Bioelectric signal collector, wearable physiological monitoring device and physiological monitoring system

Abstract

The invention relates to a bio-electricity signal collector, a wearable physiological monitoring device and a physiological monitoring system. The wearable physiological monitoring device comprises a signal collection host and a bio-electricity signal collector. The bio-electricity signal collector comprises a flexible substrate, and the flexible substrate is provided with a conducting layer, a plurality of signal collecting electrodes and a plurality of connecting layers. By arranging the connecting layer, leakage of energy applied to the body surface of the to-be-detected user can be prevented, and the situation that the energy is transmitted to the signal collection host through the conductive layer to cause host damage can be inhibited.

Description

[0001] This invention patent application is a divisional application of the Chinese invention patent application with application date of September 11, 2024, application number 2024112689767, and name “Bioelectric signal collector, wearable physiological monitoring device and physiological monitoring system”. Technical Field

[0002] The present application relates to the technical field of medical equipment, and in particular to a bioelectric signal collector, a wearable physiological monitoring device and a physiological monitoring system. Background Art

[0003] As an important indicator of various physiological parameters of the human body, bioelectric signals have always played an important role in people's lives. In clinical practice, people have obtained various bioelectric signals relatively accurately. However, with the continuous demand for medical technology and the in-depth development of electrocardiogram diagnosis, neuromedicine, cognitive psychology and artificial intelligence research, human bioelectric signals are being increasingly used in telemedicine, medical monitoring, real-time monitoring and emerging brain-computer interfaces.

[0004] The most widely used bioelectric signals of the human body are ECG signals and EEG signals. Among them, ECG signals directly reflect various indicators of heart activity. People obtain ECG signals to monitor various diseases such as the heart's atrioventricular septum and arteriovenous valves, and perform clinical or remote life monitoring on patients. For example, they are designed as wearable monitoring devices to perform real-time health monitoring on special groups such as athletes, users who are to be tested for hypertension, and users who are to be tested for cardiovascular diseases. EEG signals directly represent the state of neural activity in different regions of the cerebral cortex, and are an important reference for detecting a person's physiological and psychological state. They can provide important diagnostic information for the diagnosis of brain diseases such as epilepsy, dementia, and tumors.

[0005] In specific usage scenarios, such as defibrillation therapy and high-frequency electrosurgical unit therapy, strong current is applied to the body of the user to be tested to achieve the purpose of treatment. At this time, the bioelectric signal collector worn by the user to be tested is used as an auxiliary monitoring method. It is necessary to monitor the bioelectric signal during treatment to reflect the changes in the physiological signs of the user to be tested. However, defibrillation therapy and high-frequency electrosurgical unit therapy have specific requirements for energy consumption. At the same time, there are extremely high requirements for the design safety of the bioelectric signal collector worn by the user to be tested, that is, the bioelectric signal collector cannot consume treatment energy, and it is also necessary to avoid strong current damage to the equipment. In addition, the signal collected by the bioelectric signal also needs to exclude interference from the treatment signal to ensure the accuracy of signal acquisition. Summary of the invention

[0006] Based on this, in order to solve the problems that existing bioelectric signal collectors meet multiple treatment scenarios and accurately collect signals and are safe to use, the present application provides a bioelectric signal collector, a wearable physiological monitoring device and a physiological monitoring system.

[0007] An embodiment of the present application provides a bioelectric signal collector, which is used to be worn on the skin of a user to be tested to obtain bioelectric signals;

[0008] The bioelectric signal collector comprises a flexible substrate, on which a conductive layer and a plurality of signal collection electrodes are arranged, the plurality of signal collection electrodes are used to collect bioelectric signals at at least three different positions on the skin of the user to be tested, and the conductive layer is used to conduct the bioelectric signals to a signal collection host;

[0009] A connection layer is also provided on the flexible substrate, and the conductive layer is conductively connected to the signal collection electrode through the connection layer.

[0010] In one embodiment, the conductive layer includes a first lead portion, and an isolation portion is provided between the first lead portion and the signal collection electrode, and the isolation portion is used to isolate the conductive layer from contact with the signal collection electrode.

[0011] In one embodiment, the connection layer and the first lead portion form a first connection region, the connection layer and the signal collection electrode form a second connection region, and the first connection region and the second connection region are conductively connected.

[0012] In one embodiment, the first lead portion and the signal collection electrode are arranged in the same layer.

[0013] In one embodiment, a gap region between the first lead portion and the signal collection electrode constitutes the isolation portion.

[0014] In one embodiment, the first lead portion is provided with a first opening, the signal collection electrode is arranged in the first opening, and the connection layer is arranged at the first opening.

[0015] In one embodiment, the ratio of the inner diameter of the first lead portion to the outer diameter of the connecting layer is 0.1-0.9.

[0016] In one embodiment, the shape of the flexible substrate corresponding to the position of the first lead portion is circular, the first lead portion is arranged at the center of the flexible substrate, and the distance between the edge of the first lead portion and the edge of the flexible substrate is greater than or equal to 1.5 mm.

[0017] In one embodiment, the cross-sectional shape of the signal collection electrode is circular, and the ratio of the diameter of the signal collection electrode to the outer diameter of the connection layer is greater than or equal to 0.1 and less than 1.

[0018] In one embodiment, the cross-sectional shape of the signal collection electrode is circular, and the diameter of the signal collection electrode is 1 to 20 mm.

[0019] In one embodiment, the connection layer is disposed on a side of the signal collection electrode close to the skin of the user to be measured, and the connection layer is provided with a second opening, and the second opening is used to expose at least a portion of the conductive area of ​​the signal collection electrode.

[0020] In one embodiment, the connection layer is disposed on a side of the signal collection electrode away from the skin of the user to be measured, and the connection layer covers at least a portion of the signal collection electrode.

[0021] In one embodiment, the first lead portion and the signal collection electrode are stacked.

[0022] In one embodiment, the connection layer is disposed between the first lead portion and the signal collection electrode layer.

[0023] In one embodiment, the thickness of the connection layer is 5 μm-200 μm and / or the resistance of the connection layer is 1K-50K ohms.

[0024] In one embodiment, the conductive layer is prepared using a first conductive material, the signal collection electrode is prepared using a second conductive material, and the connecting layer is prepared using a third conductive material. The first conductive material, the second conductive material, and the third conductive material are the same, or the connecting layer contacts the signal collection electrode to form a second connecting region, and the second conductive material contacts the third conductive material without undergoing a replacement reaction, or / and the connecting layer contacts the conductive layer to form a first connecting region, and the first conductive material contacts the third conductive material without undergoing a replacement reaction.

[0025] In one embodiment, the conductive layer includes a second lead portion and a lead layer, the second lead portion is used for conductive connection with the signal collection host, one end of the lead layer is conductively connected to the first lead portion, and the other end is conductively connected to the second lead portion.

[0026] In one embodiment, the signal collection electrode, the connection layer, the first lead portion, the second lead portion, and the lead layer are printed on the flexible substrate.

[0027] In one embodiment, the bioelectric signal collector further includes an adhesive sticker, and the adhesive sticker is used to fix the signal collection electrode sticker on the skin of the user to be tested.

[0028] In one embodiment, three signal collection electrodes are provided, at least two of the signal collection electrodes are provided adjacent to each other, and the adjacent signal collection electrodes are attached to the skin of the user to be tested using a piece of adhesive sticker.

[0029] In one embodiment, four signal collection electrodes are provided, at least two of the signal collection electrodes are provided adjacent to each other, and the adjacent signal collection electrodes are attached to the skin of the user to be tested using a piece of adhesive sticker.

[0030] In one embodiment, ten signal collection electrodes are provided, at least two of the signal collection electrodes are provided adjacent to each other, and the adjacent signal collection electrodes are attached to the skin of the user to be tested using a piece of adhesive sticker.

[0031] In one embodiment, the bioelectric signal collector further comprises a bracket, and the bracket and the adjacent signal collection electrodes are fixed on the skin of the user to be tested by using an adhesive sticker.

[0032] In one embodiment, the ten signal acquisition electrodes include a first chest lead electrode group and a second chest lead electrode group, and the first chest lead electrode group and the second chest lead electrode group are respectively arranged on the left and right sides of the central extension line of the bracket, and the flexible substrate is provided with an expansion opening along the central extension line of the bracket, and the expansion opening is used to expand the distance between the first chest lead electrode group and the second chest lead electrode group.

[0033] In one embodiment, the ten signal acquisition electrodes further include a limb lead electrode group, the limb lead electrode group includes a first limb lead electrode, a second limb lead electrode, a third limb lead electrode, and a fourth limb lead electrode, the first chest lead electrode group includes a first chest lead electrode, the second chest lead electrode group includes a second chest lead electrode, a third chest lead electrode, a fourth chest lead electrode, a fifth chest lead electrode, and a sixth chest lead electrode,

[0034] The fourth limb lead electrode is arranged adjacent to the first limb lead electrode, and a piece of the adhesive tape is used to simultaneously fix the first limb lead electrode and the fourth limb lead electrode, or the fourth limb lead electrode is arranged adjacent to the second limb lead electrode, and a piece of the adhesive tape is used to simultaneously fix the second limb lead electrode and the fourth limb lead electrode, or the fourth limb lead electrode is arranged adjacent to the first chest lead electrode, and a piece of the adhesive tape is used to simultaneously fix the fourth limb lead electrode and the first chest lead electrode.

[0035] In one embodiment, at least one bending structure is provided on the flexible substrate, and the bending structure is used to extend or shorten the length of the lead layer.

[0036] In one embodiment, a defibrillation resistor is provided on the flexible substrate, and the defibrillation resistor is connected in series with the lead layer.

[0037] Another embodiment of the present application further provides a wearable physiological monitoring device, which includes the above-mentioned bioelectric signal collector and a signal collection host.

[0038] Another embodiment of the present application further provides a physiological monitoring system, including the above-mentioned bioelectric signal collector, or including the above-mentioned wearable physiological monitoring device.

[0039] The bioelectric signal collector provided in the embodiment of the present application uses a connecting layer to conductively connect the signal collection electrode and the conductive layer. In special treatment scenarios, the use of the connecting layer is beneficial to preventing the leakage of energy applied to the body surface of the user to be tested, and can inhibit the energy from being transmitted to the signal collection host through the conductive layer, causing damage to the host. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 A schematic diagram of a flexible substrate, a signal collection electrode mounting bracket and a signal collection host according to an embodiment;

[0041] Figure 2 for Figure 1 and Figure 2 The exploded view after the structure is installed and the power supply is installed;

[0042] Figure 3 for Figure 1 A schematic diagram of the structure without the bracket and the signal collection host installed;

[0043] Figure 4 for Figure 3 The enlarged view of point A in the middle;

[0044] Figure 5 is a schematic diagram of a wearable physiological monitoring device according to an embodiment;

[0045] Figure 6 for Figure 5 The correspondence between the characters in and the human body;

[0046] Figure 7 is a schematic diagram of the sleeve;

[0047] Figure 8 is a schematic diagram of a guide section between two adjacent attachment sheets;

[0048] Fig. 9 is a schematic diagram of a telescopic sleeve;

[0049] Fig.10 is a schematic diagram of a wearable physiological monitoring device according to yet another embodiment;

[0050] Fig.11 is a schematic diagram of a wearable physiological monitoring device according to another embodiment;

[0051] Fig.12 This is a process flow chart of a bioelectric signal collector according to an embodiment;

[0052] Fig.13 The present invention is a process flow chart of a bioelectric signal collector according to another embodiment.

