and the conductive pads 111 are respectively disposed at opposite ends of the first AC line 114, and electrically connected to each other through the first AC line 114. The second pad 113C is disposed at an end of the second AC line segment 116 of the first AC line 114, and the conductive pad 111 is disposed on the first line segment 115 of the first AC line 114. The flexible board substrate 11 is welded with the ceramic transduction piece 12 through the conductive disc 111 arranged on the first AC line segment 115 of the first AC line 114C, and the second bonding pad 113C arranged at the tail end of the second line segment 116 of the first AC line 114C is welded with the male seat 15, so that the electrical connection between the male seat 15 and the ceramic transduction piece 12 is realized. The flexible board substrate 11 is welded with the grounding end 14A of the temperature sensor 14 through a first bonding pad 112A arranged at one end of the first grounding wire 114A, a first bonding pad 112B arranged at one end of the first signal wire 114B is welded with the signal end 14B of the temperature sensor 14, a second bonding pad 113A arranged at the other end of the first grounding wire 114A and a second bonding pad 113B arranged at the other end of the first signal wire 114B are welded with the male seat 15, so that the electrical connection between the temperature sensor 14 and the male seat 15 is realized.

At least three second bonding pads 113 are welded with the male base 15, so that the male base 15 and the flexible board base 11 can be firmly welded when the male base 15 is welded to the flexible board base 11 through the second bonding pads 113, and good electrical connection between the male base 15 and the flexible board base 11 is ensured. And the conductive plate 111 is welded to the male socket 15 through at least one second bonding pad 113C disposed on the second AC line segment 116 of the first AC line 114C, so as to ensure stable electrical connection between the conductive plate 111 and the male socket 15, so that an electrical signal for tumor therapy is transmitted to the conductive plate 111 through the first AC line 114C, and then transmitted to the ceramic transducer 12 through the conductive plate 111. In this embodiment, the four second pads 113C soldered to the male socket 15 are respectively connected to the second AC line segments 116 of the first AC line 114C. Other embodiments are possible for the purpose of achieving the weld tightness between the reinforcing male socket 15 and the flexible board base 11. For example, one of the plurality of second pads 113 is connected to the first ground line 114A, one of the second AC line segments 116 connected to the first AC line 114C, and the remaining ones are connected to the corresponding first signal lines 114B in one-to-one correspondence, respectively. For another example, one of the plurality of second pads 113 is connected to the first signal line 114B, one is connected to the first AC line 114C, and the remaining is connected to the first ground line 114A, respectively. That is, two of the plurality of second pads 113 are connected to two lines of the first ground line 114A, the first signal line 114B, and the first AC line 114C, respectively, and the remaining second pads 113 are connected to the remaining one lines of the first ground line 114A, the first signal line 114B, and the first AC line 114C.

The grounding signal of the temperature sensor 14 is transmitted to the corresponding second bonding pad 113A electrically connected with the first grounding wire 114A through the first grounding wire 114A electrically connected with the grounding end 14A; the temperature signal detected by the temperature sensor 14 is transmitted to the corresponding second bonding pad 113B electrically connected to the first signal line 114B through the first signal line 114B electrically connected to the signal end 14B; and the second bonding pad 113 is welded with the male seat 15, the male seat 15 is spliced with the adapter plate 20, the adapter plate 20 is electrically connected with the lead 30, and the lead 30 is spliced with the electric field generator (not shown), so that a temperature signal detected by the temperature sensor 14 is transmitted to the electric field generator (not shown), and the purpose that the electric field generator (not shown) controls an alternating electric signal transmitted to the ceramic transduction piece 12 through the detected temperature signal to avoid low-temperature scalding of the tumor body surface of a patient caused by overhigh temperature is achieved. An AC signal generated by an electric field generator (not shown) is transmitted to the first AC line 114C disposed in a ring shape through the corresponding at least two second bonding pads 113C, and then transmitted to the ceramic transduction sheet 12 through the plurality of conductive pads 111 welded to the first AC line 114C, so as to apply an AC electric signal to a tumor site for tumor electric field treatment. The AC signal required for the ceramic transducer sheet 12 is an AC signal and is output from an electric field generator (not shown). The electric field generator (not shown) also outputs a dc electrical signal to the temperature sensor 14, causing the temperature sensor 14 to be connected to a ground signal and operate to generate a temperature signal.

The support plate 13 is adhered to a side surface of the flexible plate base 11 remote from the conductive plate 111 by an adhesive (not shown). The support plates 13 are in one-to-one correspondence with the ceramic transduction plates 12 in the thickness direction. The temperature sensor 14 is welded at the positions of the flexible board substrate corresponding to the two first bonding pads 112, the ceramic transduction piece 12 is welded at the positions of the flexible board substrate 11 corresponding to the plurality of conductive plates 111, and the male seat 15 is welded at the position of the second bonding pad 113 of the flexible board substrate 11. The temperature sensor 14, the ceramic transduction piece 12 and the supporting plate 13 are all arranged at the same end of the flexible plate base body 11. When the temperature sensor 14 and the ceramic transduction piece 12 are welded, the supporting plate 13 provides strength support for the flexible plate base 11, provides a flat welding plane for welding operation between the flexible plate base 11 and the temperature sensor 14 and the ceramic transduction piece 12, and improves the product yield. The stiffening plate 16 is stuck and arranged at one end of the flexible board base 11, which is positioned at the welded male base 15, the stiffening plate 16 is arranged on the surface of one side of the flexible board base 11, which is opposite to the male base 15, so as to provide strength support for the flexible board base 11, so that the male base 15 is welded on the stiffening plate base, and meanwhile, the situation that the welding part of the flexible board base 11 and the male base 15 bends when the male base 15 of the electrode unit 10 is plugged and unplugged with the adapter plate 20 is avoided, so that the conductive trace embedded in the flexible board base 11 is broken. The reinforcing plate 16 and the male seat 15 are respectively arranged on two opposite sides of the flexible board base 11. The reinforcing plate 16 and the male seat 15 are positioned at the same end of the flexible board base 11.

