Flexible physiological data acquisition device, preparation method, electrocardiogram monitoring system and monitoring system

Abstract

The invention provides a flexible physiological data acquisition device, a preparation method, an electrocardiogram monitoring system and a monitoring system.The flexible physiological data acquisition device comprises an acquisition end, at least one lead wire and a recording end, the lead wire comprises a flexible sheet-shaped substrate and a lead layer printed on the flexible sheet-shaped substrate, and the recording end is connected with the flexible sheet-shaped substrate. The flexible physiological data acquisition device further comprises a step-down circuit, the step-down circuit comprises a printed resistor printed on the flexible sheet-shaped substrate, and the printed resistor is connected with the lead layer in series. Wherein the acquisition end acquires a physiological signal of a user, the lead wire transmits the physiological signal, the step-down circuit performs step-down processing on the physiological signal, and the recording end records the physiological signal subjected to the step-down processing, so that the step-down processing on the physiological signal transmitted on the lead layer can be realized; in addition, the occupied area and the size of the flexible physiological data acquisition device are reduced under the condition that the anti-pressure capability is improved, the miniaturization of equipment is facilitated, and the application scene of the flexible physiological data acquisition device is expanded.

Description

Technical Field

[0001] This application belongs to the technical field of medical devices, and particularly relates to a flexible physiological data acquisition device, a preparation method of the flexible physiological data acquisition device, an electrocardiogram monitoring system, and a monitoring system. Background Art

[0002] An electrocardiogram (also known as ECG) is a test used to record the timing and intensity of the electrical signals that cause the heart to beat. By looking at an electrocardiogram, doctors can gain in-depth understanding of heart rhythm changes and check for the presence of arrhythmias. Therefore, the designed electrocardiogram recording device is required to meet the highest safety standards to ensure the safety and effectiveness of ECG recording. Any current passing through an ECG electrode that may exceed the recommended limit of 10 μA rms can affect patients and operators. High voltages, currents, etc. conducted through the lead wires during defibrillation or electrosurgical treatment may damage the ECG measurement system or affect the measurement data. Therefore, when designing an electrocardiogram recording device, it is necessary to ensure the safety of users and prevent them from being harmed by such voltages or currents.

[0003] Therefore, for electronic monitoring devices such as electrocardiogram, blood oxygen, blood pressure, respiration, electroencephalogram, electromyogram, and body temperature, during use, it is necessary to consider how to avoid the influence of external high voltages and currents on the signal recording device while keeping the device lightweight, which has become a problem to be solved. Summary of the Invention

[0004] The purpose of this application is to provide a flexible physiological data acquisition device, a preparation method of the flexible physiological data acquisition device, an electrocardiogram monitoring system, and a monitoring system, aiming to construct a lightweight device and avoid the influence of external high voltages and currents on the device.

[0005] In a first aspect, the flexible physiological data acquisition device provided by an embodiment of this application includes an acquisition end, at least one lead wire, and a recording end. The lead wire includes a flexible sheet substrate and a lead layer printed on the flexible sheet substrate. The flexible physiological data acquisition device further includes a step-down circuit, and the step-down circuit includes a printed resistor printed on the flexible sheet substrate. The printed resistor is connected in series with the lead layer. Among them, the acquisition end is used to obtain the physiological signals of the user, the lead wire is used to transmit the physiological signals, the step-down circuit is used to perform step-down processing on the physiological signals, and the recording end is used to record the physiological signals after step-down processing.

[0006] In one of the embodiments, the lead layer includes a first lead portion, and the printed resistor is connected in series with the first lead portion.

[0007] In one of the embodiments, one end of the printed resistor forms a first overlapping region with the first lead portion.

[0008] In one embodiment, along the length direction of the flexible sheet substrate, the length of the first overlapping region is not less than 0.05 mm.

[0009] In one embodiment, the lead layer further includes a second lead portion, the printed resistor is disposed between the first lead portion and the second lead portion, and the printed resistor is connected in series with the second lead portion.

[0010] In one embodiment, the other end of the printed resistor and the second lead portion form a second overlapping region.

[0011] In one embodiment, along the length direction of the flexible sheet substrate, the length of the second overlapping region is not less than 0.05 mm.

[0012] In one embodiment, one printed resistor is provided.

[0013] In one embodiment, a plurality of printed resistors are provided, and the plurality of printed resistors are connected in series.

[0014] In one embodiment, the plurality of printed resistors are arranged in a staggered or relatively parallel manner.

[0015] In one embodiment, the cross-sectional shape of the printed resistor is a quadrilateral, a polygon, or a closed figure formed by arcs.

[0016] In one embodiment, the cross-sectional shape of the printed resistor is a rectangle.

[0017] In one embodiment, the thickness of the printed resistor is 5 μm - 200 μm.

[0018] In one embodiment, the first lead portion is provided with a bending structure, a stretching structure, or a shrinking structure.

[0019] In one embodiment, the second lead portion is provided with a bending structure, a stretching structure, or a shrinking structure.

[0020] In one embodiment, the step-down circuit further includes a TVS tube, and the printed resistor is connected in series with the TVS tube and grounded.

[0021] In one embodiment, the acquisition end includes an electrode sheet for acquiring physiological signals, and the electrode sheet is connected in series with the lead wire.

[0022] In one embodiment, the electrode sheet includes a dry electrode or a wet electrode.

[0023] Second aspect, an embodiment of the present application provides a method for manufacturing a flexible physiological data acquisition device, including:

[0024] Select a flexible sheet substrate, and form a lead layer for transmitting physiological signals on the flexible sheet substrate through a printing process;

[0025] Select a resistive material according to the selected flexible sheet substrate, and form a printed resistor through a printing process; wherein, the printed resistor is connected in series with the lead layer.

[0026] In one embodiment, the printed resistor and the lead layer form an overlapping area.

[0027] In one embodiment, the printed resistor is composed of a mixture of printed paste and conductive particles.

[0028] Third aspect, an embodiment of the present application further provides an electrocardiogram monitoring system for monitoring the electrocardiogram signal of a user, including the above flexible physiological data acquisition device.

