CN114191706A

CN114191706A - Method for manufacturing electrode patch for tumor electric field treatment

Info

Publication number: CN114191706A
Application number: CN202111651358.7A
Authority: CN
Inventors: 孙义冬; 张军
Original assignee: Jiangsu Hailai Xinchuang Medical Technology Co Ltd
Current assignee: Jiangsu Hailai Xinchuang Medical Technology Co Ltd
Priority date: 2021-12-30
Filing date: 2021-12-30
Publication date: 2022-03-18

Abstract

The invention provides a method for manufacturing an electrode patch for tumor electric field treatment, which comprises the following steps: providing a flexible circuit board, wherein the flexible circuit board is provided with a plurality of conductive discs and a plurality of pairs of welding discs; providing a plurality of insulating plates and arranging the plurality of insulating plates on the flexible circuit board in a manner corresponding to the conductive disc; providing a plurality of solder pastes and placing the solder pastes on the flexible circuit board in a mode of respectively corresponding to the conductive disc and the bonding pad; providing sealant and coating the sealant on the periphery of the surrounding area of the corresponding conductive disc in a mode of not covering solder paste; providing a plurality of temperature sensors and respectively placing the temperature sensors on the solder paste corresponding to the bonding pads; providing a plurality of dielectric elements and respectively placing the dielectric elements on the solder paste corresponding to the conductive plates; reflow soldering is carried out on the flexible circuit board; carrying out secondary sealing on the flexible circuit board; providing a lead and welding the lead with the flexible circuit board. The manufacturing method of the invention realizes the welding of the dielectric element, the temperature sensor and the flexible circuit board and the solidification of the sealant at the same time during reflow soldering, thereby shortening the manufacturing period.

Description

Method for manufacturing electrode patch for tumor electric field treatment

Technical Field

The invention relates to a method for manufacturing an electrode patch for tumor electric field treatment, belonging to the technical field of medical instruments.

Background

At present, the treatment modes of tumors mainly comprise operations, radiotherapy, chemotherapy and the like, but the methods have corresponding defects, for example, radiotherapy and chemotherapy can generate side effects and kill normal cells. The electric field 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 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 of dividing cancer cells, prevent the formation of spindles of the dividing cancer cells, inhibit the mitosis process of the cancer cells and induce the apoptosis of the cancer cells.

The electric field therapeutic apparatus for treating tumor mainly comprises an electric field generating device and an electrode patch electrically connected with the electric field generating device. The electrode patch includes a backing having a biocompatible adhesive, an electrical functional component disposed on the backing, and an adhesive member adhered to a corresponding location of the electrical functional component. The electrically functional component is adhered to the backing by a biocompatible adhesive. The adhesive member is disposed on a side of the electrical functional assembly remote from the backing and applied to the skin of a person. The electric function assembly comprises a flexible circuit board, insulating plates and dielectric elements, wherein the insulating plates and the dielectric elements are arranged on two sides of the flexible circuit board. In the process of manufacturing the electrical functional assembly, the dielectric element is welded on the flexible circuit board in a reflow soldering mode, and after welding, a gap formed by welding the dielectric element and the flexible circuit board is filled with the sealant. The existing reflow soldering and sealant filling process is complex and needs to go through a plurality of stages. Therefore, the electrode patch is long in manufacturing cycle and high in time cost.

Therefore, there is a need for an improved method for manufacturing an electrode patch for electric field therapy of tumors, which overcomes the problems of the above-mentioned manufacturing process.

Disclosure of Invention

The invention provides a manufacturing method of an electrode patch for tumor electric field treatment, which improves the productivity of products.

The manufacturing method of the electrode patch for tumor electric field treatment is realized by the following technical scheme: a manufacturing method of an electrode patch for tumor electric field treatment comprises the following steps:

s1: providing a flexible circuit board, wherein the flexible circuit board is provided with a plurality of conducting discs arranged at intervals and a plurality of pairs of welding discs which are positioned on the same side with the conducting discs;

s2: providing a plurality of insulating plates and respectively arranging the insulating plates on the flexible circuit board in a one-to-one correspondence mode with the conductive discs, wherein the insulating plates and the conductive discs are respectively positioned at two opposite sides of the flexible circuit board;

s3: providing a plurality of solder pastes and placing the solder pastes on the conductive disc and the bonding pad in a one-to-one correspondence manner with the conductive disc and the bonding pad respectively;

s4: providing a sealant and coating the sealant on the periphery of the surrounding area of the corresponding conductive disc in a mode of not covering the solder paste;

s5: providing a plurality of temperature sensors and respectively placing the temperature sensors on the solder paste corresponding to the bonding pad in a one-to-one corresponding manner with the solder paste placed on the bonding pad;

s6: providing a plurality of dielectric elements and placing the dielectric elements on the solder paste corresponding to the conductive disc in a one-to-one correspondence manner with the solder paste placed on the conductive disc, wherein the sealant is positioned between the dielectric elements and the corresponding parts of the flexible circuit board;

s7: reflow soldering is carried out on the flexible circuit board provided with the dielectric element, the temperature sensor and the sealant;

s8: carrying out secondary sealing on the flexible circuit board provided with a plurality of dielectric elements and temperature sensors;

s9: and providing a lead and welding the lead with the flexible circuit board after secondary sealing.

Further, the reflow soldering of the flexible circuit board opposing the dielectric element and the temperature sensor in step S7 is performed by melting the solder paste disposed on the conductive pad to solder the conductive pad and the dielectric element, and melting the solder paste disposed on the pad to solder the pad and the temperature sensor.

Further, in step S7, the flexible printed circuit board opposite to the dielectric element, the temperature sensor, and the sealant is reflowed by curing the sealant coated on the periphery of the surrounding region of the conductive pad to seal the dielectric element and the flexible printed circuit board for the first time.

