CN114711778A

CN114711778A - Preparation method of 12-lead dynamic electrocardiosignal acquisition patch

Info

Publication number: CN114711778A
Application number: CN202210315566.8A
Authority: CN
Inventors: 李保江; 郑建明; 韩志平; 徐怀亮
Original assignee: Hebei Deep Intelligent Medical Technology Co ltd
Current assignee: Hebei Deep Intelligent Medical Technology Co ltd
Priority date: 2022-03-28
Filing date: 2022-03-28
Publication date: 2022-07-08

Abstract

The invention relates to a preparation method of a 12-lead dynamic electrocardiosignal acquisition patch. Belongs to the technical field of collecting patches of electrocardiographs. The method specifically comprises the following steps: step 1, manufacturing an electrocardioelectrode, namely manufacturing the electrocardioelectrode by taking a PFC flexible circuit board, conductive silver paste and silver chloride paste as raw materials; step 2, welding electrodes, namely welding and connecting the four limb lead electrodes with the electrocardio-electrodes; and 3, assembling the electrocardiosignal acquisition patches, and respectively pasting and fixing the 3M adhesive patches with the electrocardio electrodes and the four limb lead electrodes. The invention meets the performance requirement of YY/T0196-2005 standard. The use of some special scenes is satisfied, for example, a defibrillator is needed when the patient is rescued, and the patient can be quickly recovered after defibrillation is completed.

Description

Preparation method of 12-lead dynamic electrocardiosignal acquisition patch

Technical Field

The invention relates to a preparation method of a patch for 12-lead dynamic electrocardiosignal acquisition. Belongs to the technical field of collecting patches of electrocardiographs.

Background

Nowadays, people suffering from heart diseases are more and more, but a lot of abnormal activities of the heart have uncertainty, do not want to happen when, so that the monitoring is very difficult, and the most effective mode is long-term wearing detection, early detection and early treatment, and early warning at the beginning of the disease. Therefore, wearable devices are increasingly used nowadays, and corresponding electrode plates are needed to transmit electrocardiosignals to the interior of the wearable devices. There are three types of commonly used electrode sheets: the first is electrode plates connected through a pull buckle, the second is to use a plastic film as a base material, print conductive silver paste on the base material, then print silver chloride paste on electrode contacts, and the third is that the conductive material of the electrode plates is a flexible copper-clad plate, and the flexible copper-clad plate is used as an electrocardio-electrode material after being etched and processed to carry out gold plating/gold melting treatment on the conductive electrode points. However, these three have several disadvantages:

first, the electrode sheet connected by the tab type is a general-purpose electrode sheet. The tabs are thick and require wire connections. This form of electrode sheet cannot be miniaturized and patch-designed. This is not suitable for use with wearable devices.

Secondly, the plastic film is used as a base material, conductive silver paste is printed on the base material, and then the electrode plate printed with silver chloride paste on the electrode contact cannot be welded, so that the processing mode is complex and the reliability is low. Further, since the direct-current impedance of this electrode connection type is large, the connection portion can be made short. The span between the electrodes of the multi-lead dynamic electrocardiograph is large, so that the electrode plate in the form is not suitable for the multi-lead dynamic electrocardiograph.

Thirdly, after the flexible copper-clad plate is etched and processed, the conductive electrode points are subjected to gold plating/gold melting treatment, and then the electrode plate used as the electrocardio-electrode material cannot recover the performance such as overload through defibrillation, cannot pass the performance test of the YY/T0196-plus 2005 standard, and cannot meet the use requirement.

Disclosure of Invention

The invention aims to solve the technical problem of providing a preparation process of an electrocardiosignal acquisition patch of a 12-lead dynamic electrocardiograph recorder. The main circuit connection inside the electrode is an FPC lead which takes PI material as a base material, and the electrode part adopts a processing technology of printing conductive silver paste on the base material and then printing silver chloride paste on electrode contacts. Thus, the electrode can be ensured to recover the performance such as overload through defibrillation, and the performance requirements of the YY/T0196-2005 standard are met. And the PI material has the characteristic of high temperature resistance, and can be welded, so that the processing technology becomes simple. The FPC conducting wire is made of copper, and direct current impedance is low, so that large-amplitude bridging between 12-lead dynamic electrocardiogram recording electrodes can be met. The FPC and the electrocardio-electrode are embedded in the 3M adhesive tape, so that the electrocardio-signal collecting adhesive tape can be made smaller, can be made into a surface-mounted type, can be directly adhered to a human body when in use, and is more suitable for wearing and use.