[0053] Description of Figure Numbers:

[0054] 100-bioelectric signal collector; 110-flexible substrate; 111-guiding section; 112-attaching sheet; 113-joining section; 114-branching section; 115-leading section; 116-joining section; 120-signal collecting electrode; 121-second lead section; 122-first lead section; 124-connecting layer; 125-conductive layer; 126-second opening; 127-first opening; 128-lead layer; 130-glue Sticker; 131-third opening; 140-conductive adhesive layer; 150-release film; 151-character; 160-sleeve; 161-telescopic sleeve; 162-bending structure; 163-defibrillator resistor; 164-adhesive; 165-fourth opening; 166-handle; 167-expanded opening; 200-wearable physiological monitoring device; 210-bracket; 211-strip hole; 220-power supply; 230-signal collection host. DETAILED DESCRIPTION

[0055] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0056] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0057] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0058] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0059] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0060] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0061] Embodiment 1:

[0062] See also Figure 1 , Figure 2 , Figure 3 as well as Figure 4 ,like Figure 1The first embodiment of the present application provides a bioelectric signal collector 100, which is worn on the skin of a user to be tested to obtain bioelectric signals. The signal collection host 230 is detachably mounted on the bioelectric signal collector 100 to collect bioelectric signals. The bioelectric signals include electrocardiogram signals, electromyogram signals, electroencephalogram signals, and electrooculogram signals. Figure 1 .

[0063] The bioelectric signal collector 100 includes a flexible substrate 110, on which a conductive layer 125 and a plurality of signal collection electrodes 120 are provided. The plurality of signal collection electrodes 120 are used to collect bioelectric signals from at least three different positions on the skin of the user to be tested, and the conductive layer 125 is used to conduct the bioelectric signals to the signal collection host 230. A connecting layer 124 is also provided on the flexible substrate 110, and the conductive layer 125 is conductively connected to the signal collection electrodes 120 through the connecting layer 124.

[0064] In the embodiment of the present application, a conductive layer 125 and a signal collection electrode 120 are prepared on a flexible substrate 110 according to a conductive pattern, and the conductive layer 125 and the signal collection electrode 120 are overlapped by a connecting layer 124 to achieve a conductive connection. The outer contour of the flexible substrate 110 is cut along the conductive layer 125 and the signal collection electrode 120 as needed, thereby forming the outer contour of the bioelectric signal collector 100. The connecting layer 124, the signal collection electrode 120, and the conductive layer 125 form a series circuit. In the application of high-current treatment scenarios such as defibrillation or high-voltage electric knife, the connecting layer 124 added to the flexible substrate 110 can prevent the defibrillation energy from being conducted and leaked through the signal collection electrode 120 and the conductive layer 125, affecting the treatment effect, and will not affect the accuracy of the bioelectric signal collected by the signal collection electrode 120.

[0065] In one embodiment, the thickness of the connection layer 124 is 5 μm-200 μm and / or the resistance of the connection layer 124 is set to 1K~50K ohms to withstand the strong current caused by the medical defibrillator or electrostatic discharge, and prevent the signal collection host 230 from being destroyed by the strong current. This embodiment proposes that the connection layer 124 made by the printing process is thin and light, the product structure is compact, and the thickness does not exceed 200 μm. The connection layer 124 is connected in series with the signal collection electrode 120 and the conductive layer 125, and no other lead connection is required. It can replace the traditional defibrillation patch resistor that must be used in the monitoring equipment due to equipment safety requirements. The traditional patch resistor is too large and requires lead connection when used. It is cumbersome to use and cannot be used in compact physiological monitoring equipment applications. In addition, the product provided in this embodiment is also suitable for home remote monitoring due to its light size and miniaturized structure. In particular, during the defibrillation treatment process, the patient needs to withstand multiple strong defibrillation currents to restore heart function. If the connection layer 124 is not provided, the defibrillation energy will enter the signal collection host 230 through the signal collection electrode 120 and the conductive layer 125, causing the signal collection host 230 to be destroyed by the strong current. The resistance of the connection layer 124 provided in this embodiment is 1K~50K ohms, which can withstand multiple strong current shocks. After the cardiac defibrillation treatment is completed, the signal collection host 230 can still be used normally to collect and record bioelectric signals, thereby enhancing the reliability of the equipment. If the resistance of the connection layer 124 is measured to be less than 1K ohms or greater than 50K ohms, signal noise will be generated, affecting the accuracy of bioelectric signal collection.

[0066] In one embodiment, the connection layer 124 is printed on the signal collection electrode 120 and the conductive layer 125 using a printing process, which will not affect the wearing weight, and is convenient for the user to be tested to wear it for a long time without interruption. The long-term monitoring of bioelectric signals, especially electrocardiogram, can help the user to be tested to more comprehensively monitor the health of the heart or potential diseases. Moreover, in a high-current treatment environment, such as the strong defibrillation current or the high voltage of the electric knife applied to the user to be tested, it will be conducted to the signal collection host 230 through the conductive layer 125, causing the host to be damaged by the strong current. Therefore, the biosignal collector 100 provided in the embodiment of the present application is not only light to wear and convenient for the user to be tested to wear it for a long time without interruption, but also considers the use requirements of the monitoring scene, ensuring that the bioelectric signal collector 100 collects accurate bioelectric signals in real time, and the equipment is safer and more reliable.

[0067] The bioelectric signal collector 100 is worn on the skin of the user to be tested to obtain bioelectric signals. The signal collection host 230 is installed on the bioelectric signal collector 100 to realize signal collection and storage recording. Multiple signal collection electrodes 120 collect bioelectric signals at least three different positions, and transmit the bioelectric signals to the signal collection host 230 through the conductive layer 125. The present application proposes that the signal collection electrode 120 and the conductive layer 125 are conductively connected through the connecting layer 124 to ensure that the connecting layer 124 suppresses the influence of strong current on the bioelectric signals collected by the bioelectric signal collector 100 on the basis of accurately collecting bioelectric signals. In this embodiment, the conductive layer 125, the signal collection electrode 120 and the connecting layer 124 can be printed on the flexible substrate 110 respectively by a printing process, and the conductive layer 125 and the signal collection electrode 120 are conductively connected through the connecting layer 124 to construct a more lightweight wearable product. Of course, the conductive layer 125, the signal collection electrode 120, and the conductive materials of the connecting layer 124 can also be adhered to the flexible substrate 110 respectively, and then the conductive materials can be removed using tools such as laser engraving or etching to obtain the conductive layer 125, the signal collection electrode 120, and the connecting layer 124, without limitation here.

[0068] Specifically, the present solution proposes to connect the conductive layer 125 and the signal collection electrode 120 respectively through the connecting layer 124 to achieve conductive connection, and the connecting layer 124 connects the conductive layer 125 and the signal collection electrode 120 respectively to construct a series circuit. The flexible substrate 110 can be made of PET sheet, which is more convenient to use and easier to prepare the connecting layer 124 and the conductive layer 125. The bioelectric signal collected by the signal collection electrode 120 is transmitted to the conductive layer 125 via the connecting layer 124. Even if the bioelectric signal carrying a strong current passes through the connecting layer 124, most of the energy is suppressed by the connecting layer 124 and will not be conducted to the signal collection host 230 by the conductive layer 125. Therefore, the signal collection host 230 records the physiological signal processed by the connecting layer 124. By setting the connecting layer 124, there is no need to introduce an additional defibrillation resistor device, which improves the suppression of energy leakage while reducing the product space size of the bioelectric signal collector 100, which is conducive to building a lighter bioelectric signal collector 100 and enriching and expanding the product application scenarios.

[0069] In one embodiment, the conductive layer 125 is isolated from the signal collection electrode 120, the conductive layer 125 is made of a first conductive material, and the signal collection electrode 120 is made of a second conductive material different from the first conductive material, so as to avoid the conductive layer 125 of different conductive materials from contacting with the signal collection electrode 120 to cause chemical reactions, such as chemical reactions, replacement reactions, or oxidation-reduction reactions, etc., which affect the accuracy of signal collection. The connecting layer 124 is prepared using a different third conductive material, wherein the second conductive material, the third conductive material, or the first conductive material, the third conductive material do not chemically react when in contact, thereby ensuring the accuracy of bioelectric signal collection and transmission. This embodiment can prepare a wearable bioelectric signal collector 100 that meets different usage scenarios according to actual product requirements, and the bioelectric signal collector 100 provided in the embodiment of the present application fully considers the use requirements for high accuracy of signal collection in different scenarios, and prevents damage to the reliability of the device in different usage scenarios.

[0070] Among them, in a further embodiment, in order to meet the use requirements of more accurate bioelectric signal collection, the signal collection electrode 120 can use a second conductive material with higher signal collection accuracy, such as silver chloride, to ensure accurate and reliable collection of bioelectric signals. The conductive layer 125 uses a first conductive material different from the second conductive material to realize the signal transmission function, such as a conductive metal. The conductive layer 125 is prepared on the flexible substrate 110, and the conductive pattern is processed according to the electrode point design requirements of the bioelectric signal collector 100; it can be processed by die cutting + laminating process or laminating + etching process or laminating + laser engraving process, and the commonly used conductive pattern processing methods are not repeated here. At the preset electrode point, the signal collection electrode 120 is prepared, and a silver chloride layer is generally used. Silver plating can be used at the electrode point and then chlorinated to generate silver / silver chloride or printed and coated with a silver chloride coating; wherein, the conductive layer 125 is prepared using a conductive material for signal transmission, and different conductive materials are prone to contact reaction. For example, a chemical reaction will occur after silver chloride contacts with a conductive agent metal, such as chloride ions corroding the conductive metal, resulting in problems such as reduced signal transmission accuracy. Therefore, an isolation portion is provided between the signal collection electrode 120 and the conductive layer 125 to isolate the first conductive material that is prone to chemical reaction from being in direct contact with the second conductive material, thereby affecting the accuracy of signal transmission. For example, the isolation portion isolates the signal collection electrode 120 made of silver chloride from being in direct contact with the conductive layer 125 made of conductive metal.

[0071] The second conductive material used in the signal collection electrode 120 includes at least one of silver, a silver-silver chloride mixture, a carbon-silver mixture, a carbon-silver-silver chloride mixture, a titanium nitride-silver mixture, or a titanium nitride-silver-silver chloride mixture.

[0072] In one embodiment, the conductive layer 125 includes a first lead portion 122, and an isolation portion (not shown in the figure) is provided between the first lead portion 122 and the signal collection electrode 120. The isolation portion is used to isolate the conductive layer 125 from the signal collection electrode 120, thereby ensuring that the signal collection electrode 120 and the first lead portion 122 using different conductive materials that are prone to chemical reactions in contact will not affect signal collection due to material contact and mixing. In addition, the first lead portion 122 and the signal collection electrode 120 are conductively connected through the connecting layer 124, and it is ensured that the first lead portion 122 accurately and reliably transmits the bioelectric signal collected by the signal collection electrode 120.