Further, in step S7, the flexible printed circuit board opposite to the dielectric element, the temperature sensor, and the sealant is reflowed to complete the soldering between the dielectric element, the temperature sensor, and the flexible printed circuit board, the curing of the sealant, and the first sealing between the dielectric element and the flexible printed circuit board.

Further, in step S8, the secondary sealing of the flexible printed circuit board with the plurality of dielectric elements and the temperature sensor is performed by filling a sealant into the gap formed between the dielectric elements and the flexible printed circuit board and located in the surrounding area of the conductive plate.

Further, the sealant in step S4 is a first sealant, and the sealant for performing the secondary sealing in step S8 is a second sealant.

Further, the dielectric element has a through hole disposed therethrough for receiving a temperature sensor or allowing gas formed in a gap between the dielectric element and the flexible circuit board to be discharged therefrom.

Further, the secondary sealing of the flexible circuit board, on which the plurality of dielectric elements and the temperature sensor are mounted, in step S8 is performed by filling a second sealant into the gap formed between the corresponding portions of the dielectric elements and the flexible circuit board along the through holes of the dielectric elements.

Further, the first sealant is a thermal curing adhesive, and the curing temperature range of the first sealant is 120-150 ℃.

Further, the first sealant is a sealant with a glass transition temperature of more than 270 ℃.

Further, the curing time of the first sealant is in the range of 4-8 minutes.

Further, the curing temperature of the first sealant is 120 ℃, and the curing time is 6 minutes.

Further, the second sealant is heat curing glue or ultraviolet curing glue.

Further, the second sealant is ultraviolet curing sealant, and the irradiation time is 5-10 seconds.

Furthermore, the melting point of the solder paste is 180-220 ℃.

Further, the melting point of the solder paste is 217 ℃.

Further, the total time period of the reflow soldering in the step S7 is 4 to 8 minutes.

Further, the reflow soldering process of the flexible printed circuit board oppositely provided with the dielectric element, the temperature sensor and the sealant in the step S7 is sequentially divided into a preheating stage, a heat preservation stage, a fast rising stage, a soldering stage and a cooling stage according to time.

Further, the temperature of the reflow soldering is changed in an ascending trend from the preheating stage to the fast-rising stage, in a parabolic trend with a downward opening in the soldering stage and in a descending trend in the cooling stage.

Furthermore, the duration of the preheating stage is 40-80 seconds, the temperature of the reflow soldering is increased from 40 ℃ to 120 ℃, and the temperature increase rate is 2-4 ℃/second.

Further, the duration of the heat preservation stage is 90-120 seconds, and the temperature of the reflow soldering is increased from 120 ℃ to 200 ℃.

Further, the time length of the fast rising stage is 10-20 seconds, and the temperature of the reflow soldering is rapidly raised from 200 ℃ to 217 ℃ of the melting point of the solder paste.

Furthermore, the duration of the welding stage is 60-90 seconds, and the temperature of reflow welding is reduced from 217 ℃ to 255 ℃ at the peak value and then to 217 ℃.

Further, the cooling period is 130-150 seconds, and the temperature of the reflow soldering is reduced from 217 ℃ to 120 ℃.

Furthermore, the plurality of dielectric elements and the plurality of temperature sensors are located on the same side of the flexible circuit board, and the plurality of insulating plates and the plurality of dielectric elements are arranged in one-to-one correspondence and are respectively located on two opposite sides of the flexible circuit board.

Furthermore, the plurality of dielectric elements are arranged on the flexible circuit board at intervals, each dielectric element is provided with a through hole which is arranged in a penetrating way, and the temperature sensor is contained in the through hole.

Further, gaps are formed between the dielectric elements and the corresponding parts of the flexible circuit board.

Furthermore, the conductive disc comprises a plurality of conductive cells arranged at intervals, and the gap is communicated with two adjacent conductive cells formed on the same conductive disc at intervals.

Furthermore, the multiple pairs of bonding pads are selectively arranged in the area of the flexible circuit board surrounded by the multiple conductive plates, and each pair of bonding pads is arranged in the area surrounded by the corresponding conductive plate.

Furthermore, the flexible circuit board is provided with a plurality of main body parts arranged at intervals, a connecting part for connecting two adjacent main body parts and a wiring part, the conductive discs are arranged on the corresponding main body parts, and each pair of the bonding pads is arranged in an area surrounded by the corresponding conductive discs on the main body parts.

Furthermore, the temperature sensor is welded with a bonding pad arranged on the main body part of the flexible circuit board through solder paste, and the dielectric element is welded with a conductive disc arranged on the corresponding main body part of the flexible circuit board through solder paste.

Further, the wiring portion has the golden finger that is staggered row form setting, the wire with the golden finger welding of the wiring portion of flexible circuit board.

Further, the insulating plates are respectively adhered to the sides of the flexible circuit board, which are far away from the conductive disc, through adhesives.

Furthermore, the dielectric element is a dielectric ceramic sheet, and an annular metal layer is arranged on one surface of the dielectric element, which is welded with the corresponding conductive plate of the flexible circuit board.

Further, the method also comprises the following steps: s10: a flexible substrate is provided and the flexible circuit board assembly with the soldered wires obtained in step S9 is disposed on the flexible substrate.

Further, the method also comprises the following steps: s11: providing a plurality of supporting pieces and attaching the supporting pieces to the flexible substrate in a mode of surrounding the dielectric elements respectively; s12: providing a plurality of adhesive members and assembling the plurality of adhesive members on the corresponding supporting members in a manner of covering the corresponding dielectric elements, respectively; s13: and providing release paper and assembling the release paper on the flexible substrate in a mode of covering the pasting piece.

Further, a layer of biocompatible adhesive is coated on one side surface of the flexible substrate, and the flexible circuit board with the soldered wires obtained in step S9 is adhered to the flexible substrate by the biocompatible adhesive.