The adapter plate 20 is provided with at least one female seat 25 corresponding to and electrically connected with the male seat 15 of the electrode unit 10. The electrode patch 100 with at least one electrode unit 10 can be formed by plugging and combining the plurality of electrode units 10 with the corresponding female seats 25 on the adapter plate 20 through the corresponding male seats 15, and the electrode unit 10 and the adapter plate 20 can be detachably combined, so that the electrode unit 10 with failure can be detachably replaced, or the adapter plate 20 with failure can be detachably replaced, the scrapping of the whole electrode patch 100 is avoided, and the yield loss of the electrode patch 100 is reduced; the whole electrode patch 100 is prevented from being scrapped, waste is avoided, and the cost is reduced; meanwhile, the number of the electrode units 10 inserted onto the adapter plate 20 can be freely combined and selected to increase or decrease the electric field intensity generated by the electrode patch 100, so as to ensure that the electrode patch 100 generates the electric field intensity of the required size of the tumor part of the patient.

The adapter plate 20 is in a sheet-like arrangement and has a body 28 for plugging and combining at least one electrode unit 10 and a connection portion 27 for electrically connecting with a lead 30. The wire connection portion 27 is integrally provided with the body 28. The wire connection portion 27 is located at one side end of the body 28. The female socket 25, which is inserted into the male socket 15 of the electrode unit 10, is provided on the body 28 by welding. The lead 30 is electrically connected to the interposer 20 by soldering with the wiring portion 27. The electrode unit 10 of the electrode patch 100 is connected with the adapter plate 20 through the male seat 15 and the female seat 25 welded on the adapter plate 20 in an inserting manner, and the adapter plate 20 is connected with the lead 30 through the wiring portion 27 and the lead 30 in an electric manner. The electrode unit 10 of the electrode patch 100 is electrically connected to the lead 30 through the interposer 20. Preferably, the interposer 20 is a flexible circuit board. Preferably, the plurality of electrode units 10 are all connected to the interposer 20 in parallel, and even if the electrical connection between one electrode unit 10 and the interposer 20 is interrupted, the electrical connection between the rest of the electrode units 10 and the interposer 20 is not affected.

Referring to fig. 5A and 5B, the interposer 20 has at least one set of third pads 23 disposed on the body 28 and soldered to the corresponding female sockets 25, and a plurality of fourth pads 24 disposed on opposite sides of the wiring portion 27 and soldered to the wires 30. The configuration of each group of third pads 23 is the same as that of the second pads 113 of the electrode unit 10, each group of third pads 23 has a plurality of third pads 23, one third pad 23A of the plurality of third pads 23 is connected to a ground signal, one third pad 23B is connected to a temperature signal, and the remaining third pads 23C are connected to an AC signal. A set of fourth pads 24 has a plurality of fourth pads 24. The fourth pads 24 include a fourth pad 24A transmitting a ground signal, a fourth pad 24C transmitting an AC signal, and a plurality of fourth pads 24B transmitting respective temperature signals. The third pads 23A transmitting the ground signal among the plurality of sets of third pads 23 are each connected in parallel to one fourth pad 24A, the plurality of third pads 23C transmitting the AC signal among the plurality of sets of third pads 23 are each connected in parallel to one fourth pad 24C, and the third pads 23B transmitting the temperature signal among the plurality of sets of third pads 23 are each connected to the corresponding fourth pad 24B.

The interposer 20 has embedded therein a plurality of second conductive traces 26. The third pads 23 and the fourth pads 24A, 24B, and 24C are respectively disposed at two opposite ends of the multiple second conductive traces 26, and are electrically connected with each other through the second conductive traces 26. The plurality of groups of third bonding pads 23 are arranged at one end of the plurality of second conductive traces 26 in parallel, and the plurality of electrode units 10 can be connected to the adapter plate 20 in parallel after the plurality of electrode units 10 are respectively inserted into the female sockets 25 welded with the plurality of groups of third bonding pads 23 through the corresponding male sockets 15, so that signal transmission between each electrode unit 10 and the adapter plate 20 is independent and is not affected by each other, and even if one electrode unit 10 is damaged, signal transmission between the rest electrode units 10 and the adapter plate 20 is not affected, and normal operation of the rest electrode units 10 is ensured without replacing or scrapping the whole electrode patch 100.

The multiplexed second conductive trace 26 includes a second ground line 26A that transmits a ground signal, a second AC line 26C that transmits an AC signal, and a second signal line 26B that transmits a corresponding temperature signal, respectively. The second AC lines 26C transmit AC signals, are arranged in a dendritic wiring manner, and are electrically connected with one third pad 23C connected with AC signals in each group of third pads 23 and one fourth pad 24C connected with AC signals in the fourth pad 24, so that each electrode unit 10 assembled with the corresponding female socket 25 of the third pad 23 is in an equipotential state, and the AC signal stability of the electrode patch 100 is ensured. One third pad 23C of each set of third pads 23, to which an AC signal is connected, is connected to the second AC line 26C in parallel, i.e., AC signal on-off of each electrode unit 10 assembled with the female socket 25 corresponding to the corresponding third pad 23 does not affect each other. Even if the electrode unit 10 is damaged during the use process, the other electrode units 10 are not influenced to continuously apply an alternating electric field to the tumor site of the patient for tumor electric field treatment. The second ground line 26A transmits a ground signal, is arranged in a dendritic wiring manner, and is electrically connected with one third pad 23A connected with the ground signal in each group of third pads 23 and one fourth pad 24A connected with the ground signal in the fourth pad 24. One third pad 23A of each set of third pads 23, to which a ground signal is connected, is connected to the second ground line 26A in parallel, i.e., the ground signal on-off of each electrode unit 10 assembled with the female socket 25 corresponding to the corresponding third pad 23 does not affect each other. The plurality of second signal lines 26B respectively transmit corresponding temperature signals and are electrically connected to one third pad 23B of the corresponding group of third pads 23, and a corresponding fourth pad 24B of the group of fourth pads 24, to which the temperature signals are connected, in a one-to-one correspondence. By means of the connection relationship between the third bonding pads 23, the fourth bonding pads 24 and the multiple second conductive traces 26, at least one group of the third bonding pads 23 are connected in parallel, so as to realize that at least one electrode unit 10 is connected to the adapter board 20 in parallel, and the connection and disconnection of the AC signal, the ground signal and the temperature signal of each electrode unit 10 are not affected.