[0029] Fourth aspect, an embodiment of the present application further provides a monitoring system, including the above flexible physiological data acquisition device, and the flexible physiological data acquisition device can be worn on the user.

[0030] The flexible physiological data acquisition device proposed by the present application includes a step-down circuit, which steps down the high voltage and current conducted by the lead wire to avoid the recording end being broken down by the high voltage and current. Moreover, the step-down circuit proposed by the present application includes a printed resistor disposed on the flexible sheet substrate, and both the printed resistor and the lead layer are printed on the flexible sheet substrate, simplifying the device structure and making the wearing more comfortable, achieving the purpose of being lightweight and easy to use. Description of the Drawings

[0031] Figure 1 It is a schematic structural diagram of the flexible physiological data acquisition device provided by an embodiment of the present application;

[0032] Figure 2 It is a schematic structural diagram of the flexible physiological data acquisition device provided by an embodiment of the present application;

[0033] Figure 3 It is a schematic structural diagram of the flexible physiological data acquisition device provided by an embodiment of the present application;

[0034] Figure 4 It is a schematic structural diagram of the flexible physiological data acquisition device provided by an embodiment of the present application;

[0035] Figure 5 It is a schematic structural diagram of the flexible physiological data acquisition device provided by an embodiment of the present application;

[0036] Figure 6It is a schematic structural diagram of a flexible physiological data acquisition device provided by an embodiment of the present application;

[0037] Figure 7 It is a schematic structural diagram of a flexible physiological data acquisition device provided by an embodiment of the present application;

[0038] Figure 8 It is a schematic structural diagram of a flexible physiological data acquisition device provided by an embodiment of the present application;

[0039] Figure 9 It is a schematic flowchart of a preparation method of a printed resistor provided by an embodiment of the present application;

[0040] Figure 10 It is a schematic diagram of an electrocardiogram monitoring system provided by an embodiment of the present application. Detailed implementation manners

[0041] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present application more clear and understandable, the present application will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.

[0042] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or indirectly connected to the other element.

[0043] It should be understood that the orientation or positional relationship indicated by the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus cannot be understood as a limitation to the present application.

[0044] In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In the description of the present application, "a plurality of" means two or more unless otherwise specifically defined.

[0045] An embodiment of the present application proposes a flexible physiological data acquisition device. Refer to Figure 1As shown in the figure, the flexible physiological data acquisition device in this embodiment includes a collection end 510, at least one lead wire 100, a recording end 520, and a voltage reduction circuit 200. The collection end 510 is used to obtain the physiological signals of the user, the lead wire 100 is used to transmit the physiological signals, the recording end 520 is used to record the physiological signals, and the voltage reduction circuit 200 is used to perform voltage reduction processing on the physiological signals. The recording end 520 records the physiological signals after the voltage reduction processing. This effectively prevents the high voltage, current, and static electricity externally applied from possibly breaking down the recording end 520.

[0046] Combined with Figure 2 As shown in the figure, the lead wire 100 in this embodiment includes a flexible sheet substrate 130 and a lead layer 112 printed on the flexible sheet substrate 130. The voltage reduction circuit 200 includes a printed resistor 210 disposed on the flexible sheet substrate 130, and the printed resistor 210 is connected in series with the lead layer 112. The flexible sheet substrate 130 can be made of PET sheet material, which is lighter to use and easier to print the lead layer 112 and the printed resistor 210. By setting the printed resistor 210 to be electrically connected to the lead layer 112, the physiological signals transmitted on the lead layer 112 are subjected to voltage reduction processing via the printed resistor 210, and the recording end 520 records the physiological signals after the voltage reduction processing. Through the resistance setting of the printed resistor 210, while improving the anti-pressure ability, the occupied area and volume of the lead wire are reduced, which is beneficial to the miniaturization of the flexible physiological data acquisition device and expands the application scenarios of the flexible physiological data acquisition device.

[0047] In one embodiment, in the actual application in the field of electrocardiogram, when defibrillation treatment (activating the heart beat by high-voltage stimulation of the human body surface) is performed, or when the user needs to receive surgical treatment using an electric scalpel, by adopting the recording end 520 in this embodiment, such as an electrocardiograph, the heart beat signals of the patient are collected in real time. The defibrillation high voltage is transmitted by the lead layer 112, first passes through the printed resistor 210, and then enters the recording end 520. Since the voltage of the circuit board in the recording end 520 is limited within a range not greater than 20V, that is, the voltage withstand requirement of the circuit board of the recording end 520 is relatively low, the voltage reduction circuit 200 can protect the recording end 520.

[0048] In an application embodiment, referring to Figure 3As shown, the step-down circuit 200 further includes a clamping device 220. The output end of the printed resistor 210 is connected in series with the clamping device 220. The physiological signal input from the acquisition end 510 can be grounded via the clamping device 220 after passing through the printed resistor 210. When defibrillation energy is input, the clamping device 220 can play a clamping protection role to ensure electrical safety. The clamping device 220 can be a Transient Voltage Suppressor (TVS). The TVS tube is a new product developed on the basis of the zener diode process. Its circuit symbol is the same as that of an ordinary zener diode, and its appearance is also the same as that of an ordinary diode. When the two ends of the TVS tube are subjected to an instantaneous high-energy impact, it can reduce its impedance suddenly at an extremely high speed (up to 1*10^-12 seconds), and at the same time absorb a large current, clamping the voltage between its two ends at a predetermined value, so as to ensure that the circuit elements at the recording end are not damaged by the transient high-energy impact.

[0049] In one embodiment, referring to Figure 4 As shown, the lead layer 112 includes a first lead portion 110, and the printed resistor 210 is connected in series with the first lead portion 110.

[0050] In one embodiment, referring to Figure 5 and Figure 8 As shown, one end of the printed resistor 210 forms a first overlapping region 201 with the first lead portion 110.