In the manufacturing method of the electrode patch for tumor electric field treatment, the curing process of the sealant and the reflow soldering of the dielectric element, the temperature sensor and the flexible circuit board are simultaneously carried out, so that the manufacturing period of manufacturing the electrode patch can be shortened, the productivity is improved, and the production cost is reduced.

Drawings

Fig. 1 is a flow chart illustrating a method for manufacturing an electrode patch for electric field therapy of tumors according to the present invention.

Fig. 2 is a schematic view of the solder paste and the sealant obtained in step S4 in fig. 1 being placed on the flexible circuit board.

Fig. 3 is a schematic view of the temperature sensor, the dielectric element and the flexible circuit board obtained in step S7 in fig. 1, wherein the temperature sensor and the dielectric element are respectively soldered to corresponding portions of the flexible circuit board, and the dielectric element and the flexible circuit board are sealed for the first time.

Fig. 4 is a temperature chart showing a temperature profile of reflow soldering of the flexible wiring board having the dielectric element applied thereto in step S7 in fig. 1.

Fig. 5 is a schematic view of the states of the temperature sensor, the dielectric element and the flexible circuit board obtained in step S8 in fig. 1, in which secondary sealing is performed between the dielectric element and the flexible circuit board.

Fig. 6 is a perspective combination view of an electrical functional assembly and a flexible substrate obtained by the manufacturing method of an electrode patch according to the present invention.

Fig. 7 is an exploded perspective view of the electrical functional assembly shown in fig. 6.

Fig. 8 is a perspective assembly view of an electrode patch obtained according to the method of the present invention, wherein a support is provided around the corresponding dielectric element.

Fig. 9 is another perspective assembly view of the electrode patch obtained by the method of the present invention, wherein the adhesive member is disposed on the support member.

Fig. 10 is another perspective assembly view of the electrode patch obtained by the method of the present invention, wherein the release paper is disposed on the flexible substrate.

Description of reference numerals:

the transducer comprises an electrode patch 100, an electrical functional assembly 10, a transducer array 1, a flexible circuit board 11, a first surface 11A, a second surface 11B, a main body 111, a connecting part 112, a wire connecting part 113, a gold finger 1130, a conductive disc 114, a conductive cell 1140, a bonding pad 115, an insulating plate 12, a dielectric element 13, a perforation 131, a temperature sensor 14, solder paste 15, a gap 16, an outer gap 16A, an inner gap 16B, first sealant 17A, second sealant 17B, a flexible substrate 2, a support member 3, a through hole 31, an adhesive member 4, a lead 5, a heat-shrinkable sleeve 51, a plug 52 and release paper 6.

Detailed Description

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

The electric field therapeutic apparatus (not shown) for treating tumor comprises an electric field generator (not shown) and an electrode patch 100 electrically connected with the electric field generator (not shown), wherein the electrode patch 100 is applied on the skin surface of a human body or is arranged on the body surface of a tumor part of a patient corresponding to the tumor part so as to apply a therapeutic electric field generated by the electric field generator (not shown) to the human body for tumor electric field therapy. Referring to fig. 6 to 10, the electrode patch 100 includes a flexible substrate 2, a transducer array 1 adhered to the flexible substrate 2, a support 3 disposed on the flexible substrate 2 and surrounding a corresponding portion of the transducer array 1, an adhesive member 4 covering the support 3 and the corresponding portion of the transducer array 1, a lead 5 electrically connected to the transducer array 1, and a release paper 6 covering the flexible substrate 2 and the adhesive member 4. The electrode patch 100 is configured on the body surface corresponding to the tumor part of the patient through the flexible substrate 2, and applies an alternating electric field to the tumor part of the patient through the transducer array 1 to interfere or prevent mitosis of tumor cells of the patient, thereby achieving the purpose of treating the tumor.

Referring to fig. 1 to 5, a method for manufacturing an electrode patch 100 for electric field therapy for tumors according to the present invention includes the steps of:

s1: providing a flexible circuit board 11, wherein the flexible circuit board 11 has a plurality of conductive pads 114 arranged at intervals and a plurality of pairs of bonding pads 115, and the conductive pads 114 and the bonding pads 115 are located on the same side of the flexible circuit board 11;

s2: providing a plurality of insulating plates 12 and arranging the insulating plates 12 on the flexible circuit board 11 in a one-to-one correspondence manner with the conductive discs 114, wherein the insulating plates 12 and the conductive discs 114 are respectively positioned at two opposite sides of the flexible circuit board 11;

s3: providing a plurality of solder pastes 15 and placing a part of the solder pastes 15 of the plurality of solder pastes 15 on the conductive pads 114 in a one-to-one correspondence with the conductive pads 114 and placing the rest of the solder pastes 15 on the bonding pads 115 in a one-to-one correspondence with the bonding pads 115;

s4: providing a sealant and coating the sealant on the periphery of the region surrounded by the corresponding conductive pads 114 in a manner that the solder paste 15 is not covered;

s5: providing a plurality of temperature sensors 14 and placing the plurality of temperature sensors 14 on the solder paste 15 corresponding to the pads 115 in a one-to-one correspondence with the solder paste 15 placed on the pads 115, respectively;

s6: providing a plurality of dielectric elements 13 and placing the plurality of dielectric elements 13 on the solder pastes 15 corresponding to the conductive pads 114 in a one-to-one correspondence with the solder pastes 15 placed on the conductive pads 114, respectively;

s7: reflow-soldering the flexible circuit board 11 having the dielectric element 13 and the temperature sensor 14 in a reflow furnace (not shown);

s8: secondarily sealing the flexible circuit board 11 provided with the plurality of dielectric elements 13 and the plurality of temperature sensors 14;

s9: a lead 5 is provided and the lead 5 is soldered to the flexible circuit board 11 after the secondary sealing.