The invention relates to a preparation method of a 12-lead dynamic electrocardiosignal acquisition patch, which specifically comprises the following steps:

step 1 electrocardio-electrode manufacturing

Manufacturing an electrocardio electrode by using a PFC flexible circuit board, conductive silver paste and silver chloride paste as raw materials;

step 2 electrode welding

Welding and connecting the four limb lead electrodes with the electrocardio-electrode;

step 3, electrocardiosignal acquisition patch assembly

And respectively sticking and fixing the 3M adhesive tape, the electrocardio electrode and the four limb lead electrodes.

Further, step 1 in the method specifically includes:

step 11, preparing raw materials, wherein the raw materials mainly comprise a PFC flexible circuit board, conductive silver paste and silver chloride paste, and determining electrode manufacturing positions on the PFC flexible circuit board;

step 12, printing conductive silver paste, namely fixing the PFC flexible circuit board, then covering a steel mesh at the electrode manufacturing position, and printing the conductive silver paste at the electrode manufacturing position;

and step 13, silver chloride slurry is printed, after the conductive silver slurry printed in the step 12 is dried, a steel mesh is covered at the electrode manufacturing position, and the silver chloride slurry is printed at the electrode manufacturing position.

Further, the printing thickness of the conductive silver paste is 100-300 μm.

Further, the printing thickness of the silver chloride is 100-300 μm.

Further, step 2 in the method specifically includes:

two ends of the four silica gel wires are respectively welded on corresponding welding pads of the PFC flexible circuit board and the four limb lead electrodes, and the button cell is welded on the corresponding welding pads of the PFC flexible circuit board.

Further, the silica gel flexible wire is 16-core 28AWG in specification, and the welding temperature is 250 ℃.

Compared with the scheme in the prior art, the preparation method of the 12-lead dynamic electrocardiosignal acquisition patch has the following advantages:

1. the electrocardiosignal acquisition patch of the 12-lead dynamic electrocardiograph recorder is made into a patch type design, has the characteristics of small size and light weight, and is convenient to be directly stuck on a human body for use. Therefore, the wearable equipment can be better matched for use, and the inconvenience brought to a user during use is reduced.

2. PI is used as a base material, and has the characteristics of good flexibility and high temperature resistance. The weldable type of the electrode is ensured, and the processing difficulty is reduced. The connecting parts are connected by using the copper-clad plates, the resistivity of the copper-clad plates is low, so that the direct current impedance of the connecting parts can be reduced, the large-amplitude bridging between the electrodes can be realized on the premise of meeting the signal quality, and the requirement of large span between the electrocardiosignal acquisition patch electrodes of the 12-lead dynamic electrocardiograph is met.

3. The combination mode of silver and silver chloride is adopted as the electrocardio-electrode, so that the electrocardiosignal acquisition patch of the 12-lead dynamic electrocardiograph recorder can recover the performance of overload and the like through defibrillation, and the performance requirements of the standard YY/T0196-2005 are met. The use of some special scenes is satisfied, for example, a defibrillator is needed when the patient is rescued, and the patient can be quickly recovered after defibrillation is completed.

Drawings

Fig. 1 is a schematic diagram of a PFC flexible circuit board of an electrocardiograph electrode.

Fig. 2 is a schematic diagram of a PFC flexible circuit board for limb leads.

Fig. 3, 4 and 5 are schematic diagrams illustrating a manufacturing process of the electrocardio-electrode.

Fig. 6 is a schematic diagram of the manufactured electrocardio-electrode.

Fig. 7 is a schematic diagram of a welded PFC flexible circuit board.

Fig. 8 is a schematic view of a 3M sticker.

Fig. 9 is a schematic view of an electrocardiograph main unit card seat.