[0051] In this embodiment, one end of the first lead portion 110 forms a first overlapping region 201 on the printed resistor 210. The printed resistor 210 can be formed in the gap between the first lead portion 110 and the second lead portion 120 by a printing process. The formation of the first overlapping region 201 between the printed resistor 210 and the first lead portion 110 can avoid the resistance mutation at the contact surface between the printed resistor 210 and the first lead portion 110, and prevent problems such as distortion of the physiological signal. Among them, one end of the printed resistor 210 is laid on the first lead portion 110, or is arranged below the first lead portion 110. The resistance value of the printed resistor 210 is greater than that of the lead layer 112. By setting the first overlapping region 201, on the one hand, it can ensure the sufficient connection between the printed resistor 210 and the first lead portion 110, prevent the distortion of the physiological signal transmission, and on the other hand, it can improve the product reliability.

[0052] In one embodiment, along the length direction of the flexible sheet substrate 130, the length of the first overlapping region 201 is not less than 0.05 mm.

[0053] In this embodiment, the length of the first overlapping region 201 is not less than 0.05 mm, which can avoid the problem that the first overlapping region 201 between the printed resistor 210 and the first lead portion 110 is too narrow, resulting in the separation between the printed resistor 210 and the first lead portion 110 during use.

[0054] In one embodiment, as shown in Figure 4 the lead layer 112 further includes a second lead portion 120. The printed resistor 210 is disposed between the first lead portion 110 and the second lead portion 120, and the printed resistor 210 is connected in series with the second lead portion 120.

[0055] In this embodiment, the lead layer 112 includes a first lead portion 110 and a second lead portion 120 which are spaced apart. There is a gap between the first lead portion 110 and the second lead portion 120. The printed resistor 210 is disposed on the gap and is electrically connected to the first lead portion 110 and the second lead portion 120 respectively.

[0056] In this embodiment, by disposing the printed resistor 210 at the gap position between the first lead portion 110 and the second lead portion 120, the printed resistor 210 is connected in series between the first lead portion 110 and the second lead portion 120, so that the resistance of the lead wire 100 can be adjusted. Moreover, under the condition of improving the compressive resistance, the occupied area and volume of the lead wire 100 are reduced, which is beneficial to the miniaturization of the device and expands the application scenarios of the lead wire 100.

[0057] In one embodiment, the first lead portion 110, the printed resistor 210, and the second lead portion 120 are printed on the flexible sheet substrate 130 in sequence. Specifically, the first lead portion 110, the printed resistor 210, and the second lead portion 120 can all be printed on the flexible sheet substrate 130 by a printing process, and the resistance value of the printed resistor 210 can be adjusted by controlling the thickness, area, aspect ratio of the printed resistor 210, and the slurry ratio used, so as to realize the diversification of the lead wire, and electrocardiogram lead wires with corresponding compressive resistance can be selected to collect the physiological signals of users in different application scenarios.

[0058] In one application embodiment, the flexible sheet substrate 130 is made into a thin sheet and can be bent arbitrarily during use. By printing the first lead portion 110, the second lead portion 120, and the printed resistor 210 on the flexible sheet substrate 130 by a printing process to form a fully flexible lead wire. Compared with the traditional lead wire, not only can the integrated preparation of the lead wire be realized, but also the volume of the lead wire can be reduced under the condition of having the same compressive resistance, and the comfort and self-wearing characteristics of the user are improved through flexibility.

[0059] In one embodiment, the printing process includes, but is not limited to, screen printing, intaglio printing, inkjet printing, etc.

[0060] In this embodiment, the printed resistor 210, the first lead portion 110, and the second lead portion 120 can all be printed onto the flexible sheet substrate 130 by a printing process.

[0061] In one embodiment, the flexible sheet substrate 130 can be a flexible insulating polymer.

[0062] In one embodiment, the flexible insulating polymer can be polyimide (PI), polyethylene terephthalate (PET), polyurethane (PU), silicone, etc.

[0063] In a specific application, the insulation performance of the flexible insulating polymer can be evaluated according to its dielectric strength. The higher the dielectric strength, the better the performance of the printed resistor 210.

[0064] In an application embodiment, the adhesion of the printed resistor on the flexible sheet substrate 130 also needs to be considered, and the printing paste in the printed resistor 210 is correspondingly selected. For example, a resin material compatible with the material of the flexible sheet substrate 130 is selected as the printing paste to enhance the adhesion between the printed resistor 210 and the flexible sheet substrate 130, and to avoid situations such as the printed resistor 210 peeling off or falling off from the flexible sheet substrate 130 during later use.

[0065] In one embodiment, as shown in Figure 5 The printed resistor 210 is printed on the flexible sheet substrate 130, and the other end of the printed resistor 210 forms a second overlapping region 202 with the second lead portion 120.

[0066] In this embodiment, the second lead portion 120 and the other end of the printed resistor 210 form a second overlapping region 202. The printed resistor 210 can be formed in the gap between the first lead portion 110 and the second lead portion 120 by a printing process. The other end of the printed resistor 210 can be formed in a partial area on the second lead portion 120, so that a second overlapping region 202 is formed between the printed resistor 210 and the second lead portion 120, which can avoid resistance mutation at the contact surface between the printed resistor 210 and the first lead portion 110 and prevent problems such as distortion of physiological signals. Among them, one end of the printed resistor 210 is placed on the second lead portion 120 or is arranged below the second lead portion 120. The resistance value of the printed resistor 210 is greater than that of the lead layer 112. By setting the second overlapping region 202, on the one hand, it ensures sufficient connection between the printed resistor 210 and the second lead portion 120 to prevent distortion of physiological signal transmission, and on the other hand, it can improve the product reliability.

[0067] In one embodiment, the printed resistor 210 includes a printed paste and conductive particles, and the conductive particles are filled in the printed paste. After mixing the conductive particles with the printed paste, it is printed into the gap between the first lead portion 110 and the second lead portion 120, and the printed resistor 210 is formed after curing.

[0068] In one embodiment, the curing temperature range of the printed paste is 80°C - 220°C.

[0069] In this embodiment, by selecting the curing temperature range of the printed paste to be between 80°C and 220°C, the printed resistor 210 can be cured within a relatively wide range.

[0070] In one embodiment, referring to Figure 6 As shown, in the width direction of the flexible sheet substrate 130, the width of the first lead portion 110 is greater than or equal to the width of the printed resistor 210.