In step S1, the pairs of pads 115 are selectively disposed in the area of the flexible circuit board 11 surrounded by the conductive pads 114. Each pair of said pads 115 is arranged in the area enclosed by the corresponding conductive pad 114 of the flexible circuit board 11. The flexible circuit board 11 has a first surface 11A and a second surface 11B opposite to each other. The conductive pad 114 and the bonding pad 115 are disposed on the first surface 11A of the flexible circuit board 11. The conductive pads 114 are disposed on the flexible circuit board 11 in an array. The flexible circuit board 11 includes a plurality of main portions 111 arranged at intervals, a connecting portion 112 located between two adjacent main portions 111, and a wiring portion 113 electrically connected to a plurality of conductive pads 114 and a plurality of pairs of pads 115. The plurality of conductive pads 114 disposed at intervals are respectively disposed on the corresponding main body 111. Each pair of said pads 115 is provided in the region of the body 111 surrounded by the corresponding conductive pad 114. The conductive pads 114 and the bonding pads 115 are disposed on the first surface 11A of the main body portion 111 of the flexible circuit board 11. The conductive plate 114 disposed on the same main body 111 includes a plurality of conductive cells 1140 disposed at intervals and in a central symmetry. Two adjacent conductive cells 1140 of the same conductive disc 114 are disposed at intervals, and an interval (not numbered) is formed between the two adjacent conductive cells 1140. Each pair of pads 115 is provided in an area surrounded by the plurality of conductive cells 1140 of the conductive pads 114 on the same body portion 111. Each pair of pads 115 is disposed at the center of the area surrounded by the plurality of conductive cells 1140 of the conductive pad 114 on the same main body portion 111. The body portion 111 is located at the end of the connecting portion 112. The wiring portion 113 is connected in series with the conductive cells 1140 of all the conductive pads 114 provided on the main body portion 111 of the flexible circuit board 11. The wire connecting portion 113 may be extended laterally from the connecting portion 112, or may be extended laterally from the main body portion 111. The wire connecting portion 113 further has gold fingers 1130 arranged in a staggered row at an end thereof distant from the end connected to the connecting portion 112 or the main body portion 111. The gold fingers 1130 are disposed on opposite sides of the wiring portion 113, one row being disposed on the first surface 11A of the wiring portion 113, and the other row being disposed on the second surface 11B of the wiring portion 113.

The insulating sheet 12 described in step S2 is assembled on the second surface 11B of the flexible circuit board 11 by means of pasting. Specifically, the plurality of insulating plates 12 are respectively adhered to the corresponding positions of the second surface 11B of the main body portion 111 of the flexible circuit board 11 facing away from the conductive pads 114 by an adhesive (not shown) to reinforce the strength of the flexible circuit board 11. The insulating plate 12 is made of an insulating material. Preferably, the insulating plate 12 is an epoxy glass cloth laminate. In step S3, the solder pastes 15 are placed on the conductive cells 1140 of the corresponding conductive pads 114 and the corresponding bonding pads 115 one by one in a steel mesh printing manner. The melting point range of the solder paste 15 is 180-220 ℃. Preferably, the melting point of the solder paste 15 is between 200 ℃ and 220 ℃.

The sealant described in step S4 is the first sealant 17A. The first sealant 17A may be applied to the periphery of an area surrounded by the plurality of conductive cells 1140 of the conductive pad 114 of the flexible circuit board 11 in a dot and/or scribe manner according to a set path. The set path of the first sealant 17A may be a regular segmented dotted line or a segmented straight line or a segmented curve, and may also be a continuous circle, a continuous rectangle, or a continuous irregular closed curve. Preferably, the first sealant 17A is applied in a continuous circular path. The curing temperature of the first sealant 17A is 120-150 ℃. Preferably, the first sealant 17A has a cure temperature of 120 deg.C. The curing time of the first sealant 17A is 4-8 minutes. Preferably, the first sealant 17A has a cure time of 6 minutes. The glass transition temperature of the first sealant 17A is higher than the melting point of the solder paste 15, so that the first sealant 17A can be prevented from carbonizing when the solder paste 15 is melted and the sealing performance of the first sealant is prevented from being affected. The first sealant 17A is a sealant with a glass transition temperature of 270 ℃ or higher.

The plurality of temperature sensors 14 described in step S5 are each attached to the pad 115 on the first surface 11A of the corresponding main body portion 111 of the flexible circuit board 11 by the solder paste 15. The temperature sensor 14 is selectively disposed in the region enclosed by the conductive core 1140 of the conductive plate 114 of the main body portion 111 of the flexible circuit board 11. The temperature sensor 14 may be a temperature sensitive resistor.

The dielectric element 13 and the insulating plate 12 described in step S6 are respectively located on opposite sides of the main body portion 111 of the flexible circuit board 11. The dielectric element 13, the insulating plate 12 and the main body 111 are provided in one-to-one correspondence in the thickness direction. The dielectric element 13, the insulating plate 12, and the body 111 have substantially the same shape. The size of the dielectric element 13 is slightly smaller than that of the main body 111, and the size of the insulating plate 12 is identical to that of the main body 111. The dielectric element 13 is adhered to the corresponding conductive core 1140 of the conductive pad 114 on the first surface 11A of the flexible circuit board 11 by the solder paste 15. The dielectric element 13 is a dielectric ceramic sheet, and a ring-shaped metal layer (not shown) is provided on one surface of the dielectric ceramic sheet, which is adhered to the solder paste 15. The dielectric elements 13 are arranged on the flexible circuit board 11 in an array and interval manner. Each dielectric element 13 has a through hole 131 penetrating through the middle thereof for receiving the temperature sensor 14 or filling the second sealant 17B. A gap 16 is formed between each dielectric element 13 and the corresponding main body 111 of the flexible circuit board 11, and the gap 16 includes an outer gap 16A located outside the area enclosed by the conductive core 1140 of the conductive pad 114 soldered to the dielectric element 13 and an inner gap 16B located inside the area enclosed by the conductive core 1140 of the conductive pad 114 soldered to the dielectric element 13. The outer gap 16A communicates with the inner gap 16B via spaces (not numbered) between the conductive cells 1140 of the respective conductive disks 114, and the inner gap 16B communicates with the perforations 131 of the dielectric element 13. The dielectric element 13 is disposed with the side provided with the metal layer (not shown) facing the main body 111, and the solder paste 15 and the first sealant 17A disposed on the periphery of the corresponding conductive pad 114 are properly pressed down, so that the solder paste 15 contacts the metal layer (not shown) of the dielectric element 13, and the first sealant 17A can fully fill the outer gap 16A formed between the main body 111 of the flexible circuit board 11 and the dielectric element 13.