Fig. 10 is a schematic view of a release plastic.

Fig. 11 is a schematic diagram of a completed 12-lead dynamic electrocardiosignal acquisition patch.

The reference numbers are as follows: 1. a first electrode site; 2. a reinforcing plate; 3. a second electrode site; 4. a third electrode position; 5. a first silica gel flexible wire bonding pad; 6. a second silica gel flexible wire bonding pad; 7. a first button cell pad; 8. a second button cell pad; 9. a third silica gel flexible wire bonding pad; 10. a fourth silica gel flexible wire bonding pad; 11. a limb lead pad; 12. a first layer of PI substrate; 13. a conductive copper clad laminate; 14. a second layer of PI substrate; 15. silver chloride slurry; 16. conductive silver paste; 17. a silica gel flexible wire; 18. provided is a button cell.

Detailed Description

The main circuit connection of the electrocardiosignal acquisition patch of the 12-lead dynamic electrocardiograph recorder is connected through an FPC flexible circuit board which takes PI as a base material. The FPC flexible circuit board is a conductive copper clad plate 13 and is clamped between a first layer of PI base material and a second layer of PI base material. And printing conductive silver paste 16 and silver chloride paste 15 on the PI base material to form an electrocardio electrode, and connecting the electrocardio electrode with a conductive copper-clad plate 13 on an FPC (flexible printed circuit). Then the four limb lead electrodes on the periphery are connected with the main body through a silica gel flexible wire 17 by a welding process. Finally, the processed flexible circuit board with the electrocardio-electrode is pasted on a 3M adhesive, thus forming the electrocardio-signal collecting paster of the 12-lead dynamic electrocardiograph recorder.

The preparation method comprises the following steps:

the manufacturing process of the present invention is mainly divided into three major parts, and the following description is provided with the accompanying drawings.

Firstly, the electrocardio-electrode is manufactured. The first step, preparation of raw materials. The raw materials mainly comprise a PFC flexible circuit board, conductive silver paste and silver chloride paste. Fig. 1 is a PFC flexible circuit board of a main body part of an electrocardiosignal acquisition patch of a 12-lead dynamic electrocardiograph recorder, wherein one electrocardiosignal acquisition patch is used for each set of electrocardiosignal acquisition patch. Fig. 2 is a limb lead PFC flexible circuit board, four are used for each set of electrocardiosignal acquisition patches. Electrocardio-electrodes need to be manufactured at positions shown as a first electrode position 1, a second electrode position 3 and a third electrode position 4 in fig. 1. And secondly, printing conductive silver paste. As shown in fig. 3, the PFC flexible circuit board prepared in the first step is fixed, and then steel meshes are covered at the positions shown by the first electrode position 1, the second electrode position 3 and the third electrode position 4, and the conductive silver paste prepared in the first step is printed at the setting position, and the thickness of the conductive silver paste can be selected as required, and is selected to be 100-. The structure of the installation site is shown in fig. 4. And thirdly, printing silver chloride slurry. After the second step of printing conductive silver paste is dried, steel meshes are covered at the positions of the first electrode position 1, the second electrode position 3 and the third electrode position 4 in the drawing, the silver chloride paste prepared in the first step is printed at the setting position, the printing thickness can be selected according to the requirement, and the thickness is selected to be 100-300 mu m. The structure of the installation site is shown in fig. 5. At this time, the electrocardio-electrode is manufactured. The FPC flexible board for the completed electrocardiograph electrode is shown in fig. 6.

Welding of the electrodes is then performed. The manufactured four limb lead electrodes are required to be connected with the PFC flexible circuit board of the main body part by adopting a welding process. Because the main electrocardio-machine does not contain a power supply, the button battery is contained in the electrocardiosignal acquisition patch of the 12-lead dynamic electrocardio-recorder to supply power for the main electrocardio-machine. First, 4 silicone threads 17 and button cells 18 are prepared for connection. The specification of the silica gel flexible wire 17 selects 16 cores 28AWG, and the wire with the specification has good flexibility and low resistivity, and the kilometer resistance is 227 omega. Then the welding temperature is adjusted to 250 °, and then one end of the silicone cord 17 is welded to the pads at the first silicone cord pad 5, the second silicone cord pad 6, the third silicone cord pad 9, and the fourth silicone cord pad 10 in fig. 6, respectively, and the other end of the silicone cord 17 is welded to the pads at the limb lead pads 11 of the four limb leads, respectively. And then welding the positive electrode and the negative electrode of the button cell 18 to the welding pads shown by the first button cell welding pad 7 and the second button cell welding pad 8 respectively. The welded PFC flexible circuit board is shown in fig. 7.