[0071] In this embodiment, in the width direction of the flexible sheet substrate 130, when the width of the first lead portion 110 is greater than or equal to the width of the printed resistor 210, one end of the first lead portion 110 can cover the printed resistor 210 after the first lead portion 110 is formed. At this time, one end of the first lead portion 110 is completely located on the printed resistor 210, which is beneficial for the physiological signal transmitted via the first lead portion 110 to quickly enter the printed resistor 210, or for the physiological signal output by the printed resistor 210 to quickly enter the first lead portion 110.

[0072] In one embodiment, referring to Figure 7 As shown, in the width direction of the flexible sheet substrate 130, the width of the first lead portion 110 is less than the width of the printed resistor 210.

[0073] In this embodiment, in the width direction of the flexible sheet substrate 130, when the width of the first lead portion 110 is less than the width of the printed resistor 210, one end of the printed resistor 210 can completely cover the first lead portion 110 after the first lead portion 110 is formed, and the printed resistor 210 also covers the edge regions on both sides of the first overlapping region 201, avoiding the exposed connection position between the first lead portion 110 and the printed resistor 210 from being accidentally touched by other conductors during use, resulting in deviation in physiological signal acquisition.

[0074] In one embodiment, referring to Figure 6 As shown, in the width direction of the flexible sheet substrate 130, the width of the second lead portion 120 is greater than or equal to the width of the printed resistor 210.

[0075] In this embodiment, along the width direction of the flexible sheet substrate 130, the width of the second lead portion 120 is greater than or equal to the width of the printed resistor 210. After the second lead portion 120 is formed, one end of the second lead portion 120 can be covered on the printed resistor 210. At this time, the second lead portion 120 is completely located on the other end of the printed resistor 210, which is conducive to the physiological signal transmitted through the second lead portion 120 to quickly enter the printed resistor 210, or to the physiological signal output by the printed resistor 210 to quickly enter the second lead portion 120.

[0076] In one embodiment, see Figure 7 As shown, along the width direction of the flexible sheet substrate 130 , the width of the second lead portion 120 is smaller than the width of the printed resistor 210 .

[0077] In this embodiment, along the width direction of the flexible sheet substrate 130, the width of the second lead portion 120 is smaller than the width of the printed resistor 210. After the second lead portion 120 is formed, one end of the second lead portion 120 can be completely covered on the printed resistor 210, and the printed resistor 210 also covers the edge areas on both sides of the first overlapping area 201, so as to avoid the junction between the second lead portion 120 and the printed resistor 210 being exposed and accidentally touching other conductors during use, resulting in deviations in the collection of physiological signals.

[0078] In one embodiment, along the length direction of the flexible sheet substrate 130 , the length of the second overlapping region 202 is not less than 0.05 mm.

[0079] In this embodiment, the length of the first overlapping area 201 is not less than 0.05 mm, which can avoid the problem of the printed resistor 210 and the second lead portion 120 being separated from each other due to the second overlapping area 202 being too narrow during use.

[0080] In one embodiment, the number of printed resistors in the step-down circuit 200 can be set to one, and the resistor value can be 1K-50K ohms.

[0081] In this embodiment, the resistance of the printed resistor 210 can be adjusted by adjusting the thickness of the printed resistor 210. The printed paste and the conductive particles are mixed and formed on the flexible sheet substrate 130 through a printing process. Figure 8 As shown, the conductive particles in the cured printed resistor 210 have a larger particle size and a smaller density. By adjusting the ratio of the printing paste and the conductive particles, the density of the conductive particles can be adjusted, thereby adjusting the current generated when the physiological sampling signal passes through the printed resistor 210, thereby achieving voltage division adjustment of the printed resistor 210.

[0082] In one embodiment, the printing paste may be a resin material, which includes but is not limited to phenolic resin, epoxy resin, acrylic resin, polyurethane, etc.

[0083] In this embodiment, the printing paste selected for the printed resistor 210 has a direct impact on the voltage division of the finally formed printed resistor 210. The influencing factors mainly include the type of paste resin, the relative content between the resin and the conductive particles, the curing temperature, the size and area of the printed resistor 210, the resistance value, etc.

[0084] In one embodiment, the conductive particles in the printed resistor 210 may be carbon-based high-resistance paste.

[0085] In specific applications, the greater the insulation strength of the resin used in the printing paste selected for the printed resistor 210, the better the final voltage division performance. The higher the ratio of the resin to the conductive particles, the greater the sheet resistance, the greater the printing thickness required to achieve the same resistance value, the better the insulation, and the better the voltage division performance. Determine the curing temperature according to the paste properties (the curing temperatures of different resins vary. For example, the curing temperature of phenolic resin is generally higher than that of polyurethane). If the curing temperature is too low, the internal solvent cannot be removed completely. If the curing temperature is too high, the resin will be damaged, both of which will result in incomplete voltage division performance.

[0086] In one embodiment, the first lead portion 110 may be formed by conductive silver paste, Ag / AgCl, carbon-based low-resistance paste, conductive copper paste, and other composite low-resistance conductive pastes.

[0087] In this embodiment, the type of conductive paste in the first lead portion 110 can be selected according to the substrate material selected for the flexible sheet substrate 130. For example, a conductive material matching the material of the flexible sheet substrate 130 is selected as the conductive paste to enhance the adhesion between the first lead portion 110 and the flexible sheet substrate 130, and avoid situations such as the first lead portion 110 peeling off or falling off from the flexible sheet substrate 130 during later use.

[0088] In one embodiment, the first lead portion 110 can be formed by printing a mixture of conductive paste and lead resin material onto the flexible sheet substrate 130. The conductive paste can be selected from conductive silver paste, Ag / AgCl, carbon-based low-resistance paste, conductive copper paste, and other composite low-resistance conductive pastes according to the application scenario requirements. The lead resin material can be selected as a material compatible with the material of the flexible sheet substrate 130, which can further enhance the adhesion between the first lead portion 110 and the flexible sheet substrate 130, and avoid situations such as the first lead portion 110 peeling off or falling off from the flexible sheet substrate 130 during later use.