In step S7, the flexible circuit board 11 with the dielectric element 13 disposed thereon is placed in a reflow oven (not shown) for reflow soldering, so that the solder paste 15 is melted to solder the temperature sensor 14 onto the pad 115 on the flexible circuit board 11, the dielectric element 13 is soldered onto the conductive core 1140 of the conductive pad 114 of the flexible circuit board 11, and the first sealant 17A disposed on the periphery of the conductive pad 114 and between the dielectric element 13 and the flexible circuit board 11 is simultaneously cured to achieve the first sealing between the dielectric element 13 and the main body 111 of the flexible circuit board 11. The length of time for which the flexible circuit board 11 having the dielectric element 13 placed thereon is placed in a reflow furnace (not shown) and reflow-soldered in step S7 is about 4 to 8 minutes. The plurality of temperature sensors 14 are soldered to the pads 115 of the corresponding body portion 111 of the flexible circuit board 11, respectively, to achieve electrical connection between the temperature sensors 14 and the flexible circuit board 11. The plurality of dielectric elements 13 are soldered to the conductive pads 114 of the respective main body portions 111 of the flexible circuit board 11 to achieve electrical connection between the dielectric elements 13 and the flexible circuit board 11. During reflow soldering of the flexible circuit board 11 having the dielectric element 13 placed thereon, the furnace temperature of the reflow furnace (not shown) changes in a substantially parabolic trend with the opening facing downward.

Taking the melting point of the solder paste 15 as 217 ℃ and the curing temperature of the first sealant 17A as 120 ℃ as an example, the process in the reflow furnace (not shown) will be described with reference to fig. 4. The reflow furnace (not shown) is subjected to five stages of a preheating stage T0, a heat-preserving stage T1, a fast rising stage T2, a soldering stage T3 and a cooling stage T4 in sequence according to time courses. Namely, the temperature sensor 14 is soldered to the pad 115 of the flexible circuit board 11 by the solder paste 15, and the dielectric element 13 is soldered to the conductive pad 114 of the flexible circuit board 11, which undergoes five stages, i.e., T0, a soak stage T1, a fast-rise stage T2, a soldering stage T3, and a cooling stage T4. In the preheating period T0 to the fast rising period T2, the furnace temperature of the reflow furnace (not shown) is changed in a rising trend; in the welding stage T3, the furnace temperature is changed in a parabolic trend with a downward opening; in the cooling period T4, the furnace temperature is changed in a downward trend.

The duration of the preheating stage T0 is 40-80 seconds, the furnace temperature is increased from 40 ℃ to 120 ℃, and the temperature rising rate is 2-4 ℃/second. The preheating stage T0 is a preheating stage of the solder paste 15 and the first sealant 17A during the reflow process. In the preheating stage T0, the solder paste 15 starts to be activated and the solvent and gas therein start to be volatilized properly under the influence of the temperature rise.

The duration of the heat preservation period T1 is 90-120 seconds, and the furnace temperature is increased from 120 ℃ to 200 ℃. In the insulation period T1, the solvent and the gas in the solder paste 15 completely evaporate and remove the surface oxides of the conductive pad 114, the metal layer (not shown) of the dielectric element 13, and the lead (not shown) of the temperature sensor 14; and the flux in the solder paste 15 wets the conductive pads 114, the metal layer (not shown) of the dielectric element 13, and the leads (not shown) of the temperature sensor 14, while the solder paste 15 softens, slump, and covers the conductive pads 114 and the lands 115 to isolate the conductive pads 114, the metal layer (not shown) of the dielectric element 13, and the leads (not shown) of the temperature sensor 14 from oxygen.

The time of the fast rising period T2 is 10-20 seconds, and the furnace temperature is rapidly raised from 200 ℃ to the melting point 217 ℃ of the solder paste 15. During the fast-rise period T2, the solder paste 15 can rapidly enter the molten state, and the surfaces of the conductive pad 114, the metal layer (not shown) of the dielectric element 13, and the lead (not shown) of the temperature sensor 14 are prevented from being oxidized again.

The duration of the welding stage T3 is 60-90 seconds, and the furnace temperature is increased from 217 ℃ to 255 ℃ at the peak value and then is decreased to 217 ℃. At the soldering stage T3, the solder paste 15 is completely melted and forms an alloy solder joint, and the soldering of the conductive pad 114 and the metal layer (not shown) of the dielectric element 13 and the soldering of the lead of the temperature sensor 14 and the pad 115 are realized.

The duration of the cooling stage T4 stage is 130-150 seconds, and the furnace temperature is decreased from 217 ℃ to a temperature of 120 ℃ or less. During the cooling period T4, the solid structure of the alloy welding spot is cooled more tightly.