That is, the plurality of third pads 23C are connected to the second AC line 26C in parallel. The plurality of third pads 23A are also connected in parallel to the second ground line 26A. The plurality of third pads 23B are connected to respective corresponding one of the signal lines 26B, and are connected to their respective fourth pads 24B through respective corresponding one of the signal lines 26B. Each female seat 25 is welded with the third bonding pad 23 of the corresponding group and is arranged on the adapter plate 20 in parallel, each electrode unit 10 can be connected to the adapter plate 20 in parallel after each electrode unit 10 is plugged onto the corresponding female seat 25 through the corresponding male seat 15, and therefore signal on-off between each electrode unit 10 and the adapter plate 20 is not affected, and even if one electrode unit 10 is damaged or the electrical connection between the electrode unit 10 and the adapter plate 20 is disconnected, the electrical connection and signal transmission between the other electrode units 10 and the adapter plate 20 are not affected.

The plurality of third bonding pads 23A for transmitting the grounding signal and one fourth bonding pad 24A for transmitting the grounding signal are respectively arranged at two opposite ends of one path of second grounding wire 26A, and the corresponding electrical connection between the third bonding pads 23A and the fourth bonding pads 24A is realized through the path of second grounding wire 26A, and the plurality of third bonding pads 23A are arranged at one end of the second grounding wire 26A in parallel connection, so that the grounding signal transmission of each electrode unit 10 is independent and does not affect each other after the plurality of electrode units 10 are inserted into the corresponding mother seat 25 of the adapter plate 20. One end of each second signal line 26B for transmitting temperature signals is connected with a third bonding pad 23B for transmitting temperature signals, and the other end is connected with a fourth bonding pad 24B for transmitting temperature signals and corresponding to the third bonding pad 23B so as to respectively transmit temperature signals collected by the temperature sensors 14 of the electrode units 10, so that the temperature signal transmission between the electrode units 10 can be independent and not affected after the electrode units 10 are plugged onto the adapter plate 20.

The third pads 23C for transmitting AC signals and the fourth pad 24C for transmitting AC signals are respectively disposed at opposite ends of a path of second AC line 26C, and electrically connected to the fourth pad 24C through the path of second AC line 26C, and the third pads 23C are disposed at one end of the second AC line 26C in parallel connection. The second AC lines 26C for transmitting AC signals are dendritic wires, one end of each second AC line is electrically connected to one third pad 23C of each third pad 23, and the other end of each second AC line is electrically connected to one fourth pad 24C of the fourth pads 24, so that the AC signal transmission of each electrode unit 10 can be independent and not affected after each electrode unit 10 is plugged into the corresponding female socket 25 of the interposer 20 through the corresponding male socket 15.

In the present embodiment, the number of fourth pads 24 is greater than the number of second conductive traces 26, which includes fourth pads 24A, 24B, 24C electrically connected to the corresponding second conductive traces 26, all being conductive pads. The fourth bonding pad 24 further includes a dummy bonding pad 24D disposed in a disconnected state from the second conductive trace 26, so as to enhance the bonding firmness between the flexible interposer 20 and the conductive leads 30.

In this embodiment, multiple second conductive traces 26 embedded in the interposer 20 are separated into two wiring layers, so as to avoid mutual interference between the second conductive traces 26. In this embodiment, the second AC lines 26C are distributed in one layer, and the second ground lines 26A and the second signal lines 26B are distributed in two wiring layers so as to avoid the second AC lines 26C. In other embodiments, the multiple second conductive traces 26 embedded in the interposer 20 are separated into three or more wiring layers, so as to improve flexibility of wiring the multiple second conductive traces 26.

As shown in fig. 4, 5A and 5B, in the present embodiment, the interposer 20 has a plurality of female sockets 25 respectively soldered with the corresponding sets of third pads 23. The plurality of female seats 25 are welded on the body 28 at intervals. The body 28 of the adapter plate 20 also has a trunk 21 and at least one limb 22. The wire connection portion 27 is located at one end of the trunk 21 of the body 28. The second conductive trace 26 of the interposer 20 is embedded in the trunk 21 and the branch 22 of the body 28. The plurality of female seats 25 are respectively welded on one trunk 21 and at least one branch 22 at intervals, so that the plurality of electrode units 10 are assembled on the adapter plate 20 at intervals through the plug-in cooperation of the female seats 25 and the male seats 15 of the electrode units 10, and meanwhile, the plurality of electrode units 10 are electrically connected with the adapter plate 20.

In this embodiment, the trunk 21 of the body 28 of the adapter plate 20 is provided with at least one through hole 211. The hollow hole 211 of the body 28 of the adapter plate 20 can allow the ceramic transduction piece 12 of the corresponding electrode unit 10 to pass through, so that the ceramic transduction piece 12 of the corresponding electrode unit 10 can be exposed to one side of the adapter plate 20 far away from the mother seat 25, and further the ceramic transduction piece 12 of the corresponding electrode unit 10 can pass through the adapter plate 20 to be configured on the skin surface of a human body.