[0073] In one embodiment, the conductive materials selected for the connection layer 124, the signal collection electrode 120, and the first lead portion 122 are all different. The connection layer 124 and the first lead portion 122 form a first connection area, and the connection layer 124 and the signal collection electrode 120 form a second connection area. The first connection area and the second connection area are conductively connected. The connection layer 124 can conductively connect the signal collection electrode 120 and the first lead portion 122 through the first connection area and the second connection area. The conductive layer 125, the signal collection electrode 120, and the connection layer 124 are designed separately to adapt to more use environments and preparation requirements, thereby improving the applicability of the bioelectric signal collector 100. In this embodiment, the connection layer 124 is made of a third conductive material, and no chemical reaction occurs when the third conductive material contacts the second conductive material. , the third conductive material will not chemically react when in contact with the first conductive material. Commonly, the signal collection electrode 120 is made of silver chloride, and the first lead 122 can be made of at least one of conductive metal, conductive ink, conductive polymer or conductive carbon. When the conductive layer 125 is made of metal, the connecting layer 124 can be made of at least one of conductive ink, conductive polymer and conductive carbon. It can be understood that, for example, the first lead portion 122 is made of conductive metal, such as aluminum, and the connecting layer 124 is made of conductive ink, but not conductive metal, because the signal collection electrode 120 made of silver chloride will react with the connecting layer 1247 made of conductive metal, which will increase signal interference. Ensure that the connecting layer 124 connects the signal collection electrode 120 with the conductive layer 125 and transmits stable signals.

[0074] In one embodiment, the first lead portion 122 and the signal collection electrode 120 are arranged in the same layer, that is, the first lead portion 122 is first printed on the flexible substrate 110, and then the signal collection electrode 120 is printed in the same layer, and the connection layer 124 is printed on the surface of the signal collection electrode 120. In addition, the connection layer 124 connects the first lead portion 122 and the signal collection electrode 120 area respectively to make it smoother, thereby preventing the uneven printing of the connection layer 124 from causing accuracy and stability in the signal collection process.

[0075] In one embodiment, the gap area between the separately designed first lead portion 122 and the signal collection electrode 120 constitutes an isolation portion, wherein the isolation portion can be an air barrier layer or an insulating layer. The purpose of the isolation portion is to prevent the conductive material of the first lead portion 122 from mixing and contacting with the conductive material of the signal collection electrode 120 to cause a chemical reaction, thereby affecting the signal collection performance of the signal collection electrode 120.

[0076] In one embodiment, the first lead portion 122 is provided with a first opening 127, the signal collection electrode 120 is arranged in the first opening 127, and the connection layer 124 is arranged at the first opening 127, that is, the connection layer 124 is conductively connected to one side of the first lead portion 122. This design can reduce the overall size of the physiological electrical signal collector 100. The signal collection electrode 120 is conductively connected to the first lead portion 122 through the connection layer 124, which greatly reduces the plane size of the physiological electrical signal collector 100. In addition, the processing difficulty of the connection layer 124 is reduced, and the product yield is improved. It is further understood that the connection layer 124 can connect the first lead portion 122 and the signal collection electrode 120 at any angle.

[0077] Specifically, the ratio of the inner diameter of the first lead portion 122 to the outer diameter of the connecting layer 124 is 0.1 to 0.9, so that the connecting layer 124 and the first lead portion 122 are concentrically arranged, and the connecting area between the connecting layer 124 and the first lead portion 122 is annular, and the connecting layer 124 is evenly covered on the first lead portion 122, ensuring that the connecting layer 124 transmits the bioelectric signal collected by the signal collection electrode 120 to the first lead portion 122 without loss.

[0078] In one embodiment, the shape of the flexible substrate 110 corresponding to the position of the first lead portion 122 is circular, the first lead portion 122 is arranged at the center of the flexible substrate 110, the distance between the edge of the first lead portion 122 and the edge of the flexible substrate 110 is greater than or equal to 1.5 mm, and the edge of the flexible substrate 110 exceeds the edge of the first lead portion 122, which can protect the first lead portion 122 from being worn and damaged by the outside world, ensuring that signal transmission is not interfered with.

[0079] In one embodiment, the ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is greater than or equal to 0.1 and less than 1. The ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is designed to be less than 1, so that the signal collection electrode 120 can be in absolute contact with the connection layer 124, ensuring that the process error avoids uneven connection between the signal collection electrode 120 and the connection layer 124, which is prone to disconnection and other problems, thereby causing uneven signal transmission. The ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is greater than 0.1, preventing the area of ​​the connection layer 124 from being too large to affect signal transmission, resulting in obstruction of bioelectric signal transmission, such as long path, high resistance and other problems, thereby ensuring that the signal collection electrode 120 collects bioelectric signals more accurately, and the first lead portion 122 transmits bioelectric signals more stably. More preferably, the cross-sectional shape of the signal collection electrode 120 is circular, and the diameter size range of the signal collection electrode 120 can be selected from 1 to 20 mm. The signal collection electrode 120, the first lead portion 122 and the connecting layer 124 are better controlled and processed to facilitate the collection and transmission of bioelectric signals.

[0080] In one embodiment, the connection layer 124 is disposed on the side of the signal collection electrode 120 close to the skin of the user to be tested, and the connection layer 124 is provided with a second opening 126, and the second opening 126 is used to expose at least part of the conductive area of ​​the signal collection electrode 120, so that the conductive area of ​​the signal collection electrode 120 can be in direct contact with the skin of the human body to be tested, thereby ensuring that the signal collection electrode 120 can completely collect the human body bioelectric signal. The cross-sectional shape of the connection layer 124 is annular. The annular connection layer 124 ensures uniform connection with the signal collection electrode 120 and the first lead portion 122, respectively, to ensure the continuity of signal collection.

[0081] In another embodiment, the connection layer 124 is arranged on the side of the signal collection electrode 120 away from the skin of the user to be tested, and the connection layer 124 covers at least a portion of the signal collection electrode 120, ensuring that the connection layer 124 is more firmly conductively connected to the signal collection electrode 120 and the first lead part 122, respectively. Since the connection layer 124 is not in direct contact with the skin of the human body to be tested, it will not affect the signal collection electrode 120 to collect bioelectric signals, ensuring that the signal collection electrode 120 can stably contact the skin of the human body to be tested, and ensuring the stability of signal collection. The cross-sectional shape of the connection layer 124 designed in this embodiment is circular. Through this design, the connection layer 124, the signal collection electrode 120, and the first opening of the first lead part 122 are designed to be circular, and the overall product form design style is unified, which has more aesthetic value.

[0082] In one embodiment, the first lead portion 122 and the signal collection electrode 120 are stacked, and the isolation portion is disposed between the first lead portion 122 and the signal collection electrode 120. The isolation portion uses an insulating layer to isolate the first lead portion 122 from contacting the signal collection electrode 120, thereby preventing the first lead portion 122 made of different conductive materials from contacting the signal collection electrode 120 and causing a chemical reaction, thereby affecting the accuracy of signal collection, and expanding different forms of products.

[0083] In another embodiment, the connecting layer 124 is disposed at the edges of the signal collection electrode 120 and the first lead portion 122, and the connecting layer 124 is not conductively connected to the isolation portion. This embodiment has lower process requirements when preparing the connecting layer 124. The connecting layer 124 only needs to conductively connect the signal collection electrode 120 and the first lead portion 122, thereby reducing the difficulty of preparation.

[0084] In another embodiment, the connection layer 124 is disposed between the signal collection electrode 120 and the first lead portion 122 . The connection layer 124 may cover the signal collection electrode 120 so that the signal collection electrode 120 and the first lead portion 122 are spatially isolated and conductively connected.

[0085] In one embodiment, the conductive layer 125 includes a second lead portion 121 and a lead layer 128, the second lead portion 121 is used for conductive communication with the signal collection host 230, one end of the lead layer 128 is conductively connected to the first lead portion 122, and the other end is conductively connected to the second lead portion 121, so as to realize the conductive connection between the bioelectric signal collector 100 and the signal collection host 230, and the bioelectric signal collected by the signal collection electrode 120 is transmitted to the signal collection host 230 through the connecting layer 124, the first lead portion 122, the lead layer 128 and the second lead portion 121. In this embodiment, the first lead portion 122, the lead layer 128 and the second lead portion 121 can also be integrally formed.

[0086] In one embodiment, the signal collection electrode 120, the connecting layer 124, the first lead portion 122, the second lead portion 121 and the lead layer 128 are printed on the flexible substrate 110, thereby ensuring that the coating of the signal collection electrode 120, the connecting layer 124, the first lead portion 122, the second lead portion 121 and the lead layer 128 is uniform, and the signal transmission can be relatively stable.

[0087] In one embodiment, the bioelectric signal collector 100 further includes an adhesive sticker 130, which is used to fix the signal collection electrode 120 on the skin of the user to be tested. By using adhesive, the bracket 210 and the signal collection electrode 120 are fixed on the skin, which is easy to install or peel off and controls the product cost.

[0088] In one embodiment, the bioelectric signal collector 100 also includes a bracket 210, and the bracket 210 and the adjacent signal collection electrode 120 are fixed on the skin of the user to be tested using an adhesive sticker 130, which is more convenient for the user. The protective layer of the adhesive sticker 130 is torn off to fix the signal collection electrode 120 on the skin of the user to be tested, and the relative position of the signal collection electrodes 120 sharing the adhesive sticker 130 is determined, and a piece of adhesive sticker 130 can fix more signal collection electrodes 120 at the same time, which is easier to operate. Preferably, the signal collection host 230 is detachably connected to the bracket 210, such as a snap connection, a threaded installation, a concave-convex combination, etc., or a gripper is provided on the bracket 210 to be installed in combination with the signal collection host 230. The combined installation or separate disassembly methods are not listed one by one in this embodiment.

[0089] See also Fig.10 In one embodiment, three signal acquisition electrodes 120 are provided, that is, in the single-lead product embodiment provided by this embodiment, at least two signal acquisition electrodes 120 are arranged adjacent to each other, and the electrode points are preferably arranged in a Y-shaped layout. Among them, two adjacent signal acquisition electrodes 120 are located above the bracket 210, and can share a sticker 130. One sticker 130 fixes two adjacent signal acquisition electrodes 120 and the bracket 210 on the human skin at the same time, which is convenient for installation. For single-lead products, as long as they are installed at any position on the human chest skin, physiological electrical signals can be collected, and can be widely used in real-time monitoring in the fields of electrocardiography, electroencephalography, electromyography and electrooculography. This embodiment provides a demonstration of the installation of a single-lead product, and the bracket 210 is fixedly installed on the midline of the human sternum, and the signal acquisition electrode 120 is installed on the human skin along the conductive layer 125. It can be seen that only the bracket 210 needs to be fixed, and the installation point of the signal acquisition electrode 120 can be fixed, providing a more convenient installation method, which is suitable for users to use remotely at home. Among them, the variation example of the single-conductor product only needs to satisfy the requirement that three signal collection electrodes 120 are provided, and the specific design method of the signal collection electrode 120 is protected in this embodiment.