The solder reflow process of the solder paste 15 described above, and the solidification process of the first sealant 17A in the reflow furnace (not shown) in five stages of the preheating stage T0, the keeping temperature stage T1, the fast rising stage T2, the soldering stage T3, and the cooling stage T4 will be described below.

In the preheating stage T0, the first sealant 17A is preheated, and the first sealant 17A is in the preheating stage. When the heat preservation stage T1 is started, since the oven temperature has reached 120 ℃ which is the curing temperature of the first sealant 17A, the first sealant 17A starts to cure, and the first sealant 17A enters the curing stage. The first sealant 17A completes curing after a cure time of about 6 minutes. The time for completion of solidification is substantially before the end of the cooling period T4. The peak value 255 c in the reflow furnace (not shown) does not exceed the glass transition temperature 270 c of the first sealant 17A, and adverse effects on the cured first sealant 17A are avoided.

In other embodiments, if the curing temperature of the first sealant 17A is higher than 120 ℃, referring to the dotted line in fig. 4, the preheating phase of the first sealant 17A corresponds to the preheating phase T0 and the front part of the holding phase T1, and the curing phase corresponds to the rear part of the holding phase T1, the fast rising phase T2, the welding phase T3 and the front part of the cooling phase T4. The curing time is less than the total time from the incubation period T1 to the cooling period T4.

In step S8, the secondary sealing of the flexible circuit board 11 on which the plurality of dielectric elements 13 and the plurality of temperature sensors 14 are provided is performed by filling the sealant into the gap 16 formed between the dielectric elements 13 and the main body portion 111 of the flexible circuit board 11 along the through holes 131 of the dielectric elements 13 after the sealant of the flexible circuit board 11 on which the plurality of dielectric elements 13 and the temperature sensors 14 are provided is cured, which is obtained in step S7, to perform the secondary sealing. The gap 16 filled by the secondary sealing is an inner gap 16B formed between the dielectric element 13 and the flexible circuit board 11, and the sealant for the secondary sealing is a second sealant 17B. The second sealant 17B fills the inner gap 16B by its own fluidity and its own weight, and the gas in the inner gap 16B can be discharged through the through hole 131 of the dielectric element 13. The second sealant 17B may use a heat-curable adhesive or an ultraviolet-curable adhesive. Preferably, the second sealant 17B is an ultraviolet light curing sealant, and the irradiation time is 5 seconds to 10 seconds. The second sealant 17B has lower wettability than the first sealant 17A, but has higher fluidity than the first sealant 17A.

After the corresponding solder paste 15 is placed on the corresponding bonding pad 115 and the corresponding conductive pad 114, the first sealant 17A is applied to the periphery of the region surrounded by the corresponding conductive pad 114 in a manner of not covering the solder paste 15 placed on the corresponding conductive pad 114 or the conductive pad 115, and reflow soldering is performed after the temperature sensor 14 and the dielectric element 13 are placed on the flexible circuit board 11, so that the temperature sensor 14 can be soldered on the bonding pad 115 of the flexible circuit board 11 by melting the solder paste 15, the dielectric element 13 can be soldered on the conductive cell 1140 of the conductive pad 114 of the flexible circuit board 11, and the first sealant 17A between the dielectric element 13 and the main body 111 of the flexible circuit board 11 can be cured synchronously, thereby greatly shortening the manufacturing time of the electrode patch 100 and improving the productivity of the electrode patch 100. In addition, the outer gap 16A formed between the dielectric element 13 and the main body 111 of the flexible circuit board 11 is filled with the first sealant 17A with strong wettability at the periphery of the conductive pad 114, the inner gap 16B formed between the through hole 131 of the dielectric element 13 and the flexible circuit board 11 and located in the region surrounded by the conductive pad 114 is filled with the second sealant 17B with strong fluidity, the sealing adhesives with different characteristics are used for filling twice, and the first sealant 17A may climb into the inner gap 16B through the spaces (not numbered) between the conductive cells 1140 of the corresponding conductive pads 114 under capillary action, it is ensured that the outer gap 16A and the inner gap 16B formed between the dielectric element 13 and the corresponding main body 111 of the flexible circuit board 11 and the through hole 131 of the dielectric element 13 are sufficiently filled, thereby preventing the occurrence of popcorn phenomenon due to the generation of voids and the failure of the electrode patch 100.

In addition, the gap 16 formed between the dielectric element 13 and the corresponding main body portion 111 of the flexible circuit board 11 is filled with the first sealant 17A and the second sealant 17B, so that a solder joint formed by melting the solder paste 15 and located between the dielectric element 13 and the corresponding main body portion 111 can be protected, and the dielectric element 13 is prevented from being influenced by an external force to cause the welding position of the conductive core 1140 of the conductive plate 114 corresponding to the flexible circuit board 11 and the dielectric element 13 to be broken to influence the electrical connection between the dielectric element 13 and the flexible circuit board 11, and further cause that an alternating electric field cannot be applied to a tumor part of a patient through the dielectric element 13; meanwhile, the second sealant 17B may cover the temperature sensor 14 when being filled between the dielectric element 13 and the corresponding main body 111 of the flexible circuit board 11 through the through hole 131 of the dielectric element 13, so as to prevent the temperature sensor 14 from being damaged by water vapor and causing short circuit of electrical connection of the temperature sensor 14, thereby failing.

The flexible circuit board 11, the dielectric element 13 and the insulating plate 12 which are arranged on two opposite sides of the flexible circuit board 11, the temperature sensor 14 which is arranged on the flexible circuit board 11 and is accommodated in the through hole 131 of the dielectric element 13, and the first sealant 17A and the second sealant 17B which are filled in the gap 16 between the dielectric element 13 and the main body part 111 corresponding to the flexible circuit board 11 constitute the transducer array 1 of the electrode patch 100.