In this embodiment, the adapter board 20 has 1 trunk 21 and 4 branches 22 extending from the trunk 21 toward two sides, and two sides of the trunk 21 are respectively provided with 2 branches 22. The branches 22 on different sides of the trunk 21 are aligned in pairs. The interval 221 which can allow the ceramic transduction piece 12 of the corresponding electrode unit 10 to pass through is arranged between the two adjacent limbs 22 positioned on the same side of the trunk 21, so that the ceramic transduction piece 12 of the corresponding electrode unit 10 can be exposed to the side of the adapter plate 20 far away from the mother seat 25, and the ceramic transduction piece 12 of the corresponding electrode unit 10 can be arranged on the skin surface of a human body through the adapter plate 20.

In this embodiment, 13 female sockets 25 are disposed on the adapter board 20, and the 13 female sockets 25 are respectively disposed on 1 trunk 21 and 4 branches 22 of the body 28. The trunk 21 is provided with 3 female seats, two limbs 22 close to the wiring part 27 are respectively provided with 2 female seats, and the other two limbs 22 are respectively provided with 3 female seats. Two hollow holes 211 are formed in the trunk 21 in a penetrating manner so as to accommodate the ceramic transduction plates of the corresponding 1 electrode unit 10 respectively. The 3 female seats 25 on the main body 21, the two hollow holes 211 on the main body 21 and the wiring portion 27 are all axisymmetrically arranged, and the symmetry axes of the three are in line coincidence. As shown in fig. 4, the 3 female seats 25 on the trunk 21 are aligned with two hollow holes 211 on the trunk 21 in a longitudinal direction. 2 of the 3 female seats 25 on the trunk 21 are arranged on the same side of one hollow hole 211 far away from the wiring part 27, and the other is arranged at a position between the two hollow holes 211 of the trunk 21.

The 2 female sockets 25 provided on the limbs 22 near the wire connection portion 27 are disposed on the corresponding limbs 22 in a substantially "L" shape. The 3 female seats 25 arranged on the branch 22 far from the wiring part 27 are approximately n-shaped and are arranged on the corresponding branch 22, and the opening of the n-shaped formed by the 3 female seats 25 faces the trunk 21. The plurality of female seats 25 provided on the limbs 22 are symmetrically arranged along the longitudinal symmetry axis of the trunk 21. 2 of the 5 female seats 25 on the two limbs 22 on the same side of the trunk 21 are respectively arranged at the end parts of the corresponding limbs 22 in a longitudinal alignment manner, and the remaining 3 are respectively arranged at the positions of the corresponding limbs 22 close to the trunk 21 in a longitudinal alignment manner. The 3 female seats 25 provided on the trunk 21 are arranged in longitudinal alignment. The 4 female seats 25 on the branches 22 located on opposite sides of the trunk 21 and both close to the connection portion 27 are arranged in a transverse alignment manner, specifically, the two female seats 25 respectively located on the ends of the two branches 22 close to the connection portion 27 are arranged in a transverse alignment manner, and the two female seats 25 respectively located on the two branches 22 close to the connection portion 27 and close to the trunk 21 are also arranged in a transverse alignment manner. Two female seats 25 which are arranged on two limbs 22 far from the wiring part 27 and are positioned at the end parts of the corresponding limbs 22 are arranged in a transverse alignment mode, 2 of 4 female seats 25 which are arranged on two limbs 22 far from the wiring part 27 and are positioned at the position, close to the trunk 21, of the corresponding limbs 22 are arranged in a transverse alignment mode, and the other 2 female seats are also arranged in a transverse alignment mode.

In this embodiment, the female sockets 25 located on the limbs 22 are uniformly distributed on the edges of the corresponding limbs 22, and the female sockets 25 located on the trunk 21 and the corresponding female sockets 25 located on the limbs 22 are respectively arranged in a transverse alignment manner, so that the second conductive traces 26 of the interposer 20 are arranged in a wiring manner, and each female socket 25 is arranged on the interposer in parallel through the second conductive traces 26. As shown in fig. 4 and 6B, the electrode units 10 detachably connected to the female sockets 25 located at the ends of the respective limbs 22 are horizontally assembled to the adapter plate 20, and the electrode units 10 detachably assembled to the female sockets 25 located outside the ends of the respective limbs 22 are longitudinally assembled to the adapter plate 20. In other embodiments, since the electrode units 10 are connected to the adapter plate 20 in parallel, the AC signal, the ground signal and the temperature signal of each electrode unit 10 are not affected by each other, and the number of the electrode units 10 detached from the adapter plate 20 is less than the number of the female sockets 25 on the adapter plate 20.

Referring to fig. 4, 5A, 5B and 8A, one end of the wire 30 is electrically connected to the connection portion 27 of the interposer 20, and the other end is provided with a plug 32. Preferably, the lead 30 is a lightning Mo Mu head sheathed wire. The wire 30 has a plurality of wire cores (not shown), each wire core (not shown) being soldered to a corresponding fourth pad 24 on both side surfaces of the wire connection portion 27, respectively. In the present embodiment, the number of electrode units 10 of the electrode patch 100 is 13, and the number of cores (not shown) of the wires 30 is 16. Accordingly, the wire 30 has a core (not shown) soldered to the fourth pads 24A, 24B, 24C and a core (not shown) soldered to the dummy pad 24D. The periphery of the welding position of the lead 30 and the wiring part 27 is also covered with a circle of heat-shrinkable sleeve 31 for sealing and insulating the welding position of the adapter plate 20 and the lead 30, so that the welding position of the adapter plate 20 and the lead 30 is prevented from being broken, and meanwhile, the waterproof and dustproof welding device can be used for preventing dust and water.