[0089] In one embodiment, the conductive paste and the lead resin material are mixed and then printed onto the flexible sheet substrate 130 and then cured to form the first lead portion 110. Combining Figure 8 , after the conductive paste in the first lead portion 110 is cured, lead particles are formed. The particle size of the lead particles is extremely small, and the density of the lead particles is extremely large, which can reduce the sheet resistance of the first lead portion 110, and enhance the adhesion between the first lead portion 110 and the flexible sheet substrate 130 through the lead resin material compatible with the flexible sheet substrate 130, avoiding problems such as the lead wire falling off during use.

[0090] In one embodiment, the lead resin material is also compatible with the printing paste in the printed resistor 210. After the first lead portion 110 and the printed resistor 210 are cured, the lead resin material and the printing paste in the printed resistor 210 are integrated into one body, which can improve the integration level of the lead wire. When the physiological signal is transmitted between the first lead portion 110 and the printed resistor 210, it is transmitted from the lead particles with a larger density to the conductive particles with a smaller density. By controlling the ingredient ratio in the printed resistor 210, the voltage division effect of the printed resistor 210 is adjusted.

[0091] In one embodiment, the second lead portion 120 can be formed by conductive silver paste, Ag / AgCl, carbon-based low-resistance paste, conductive copper paste and other composite low-resistance conductive pastes.

[0092] In this embodiment, the type of the conductive paste in the second lead portion 120 can be selected according to the base material selected for the flexible sheet substrate 130. For example, a conductive material matching the material of the flexible sheet substrate 130 is selected as the conductive paste to enhance the adhesion between the second lead portion 120 and the flexible sheet substrate 130, avoiding situations such as the second lead portion 120 peeling off or falling off from the flexible sheet substrate 130 during later use.

[0093] In one embodiment, the second lead portion 120 can be formed by mixing the conductive paste and the lead resin material and then printing them onto the flexible sheet substrate 130. The conductive paste can be selected from conductive silver paste, Ag / AgCl, carbon-based low-resistance paste, conductive copper paste and other composite low-resistance conductive pastes according to the application scenario requirements. The lead resin material can be selected as a material compatible with the material of the flexible sheet substrate 130, which can further enhance the adhesion between the second lead portion 120 and the flexible sheet substrate 130, avoiding situations such as the second lead portion 120 peeling off or falling off from the flexible sheet substrate 130 during later use.

[0094] In one embodiment, the conductive paste and the lead resin material are mixed and then printed onto the flexible sheet substrate 130 and then cured to form the second lead portion 120. After the conductive paste in the second lead portion 120 is cured, lead particles are formed. The particle size of the lead particles is extremely small, and the density of the lead particles is extremely large, which can reduce the sheet resistance of the second lead portion 120, and enhance the adhesion between the second lead portion 120 and the flexible sheet substrate 130 through the lead resin material compatible with the flexible sheet substrate 130, avoiding problems such as detachment of the second lead portion 120 during use.

[0095] In one embodiment, the lead resin material is also compatible with the printing paste in the printed resistor 210. After the second lead portion 120 and the printed resistor 210 are cured, the lead resin material and the printing paste in the printed resistor 210 are integrated, which can improve the integration level of the lead wire. When the physiological signal is transmitted between the second lead portion 120 and the printed resistor 210, it is transmitted from the lead particles with a larger density to the conductive particles with a smaller density. By controlling the ingredient ratio in the printed resistor 210, the voltage division effect of the printed resistor 210 is adjusted.

[0096] In one embodiment, the number of printed resistors 210 in the step-down circuit 200 can be set to multiple, and the multiple printed resistors 210 are connected in series.

[0097] In this embodiment, the multiple printed resistors 210 can be connected in series via the lead layer 112.

[0098] In one embodiment, the multiple printed resistors 210 are arranged in a staggered or relatively parallel manner.

[0099] In one embodiment, the cross-sectional shape of the printed resistor 210 is a quadrilateral, a polygon, or a closed figure formed by arcs.

[0100] In this embodiment, the conductive paste and the lead resin material are mixed and then printed onto two opposite regions of the flexible sheet substrate 130 and then cured to form the first lead portion 110 and the second lead portion 120 respectively. After the first lead portion 110 and the second lead portion 120 are cured, by printing the printing paste filled with conductive particles in the gap between the first lead portion 110 and the second lead portion 120, the printing paste can be cured in a natural state. Due to the gravitational force, at this time, the cross-sectional shape of the printed resistor 210 formed after curing is an arc structure, and the cross-section of this arc structure is a closed figure formed by arcs.

[0101] In one embodiment, according to the application requirements of the lead wire or according to the resistance value requirements of the printed resistor 210, after the printing paste filled with conductive particles is printed into the gap between the first lead portion 110 and the second lead portion 120, a mold can also be used to shape the printed resistor 210, so as to obtain a printed resistor 210 with a cross-sectional shape of a quadrilateral, a polygon or a closed figure formed by arcs.

[0102] In one embodiment, the cross-sectional shape of the printed resistor 210 is rectangular.

[0103] In one embodiment, the thickness of the printed resistor 210 is 5 μm - 200 μm.

[0104] In one embodiment, to facilitate adaptation for users of different body sizes, the first lead portion 110 is provided with a bending structure, a stretching structure or a shrinking structure. The bending structure, the stretching structure or the shrinking structure can achieve an elongation of the length of the lead wire during use.

[0105] In one embodiment, the second lead portion 120 is provided with a bending structure, a stretching structure or a shrinking structure. The bending structure, the stretching structure or the shrinking structure can achieve an elongation of the length of the lead wire during use.

[0106] In one embodiment, the acquisition end 510 includes an electrode sheet for acquiring physiological signals, and the electrode sheet is connected in series with the lead wire.

[0107] In one embodiment, the electrode sheet includes a dry electrode or a wet electrode.

[0108] In one embodiment, the lead wire 100 further includes an insulating layer, and the insulating layer is provided on the outer periphery of the printed resistor 210 and the lead layer 112.