The lead 5 in step S9 is soldered to the wiring portion 113 of the flexible circuit board 11 after the second sealant 17B of step S8 is cured. One end of the lead 5 is welded to the gold finger 1130 of the connection portion 113, and the other end is provided with a plug 52 electrically connected to an electric field generator (not shown) to provide an alternating current signal for tumor therapy to the dielectric element 13 of the electrode patch 100 and a direct current signal to the temperature sensor 14 of the electrode patch 100 during tumor electric field therapy. The periphery of the welding position of the lead 5 and the gold finger 1130 of the wire connecting part 113 is covered with a heat-shrinkable sleeve 51. The heat-shrinkable sleeve 51 performs insulation protection on the connection part of the lead 5 and the wiring part 113 of the transducer array 1, provides support, prevents the connection part of the lead 5 and the wiring part 113 of the flexible circuit board 11 from being broken, and is dustproof and waterproof.

The wires 5 and the transducer array 1 welded to the wires 5 form an electrical functional assembly 10 of the electrode patch 100.

The manufacturing method of the electrode patch for tumor electric field treatment further comprises the following steps:

s10: providing a flexible substrate 2, and arranging the electrical functional assembly 10 obtained in the step S9 on the corresponding part of the flexible substrate 2;

s11: providing a plurality of supports 3 and assembling the supports 3 on the flexible substrate 2 in a manner to surround the periphery of the dielectric elements 13 of the transducer array 1 of the electrical functional assembly 10;

s12: providing a plurality of adhesive members 4 and assembling the adhesive members 4 on the respective support members 3 in such a manner as to cover the respective dielectric elements 13;

s13: providing a release paper and assembling the release paper on the flexible substrate in a manner of covering the adhesive element.

In the above step S10, the flexible substrate 2 is mainly made of a flexible gas-permeable insulating sterilization-compatible material. The flexible substrate 2 may be a mesh fabric, and specifically, the flexible substrate 2 is a mesh nonwoven fabric. One side surface of the flexible substrate 2 is coated with a layer of biocompatible adhesive (not shown) for tightly adhering the flexible substrate 2 to the body surface of the target region of the patient. The electrical functional component 10 is adhered to the flexible substrate 2 by a biocompatible adhesive (not shown). The connection portion 112 of the insulating plate 12 and the flexible circuit board 11 of the electrical functional assembly 10 is adhered to the flexible substrate 2.

In the step S11, the supporting member 3 may be made of Polyethylene (PE) or PET or heat conductive silicone sheet or an insulating material compounded by polyurethane, polyethylene, dispersant, flame retardant, carbon fiber, etc. which is soft, chemically stable, light in weight, not easy to deform and non-toxic. Preferably, the support 3 is a flexible foam. A through hole 31 is formed through the support 3 for receiving the dielectric element 13 of the transducer array 1. The number of the supporting members 3 may be multiple, and the multiple supporting members 3 are arranged in parallel at intervals and respectively surround the outer sides of the dielectric elements 13 in different rows. The number of the support 3 may be 1, and the support 3 has a plurality of through holes 31 to receive all the dielectric elements 13 of the transducer array 1. The support 3 is flush with the surface of the dielectric element 13 on the side remote from the flexible substrate 2.

In the above step S12, the adhesive member 4 has double-sided adhesiveness. One side of the adhesive member 4 is adhered to the support member 3 and the surface of the dielectric element 13 on the side away from the flexible substrate 2. The other side of the pasting piece 4 is used as a pasting layer and is pasted on the skin of the surface of a human body to keep the skin surface moist and relieve local pressure. The adhesive element 4 may preferably be a conductive hydrogel to act as a conductive medium. The adhesive member 4 has better application property with the skin of the human body under the supporting action of the supporting member 3.

In the method for manufacturing the electrode patch 100 for electric field therapy for tumor according to the present invention, the curing process of the first sealant 17A and the reflow soldering of the dielectric element 13 and the temperature sensor 14 to the main body 111 of the flexible circuit board 11 are performed simultaneously in a reflow furnace (not shown), so that the manufacturing period for manufacturing the electrode patch 100 can be shortened, the productivity can be improved, and the production cost can be reduced.

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

Claims

1. A manufacturing method of an electrode patch for tumor electric field treatment is characterized by comprising the following steps:

2. The method of claim 1, wherein the step S7 of reflowing the flexible circuit board with the temperature sensor and the dielectric element disposed thereon is performed by melting solder paste disposed on the conductive pads to solder the conductive pads to the dielectric element and by melting solder paste disposed on the pads to solder the pads to the temperature sensor.

3. The method of claim 1, wherein the reflow soldering of the flexible circuit board opposite to the dielectric element, the temperature sensor and the sealant in step S7 is performed by curing the sealant coated on the periphery of the surrounding region of the conductive plate to perform the first sealing between the dielectric element and the flexible circuit board.

4. The method of claim 1, wherein the step S7 reflows the flexible printed circuit board with the dielectric element, the temperature sensor and the sealant disposed thereon to complete the soldering between the dielectric element, the temperature sensor and the flexible printed circuit board, the curing of the sealant, and the first sealing between the dielectric element and the flexible printed circuit board.

5. The manufacturing method according to claim 3 or 4, wherein the secondary sealing of the flexible circuit board having the plurality of dielectric elements and the temperature sensor in the stack in step S8 is performed by filling a sealant into a gap formed between the dielectric elements and the flexible circuit board and located in the region surrounded by the conductive pads.

6. The method of claim 5, wherein the sealant in step S4 is a first sealant, and the sealant in step S8 for the second sealing is a second sealant.

7. The method of manufacturing according to claim 5, wherein the dielectric member has a through-hole provided therethrough for receiving a temperature sensor or allowing a gas formed in a gap between the dielectric member and the flexible circuit board to be discharged therefrom.