The wire 30 further includes shielding grid lines (not shown) wrapped around the plurality of wire cores (not shown). The fourth bonding pad 24 further includes a fourth bonding pad 24E at an end of the connection portion 27, which is soldered to a shielding grid line (not shown) of the wire 30 to shield the wire 30 from external signals interfering with signals transmitted from a plurality of cores (not shown) of the wire 30. The fourth pad 24E for shielding and the fourth pad 24A for transmitting a ground signal are connected to the second ground line 26A of the second conductive trace 26.

As shown in fig. 8A and 8B, the plug 32 of the lead 30 may be plugged with a patch cord 33, and the electrical connection between the plug and the electric field generator (not shown) may be achieved by plugging the patch cord 33 into the electric field generator (not shown), or the electrical connection between the plug and the electric field generator (not shown) may be achieved by plugging the patch cord 33 into an adapter (not shown) and plugging the plug and the electric field generator (not shown) into an adapter (not shown). The patch cord 33 is detachably connected with the lead 30, so that the distance between the lead 30 and the electric field generator (not shown) or the adapter (not shown) can be increased or shortened as required, and only the lead 30 welded with the patch panel 20 can be scrapped when the electrode patch 100 is scrapped and needs to be replaced, without scrapping the patch cord 33, the cost can be reduced, and unnecessary waste can be avoided. The number of cores (not shown) of the patch cord 33 is identical to the number of cores (not shown) of the wire 30, and corresponds one by one. The patch cord 33 is a Rameret double-male-head sheath cord.

The backing 40 is provided in a sheet form and has at least one through hole 41 corresponding to the electrode unit 10 and provided therethrough. The through holes 41 of the backing 40 allow the corresponding portions of the electrode unit 10 to be exposed on a side surface thereof remote from the adapter plate 20, which is advantageous for dissipating heat generated by the electrode patch 100 during tumor electric field therapy. In this embodiment, the support plate 13 of the electrode unit 10 passes through the through hole 41 of the backing 40 and exposes a side surface of the backing 40 remote from the interposer 20. The through holes 41 of the backing 40 are slightly larger in size than the support plate 13.

The support 50 is provided in the form of a sheet having a plurality of perforations 51 provided therethrough. The plurality of through holes 51 of the support 50 include a plurality of first through holes 51A distributed corresponding to the respective electrode units 10 and two second through holes 51B arranged in a long bar shape and located between the plurality of first through holes 51A. Each first through hole 51A accommodates the ceramic transduction sheet 12 of the corresponding electrode unit 10. The surface of the support member 50 near the patient's body surface is flush with the surface of the ceramic transducer sheet 12 near the patient's body surface, so that the adhesive member 60 can be smoothly covered on the support member 50 and the ceramic transducer sheet 12, and the application comfort of the electrode patch 100 is improved. The two second through holes 51B correspond to the positions where the trunk 21 of the adapter plate 20 extends laterally to form the branches 22, so that part of heat of the electrode patch 100 can be transferred from the adapter plate 20 to the external environment through the backing 40 to achieve the purpose of heat dissipation. Both the second through holes 51B are long holes. The first through holes 51A are each slightly larger in size than one end of the electrode unit 10 to which the ceramic transducer sheet 12 is welded. Preferably, the support 50 is foam.

The adhesive member 60 is provided with a plurality of strips. Each adhesive member 60 is generally in the form of a strip having a double-sided adhesive surface that engages the corresponding portion of the support member 50 and ceramic transducer sheet 12 on one side and engages the patient's body surface on the other side. Preferably, the adhesive member 60 is an electrically conductive hydrogel. Each adhesive member 60 covers at least one ceramic transducer sheet 12 of an electrode unit 10. In this embodiment, the adhesive member 60 is provided with 5 pieces of ceramic transducer sheet 12 each covering 2 or 3 electrode units 10. The 3 adhesive pieces 60 are arranged transversely in parallel and cover the ceramic transduction plates 12 of the 3 electrode units 10; there are 2 adhesive members 60 arranged in parallel in the longitudinal direction and each covering 2 ceramic transduction plates 12 of the electrode unit 10. The 2 strips of adhesive means 60 arranged longitudinally in parallel are distributed on both sides of the 3 strips of adhesive means 60 arranged transversely in parallel.

The electrode patch 100 may further include at least one release paper 70. The release paper 70 is positioned on the side of the adhesive element 60 facing away from the backing 40 and covers the adhesive element 60 and the corresponding portion of the backing 40 to protect the adhesive element 60 and the backing 40 from contamination of the adhesive element 60 and the backing 40. In this embodiment, the electrode patch 100 has two release papers 70. Two release papers 70 collectively cover the adhesive 60 and the backing 40.

Fig. 9 to 11 are electrode patches 100' according to a second embodiment of the present invention. The electrode patch 100' of the present embodiment includes an electrode unit 10', an adapter plate 20' detachably connected to the electrode unit 10', a lead 30' electrically connected to the adapter plate 20', a backing 40' attached to respective portions of the electrode unit 10' and the adapter plate 20', a support member 50' surrounding the respective portions of the electrode unit 10' and attached to the backing 40', and an adhesive member 60' covering the support member 50' and the respective portions of the electrode unit 10' and adhering to the skin of the body surface corresponding to the tumor site of the patient. The electrode patch 100 'is attached to the body surface corresponding to the tumor site of the patient through the backing 40', and an alternating electric field is applied to the tumor site of the patient through the 1 electrode unit 10 'detachably connected with the adapter plate 20' to interfere or prevent the mitosis of tumor cells of the patient, thereby achieving the purpose of treating tumors.