[0090] See also Fig.11In one embodiment, four signal collection electrodes 120 are provided, that is, this embodiment provides a three-conductor product embodiment, at least two signal collection electrodes 120 are arranged adjacent to each other. In this embodiment, two adjacent signal collection electrodes 120 are located below the bracket 210, and one adhesive sticker 130 can be used respectively. The third signal collection electrode 120 is located above the bracket 210, and the fourth signal collection electrode 120 is located above the bracket 210. The two signal collection electrodes 120 located above the bracket 210 use one adhesive sticker 130 respectively. Among them, the bracket 210 and the signal collection electrode 120 can share one adhesive sticker 130. Similar to the previous embodiment, only the bracket 210 needs to be fixed, and the installation point of the signal collection electrode 120 can be fixed, providing a more convenient installation method, which is suitable for users to use remotely at home, and further improves the applicability of the product. Among them, the variation of the three-conductor product only needs to meet the requirement that four signal collection electrodes 120 are provided, and the specific design method of the signal collection electrode 120 is protected in this embodiment.

[0091] In the above embodiment, since the number of signal acquisition electrodes 120 is small, that is, there are three or four signal acquisition electrodes 120, the signal acquisition electrodes 120 can be installed on the human skin according to the product instructions, without strict usage requirements, which is convenient for home care use, lowering the usage threshold, allowing more users to obtain bioelectric signal data through the bioelectric signal collector 100, even special groups can use it conveniently, further expanding the user group of the product. In addition, this product uses an adhesive sticker 130 for application on the skin, and as a disposable product, it is more convenient to promote home care use.

[0092] In one embodiment, ten signal collection electrodes 120 are provided, and at least two signal collection electrodes 120 are provided adjacent to each other. The ten signal collection electrodes 120 include six chest lead electrodes and four limb electrodes, and the collected bioelectric signals are richer. For the bioelectric signal analysis system or monitoring system, rich bioelectric signals are provided to ensure that the processing results are more accurate and meet the medical analysis needs.

[0093] like Figure 1 and Figure 7 , Figure 7 for Figure 1In another implementation of the flexible substrate 110 of the embodiment, the ten signal collection electrodes 120 include a first chest lead electrode group and a second chest lead electrode group, the first chest lead electrode group and the second chest lead electrode group are respectively arranged on the left and right sides of the central extension line of the bracket 210, and the flexible substrate 110 is provided with an extension opening 167 along the central extension line of the bracket 210, and the extension opening 167 is used to extend the distance between the first chest lead electrode group and the second chest lead electrode group, so that the extension opening 167 can be torn open according to different users to adjust the distance between the first chest lead electrode group and the second chest lead electrode group to improve the applicability of the wearable physiological monitoring device 200. For example, for female users, the extension opening 167 is more suitable for installing the first chest lead electrode group and the second chest lead electrode on the breast to collect signals.

[0094] See also Figure 5 and Figure 6 In one embodiment, the ten signal acquisition electrodes further include a limb lead electrode group, the limb lead electrode group includes a first limb lead electrode marked as R, a second limb lead electrode marked as L, a third limb lead electrode marked as F, and a fourth limb lead electrode marked as N. The first chest lead electrode group includes a first chest lead electrode marked as C1, the first chest lead electrode group includes a first chest lead electrode marked as C1, the second chest lead electrode group includes a second chest lead electrode marked as C2, a third chest lead electrode marked as C3, a fourth chest lead electrode marked as C4, and a The fifth chest lead electrode is C5, and the sixth chest lead electrode is marked as C6, wherein the fourth limb lead electrode is arranged adjacent to the first limb lead electrode, and a piece of adhesive tape 130 is used to simultaneously fix the first limb lead electrode and the fourth limb lead electrode, or the fourth limb lead electrode is arranged adjacent to the second limb lead electrode, and a piece of adhesive tape 130 is used to simultaneously fix the second limb lead electrode and the fourth limb lead electrode, or the fourth limb lead electrode is arranged adjacent to the first chest lead electrode, and a piece of adhesive tape 130 is used to simultaneously fix the fourth limb lead electrode and the first chest lead electrode.

[0095] In one embodiment, at least one bending structure 162 is provided on the flexible substrate 110, and the bending structure 162 is used to extend or shorten the length of the lead layer 128. When the signal collection electrode 120 needs to be pasted to a farther place, it is only necessary to hold the handle 166 to stretch and deform the bending structure 162, so that the installation position of the signal collection electrode 120 can be adjusted according to the use requirements, thereby improving the applicability of the bioelectric signal collector 100 to users of different body shapes.

[0096] In one embodiment, a defibrillator resistor 163 is provided on the lead layer 128. The defibrillator resistor 163 is capable of withstanding the strong current caused by a medical defibrillator or electrostatic discharge. The overcurrent generated by the defibrillator device is processed by the defibrillator resistor 163 to avoid affecting signal collection, thereby ensuring the safe use of the signal collection host 230.

[0097] An embodiment of the present application also provides a wearable physiological monitoring device 200, including the bioelectric signal collector 100 of the above embodiment, which will greatly expand the usage scenarios and provide more accurate bioelectric signal monitoring functions for target users.

[0098] In one embodiment, the wearable physiological monitoring device 200 further includes a signal collection host 230 which is assembled with or separated from the bioelectric signal collector 100 , and the signal collection host 230 is used to collect and record the bioelectric signals.

[0099] An embodiment of the present application further provides a physiological monitoring system, including the wearable physiological monitoring device 200 in the above embodiment or the bioelectric signal collector 100 in the above embodiment.

[0100] Embodiment 2:

[0101] Embodiment 2 mainly expands some structures of Embodiment 1, wherein the bioelectric signal collector 100, the wearable physiological monitoring device 200 and the physiological monitoring system all correspond to the bioelectric signal collector 100, the wearable physiological monitoring device 200 and the physiological monitoring system in Embodiment 1.

[0102] See also Figure 3 , Figure 3 The schematic diagram of the structure of the bioelectric signal collector 100 in an embodiment of the present application is shown. The present embodiment describes the bioelectric signal collector 100 in detail in combination with the field of electrocardiogram monitoring. The bioelectric signal collector 100 is used to collect electrocardiogram signals of a human body. The bioelectric signal collector 100 provided in an embodiment of the present application includes: a flexible substrate 110 and a conductive pattern layer disposed on the surface of the flexible substrate 110. The conductive pattern layer includes a plurality of signal collection electrodes 120, a connection layer 124, and a conductive layer 125.

[0103] See also Figure 1 , Figure 2 as well as Figure 3In the above-mentioned bioelectric signal collector 100, the signal collection electrode 120 is used to contact with human skin to obtain ECG signals, the conductive layer 125 is used to transmit ECG signals, and an isolation portion is formed between the signal collection electrode 120 and the conductive layer 125, the isolation portion is used to isolate the signal collection electrode 120 from direct contact with the conductive layer 125, and the conductive layer 125 is conductively connected to the signal collection electrode 120 through the connecting layer 124. The bioelectric signal collector 100 provided in the present application uses the connecting layer 124 to conductively connect the signal collection electrode 120 and the conductive layer 125, which meets the requirements in special treatment scenarios. The use of the connecting layer 124 is beneficial to prevent the leakage of energy applied to the body surface of the user to be tested, and can inhibit the energy from being transmitted to the signal collection host 230 via the conductive layer 125 to avoid damage to the host.

[0104] In one embodiment, the conductive layer 125 includes a plurality of first lead portions 122, each of the first lead portions 122 is provided with a first opening 127, the signal collection electrode 120 is accommodated in the first opening 127, and an isolation portion is formed between the signal collection electrode 120 and the first lead portion 122. This embodiment allows the connecting layer 124 to connect the first lead portion 122 and the signal collection electrode 120 at any angle.

[0105] Among them, the gap area between the separately designed first lead part 122 and the signal collection electrode 120 constitutes an isolation part, wherein the isolation part can be an air barrier layer or an insulating layer. The purpose of the isolation part is to prevent the conductive material of the first lead part 122 from mixing and contacting with the conductive material of the signal collection electrode 120 to cause a chemical reaction, thereby affecting the signal collection performance of the signal collection electrode 120.

[0106] Specifically, the conductive layer 125 includes a lead layer 128, which is used to expand the contact points of the signal collection electrode 120 on the human skin, and the lead layer 128 is electrically connected to the first lead portion 122. The first lead portion 122, the lead layer 128 and the signal collection electrode 120 correspond one to one, and the first lead portion 122 and the lead layer 128 can be printed as one piece to improve printing efficiency, or they can be printed separately and connected to improve the application range of the bioelectric signal collector 100.

[0107] Specifically, in one embodiment, at least one first connection area is formed between the connection layer 124 and the first lead portion 122, and at least one second connection area is formed between the connection layer 124 and the signal collection electrode 120. Specifically, the connection layer 124 and the first lead portion 122 and the lead layer 128 may be in direct contact or partial contact, or may be conductively connected through a certain number of components with conductive functions.

[0108] In another embodiment, the outline shape of the signal collection electrode 120 is circular, the outline shape of the first lead portion 122 is annular, and the signal collection electrode 120 is located in the annular first lead portion 122 .

[0109] Preferably, the signal collection electrode 120, the first lead portion 122 and the connecting layer 124 are concentric, wherein the connecting layer 124 is circular or annular, thereby ensuring that the connecting layer 124 forms an annular connecting area with the signal collection electrode 120 and the first lead portion 122 respectively, maintaining stable transmission of the collected ECG signal.

[0110] Preferably, the ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is greater than or equal to 0.1 and less than 1. The cross-sectional shape of the signal collection electrode 120 is designed to be circular, and the cross-sectional shape of the connection layer 124 is designed to be annular. The ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is designed to be less than 1, so that the signal collection electrode 120 can be guaranteed to be in absolute contact with the connection layer 124, ensuring that the process processing error causes uneven connection between the signal collection electrode 120 and the connection layer 124, which is prone to disconnection and other problems, thereby causing uneven signal transmission. The ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is greater than or equal to 0.1, preventing the area of ​​the connection layer 124 from being too large to affect signal transmission, resulting in obstruction of bioelectric signal transmission, such as long path, high resistance and other problems, thereby ensuring that the signal collection electrode 120 collects bioelectric signals more accurately and the first lead part 122 transmits bioelectric signals more stably. More preferably, the cross-section of the signal collection electrode 120 is circular, and the diameter of the signal collection electrode 120 can be selected from 1 to 20 mm. The signal collection electrode 120 and the first lead portion 122 and the connecting layer 124 are better controlled and processed to facilitate the collection and transmission of bioelectric signals.

[0111] In one embodiment, the bioelectric signal collector 100 further includes a bracket 210 , which is used to install an electrocardiograph recorder. The lead layer 128 is assembled and installed on the bracket 210 and is conductively connected to the electrocardiograph recorder.

[0112] Specifically, the support 210 is provided with a strip-shaped hole 211 , and one end of the plurality of lead layers 128 away from the corresponding first lead portion 122 is passed through the strip-shaped hole 211 and attached to the support 210 .

[0113] In one embodiment, the bioelectric signal collector 100 also includes a plurality of adhesive stickers 130, the flexible substrate 110 is attached to the non-adhesive layer of the adhesive sticker 130, the adhesive layer of the adhesive sticker 130 is used to attach the signal collection electrode 120 and the bracket 210 to the human skin, and the adhesive sticker 130 is provided with a third opening 131, and the third opening 131 is used to expose the signal collection electrode 120 so that the signal collection electrode 120 is in contact with the human skin.

[0114] In one embodiment, if Figure 2 and Figure 4 The bioelectric signal collector 100 further includes a conductive adhesive layer 140, which may be a hydrogel. The signal collection electrode 120 contacts the human skin through the conductive adhesive layer 140, so as to fix the signal collection electrode 120 to the human skin and collect the ECG signal.