8. The method of claim 7, wherein the secondary sealing of the flexible circuit board with the plurality of dielectric elements and the temperature sensor is performed by filling a second sealant into a gap formed between the corresponding portions of the dielectric elements and the flexible circuit board along the through holes of the dielectric elements in step S8.

9. The method of manufacturing of claim 6, wherein the first sealant is a heat curable sealant having a curing temperature in the range of 120 ℃ to 150 ℃.

10. The method of manufacturing according to claim 9, wherein the first sealant is a sealant having a glass transition temperature of 270 ℃ or higher.

11. The method of manufacturing of claim 10 wherein said first sealant has a cure time in the range of 4 to 8 minutes.

12. The method of manufacturing of claim 10 wherein said first sealant has a cure temperature of 120 ℃ and a cure time of 6 minutes.

13. The method of manufacturing of claim 10, wherein the second sealant is a heat-curable adhesive or a uv-curable adhesive.

14. The method of manufacturing of claim 13 wherein the second sealant is a uv curable sealant and the exposure time is between 5 seconds and 10 seconds.

15. The method of manufacturing according to claim 1, wherein the solder paste has a melting point of 180 ℃ to 220 ℃.

16. The manufacturing method according to claim 15, wherein the melting point of the solder paste is 217 ℃.

17. The manufacturing method according to claim 1, wherein the total time period of the reflow soldering in step S7 is 4 to 8 minutes.

18. The method of claim 17, wherein the reflow process of the flexible printed circuit board opposite to the dielectric element, the temperature sensor and the sealant in step S7 includes a preheating stage, a heat-preserving stage, a fast-rising stage, a soldering stage and a cooling stage.

19. The method of manufacturing of claim 18, wherein the temperature of the reflow solder is ramped up during the pre-heat phase to the ramp-up phase, ramped down during the solder phase, and ramped down during the cool-down phase.

20. The method of claim 19, wherein the duration of the preheating stage is 40-80 seconds, the temperature of the solder reflow is increased from 40 ℃ to 120 ℃, and the temperature increase rate is 2-4 ℃/sec.

21. The method of claim 20, wherein the holding period is 90-120 seconds, and the temperature of the reflow soldering is increased from 120 ℃ to 200 ℃.

22. The method of claim 21, wherein the fast ramp-up phase is 10-20 seconds long and the temperature of the solder reflow is rapidly ramped from 200 ℃ to 217 ℃ which is the melting point of the solder paste.

23. The method of manufacturing of claim 22, wherein the duration of the soldering phase is 60-90 seconds, and the temperature of the reflow soldering is lowered from 217 ℃ to 255 ℃ peak to 217 ℃.

24. The method as claimed in claim 23, wherein the cooling period is 130-150 seconds, and the reflow temperature is decreased from 217 ℃ to 120 ℃.

25. The method of manufacturing according to claim 1, wherein the plurality of dielectric elements and the plurality of temperature sensors are located on a same side of the flexible circuit board, and the plurality of insulating plates and the plurality of dielectric elements are disposed in one-to-one correspondence and located on opposite sides of the flexible circuit board, respectively.

26. The method of claim 1, wherein the plurality of dielectric elements are spaced apart from each other on the flexible printed circuit board, each of the dielectric elements has a through hole, and the temperature sensor is received in the through hole.

27. The method of manufacturing of claim 26, wherein a gap is formed between the dielectric element and a corresponding portion of the flexible circuit board.

28. The method of manufacturing of claim 27, wherein the conductive disc comprises a plurality of conductive cells arranged at intervals, and the gap is in spaced communication with two adjacent conductive cells formed on the same conductive disc.

29. The method of manufacturing of claim 1, wherein the plurality of pairs of pads are selectively disposed in an area of the flexible circuit board surrounded by a plurality of conductive pads, each pair of pads being disposed in an area surrounded by a corresponding conductive pad.

30. The method of manufacturing according to claim 29, wherein the flexible circuit board has a plurality of body portions arranged at intervals, a connecting portion connecting two adjacent body portions, and a wiring portion, the conductive pads are provided on the respective body portions, and each pair of the lands is provided on the body portions in an area surrounded by the respective conductive pad.

31. The method of manufacturing of claim 30, wherein the temperature sensor is soldered to a solder pad provided on the main body portion of the flexible circuit board by solder paste, and the dielectric element is soldered to a conductive pad provided on the corresponding main body portion of the flexible circuit board by solder paste.

32. The manufacturing method as set forth in claim 30, wherein the wiring portion has gold fingers arranged in a staggered row, and the lead wire is soldered to the gold fingers of the wiring portion of the flexible circuit board.

33. The manufacturing method according to claim 1, wherein the plurality of insulating plates are respectively adhered to sides of the flexible circuit board facing away from the conductive pads by an adhesive.

34. The manufacturing method according to claim 1, wherein the dielectric element is a dielectric ceramic sheet, and a ring-shaped metal layer is provided on a surface of the dielectric element to which the corresponding conductive pad of the flexible circuit board is soldered.

35. The manufacturing method according to claim 1, further comprising the steps of: s10: a flexible substrate is provided and the flexible circuit board assembly with the soldered wires obtained in step S9 is disposed on the flexible substrate.

36. The method of manufacturing of claim 35, further comprising the steps of:

s11: providing a plurality of supporting pieces and attaching the supporting pieces to the flexible substrate in a mode of surrounding the dielectric elements respectively;

s12: providing a plurality of adhesive members and assembling the plurality of adhesive members on the corresponding supporting members in a manner of covering the corresponding dielectric elements, respectively;

s13: and providing release paper and assembling the release paper on the flexible substrate in a mode of covering the pasting piece.

37. The manufacturing method of claim 36, wherein a side surface of the flexible substrate is coated with a biocompatible adhesive, and the flexible circuit board with the soldered wires obtained in step S9 is adhered to the flexible substrate by the biocompatible adhesive.