In comparison with the electrode patch 100 of the first embodiment, the electrode patch 100' of the present embodiment also includes the adapter plate 20', one electrode unit 10' detachably assembled on the adapter plate 20', the lead 30' welded to the adapter plate 20', the backing 40' attached to the respective portions of the electrode unit 10' and the adapter plate 20', the support member 50' surrounding the respective portions of the electrode unit 10' and attached to the backing 40', and the attaching member 60' covering the support member 50' and the respective portions of the electrode unit 10' and attached to the skin of the body surface corresponding to the tumor site of the patient. The electrode unit 10 'of the electrode patch 100' of the present embodiment has the same structure as the electrode unit 10 of the electrode patch 100 of the first embodiment, and also includes insulating plates 13 'and ceramic transduction plates 12' on opposite sides of a flexible plate base 11', and male seats 15' on opposite ends of the same side of the flexible plate base 11 'as the ceramic transduction plates 12'. The electrode patch 100' of the present embodiment is different from the electrode patch 100 of the first embodiment in that: the electrode patch 100 'includes only one electrode unit 10' detachably coupled to the adapter plate 20', and the shapes of the adapter plate 20' and the backing 40 'are different depending on the number of the electrode units 10' coupled.

Referring specifically to fig. 9A to 11B, the adapter plate 20' also includes a body 28' inserted into the electrode unit 10', a female socket 25' provided on the body 28', and a wire connection portion 27' extending laterally from the body 28 '. The male seat 15' of the electrode unit 10' is connected with the female seat 25' in a plugging manner so as to realize the electrical connection between the electrode unit 10' and the adapter plate 20 '. The wire connection portion 27 'is soldered to the wire 30' to electrically connect the interposer 20 'to the wire 30'. The body 28 'has only one trunk 21', and the female seats 25 'are disposed on the trunk 21' and located at opposite ends of the trunk 21 'with the wire connection portions 27', respectively. The stem 21' has only one set of third pads 23' soldered to the female mount 25 '. The third pad 23 'includes one third pad 23B' for transmitting a temperature signal, one third pad 23A 'for transmitting a ground signal, and a plurality of third pads 23C' for transmitting an alternating current signal. The plurality of third pads 23C' are each electrically connected to a transmission AC signal line. The number of the third pads 23 'is six in this embodiment, wherein the number of the third pads 23B' transmitting the temperature signal is one, the number of the third pads 23A 'transmitting the ground signal is one, and the number of the third pads 23C' transmitting the ac signal is four. The female seats 25' are only one. The wire connection portion 27' is provided on both side surfaces thereof with a plurality of fourth pads 24' to be soldered with the wires 30 '. The fourth pad 24 'includes a fourth pad 24A' transmitting a ground signal, a fourth pad 24B 'transmitting a temperature signal, a fourth pad 24C' transmitting an alternating current signal, a plurality of fourth pads 24D ', and a fourth pad 24E' for shielding. The fourth pads 24D ' are respectively provided at opposite sides of the wiring portion 27' of the interposer 20 '. In this embodiment, the number of the fourth pads 24D ' is seven, two of which are disposed on the same side of the interposer 20', and the other five of which are disposed on the other side of the interposer 20 '. The two fourth pads 24D ' on the same side are provided on the end side of the wiring portion 27' in a spaced-apart relationship with the three fourth pads 24A ', 24B ', 24C ' on the same side. The fourth bonding pad 24D 'may be welded with the core corresponding to the wire 30', so as to make the welding between the wire connection portion 27 'and the wire 30' stronger, and avoid the damage of the interposer 20 'and the failure of signal transmission due to the disconnection of the wire connection portion 27' and the wire 30 'when the wire 30' is pulled under force.

Three second conductive traces 26 'are embedded in the interposer 20'. None of the fourth pads 24D 'is electrically connected to the second conductive trace 26'. The three second conductive traces 26 'are a second ground line 26A', a second signal line 26B ', and a second AC line 26C', respectively. One end of the second ground line 26A ' is connected to the third pad 23A ', and the other end is connected to a fourth pad 24A ' for transmitting a ground signal. One end of the second signal line 26B ' is connected to the third pad 23B ' and the other end is connected to the fourth pad 24B ' for transmitting a temperature signal. The second AC line 26C ' has one end connected to the remaining 4 third pads 23C ' in series and the other end connected to one fourth pad 24C ' for transmitting an alternating current signal. The number of the fourth pads 24' in the present embodiment is greater than the number of the fourth pads 24' connected to the second conductive trace 26, and the fourth pads 24' located on each side of the connection portion 27' are 5, wherein the fourth pads 24' on one side include the fourth pads 24A ', 24B ', 24C ' electrically connected to the second ground line 26A ', the second signal line 26B ', and the second AC line 26C ', respectively, and two fourth pads 24D ' not electrically connected to the second ground line 26A ', the second signal line 26B ', and the second AC line 26C '. The 5 fourth pads 24 'on the other side of the connection portion 27' are all fourth pads 24D ', which are not electrically connected to the second conductive trace 26'. The fourth pads 24 'electrically connected to the second conductive traces 26' are all conductive pads 24A ', 24B', 24C ', and the fourth pads 24' not electrically connected to the second conductive traces 26 'are all dummy pads 24D'. The 3 conductive pads 24A ', 24B ', 24C ' are all located on the same side of the interposer 20' as the third pads 23A ', 23B ', 23C '. The fourth pad 24E 'for shielding is also electrically connected to the second ground line 26A'.

The wire 30' has 10 cores (not shown), wherein 3 cores (not shown) are soldered to 3 conductive pads 24A ', 24B ', 24C ' in the fourth pad 24' of the wire connection portion 27', respectively, and the remaining 7 cores (not shown) are soldered to 7 dummy pads 24D ', respectively. The wire 30' is provided with a plug 32' at an end remote from the terminal portion 27 '. The plug 32 'may also be connected to a transfer cord 33'. The number of cores (not shown) of the patch cord 33 'is identical to the number of cores (not shown) of the wire 30', and corresponds one by one. The welding part of the wire 30 'and the connection part 27' of the adapter plate 20 'is peripherally covered with a heat-shrinkable sleeve 31'.