And finally assembling the electrocardiosignal acquisition patch of the 12-lead dynamic electrocardiograph recorder. Firstly, preparing 3M adhesive plaster, conductive gel, an electrocardio main machine clamping seat and anti-sticking plastic. The 3M glue is adhered with four kinds of glue shown in figure 8, which are respectively named as A, B, C, D from top to bottom, wherein one side A and one side C contain glue, the other side has no glue, and the 3M glue shown in A is provided with a square hole shown in the figure. The 3M adhesive patches shown in B and D have adhesive on both sides and are provided with circular holes as shown in the figure. The electrocardio host cassette is shown in figure 9. There are two types of release plastics shown in figure 10. And secondly, sticking the main body part of the PFC flexible circuit board containing the electrode prepared above to the surface of the 3M adhesive shown in the A, paying attention to placing the reinforcing plate 2 in the figure 1 into the square opening, sticking the 3M adhesive shown in the B to the surface of the A containing the adhesive, paying attention to the coincidence of the circular opening shown in the B and the electrocardio-electrode, and clamping the main body part of the PFC flexible circuit board between A, B kinds of adhesive. And thirdly, fixing the four limb lead electrodes by using C, D two kinds of adhesive tapes by adopting the same method. And fourthly, matching the electrocardio host card seat with the reinforcing plate marked with 2, and fixing the electrocardio host card seat on the 3M adhesive tape. Finally, the two release plastics shown in fig. 10 were applied to the other side of the B, D two types of 3M glue. Thus, the whole electrocardiosignal collecting patch of the 12-lead dynamic electrocardiograph recorder is manufactured, as shown in fig. 11. When the electrocardio main machine is used, the electrocardio main machine is clamped on the electrocardio main machine clamping seat, so that electrocardio signals can be transmitted into the electrocardio main machine, and then the electrocardio main machine can be directly stuck to a human body for use by uncovering the anti-sticking plastic.

The above-mentioned embodiments are merely illustrative of the preferred embodiments of the present invention, and do not limit the scope of the present invention, and various modifications and improvements of the technical solution of the present invention by those skilled in the art should fall within the protection scope defined by the claims of the present invention without departing from the spirit of the present invention.

Claims

1. A preparation method of a 12-lead dynamic electrocardiosignal acquisition patch is characterized by comprising the following steps: the method specifically comprises the following steps:

step 1 electrocardio-electrode manufacturing

step 2 electrode welding

step 3, electrocardiosignal acquisition patch assembly

2. The method for preparing a 12-lead dynamic electrocardiosignal acquisition patch according to claim 1, which is characterized in that: the method comprises the following steps of 1:

3. The method for preparing a 12-lead dynamic electrocardiosignal acquisition patch according to claim 2, which is characterized in that: the printing thickness of the conductive silver paste is 100-300 mu m.

4. The method for preparing a 12-lead dynamic electrocardiosignal acquisition patch according to claim 2, which is characterized in that: the silver chloride printing thickness is 100-300 μm.

5. The method for preparing a 12-lead dynamic electrocardiosignal acquisition patch according to claim 1, which is characterized in that: the method comprises the following steps of 2:

two ends of the four silica gel wires are respectively welded on corresponding welding pads of the PFC flexible circuit board and the four limb lead electrodes, and the button battery is welded on the corresponding welding pads of the PFC flexible circuit board.

6. The method for preparing a 12-lead dynamic electrocardiosignal acquisition patch according to claim 5, wherein the method comprises the following steps: the silica gel flexible wire is 16-core 28AWG in specification, and the welding temperature is 250 ℃.