[0115] In one embodiment, Fig.10 In the embodiment, three signal collection electrodes 120 are provided, including a first electrode, a second electrode and a third electrode. With the bracket 210 as the center, the lead layer 128 extends upward to form a first branch and a second branch respectively, and the lead layer 128 extends downward to form a third branch. The first branch includes a first electrode conductively connected to the signal collection electrode 120, the second branch includes a second electrode conductively connected to the signal collection electrode 120, and the third branch includes a third electrode conductively connected to the signal collection electrode 120. The spatial layout of the first electrode, the second electrode and the bracket 210 forms a Y shape, and the adhesive tape 130 includes a first adhesive tape 130 and a second adhesive tape 130. The first adhesive tape 130 is used to fix the first electrode, the second electrode and the bracket 210, and the second adhesive tape 130 is used for the third electrode.

[0116] In one embodiment, Fig.11 In the embodiment, four signal collection electrodes 120 are provided, and the lead layer 128 extends downward to form a fourth branch, which includes a fourth electrode conductively connected to the signal collection electrode 120, and the second electrode, the fourth electrode and the bracket 210 form a Y shape.

[0117] In one embodiment, the adhesive tape 130 further includes a third adhesive tape 130 , and the third adhesive tape 130 is used to fix the first electrode, the second electrode, the third electrode, the fourth electrode and the bracket 210 respectively.

[0118] In the above-mentioned embodiment, three or four signal collection electrodes 120 are provided, which can meet the needs of the user to be tested to stick the signal collection electrodes 120 to the skin as needed, without the need to use them according to higher medical requirements, thus lowering the usage threshold and enabling more users to obtain bioelectric signals through the bioelectric signal collector 100.

[0119] See also Figure 5 and Figure 6In one embodiment, ten signal collection electrodes 120 are provided, and the signal collection electrodes 120 also include a fifth electrode. The lead layer 128 extends downward to form a fifth branch. The fifth branch and the third branch are respectively arranged on both sides of the center line of the bracket 210. The third branch continues to extend and is conductively connected to the fifth electrode. The fifth branch is conductively connected to the six signal collection electrodes 120. In this embodiment, specifically, characters 151 are printed on the side of the flexible substrate 110 away from the first lead portion 122 to indicate the position of the signal collection electrode 120 corresponding to the human body. The characters 151 include R, L, N, F, C1, C2, C3, C4, C5, and C6. Figure 6 , introduce different forms of bioelectric signal collectors 100, the positions are as follows:

[0120] Letter R, lead position is below the right midclavicular line;

[0121] Letter L, lead position is below the left midclavicular line;

[0122] Character N, lead position is the fifth intercostal space at the right midclavicular line;

[0123] Letter F, lead position is the sixth intercostal space at the left midclavicular line;

[0124] Character C1, lead position is the right end of the sternum, fourth intercostal space;

[0125] Character C2, lead position is the left end of the sternum, the fourth intercostal space;

[0126] Character C4, lead position is the left midclavicular line, fifth intercostal space;

[0127] Character C3, the lead position is between the signal collection electrode 120 indicated by character C2 and the signal collection electrode 120 indicated by character C4, the fifth intercostal space;

[0128] Character C5, the lead position is the left anterior axillary line, and is located on the same horizontal line as the signal collection electrode 120 indicated by character C4;

[0129] Character C6, the lead position is the left mid-axillary line, and is located at the same level as the signal collection electrode 120 indicated by character C4.

[0130] The meanings of the characters 151 set in the lead layer 128 at each position above all use existing standards, mainly referring to the definition and reference connection method of the American standard 12-lead electrode.

[0131] The bioelectric signal collector 100 with ten signal collection electrodes 120 is mainly used in medical scenarios, and more electrocardiogram signals collected are used for accurate disease monitoring and analysis.

[0132] See also Figure 3In one embodiment, the adhesive tape 130 includes a fourth adhesive tape 130, and the fourth adhesive tape 130 is used to fix the two signal collection electrodes 120 on the third branch or at least two adjacent signal collection electrodes 120 on the fifth branch.

[0133] The adhesive tape 130 exposes the signal collection electrode 120 through the third opening 131 , so that the signal collection electrode 120 is attached to the skin surface of the user to be tested by the adhesive tape 130 surrounding the signal collection electrode 120 , thereby improving the pasting efficiency and making the pasting position more accurate.

[0134] In one embodiment, any number of signal collection electrodes 120 share one adhesive patch 130 , and any number of signal collection electrodes 120 share one adhesive patch 130 .

[0135] Specifically, there are other feasible embodiments that allow any number of signal collection electrodes 120 to share one adhesive patch 130 , which should all be within the protection scope of this embodiment.

[0136] See also Figure 8 and Fig.10 In one embodiment, the lead layer 128 and the flexible substrate 110 between any two adjacent first lead portions 122 are curved, specifically, S-shaped or coiled, so that when the signal collection electrode 120 needs to be pasted to a farther place, the lead layer 128 can be stretched and deformed by simply stretching and deforming the flexible substrate 110, thereby enabling the signal collection electrode 120 to be moved to a farther place, thereby improving the applicability of the bioelectric signal collector 100 to users of different body shapes.

[0137] Specifically, the flexible substrate 110 has light-transmitting properties.

[0138] Specifically, the material of the signal collection electrode 120 is one of silver chloride, metal, conductive ink, conductive polymer, and conductive carbon, preferably silver chloride.

[0139] Specifically, the conductive layer 125 is one of metal, conductive ink, conductive polymer, and conductive carbon.

[0140] Specifically, the connection layer 124 is one of conductive ink, conductive polymer, and conductive carbon, preferably conductive carbon.

[0141] The signal collection electrode 120 is made of silver chloride, and the connection layer 124 is made of a conductive material that cannot react with silver chloride. For example, conductive metals are prone to electron transfer reactions with silver chloride, and metal atoms are corroded by chloride ions. The conductive layer 125 can be made of a conductive material that does not chemically react with the connection layer 124, such as conductive ink, conductive polymer, conductive carbon, or conductive metal.

[0142] In one embodiment, the connection layer 124 and the first lead portion 122 are insulated on a side facing away from the flexible substrate 110, thereby preventing the bioelectric signal from being transmitted through the connection layer 124 and the first lead portion 122, ensuring that the ECG signal is only collected by the signal collection electrode 120 through the conductive adhesive layer 140, thereby ensuring the stability of the ECG signal collection.

[0143] In one embodiment, an insulating protective layer is disposed on the side of the connection layer 124 and the first lead portion 122 facing away from the flexible substrate 110. Providing the insulating protective layer includes providing insulating protective oil and / or a flexible protective film on the side of the connection layer 124 and the first lead portion 122 facing away from the flexible substrate 110.

[0144] See also Figure 1 , Figure 2 as well as Figure 3 In one embodiment, the bioelectric signal collector 100 further includes a plurality of release films 150, which are arranged corresponding to the adhesive stickers 130, and are attached to the side of the corresponding adhesive stickers 130 away from the signal collection electrode 120, and cover the conductive adhesive layer 140. In actual use, the operator needs to tear off the release film 150 from the adhesive layer to expose the adhesive stickers 130 and the conductive adhesive layer 140, and then attach the adhesive stickers 130 and the conductive adhesive layer 140 to the corresponding positions of the skin of the user to be tested, thereby improving the pasting efficiency.

[0145] like Figure 2 and Figure 4 Specifically, the adhesive sticker 130 is adhered to the flexible substrate through the adhesive member 164, and the adhesive member 164 is provided with a fourth opening 165, so that the conductive adhesive layer 140 contacts the signal collection electrode 120 through the third opening 131 and the fourth opening 165, so that the signal collection electrode 120 contacts the human skin through the conductive adhesive layer 140, so as to fix the signal collection electrode 120 to the human skin and conduct electricity.

[0146] See also Figure 1 , Figure 2And 3. In one embodiment, the guide section 111 includes a connecting portion 113 and a branching portion 114 connected to each other; a portion of the lead layer 128 is attached to the connecting portion 113, and the other portion is attached to the branching portion 114; one end of the connecting portion 113 is connected to one end of the branching portion 114, and the other end is connected to the attachment sheet 112. Multiple connecting portions 113 are connected. When it is necessary to connect to the signal collection electrode 120, the lead layer 128 is led from the connecting portion 113 to the branching portion 114, and then to the signal collection electrode 120 on the attachment sheet 112, and connected to the signal collection electrode 120, so that the lead layer 128 can extend with the connecting portion 113 and the branching portion 114, making the lead layer 128 more regular, without the need for line arrangement, and only needs to arrange and paste the entire bioelectric signal collector 100 according to the extension of the guide section 111.

[0147] See also Figure 7 In one embodiment, the bioelectric signal collector 100 further includes a sleeve 160, and a plurality of line-joining portions 113 are overlapped and arranged on the sleeve 160; the sleeve 160 is sleeved on the outer periphery of the plurality of line-joining portions 113, and the inner wall of the sleeve 160 abuts against the line-joining portions 113 and can slide along the extension direction of the line-joining portions 113, so that the line-joining portions 113 can be separated according to the different body structures of different users to be tested, thereby extending the length of the branching portion 114 in disguised form, and then the sleeve 160 is slid along the line-joining portion 113, so that the movable and direction-changing branching portion 114 can be attached according to actual conditions, so that the signal collection electrode 120 of the branching portion 114 away from the line-joining portion 113 can be attached to a wider range, thereby improving the applicability of the bioelectric signal collector 100.

[0148] In one embodiment, two adjacent dividing line portions 114 are partially connected.

[0149] Specifically, the branching portion 114 includes a lead-out section 115 and a merging section 116; one end of the lead-out section 115 is connected to one end of the merging section 116, and the other end is connected to the attachment sheet 112; the end of the merging section 116 facing away from the lead-out section 115 is connected to the merging section 113, and any number of adjacent merging sections 116 can be selectively merged and connected, so that the lead layers 128 corresponding to adjacent signal collection electrodes 120 can first be merged and led out at the merging section 116, and then when it is necessary to connect to the signal collection electrode 120, the lead-out section 115 is led out from the merging section 116 to form a separate lead layer 128 connected to the signal collection electrode 120, so that the entire line lead-out is smoother, does not cause line disorder, avoids the need for line regularization during use, and improves the pasting efficiency.

[0150] See also Figure 5 and Fig. 9In one embodiment, the bioelectric signal collector 100 further includes a telescopic sleeve 161, and the lead layer 128 and the flexible substrate 110 between any two adjacent first lead portions 122 are folded in a direction away from the first lead portion 122 and in a direction close to the first lead portion 122 in the thickness direction of the flexible substrate 110 to form a bending structure 162, and the telescopic sleeve 161 is sleeved on the bending structure 162 and abuts against the bending structure 162. When the signal collection electrode 120 needs to be pasted to a farther place, it is only necessary to stretch and deform the flexible substrate 110 on both sides of the telescopic sleeve 161 to stretch and deform the lead layer 128, so that the signal collection electrode 120 can be moved to a farther place, thereby improving the applicability of the bioelectric signal collector 100 to users of different body shapes.

[0151] See also Figure 2 In one embodiment, the wearable physiological monitoring device 200 further includes a defibrillator resistor 163, which is connected to the side of the lead layer 128 facing away from the flexible substrate 110. Specifically, the defibrillator resistor 163 can be set by a printing process. The defibrillator resistor 163 proposed in this embodiment meets the high resistance requirement, and is further suitable for the defibrillator protection function.