The backing 40' is generally square and sheet-like in configuration with at least two lugs 42' at its edges to facilitate handling of the electrode patch 100' by an operator and application of the electrode patch 100' to a corresponding body surface of a patient's tumor site. The side of the electrode unit 10' remote from the ceramic transduction sheet 12' is attached to a backing 40 '. The backing 40' also adheres to the respective portions of the adapter plate 20' and heat shrink 31'. The heat shrink 31 may also be wrapped around the outer periphery of the male seat 15 'and the female seat 25' when assembled and disassembled.

The supporting member 50 'is substantially square and sheet-shaped, and has a through hole 51' formed therein. The through hole 51' is similar to the first through hole 51A of the embodiment for receiving the ceramic transduction sheet 12' of the electrode unit 10 '. As in the first embodiment, the support 50 'is substantially flush with a side surface of the ceramic transduction sheet 12' of the electrode unit 10 'remote from the backing 40'.

The adhesive member 60' is provided in a substantially square sheet shape, covering and supporting the ceramic transduction sheet 12' of the electrode unit 10' and the support member 50' on a side surface thereof remote from the backing 40 '. The size of the adhesive member 60 'is substantially the same as the size of the support member 50'.

The electrode patches 100 and 100 'of the tumor electric field therapeutic apparatus (not shown) are formed by detachably connecting at least one electrode unit 10 and 10' with the adapter plates 20 and 20', so that the electrode units 10 and 10' which fail on the detachable replacement electrode patches 100 and 100 'or the adapter plates 20 and 20' which fail on the detachable replacement electrode patches 100 and 100 'are realized, the loss of the whole electrode patches 100 and 100' is reduced, the yield loss of the electrode patches 100 and 100 'is reduced, and the scrapping and the waste of the whole electrode patches 100 and 100' caused by the damage of one of the electrode units 10 and 10 'and the adapter plates 20 and 20' are avoided. In addition, the electrode patch 100 of the present application is matched with the plurality of female seats 25 and the electrode units 10 which can be inserted into the female seats 25 through the plurality of female seats 25 arranged on the adapter plate 20, so that a proper number of electrode units 10 can be freely selected according to the size of the tumor part and the position of the tumor part to be inserted into the adapter plate 20', and the coverage area of the electrode patch 100 and the strength of the applied alternating electric field can be ensured to reach the electric field strength required by tumor treatment.

Fig. 12 is a method of manufacturing the electrode patch 100, 100' of the present invention shown in fig. 1 to 11, which includes the steps of:

s11, providing an interposer 20, 20', wherein the interposer 20, 20' has at least one set of third pads 23, 23 'and a wiring portion 27, 27';

s12, providing at least one female seat 25, 25', and respectively welding the female seats 25, 25' on the corresponding third bonding pads 23, 23 'of the adapter plates 20, 20';

s13, providing a lead 30, 30', and arranging the lead 30, 30' on the wiring parts 27, 27 'of the adapter plates 20, 20';

s14, providing a heat-shrinkable sleeve 31, 31', and wrapping the heat-shrinkable sleeve 31, 31' at the joint of the adapter plate 20, 20 'and the lead 30, 30';

s15, providing at least one electrode unit 10, 10' detachably connected with the adapter plates 20, 20', and clamping the electrode units 10, 10' with the female seats 25, 25' on the adapter plates 20, 20 ';

s16, providing a back lining 40 and 40', and adhering the corresponding part of one side surface of the adapter plate 20 and 20' with the mother seats 25 and 25' and the surface of the electrode units 10 and 10' on the same side on the back lining 40 and 40 '.

In the above step S11, the adapter plate 20, 20 'further includes the bodies 28, 28' of the foregoing first and second embodiments. At least one set of third pads 23, 23 'is distributed on the body 28, 28'. The bodies 28, 28 'are arranged in engagement with the connection portions 27, 27'.

In the above step S13, the wires 30, 30 'may be plugged with the patch cords 33, 33' of the first and second embodiments.

The method of manufacturing the electrode patch 100, 100' of the present invention further includes the steps of:

s17, providing a supporting piece 50, 50', and adhering the supporting piece 50, 50' on the backing 40, 40 'in a surrounding shape surrounding the corresponding part of the electrode unit 10, 10';

s18, providing an adhesive piece 60, 60', and adhering the adhesive piece 60, 60' to the surface of one side of the corresponding part of the support piece 50, 50' and the electrode unit 10, 10' away from the backing 40, 40 ';

s19, providing a release paper 70, and covering the release paper 70 on the surface of the back lining 40, 40 'and the surface of the adhesive piece 60, 60' close to the skin of the patient.

In the above step S17, the supporting members 50, 50' have at least one through hole 51, 51' formed therethrough to accommodate the corresponding portion of the corresponding electrode unit 10, 10 '.

Referring to fig. 13, the method of manufacturing the electrode unit 10, 10 'of the electrode patch 100, 100' of the present invention includes the steps of:

s21, providing a flexible board substrate 11, wherein one end of the flexible board substrate 11 is provided with a plurality of conductive plates 111 arranged at intervals, two first bonding pads 112 positioned in the surrounding area of the conductive plates 111, and the other end is provided with a plurality of second bonding pads 113;

S22, providing a supporting plate 13, and respectively arranging the supporting plate 13 on the flexible plate base 11 in a one-to-one correspondence manner with a plurality of conductive plates 111, wherein the supporting plate 13 and the conductive plates 111 are respectively positioned on two opposite sides of the flexible plate base 11;

s23, providing a temperature sensor 14, and welding the temperature sensor 14 on the two first bonding pads 112;

s24, providing a ceramic transduction piece 12 with an opening 121, welding the ceramic transduction piece 12 on a plurality of conductive plates 111 in a mode of accommodating corresponding temperature sensors in the opening, wherein the temperature sensors 14 are accommodated in the opening 121 of the ceramic transduction piece 12;

s25, providing a male seat 15, and welding the male seat 15 on the plurality of second bonding pads 113.