[0109] In this embodiment, the insulating layer needs to completely cover other regions except for the contact sites with the peripheral hardware and the human body, and the insulating layer can adopt a thermal curing or UV curing process.

[0110] In one embodiment, the insulating layer can include, but is not limited to, acrylic resin, polyurethane, and epoxy resin.

[0111] The embodiment of the present application also proposes a preparation method for a flexible physiological data acquisition device. Refer to Figure 9 As shown, the preparation method in this embodiment includes: step S100 and step S200.

[0112] In step S100, a flexible sheet substrate is selected, and a lead layer for transmitting physiological signals is formed on the flexible sheet substrate through a printing process.

[0113] In step S200, a resistance material is selected according to the selected flexible sheet substrate, and a printed resistor is formed through a printing process.

[0114] In this embodiment, in combination with Figure 1 As shown, the physiological signal is transmitted from the acquisition end 510 to the recording end 520 through the lead layer 112. After selecting the flexible sheet substrate 130, the lead layer 112 is formed on the flexible sheet substrate 130 by a printing process. Then, according to the selected flexible sheet substrate 130, a resistive material is selected to form a printed resistor 210 on the flexible sheet substrate 130 by a printing process. The printed resistor 210 is electrically connected to the lead layer 112. The printed resistor 210 is used to divide the voltage of the physiological signal when the lead layer 112 transmits the physiological signal. In this embodiment, by setting the printed resistor 210 to be connected in series with the lead layer 112, the physiological signal transmitted on the lead layer 112 is subjected to voltage division processing via the printed resistor 210, so as to obtain a lead wire with voltage division performance. And through the resistance setting of the printed resistor 210, while improving the compressive resistance, the occupied area and volume of the lead wire are reduced, which is beneficial to the miniaturization of the device and expands the application scenarios of the lead wire.

[0115] In one embodiment, an overlapping area is formed between the printed resistor 210 formed on the flexible sheet substrate 130 by a printing process and the lead layer 112.

[0116] In one embodiment, referring to Figure 4 As shown, the lead layer 112 includes a first lead portion 110, and the printed resistor 210 is connected in series with the first lead portion 110.

[0117] In one embodiment, referring to Figure 5 and Figure 8 As shown, one end of the printed resistor 210 forms a first overlapping area 201 with the first lead portion 110.

[0118] In this embodiment, one end of the first lead portion 110 forms a first overlapping area 201 with the printed resistor 210. The printed resistor 210 can be formed in the gap between the first lead portion 110 and the second lead portion 120 by a printing process. The formation of the first overlapping area 201 between the printed resistor 210 and the first lead portion 110 can avoid the resistance mutation at the contact surface between the printed resistor 210 and the first lead portion 110 and prevent problems such as distortion of the physiological signal. Among them, one end of the printed resistor 210 is placed on the first lead portion 110 or is arranged below the first lead portion 110. The resistance value of the printed resistor 210 is greater than that of the lead layer 112. By setting the first overlapping area 201, on the one hand, it ensures the full connection between the printed resistor 210 and the first lead portion 110 and prevents the distortion of the physiological signal transmission. On the other hand, it can improve the product reliability.

[0119] In one embodiment, the preparation method in this embodiment further includes: during the preparation process, the resistance value of the printed resistor 210 is adjusted by adjusting the thickness of the printed resistor 210 to adapt to different voltage division performances.

[0120] In this embodiment, the resistance value of the printed resistor 210 can be adjusted by adjusting the thickness of the printed resistor 210, so as to adjust the voltage division performance of the printed resistor 210. For example, appropriately increasing the resistance value of the printed resistor 210 in the printing process according to application requirements is beneficial to improving the voltage division performance of the lead wire.

[0121] In one embodiment, the preparation method in this embodiment further includes: during the preparation process, the resistance value of the printed resistor 210 is adjusted by adjusting the ratio of the conductive paste of the printed resistor 210 to adapt to different voltage division requirements.

[0122] In this embodiment, the printed resistor 210 is formed by curing the mixture of the printing paste and the conductive particles. The conductive particles are filled in the printing paste, and after mixing the conductive particles with the printing paste, it is printed into the gap between the first lead portion 110 and the second lead portion 120, and the printed resistor 210 is formed after curing.

[0123] In this embodiment, the conductive paste and the lead resin material are mixed and then printed onto two opposite regions of the flexible sheet substrate 130, and then the first lead portion 110 and the second lead portion 120 are respectively formed by curing. After the first lead portion 110 and the second lead portion 120 are cured, by printing the printing paste filled with conductive particles in the gap between the first lead portion 110 and the second lead portion 120, the printing paste can be cured in the natural state. Due to the gravity, the cross-sectional shape of the printed resistor 210 formed after curing at this time is an arc structure, and the cross-section of this arc structure is a closed figure composed of arcs.

[0124] In one embodiment, according to the application requirements of the lead wire or according to the resistance value requirements of the printed resistor 210, after the printing paste filled with conductive particles is printed into the gap between the first lead portion 110 and the second lead portion 120, a mold can also be used to shape the printed resistor 210, so as to obtain a printed resistor 210 with a cross-sectional shape of a quadrilateral, a polygon or a closed figure composed of arcs.

[0125] In one embodiment, based on the sheet resistance characteristics of the printing paste and the circuit design, the resistance value adjustment range of the printed resistor 210 can be set between 1K - 50K ohms.

[0126] In this embodiment, the printing paste and the conductive particles are mixed and then formed on the flexible sheet substrate 130 through a printing process, combined with Figure 6As shown, the particle size of the conductive particles in the cured printed resistor 210 is relatively large, and the density is relatively small. By adjusting the ratio of the printing paste to the conductive particles, the density of the conductive particles can be adjusted, thereby adjusting the current generated when the physiological sampling signal passes through the printed resistor 210, and achieving the adjustment of the voltage reduction effect of the printed resistor 210.

[0127] In one embodiment, the printing paste can be a resin material, and the resin material includes but is not limited to phenolic resin, epoxy resin, acrylic resin, polyurethane, etc.