[0152] In one embodiment, the outer diameter of the signal collection electrode 120 is 1 to 20 mm, and more preferably, the outer diameter of the signal collection electrode 120 is 3 to 10 mm.

[0153] See also Figure 1 Figure 2 , Figure 3 as well as Figure 5 An embodiment of the present application further provides a wearable physiological monitoring device 200, which includes an electrocardiograph recorder 230 and a bioelectric signal collector 100, wherein the electrocardiograph recorder 230 and the bioelectric signal collector 100 are conductively connected.

[0154] See also Figure 2 In one embodiment, the wearable physiological monitoring device 200 further includes a power supply 220 , which is connected to an end of the lead layer 128 away from the corresponding first lead portion 122 , thereby being able to supply power to the electrocardiograph or the signal collection host 230 .

[0155] See also Figure 2 Specifically, the wearable physiological monitoring device 200 further includes a protective member, which covers the power supply member 220 and is connected to the flexible substrate 110 , thereby achieving the function of protecting the power supply member 220 .

[0156] Embodiment 3:

[0157] An embodiment of the present application provides a method for manufacturing a bioelectric signal collector, such as Fig.12The manufacturing method is used to prepare a bioelectric signal collector 100 with at least three different electrode points. The manufacturing method of the bioelectric signal collector includes:

[0158] Providing a flexible substrate 110;

[0159] Prepare a conductive layer 125 on the surface of the flexible substrate 110;

[0160] Prepare at least three signal collection electrodes 120 at different electrode points on the surface of the flexible substrate 110;

[0161] A connection layer 124 is prepared on the surface of the flexible substrate 110 , and the signal collection electrode 120 , the connection layer 124 and the conductive layer 125 form a series conductive connection. The thickness of the connection layer 124 is processed to be 5 μm-200 μm.

[0162] In this embodiment, a conductive layer 125, a signal collection electrode 120, and a connecting layer 124 are prepared on the flexible substrate 110, respectively. The connecting layer 124, the signal collection electrode 120, and the conductive layer 125 form a series circuit to realize conductive connection between the connecting layer 124, the conductive layer 125, and the signal collection electrode 120. In this embodiment, the resistance of the connecting layer 124 is measured to be 1K to 50K ohms by adjusting the thickness of the connecting layer 124 and / or adjusting the resistivity of the connecting layer 124. Specifically, the resistivity of the connecting layer 124 can be adjusted by adjusting the square resistance or resistivity of the printing paste of the connecting layer 124, or the thickness of the connecting layer 124 is processed by a printing process to be 5μm-200μm to measure the resistance of the connecting layer 124 to be set to 1K to 50K ohms, so as to withstand the strong current caused by the medical defibrillator or electrostatic discharge, and prevent the signal collection host 230 from being destroyed by the strong current. The present embodiment proposes that the connection layer 124 made by the printing process is thin and light, with a thickness not exceeding 200 μm, and is connected in series with the signal collection electrode 120 and the conductive layer 125, and no other lead connection is required, which can replace the traditional defibrillation patch resistor that must be used in the monitoring equipment due to equipment safety requirements. The traditional patch resistor is too large and requires lead connection when used. It is bulky and cannot be used for compact physiological monitoring equipment applications. In particular, during the defibrillation treatment process, the patient needs to withstand multiple defibrillation strong currents to restore heart function. If the connection layer 124 is not provided, the defibrillation energy will enter the signal collection host 230 through the signal collection electrode 120 and the conductive layer 125, causing the signal collection host 230 to be destroyed by the strong current. The resistance value of the connection layer 124 provided in the present embodiment is measured to be 1K~50K ohms, which can withstand multiple strong current shocks. After the cardiac defibrillation treatment is completed, the signal collection host 230 can still be used normally to collect and record bioelectric signals, thereby enhancing the reliability of the equipment. If the resistance of the connection layer 124 is determined to be less than 1K ohm or greater than 50K ohm, signal noise will be generated, affecting the accuracy of bioelectric signal collection.

[0163] The printing paste provided in this embodiment may be a resin material.

[0164] In this embodiment, the factors that affect the energy leakage of the printing paste selected for the connection layer 124 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 connection layer 124, and the resistance value.

[0165] In one embodiment, in order to provide a lighter wearing experience, the connection layer 124 is printed on the signal collection electrode 120 and the conductive layer 125 using a printing process, which will not affect the wearing weight and is convenient for the user to be tested to wear it for a long time without interruption. The long-term monitoring of bioelectric signals, especially electrocardiogram, can help the user to be tested to more comprehensively monitor the health of the heart or potential diseases. Moreover, in a high-current treatment environment, such as the strong defibrillation current or the high voltage of the electric knife applied to the user to be tested, it will be conducted to the signal collection host 230 through the conductive layer 125, causing the host to be damaged by the strong current. Therefore, the biosignal collector 100 provided in the embodiment of the present application not only takes into account the lightness of wearing and the convenience of the user to be tested to wear it for a long time without interruption, but also takes into account the use requirements of the monitoring scene, ensuring that the bioelectric signal collector 100 collects accurate bioelectric signals in real time, and the equipment is safer and more reliable.

[0166] The bioelectric signal collector 100 is worn on the skin of the user to be tested to obtain bioelectric signals. The signal collection host 230 is installed on the bioelectric signal collector 100 to realize signal collection and storage recording. Multiple signal collection electrodes 120 collect bioelectric signals at least three different positions, and transmit the bioelectric signals to the signal collection host 230 through the conductive layer 125. The present application proposes that the signal collection electrode 120 and the conductive layer 125 are conductively connected through the connecting layer 124 to ensure that the connecting layer 124 suppresses the influence of strong current on the bioelectric signals collected by the bioelectric signal collector 100 on the basis of accurately collecting bioelectric signals. In this embodiment, the conductive layer 125, the signal collection electrode 120 and the connecting layer 124 can be printed on the flexible substrate 110 respectively by a printing process, and the conductive layer 125 and the signal collection electrode 120 are conductively connected through the connecting layer 124 to construct a more lightweight wearable product. Of course, the conductive layer 125, the signal collection electrode 120, and the conductive materials of the connecting layer 124 can also be adhered to the flexible substrate 110 respectively, and then the conductive materials can be removed using tools such as laser engraving or etching to obtain the conductive layer 125, the signal collection electrode 120, and the connecting layer 124, without limitation here.

[0167] Specifically, the present solution proposes to connect the conductive layer 125 and the signal collection electrode 120 respectively through the connecting layer 124 to achieve conductive connection, and the connecting layer 124 connects the conductive layer 125 and the signal collection electrode 120 respectively to construct a series circuit. The flexible substrate 110 can be made of PET sheet, which is more convenient to use and easier to prepare the connecting layer 124 and the conductive layer 125. The bioelectric signal collected by the signal collection electrode 120 is transmitted to the conductive layer 125 via the connecting layer 124. Even if the bioelectric signal carrying a strong current passes through the connecting layer 124, most of the energy is suppressed by the connecting layer 124 and will not be conducted to the signal collection host 230 by the conductive layer 125. Therefore, the signal collection host 230 records the physiological signal processed by the connecting layer 124. By setting the connecting layer 124, there is no need to introduce an additional defibrillation resistor device, which improves the suppression of energy leakage while reducing the product space size of the bioelectric signal collector 100, which is conducive to building a lighter bioelectric signal collector 100 and enriching and expanding the product application scenarios.

[0168] Specifically, the flexible substrate 110 can be a base formed of a flexible material, and can be a flexible material with the advantages of being light, thin, transparent, flexible and stretchable. For example, the flexible substrate 110 can be polyvinyl alcohol (PVA), polyester (PET), polyimide (PI), polyethylene naphthalate (PEN), etc.; as an example, a PET film is used as the flexible substrate 110 of the bioelectric signal collector, and a conductive layer 125 and a signal collection electrode 120 are arranged on the flexible substrate 110.

[0169] The manufacturing method provided in this embodiment also includes:

[0170] Composite forming of the conductive layer 125 and the flexible substrate 110;

[0171] The conductive pattern of the conductive layer 125 is planned according to the design requirement of providing at least three signal collection electrodes 120 on the flexible substrate 110;

[0172] The conductive layer 125 is divided into a first lead portion 122, a lead layer 128 and a second lead portion 121 which are conductively connected; the first lead portion 122 is conductively connected to the signal collection electrode 120 through the connection layer 124; the second lead portion 121 is used for conductively connecting to the signal collection motor 230;

[0173] The connection layer 124 and the first lead portion 122 are connected to form a first connection area;

[0174] The connection between the signal collection electrode 120 and the connection layer 124 forms a second connection area;

[0175] The first connection region is electrically connected to the second connection region.

[0176] In this embodiment, in order to improve the accuracy of signal acquisition, the signal acquisition electrode 120 can be made of precious metals, such as silver, the first lead portion 122 can be made of at least one of conductive metals, conductive inks, conductive polymers or conductive carbon, and the connecting layer 124 can be made of at least one of conductive inks, conductive polymers and conductive carbon. It can be understood that, for example, the first lead portion 122 is made of conductive metals, such as aluminum, and the connecting layer 124 is made of conductive ink, but not conductive metals, because the signal acquisition electrode 120 made of silver chloride will react with the connecting layer 1247 made of conductive metal to increase signal interference. The connecting layer 124 and the first lead part 122 form a first connecting area, and the connecting layer 124 and the signal collection electrode 120 form a second connecting area. The first connecting area and the second connecting area are conductively connected, and the signal collection electrode 120 and the first lead part 122 are conductively connected through the first connecting area and the second connecting area. The conductive layer 125, the signal collection electrode 120 and the connecting layer 124 are designed separately to adapt to more usage environments and preparation requirements, thereby improving the applicability of the bioelectric signal collector 100. Printing or coating processes can be used to make the connection between the connecting layer 124 and the signal collection electrode 120 and the first lead part 122 smoother and more uniform to ensure the lead quality.

[0177] In this embodiment, the first lead portion 122, the lead layer 128 and the second lead portion 121 can also be integrally formed. The signal collection electrode 120, the connection layer 124, the first lead portion 122, the second lead portion 121 and the lead layer 128 are printed on the flexible substrate 110 by printing, thereby ensuring that the coating of the signal collection electrode 120, the connection layer 124, the first lead portion 122, the second lead portion 121 and the lead layer 128 is uniform, and the signal transmission can be relatively stable. The bioelectric signal collector 100 also includes a bracket 210, and the second lead part 121 is exposed and installed on the bracket 210. When the signal collection host 230 is installed on the bracket 210, the signal collection host 230 is conductively connected to the second lead part 121, one end of the lead layer 128 is conductively connected to the first lead part 122, and the other end is conductively connected to the second lead part 121. The bioelectric signal is transmitted to the signal collection host 230 through the signal collection electrode 120, the first lead part 121, the first connection area, the lead layer 128, the second connection area and the second lead part 121, thereby achieving the purpose of signal transmission.

[0178] In one embodiment, the material for preparing the conductive layer 125 includes at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material;

[0179] In one embodiment, the material for preparing the connection layer 124 includes at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material;

[0180] A connection layer 124 is formed on the surface of the first lead portion 122 and the signal collection electrode 120 by printing or coating process using at least one of conductive ink, conductive polymer, conductive carbon powder and metal material.