The conductive pad 111, the first pad 112, and the second pad 113 in step S21 are all provided on the same side surface of the flexible board base 11. The conductive pads 111 and the second pads 113 are respectively located at opposite ends of the flexible board base 11.

The foregoing description of the preferred embodiments of the present application is not intended to be limiting, but rather is intended to cover any and all modifications, equivalents, alternatives, and improvements that fall within the spirit and principles of the present application.

Claims

1. The electrode patch is used for tumor electric field treatment and is characterized by comprising a plurality of electrode units, an adapter plate and a backing, wherein the adapter plate is formed by a flexible circuit board, the electrode units and the adapter plate are adhered to the backing, the electrode units comprise a flexible plate substrate, transduction plates and a male seat, the transduction plates and the male seat are respectively arranged at two opposite ends of the same side surface of the flexible plate substrate, the flexible plate substrate is provided with a conductive disc electrically connected with the transduction plates, a second bonding pad electrically connected with the conductive disc, and the male seat is welded with the second bonding pad and electrically connected with the second bonding pad; the adapter plate is provided with a plurality of female seats, a plurality of groups of third bonding pads which are welded with the corresponding female seats in a one-to-one correspondence manner and a wiring part with a plurality of fourth bonding pads, and the third bonding pads are electrically connected with the corresponding fourth bonding pads through second conductive traces embedded in the adapter plate; the male seat and the corresponding female seat are positioned at the overlapping part of the electrode unit and the adapter plate and are inserted into each other so that the electrode unit is connected to the adapter plate in parallel in a detachable manner; the electrode units are clamped between the back lining and the adapter plate, the adapter plate comprises a body and a wiring part connected with one end of the body, a plurality of female seats are arranged on the body, and the body is provided with hollowed holes or intervals for exposing the transduction piece of each electrode unit.

2. The electrode patch of claim 1, wherein the electrode unit includes a support plate provided on the other side surface of the flexible board substrate, the transduction piece is a ceramic transduction piece, and the ceramic transduction piece and the support plate are located on opposite sides of the same end of the flexible board substrate.

3. The electrode patch of claim 2, wherein the electrode unit further comprises a temperature sensor disposed on the flexible board substrate and on the same side as the ceramic transduction piece, the ceramic transduction piece having an opening therethrough, the temperature sensor being received in the opening of the ceramic transduction piece.

4. The electrode patch of claim 3, wherein the body has a trunk, a portion of the female seat is located on the trunk, and the trunk of the body is provided with the hollowed-out hole.

5. The electrode patch of claim 4, wherein the body further comprises a plurality of limbs positioned on both sides of the trunk, a portion of the female seats being positioned on the limbs, and adjacent two of the limbs positioned on the same side of the trunk having the space therebetween.

6. The electrode patch of claim 5, further comprising a wire electrically connected to the connection portion of the interposer, wherein one end of the wire is electrically connected to the connection portion of the interposer, and the other end of the wire is provided with a plug.

7. The electrode patch according to claim 6, wherein a circle of heat-shrinkable sleeve is further provided around the periphery of the junction of the lead and the wire connection portion.

8. The electrode patch of claim 6, wherein the plug of the lead is further removably plugged into a patch cord.

9. The electrode patch of claim 1, wherein the backing is sheet-like and has at least one through hole corresponding to the electrode unit and disposed therethrough, the through hole of the backing allowing a corresponding portion of the electrode unit to expose a side surface of the backing remote from the adapter plate.

10. The electrode patch of claim 9, further comprising a support member surrounding the respective portion of the electrode unit and adhered to the backing, and an adhesive member covering the support member and the respective portion of the electrode unit and conforming to the skin of the body surface corresponding to the tumor site of the patient.

11. The electrode patch of claim 10, wherein the support member has at least one perforation disposed therethrough, the perforation including a first perforation corresponding to a respective electrode unit and receiving a respective portion of the respective electrode unit, and a second perforation located between the plurality of first perforations and opposite the adapter plate.

12. A method of manufacturing the electrode patch according to any one of claims 1 to 11, comprising the steps of:

s11, providing an adapter plate, wherein one side surface of the adapter plate is provided with at least one group of third bonding pads and a wiring part;

s15, providing a plurality of electrode units detachably connected with the adapter plate, wherein the opposite ends of the same side face of the electrode units are respectively provided with a transduction piece and a male seat, and the male seat of the electrode units is spliced with a female seat on the adapter plate to fix the electrode units to the adapter plate;

s16, providing a backing, adhering the adapter plate and the electrode unit which are subjected to the steps to the backing in a mode that the side face of the adapter plate faces the backing, and clamping the electrode unit between the backing and the adapter plate.

13. The method of manufacturing an electrode patch according to claim 12, further comprising, after said step S16, the steps of:

14. The method of manufacturing an electrode patch according to claim 13, wherein the method of manufacturing an electrode unit includes the steps of:

s24, providing a transduction piece with an opening, and welding the transduction piece on a plurality of conductive plates in a mode of accommodating corresponding temperature sensors in the opening;

And S25, welding the male seats on the plurality of second bonding pads.

15. An electric field tumor therapeutic apparatus comprising an electric field generator and at least one pair of electrode patches according to any one of claims 1 to 11 electrically connected to the electric field generator.