[0128] In this embodiment, the printing paste selected in the printed resistor 210 has a direct impact on the voltage division performance of the finally formed printed resistor 210. The influencing factors mainly include the type of the paste resin, the relative content between the resin and the conductive particles, the curing temperature, the size and area of the printed resistor 210, the resistance value, etc.

[0129] In one embodiment, the conductive particles in the printed resistor 210 can be carbon-based high-resistance paste.

[0130] In specific applications, the greater the insulation strength of the resin used in the printing paste selected in the printed resistor 210, the better the final voltage division performance. The higher the ratio content of the resin compared to the conductive particles, the greater the sheet resistance, the greater the printing thickness to achieve the same resistance value, the better the insulation, and the better the voltage division performance. Determine the curing temperature according to the properties of the paste (the curing temperatures of different resins are different. For example, the curing temperature of phenolic resin is generally higher than that of polyurethane). If the curing temperature is too low, the internal solvent cannot be removed completely. If the curing temperature is too high, the resin will be damaged, both of which will cause the voltage division performance not to be fully exerted.

[0131] In one embodiment, the preparation method in this embodiment further includes: adjusting the resistance value of the printed resistor 210 by adjusting the printing area of the printed resistor 210.

[0132] In this embodiment, in this embodiment, by the area of the printed resistor 210 printed on the flexible sheet substrate 130, or when the mixture of the printing paste and the conductive particles is printed on the flexible sheet substrate 130, the resistance value of the printed resistor 210 can be adjusted by cutting to obtain the printed resistor 210 with the corresponding area, achieving the corresponding voltage division performance, and the resistance value of the printed resistor 210 can be increased as much as possible in the corresponding application scenarios to improve the voltage division performance of the lead wire.

[0133] In one embodiment, when the printing area of the printed resistor 210 remains unchanged, the resistance of the printed resistor 210 can be reduced by changing the thickness of the printed resistor 210. For example, by increasing the thickness of the printed resistor 210 to reduce the resistance of the printed resistor 210, and increasing the resistance value of the printed resistor 210 by reducing the thickness of the printed resistor 210.

[0134] In one embodiment, when the printing area of the printed resistor 210 remains unchanged, the resistance value of the printed resistor 210 can be changed by adjusting the ratio of the conductive paste of the printed resistor 210 (for example, the relative content of the printing paste and the conductive particles) to meet different usage requirements.

[0135] In one embodiment, adjusting the resistance value of the printed resistor 210 by adjusting the printing area of the printed resistor 210 includes: adjusting the ratio of the long side to the short side of the printed resistor 210 to adjust the printing area of the printed resistor 210.

[0136] In this embodiment, when the resistance value of the printed resistor 210 remains unchanged, the ratio of the long side to the short side of the printed resistor 210 can be adjusted to adjust the printing area of the printed resistor 210, so as to achieve the purpose of adjusting the resistance value of the printed resistor 210 by adjusting the printing area of the printed resistor 210.

[0137] In one embodiment, adjusting the resistance value of the printed resistor 210 by adjusting the printing area of the printed resistor 210 includes: increasing the long side of the printed resistor 210 and simultaneously increasing the thickness of the printed resistor 210.

[0138] In this embodiment, when the resistance value of the printed resistor 210 remains unchanged, in order to meet the area requirements of the lead wire, the long side of the printed resistor 210 can be increased and the thickness of the printed resistor 210 can be increased simultaneously, so as to offset the change in the resistance value of the printed resistor 210 mutually, and adjust the shape of the printed resistor 210 without changing the resistance value of the printed resistor 210, so that the design of the printed resistor 210 meets the requirements.

[0139] In one embodiment, the preparation method further includes: by setting a threshold value, setting the resistance value and area of the printed resistor 210 according to the threshold value to adjust the voltage difference across the printed resistor 210.

[0140] In this embodiment, in the specific application environment of the lead wire, there is a certain threshold value. When it is lower than the threshold value, the printed resistor 210 is extremely easy to be broken down. When it is much higher than the threshold value, the voltage division performance of the lead wire is improved limitedly. Therefore, the resistance value and area of the printed resistor 210 are set based on the threshold value to adjust the voltage difference across the printed resistor 210, so that an extreme design can be adopted to keep the resistance value and area in the minimum state, give full play to the best voltage division performance of the lead wire, and have the minimum area.

[0141] In one embodiment, the printing process adopted in the preparation method in this embodiment includes screen printing, intaglio printing, and inkjet printing.

[0142] The embodiment of the present application also provides an electrocardiogram monitoring system. The electrocardiogram monitoring system in this embodiment includes at least one flexible physiological data acquisition device in any one of the above embodiments.

[0143] In one embodiment, the lead wire 100 can be integrated into the flexible physiological data acquisition device. By arranging the printed resistor 210 and the first lead portion 110 and the second lead portion 120 on both sides thereof to be printed on the substrate together, the space of the circuit board for arranging the defibrillation-resistant resistor in the flexible physiological data acquisition device can be saved, so that the flexible physiological data acquisition device can be miniaturized on the basis of improving the compressive resistance.

[0144] In an application embodiment, the printed resistor 210 and the first lead portion 110 and the second lead portion 120 on both sides thereof are printed on the flexible substrate together.

[0145] In one embodiment, referring to Figure 10 As shown, the electrocardiogram monitoring system further includes a mounting member 400 and a recording box 310. One end of the lead wire 100 is mounted in the mounting member 400 and is electrically connected to the recording box 310. The recording end 520 can be integrated into the recording box 310, and the other end of the lead wire 100 is electrically connected to the acquisition end 510.

[0146] In this embodiment, the acquisition end 510 can be used to fit against the user's skin to acquire the user's physiological signals, and transmit them to the recording box 310 via the first lead portion 110 through the printed resistor 210. The printed resistor 210 can be used to step down the physiological signals, and the recording box 310 is used to perform data processing on the stepped-down physiological signals to obtain physiological measurement data.

[0147] In one embodiment, the acquisition end 510 includes a dry battery or a wet electrode attached to the patient's skin surface.