[0181] In one embodiment, the signal collection electrode 120 and the first lead part 122 are formed on the same layer of the flexible substrate 110; the first lead part 122 is provided to form a first opening 127, the signal collection electrode 120 is provided in the first opening 127, and the signal collection electrode 120 is conductively connected to the first lead part 122 through the connection layer 124, which can reduce the overall size of the physiological electrical signal collector 100. In addition, the processing difficulty of the connection layer 124 is reduced, and the product yield rate is improved. It is further understood that the connection layer 124 can conductively connect the first lead part 122 and the signal collection electrode 120 at any angle. The signal collection electrode 120 is arranged in the same layer as the first lead portion 122, that is, the first lead portion 122 is first printed on the flexible substrate 110, and then the signal collection electrode 120 is printed in the same layer, and the connection layer 124 is printed on the surface of the signal collection electrode 120. The connection layer 124 is used to connect the first lead portion 122 and the signal collection electrode 120 area respectively, so as to make it smoother and prevent the uneven printing of the connection layer 124 from affecting the accuracy and stability of signal collection. The gap between the signal collection electrode 120 and the first lead portion 122 forms an isolation portion, which is used to isolate the first lead portion 122 from direct contact with the signal collection electrode 120. The isolation portion can be an air barrier or an insulating layer. The purpose of the isolation portion is to prevent the conductive material of the first lead portion 122 from mixing with the conductive material of the signal collection electrode 120 to cause a chemical reaction, thereby affecting the signal collection accuracy of the signal collection electrode 120. Therefore, for the isolation part provided in the embodiment of the present application, it is possible to use different conductive materials to prepare the signal collection electrode 120 and the first lead part 122 without affecting the collection and transmission of bioelectric signals.

[0182] In one embodiment, the cross-sectional shape of the signal collection electrode 120 is set to be circular, the cross-sectional shape of the connection layer is annular, and the ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is greater than or equal to 0.1 and less than 1. Therefore, it can ensure that the signal collection electrode 120 is in absolute contact with the connection layer 124, and ensure that the process processing error avoids the uneven connection between the signal collection electrode 120 and the connection layer 124, which is prone to disconnection and other problems, thereby causing uneven signal transmission. The ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is 0.1, which prevents the area of ​​the connection layer 124 from being too large to affect signal transmission, resulting in obstruction of bioelectric signal transmission, such as long path, high resistance and other problems, thereby ensuring that the signal collection electrode 120 collects bioelectric signals more accurately, and the first lead part 122 transmits bioelectric signals more stably. More preferably, the cross-sectional shape of the signal collection electrode 120 is circular, and the diameter size range of the signal collection electrode 120 can be selected from 1 to 20 mm. The signal collection electrode 120, the first lead portion 122 and the connecting layer 124 are better controlled and processed to facilitate the collection and transmission of bioelectric signals.

[0183] In one embodiment, a connection layer is provided on the side of the signal collection electrode 120 close to the skin of the user to be tested, and the connection layer 124 is provided with a second opening 126, and the second opening 126 is used to expose at least part of the conductive area of ​​the signal collection electrode 120, so that the conductive area of ​​the signal collection electrode 120 can be in direct contact with the skin of the human body to be tested, thereby ensuring that the signal collection electrode 120 can completely collect the human body bioelectric signal. The cross-sectional shape of the connection layer 124 is annular. The annular connection layer 124 ensures uniform connection with the signal collection electrode 120 and the first lead portion 122, respectively, to ensure the continuity of signal collection.

[0184] In one embodiment, a connection layer 124 is provided on the side of the signal collection electrode 120 away from the skin of the user to be tested, and the connection layer 124 covers at least a portion of the signal collection electrode 120, ensuring that the connection layer 124 is more firmly conductively connected to the signal collection electrode 120 and the first lead portion 122, respectively. Since the connection layer 124 is not in direct contact with the skin of the human body to be tested, it will not affect the signal collection electrode 120 to collect bioelectric signals, ensuring that the signal collection electrode 120 can stably contact the skin of the human body to be tested, ensuring the stability of signal collection. The cross-sectional shape of the connection layer 124 is circular. Through this design, the connection layer 124, the signal collection electrode 120, and the first opening of the first lead portion 122 are designed to be circular, and the overall product form design style is unified, which has more aesthetic value.

[0185] A flexible protective film is formed on the protective layer. The protective layer may be a protective layer made of insulating oil. The flexible protective film may be a protective film for insulation and having flexible properties, and may be made of a polymer material, such as polyethylene, polypropylene, etc. The flexible protective film can achieve the pressure resistance of the protective layer and prevent interference with the collection of ECG signals, so that the ECG signals can be effectively collected through the thin and flexible wearable physiological monitoring device 200, reducing the thickness of the device for collecting ECG signals.

[0186] Optionally, a die-cutting process may be further used to die-cut the flexible substrate 110, signal collection electrode 120, conductive layer 125, conductive connection point, protective layer, flexible protective film, etc. according to a preset pattern to obtain a printed die-cut finished product.

[0187] In one embodiment, a protective layer is formed on the surface of the conductive layer 125; the protective layer may cover the connection layer 124 or may not cover the connection layer 124, and the protective layer may not cover the signal collection electrode 120. In some specific embodiments, by forming a protective layer on the conductive layer 125 and forming a flexible protective film on the protective layer, the pressure resistance of the protective layer can be achieved, and interference with the collection of the electrocardiogram signal can be prevented, so that the electrocardiogram signal can be effectively collected through the thin and flexible wearable physiological monitoring device 200, and the thickness of the device for collecting the electrocardiogram signal can be reduced.

[0188] In one embodiment, an insulating protective layer is disposed on the side of the connection layer 124 and the first lead portion 122 facing away from the flexible substrate 110. Providing the insulating protective layer includes providing insulating protective oil and / or a flexible protective film on the side of the connection layer 124 and the first lead portion 122 facing away from the flexible substrate 110.

[0189] For example, a printing process can be used to form a layer of insulating oil on the conductive layer 125 as an insulating protective layer. A flexible protective film can be formed on the protective layer as another insulating protective layer. As an example, a finished flexible protective film can be directly covered on the protective layer as an insulating protective layer.

[0190] In some specific embodiments, by forming a protective layer on the conductive layer 125 and forming a flexible protective film on the protective layer, the pressure resistance of the protective layer can be achieved and interference with the collection of ECG signals can be prevented, so that effective collection of ECG signals can be achieved through a thin and flexible wearable physiological monitoring device 200, and the thickness of the device for collecting ECG signals can be reduced.

[0191] Embodiment 4:

[0192] An embodiment of the present application provides another method for manufacturing a bioelectric signal collector, such as Fig.13The manufacturing method is used to prepare a bioelectric signal collector 100 with at least three different electrode points. The manufacturing method of the bioelectric signal collector includes:

[0193] Providing a flexible substrate 110;

[0194] A conductive layer 125 is prepared on the surface of the flexible substrate 110 using a first conductive material.

[0195] On the surface of the flexible substrate 110, a second conductive material is used to prepare at least three signal collection electrodes 120 at different electrode points, and the second conductive material is different from the first conductive material;

[0196] An isolation portion is formed between the conductive layer 125 and the signal collection electrode 120, and the conductive layer 125 is isolated from direct contact with the signal collection electrode 120 by the isolation portion;

[0197] A connection layer 124 is prepared on the surface of the flexible substrate 110 using a third conductive material, and the conductive layer 125 is conductively connected to the signal collection electrode 120 through the connection layer 124; the third conductive material is different from the first conductive material and the second conductive material;

[0198] The connection layer 124 and the conductive layer 125 form a first connection area, the connection layer 124 and the signal collection electrode 120 form a second connection area, the first connection area and the second connection area are electrically connected, and the second conductive material in the second connection area does not chemically react with the third conductive material, and the first conductive material in the first connection area does not chemically react with the third conductive material, so as to ensure that the signal collection electrode 120 collects signals accurately.

[0199] In one embodiment, the first conductive material includes at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material;

[0200] The manufacturing method of the bioelectric signal collector includes: composite molding of a flexible substrate 110 and a conductive layer 125 made of at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material;

[0201] A conductive pattern of the conductive layer 125 is planned according to the spatial distribution of at least three different electrode points;

[0202] The conductive layer 125 is processed according to the conductive pattern to obtain the first lead portion 122, the lead layer 128 and the second lead portion 121; the first lead portion 122 is conductively connected to the signal collection electrode 120 through the connecting layer 124;

[0203] The first lead portion 122 is electrically connected to the second lead portion 121 through the lead layer 128 .

[0204] In this embodiment, the first lead portion 122 is connected to the signal collection electrode 120 through the conductive layer 125 , and accurate and reliable signal transmission between the first lead portion 122 and the signal collection electrode 120 is ensured. The bioelectric signal collector 100 also includes a bracket 210, and the conductive layer 125 includes a second lead portion 121 and a lead layer 128. The second lead portion 121 is fixed on the bracket 210. When the signal collection host 230 is installed on the bracket 210, the signal collection host 230 is conductively connected to the second lead portion 121. One end of the lead layer 128 is conductively connected to the first lead portion 122, and the other end is conductively connected to the second lead portion 121, so that the connection between the bioelectric signal collector 100 and the signal collection host 230 can be achieved through the bracket 210. The bioelectric signal is transmitted to the signal collection host 230 through the signal collection electrode 120, the connection layer 124, the first connection area, and the second connection area. Preferably, the signal collection host 230 is detachably connected to the bracket 210, such as a snap connection, a threaded installation, a concave-convex combination, etc., or a gripper is provided on the bracket 210 to be combined and installed with the signal collection host 230. The combined installation or separate disassembly methods are not listed one by one in this embodiment.

[0205] Specifically, the connection layer 124, the signal collection electrode 120 and the conductive layer 125 form a series circuit. In this embodiment, the resistance of the connection layer 124 is determined to be 1K to 50K ohms by adjusting the thickness of the connection layer 124 and / or adjusting the resistivity of the connection layer 124.

[0206] The flexible substrate 110 may be a base formed of a flexible material, and may be a flexible material having the advantages of being light, thin, transparent, flexible, and stretchable. For example, the flexible substrate 110 may be polyvinyl alcohol (PVA), polyester (PET), polyimide (PI), polyethylene naphthalate (PEN), etc. As an example, a PET film is used as the flexible substrate 110 of the bioelectric signal collector, and a conductive layer 125 and a signal collection electrode 120 are arranged on the flexible substrate 110.

[0207] In one embodiment, the third conductive material includes at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material;

[0208] A connection layer 124 is formed on the surface of the first lead portion 122 and the signal collection electrode 120 by printing or coating process using at least one of conductive ink, conductive polymer, conductive carbon powder and metal material.

[0209] In this embodiment, the signal collection electrode 120 can use precious metals, such as silver, the first lead portion 122 can be made of at least one of conductive metals, conductive inks, conductive polymers or conductive carbon, and the connecting layer 124 can be made of at least one of conductive inks, conductive polymers and conductive carbon. It can be understood that, for example, the first lead portion 122 is made of conductive metals, such as aluminum, and the connecting layer 124 is made of conductive ink, but not conductive metals. The connecting layer 124 and the first lead part 122 form a first connecting area, and the connecting layer 124 and the signal collection electrode 120 form a second connecting area. The first connecting area and the second connecting area are conductively connected. The connecting layer 124 can conductively connect the signal collection electrode 120 and the first lead part 122 through the first connecting area and the second connecting area. The conductive layer 125, the signal collection electrode 120 and the connecting layer 124 are designed separately to adapt to more usage environments and preparation requirements, thereby improving the applicability of the bioelectric signal collector 100. The printing or coating process makes the connection between the connecting layer 124 and the signal collection electrode 120 and the first lead part 122 smoother and more uniform to ensure the lead quality.

[0210] In one embodiment, the second conductive material includes silver chloride; the method for manufacturing the bioelectric signal collector includes: preparing a silver chloride layer at corresponding positions of at least three different electrode points; attaching the silver chloride layer to the skin of a user to be tested through a conductive gel patch to collect the bioelectric signals of the user to be tested.

[0211] In one embodiment, the first lead portion 122 is etched to form a first opening 127, and a silver chloride layer is formed in the first opening 127. The silver chloride layer is arranged in the same layer as the first lead portion 122, that is, the first lead portion 122 is first printed on the flexible substrate 110, and then the signal collection electrode 120 is printed in the same layer, and the connection layer 124 is printed on the surface of the signal collection electrode 120. In addition, the connection layer 124 connects the first lead portion 122 and the signal collection electrode 120 area respectively, which is more flat, and prevents the connection layer 124 from printing unevenly, resulting in accuracy and stability during the signal collection process. The gap between the silver chloride layer and the first lead portion 122 forms an isolation portion. Since silver chloride and other metal conductive materials will undergo a chemical replacement reaction, the chemical reaction will directly affect the accuracy of signal collection. The isolation portion solution provided in the embodiment of the present application can reduce the overall size of the physiological electrical signal collector 100. The signal collection electrode 120 is conductively connected to the first lead portion 122 through the connection layer 124, which greatly reduces the plane size of the physiological electrical signal collector 100. Moreover, the processing difficulty of the connection layer 124 is reduced, and the product yield is improved. It is further understood that the connection layer 124 can connect the first lead part 122 and the signal collection electrode 120 at any angle. The isolation part is used to isolate the conductive layer 125 from the signal collection electrode 120, ensuring that the signal collection electrode 120 and the first lead part 122 using different conductive materials will not affect signal collection due to material contact and mixing. In addition, the first lead part 122 is conductively connected to the signal collection electrode 120 through the conductive layer 125, and it is ensured that the first lead part 122 accurately and reliably transmits the bioelectric signal collected by the signal collection electrode 120.

[0212] In one embodiment, the cross-sectional shape of the etched silver chloride layer is circular, the cross-sectional shape of the etched connection layer 124 is annular, and the ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is greater than or equal to 0.1 and less than 1. In this embodiment, the ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is designed to be less than 1, so that it can ensure that there is a sufficient gap between the signal collection electrode 120 and the first lead part 122, thereby preventing the signal collection electrode 120 and the first lead part 122 from being directly connected or even overlapped due to a slight offset when preparing the signal collection electrode 120 and the first lead part 122, thereby causing uneven signal transmission. The ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is greater than 0.1, which prevents the area of ​​the connection layer 124 from being too large to affect signal transmission, resulting in obstruction of bioelectric signal transmission, such as long path, large resistance, etc., thereby ensuring that the signal collection electrode 120 collects bioelectric signals more accurately and the first lead part 122 transmits bioelectric signals more stably. More preferably, the cross-section of the signal collection electrode 120 is circular, and the diameter of the signal collection electrode 120 can be selected from 1 to 20 mm. The signal collection electrode 120 and the first lead portion 122 and the connecting layer 124 are better controlled and processed to facilitate the collection and transmission of bioelectric signals.

[0213] In one embodiment, the diameter of the silver chloride layer is 1 to 10 mm. More preferably, the cross-sectional shape of the signal collection electrode 120 is circular, and the diameter of the signal collection electrode 120 made of silver chloride can be selected from 1 to 20 mm. The signal collection electrode 120 and the corresponding first lead portion 122 and the connecting layer 124 are better controlled and processed to facilitate the collection and transmission of bioelectric signals.

[0214] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0215] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A bioelectric signal collector, characterized in that: The bioelectric signal collector (100) is used to be worn on the skin of a user to be tested to obtain bioelectric signals; the bioelectric signal collector (100) comprises a flexible substrate (110), on which a conductive layer (125) and a plurality of signal collection electrodes (120) are printed, and the plurality of signal collection electrodes (120) are used to collect bioelectric signals; the conductive layer (125) is in isolated contact with the signal collection electrodes (120); and a connecting layer (124) is printed on the flexible substrate (110), and the conductive layer (125) is conductively connected to the signal collection electrodes (120) via the connecting layer (124).

2. The bioelectric signal collector according to claim 1, characterized in that: The connection layer (124) is prepared using a third conductive material, and the connection layer (124) is printed on the signal collection electrode (120) and the conductive layer (125) using a printing process.

3. The bioelectric signal collector according to claim 2, characterized in that: The conductive layer (125) is prepared using a first conductive material, and the connecting layer (124) contacts the conductive layer (125) to form a first connecting region. In the first connecting region, the first conductive material contacts the third conductive material without chemical reaction.

4. The bioelectric signal collector according to claim 3, characterized in that: The signal collection electrode (120) is prepared using a second conductive material different from the first conductive material. The connection layer (124) contacts the signal collection electrode (120) to form a second connection region. In the second connection region, the second conductive material contacts the third conductive material without chemical reaction. The first connection region is electrically connected to the second connection region through the connection layer (124).

5. The bioelectric signal collector according to claim 4, characterized in that: The second conductive material includes at least one of silver, a silver-silver chloride mixture, a carbon-silver mixture, a carbon-silver-silver chloride mixture, a titanium nitride-silver mixture, or a titanium nitride-silver-silver chloride mixture.

6. The bioelectric signal collector according to any one of claims 3 to 5, characterized in that: The first conductive material is at least one of conductive metal, conductive ink, conductive polymer or conductive carbon.

7. The bioelectric signal collector according to any one of claims 2 to 5, characterized in that: The third conductive material includes at least one of conductive ink, conductive polymer, conductive carbon powder and metal material.

8. The bioelectric signal collector according to claim 4 or 5, characterized in that: The third conductive material is different from the first conductive material and the second conductive material.

9. The bioelectric signal collector according to claim 1, characterized in that: An isolation portion is provided between the conductive layer (125) and the signal collection electrode (120), and the isolation portion is used to isolate the conductive layer (125) from contact with the signal collection electrode (120).

10. The bioelectric signal collector according to claim 9, characterized in that: The conductive layer (125) comprises a first lead portion (122), the first lead portion (122) is provided with a first opening (127), the signal collection electrode (120) is arranged in the first opening (127), and the connection layer (124) is arranged at the first opening (127).

11. The bioelectric signal collector according to claim 10, characterized in that: The gap area between the first lead portion (122) and the signal collection electrode (120) constitutes the isolation portion.

12. The bioelectric signal collector according to claim 10, characterized in that: The first lead portion (122) is made of a conductive metal, and the connection layer (124) is made of a non-conductive metal.

13. A bioelectric signal collector, characterized in that: The bioelectric signal collector (100) comprises a flexible substrate (110), a conductive layer (125) and a plurality of signal collection electrodes (120) are printed on the flexible substrate (110), a connection layer (124) is printed on the surface of the signal collection electrode (120), the conductive layer (125) is conductively connected to the signal collection electrode (120) via the connection layer (124), wherein the conductive layer (125) is made of a first conductive material, and the signal collection electrode (120) is made of a second conductive material different from the first conductive material.

14. The bioelectric signal collector according to claim 13, characterized in that: The connection layer (124) is prepared using a third conductive material, the third conductive material being different from the first conductive material and the second conductive material.

15. The bioelectric signal collector according to claim 14, characterized in that: The third conductive material does not chemically react with the second conductive material when in contact with the third conductive material, and the third conductive material does not chemically react with the first conductive material when in contact with the third conductive material.

16. The bioelectric signal collector according to any one of claims 13 to 15, characterized in that: The conductive layer (125) comprises a first lead portion (122), and the connection layer (124) and the first lead portion (122) form a first connection region.

17. The bioelectric signal collector according to claim 16, characterized in that: The connection layer (124) and the signal collection electrode (120) form a second connection region, and the first connection region is electrically connected to the second connection region.

18. The bioelectric signal collector according to claim 17, characterized in that: The second conductive material includes at least one of silver, a silver-silver chloride mixture, a carbon-silver mixture, a carbon-silver-silver chloride mixture, a titanium nitride-silver mixture, or a titanium nitride-silver-silver chloride mixture.

19. The bioelectric signal collector according to claim 18, characterized in that: The first conductive material is at least one of conductive metal, conductive ink, conductive polymer or conductive carbon.

20. The bioelectric signal collector according to claim 19, characterized in that: The third conductive material includes at least one of conductive ink, conductive polymer, conductive carbon powder and metal material.

21. The bioelectric signal collector according to claim 16, characterized in that: The first lead portion (122) is made of a conductive metal, and the connection layer (124) is made of a non-conductive metal.

22. The bioelectric signal collector according to claim 16, characterized in that: An isolation portion is provided between the signal collection electrode (120) and the first conductive portion (122), and the isolation portion is used to prevent the conductive material of the first lead portion (122) from mixing with the conductive material of the signal collection electrode (120) to cause a chemical reaction.

23. The bioelectric signal collector according to claim 22, characterized in that: The connection layer (124) is arranged at the edges of the signal collection electrode (120) and the first lead portion (122), and the connection layer (124) is not electrically connected to the isolation portion.

24. The bioelectric signal collector according to claim 23, characterized in that: The isolation portion is an air barrier or an insulating layer.

25. A bioelectric signal collector, characterized in that: The bioelectric signal collector (100) comprises a flexible substrate (110), on which a conductive layer (125) and a plurality of signal collection electrodes (120) are arranged, and the conductive layer (125) is used to transmit the bioelectric signal to a signal collection host (230); a connection layer (124) is also printed on the flexible substrate (110), and the connection layer (124) is used to suppress energy from being transmitted to the signal collection host (230) via the conductive layer 125, and the conductive layer (125) and the signal collection electrodes (120) are conductively connected via the connection layer (124).

26. The bioelectric signal collector according to claim 25, characterized in that: The connection layer (124) is arranged on a side of the signal collection electrode (120) close to the skin of the user to be tested, and the connection layer (124) is provided with a second opening (126), and the second opening (126) is used to expose at least part of the conductive area of ​​the signal collection electrode (120).

27. The bioelectric signal collector according to claim 25, characterized in that: The connection layer (124) is arranged on a side of the signal collection electrode (120) away from the skin of the user to be measured, and the connection layer (124) covers at least a portion of the signal collection electrode (120).

28. The bioelectric signal collector according to claim 26 or 27, characterized in that: The thickness of the connecting layer (124) is 5 μm-200 μm.

29. A wearable physiological monitoring device, characterized in that: The wearable physiological monitoring device (200) comprises a bioelectric signal collector (100) according to any one of claims 1 to 28 and a signal collection host (100).

30. A physiological monitoring system, characterized in that: The bioelectric signal collector (100) comprises any one of claims 1 to 28, or the wearable physiological monitoring device (200) as described in claim 29.

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