[0148] In one embodiment, the first lead portion 110 and the second lead portion 120 on both sides of the printed resistor 210 can be formed by a plurality of lead portions, and the plurality of lead portions can be commonly connected to the same printed resistor 210. For example, the first lead portion 110 includes a plurality of first sub-lead portions, and the plurality of first sub-lead portions are all connected between the printed resistor 210 and the recording box 310. The second lead portion 120 includes a plurality of second sub-lead portions, and the plurality of second sub-lead portions are connected between the plurality of acquisition ends 510 and the printed resistor 210.

[0149] In one embodiment, the acquisition end 510 can be formed by conductive silver paste, Ag / AgCl, carbon-based low-resistance paste, conductive copper paste, and other composite low-resistance conductive pastes.

[0150] In one embodiment, the mounting member 400 is provided with a receiving portion adapted to the outer shape of the recording box 310, and the recording box 310 is detachably mounted in the receiving portion.

[0151] In one embodiment, the accommodating portion is provided with a hook, and the recording box 310 is provided with a correspondingly adapted slot.

[0152] In one embodiment, the flexible physiological data acquisition device may include one or more lead wires, such as three lead wires.

[0153] The embodiment of the present application further provides a monitoring system, including the flexible physiological data acquisition device according to any one of the above embodiments, which can be used to monitor various physiological data of a patient, such as electrocardiogram, blood oxygen, blood pressure, respiration, electroencephalogram, electromyogram, body temperature, etc.

[0154] It should be understood that the magnitudes of the sequence numbers of the steps in the above embodiments do not mean the order of execution is prior or posterior. The order of execution of each process should be determined by its function and internal logic, and should not constitute any limitation to the implementation process of the embodiments of the present invention.

[0155] The above-described embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some of the technical features; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention, and should all be included within the protection scope of the present invention.

Claims

1. Flexible physiological data acquisition device, Characterized in that, It includes a collection end, at least one lead wire and a recording end. The lead wire includes a flexible sheet substrate and a lead layer printed on the flexible sheet substrate. The flexible physiological data acquisition device further includes a step-down circuit. The step-down circuit includes a printed resistor printed on the flexible sheet substrate. The printed resistor is connected in series with the lead layer; wherein, the collection end is used to acquire the physiological signal of the user, the lead wire is used to transmit the physiological signal, the step-down circuit is used to perform step-down processing on the physiological signal, and the recording end is used to record the physiological signal after step-down processing.

2. The flexible physiological data acquisition device according to claim 1, Characterized in that, The lead layer includes a first lead part, and the printed resistor is connected in series with the first lead part.

3. The flexible physiological data acquisition device according to claim 2, Characterized in that, One end of the printed resistor forms a first overlapping area with the first lead part.

4. The flexible physiological data acquisition device according to claim 3, Characterized in that, Along the length direction of the flexible sheet substrate, the length of the first overlapping area is not less than 0.05 mm.

5. The flexible physiological data acquisition device according to any one of claims 2 to 4, Characterized in that, The lead layer further includes a second lead part. The printed resistor is arranged between the first lead part and the second lead part, and the printed resistor is connected in series with the second lead part.

6. The flexible physiological data acquisition device according to claim 5, Characterized in that, The other end of the printed resistor forms a second overlapping area with the second lead part.

7. The flexible physiological data acquisition device according to claim 6, Characterized in that, Along the length direction of the flexible sheet substrate, the length of the second overlapping area is not less than 0.05 mm.

8. The flexible physiological data acquisition device according to any one of claims 1 or 2 or 3 or 4 or 5 or 6 or 7, Characterized in that, There is one printed resistor, and its resistance value is 1K - 50K ohms.

9. The flexible physiological data acquisition device according to claim 1, Characterized in that, There are multiple printed resistors, and the multiple printed resistors are connected in series.

10. The flexible physiological data acquisition device according to claim 9, Characterized in that, The multiple printed resistors are arranged in a staggered or relatively parallel manner.

11. The flexible physiological data acquisition device according to claim 1, Characterized in that, The cross-sectional shape of the printed resistor is a quadrilateral, a polygon or a closed figure composed of arcs.

12. The flexible physiological data acquisition device according to claim 11, Characterized in that, The cross-sectional shape of the printed resistor is a rectangle.

13. The flexible physiological data acquisition device according to claim 11 or 12, Characterized in that, The thickness of the printed resistor is 5μm - 200μm.

14. The flexible physiological data acquisition device according to any one of claims 2 to 4, Characterized in that, The first lead part is provided with a bending structure, a stretching structure or a shrinking structure.

15. The flexible physiological data acquisition device according to claim 5, characterized in that, a bending structure, a stretching structure or a shrinking structure is provided on the second lead part.

16. The flexible physiological data acquisition device according to claim 1, characterized in that, the step-down circuit further includes a clamping device, and the output end of the printed resistor is connected in series with the clamping device.

17. The flexible physiological data acquisition device according to claim 1, characterized in that, the acquisition end includes an electrode sheet for acquiring physiological signals, and the electrode sheet is connected in series with the lead wire.

18. The flexible physiological data acquisition device according to claim 17, characterized in that, the electrode sheet includes a dry electrode or a wet electrode.

19. A method for manufacturing a flexible physiological data acquisition device, characterized in that, comprising: selecting a flexible sheet substrate, and forming a lead layer for transmitting physiological signals on the flexible sheet substrate by a printing process; selecting a resistor material according to the selected flexible sheet substrate, and forming a printed resistor by a printing process; wherein, the printed resistor is connected in series with the lead layer.

20. The method for manufacturing a flexible physiological data acquisition device according to claim 19, characterized in that, the printed resistor and the lead layer form an overlapping area.

21. The method for manufacturing a flexible physiological data acquisition device according to claim 20, characterized in that, the printed resistor is composed of a mixture of printed paste and conductive particles.

22. An electrocardiogram monitoring system for monitoring the electrocardiogram signal of a user, characterized in that, comprising the flexible physiological data acquisition device according to any one of claims 1 to 18.

23. A monitoring system, characterized in that, comprising the flexible physiological data acquisition device according to any one of claims 1 to 18, and the flexible physiological data acquisition device can be worn on the user.

Images